GEMINI GEMINI COMBO Compact Microplate Processor 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Instructions for use
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 1 of 425 Edition: Date: September 2017 Part No.: 15100013290 Revision: 10
Software: GEMINI / GEMINI COMBO: User Software from Version 2.03
Original Document 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
We reserve the right to make changes in the course of technical development without previous notice.
Copyright © 2017, STRATEC Biomedical AG. All rights reserved.
STRATEC Biomedical AG Gewerbestraße 37 75217 Birkenfeld, GERMANY
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of STRATEC Biomedical AG.
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 2 of 425 Known Limitations
KL Known Limitations
Load: Plates If the order of plates within a worklist is changed, the order of the wash buffer bottles and Bottles can change as well. Always check for the correct positioning of the wash buffer Order bottles before starting the worklist from the load dialog. Manual assigned wash buffer positions or blind reagent positions (in the dilution areas) have to be checked carefully before starting the worklist by pressing the "Start" button of the Load window. Assigned positions can change if the order of the plates has been changed by "Edit Panel".
Loading Bay In case a pipettor error occurred, do not remove any racks from the instrument even if the LED is flashing. If this rack is still required the accurate tracking might not be working exact anymore.
Movable After a crash of the movable scanner with an obstacle (and the option "Abort" is Barcode selected), consecutive move problems can occur. Turn off the scanner and then set Scanner the scanner focus on the required lane. In case a positioning error of the scanner unit occurs after a crash, the button "Abort worklist" in this case only aborts the current step and actually follows an "Abort" logic.
Unload Plate If a plate in a larger worklist is aborted during a shake step on the plate transport, wait to unload the plate until the shaking is finished. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 KL-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 3 of 425 Known Limitations
Intentionally left blank. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
KL-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 4 of 425 Table of Contents
KL Known Limitations...... KL-1 1 Introduction ...... 1-1 1.1 Intended Use ...... 1-1 1.1.1 Operator Requirements ...... 1-2 1.1.2 Good Laboratory Practice...... 1-2 1.1.3 Limited Warranty...... 1-2 1.2 Typographical Conventions ...... 1-3 1.2.1 Display of Warnings and Notes...... 1-3 1.2.2 Used Warning Symbols ...... 1-4 1.2.3 Other Symbols ...... 1-5 1.2.4 Special Types ...... 1-5 1.3 Safety Instructions...... 1-6 1.3.1 General Safety ...... 1-6 1.3.2 Electrical Safety ...... 1-8 1.3.3 Laser Safety ...... 1-9 1.3.4 Mechanical Safety ...... 1-10 1.3.5 Biological Safety ...... 1-11 1.4 Positions of Safety Labels and Type Label...... 1-12 1.4.1 General Warning Labels ...... 1-12 1.4.2 Biological Hazard Labels ...... 1-12 1.4.3 Electrical Hazard Labels ...... 1-12 1.4.4 Laser Hazard Labels...... 1-12 1.4.5 Cut Injury Hazard Labels ...... 1-13 1.4.6 Type Label ...... 1-13 1.5 Radio Interferences ...... 1-14 1.6 Abbreviations...... 1-15 2 Instrument Description ...... 2-1 2.1 Instrument Overview ...... 2-2 2.1.1 Instrument...... 2-2 2.1.2 Liquid Connections ...... 2-5 2.1.3 Electrical Connections ...... 2-7 2.2 Use of the Modules ...... 2-8 2.2.1 Microplates in the Plate Transport ...... 2-8 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2.2.2 Disposable Tip Racks ...... 2-10 2.2.3 Dilution Plates, Archive Plates, and Large Reagent Bottles . . . 2-11 2.2.4 Loading Bay for Samples and Reagents ...... 2-14 2.2.5 Washer and Wash Buffers ...... 2-18 2.2.6 Waste Container ...... 2-18 2.2.7 Incubator and Stacker...... 2-19 2.2.8 Photometer ...... 2-19 2.2.9 Pipettor and Diluter Pump...... 2-20 2.2.10Touch Screen ...... 2-22 2.2.11IFA Bay, IFA Trays and IFA Slides (optional)...... 2-23 2.3 Accessories and Consumables ...... 2-25 2.4 Principles of Methods ...... 2-26 2.4.1 Absorbance Photometry ...... 2-26 2.4.2 Bichromatic Measurement ...... 2-26
Gemini - Instructions for use manual - Rev. 10 TOC-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 5 of 425 3 Basic Functions ...... 3-1 3.1 Menus and Symbols ...... 3-1 3.2 Open/Load ...... 3-10 3.3 Save ...... 3-11 3.4 Print on the Printer ...... 3-13 3.4.1 Print ...... 3-13 3.4.2 Print Setup ...... 3-14 3.4.3 Print Preview ...... 3-15 3.5 Online Keyboard ...... 3-16 3.6 Selection Dialog ...... 3-16 4 Use of the Instrument ...... 4-1 4.1 Safety and Hints ...... 4-1 4.2 Brief Sequence Plan ...... 4-2 4.3 Start-up ...... 4-3 4.3.1 Registered Users ...... 4-4 4.3.2 Unknown User Name / Unregistered Users...... 4-4 4.3.3 First-Time Use (Password Registration) ...... 4-5 4.3.4 Incorrect Password ...... 4-6 4.3.5 Successive Users ...... 4-6 4.3.6 Users with Restricted Access Rights ...... 4-7 4.4 Load Samples and Assign Assays ...... 4-8 4.4.1 Load Samples ...... 4-8 4.4.2 Assign Assays to the Samples (Tabular Sample Editor). . 4-10 4.4.3 Import Sample Data and Linked Assays through Host Connection4- 13 4.5 Create a Worklist...... 4-14 4.6 Lot Specific Values ...... 4-15 4.7 The Worklist Window ...... 4-18 4.7.1 Worklist Parameters...... 4-20 4.7.2 Schedule ...... 4-21 4.7.3 Plate Layouts ...... 4-23 4.7.4 Reagent Requirements ...... 4-24 4.7.5 System Status ...... 4-26 4.7.6 Active Event Log ...... 4-27 4.7.7 Job List ...... 4-30 4.7.8 Sample Archiving Information ...... 4-30 4.8 Start Worklist...... 4-31 4.8.1 Load Dialog ...... 4-33 4.8.2 Load Samples ...... 4-36 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 4.8.3 Load Reagents ...... 4-39 4.8.4 Load Unstable Reagents ...... 4-42 4.8.5 Load Dilution Plates...... 4-44 4.8.6 Load Tip Racks ...... 4-45 4.8.7 Fill Wash Buffer and Clean Fluid ...... 4-48 4.8.8 Fill System Liquid...... 4-49 4.8.9 Load Test Plates ...... 4-49 4.9 Processing the Run ...... 4-51 4.9.1 Pre-Run Checks ...... 4-52 4.9.2 Steps of a Typical Test Run ...... 4-55 4.9.3 What You Can Do While the Run is Being Processed...... 4-56 4.9.4 Instrument/Pipetting Errors ...... 4-57 4.9.5 The System Paused Dialog ...... 4-57 4.9.6 Pipetting Errors/Manual Pipetting ...... 4-59 4.9.7 Emergency Stop/Cancel a Run ...... 4-60 4.10 End of Run/Result Report Window ...... 4-61
TOC-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 6 of 425 4.10.1Result Reports ...... 4-63 4.10.2Result Interpretation ...... 4-65 4.10.3Save/Open the Result Report...... 4-68 4.10.4Print the Result Report ...... 4-68 4.10.5Export the Results ...... 4-69 4.11 Unloading ...... 4-70 4.11.1 Unload Test Plates ...... 4-70 4.11.2 Unload Sample Racks ...... 4-72 4.11.3 Unload Reagent Racks...... 4-73 4.11.4 Unload Tip Racks and Dilution Plates...... 4-73 4.11.5 Unload Other Resources ...... 4-74 4.11.6 Unload Waste Disposal...... 4-74 4.12 Shut Down / End of Day Maintenance ...... 4-75 5 Use of the Instrument with IFA (optional) ...... 5-1 5.1 Safety and Hints...... 5-2 5.2 Brief Sequence Plan ...... 5-3 5.3 Start-up ...... 5-4 5.4 Load Samples and Assign Assays...... 5-5 5.4.1 IFA Assays with Dynamic Dilutions ...... 5-5 5.5 Create a Worklist ...... 5-6 5.5.1 Primary- and Sub-Assays ...... 5-7 5.6 Lot Specific Values ...... 5-8 5.7 The Worklist Window...... 5-10 5.7.1 Worklist Parameters ...... 5-12 5.7.2 Schedule...... 5-13 5.7.3 Slides Layouts ...... 5-15 5.7.4 System Status...... 5-16 5.8 Start Worklist ...... 5-17 5.8.1 Load Dialog...... 5-19 5.8.2 Load Slides ...... 5-21 5.9 Processing the Run ...... 5-22 5.9.1 Pre-Run Checks ...... 5-22 5.9.2 Steps of a Typical Test Run ...... 5-23 5.9.3 What You Can Do While the Run is Being Processed ...... 5-24 5.9.4 Instrument/Pipetting Errors ...... 5-24 5.9.5 The System Paused Dialog ...... 5-25 5.9.6 Pipetting Errors/Manual Pipetting ...... 5-26 5.9.7 Emergency Stop/Cancel a Run ...... 5-27 5.10 End of Run/Result Report Window ...... 5-28
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 5.10.1Result Report and Result Interpretation ...... 5-29 5.10.2Save/Open the Result Report...... 5-29 5.10.3Print the Result Report ...... 5-29 5.11 Unloading ...... 5-30 5.11.1 Unload Slides ...... 5-30 5.11.2 Unload ...... 5-31 5.12 Shut Down / End of Day Maintenance ...... 5-31 6 Advanced Functions ...... 6-1 6.1 Initialization and Selftest...... 6-1 6.1.1 Manually Start Selftest ...... 6-3 6.1.2 Selftest before each Run ...... 6-3 6.1.3 Selftest Failures ...... 6-3 6.2 Complete Sample Editor ...... 6-4 6.2.1 Add new Samples...... 6-6 6.2.2 Edit Sample Details ...... 6-7 6.2.3 Assign Assays to the Samples (Complete Sample Editor) . . . . . 6-9 6.2.4 Edit Assigned Assays ...... 6-10
Gemini - Instructions for use manual - Rev. 10 TOC-3
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 7 of 425 6.3 Create your own Worklist...... 6-11 6.3.1 Set-up Panel Dialog ...... 6-15 6.3.2 Add Samples ...... 6-20 6.3.3 Processing Several Assays per Plate ...... 6-21 6.3.4 Save or Open a Worklist ...... 6-25 6.4 Worklist Options ...... 6-27 6.4.1 Worklist Options: Scheduling ...... 6-27 6.4.2 Worklist Options: Before Worklist will be started ...... 6-30 6.4.3 Worklist Options: During Worklist is running ...... 6-32 6.4.4 Worklist Options: After Worklist was finished ...... 6-34 6.5 Advanced Options ...... 6-35 6.5.1 Optimize the Schedule...... 6-35 6.5.2 Advanced Load Options ...... 6-36 6.5.3 Test Plate Removal ...... 6-41 6.5.4 Editing/Recalculating the Results ...... 6-43 6.6 Continuous Loading ...... 6-48 6.6.1 Check Reloading Time(s)...... 6-49 6.6.2 Preparing and Loading the New Samples ...... 6-50 6.6.3 Redefining the Worklist ...... 6-50 6.6.4 Reloading other Resources ...... 6-51 6.6.5 Reloading Test Plates and Further Processing of the Worklist . 6-52 6.6.6 Reloading IFA Slides and Further Processing of the Worklist . . 6-52 6.7 Archiving Samples ...... 6-53 6.7.1 Independent Sample Archiving ...... 6-53 6.7.2 Archiving Samples within a Normal Run ...... 6-56 6.7.3 Imported Worklists with Sample Archiving Orders ...... 6-57 6.7.4 Archiving Parameters...... 6-58 6.7.5 Archiving in Archive Plates...... 6-63 6.7.6 Archiving in Secondary Tubes ...... 6-64 6.7.7 Archiving Information and Archiving Report...... 6-64 6.7.8 Testing Archived Samples ...... 6-65 6.7.9 Archiving Tips ...... 6-68 6.8 Sample Result Report...... 6-69 6.8.1 Filter Configuration ...... 6-71 6.9 Quality Control Analysis Report (Levey Jennings Plot) ...... 6-72 6.10 APM Report ...... 6-73 6.11 Software Language...... 6-74 6.12 Simulation Mode / Demo Mode ...... 6-75 7 Connection to a Host Computer ...... 7-1
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 7.1 ASCII File Transfer ...... 7-2 7.1.1 Hardware Configurations ...... 7-2 7.1.2 Importing Sample Data and Worklist Files (Types of Import Files) 7- 3 7.1.3 Defining Import Parameters...... 7-5 7.1.4 Export of Test Results ...... 7-10 7.2 Communication through an ASTM Link ...... 7-14 7.2.1 ASTM Link Set-Up ...... 7-14 7.2.2 Definition of LIS Assay Names...... 7-15 7.2.3 Communication Procedure ...... 7-17 7.2.4 Low-Level Protocol ...... 7-18 7.2.5 Logical Structure of the Message Level Protocol...... 7-19 7.2.6 Incoming and Outgoing Transmission Examples...... 7-20
TOC-4 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 8 of 425 8 System Configuration ...... 8-1 8.1 Defining User Rights and User Groups ...... 8-1 8.1.1 Defining the Rights of Individual Users...... 8-1 8.1.2 Creating and Editing User Groups ...... 8-4 8.1.3 Special Authorizations for Users with Restricted Rights ...... 8-6 8.1.4 Password Settings / Forgotten Password...... 8-7 8.1.5 Questions about Password Settings...... 8-8 8.2 System Options ...... 8-9 8.2.1 User Groups Tab...... 8-9 8.2.2 Users Tab ...... 8-9 8.2.3 Password Tab ...... 8-9 8.2.4 Preferences Tab ...... 8-10 8.2.5 File Polling Tab ...... 8-11 8.2.6 ASTM Tab ...... 8-12 8.2.7 Laboratory Tab ...... 8-14 8.2.8 Directories Tab ...... 8-15 8.3 System Set-up ...... 8-18 8.3.1 System Tab...... 8-19 8.3.2 Incubators Tab ...... 8-21 8.3.3 Colorimeter Tab (Photometer) ...... 8-23 8.3.4 Pipette Tab ...... 8-25 8.3.5 IFA Tab (optional) ...... 8-31 8.3.6 Sample Rack Tab ...... 8-33 8.3.7 Washer Tab...... 8-38 8.3.8 Plate Transport Tab...... 8-41 8.3.9 Maintenance Tab ...... 8-42 8.4 Aspirate Pressure Monitoring (APM) ...... 8-47 8.5 Volume Offset ...... 8-50 9 Maintenance and Cleaning ...... 9-1 9.1 Safety and Hints about Cleaning/Decontamination ...... 9-1 9.2 Daily Maintenance ...... 9-4 9.2.1 Start-Up ...... 9-4 9.2.2 After Each Run ...... 9-5 9.2.3 Shut Down ...... 9-6 9.3 Weekly Maintenance ...... 9-8 9.3.1 Washer Performance ...... 9-10 9.4 Monthly Maintenance ...... 9-14 9.4.1 Performance Evaluation ...... 9-15 9.4.2 Backup System Files ...... 9-16 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 9.5 Maintenance Jobs ...... 9-18 9.6 Special Maintenance Procedures/Emergencies ...... 9-19 9.6.1 Visually Check Tubing ...... 9-19 9.6.2 Visually Check Syringe and Three-Way-Valve ...... 9-20 9.6.3 Heavy Liquid Overflow ...... 9-21 9.6.4 Pipettor Malfunction ...... 9-22 9.6.5 Washer Malfunction ...... 9-23 9.6.6 Power Supply Malfunction ...... 9-24 9.6.7 Photometer Malfunction ...... 9-26 9.6.8 Reader Confidence Check with Reader Verification Plate . . . . 9-28 9.7 Damaged Parts...... 9-36
Gemini - Instructions for use manual - Rev. 10 TOC-5
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 9 of 425 10 Troubleshooting and Error Messages ...... 10-1 10.1 Error Messages ...... 10-1 10.2 Troubleshooting while Loading...... 10-16 10.2.1Troubleshooting while Loading Samples ...... 10-16 10.2.2Troubleshooting while Loading Reagents ...... 10-20 10.3 Worklist Troubleshooting ...... 10-21 10.3.1Error Detection while creating Worklist ...... 10-21 10.3.2Monitoring of the Incubation Temperature ...... 10-22 10.3.3Pipettor Crash with attached Disposable Tip ...... 10-23 10.4 Archiving Troubleshooting ...... 10-24 10.4.1Pipetting errors during the archiving process...... 10-24 10.4.2Sample Aspirate/Dispense Volumes ...... 10-24 10.4.3Volume Offset Error ...... 10-24 10.4.4Secondary Tubes Loaded on ordinary Sample Racks...... 10-24 11 Installation or Removal of the Instrument ...... 11-1 11.1 Installation of the Instrument...... 11-1 11.2 Removal of the Instrument...... 11-2 12 Technical Data ...... 12-1 12.1 Instrument Data...... 12-1 12.2 Specifications ...... 12-4 13 Appendix...... 13-1 13.1 Accessories and Consumables (Ordering Information) ...... 13-1 13.2 Checklists and Information ...... 13-2 Do´s and Don’ts ...... 13-3 Do ...... 13-3 • Do Not ...... 13-3 Maintenance ...... 13-5 Daily Checklist ...... 13-5 Maintenance ...... 13-6 Weekly Checklist...... 13-6 Maintenance ...... 13-6 Weekly Checklist...... 13-6 Maintenance ...... 13-7 Monthly and Special Checklist ...... 13-7 Service Information ...... 13-9 14 Contact ...... 14-1 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 15 Index ...... 15-1
TOC-6 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 10 of 425 Introduction Intended Use 1 Introduction
Target of this manual is the explanation of the GEMINI and GEMINI COMBO instrument, respectively. After having read the manual, the user should be able to safely operate the GEMINI/GEMINI COMBO instrument.
1.1 Intended Use
The GEMINI/GEMINI COMBO instrument is classified as other IVD.
The GEMINI is designed to automate diagnostic ELISA / EIA and autoimmune assays. The GEMINI COMBO is further able to process IFA slides for external evaluation under an immunofluorescence microscope. The instrument is to be used in clinics, laboratories, universities and hospitals containing diagnostic facilities as well as blood banks. The workplace for the instrument shall be a dedicated laboratory (area) for diagnostic purposes. The laboratories are not restricted to, but may include small working spaces (areas). The GEMINI/GEMINI COMBO consists of a platform that performs ELISA and similar structured assays, and PC software that performs several instrument tasks and provides a graphical user interface. The GEMINI/GEMINI COMBO has an interface that can accommodate with an internal PC. The PC has a data connection to an external laboratory information system (which is not included in the GEMINI/GEMINI COMBO). The GEMINI/GEMINI COMBO has a loading bay for samples and reagents, and positions for disposable tips. The GEMINI also has a transport system and fixed positions for loading microplates. Loading of any of these items into the GEMINI/ GEMINI COMBO instrument is to be performed by the operator. Sample and reagent vessels come with attached barcodes that encode the identifier of the corresponding sample or reagent. The GEMINI/GEMINI COMBO reads the barcodes and stores the identifier. Barcodes on microplates cannot automatically be scanned by the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 instrument. Using the GEMINI COMBO immunofluorescence assays can be processed on individual slides which are placed in IFA trays on an especially designed IFA bay. The IFA bay is inserted on the deck top of the instrument. The device must be validated in the specific application according to laboratory practice and state-of-the-art before putting into service and after changes. Use of kits or kit components on the GEMINI/GEMINI COMBO instrument is only allowed after validation. Using/running hazardous substances on the GEMINI/GEMINI COMBO instrument is in the responsibility of the operator. For the GEMINI COMBO instrument IFA and ELISA assays must be validated.
Gemini - Instructions for use manual - Rev. 10 1-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 11 of 425 Introduction Intended Use
1.1.1 Operator Requirements
Although the GEMINI instructions for use manual contains all information needed to operate the instrument, operators are required to attend training in operating it.
1.1.2 Good Laboratory Practice
Laboratories using GEMINI and software are expected to have routines according to Good Laboratory Practice (GLP).
1.1.3 Limited Warranty
STRATEC warrants that, at the time of shipment, the instrumentation provided to the customer is free from defects in material and workmanship. This limited warranty is conditioned upon the customer giving STRATEC notice of any defect within one (1) year shipment. This limited warranty will not apply if the instrumentation (a) has not been installed, operated, or maintained in accordance with applicable instructions and manuals; (b) has been repaired or altered by unauthorized persons or misused, abused, accidentally damaged or subjected to operation for which it was not intended; or (c) has had its serial number altered or removed. This limited warranty does not apply to expendable items such as fuses, external tubing, tubing connectors, and reagent and waste bottles. Except as expressly stated herein, STRATEC makes no other warranties, express or implied, including warranties or merchantability or fitness for particular purpose. Under this limited warranty, STRATEC, at its option, will repair or replace any defective instrumentation. This is the sole remedy for any breach of warranty. Any instrumentation to be returned for repair or replacement must be properly packaged and shipped via prepaid flight in accordance with STRATEC instructions. This limited warranty does not apply to the use of the GEMINI instrument other than as described herein. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
1-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 12 of 425 Introduction Typographical Conventions
1.2 Typographical Conventions
The warnings, notes and symbols described hereafter are used in the current manual, on the instrument and on its packaging.
1.2.1 Display of Warnings and Notes
DANGER Danger indicates a hazardous situation that, if not avoided will result in death or serious injury.
WARNING Warning indicates a hazardous situation that, if not avoided, could result in death or serious injury.
CAUTION Caution indicates a hazardous situation that, if not avoided, could result in minor or moderate injury.
NOTICE Notice indicates information considered important, but not hazard-related (e.g. messages related to property damage). The non-observance of a safety instruction can result in damage of the instrument or an adverse effect on the instrument function.
INFO 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The non-observance of information can result in an adverse effect on the instrument function (result deterioration).
Gemini - Instructions for use manual - Rev. 10 1-3
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 13 of 425 Introduction Typographical Conventions
1.2.2 Used Warning Symbols
Caution, risk of danger to person or damage to equipment! Consult instructions for use!
Biohazard!
Electrical hazard!
Laser hazard!
Caution, hot surface!
Mechanical hazard!
Cut injury hazard!
Automatic start-up!
Disconnect mains power connector before servicing!
Consult instructions for use!
Information about the required access rights for GEMINI instrument software functions. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
1-4 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 14 of 425 Introduction Typographical Conventions
1.2.3 Other Symbols
CE mark
Certification label of the CSA Group (Canadian Standards Association)
Date of production
Disposal of electrical and electronic equipment In the European Union, electrical and electronic equipment shall not be disposed with other household-type waste. It shall be collected separately. Please observe the relevant legal regulations effective in your country. Expiration date
Fuse ID number
In Vitro Diagnostic
Lot number
Manufactured by
Serial number
Temperature limitations
1.2.4 Special Types 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 LEDs and LEDs (light emitting diode) and signal lamps are printed in special type. Signal Lamps Example: Power LED
Fields Fields are printed in bold type. Example: ID field
Menu items and Menu items and buttons are printed in spaced type. Buttons Example: Open button.
Keys Keys are printed in slanted type. Example: Press Enter
File examples File examples are printed in typewriter font. Example: DRIVER=C:\SERVICE\DRIVERS
Gemini - Instructions for use manual - Rev. 10 1-5
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 15 of 425 Introduction Safety Instructions
1.3 Safety Instructions
The following safety instructions shall be observed at all times, both before and during operation and during maintenance.
Handling of Instructions for use manual The instructions for use manual is provided for your safety and gives important instructions for the handling of the instrument described. • Read all instructions! • Keep the instructions for use manual nearby the instrument. • The instructions for use manual shall be accessible to the user at any time.
The GEMINI instrument is designed and manufactured in accordance with the safety requirements for electronic and medical systems. If the law issues regulations concerning the installation and/or operation of the instrument, then it is the operator's responsibility to adhere to them. The manufacturer has done everything possible to guarantee that the equipment functions safely, both electrically and mechanically. The instruments are tested by the manufacturer and supplied in a condition that allows safe and reliable operation.
1.3.1 General Safety
Non-observance of safety instructions The non-observance of safety instructions may result in serious personal injury and material damage. • Follow all safety instructions included in this manual. • Follow all warnings marked on the instrument.
Improper use of the instrument 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Improper use of the instrument can cause personal injury, produce erroneous results and produce damage to the instrument. • The handling and maintenance of the instrument shall be performed only by trained and authorized personnel. • Before operating the instrument, the instruction for use manual shall be completely read and understood. • Only use the instrument in accordance with the intended use as described in this manual. • Use only the approved consumables and accessories described herein (e. g. disposable tips, microplates etc.). • The manufacturer assumes no liability for any damage, including those to third parties, caused by improper use or handling of the instrument.
1-6 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 16 of 425 Introduction Safety Instructions
Moving barcode scanner The movement of the moveable barcode scanner can trap you or knock over objects put down on the loading bay. • Never enter the loading bay when the instrument is switched on and you have not received an approval by the instrument! • Never enter the loading bay before the moveable barcode scanner has come to a standstill! • Never use the loading bay as storage space!
Interference by mobile phones Mobile phones can affect the correct function of the instrument. • Do not use mobile phones next to a running instrument.
Laboratory equipment The instrument has been designed and developed as laboratory equipment in accordance to the requirements of the EC directive 98/79/EC (IVD directive, directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices). In order to assure compliance, applicable standards recorded in the list of standards harmonized for the IVD directive were observed. The application of this product for in vitro diagnostics purposes requires a separate conformity assessment according to EC directive 98/79/EC for the complete system into which it will be incorporated and/or has to be used in combination with (e.g. reagent).
Unauthorized changes to the instrument Any changes to the instrument that are not authorized by the manufacturer will lead to the loss of the validity of the conformity to the applicable regulations the manufacturer has declared. In this case, the customer is responsible for the fulfillment of the applicable regulations. • Do not perform unauthorized changes. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 1-7
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 17 of 425 Introduction Safety Instructions
1.3.2 Electrical Safety
Non-observance of rules and regulations Non-observance of rules and regulations will cause serious personal injury with deadly consequences and material damage. • National rules and legal regulations for the safe electrical operation of the instrument shall be observed.
Improper connection of mains supply Improper connection of the instrument and the peripheral devices to the mains supply can cause serious personal injury with potentially deadly consequences and material damage (e.g. fire). • Only use grounded connection and extension cables with sufficient capacity (voltage and current) to connect the instrument and any peripheral devices to the mains power supply. • Never remove ground connections. • Grounding of the instrument and its peripheral devices to the same protective earth potential shall be ensured. • The use of a multi-outlet power strip is not allowed! • Only use power cables that fulfill the minimum requirements for this instrument.
Damaged power cables Damaged power cables will cause serious personal injury with potentially deadly consequences and material damage (e.g. fire). • Damaged power cables shall be replaced immediately! • No objects may be placed on the power cables. • Power cables shall be laid so that they cannot be squeezed or damaged. • Power cables shall be laid so that they do not lay in accessible or drivable areas. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Defective instrument Any defective instrument will result in serious injuries with deadly consequences and material damage (e.g. fire). • Immediately disconnect the defective instrument from the mains supply, if a safe usage is no longer possible. • Secure the defective instrument against reconnection. • Label the defective instrument clearly as being defective.
1-8 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 18 of 425 Introduction Safety Instructions
Electric shock by electrical devices on wet surfaces Working with electrical devices on wet surfaces (floors, work table) will cause serious injuries with deadly consequences and material damage due to electric shock. • Only work on dry surfaces (floors, work table). • Never use the mains supply near liquids and in rooms with high humid.
Replacement of power supply The power supply contains no serviceable parts! Repairs will cause accidents with serious injuries with deadly consequences, fire or serious instrument damage. • Replace the whole power supply when it is faulty!
Emergency shutdown in case of functional disorder Functional disorder of the instrument will cause electrical shock, burns, cuts or bruises. • Use the mains switch to switch off the instrument or the mains plug to separate the instrument from the mains supply!
Blockade of access to mains supply Improper placing of the instrument can cause accidents with serious injuries with deadly consequences, fire or serious instrument damage because the instrument cannot be switched off or be separated from the mains supply. • Ensure that the power supply and mains switch are easily accessible.
1.3.3 Laser Safety
Eye injuries due to laser radiation Laser radiation cause eye injuries when you look into the laser beam. • Never look directly into the laser beam!
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Do not use optical devices (e.g. mirror). • Take off watches and mirroring jewelry before operating the laser. • Be careful during operation and testing the laser of the barcode scanner. A class 2 laser is used. • Note that the wrong usage of operating elements or of adjustments or the non-observance of processes can cause a dangerous emission of laser radiation.
Gemini - Instructions for use manual - Rev. 10 1-9
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 19 of 425 Introduction Safety Instructions
1.3.4 Mechanical Safety
Missing, improperly opened, damaged or opened protective covers To avoid serious injuries with deadly consequences due to electric shock or injuries by the instrument (e.g. contusion, cuts etc.), protective covers may only be opened or removed for certain maintenance procedures and with the highest level of caution. • Only perform maintenance procedures described in this manual. • Make sure that nobody is working on the instrument and that all covers are attached and closed before reconnecting the instrument to the mains supply. • Make sure that all covers are attached and intact before switching on the instrument. • Switch off the instrument, separate it from the mains supply and protect the instrument against restarting, if protective covers/gears are missing or damaged. • Make sure that the motion of the barcode scanner has stopped before opening covers and/or accessing the working area of the instrument. • Avoid touching the barcode scanner and other moving parts while the instrument is in operation. • Perform all maintenance procedures with the highest level of caution.
Overheating Improper placing of the instrument may cause fire or serious instrument damage in case of overheating. • Do not block or cover ventilation slots. • The air shall be able to circulate. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
1-10 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 20 of 425 Introduction Safety Instructions
1.3.5 Biological Safety
Risk of infection! The instrument shall be treated as potentially infectious. Improper handling of infectious parts will cause skin irritations, illnesses and possible death. • Strictly follow the local and national provisions, legislation and laboratory regulations. • Use appropriate gloves! • Use an appropriate lab coat! • Use an appropriate eye protection (e.g. protective glasses)! • Avoid contact between skin/mucous membrane and samples/test reagents or parts of the instrument. • Clean, disinfect and decontaminate the instrument immediately if potentially infectious material has been spilled. • Do not use broken or chipped tubes or bottles. • Observe the instructions in the package inserts for correct use of reagents. • Observe the legal regulations for the handling of infectious material. • Never use bio-hazardous liquids for testing the instrument! • The instrument shall be cleaned, disinfected and decontaminated before servicing! 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 1-11
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 21 of 425 Introduction Positions of Safety Labels and Type Label
1.4 Positions of Safety Labels and Type Label
Missing warnings Missing or unreadable warning labels or type labels will result in non-identified dangers. This could result in serious personal injury and material damage. • Check the instrument for missing or unreadable warning labels and type labels. • Missing or unreadable warning labels or type labels shall be replaced.
1.4.1 General Warning Labels
General warning labels are positioned on: • on the pipettor arm, • on both sides of the loading bay, • on both edges of the cover, and • next to the diluter pump
1.4.2 Biological Hazard Labels
Biological hazard labels are positioned on: • the washer service cover, • the disposable tip ramp, • the washer needles, • the pumps module cover, • the waste liquid container, and • both washer aspiration bottles. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 1.4.3 Electrical Hazard Labels
Electrical hazard labels are positioned on: • the main power connector/switch.
1.4.4 Laser Hazard Labels
Laser hazard labels are positioned on: • the loading bay barcode scanner.
1-12 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 22 of 425 Introduction Positions of Safety Labels and Type Label
1.4.5 Cut Injury Hazard Labels
A cut injury label is positioned on: • the washer needles.
1.4.6 Type Label
The type label is positioned on the right side of the instrument (near by the mains switch). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 1-13
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 23 of 425 Introduction Radio Interferences
1.5 Radio Interferences
Electromagnetic Compatibility (EMC) This instrument complies with the emissions and immunity requirements as described in standard IEC 61326-2-6. This instrument has been developed and tested according to CISPR11 Class A. It may cause radio interference in domestic environments. • If the instrument causes radio interference, you may need to take measures to eliminate the interference. • The electromagnetic environment shall be evaluated before setup and operation of the instrument, • Do not use the instrument in the proximity of sources with excessive electromagnetic radiation (e.g. unshielded, deliberately operated high frequency sources) since they could interfere with the proper operation of the instrument.
Federal Communications Commission (FCC) Notice This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to CFR Title 47 Vol1 Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the Instructions for use Manual, may cause harmful interferences to radio communications. Operation of this equipment in a residential area is likely to cause harmful interferences. In which case, the user will be required to correct the interferences at his own expense.
Canadian Department of Communications Compliance Statement This equipment does not exceed Class A limits per radio noise emissions for digital apparatus set out in the Radio Interference Regulations of the Canadian Department 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 of Communications. Operation in a residential area may cause unacceptable interference to radio and TV reception requiring the owner or operator to take whatever steps are necessary to correct the interference.
1-14 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 24 of 425 Introduction Abbreviations
1.6 Abbreviations
Abbreviation Meaning
*.??? Different file extensions (e.g. *.asy, *.txt), (see chapter 8.2.8.1 on page 8-16). APM Aspirate Pressure Monitoring system ASCII American Standard Code for Information Interchange (ASCII), pronounced is a character encoding based on the English alphabet. ASTM ASTM International, is an international standards organization that develops and publishes voluntary consensus technical standards. ASTM 1381 and ASTM 1394 are determinations for the communication between computers. COM COM is the original, yet still common, name of the serial port interface on PCs. It might not only refer to physical ports, but also to virtual ports, such as ports created by RS/232 or USB adapters. COP Command Operating Processor CU Control Unit CV The abbreviation CV stands for “coefficient of variation” and is the relative standard deviation, which is the quotient of the absolute standard deviation and the mean of a measured value. %CV: The CV multiplied with 100% EEPROM An Electrically Erasable Programmable Read-Only Memory, is a type of non-volatile memory used in computers and other electronic devices to store small amounts of data that must be saved when power is removed, e.g., calibration tables or device configuration. EIA Enzyme Immuno Assay 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 ELISA Enzyme Linked Immuno Sorbent Assay Host In computer networking a host is a main computer (e. g. server, central computer). ID Identification (Number). IFA Indirect Fluorescent Antibody / Immunofluorescence Assay LAN A Local Area Network is a computer network. LED Light Emitting Diode LIMS A Laboratory Information Management System (LIMS) is computer software that is used in laboratories for the management of samples, laboratory users, instruments, standards and other laboratory functions such as invoicing, plate management, and work flow automation.
Gemini - Instructions for use manual - Rev. 10 1-15
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 25 of 425 Introduction Abbreviations
Abbreviation Meaning
LIS A Laboratory Information System, is a class of software which handles receiving, processing and storing information generated by medical laboratory processes. LLD Liquid Level Detection µl A microliter is a unit of volume in the metric system. (1 µl = 0.001 ml = 1*10-6 l) nm A nanometer is a unit of length in the metric system. (1 nm = 0.000001 mm = 1*10-9 m = 39.37*10-9 in) OD Optical Density PC Personal Computer QA Quality control Analysis RS232 Serial bus standard to connect devices to a computer. USB The Universal Serial Bus is a serial bus standard to connect devices to a computer. VC Validation Criteria VGA The Video Graphics Array is a standard interface to connect a screen to a computer.
Table 1-1: Abbreviations 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
1-16 Gemini - Instructions for use manual - Rev. 10
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2 Instrument Description
The GEMINI is a fully automated microtiter plate analyzer performing the complete sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes, plate transports) as well as the photometric measurement and evaluation. The instrument is controlled via the Windows PC GEMINI instrument software. This software, which was specifically designed for this purpose, allows the user to process the pre-defined assays as well as assays programmed by the user. The clear structure with intuitive user-guidance allows simple and quick operation of daily routine jobs as well as programming of user- specific assays. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 27 of 425 Instrument Description Instrument Overview
2.1 Instrument Overview
The room where the GEMINI is operating should be evenly heated (summer and winter), since most immuno assays are temperature sensitive. The operation temperature is between 15 °C and 30 °C. We recommend to set up the GEMINI in air-conditioned rooms. During normal operation the ventilation slits must not be blocked. Ensure a minimum of 15 cm distance from the rear panel to a wall or other structure when installing the instrument.
2.1.1 Instrument 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 2-1: GEMINI instrument
1 Cover 2 Touch screen with PC (All-in-one-PC) 3 Loading bay for samples and reagents (see chapter 2.2.4 on page 2-14) Loading bay barcode scanner and shield for protection between pipettor and loading bay (see chapter 2.2.4 on page 2-14) 4Pipettor (see chapter 2.2.9 on page 2-20) 5 Service cover of washer (see chapter 2.2.5 on page 2-18) 6 Plate transport (see chapter 2.2.1 on page 2-8)
2-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 28 of 425 Instrument Description Instrument Overview
7 3 positions for disposable tip racks (see chapter 2.2.2 on page 2-10) 8 2 positions for dilution plates, archive plates or large reagent bottles (see chapter 2.2.3 on page 2-11) 9 Pipettor wash station, tip eject station and cover locking mechanism (see chapter 2.2.9.4 on page 2-21) 10 Waste bag for disposable tips (see chapter 2.2.9.4 on page 2-21) 11 Wash buffer bottles and waste bottles for the washer (see chapter 2.2.5 on page 2-18)
Use handle! Only open and close the cover with the handle! 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-3
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 29 of 425 Instrument Description Instrument Overview
2.1.1.1 IFA Bay (optional)
Figure 2-2: IFA bay with tray and slides
1IFA bay (see chapter 2.2.11 on page 2-23) 2 IFA tray with slides 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
2-4 Gemini - Instructions for use manual - Rev. 10
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2.1.2 Liquid Connections
Figure 2-3: Left side - liquid connections
12 Diluter pump (see chapter 2.2.9 on page 2-20) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 13 Liquid connections (for details see below) 14 2 washer waste bottles (vacuum extraction) (see chapter 2.2.5 on page 2-18) 15 3 wash buffer bottles (see chapter 2.2.5 on page 2-18) 16 System liquid container (see chapter 2.2.9.2 on page 2-20) 17 Waste liquid container (see chapter 2.2.6 on page 2-18)
Waste liquid container arrangement The waste liquid container should be placed always under the level of the analyzer.
Gemini - Instructions for use manual - Rev. 10 2-5
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 31 of 425 Instrument Description Instrument Overview
Washer liquid waste bottle and washer foam bottle arrangement The installation of washer liquid waste bottle and washer foam bottle must be lined up, that they cannot accidentally fall over during operation!
Figure 2-4: Liquid connections
Figure 2-5: Liquid connections with IFA function (optional) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
System Liquid System liquid container System Waste Waste liquid container Vacuum Washer liquid waste bottle (trap bottle) Wash buffer 1 Wash buffer bottle - red channel Wash buffer 2 Wash buffer bottle - blue channel Wash buffer 3 Wash buffer bottle - yellow channel Wash buffer 4 Wash buffer bottle - green channel (for IFA) Wash buffer 5 Wash buffer bottle - white channel (for IFA) Washer Waste Washer foam bottle (vacuum bottle)
2-6 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 32 of 425 Instrument Description Instrument Overview
2.1.3 Electrical Connections
Figure 2-6: Right side - electrical connections
USB 3 USB-connectors VGA External monitor connector 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 PS2 External mouse/keyboard connector RS232 Serial interface connector (RS 232) LAN Local Area Network connector (LAN) 18 Main power connector with power switch and main fuses
Gemini - Instructions for use manual - Rev. 10 2-7
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 33 of 425 Instrument Description Use of the Modules
2.2 Use of the Modules
2.2.1 Microplates in the Plate Transport
The plate transport moves microplates between the modules of the GEMINI instrument. The plate transport can also shake a microplate in order to mix the well contents. The microplate is moved linearly at a given frequency and amplitude. The shaking time is controlled through the assay protocol.
Use of the plate transport You may only insert the microplates into the plate transport if you are requested to do so by the GEMINI software!
Use only exact modeling of microplates to ensure correct tracking. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 2-7: Microplate in the plate transport
2-8 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 34 of 425 Instrument Description Use of the Modules
Load the microplate into the plate frame of the plate transport after the request of the GEMINI software. Position A1 should be at the rear right. Push the microplate firmly down so that it lies on the floor completely and evenly. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-9
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 35 of 425 Instrument Description Use of the Modules
2.2.2 Disposable Tip Racks
Figure 2-8: Disposable tip racks
Use of conductive Disposable Tips Disposable tips must have specific conductive properties which are used for liquid level detection and sample clot detection. Do not use other types of disposable tips.
Tip type detection Never disable tip type detection in the worklist options. If disabled, a tip misplaced cannot be recognized by the instrument and may cause mechanical damage!
Check tip racks allocation Please carefully check the tip racks allocation, following the specific color code and type in the software.
Insert the disposable tip racks into the corresponding rack position after the request
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 of the GEMINI software. The rack marker should be at the rear right (see triangular markers). Push the disposable tip rack(s) firmly down so that it/they lies/lie on the floor completely and evenly.
2-10 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 36 of 425 Instrument Description Use of the Modules
2.2.3 Dilution Plates, Archive Plates, and Large Reagent Bottles
2.2.3.1 Dilution or Archive Plates
To be able to use dilution or archive plates, it is required to use a metal base plate. The metal base plate allows the correct detection of liquid surface as well as the usage of the complete liquid volume in the dilution or archive plate (less the specified remaining volume).
Use only exact modeling of microplates to ensure correct tracking.
Figure 2-9: Metal base plate in the right position
Lay the metal base plate on the corresponding position after the request of the GEMINI software. Push the metal base plate firmly down so that they lies on the floor 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 completely and evenly.
Gemini - Instructions for use manual - Rev. 10 2-11
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Figure 2-10: Dilution or archive plate in the right position
Lay the dilution or archive plate on the metal base plate. Position A1 should be at the rear right. Push the dilution or archive plate firmly down so that they lies on the floor completely and evenly.
2.2.3.2 Large Reagent Bottles
It is also possible to use one or two large reagent bottles with the GEMINI. For this it is only necessary to insert a special bottle adapter into the intended position. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 2-11: Large reagent bottle adapter
Insert the large reagent bottle adapter completely into the dilution position.
2-12 Gemini - Instructions for use manual - Rev. 10
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Figure 2-12: Large reagent bottle adapter
Insert the large reagent bottle into the adapter. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-13
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 39 of 425 Instrument Description Use of the Modules
2.2.4 Loading Bay for Samples and Reagents
The loading bay is used for loading samples and reagents located in reagent tubes or bottles into the GEMINI instrument by means of so-called racks. With the pipettor, the samples and the reagents can then be distributed in the course of a test run. To avoid the confusion of samples or reagents, the loading bay is provided with a barcode scanner (on the right hand side). By means of this scanner, the barcodes, which are applied on the corresponding reagent tubes or bottles can be read and processed in the GEMINI instrument software later. The loading bay is provided with 12 tracks for insertion of up to 12 racks, depending on their width. The track to be used is marked by lamp (LED). Above the loading bay, a grid is located as a protection for the moving pipettor.
Improper loading or unloading of racks, reagents and samples Improperly loaded or unloaded racks, reagents and samples can produce erroneous results due to incorrect pipetting activities. • Only load and unload racks if you are explicitly requested to do so. • Only load and unload racks on the specified lanes. • Check the correct transfer or input of all reagent and sample names.
Injury hazard! Never move your hand into the loading bay, if the GEMINI instrument is operating. The pipettor could cause injury during the loading of samples or reagents with its tip.
Use of Racks Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.
Moving barcode scanner
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The movement of the moveable barcode scanner can trap you or knock over objects put down on the loading bay. • Never enter the loading bay when the instrument is switched on and you have not received an approval by the instrument! • Never enter the loading bay before the moveable barcode scanner has come to a standstill! • Never use the loading bay as storage space!
Barcode Scanner Unit Damages Do not lean on the loading bay barcode scanner unit!
2-14 Gemini - Instructions for use manual - Rev. 10
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Handling and cleaning of optical surfaces Improper optical surfaces (e. g. scanners, lenses, sensors) could generally degrade the quality of images, data, etc. • Do not touch any optical surfaces. • Only clean the optical surfaces with a soft and lint-free cloth. • Do not use any aggressive detergents or solutions (e.g. acetone).
Do always push in the racks into the loading bay with the handle or pull it out again with the handle.
Never load more than one rack at the same time! For proper barcode identification the racks must be loaded one after the other, as indicated by the LEDs.
Figure 2-13: Loading bay with racks
2.2.4.1 Racks
Racks are used for loading samples and reagents located in reagent tubes or bottles 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 into the loading bay in a controlled way. Depending on the purpose of use, there are different racks.
Depository of Reagent Racks Do not refrigerate reagent racks! Because they are made of metal, excessive cooling of the racks could influence the temperature of the reagents and of the work area inside the instrument.
In one rack, only tubes of the same type may be used to avoid problems during the aspiration of liquids. The tube type must be approved for the relevant rack.
Gemini - Instructions for use manual - Rev. 10 2-15
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 41 of 425 Instrument Description Use of the Modules
Use only exact modeling of tubes and bottles to ensure correct tracking.
Figure 2-14: Several racks
Each rack includes a contact pin; on racks occupying one track, this pin is located at the top centre, and on the broader racks at the top right. The software specifies which track is to be used for the respective rack. This is indicated by a LED. A reagent rack occupying 2 tracks must be inserted such that the contact tappet is in contact with the lit up LED. Each rack has to be inserted up to the limit stop. Reloading of sample and reagent racks is possible when the instrument is in the incubation mode. The following racks are supplied:
T: Sample rack for 16 samples (occupies one track). 2: Reagent rack for 16 bottles for reagents (occupies one track). 1: Reagent rack for 8 bottles for reagents (occupies 2 tracks).
Sample racks as provided with the system are used for 10 mm tubes. For other tubes used, new sample rack definitions have to be created by your service engineer. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
2-16 Gemini - Instructions for use manual - Rev. 10
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2.2.4.2 Barcodes
Barcodes used must fulfill the CLSI AUTO2-A2 requirements and must fulfill at least quality level C.
Figure 2-15: Barcode label on a tube
Length of tube: Max. length of barcode (lbarcode) 75 mm (2.95 in.) 41 mm (1.61 in.) 100 mm (3.94 in.) 66 mm (2.60 in.)
Table 2-1: Length of barcode
Ensure that the barcode labels face towards the right (open side of the rack) when loading. Otherwise they cannot be properly read.
2.2.4.3 Fill Height of Reagents Bottles
Do not fill reagent bottles above the bottle shoulder height. Overfilling the bottle could cause errors in the volume of reagent aspirated. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 2-16: Fill height of reagent bottles
Gemini - Instructions for use manual - Rev. 10 2-17
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2.2.5 Washer and Wash Buffers
To be able to wash microplates in the course of a test, the GEMINI instrument is provided with a washer. By means of the washer, the microplates can be cleaned strip-wise with different wash buffers. The wash head of the washer aspirates liquid from the microplate wells as well as dispenses wash buffer into them. The wash head comprises eight-dispense nozzles and eight slightly longer aspiration nozzles. The wash head is lowered into the microplate wells for each aspiration or dispensing step. The washer is located behind a cover. A maximum of 3 bottles (1 x 1 litre, 2 x 2 liters) can be used for various wash buffers to clean the microplates and cleaning fluid (e.g. distilled water) to clean the washer head. The connection fitting consists of 3 color-coded connection pairs: one tubing and one level sensor each per bottle. Two waste bottles are available for the wash unit. One waste bottle contains the liquid waste which is pumped to the waste container which is positioned below the instrument (see chapter 2.2.6 on page 2-18). The second bottle serves as overflow protection.
2.2.6 Waste Container
Infectious waste Potential infectious material and all parts that may come in contact with potential infectious material will cause severe environmental contamination. • Strictly follow the local and national provisions, legislation and laboratory regulations.
The waste container is located beside, behind or under the instrument and connected through tubing. The waste container is fitted with an electric level sensor. The waste container can be emptied as soon as the instrument is properly installed.
To empty the waste container: 1. Open the container screw cap. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2. Empty and decontaminate the waste container. 3. Close the screw cap and make sure the level sensor and connections are correctly set.
The level sensor is used by the instrument to check the liquid level. This check is performed each time a selftest is conducted. The instrument will also warn the operator if the level of waste liquid becomes full during a run. A visual check of the waste container is recommended every morning before starting the instrument.
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2.2.7 Incubator and Stacker
Next to the washer there are two independent heatable incubator chambers; the microplates are automatically transported into these incubators and out again according to the assay protocol. The heatable incubator chambers can also shake a microplate in order to mix the well contents. The microplate is moved linearly at a given frequency and amplitude. The shaking time is controlled through the assay protocol. The instrument is also equipped with three light-protected storage chambers (stacker) accommodating microplates for room temperature incubation. It is located below the incubator.
2.2.8 Photometer
The photometer uses photodiodes located above the microplate to measure the amount of light passing through the microplate wells from the light source below the microplate. The optical system includes optical interference filters (up to 8 filters), mounted in a filter wheel, to obtain monochromatic light of the desired wavelength and optical lenses to obtain an optimal light beam passing through the microplate wells. The photometer measures the absorbance in eight wells simultaneously as the microplate moves through the photometer. Comparing the measurement values to the zero value with air in between (equivalent to 100 % light source output), the absorbance is calculated using the Lambert-Beer law. A reference channel continuously compensates for any instability of the light source. The photometer (400 - 700 nm) is installed in the lower left part of the instrument. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-19
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2.2.9 Pipettor and Diluter Pump
The GEMINI instrument is provided with a fully automatic pipetting system. The microprocessor-controlled diluter pump with 1000 µl syringe installed on the left side of the instrument allows a very precise aspiration and dispensing of the liquids to be pipetted. The tube system of the pipetting system is filled with system liquid. The pipettor uses disposable tips to avoid cross-contamination. Different sizes of disposable tips (300 µl or 1100 µl) can be attached to the tip adapter of the pipettor automatically. After pipetting the disposable tips can be emptied in the wash station or dropped into the tip eject station. The pipettor automatically flushes with system liquid between each aspirate/ dispense cycle of samples and reagent during a pipetting sequence.
Use of covers A plastic cover protects the visible working area. The closed position of this flap is monitored by a contact switch. The GEMINI cannot be operated without this cover, in order to protect the operator from getting in contact with the working area during a run. If these safety precautions are not observed strictly, the operator may get hurt or contract an infection, or the instrument may get damaged.
2.2.9.1 Diluter Pump
The diluter pump is used for transferring liquids (samples, controls, standards, reagents or diluents). The disposable tip is moved into the source position (e.g. sample, reagent) by the pipettor to aspirate liquid. The downward motion of the pump’s syringe plunger causes the system liquid to aspirate fluid into the disposable tip. After the liquid is aspirated, the tip is moved to the destination position (e.g. microplate, dilution plate). The upward motion of the syringe plunger causes the system liquid to dispense fluid through the disposable tip into the destination position. The motion of the syringe plunger coupled with the system liquid causes system fluid to move throughout the tubing and the aspiration and dispensing of liquid and air gaps in the disposable tip.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2.2.9.2 System Liquid Container
The system liquid container is located beside, behind or under the instrument and connected through tubing. The system liquid container is fitted with an electric level sensor.
Air in system tubing Both filter and liquid tubing must not run dry. Air in the system tubing may affect pipetting performance.
To fill system liquid: 1. Prepare the system liquid (deionised water). 2. Open the container screw cap and pour in the system liquid. 3. Close the screw cap and make sure the level sensor and connections are correctly set.
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The level sensor is used by the instrument to check the available quantity of system liquid. This check is performed each time a selftest is conducted. The instrument will also warn the operator if the level of system liquid becomes insufficient during a run. A visual check of the system liquid container is recommended every morning before starting the instrument (see chapter 9.2 on page 9-4).
2.2.9.3 Liquid Level Detection (LLD)
Each disposable tip possesses independent liquid level detection (LLD) capabilities. LLD detects liquid by detecting a change in capacitance. As a tip enters the sample or reagent well (source or destination) the LLD circuitry baselines. The tip continues to track down until a change of capacitance is detected. Once liquid is detected, the tips submerge in the liquid to a programmed submerge depth. As the instrument aspirates/dispenses liquid the tip tracks down/up while liquid level decreases/ increases. Tracking is done by calculating the change of liquid level using the well geometry. This mechanism ensures that sample or reagent will be aspirated/ dispensed without unnecessary external contamination of the tip.
Use of conductive disposable tips Disposable tips must have specific conductive properties which are used for liquid level detection and sample clot detection. Do not use other types of disposable tips.
Restrictions of the liquid level detection It is not possible to detect liquids with low ionic strengths. These liquids do not allow capacitive detection.
Restrictions of the liquid level detection on IFA slides It is not possible to detect liquids on IFA slides.
2.2.9.4 Tip Ejection Station and Pipettor Wash Station
Tip ejection station and waste bag:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The opening serves as ejection station for disposable tips. The ejected tip is transported into the waste bag via a slide which is attached to the front side of the instrument. The waste bag can be taken out of the holding device and replaced. After removal of the waste bag, the ejection station can be pulled off by hand.
Pipettor wash station: The pipettor wash station is located behind the tip ejection station.
Gemini - Instructions for use manual - Rev. 10 2-21
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2.2.10 Touch Screen
With the integrated touch screen it is very easy to use the instrument. You make all inputs with a stylus (tip R0.8 or over) or a finger directly on the touch screen. An external keyboard or mouse are not needed. Use: • Keyboard (alphanumeric inputs, e.g. A - Z, 0 - 9, etc.): The GEMINI software provides special input dialogs to enter letters or numbers (see chapter 3.5 on page 3-16). Additional there is a callable screen keyboard to enter letters or numbers on the windows systems (see Windows Start button). • Mouse: • Mouse pointer: Touch the screen with your finger. Now the mouse pointer will follow your moving finger. • Single mouse click: Touch the screen with your finger once. • Double mouse click (double click): Touch the screen with your finger twice. Do not wait between the first and the second touch.
Damage of touch screen while operating Improper use could damage the touch screen surface. • Never use sharp edged or hard articles. • Keep the surface clean (see chapter 9.1 on page 9-1). • Operate with your finger without applying excessive pressure. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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2.2.11 IFA Bay, IFA Trays and IFA Slides (optional)
Use of IFA and ELISA assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time.
With a GEMINI COMBO instrument it is possible to process IFA assays on slides (sample and reagent pipetting, washing, incubation) as preparation for further processing by the user. To start an IFA worklist it is indispensable to insert the IFA bay and use the IFA trays for the slides. Evaluation of the processed slides has to be done under an external fluorescence microscope.
Figure 2-17: IFA bay with tray and slides
1 IFA bay for four IFA trays 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • 1a: front fasteners for the IFA bay • 1b: rear fasteners for the IFA bay 2 IFA tray for four slides • 2a: in each case two fasteners for four trays 3 Slides 4 IFA pipettor needle wash station
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IFA slides:
Use only exact modeling of slides to ensure correct pipetting and washing.
Slide dimension: At least 25 x 42 x 1 mm Maximum 26 x 76 x 1 mm Slide wells: Circular, oval and square shaped Inner diameter at least 5 mm Maximum 12 wells per slide
Installation and loading procedures:
Insert the IFA 1. Put the IFA bay (1) onto both rear fasteners (1b). Bay 2. Put the IFA bay (1) with its front guide pins into the adjustment holes (1a). 3. Push the IFA bay (1) firmly down so that it lies on completely and evenly.
Insert an IFA 1. Put the IFA tray (2) onto both fasteners (2a). Tray 2. Push the IFA tray (2) firmly down so that it lies on the IFA bay (1) completely and evenly. 3. If necessary, repeat the steps for the other IFA trays.
Insert a Slide 1. Insert the slide (3) carefully into the guide grooves of the IFA tray (2). 2. Push the slide (3) carefully to the limit stop of the IFA tray (2). Ensure that the slide is not skipped or tilted. 3. If necessary, repeat the steps for the other slides.
Removal procedures:
Remove the IFA 1. Remove all slides (3) and IFA trays (2). Bay 2. Pull the IFA bay (1) on its front guide pins out of the adjustment holes (1a). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 3. Remove the IFA bay (1).
Remove an IFA 1. Pull the IFA tray (2) straight out of the IFA bay (1). Tray 2. Remove all slides (3). 3. If necessary, repeat the steps for the other IFA trays.
Remove a Slide 1. Draw the slide (3) carefully out of the IFA tray (2). 2. Remove the slide from the instrument. 3. If necessary, repeat the steps for the other slides.
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2.3 Accessories and Consumables
The necessary accessories and the following consumables can be purchased: • Sample and reagent racks (with barcodes). • Tip racks with 300 µl / 1100 µl disposable tips. • Waste and system liquid containers with or without level sensors and tubing connections. • Wash buffer and clean fluid bottles. • Trap flask and vacuum flask. • Barcode labels for reagent bottles. • Various tubings. • Filters for the photometer. • Halogen lamp for the photometer. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 2-25
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2.4 Principles of Methods
2.4.1 Absorbance Photometry
The measurement principle of absorbance photometry plays the most important role in clinical chemistry. With this method, the intensity of a monochromatic light beam of a suitable wavelength is compared before and after passing through a sample. The degree of attenuation of intensity of the light beam provides a measure of the concentration of the substance under investigation. The photometer consists of a polychromatic or monochromatic light source. In the case of the GEMINI, this is a halogen lamp which emits a spectrum. The desired wavelength is filtered out using a wavelength selector (i. e. a filter). The light with this wavelength passes through the sample with the substance to be measured in an optically clear solution. A part of the light is absorbed in the sample. The intensity of the light coming out of the sample is measured with a measuring cell (detector). The light striking the detector is converted into an electrical signal and stored as the measurement signal.
2.4.2 Bichromatic Measurement
In the case of the bichromatic measurement principle, measurements are performed at two wavelengths, the measuring and the reference wavelength. The measuring wavelength is close to the absorbance maximum of the chromogen. The absorbance is mainly dependent on the amount of chromogenic substance in the sample. The reference wavelength lies outside the absorbance range of the chromogen and indicates the blank value of the sample. The absorbance value of the reference wavelength is substracted from the absorbance value of the measuring wavelength. In this manner, external influences such as scratches on the microtiter plate, dust, turbidity of the solution and the drift of the electronic measuring instrument can be compensated. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
2-26 Gemini - Instructions for use manual - Rev. 10
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This chapter describes the basic functions of the GEMINI instrument software. Additionally, a short overview over software menus and symbols is included in this chapter.
Required access rights: Start Worklists
3.1 Menus and Symbols
The following alphabetic sorted tables describe all various menu items. Several menu items are enabled only when you can use them.
General functions
Edit OK The input/change is applied and the corresponding dialog is closed.
Edit Cancel The input/change is not applied and the corresponding dialog is closed. Edit Redo With this function, you can redo the changes previously made. Edit Undo With this function, you can undo the previous changes. Help Help Shows the on-line help. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Keyboard Ctrl Simulates the Ctrl key on your keyboard. If you select this function, you can select several non- consecutive items in a list. Keyboard Shift Simulates the Shift key on your keyboard. If you select this function, you can select several consecutive items in a list. Search Scroll buttons Jump to the previous/next line. (active in case of multiple page documents)
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Search Scroll buttons Jump to the previous/next page. (active in case of multiple page documents)
Search Scroll buttons Jump to the first/last page. (active in case of multiple page documents)
Selection Select All This function selects all shown items in a list. Selection This symbol indicates that the corresponding function is not selected. Selection This symbol indicates that the corresponding function is selected.
Functions of the menu and selection dialog File Shows a selection dialog (see chapter 3.6 on page 3-16) for the following functions. These are the same functions as in the menu File. Close Closes the active document.
Exit Terminates the program.
New Shows a selection dialog to create new document (e. g. assays, worklists or reports). New Opens the Set-Up Panel dialog to create a new Worklist worklist. See chapter 4.5 on page 4-14 + chapter 6.3 on page 6-11 or chapter 5.5 on page 5-6 (IFA) + chapter 6.3 on page 6-11 Open Shows a selection dialog to open a document.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 See chapter 3.2 on page 3-10 Print Prints the active document (e. g. worklist, report). See chapter 3.4.1 on page 3-13 Print Shows the active document as print preview. Preview See chapter 3.4.3 on page 3-15 Print Setup Defines the printer and printing options. See chapter 3.4.2 on page 3-14 Save Saves the active document (e. g. worklist, report). See chapter 3.3 on page 3-11 Save as Saves active document (e. g. worklist, report) under a new name. See chapter 3.3 on page 3-11
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Recent Shows the last opened and already saved assay protocol Protocols files for selection.
Recent Shows the last opened and already saved result files for Results selection. See chapter 4.10.3 on page 4-68 Recent Shows the last opened and already saved worklists for Worklists selection. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Functions of the menu Edit (Worklist) The functions of the menu Edit can only be used if a worklist is active. Export Exports archiving information as file. Archive See chapter 6.7.7 on page 6-64 Load Allows the reloading of disposable tips. Additional See chapter 4.8.6.1 on page 4-46 Tips Lot Specific Opens the Lot Specific Values dialog to show or Values edit the required reagents information. See chapter 4.6 on page 4-15 Optimise Optimises the schedule of the defined worklist. See chapter 6.5.1 on page 6-35
Panel Opens the Set-up Panel dialog to edit the current Definition worklist. This function is also called Edit Panel See chapter 6.3.1 on page 6-15 Panel Opens the Worklist Options dialog to change Options worklist processing options. This function is also called Edit Options See chapter 6.4 on page 6-27 Start Opens the Load dialog to allocate the required resources. After that, a run using the current worklist will be started. See chapter 4.8 on page 4-31 or chapter 5.8 on page 5-17 (IFA) Stop Pauses the current run. The run can be continued again and one or several plates can be removed from processing. Or the entire run can be aborted completely. See chapter 4.9.5 on page 4-57 or chapter 5.9.5 on page 5-25 (IFA) Unload Allows the unloading of fully processed plates before the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Finished end of the run Plates See chapter 4.11.1.2 on page 4-70
Functions of the menu Edit (Results) The functions of the menu Edit can only be used if a result is active. See chapter 4.10 on page 4-61
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Functions of the menu and selection dialog Utilities
APM Definition of Aspirate Pressure Monitoring parameters. See chapter 8.4 on page 8-47
Backup Opens the System Backup dialog allowing you to create backup files. See chapter 9.4.2 on page 9-16 Export Each time a (*.res) result report is calculated and Results displayed on the screen, you can decide to export it. See chapter 7.1.4.1 on page 7-10 Note for IFA: It will be not possible to send IFA results to a host computer, because the result of a IFA slide must be done in a further process step outside of the GEMINI instrument. Log-Off/Log- Allows to change the user. On If the instrument has been started by one user and another user wants to take over, the second user should log-in under his/her own user name. To do so, it is not necessary to shut down the instrument and restart it. See chapter 4.3.5 on page 4-6 Maintenance Allows to select and execute programmed maintenance jobs. See chapter 9.5 on page 9-18 Options Definition of software parameters (e. g. user access rights, laboratory details, preferences, directories, file polling, ASTM). See chapter 8.2 on page 8-9 Sample Opens the complete Sample Editor dialog to view or Details edit sample data. See chapter 6.2 on page 6-4
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Present Manual plate control. Carriers Not recommended for normal use. See chapter 6.5.3 on page 6-41 Scan Now The loading bay barcode scanner moves to the next free lane and switches the barcode scanner on.
Scanner Allows to choose the track where the instrument will accept the next rack. Click on the desired track in the Select a Track dialog. Note: Double lane racks can only be inserted in every 2nd track (the software will reject rack otherwise. Select Allows to change the software language. Language Only visible when no window is opened. See chapter 6.11 on page 6-74
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Selftest Performance of a selftest (initialization). See chapter 6.1 on page 6-1
System Definition of instrument parameters. Setup See chapter 8.3 on page 8-18
System Manual plate control. Utilities Not recommended for normal use. See chapter 6.5.3 on page 6-41 Turn Scanner Switches the loading bay barcode scanner off. Off Note: The loading bay barcode scanner moves back to its park position. Turn Scanner Switches the loading bay barcode scanner on. On
Verify Checks the photometer using the reader verification plate. See ’Reader Verification Plate Manual’
Volume Definition of pipetting volume correction. Offset Only used for development and manufacturing. See chapter 8.5 on page 8-50
Functions of the menu and selection dialog Windows
Arrange Stacks all minimized windows and aligns them from the Icons lower left to the upper right of the workspace. Cascade Stacks all windows and aligns them from the upper left to the lower right of the workspace. New Shows the active document in a new window. The new Window window is only a new view of the document and not a new document. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 More Entries Shows the name of all opened documents/windows. Select one entry to move the document on the top. Tile Stacks all windows and aligns them in rows.
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Functions of the Menu and Selection Dialog Help
About Shows the version number of the GEMINI instrument GEMINI software.
Context Shows the on-line help of the selected function (when Sensitive available). Help Help Topics Shows the on-line help (when available). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Functions of the selection dialog New
APM Report Shows all APM threshold sets sorted by liquid types in a report that can be printed out. See chapter 6.10 on page 6-73 Assay Opens the Select Assay Protocol Type dialog to create a new assay. See "Assay Programming Manual" Job List Shows a list of sample IDs with the assays to be performed for each sample, i.e. sample data and test orders already stored in the instrument and not yet processed. This corresponds to the data currently available in the Sample Editor dialog. This function is useful because it allows you to know rapidly if there is any "back log" or if there is a lot of work remaining to be done. This Job List can be printed. This Job List is different from the Job List displayed in the Worklist window. The Job List displayed in the Worklist window shows the sample IDs and assays included in that worklist Sample Opens the Sample Results dialog to create a sample Results result report. Report See chapter 6.8 on page 6-69 QA Analysis Opens the Q.A. Analysis dialog to create a QA Report analysis report. See chapter 6.9 on page 6-72 Reagent Shows a complete list of all reagents included in the current Parameters reagent database. Report Spectral If you select Spectral Response, the instrument Response asks you to load a test plate. The photometer then performs readings of the 96 wells on the plate using all the installed filters. From these readings, the instrument produces a 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 spectral response curve. Suggested test and reference filters are displayed on the screen. Double-click on a specific well to display the curve recorded for this well. A further double-click shows the overview again. Volume Volume offset parameters are used to optimise pipetting Offset accuracy. They are defined by the manufacturer only and Report cannot be edited by users. Users are only allowed to view the Volume offset report. Worklist Opens the Set-Up Panel dialog to create and start a new worklist. See chapter 4.5 on page 4-14
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Functions of the selection dialog Open With the function Open, results, worklists, event logs etc. stored/saved on the PC can be reloaded and displayed. In a first step, the type of file is selected, in the second step, the file itself is selected. ASCII Shows the Open dialog to open ASCII sample Sample information files. Information See chapter 7.1.3 on page 7-5 Assay Shows the Open dialog to open assay protocol files. Protocol See "Assay Programming Manual" Files Event Log Shows the Open dialog to open event log files. Files See chapter 4.7.6 on page 4-27
External Shows the Open dialog to open external archive Archive information files. Information See chapter 6.7 on page 6-53 Reagent Shows the Open dialog to open reagent layout files. Layout Files
Result Files Shows the Open dialog to open result files. See chapter 4.10.3 on page 4-68
Selftest Shows the Open dialog to open selftest report files. Reports See chapter 6.1 on page 6-1
Spectrum Shows the Open dialog to open spectrum files. Files
Verification Shows the Open dialog to open verification report files. Reports
Worklist Shows the Open dialog to open worklist files. Files See chapter 6.3.4 on page 6-25 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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3.2 Open/Load
With the function Open, results, worklists, etc. stored on the PC can be reloaded and displayed. For this purpose, the Open dialog is selected. In this dialog, the storage position (folder) and the file can be selected.
Figure 3-1: Open dialog
File name - Files of type Shows the file type (see chapter 8.2.8.1 on page 8-16). Filter With this function, the number of files displayed can be limited. After pushing the button, the Edit Text dialog (see chapter 3.5 on page 3-16) is opened. After the entry, only those files containing the entered text are displayed. The filter ignores capitalization. Example: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Filter input: 0706 Displayed files: Plate07062001, Plate07062701 Folder up With this button, you can move to the superordinate folder. Example: C:\Gemini\System => C:\Gemini Look in Shows the selected or defined folder (see chapter 8.2.8 on page 8-15) to open the file. Recent Files After clicking on this function, only files are displayed which have already been opened recently. If this function is clicked on again, all files are displayed again. This function has priority over the Filter function.
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3.3 Save
Save
With the function Save, results, worklists, etc. can be saved on the PC. If no file has been assigned up to now, the function Save as is opened automatically.
Save as With the function Save as, results, worklists, etc. can be saved on the PC. For this purpose, the Save as dialog is opened. Here, the storage location (folder) and the file name can be defined. If a file with the entered file name already exists, GEMINI instrument software requires whether to overwrite the existing file.
Figure 3-2: Save as dialog
Edit After clicking on the Edit button, the Edit Text dialog (see
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 chapter 3.5 on page 3-16) is displayed. Here, a new file name can be entered. File name Shows the existing, or automatically generated file name Folder up With this button, you can move to the superordinate folder. Example: C:\Gemini\System => C:\Gemini New folder By means of this button, a new folder can be created. The name is entered in the Edit Text dialog (see chapter 3.5 on page 3-16).
Save After clicking on the Save button, the file is saved with the entered file name. Save as type Shows the file type (see chapter 8.2.8.1 on page 8-16).
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Save in Shows the selected or defined folder (see chapter 8.2.8 on page 8-15) to save the file. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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3.4 Print on the Printer
With the function Print, results, worklists, etc. can be printed with the printer. Before printing, there is the possibility to select the printer, to adapt the printer settings and to view the printout as preview on the screen.
3.4.1 Print
With the function Print, results, worklists, etc. can be printed directly.
Figure 3-3: Print dialog
Printer Area Name Displays the standard printer. With the list, another printer can be selected. Print to file After the selection of this function, a file is created instead of a printout. The file is a pure print file and cannot be opened with the GEMINI instrument software.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Properties Shows the properties dialog of the selected printer. See printer manual for detailed information an settings. Status/Type/ Information about the printer. Where
Print range Area All Prints the complete document (results, assay etc.). Pages Prints the specified pages of the document. Selection Prints the marked part of the document.
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Copies Area Collate If more than one copy is to be printed, you can specify here whether the printouts are to be collated. Number of By means of this function, the number of copies can be set. copies
3.4.2 Print Setup
With the function Print Setup, the printer to be used can be selected and pre- configured. The settings are applicable for all subsequent printouts.
Printer Area Name The standard printer is displayed. With the list, another printer can be selected. Print to file After the selection of this function, a file is created instead of a printout. The file is a pure print file and cannot be opened with the GEMINI instrument software. Properties Shows the properties dialog of the selected printer. See printer manual for detailed information an settings. Status/Type/ Information about the printer. Where
Paper Area Size Allows the selection of the size if the paper to be used. Source Allows the selection of the paper tray where the selected paper lays in.
Orientation
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Area Landscape The selected paper is used crosswise. Portrait The selected paper is used on edge.
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3.4.3 Print Preview
This function allows a preview of the printout on the screen. In this way, for example printer presettings can be checked.
Close Close the print preview. Next Page Shows the next page. Prev Page Shows the previous page. Print Allows the printout of the preview (see chapter 3.4.1 on page 3-13). Two Page Shows two pages on the screen. Zoom In Scale up the shown page. Zoom Out Scale down the shown page. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 3-15
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3.5 Online Keyboard
The Edit Text dialog and the Edit a Number dialog allows the convenient entry of text or numbers on a touch screen monitor. For that, a online keyboard is displayed on the screen for the entry of the text. The entry itself is displayed in a separate text area. Next to this text area, the relevant purpose is displayed (e.g. password).
Cancel The entry is not imported and the dialog is closed.
Delete Pushing the Delete button deletes the character or digit on the left side of the cursor. Left Only Edit Text dialog: Pushing the left button makes the cursor jumping to the left by one figure. Minus Only Edit a Number dialog: The displayed value is decreased by one. OK The entry is applied and the dialog is closed.
Plus Only Edit a Number dialog: The displayed value is increased by one.
Right Only Edit Text dialog: Pushing the right button makes the cursor jumping to the right by one figure. Shift Shift switches to upper case for the next typed character only. Shift Lock Only Edit Text dialog: Shift Lock switches between upper and lower case, respectively between numbers or special characters. • Not activated: Numbers or special characters can be used, which are displayed in the lower part of the corresponding button, as well as lower case characters. • Activated: Special characters can be used which are displayed in 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 the upper part of the corresponding button and all characters in upper case.
3.6 Selection Dialog
Selection dialogs allow you to select a special function. The use of the selection dialogs is very easy. Search your desired function. If necessary, use the arrow buttons (see chapter 3.1 on page 3-1). Click on the desired function.
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The GEMINI is controlled via the GEMINI instrument software, a Microsoft Windows application running on the integrated PC. Procedures in this manual assume familiarity with Windows. If you are unfamiliar with the use of Windows, refer to the extensive on-line help of Windows. The usual Windows conventions apply. Deviations from these conventions are described where appropriate. In this chapter, the process of a test case from switching on till switching off the instrument for a "normal" user is described with the right to start a worklist. The basic functions of the GEMINI instrument software are described in chapter 3 on page 3-1. Additional functions for "normal" users and for users with additional rights are described in chapter 6 on page 6-1.
Required access rights: Start Worklists
Use of IFA and ELISA assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time.
4.1 Safety and Hints
Liquid in instrument Liquid which gets into the instrument can cause illnesses with deadly consequences in case of contact. The instrument can be damaged by liquids. • Switch off the instrument. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Separate the instrument from the mains supply. • Wear suitable protective clothing. • Clean, disinfect or decontaminate and dry the instrument according to the applicable local and national provisions, legislation and laboratory procedures.
Erroneous operation of the instrument or the software Malfunctions can cause serious injuries with deadly consequences or damage of the instrument. • Closely follow the steps contained in the individual instructions. • Check correct data input. • Check process of loading. • In case of constantly erroneous operation call service.
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4.2 Brief Sequence Plan
Start-up • Maintenance chapter 4.3 on page 4-3 • Switch on •Start GEMINI instrument software Load Samples and Assign • Load samples chapter 4.4 on page 4-8 Assays • Assign assays Create a Worklist • Check plates chapter 4.5 on page 4-14 • Check assays • Check samples Lot Specific Values • Enter batch numbers chapter 4.6 on page 4-15 • Enter assay protocol parameters The Worklist Window • Check worklist chapter 4.7 on page 4-18 Start Worklist • Load samples chapter 4.8 on page 4-31 • Load reagents • Load unstable reagents • Load dilution plates • Load tip racks • Fill wash buffer and clean fluid • Fill system liquid • Load test plates Processing the Run • Pre-run checks chapter 4.9 on page 4-51 • Steps of a typical test run • What you can do • Instrument/Pipetting errors • Instrument pause End of Run/Result Report •Structure chapter 4.10 on page 4-61 Window • Result interpretation • Editing/Recalculating the results • Save/Open the result report
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Print the result report • Export the results Unloading • Unload test plates chapter 4.11 on page 4-70 • Unload sample racks • Unload reagent racks • Unload tip racks and dilution plates • Unload other resources • Unload waste disposal Shut-down • Maintenance chapter 4.12 on page 4-75 • Terminate GEMINI instrument software • Shutdown operating system • Switch off
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4.3 Start-up
Assay Kit Read the instructions for use of the desired assay kit!
IFA Bay 1. If installed, remove the IFA bay and the IFA trays (see chapter 2.2.11 on page 2- (optional) 23).
Maintenance
Air in system tubing Both filter and liquid tubing must not run dry. Air in the system tubing may affect pipetting performance.
• Check the level of system liquid in the system liquid container. If low, refill it (see chapter 2.2.9.2 on page 2-20). • Check the level of waste liquid in the waste liquid container. If full or nearly full, empty and decontaminate it. Dispose waste liquid in accordance with legal regulations for biological hazardous waste. • Check pipettor tubing and syringe for air bubbles or leakages as these can cause pipetting errors.
See also chapter 9.2.1 on page 9-4.
After a period of instrument downtime (e.g. weekend), perform selftest twice (see chapter 6.1 on page 6-1). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Procedure Switch on: 1. Close the cover. 2. Switch on the instrument. The instrument is initialized and the integrated PC starts the Windows operating system.
Start GEMINI instrument software and log-on:
3. Double-click on the program icon to start the GEMINI instrument software. The GEMINI instrument software shows the Log-On dialog.
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Figure 4-1: Log-On dialog
Log On Shows a dialog to select a registered user. Demo mode Starts the GEMINI instrument software without connection to the instrument. The demo mode can be used to check assays or processes. See chapter 6.12 on page 6-75. Shut Down Terminates the program. Help Shows the on-line help.
4. Click on the Log On button. The GEMINI instrument software shows the Make a Selection dialog to select your user profile. Choose one of the following chapter: • Registered Users (see chapter 4.3.1 on page 4-4) • Unknown User Name / Unregistered Users (see chapter 4.3.2 on page 4- 4) • First-Time Use (Password Registration) (see chapter 4.3.3 on page 4-5) • Incorrect Password (see chapter 4.3.4 on page 4-6) • Successive Users (see chapter 4.3.5 on page 4-6)
4.3.1 Registered Users
If you are a registered user: 1. Select your user profile (user name). The GEMINI instrument software shows the Edit Text dialog (see 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 chapter 3.5 on page 3-16). 2. Enter your correct password. Instead of the entered password, "*"-symbols are displayed. 3. Click on the OK button. After the checking of the password, the instrument is initialized first. Then, a selftest is performed and its result is displayed (see chapter 6.1 on page 6-1).
4.3.2 Unknown User Name / Unregistered Users
If you do not have a user name or do not know it, you cannot set one for yourself directly in the Log-On dialog. You have to refer to an authorized supervisor (i.e. an GEMINI registered user who is allowed to Administer Users) in your laboratory who will declare you as a registered user and define your access rights according to the procedure described in (see chapter 8.1.1 on page 8-1).Then, when you first log-in under your new user name, you will have to set your first password as described below.
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4.3.3 First-Time Use (Password Registration)
If you are a registered user but this is the first time you use the GEMINI instrument: 1. Select your user profile. The GEMINI instrument software shows the Edit Text dialog (see chapter 3.5 on page 3-16). 2. Do not enter anything in the Password field or enter your temporary password (ask your supervisor). 3. Click on the OK button. After the checking of the password, the instrument is initialized first. Then, a selftest is performed and its result is displayed (see chapter 6.1 on page 6-1). 4. Select the Utilities > Options menu item to open the Options dialog. 5. Click on the Password tab.
Figure 4-2: Options dialog: Password tab
User Name Your user profile name. Current Field for your current password. Password 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 New Password Field for your new password. Any alphanumeric chain of characters can be used as password. Retype Field to retry your new password. Password Change Applies the change of the password,
6. Enter your current password (nothing or temporary password) in the Current Password field. 7. Enter your new password in the New Password field. 8. Retry to enter your new password in the Retype Password field. 9. Click on the Change button. 10. Click on the OK button to close the Options dialog.
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When you next start the GEMINI software, you will have to use the new password. If, later, you want to change it, you can do so as described above except that you first have to type in your current password in the Current Password field before defining a new password.
4.3.4 Incorrect Password
If the password you entered in the Log-On dialog does not match the password which has been defined for that particular user name, the instrument displays the following message:
Figure 4-3: Incorrect password message
1. Click on the OK button and try entering the password again.
If you have forgotten your password, see chapter 8.1.4 on page 8-7.
4.3.5 Successive Users
The user name entered when logging in will automatically appear in the Operator field in the selftest report and also in the header of the result files and result reports. It ensures a better traceability of tests performed. Therefore, if the instrument has been started by one user and another user wants to take over, the second user should log-in under his/her own user name. To do so, it is not necessary to shut down the instrument and restart it. You only need to: 1. Select the File > Close menu item to close all open windows (including the selftest report). You should see only the menu bar and toolbar above a gray screen. 2. In the Utilities menu, select the Log-Off/Log-On menu item. The Log- On dialog is displayed. 3. Click on the Log On button. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 4. Select your user profile. The GEMINI instrument software shows the Edit Text dialog (see chapter 3.5 on page 3-16). 5. Enter your correct password. Instead of the entered password, "*"-symbols are displayed. 6. Click on the OK button.
This cannot be done when a worklist is being processed. You have to wait until the processing is over.
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4.3.6 Users with Restricted Access Rights
The GEMINI instrument allows the creation of various user groups with different access rights, e.g. users belonging to one group may be allowed only to run the instrument while users with more extensive rights will be allowed to define assays or change the system set-up. Users with restricted access rights can always start the instrument and log-in as long as they are registered users (have a valid user name and password). For more information on defining user groups and assigning each user to a specific group, see chapter 8.1 on page 8-1. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.4 Load Samples and Assign Assays
In this section, it is described how samples with or without barcode can be loaded into the instrument and how they can be assigned to one or several assays.
Information Before processing an assay (especially if it is the first time you are using this assay), about used you may want to review the various steps to be performed, the task sequence, the Assays incubation times, the reagents used, etc. To do this, open and print the assay file as described in chapter 3.2 on page 3-10 and chapter 3.4 on page 3-13. For more details about assays, see "Assay Programming Manual".
4.4.1 Load Samples
Improper loading or unloading of racks, reagents and samples Improperly loaded or unloaded racks, reagents and samples can produce erroneous results due to incorrect pipetting activities. • Only load and unload racks if you are explicitly requested to do so. • Only load and unload racks on the specified lanes. • Check the correct transfer or input of all reagent and sample names.
Use of Racks Insert the racks carefully to avoid tipping over and spilling of bottles or tubes.
Moving barcode scanner The movement of the moveable barcode scanner can trap you or knock over objects put down on the loading bay. • Never enter the loading bay when the instrument is switched on and you
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 have not received an approval by the instrument! • Never enter the loading bay before the moveable barcode scanner has come to a standstill! • Never use the loading bay as storage space!
Do not touch the barcode scanner while loading a rack!
To avoid clots, the samples should have been treated accordingly (e.g. centrifuged) prior to the use in the GEMINI instrument.
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Samples for multi-preparation assays For multi-preparation assays always the multi-preparation samples must be loaded in the same order as defined in the assay!
Procedure 1. Place the sample tubes in the sample racks. • Barcoded samples: Make sure that the barcode labels on the individual samples face right so that they can be scanned by the barcode reader when the rack is inserted. • Non barcoded samples: If you are using non barcoded sample tubes and you want to use the Auto Arrange function to allocate samples, be sure to place the samples in the racks in the order that will be used by the instrument to allocate the samples (see chapter 4.8.2 on page 4-36).
2. Click on the Utilities button.
3. Click on the Turn Scanner On button. 4. Insert the first rack on the lane marked by the LED illuminated permanently. Place the rack in front of the lane and then push evenly up to the limit stop (with the tappet in the contact opening on the rear panel). The rack barcodes and the individual sample barcodes are read. If the rack has been inserted properly all the way, the LED goes off for this position, and turns on at the next position that can be loaded. 5. Enter ID for non barcoded samples and assign assays to all loaded samples (see chapter 4.4.2 on page 4-10). 6. Insert the other sample racks in the same manner.
Error recovery • Troubleshooting while Loading Samples (see chapter 10.2.1 on page 10-16) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.4.2 Assign Assays to the Samples (Tabular Sample Editor)
Wrong Results It is necessary to use only for GEMINI validated assays to avoid wrong results.
This dialog is not displayed if you use the GEMINI instrument software in demo mode. In this case, please refer to the manual procedure with the complete Sample Editor dialog (see chapter 6.2 on page 6-4).
The instrument displays one dialog per inserted rack (if you insert three racks, the instrument will display this dialog three times).
Sample ID The entered sample ID must be unique! If non-unique sample IDs are used (e.g. same ID for different persons at different worklists), the sample database is incorrect. In this case, features like sample history or sample result report must not be used. • Recheck entered sample ID and original sample ID!
Sample IDs of multi-preparation assays Sample IDs on multi-preparation assays must not be unique. All multi-preparation samples that belong together may have the same Sample ID.
In the results, all manually entered sample IDs will be flagged ("ManID" flag).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Samples for multi-preparation assays A multi-preparation assay supports the using of different preparations of probes from an unique sample to transfer them to a combined result. • For multi-preparation assays always the multi-preparation samples must be loaded in the same order as defined in the assay! • If you assign the first multi-preparation sample to a multi-preparation assay, the following samples are occupied as corresponding preparations. All preparation sample tubes are assigned to the sample ID of the first preparation sample tube!
The left side of the dialog shows you an enlarged view of the red marked area on the right side.
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Pre-Defined In this chapter, it is assumed that the tests are performed using pre-defined assays. Assays However, the GEMINI instrument also allows users to create and use their own assays (see ’GEMINI - Assay Programming Manual’)
Processing The GEMINI instrument and software allow the user to process different assays in Several Assays the same test run. In most cases, a different test plate will be used for each assay. This is described in this section. However, the GEMINI instrument is flexible and also allows the user to combine several compatible assays on the same test plate (see chapter 6.3.3 on page 6-21).
Procedure Each time you load a sample rack as described in chapter 4.4.1 on page 4-8, the following tabular Sample Editor dialog is automatically displayed:
Figure 4-4: Tabular Sample Editor dialog (with sample IDs and assigned assays)
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Barcoded samples: If you are working with barcoded samples, column 1 shows the Sample IDs as read on the barcodes.
Barcoded and non barcoded samples: If you have both barcoded and non barcoded samples on the same rack, the barcoded positions in column 1 will be filled while the non barcoded positions will be blank. You have to enter the (non barcoded) Sample IDs manually in column 1: 1. Select the empty Sample ID field. Do not remove or exchange any of the barcoded samples (the instrument compares successive readings). 2. Enter the correct sample ID.
A blank position can also indicate either that a position is empty (no test tube was inserted) or that the instrument has not been able to read the sample barcode correctly.
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Non barcoded samples: If you are working with non barcoded samples, you have to enter the Sample IDs manually in column 1 (see above). If you have a lot of non barcoded samples to process, you may prefer to close this dialog box (click on the Close button) and do the assay assignments using the manual procedure described in chapter 6.2 on page 6-4.
Assign one or more assays to each sample: 1. Click on the button over the first free column. 2. Select the assays in the selection dialog (see chapter 3.6 on page 3-16) to be processed in this test run. If you want to assign more assays, additional columns will be automatically displayed. 3. Select the cell in the assay columns for the samples who are to be tested with the assay you selected in the corresponding drop-down list. Use the green arrow buttons to scroll the screen. 4. Click on the Close button to close the tabular Sample Editor dialog. Never use the x button in the top right-hand corner of the dialog to close it - entered data would not be retained. 5. If you inserted more than one rack, the instrument displays the dialog for the next rack (it may take a little while to show on the screen). Repeat the procedure for each rack. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.4.3 Import Sample Data and Linked Assays through Host Connection
If the GEMINI instrument is connected to a host computer, sample data can be downloaded to the system via this connection. These downloads can be requested by the user or performed automatically as described in chapter 7.1.2 on page 7-3 and chapter 7.2.3 on page 7-17. The downloaded data can include the sample details (ID Code, Name, Birth date, Sex) and the tests/assays required for each sample if these have already been assigned (at the host computer level).
Procedure If the data was imported before the racks were loaded: If the rack(s) you inserted correspond to a test order that has already been imported into the GEMINI instrument, the tabular Sample Editor dialog will be automatically displayed with all the appropriate fields already filled in. 1. Just check that everything is correct and click on the Close button. Never use the x button in the top right-hand corner of the dialog to close it - entered data would not be retained. 2. If you have inserted more than one rack, the tabular Sample Editor dialog corresponding to the next rack will be displayed. Check it and close it. 3. Repeat the steps for each inserted rack.
If you have inserted the rack(s) before importing the data and are using ASCII file imports: 1. The tabular Sample Editor dialog is blank when it is displayed. Click on the Close button to close it. Repeat this step, if you had inserted more than one rack, to close all tabular Sample Editor dialogs. 2. Import the desired file as described in chapter 7.1.3.1 on page 7-6. 3. When you have obtained a message indicating that the file has been successfully imported, click on the OK button. 4. Pull out your sample racks and load them again. 5. Wait until the tabular Sample Editor dialog is displayed again with the appropriate data already entered. This may take some time. 6. Check that everything is correct and click on the Close button. 7. If you have inserted more than one rack, the tabular Sample Editor
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 dialog corresponding to the next rack will be displayed. Check it and close it. Repeat this for each inserted rack.
On importing multiple test order requests for the same sample, see chapter 7.1.3.5 on page 7-9.
If you have inserted the rack(s) before importing the data and are using an ASTM connection: 1. If you have checked the Query Host For Test Orders item in the ASTM dialog (see chapter 8.2.6 on page 8-12) the software will automatically interrogate the host for test orders related to the samples you have just loaded. 2. If you have not previously checked this item, you can check it now and then reload your samples.
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4.5 Create a Worklist
A worklist is a work instruction for the GEMINI instrument. In the worklist, the sequence and the plates to be processed with the assigned assays are defined.
The following instruction describes how to generate and check a worklist which was automatically suggested by the GEMINI instrument. The GEMINI instrument suggests a worklist whenever you load samples as described in the previous chapters. If the assays included in the worklist belong to the same combination group and if the assay parameters (incubation time, shaking parameters, wash steps …) are compatible, the instrument will automatically try to combine several assays on the same plate (provided the number of samples allows this). For more information on processing several assays on one plate, see chapter 6.3.3 on page 6-21. If you want to edit a suggested worklist or generate a worklist yourself, please refer to chapter 6.3 on page 6-11.
Procedure (Check Worklist)
1. Click on the menu item New > Worklist or the New Worklist button. The GEMINI instrument software shows the Set-up Panel dialog (see chapter 6.3.1 on page 6-15). 2. Check the worklist (see also chapter 6.3 on page 6-11):
• Click on the + sign of the first plate to open the complete plate/assays tree. • Check the assays! If something does not work ok, please make the required changes. • Click on the + sign of the first assay to open the complete assay/ 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 samples tree. • Check the assigned samples! If something does not work ok, please make the required changes. • Repeat the steps for all other assays on the selected plate. • Repeat the steps for all other plates.
3. If everything works correct, click on the OK button. The GEMINI instrument software shows the Lot Specific Values dialog (see chapter 4.6 on page 4-15). If something does not work correct, please make the required changes and then click on the OK button.
Once the worklist is defined, the instrument checks all parameters and signals any error. Errors must be corrected before you start a run.
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4.6 Lot Specific Values
After an internal check of the worklist, of the assay protocols and of the required resources, the GEMINI instrument software asks for required reagents (diluent, conjugate, substrate, stop solution, etc.), controls, standards, wash buffers and clean fluid in the Lot Specific Values dialog. The Lot Specific Values dialog also allows you to enter additional information for specific kit types.
Reagents of different lots (but with same ID) are interchangeable for the software.
For every used plate, an individual Lot Specific Values dialog is displayed. In this dialog, the lot specific values for all assays are listed, which are used on the relevant plate. The name of the plate is displayed in the title of the dialog (top left). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 4-5: Lot Specific Values dialog (e.g. ’Plate 1’ with two assays)
The Lot Specific Values dialog is subdivided into two areas:
Batch Numbers Parameters of the lot specific values.
Assay Protocol If the assay includes standards for which the concentration is batch dependent or if Parameters control value ranges are batch-dependent, these items are listed here with their respective batch-specific values/data (otherwise the list is blank).
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Functions The following functions always refer to the highlighted line in one of the two lists:
Assay registers Via the assay registers, you reach the lot specific values belonging to the relevant assay.
Add Batch Click this button if a QA of a reagent or sample will be made. For example if you want to generate a QA Analysis Report (see chapter 6.9 on page 6-72) of replicates of reagents or of a reference sample this function can be used. Enter the name of the new observable and assign the assay layout label being used by this. Edit Batch With this function, you can edit the Batch Name, if necessary. Name The shown name is defined in the reagent database and in the assay definition. Edit Batch With this function, you can edit the Batch Number. After clicking Number on it, a selection dialog is displayed where you can select a suggested Batch Number. If you want to enter your own number, select Other and enter the Batch Number afterwards. Edit Expiry With this function, you can enter the expiry date for the selected Date batch. Edit QA Label Entering QA labels (e.g. NC, NC1, PC2, etc.) for controls allows you to follow the results obtained with a particular control over a period of time by compiling a QA Analysis Report (see chapter 6.9 on page 6-72). Edit Tolerance With this function you can enter a tolerance range for the selected batch. Edit Units With this function you can enter the unit of the tolerance range for the selected batch. Remove Batch Removes the highlighted reagent from the list. This function delete the reagent only from the list and you can’t enter the Batch Number etc. Scan Barcode Allows you to scan 1D/2D barcode of a kit with an installed handheld barcode scanner. It is also possible to enter the barcode manually.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The instrument software applies the following information: • Kit lot number • Expiry date of the kit • Standard reference value • 4-parameter fit A,B, C and D • Cutoff values • Conjugate grade
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Procedures 1. Edit the following batch data if they are required (see above): • Batch Number: Click on the Edit Batch Number button. • Expiry Date: Click on the Edit Expiry Date button. • QA Label: Click on the Edit QA Label button. 2. Click on the Add Batch button if a QA of a reagent or sample will be made (see above). 3. Edit your assay protocol parameter(s) if required (see above). 4. Repeat the stated steps for all assays on the plate. For that, click on the corresponding register. 5. Click on the OK button to confirm the entries for the plate. 6. Repeat this process for all other plates. After the entry for the last plate, the Worklist window is displayed automatically (see chapter 4.7 on page 4-18). Use of these lot specific values: 7. If you will use these lot specific values for all other assays: • Click on the OK button. • Click on the Yes button in the following message. The Worklist window is displayed automatically (see chapter 4.7 on page 4-18). 8. If you will use different lot specific values for all other assays: • Repeat the stated steps for all assays on the plate. For that, click on the corresponding register. • Click on the OK button to confirm the entries for the plate. • Repeat this process for all other plates. After the entry for the last plate, the Worklist window is displayed automatically (see chapter 4.7 on page 4-18).
Error recovery • Error Detection while creating Worklist (see chapter 10.3.1 on page 10-21) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7 The Worklist Window
The worklist window shows all data of the generated worklist and the current process status during the start later on. With the buttons on the left side, the individual data can be displayed. Additionally, the menu Edit is activated (see chapter 3.1 on page 3- 1).
Figure 4-6: Worklist window - worklist parameters information 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Worklist Shows worklist details (e.g. plate ID, start and finish time, load status, parameters assays and amount of samples). See chapter 4.7.1 on page 4-20 Schedule The schedule displays graphically the actions being performed (e.g. pipette, wash, incubate etc.). See chapter 4.7.2 on page 4-21 Plate layouts Shows the plate layout (e.g. assays, controls, samples) of all plates. See chapter 4.7.3 on page 4-23
Reagent Shows all required reagents. requirements See chapter 4.7.4 on page 4-24
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System status Shows the status of the instrument components (e.g. incubators, loading bay etc.). See chapter 4.7.5 on page 4-26 Active event Shows a list of all steps of the run as they are performed. The screen log is blank when viewed before the start of the run. See chapter 4.7.6 on page 4-27 Job list Shows all samples and its assigned assays. See chapter 4.7.7 on page 4-30
Sample Shows information about the sample archiving. archiving See chapter 4.7.8 on page 4-30 information Edit Panel Opens the Set-up Panel dialog box with editing options of the current worklist. This function is also called Panel Definition. See chapter 6.3.1 on page 6-15 Edit Options Opens the Worklist Options dialog box to change worklist processing options. This function is also called Panel Options. See chapter 6.4 on page 6-27 Other Options Opens a selection dialog to select further options (e.g. lot specific values - see chapter 4.6 on page 4-15, or export archive etc.).
Start Opens the Load dialog to allocate the required resources. After that, a run using the current worklist will be started. See chapter 4.8 on page 4-31
Procedures 1. Look for the worklist settings and/or change the worklist settings. 2. To start the worklist see chapter 4.8 on page 4-31. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.1 Worklist Parameters
This window shows the parameters of the worklist (see chapter 4.7 on page 4-18) in the following columns:
Plate ID List of defined plates and indication of the plate names. Start Start time of run. This is the time at which you have quit the Set-up Panel dialog by clicking OK and the worklist was displayed. Finish Time at the end of the run, calculated using the work steps and their duration. Note: The actual finish time depends on when the run is actually started. The time displayed here allows you to calculate how long the run will take. Status Shows the status of each plate. If Error is displayed, see (see chapter 10.3.1 on page 10-21). Otherwise, you see Not loaded as long as the test plates have not yet been loaded. The status then changes to Processing and finally to Finished (or Aborted if the processing of that plate has been stopped and not resumed). Assay Shows the name of the respective assay file. If there are more than one assay on a given plate, all the names are listed one below the other. #Samples Shows the number of samples per plate (and per assay if there are more than one on the same plate) as defined in the worklist. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.2 Schedule
The Schedule shows how the test will actually be performed. This allows the user to get an accurate view of the duration of each step and the sequence in which they will be conducted, as well as how the instrument will combine the processing of all the plates that are to be processed in the same run (interlacing). It is therefore a good idea to check the Schedule before starting the run (the Schedule is also useful afterwards, when the run is being processed, to follow how the test run is executed and which step is currently being performed on which plate).
The schedule is displayed in two ways:
Module Schedule (top): Each strip or segment shows at which time each instrument module (pipettor, washer, colorimeter, incubator, plate transport unit) will be used for each plate. Each plate is depicted in a different color. The run time scale is on a horizontal line above the strips. When the test run is started, the vertical line on the left will move forward (towards the right), allowing the user to check at any given time what part of the run is currently being processed.
Plate Schedule (bottom): Each plate is shown as a horizontal strip. The various steps of the process (pipetting, incubation, reading, washing) are shown as segments on this strip (each step marked by a different color). As in the Module Schedule view, the time scale is at the top and the vertical line on the left will move forward once the run is started. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 4-7: Worklist window - schedule
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Below the strips, additional information is displayed:
System Shows when the sample archiving operations (if any, see chapter 6.7 on page 6-53) will be performed. Additional Shows when additional resources such as tips or reagents resources are to be loaded. If such reloading is necessary, a line saying "Operator intervention required in X minutes" will also displayed. Additional Shows the time periods when it is possible to reload test plates plates (corresponds to periods when all the plates being processed are incubating).
When you click on a segment of the schedule view, a screen with detailed information about the respective assay step will be displayed. Clicking again on this screen will display again the complete schedule.
When processing a run in Demo Mode (see chapter 6.12 on page 6-75) the run time displayed in the Schedule window will be accelerated, i.e. 1 second in the Schedule window = 1 minute in a real run. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.3 Plate Layouts
Selecting Plate Layouts will show the exact plate layouts. All plate layouts defined in the current worklist are displayed one below the other.
Figure 4-8: Worklist window - plate layouts
See chapter 6.3.1 on page 6-15 for used plate layout labels. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.4 Reagent Requirements
Selecting Reagent requirements shows the list of all reagents required for the tests.
Figure 4-9: Worklist window - reagent requirements
This window shows the reagent information in the following columns:
Position Indicates where each reagent has been loaded on the instrument. This column remains empty until all reagents are loaded and allocated (see chapter 4.8.3 on page 4-39). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Reagent List of all the required reagent. The order of the list follows the order of the assays to be processed. Clean fluid and wash buffers are listed separately at the bottom. Required Volume of each reagent required for the run. Left Volume available. This entry will decrease as the run is being performed. By default, the volume that is displayed before the worklist begins and which will be used to calculate the available volume while the run is being performed is the volume of the respective reagent bottle when full. If you want the instrument to determine the exact volume that is actually available in the bottles, you have to enable the Check reagent levels before a run option in the Worklist Options dialog (see chapter 6.4 on page 6-27). This will then be used as the starting basis.
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It is possible to print this list and use it as a checklist when preparing the various reagent and control bottles before loading them onto the reagent racks. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.5 System Status
The System status displays a graphical presentation of the work area.
Figure 4-10: Worklist window - system status
1 Clean fluid and wash buffers 2 2 incubator and 3 ambient positions 3 3 tip racks positions 4 2 dilution plate, archive plate, or large reagent bottle positions 5 Loading bay 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 This display is useful to check the status of the incubators. If they are functioning correctly, they appear in green; if any problem is detected or before they have reached the correct temperature during preheating, they appear in red.
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4.7.6 Active Event Log
The Active Event Log lists in real time the steps of the run as they are performed. The screen is blank when viewed before the start of the run. The scripting is always done at the top of the list, i.e. the step currently being performed is always at the top of the list while already completed steps are further down.
Contents: The wording used in the log file is generally simple and descriptive, making it easy to follow for any operator after minimal use of the GEMINI instrument. The only exception to this rule regards the "Dive In/Dive Out" values. These values are included in the log file to allow detailed monitoring of the pipetting/liquid detection system. This monitoring is intended for GEMINI specialized technicians only. General users can safely rely on existing flags to detect and signal pipetting errors (Clot, NoLiq, InsLiq, see chapter 4.10.2.1 on page 4-66). If you require assistance in understanding a particular log file, you can easily save it (see below) and mail it to your service engineer.
Colors: Different colors are used in the log.
Black Used to describe steps that have been correctly performed. Red Signals any problem occurring during the run (e.g. incorrect dispense, instrument paused, errors...) Green Signals actions taken by the operator to enable the instrument to resume or continue the run.
Example: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 4-11: Example of an active event log
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Backwards line-wrap. Generally, each operation or user intervention starts on a new line. When the line is too long, it wraps automatically. Note, however that when the log file is "active" (during the actual run), the scripting is done from bottom to top, so that the end of a line will be above the beginning of the line instead of below. In a saved log file on the contrary, the correct line-wrap order (with the end of the line below) is restored.
Use: The active event log is an important document. It can: • Be followed while the run is being processed so that the operator can act rapidly to correct any malfunction of the instrument. • Be used, after the run is over, to check whether all steps have been properly performed. If, for example, some results are flagged, the active event log enables the user to understand why this is so. • Be printed. • Be used at a later date to check how the run was processed.
4.7.6.1 Open a formerly saved Event log File
Event log files are automatically saved by the instrument. By default, they are saved in the C:\...\Log Files directory. They have a (*.log) extension and the file name corresponds to the date on which the run(s) was (were) performed: e.g. "20080315.log" (YYYYMMDD)
The logs of all the test runs performed on the same day are aggregated in the same log file. Access to the event log file of the current day is restricted. It can only be viewed from the Worklist window. It cannot be opened through the File > Open menu item as indicated below.
Open an event log file:
1. Click on the Open button. 2. Click on the Event Log Files button. 3. Click on the corresponding event log file. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 When the log file is created, the scripting is done in a way that the current step is always at the top while earlier steps are further down. But when you open a formerly saved event log, the daily chronological order is rearranged from start-up to shutdown.
Event Log Filter The purpose of the event log filter is to allow the user to find in the log file all the lines related to one specific worklist, one specific plate or even one specific sample. The event log filter is available only if you open a formerly saved event log. It is not available from the Worklist window or when the run is being processed. To open the Event Log Filter dialog: 1. Open an event log file as described above. 2. Click on the View > Filter button.
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Figure 4-12: Event Log Filter dialog
3. Select a Worklist. 4. Select a Plate ID (if wished). 5. Select a Sample ID (if wished). 6. Click on the OK button.
Event log in Each time a log file is created in (*.log) format, an identical file is created with a (*.txt) (*.txt) format format with the same filename and in the same directory (e.g. "20060228.log" => "20060228.txt"). The (*.txt) file can be viewed with any text editor.
The (*.txt) version of the log may be changed, even inadvertently. As a result, if you need to send a log file back to your service engineer for troubleshooting or expertise, always send a copy of the actual (*log) file rather than the (*.txt) version. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.7.7 Job List
Selecting Job List shows a reminder of which test(s) are to be performed for which Sample IDs.
Figure 4-13: Worklist window - job list
4.7.8 Sample Archiving Information
On sample archiving, see chapter 6.7 on page 6-53. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8 Start Worklist
If the loaded worklist is error-free, the Start button in the worklist window is enabled (appears in green instead of gray). If you click this button, the instrument prompts you to load the instrument with the required resources (samples, reagents, dilution plates, tip racks, wash buffer, clean fluid…) and opens the Load dialog box. Test plates are loaded at a later stage. The loading process on the GEMINI instrument includes three stages: • The actual (physical) loading of reagents, racks and accessories in the instrument. • The allocation of these resources in the software. • The loading of the test plates.
The purpose of the allocation process is to enable the software to track whether each sample, each reagent and each of the other required resources has been loaded, and where it has been placed in the instrument. When using barcoded components, part of the allocation process is done automatically since the instrument can then identify each component and monitor its location through the barcode. For items that are not barcoded, the allocation process is done on the screen in the Load dialog (for samples, reagents, dilution plates, and tip racks). For those elements that have a set location on the instrument (wash buffer, system liquid) the system is able to monitor directly through other devices (e.g. sensors) which quantity is available on the instrument and if more is required for the current worklist, this is displayed in the Load dialog. For those elements, no allocation process as such is necessary but they should be loaded on the instrument in strict accordance with what is displayed in the Load dialog.
Procedures
1. Click on the Reagent requirements button to note the required wash buffer and clean fluid volume (see chapter 4.7.4 on page 4-24). If necessary fill the wash buffer and clean fluid bottles. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
2. Click on the Start button in the worklist window to start the worklist (see chapter 4.7 on page 4-18). The GEMINI instrument software shows the Load dialog (see chapter 4.8.1 on page 4-33). • Usually, all samples must be loaded and assigned at this point of time. If, however, you did make supplements during the generation of the worklist, those samples must still be assigned (see chapter 4.8.2 on page 4-36). • Load all required reagents (see chapter 4.8.3 on page 4-39). Please observe the hints about unstable reagents (see chapter 4.8.4 on page 4- 42). • Load all required dilution plates (see chapter 4.8.5 on page 4-44). • Load all required disposable tips (see chapter 4.8.6 on page 4-45). • Fill wash buffer and clean fluid bottles (see chapter 4.8.7 on page 4-48). • Fill system liquid container, if necessary (see chapter 4.8.8 on page 4-49).
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3. Click on the OK button to confirm the Load dialog. 4. Load all required test plates (see chapter 4.8.9 on page 4-49). After the last plate, the worklist will be started automatically (see chapter 4.9 on page 4-51). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.1 Load Dialog
The Load dialog illustrates the top level of the instrument (work area):
Figure 4-14: Load dialog
Auto Arrange Click this button to allocate all samples in the Unallocated Samples resources column in ascending order on the sample racks (from right to left) (see chapter 4.8.2.2 on page 4-37 on when to use this button). Clean fluid and The clean fluid and wash buffers symbols indicate which type of clean wash buffers fluid and wash buffers is required in which bottle (color-coded lids). By clicking on the corresponding symbol, the type of clean fluid and wash buffers is displayed.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Dilution plate The dilution plate symbol indicates which type and how many dilution plates you need. If required, you can arrange the dilution plates in another way than suggested (see chapter 4.8.5 on page 4-44). Edit Allows you to use already used reagents. After clicking on a reagent and than on the Edit button the Reagent Properties dialog is opened. Enter the remaining liquid in percent. Free position Free position for dilution plates or large bottles.
Free position Free position for tip racks.
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Open Reagent With this function, you can load the positions for reagents saved Layout earlier. This makes the manual assignment obsolete. After clicking on the function, the Open dialog is opened. Warning: The instrument won’t check opened reagent layouts. Make sure that positions are correct! See chapter 6.5.2.1 on page 6-36 for further information. Reagents and In the sector loading bay, all racks are displayed which have already samples in racks been loaded. The individual reagents or samples can be assigned to this rack positions. Click on the relevant symbol to get more information on it or the rearrange it. See chapter 2.2.4.1 on page 2-15 for rack identification. Redraw If reagents or samples are pushed into the sector Unallocated Unallocated Resources again, it can happen that they are laid on top of each Resources other. With the function Redraw Unallocated Resources, you can have the sector Unallocated Resources rearranged. Save Reagent With this function, you can save the selected positions for the Layout reagents and re-use them later for a similar test. After clicking on the function, the Save dialog is opened (see chapter 3.3 on page 3-11). See chapter 6.5.2.1 on page 6-36 for further information. Scanner Allows to choose the track where the instrument will accept the next Focus rack. Click on the desired track in the Select a Track dialog. Note: Double lane racks can only be inserted in every 2nd track (the software will reject rack otherwise. See warnings below. Scanner Off Switches the barcode scanner off. See warnings below. Scanner Setup Opens the Scanner Configuration dialog and you can view and edit the scanner parameters or the rack types and positions (see chapter 6.5.2.2 on page 6-37 on when to use this button). Start Closes the dialog when all required resources (samples, reagents, dilution plates, tip racks, wash buffer/clean fluid and system liquid) are properly loaded and allocated and starts the test plate loading procedure (see chapter 4.8.9 on page 4-49). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Tip rack The tip rack symbols indicate which tip size and how many tips are required. If required, the tip racks can be arranged in another way than suggested (see chapter 4.8.6 on page 4-45). Note: If more tips are required than can be loaded, the missing tips must be reloaded at a later time. The GEMINI instrument software indicates the relevant point of time (see chapter 4.7.2 on page 4-21). Unallocated In the area Unallocated Resources, all reagents and Resources: samples required for the test run but have not yet been assigned or Reagents and loaded are displayed. By clicking on the relevant symbol, you receive samples more information on it or its assignment. Zoom In With this function, you can enlarge the sector loading bay and Unallocated Resources. With this enlarged presentation, the assignment of samples and reagents is facilitated.
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Zoom Out After clicking on this function, the complete Load dialog is presented.
Check correct Position Always check for the correct positioning of the sample tubes, reagent bottles and the wash buffer bottles before starting the worklist!
Editing the worklist after the Load dialog is displayed: Sometimes, it is only when the Load dialog is displayed that you realize that some elements of your worklist have not been correctly defined. In this case, you need to go back to the Set-Up Panel dialog and change what you need to change. To do this: 1. Close the Load dialog by clicking the Cancel button (NOT the OK button!). This takes you back to the Worklist window. 2. Click on the Edit Panel button to open the Set-Up Panel dialog. 3. Change what you need to change and click on the OK button. 4. Click on the Start button. A new Load dialog is displayed, reflecting the changes you made.
The same applies for Worklist Options. If you want to change them (e.g. if you have forgotten to specify that you wanted to archive some samples or if you want to work with full tip racks only), repeat the steps described above but click on the Edit Options button. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.2 Load Samples
At this stage, the sample racks should already have been loaded in the instrument as described in chapter 4.4 on page 4-8 (it is usually the first thing to do when starting a test run). However, if it has not been done, you can refer to that section and load them now. • Load Samples and Assign Assays (see chapter 4.4 on page 4-8) • Allocate Barcoded Racks and Individual Samples (see chapter 4.8.2.1 on page 4-36) • Allocate Barcoded Racks and Non-barcoded Individual Samples (see chapter 4.8.2.2 on page 4-37) • Allocate Non-barcoded Racks and Samples (see chapter 6.5.2.3 on page 6-40)
Samples for multi-preparation assays For multi-preparation assays always sample tubes must be loaded as described in chapter 4.4 on page 4-8!
4.8.2.1 Allocate Barcoded Racks and Individual Samples
If the racks and the individual samples were barcoded, they should now appear in the central section of the Load dialog as rows of small dots. Moving the mouse pointer over a dot will show the Sample ID of each sample. The color of each dot indicates the status of each sample.
Colored Indicates samples that have been correctly loaded by the operator and correctly identified by the instrument through their barcodes. No further allocation is needed. The actual color used depends on what has been specified in the Pipette tab of the System Set-Up dialog (see chapter 8.3.4 on page 8-25). Blank Signals either an empty position (i.e. partially full racks) or a sample tube without barcode (or a barcode the instrument cannot read). Allocate manually if necessary (see chapter 4.8.2.2 on page 4-37).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Black Indicates a sample that has been loaded but which is not required for the run, i.e. no assay is assigned to that sample. Either remove the sample from the rack or go back to the Set-Up Panel dialog to check why this is so and correct the assay assignment for this sample.
For more details on barcode settings, see chapter 8.3.6 on page 8-33.
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4.8.2.2 Allocate Barcoded Racks and Non-barcoded Individual Samples
If the racks were barcoded but not the individual samples, the racks are depicted as empty (rows of blank dots) in the central section of the Load dialog while the samples are depicted as Unallocated resources. You now need to allocate them either manually or automatically. To allocate samples manually: 1. Click on the first sample (colored dot) in the Unallocated resources area you want to allocate. This will shown its code name/ID. 2. Click on the rack position, where the sample is located in the instrument. The sample is moved in the Load dialog. 3. Repeat for each sample.
Correct Sample Position Make sure that the position to which you allocate a sample on the screen corresponds exactly to the real position of the corresponding sample tube in the rack! This is very important as wrong allocation is equivalent to mixing up samples.
Auto Arrange To allocate samples automatically: Samples 1. Click on the Auto Arrange Samples button in the Load dialog. The unallocated samples are then allocated to the available sample racks, from the top down and starting with the first rack on the right. The order in which samples are allocated to the consecutive rack positions (position 1, position 2, etc.) follows the order selected in the Sample Editor dialog (Ascending, Descending or None - see chapter 6.2 on page 6-4) as illustrated below.
Order: Sample Editor: Sample Rack:
Ascending 6030 6040 6041 6042 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 6060
None 6040 6030 6060 6041 6042
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Automatic allocation Automatic allocation is a timesaving option if you have a lot of non-barcoded samples to allocate. It implies that the person who actually places the sample tubes in the racks and the racks in the instrument does it in strict compliance with the order resulting from the automatic allocation. • Make sure that the position to which the instrument or the user allocate a sample on the screen corresponds exactly to the real position of the corresponding sample tube in the rack! This is very important as wrong allocation is equivalent to mixing up samples. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.3 Load Reagents
4.8.3.1 Placing the Reagents on the Racks
On the GEMINI instrument, there is no need to transfer the kit reagents into any particular container before loading them on the instrument. The GEMINI reagent racks have been designed to accept most types of kit bottles, vials or tubes available on the market. The reagents can therefore generally be placed directly in the racks. There are only a few cases where this is not possible: unstable reagents which have to be prepared separately, kit bottles too large (e.g. 125 ml bottles) or too small for the racks, controls which have to be decanted in haemolysis tubes. These cases are dealt with in chapter 4.8.3 on page 4-39 and chapter 4.8.4 on page 4-42. For more information on rack types, see chapter 2.2.4 on page 2-14. Using the reagent requirements checklist (see chapter 4.7.4 on page 4-24), check that you have fitted all the required reagents on the racks. If you need a reminder of where you placed each reagent/control, you can copy and fill in the rack layout forms. When opening the reagent bottles, be careful not to mix the bottle caps as these may be needed again after the run and should not be exchanged from one bottle to another.
4.8.3.2 Loading the Racks on the Instrument
1. Once you have fitted all the required reagents on the racks. 2. Insert the first rack on the lane that is marked by a LED. Place the rack in front of the lane and then push evenly up to the limit stop (with the tappet in the contact opening on the rear panel). A reagent rack occupying 2 or 3 tracks must be inserted so that the contact tappet is opposite the lit up LED. The barcode labels (if any) must face right towards the barcode reader. 3. The LED goes off and moves to the next position that can be loaded. A graphical representation of the correctly inserted rack appears in the Load dialog on the screen. 4. Insert the next reagent racks (if any) as described.
4.8.3.3 Allocate Barcoded Racks and Barcoded Reagent Containers
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 If both the racks AND the individual reagent containers, vials or bottles were barcoded and were correctly inserted, the racks and the reagent containers should now be displayed on the screen in the loading bay area of the Load dialog: • The reagents that are required for the run and have been correctly loaded and identified (through their barcodes) are automatically allocated and appear in the racks as larger or smaller colored dots (a different color is used for each reagent) with a cross. • Loaded reagents that are on the instrument and have already been identified through their barcodes (or otherwise allocated) but are not needed for the current worklist are presented in black.
For more details on barcode settings, see chapter 8.3.6 on page 8-33.
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4.8.3.4 Allocate Non-barcoded Individual Reagent Containers
Unlike samples, reagent containers usually have barcodes. Reagent barcode stickers can also be ordered separately. However, it can happen that a barcode is missing, damaged or illegible. When a container with a missing or damaged barcode is loaded and the instrument is not able to identify the reagent, the corresponding rack position is displayed as empty (larger blank dot) and the required reagent remains depicted in the Unallocated resources area of the Load dialog. It has to be manually allocated.
Manual allocation of reagents: 1. In the Unallocated resources area, identify the reagent you want to allocate by clicking on it. This shows its code name/ID. 2. Click on that reagent and then click on the desired location (corresponding blank position in the reagent racks in the instrument rack area of the Load dialog). 3. Repeat for each unallocated reagent.
Correct Reagent Position The user has to make sure that the manually allocated positions correspond to the actual placement on the reagent rack. Manually allocated reagents are not crossed. In the log file, manually allocated reagents can be tracked as such.
The Auto Arrange function (automatic allocation of non-barcoded resources) is not available for reagents (only for samples, see chapter 4.8.2.2 on page 4-37). For reagents, a similar function is provided by the Save Reagent Layout/Open Reagent Layout buttons (see chapter 6.5.2.1 on page 6-36).
4.8.3.5 Allocate "Blind" Reagent Positions (Large Reagent Bottles)
Manual allocation is also necessary when reagent bottles (whether barcoded or not) are placed in any of the dilution plate positions (with intended adapter, see chapter 2.2.3.2 on page 2-12). These positions cannot be scanned for barcodes. As a general rule, avoid using these positions if other positions of the same size are still available. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 4.8.3.6 Allocate Non-barcoded Reagent Racks
If the reagent racks do not have barcodes, you can identify them manually as described for non-barcoded sample racks (see chapter 6.5.2.3 on page 6-40). Replacement barcode labels for reagent racks can be ordered.
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4.8.3.7 Identical Reagent in Two Separate Bottles
In some cases, two separate bottles of the same reagent are required for the same assay. If this has been taken into account in the assay definition and when entering the reagent in the reagent database (see "Assay Programming Manual" - "Allow changing of bottles during a dispense"), the pipettor will automatically switch from one bottle to the other during the run avoiding having to pause the run, exchange bottles, etc. To make sure this switch is correctly performed: • Make sure to fill each bottle with the appropriate volume (as specified in the Reagent Requirements list, see chapter 4.7.4 on page 4-24). At any rate, the total volume should equal the total volume specified in the list. • Load both bottles on the rack before the start of the run. • If the bottles are non-barcoded, allocate them manually in the Load dialog to the respective rack locations (if the bottles are barcoded, they should already be allocated when the Load dialog is displayed). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.4 Load Unstable Reagents
Some unstable reagents have to be prepared separately and loaded on the instrument only after the test run has begun.
Preparing the The preparation procedure depends on the reagent required. Please refer to the Reagent appropriate documentation. However, the following recommendations apply to all separately prepared reagents: • Do not fill the bottle above the shoulder level. • If a bottle for this preparation is not included in the kit but a specific bottle type is recommended, always use the recommended type. • Follow strictly the recommendations on reusing the bottles. Even if reusing a bottle is allowed, never use the same bottle for different reagents and follow strictly the recommended maintenance procedure. • Attach a barcode label to the bottle. Using non-barcoded bottles for unstable reagents is not recommended (see chapter 10.2.2.1 on page 10-20).
Loading the If an unstable reagent is required for a test, it will be listed in the Reagent Reagent requirements list (see chapter 4.7.4 on page 4-24). When the Load dialog opens for the first time, load all required reagents except the unstable reagent. Allocate the unstable reagent manually, click on it in the Unallocated resources area and then click on the rack position where you will later load it. Because the properties of this reagent have been included in the reagent database (see "Assay Programming Manual"), the instrument knows that this reagent requires a preparation time. Before the reagent is actually needed, the instrument prompts the operator with an acoustic signal and a message on the screen to prepare and load the reagent ("Prepare [name of reagent] and load in xxx minutes").
The time span specified in this message to prepare the reagent is a theoretical time span determined by the instrument from the data included in the reagent database (see "Assay Programming Manual").It is recommended that you do not wait until this message is displayed to prepare the reagent (i.e. you should anticipate its preparation).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 1. Click on the OK button to close this message. The processing of the worklist continues and when the indicated time span is over, the Load dialog is displayed again with an additional message "Please load the requested items as soon as possible as the instrument is paused". 2. Remove the reagent rack in which you initially allocated the unstable reagent. 3. Place the reagent bottle in the position indicated in the Load dialog. 4. Re-insert the rack and close the door of the sample and reagent unit. 5. Then click on the OK button.
The time span available to actually load the reagent has been defined in the Worklist Options dialog (see chapter 6.4 on page 6-27). Recommended time is 180 seconds (3 minutes). If the reagent has not been loaded within that time, the instrument will either: • abort the plate for which this reagent is required if this option has been checked in the Worklist Options dialog, or • pause the instrument until an operator loads the required reagent.
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Wrong Results Note that in the latter case, the resulting pause can lead to wrong incubation times and - if a washing step is affected - dehydration of wells. In case an unstable reagent is loaded not in time, carefully check the results and the event log. Excessive incubation times will be flagged automatically, but in doubt discard the results produced when a long pause of the worklist is reported.
Wrong Results Never click on the OK button before loading the reagent! Even if you could do it, the instrument would not take it into account and would not dispense the reagent.
Error recovery • Non-Barcoded unstable Reagents (see chapter 10.2.2.1 on page 10-20) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.5 Load Dilution Plates
Cross-contamination by multi-use Repeatedly use of single-use dilution plates will cause cross-contamination. • Never reuse single-use dilution plates.
Types of dilution plates: Various types of dilution plates may be used on the GEMINI instrument: flat bottom plates, round bottom plates or deep well dilution plates. The specifications of each plate type are stored in a coordinate file. Plate coordinate files have a (*.mpc) extension. They cannot be opened directly. A default dilution plate type is selected at system level in the Pipette tab of the System Set-up dialog (Dilution Plates field, see chapter 8.3.4 on page 8-25.
When loading the required resources for your worklist, you can check which type of dilution plate is required by clicking on the dilution plate in the Load dialog.
If you want to change the type of dilution plate used (for example, if you want to use a deep well dilution plate instead of a flat bottom standard dilution plate), change the default dilution plate type (see chapter 8.3.4 on page 8-25).
Load Dilution 1. Make sure that the metal base plate(s) are in place. Plates 2. Insert the dilution plate(s), shown in the Load dialog, into its correct position(s). Push the dilution plate(s) firmly down so that they lay on the metal base plate(s) completely and evenly. Position A1 should be at the rear right.
To change the default dilution plate type, see chapter 8.3.4 on page 8-25.
When loading dilution plates, make sure not to mix pre-dilution plates (for assays which require a pre-dilution step) and archive plates (for sample archiving). In the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Load dialog, these are identified by different colors. For more information, see chapter 6.7.5 on page 6-63.
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4.8.6 Load Tip Racks
Cross-contamination by multi-use Repeatedly use of single-use tips will cause cross-contamination. • Never reuse single-use tips.
Tip Types The pipettor on the GEMINI instrument operates with disposable tips. Two different types of tips can be loaded on the instrument: • 1100 µl tips (long tips) • 300 µl tips (small tips)
Ordering information for recommended tips is available in chapter 13.1 on page 13-1.
Tip Rack in the The Load dialog shows the number of tips of each size required to perform the Load dialog current worklist. The colors in which the tip racks are displayed vary not only according to the required tip size but also according to whether racks are already available on the instrument.
Color Tip size Description
Grey 1100 µl Load a full new tip rack with 1100 µl tips. Green 300 µl Load a full new tip rack with 300 µl tips. Red 300 µl or An incomplete tip rack is already loaded. The number of 1100 µl tips that are still available is taken into account by the software.
Table 4-1: Tip racks in the Load dialog
Load Tip Racks 1. Insert the tip rack(s), shown in the Load dialog, into its correct position(s). Push the dilution plate(s) firmly down so that they lay on the floor completely and evenly.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Place the tip rack into the holding device of the instrument, so that the pin sits in the groove of the tip rack (right rear).
Correct Disposable Tip Rack Position Always observe the position of the disposable tip racks defined in the Load dialog! Using a short tip instead of a long one may cause splashing and contamination. Using a long tip instead of a short one may cause the pipettor to crash and be damaged. Note that the GEMINI instrument can be configured to perform an automatic tip size check (see chapter 4.9.1.4 on page 4-54).
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4.8.6.1 Tip Management Options
The GEMINI instrument offers several tip management options depending on whether you want to be able to reuse partial tip racks and whether you are prepared to reload tips during a run or want the instrument to operate unattended as much as possible.
Use only full Tip If you prefer starting a run with only full tip racks: Racks • Deselect in the Panel Options the Re-use partial disposable tip racks checkbox (see chapter 6.4 on page 6-27).
Worklist options settings are retained until they are edited again. This means that you do not have to do this before each run (the option continues to apply to all later runs unless you decide to change it). When you actually load the tip racks on the instrument, make sure to unload all partially used tip racks and load only full tip racks (in the Load dialog, only gray and green tip racks should be displayed).
Reuse partially If you prefer starting a run with partially used tip racks (i.e. the tips left over from the used Tip Racks previous runs): • Select in the Panel Options the Re-use partial disposable tip racks checkbox (see chapter 6.4 on page 6-27).
This is possible because, while it operates, the instrument monitors the number of tips used. At the end of a run, it knows how many tips of each size are still available. If the Re-use partial disposable tip racks option is selected, when the instrument calculates the number of tips required to perform the next worklist, it takes into account the number of tips still available on the instrument. In the Load dialog, partially used tips racks are displayed in red.
Reload Tip If you want to try and avoid having to reload tips during the run, it is recommended Racks during a to work only with full tip racks (i.e. to deselect the Re-use partial disposable run tip racks checkbox (see chapter 6.4 on page 6-27)). However, even if you started the run with only full tip racks, it may still be required to reload tips during the run if you are processing "heavy" worklists (e.g. with several tests, many samples, a predilution and/or a sample archiving step). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 If tip reloading is going to be required in the course of a run: • At the bottom of the Schedule display (see chapter 4.7.2 on page 4-21), the instrument displays the following indication: "Operator intervention required in X minutes". • A message on the screen and an acoustic signal warns you when it is time to get ready to reload.
•The Load Additional Tips button is then enabled. • Click on the Load Additional Tips button and reload the tips as described in (see chapter 4.8.6 on page 4-45).
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Abort Plate if The Panel Options dialog also includes a Abort plate if 300 µl tips small Tips run run out option checkbox. This option is useful when the instrument operates out mostly unattended (e.g. at night). • Select in the Panel Options the Abort plate if 300 µl tips run out option checkbox (see chapter 6.4 on page 6-27) to use this function.
In most cases, if you initially loaded the tips as required in the Load dialog, the need for reloading will arise only for the last plate of a worklist. If this option is not selected, the instrument then prompts you to reload and pauses the pipetting until new tips have been reloaded, with the risk of blocking the whole run for a long time if no operator is there to load the new tips. With this option, you can decide that if such a situation arises, only the last plate is aborted but the processing of the run continues normally for those plates that have already been dispensed. This option is available for small tips (300 µl) only as these are the tips used for sample dispensing and likely to run out. Generally, the rest of the processing (e.g. reagent dispensing using large tips - 1000 µl) can continue unaffected. Note that it is not possible for the instrument to switch to large tips if it runs out of small tips as this would alter the pipetting accuracy negatively. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.8.7 Fill Wash Buffer and Clean Fluid
Instrument The wash buffer and clean fluid bottles are located on the left side of the instrument. • Two 2-liter bottles can be used for various buffers. • Another position (1-liter bottle) is reserved for the clean fluid used to clean the washer head. The connection fitting consists of 3 color-coded lines (cap, tubing, filter) allowing a better identification of each one as well as level sensor per bottle.
Load Dialog In the Load dialog, when you have loaded a correct worklist and clicked on the Start button, the required wash buffer(s) and clean fluid are displayed in the respective containers (see chapter 4.8.1 on page 4-33). The containers are identified through colored screw caps. Under default settings, the clean fluid bottle is the first bottle on the left. For wash buffers, the instrument determines what buffer should be put in each bottle. Click on each bottle to see the name of its corresponding buffer. If, for some reason, you do not wish to fill a buffer in the bottle specified by the instrument (e.g. if the blue-capped bottle is damaged) you can click on the desired buffer and allocate it to the desired bottle. If you want to always use the same bottle for the same type of wash buffer (e.g. blue-capped bottle for wash buffer), you can do so by changing the washer default settings (see chapter 8.3.7 on page 8-38). In any case, make sure that when you actually fill the bottles, you do it in strict compliance with what it set in the Load dialog.
Correct Wash Buffer Bottles Allocation Before loading the wash buffer bottles, ensure that the color coded tubing of each wash buffer solution corresponds to the color of the cap designated on the Load screen.
To fill in wash buffer/clean fluid: 1. Unscrew the cap of the respective wash buffer bottle. Refill it or replace it with another full wash buffer bottle. 2. Screw the cap back on carefully and watch out for correct seat of level sensor
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 and connections.
Type of Wash The type of wash buffer to be used for a test is specified during assay definition (see Buffer/Clean "Assay Programming Manual"). The properties of each wash buffer are stored in the Fluid reagent database and can (in some cases) be edited. Deionised water is used as clean fluid.
Quantity of The Reagent requirements list (see chapter 4.7.4 on page 4-24) lets you know wash buffer/ the quantity of wash buffer and clean fluid required for the respective worklist. If you clean fluid have filled in the correct quantities, then no refill should be needed during the run. The instrument automatically monitors the quantity of wash buffer left and warns the operator before each run or before each wash cycle, if the quantity still available is not sufficient (see chapter 4.9.1.1 on page 4-52).
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4.8.8 Fill System Liquid
Normally, system liquid can be filled in as soon as the instrument is installed, as described in chapter 2.1.2 on page 2-5 and chapter 2.2.9.2 on page 2-20. Checking the level of system liquid (and refilling the container if necessary) is also prescribed as part of the daily start-up maintenance routine (see chapter 9.2.1 on page 9-4). If this has been done as prescribed, no additional refilling should be required before each run.
4.8.9 Load Test Plates
Cross-contamination by multi-use Repeatedly use of single-use test plates will cause cross-contamination. • Never reuse single-use test plates.
When all the required resources (samples, reagents, dilution plates, tip racks, wash buffer/clean fluid and system liquid) are properly loaded and allocated, close the Load dialog by clicking on the Start button. The instrument automatically moves a plate carrier to the loading position. The Load Plate dialog is displayed. The software uses this dialog box to request the test plates that are needed to perform the current worklist.
Figure 4-15: Load Plate dialog 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Plate ID Shows the name of the requested plate as defined in the Set-up Panel dialog. If you have not yet defined a plate ID, click on the Plate ID button and enter a plate ID of up to 12 characters. It is advantageously to add an 8-character "YYMMDDNN" identifier (with YY = year, MM = month, DD = day and NN = "00" for the first plate of the day, "01" for the second plate, etc.) at the end of the plate IDs. Depending on the instrument configuration provided by the manufacturer this will be automatically done by the software. Assay(s) Shows the assay(s) used on the displayed plate. Plate Layout Shows the sample/well allocation on the plate.
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Test plates used on the GEMINI instrument are 96-well microplates (8 rows of 12) with or without removable strips. The precise type of plate used for a test is specified during assay definition (see "Assay Programming Manual").
Microplate and Assay Check that you are using the correct microplate corresponding with the assay! If you are using more than one assay per plate check that the strips correspond with the plate layout!
Microplate Check if the plate has been inserted correctly and makes sure no strip extends beyond the edge of the frame.
To load the test plates: 1. In the Load Plate dialog, the first plate (of the current worklist) is requested for loading. Check the Plate Layout displayed in the right- hand side of the dialog. 2. Place the requested test plate correctly onto the plate transport unit before the test plates can be loaded into the instrument. Procedure: Fit the plate into the frame so that the A1 corner of the plate matches the A1 inscription on the frame (rear right), then push it in, overcoming a slight resistance. Make sure that you do not move the plate carrier. It must remain firmly held by the catch spring of the plate transport. 3. As soon as you have inserted the plate, enter the plate name and then click on the OK button. The test plate is pulled in. In order to save time in case OK is accidentally clicked before the plate is actually loaded, the software will not close the Load Plate dialog in case no opening and closing of the cover for loading a plate has been detected. 4. The test plate is then moved first into the photometer to check that the correct number of strips is present. The plate is then moved into the stacker. Meanwhile the Load Plate dialog is closed. 5. The plate transport unit moves the next plate carrier to the load position and the Load Plate dialog prompts you to insert the second plate. 6. Repeat the procedure for each requested plate. After the last plate, the worklist will be started automatically (see chapter 4.9 on 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 page 4-51).
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4.9 Processing the Run
Worklist download Do not insert or remove racks while the worklist is downloaded!
Once all the prerequisites steps (load samples, assign assays to samples, define worklist, load required resources, load test plates) have been completed and you have clicked OK in the Load Plate dialog, the software downloads all the processing information to the instrument and the test run starts.
Figure 4-16: Downloading Progress dialog
The GEMINI instrument is locked during a run. The cover is automatically locked before the processing can start. If the cover is not completely closed the instrument cannot be locked and the processing cannot start, and the software will ask you to close the cover first. If the instrument has been configured so that a selftest is performed before each run (see chapter 6.1 on page 6-1) the cover is locked during this pre-run selftest. It is possible to disable the automatic cover lock (in the System Set-up, see chapter 8.3.1 on page 8-19). This, however, is not recommended and may be done only by supervisors or users who are authorized to change the System Set-up. Even if the cover may be opened, opening it will automatically stop the processing (pause the worklist). The cover will automatically unlock if an error occurs or if the Stop button is clicked (see chapter 4.9.5 on page 4-57). It will be locked again when the error is cleared or when the Resume button has been clicked. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.9.1 Pre-Run Checks
Before actually processing the assays, the instrument will perform pre-run checks. The wash buffer / clean fluid volume check is performed automatically. The three other pre-run checks (reagent volume check, sample volume check and tip size check) are optional. They are performed only if the user has requested them by checking the corresponding items in the Worklist Options dialog (see chapter 6.4 on page 6-27).
4.9.1.1 Wash Buffer/Clean Fluid Volume Check
The level of liquid in the wash buffer/clean fluid bottles is monitored through level sensors. If the level detected in a bottle is not sufficient for the current worklist, the following message is displayed: "Insufficient volume of ’LIQUID’, position POS, for the worklist."
Figure 4-17: Insufficient volume dialog
The message tells you which buffer is required in which bottle (color indication). Refill: 1. Refill the liquid bottle (see chapter 4.8.7 on page 4-48). 2. Click on the Retry button. The instrument rechecks the volume and, if satisfactory, goes on to check the volume of the next wash buffer. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Only applicable if washer bottles with advanced level sensors installed. With standard washer bottles, the instrument will only raise an error message if the remaining volume is below the minimum volume (dead volume).
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4.9.1.2 Reagent Volume Check
The instrument checks that all the reagents needed for the current worklist have been loaded in sufficient quantity. To do this, the pipettor actually checks every reagent bottle until the tip touches the surface of the reagent and the instrument calculates the volume that is available. If the instrument finds that the volume of a reagent is lower than what is required for the current worklist, the error message (see figure 4-17: on page 4-52) is displayed. The message shows the name and the location of the reagent to be restocked. To refill the respective reagent or to replace it by a new bottle: 1. Click on the Refill Bottle (the instrument checks the reagent volume with the same tip) or Refill with new tip (the instrument checks the reagent volume with a new tip) button. 2. Move out the respective reagent rack. The Load dialog shows you where it should be placed. 3. Refill the respective reagent bottle or replace the bottle. 4. Insert the rack again. If the reagent was allocated manually, the position in the rack has to be allocated again. 5. Click on the OK button. The software will check that all of the barcoded reagents in that rack are still in their correct positions. If not, an error message will be displayed and you will be given the opportunity to reload the rack or to continue anyway. If you chooses to continue anyway then this will be logged in the event log and all wells that will subsequently use one of the incorrect reagents will be flagged with the RgtRem flag. When all of the barcodes have been verified the rack LED will be turned off. The instrument will check the volume of the next reagent.
If the reagent cannot be supplied: In this case there are two possibilities: • Click on the Abort Worklist button. This will abort any further volume check but it will also abort whole the test run. • Click on the Continue button. This skips the volume check for this specific reagent only and continues with the reagent check for the next one. The insufficient volume is logged. With this option, you may decide to start the run and load the missing reagent at a later stage. If you do not refill the corresponding reagent, then some wells will not have reagent dispensed. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
The reagent volume check is a good option if you intend to use the GEMINI as a "walk away" instrument (e.g. at night). However, it takes time and uses several tips (one per reagent bottle or control vial).
Delayed volume check for unstable reagents: Unstable reagents have to be prepared and loaded just before use, i.e. while the run is already being processed (see chapter 4.8.4 on page 4-42). As a consequence, they cannot be included in the pre-run reagent volume check. If the reagent volume check option has been selected for a run including unstable reagents, the instrument will perform the pre-run check for all other reagents but will also perform a volume check on the unstable reagents later, once these have been loaded. If the volume detected is not sufficient, the available options are: • Continue to continue the worklist and flag the corresponding results.
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• Refill Bottle to load additional reagent and allow the instrument to continue the worklist without flagging the results • Abort Plate(s) to abort all plates that require this particular unstable reagent.
4.9.1.3 Sample Volume Check
The sample volume check is very similar to the reagent volume check. Obviously (depending on the number of samples you intend to test), it is likely to take even longer than the reagent volume check and use even more tips (one per sample tube). It is therefore recommended only as a response to specific sample volume problems.
4.9.1.4 Tip Size Check
If the Verify disposable tip racks option in the Worklist Options dialog (see chapter 6.4 on page 6-27) has been checked, the instrument automatically checks the size of the first tip of each rack to make sure the racks have been loaded in the correct locations.
Tip Type Detection Never disable tip type detection in the worklist options. If disabled, a tip misplaced cannot be recognized by the instrument and may cause mechanical damage!
The consequence of this verification depends on whether the tip checked corresponded (or not) to the type of tip the software expected to find on that rack (as displayed in the Load dialog).
Consequence
Expected tip size The pipettor uses this tip normally for the pipetting step. = Detected tip size Expected tip size The pipettor ejects the tip. The instrument displays an error <> message telling the user to go back to the Load dialog,
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 check in which order the tip racks should be loaded and Detected tip size change them accordingly in the instrument. When the user closes the Load dialog, the instrument checks the tip size once more.
Table 4-2: Tip size detection
Long tips have to be systematically discarded after a check because the checking process is a mechanical process, which means that long tips come in contact with the stopper (but not small tips). The instrument keeps track of all tips retained or discarded during this process when calculating the number of tips left in the partially used racks.
To change incorrectly loaded tips: 1. Remove the tip rack with the wrong-size tips and replace it with a correct tip rack.
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4.9.2 Steps of a Typical Test Run
The different steps (also their duration and sequence) that will be performed by the instrument during a run depend on which assays are to be tested in the run. In a typical test run: • The test plate will be transported to the pipetting position. • The pipettor will aspirate the samples from the tubes (in the order defined in the complete Sample Editor, see chapter 6.2 on page 6-4) and the controls from their respective bottles. It will then dispense them into the test plate. • The plate will be transported to the photometer for dispense verification. • The plate will go through an incubation period. • The plate will be transported to the wash unit for washing. • The pipettor will dispense the reagent. • The plate will be transported to the photometer for dispense verification. • The plate will go through a second incubation period and a second wash. • The pipettor will dispense the substrate. • The plate will go through a third incubation period. • The pipettor will dispense the stop solution. • The plate will be transported back to the photometer for the final read.
In some cases (depending on the assay): • A pre-dilution step will be performed at the beginning. This pre-dilution can take place either directly in the test plates or in dilution plates. • Shaking steps will also be included. The test plates can be shaken either when they are in the heated incubators or on the plate transport unit.
When several assays are combined in the same worklist, the instrument does not process one plate after the other but optimizes the process so as to shorten the total processing time (see chapter 4.7.2 on page 4-21). When sample archiving has been specified (see chapter 6.7 on page 6-53), the pipettor will transfer some samples to the dilution plates at any time during the run when it is not busy performing other pipetting steps. On partial processing (i.e. processing only some steps of an assay, see "Assay Programming Manual"). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.9.3 What You Can Do While the Run is Being Processed
The GEMINI instrument has been designed as a "walk-away" instrument, which means that if everything has been correctly planned it can operate unattended.
Three exceptions, however, require the intervention of an operator during the run: • When tips need to be reloaded. • When an unstable reagent needs to be loaded. • When a instrument error or a pipetting error occurs.
If you wish to monitor the run process:
• Click on the Schedule button in the Worklist window to follow the run on the Schedule screen (see chapter 4.7.2 on page 4-21).
• Click on the Active event log button to check the active event log (see chapter 4.7.6 on page 4-27) to see if the different steps are correctly executed.
While the run is being processed DO NOT interferes in any way with the process unless it is requested by the software. For the emergency stop procedure, see chapter 4.9.7 on page 4-60. On removing sample or reagent racks before the end of a run, see chapter 4.11.2 on page 4-72 and chapter 4.11.3 on page 4-73. On reloading samples or test plates, refer to chapter 6.6 on page 6-48.
Reloading Tips If tip reloading is going to be required in the course of a worklist, see chapter 4.8.6.1 on page 4-46
Loading an If a specific reagent needs to be prepared after the run has been started, the software unstable will warn you in advance and direct you to load it as described in chapter 4.8.4 on Reagent page 4-42. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.9.4 Instrument/Pipetting Errors
The instrument automatically pauses the run when instrument errors are detected. Check the error message list in chapter 10.1 on page 10-1. Depending on the kind of error detected the instrument will either display a specific error message, describing the problem, or open the System Paused dialog (see chapter 4.9.5 on page 4-57)and describe the problem detected in the status bar. When specific pipetting errors occur, the instrument can also pause the run and request the intervention of an operator.
4.9.5 The System Paused Dialog
This dialog is displayed either when a instrument error occurs (see chapter 4.9.4 on page 4-57) or if you click on the Stop button in the toolbar.
Figure 4-18: System Paused dialog
Plate(s) Shows the plates that have yet to be processed. Plates that have not yet been completely processed are displayed as well. Resume Continue the run. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Abort Plate(s) In the plates list, select the plate(s) that you do not want to process any more. Then click on this button to delete them from the worklist. You can then continue the run with the remaining plates only. Abort Worklist The run is over. None of the plates listed in the Plates list will be processed any more.
When you click on the Abort Plate(s) or the Abort Worklist button, the instrument will take some time to respond because it has to communicate with the instrument to alter all the processing information that has been downloaded to the instrument at the start of the run.
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4.9.5.1 Consequences of a System Pause
If the instrument is paused and you remove some sample or reagent racks before their processing is completed, see chapter 4.11.2 on page 4-72 and chapter 4.11.3 on page 4-73. If the instrument is paused but you resume the run without removing any racks, the processing continues normally (for all non-aborted plates).The pause duration is mentioned in the Title Block section of the Result Report. These results should be closely examined by a user who will validate them or not, depending on why the instrument was paused and for how long, and on whether the samples may have been tampered with. The Event Log lets you know at which stage of the process a pause occurred. Taking into account the results obtained on the control wells and/or on the standards and referring to the kit insert may also be helpful in assessing the potential impact of the pause on the analysis. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.9.6 Pipetting Errors/Manual Pipetting
Depending on what has been defined in the assay (see "Assay Programming Manual"), when pipetting errors (insufficient liquid, clot, pipettor hardware error…) occur, the instrument will either: • Raise alarm and stop: In this case, a specific error message is displayed on the screen explaining the problem and what the operator can do (e.g. Abort, Retry, Ignore…). • Log and continue: In this case, the error is documented (log and flag) but the run continues without any operator intervention. • or order the operator to Manually pipette at end of step (see below).
Whatever the case, the pipetting error is entered in the Event log and the affected samples / controls are flagged in the Combined Report (see chapter 4.10.2 on page 4-65).
4.9.6.1 Manual Pipetting
When manual pipetting is required, the instrument displays a message indicating precisely what to pipette and where. If the manual pipetting needs to be done into a test plate, the appropriate plate is automatically moved to its load / unload position. The instrument is unlocked and you can access other resources (dilution plates, sample racks…) as required to perform the manual pipetting.
Note the Rack Position If you need to pull out racks, please make sure to put them back exactly in the same position! Make sure everything is reloaded before clicking on the OK button in the manual pipetting message.
Improper loading or unloading of racks, reagents and samples Improperly loaded or unloaded racks, reagents and samples can produce erroneous results due to incorrect pipetting activities. • Only load and unload racks if you are explicitly requested to do so.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Only load and unload racks on the specified lanes. • Check the correct transfer or input of all reagent and sample names.
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4.9.7 Emergency Stop/Cancel a Run
If you need to stop the processing immediately, what you can do is:
• In the software, click on the Stop button in the toolbar. This will open the System Paused dialog (see chapter 4.9.5 on page 4-57) and unlock the instrument so that you can open the cover flap and access the work area (in case of liquid overflow, see chapter 9.6.3 on page 9-21). • If the problem can be corrected, you can choose to continue the processing by clicking the Resume button of the System Paused dialog. • If the problem cannot be corrected rapidly, you can choose to abort the processing of one plate (highlight the plate and click the Abort Plate(s) button) or to cancel the run altogether by clicking Abort All Plates. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.10 End of Run/Result Report Window
On the GEMINI instrument, it is not necessary to wait for the entire processing to be finished to view the results. As soon as the processing of one test plate is finished, the instrument generates the result file for this plate (not per worklist or per assay).
Prevention of wrong Results To prevent wrong results it is essential to check the result report carefully on flags, entries in the event list or other irregularities. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 4-19: Result window
Assays This function allows you to recalculate the results with another assay protocol while retaining the original OD values of your plate. See chapter 6.5.4.3 on page 6-45 Export This function allows you to export test results to a host computer Results either through an ASTM link or as a (*.txt) file. See chapter 4.10.5 on page 4-69 Linked Plate Allows to change the linked plate ID to use the blank and standard ID values from an other plate.
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Lot Specific Opens the Lot Specific Values dialog box to show or edit the Values required reagents information. See chapter 4.6 on page 4-15 and chapter 6.5.4.2 on page 6-45 Outliers The Outliers function allows you to manually remove from the results some OD values which you think are not consistent with the test. See chapter 6.5.4.1 on page 6-43 Recalculate This function allows you to recalculation the results again. See chapter 6.5.4.4 on page 6-47 Retest In most cases, if a sample is found to be reactive in a first test, at least one re-testing is required to confirm (or infirm) the result obtained in the first test and the sample status as positive (or negative). The re-testing of reactive samples can be ordered manually, on a case by case basis, after examining the results of the first test. Note: The retest function can only be used for assays that do not use multiple determinations. Note: Do not remove outliers or assign assays while the retest function is working. Store Model This function allows you to save the statistic model used for the calculation of the quantitative results so that they can be used in a new assay. See ’Assay Programming Manual’ 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.10.1 Result Reports
Normally, a result report (in the result window or as printout) contains the following sections:
Figure 4-20: Printed result report
1 General information This section shows the plate ID, the person responsible for running the test, the used assay, the date and time of the test performance, and certain default settings such as the upper cut-off and the wavelength as well as the reference wavelength of the photometric measurement. 2 Important notes and warnings This section shows critical events that occurred during the run and may
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 have had a negative impact on the results. If this section includes to many warnings, all results on the plate must be individually reviewed and validated by the laboratory supervisor. 3 OD values (read by the photometer) 4 Incubation information (parameters) 5 Validation criteria The displayed data indicate if the control values of the test meet the defaulted criteria. • PASSED: The test is considered valid and can therefore be evaluated • FAILED: If one of the criteria failed, the test will not be evaluated. 6 Quantitative results This section shows the graph which is created with the standards defined in the assay (see "Assay Programming Manual").
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7 Validation criteria 8 Qualitative results This section provides information regarding the cut-off value of the test. The parameters and terms used are set during assay definition (for details, see "Assay Programming Manual"). 9 Combined report The Combined report is very important, because it gives a view of the results per sample (Sample ID).
The exact structure of the Result Report (and printout) depends on what has been specified for that particular assay when it was defined (see "Assay Programming Manual"). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.10.2 Result Interpretation
Accurate result interpretation depends on the assay that was processed in the test run. Only a general outline is given here.
Rounding and correct calculation Windows rounds the depicted OD values. For borderline measurements this could lead to different results for the same rounded OD value. Example: If the measured values for two samples are 0.99999 and 1.00000 and the result criterion is: < 1,0000 is negativ >= 1,0000 is positive One sample will be reported as negative (0.99999) and one sample as positive (1.00000), while both values are depicted as 1.0000.
Per Plate The first part of the Result Report (all sections except the Combined Report) gives you a global view of the test run per plate. You can trace who the operator was, what reagents and batches were used, you can check if the incubation steps were correctly carried out, you can detect any discrepancy in the OD values (e.g. according to the locations of the wells on the plate), you can check if controls met the validation criteria, if some wells were removed due to bad pipetting, etc. Make sure to note any WARNING! line(s) in the Title Block section. If your Result Report includes an Events section, check the red lines to see if any critical event occurred during the run.
Per Sample The Combined Report, on the other hand, gives you the results per Sample ID. The precise data fields included in the Combined Report depend on what has been specified for each assay (see "Assay Programming Manual"). The order in which samples are listed in the Combined Report depends on the option selected in the complete Sample Editor dialog (see chapter 6.2 on page 6-4). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.10.2.1 Flags
Flagged results are not necessarily wrong results. A flag indicates that something happened during the run that may have affected the result on this sample. The software uses different flags to give an indication of the type of problem encountered:
Clot Clot detected. Results for flagged samples are not calculated. IncKo Incubation overrun. This flag is used when there is a discrepancy between the incubation temperature/time actually observed during a run and the incubation temperature/time defined in the assay. Results for all samples on an incorrectly incubated plate are not calculated. Results for all samples on an incorrectly incubated plate can be recalculated. InsLiq Insufficient liquid detected. Results for flagged samples are not calculated. ManID This flag is used if a sample ID has been manually assigned (see chapter 4.4 on page 4-8). This does not affect result calculation (the results are calculated).If a manually assigned sample is used for several assays (through direct pipetting or through pipetting of the same predilution made from this sample), the ManID flag is included in the Result Report for each assay. NoLiq No liquid detected. Results for flagged samples are not calculated. P_delay APM: Pressure rise delayed (cause foam or air). Results for flagged samples are not calculated. P_max_high APM: Aspiration pressure to high (possible cause clot). Results for flagged samples are not calculated. P_mean_low APM: Mean pressure to low (possible cause foam or air). Results for flagged samples are not calculated. P_min_low APM: Aspiration pressure to low (possible cause clot). Results for flagged samples are not calculated. P_static_high APM: Static pressure to high (possible cause clot). Results for flagged samples are not calculated. P_static_low APM: Static pressure to low (possible cause foam or air). Results for flagged samples are not calculated. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 P_stop_high APM: Pressure at pump stop to high (possible cause clot). Results for flagged samples are not calculated. PipErr Pipettor hardware error. Results for flagged samples are not calculated. REAG EXP Reagent Expired. This flag is used when a reagent was used after its expiry date. When an expired reagent is loaded and identified, the user is warned that the expiry date has been reached/exceeded but can choose to override the warning and still use the reagent for the run. This does not affect result calculation (the results are calculated). RgtRem Reagent rack removed. This flag is used if a reagent rack has been removed during processing (see chapter 4.11.3 on page 4-73). This does not affect result calculation (the results are calculated). SplRem Sample rack removed. This flag is used if a sample rack has been removed before it had been completely pipetted (see chapter 4.11.2.2 on page 4-72). No results are calculated for samples that had not yet been pipetted at that stage.
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VCFail Validation criteria failure. Results for flagged samples are not calculated. VDFail Verify dispense failure. This flag is used when a reagent/sample/control has not been correctly dispensed into a well. Results for flagged samples are not calculated.
When results are flagged but calculated, it is the user’s responsibility to check the Result Report and the Active event log, to find out precisely why a particular result was flagged. Only then will it be possible to determine whether the result can be accepted as valid or if the sample must be re-tested. When results are flagged and not calculated, it is possible, in some cases, to force the instrument to calculate the results in spite of the problem that occurred. This is done via the Outliers function (see chapter 6.5.4.1 on page 6-43). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.10.3 Save/Open the Result Report
The Result report is automatically saved to a result file. By default, this result file is saved in the C:\Gemini\Resources\Result directory. By default, the name of the result file is the name of the Plate ID, plus a (*.res) extension.
Save To save the result file under a specific name: To do this: 1. Click on the File > Save Result as menu item. 2. The Save As dialog is shown (see chapter 3.3 on page 3-11). Enter an appropriate file name and save the reagent report. (Reagent layout files have a (*.res) extension.)
File name in case of recalculated/changed results: If the results are changed for any reason and the file is saved again then the software creates a backup of the original result file before saving the changes. The backup will have the same basic filename but with a revision index appended. The revision index will start at "0" and will automatically increment whenever a new file is saved. For example, if "Plate_07030601.res" is changed and saved again the original result file will be backed up as "Plate_070306010.res".
Open To do this: 1. Click on the Open button. 2. In the Open dialog which is displayed, select the entry Result Files (*.res). 3. Select the desired (*.res) file and open it. The file is loaded and the calculation is performed again before it is displayed.
4.10.4 Print the Result Report
To print the complete Result report:
1. Click on the Print button (see chapter 3.4 on page 3-13). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
If you had checked the Automatically print result item in the Worklist Options dialog (see chapter 6.4 on page 6-27), the Result report will be automatically printed each time it is generated.
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4.10.5 Export the Results
Required access rights: Post Results to LIMS
The GEMINI instrument can export test results to a host computer either through an ASTM link or as a (*.txt) file. The export of test results can be ordered individually by the operator once a result report is displayed on the screen or the GEMINI instrument software can be configured to systematically export the results. The choice between these two possibilities will generally depend on whether the user wants to examine and validate the results before exporting them or whether the validation will be done at host computer level. For more information on result exports, see chapter 7.1.4 on page 7-10. On the format, structure and contents of (*.txt) export files, (see "Assay Programming Manual"). On ASTM export of test results, see chapter 7.2.6.2 on page 7-21. It is possible to restrict the right of some users to export test results. In that case, the intervention of a supervisor is needed as described in chapter 8.1.3 on page 8-6. It is possible to restrict the right of some users to export test results. In that case, the intervention of a supervisor is needed as described in ’Instructions for use Manual’. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.11 Unloading
Pipettor error Do not remove a rack after a pipettor error occurred even if the LED is blinking.
Inspection Inspect instrument deck, plates, racks, etc. for spillages. If there are spillages, check instrument for leakages (see chapter 9.2 on page 9-4).
4.11.1 Unload Test Plates
Plate inspection Inspect test plates after unloading for unexpected or irregular fill heights.
4.11.1.1 At the End of the Run - Basic Procedure
By default, fully processed plates ("finished plates") are stored on the instrument in the room-temperature incubators. Then, once the processing of the complete worklist is finished, the instrument prompts you to start unloading the plates by displaying the following message: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 4-21: Remove plate message
To remove the test plate: 1. Open the cover of the instrument. 2. Remove the test plate. 3. Close the cover of the instrument. 4. Click on the OK button to confirm removal in the software.
4.11.1.2 Before the End of the Run - Fully processed Plates
If some plates are already fully processed and you want to unload them before waiting for the end of the run: 1. Select the Edit > Unload Finished Plates menu item. This opens the Unload Plates dialog.
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Figure 4-22: Unload Plates dialog
2. In the list, select the plate or plates that you want to unload and click Unload Plate(s) or simply click Unload All if you want to unload all the plates listed. Only fully processed plates are shown in the list. 3. Remove the plate(s) (see chapter 4.11.1.1 on page 4-70)
Choosing to unload finished plates before the end of the run can be useful for example if you want to visualize a plate in which some wells have been incorrectly pipetted or if you want to further process a plate manually or on another instrument. You do not need to use this procedure if you intend to reload additional samples and plates using the "Continuous Loading" feature. In this case, the instrument automatically lets you remove fully processed plates before allowing you to reload new plates (see chapter 6.6.5 on page 6-52).
4.11.1.3 Before the End of the Run - Unfinished plates
The only way to remove plates that are not fully processed is by using the pause and test plate removal procedure (see chapter 4.9.5 on page 4-57). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.11.2 Unload Sample Racks
Unload racks always completely to avoid crashes with the barcode scanner!
4.11.2.1 At the End of the Run
To remove/unload a rack at the end of a run: 1. Pull out the rack(s) designated by a flashing LED.
4.11.2.2 Before the End of the Run
Technically, it is possible to remove a rack from the instrument even while the run is still being processed. Two cases have to be considered: either the rack which you want to remove is fully processed or it is not. A rack is fully processed when all the pipetting operations out of that rack has been completed (i.e. that rack will not be needed for the rest of the run). You know that a rack is fully processed when the corresponding LED starts flashing. Removing fully processed racks is necessary for instance if you want to reload new samples on Continuous Loading, see chapter 6.6.2 on page 6-50. If the rack is fully processed (and the LED is flashing): 1. If necessary, turn the barcode scanner off and wait while it is moving to its park position on the right. 2. Pull out the rack(s) designated by a flashing LED.
If the rack is not yet fully processed (the corresponding red LED is not flashing) you should NOT remove it. If there is a specific problem and you absolutely have to remove it, do so as described above (except that no LED is flashing).
Note, however, that if you remove and reload a sample rack that was not fully processed, any sample that will be pipetted from that rack after you have removed and reloaded it will be flagged SplRem and that the respective results will not be calculated (see chapter 4.10.2 on page 4-65). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.11.3 Unload Reagent Racks
Unload racks always completely to avoid crashes with the barcode scanner!
Basically, the rules that apply to reagent racks are equivalent to those described for sample racks, i.e.: • Technically, it is always possible to remove a reagent rack, even while the run is being performed. • You should not remove a reagent rack before it is fully processed (i.e. the corresponding LED is flashing) unless you absolutely need to do so or are prompted to do so by the software (see below).
However, the following differences apply: • If you remove a reagent rack before it is fully processed, all the samples which had not yet been pipetted when the rack was removed will be flagged RegtRem but the corresponding results will still be calculated. • If you need to load an unstable reagent, the instrument will direct you to do so as described in (see chapter 4.8.4 on page 4-42) and the samples will not be flagged.
Unloading a reagent rack (during or at the end of a run) is done as described above for sample racks.
4.11.4 Unload Tip Racks and Dilution Plates
The cover is normally locked during the whole run (it can be unlocked only for a short time when it is necessary to reload tip racks, see (see chapter 4.8.6 on page 4-45). You will have to wait until the end of the run to unload dilution plates and tip racks. To remove them: 1. Open the cover. 2. Take dilution plate(s) or empty tip racks out of the respective holding devices. 3. Close the cover.
If you are using the Re-use partial tip racks option (see chapter 6.4 on page 6-27), 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 remove tip racks only if they are completely empty. DO NOT remove partially empty racks! The instrument monitors the number of tips left and will include them in planning the next worklist.
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4.11.5 Unload Other Resources
Clean fluid and instrument liquid do not need to be emptied or unloaded after each run. For wash buffers, follow the storage conditions in assay kit inserts. For additional information, refer to the maintenance plan and procedures.
4.11.6 Unload Waste Disposal
• Dispose of test plates, dilution plates and sample tubes in accordance with legal regulations for biological hazardous waste. • Visually check the contents of the tip ejection waste container. There is no sensor for this container. If full or nearly full, replace as described in chapter 9.2.3 on page 9-6. • Check the liquid waste level in the liquid waste container. If full or nearly full, empty and clean as described in chapter 9.2.3 on page 9-6. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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4.12 Shut Down / End of Day Maintenance
Procedure
Maintenance Before shut down the instrument see maintenance procedures in chapter 9.2.3 on page 9-6.
Windows shutdown Always shutdown the computer (Windows shutdown) before switch off the instrument! Otherwise the computer could lose data or could get hard-disk failures.
1. Click on the File > Exit menu item to terminate the GEMINI instrument software. 2. Click on the Start > Shutdown menu item of the Windows operating system. 3. Select the Shutdown item. 4. Click on the OK button. The software system is shut down and the PC is switched off automatically. 5. Switch off the GEMINI instrument. 6. Inspect and clean the instrument as described in chapter 9.2.3 on page 9-6. 7. Observe the complete maintenance instructions (see chapter 9 on page 9-1). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5 Use of the Instrument with IFA (optional)
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time.
The GEMINI COMBO is controlled via the GEMINI COMBO instrument software, a Microsoft Windows application running on the integrated PC. Procedures in this manual assume familiarity with Windows. If you are unfamiliar with the use of Windows, refer to the extensive on-line help of Windows. The usual Windows conventions apply. Deviations from these conventions are described where appropriate. In this chapter, the process of a test case with IFA slides from switching on till switching off the instrument for a "normal" user is described with the right to start a worklist. The basic functions of the GEMINI COMBO instrument software are described in chapter 3 on page 3-1. Additional functions for "normal" users and for users with additional rights are described in chapter 6 on page 6-1.
Required access rights: Start Worklists
Most of the processes of IFA and ELISA assays are similar, so in some chapters it will only be referred to the corresponding chapter 4 of the ELISA description.
The instrument does not generate any end result for slides. The slides will only be prepared for further processing (e.g. examination of reaction under a fluorescence microscope) by the user. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.1 Safety and Hints
Liquid in instrument Liquid which gets into the instrument can cause illnesses with deadly consequences in case of contact. The instrument can be damaged by liquids. • Switch off the instrument. • Separate the instrument from the mains supply. • Wear suitable protective clothing. • Clean, disinfect or decontaminate and dry the instrument according to the applicable local and national provisions, legislation and laboratory procedures.
Erroneous operation of the instrument or the software Malfunctions can cause serious injuries with deadly consequences or damage of the instrument. • Closely follow the steps contained in the individual instructions. • Check correct data input. • Check process of loading. • In case of constantly erroneous operation call service. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.2 Brief Sequence Plan
Start-up • Install the IFA bay chapter 2.2.11 on page 2-23 • Maintenance (e.g. flush IFA wash and chapter 5.3 on page 5-4 buffer bottles) • Switch on •Start GEMINI COMBO instrument software Load Samples and Assign • Load samples chapter 5.4 on page 5-5 Assays • Assign assays Create a Worklist • Check slides chapter 5.5 on page 5-6 • Check assays • Check samples Lot Specific Values • Enter batch numbers chapter 5.6 on page 5-8 • Enter assay protocol parameters The Worklist Window • Check worklist chapter 5.7 on page 5-10 Start Worklist • Load samples chapter 5.8 on page 5-17 • Load reagents • Load unstable reagents • Load dilution plates • Load slides on IFA tray • Load tip racks • Fill wash buffer and clean fluid • Fill system liquid Processing the Run • Pre-run checks chapter 5.9 on page 5-22 • Steps of a typical test run • What you can do • Instrument/Pipetting errors • Instrument pause End of Run/Result Report • Structure chapter 5.10 on page 5-28
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Window • Result file (check for flags) • Save/Open the result report • Print the result report • Export the results Unloading • Unload slides and IFA trays chapter 5.11 on page 5-30 • Unload sample racks • Unload reagent racks • Unload tip racks and dilution plates • Unload other resources • Unload waste disposal • Unload IFA bay Shut-down • Maintenance chapter 5.12 on page 5-31 • Terminate GEMINI COMBO instrument software • Shutdown operating system • Switch off
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5.3 Start-up
Assay Kit Read the instructions for use of the desired assay kit!
1. Install the IFA bay (see chapter 2.2.11 on page 2-23). 2. Start with the maintenance and "switch-on"-procedure (see chapter 4.3 on page 4-3). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.4 Load Samples and Assign Assays
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time.
See chapter 4.4 on page 4-8
5.4.1 IFA Assays with Dynamic Dilutions
Some IFA assays offer the possibility of the so-called dynamic dilutions. This means that a sample can be pipetted in different dilutions onto an IFA slide. After selection of the IFA assay, the user decides which dilutions of the individual sample should be applied. For each selected dilution for a sample a new well is used on the slide (e.g. 1 sample * 2 dilutions = 2 assigned wells).
Procedure Each time you load an IFA assay with dynamic dilutions function, the following tabular Select Dilutions dialog is automatically displayed: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 5-1: Select Dilutions dialog
1. Select the cell in the dilution columns for the samples which are to be pipetted with this dilution. Use the green arrow buttons to scroll the screen. 2. Click on the OK button to close the tabular Select Dilutions dialog.
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5.5 Create a Worklist
A worklist is a work instruction for the GEMINI COMBO instrument. In the worklist, the sequence and the slides to be processed with the assigned assays are defined.
The following instruction describes how to generate and check a worklist which was automatically suggested by the GEMINI COMBO instrument. The GEMINI COMBO instrument suggests a worklist whenever you load samples as described in the previous chapters. If you want to edit a suggested worklist or generate a worklist yourself, please refer to chapter 6.3 on page 6-11.
Further Information and Screenshots See chapter 6.3 on page 6-11.
Procedure (Check Worklist)
1. Click on the menu item New > Worklist or the New Worklist button.
Selected Assays without sub assay function: • Go to step 2.
Selected Assays with sub assay function: •Go to chapter 5.5.1 on page 5-7 to use the sub assay function. • Go to step 2
2. Check the worklist: • Click on the + sign of the first assay to open the complete assay/
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 samples tree. • Check the assigned samples! If something does not work ok, please make the required changes. • Click on the assay name. • Check if the correct slide layout and rac file name to the corresponding assay is displayed in the Set-Up Panel. • Repeat the steps for all other assays.
Wrong Results Note the well labels of the slides. The topmost sample in the assay list has the well label T1 of the corresponding slide.
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Maximum Number of 16 Slides per Worklist It is not possible to load more than 16 slides to a worklist. More than 16 slides lead to a schedule error.
Dynamic Dilutions For each selected dilution for a sample a new well is used on the slide (e.g. 1 sample * 2 dilutions = 2 assigned wells). The number of dilutions will be shown behind the sample ID.
3. If everything works correct, click on the OK button. The GEMINI COMBO instrument software shows the Lot Specific Values dialog (see chapter 5.6 on page 5-8). If something does not work correct, please make the required changes (see chapter 6.3 on page 6-11 and chapter 6.3.1 on page 6-15) and then click on the OK button.
Once the worklist is defined, the instrument checks all parameters and signals any error. Errors must be corrected before you start a run.
5.5.1 Primary- and Sub-Assays
Sub-assays can be used to reduce the number of controls on slides from the same batch. This allows to test more samples with the same number of slides. For this purpose, an IFA assay is divided into two parts: • Primary-assay: Assay with controls and samples. • Sub-assay: Assay only for samples.
A sub-assay contains all steps from the primary assay. Sub assays will be displayed with a ’*’-character in front of the assay name.
Use of primary- and sub-assay You can decide whether to: • use the primary-assay for all slides of a worklist. (Choice Always) • use the primary-assay only for the first slide. For all other slides the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 instrument uses the sub-assay. (Choice Once) • use only the sub-assay for all slides of a worklist. (Choice Never)
Deleted Primary Assay Sub-assays could be used without a primary-assay. Note that in this case there are no controls present in the worklist.
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5.6 Lot Specific Values
After an internal check of the worklist, of the assay protocols and of the required resources, the GEMINI COMBO instrument software asks for required reagents (diluent, conjugate, substrate, etc.), controls, wash buffers and clean fluid in the Lot Specific Values dialog. The Lot Specific Values dialog also allows you to enter additional information for specific kit types.
For processed IFA slides result evaluation must be done under an external fluorescence microscope. The GEMINI COMBO instrument software only displays a result file containing the selected information.
Reagents of different lots (but with same ID) are interchangeable for the software.
For every used IFA assay/slide, an individual Lot Specific Values dialog is displayed. The name of the slide is displayed in the title of the dialog (top left). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 5-2: Lot Specific Values dialog (e.g. ’Slide 1’)
The Lot Specific Values dialog is subdivided into two areas:
Batch Numbers Parameters of the lot specific values.
Assay Protocol If the assay includes standards for which the concentration is batch dependent or if Parameters control value ranges are batch-dependent, these items are listed here with their respective batch-specific values/data (otherwise the list is blank).
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Functions The functions are similar to the described functions in the ELISA description, see chapter 4.6 on page 4-15.
Procedure First slide: 1. Edit the following batch data if they are required (see above): • Batch Number: Click on the Edit Batch Number button. • Expiry Date: Click on the Edit Expiry Date button. • QA Label: Click on the Edit QA Label button. 2. Click on the Add Batch button if a QA of a reagent or sample will be made (see above). 3. Edit your assay protocol parameter(s) if required (see above). 4. Confirm your inputs by clicking on the OK button.
Another slides: 5. Slides with the same assay which was confirmed: If you will use the entered lot specific values for slides with the same assays, click on the Yes button on the message, otherwise click on the No button and repeat this procedure for all other slides. 6. Slides with other assays: Repeat this procedure for all slides.
After the last confirmation: 7. After the last confirmation the Worklist window is displayed automatically (see chapter 5.7 on page 5-10).
Error recovery • Error Detection while creating Worklist (see chapter 10.3.1 on page 10-21) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.7 The Worklist Window
The Worklist window shows all data of the generated worklist and the current process status during the start later on. With the buttons on the left side, the individual data can be displayed. Additionally, the menu Edit is activated.
Figure 5-3: Worklist window - worklist parameters information
Worklist Shows worklist details (e.g. slide ID, start and finish time, load status, parameters assays and amount of samples). See chapter 5.7.1 on page 5-12 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Schedule The schedule displays graphically the actions being performed (e.g. pipette, wash, incubate etc.). See chapter 5.7.2 on page 5-13 Slide layouts Shows the slide layout (e.g. assays, controls, samples) of all slides. See chapter 5.7.3 on page 5-15
Reagent Shows all required reagents. requirements See chapter 5.7.4 on page 5-16
System status Shows the status of the instrument components (e.g. loading bay etc.). See chapter 5.7.4 on page 5-16
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Active event Shows a list of all steps of the run as they are performed. The screen log is blank when viewed before the start of the run. See chapter 4.7.6 on page 4-27 Job list Shows all samples, its assigned assays and its dilutions. See chapter 4.7.7 on page 4-30
Sample Shows information about the sample archiving. archiving See chapter 4.7.8 on page 4-30 information Edit Panel Opens the Set-up Panel dialog box with editing options of the current worklist. This function is also called Panel Definition. See chapter 6.3.1 on page 6-15 Edit Options Opens the Worklist Options dialog box to change worklist processing options. This function is also called Panel Options. See chapter 6.4 on page 6-27 Other Options Opens a selection dialog to select further options (e.g. lot specific values - see chapter 5.6 on page 5-8, or export archive etc.).
Start Opens the Load dialog to allocate the required resources. After that, a run using the current worklist will be started. See chapter 5.8 on page 5-17
Procedures 1. Look for the worklist settings and/or change the worklist settings. 2. To start the worklist see chapter 5.8 on page 5-17. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.7.1 Worklist Parameters
This window shows the parameters of the worklist (see chapter 5.7 on page 5-10) in the following columns:
Slide ID List of defined slides and indication of the slide names. Start Start time of run. This is the time at which you have quit the Set-up Panel dialog by clicking OK and the worklist was displayed. Finish Time at the end of the run, calculated using the work steps and their duration. Note: The actual finish time depends on when the run is actually started. The time displayed here allows you to calculate how long the run will take. Status Shows the status of each slide. If Error is displayed, see (see chapter 10.3.1 on page 10-21). Otherwise, you see Not loaded as long as the slides have not yet been loaded. The status then changes to Processing and finally to Finished (or Aborted if the processing of that slide has been stopped and not resumed). Assay Shows the name of the respective assay file. #Samples Shows the number of samples per slide as defined in the worklist. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.7.2 Schedule
The Schedule shows how the test will actually be performed. This allows the user to get an accurate view of the duration of each step and the sequence in which they will be conducted, as well as how the instrument will combine the processing of all the slides that are to be processed in the same run (interlacing). It is therefore a good idea to check the Schedule before starting the run (the Schedule is also useful afterwards, when the run is being processed, to follow how the test run is executed and which step is currently being performed on which slide).
The schedule is displayed in two ways:
Module Schedule (top): Each strip or segment shows at which time each instrument module (e.g. pipettor) will be used for each slide. Each slide is depicted in a different color. The run time scale is on a horizontal line above the strips. When the test run is started, the vertical line on the left will move forward (towards the right), allowing the user to check at any given time what part of the run is currently being processed.
Slide Schedule (bottom): Each slide is shown as a horizontal strip. The various steps of the process (e.g. pipetting, incubation) are shown as segments on this strip (each step marked by a different color). As in the Module Schedule view, the time scale is at the top and the vertical line on the left will move forward once the run is started. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 5-4: Worklist window - schedule
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Below the strips, additional information is displayed:
System Shows when the sample archiving operations (if any, see chapter 6.7 on page 6-53) will be performed. Additional Shows when additional resources such as tips or reagents resources are to be loaded. If such reloading is necessary, a line saying "Operator intervention required in X minutes" will also displayed. Additional Shows the time periods when it is possible to reload slides slides (corresponds to periods when all the slides being processed are incubating).
When you click on a segment of the schedule view, a screen with detailed information about the respective assay step will be displayed. Clicking again on this screen will display again the complete schedule.
When processing a run in Demo Mode (see chapter 6.12 on page 6-75) the run time displayed in the Schedule window will be accelerated, i.e. 1 second in the Schedule window = 1 minute in a real run. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.7.3 Slides Layouts
Selecting Slide Layouts will show the exact slide layouts. All slide layouts defined in the current worklist are displayed one below the other.
Figure 5-5: Worklist window - slide layouts
See chapter 6.3.1 on page 6-15 for used slide layout labels. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.7.4 System Status
The System status displays a graphical presentation of the work area.
Figure 5-6: Worklist window - system status
1 Clean fluid and wash buffers 2 2 incubator and 3 ambient positions 3 3 tip racks positions 4 2 dilution plate, archive plate, or large reagent bottle positions 5 Loading bay 6 IFA bay with 16 slide positions. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The color of the slides changes depending on the process status: • Yellow: The slides are loaded but not in process. • Red: The slides are in process. • Green: The slides are finished or aborted.
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5.8 Start Worklist
If the loaded worklist is error-free, the Start button in the worklist window is enabled (appears in green instead of gray). If you click this button, the instrument prompts you to load the instrument with the required resources (samples, reagents, slides, dilution plates, tip racks, wash buffer, clean fluid…) and opens the Load dialog box. The loading process on the GEMINI COMBO instrument includes two stages: • The actual (physical) loading of reagents, racks, slides and accessories in the instrument. • The allocation of these resources in the software.
The purpose of the allocation process is to enable the software to track whether each sample, each reagent, each slide and each of the other required resources has been loaded, and where it has been placed in the instrument. When using barcoded components, part of the allocation process is done automatically since the instrument can then identify each component and monitor its location through the barcode. For items that are not barcoded, the allocation process is done on the screen in the Load dialog (for samples, reagents, slides, dilution plates, and tip racks). For those elements that have a set location on the instrument (wash buffer, system liquid) the instrument is able to monitor directly through other devices (e.g. sensors) which quantity is available on the instrument and if more is required for the current worklist, this is displayed in the Load dialog. For those elements, no allocation process as such is necessary but they should be loaded on the instrument in strict accordance with what is displayed in the Load dialog.
Procedures
1. Click on the Reagent requirements button to note the required wash buffer and clean fluid volume (see chapter 4.7.4 on page 4-24). If necessary fill the wash buffer and clean fluid bottles.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2. Click on the Start button in the worklist window to start the worklist (see chapter 5.7 on page 5-10). The GEMINI COMBO instrument software shows the Load dialog (see chapter 5.8.1 on page 5-19). • Usually, all samples must be loaded and assigned at this point of time. If, however, you did make supplements during the generation of the worklist, those samples must still be assigned (see chapter 4.8.2 on page 4-36). • Load all required reagents (see chapter 4.8.3 on page 4-39). Please observe the hints about unstable reagents (see chapter 4.8.4 on page 4- 42). • Load all IFA trays containing the required slides onto the IFA bay. • Load all required dilution plates (see chapter 4.8.5 on page 4-44). • Load all required disposable tips (see chapter 4.8.6 on page 4-45). • Fill wash buffer and clean fluid bottles (see chapter 4.8.7 on page 4-48). • Fill system liquid container, if necessary (see chapter 4.8.8 on page 4-49).
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3. Click on the OK button to confirm the Load dialog. After that, the Confirm Slides window is displayed automatically.
Figure 5-7: Confirm slide positions
4. Check the slide positions. 5. If necessary, click on the Slide ID (name) button to change the slide ID (name) of the slide. In the Slide dialog you can change the slide ID manually or scan a barcode. Take care that the slide ID is clear and unique, i.e. is not used by another slide in this worklist yet. For safety reasons the renaming of slide names must be inserted twice to confirm first scan or manually entry. 6. Click on the OK button to confirm the slide positions. 7. The worklist will be started automatically (see chapter 5.9 on page 5-22).
Unload Finished Slides To unload finished slides while the instrument processes other slides, it is useful to use all trays. The slides can be distributed to all trays. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.8.1 Load Dialog
The Load dialog illustrates the top level of the instrument (work area):
Figure 5-8: Load dialog
Auto Arrange Click this button to allocate all slides in the Unallocated Slides resources column in order of the end times. This means that the slide, which is finished first is placed on the lowest tray position. Note: To unload finished slides while the instrument processes other slides, it is useful to use all trays. The slides can be distributed to all trays. In this case do not use the Auto Arrange Slides function. IFA bay Free positions for slides. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Start Closes the dialog when all required resources (samples, reagents, dilution plates, tip racks, wash buffer/clean fluid and system liquid) are properly loaded and allocated and starts the test procedure (see chapter 5.9 on page 5-22). Slide The slide symbol indicates which type and how many slides you need (see chapter 5.8.2 on page 5-21).
All other functions are similar to the described functions in the ELISA description, see chapter 4.8.1 on page 4-33.
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Check correct Position Always check for the correct positioning of the sample tubes, reagent bottles, slides and the wash buffer bottles before starting the worklist!
Editing the worklist after the Load dialog is displayed: Sometimes, it is only when the Load dialog is displayed that you realize that some elements of your worklist have not been correctly defined. In this case, you need to go back to the Set-Up Panel dialog and change what you need to change. To do this: 1. Close the Load dialog by clicking the Cancel button (NOT the OK button!). This takes you back to the Worklist window. 2. Click on the Edit Panel button to open the Set-Up Panel dialog. 3. Change what you need to change and click on the OK button. 4. Click on the Start button. A new Load dialog is displayed, reflecting the changes you made.
The same applies for Worklist Options. If you want to change them (e.g. if you have forgotten to specify that you wanted to archive some samples or if you want to work with full tip racks only), repeat the steps described above but click on the Edit Options button. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.8.2 Load Slides
Cross-contamination by multi-use Repeatedly use of single-use slides will cause cross-contamination. • Never reuse single-use slides.
Types of slides: Various types of slides may be used on the GEMINI COMBO instrument. The specifications of each slide type are stored in a coordinate file (slide rac file). The slide layout is defined in the Slide Editor and stored in the slide database. The slide type is selected in the assay, see ’Assay Programming Manual’.
Load slides 1. Insert the slide, shown in the Load dialog, onto the IFA tray and insert the IFA tray onto the IFA bay (see chapter 2.2.11 on page 2-23). 2. Move the corresponding slide icon in the Load windows from the Unallocated Resources area into the used IFA bay/tray position. The software gives every slide a default name like "Slide X - YYMMDDZZ" (with X = slide index in the current worklist, YY = year, MM = month, DD = day and ZZ= index of the slide on the current day).
Slide and Assay Check that you are using the correct slide corresponding with the assay!
Dry out of Slide Wells When starting an IFA worklist with different amounts of wells the compatibility of the assays has to be checked to avoid that slide wells can dry out during processing. In addition, its possible to unload finished slide trays. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.9 Processing the Run
Worklist download Do not insert or remove racks while the worklist is downloaded!
Once all the prerequisites steps (load samples, assign assays to samples, define worklist, load required resources, load slides on IFA tray) have been completed and you have clicked OK in the Load dialog, the software downloads all the processing information to the instrument and the test run starts.
Figure 5-9: Downloading Progress dialog
The GEMINI COMBO instrument is locked during a run. The cover is automatically locked before the processing can start. If the cover is not completely closed the instrument cannot be locked and the processing cannot start, and the software will ask you to close the cover first. If the instrument has been configured so that a selftest is performed before each run (see chapter 6.1 on page 6-1) the cover is locked during this pre-run selftest. It is possible to disable the automatic cover lock (in the System Set-up, see chapter 8.3.1 on page 8-19). This, however, is not recommended and may be done only by supervisors or users who are authorized to change the System Set-up. Even if the cover may be opened, opening it will automatically stop the processing (pause the worklist). The cover will automatically unlock if an error occurs or if the Stop button is clicked (see chapter 5.9.5 on page 5-25). It will be locked again when the error is cleared or when the Resume button has been clicked.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 5.9.1 Pre-Run Checks
See chapter 4.9.1 on page 4-52
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5.9.2 Steps of a Typical Test Run
The different steps (also their duration and sequence) that will be performed by the instrument during a run depend on which assays are to be tested in the run. In a typical test run: • The pipettor will aspirate the samples from the tubes (in the order defined in the complete Sample Editor, see chapter 6.2 on page 6-4) and the controls from their respective bottles. It will then dispense them into the dilution plate. • The pipettor will dispense the reagent (dilution liquid) into the dilution plate. • The pipettor will aspirate the diluted sample from the dilution plate and dispense it onto the slide. • The pipettor will dispense the controls onto the slide. • The slide will go through an incubation period at room temperature. • The pipettor will wash the slide. • The pipettor will dispense the reagent (e.g. fluorescence labelled conjugate) onto the slide. • The slide will go through an incubation period at room temperature. • The pipettor will wash the slide. • The pipettor will dispense wash buffer on the slide • The slide will be prepared for further processing (e.g. examination of reaction under a fluorescent microscope) by the user.
When several assays are combined in the same worklist, the instrument does not process one slide after the other but optimizes the process so as to shorten the total processing time (see chapter 5.7.2 on page 5-13). When sample archiving has been specified (see chapter 6.7 on page 6-53), the pipettor will transfer some samples to the dilution plates at any time during the run when it is not busy performing other pipetting steps. On partial processing (i.e. processing only some steps of an assay, see "Assay Programming Manual"). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.9.3 What You Can Do While the Run is Being Processed
The GEMINI COMBO instrument has been designed as a "walk-away" instrument, which means that if everything has been correctly planned it can operate unattended.
For exceptions, however, require the intervention of an operator during the run: • When tips need to be reloaded. • When an unstable reagent needs to be loaded. • When a instrument error or a pipetting error occurs. • When finished slides can be unloaded.
If you wish to monitor the run process:
• Click on the Schedule button in the Worklist window to follow the run on the Schedule screen (see chapter 5.7.2 on page 5-13).
• Click on the Active event log button to check the active event log (see chapter 4.7.6 on page 4-27) to see if the different steps are correctly executed.
While the run is being processed DO NOT interfere in any way with the process unless it is requested by the software. For the emergency stop procedure, see chapter 5.9.7 on page 5-27. On removing sample or reagent racks before the end of a run, see chapter 4.11.2 on page 4-72 and chapter 4.11.3 on page 4-73. On reloading samples or slides, refer to chapter 6.6 on page 6-48.
Reloading Tips If tip reloading is going to be required in the course of a worklist, see chapter 4.8.6.1 on page 4-46.
Loading an If a specific reagent needs to be prepared after the run has been started, the software unstable will warn you in advance and direct you to load it as described in chapter 4.8.4 on Reagent page 4-42. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 5.9.4 Instrument/Pipetting Errors
The instrument automatically pauses the run when instrument errors are detected. Check the error message list in chapter 10.1 on page 10-1. Depending on the kind of error detected the instrument will either display a specific error message, describing the problem, or open the System Paused dialog (see chapter 5.9.5 on page 5-25) and describe the problem detected in the status bar. When specific pipetting errors occur, the instrument can also pause the run and request the intervention of an operator.
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5.9.5 The System Paused Dialog
This dialog is displayed either when a instrument error occurs (see chapter 5.9.4 on page 5-24) or if you click on the Stop button in the toolbar.
Figure 5-10: System Paused dialog
Slide(s) Shows the slides that have yet to be processed. Slides that have not yet been completely processed are displayed as well. Resume Continue the run. Abort Slide(s) In the slide list, select the slide(s) that you do not want to process any more. Then click on this button to delete them from the worklist. You can then continue the run with the remaining slides only. Abort Worklist The run is over. None of the slides listed in the slide list will be processed any more. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 When you click on the Abort Slide(s) or the Abort Worklist button, the instrument will take some time to respond because it has to communicate with the instrument to alter all the processing information that has been downloaded to the instrument at the start of the run.
For consequences of a instrument pause, see chapter 4.9.5.1 on page 4-58.
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5.9.6 Pipetting Errors/Manual Pipetting
Depending on what has been defined in the assay (see "Assay Programming Manual"), when pipetting errors (insufficient liquid, clot, pipettor hardware error…) occur, the instrument will either: • Raise alarm and stop: In this case, a specific error message is displayed on the screen explaining the problem and what the operator can do (e.g. Abort, Retry, Ignore…). • Log and continue: In this case, the error is documented (log and flag) but the run continues without any operator intervention. • or order the operator to Manually pipette at end of step (see below).
Whatever the case, the pipetting error is entered in the Event log and the affected samples / controls are flagged in the Combined Report (see chapter 5.10.1 on page 5-29).
5.9.6.1 Manual Pipetting
When manual pipetting is required, the instrument displays a message indicating precisely what to pipette and where. If the manual pipetting needs to be done into a slide, the instrument is unlocked and you can access to the slide and the other resources (dilution plates, sample racks…) as required to perform the manual pipetting.
Note the Slide Position If you need to pull out a slide, please make sure to put them back exactly in the same position! Make sure everything is reloaded before clicking on the OK button in the manual pipetting message.
Note the Rack Position If you need to pull out racks, please make sure to put them back exactly in the same position! Make sure everything is reloaded before clicking on the OK button in the manual pipetting message. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Improper loading or unloading of racks, reagents and samples Improperly loaded or unloaded racks, reagents and samples can produce erroneous results due to incorrect pipetting activities. • Only load and unload racks if you are explicitly requested to do so. • Only load and unload racks on the specified lanes. • Check the correct transfer or input of all reagent and sample names.
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5.9.7 Emergency Stop/Cancel a Run
If you need to stop the processing immediately, what you can do is:
• In the software, click on the Stop button in the toolbar. This will open the System Paused dialog (see chapter 5.9.5 on page 5-25) and unlock the instrument so that you can open the cover flap and access the work area (in case of liquid overflow, see chapter 9.6.3 on page 9-21). • If the problem can be corrected, you can choose to continue the processing by clicking the Resume button of the System Paused dialog. • If the problem cannot be corrected rapidly, you can choose to abort the processing of one slide (highlight the slide and click the Abort Slide(s) button) or to cancel the run altogether by clicking Abort Worklist.
Pipettor Crash Risk of pipettor crash when aborting IFA run while pipettor is aspirating liquid.
When aborting a slide during IFA sweep the pipettor moves with a lower speed to waste station. This happens only when sweep speed is lower than 10 %. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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5.10 End of Run/Result Report Window
As soon as the processing of one slide is finished, the instrument generates the result file for this slide (not per worklist).
Prevention of wrong results To prevent wrong results it is essential to check the result report carefully on flags, entries in the event list or other irregularities.
The instrument does not generate any end result for slides. The slides will only be prepared for further processing (e.g. examination of reaction under a fluorescence microscope) by the user. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 5-11: Result window
Lot Specific Opens the Lot Specific Values dialog box to show or edit the Values required reagents information. See chapter 5.6 on page 5-8 and chapter 6.5.4.2 on page 6-45
All other functions are similar to the described functions in the ELISA description, see chapter 4.10 on page 4-61.
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5.10.1 Result Report and Result Interpretation
The IFA result report did not contain any measured results, but it is important to note the processing information and errors.
See chapter 4.10.1 on page 4-63 and chapter 4.10.2.1 on page 4-66 for flags
5.10.2 Save/Open the Result Report
See chapter 4.10.3 on page 4-68
5.10.3 Print the Result Report
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5.11 Unloading
Pipettor error Do not remove a rack after a pipettor error occurred even if the LED is blinking.
Inspection Inspect instrument deck, slides on trays, plates, racks, etc. for spillages. If there are spillages, check instrument for leakages (see chapter 9.2 on page 9-4).
5.11.1 Unload Slides
Slide inspection Inspect slides after unloading for unexpected or irregular appearances, e.g. for evaporation of liquid.
Finished slide trays can be unloaded during the worklist run. The status can be checked in the instrument status dialog. Finished slides are marked in green. To facilitate unloading of already finished slides it is possible to place slides on different trays which can be unloaded as soon as the trays on the slides are finished.
5.11.1.1 At the End of the Run - Basic Procedure
By default, fully processed slides ("finished slides") are stored on the instrument in
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 the IFA bay. Then, once the processing of the complete worklist is finished, you can unload all slides. To remove the slides: 1. Open the cover of the instrument. 2. Remove the IFA trays containing the slides.
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5.11.2 Unload
• Unload Sample Racks (see chapter 4.11.2 on page 4-72) • Unload Reagent Racks (see chapter 4.11.3 on page 4-73) • Unload IFA trays • Unload IFA bay • Unload Tip Racks and Dilution Plates (see chapter 4.11.4 on page 4-73) • Unload Other Resources (see chapter 4.11.5 on page 4-74) • Unload Waste Disposal (see chapter 4.11.6 on page 4-74)
5.12 Shut Down / End of Day Maintenance
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This chapter describes further functions of the GEMINI instrument software and the GEMINI COMBO instrument software, respectively.
6.1 Initialization and Selftest
Required access rights: Nothing
A selftest is performed each time you start the GEMINI software. The instrument is initialized and checks all instrument modules. These are checked as follows:
COP (Command The serial connection to all modules of the GEMINI is Operating Processor) verified. Pipettor The pipettor is initialized. The movement in x-, y-, z- axis is checked, the encoders and the home sensors in these directions are tested. The pipettor is primed with system liquid five times. Washer The home sensors, encoders, aspirate and diluter pump are checked. Photometer The reference voltage of the front end and also the photodiode dark background signals is measured. Each filter is tested to choose the optimum read gain and for noise at optimum gain. The optic channel transmissions are measured. Plate Transport The movement in x-, y-, z-axis is checked and the encoders in these directions are tested. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Incubators The temperature sensors are tested and it is checked if the heater drives are not in open circuit.
The results of this instrument check are then displayed on the screen:
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Figure 6-1: Selftest report
The result of the selftest is satisfactory if the word "Passed" is displayed for each instrument module. The Maintenance field remains empty unless you have defined specific maintenance checks to be performed by the instrument (see chapter 9.5 on page 9-18). Under default settings, selftests are performed only each time you start the software. But other options are available. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.1.1 Manually Start Selftest
The GEMINI instrument allows the user to request a selftest punctually at any other time (not, however, while a worklist is being processed). This is useful, for example, if you suspect that an instrument module is not responding or functioning correctly. To do this: 1. Select Selftest in the Utilities menu. After a confirmation dialog, a selftest will be immediately performed and the results shown as above.
6.1.2 Selftest before each Run
Required access rights: Change system setup
1. Select the Utilities > System Setup menu item to open the System tab of the System Set-Up dialog (see chapter 8.3.1 on page 8- 19). 2. Check the Perform self-diagnostics before a run item in the Self-diagnostics area.
This dialog also lets you program the software to automatically print a report each time a selftest is performed. To do this: 3. Check the Auto print self-diagnostics report item in the Self- diagnostics area.
If this item is not checked, select File > Print or click the Print button in the toolbar to print a selftest report.
Performing a selftest check before each run is a good safety procedure. However, it takes time (approx. 2 minutes), and is recommended mostly for operators who are not familiar with the instrument. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
6.1.3 Selftest Failures
If one or more of the instrument modules that are checked during the selftest are found to be not responding correctly, a corresponding error message will be displayed in the selftest report. Before interfering with the faulty or non-responding module, try to perform the selftest again by selecting Selftest in the Utilities menu. If this also fails, refer to the error message list in chapter 10.1 on page 10-1 and check what corresponding action can be undertaken to solve the problem.
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6.2 Complete Sample Editor
Required access rights: Edit sample details
The complete Sample Editor dialog allows the direct input of sample data and the assignment of assays. It is required in the following situations: • If you prefer to assign tests before loading the samples on the instrument. • If you have already created a new worklist (see chapter 6.3 on page 6-11) and have not yet assigned tests to some samples. • If you are reusing a formerly saved worklist and want to assign the tests to some new samples. • If only samples without barcoded tubes are used. • If additional sample data (e.g. name, sex, date of birth etc.) are to be entered. • If you are using the software in demo mode.
Samples for multi-preparation assays Sample ID's for multi-preparation assays cannot be defined via the complete sample editor, it is mandatory to define these ID's by loading a filled sample rack to loading bay to avoid the exchange of sample tubes.
To enter sample data manually:
Select the Utilities > Sample Details menu item. The GEMINI software shows the complete Sample Editor dialog: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-2: Complete Sample Editor dialog
Left list Shows all samples and its assigned assays as a tree. (Click on the plus sign to display the assays.)
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Right list Shows all samples. Select only one sample to: • edit the sample details, or • edit the assigned assays
Select one sample or several samples to: • delete the sample/samples, or • add assays.
Add Samples New samples ID can be created with this function (see chapter 6.2.1 on page 6-6). Add Tests This function allows the assignment of samples and assays (see chapter 6.2.3 on page 6-9). Delete All All created samples can be deleted with this function. Delete (Date) This function allows the deletion of samples already created which were created before a certain date. Delete Samples already created and selected can be deleted again with this function. Samples Edit Sample Additional detail (e.g. name, sex) can be entered for a selected sample by means of this function (see chapter 6.2.2 on page 6-7). Edit Tests With this function, the assignment of a selected sample and the assigned assay can be changed (see chapter 6.2.4 on page 6-10). Select All All created samples can be selected with this function. Sort Order The Sort Order field allows you to define the order in which the samples will be pipetted from the tubes. The Sort Order selected also serves to determine: • the samples' order for the Auto Arrange function in the Load dialog (see chapter 4.8.1 on page 4-33) • the order in which samples are listed in the results (in the Combined Report) • the order in which sample IDs will be sorted in the Sample Editor after a successful worklist import. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Selectable sort order: • Ascending: Sorted in alphanumeric ascending order (based on the sample IDs entered or read by the barcode scanner). • Descending: Sorted in alphanumeric descending order (based on the sample IDs entered or read by the barcode scanner). • None: The samples will be pipetted from the tubes in the order in which they are placed in the racks.
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6.2.1 Add new Samples
If the button Add Samples has been clicked in the complete Sample Editor dialog, the Add Sample(s) dialog is displayed:
Figure 6-3: Add Sample(s) dialog
First sample In this box, the (first) sample ID number can be entered. ID For the input of the sample ID, the Edit Sample ID dialog can be used (see chapter 3.5 on page 3-16). Number of In this box, the number of samples to be created with a consecutive sample ID can samples be entered. Example: Input: ID: P0001; Number: 5 Result: P0001, P0002, P0003, P0004, P0005
For the entry of the value, click on the Edit a Number button (see chapter 3.5 on page 3-16).
Sample ID The entered sample ID must be unique! If non-unique sample IDs are used (e.g. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 same ID for different persons at different worklists), the sample database is incorrect. In this case, features like sample history or sample result report must not be used. • Recheck entered sample ID and original sample ID!
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6.2.2 Edit Sample Details
Only the Sample ID is absolutely needed to process a test run. However, the GEMINI instrument also allows the user to enter and store the following sample details: • last name • birth date •sex
Figure 6-4: Sample Details dialog
Practice In this box, the selected sample ID number can be changed. Please note that the Assigned sample ID must remain unique. Sample ID It is also possible to click on the Edit button to open the Edit Text dialog (see chapter 3.5 on page 3-16). Last Name In this box, the last name of the sample can be entered. It is also possible to click on the Edit button to open the Edit Text dialog (see chapter 3.5 on page 3-16).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Birthdate After the activation of this option, the date of birth of the sample can be selected in the adjoining box. For a simplified entry of the date of birth, a calendar is available which is opened after clicking on the arrow. Year, Month, The date of birth can also be entered by pushing the buttons. After pushing, the and Day Enter a Number dialog is opened (see chapter 3.5 on page 3-16). Sample Sex After pushing the button Edit a dialog appears for selecting the sex of the sample. The following selection options are available: • F: female • M: male • U: undefined/unknown
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If you are using barcodes or importing test orders from a host computer, the sample details can be entered automatically provided the pertinent information is included in the barcode or in the imported file/data. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.2.3 Assign Assays to the Samples (Complete Sample Editor)
Wrong Results It is necessary to use only for GEMINI validated assays to avoid wrong results.
Before a sample can be tested, an assay must be assigned to the sample. This assignment is made in two steps: • In the first step, all samples must be selected which are to be assigned to an assay. • In the second step, the required assays are selected.
Procedure 1. Select all involved samples in the complete sample editor. 2. Press on the Add Tests button. The Select Assay(s) dialogs opened: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-5: Select Assay(s) dialog
Filter With this function, the number of assays displayed can be limited. After pushing the button, the Edit Text dialog (see chapter 3.5 on page 3-16) is opened. After the entry, only those assays containing the entered text are displayed. The filter ignores capitalization. Example: Filter input: igg Displayed Assays: CMV IgG, HSV IgG, MUMPS IgG, Toxo IgG Recent After clicking on this function, only assays are displayed which have already been used once in a worklist. If this function is clicked on again, all assays are displayed again.
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After the selection of the assays and the pushing of the OK button, the Sample Editor dialog appears again. The assignment of samples and assays is now executed.
6.2.4 Edit Assigned Assays
With this function, the assignment of a selected sample and the assigned assay can be changed.
Figure 6-6: Sample Editor - Tests dialog
Add Tests This function allows the assignment of the sample and assays (see chapter 6.2.3 on page 6-9). Edit Test Shows the Test Order Details dialog to add/edit the collection date of the selected assay. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Delete Test Selected tests can be deleted with this function. Delete All All assigned assays can be deleted with this function.
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6.3 Create your own Worklist
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assays is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
Required access rights: Start Worklists
The worklist is at the core of how the GEMINI instrument operates. In the Sample Editor dialog, you defined the tests (assays) to be performed for each sample (e.g. sample 000001 must be tested for HIV and Hepatitis, sample 000002 must be tested for HIV only, sample 000003 must be tested for HIV, Hepatitis and Toxoplasmosis, etc.). Now, you will use the worklist to define how these tests will actually be implemented on the test plates (e.g. Plate 1 will be used to test sample 000001, 000002 and 000003 for HIV, Plate 2 will be used to test sample 000001 and 000003 for Hepatitis, and Plate 3 will be used to test sample 000003 for Toxoplasmosis …). Once the worklist is defined, the instrument checks all parameters and signals any error. Errors must be corrected before you start a run. A new worklist is generally created for each test run but if similar test runs are performed regularly, the instrument allows the user to save and re-use previously defined panels.
The main element of worklist definition is the Set-Up Panel dialog. Here, the user organizes the test run to be performed: which assay on which plate and the order of the plates. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 In the Sample Editor dialog, you defined the tests (assays) to be performed for each sample (e.g. sample 000001 must be tested for HIV and Hepatitis, sample 000002 must be tested for HIV only, sample 000003 must be tested for HIV, Hepatitis and Toxoplasmosis, etc.). Now, you will use the worklist to define how these tests will actually be implemented on the test plates or slides (e.g. Plate 1/Slide 1 will be used to test sample 000001, 000002 and 000003 for HIV, Plate 2/Slide 2 will be used to test sample 000001 and 000003 for Hepatitis, and Plate 3/Slide 3 will be used to test sample 000003 for Toxoplasmosis …). Once the worklist is defined, the instrument checks all parameters and signals any error. Errors must be corrected before you start a run. A new worklist is generally created for each test run but if similar test runs are performed regularly, the instrument allows the user to save and re-use previously defined panels.
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The main element of worklist definition is the Set-Up Panel dialog. Here, the user organizes the test run to be performed: which assay on which plate/slide and the order of the plates/slides. The Set-Up Panel dialog is blank when it opens, i.e. when the instrument does not yet have the required information on the samples or on the tests to generate a suggested worklist. Use this method particularly if: • you create a worklist before loading the sample racks onto the instrument. • you do not import data from a host computer. • you are using the software in demo mode (see chapter 6.12 on page 6-75).
If you have already loaded the sample racks and assigned assays to samples as described in chapter 4.4 on page 4-8, or if you have imported sample data and test orders from a host computer, the instrument will automatically suggest a worklist; you can refer directly to chapter 4.5 on page 4-14.
The instrument enables additionally the combination of several assays on one plate. But all assay must belong to the same combination group and all assay parameters (incubation time, shaking parameters, wash steps …) must be compatible.
Create a Worklist (ELISA)
1. Click on the new worklist button. An empty Set-Up Panel dialog is shown (see chapter 6.3.1 on page 6-15). 2. Click on the Add Plate button. A new plate is added. 3. Click on the Add Assay button. The Open dialog is shown. 4. Select the desired assay file. The assay is added. 5. Click on the Add Sample button. The Select Sample(s) dialog is shown (see chapter 6.3.2 on page 6-20). 6. Select the desired sample(s) and click on the OK button. The sample(s) are shown in the Set-Up Panel dialog.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 7. Optional: • Click on the Add Assay button to add a further assay to the (selected) plate. • Click on the Add Sample button to add further samples to the (selected) assay. • Click on the Add Plate button to add a further plate. • Click on the Edit button to change the name of the (selected) plate. • Move the plate order: The GEMINI will process plates in order from top to bottom as shown in the list. The order of the plates can be edited by clicking on the Move Up/Move Down buttons. 8. If you are ready, click on the OK button. The GEMINI instrument software shows the Lot Specific Values dialog (see chapter 4.6 on page 4-15).
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The GEMINI is a two-plate instrument. However, in order to provide a longer walk- away time, a third plate can be initially loaded, which will be processed usually after the processing of the first plate is finished. Furthermore, it is possible to load more plates during the run. Please refer to the section on continuous loading (see chapter 6.6 on page 6-48) if you add plates during a run.
Maximum number of plates included in a worklist at the same time: It is normally possible to add up to 3 plates in the same worklist. This depends, however, on the assays and on the number of samples to be processed. In most cases, the instrument will then schedule the run so that the processing of the last plate begins only when the processing of the first plate is finished. If you need to process heavy workloads, it is sometimes preferable to do two consecutive runs (see the end of chapter 4.7.2 on page 4-21 on how to optimize your workflow) or to rely on continuous loading (see chapter 6.6 on page 6-48) rather than add a maximum number of plates in the same worklist.
Create a Worklist (IFA)
1. Click on the new worklist button. An empty Set-Up Panel dialog is shown (see chapter 6.3.1 on page 6-15). 2. Click on the Add Assay button. The Open dialog is shown. 3. Select the desired assay file. The assay is added to a new added slide. 4. Click on the assay name. 5. Check if the correct slide layout and rac file name to the corresponding assay is displayed in the Set-Up Panel. 6. Click on the Add Sample button. The Select Sample(s) dialog is shown (see chapter 6.3.2 on page 6-20). 7. Select the desired sample(s) and click on the OK button. The sample(s) are shown in the Set-Up Panel dialog. 8. Optional: • Click on the Add Assay button to add a further assay with a new
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 slide. • Click on the Add Sample button to add further samples to the (selected) slide. • Click on the Edit button to change the name of the (selected) slide. • Move the slide order: The GEMINI COMBO will process slides in order from top to bottom as shown in the list. The order of the slides can be edited by clicking on the Move Up/Move Down buttons. 9. If you are ready, click on the OK button. The GEMINI COMBO instrument software shows the Lot Specific Values dialog (see chapter 5.6 on page 5-8).
Maximum Number of 16 Slides per Worklist It is not possible to load more than 16 slides to a worklist. More than 16 slides lead to a schedule error.
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Maximum number of slides included in a worklist at the same time: It is possible to add up to 16th slides in the same worklist. This depends, however, on the assays and on the number of samples to be processed. In most cases, the instrument will then schedule the run so that the processing of the last slide begins only when the processing of the first slide is finished. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.3.1 Set-up Panel Dialog
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
Figure 6-7: Set-up Panel dialog with two plates 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Figure 6-8: Set-up Panel dialog with two slides
Add Assay With this function, you can add a new assay to the (selected) plate or add a new assay with slide. After clicking on the function, an Open dialog for the selection of assays is opened automatically. Add Sample With this function, you can add a new sample to the (selected) assay. After clicking on the function, the Select Sample(s) dialog for selecting the samples is opened automatically (see chapter 6.3.2 on page 6-20). Add Plate With this function, you can add a new plate to the worklist. After clicking on the function, the new plate is added. Not used for IFA assays. Archived Assign archived samples to the selected assay (when samples are to be pipetted Sample out of an archive plate (see chapter 6.7.8 on page 6-65).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Collapse Opens the complete plates/assays/samples tree.
Delete With this function, you can delete a selected plate/slide, assay, or sample from the worklist. Edit This function allows you to change the plate ID/slide ID (name) of a (selected) plate/slide. Take care that the plate ID/slide ID is clear and unique, i.e. is not used by another plate/slide in this worklist yet.
Only for ELISA assays! If you will use the "linked plate ID"-function to use the blank and standard values from an other plate, you must enter the name (ID) of the linked plate in the field Linked Plate ID. This is only necessary if the assay allows the use of linked plates. If the field Linked Plate ID is empty, the instrument uses the current plate.
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Edit Dilutions Only accessible at IFA mode for assays with dynamic dilutions: Option to edit the dilutions applied for an individual sample of an IFA assay. Edit Layout This function opens the Plate Layout/Assay Layout dialog for a selected assay (see chapter 6.3.1.1 on page 6-19). The software ignores any plate/assay layout given by the "Assay Layout" after import of a plate/assay layout when processing the plate (also recalculation of the results) or slide. Expand Opens the complete plates/slides/assays/samples tree.
Import layout This option allows the generation of a worklist using information of the "Plate layout" file. In Opens the lower part of the selected plates/slides/assays/samples tree.
Load Plate This option allows the recall of a plate map used in the last 7 days. Map Note: Plate maps which were created before will be deleted automatically. Move Down This function changes the sequence of the plate/slide processing. A plate/slide can be processed after another one. Move Up This function changes the sequence of the plate/slide processing. A plate/slide can be processed before another one. Open Panel Opens a saved worklist (see chapter 6.3.4 on page 6-25). Out Closes the lower part of the selected plates/slides/assays/samples tree.
Sample With this function, you can open the complete Sample Editor dialog (see Details chapter 6.2 on page 6-4). Plates/Slides, In the tree, all plates/slides are displayed which will be used in the worklist. Later, assays and samples they are processed in top down sequence. The individual plate/slide can be selected by clicking on them. After the selection, the assignment is indicated in the plate/assay layout. After clicking on the plus sign of a plate/slide or double clicking on the plate/slide, all assays are displayed which will be used on the selected plate/slide. The individual assay can be selected by clicking on them. After clicking on the plus sign of an assay or double clicking on the assay, all samples are displayed which will be processed with the selected assay. The individual samples can be selected by clicking on them. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Note: Samples for multi-preparation assays: All preparation sample tubes are assigned to the sample ID of the first preparation sample tube. Only this sample ID will be shown. Save Panel Saves the created worklist (see chapter 6.3.4 on page 6-25). Start assay By activating this function, you can make sure that the selected assay starts in a with a new new column, even if there are unused wells left in the previous column (see strip chapter 6.3.3 on page 6-21 and chapter 6.3.3.4 on page 6-23). This function is activated by default. Not used for IFA assays.
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Plate Layout The upper right-hand side of the Set-Up Panel dialog shows the plate layout. The 96 cells in this table represent the actual test plate with its 96 wells. Columns are numbered from 1 to 12, and rows are lettered from A to H so that each individual cell/ well has a unique location (e.g. E5). The upper right-hand side of the Set-Up Panel dialog shows the plate/assay layout. Plate layout • The 96 cells in this table represent the actual test plate with its 96 wells. Columns are numbered from 1 to 12, and rows are lettered from A to H so that each individual cell/well has a unique location (e.g. E5). Assay layout • The cells in this table represent the actual slide with its fields In the plate/assay layout, sample types are precisely labelled (B1, NC1, T3, etc.).
Label: Description
B Blank value for background reading S Standard T Test (sample) NC Negative control PC Positive control CO Cutoff
Table 6-1: Plate layout labels
To help distinguish them visually, a set color is generally assigned to each sample type, e.g. NC wells are green, PC wells are red, T wells are black, etc. These colors are assigned when the assay is defined (see "Assay Programming Manual"). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.3.1.1 Editing the Plate Layout
The Plate Layout is the way in which the different samples (samples (T) but also negative control (NC), positive control (PC), standards (S), blank samples (B), etc.) are arranged on a test plate. This arrangement is specifically defined for each assay when the assay is created, as described in the "Assay Programming Manual".
If you are using a validated pre-defined assay, you should not attempt to edit the Plate Layout at this stage.
Even if you are using your own assays, it is generally not recommended to alter the Plate Layout at this stage as any changes made will apply only to this run (the assay file itself will not be changed so that if you process the assay again later, the original layout will apply).
Only for test plates: At this stage, the best way to optimize the Plate Layout, if you are not processing full plates, is to process several assays per plate and eliminate "empty" wells as explained in (see chapter 6.3.3.4 on page 6-23).
If you use a multi-preparation assay (only ELISA assays), then you must select at least as many wells as you have different preparations.
If you use replicates, then you must select at least as many wells as you have different replicates. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.3.2 Add Samples
Figure 6-9: Select Sample(s) dialog
Select Loaded This function allows you to select automatically those samples that are already loaded on the instrument. In the list, those samples are indicated by a (*) sign next to the sample ID. Allow multiple If a sample is already assigned to the worklist (e.g. has already been selected determinations on another plate), it no longer appears on the list. To test the same samples with the same assay twice in the same run, check the Allow multiple determinations item. Already assigned samples are displayed again in the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 list and can be reselected.
If the Select Sample(s) dialog is empty when it opens, this means that you have not already assigned this particular assay to any samples as explained in chapter 6.2 on page 6-4. You can click the Sample Editor button in the Set-up Panel dialog and do this now. If necessary, refer first to the explanations given in that section.
If sample are run multiple times using the same assay, the software asks for confirmation. In case many samples are selected, the dialog window might be to small to display the message completely.
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Samples for multi-preparation assays For multi-preparation assays always sample tubes must be loaded as described in (see chapter 4.4 on page 4-8)!
6.3.3 Processing Several Assays per Plate
Only for ELISA Assays!
Combining several assays on the same plate is a way to save time (and test plates) if you intend to test several different assays on a fairly small number of samples (e.g. 8 assays on 20 samples). It is also done on a regular basis for some tests, e.g. Toxo IgG and Toxo IgM. The GEMINI instrument allows you to combine several assays on the same test plate but only if the following conditions are met. Assays can be combined on the same plate only if: • They have a compatible assay structure, i.e. compatible parameters for incubation steps, shake steps, conditional delay (if any), reading parameters, etc. and • They belong to the same assay group.
Incompatible Functions Avoid combining assays with Plate wash mode and assays with Strip wash mode on the same plate! This could result in a delayed final aspiration including on the Plate wash mode assay.
Incompatible Functions Assays with even small differences in the wash steps (e.g. dispense rate, dispense volume) but requiring elimination assay drift must not combined on one plate. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
If one of the assays you intend to combine requires the use of unstable reagents, it is best to place it as the first assay on the plate.
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6.3.3.1 Compatible Assay Structure / Parameters
To check whether the assays you intend to combine on the same plate have compatible assay structures, you can either open these assays and review their respective parameters as described in (see chapter 4.4 on page 4-8) or use the instrument to check their compatibility automatically. If the assays you have tried to combine on the same plate are compatible, the Worklist window is displayed normally (plate status is Not Loaded).
Incompatible Functions The GEMINI software does not check compatibility of shake steps. If an assay that does not need shaking is combined with a second assay that needs shaking, the plate will shaken.
If the assays you have tried to combine are not compatible, a warning message is displayed telling you why these assays cannot be combined on the same plate. If you click on the OK button on the warning message, Error will appear as the status of the respective plate in the Worklist window. To correct the worklist definition and assign each assay to a different plate, go back to the Set-Up Panel dialog (see chapter 6.3 on page 6-11).
6.3.3.2 Assay Combination Groups
Assay combination groups are intended for assays that are commonly processed together. Assigning assays to the same assay group serves to confirm to the instrument that these assays can be combined on the same plate. Conversely, if assays belong to different combination groups, the instrument will never allow them to be processed on the same plate (even if their parameters are compatible). See "GEMINI Assay Programming Manual" for detailed information.
6.3.3.3 Automatic Worklist Definition
If you import worklist/test orders from the LIS and you use barcoded samples, as soon as you load new samples on the instrument, the instrument automatically suggests a suitable worklist to process the samples you just loaded (see chapter 4.5 on page 4-14). This also true when you reload samples in an on-going worklist using the continuous loading procedure (see chapter 6.6 on page 6-48). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Under default settings, whenever a worklist is thus automatically generated by the instrument, the instrument always tries to combine as many assays as possible on each plate (provided, of course, that assay parameters are compatible and that the assays belong to the same assay combination group).
Incompatible Functions Note, however, that this redefinition applies to the current worklist only. If you decide that there are some assays which you never want to combine on the same plate (even though they have compatible structures), you have to change their combination group as described in the ’GEMINI Assay Programming Manual’ so that they belong to different groups.
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6.3.3.4 Strip Management/Optimizing the Plate Layout
If you use coated microplates with removable strips, when combining several assays on the same plate, you have to make sure that: • In the software, each assay starts on a new strip. • You rearrange the microplate you intend to load so that the strips correspond exactly to what has been defined in the software.
New Strip The Set-up Panel dialog includes a Start assay with a new strip checkbox (see chapter 6.3.1 on page 6-15). If you enable the Start assay with a new strip checkbox (default), you can see that Assay2 now starts on Strip 5 only. This is required if you use coated plates with removable strips. You can then prepare your microplate accordingly.
Figure 6-10: Two Assays on a plate (start assay with a new strip)
If you combine two assays on the same plate without checking this box, the second assay starts immediately after the last well of the first assay as shown below: Assay2 starts in well B4, immediately after the last sample well for Assay1. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-11: Two Assays on a plate (start assay after previous assay)
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Layout However, starting each assay on a new strip means you may have unused wells on Optimization a test plate, as in the example above where only one well is used respectively on Strip 4 and Strip 8. This means that you will "loose" the seven unused wells located on each of these strips. In that case, it may be worth it to decide to test sample T21 (for each assay) in a later run. See chapter 6.3.1 on page 6-15 to remove sample T21 from the worklist/plate.
Figure 6-12: Two Assays on a plate (without sample T21)
You now have an optimized layout and you can prepare your microplate accordingly.
6.3.3.5 Results
If you process several assays on the same plate, the instrument will still generate only one result file per plate. The results corresponding to each assay will be displayed in this file one after the other, with the same order that they had on the plate (i.e. full results for Assay 1, then full results for Assay 2...). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.3.4 Save or Open a Worklist
If you generally use the GEMINI instrument for the same assays or for repetitive jobs, you can shorten the worklist creation process by reusing previously defined (and saved) worklists (also called panels).
When a worklist is saved, the instrument stores only the plate and assay arrangements but not the sample IDs. This is because it is assumed that if the worklist file is used again in a new worklist and for a new test run, it will normally be for a new set of samples. This is why, even if you use an existing worklist file to create a new worklist, you have to redo the Add sample step.
Save Worklist 1. Create a worklist with your plate and assay arrangement. 2. In the Worklist window: • For new or changed worklists: Click on the Save button or select the File > Save Panel menu item. • For changed worklists with changed file name: Select the File > Save Panel as menu item. 3. Enter the file name and save the worklist (see chapter 3.3 on page 3-11).
Worklist files have a (*.wor) extension. By default, they are saved in the default directory (see chapter 8.2.8.1 on page 8-16).
Load Worklist 1. Click on the Open button. 2. Click on the Worklist Files (*.wor) symbol. 3. Select your desired worklist file and load it. 4. Select sample(s) for the plates. 5. Start the worklist.
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The following instruction describes both assay types together. Specifics will additionally be described.
If you generally use the GEMINI instrument for the same assays or for repetitive jobs, you can shorten the worklist creation process by reusing previously defined (and saved) worklists (also called panels).
When a worklist is saved, the instrument stores only the plate/slide and assay arrangements but not the sample IDs. This is because it is assumed that if the worklist file is used again in a new worklist and for a new test run, it will normally be for a new set of samples. This is why, even if you use an existing worklist file to create a new worklist, you have to redo the add sample step.
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Save Worklist 1. Create a worklist with your plate/slide and assay arrangement. 2. In the Worklist window: • For new or changed worklists: Click on the Save button or select the File > Save Panel menu item. • For changed worklists with changed file name: Select the File > Save Panel as menu item. 3. Enter the file name and save the worklist (see chapter 3.3 on page 3-11).
Worklist files have a (*.wor) extension. By default, they are saved in the default directory (see chapter 8.2.8.1 on page 8-16).
Load Worklist 1. Click on the Open button. 2. Click on the Worklist Files (*.wor) symbol. 3. Select your desired worklist file and load it. 4. Select sample(s) for the plates/slides. 5. Start the worklist. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.4 Worklist Options
Required access rights: Edit Worklist Options
After a worklist has been prepared and before it is started it is possible to check and/ or edit the worklist processing options. By default, the instrument uses the previously defined worklist options. Some options are locked and cannot be changed even by supervisors (users with full access rights).
Click on the Edit Options button or select the Edit > Panel Options menu item to invoke the Worklist Options dialog. The Worklist Options dialog will shown with several registers: • Scheduling (see chapter 6.4.1 on page 6-27) • Before worklist will be started (see chapter 6.4.2 on page 6-30) • During worklist is running (see chapter 6.4.3 on page 6-32) • After worklist was finished (see chapter 6.4.4 on page 6-34)
6.4.1 Worklist Options: Scheduling 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-13: Worklist Options dialog - register Scheduling
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Allow assay protocols with Worklist definitions are permitted where different wash buffers different wash buffers to be are being used. This option is always checked and may not be run on the same plate unchecked (even by users with supervisor status). Allow assay protocols with different wash buffers to be run on the same slide (optional) Archive Parameters Shows the archive parameters (see chapter 6.7.4 on page 6-58). Not used for IFA assays. Archive samples during the Enables the archive function (see chapter 6.7.4 on page 6-58). run Not used for IFA assays. Aspirate profile Only used for multipipetting: Select the desired aspirate profile. The aspirate profile you define here will apply to both samples and reagents (controls, standards or diluents). Aspirate + Shows next aspirate profile. Aspirate - Shows previous aspirate profile. Aspirate Shows the selection dialog with all aspirate profiles. Dispense profile Only used for multipipetting: Select the desired dispense profile. The dispense profile you define here will apply to both samples and reagents (controls, standards, diluents). Disp. + Shows next dispense profile. Disp. - Shows previous dispense profile. Disp. Shows the selection dialog with all dispense profiles. Multi pipetting mode Select one of the following options: • Disabled: Multipipetting is not allowed. • All microplates or Same microplate only: If a sample is to be pipetted into more than one well on a plate, this option allows to pipette this sample with only one 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 tip into all wells required together. Note: On GEMINI, the option All microplates is the same as Same microplate only, because multiple pipetting can be done only on one plate. Risk: Drift constraints!
See note below! Re-use partial dilution Partially used dilution plates are registered and re-used for plates later worklists. Re-use partial disposable Partially used tip racks are registered and re-used for later tip racks worklists. See chapter 4.8.6 on page 4-45 on when to select this option or not.
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Scheduling gap This is a duration of between 0 and 10000 seconds (default: 0 seconds). The software schedules all operations that use the same module to ensure that at least this gap is present between operations on different plates. Note: This should have the effect of providing a "safety zone" so that a instrument error on one plate will have less chance of causing incubation overruns on other plates.
Wrong Results It is necessary to use only validated assay/profile combinations to avoid wrong results.
Multi Pipetting
Incompatible Functions Do not use the multi pipetting function, if you use assays where the functions Eliminate assay drift caused by this operation (pipette or dispense step) or Time incubation from start to previous assay step (incubate step) are enabled (see "Assay Programming Manual")!
Note that if this option has been selected, samples that are pipetted in parallel within the plate are pipetted before all other samples on the same plate. This makes this option strictly incompatible with all assays that include the "assay drift compensation" feature (see "Assay Programming Manual"). This can also create unsuitable pipetting sequences when: • only some samples are assigned to both tests. • or, the multiple determination option (see chapter 6.3.2 on page 6-20) has been used for some or all samples. • or, the assays include a predilution step. • or, the order in which the controls have to be dispensed (i.e. strictly before or strictly after the samples) must not be changed. If in doubt, do not select this option or call your application engineer for assistance. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.4.2 Worklist Options: Before Worklist will be started
Figure 6-14: Functions of the Worklist Options dialog - register Before
Check sample levels before See chapter 4.9.1.3 on page 4-54 a run
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Check reagent levels before See chapter 4.9.1.2 on page 4-53. a run Tip size to use for checks For checking if there is sufficient liquid in sample/reagent vials before run, additional tips are consumed. You can select which kind of tips will be used for this check. Verify disposable tip racks Tip type detection: When starting to process the worklist, the instrument checks the size of the first tip of each rack to make sure the racks have been loaded as displayed in the Load dialog box (i.e. long tips and short tips have not been mixed up). See chapter 4.9.1.4 on page 4-54. See note below!
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Verify strip presence before Each time a test plate is loaded, it is first moved into the a run photometer so that the instrument can check that it includes the correct number of strips. This is useful especially when using plates with removable strips. This item is checked by default and may not be unchecked (even by users with supervisor status). Note: This function should always be activated to avoid wrong results, contaminations or damages.
Tip Type Detection Never disable tip type detection in the worklist options. If disabled, a tip misplaced cannot be recognized by the instrument and may cause mechanical damage! 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.4.3 Worklist Options: During Worklist is running
Figure 6-15: Functions of the Worklist Options dialog - register During
Abort plate if reagent is not Aborts the respective plate processing if the reagent is not loaded within the time loaded within the time specified above. Check this item if you specified above intend to use GEMINI as a "walk away" instrument (e.g. at 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 night). That way, the respective plate will be aborted but the rest of the run will continue. If 300 µl tips run out Select one of the following options: • Raise alarm and stop: The instrument pauses the processing and prompts you to load more tips. • Abort plate: The instrument aborts the processing of the current plate. The processing of other, already pipetted plates, can continue as planned. • Log and continue: The instrument automatically skip any processing steps that require 300 µl tips and removes any affected wells from the results.
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Pause worklist if system Stops the instrument immediately when the instrument cover cover open has been opened. This item is checked by default and may not be unchecked (even by users with supervisor status). Play sound when additional An acoustic signal will warn the operator when additional plates can be loaded plates can be loaded to a running worklist. This item applies to Continuous Loading (see chapter 6.6 on page 6-48) and is generally checked. Play sound when additional An acoustic signal will warn the operator when additional slides slides can be loaded can be loaded to a running worklist. This item applies to Continuous Loading (see chapter 6.6 on page 6-48) and is generally checked. Reagent load time Enter the maximum reagent load time in seconds. This applies when unstable reagents have to be loaded while a worklist is being processed (see chapter 4.8.4 on page 4-42). The instrument will warn the operator beforehand (warning message in the software and acoustic signal) and pause the instrument during the specified load time. This load time should be long enough to allow correct loading but not so long as to affect the processing of the run. Recommended time is 180 seconds (3 minutes). Entries between 0 and 1000 are acceptable. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.4.4 Worklist Options: After Worklist was finished
Figure 6-16: Functions of the Worklist Options dialog - register After
Automatically print results Check this option if you want the instrument to print the result file as soon as it is generated, i.e. as soon as the processing of the respective plate/slide is over. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.5 Advanced Options
6.5.1 Optimize the Schedule
When you have finished defining your worklist (in the Set-Up Panel dialog) and your worklist options (see chapter 6.4 on page 6-27), the GEMINI instrument software calculates the best way to combine the various steps of each process, while maintaining the plate processing sequence you defined. If you want to try and optimize this process even further by changing the order in which the various plate are going to be processed: 1. Select the Edit > Optimize menu item. The instrument tries all possible plate orders and automatically reschedules the run using the plate order with the shortest overall processing time.
For very complex worklists, the optimization process may take a long time while the instrument calculates all possible combinations. If no solution has been reached within a few minutes, it is recommended to abort the process (click on the Abort button in the Optimizing dialog) and reschedule the worklist manually if necessary.
If you want to optimize the processing manually: 1. Go back to the Set-Up Panel dialog by selecting the Edit > Panel Definition menu item. 2. Edit the worklist by highlighting the elements you want to change and using the Edit, Delete, Move Up/Move Down buttons (see chapter 6.3.1 on page 6-15 for more information on these buttons). 3. Click on the OK button.
Planning a Daily Optimizing the schedule is particularly important if you want to process a large Workload number of samples in a minimum time (e.g. processing 500 samples with several assays and within an 8-hour work shift). In such cases, determining the best 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 schedule may require you to try out many different solutions (Some assays are easier to combine than others. Sometimes it is better to do two runs. Sometimes you want to avoid operator intervention at a certain time of day, etc.). If finding the right schedule is not obvious, you can use the Demo Mode (see chapter 6.12 on page 6-75) to do all your planning/optimizing and to simulate the various possibilities.
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6.5.2 Advanced Load Options
6.5.2.1 Save/Open Reagent Layout
If you are using non-barcoded reagent bottles and if you are generally repeating the same tests over and over, you may try to shorten the reagent allocation process by using the Save Reagent Layout and Open Reagent Layout function.
Reagent Positions The instrument will not check opened reagent layouts. Make sure that positions are correct!
Save To do this: 1. The first time you use the desired worklist, load the reagents on the instrument and allocate them manually in the Load dialog as described in chapter 6.5.2.3 on page 6-40. 2. Click on the Save Reagent Layout button. 3. After clicking on the function, the Save dialog is opened (see chapter 3.3 on page 3-11). Enter an appropriate file name and save the reagent layout. (Reagent layout files have a (*.rea) extension.)
Open To do this: 1. The next time you want to process exactly the same tests with the same reagents (and new samples of course), in the Load dialog, click on the Open Reagent Layout button. 2. In the Open dialog which is then displayed, select the desired (*.rea) file and open it. All the reagents are automatically allocated. Now fit the reagent bottles in the racks making sure you reproduce exactly the layout which is displayed in the Load dialog.
If you intend to use this function on a standard basis, include small labels on the rack itself or copy and fill in the rack layout forms in order to keep a "reference picture" of each saved layout. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.5.2.2 Scanner Configuration
Sample Rack Tab
Figure 6-17: Scanner Configuration dialog: Sample Rack tab
Auto Load Enter the first line to be loaded. See also chapter 10.2.1.8 on page 10-19. Track Barcode If the digits to be disregarded are at the beginning of the barcode ID, enter them Prefix under Prefix. For example, if the sample barcodes include 10 digits altogether but you want the barcode scanner to read only the last 8 digits, enter two digits in the Prefix field (any digits; the actual digits you type in are irrelevant, two "wildcards" appear in the field). Barcode If the digits to be disregarded are at the end of the barcode ID, enter them under Suffix Suffix. For example, to omit a six digit date format at the end of a barcode, enter six digits (six "wildcards"). You can also combine the Prefix and Suffix fields. For example, if you want to disregard one digit at the beginning and one at the end, enter one digit in each field.
Prefix / Suffix / Checksum
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Do not use the Prefix / Suffix fields to exclude a Checksum. • If you intend to make use of the Checksum and/or the Prefix / Suffix options, it is essential that you label empty tubes and validate your settings on these before running actual sample tubes. Check in particular that the sample IDs read by the barcode scanner and the sample IDs in the result report correspond to what you expected.
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Barcodes Types Tab
Figure 6-18: Scanner Configuration dialog: Barcodes Type tab
List List of all barcode types that can be read by the integrated barcode scanner. If a checkbox is selected, the scanner is able to read the respective barcode type. It is possible to select several checkboxes but the more checkboxes are selected, the slower and less accurate the reading will be. Some barcodes types are always selected and cannot be unchecked (barcode types used on GEMINI racks and reagents). The following barcode types can be used for samples and reagents to be processed on the GEMINI instrument: • 2/5 Interleaved, • Code 39, • 2/5 IATA, • 2/5 Industrial, • UPCA, UPCE, • EAN 8 or 13 digits, • Code 128, EAN 128, • EAN Addendum, 2or 5 digits, • Codabar Typically, when the instrument is installed, your service engineer configures the barcode scanner to accept the barcode types you generally use on the samples you process. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 If you later need to change the pre-configured barcode settings, see chapter 8.3.6.1 on page 8-36. Enabled Enables a barcode type in the list.
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Minimum Minimum and maximum character length of each barcode type. Length + Note: Generally, if you do not know these values, you can leave the default Maximum values. However, if you also use the Barcode Prefix and Barcode Length Suffix options to exclude some digits, you should enter in the Minimum Length and Maximum Length fields exactly the number of significant digits (including the prefix and suffix) in the respective barcode type. For example, if you use a barcode format with 14 digits altogether and exclude the date suffix (6 digits), enter "14" in both the Minimum Length and Maximum Length fields. Note: Wrong settings could lead to false barcode values. Example: • Max. = 6 • Barcode 1: 2007P45 • Barcode 2: 2007P48 • Result: 2007P4 for both barcodes! Checksum Some barcode formats include a checksum digit placed either at the end or at the beginning or the actual barcode number. In some cases, this checksum digit is included in the barcode labels attached to the samples but not in the sample IDs of the test order requests sent by the LIS. In this case, the GEMINI instrument cannot match the imported sample IDs with the barcode IDs scanned during the sample loading process. To avoid this, the Checksum column can be used to tell the instrument to "drop" the checksum digit scanned by the barcode reader. If item is checked, GEMINI excludes the checksum digit (if any) from the scanned barcode ID. The checksum is excluded whatever its position (last, first…) in the barcode. If there is no checksum in the barcode label, no other digit is excluded. If item is unchecked, GEMINI includes the checksum digit (if any) in the scanned barcode ID. Greyed items show barcode formats that normally require a checksum digit and for which the GEMINI instrument always disregards the checksum.
Barcode Settings If you change the barcode settings (e. g. length, checksum) it is necessary to validate this settings with your barcodes. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Racks Tab
Figure 6-19: Scanner Configuration dialog: Racks tab
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Racks If a rack is identified through barcodes, the rack type is automatically displayed. If identification via barcodes was not possible (damaged or dirty barcodes), you have to select the rack type manually. With three-track racks the same rack type must occupy the respective tracks.
6.5.2.3 Allocate Non-barcoded Racks and Samples
If you are using non-barcoded racks (or racks with damaged or dirty barcodes), the central section of the Load dialog is empty when it opens: 1. Click on the Scanner Setup button at the bottom of the Load window. This will open the Sample Rack tab in the Scanner configuration dialog (see chapter 6.5.2.2 on page 6-37). 2. In the Rack tab, use the lane buttons to specify which type of rack you have loaded or intend to load on which track. 3. Confirm with OK.
Correct Sample Position Make sure that the position to which the instrument or the user allocates a sample on the screen corresponds exactly to the real position of the corresponding sample tube in the rack! This is very important as wrong allocation is equivalent to mixing up samples.
Now the racks are depicted as empty (rows of blank dots) in the loading bay area of the Load dialog. The required samples are depicted as Unallocated resources. Allocate the samples as described in chapter 4.8.2.2 on page 4-37. Replacement barcode labels for sample racks can be ordered. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.5.3 Test Plate Removal
It is not necessary to use this function (see chapter 4.9.7 on page 4-60).
If you notice a serious problem on one plate while the run is being processed, you can use a special procedure to remove this plate from the instrument. This is an emergency procedure only. It should not be used on a standard basis. Removing the plate may affect the results. To remove the plate: 1. From the Worklist window, select System Utilities in the Utilities menu. The System Utilities dialog is displayed.
Figure 6-20: System Utilities dialog
2. In the System Control field, click on the Pause button. 3. In the Move Plate field, use the two drop-down lists to specify how to move the plate. • In the From field, select the present location (washer, photometer, incubator, pipetting area...) of the plate you want to remove from the instrument. • In the To field, select Load/Unload so that the plate transport unit
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 brings the plate to its unloading position. 4. Click on the Move button. 5. In the System Control field, click on the Resume button. 6. Close the System Utilities dialog with the Close button.
If you are able to correct the problem rapidly enough and you think it is worth reloading this plate and processing it further: 1. From the Worklist window, select System Utilities in the Utilities menu. The System Utilities dialog is displayed. 2. In the System Control field, click on the Pause button. 3. In the Move Plate field, use the two drop-down lists to specify how to move the plate. • In the From field, select Load/Unload. • In the To field, select the module where the transport unit should move the plate to resume its processing (if you did not close the System Utilities dialog after unloading the plate, the From and
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To fields should already be correctly set - by default, the instrument reverses the locations selected when unloading the plate). 4. Click on the Move button. 5. In the System Control field, click on the Resume button. 6. Close the System Utilities dialog with the Close button. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.5.4 Editing/Recalculating the Results
Only for ELISA Assays!
Export files are generated and transmitted automatically if this has been defined in the respective assay. • Recalculation of results will automatically create a new export file!
If you think the results are not entirely satisfactory, the GEMINI instrument software allows you to edit and/or recalculate them before saving, printing or exporting them. To edit the results, select one of the following functions: • Outliers • Parameters/Lot Specific Values • Assays These items are enabled only when a result file is open.
6.5.4.1 Editing Outliers
Only for ELISA Assays!
Required access rights: Manually remove outliers
The Outliers function allows you to manually remove from the results some OD values which you think are not consistent with the test (e.g. if some samples were not properly treated or processed) and should not be taken into account when calculating the results. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Figure 6-21: Outliers dialog
Assay Opens a dialog to change the used assay for the plate. After the change, the Protocol Outliers dialog shows the used wells for the selected assay. Reading The Reading button shows the filter(s) used for the reading. Data Set Not used Select All Selects all wells of the plate. Remove Marks the selected well as outlier. Restore Remove the outlier mark.
You cannot edit the values but only remove them. A removed value is displayed crossed out. Conversely, if a value was removed from the calculation automatically 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 by the software (for example, because of bad pipetting or dispense verification errors), you can choose to restore it.
Use: 1. Click on the Outliers button in the Result window. 2. Even if you belong to a user group authorized to edit outliers, the Log On dialog (see chapter 4.3 on page 4-3) will be displayed again and you will have to log yourself on again before you can access the Outliers dialog. 3. Remove all outliers. 4. Click on the OK button. The new result report includes the following comment: "Removed wells: ..." 5. Click on the Recalculate button to recalculate the results taking into account the changes you made. The new result report includes the following comment: "WARNING! Results have not been processed using the original assay."
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Recalculating The Restore button of the Outliers dialog can be used to force the instrument flagged Results to calculate results for flagged samples that have automatically been removed from result calculation (e. g. if you opened the instrument cover during a run but still want to know the results for those samples pipetted after you opened / closed the cover).
This possibility can only be used for samples with the following flags: SplRem (Sample rack removed), CovOp (Cover open), VCFail (Validation criteria failure) or IncKo (Incubation overrun).
To do so: 1. In the original Result Report, display the Combined Report part. 2. Check the flagged samples. 3. If you want to recalculate some of these flagged samples, note their locations on the plate (layout labels). 4. Open the Outliers dialog and restore the corresponding wells (layout labels) as described above. 5. Recalculate the Result Report as described above. In the recalculated Result Report, the selected flagged results are now calculated but the original flags remain. It is the user’s responsibility to check and validate such recalculated results.
6.5.4.2 Changing the Lot Specific Parameters
The Parameters function (Lot Specific Values button) opens the Lot Specific Values dialog (see chapter 4.6 on page 4-15), showing the data of the reagents used for each assay. This lets you correct possibly incomplete lot data or edit some parameters. When you click OK, the results are recalculated taking into account the changes you made. The new result report includes the following comment: "WARNING! Results have not been processed using the original assay."
6.5.4.3 Recalculation with another Assay
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The Assays button opens the Change Assay Protocol dialog.
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Figure 6-22: Change Assay Protocol dialog
Assay(s) Shows all used assay for the plate. After the change, the Change Assay Protocol dialog shows the used wells for the selected assay. Change Opens a dialog to change the used assay for the plate. After the change, the Change Assay Protocol dialog shows the labels of the used wells for the selected assay. Edit Layout This function opens the Assay Layout dialog (see chapter 6.3.1.1 on page 6-19).
This function allows you to recalculate the results with another assay protocol while retaining the original OD values of your plate. This can be useful, for instance, if you have several versions of the same assay, all with the same processing steps but with different evaluation steps or validation criteria.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 1. Click on the Assays button in the Result window. 2. Click on the Change button and change the assay protocol. 3. Click on the Close button. When you click the Close button in the Change Assay Protocol dialog, the results are recalculated. The new result report includes the following comment: "WARNING! Results have not been processed using the original assay."
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6.5.4.4 Recalculating the Results
Only for ELISA Assays!
A recalculation of the results is performed automatically each time you use some of the editing functions described above. But the GEMINI instrument software also allows you recalculate results independently from the above editing operations. To do so: 1. Click on the Recalculate button in the Result window. The new result report includes the following comment: "WARNING! Results have not been processed using the original assay."
This function is useful if you are editing or defining an assay. If you change the assay evaluation parameters and recalculate, the data reduction of the raw data will be done using the new parameters (you need to save your assay changes before recalculating). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.6 Continuous Loading
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
Required access rights: Edit running Worklists
Continuous loading is the process by which new samples and new test plates/slides are inserted into the instrument while the instrument is running a worklist. The GEMINI instrument allows this but only at certain times and under specific conditions. The main advantage of continuous loading is that it allows the user to test more samples and/or to use more than 3 test plates or 16 slides in a single test run.
An absolute maximum of 3 plates or 16 slides can be in the instrument at the same time. If you want to process more than 3 plates or 16 slides in the same run, you will first have to unload completely processed plates/slides (the instrument will prompt you to do so).
Change of worklist options during continuous loading: The only worklist option (see chapter 6.4 on page 6-27) that cannot be changed during continuous loading is the Reagent load time (which is greyed out). But any changes that are made are only applied to the new plates/slides. So, the already loaded plates/slides will continue to use whatever multi pipetting mode was in force at the time that they were scheduled. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.6.1 Check Reloading Time(s)
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
The first thing to do if you intend to add new samples and new plates/slides to an already running worklist is to check when this will be possible. Reloading sample racks can be done at any time as soon as a red LED opposite an already loaded sample rack is flashing. But the actual reloading process, in which the instrument recalculates the worklist and directs the operator to load (and allocate) the other required resources and the test plates/slides, and unlocks the instrument accordingly, this can only be done when the pipettor is not busy. The only time this is allowed is when all the plates/slides on the current worklist are incubating.
To check the reloading intervals:
1. In the Worklist window of the running worklist, click on the Schedule button (see chapter 4.7.2 on page 4-21). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-23: Schedule (example)
2. In the Additional plates/Additional slides line, the brown sections indicate the time intervals when reloading will be possible. This line is seen both in the module view and in the plate/slide schedule view.
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The more complex your current worklist, the more restrictive the available reloading intervals will be.
6.6.2 Preparing and Loading the New Samples
1. Place your new samples in sample racks. If you are using barcoded sample tubes, make sure the barcode labels face right so that they can be scanned by the barcode reader when the rack is inserted. 2. As soon as a red LED opposite a sample rack is flashing, you can remove the respective rack (the flashing red LED indicates that the pipetting is over for this rack) and load the rack with your new samples. 3. Repeat this step if you are loading more than one additional sample rack. 4. The instrument will display the tabular Sample Editor dialog (see chapter 4.4.1 on page 4-8). If the samples were barcoded, the sample IDs are already entered in the first column. If samples were not barcoded or the barcodes could not be read, you have to enter the sample IDs manually. 5. Using the drop-down lists, select the appropriate assays and assign them by checking the corresponding lines (see chapter 4.4.1 on page 4-8). 6. Click on the Close button. If you reload more than one new sample rack, the instrument will display the tabular Sample Editor dialog again for each rack.
For this step, you do not need to wait until all the currently loaded plates are incubating. Therefore: • Make sure all your sample racks are ready before you remove it.
6.6.3 Redefining the Worklist
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Once you have loaded the additional sample racks and assigned assays in the Sample Editor dialog boxes as described above, the instrument automatically reschedules the current worklist to include the additional plates/slides. If the additional samples you loaded correspond to samples included in test orders downloaded from the LIS, assays are already assigned in the successive Sample Editor dialog boxes and you just need to close these dialog boxes by clicking the Close button. You now need to confirm the automatically redefined worklist and specify the reagent lots for the additional tests. To do so: 1. Click on the Edit Panel button. This opens the Set-up Panel dialog (see chapter 6.3.1 on page 6-15). In the left-hand side window, you can see the new plates/slides that have been automatically added to the worklist.
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By default, when the instrument reschedules the worklist to include the additional samples you have loaded it systematically tries to combine several assays on each plate (provided these assays have compatible processing parameters)/slide.
2. If you are satisfied with the automatically redefined worklist, click on the OK button to close the Set-up Panel dialog. If not, edit the worklist and then click on the OK button. The Lot Specification dialog is displayed for the first additional plate/slide. 3. Identify the lot numbers and expiration data for all assay kits and assay components for this plate/slide and all additional plates/slides and click on the OK button.
6.6.4 Reloading other Resources
Use of IFA and ELISA Assays It is not possible to use IFA assays (slides) and ELISA assays (microtiter plates) at the same time. To work with IFA assay is an optional feature. The following instruction describes both assay types together. Specifics will additionally be described.
After you have clicked on the OK button in the Lot Specific Values dialog, the instrument checks its current status: • If it is currently going through an incubation phase (for all plates/slides), reloading is allowed and the Load dialog box appears. In that case: • Refill or add the resources (reagents, dilution plates, tip racks, wash buffer, slides) required for the additional processing as shown in the Load dialog. IFA assays only: Remove fully processed slides. • Allocate them as if you were starting a new run. The new samples should already be allocated. If not, allocate them manually if they are not barcoded. If they are barcoded, open the door of the rack unit, withdraw the new racks and insert them again, see chapter 6.6.2 on
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 page 6-50. • After loading and allocation of all required resources, click on the OK button. ELISA assays only: The Load Plate dialog is displayed. • If the instrument is currently (or will soon be) performing other steps of the running worklist (e.g. pipetting), a instrument busy warning message appears. In that case: • Click on the OK button to close the warning message. • When you reach the allowed reloading time, click on the Edit Panel button once more and confirm it with OK. The Load dialog is displayed.
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6.6.5 Reloading Test Plates and Further Processing of the Worklist
Only for ELISA Assays!
When the Load Plate dialog is displayed: 1. Load the required additional test plate(s) in the same way as done at start of run (as described in chapter 4.8.9 on page 4-49) and confirm with OK.
If some of the plates of the initial worklist are already fully processed when you are ready to reload additional test plates, the instrument automatically brings them forward to the loading/unloading compartment so that you can remove them before loading the additional plates.
When you click on the OK button in the Load Plate dialog, the instrument recalculates and reschedules the worklist (interlacing or adding new plates/assays to be processed). Further processing is then carried out in accordance with this new rescheduled worklist.
6.6.6 Reloading IFA Slides and Further Processing of the Worklist
Only for IFA Assays!
The instrument pauses during reloading process!
When the Load dialog is displayed: 1. Load the required additional slide(s) in the same way as done at start of run
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 (as described in chapter 5.8.2 on page 5-21) and confirm with OK.
Maximum Number of 16 Slides per Worklist It is not possible to load more than 16 slides to a worklist. More than 16 slides lead to a schedule error.
Reloaded IFA assays with active sub-assay are always primary assays (once)!
2. When you click on the Start button in the Load dialog, the instrument recalculates and reschedules the worklist (interlacing or adding new slides/ assays to be processed). 3. Click on the Start button. Further processing is then carried out in accordance with this new rescheduled worklist.
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6.7 Archiving Samples
Only for ELISA Assays!
The GEMINI instrument includes a sample archiving function. The purpose of the sample archiving process is to set aside a small volume of each sample to be later frozen and saved (as reference or in case re-testing is needed). This can be done either: • as an independent process i.e. a run defined only for sample archiving • in conjunction with a normal run. The GEMINI instrument also allows you to perform runs directly from previously archived samples and even to process samples archived on another system (external archives).
6.7.1 Independent Sample Archiving
6.7.1.1 Enable/Disable Archiving Samples
Required access rights: Edit Worklist Options
1. Create a new worklist (see chapter 6.3 on page 6-11) without samples. • Add one plate. • Add any assay to this plate (only one). • Do not add samples (as you would if you were creating a normal worklist). 2. Click on the OK button to confirm the Set-up Panel dialog. 3. Click on the OK button to confirm the Lot Specific Values dialog. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 4. When the Worklist window is displayed, click on the Edit Options button. This opens the Worklist Options dialog (see chapter 6.4 on page 6-27). 5. Activate the Archive samples during the run option to enable the archiving function. 6. Click on the Archiving Parameters button to open the Archiving Parameters dialog. 7. In the Archiving Parameters dialog, deselect the Automatically archive loaded samples and the Archive at end of worklist items (or make sure they are deselected), then define the other parameters as explained in chapter 6.7.4 on page 6-58. 8. Click on the OK button to close the Archiving Parameters dialog. 9. Click on the OK button again to close the Worklist Options dialog and return to the Worklist window. 10. Select the File > Close menu item to close the Worklist window. A message is displayed asking you if you want to save this worklist. 11. Click on the No button to close the message without saving the worklist.
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12. Click on the New Worklist button again. The Set-up Panel dialog is displayed and, this time, an Archive "plate" is automatically displayed (see below).
Figure 6-24: Set-up Panel with archive plate
This complete procedure needs only to be performed once. Thereafter, as long as the items Automatically archive loaded samples and Archive at end of run remain unchecked in the Archiving Parameters dialog, the Set-up Panel will always display an Archive "plate" when you open it.
6.7.1.2 Archiving Run
Load Samples 1. Load the samples you want to archive on the instrument as described in to Archive chapter 4.4.1 on page 4-8.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2. Wait until the column format Sample Editor is displayed (see chapter 4.4.2 on page 4-10) with the sample IDs in the first column. 3. Check that all barcodes have been correctly read (otherwise, refer to chapter 4.4.2 on page 4-10) and click on the Close button. The Sample Editor dialog is closed and you return to the Set-up Panel dialog.
If the samples you want to archive are not barcoded, you can either operate as said and then enter the sample IDs manually in the first column of the Sample Editor (column format) or click on the Sample Details button in the Set-up Panel dialog and enter the samples there as described in chapter 6.2.1 on page 6-6.
Define Sample 4. Back in the Set-up Panel dialog, select the Archive "plate". Archiving Run 5. Click on the Edit button. This opens the Set-up Panel: Archive dialog. 6. Click on the Add Sample button. This opens the Select Sample(s) dialog.
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7. Select the samples you want to archive and click on the OK button. The selected samples are now displayed in the Set-up Panel: Archive. 8. Confirm with OK. 9. For multiple archiving (i.e. if you want a primary sample to be archived in two or more secondary tubes or plate wells), you can click Edit and Add Sample again. In the Select Sample(s) dialog, check the Allow multiple determinations item and select some sample IDs again. When you click on the OK button and go back to the Set-up Panel: Archive, a "(x2)" tag has been added to each twice selected sample ID. Note: This can also be done automatically via the No. of replicates field of the Archiving Parameters dialog (see chapter 6.7.4 on page 6-58), but only if multiple archiving is intended for all sample IDs. 10. Click on the OK button to close the Set-up Panel dialog and open the Worklist window.
Load other 11. In the Worklist window, click on the Start button to open the Load dialog. Resources and 12. Load the required resources (tips, archive plate or secondary tubes) as Start the Run shown in the Load dialog. On loading and identifying the archive plate, see chapter 6.7.5 on page 6-63. On loading and identifying secondary tubes, see chapter 6.7.6 on page 6-64. 13. Click on the OK button to start the sample archiving run. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.2 Archiving Samples within a Normal Run
The way to add a sample archiving process to a normal (assay testing) run depends on whether you want to automatically archive all the samples tested or to archive only some of the samples tested.
To automatically archive all the samples tested: 1. Create your worklist as usual. 2. When you have finished defining your worklist and the Worklist window is displayed, click on the Edit Options button. This opens the Worklist Options dialog. 3. In this dialog, check the Archive samples during the run item. 4. Then click on the Archiving Parameters button to open the Archiving Parameters dialog. 5. In this dialog box, check the Automatically archive loaded samples item. 6. After setting the other archiving parameters (see below), click on the OK button to go back to the Worklist window and perform your test run as usual.
To archive only some of the samples tested: 1. Create your worklist as usual. 2. Make sure the Archive "plate" is displayed in the Set-up Panel dialog. If not, display it using the procedure described in chapter 6.7.1.1 on page 6-53. 3. Click on the Edit button. This opens the Set-up Panel: Archive dialog. 4. Select the sample IDs you want not to archive. 5. Click on the Delete Sample button. 6. Click on the OK button to close this dialog. 7. For multiple archiving (i.e. if you want a primary sample to be archived in two or more secondary tubes or plate wells), you can click Edit and Add Sample again. In the Select Sample(s) dialog, check the Allow multiple determinations item and select some sample IDs again. When you click on the OK button and go back to the Set-up Panel: Archive, a "(x2)" tag has been added to each twice selected sample ID. Note: This can also be done automatically via the No. of replicates field of the Archiving Parameters dialog (see chapter 6.7.4 on page 6-58), but only 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 if multiple archiving is intended for all sample IDs. 8. Perform your test run as usual.
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6.7.3 Imported Worklists with Sample Archiving Orders
It is possible to include sample archiving orders in imported worklists.
This feature is available only with ASCII file imports, not ASTM.
The basic structure of imported ASCII (*.txt) worklist files is described in chapter 7.1.3 on page 7-5. It generally includes at least a "Sample ID" field and one or more "Test name" fields. For each "Sample ID", if one "Test name" is "Archive", the respective sample will be archived. The imported worklist file may also include an optional "Secondary Tube" field used to specify the barcode ID of the secondary tube when archiving is to be done in tubes.
The Secondary Tube ID is only used for identifying the tube(s) the sample is archived to. The secondary tube ID is neither reported in the archive information nor available in the dialog for selection of archived samples. If the Archive to setting of the Archiving Parameters dialog is set to "dilution plate", the samples will be archived into plates even if the import file includes a Secondary tube value.
When a file in which an "Archive" test name is included (for some or all sample IDs) has been imported and you load the corresponding samples on the instrument, the instrument automatically generates the corresponding worklist, including an Archive "plate". After clicking OK to confirm the worklist and close the Set-up Panel dialog, you can review and, if you want, edit the other archiving parameters as explained below (click on the Edit Options button, then click on the Archiving Parameters button to open the Archiving Parameters dialog). When the worklist is processed, the samples for which an "Archive" test name has been included will be archived. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.4 Archiving Parameters
Required access rights: Edit Worklist Options
After a worklist has been prepared and before it is started it is possible to check and/ or edit the archiving parameters.
1. Click on the Edit Options button or select the Edit > Panel Options menu item to invoke the Worklist Options dialog. 2. Activate the Archive samples during the run option to enable the archiving function. 3. Click on the Archiving Parameters button to open the Archiving Parameters dialog.
The Archiving Parameters dialog will shown with several tabs: • Options (see chapter 6.7.4.1 on page 6-58) • Aspirate (see chapter 6.7.4.2 on page 6-60) • Dispense (see chapter 6.7.4.3 on page 6-61) • Wash (see chapter 6.7.4.4 on page 6-62)
6.7.4.1 Archiving Parameters: Options 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-25: Archiving Parameters dialog: Options tab
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Options Area
Automatically archive Check this item only if you want to automatically archive all the loaded samples samples tested in a worklist. Deselect it if you want: • to archive samples independently (not within a worklist), or • to archive samples within a worklist but only selected samples. Archive at end of worklist This item is relevant only when the sample archiving process is added to a normal worklist. If this item is checked, the archiving is done only when the samples have already been pipetted into all the test plates. If this item is not checked, the archiving is done at any time during the run when the pipettor is not already busy. No. of replicates You can use this item for multiple archiving (i.e. if you want each primary sample to be archived in two or more secondary tubes or plate wells). For example, if this item has been set to "2", when you add the sample IDs in the Set-up Panel: Archive dialog, they will be automatically selected twice (signalled by the "(x2)" tag). Note however that this means that ALL sample IDs will be archived twice. If you want multiple archiving only on some specific samples (and single archiving on the rest), set this item to "1" and use instead the multiple determination option in the Select Sample(s) dialog box (as described in Section 3.5.1 under 3)). Minimum number of replicates = 1, maximum = 96. + Reps, - Reps Increase or decrease the number of replicates. Edit Shows the Enter a Number dialog to enter the number of replicates (see chapter 3.5 on page 3-16).
Archiving Specify where the samples should be archived. Area
Archive to The choice here is between dilution plates and test tubes (i.e. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 secondary sample tubes). For details, see chapter 6.7.5 on page 6-63 and chapter 6.7.6 on page 6-64 below. Click on the Edit button the select the archive plate or tube. Plate Type Show a plate type (e.g. deepwell plate). Click on the Edit button the select a plate type.
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6.7.4.2 Archiving Parameters: Aspirate
Figure 6-26: Archiving Parameters dialog: Aspirate tab
Volume Specify the aspirate volume. Default is 800 µl. For multi-pipetting and large volume archiving (see chapter 6.7.9 on page 6-68). Click on the Edit button to show the Enter a Number dialog to enter the volume (see chapter 3.5 on page 3-16). Note: The maximum archiving volume is already restricted to 1000 µl.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Profile Specify the aspirate profile to be used. Default is profile 0 (on pipetting profiles, see chapter 8.3.4.1 on page 8-29). + Profile, - Increase or decrease the profile number. Profile Profile Shows a dialog to select the desired aspirate profile. Pressure Check this item to enable the aspirate pressure monitoring system (APM). Monitoring If APM is enabled, the instrument compares the measured aspiration pressure data with thresholds in order to detect pressure errors immediately after the aspiration. Note that the pressure monitoring is generally enabled (see chapter 8.3.4 on page 8- 25). Liquid Type Click on the Edit button the select the liquid type. This is required for the pressure monitoring.
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Wrong Results It is necessary to use only validated assay/profile combinations to avoid wrong results.
6.7.4.3 Archiving Parameters: Dispense
Figure 6-27: Archiving Parameters dialog: Dispense tab 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Volume Specify the dispense volume. Default is 800 µl. Enter a smaller volume if using ordinary flat-bottom or round bottom plates (see chapter 6.7.9 on page 6-68). The Sample Dispense / Volume cannot be greater than the Sample Aspirate / Volume. Click on the Edit button to show the Enter a Number dialog to enter the volume (see chapter 3.5 on page 3-16). Profile Specify the dispense profile to be used. Default is profile 0 (on pipetting profiles, see chapter 8.3.4.1 on page 8-29). + Profile, - Increase or decrease the profile number. Profile Profile Shows a dialog to select the desired dispense profile. In Liquid If this item is checked, the instrument starts by dispensing the Z-max volume at the Dispense Z-max position (deepest position) and dispenses the remaining volume with reverse tracking of the pipettor. This option is useful as it prevents splashing and reduces significantly the risk of contamination.
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Z-max volume Define the volume to be dispensed at the Z-max position. Example: Z-max volume = 50 The pipettor moves to the Z-max position (LLD not active), dispenses 50 µl and starts dispensing the remaining volume with reverse tracking. Example: Z-max volume = 0 The pipettor moves to the liquid surface (LLD active) and starts dispensing the dispense volume with reverse tracking. Click on the Edit button to show the Enter a Number dialog to enter the volume (see chapter 3.5 on page 3-16).
Wrong Results It is necessary to use only validated assay/profile combinations to avoid wrong results.
6.7.4.4 Archiving Parameters: Wash
Do not specify anything in this tab. This tab was included in case the pipetting would be done through aspirating and dispensing needles. It is inapplicable in the case of instruments operating with a pipettor and disposable tips. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.5 Archiving in Archive Plates
The samples will be archived into archive plates if you have selected Dilution plate in the Archive to field of the Archiving Parameters dialog (see chapter 6.7.4 on page 6-58). The archive plates have to be loaded on the instrument in the dilution area. In the Load dialog, you can see in which position(s) the archive plate(s) should be placed. Note that if you intend to archive the samples within a test run which also includes an assay with a pre-dilution step, two types of plates will be shown in the dilution area of the Load dialog. Different colors let you identify which plates are pre-dilution plates and which plates are archive plates. • Green: Pre-dilution plate • Blue-green: Archive plate
Moving your mouse over each plate also lets you know what type of plate it is. Double-clicking on an archive plate opens the Object ID dialog. In this box, you can enter a specific ID for your archive plate (max. = 20 characters).
The software cannot run with more than two archive plates requested. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.6 Archiving in Secondary Tubes
The samples will be archived into secondary tubes if you have selected Test tubes in the Archive to field of the Archive Parameters dialog (see chapter 6.7.4 on page 6-58).
6.7.7 Archiving Information and Archiving Report
In the Worklist window, clicking on the sample archiving information button will display the Sample Archiving Information for the current worklist. This information includes, for each archived sample: Sample ID, Location, Volume, and Flag. To print this information, click on the Print button or select the File > Print menu item.
To save and/or export a (*.txt) file archiving report: 1. When your worklist is fully processed, select the Edit > Export Archive menu item. This will open the Save as dialog. 2. Select the directory in which you want to save (or to which you want to export) the file. 3. If you want, change the file name (the default file name has the following format "Ayymmdd.txt" - yy = year, mm = month, dd = day). 4. Click on the Save button.
The (*.txt) archiving report includes the following items: When archiving into tubes: Sample ID, Volume, and Flags. Note that the Secondary tube ID is not included in the report. When archiving into plates: Primary tube ID, Archive plate ID, Location within plate, Volume archived (µl), and Flags. Use any text editor to open and print this report (but not the GEMINI software).
No sample archiving information is displayed if the GEMINI instrument is in Demo Mode. The (*.txt) archive report file will be generated but it will be empty. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.8 Testing Archived Samples
The special procedures described below apply only to samples archived into archive plates. When samples have been archived into secondary tubes, you can process them normally (as if they were primary samples).
6.7.8.1 Samples Archived on the GEMINI Instrument
When you need to test or retest samples that have been archived on an archive plate at an earlier date and the archiving process has been done on the same GEMINI instrument: 1. Click on the New Worklist button to open the Set-up Panel dialog and start creating your worklist normally (Add Plate, Add Assay). 2. But instead of the Add Sample button, click on the Archived sample button. This opens the following dialog:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Figure 6-28: Select Archived Samples dialog
Sample ID Archived sample IDs. Archive Plate ID of the archive plate(s). ID Well Location Location of each sample on each archive plate. Date Archived Date on which the archive plate was created (for external archives - see below - this is the date on which the External Archive Information file was imported into the GEMINI instrument). Allow multiple If a sample is already assigned to the worklist (e.g. has already been selected on determination another plate), it no longer appears on the list. To test the same samples with the s same assay twice in the same run, check this item. Already assigned samples are displayed again in the list and can be reselected.
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All Archived Includes in the list samples from all plates archived on the GEMINI instrument. Plates Archive Plate Allows you to look only for samples archived on one specific archive plate (check ID the item and enter the plate ID in the respective field). All Sample IDs Depending on the item selected before, includes in the list all the samples archived on all plates or on a specific plate. Sample IDs Allows you to look only for specific samples (check the item and enter the sample between (…) IDs in the respective fields). and (…) Apply Filter When you have checked the desired sort criteria, click this button to view the results.
3. If necessary, use the Filter options to reorganize the sample list and find the samples you want to (re)test and click Apply Filter. 4. Then, in the displayed list, select the samples you want to (re)test and click on the OK button. 5. The instrument returns to the Set-up Panel in which the selected archived samples are now displayed. Finish the rest of the worklist creation process as usual.
When loading the required resources, the instrument prompts you (through the Load dialog) to load the archive plate (containing the archived samples to be tested) in the dilution area. During the run, the pipettor will pipette each archived sample directly from the archive plate into the test plate.
The Result Report does not include any indication that the samples used were pipetted from an archive plate.
If flags (e.g. clot, insufficient liquid) were returned during the archiving process, they are saved in the original archive report (see chapter 6.7.7 on page 6-64) but not mentioned again in the new Result Report.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 6.7.8.2 Samples Archived on Another System
If the archive plate has been prepared manually or on another system (including another GEMINI instrument), you can still use the archive plate directly, i.e. without having to transfer the archived samples into tubes. But first you need to import an External Archive Information file so that the GEMINI instrument can identify the exact location of each sample on the archive plate. External Archive Information files are fixed format ASCII files with an (*.aim) extension. They include the following data (separated by a comma and a space): Sample ID, Plate ID, Well Location, Sample Volume, Flag(s) (if any)
Example: 1750, 030930-002, A1, 200, ManID, , , , , , , 1753, 030930-002, B1, 200, ManID, , , , , , , 1752, 030930-002, C1, 200, ManID, , , , , , , 1759, 030930-002, D1, 200, NoLiq, ManID, , , , , , 1751, 030930-002, E1, 200, ManID, , , , , , ,
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If you prepared your archive plate manually, you can create a corresponding external archive information file on any text editor. Create a (*.txt) text file then change its extension into (*.aim). Make sure the commas and spaces are correct. If you prepared your archive plate on another GEMINI instrument, copy the (*.txt) archiving report (see chapter 6.7.7 on page 6-64) and change the copy's extension into (*.aim). If you prepared your archive plate on a different instrument, adapt and rename the archiving report file created by the instrument so that it corresponds to the above import format.
To import an External Archive Information file: 1. Click on the Open button. 2. Click on the External Archive Information (*.aim) symbol. 3. Select the desired External Archive Information file. 4. Click on the OK button to close the import message. 5. Create your worklist as described in the previous chapter. 6. When you click on the Archived Sample button in the Set-up Panel: Assay dialog, the archived information you imported is now included in the list displayed in the Select Archived Sample dialog. 7. Finish your worklist creation process and start your run as described in the previous chapter. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.7.9 Archiving Tips
6.7.9.1 Multiple Archiving
If multiple archiving has been programmed, during the archiving process, the pipettor will dispense each sample in consecutive wells of the archive plate (e.g. Sample 1 => A1 and B1, Sample 2 => B3 and B4, etc.) or in two or more secondary tubes. If you want the pipettor to make a multishot dispense (e.g. aspirate once then dispense the two wells in succession), make sure to enter the appropriate values in the Sample Aspirate / Volume and Sample Dispense / Volume fields of the Archive Parameters dialog (see chapter 6.7.4 on page 6-58). For example 220 µl as sample aspirate volume (allowing for oversoak) and 100 µl as dispense volume.
6.7.9.2 Archiving large Volumes
If you select an archiving volume higher than 1000 µl (maximum capacity for large tips), the instrument will automatically perform several pipetting operations in order to archive the selected volume. For example, if, in the Archive Parameters dialog (see chapter 6.7.4 on page 6-58), you have set the Sample Aspirate / Volume to 2500 µl and the Sample Dispense / Volume also to 2500 µl, the pipettor will execute three successive pipetting operations from the primary to the secondary tube (with the same tip).
6.7.9.3 Microtube Trays
Because the GEMINI pipettor uses disposable tips and not pipetting needles, it is recommended not to use trays with individually removable microtubes for sample archiving as these can be responsible for various pipetting errors: collisions because of misplaced tubes, tubes sucked out of the tray when the tip moves out… If you need to archive large volumes, use deepwell plates with fixed wells or, for even larger volumes, secondary tubes.
6.7.9.4 Barcode Labels for Primary and Secondary Tubes
If, as recommended, you have used the same barcode IDs for your primary and secondary tubes (e.g. primary sample tube "00001" corresponds to a secondary tube also labelled "00001") you may want to add on or two digits / characters to be able
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 to visually differentiate sample tubes from archive tubes. For example you may decide to label the primary tubes with an additional "S" for "sample" (e.g. "S00001") and the secondary tubes with an "A" for "Archive" ("A00001"). If you want this prefix to be for visual determination only and to be overlooked by the barcode reader, edit the scanner settings so that this prefix is omitted when the tubes are scanned (see chapter 8.3.6.1 on page 8-36).
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6.8 Sample Result Report
The sample result report shows a compact summary of the sample results of all selected assays.
Figure 6-29: Sample Results dialog
Assays Shows all processed assays. Delete Deletes a selected filter. Delete All Deletes all filters. Edit Allows to edit a selected filter for the sample result report (see chapter 6.8.1 on page 6-71).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Filter(s) This area shows all existing filters for the sample result report. With a filter, the number of reported samples can be limited. Select a filter to use them. Click on a free position on the area to deselect the filter. New Adds a new filter for the sample result report (see chapter 6.8.1 on page 6-71). Sort Order The Sort Order field allows you to define the order in which the samples will be shown in the report. Selectable sort order: • Ascending: Sorted in alphanumeric ascending order (based on the sample IDs entered or read by the barcode scanner). • Descending: Sorted in alphanumeric descending order (based on the sample IDs entered or read by the barcode scanner). • None: The samples will be shown in the added order.
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Proceed as follows: 1. Select the File > New menu item. 2. In the New dialog, select the Sample Result Report symbol. This shows the Sample Result dialog. 3. Click on the New button to create a filter (e.g. only sample IDs between 0070 and 0100) 4. Select one or more assays. 5. Select the Sort Order (see chapter 6.2 on page 6-4). 6. Click on the OK button to confirm the entries. The instrument shows you the sample result report.
Figure 6-30: Sample result report 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Results of IFA Assays The instrument does not generate any end result for slides. The slides will only be prepared for further processing (e.g. examination of reaction under a fluorescence microscope) by the user. The result report shows only that the samples were processed.
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6.8.1 Filter Configuration
With the function you can limit the number of reported samples.
Figure 6-31: Filter dialog
Filter On Shows the selected filter argument (e.g. Sample ID, Birthdate, Date). Click on the Edit button to change the argument. Containing The argument must contain the edited value. Example: • Filter: Sample ID, Containing: 10 • Report: Sample 10, Sample 101, Sample 1030, Sample 310, etc. Between The argument must between the edited values. Example: • Filter: Date, Between: 2008-07-01 and 2008-07-30 • Report: all tested Samples between 2008-07-01 and 2008-07-30 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.9 Quality Control Analysis Report (Levey Jennings Plot)
Results of IFA Assays The instrument does not generate any end result for slides. The slides will only be prepared for further processing (e.g. examination of reaction under a fluorescence microscope) by the user. A quality control analysis report will not generated.
The quality control analysis report (Levey Jennings plot) shows the results of a selected reagent over a period of time. To generate a QA Analysis Report you have to activate the QA-analysis by defining QA-Labels in the Lot Specific Values (see chapter 4.6 on page 4- 15) while preparing a worklist. Proceed as follows: 1. Select the File > New menu item. 2. In the New dialog, select the QA Analysis Report symbol. 3. In the Q.A. Analysis dialog, select in the Controls list the respective reagent. 4. Select in the Batch Numbers list the respective batch number. 5. Select the period of time in the boxes Date from and to. 6. Choose between Show mean values only or Show all values. 7. Choose between Reader values (raw OD values) or Calculated values. 8. Click OK to confirm the entries. The instrument shows you the quality control analysis report (Levey Jennings plot). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 6-32: Levey Jennings plot
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6.10 APM Report
GEMINI COMBO The GEMINI COMBO instrument does not support the APM function.
The APM report shows a list of all APM parameters. Proceed as follows: 1. Select the File > New menu item. 2. In the New dialog, select the APM Report symbol.
Figure 6-33: APM report 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.11 Software Language
Required access rights: Nothing
It is possible to choose the language in which to use the GEMINI software. This will affect the software layout (menus, dialogs, buttons) but also the documents (assay files, result reports, event logs...) used or generated by the instrument. To select the language: 1. Select the File > Close menu item to close all open windows (including the selftest report). You should see only the menu bar and toolbar above a gray screen. 2. In the Utilities menu, select the Select Language menu item. The Select Language dialog is displayed.
Figure 6-34: Select Language dialog
3. In the Select Language dialog, select one of the available languages from the drop down list. 4. Click on the OK button. 5. Close the GEMINI software and restart it.
If you have changed the software language but some elements continue to be displayed in English, this may be because you are using an English-language version of Windows (in this case, some buttons will be in English), or you are using assays that were defined in English. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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6.12 Simulation Mode / Demo Mode
The simulation/demo mode allows you to work with the GEMINI software even if no instrument is connected or turned on. • To do this, check the Demo Mode item in the Log-On dialog (see chapter 4.3 on page 4-3). The COM port between the PC and the instrument is then disabled.
Required access rights: The demo mode allows you to access and use all the functions that you would normally use.
You can, for instance, use it to create a worklist and check, on the Schedule view how it would actually be performed on the instrument. The only difference is that the time scale is changed (one minute of a real process is rendered as one second in demo mode) and that no reading values are returned in the results. You can also use the demo mode to edit the instrument parameters, edit assays, create panels, access and print former results, etc. Changes made or files created while in demo mode are saved on the instrument just as they would be normally. It is therefore a very useful (and safe) mode to use for all operations for which you do not need to use the instrument. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7 Connection to a Host Computer
The GEMINI instrument has been designed to easily integrate into a laboratory environment. The integrated PC that operates the instrument then has to be also connected to a host computer. This connection enables data to be imported or exported from the host to the GEMINI instrument, and back (e.g. download of sample data to the system, upload of test results to the host computer). For connection, two different methods of exchanging data between the GEMINI instrument and a host computer are supported: • Transfer of ASCII files (import of sample data or worklists into the GEMINI and export of sample test results to the host computer) - see chapter 7.1 on page 7-2. • Transfer through an ASTM link (download of test orders to the GEMINI instrument and upload of sample results to the host computer) - see chapter 7.2 on page 7-14.
These two methods are described in the following chapters.
Lab System Integration It is necessary to validate the integration in a lab system!
Linking of Assays It is necessary to validate the linking of assay names between software and LIS system.
Sample ID The imported sample ID must be unique! If non-unique sample IDs are used (e.g. same ID for different persons at different worklists), the sample database is incorrect. In this case, features like sample history or sample result report must not be used.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Note that it is not possible to import absorbance data, pipette data or other file types from other systems or readers.
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7.1 ASCII File Transfer
The GEMINI has the possibility to import (*.txt) worklist or sample data files and export (*.txt) result files from and to a network server. The import of worklist files can be performed manually by the user or automatically with a polling sequence. Export files are generated and transmitted automatically if this has been defined in the respective assay.
7.1.1 Hardware Configurations
The communication between the GEMINI computer and the host system is established using an Ethernet card. In case the GEMINI computer should be connected to another host system, please install the necessary protocol or client and configure it according to the specifications for this host. File name restrictions: 1. For all types of servers, note the following restrictions: • File names should not include more than 20 characters. • File names should not include special characters except "-" and "_". 2. Characters allowed in file names are: • Numbers from 0 to 9. • Letters from A to Z (small and big capitals). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.1.2 Importing Sample Data and Worklist Files (Types of Import Files)
Import files are (*.txt) files generated by a host computer, which include information about samples and test orders for these samples. The GEMINI instrument will be able to import and process these files only if their structure and contents are arranged in a certain order.
Standard Data Fields: The standard data fields that can be expected by the GEMINI instrument in an import file are: the Sample ID, the Sample Name, the sample's Birthday, the sample's Sex, the Test Name(s) and the Collection Date. Not all these fields have to be included in the imported files. For instance, you can import worklist files that include only the Sample IDs and the Test Name for each Sample ID (see examples below). For certain fields, a specific format has to be obeyed (e.g. birth dates must have a YYYYMMDD format, collection dates a YYYYMMDDHHMMSS format.
Header/No Header: The GEMINI instrument is able to analyze import files with or without header. A file has a header if the first line of the file lists the various data fields included in the file.
Examples of import files with header: a)
Sample ID,Test name,Test name,Test name,Test name Header Row 001,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab Data 002,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab Fields 003,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 004,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 005,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 1001,HBs+ Ag,HSV-IgM 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 1002,HBs+ Ag,HSV-IgM 1003,HBs+ Ag,HSV-IgM
b)
Sample ID,Sample name,Test Header name,Birthdate,Sex,Collection Date Row 001,David,HBc+ Ab,19690330,,20020330102944 Data 324,Marco,HBs+ Ag,19770119,M,20020330103344 Fields BF221,Dupont Jean,HIV Ag- Ab,19661101,M,20020330112121 33SD321,Durand Sophie,HIV Ag- Ab,19770202,F,20020324120229
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Using headers makes it easier if several Test Names are included for each sample. Otherwise, a new line has to be included for each Test Name (see below). Without a header row, file a) above would have to be structured as follows:
001,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab Data 002,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab Fields 003,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 004,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 005,HBc+ Ab,HBs+ Ag,HIV Ag-Ab,HCV Ab 1001,HBs+ Ag,HSV-IgM 1002,HBs+ Ag,HSV-IgM 1003,HBs+ Ag,HSV-IgM
For file b), things would be easier since only one Test Name is included per Sample ID:
001,David,HBc+ Ab,19690330,,20020330102944 Data 324,Marco,HBs+ Ag,19770119,M,20020330103344 Fields BF221,Dupont Jean,HIV Ag- Ab,19661101,M,20020330112121 33SD321,Durand Sophie,HIV Ag- Ab,19770202,F,20020324120229
Separator: The header fields and the data fields are separated by a special character. In the examples above it is a comma (,) but the instrument lets you specify which character you intend to use as a separator: colon (:), semi-colon (;), vertical bar (|)... No space should be included between the separator and the data. Note that if for a given sample all data fields are not filled (e.g. in example b) the birthday of Sample 001 is not known), the data field remains empty but there must still be the same number of separators.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 This is true except for the fields at the end of a line (e.g. in example a) for samples 1001, 1002 and 1003 for which only two test are assigned).
Several tests for samples in one line: Example file header row: ...,Test name,Test name, ... Example file data rows: ...,HBc+ Ab,HBs+ Ag,...
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7.1.3 Defining Import Parameters
The ASCII Sample Information Import dialog allows the user to "tell" the GEMINI instrument what type of import file it is faced with or should expect. This dialog is displayed each time you import files or when you define your file polling (automatic import) parameters.
Figure 7-1: ASCII Sample Information Import dialog
Has Header Select this item if the import file has a header. In this case, the next item is Row enabled. Use Header If you check this item, the instrument will automatically use the header row to Row to interpret the data fields. In this case, you do not have to specify which data fields Determine are included; the Available Fields list and the Selected Fields list are Mappings disabled. If you do not check this item, you are telling the instrument to disregard the header row and to interpret the data fields according to what you select in the Selected Fields list. Separator Enter the character used as separator (see chapter 7.1.2 on page 7-3). Available Shows the available fields. Select the fields that the sample ASCII file includes Fields from this list. If you need additional fields, you can load them from a file by clicking on the Open Settings button. This file must include the fields row-wise in the ASCII format. If necessary, you have to create a file with the field names and copy it to the respective subdirectory. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 See below for field description. >, >>, Use these buttons to transfer data fields from the Available Fields list to the <, << Selected Fields list (or back). You can also transfer fields from one list to the other by double-clicking on them. Selected Shows the data fields which the instrument should expect to find in the import file. Fields Make sure that the order of the data fields in the Selected Fields list is in accordance with the order of the data fields in the import file! You can move a field in the list by selecting it with the mouse and dragging it upwards or downwards without releasing the mouse button. See below for field description.
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Open Settings, If the files you import from the host computer always have the same structure and Save Settings include the same data fields, you do not have to redefine the import parameters each time. Once you have defined the parameters (header row or not, separator, selected data fields), you click on the Save Settings button. This creates a (*.apm) ASCII Sample Information Mappings file which you can re-use for later imports by clicking on the Open Settings button. However, this is useful mainly if your import files do not have header rows that can be used for mappings.
Field description:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 After import of all sample information, the file will be deleted automatically!
7.1.3.1 Manual Import of a Sample Information
To import a worklist file manually: 1. Select the menu item File > Open. 2. Click on the ASCII Sample Information (*.exe) entry. 3. Search and select your file. 4. This opens the ASCII Sample Information Import dialog. Define your import parameters as described in chapter 7.1.3 on page 7-5. 5. Click on the OK button to import the sample information.
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7.1.3.2 Automatic Import (File Polling)
The GEMINI software allows the user to define specific locations that the software will poll on a regular basis to look for ASCII sample information files. When a valid file is found, it is automatically imported into the software, interpreted and the sample database is updated with the new sample details. To specify the file polling intervals and the structure of the files to be imported: 1. Select the Utilities > Options menu item to open the Options dialog. 2. Click on the Users tab.
Figure 7-2: Options dialog: File Polling tab
Enable polling Check this item if the GEMINI computer is connected to a host computer. If you for files of select this item, the other boxes on this tab are enabled. type In the drop-down selection list you can select the file type for the sample information. Currently, the only available format is the ASCII format. every n Enter the intervals (in minutes) information is to be polled from the host computer. minutes
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 in directory Specify the location (directory in the host computer) to be polled. Enter the full path (including a filename). To browse/search, click on the ... button. Find the desired directory and select a file name in that directory. File Options Opens the ASCII Sample Information Import dialog and you can enter the structure of the ASCII files to be imported (see chapter 7.1.3 on page 7-5).
3. Activate the Enable polling for files of type checkbox. 4. Enter the intervals to request for files. 5. Enter the desired directory. 6. Click on the File Options button to open the ASCII Sample Information Import dialog. Define your import parameters as described in chapter 7.1.3 on page 7-5. 7. Click on the OK button twice.
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The system time of the server and the system time of the GEMINI computer must be synchronized! If the system time of the server is ahead of the system time of the GEMINI computer and they deviate more than the defined polling time the sample information files will never be imported!
7.1.3.3 Successful Import / Import Failure
If you import a sample data file manually, once you have clicked on the OK button in the ASCII Sample Information Import dialog, the instrument displays a succeeded import message. This message just confirms that the file has been imported. It does not confirm the correct import of all the data fields! To make sure that all the data included in the file have been successfully and correctly imported into the GEMINI instrument, you have to check the Sample Editor dialog (see chapter 6.2 on page 6-4). The same method can be used to check if an automatic file polling and import process has been successfully carried out.
If the sample data that you imported (whether manually or automatically) correspond to samples that you are loading or have loaded on the GEMINI instrument, the instrument will automatically display the imported data in the column format Sample Editor dialog (see chapter 4.4 on page 4-8).
Import Failure If the sample data was not correctly imported: • Check that the import parameters that you defined in the ASCII Sample Information Import dialog correspond to the actual structure and contents of the file you tried to import. • Check that the file polling path you specified in the Options dialog / File Polling tab is correct. • Check that network communication is not down. • Check that the system times of the GEMINI computer and of the host computer are synchronized.
7.1.3.4 Deletion of Imported *.txt Files 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 To prevent imported worklists from remaining for ever in the import directory, imported *.txt files are automatically deleted by the system after importing, (whether by manual import or file polling). Before the file is deleted a copy is made in the Backup folder (see chapter 8.2.8 on page 8-15). The filename of the copy is the same as the filename of the original import file but with a prefix "Copy of", e.g. if the import file is named "worklist4.txt", then the backup copy will be named "copy of worklist4.txt". If the import file always uses the same filename, then the name of the backup copy will be incremented, e.g. "Copy (2) of worklist4.txt", "Copy (3) of worklist4.txt", etc.
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7.1.3.5 Importing of Multiple Test Order Requests for the Same Sample
The software uses a registry setting to control what happens when a duplicate test order request is received for the same sample. The registry setting either allows or ignores the duplicate test order request. The default setting is that the duplicate test order request is ignored (and processed as an individual test order). If the duplicate test order request is allowed then, after a successful import, multiple test order requests are shown for the respective sample in the Sample Editor dialog (see chapter 6.2 on page 6-4). Then, when a worklist is created for this sample a number of wells equal to the number of test order requests will be allocated to the sample. These will be combined by the software and given the same layout label ID (e.g. sample 000001 (x2)).
This only applies when importing from text files. Duplicate ASTM test order requests will always be ignored. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.1.4 Export of Test Results
Results of IFA Assays The instrument does not generate any end result for slides. The slides will only be prepared for further processing (e.g. examination of reaction under a fluorescence microscope) by the user. The result export shows only that the samples were processed.
7.1.4.1 Individual Export Requests
Each time a (*.res) result report is calculated and displayed on the screen, you can decide to export it. To do so: 1. Select the Utilities > Export Results menu item.
If you belong to a user group not authorized to Post Results to LIMS, the Log-On dialog will be displayed and you will need the assistance of a supervisor to export the results (see chapter 8.1.3 on page 8-6).
If the Utilities > Export Results menu item is disabled, it means that the GEMINI software has already been configured to automatically export the results as described below.
7.1.4.2 Automatic Export
See chapter 8.2.4 on page 8-10. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.1.4.3 Contents of ASCII Export Files
The structure and contents of the ASCII export files depend on what has been defined for each assay (see "Assay Programming Manual").
Examples of Export file without header field: ASCII Export Files [HBsAg] No header informati on [Results] Sample ID|Assay|Reader value|Qual. value Data field ""|"HBsAg"|"0.009"|"NC1" header Separator ""|" HBsAg"|"0.011"|"NC2" is a ""|" HBsAg"|"0.093"|"NC3" vertical ""|" HBsAg"|"1.455"|"PC1" bar (|) ""|" HBsAg"|"1.465"|"PC2" "001"|" HBsAg"|"0.004"|"neg" "002"|" HBsAg"|"0.011"|"neg" "003"|" HBsAg"|"0.011"|"neg" "004"|" HBsAg"|"0.002"|"neg" "005"|" HBsAg"|"0.987"|"pos" "006|" HBsAg"|"0.009"|"neg" "007 HBsAg"|"0.075"|"equ" "008 HBsAg"|"0.011"|"neg" [End of Results] 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Export files with header field:
[HBsAg] Time:;11:15:00 Assay Date:;27/09/07 Header Field OVER limit:;3.000 Operator:;User Wavelengths:;450nm/620nm -0.01<=NCi<=0.50; Validation -0.01<=0.010<=0.50; Criteria Header -0.01<=0.009<=0.50; Field -0.01<=0.011<=0.50; -0.01<=0.093<=0.50;Removed Valid(NC)>=2;2>=2 PCi>=0.550; 1.460>=0.55; 1.455>=0.55; 1.465>=0.55; valid(PC)=2;2=2 If 'Sample<(NC+0.05)*0.9' Then Qualitativ Result:='neg' e Header Field If 'Sample>=(NC+0.05)*1.1' Then Result:='pos' Default result := equ [Results] Sample ID,Assay,Reader value,Qual. value Data field "","HBsAg","0.009","NC1" header Separator ""," HBsAg","0.011","NC2" is a ""," HBsAg","0.093","NC3" comma (,) ""," HBsAg","1.455","PC1"
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 ""," HBsAg","1.465","PC2" "001"," HBsAg","0.004","neg" "002"," HBsAg","0.011","neg" "003"," HBsAg","0.011","neg" "004"," HBsAg","0.002","neg" "005"," HBsAg","0.987","pos" "006," HBsAg","0.009","neg" "007 HBsAg","0.075","equ" "008 HBsAg","0.011","neg" [End of Results]
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7.1.4.4 Target Directory for Export Files
Under default settings: • Result files (*.res) are saved in the C:\Gemini\Resources\Result directory. • Result Export files (*.txt) are saved in the C:\Gemini\Export directory.
If you are using the GEMINI COMBO instrument software, the directory is called "GeminiCombo" instead of "Gemini".
To change the directory where export files are to be saved (for example if you want them to be saved on a host computer and not on the GEMINI Computer), see chapter 8.2.8 on page 8-15.
7.1.4.5 Opening ASCII Result Export Files
Result export files are ordinary (*.txt) files which can be opened with any standard word processor or spreadsheet software. They cannot be opened with the GEMINI software! If you try to open a (*.txt) result export file with the GEMINI software, the instrument will assume that it is a (*.txt) worklist import file and will automatically display the ASCII Sample Information Import dialog as if you had to define import parameters (see chapter 7.1.3 on page 7-5). Just click on the Cancel button in this dialog and use the correct software to open the export file. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.2 Communication through an ASTM Link
Communication between the GEMINI and an external host computer is then accomplished via an RS232 connection and follows the ASTM 1394 (high level) and 1381 (low level) standards for communication.
ASTM stands for American Society for Testing and Materials. The ASTM has developed standards on data transfer to/from host computer in the medical field. For more information on ASTM standards, see www.astm.org.
The GEMINI host interface consists of: • ASTM 1381 low-level transfer protocol used to transmit or receive messages • Interpretation of received data from the intermediate files and entering it into the GEMINI database The ASTM 1394 defines how the data to be transmitted is represented as a structured message consisting of several records. These messages are then translated into one or more frames that will actually be transmitted according to ASTM 1381.
7.2.1 ASTM Link Set-Up
It is possible to configure the ASTM connection settings if the software is in Demo Mode but not to use the ASTM connection.
To set-up the connection parameters according to ASTM specification for connection to a host computer: 1. Select the Utilities > Options menu item. 2. Click on the ASTM tab. 3. Click the Enable ASTM E 1381/1394 link checkbox. Then all boxes on this tab are enabled. The connection setting of the delimiter and the interface are defined in accordance with the ASTME standard. For other
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 settings, see chapter 8.2.6 on page 8-12 4. Select the correct COM port. 5. Confirm with OK.
Please make sure that you do not select the internal COM Port between PC and instrument.
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7.2.2 Definition of LIS Assay Names
Because the actual assay file names are often relatively long, it is sometimes not convenient or not technically possible to use them for file transfer purposes (for file transfers between the GEMINI software and the host computer/LIS).
Linking of Assays It is necessary to validate the linking of assay names between software and LIS system.
In this case, shorter code names or "LIS assay names" can be defined. Once defined, these LIS assay names can be used either for ASTM file transfers chapter 7.2.3 on page 7-17 or for ASCII file transfers (see chapter 7.1.3 on page 7-5 [import] and "Assay Programming Manual" [export]).
To define LIS assay names: 1. Select the Utilities > Options menu item. 2. Click on the ASTM tab. 3. On this tab, click on the Assay Links button. This opens the following dialog showing the list of already defined LIS assay names and the corresponding assay file names. If you have not yet defined any LIS names, the list is empty. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 7-3: Assay Links dialog
Add a new 4. To define a new LIS assay name, click on the Add button. This opens the Name following dialog.
Figure 7-4: Assay Link dialog
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5. Click on the Browse button to open the assay file directory and select the assay file for which you want to define a LIS assay name. 6. Click on the Open button to close the assay file directory and insert the selected file in the Assay Protocol Filename field. It is recommended to always use the Browse button instead of entering the assay file name via the keyboard to avoid typing errors. 7. In the LIS Assay Name field, enter the short name you want to use as LIS assay name for this assay. 8. When done, click on the OK button. This takes you back to the Assay Links dialog and you can check that the newly defined LIS name is now in the list. 9. Click on the OK button again to close this dialog and go back to the ASTM tab of the Options dialog. 10. Click on the OK button to close this dialog.
LIS assay names can include letters, digits and blank spaces. Capitals and lower case letters are visually different but are treated by the system as the same character. For example, if "HIV1" is an existing LIS assay name, you cannot define another LIS assay name as "HIV1". If you try, a message is displayed saying: "A link already exists for this assay name. Do you want to overwrite the existing link?"
Edit a Name To edit an existing LIS assay name, select it in the Assay Links dialog and click on the Edit button.
Delete a Name To delete an existing LIS assay name, select it in the Assay Links dialog and click on the Delete button. If you click on the Delete All button, you will be prompted to confirm that you really want to delete all existing LIS assay names. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.2.3 Communication Procedure
Communication sessions between the GEMINI and a host computer can be initiated upon request by the GEMINI operator or automatically.
Import of test order requests: When samples are loaded on the instrument, all tests previously ordered for these samples at host computer level and downloaded to the GEMINI computer will appear on the column format Sample Editor dialog box (see chapter 4.4 on page 4-8). If you have checked the Query Host For Test Order Requests item in the ASTM dialog, each time you load new samples on the system, the software will automatically interrogate the host computer to know if test order requests are available for these samples. When a test order request is received from the LIS, a search is first made within the list of LIS assay names/assay protocol filename pairings. If a matching LIS assay name is found, then the software uses the linked assay protocol filename when the test request is effected. If no match is found, the software assumes that the assay name received from the LIS is the exact assay protocol filename.
Export of test results: It is possible to export test results manually (via the Utilities > Export Results menu item, available when a result report is displayed on the screen) or to configure the GEMINI software to create and export test results automatically. This is done as described for ASCII files in (see chapter 7.1.4 on page 7-10). The ASTM format and the data included in the transmission are defined as described in chapter 7.2.1 on page 7-14 and chapter 7.2.6.2 on page 7-21. Additional assay-specific data fields may be included at assay level. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.2.4 Low-Level Protocol
7.2.4.1 Physical Layer
(Refer to the ASTM 1381 Standard, section 5)
Figure 7-5: RS232 Connection to Host
7.2.4.2 Data Link Layer
Establishment Phase: (Refer to the ASTM 1381 Standard, section 6.2)
Transfer Phase: (Refer to the ASTM 1381 Standard, section 6.3) The checksum is encoded as two characters sent after the
Termination Phase: (Refer to the ASTM 1381 Standard, section 6.4) After the GEMINI transmits or receives the
Error Recovery: (Refer to the ASTM 1381 Standard, section 6.5) The GEMINI checks every frame it receives to guarantee its validity and sends an
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During the establishment phase, the GEMINI expects to receive a reply within 15 seconds after sending
7.2.5 Logical Structure of the Message Level Protocol
The blocked stream of data sent between a host computer and the GEMINI at a given time is called a message. Messages consist of a hierarchy of records of various types:
Identifier (Record Level Segment Name Comments Type ID)
0 Message Header Record 'H' 0 Message Terminator Record 'L' 1 Sample Information Record 'P' 1 Request Information Segment 'Q' 1 Scientific Record 'S' not allowed for GEMINI 2 Test Order Record 'O' 3 Result Record 'R' common Comment Record 'C' 1 Manufacturer Information 'M' not allowed Record for GEMINI
Table 7-1: Message Level Protocol
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 A record is identified by the first field of a record, the RecordTypeID. Most of the various record types are related to each other in a definite hierarchy: A lower level record may never appear without the preceding higher level record (i.e. order records must be preceded by a sample record, result records must be preceded by an order record...). A sequence of records at one level is terminated by the appearance of a record of the same or higher level. In some other descriptions a record might also be called segment.
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7.2.6 Incoming and Outgoing Transmission Examples
7.2.6.1 Host to GEMINI (Test Orders)
The host response includes sample demographics, Sample ID, sample ID, and test orders according to the following record hierarchy. The response to requests for test orders is expected to be received within
Structure defined by ASTM 1394 Structure defined by ASTM 1381 (multiple records comprise a single (each record is sent as one or more message) frames) Message Header Record Sample Information Record 1 Test Order Record 1 : Test Order Record n : => Frame 1 Sample Information Record n : Test Order Record 1 Frame n : Test Order Record n Message Terminator Record
Table 7-2: Structures
In case there are no test orders available the LIS should respond with an empty message containing header and terminator records only. The terminator record should contain an 'I' (no information available) flag in the Termination Code Field.
Example: H|\^&|||EDVLab||||||||1|19941115202738 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 P|1||SampleID01||Anderson^Anna||19741001|F|||||MARTINEZ O|1|||^^^AFP^1:10||19980506|||||||||S||||||||||X P|1||SampleID02||Newman^Tony||19741001|F|||||MARTINEZ O|1|||^^^AFP||19980506|||||||||S||||||||||X O|1|||^^^TSH||19980506|||||||||S||||||||||X O|1|||^^^T3||19980506|||||||||S||||||||||X O|1|||^^^T4||19980506|||||||||S||||||||||X P|1||Barcode15||Palmer^John||19741001|F|||||MARTINEZ O|1|||^^^AFP^1:10||19980506|||||||||S||||||||||X P|1||12345|||||F|||||MARTINEZ O|1|||^^^AFP^1:10||19980506|||||||||S||||||||||X L|1|N
After the GEMINI receives all test orders from the host, the records are interpreted. Valid test orders are entered into the load list database, while invalid test orders are not.
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7.2.6.2 GEMINI to Host (Test Results)
Only the final calculated result (Abs, concentration or interpretation) is transferred per test. For multiple replicate results the mean is transmitted only. GEMINI to Host: (transmit sample information with corresponding tests and results)
Structure defined by ASTM 1394 Structure defined by ASTM 1381 (multiple records comprise a single (each record is sent as one or more message) frames) Message Header Record Sample Information Record 1 Test Order Record 1 Result Record 1 Comment 1 : Result Record n Comment 1 : Test Order Record n Result Record 1 Comment 1 : Result Record n Comment 1 : Frame 1 Sample Information Record n => : Test Order Record 1 Frame n Result Record 1 Comment 1 : Result Record n Comment 1
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 : Test Order Record n Result Record 1 Comment 1 : Result Record n Comment 1 Message Terminator Record
Table 7-3: Structures
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Example: H|\^&|||EDVLab||||||||1|19941115202738 P|1||SampleID01||ANDERSON^ANNA||19741001|F|||||MARTINEZ O|1|||^^^AFP||19980506|||||||||S||||||||||F R|1|^^^AFP|13.1|IU/ml||H||F||||19980506123145| P|2 O|1||NC1|^^^AFP R|1|^^^AFP|9.5|IU/ml L|1|N
Data Record Usage: (Refer to the ASTM Standard 1394, particularly sections 6 through 13) Each record sent by the GEMINI will contain up to the last field used by the GEMINI, which may or may not be all fields possible for the record. An 'O' in Required or Sent field indicates optional. The first
7.2.6.3 Message Header Record
Field Valid Max ASTM Field Description Required No. Contents Length
1 Record Type ID Character identifying the record as 'H' 1 Y a message header 2 Delimiter Any received delimiter set is 4Y Definition accepted. The delimiters defined in ASTMSetupDialog are sent. 3 Message Control ID N 4 Access Password N 5 Sender Name / ID 20 N 6 Sender Street N Address 7 Reserved Field N 8 Sender Telephone N 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 No. 9 Characteristics of N Sender 10 Receiver ID 11 Comment N 12 Processing ID N 13 Version No. '1' 1 N 14 Date and Time of Format is YYYYMMDD HHMMSS 14 N Message
Table 7-4: Message Header Record
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7.2.6.4 Sample Information Record
Field Valid Max ASTM Field Description Required No. Contents Length
1 Record Type ID Character identifying the record as 'P' 1 Y a sample information record 2 Sequence Number Y 3 Practice Assigned N Sample ID 4 Laboratory Becomes our SampleID, empty for Y Assigned Sample controls. ID 5 Sample ID No. 3 N 6^1 Sample Name O 6^2 Sample First Name O 7 Mother's Maiden N Name 8Birthdate 8 O 9 Sample Sex 1 O 10 Sample Race - N Ethnic Origin 11 Sample Address N 12 Reserved Field N 13 Sample Telephone N Number 14 Attending Becomes our SenderID N Physician ID 15 Special Field 1 N
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 16 Special Field 2 N 17 Sample Height N 18 Sample Weight N 19 Diagnosis N 20 Active Medications N 21 Diet N 22 Practice Field No. 1 N 23 Practice Field No. 2 N 24 Admission and N Discharge Dates 25 Admission Status N 26 Location N
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Field Valid Max ASTM Field Description Required No. Contents Length
27 Nature of Alternative N Diagnostic Code and Classifiers 28 Alternative N Diagnostic Code and Classification 29 Religion N 30 Marital Status N 31 Isolation Status N 32 Language N 33 Hospital Service N 34 Hospital Institution N 35 Dosage Category N
Table 7-5: Sample Information Record 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.2.6.5 Test Order Record
Field Valid Max ASTM Field Description Required No. Contents Length
1 Record Type ID Character identifying the record as 'O' 1 Y a test order record 2 Sequence Number Y 3 Specimen ID N 4 Instrument Y 5^4 Universal Test ID Test Abbreviation Y 5^5 Dilution N 6Priority N 7 Requested/ N Ordered Date and Time 8 Specimen Collection 'YYYYMMDDHHMMSS' 14 Y Date and Time 9 Collection End Time N 10 Collection Volume N 11 Collector ID N 12 Action Code N 13 Danger Code N 14 Relevant Clinical N Information 15 Date/Time N Specimen Received 16 Specimen N Descriptor (Type) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 17 Ordering Physician N 18 Physician's N Telephone Number 19 User Field No. 1 N 20 User Field No. 2 N 21 Laboratory Field No. N 1 22 Laboratory Field No. N 2 23 Date/Time Results N Reported or Last Modified
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Field Valid Max ASTM Field Description Required No. Contents Length
24 Instrument Charge N to Computer System 25 Instrument Section N ID 26 Report Types N 27 Reserved Field N 28 Location of Ward of N Specimen Collection 29 Nosocomial N Infection Flag 30 Specimen Service N 31 Specimen Institution N
Table 7-6: Test Order Record
Example test order import: H|\^&|||EDVLab||||||||1|19941115202738 P|1||SampleID01||Anderson^Anna||19741001|F|||||MARTINEZ O|1| ||^^^AFP^1:10||19980506|||||||||S||||||||||X P|1|| SampleID02||Newman^Tony||19741001|F|||||MARTINEZ O|1| ||^^^AFP||19980506|||||||||S||||||||||X O|1| ||^^^TSH||19980506|||||||||S||||||||||X O|1| ||^^^T3||19980506|||||||||S||||||||||X O|1| ||^^^T4||19980506|||||||||S||||||||||X P|1||Barcode15||Palmer^John||19741001|F|||||MARTINEZ O|1| ||^^^AFP^1:10||19980506|||||||||S||||||||||X P|1||12345|||||F|||||MARTINEZ O|1|||^^^AFP^1:10||19980506|||||||||S||||||||||X L|1|N 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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7.2.6.6 Result Record
Field Valid Max ASTM Field Description Required No. Contents Length
1 Record Type ID Character identifying the record as R1 Y a result record 2 Sequence Number Y 3Test ID N 4 Data or depends Y Measurement on value Value 5Units Y 6 Reference Ranges Y 7 Result Abnormal N Flags 8 Nature of N Abnormality Testing 9 Result Status N 10 Date of Change in N Instrument Normative Values or Units 11 Operator N Identification 12 Date/Time Test N Started 13 Date/Time Test N Completed 14 Instrument ID N
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Table 7-7: Result Record
Example result export: H|\^&|||EDVLab||||||||1|19941115202738 P|1||SampleID01||ANDERSON^ANNA||19741001|F|||||MARTINEZ O|1| ||^^^AFP||19980506|||||||||S||||||||||F R|1|^^^AFP|13.1|IU/ml||H||F||||19980506123145| L|1|N
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7.2.6.7 Comment Record
Comment Records are used either to describe reasons for rejected test orders or to supply additional result information. One comment record is used for the kit/reagent/control batch number. Another comment record is used for the relevant flags. Comment records begins with a C character.
7.2.6.8 Request Information Record
Not applicable.
7.2.6.9 Message Terminator Record
Field Valid ASTM Field Description Required Sent No. Contents
1 Record Type ID Character identifying the record as 'L' Y Y the last record in the message 2 Sequence Number Y Y 3 Termination Code N N
Table 7-8: Message Terminator Record
7.2.6.10 Scientific Record
Must not be sent.
7.2.6.11 Manufacturer Information Record
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8.1 Defining User Rights and User Groups
The purpose of user groups is to allow the laboratory supervisor to individually define the rights of each user. For example, it makes it possible to specify that some technicians will only be allowed to use the GEMINI instrument to process pre-defined assays but not to program new assays or change the system settings. It also makes it possible to ensure that only authorized personnel can access sample data or validate results before they are exported to a host computer. Under default settings, two pre-defined user groups are available:
Supervisors Full access group. Members of this group are allowed to use all the functions available on the GEMINI instrument. Users Restricted access group. Members of this group are only allowed to Start Worklists, Edit Worklist Options and Post Results to LIMS. For details on these and other access rights, see table in chapter 8.1.2 on page 8-4.
8.1.1 Defining the Rights of Individual Users
Required access rights: Administer Users
To define the access rights of a user, you need first to register that user (specify his/ her user name) and then assign him/her to an existing user group. The Users tab also allows you to check which group(s) a given user belongs to and, if necessary, change it.
Open Users 1. Select the Utilities > Options menu item to open the Options 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Tab dialog. 2. Click on the Users tab.
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Figure 8-1: Options dialog: Users tab
New User
Add User Adds the new user into the users list. User Name Name of a new user. The user name must be unique. Any sequence of alphanumeric characters (spaces are allowed) can be entered as a user name.
Existing Users
Available Shows all created and available user groups (see chapter 8.1.2 on page 8-4). Groups Clear Deletes the password of the shown user in the users list. Password Delete User Deletes the shown user in the users list. Member Of Shows which user groups are available for the shown user in the users list. The same user can belong to more than one user group. In this case, his/her access rights are the same as those defined for members of that user group with
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 the most extensive access rights (e.g. if User A belongs to both the Users and the Supervisors groups, User A will have the same access rights as Supervisors). User Name List of all users. >, >> Adds a user group or all user groups to the Member Of list. <, << Deletes a user group or all user groups from the Member Of list.
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New Users 1. Enter the new user name in the User Name field of the New User area. 2. Click on the Add User button. The new user name is then automatically displayed in the lower User Name drop-down list. 3. In the Available Groups list, select the appropriate user group for this user. 4. Click on the > button to transfer the selected user group into the Member Of list. 5. Confirm with OK.
Check or 1. Select the desired user in the User Name drop-down list of the Change User Existing Users area. Groups 2. The group(s) this user belongs to is (are) now displayed in the Member Allocation Of list. 3. Using the arrow buttons (>, >>, <, <<) you may now, if you want, change the user group(s) to which this particular user belongs by transferring items from the Available Groups list to the Members Of list (or vice- versa). 4. Confirm with OK.
Delete a User 1. Select the desired user in the User Name drop-down list of the Existing Users area. 2. Click on the Delete User button. 3. Confirm with OK. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.1.2 Creating and Editing User Groups
Open User 1. Select the Utilities > Options menu item to open the Options Groups Tab dialog. 2. Click on the User Groups tab.
Figure 8-2: Options dialog: User Groups tab
Add Adds a new user group. Enter the unique name of the user group into the field next to the button. Delete Deletes the selected user group in the Groups list. Groups List of all user groups.
This tab includes a list of access control items (user rights). When an item is checked, this means that members of the respective user group (highlighted in the Groups list) are allowed to use the corresponding functions:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Administer ...register new users and define their rights. Define, edit or Users delete user groups. Clear user passwords. Create assays ...create new assays. Change ...access the Preferences tab in the Options dialog preferences and change the settings on this tab (see chapter 8.2.4 on page 8-10). Change ...open the System Set-Up dialog and change the system setup settings on any of the tabs (see chapter 8.3 on page 8-18). Edit assays ...edit assays. Note however that even if a group of users is allowed to edit assays, assays themselves can be individually protected by a specific password set by the person or company which created the assay (e.g. validated pre-defined assays are normally password protected).
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Edit sample ...access and edit sample personal information (see details chapter 6.2 on page 6-4). Edit running ...access the Edit > Panel Definition menu item in worklists order to change the settings of an existing worklist (e.g. to add new plates - see chapter 6.6 on page 6-48 on continuous loading). Edit Worklist ...open the Worklist Options dialog and decide on a Options number of operations to be performed (or not) as the worklist is being processed (e.g. pre-run checks, sample archiving, tip management, reagent reloading, result printing - see chapter 6.4 on page 6-27). Post Results ...allow test results to be exported to a host computer. Note to LIMS that for users who are not generally allowed to undertake this action, a special authorization procedure may apply. Manually ...remove outliers manually (see chapter 6.5.4.1 on page 6-43). remove outliers Restore ... allow to replace all current system files by system files Backups from a previous backup (e.g after a system crash), see chapter 9.4.2 on page 9-16. Start ...define a worklist, load the instrument and start the Worklists processing (perform a run). This is one of the basic rights. For users who are not allowed even to start worklists, a special authorization procedure may apply.
Define a new 1. Enter the unique name of the user group into the field next to the Add button User Group (instead of "New Group"). 2. Click on the Add button. Your new user group is entered in the Groups list. A new user group is always entered at the bottom of the list. If you want the user groups to be displayed in the list according to a specific order (e.g. those with extensive rights at the top and those with more restricted rights down the list), you have to define them in that order! 3. Check the appropriate items in the list to specify which actions members of this group are allowed to undertake (e.g. you may want to create an 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 "Advanced Users" group in which users will be entitled to all the above rights except Administer Users and Edit Sample Details). 4. Confirm with OK.
Check or 1. In the Groups list, select the desired user group. Change User 2. Check items on the right-hand side of the dialog if you want to allow members Group Rights of this group to undertake actions which they were not formerly allowed to do (e.g. you may decide to allow Users to Ignore Errors if you think it is more important that runs be fully processed). Deselected items if you want to restrict the rights of this user group. 3. Confirm with OK.
Delete a User 1. In the Groups list, select the user group which you want to delete. Group 2. Click on the Delete button. 3. Confirm with OK.
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8.1.3 Special Authorizations for Users with Restricted Rights
Normally, if a user belongs to a group which is not authorized to undertake a given action, this user will not be able to even access the corresponding menus or dialogs. There are, however, two exceptions which apply to the start worklists and to the post results to LIMS items. A user who is not allowed to start a worklist will be nevertheless allowed to define a worklist and load the instrument accordingly. When he/she attempts to start the worklist, the Log-On dialog will be displayed. This user then has to seek the assistance of a supervisor or of another user who is allowed to start worklists. This other user will then log in under his/her own name and authorize the start of the worklist. This is only a log-on for authorization purposes. It is recorded as such in the event log (mentioning the user name of the person who gave the authorization). The original user remains logged in and will continue to appear as operator in the result report for instance. The same applies to post results to LIMS. If this action is requested by a user who is not allowed to undertake it, the Log-On dialog is displayed and a supervisor or a more advanced user has to authorize the transfer. These special authorizations allow supervisors to let even new users work on the instrument while still making sure they themselves can verify the processing and validate the results. Do not confuse this situation with the "successive users" case described in chapter 4.3.5 on page 4-6. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.1.4 Password Settings / Forgotten Password
Although user registration (i.e. defining the user name and user group of a new user) has to be done by a supervisor or another user entitled to Administer Users (see chapter 8.1.2 on page 8-4), password definition can only be done by the user himself/herself. This is done, as described in chapter 4.3.3 on page 4-5, when the user logs in for the first time under his/her new user name. Similarly, only a user himself/herself can change his/her password (as explained in the same section). This ensures that nobody, even supervisors, can have knowledge of someone else's password and, consequently, that nobody can use the GEMINI instrument under someone else's user name.
Forgotten The only situation in which supervisor intervention is required is when a user has Password forgotten his/her password. In this case, the user has to seek the assistance of a supervisor or of another user who is allowed to Administer Users. This supervisor has to: 1. Log in as supervisor. 2. Select the Utilities > Options menu item to open the Options dialog and select the Users tab. 3. In the Users tab, display the User Name drop-down list and select the user name of the user with the forgotten password. 4. Click on the Clear Password button. A information message is displayed. 5. Click on the OK button to close the message, then click on the OK button again to close the Options dialog. The next time the user logs in under his/her own user name, he/she has to define a new password exactly as if he/she was defining his/her first password (refer to the procedure described in chapter 4.3.3 on page 4-5 for defining a first password). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.1.5 Questions about Password Settings
Blank Password Can I keep a blank password? Technically, yes. However, this is NOT recommended. When a new user has just been registered, he/she can open the GEMINI software without a password until he/she has defined his/her first password as described in chapter 4.3.3 on page 4-5. As long as this has not been done, this user will remain able to open the GEMINI software (and work on the instrument) without a password. But it also means that anybody else may be able to operate the instrument under this user name.
Temporary As a supervisor, can I set temporary passwords for the new users I register? Password Yes. If you want to do so, once you have registered a new user you have to: 1. Log in under the name of the new user you have just registered. 2. Enter the temporary password as if you were the new user entering his/her first password (see procedure described in chapter 4.3.3 on page 4-5). 3. Let the new user know this temporary password. When that user logs in under his/her own user name, he/she will be able to change this password as explained in that same chapter.
Restricted Can I use some restricted functions in Demo Mode? Functions in No. Demo Mode If you belong to a user group for which access to some functions is restricted, these restrictions will apply in Demo Mode as they apply if you are working with the instrument. For example, if you are not allowed to change the system set-up, the Utilities > System Setup menu item will be disabled even if you start the system in Demo Mode. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.2 System Options
The System Set-Up dialog (see chapter 8.3 on page 8-18) and the Options dialog allow you to adapt the GEMINI instrument to your specific circumstances and needs. The Options dialog lets you specify software options.
If tabs in the Options dialog aren’t shown, this means that you belong to a user group with restricted access rights. For more information on access rights and user groups, see chapter 8.2.1 on page 8-9 and chapter 8.2.2 on page 8-9.
Click on the Utilities > Options item to open the Options dialog.
8.2.1 User Groups Tab
See chapter 8.1.2 on page 8-4.
8.2.2 Users Tab
See chapter 8.1.1 on page 8-1.
8.2.3 Password Tab
See chapter 4.3.3 on page 4-5. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.2.4 Preferences Tab
Required access rights: Change preferences
Figure 8-3: Options dialog: Preferences tab
Well Orientation
Columns Displays the results column wise. Rows Displays the results row wise.
This option is a software option. It does not change the way the pipettor operates. It changes the way the results are displayed. Default is columns. To change the direction in which the pipettor operates, you have to change the fill orientation in the Assay Layout dialog (see "Assay Programming Manual"). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Export Options
Automatically Check this option to systematically export the results each time. A result file (*.res) create will be generating in the result folder. exported results files Export results This item allows you to enable / disable the automatic result file export if the if VC fail validation criteria for the test have not been met.
The result report apply both to ASCII and ASTM exports. Prerequisites for these exports are, however, that the appropriate settings have been defined at assay level (see "Assay Programming Manual") and, for ASTM exports, that the connection has been enabled as described in chapter 8.2.6 on page 8-12.
IFA Results It will be not possible to send IFA results to a host computer, because the result of a IFA slide must be done in a further process step outside of the GEMINI COMBO instrument.
General
Left Margin Defines the left paper margin for printout of the assay protocols and the result report.
8.2.5 File Polling Tab
See chapter 7.1.3.2 on page 7-7. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.2.6 ASTM Tab
Required access rights: Nothing
Typically, it will not be necessary to modify these parameters.
Contact your technical support before you are modifying one of these parameters.
Figure 8-4: Options dialog: ASTM tab
The connection setting of the delimiter and the interface are defined in accordance with the ASTM standard.
ASTM E 1394
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 ... Delimiter These fields specify the set of delimiters used for transmissions. Compact Mode If this item is checked, each sample result information is sent in a separate package. ID Instrument ID is included in the result record. Query Host If this item is checked, the Query to Host mode is enabled (see below). For Test Order Requests Time Out If no response is received to the query within the time out specified in the field then the software will send no further query requests.
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ASTM E 1381
Baud Rate Specifies the baud rate used for transmissions between the GEMINI and the host; any values from 110 to 56,000 can be chosen. Default is 9600. COM Port This field specifies the serial port used for host transmissions. Please make sure that you do not select the internal COM Port between PC and instrument. Create Log If this item is checked, a log file (yyyymmdd.txt) of the ASTM communication is File created in the C:\Gemini\Resources\Event_log directory. Data Bits 7 or 8, default is 7. Parity None, odd, even, mark, space. Default is None. Stop Bits 1, 1.5 or 2, default is 1.
General
Assay Links Click this button to review existing LIS assay names or create new ones (see chapter 7.2.2 on page 7-15). Enable ASTM Select this item if communication with a host computer exists. E 1381/1394 Link 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.2.7 Laboratory Tab
Required access rights: Nothing
Figure 8-5: Options dialog: Laboratory tab
The laboratory details entered here are included in the result reports (see chapter 4.10 on page 4-61).
Address Address of your laboratory (no specific format is required by the system). FAX Fax number of your laboratory (no specific format is required by the system). ID Not used, enter 0. Name Name of your laboratory (no specific format is required by the system). Telephone Telephone number of your laboratory (no specific format is required by the system). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.2.8 Directories Tab
Required access rights: Nothing
Figure 8-6: Options dialog: Directories tab
Directories Shows all file types and the path/folder where they are saved. Browse Enables to change the path/folder of the file types: 1. Select a file type in the directories list. 2. Click on the Browse button. 3. In the Browse dialog, find the directory where you want to save this file type. 4. In this directory, select any file and click on the Open button (see note below). 5. Back in the Directories tab, check that the corresponding change has been taken into account. 6. Confirm with OK. 7. Repeat this procedure for the other file types if necessary. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
If this new target directory in which you want to save certain file types is empty just copy or create any file into it, so you can select it for that purpose (you can later delete it). If you select only the directory (and no file) and click on the Open button, the change will not be retained.
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8.2.8.1 File Types and Locations
The GEMINI software uses a number of different file types. Under default settings these files are saved in the following directories:
Extension File types Path/Folder
*.apm File polling format setting of the import C:\Gemini\System file for host systems. *.asy Assay protocol files. C:\Gemini\Resources\Apf *.dat Only one file: Koordina.dat (file C:\Gemini\System containing the instrument coordinates). *.log Active event log files (documenting daily C:\Gemini\Resources\Eve data communication between PC and nt log GEMINI instrument as well as error messages). *.mpc Coordinate files for test plates or dilution C:\Gemini\System plates. *.pan Panel files. C:\Gemini\Resources\Apf *.rac Coordinate files for rack and slide types. C:\Gemini\System *.rea Reagent layout files. C:\Gemini\System *.res Result files. C:\Gemini\Resources\Res ult *.spe Spectrum files (contain data of a C:\Gemini\System spectrum acquisition). *.tst Selftest report files with information C:\Gemini\System about the selftests that were performed. *.txt Export files in ASCII format C:\Gemini\Export *.txt ASCII sample data import files can be C:\Gemini\Import or downloaded from a host computer to the selected directory on host GEMINI software (sample with computer associated assays). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 *.txt Duplicate log file in (*.txt) format. C:\Gemini\Resources\Eve nt log *.ver Photometer verification report files. C:\Gemini\System *.wor Worklist files. C:\Gemini\Resources\Apf
Table 8-1: File types and locations
The system uses also some other file types (*.rec, *.db, *.mdb, *.lsv, *.con) but these are hidden for the user.
If, when installing the software, you have chosen to install it in a different directory than the default directory, you will have to edit manually the default directory for each file type as described below. This can be a source of errors. Therefore, unless you
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have a specific reason to do otherwise, it is recommended that you install the GEMINI software in the default directory.
If you are using the GEMINI COMBO instrument software, the directory is called "GeminiCombo" instead of "Gemini". 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3 System Set-up
Required access rights: Change system setup
The System Set-Up dialog and the Options dialog (see chapter 8.2 on page 8- 9) allow you to adapt the GEMINI system to your specific circumstances and needs. The System Set-Up dialog allows you to adapt the parameters of each instrument module (incubators, pipetting system, wash unit, etc.). Typically, it will not be necessary to modify these parameters.
Contact your technical support before you are modifying one of these parameters.
If the System Setup item in the Utilities menu is disabled, this means that you belong to a user group with restricted access rights. For more information on access rights and user groups, see chapter 8.2.1 on page 8-9 and chapter 8.2.2 on page 8-9.
Click on the Utilities > System Setup item to open the System Set-Up dialog. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.1 System Tab
Figure 8-7: System Set-Up dialog: System tab
Communication Defines the PC's communication link to GEMINI instrument. Links
COM port Select the COM port for the computer-to-instrument link. Default is COM port 3 (see chapter 7 on page 7-1). Simulate This item is automatically checked when you check the Demo mode item in system the Log-On dialog (see chapter 4.3 on page 4-3). Generate a Select this item to document communication via the selected COM port in a log 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 COM port log file.
Self-diagnostic Enables an additional check of the GEMINI instrument.
Perform self- Select this item to perform automatically a selftest before run a worklist (see diagnostics chapter 6.1 on page 6-1). before a run Auto print Select this item to print automatically the selftest result report. self- diagnostics report
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System
Serial number Serial number of the GEMINI instrument. This number will be needed if you call your representative for support or service. The serial number is also printed on the type label (see chapter 1.4.6 on page 1-13). Sound volume Volume of the audible signal.
Command Processor Information
Serial number Shows the COP serial number Firmware Shows the COP firmware version. version
Information on the GEMINI central operation processor (COP).
Assay Portfolio The processing of assays can be limited with assay portfolio groups. Only assays of Groups the same assay portfolio group could be used after the entry of a assay portfolio group name (see also "Assay Programming Manual", chapter "Assay Protocol Header Information"). Not allowed entries: space characters 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.2 Incubators Tab
Figure 8-8: System Set-Up dialog: Incubators tab
Configuration
Incubator Specify how many heat able incubators are to be used. slots Ambient slots Specify how many room-temperature incubators are to be used. Incubators Enable the shaking function of the heat able incubators. support shaking 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Pre-heat Setting for the incubators preheat function on power-up. The incubators take some time to reach high temperatures. The system will not start a run if the temperatures required for the assays to be processed are not reached. If you intend to process assays with high incubation temperatures, it is a good idea to select pre-heating on power-up option.
Disabled Incubators are not preheated on power-up. Last used Incubators are preheated to the last used temperature on power-up (default temperature setting). Prompt for Incubators are preheated to the temperature selected in the window coming up on temperatures power-up.
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User-defined Incubators are preheated to the temperature defined in the fields for Incubator #1 and Incubator #2 on power-up (values between 21 and 55 can be entered). Incubator #1, (see User-defined) Incubator #2
Information Incubators information.
Firmware Shows the firmware version number for the incubators. version 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.3 Colorimeter Tab (Photometer)
In the software and in this manual, the words "photometer" and "colorimeter" are synonymous.
Figure 8-9: System Set-Up dialog: Colorimeter tab
Filters By default, the photometer on the GEMINI instrument is equipped with three filters. Six more filters can be added to suit the user-specific needs. To add filters, contact your service engineer.
Correct Filter Position The system is not able to check automatically in which position each filter is installed.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 When the system is installed, the appropriate data is entered in the software by your service engineer using the Colorimeter tab below. If you ever add or change filters, always make sure the parameters specified in the software (number of filters, order, wavelengths) strictly correspond to the filters that are on the instrument.
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Number of Number of filters used in the instrument (default is 6). filters Filter 1 - Filter The number of boxes that are enabled depends on the number that has been 8 specified above. Shows the wavelength of each filter in nm. The numbering of the filter in the instrument must match the numbering on this tab! Defaults: • Filter 1: 405 nm • Filter 2: 450 nm • Filter 3: 492 nm • Filter 4: 620 nm • Filter 5: 650 nm • Filter 6: 690 nm • Filter 7: - • Filter 8: -
Out Of Range Values
OVER limit Enter the upper limit value (OD) for the photometer (e.g. 2.5). The maximum value that can be set is 3.5. The lower limit value is equal to the negative value of the upper limit value. The photometer is linear up to 2.000. For other specifications, see chapter 12 on page 12-1. OVER When the value read by the photometer is OVER the upper limit (or UNDER the replacement lower limit), you can choose to replace, in the results, the actual value by another value a nd UNDR character string, e.g. a wildcard (*), a digit or a comment. In this case, check the replacement item and enter the replacement string in the respective field (default is a wildcard value sign).
Information Photometer information
Firmware Shows the firmware version number.
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General
Verification Enables to enter the reference values of the reader verification plate. You don’t Plate need this function, if you use the verification plate data disk. See ’Reader Verification Plate Manual’ for photometer verification.
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8.3.4 Pipette Tab
Pipetting Parameters The Pipette tab is used to define the Pipetting parameters at system level, i.e. to define how the pipettor works. Do not confuse it with the Pipette dialog or the Dispense dialog (see "Assay Programming Manual") which are used to define, at assay level, which aspirate/dispense steps the pipettor should execute.
Figure 8-10: System Set-Up dialog: Pipette tab
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Options
Syringe Shows the syringe volume of the pipettor pump in microliters (1000 µl). volume Disposable This item is always checked (it ensures that a warning message is displayed if a tips problem occurs when the pipettor picks up or ejects a tip). Enable clot This item is always checked. It ensures that a warning message is displayed if a detection clot is detected. Enable liquid This item must always be checked (see note below). The liquid level detection level process enables the system to monitor the height at the surface of the respective detection liquid. It then calculates how the pipettor should move during aspiration/dispense in relation to the surface of the liquid and the volume to be aspirated/dispensed. Enable Check this item to enable the aspirate pressure monitoring system (APM). pressure If APM is enabled, the system compares the measured aspiration pressure data monitoring with thresholds in order to detect pressure errors immediately after the aspiration.
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Liquid Level Detection Do not deactivate liquid level detection! There are a risk on aspiration/dispense failures!
GEMINI COMBO The GEMINI COMBO system does not support the APM function.
Dilution Plates See also chapter 4.8.5 on page 4-44
Coordinates The parameters offered here are based on a (*.mpc) file. Here you select the dilution plates used. The respective file must be in the GEMINI program directory (C:\Gemini\System). Maximum Enter the maximum volume of a cavity of the dilution plate. Volume Minimum Enter the minimum detectable volume of a cavity of the dilution plate. Volume
Dilution Tubes Information about the dilution tubes. Dilution tubes may be used for sample archiving and pre-dilution steps (for assays for which such a step is necessary).
Max. Volume Enter the maximum volume of a dilution tube. Min. Volume Enter the minimum detectable volume of a dilution tube. Colour Select the color in which dilution tubes are displayed in the Load dialog.
Information Pipettor information. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Firmware Shows the current firmware version of the pipetting system. version Bridge version Shows the current firmware version of the X-motor controller main system. X-axis version Shows the current firmware version of the X-motor controller. Z-axis version Shows the current firmware version of the Y-/Z-motor controller.
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Aspirate Profile See also chapter 8.3.4.1 on page 8-29 below on pipetting profiles.
Wrong Results/Spillage It is necessary to validate pipetting profiles with affected assays to avoid wrong results or spillage.
Profile Select the profile which you want to view or edit. number Enable The corresponding profile (selected in the Profile number field) can only be used by the system if this item is checked. When this item is not checked, assays using the corresponding pipetting parameters cannot be processed. To edit a profile, you need to check this item and then edit the profile parameters (profiles 5 - 9). If this item is disabled ("grayed"), the corresponding profile is protected and cannot be edited (profiles 0 - 4). Description Name of the aspirate profile. Start velocity Velocity at the start of aspiration (in Hz). Top velocity Maximum aspirate velocity (in Hz). Acceleration Enter the acceleration of the aspirate velocity in kHz/s. Airgap This airgap is aspirated before a reagent and blown out after the reagent to ensure the full dispense of the reagent. Clot threshold This parameter is used by COMGEN to determine if a clot has been detected during aspiration. Dive out Velocity in percent of the maximum velocity used to move the tip out of the liquid. velocity Dive out Distance the tip has to travel up when being moved out of the liquid in steps of the stepper motor. Submerge Number of steps the tip is to submerge into the liquid following liquid detection. steps LLD Speed Velocity of liquid detection in percent of the maximum velocity.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Transportatio This airgap is aspirated after a reagent. n airgap Aspirate delay Delay time after aspiration to allow the liquid to settle.
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Dispense See also chapter 8.3.4.1 on page 8-29 below on pipetting profiles. Profile
Wrong Results/Spillage It is necessary to validate pipetting profiles with affected assays to avoid wrong results or spillage.
Profile Select the profile which you want to view or edit. number Enable The corresponding profile (selected in the Profile number field) can only be used by the system if this item is checked. When this item is not checked, assays using the corresponding pipetting parameters cannot be processed. To edit a profile, you need to check this item and then edit the profile parameters (profiles 5 - 9). If this item is disabled ("grayed"), the corresponding profile is protected and cannot be edited (profiles 0 - 4). Description Name of the dispense profile. Start velocity Velocity at the start of dispensing (in Hz). Top velocity Maximum dispense velocity (in Hz). Acceleration Enter the acceleration of the dispense velocity (in kHz/s). Cutoff velocity Cutoff velocity in Hz (stop velocity). Dive out Velocity in Hz with which the tip is moved out of the liquid. velocity Dive out Distance the tip to travel when being moved out of the liquid (in steps of the stepper motor). Resoak Define how much liquid in µl is resoaked again after dispensing. Dispense Delay time before dispensing (the pipettor moves from the reagent bottle to the delay test plate and waits) to allow the liquid to settle.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Active washing Pipette parameters for washing:
Dive out Velocity in Hz with which the tip is moved up out of the liquid. This should be set velocity slower than the normal velocity. Dive out Distance the tip has to travel when being pulled out of the liquid (in steps of the stepper motor).
Sample Tubes See also chapter 4.8.2 on page 4-36.
Colour Select the color in which sample tubes are displayed in the Load dialog.
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LLD Parameters Liquid Level Detection parameters:
Verifies Do not change the default settings. Retries Do not change the default settings. Bubble Kill Do not change the default settings.
Dispense Purge Cycles
Purge every ... Allows to perform an additional cleaning of the pipettor after every specified disp. steps number of dispensing steps. 0 disables the function.
Pressure Monitoring
Enable Only used for development or service. Pressure Note: Activated pressure tracing can lead to longer pipetting times than assumed Tracing in the scheduler and may lead to incubation overrun. Calibration Only used for development or service. Mode
8.3.4.1 Pipetting Profiles
Wrong Results/Spillage It is necessary to validate pipetting profiles with affected assays to avoid wrong results or spillage.
The purpose of pipetting profiles is to optimize the pipetting process (e.g. increase
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 accuracy and precision, avoid dripping, air bubbles, splashing, hanging drops, etc.) by adjusting the pipetting parameters to the type of liquid (samples, controls, reagents) which is aspirated/dispensed and to other specific circumstances (e.g. multishots, low volumes, large volumes, etc.).
Defining Defining pipetting profiles is done at system level, using the Aspirate Profile Pipetting and the Dispense Profile fields in the Pipette tab (see above). However, Profiles defining pipetting profiles is a fairly complex process which requires a good knowledge of how the pipettor operates and adequate testing. This is why the software includes some pre-defined profiles.
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Profile Number: Description:
0 to 4 (included) Pre-defined profiles. These profiles are protected (read-only). They cannot be edited but the profile parameters can be viewed in the Pipette tab. 5 to 9 (included) User-definable profiles. To define a new profile, select one of these profiles (e.g. Aspirate 6), rename it and enter the desired 10 to 19 Pre-defined profiles. (included) These pre-defined profiles are included in the software but they are "hidden". This means that you can use them (see below) but you cannot view them in the Pipette tab (this is why the Profile number field only scrolls up to 9).
Table 8-2: Profile description
This adds up to a total of 20 possible aspirate profiles and 20 possible dispense profiles.
Using a If you are using pre-defined assays, the profiles to be used for each aspirate or Pipetting Profile dispense operation are already specified in the assay. If you are creating your own assays, you have to specify the profiles you want to use: • when you define your Pipetting steps (see "Assay Programming Manual"), • and when you enter your reagent data in the reagent database (see "Assay Programming Manual").
Error recovery Defining profiles or even selecting the right profile to use can be difficult in some cases. If in doubt, contact your application engineer. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.5 IFA Tab (optional)
Figure 8-11: System Set-Up dialog: IFA tab
Reagent Bottles Parameters for the IFA wash buffer and clean fluid containers.
Number of Number of IFA wash buffers used (default is 2). reagent bottles 1 litre bottle Dead volume of each wash buffer in ml. dead volume
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 2 litre bottle Dead volume of each wash buffer in ml. dead volume Capacity Use these items if you want to use a 1-liter bottle or a 2-liter bottle for the White or Green channel. The change will be reflected in the Load dialog display of the wash buffers (see chapter 5.8.1 on page 5-19). In any case, always make sure what is specified in the software corresponds to the actual wash buffer/clean fluid bottles loaded on the instrument. Default With these drop-down lists, you can change a default reagent so that a given wash Reagent buffer should always be assigned to a specific bottle for the White or Green channel. The change will be reflected in the Load dialog display of the wash buffers (see chapter 5.8.1 on page 5-19).
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Times
Max. Slide Maximal time (in minutes) between the finish time of a slide and the finish time of Rest Time the last slide. A value of 0 (zero) disables the feature.
Sweep Parameters
Direction The direction of sweeping depends on the way of build in the IFA needle. Note: This is only important if only the IFA needle is exchanged. All assays using the sweep parameters have to be re-validated. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.6 Sample Rack Tab
Figure 8-12: System Set-Up dialog: Sample Rack tab
Scanner firmware version
Scanner Reference of the scanner firmware installed on the instrument. firmware version 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Barcode Type
Barcode Type List of all barcode types that can be read by the integrated barcode scanner. If a checkbox is selected, the scanner is able to read the respective barcode type. It is possible to select several checkboxes but the more checkboxes are selected, the slower and less accurate the reading will be. Some barcodes types are always selected and cannot be unchecked (barcode types used on GEMINI racks and reagents). The following barcode types can be used for samples and reagents to be processed on the GEMINI instrument: • 2/5 Interleaved, • Code 39, • 2/5 IATA, • 2/5 Industrial, • UPCA, UPCE, • EAN 8 or 13 digits, • Code 128, EAN 128, • Pharmacode, • EAN Addendum, 2or 5 digits, • Codabar. Typically, when the system is installed, your service engineer configures the barcode scanner to accept the barcode types you generally use on the samples you process. If you later need to change the pre-configured barcode settings, see chapter 8.3.6.1 on page 8-36. Lengths Min. Minimum and maximum character length of each barcode type. Max. Note: Generally, if you do not know these values, you can leave the default values. However, if you also use the Prefix and Suffix options to exclude some digits (see below), you should enter in the Min. and Max. fields exactly the number of significant digits (including the prefix and suffix) in the respective barcode type. For example, if you use a barcode format with 14 digits altogether and exclude the date suffix (6 digits), enter "14" in both the Min. and Max. fields. Note: Wrong settings could lead to false barcode values. Example: • Max. = 6 • Barcode 1: 2007P45
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Barcode 2: 2007P48 • Result: 2007P4 for both barcodes! Checksum Some barcode formats include a checksum digit placed either at the end or at the beginning or the actual barcode number. In some cases, this checksum digit is included in the barcode labels attached to the samples but not in the sample IDs of the test order requests sent by the LIS. In this case, the GEMINI instrument cannot match the imported sample IDs with the barcode IDs scanned during the sample loading process. To avoid this, the Checksum column can be used to tell the system to "drop" the checksum digit scanned by the barcode reader. If item is checked, GEMINI excludes the checksum digit (if any) from the scanned barcode ID. The checksum is excluded whatever its position (last, first…) in the barcode. If there is no checksum in the barcode label, no other digit is excluded. If item is unchecked, GEMINI includes the checksum digit (if any) in the scanned barcode ID. Grayed items show barcode formats that normally require a checksum digit and for which the GEMINI instrument always disregards the checksum.
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Barcode Settings If you change the barcode settings (e. g. length, checksum) it is necessary to validate this settings with your barcodes. • For better reading accuracy, select only those barcode types which you actually use. Never select all barcode types. • To edit the barcode settings just before a run (e. g. to select a barcode type which you specifically need for this run) you can access this dialog by clicking the Scanner Setup button in the Load dialog.
Auto Load
Track Enter the first line to be loaded. See also chapter 10.2.1.8 on page 10-19.
Options If the barcode labels include digits which are not relevant to the sample IDs as used on GEMINI, you can tell the scanner to skip them by entering the appropriate number of digits in the Options fields.
Prefix If the digits to be disregarded are at the beginning of the barcode ID, enter them under Prefix. For example, if the sample barcodes include 10 digits altogether but you want the barcode scanner to read only the last 8 digits, enter two digits in the Prefix field (any digits; the actual digits you type in are irrelevant, two "wildcards" appear in the field). Suffix If the digits to be disregarded are at the end of the barcode ID, enter them under Suffix. For example, to omit a six digit date format at the end of a barcode, enter six digits (six "wildcards"). You can also combine the Prefix and Suffix fields. For example, if you want to disregard one digit at the beginning and one at the end, enter one digit in each field.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Prefix / Suffix / Checksum Do not use the Prefix / Suffix fields to exclude a Checksum. • If you intend to make use of the Checksum and/or the Prefix / Suffix options, it is essential that you label empty tubes and validate your settings on these before running actual sample tubes. Check in particular that the Sample IDs read by the barcode scanner and the Sample IDs in the result report correspond to what you expected.
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Rack Types If a rack is identified through barcodes, the rack type is automatically displayed. If identification via barcodes was not possible (damaged or dirty barcodes), you have to select the rack type manually. With three-track racks the same rack type must occupy the respective tracks.
Track Lane of the sample and reagent unit. Type Rack type.
Multi- preparation
Force tube IDs With activated checkbox it is not allowed to use preparation sample tubes without sample ID in the tabular Sample Editor.
8.3.6.1 Using several Barcode Types
You will frequently have to select several barcode types, e.g. when a laboratory uses one set of barcodes for racks and sample tubes differ from one customer to the other. In this case, click the corresponding checkboxes. The scanner will work faster and more precisely if you choose fewer barcode types. Choose only those you will use. Never check all the barcode types. If you don't know the type of barcode used In most cases, the types of barcodes used are specified by the suppliers of the various accessories or products. However, it can happen that the user does not know the type of barcode used. For example, if a laboratory receives barcoded samples or reagent containers but is not sure of the type of barcode used. What you can do to identify the barcode type: 1. Fit the barcoded sample(s) in a rack. 2. Select the Utilities > System Setup menu item and click on the Sample Rack tab. 3. Select three deselected barcode types (notice them). 4. Click on the OK button. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 5. Insert the rack in its lane. 6. When the Sample Editor dialog opens (see chapter 4.4.1 on page 4-8), check the first column. 7. If the instrument has not been able to read the barcodes, the first column is blank. In this case, click on the Close button in the Sample Editor dialog, remove the rack, open the Sample Rack tab again, and repeat the procedure for three other barcodes (deselect the previous barcodes). 8. If the instrument has been able to read the barcodes, the sample IDs are already displayed in this first column. In this case, click on the Close button in the Sample Editor dialog, remove the rack, open the Sample Rack tab again, and select each of these three barcode types one at a time and, for each type, pull out the rack and then re-insert it until you determine which of the three barcode types is correct.
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8.3.6.2 Rack Barcodes
All GEMINI sample and reagent racks are barcoded. The barcode labels are located on the right-hand side of each rack. They serve to identify both the rack type and individual positions on each rack. The instrument is pre-configured to be able to read the rack barcodes. It is recommended not to use racks with missing or damaged barcodes. Replaced barcode labels for GEMINI racks can be ordered (see chapter 13.1 on page 13-1). However, if you need to use non-barcoded racks (or racks with damaged labels), follow the instructions in chapter 6.5.2.3 on page 6-40 and allocate the on-board samples or reagents manually.
Rack barcodes are used by the instrument to identify different rack types but not individual racks. For example, the instrument can differentiate a reagent rack from a sample rack or a "T" sample rack from a "Z" archiving rack but it cannot differentiate one "T" sample rack from another "T" sample rack.
8.3.6.3 Reagent Barcodes
Most reagents included in kits are barcoded. In some cases, barcode labels are provided in the kits and need to be attached to the respective vials before use. In some cases, barcode labels can be ordered separately. The barcode settings of the GEMINI instrument are pre-configured so that the instrument can read all barcode types used on reagent bottles. For reagents from other suppliers, select the appropriate barcode types selected on the Sample Rack tab of the System Set-up dialog as described above. Note however that the Prefix / Suffix options apply to sample barcodes only, not reagent barcodes. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.7 Washer Tab
The parameters of the wash unit are entered by your service engineer when the GEMINI instrument is first installed.
Figure 8-13: System Set-Up dialog: Washer tab
If you find that the wash unit is not operating correctly, please refer to the procedures described in chapter 9.6.5 on page 9-23. On defining wash steps in an assay, see "Assay Programming Manual".
Reagent Bottles Parameters for the wash buffer and clean fluid containers.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Number of Number of wash buffer/clean fluid containers used (default is 3). reagent bottles 1 litre bottle Dead volume of each wash buffer/clean fluid container in ml. dead volume 2 litre bottle Dead volume of each wash buffer/clean fluid container in ml. dead volume Capacity Use these items if you want to use a 1-liter bottle or a 2-liter bottle for the Red, Blue, or Yellow channel. The change will be reflected in the Load dialog display of the wash buffer/clean fluid bottles (see chapter 4.8.1 on page 4-33). In any case, always make sure what is specified in the software corresponds to the actual wash buffer/clean fluid bottles loaded on the instrument.
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Default With these drop-down lists, you can change a default reagent so that a given wash Reagent buffer should always be assigned to a specific bottle for the Red, Blue, or Yellow channel. The change will be reflected in the Load dialog display of the wash buffer/clean fluid bottles (see chapter 4.8.1 on page 4-33). Check reagent The wash buffer volume sensor (float switch) is checked at the beginning of each wash cycle. Note: Always activate this function. Deactivation may lead to incorrect washing in case remaining buffer is not sufficient for complete cycle and should not be used.
Default Heights Set the height of the dispensing needle during washing.
Top Wash Aspiration needle on the level of the upper edge of the plate. Height Bottom Wash Aspiration needle on a level slightly above the well bottom. On this level, the Height dispense tip is also in the liquid for intense washing of the wells (simultaneous aspiration during dispensing). Aspirate Aspiration needle on the same level as the well bottom. Set the height such that Height the aspiration needles. Notches in the aspiration needles prevent that the washer heads get stuck. Show You can check the exact height setting as follows: Enter a height (0 means: highest position of dispensing needle.) and click the Show button. The dispensing needle is then moved to the defined height. If the setting is not yet adequate, correct the height and click the Show button again. Should be done only by your service engineer.
Information Washer information.
Firmware Shows the current firmware version of the washer. version 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Purging Purge parameters (= cleaning before the first wash step of the worklist).
Volume Purge volume in µl per tip.
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Cleaning Cleaning parameters.
Volume Cleaning volume (µl per tip). Fluid Select a reagent/buffer for cleaning. Reagents If the desired buffer is not available in the drop-down list, you may define or load another wash buffer by clicking the Reagents button (this opens the Buffer section of the Reagent Database and lets you select or create the desired buffer, see "Assay Programming Manual". Clean after Select this item if you want to clean after each wash step. every wash step
General
Calibrate Click this button to perform an internal calibration of the 3 dosing units of the wash system. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.8 Plate Transport Tab
Figure 8-14: System Set-Up dialog: Plate Transport tab
Information Plate transport information.
Firmware Shows the current firmware version of the plate transport. version 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.3.9 Maintenance Tab
As part of its normal operating routine, the GEMINI instrument performs a number of maintenance jobs automatically. For example: • During each selftest (see chapter 6.1 on page 6-1), the instrument checks the status of all instrument modules. • During each run, the pipettor is primed with system liquid. • Following each wash step, the washer is purged with clean fluid (deionised water). These maintenance jobs are controlled automatically without any user intervention. But the GEMINI instrument also includes a feature allowing users to predefine some maintenance tasks and maintenance reminders.
Figure 8-15: System Set-Up dialog: Maintenance tab 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Maintenance Jobs
Maintenance Jobs Shows the name of all created maintenance jobs. Add Job Adds a new maintenance job to the maintenance job list. Delete Job Deletes a selected maintenance job. Clear All Jobs Deletes all maintenance jobs.
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Job Definition
If Specifies the condition to be fulfilled to perform a certain maintenance job. is true then Name of the maintenance job to be performed if the specified condition is fulfilled. run job Insert Shows the Insert Function dialog to select a function. Function User can skip This option allows the user to skip an incidental maintenance job. The job maintenance job can then be performed later. Tasks Indicates all actions to be performed if the maintenance job is started. Arrows By means of the arrows, the position of a selected action can be changed. The actions are performed according to their sequence. Add Task Inserts a new task. Possible tasks: • Display message: With the action Display message, a message can be displayed on the screen during the performance of a maintenance job. The user must acknowledge this message. • Prime pipettor: This action allows the cleaning of the pipettor. With an input dialog, the volume to be aspired can be specified. • Purge washer: With this action, the washer can be cleaned. With an input dialog, the bottle to be used and the volume can be entered. • Verify colorimeter: Allows the verification of the reader. With an input dialog, the filters to be checked can be selected. • Flush Pipes (only for IFA): With this action the complete tubing used for washing IFA slides can be flushed with system liquid, liquid in the white or green wash buffer bottle. It is recommended to use this maintenance option for the GEMINI COMBO. Edit Task Allows the editing of a selected action. Delete Task Deletes a selected task.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Clear All Deletes all tasks. Tasks
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8.3.9.1 Functions for Maintenance Jobs
IF IF(condition;then;else) If the condition is true the "then" expression is evaluated, otherwise the "else" expression. AND AND(condition;...) Returns true if all of the conditions evaluate to true, otherwise returns false. OR OR(condition;...) Returns true if any of the conditions evaluate to true, otherwise returns false. Days The number of days since this reminder was last displayed. Plates The number of plates processed since this reminder was last displayed. Samples The number of samples processed since this reminder was last displayed. Tips The number of tips used since this reminder was last displayed. Worklists The number of worklists processed since this reminder was last displayed. abs ABS(value) Returns the absolute value of the value argument. log LOG(value) Returns the base 10 logarithm of value. alog ALOG(value) Returns the base 10 anti-logarithm of value. ln LN(value) Returns the natural logarithm of value. exp EXP(value) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Returns the natural anti-logarithm of value. Int INT(value) Returns the integer part of value. ROUND ROUND(value) Returns the nearest integer value.
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8.3.9.2 Definition of Maintenance Jobs
Example 1 Defining a conditional maintenance reminder: In this example you want to define a maintenance message that will remind the operator, every morning when starting-up the instrument, to check the system liquid level (full), liquid waste and tip waste levels (empty). To do this: 1. Click on the Add Job button to define a new maintenance job. 2. In the is true then run job field enter the general name of the maintenance reminder you want to define, e.g. "General level checking prompt". This text is automatically entered in the maintenance jobs list. 3. Click on the Add Task button to define the task(s) included in this maintenance job. This opens the Add Maintenance Task dialog. 4. Select Display message and click on the OK button. This opens the Display Message Task dialog. 5. In the blank space, enter the text of the message prompt. For example, enter: "Please check that the system liquid container is full, that the liquid waste container is empty and that the tip waste container is empty." 6. Click on the OK button to close this dialog and go back to the main Maintenance tab. 7. Now you have to specify when this message prompt should be displayed. To do this, click on the Insert Function button. This opens the Insert Function dialog. 8. In the current example, you want to specify that the message prompt should be displayed every day upon start-up. Define the condition ("Days>=1") in the If edit box by using the Insert Function dialog (e.g. "Days") and the keyboard (for ">=1"). 9. When done, click on the OK button to confirm and close the Maintenance tab.
Now every morning when you start-up your GEMINI instrument, the entered prompt is displayed.
Example 2 Defining an automated maintenance task In this example you want to predefine an additional "Purge washer routine" that can be launched easily when needed (e.g. after using specific wash buffers…). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 To do this: 1. Start as described in the previous example. In the is true then run job field enter "Purge washer routine". 2. When you get to the Add Maintenance Task dialog, select Purge washer and click on the OK button. 3. You are then prompted to specify from which container and with how much liquid you want to purge the washer (e.g. "Red" container for Clean fluid and "10 ml/tip"). It is possible and advantageous to define additionally a display message to inform the use about the function of this maintenance job (see example 1 and complex jobs). 4. When done, click on the OK button to confirm and close the Maintenance tab.
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In this case, you have defined the task but you have not defined a condition upon which the instrument would automatically perform the maintenance routine. You must start this maintenance job manually (see chapter 9.5 on page 9-18).
Complex Jobs More elaborate maintenance routines: From these two relatively simple examples, you can program all sorts of more complex maintenance checklists or conditional routines such as: • Start-up checklist: add several consecutive "Display message" tasks and a "Days>=1" condition. • Weekly maintenance routine reminder: condition "Days>=7". • Prime / Purge routine if the instrument has not been used for over 2 weeks: condition "Days>=15 AND Worklists=0". • Empty tip waste reminder if 900 or more tips have been used: condition "Tips>=900". • Rinse all four washer lines: combine messages to prompt user to fill all four wash containers with rinse fluid and 4 purge washer tasks, one for each container/washer line. End with a message. •Etc.
Note however that the maintenance status and conditions are checked only each time the instrument is initialized. So, if, for example, you define a message to remind you to empty the tip waste container when you have used more than "n" tips, the message will not be displayed as soon as tip "n + 1" is used but only the next time the instrument is initialized (i.e. upon start-up or when a selftest is performed).
Log and Skip Logged maintenance jobs / skipped maintenance jobs Each time you perform (or allow the system to execute) a predefined maintenance routine, this is recorded in the log file. The log file also keeps track of all cases where the operator was prompted to execute a conditional routine but decided to skip it. In the log file, performed routines are displayed in black, skipped routines in red. A required maintenance routine can only be skipped by the operator if the person who defined it selected the User can skip job checkbox in the Maintenance tab. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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8.4 Aspirate Pressure Monitoring (APM)
GEMINI COMBO The GEMINI COMBO instrument does not support the APM function.
Wrong Results It is necessary to validate the APM threshold sets!
1. Click on the Utilities button.
2. Select the APM symbol. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Figure 8-16: APM Information dialog
Liquid Types Displays the names of all liquid types for which APM profiles for one or more volumes has been stored. New Opens the Liquid Type dialog to add new liquid type information. Edit Opens the Liquid Type dialog to edit the selected liquid type in the Liquid Types list. Delete Deletes the selected liquid type in the Liquid Types list. Copy Makes a copy of the selected Liquid Type under a new name.
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APM Allows tracing of different versions of APM databases. Database Version Number
Add or Edit a Liquid Type
Figure 8-17: Liquid Type dialog
Liquid Types Name of corresponding liquid type Threshold For details see below. Set(s) New Opens the Threshold Set dialog to add a new Set. Edit Opens the Threshold Set to edit the selected threshold set in the Threshold Set(s) list. Delete Deletes the selected threshold set in the Threshold Set(s) list. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Copy Makes a copy of the selected Threshold Set(s) under a new name.
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Threshold Set
Figure 8-18: Threshold Set dialog
Volume Volume that is aspirated in the modelled step. Tip Size Tip size used, 300 µl or 1100 µl can be selected. Aspirate Aspirate profile used. Profile p max Maximal value of aspiration pressure peak that is accepted (p>p max = clot). p min Minimal value of aspiration pressure peak that is accepted (p
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8.5 Volume Offset
The volume offset is used to correct systematic deviations of the pipetted volume from its nominal volume.
Types list Shows a list of all applied volume offset types (volume offset curves). Name Shows the name of the selected entry in the Types list. Comments Shows the comment of the selected entry in the Types list. Edited Shows the date and time of the last change of the selected entry in the Types list. Add Opens the Volume Offset (type) dialog to add an new volume type entry. Edit Opens the Volume Offset (type) dialog to edit/show the volume values of the selected entry in the Types list. Delete Deletes the selected entry in the Types list. Database Number of the used volume offset database. If you change a volume offset type, version increase the database version number. Close Closes the dialog. All changes are applied. Help Calls the online help.
Add or Edit a Volume Offset Type
Name Name of the volume offset type (volume offset curve). Comments Comment (explanation) of the volume offset type. Edited Shows the date and time of the last change.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Volumes list Shows a list of all applied volume pairs (data points of the volume offset curve). Add Opens the Volume Offset (volume) dialog to add an new volume entry. Edit Opens the Volume Offset (volume) dialog to edit/show the volume values of the selected entry in the Volumes list. Delete Deletes the selected entry in the Volumes list. OK Closes the dialog. All changes are applied. Cancel Closes the dialog. No changes are applied. Help Calls the online help.
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Add or Edit a Volume
Requested Value of the required volume. Volume Actual Volume Value of the actually received volume. OK Closes the dialog. All changes are applied. Cancel Closes the dialog. No changes are applied. Help Calls the online help. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 8-51
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Intentionally left blank. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
8-52 Gemini - Instructions for use manual - Rev. 10
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In order to operate correctly, it is essential that the GEMINI instrument be maintained in accordance with the maintenance plan and procedures described below.
9.1 Safety and Hints about Cleaning/ Decontamination
Electric shock or mechanical injury by mains supply If the instrument is not separated from the mains supply before performing maintenance, this will cause serious injuries with deadly consequences due to electric shock. Additionally, there is the danger that the instrument could start and cause injury (e.g. contusion, cuts etc.) to the person working with the instrument. • Switch off the instrument, separate it from the mains supply and protect it against restarting. • Make sure that nobody is working on the instrument and that all covers are attached and closed before reconnecting the instrument to the mains supply. • Only start cleaning, disinfection, decontamination, maintenance or repair work when instrument is secured.
Infectious waste Potential infectious material and all parts that may come in contact with potential infectious material will cause severe environmental contamination. • Strictly follow the local and national provisions, legislation and laboratory regulations.
Unapproved or improper maintenance work
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Unapproved or improper carried out maintenance work will result in serious personal injury and material damage. • Follow all safety instructions in chapter 1.3 on page 1-6 and this chapter. • Take off watches and jewelry before performing any maintenance works. • Only perform maintenance procedures described in this manual. • Closely follow the steps contained in the individual instructions. • For maintenance, only use the parts mentioned in this instruction. • Tests and maintenance specified by the manufacturer shall be performed to ensure the safe operation of the instrument and the proper functioning of the instrument. • All service and maintenance which are not described in this instruction shall be performed by qualified and authorized service technicians. • Any changes made to the instrument that are not authorized by the manufacturer will void the manufacturer’s warranty.
Gemini - Instructions for use manual - Rev. 10 9-1
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Disposal of non-contaminated parts Material out of use (e.g. packaging material) should be properly disposed. Material that might be used should be kept to avoid future transportation damage. • Strictly follow the local and national provisions, legislation and laboratory regulations. • Keep the packaging to allow for safe transportation in case the instrument shall be shipped at some future date.
Cleaning, disinfection or decontamination Observe the following aspects during cleaning, disinfection or decontamination because otherwise breakdowns or damage can be the result. • Disinfect or decontaminate components with a suitable disinfection or decontamination method. • Only use liquid cleaning, disinfection or decontamination solutions with a moistened cleaning tissue. • Use only approved cleaning, disinfection or decontamination solutions and methods. • Avoid cleaning, disinfection or decontamination solutions to come into contact with bearings and guides, as otherwise the greasy film may dissolve! • Do not use cleaning, disinfection or decontamination solutions in the proximity of circuit boards, light barriers and acrylic glass surfaces! • Do not pour or spray liquid cleaning, disinfection or decontamination solutions into the instrument. • Do not autoclave containers and components for liquids or waste.
Handling of decontamination products Pay attention to managing the decontamination products, because they are harmful as indicated on the bottle. • Strictly follow the local and national provisions, legislation and laboratory regulations. • Do not use bleach or decontamination liquid with alcohol! • Do not use improper decontamination products. We recommend Gigasept®, Liquinox® or Rivascop® to decontaminate the instrument.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Only use decontamination liquid in accordance with the instructions for use!
Handling and cleaning of optical surfaces Improper optical surfaces (e. g. scanners, lenses, sensors) could generally degrade the quality of images, data, etc. • Do not touch any optical surfaces. • Only clean the optical surfaces with a soft and lint-free cloth. • Do not use any aggressive detergents or solutions (e.g. acetone).
9-2 Gemini - Instructions for use manual - Rev. 10
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Damage of touch screen while cleaning Improper cleaning could damage the touch screen surface. • Use a soft and lint-free cloth with neutral detergent or with ethanol to clean the touch screen. • Do not use any chemical solvent, acidic or alkali solution. • If dust is accumulated on the case surface, remove it by using a special vacuum cleaner for computers.
Organic solvents Reagent containers and hoses for 1: system liquid and waste can be seriously damaged by organic solvents and become unusable. • Never use organic solvents.
Spare wash buffer bottles (with normal caps) can be ordered. Having spare bottles allows you to remove your partially full bottles from the instrument and to store them directly while performing the cleaning procedure with the spare bottles (instead of having to transfer the buffer into storage containers at night and re-transfer it back into the bottles later). When the instrument is turned off, mobile modules such as the pipettor guide rail or the plate transport unit may be moved manually, to get better access to certain parts of the instrument. This is to be done as gently as possible, in order not to damage or misalign the modules. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 9-3
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9.2 Daily Maintenance
9.2.1 Start-Up
Maintenance Power See also
System liquid container Check the level of system liquid in the OFF chapter 2.2.9.2 on page 2-20 system liquid container. If low, refill it. NOTICE: Both filter and liquid tubing must not run dry. Air in the system tubing may affect pipetting performance. Waste liquid container Check the level of waste liquid in the OFF - waste liquid container. If full or nearly full, empty and decontaminate it. Dispose waste liquid in accordance with legal regulations for biological hazardous waste. Pipettor Check pipettor tubing and syringe for OFF chapter 9.6.1 on page 9-19, air bubbles or leakages as these can chapter 9.6.2 on page 9-20 cause pipetting errors. IFA needle (optional) Check IFA needle for clots/particles ON chapter 6.1 on page 6-1 and leakages during selftest of the (selftest) instrument.
Table 9-1: Daily maintenance: Start-up 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
9-4 Gemini - Instructions for use manual - Rev. 10
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9.2.2 After Each Run
Maintenance Power See also
Inspect instrument Inspect instrument deck, plates, racks, ON chapter 9.6.1 on page 9-19, etc. for spillages. If there are spillages, chapter 9.6.2 on page 9-20 check instrument for leakages. Remove racks Remove sample and reagent racks. ON chapter 4.11.2 on page 4-72, Dispose tubes and bottles in chapter 4.11.3 on page 4-73 accordance with legal regulations for biological hazardous waste. Remove plates Unload used test and dilution plates. ON chapter 4.11.1 on page 4-70, Dispose plates in accordance with chapter 4.11.4 on page 4-73 legal regulations for biological hazardous waste. Remove slides Unload used slides. ON chapter 5.11.1 on page 5-30 Dispose slides in accordance with legal regulations for biological hazardous waste. Waste bag for disposable Check the waste bag for disposable ON - tips tips. If full or nearly full, replace it. Dispose the waste bag in accordance with legal regulations for biological hazardous waste. System liquid container Check the level of system liquid in the ON chapter 2.2.9.2 on page 2-20 system liquid container. If low, refill it. NOTICE: Both filter and liquid tubing must not run dry. Air in the system tubing may affect pipetting performance. Waste liquid container Check the level of waste liquid in the ON - waste liquid container. If full or nearly
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 full, empty and decontaminate it. Dispose waste liquid in accordance with legal regulations for biological hazardous waste. Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1).
Table 9-2: Daily maintenance: After each run
Gemini - Instructions for use manual - Rev. 10 9-5
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9.2.3 Shut Down
Maintenance Power See also
Inspect instrument Inspect instrument deck, plates, racks, ON chapter 9.6.1 on page 9-19, etc. for spillages. If there are spillages, chapter 9.6.2 on page 9-20 check instrument for leakages. Remove racks Remove sample and reagent racks. ON chapter 4.11.2 on page 4-72, Dispose tubes and bottles in chapter 4.11.3 on page 4-73 accordance with legal regulations for biological hazardous waste. Remove plates Unload used test and dilution plates. ON chapter 4.11.1 on page 4-70, Dispose plates in accordance with chapter 4.11.4 on page 4-73 legal regulations for biological hazardous waste. Remove slides Unload used slides. ON chapter 5.11.1 on page 5-30 Dispose slides in accordance with legal regulations for biological hazardous waste. Flush IFA tubing with Flush complete IFA tubing with system ON chapter 9.5 on page 9-18 system liquid liquid. For this the maintenance task can be used. Close worklists and files Close all finished worklists and opened ON chapter 3.1 on page 3-1 files (assay files, result files...). Exit user software Close the GEMINI software (select the ON - File > Exit menu item). Shut down windows Shut down windows ON - Switch off Switch off the instrument OFF - Waste bag for disposable Check the waste bag for disposable OFF - tips tips. If full or nearly full, replace it. Dispose the waste bag in accordance 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 with legal regulations for biological hazardous waste. System liquid container Check the level of system liquid in the OFF chapter 2.2.9.2 on page 2-20 system liquid container. If low, refill it. NOTICE: Both filter and liquid tubing must not run dry. Air in the system tubing may affect pipetting performance.
9-6 Gemini - Instructions for use manual - Rev. 10
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Maintenance Power See also
Waste liquid container Check the level of waste liquid in the OFF - waste liquid container. If full or nearly full, empty and decontaminate it. Dispose waste liquid in accordance with legal regulations for biological hazardous waste. Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1). Disposable tip racks Unload disposable tip racks. Partially OFF - used tip racks may remain on the instrument overnight (particularly if you are using the "Re-use partially used racks" option (see chapter 4.8.6 on page 4-45). Reagent and control If they are not empty and can be re- OFF - bottles used, remove the reagent and control bottles from the racks or instrument, close them (be careful not to mix the caps!) and store them in a refrigerator. Otherwise, dispose of them in accordance with legal regulations for biological hazardous waste. Note: Do not store racks in a refrigerator! Inspection/Cleaning/ Every evening after shut down, inspect OFF - Decontamination the instrument for stains or spills. Make sure to inspect all individual surfaces, compartments and work areas: • Outer surfaces, particularly around the handle of the cover. • Open the cover to check the upper work areas. • Pipettor wash station 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Sample and reagent unit • IFA bay and IFA trays (optional) • Make sure no tips have remained blocked in the waste slide (ramp). If necessary, pull out the slide to do so. • Do not forget to check for liquid underneath the wash buffer bottles. If you detect stains, small spills or areas that are generally dirty, decontaminate them (see chapter 9.3 on page 9-8). Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1).
Table 9-3: Daily maintenance: Shut down
Gemini - Instructions for use manual - Rev. 10 9-7
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9.3 Weekly Maintenance
Maintenance Power See also
IFA Pipettor tip needles Clean the IFA pipettor tip needles with ON chapter 9.6.4.1 on page 9-22 cleaning the IFA cleaning tool. Washer cleaning/ Clean the wash head with the cleaning ON chapter 9.6.5.1 on page 9-23 decontamination needle.
Use an assay to decontaminate and flush the washer. Procedure: 1. Fill diluted decontamination liquid into an empty wash buffer bottle. 2. Fill deionised water into a second empty wash buffer bottle. 3. Start an assay which first use the diluted decontamination liquid and after that the deionised water. 4. After the run, remove the bottle with diluted decontamination liquid and put the bottle with deionised water to this washer channel. 5. Start a second assay to rinse the channel tubings. 6. After the second run, empty and clean all wash buffer bottles.
Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Daily maintenance Perform the shut down steps of the - chapter 9.2.3 on page 9-6 daily maintenance.
9-8 Gemini - Instructions for use manual - Rev. 10
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Maintenance Power See also
Instrument and Clean and decontaminate all individual OFF - accessories cleaning/ surfaces, compartments, work areas decontamination and accessories: • Outer surfaces • All work areas • Pipettor wash station • IFA bay and IFA trays (optional) • Tip eject station • Loading bay • Loading bay barcode scanner • Waste slide (ramp) • Plate transport module • Do not forget to check for liquid underneath the wash buffer bottles. • Touch screen (only with soft clothes with neutral detergent or with ethanol) • Racks • Plate carriers
Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1). Washer performance Check the performance of the washer. ON chapter 9.3.1 on page 9-10
Table 9-4: Weekly maintenance 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 9-9
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9.3.1 Washer Performance
We supply predefined washer performance assays together with the instrument. We recommend to run them every week to ensure correct washer performance. There are two tests available: • Dispense check (see chapter 9.3.1.1 on page 9-10) • Aspirate check (see chapter 9.3.1.2 on page 9-12) Both washer performance tests can be run with the same plate, in case the dispense test was successful. Otherwise a new plate has to be filled with 300 µl wash buffer per well for the second assay (after the initial weight has been noted).
Tools and • Precision weighing equipment Accessories • Microplate (U-bottom or F-bottom) with single strips E.g. Nunc Microplate "Maxi Sorp" (F-bottom, top height 134, aspiration height 30, aspiration mode "sweep")
9.3.1.1 Washer Dispense Check
1. Note the strip numbers (1-12) on the single strips of an empty microplate. 2. Weigh out all single strips in groups and note the weight in the column "Weight empty" (see table 9-5 on page 9-11 below). Do not confuse the strip groups! • Group 1: Strips 1 - 4 • Group 2: Strips 5 - 8 • Group 3: Strips 9 - 12 3. Insert all strips into the microplate frame (mind the strip order). 4. Weigh out the microplate and note the weight in the column "Weight empty" (see table 9-6 on page 9-11 below). 5. Connect bottles with wash buffer to all three washer channels. 6. Run the "Dispense300_wash.asy" assay and follow the instructions. The software dispenses 300 µl per well, four columns for each pump. 7. Remove the filled microplate carefully after the test. 8. Visually compare the fill heights between the pumps. Check that all rows are filled equally and that none of the needles is blocked. 9. Weigh out the microplate and note the weight in the column "Weight full" (see table 9-6 on page 9-11 below). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 10. Remove all strips carefully. Weigh out all single strips in groups and note the weight in the column "Weight full" (see table 9-5 on page 9-11 below). Do not confuse the strip groups! • Group 1: Strips 1 - 4 • Group 2: Strips 5 - 8 • Group 3: Strips 9 - 12 11. Calculate the weight of the liquid and the volume per well (see formula below the tables). 12. Evaluate the test. If the washer dispenses outside the tolerance for any of the three pumps, call you service contact for help.
9-10 Gemini - Instructions for use manual - Rev. 10
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Check Pump Strip Weight empty Weight full Weight liquid Volume per well OK?
11-4______mg ______mg ______mg ______µl
25-8______mg ______mg ______mg ______µl
39-12______mg ______mg ______mg ______µl
Table 9-5: Washer dispense check values and results (strips)
Formulas for strip groups:
Tolerances for evaluation (strip groups): • 8160 mg <= Weight liquid <= 11040 mg or • 255 µl <= Volume per well <= 345 µl
Check Pump Strip Weight empty Weight full Weight liquid Volume per well OK?
1-3 all ______mg ______mg ______mg ______µl
Table 9-6: Washer dispense check values and results (plate)
Formulas for the plate: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Tolerances for evaluation (plate): • 24480 mg <= Weight liquid <= 33120 mg or • 255 µl <= Volume per well <= 345 µl
Gemini - Instructions for use manual - Rev. 10 9-11
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9.3.1.2 Washer Aspirate Check
1. Run the washer dispense check (see chapter 9.3.1.1 on page 9-10). 2. Insert all strips carefully into the microplate frame (mind the strip order). 3. Note all "Weight full" values: • Strip groups: table 9-5 on page 9-11 => table 9-7 on page 9-12 • Plate: table 9-6 on page 9-11 => table 9-8 on page 9-13 4. Run the "Washer_aspirate_test.asy" assay and follow the instructions. The software aspirates all wells. 5. Remove the emptied microplate carefully after the test. 6. Weigh out the microplate and note the weight in the column "Weight empty" (see table 9-8 on page 9-13 below). 7. Remove all strips carefully. Weigh out all single strips in groups and note the weight in the column "Weight full" (see table 9-7 on page 9-12 below). Do not confuse the strip groups! • Group 1: Strips 1 - 4 • Group 2: Strips 5 - 8 • Group 3: Strips 9 - 12 8. Calculate the weight of the liquid and the volume per well (see formula below the tables). 9. Evaluate the test. If the washer aspirates outside the tolerance, call you service contact for help. Weigh empty plate before assay and re-emptied plate afterwards. Run washer aspirate test in U well plate or flat bottom plate (different residual volumes specified) filled with 300 µl of wash buffer. Start the "Washer_aspirate_test.asy" in the user software. Calculate remaining volume: weight difference [mg] / 96 wells = mean residual volume [µl]
Weight residual Residual volume Check Strip Weight empty Weight full liquid per well OK?
1-4 ______mg ______mg ______mg ______µl
5-8 ______mg ______mg ______mg ______µl 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 9-12 ______mg ______mg ______mg ______µl
Table 9-7: Washer dispense check values and results (strips)
Formulas for strip groups:
9-12 Gemini - Instructions for use manual - Rev. 10
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Tolerances for evaluation (strip groups): • Weight residual liquid <= 80 mg (U-bottom microplates) • Weight residual liquid <= 128 mg (F-bottom microplates) or • Residual volume per well < 2.5 µl (U-bottom microplates) • Residual volume per well < 4 µl (F-bottom microplates)
Weight residual Residual volume Check Strip Weight empty Weight full liquid per well OK?
all ______mg ______mg ______mg ______µl
Table 9-8: Washer dispense check values and results (plate)
Formulas for the plate:
Tolerances for evaluation (plate): • Weight residual liquid <= 240 mg (U-bottom microplates) • Weight residual liquid <= 384 mg (F-bottom microplates) or • Residual volume per well < 2.5 µl (U-bottom microplates) • Residual volume per well < 4 µl (F-bottom microplates) 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 9-13
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9.4 Monthly Maintenance
Maintenance Power See also
Weekly maintenance Perform the weekly maintenance. - chapter 9.3 on page 9-8 Instrument and Clean and decontaminate all individual OFF - accessories cleaning/ surfaces, compartments, work areas decontamination and accessories: • Wash buffer bottles. Clean the bottles only, not the caps and sensor devices. • System liquid container. Inspect the filter in the cap. • Use a soft lint-free cloth, moistened with ethanol, to gently clean the head of the pipettor. Allow to dry.
Observe all safety notes and hints about cleaning/decontamination (see chapter 9.1 on page 9-1). Backup Perform a backup. ON chapter 9.4.2 on page 9-16 Performance evaluation Check the performance of the pipettor ON chapter 9.4.1 on page 9-15 on regular basis using qualified kits.
Table 9-9: Monthly maintenance 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
9-14 Gemini - Instructions for use manual - Rev. 10
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9.4.1 Performance Evaluation
We supply predefined performance evaluation assays together with the instrument. We recommend to run them every month to ensure correct pipettor performance. The assays work with the Performance Check Dye Kit from Gold Standard Diagnostics to ensure correct pipettor performance or to perform an alternative Performance Evaluation Kit. The assays work with the Performance Check Dye Kit from Gold Standard Diagnostics (Or-Nr. GSD10-640 (10x kit), GSD01-640 (1x kit), [email protected], 2851 Spafford Street, Suite A, Davis, CA 95618 USA). As a prerequisite, you will need a 450 nm and a 620 nm filter installed. Functions of the assays: • Standard check at 20 µl and 100 µl with single pipetting steps and multi dispense. Only the precision (Coefficient of Variance), not the accuracy is checked by the instrument. An additional assay checks the dilution performance in terms of accuracy and precision (see chapter 9.4.1.1 on page 9- 15).
9.4.1.1 Procedure for Assays without Manual Pipetted Standards
For the regular check, it is sufficient to control the precision of the pipetting. The following three assays all fit on one 96 well plate. • Gemini CV Pipettor High.asy • Gemini CV Pipettor Low.asy • Gemini Control Dilution.asy
To run this plate: 1. Click on the New worklist button in the toolbar. 2. Click on the Add plate button in the Set-up Panel. 3. Click on the Add assay button and select the "Gemini CV Pipettor Low.asy" assay. 4. Click on the Add assay button and select the "Gemini CV Pipettor High.asy" assay. 5. Click on the Add assay button and select the "Gemini Control Dilution.asy" assay. 6. Click on the OK button to close the Set-up Panel.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 7. Confirm the Lot Specific Values dialog with the required reagents with OK. 8. Click on the Start button and load the required reagents and consumables as displayed in the Load dialog. 9. Start the worklist and load the test plate. 10. After finishing, carefully review the results. All validation criteria must be passed. If any validation criteria are FAILED, call your service engineer.
Gemini - Instructions for use manual - Rev. 10 9-15
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9.4.2 Backup System Files
Required access rights: Restore Backup Files
1. Select the Utilities > Backup menu item.
Figure 9-1: System Backup dialog
Backup Click this button to start a backup of all current files that are not part of the System Files standard installation. The process creates backup copies of these files and stores them, under default settings, in an individual directory created in the C:\Gemini\Backup directory. To change the target directory, see chapter 8.2.8 on page 8-15. The name of the individual system backup directory is formed as follows: "SYSyyyymmddnn" (y = year, m = month, d = day, n = number of backups done on that day). A new individual directory is created each time you launch a new backup process (the previous backup is not overwritten).
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Restore Click this button to replace all current system files by system files from a previous System Files backup (e.g after a system crash). When you click this button, the Open dialog is displayed. Browse to the directory you want to restore the files from (under default settings, "C:\Gemini\Backup\SYSyyyymmddnn"). Select any file in this directory and click on the OK button. A message on the screen tells you when the restore process is completed. Click on the OK button to close this message.
9-16 Gemini - Instructions for use manual - Rev. 10
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Backup Error Click this button to start a backup of all error files. The process creates backup Files copies of all files required for error diagnosis and troubleshooting (i.e. all *.dbg, *.trw, *.asy, *.res, *.log, *.db, *.mpc, *.rac files plus the "koordina.dat" file) and stores them, under default settings, in an individual directory created in the C:\Gemini\Backup directory. To change the target directory, see chapter 8.2.8 on page 8-15. The name of the individual error backup directory is formed as follows: "ERRyyyymmddnn" (y = year, m = month, d = day, n = number of backups done on that day). A new individual directory is created each time you launch a new backup process (the previous backup is not overwritten). The error files backup is meant as a troubleshooting procedure. If you encounter operating problems, backup the error files and send the resulting directory to you service engineer who will then be able to identify precisely the cause of the problems you are facing. Error files do not need to be backed-up on a regular basis but only as requested by your service engineer. You can also delete former error files backup directories once the respective operating problems have been solved.
Create a complete system backup every month. Do not delete previous system backup directories manually. Save them as a way to trace back your system history. If necessary, archive them on external media (USB stick or CD) or in a different network location.
Backup System Files and Restore System Files do not affect the "Results.mdb" and "QA.mdb files". 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 9-17
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9.5 Maintenance Jobs
As part of its normal operating routine, the GEMINI instrument as well as the GEMINI COMBO performs a number of maintenance jobs automatically. For example: • During each selftest, the instrument checks the status of all instrument modules. • During each run, the pipettor is primed with system liquid. • Following each wash step, the washer is purged with clean fluid (deionised water). These maintenance jobs are controlled automatically without any user intervention. But the instrument also includes a feature allowing users to predefine some maintenance tasks and maintenance reminders (see chapter 8.3.9 on page 8-42).
Some of this predefined maintenance tasks will start automatically, if a special condition is fulfilled. But you can also this and all other predefined maintenance tasks start manually.
If you want to start this predefined maintenance task:
1. Click on the Utilities button.
2. Select the Maintenance symbol. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Figure 9-2: System Maintenance dialog with examples
3. Select the desired maintenance job. 4. Click on the Execute button. 5. Click on the Yes button to start the maintenance job. 6. Follow the job information.
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9.6 Special Maintenance Procedures/ Emergencies
This section describes maintenance procedures that are not to be performed on a regular basis but as needed depending on events/incidents affecting the instrument or its environment. On emergency stop (canceling a run) and emergency test plate removal, see chapter 4.9.7 on page 4-60 and chapter 6.5.3 on page 6-41.
9.6.1 Visually Check Tubing
Defects in the liquid system Defect or leaky tubes, syringes, valves or pumps lead to deterioration of the pipetting results and consequently corruption of final results. Furthermore incorrectly flushed tips can cause mixing up of sample material. • Check the instrument for drops and pooling of liquid on surfaces. • Check tubes, syringes, valves or pumps periodically.
Make sure all tubing is in good condition and properly connected to connectors. The visually check is only possible if the instrument is switched off or no tests are running.
1. Check all tubing connections accurately. • If they are poor or loose tighten them properly. 2. Check tubing for any signs of wear or leaking. • Call service to change wear or leaking tubing. 3. Make sure tubing insides are clean and free from any deposits, residue or clogs. • If the tubing seems to have residue, deposits or air bubbles flush the instrument. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 If necessary decontaminate the instrument as described in the decontamination procedures. • If there are furthermore any deposits, residue or clogs, call service to change the tubing.
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9.6.2 Visually Check Syringe and Three-Way-Valve
Defects in the liquid system Defect or leaky tubes, syringes, valves or pumps lead to deterioration of the pipetting results and consequently corruption of final results. Furthermore incorrectly flushed tips can cause mixing up of sample material. • Check the instrument for drops and pooling of liquid on surfaces. • Check tubes, syringes, valves or pumps periodically.
The visually check is only possible if the instrument is switched off or no tests are running.
1. Check if all syringes connections accurately. • If they are poor or loose tighten them properly by hand. • Syringes have to be leak free and clean. • If they are leaking or the glass barrel is scratched call service to change it. 2. Check in all valves connections accurately. • If after inspecting of the liquid paths, dripping is observed at the end of a tip adapter, the valve may require replacement. • Call service to change the valve. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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9.6.3 Heavy Liquid Overflow
In case liquid overflows into the instrument modules while the instrument is running:
1. Switch off the GEMINI instrument immediately. 2. Disconnect the power cord. 3. Using absorbent paper, clean-up all excess liquid. 4. Make sure to check all areas that may have been affected. Unload the racks from the sample and reagent units, check the various modules (including incubators, photometer). 5. Dispose of used absorbent paper in accordance with legal regulations for biological hazardous waste. 6. Decontaminate the affected areas as described in the maintenance sections. 7. Allow to dry. 8. Before turning the instrument on again, identify the source of the problem (damaged tubing, faulty washer...) and take appropriate actions. If in doubt, call your service engineer.
The procedure is identical if the liquid overflow is noticed only some time after the incident has occurred. Even if the instrument is already turned off, do not forget to disconnect the power cord. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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9.6.4 Pipettor Malfunction
9.6.4.1 Cleaning a Clogged IFA Pipettor Tip (optional)
Sharp edges! The needles of the pipettor tip and the IFA cleaning tool have sharp edges. Contact might lead to injuries. • Wear cut resistant gloves! • Use caution at the needles!
If the pipettor function is not longer adequate, you have to clean the needles of the pipettor tip. 1. Using the supplied IFA cleaning tool and clean both needles of the pipettor tip. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 9-3: Cleaning the IFA pipettor tip needles
2. Perform a selftest (see chapter 6.1.1 on page 6-3).
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9.6.5 Washer Malfunction
9.6.5.1 Cleaning a Clogged Wash Head
Sharp Edges! The needles of the wash head and the cleaning needles have sharp edges. Contact might lead to injuries. • Wear cut resistant gloves! • Use caution at the needles!
If the wash function is not longer adequate, you have to clean the needles of the wash head. 1. Open the service cover of washer, see chapter 2.1.1 on page 2-2 and remove it. 2. Using the supplied cleaning needle, clean the 8 dispense and the 8 aspirate needles of the wash head. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 9-4: Cleaning the wash head needles
3. Install the service cover of washer.
9.6.5.2 Other Problems
If you have performed all the above actions but the washer still does not operate correctly, other parts such as filters or pumps may be involved. Call your service engineer for assistance.
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9.6.6 Power Supply Malfunction
9.6.6.1 Power Cuts/Outages
If a power cut occurs during a run, the instrument can rely on a recovery file to resume the run automatically when the power cut is over. When the power supply is reset, the GEMINI instrument will normally prompt you to continue the run from where it was interrupted (your decision to continue the run will depend on the duration of the power cut). Note however that if only a part of a plate has been processed, the instrument does not keep track of the sample locations and you may have to reselect the samples to be tested. Note: If there is still a disposable tip on the pipettor tip adapter, then it must be removed by hand. If the power cut occurs outside a run, turn off the instrument. If you frequently experience power supply fluctuations, it is recommended that you install a UPS (Uninterruptedly Power Source) device to protect your GEMINI instrument.
9.6.6.2 Replacement of Main Fuses
Electric shock by improper replacement of fuses Improper replacement of fuses will cause serious injuries with deadly consequences and material damage (e.g. fire). • Separate the instrument from the mains supply and secure it against restarting before you replace fuses. • Check fuses if they match the values (nominal voltage, nominal current, and type) specified by the manufacturer. • Never repair or bridge blown fuses. • Never short-circuit the fuse holder.
The GEMINI instrument operates with (two) fuses that are located in a fuse holder at the right side of the instrument, just above the power supply cord (see chapter 2.1.3 on page 2-7). If the instrument does not power on when you press the ON/OFF switch, the power fuses may be blown. Spare fuses are supplied with the instrument or can be 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 purchased (see chapter 13.1 on page 13-1).
To replace a blown fuse:
1. Switch off the instrument. 2. Disconnect main power from the instrument. 3. Pull out the fuse carrier with a screw driver.
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Figure 9-5: Fuse carrier
4. Change the faulty fuse(s): Fuse: 3.2 A T, 250 V
Figure 9-6: Fuse carrier with fuses
5. Insert the fuse carrier. 6. Connect the main power. 7. Switch on the instrument.
Blown fuses Blown fuses are very often indicators of other malfunctions that may be affecting 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 instrument modules, components or wires. • Call your service engineer if in doubt or if the fuse blows again shortly after you have replaced it.
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9.6.7 Photometer Malfunction
9.6.7.1 Replacement of Photometer Lamp
Risk of burn The halogen lamp will reach high temperatures during operation and testing. Contact will cause injuries. • Use appropriate gloves! • Let the halogen lamp cool down before cleaning or maintenance.
Handling and cleaning of optical surfaces Improper optical surfaces (e. g. scanners, lenses, sensors) could generally degrade the quality of images, data, etc. • Do not touch any optical surfaces. • Only clean the optical surfaces with a soft and lint-free cloth. • Do not use any aggressive detergents or solutions (e.g. acetone).
In the event of a lamp failure, replace the lamp with the recommended part only. Use of other lamps is not acceptable.
Removal
1. Shut down the computer and switch off the instrument. 2. Disconnect main power from the instrument. 3. Remove both retaining screws (2) and the photometer service cover (1). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 9-7: Photometer service cover
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4. Lift the lamp retaining clip (3) and remove the lamp (4).
Figure 9-8: Photometer lamp
5. Disconnect the lamp connector (5).
Installation 6. Plug the new lamp (4) into the lamp connector (5). 7. Lift the lamp retaining clip (3) and insert the lamp (4). 8. Install the photometer service cover (1) and tighten both retaining screws (2). 9. Execute the verification plate process with the reader verification plate to verify the new lamp(see chapter 9.6.8 on page 9-28). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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9.6.8 Reader Confidence Check with Reader Verification Plate
The Reader Verification Plate (RVP) shall be applied prior to first use after reader maintenance and service actions or as regular reader confidence check (half-yearly). Every Reader Verification Plate is certified by the manufacturer. Under the condition that the Reader Verification Plate is used according to the instructions given in this manual the certificate is valid for three years.
Figure 9-9: Reader Verification Plate
Risk of infection! As the Reader Verification Plate may be used in a potentially contaminated environment, it should be treated as potential infectious. Therefore it must be decontaminated before it is removed from the laboratory. • Use γ?-radiation for decontamination of the Reader Verification Plate.
Avoid mechanical and temperature shocks!
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The Reader Verification Plate should always be transported and stored in the protective plastic case provided.
9.6.8.1 Functions of the Reader Verification Plate
Accuracy To verify measurements are within the stated accuracy of the absorbance reader and the accuracy, uncertainty of the reference standard and reading method used. The accuracy test uses the average value calculated from all 8 channels at all filter wavelengths installed (nominally 405 nm - 690 nm), read ten times. The verification plate contains a strip of ‘Neutral Density Glass’ in column 7 across each channel for this purpose. The value measured must be within the absorbance reader accuracy plus the accuracy of the reference standard of the value in the certificate file. The limits are shown in the report and are calculated from the values stored in the certificate file.
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Since the uncertainty of the reference standard is quoted in %transmission, the software calculates the OD equivalent based on the certificate value for each filter.
Plate area: • column 7, row A – H
Troubleshooting: • This test is just for the laboratory recordings. • Typically failures in accuracy will also be indicated by additional RVP Tests.
Linearity To verify measurements are within the stated linearity of the absorbance reader specification. Linearity is verified by measuring at 4 points within the dynamic range of the absorbance reader. The linearity test uses the average value calculated from all 8 channels at all filter wavelengths installed. The verification plate contains 4 strips of ‘Neutral Density Glass’ in columns 5, 6, 7 and 8. These produce readings across the dynamic range of the reader. There are 2 tests applied to determine linearity performance. The first is a repeat of the above accuracy test criteria for each glass, the average value read is compared to values within the certificate file, and must be within the absorbance reader accuracy plus the accuracy of the reference standard. See above. The second test is a statistical analysis to determine if the points lie on a straight line. From the 4 known certificate values (known y’s) and the 4 measured average values (known x’s) for each filter, using a least squares fit, the slope (m) and standard error (Se) is calculated. The ratio of slope divided by standard error (m/Se) is compared to the t value obtained from statistical tables. From table ‘Percentage points of the t distribution, v = 2 (degrees of freedom) alpha 0.005, critical t value = 9.925. The calculated value must be above the critical t value.
Plate area: • column 5 - 8, row A – H
Troubleshooting: • Mere accuracy failures, especially at shorter wavelengths (405 nm) indicate electronics problems or simply degrading laps.
Uniformity To verify every optic channel measures the same value. The test assumes that the glass strip is nominally the same value across its length.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 The uniformity test uses the same glass as the accuracy test. All filters installed are tested. The median value is calculated from the measured readings for each filter. The limit used is based on the uniformity specification of the reader plus the manufacturing tolerance for the parallelism of the glass strip. Since the thickness of the glass is directly proportional to transmission, the effective OD contribution from the glass parallelism is determined based on the median value read. The limits applied are included in the report. Each channel’s reading must be within the limits applied to the median value.
Plate area: • column 7, row A – H
Troubleshooting: • Uniformity failures would be typically related to fibre bundle problems (then usually related to lower wavelengths, otherwise the fibre bundle should also
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not have passed the module test), spotty lamps or pinholes or scratches in the filter coatings (then also the filter blocking tests are likely to fail).
Optical To verify the measurements are taken at the optimum position within the micro plate. Alignment At each of the 4 corner locations, a reference hole exists (nominal diameter 1.4 mm) on the nominal optic axis. Other holes with known offsets from the nominal centres occupy the remaining positions of the first and last column. From the readings obtained it is possible to determine the X, Y and skew of the reading configuration. The limits applied are indicated on the report. The calculated deviation in X, Y and skew must be within the limits.
Plate area: • column 1 + 12, row A – H
Troubleshooting: • This is just a plausibility test to confirm the reader mechanics are not misaligned. • Call service to perform an alignment test to get more accurate alignment data in cases of doubt.
Cross Talk To verify cross talk between channels is below limits that maintain the stated specifications. Within columns 2 to 4 of the verification test plate there is a checker board pattern of blocked locations and unblocked locations. The average reading of all the blocked locations will be compared to the specified OD maximum value, of 2.500 O.D. The reading must be greater than 2.500 O.D. when neighboring holes read nominally 0.000 OD (100 % transmission).
Plate area: • column 2 + 4, row A – H
Troubleshooting: • Failures of the Cross talk 0 % transmission test indicate either noisy electronics (see also linearity test) or scattered light.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Dynamic Range To verify the measurements span the dynamic range as stated within the absorbance reader. Using the same area as above, the large holes (diameter 7 mm) that do not infringe on the optical path are used to read the 0.000 O.D., 100 % transmission value. This reading, taken with selected channels verifies one end of the scale. The blocked areas of the plate will totally block the optic path, therefore reading greater than 2.500 OD or 0 % transmission, this verifies the other end of the scale. The readings for 100 % transmission or 0.000 OD must not be greater than 0.005 and the readings for 0 % transmission must be greater than 2.500 O.D.
Plate area: • column 2 - 4, row A – H
Troubleshooting: • See cross talk
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Filter Blocking To verify the correct filter is installed and has no major defects. Readings will be taken Test using each filter installed and compared to the expected value for the long pass filters. Any filter within 50 nm of the nominal centre wavelength will be ignored. If the filter is below the cut-on frequency of the long pass filter the reading is expected to be above the over limit. If the filter is above the cut-on frequency of the long pass filter the reading is expected to be below the lower limit, which has been set at 10 % transmission or 1.000 O.D. Defective filters with unblocked light, typical produced by pin holes or poor fabrication should fail the test. The limits are shown on the report, long pass filters within 50 nm of the nominal centre wavelength have no limit applied and therefore none is shown.
Plate area: • column 10 - 11, row A – H
Troubleshooting: • Failures indicate damages of the filter coatings.
Filter To verify correct filter is installed. Wavelength Using a conversion filter it is possible to determine the centre wavelength (CWL) of the filter under test to within ±20 nm. The conversion filter is situated in column 9 of the plate. The certificate file contains a calibration value for the conversion file which is used to determine the predicted CWL. The nominal CWL value stored in the reader is compared to the predicted value and must be within the limits indicated on the report.
In this test all filters of standard configurations can be analyzed. The correct filter verification must not be applied at nominal wavelengths between 405 nm and 450 nm.
Plate area: • column 9, row A – H
Troubleshooting: • Plausibility check of filter placement versus firmware settings. The tolerance range of 20 nm is due to the measurement process used on the RVP, filters
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 should be manufactured to a tolerance of +/-2 nm. • Failures may also indicate damaged filter coatings or degrading lamps.
Precision Test To verify the measurements remain constant within repeated readings of the same sample. The precision test uses the same glass as used in the accuracy test, for all filters installed. The maximum deviation measured on each channel, during the ten reads for each filter is compared to the limit, which has been set to 0.010 O.D. The deviation on any channel for each filter must not exceed the precision limit indicated on the report.
Plate area: • column 7, row A – H
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Troubleshooting: • This test is just for the laboratory recordings. • Typically failures in accuracy will also be indicated by additional RVP Tests.
9.6.8.2 Verification of the Photometer with the GEMINI User Software
Before use blow any dust and clean the outer protective glasses with dry microfibre cloths. Never use any liquids or solvents!
Preparations
Following steps must be performed if the Reader Verification Plate is used the first time on the instrument or if you use a Reader Verification Plate with a different serial number. If the instrument was already checked with the RVP, there is no need to perform the following steps.
1. Compare the serial number of the reader verification plate with the serial number of the USB-Memory stick. Both must have the same serial number. 2. Switch on the instrument. 3. Connect the USB-Memory stick into one of the USB-Connectors (see chapter 2.1.3 on page 2-7). Wait until Windows installs all necessary drivers. 4. Start the Windows Explorer. 5. Copy the certification file ([serialnumber].cer) from the USB-Memory stick into the directory C:\Gemini\System. 6. If existing, delete the file Verifiy.cer in the directory C:\Gemini\System.
Depending upon Windows file options it is possible that you cannot see the file 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 extension ".cer". In this case enter only "Verify" during file name modification.
7. Rename the certification file as Verify.cer. 8. Close the Windows Explorer.
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Verification
Required access rights: Change system setup
1. Switch on the instrument. 2. Start the GEMINI user software. 3. Select Utilities > System Setup... from the main menu bar. 4. Click on the Colorimeter tab. 5. Click on the Verification Plate… button.
Figure 9-10: Verification Plate dialog
6. Compare the serial number of the reader verification plate with the Serial Number (1) of the Verification Plate dialog. Both must have the same serial number. 7. Compare the Calibration Expiry Date (2) with the date written on the certificate. The Calibration Expiry Date must be three years after the 'Date of Certification'. 8. Compare the Wavelengths and their values (3) with the wavelengths and their values written on the certificate. 9. Press on the OK button to close the Verification Plate dialog. 10. Press on the OK button to close the Service Set-Up dialog.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 11. Select Utilities > Verify > Colorimeter… from the main menu bar. The Verify Colorimeter dialog shows all filter installed in the instrument. 12. Select the wavelength(s) you want to verify. An enabled Reset long term drift values option has following function. When the plate is first read the values obtained are stored and later readings are compared against them to check that the reader hasn't "drifted".
Figure 9-11: Verify Colorimeter dialog (e.g. 3 filters)
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13. Press on the OK button. 14. Load the reader verification plate onto the instrument.
Figure 9-12: Reader Verification Plate (RVP): Insert orientation
15. Press on the OK button. The user software shows you the progress of the process. Wait for the end of the process. After the end of the process a message appears to unload the Reader Verification Plate. 16. Unload the Reader Verification Plate. 17. Press on the OK button.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 18. The user software shows the Summary of the Verification Plate Results.
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Figure 9-13: Verification plate results
19. Select View > Detailed from the main menu bar for the long version of the Verification Plate Results. 20. Check the test results if necessary (see chapter 9.6.8.1 on page 9-28). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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9.7 Damaged Parts
In most cases, repairing and/or replacing damaged parts will require the assistance of your service engineer. If in doubt, please call before trying to repair/change the part yourself. However, two specific cases need to be mentioned.
Parts damaged during shipment: If you have ordered parts that are shipped directly to you, examine them carefully when unpacking. Although they are packed to provide maximum protection, damage can occur. In this case, report the damage in the first place to the carrier/shipping company and then to the supplier.
Decontamination: If you want to return damaged parts to your local supplier (e.g. if under guarantee), please note that the parts must be decontaminated first. Follow the maintenance procedures to decontaminate the instrument and accessories (see chapter 9.2 on page 9-4, chapter 9.3 on page 9-8, and chapter 9.4 on page 9-14). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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10.1 Error Messages
If the GEMINI does not work, this is often due to minor problems which you can deal with yourself. This chapter describes error messages and gives instruction on error recovery. System messages appear in the status bar of the GEMINI instrument software, error messages are displayed in a separate window, which has to be confirmed. Some of that messages are also written into the result report. '%1' and '%2' are place holders for a instrument module or the designation of a plate, a reagent or an error number.
Error message: Cause: Action:
A result file already The instrument will Unless you specifically want to overwrite the exists for plate "xxxx" automatically generate a former result file, click on the No button and result file not for each worklist go back to the Load Plate dialog to but for each plate included in change the Plate ID. To do so just delete the a worklist. This result file will name shown in the Plate ID field and enter a be named after the Plate ID new name. displayed in the Load Therefore, when choosing a Plate ID, try to Plate dialog (e.g. find a precise name that will differentiate each "HBc01.res"). Therefore, if test from previous or future tests. Do not retain you choose a Plate ID that the "Plate 1", "Plate 2"... default ID and do not has already been used in a enter just the test ID "HBc", "HIV", etc. The former worklist, when you instrument does not expect any specific click on the OK button, the format so any chain of alphanumeric instrument will display this characters (with or without blank spaces) can warning message. be entered. To replace the existing result file, click on the Yes button. Note that the overwritten result file will be lost.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 ABORT button The Stop button has been The run has been interrupted and may be pressed clicked during a run. continued or aborted completely (see chapter 4.9.7 on page 4-60). Aborting plate ... The operator clicked the You can decide to resume the run for the Stop button during a run and remaining plates or abort it completely (see then, in the Pause dialog, chapter 4.9.7 on page 4-60). requested that the processing of one or more plates be aborted. All of the dilution Not enough liquid in archive See chapter 10.4.2 on page 10-24 resources have been plate. used Argument error in During initialization procedure. Call service to reinstall the firmware for the command Faulty firmware is installed. concerning module. If error recurs the PCB of concerning module has to be checked.
Gemini - Instructions for use manual - Rev. 10 10-1
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Error message: Cause: Action:
Aspirate check failed During the run. Aspirate step Recovery options: for reagent %1 of reagent was faulty. • Retry button: Pipettor will dispense back Possible causes: the aspirated liquid and repeats the • Incorrect tracking due to aspirate step. wrong bottle type. • Abort Plate button: Plate will be aborted. • Continue button: Instrument goes on but all concerning samples will be flagged.
Troubleshooting: • Check, if correct bottles were used. • If error recurs, call service to check the teaching. Aspiration pressure APM error. The result will be flagged: P_max_high to high
Aspiration pressure APM error. The result will be flagged: P_min_low to low
Barcode IC error The barcode cannot be read. Verify the readability of the barcodes. Select the Utilities > System Set-up menu item, click on the Sample Rack tab and check the barcode parameters (see chapter 8.3.6.2 on page 8-37). Try reading the barcodes once more (withdraw and insert your rack again). If this attempts fail, call your service engineer. Clot detected in Clots were detected in the Pause the run (see chapter 4.9.7 on page 4-60) reagent ... respective reagent. and replace reagent. Clot detected in During the run. Clots were Recovery options: sample %1 detected in sample %1. • Skip Sample button: Instrument will Possible causes: skip the concerning sample and will go on • Deficient sample with the worklist. preparation • Abort Plate button: plate will be • Incorrect tracking due to aborted. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 wrong sample rack type • Continue button: Instrument goes on • Incorrect tracking due to but concerning sample will be flagged. wrong tube diameter • Tip touches the (wet) wall Troubleshooting: of a tube. • Check, if correct tubes were used. • If error recurs, call service to check the teaching. Colorimeter A/D error During the initialization Please, restart the instrument. If the error procedure or during a run. recurs, call service to check the photometer Error of the analog/digital module. converter of the photometer.
10-2 Gemini - Instructions for use manual - Rev. 10
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Error message: Cause: Action:
Colorimeter A/D over During the initialization Recovery options: range error procedure or during a run. • Retry button: Instrument will try to repeat Upper limit of analog/digital the last step. converter of the photometer • Ignore button: Not advisable cause has been exceeded due to the instrument cannot go on without sequence signal height of the pre- errors. selected resolution. Push the Retry button, if the error recurs, abort the worklist and check the filters and the photometer lamp.
Troubleshooting: If error recurs after checking the filters and the lamp, call service to check the whole photometer module. Colorimeter A/D During the initialization Recovery options: under range error procedure or during a run. Too • Retry button: Instrument will try to repeat less light reaches the the last step. electronic of photometer. • Ignore button: Not advisable cause instrument cannot go on without sequence errors. • Abort button: The worklist will be aborted. Press the Retry button. If the error recurs, abort the worklist. The whole photometer module has to be checked.
Troubleshooting: The halogen lamp of the photometer is faulty and has to be replaced. If the error persists, the optical components in the photometer (filter, upper or lower optic block) may be dirty. Call service to clean or replace the photometer. Colorimeter During the initialization Restart the software to initialize the
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 backgrounds out of procedure or during a run. photometer again. Please check if the range Typically occurs when light photometer cover, all instrument sheet metal entered the measurement covers and the deck top are installed correctly chamber. and all filters are installed. If the error recurs, please call service. Colorimeter EEPROM During the communication Initialize the module again. If the error recurs error between colorimeter and PC. the photometer board has to be checked, please call service. Colorimeter filter During the initialization Restart the software. If the error recurs, the motor home error procedure. The instrument filter wheel has to be checked, please call does not recognize the current service. position of the filter motor. Colorimeter filter During the initialization Restart the software. If the error recurs, the motor movement procedure. The movement of filter wheel has to be checked, please call error the filter wheel is faulty. service.
Gemini - Instructions for use manual - Rev. 10 10-3
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 371 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Colorimeter invalid During initialization procedure. Restart the software to initialize the filter %1 error The gain factor for the photometer again, after checking the filter respective filter cannot be configuration. identified. If error recurs, change the concerning filter, please call service. Colorimeter lamp During the initialization Replace halogen lamp and restart the error procedure. Halogen lamp of software to initialize the photometer again. photometer is faulty. Colorimeter optic During the initialization The lower or upper optic blocks have to be channel %1 error procedure. One of the optical cleaned, or the fibre has to be replaced, channels is faulty. please call service. Colorimeter Plate movement is faulty. If the error recurs, call service to check the positioning error plate transport teaching of the reader position, the guide rails and the plate carriers. COMGEN error '%1' At start-up. Cable connection Start instrument again. If this error recurs, call between PC board and service. instrument CU board is faulty. Command execution During initialization procedure. Please call service to reinstall the firmware for error Faulty firmware is installed. the concerning module. Command not During initialization procedure. Please call service to reinstall the firmware for implemented Faulty firmware is installed. the concerning module. COP serial port test At start-up. Error in serial Start instrument again. If error recurs, the error interface on instrument CU instrument CU board has to replaced, call board. service. Disposable tip The disposable tip has fallen The user should pick up the dropped tip, dropped off the adaptor unexpectedly. check for possible contamination and for what Possible causes: could have caused the problem and select the appropriate recovery option. Warning: • Defective tip Especially, if the error occurred while the • Insufficient tip pick-up force pipettor was moving across any wells, due to excessive friction vials or tubes, the affected plate must be inside the z drive aborted. The error is logged in the event log. • Insufficient tip pick-up force due to excessive flexibility Recovery options: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 in the tip tray or deck top. • Retry button: The instrument will repeat the pipetting step where the error occurred after initialization of the pipettor arm. • Abort Plate button: The whole plate will be aborted. • Ignore button: The concerning sample will be flagged. Instrument goes on with the next pre-dilution.
10-4 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 372 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Crash cover file After power failure. Warning: It is not recommended to use the detected. crash recovery. Any results produced in a Do you want to try recovered run have to be discarded. and recover the Details on recovery procedure: worklist? Message: "Do you want to try and recover the worklist?" • No button: Software continuous with initializing the instrument. Old worklist will be deleted. • Yes button: The following message appears: "Is the system still running?" • No button: The instrument will initialize first the modules before continuing the next worklist step. • Yes button: The instrument continues with the next worklist step.
Note: If there is still a disposable tip on the pipettor tip adapter, then it must be removed by hand. Drive not moving Motor error in scanner of If error occurs please use the possibility to reagent and sample rack. allocate the reagents and samples, manually. Scanner firmware does not The barcode scanner of the loading bay has to work correctly. Electrical or be checked, please call service. mechanical problems of scanner. Duplicate sample ID Two loaded sample tubes with Remove the sample tubes and use another ………! identical barcodes. barcode for one of these tubes (see Edit the sample IDs chapter 10.2.1.9 on page 10-19). so that only one tube For archiving see chapter 10.4.4 on page 10-24. is used per sample. Error during assay After adding assay and Push the OK button and reduce the numbers layout reduction. sample to the plate. Too many of samples, that a maximum of 96 wells on
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Reduce the number of samples are used on this one plate are used. samples. Check that plate. the assay layout is reducible. Error opening file ... Error during reading or writing Check or change the target directory in the a file (network down or Directories tab of the Options dialog directory moved/deleted). (see chapter 8.2.8 on page 8-15). Error scheduling After adding plate and assay. Push the OK button and modify the assay or plate '...' The assay programming is not worklist. correct or the combination of different plates cannot be scheduled. Error: Argument error During the initialization Restart software and analyzer. If the error in '%1' procedure. Component recurs, the concerning module has to be cannot be actuated. checked, please call service.
Gemini - Instructions for use manual - Rev. 10 10-5
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Error message: Cause: Action:
Illegal parameter During initialization procedure. Please call service to reinstall the firmware for (length/type) Faulty firmware is installed. the concerning module. Incubator heater %1 During the initialization The heater foil of concerning incubator box error procedure or during the run. has to be checked, please call service. The heater foil of incubator box %1 is faulty. Incubator sensor %1 During the initialization The temperature sensor of concerning error procedure or during the run. incubator box has to be checked, please call The temperature sensor of service. incubator box is faulty. Insufficient volume of During the run. Instrument Recovery options: pre-dilution %1 cannot find enough volume in • Retry button: Instrument will try to repeat pre-dilution. the last measurement of level height. • Abort button: The concerning sample will be aborted. • Abort Plate button: The whole plate will be aborted. • Ignore button: The concerning sample will be flagged. Instrument goes on with the next pre-dilution.
Troubleshooting: • Check if the metal plate was put under the dilution plate. • Check if the correct *.mpc file is selected for the pre-dilution plate used. • LLD problems can occur in the pre-dilution plate if liquid with low conductivity is pipetted (e.g. DI water). • The minimal volume that can be detected by the LLD in a well of a dilution plate is 120 µl to 150 µl (depending on the plate used). • Call service to check the teaching of the pre-dilution position.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Call service to double-check the teaching of the *.mpc file used.
10-6 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 374 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Insufficient volume of At reagent check if volume of Recovery options: reagent %1 reagent is insufficient. • Abort check button: reagent check will be aborted. The instrument goes on with the worklist. • Refill bottle button: software jumps back to the loading window where reagents can be filled up. • Continue button: Instrument will go on with checking the next reagent. To make sure that worklist will run without miss pipetting errors, please push Refill bottle and make sure that enough reagent liquid is available.
Troubleshooting: If this error occurs although there is enough liquid provided in the reagent bottle, check if the bottle type used is correct. Call service to check the teaching. Insufficient volume of During the run if volume of Recovery options: sample %1 sample is insufficient. • Retry button: Instrument will try to repeat the last measurement of level height. • Abort button: The sample will be aborted. • Abort Plate button: The whole plate will be aborted. • Ignore button: The concerning sample will be flagged. Instrument go on with the next sample. Invalid pipettor After adding plate and assay. Push the OK button. coordinates on plate The assay programming is Modify the assay definition and restart the X, label sample “…”. faulty. A label of a sample is worklist. Check that the undefined. dispense labels and aspirate labels are
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 consistent. Invalid unlock code During initialization procedure. Call service to reinstall the firmware for the Faulty firmware is installed. concerning module. Mean pressure to low APM error. The result will be flagged: P_mean_low
Gemini - Instructions for use manual - Rev. 10 10-7
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Error message: Cause: Action:
No disposable tips During the run. No more tips Automatically appearance of the loading left available or found. window after instrument message occurs. Load the correct tips to the suggested position. After pushing the OK button the worklist will go on.
Troubleshooting: If this error occurs although there is enough liquid provided in the tube, check if the tube size used is correct. Call service to check the teaching. No liquid detected for During the run. No liquid for Recovery options: reagent %1 reagent %1 is detected, if • Retry button: Instrument will check level reagents check was disabled. of reagent again. • Abort Plate button: Plate will be aborted. • Abort button: The worklist will be aborted. To make sure that the worklist will run without miss pipetting errors, push Abort and enable the Reagent check in the panel options. After that, you have to start the worklist again. The old worklist cannot be recovered. No liquid detected for During the run. No liquid for Recovery options: sample %1 sample %1 is detected, if • Retry button: Instrument will check level sample check was disabled. of sample again. • Ignore button: Instrument goes on but concerning sample will be flagged. Note: air can be pipetted if you will push the Ignore button. • Abort Plate button: Plate will be aborted. • Abort button: The concerning sample will be aborted. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 No response to Instrument cannot Recovery options: command '%1' communicate with PC. • Retry button: PC will try to connect to instrument again. • Abort button: the worklist will be aborted. If error message recurs after pushing Retry, restart the instrument.
Troubleshooting: Check the cable between PC board COP. Please call service to check the electronics.
10-8 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 376 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Open loop error at tip Remove tip manually from pipettor or trigger eject eject mechanism manually. Press the OK button after removing the tip manually. Press Retry. The instrument logs the failure in the event log and goes on with the next step. If the error recurs call service to check the teaching and the friction force of the Z drive Init not reached During initialization procedure Please, restart the software and instrument. or of the plate transport (can also If the error occurs during a run, please press be initiated by washer or Init not in init the Abort button to cancel the worklist. After reader). Error of the plate direction this error occurs a recovery isn’t possible. transport init light barrier or If the error recurs the plate transport drive and plate transport drive. its init light barrier have to be checked, please call service. Parameter not During initialization procedure. Call service to reinstall the firmware for the allowed/found Faulty firmware is installed. concerning module. Pipettor error 0X0E- During a pipettor movement. Recovery options: LY (or LX) position Pipettor crashes or • Retry button: After initialization, the not reached mechanical problems. instrument will try to reach the position again. • Ignore button: Not advisable cause instrument cannot go on without sequence errors. • Abort button: The worklist will be aborted.
Troubleshooting: Push the Retry button to repeat the last step. After pressing Retry, press the Resume button to continue worklist. If the error recurs please open instrument flap and check if they’re any obstacles that disturb the pipettor movement. If there are no obstacles, the pipettor module has to be checked, please
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 call service.
Gemini - Instructions for use manual - Rev. 10 10-9
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Error message: Cause: Action:
Pipettor open loop / Pipettor crash during a run. Recovery options: overload error • Retry button: After initialization, the instrument will try to repeat the former pipetting step. • Ignore button: Instrument will continue with the next pipetting step. • Abort button: The whole plate will be aborted.
Troubleshooting: Push the Retry button to repeat the last step. After pressing Retry, press the Resume button to continue worklist. If the error recurs please open instrument flap and check if they're any obstacles that disturb the pipettor movement. If there are no obstacles, the pipettor module has to be checked, please call service. Plate not detected During plate transport Recovery options: movement. A plate carrier is • Retry button: Plate transport will try to not detected where it is load / unload the plate again. expected. • Ignore button: Not advisable cause Possible reasons for the error instrument cannot go on without sequence • Wrong teaching errors. • Plate carrier does not • Abort button: Instrument will try to abort interrupt a "plate in" light the plate. barrier in an incubator (or room temperature) slot: Troubleshooting: Defective light barrier, Plate transport and incubator slots must be tolerance issue in the room checked, please call service. temperature slots with the guiding rails (try to push the guiding rails farther to the back or exchange the plate carrier). Defective shake mechanism. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
10-10 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 378 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Plate transport %1 During the initialization Recovery options: positioning error procedure or during the run. • Retry button: Instrument will try to repeat Plate transport can’t reach the the last movement step. demanded position. • Ignore button: Not advisable cause Possible reasons for the error: instrument cannot go on without sequence • Inaccurate teaching. errors. Especially, the teaching of • Abort button: Plate will be aborted. the z position of the incubator drive and the Troubleshooting: "plate in" y position are After error message occurs, make sure that critical for the loading and there are no obstacles that jammed the plate unloading of plate carriers. transports movement. • Defective encoders. Push Retry button, if the error recurs, please • Wrong belt tension call service to check the plate transport misadjustment of the module. incubator slots • Insufficient lubrication Plate transport EEPROM error while reading / Restart instrument again. If error recurs, EEPROM error writing procedure. please call service to change the instrument CU board. Please close the During initialization or when Close the instrument flap and push the OK system cover resuming from pause. button. Instrument cover isn’t closed. If the error recurs after closing the flap, please call service to check the cover sensor. Please configure the After adding plate and assay. Push OK button. Make sure that correct system in preparation Wrong predilution area is predilution area is chosen for this assay and for a standard WL. defined. start worklist again. Ensure that the dilution tube rack is inserted. Please remove the During starting or stopping of Open the instrument cover and (after approx. plate from the system a worklist. In order to save one second) close it again. Then, the dialog time in case OK is can be closed by pressing OK. accidentally clicked before the plate is actually loaded, the 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 software will not close the Load Plate dialog in case no opening and closing of the cover for loading a plate has been detected. Positioning error Motor error in scanner of If error occurs, please call service to check the reagent and sample rack. barcode scanner of the loading bay. Scanner firmware does not work correctly. Electrical or mechanical problems of scanner. Pressure at pump APM error. The result will be flagged: P_stop_high stop to high
Pressure rise delayed APM error. The result will be flagged: P_delay
Gemini - Instructions for use manual - Rev. 10 10-11
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Error message: Cause: Action:
Rack scanner During a reading step of If error occurs please use the possibility to focusing error barcoded sample / reagent allocate the reagents and samples, manually. rack. The barcode scanner The barcode scanner has to be checked, cannot be focused. please call service. Rack scanner motor Motor error in scanner of If error occurs please use the possibility to error reagent and sample rack. allocate the reagents and samples, manually. Scanner firmware does not The barcode scanner has to be checked, work correctly. Electrical or please call service. mechanical problems of scanner. Rack scanner not During the initialization If error occurs please use the possibility to detected procedure. Scanner of loading allocate the reagents and samples, manually. bay is not connected. The barcode scanner has to be checked, please call service. Reagent ... is After adding plate, assay and Open assay and add the missing reagent into undefined sample. A reagent has not reagent database. Restart the worklist. been defined. Note: the changes have to be saved, with the Save Button before they will get active. Some required After the loading dialog. Not Push OK button. Load all resources from the resources have not all required reagents have unallocated resources field into the allocated to system been allocated to a position. appropriate position (reagents, samples, positions dilution tubes/plates, tips, buffers). Static pressure to APM error. The result will be flagged: P_static_high high
Static pressure to low APM error. The result will be flagged: P_static_low
Suspect tip pick up During tip pick up. The This is a warning that is logged in the event disposable tip adapter log. No results are flagged. The software reached the Zmax position, continues pipetting with the tip without user the tip sensor detects a tip, but interaction. If the error recurs frequently, the the pick-up force was not as teaching positions (mainly Zmax at the tip high as expected. trays) and the disposable tip adapter have to 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 be checked, please call service. System fluid low During the initialization Fill up the system liquid container with procedure or during the run. deionised water and push OK. If the error recurs after filling up the container, the level sensor has to be checked, please call service. System waste full. During initialization procedure Empty the waste container and push OK Empty the waste or during the run. button. container. If the error recurs after emptying the waste container the level sensor has to check, please call service. The disposable tips During the tip type detection. After pushing the OK button the software have been incorrectly Software detected a wrong displays to the loading dialog where you have loaded. type of tip. to check if the correct type of tips (300 µl or 1100 µl) are loaded to the correct position.
10-12 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 380 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
The IFA slide bay is ELISA operation mode, but Remove the IFA bay. currently inserted. installed IFA bay or defective If no IFA bay is inserted, the IFA bay sensor ELISA worklists can IFA bay sensor. has to be checked, please call service. only run if the slide bay is removed. Please remove the slide bay and try again. The IFA slide bay is The IFA bay is not inserted Insert the IFA bay correctly. currently removed. correctly or IFA bay sensor If the IFA bay is inserted, the IFA bay sensor IFA worklists can only defective. has to be checked, please call service. run if the slide bay is inserted. Please insert the slide bay and try again. The slide bay was The IFA bay was installed Remove the IFA bay. inserted but is not during a ELISA run or IFA bay If no IFA bay is inserted, the IFA bay sensor needed by this sensor defective. has to be checked, please call service. worklist. Please remove the slide bay from the instrument. The slide bay was The IFA bay was removed Insert the IFA bay correctly. removed but is during a IFA run or IFA bay If the IFA bay is inserted, the IFA bay sensor needed by this sensor defective. has to be checked, please call service. worklist. Please re- insert the slide bay to it's correct position. There was an error After finishing a plate and Recovery options: found when printing getting a result. • Retry button: Software will try to start the the Document to print job, again. LPT1: The device is • Cancel button: The print job will be not connected. Do cancelled. you want to retry or Please check that the printer is switched ON cancel the job? and all cables are connected. Make sure that the right printer driver is 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 installed. If the error recurs after checking the printer, please call service. Tip eject failure Error during the tip ejection in Remove tip manually from pipettor or trigger the tip eject station. The tip eject mechanism manually. Press the OK could not be ejected (the tip button after removing the tip manually. The sensor still detects a tip instrument logs the failure in the event log and although the pipettor goes on with the next step. performed a tip eject If the error recurs the disposable tip adapter movement) and the teaching have to be checked, please call service. Unable to create text Error during writing a file Check or change the target directory in the file ... (network down or directory Directories tab of the Options dialog moved/deleted). (see chapter 8.2.8 on page 8-15).
Gemini - Instructions for use manual - Rev. 10 10-13
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Error message: Cause: Action:
Unknown colorimeter Unknown photometer error. Restart instrument and software, if the error error code %1 recurs, the whole photometer module has to be checked, please call service. Unknown command During initialization procedure. Call service to reinstall the firmware for the Faulty firmware is installed. concerning module. Unknown incubator Unknown incubator error. Restart instrument and software, if the error error code %1 recurs, the whole incubator module has to be checked, please call service. Unknown plate Unknown plate transport error. Abort the worklist, and restart software to transport error code initialize the plate transport. Restart the %1 worklist. If the error recurs the plate transport has to be checked, please call service. Unknown washer Unknown washer error. Restart instrument and software, if the error error code %1 recurs, the whole washer module has to be checked, please call service. Verification failed: %1 During the photometer If the error occurs, change the lamp and check verification. the filter configuration. Repeat the colorimeter verification test. If the error recurs the photometer module has to be checked, please call service. Warning! Incubator For elevated temperature See chapter 10.3.2 on page 10-22 tolerance of xx°C was incubation, if the incubation exceeded. temperature monitored during the run does not correspond to the incubation temperature defined in the assay. Washer aspirate During the initialization Recovery options: pump drive failure procedure or during a wash • Retry button: Software tries to repeat the step. The aspirate pump is dispensing step. faulty. • Abort Plate button: The plate will be aborted. Push the Retry button. If the error recurs, please call service to check the aspirate
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 pump. Washer aspirate During the initialization Recovery options during wash step: pump error procedure or during a wash • Retry button: Software will try to activate step. The poor vacuum quality the aspirate pump again. is detected. • Abort Plate button: Plate will be aborted. Before pushing the Retry button, please check that all tubes are connected correctly. Check that there are no kinks in the tubing. Check the bottle seals. Are the bottle lids closed correctly? If the error recurs, please call service to check the vacuum sensor and the washer aspiration pump.
10-14 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 382 of 425 Troubleshooting and Error Messages Error Messages
Error message: Cause: Action:
Washer dispense During the initialization Recovery options: pump drive failure procedure or during a wash • Retry button: Software tries to repeat the step. One of the wash buffer dispensing step. pumps is faulty. • Abort Plate button: The plate will be aborted. Push the Retry button. If the error recurs, please call service to check the wash buffer pumps. Washer EEPROM EEPROM error while reading / Restart the instrument again. error writing procedure. If the error recurs the washer PCB has to be changed, please call service. Washer reagent level After loading dialog or during Recovery options: low the run. One of the washing • Retry button: Software checks the level liquids is empty. sensor again. • Abort button: the worklist will be aborted. • Ignore button: the worklist goes on without filling up the buffer. Refill the washer reagent and push the Retry button. If the error recurs after refilling, check the cables connections of level sensors or call service. Washer strip error Before wash step. One of the • Retry button: Strip check will be strips of micro plate isn’t repeated. inserted correctly. • Abort Plate button: Plate will be aborted. After error occurs push the Retry button. The instrument will go on, if the error recurs abort the plate. Washer waste full During initialization procedure Recovery options: or during the run. Waste bottle • Retry button: Instrument will check the is full. level sensor again. • Abort Plate button: Plate will be aborted.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Empty washer waste bottle manually and push the Retry button. If the error recurs, the washer level sensor has to be checked, please call service. Your system is The user software allows only Choose only assays of the specified assay currently limited to assays of a specified assay portfolio group. certain assay portfolio group. The chosen portfolios. ... assay does not belong to the specified assay portfolio group.
Table 10-1: General Error Messages
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10.2 Troubleshooting while Loading
This section describes the possibilities of troubleshooting in relation to the loading of samples, reagents, microtiter plates or other resources.
10.2.1 Troubleshooting while Loading Samples
10.2.1.1 Unreadable Barcodes
If the instrument has not been able to read one or several barcodes of samples: 1. Close the shown tabular Sample Editor dialog by clicking the Close button. 2. Remove the inserted rack. 3. Check the barcode labels on the tubes that the instrument failed to read. Make sure the labels are facing on the right-hand side and are not damaged or dirty. Make sure the barcode type is the same as on the tubes that were correctly read (otherwise, you may need to change your barcode settings, see chapter 8.3.6.2 on page 8-37). 4. Check the loading bay barcode scanner. If necessary, clean the glass pane (see chapter 9.3 on page 9-8). 5. Try to insert the rack again. The tabular Sample Editor dialog is displayed again. 6. If the instrument still fails to read these barcodes, remove the rack once more (without closing the tabular Sample Editor dialog). 7. Enter the unreadable Sample IDs manually. Do not remove or exchange any of the barcoded samples (the instrument compares successive readings). 8. Insert the rack again. 9. Assign the assays (see chapter 4.4.2 on page 4-10).
In the results, all manually entered samples will be flagged ("ManID" flag). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 10.2.1.2 Problems with reinserted Sample Rack
Each time you reinsert a sample rack on the same lane, the instrument compares the data read by the barcode scanner during two successive readings. If any difference is found between the first and the second reading, the instrument assumes that tampering may have occurred and: • All Sample IDs entered manually in the tabular Sample Editor dialog between the first and second reading are deleted. • Rack positions that returned discrepancies between the first and the second reading are signalled visually (see below) and the corresponding data is cleared. • Rack positions for which the second reading is identical to the first are retained.
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Example: You insert a rack with 8 barcoded sample tubes for Sample IDs. The barcode scanner fails to read the barcode label on Position 6. When the tabular Sample Editor dialog is displayed, the first Sample ID is missing.
Figure 10-1: Result of the first reading
You remove the rack, type in the missing Sample ID (e. g. "Sample 11") (or scan it with the hand-held scanner) and click on the Close button to close the tabular Sample Editor dialog. Then you reinsert the rack on the same lane. When the tabular Sample Editor dialog is displayed again, if nothing else has changed, all 8 Sample IDs are listed in the Sample ID column.
Figure 10-2: Result of the second reading (no errors)
But, if you changed anything else on that rack, the manually entered ID(s) are deleted and any sample for which the barcode read in the second reading is not identical to the first barcode is corrected and marked. For example, if you inadvertently exchanged sample tubes "Sample 10" and "Sample 12" between the first and second readings, the tabular Sample Editor dialog displayed after the second reading looks like this: 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Figure 10-3: Result of the second reading (with errors)
You can see that the manually entered ID "Sample 11" has been deleted. Changed Sample IDs "Sample 10" and "Sample 12" have also been corrected and small boxes around position numbers 5 and 7 indicate that these positions have been changed between the first and the second readings.
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To correct this: 1. Click on the Close button, remove the rack and insert it once more. 2. Enter the missing IDs manually without changing anything else. 3. Click on the Close button and reinsert the rack. All Sample IDs should now be displayed. You can assign assays to each sample as described below.
10.2.1.3 Racks tend to tip over Sideways
When inserting a sample rack onto a lane, make sure to keep your rack strictly level while pushing it in. If you push down on the end that you are holding, the other end may lift out of the lane and the rack may tip over. If this happens, please refer to the clean-up and decontamination procedures described in chapter 9.6 on page 9-19.
10.2.1.4 Using different Sizes of Sample Tubes
The standard T sample racks (see chapter 2.2.4.1 on page 2-15) usually accommodate tubes with a diameter between 9 and 16 mm and a height not to exceed 10 cm. If you need to use smaller size tubes (e.g. Eppendorf tubes), narrower tubes or tubes with a specific shape, contact your service engineer to adapt and re-align your racks accordingly. The adapted racks will be identified by colored stickers and, in the Load dialog, these racks will be displayed in the corresponding color and identified by a different code letter (U, V, W, Y and Z). The GEMINI instrument will not accommodate sample tubes that exceed 10 cm in height; therefore, these samples must be transferred into smaller tubes to be processed.
10.2.1.5 There is not enough Space to fit all the Sample Tubes
Each rack can accommodate 16 tubes. The sample and reagent unit includes 12 rack tracks, some of which are reserved for the reagents. Therefore, the maximum number of sample tubes that you may load at the beginning of a run is: • 144 tubes (9 racks) if you intend to process one or two assays; • 96 tubes (6 racks) if you intend to process more than two assays. The continuous loading system may allow you to insert new samples at a later stage. The continuous loading system is explained in chapter 6.6 on page 6-48.
10.2.1.6 Sample Tubes with unknown Barcode Label Types
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 See chapter 8.3.6.2 on page 8-37 on how to set the scanner parameters and determine the type of barcode used.
10.2.1.7 The Instrument has not been able to read some of the Sample Barcodes
Either the problem is also a problem of barcode settings (i.e. the barcode scanner has not been set to read the type of barcode that is actually used on the tubes), then the answer is the same as in chapter 10.2.1.6 above, or the setting are correct but the scanning fails for another reason (e.g. the barcode printing is fuzzy); in this case, see chapter 4.4.2 on page 4-10
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10.2.1.8 The Instrument always requires that the loading Process be carried out from right to left
Under standard scanner settings, loading will always be directed from right to left, i.e. the LED to the very right will light up. The standard direction can be changed in the System Setup, under the Sample Rack tab in the field Auto Load (see chapter 8.3.6 on page 8-33).
10.2.1.9 You want to process two Tubes of each Sample (Duplicate Sample Tubes)
You are not allowed to load sample tubes with identical barcodes. If you do, an error message is displayed: Duplicate sample ID ………! Edit the sample IDs so that only one tube is used per sample.
If you really want to process two tubes of each sample, you have to use different barcode labels for each tube. What the instrument does allow you to do is to test the same sample twice with the same assay on the same plate (replicate wells), by using the multiple determination option of the Add Sample dialog (see chapter 6.2.1 on page 6-6). In that case, the sample will be pipetted twice out of the same tube and dispensed into two consecutive wells of the same plate. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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10.2.2 Troubleshooting while Loading Reagents
10.2.2.1 Non-Barcoded unstable Reagents
If the unstable reagent you loaded is not barcoded (or has an incorrect barcode), an error message is displayed: "Error! Barcode "…" is not correct for reagent "(reagent name)". You can click on the OK button to close the message but it will appear again and again until the end of the preset preparation time. When the preparation time is over, the instrument assumes that you have not loaded the required unstable reagent and that you need to abort the plate for which this reagent was required. It therefore opens the System Paused dialog (see chapter 4.9.5 on page 4-57) to allow you to abort this plate. At this stage, if you had actually loaded the required unstable reagent, DO NOT abort any plates and just click on the Resume button. The run continues normally (the instrument actually dispenses the unstable reagent) but in the log file, a warning is included stating that the reagent was not loaded on time and the volume of the unstable reagent is not checked. This procedure is therefore not satisfactory. This is why it is recommended to always use barcoded unstable reagents.
10.2.2.2 Unreadable Barcodes
If the instrument has not been able to read one or several barcodes of reagents: 1. Remove the inserted rack. 2. Check the barcode labels on the tubes/bottles that the instrument failed to read. Make sure the labels are facing on the right-hand side and are not damaged or dirty. Make sure the barcode type is the same as on the tubes/ bottles that were correctly read (otherwise, you may need to change your barcode settings, (see chapter 8.3.6.2 on page 8-37)). 3. Check the loading bay barcode scanner. If necessary, clean the glass pane (see chapter 9.3 on page 9-8). 4. Try to insert the rack again. 5. If the instrument still fails to read these barcodes, assign the reagents manually in the Load window. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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10.3 Worklist Troubleshooting
10.3.1 Error Detection while creating Worklist
If, while conducting its verification process (after you click on the OK button in the Lot Specific Value dialog), the instrument does not identify any problem, the Worklist window will be displayed and the status of the plates in the Worklist Parameters will be Not loaded (see chapter 4.7.1 on page 4-20). Conversely, if the instrument detects a problem, a corresponding error message will be displayed. If the error is related to the way you defined your worklist (e.g. if you tried to combine too many assays and samples and the instrument cannot find a way to schedule them adequately), correcting the source of the error will involve going back to the Set-up Panel dialog. To do this: 1. Click on the OK button in the error message box. The Worklist window appears but Error is displayed (instead of Not loaded) as the status for that plate. If the status for a plate appears as Error, the respective plate cannot be processed.
2. Click on the Lot Specific Values button in the Worklist window to re- open the Lot Specific Values dialog. 3. Carry out the necessary changes and click on the OK button again. If you have successfully corrected the problem, the Worklist window will be displayed again but this time the status for this plate in the Worklist Parameters is Not loaded.
If the error is related to the assay file you are using (e.g. if the reading parameters refer to a photometer filter not available on the instrument or if one of the reagents required for the assay has not been entered in the reagent database (see "Assay Programming Manual"), open your assay file and check it thoroughly (edit it if necessary). If you use only validated assays for GEMINI, you should not encounter this kind of problem. If the error is related to a problem in the instrument itself, please refer to the error message list (see chapter 10.1 on page 10-1). 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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10.3.2 Monitoring of the Incubation Temperature
For elevated temperature incubation, if the incubation temperature monitored during the run does not correspond to the incubation temperature defined in the assay: • A general warning will be included in the Title Block section of the Result Report ("Warning! Incubator tolerance of xx°C was exceeded." (see chapter 4.10.1 on page 4-63). • In the Combined Report, all affected samples will be flagged (IncKo - Incubation overrun, see chapter 4.10.1 on page 4-63 and chapter 4.10.2.1 on page 4-66) and the results for these samples will not be calculated.
Example: If the temperature defined in the assay is 37°C +/- 1°C, there is a flag and no result calculation when: • the mean incubation temperature is < 36°C or > 38°C or • the maximum incubation temperature is > 38°C. If the temperature defined in the assay is 37°C +/- 1°C, there is no flag and the results are calculated when: • the minimum incubation temperature is < 36°C and • the mean incubation temperature is > 36°C and < 38°C.
Temperature (°C)
Min. Mean Max.
36.3 37 37.5 No Flag, Result calculated 35.5 36.5 37.5 No Flag, Result calculated 36.3 37.5 38.2 Flagged, Result not calculated 34.3 35.8 37.5 Flagged, Result not calculated
The same warning and flags apply if there is a discrepancy between the actual duration of an incubation step during a run and the incubation duration defined in the assay. Incubation duration errors apply both to room-temperature and elevated- temperature incubations. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Using the Outliers dialog, it is possible to calculate results for samples invalidated because of incubation errors (see "Instructions for use Manual"). This, however, should only be done for reference purposes and under the laboratory supervisor's sole responsibility.
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10.3.3 Pipettor Crash with attached Disposable Tip
After a pipettor crash with attached disposable tip the pipettor needs to be initialized! Follow the steps: 4. Open the cover. 5. Grip the disposable tip adapter on its front and back side between your fingers. 6. Move the disposable tip adapter with the attached tip up until it reaches the mechanical stop. 7. Move the pipettor by hand to the eject position. Grip the pipettor on the pipettor arm (move left or right) and the sledge (move to the front or rear).
Risk of Cross-contamination Do not move across microplates, sample or reagent tubes, slides etc.
8. Move the disposable tip adapter with the attached tip down until it reaches the eject position. 9. Remove the tip carefully above the eject position. 10. Drop the tip into the eject duct. 11. Close the cover. 12. Press the OK button to allow the instrument to proceed. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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10.4 Archiving Troubleshooting
10.4.1 Pipetting errors during the archiving process
The Archiving Parameters dialog (see chapter 6.7.4 on page 6-58) does not include a field allowing users to specify an "action on error" option (as exists in the Pipette step dialog (see "Assay Programming Manual"). If a pipetting error occurs during a sample archiving operation the instrument automatically uses the "log and continue" mode. For example, if a clot is detected in a sample, the pipettor moves on to the assigned archiving tube or archiving plate and dispenses whatever quantity of liquid is present in the tip (i.e. the quantity it has been able to aspirate before the clot). The respective sample is flagged with "Clot" in the Archiving Report and the pipetting error is traced in the log file.
10.4.2 Sample Aspirate/Dispense Volumes
In the Archiving Parameters dialog (see chapter 6.7.4 on page 6-58), the default Sample Dispense / Volume is 800 µl. If you intend to archive your samples in standard flat-bottom or round-bottom plates, do not forget to enter a smaller dispense volume (recommended is 300 µl for flat-bottom and 200 µl for round-bottom plates). Otherwise, when you confirm your archiving parameters by clicking OK, the instrument will display an error message stating: "All of the dilution resources have been used." Another option is to select deepwell plates as archive plates in the Plate type drop- down list.
10.4.3 Volume Offset Error
A volume offset error message is displayed if the aspirate volume and dispense volume values you defined are incompatible with the volume offset values stored in the instrument. If this happens, click on the OK button to close the error message. A second error message is displayed ("Scheduling error"). Click OK again to close this second
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 message. Then go back to the Archiving Parameters dialog (see chapter 6.7.4 on page 6-58) and edit Sample Aspirate / Volume and Sample Dispense / Volume values until this error message is no longer displayed.
10.4.4 Secondary Tubes Loaded on ordinary Sample Racks
If the "Duplicate sample ID" error message is displayed, this generally means that the instrument has detected two identically barcoded tubes although no multiple determination has been defined in the worklist. Check that you have not inadvertently loaded some secondary archiving tubes (with identical barcode labels) on a standard T sample rack instead of on a Z archiving rack.
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11.1 Installation of the Instrument
Installation by unauthorized personnel Improper installation can cause damage or malfunctions. • Installation shall be executed by authorized service personnel.
Installation qualification (IQ) After the installation, the user of the instrument receives an installation qualification which documents the proper installation of the instrument.
Microsoft software license terms (EULA) Please note the enclosed Microsoft software license terms for the Microsoft Windows embedded operating system. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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11.2 Removal of the Instrument
Removal by unauthorized personnel Improper removal will cause damage. • Removal shall be executed by authorized service personnel.
Omitted reinstallation If the instrument moves within the plant, the authorized service personnel shall perform a complete reinstallation. If this reinstallation is omitted, this will cause damage of the instrument or irregular pipetting performance! • Reinstallation shall be executed by authorized service personnel. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Specification Values are achieved under optimal conditions and can vary depending on environmental conditions, instrument status and processing conditions! Specifications are subject to change with notice according to STRATEC`s “Change control system”.
12.1 Instrument Data
Power requirements of the instrument:
Voltage/Frequency: 100 V - 240 V / 50 - 60 Hz Amperage: 3.2 A - 1.3 A Fuses: primary 250 VAC / T 4 AH
Power requirements of the All-In-One-PC power supply:
Voltage/Frequency: 100 V - 240 V / 50 - 60 Hz Amperage: 2 A DC output: 24 V / 2.5 A
Laser of the barcode scanner:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Class: Class 2 laser product Maximal output radiation: 1.3 mW Pulse duration: 420 µs Emitted wave length: 650 nm
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Integrated computer and connections:
Hardware All-In- Processor: Intel Celeron J1900 One-PC: Memory (RAM): 4 GB Hard disk: 500 GB Ports: 1x USB 3.0 ports (rear), 4x USB 2.0 ports (rear and side bezel), 1x external monitor connector, 2x serial RS 232 ports, 1x LAN (Gigabit) Integrated monitor: Touch screen, 15 inch
Software: Operating system Microsoft® Windows ® 7 (32 Bit; UK English) The user software is also compatible to Microsoft® Windows ® XP (UK English) with Service Pack 2
Installation dimensions and weight:
Width: With touch screen on the cover: 97 cm (38.2 inch) With touch screen on the right side: 140 cm (55.1 inch) Depth: 67 cm (26.4 inch) Height: 75 cm (29.9 inch) Weight: 100 kg (220.5 lb.) without accessories
Environmental conditions: The following table shows the range of conditions needed to run the instrument safely.
Environmental The instrument is made for indoor use. Condition:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Temperature: Operating: 15 to 30 °C (59 to 86 °F) Storage: 5 to 50 °C (41 to 122°F) Transport: 5 to 50 °C (41 to 122°F) Humidity: Operating: 30 - 80 % non-condensing Storage: 10 - 85 % non-condensing Transport: 10 - 85 % non-condensing Pollution degree: 2 Installation Class: 2 Sunlight: No direct sunlight May mislead optical sensors and affect performance Altitude Up to 2000 m (6561 ft.) above mean sea level Storage: as required for air travel Dust: No excessive dust
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Noise:
70 dB A (distance 1 m (39.37 inch))
Packaging:
Dimensions (WxDxH): 125 cm x 90 cm x 115 cm (49.2 inch x 35.4 inch x 45.3 inch) Weight: 153 kg (337.3 lb.) with accessories 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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12.2 Specifications
Photometer (Reader):
Photometric range 0 to 3.0 OD Spectral range 400 nm to 700 nm (up to 8 filters) Read time < 15 sec single, < 30 sec dual Precision 1 % CV at 1.0 OD Accuracy +/-0.005 OD or 2.5 % (whichever is greater) Linearity 0 to 2.0 OD +/- 1 %
Pipettor:
Min. / max. volumes 10 µl to 300 µl with 300 µl tip 301 µl to 1000 µl with 1100 µl tip Precision (single dispense) < 3 % CV at 20 µl < 3 % CV at 100 µl Precision (multi dispense) < 10 % CV at 16 x 20 µl < 3 % CV at 8 x 100 µl Features Pipetting pressure monitoring, capacitive liquid level detection, tip detection, mixing, multiple dilution steps, archiving
Capacity:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Sample and reagent capacity Up to 192 samples Flexible: e.g. 144 samples + 8 reagents + 16 controls
Incubator:
Temperature range Up to 45°C (113°F) Temperature uniformity +/- 1.5°C (34.7°F) (with in-process temperature monitoring) Shaking 20 Hz
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Washer:
Precision 10% CV at 300 µl Residual volume < 2.5 µl in U-bottom (mean) < 4 µl in flat bottom (mean) Wash buffer capacity 3 wash buffers Modes Sweep mode, soak, top and bottom wash, variable pump speed
All values are achieved under optimal conditions and can vary depending on environmental conditions, instrument status and processing conditions. Specifications are subject to change with notice according to the "Change control system".
Additional functionality through software middleware:
Easy integration Wide range of interfaces allows consolidation of results from other instruments Connects host Provides smooth real time bi-directional communication between device and LIS Connects instruments Operates with single or multiple GEMINI installations
Additional benefits:
Short/long term data storage Can operate with local dbase or SQL server Retest management User definable retest and reflex management Drill down Extensive drill down capability on 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 sample or plate data Open and definable User definable functions (e.g. reporting) allows maximum flexibility Closed and secure Software can be locked to operate as a secure closed system
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13.1 Accessories and Consumables (Ordering Information)
Non-recommended consumables and accessories The usage of non-recommended consumables and accessories can produce erroneous results or damage to the instrument. • Use only the consumables and accessories described herein.
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13.2 Checklists and Information
Do´s and Don’ts The "Do´s and Don’ts" list is a reminder of the main basic operating rules and safety precautions. It is provided to be copied and posted in your laboratory next to the GEMINI instrument. Maintenance Checklists The maintenance checklists should be copied and used to document the maintenance tasks as they are carried out by the GEMINI operators or laboratory workers. For details on how to perform the various maintenance procedures, see chapter 9 on page 9-1. Service Information The service information should be copied and used to document the service tasks as they are carried out by your service engineer. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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Do
• Always wear proper personal protective equipment: lab coat and gloves (plus eye protection when performing mainte- nance tasks). • Always turn off the instrument before cleaning. • If liquid gets inside the instrument, immediately disconnect the power cord and clean the affected areas as described in the Instruction for use Manual. • Always dispose of waste and used consumables in compli- ance with your laboratory guidelines and federal, state and local regulations. • Check system liquid and liquid waste container before a run.
Do Not
• Do not interfere with the processing unless absolutely neces- sary. If you need to do so, pause the instrument first. • Do not use any disinfectant containing alcohol for perspex surfaces (e.g. instrument cover) or for the manifold.
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Do not bring disinfectant into contact with bearings and guides (lubricant may dissolve). • Do not use disinfectant in the vicinity of circuit boards and light barriers. • Do not clean heated incubators. • Do not refrigerate reagent racks.
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DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 404 of 425 GEMINI Maintenance Laboratory: Week No: GEMINI COMBO Daily Checklist Instrument No: Month / Year:
Daily Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday Start Up Check system liquid and waste liquid containers Check pipettor tubing and syringe for air bubbles or leakages After each Inspect instrument deck, plates, racks, etc. for run spillages Remove reagent and sample racks Remove used test and dilution plates Check the waste bag, system liquid and waste liq- uid containers Shut Inspect instrument deck, plates, racks, etc. for Down spillages Remove reagent and sample racks Close the finished worklist(s) and files Exit the user software and shut down windows Switch off the instrument Check the waste bag, system liquid and waste liq- uid containers Remove all disposable tip racks Remove all reagent and control bottles from the racks or instrument and store them Clean or decontaminate the instrument (if neces- sary) 350 Effective (geltend) / Review am: 02.10.2032 - stuff / 18.10.2017 09:09:14 / 18.10.2017 - stuff 02.10.2032 am: / Review (geltend) Effective 350
Operator/Supervisor: ......
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 405 of 425 GEMINI Maintenance Laboratory: Week No: GEMINI COMBO Weekly Checklist Instrument No: Month / Year:
Weekly Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday Clean the IFA pipettor tip needles Run an assay to clean/decontaminate the washer Perform the shut down steps of the daily maintenance Clean and decontaminate the instrument Check the washer performance
Operator/Supervisor: ......
GEMINI Maintenance Laboratory: Week No: GEMINI COMBO Weekly Checklist Instrument No: Month / Year:
Weekly Maintenance Procedure Monday Tuesday Wednesday Thursday Friday Saturday Sunday Clean the IFA pipettor tip needles Run an assay to clean/decontaminate the washer Perform the shut down steps of the daily maintenance Clean and decontaminate the instrument
350 Effective (geltend) / Review am: 02.10.2032 - stuff / 18.10.2017 09:09:14 / 18.10.2017 - stuff 02.10.2032 am: / Review (geltend) Effective 350 Check the washer performance
Operator/Supervisor: ......
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 406 of 425 GEMINI Maintenance Laboratory: GEMINI COMBO Monthly and Special Checklist Instrument No: Year:
Monthly Maintenance January February March April May June July August September October November December Perform the weekly mainte- nance Clean and decontaminate the system liquid and waste liquid containers Clean and decontaminate the wash buffer bottles (bot- tles only) Clean the head of the pipet- tor Clean the room-temperature incubators Perform a backup Check the performance of the pipettor
Special procedures Date Operator Comments (circumstances, parts affected, details...) Heavy liquid overflow clean-up Washer manifold needles (clean needles) Photometer (bulb replacement, filter maintenance or replacement) 350 Effective (geltend) / Review am: 02.10.2032 - stuff / 18.10.2017 09:09:14 / 18.10.2017 - stuff 02.10.2032 am: / Review (geltend) Effective 350 Reader confidence check with reader verification plate Fuse replacement Other
Operator/Supervisor: ......
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DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 408 of 425 GEMINI GEMINI COMBO Service Information
(To be completed by your service engineer or your local technical support person.)
Contact Information:
Instrument Serial Number:
Maintenance and Servicing Visits:
Date Description Done by 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Service Information 1 / 2
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 409 of 425 Date Description Done by 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
2 / 2 Service Information
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 410 of 425 Contact
14 Contact
Germany STRATEC Biomedical AG Gewerbestraße 37 75217 Birkenfeld Germany Phone: +49 (0) 7082 7916-0 Fax: +49 (0) 7082 7916-999 E-Mail: [email protected] Internet: www.stratec.com
Switzerland STRATEC Biomedical Switzerland AG Neuwiesenstrasse 4 8222 Beringen Switzerland Phone: +41 (0) 52 6876 200 Fax: +41 (0) 52 6876 202 E-Mail: [email protected] Internet: www.stratec.com 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 14-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 411 of 425 Contact
Intentionally left blank. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
14-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 412 of 425 Index
15 Index
A Combination groups ...... 6-22 Compatible structure/parameters ...... 6-22 Abbreviations ...... 1-15 Optimizing the plate layout ...... 6-23 Abort plate if small tips run out ...... 4-47 Several assays per plate ...... 6-21 Abort run ...... 4-57 Strip management ...... 6-23 Abort run (IFA) ...... 5-25 Assay protocol parameters ...... 4-15 Access rights (see Restricted access rights) Assay protocol parameters (IFA) ...... 5-8 Accessories ...... 2-25, 13-1 Assays ...... 4-8 Active event log ...... 4-27 Assign assays ...... 4-8, 4-10, 6-9, 6-20 Event log filter ...... 4-28 Assign assays (IFA) ...... 5-5 Open ...... 4-28 ASTM ...... 4-13 Textfile ...... 4-29 ASTM (see connection) APM report ...... 6-73 ASTM link (see connection) Archiving ...... 6-53 Archive plates ...... 6-63 Archiving parameters dialog ...... 6-58 B Archiving within a normal run ...... 6-56 Bar code Imported Worklists ...... 6-57 Unknown labels ...... 10-18 Independent archiving ...... 6-53 Barcode • Archiving run ...... 6-54 Unknown labels ...... 10-18 • Enable/Disable ...... 6-53 unreadable ...... 10-16, 10-20 Information and Report ...... 6-64 Batch numbers ...... 4-15 Samples ...... 6-53 Batch numbers (IFA) ...... 5-8 Secondary tubes ...... 6-64 Testing archived samples ...... 6-65 Brief sequence plan ...... 4-2, 5-3 • On another system ...... 6-66 • On the system ...... 6-65 C Tips ...... 6-68, 10-24 • Archiving large volumes ...... 6-68 Cancelling a run ...... 4-60
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 • Barcode labels for primary and secondary Cancelling a run (IFA) ...... 5-27 tubes .....6-68 Check • Microtube trays ...... 6-68 Clean fluid volume ...... 4-52 • Multiple archiving ...... 6-68 Pre-run checks ...... 4-52 Troubleshooting ...... 10-24 Reagent volume ...... 4-53 • Pipetting errors ...... 10-24 Sample volume ...... 4-54 • Sample aspirate/dispense volumes .10-24 Tip size volume ...... 4-54 • Secondary tubes on sample racks ...10-24 Wash buffer volume ...... 4-52 • Volume offset error ...... 10-24 Checklists ...... 13-2 ASCII file ...... 4-13 Cleaning ...... 9-1 ASCII file transfer (see connection) Clogged pipettor tip ...... 9-22 Aspirate pressure monitoring (APM) ..8-25, Clogged wash head ...... 9-23 8-47 Safety ...... 9-1 Assay Computer and connections ...... 12-2 Automatic worklist ...... 6-22 Configuration ...... 8-1, 8-9, 8-18
Gemini - Instructions for use manual - Rev. 10 15-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 413 of 425 Index
Connection E ASCII • Automatic export ...... 7-10 Edit number dialog ...... 3-16 • Automatic import ...... 7-7 Edit text dialog ...... 3-16 • Contents of export files ...... 7-11 Editing the results ...... 6-43 • Defining Import Parameters ...... 7-5 Emergency stop ...... 4-60 • Deletion of imported files ...... 7-8 Emergency stop (IFA) ...... 5-27 • Export test results ...... 7-10 End of day maintenance ...... 4-75 • File polling ...... 7-7 End of run ...... 4-61 • Hardware configuration ...... 7-2 End of run (IFA) ...... 5-28 • Import failure ...... 7-8 Environmental conditions ...... 12-2 • Importing patient data ...... 7-3 Error ...... 10-1 • Individual export requests ...... 7-10 Messages ...... 10-1 • Manual import ...... 7-6 Event log (see Active event log) • Multiple test order ...... 7-9 Export the result report ...... 4-69 • Opening ASCII result export files ...... 7-13 • Successful import ...... 7-8 • Types of import files ...... 7-3 F • Worklist files ...... 7-3 ASCII file transfer ...... 7-2 File types ...... 8-16 ASTM ...... 7-14 Fill clean buffer ...... 4-48 • Communication procedure ...... 7-17 Fill system liquid ...... 4-49 • Definition of LIS assay names ...... 7-15 Fill wash buffer ...... 4-48 • Low-Level Protocol ...... 7-18 Flag • Message level protocol ...... 7-19 Clot ...... 4-66 • Transmission examples ...... 7-20 IncKo ...... 4-66 ASTM link ...... 7-14 InsLiq ...... 4-66 ASTM link set-up ...... 7-14 ManID ...... 4-10, 4-66, 10-16 Connection to a host computer ...... 7-1 NoLiq ...... 4-66 Consumables ...... 2-25, 13-1 PipErr ...... 4-66 Contact ...... 14-1 REAG EXP ...... 4-66 Continuous loading ...... 6-48 RegtRem ...... 4-73 Check reloading time ...... 6-49 RgtRem ...... 4-53, 4-66 Load new patient samples ...... 6-50 SplRem ...... 4-66, 4-72 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Redefining worklist ...... 6-50 VCFail ...... 4-67 Reloading IFA slides ...... 6-52 VDFail ...... 4-67 Reloading other Resources ...... 6-51 Flags ...... 4-66 Reloading test plates ...... 6-52 Forgotten password ...... 8-7 Create a Worklist ...... 4-14, 6-11 Create a Worklist (IFA) ...... 5-6 G
D Good laboratory practice ...... 1-2
Demo mode ...... 4-4, 6-75 H Different sizes of tubes ...... 10-18 Disposable tips ...... 4-45 Hints ...... 4-1, 5-2 Duplicate sample tubes ...... 10-19 Host Dynamic dilutions ...... 5-5 ASCII file ...... 4-13
15-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 414 of 425 Index
ASTM ...... 4-13 Liquid level detection (LLD) ...... 2-21 Host computer ...... 7-1 Liquid overflow (heavy) ...... 9-21 Host connection ...... 4-13 Load dialog ...... 4-33, 6-36 Scanner configuration ...... 6-37 I Load dialog (IFA) ...... 5-19 Load dilution plates ...... 4-44 Identical reagent in two separate bottles 4- Load plates dialog ...... 4-49 41 Load reagent rack ...... 4-39 IFA bay, IFA tray and IFA slides handling ... Load reagents ...... 4-39 2-23 Load required resources ...... 4-31 Import patient data ...... 4-13 Load required resources (IFA) ...... 5-17 Importing patient data ...... 7-3 Load samples ...... 4-8, 4-36 Incorrect password ...... 4-6 Load samples (IFA) ...... 5-5 Information ...... 13-2 Load slides ...... 5-21 Initialization ...... 6-1 Load test plates ...... 4-49 Input dialog ...... 3-16 Load tip racks ...... 4-45 Installation dimensions ...... 12-2 Load unstable reagents ...... 4-42 Installation of the instrument ...... 11-1 Loading direction ...... 10-19 Instrument description ...... 2-1 Log-On ...... 4-3 Instrument errors ...... 4-57 Log-on ...... 4-3 Instrument errors (IFA) ...... 5-24 Lot specific parameters ...... 6-45 Instrument overview (see Overview) Lot specific values ...... 4-15 Intended Use ...... 1-1 Lot specific values (IFA) ...... 5-8 Introduction ...... 1-1 M J Maintanance Job list ...... 4-30 Maintenance jobs ...... 8-42 • Definition ...... 8-45 K • Examples ...... 8-45 • Execute ...... 9-18 Known limitations ...... KL-1 Performance evalution ...... 9-15
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Washer performance ...... 9-10 Maintenance ...... 9-1 L Backup system files ...... 9-16 Label Daily ...... 9-4 Biological Hazard ...... 1-12 • After each run ...... 9-5 Cut Injury Hazard ...... 1-13 • Shut down ...... 9-6 Electrical Hazard ...... 1-12 • Start-up ...... 9-4 General Warning ...... 1-12 Damaged parts ...... 9-36 Laser Hazard ...... 1-12 Heavy liquid overflow ...... 9-21 Type ...... 1-13 Monthly ...... 9-14 Photometer ...... 9-26 Language ...... 6-74 • Photometer Lamp ...... 9-26 Laser ...... 12-1 Pipettor malfunction ...... 9-22 Levey Jennings Plot ...... 6-72 Power supply ...... 9-24 Limited warranty ...... 1-2 • Main fuses ...... 9-24
Gemini - Instructions for use manual - Rev. 10 15-3
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 415 of 425 Index
• Power cuts/outages ...... 9-24 Overview ...... 2-2 Procedures/Emergencies ...... 9-19 Electrical connections ...... 2-7 Reader confidence check ...... 9-28 IFA bay ...... 2-4 Reader verification plate ...... 9-28 Instrument ...... 2-2 Safety ...... 9-1 Liquid connections ...... 2-5 Visually check syringe ...... 9-20 PC connections ...... 2-7 Visually check tubing ...... 9-19 Visually check valve ...... 9-20 Washer P • Clogged pipettor tip ...... 9-22 Packaging ...... 12-3 • Clogged wash head ...... 9-23 Panel (see Worklist) • Other problems ...... 9-23 Password ...... 4-4, 4-6 Washer malfunction ...... 9-23 First-time use ...... 4-5 Weekly ...... 9-8 Incorrect password ...... 4-6 Maintenance jobs ...... 9-18 Password registration ...... 4-5 Make a selection dialog ...... 3-16 Registered users ...... 4-4 Manual pipetting ...... 4-59 Restricted access rights ...... 4-7 Manual pipetting (IFA) ...... 5-26 Successive users ...... 4-6 Menu ...... 3-1 Unknown user name ...... 4-4 Edit (worklist) ...... 3-4 Unregistered users ...... 4-4 File ...... 3-2 Password (see Restricted access rights) General Functions ...... 3-1 Password forgotten ...... 8-7 Help ...... 3-7 Patient archiving information ...... 4-30 Utilities ...... 3-5 Patient details ...... 6-4 Windows ...... 3-6 Patient editor Add patients manually ...... 6-6 N Assign assays ...... 6-9 complete ...... 6-4 Network ...... 7-1 Edit assigned assays ...... 6-10 Noise ...... 12-3 Edit patient details ...... 6-7 Notes ...... 1-3 Tabular ...... 4-10 Patient result report ...... 6-69 O Performance evalution ...... 9-15 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Pipetting errors ...... 4-57, 4-59 Online keyboard ...... 3-16 Pipetting errors (IFA) ...... 5-24, 5-26 Open ...... 3-10 Pipetting order ...... 6-5 Open the result report ...... 4-68 Pipetting profiles ...... 8-29 Options ...... 6-27, 8-1, 8-9 Plate layout ...... 6-18 ASTM tab ...... 8-12 Plate layouts ...... 4-23 Directories tab ...... 8-15 Power requirements ...... 12-1 File polling tab ...... 8-11 Preparing reagent rack ...... 4-39 Laboratory tab ...... 8-14 Primary-assay ...... 5-7 Password tab ...... 8-9 Print ...... 3-13 Preferences tab ...... 8-10 Preview ...... 3-15 User groups tab ...... 8-9 Print ...... 3-13 Users tab ...... 8-9 Setup ...... 3-14 Outliers ...... 6-43 Print the result report ...... 4-68, 5-29
15-4 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 416 of 425 Index
Processing the run ...... 4-51 Result report window (IFA) ...... 5-28 Processing the run (IFA) ...... 5-22 Save ...... 4-68 Result interpretation ...... 4-65 Q Result interpretation (IFA) ...... 5-29 Result report ...... 4-63 QA Analysis Report ...... 6-72 Result report (IFA) ...... 5-29 Quality Control Analysis Report ...... 6-72 Result report window ...... 4-61 Quantity of clean fluid ...... 4-48 Result report window (IFA) ...... 5-28 Quantity of wash buffer ...... 4-48 Reuse partially used tip racks ...... 4-46 Rights (see Restricted access rights) R Run Abort run ...... 4-57 Radio interferences ...... 1-14 Abort run (IFA) ...... 5-25 Reader verification plate ...... 9-28 Cancelling ...... 4-60 Reagent rack storage ...... 2-15 Cancelling (IFA) ...... 5-27 Reagent requirements ...... 4-24 Clean fluid volume check ...... 4-52 Emergency stop ...... 4-60 Recalculating the results ...... 6-43 Emergency stop (IFA) ...... 5-27 Recalculation ...... 6-45, 6-47 Instrument errors ...... 4-57 Reinserted sample rack ...... 10-16 Instrument errors (IFA) ...... 5-24 Reload tip racks ...... 4-46 Manual pipetting ...... 4-59 Removal of the instrument ...... 11-1 Manual pipetting (IFA) ...... 5-26 Report order ...... 6-5 Pipetting errors ...... 4-57, 4-59 Requirements ...... 1-2 Pipetting errors (IFA) ...... 5-24, 5-26 Restricted access rights ...... 4-7, 8-1 Pre-run checks ...... 4-52 Forgotten password ...... 8-7 Processing the run ...... 4-51 Individual users ...... 8-1 Processing the run (IFA) ...... 5-22 Password settings ...... 8-7 Reagent volume check ...... 4-53 Questions ...... 8-8 Sample volume check ...... 4-54 Special authorization ...... 8-6 Steps of a typical test run ...... 4-55 User groups ...... 8-1, 8-4 Steps of a typical test run (IFA) ...... 5-23 Result System paused dialog ...... 4-57 Editing ...... 6-43 System paused dialog (IFA) ...... 5-25
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 End of run ...... 4-61 Test plate removal ...... 6-41 End of run (IFA) ...... 5-28 Tip size volume check ...... 4-54 Export ...... 4-69 Walk-away ...... 4-56 Flags ...... 4-66 Walk-away (IFA) ...... 5-24 Lot specific parameters ...... 6-45 Wash buffer volume check ...... 4-52 Open ...... 4-68 Outliers ...... 6-43 S Print ...... 4-68, 5-29 Recalculating ...... 6-43 Safety ...... 4-1, 5-2, 9-1 Recalculation ...... 6-45, 6-47 Safety instructions ...... 1-6 Result interpretation ...... 4-65 Safety labels ...... 1-12 Result interpretation (IFA) ...... 5-29 Samples ...... 4-8 Result report ...... 4-63 Samples (IFA) ...... 5-5 Result report (IFA) ...... 5-29 Save ...... 3-11 Result report window ...... 4-61
Gemini - Instructions for use manual - Rev. 10 15-5
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 417 of 425 Index
Save the result report ...... 4-68 Sample rack tab ...... 8-33 Scanner configuration ...... 6-37, 8-33 System tab ...... 8-19 Schedule ...... 4-21 Washer tab ...... 8-38 Optimize ...... 6-35 System status ...... 4-26 Schedule (IFA) ...... 5-13 System status (IFA) ...... 5-16 Selection dialog ...... 3-16 Selection window T File ...... 3-2 Help ...... 3-7 Technical data ...... 12-1 New ...... 3-8 Tip types ...... 4-45 Open ...... 3-9 Touch screen handling ...... 2-22 Windows ...... 3-6 Troubleshooting ...... 10-1 Selftest ...... 6-1 Crash with Disposable Tip ...... 10-23 Before each run ...... 6-3 Different sizes of tubes ...... 10-18 Failures ...... 6-3 Duplicate sample tubes ...... 10-19 Manually start ...... 6-3 Incubation temperature ...... 10-22 Set-up (see System set-up) ...... 8-18 Loading ...... 10-16 Set-up panel (see Worklist) Loading direction ...... 10-19 Shut down ...... 4-75 Loading reagents ...... 10-20 Simulation mode ...... 6-75 Loading samples ...... 10-16 Slide layouts ...... 5-15 Maximum number of tubes ...... 10-18 Slides handling ...... 2-23 Non-barcoded unstable reagents ...... 10-20 Racks tend to tip over sideways ...... 10-18 Software language ...... 6-74 Reinserted sample rack ...... 10-16 Special types ...... 1-5 Unknown barcode labels ...... 10-18 Specifications ...... 12-4 Unreadable barcode ...... 10-16, 10-20 Start worklist ...... 4-31 Worklist ...... 10-21 Start worklist (IFA) ...... 5-17 Worklist creation ...... 10-21 Start-up ...... 4-3 Tube Start-up (IFA) ...... 5-4 Maximum number ...... 10-18 Storage conditions ...... 2-15 Sizes ...... 10-18 Sub-assays ...... 5-7 Type label, Labels ...... 1-12 Successive users ...... 4-6 Type of clean fluid ...... 4-48
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Symbol ...... 3-1 Type of wash buffer ...... 4-48 Symbols Typographical conventions ...... 1-3 Other ...... 1-5 Warning ...... 1-4 System configuration ...... 8-1, 8-9, 8-18 U System liquid container ...... 2-20 Unload System paused dialog ...... 4-57 Dilution plates ...... 4-73 System paused dialog (IFA) ...... 5-25 Other resources ...... 4-74 System set-up ...... 8-1, 8-18 Reagent racks ...... 4-73 Colorimeter tab (photometer) ...... 8-23 Sample racks ...... 4-72 IFA tab ...... 8-31 Slides ...... 5-30 Incubators tab ...... 8-21 Test plates ...... 4-70 Maintenance tab ...... 8-42 Tip racks ...... 4-73 Pipette tab ...... 8-25 Waste disposal ...... 4-74 Plate transport tab ...... 8-41
15-6 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 418 of 425 Index
Unloading ...... 4-70 Fill wash buffer ...... 4-48 Unloading (IFA) ...... 5-30 Load dialog ...... 4-33, 6-36 Use Load dialog (IFA) ...... 5-19 Archive plates ...... 2-11 Load dilution plates ...... 4-44 Diluter pump ...... 2-20 Load options ...... 6-36 Dilution plates ...... 2-11 Load plates dialog ...... 4-49 Disposable tip racks ...... 2-10 Load reagents ...... 4-39 Incubator ...... 2-19 Load required resources ...... 4-31 Large reagent bottles ...... 2-11 Load required resources (IFA) ...... 5-17 Microplates ...... 2-8 Load samples ...... 4-36 Photometer ...... 2-19 Load slides ...... 5-21 Pipettor ...... 2-20 Load test plates ...... 4-49 Plate transport ...... 2-8 Load tip racks ...... 4-45 Stacker ...... 2-19 Load unstable reagents ...... 4-42 Wash buffers ...... 2-18 Open ...... 6-25 Washer ...... 2-18 Optimizing the plate layout ...... 6-23 Use loading bay ...... 2-14 Options ...... 6-27 Use of the instrument ...... 4-1 Plate layout ...... 6-18 Result ...... 6-24 Use of the instrument with IFA ...... 5-1 Save ...... 6-25 Use of the modules ...... 2-8 Set-up panel dialog ...... 4-14, 6-11, 6-15 Use only full tip racks ...... 4-46 Set-up panel dialog (IFA) ...... 5-6 User groups (see Restricted access rights) Several assays per plate ...... 6-21 User rights (see Restricted access rights) Start ...... 4-31 Utilities ...... 3-5 Start (IFA) ...... 5-17 Strip management ...... 6-23 V Worklist options ...... 6-27 After register ...... 6-34 Volume offset ...... 8-50 Before register ...... 6-30 During register ...... 6-32 W Scheduling register ...... 6-27 Worklist parameters ...... 4-20 Walk-away ...... 4-56 Worklist parameters (IFA) ...... 5-12 Walk-away (IFA) ...... 5-24 Worklist window ...... 4-18 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14 Warning symbols ...... 1-4 Active event log ...... 4-27 Warnings ...... 1-3 Job list ...... 4-30 Washer performance ...... 9-10 Patient archiving information ...... 4-30 Waste container ...... 2-18 Plate layouts ...... 4-23 Weights ...... 12-2 Reagent requirements ...... 4-24 Worklist Schedule ...... 4-21 Schedule (IFA) ...... 5-13 Add patient ...... 6-20 Slide layouts ...... 5-15 Automatic worklist ...... 6-22 System status ...... 4-26 Continuous loading (see Continuous loading) System status (IFA) ...... 5-16 Create (automatically, IFA) ...... 5-6 Worklist parameters ...... 4-20 Create (automatically) ...... 4-14 Worklist parameters (IFA) ...... 5-12 Create (manually) ...... 6-11 Fill clean buffer ...... 4-48 Worklist window (IFA) ...... 5-10 Fill system liquid ...... 4-49
Gemini - Instructions for use manual - Rev. 10 15-7
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 419 of 425 Index
Intentionally left blank. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
15-8 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 420 of 425 Change History
HIS Change History
Change: Chapter
Changed water and DI-water to wash buffer. chapter 9.3.1, chapter 9.3.1.1, chapter 9.3.1.2 Add note to alternative evaluation kits. chapter 9.4.1 Distribution of the Instructions for use manual at the customer as FINAL version. DMS (Gemini/Gemini COMBO / 15100013290 / (Rev. 10)). 10054302
Table HIS-1: Change History 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
Gemini - Instructions for use manual - Rev. 10 HIS-1
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 421 of 425 Change History 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
HIS-2 Gemini - Instructions for use manual - Rev. 10
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 422 of 425 Unterschriftenblatt
Zeitangabe Name/Funktion Unterschrift Erstellt 20.09.2017 10:09:56 Kempf, Oliver /450 100: Hiermit bestätige ich, Kempf, Oliver (kempf) signiert als kempf, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" fertiggestellt und zur Prüfung gesendet zu haben. Erstellt 22.09.2017 09:29:50 Kempf, Oliver /450 100: Hiermit bestätige ich, Kempf, Oliver (kempf) signiert als kempf, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" fertiggestellt und zur Prüfung gesendet zu haben. Freigegeben 22.09.2017 09:49:24 Fuchs, Stephanie /150 345: Hiermit gebe ich, Fuchs, Stephanie (sfuchs) signiert als sfuchs, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" frei. Geprüft 28.09.2017 16:25:46 Stuff, Marco /770 200: Hiermit bestätige ich, Stuff, Marco (stuff) signiert als stuff, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" erfolgreich geprüft zu haben. Geprüft 02.10.2017 09:10:43 Schmitt, Oliver /470 200: Hiermit bestätige ich, Schmitt, Oliver (schmitt) signiert als schmitt, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" erfolgreich geprüft zu haben. In Kraft gesetzt 02.10.2017 09:11:23 Schmitt, Oliver /470 351: Hiermit setze ich, Schmitt, Oliver (schmitt) signiert als schmitt, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" in Kraft.
Diese Informationen sind vom Mittwoch, 18. Oktober 2017 09:09 Uhr. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
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GEMINI - INSTRUCTIONS FOR USE
Nummer FM: 15100013290_10054302 Versionsnummer: 1.0 Lifecycle-Status: 350 Effective (geltend) Gültig ab: 02.10.2017 Gültig bis: 02.10.2032 Autor: Kempf, Oliver (kempf) QM-Hierarchie-Typ:
350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 424 of 425 Audit Trail
Zeitangabe Benutzer Aktion Grund 20.09.2017 Kempf, Oliver Lifecycle definiert 060: Hiermit bestätige ich, Kempf, Oliver (kempf) 10:09:48 signiert als kempf, die Lifecycleroute für das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" erstellt zu haben. 20.09.2017 Kempf, Oliver Bearbeitung 100: Hiermit bestätige ich, Kempf, Oliver (kempf) 10:09:56 signiert als kempf, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" fertiggestellt und zur Prüfung gesendet zu haben. 22.09.2017 Kempf, Oliver Lifecycle abgebrochen 061: Hiermit bestätige ich, Kempf, Oliver (kempf) 09:26:51 signiert als kempf, den Dokumentenumlauf für das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" zurückgezogen zu haben. 22.09.2017 Kempf, Oliver Lifecycle geändert 065: Hiermit bestätige ich, Kempf, Oliver (kempf) 09:29:42 signiert als kempf, die Lifecycleroute für das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" geändert zu haben. 22.09.2017 Kempf, Oliver Bearbeitung 100: Hiermit bestätige ich, Kempf, Oliver (kempf) 09:29:50 signiert als kempf, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" fertiggestellt und zur Prüfung gesendet zu haben. 22.09.2017 Fuchs, Stephanie Freigabe 345: Hiermit gebe ich, Fuchs, Stephanie (sfuchs) 09:49:24 signiert als sfuchs, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" frei. 28.09.2017 Stuff, Marco Prüfung 200: Hiermit bestätige ich, Stuff, Marco (stuff) 16:25:46 signiert als stuff, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" erfolgreich geprüft zu haben. 02.10.2017 Schmitt, Oliver Prüfung 200: Hiermit bestätige ich, Schmitt, Oliver (schmitt) 09:10:43 signiert als schmitt, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" erfolgreich geprüft zu haben. 02.10.2017 Schmitt, Oliver Inkraftsetzung 351: Hiermit setze ich, Schmitt, Oliver (schmitt) 09:11:23 signiert als schmitt, das Dokument "GEMINI - INSTRUCTIONS FOR USE (15100013290_10054302)" in Kraft.
Diese Informationen sind vom Mittwoch, 18. Oktober 2017 09:09 Uhr. 350 Effective (geltend) / Review am: 02.10.2032 - stuff 18.10.2017 09:09:14
DMS Signature Authentication Code: 7fc3b1f5-dca2-4d01-9e52-f134b5141473 / DMS Document Id: [P000795646] / Version 1.0 / Page 425 of 425