QuickScan Touch Visible Scanning Densitometer

Operator's Manual Catalog Numbers 1690, 1691, and 1692 QuickScan Touch Visible Scanning Densitometer

Operator’s Manual WARNING! DO NOT ATTEMPT TO MOVE, INSTALL, OR OPERATE THIS INSTRUMENT BEFORE READING AND UNDERSTANDING THE CONTENTS OF THIS MANUAL, PARTICULARLY THE PRECAUTIONS, LIMITATIONS AND HAZARDS IN SECTIONS THREE AND FOUR. QuickScan Touch Program License Agreement This copy of the QuickScan Touch program is sold on the condition that the purchaser agrees to the terms of this license agreement. If not, the purchaser should return the uno- pened diskette package to Helena Laboratories to obtain a refund. Retention of the product will constitute acceptance of this license. 1. Helena Laboratories Corp. (Helena) warrants to the ORIGINAL PURCHASER ONLY (Purchaser) that the diskette on which the computer program is contained shall be free of defects in materials and workmanship under normal use for 6 months from the date of pur- chase. Helena will repair or, at its option, replace any defective diskette returned to the address below during the 6-month period. 2. THIS IS THE ONLY WARRANTY MADE BY HELENA COVERING THE QUICKSCAN Touch PROGRAM. THE COMPUTER PROGRAM AND THE ENCLOSED INSTRUCTIONAL MATERIALS ARE SOLD “AS IS”, WITHOUT ANY WARRANTY OF ANY KIND, EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO: ANY WARRANTY OF PERFORMANCE, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE. PURCHASER ASSUMES ALL RISKS AS TO THE PERFORMANCE AND RESULTS OF THE PROGRAM. IN NO EVENT WILL HELENA OR ITS SUPPLIERS BE LIABLE FOR ANY INCIDENTAL, CONSEQUENTIAL OR OTHER DAMAGES, INCLUDING BUT NOT LIMITED TO ANY DAMAGES ARISING FROM USE OR MISUSE OF THE PROGRAM. 3. This computer program is for the use of purchaser only, and only on the computer sys- tem specified. No part of the program may be reproduced, nor may any part of the program be utilized in or transferred to any information storage and retrieval system of electronic or mechanical medium without prior written permission of Helena. Purchaser may make up to two back-up copies of the program for Purchaser’s personal use only, and should forward any questions concerning reproduction or transfer of the program, and requests for permis- sion to do so, to Helena Laboratories, P.O. Box 752, Beaumont, TX 77704-0752. Any noncompliance with this paragraph will result in termination of this license, and may also re- sult in legal liability under U.S. copyright laws. 4. Use of this program constitutes acceptance of the terms and conditions of this agree- ment.

© July, 2017 Helena Laboratories Helena Laboratories 1530 Lindbergh Dr./P.O. Box 752 Beaumont, Texas 77704 USA Telephone (409) 842-3714

QuickScan Touch Table of Contents

List of Sections

Section 1 - Instrument Use and Function ...... 1-1

Section 2 - Principles of Operation ...... 2-1

Section 3 - Precautions and Limitations ...... 3-1

Section 4 - Hazards ...... 4-1

Section 5 - Installation ...... 5-1

Section 6 - User Setup ...... 6-1

Section 7 - Operating Instructions ...... 7-1

Section 8 - Test Functions and Quality Control ...... 8-1

Section 9 - Performance Specifications ...... 9-1

Section 10 - Maintenance, Troubleshooting, and Warranty ...... 10-1

Section 11 - Symbology...... 11-1

Section 12 - Communication Specifications ...... 12-1

Section 13 - V8 interface (optional) ...... 13-5

Section 14 - Tracking Software (optional) ...... 14-1

Section 15 - Index ...... 15-1

-i- QuickScan Touch Table of Contents

List of Figures

Figure 1-1 QuickScan Touch System...... 1-2

Figure 2-1 Functional Units of the QuickScan Touch Block Diagram ...... 2-3

Figure 2-2 Visible Scan Optics ...... 2-3

Figure 5-1 Back view of computer ...... 5-6

Figure 6-1 Main Menu ...... 6-2

Figure 6-2 Sign-In Menu ...... 6-2

Figure 6-3 User Setup, Demographics ...... 6-27

Figure 6-4 User Setup, Tests ...... 6-28

Figure 6-5 Test Setup, Test Types ...... 6-28

Figure 6-6 Test Setup, Gel Properties ...... 6-29

Figure 6-7 Test Setup, Scan Settings ...... 6-32

Figure 6-8 Test Setup, Scan Locations, IFE ...... 6-33

Figure 6-9 Test Setup, Scan Locations, SPE ...... 6-34

Figure 6-10 Test Setup, Fractions/ Ratios/Ranges ...... 6-35

Figure 6-11 Worklist Template Setup ...... 6-35

Figure 6-12 Worklist Template Setup ...... 6-36

Figure 6-13 Worklist Template Setup, Overlays ...... 6-37

Figure 6-14 Display Settings, Ranges ...... 6-38

Figure 6-15 Export Setting – Worklist Template ...... 6-39

Figure 6-16 User Setup, Comments ...... 6-40

Figure 6-17 User Setup, Comment / Interpretation ...... 6-41

Figure 6-18 Setup, Auto Interpret ...... 6-42

Figure 6-19 User Setup: Reports ...... 6-43

Figure 6-20 Report Setup, List Report ...... 6-44

-ii- QuickScan Touch Table of Contents

Figure 6-21 Reports Setup: Levey Jennings ...... 6-45

Figure 6-22 User Setup, Import/Export ...... 6-46

Figure 6-23 User Setup, Sample Handler...... 6-47

Figure 6-24 User Setup, Quality Control ...... 6-48

Figure 6-25 User Setup, Add User ...... 6-0

Figure 7-1 Main Menu ...... 7-42

Figure 7-2 New Worklist ...... 7-42

Figure 7-3 Label Worklist ...... 7-43

Figure 13-1 Main menu with V8 icon ...... 13-1

Figure 13-2 Connecting the QST to the V8 ...... 13-1

Figure 13-3 V8 Test Setup ...... 13-2

Figure 13-4 Import V8 Scans ...... 13-2

Figure 14-1 Main Menu ...... 14-0

Figure 14-2 Users and Passwords ...... 14-0

Figure 14-3 Open Worklist in the Review folder ...... 14-1

Figure 14-4 Review folder ...... 14-1

Figure 14-5 Open Worklist in the Re-Edit folder ...... 14-2

Figure 14-6 Re-Edit folder ...... 14-2

Figure 14-7 Open Worklist in the Accept folder ...... 14-3

Figure 14-8 Accept folder ...... 14-3

Figure 14-9 Accept folder ...... 14-4

Figure 14-9 Sending Scans to Review ...... 14-4

-iii- QuickScan Touch Table of Contents

List of Tables

Table 5-1 Inventory ...... 5-1

Table 5-2 System Requirements ...... 5-2

Table 10-1 Troubleshooting ...... 10-2

-iv- QuickScan Touch ONE - Instrument Use and Function Step-by-Step Method Section 1 - Instrument Use and Function Evaluation of the Bands

Helena’s QuickScan Touch (Figure1-1) is Stability of End Product a visible scanning densitometer used to scan electrophoretic gels, quantitate data, Results and display and print results. The QuickScan Touch is intended for in-vitro Expected Values diagnostic use only, in a laboratory or simi- lar environment. Performance Characteristics Visible sample gels are placed in the Interpretation of Results QuickScan Touch and scanned. Results for a number of different tests can then be Bibliography viewed on the monitor and printed in a re- port. A built-in computer directs all operations of the system. Varieties of test types are preprogrammed in the QuickScan Touch. Presently, these tests are Serum and Urine Proteins using acid blue stain, Serum Proteins using Pon- ceau S stain, Acid and Alkaline Hemoglobins, Alkaline Phosphatase, Cho- lesterol Profile, CK - Creatine Kinase, LD - Lactic Dehydrogenase, IFE - Immunofixa- tion, L/S - Lecithin/Sphingomyelin and Lipoproteins. Parameters for up to 20 tests can be stored in the unit. Stored results can be retrieved in seconds. Full editing features are provided so that fractions may be selected, baselines ad- justed, comments added to the file, etc. Up to 100 copies of a test report can be printed. Refer to the procedure supplied with the gels for information on the following areas:

Summary

Principle

Reagents

Instruments

Specimen Collection and Handling

1-1 QuickScan Touch ONE - Instrument Use and Function

Figure 1-1 QuickScan Touch System

1-2 QuickScan Touch TWO - Principles of Operation Reference pattern over the sample pattern Section 2 - Principles of Operation on the display or report, if desired. The QuickScan Touch program contains factory preset default values for scanning 2.3. Other Aspects of Operation parameters. These values can be The computer directs all system operation changed, permanently or temporarily. Re- according to the information contained in fer to section six for programming the memory and in response to commands instructions. If default parameters are al- from the user. The user makes selections tered, they can be reinstalled as needed. from information on the Color Display using the keyboard or mouse or the touchscreen The functional units of the QuickScan if available. Access to the setup can be Touch are shown in Figure 2-1. limited by use of a password. 2.1. Transmittance Densitometry Patient files can be duplicated and stored The visible mode optics configuration is at the user’s option. The backup infor- shown in Figure 2-2. A lamp (1) provides mation can be restored to the memory white light which passes through the sam- should this become necessary. Excessive ples on the electrophoretic gel (2). The data slows the computer, so periodic ar- entire gel is scanned in one pass. chiving of data is recommended. The amount of light passing through the The computer uses the sensor signal level sample is an inverse logarithmic function of to calculate fraction data for each pattern. sample density. For example, if the sam- An analog graph of the data is produced, ple density is doubled, the transmitted light which the user can edit as desired. The is reduced by a factor of ten. peak areas are expressed as percentages, with integration counts included if desired. The transmitted light falls on a CCD array When the total quantity in the sample is (3), generating current in proportion to the known, the quantity in each fraction can be amount of light hitting the sensors. This determined. signal is stored in memory, and used by the computer to calculate the area under When the results are displayed on the the curve for the various signal peaks, rep- monitor, the user can elect to edit the pat- resenting sample densities on the pattern. tern at that time, or later. If a printout is requested by the user, the printer produces The aperture size, selected by the user, a copy of the scan data and other user- mathematically determines the area of the entered information. Deviations in the re- scanned pattern used in calculations. If sults from reference ranges are indicated the aperture is too small, resolution will be as high (+) or low (-) on the printout. All high, but noisy or jagged patterns may re- the data for each scan can be automatical- sult. If the aperture is too large, a smooth ly stored on the hard disk. The user can curve results, but resolution may be too also “export” data through a serial output low. port to an external computer and data can be emailed. 2.2. References QuickScan Touch is completely prepro- Control samples should be designated as grammed and is ready for use as is for the Reference samples when the operator is more common applications. However, using the Reference Overlay feature. This scan parameters can be altered if so de- feature allows the program to overlay the

2-1 QuickScan Touch TWO - Principles of Operation sired. All user input is through the mouse, keyboard, or the touchscreen if used. In normal use, the operator selects the type of test, enters patient demographics, plac- es the gel in the scanner and starts or stops the automatic sequence of opera- tions. The computer runs a self-test at power on to detect error conditions or potential prob- lems. If an error is detected, the computer responds by displaying an error message (Section 10.2).

2-2 QuickScan Touch TWO - Principles of Operation

Keyboard Monitor Display

Mouse Printer

Computer CPU, Memory, Hard Drive

Scanner

Disk Drive(s)

Figure 2-1 Functional Units of the QuickScan Touch Block Diagram

(1) White Light Source

(2) Gel

(3) CCD Array

Signal to Computer Figure 2-2 Visible Scan Optics

2-3 QuickScan Touch THREE - Precautions and Limitations 3.9. Do not place the instrument near a Section 3 - Precautions and Limitations strong source of electromagnetic interfer- 3.1. For emergency shutdown, turn off the ence, such as a centrifuge, x-ray machine, instrument using the computer power etc. switch or disconnect the main power cord 3.10. Use standard precautions when from the wall outlet. handling CD. Refer to the CD jackets or 3.2. Do not attempt to move or operate the inserts for appropriate precautions. instrument until the entire Operator’s Man- 3.11. The CD should be removed when ual, and the manuals provided with the not in use, to prevent damage. scanner, monitor and printer, have been 3.12. Installation should not be attempted read and understood. unless a representative of Helena Labora- 3.3. Keep the scanner lid closed. Do not tories or of its subsidiaries or distributors is place objects on the glass surface other present, or unless verbal or written permis- than items to be scanned. sion to proceed has been given by Helena 3.4. Always keep all glass surfaces in the Laboratories, its subsidiaries or distribu- scanner clean and dust free, or results may tors. be compromised. 3.13. Although the QuickScan Touch is 3.5. The instrument should be kept dust factory programmed for some procedures, free if possible. No harsh cleansers, acids you may alter scanning parameters if de- or bases should be used either inside or sired. If scanning problems occur, return out. Do not immerse the unit. ALWAYS to default parameters. UNPLUG THE MAIN POWER CORD 3.14. Provide adequate room at the sides BEFORE CLEANING. and back of the instrument for good air cir- 3.6. Should an instrument be contaminated culation. by blood or blood derivatives, spray any 3.15. Use only gels and other media com- contaminated surface with a commercial patible with this system. virucidal and germicidal agent. Observe where the specimens are used inside the instrument and confine cleaning to that ar- ea. Wipe up the residue. These materials contain alcohol, which is corrosive to metal surfaces. 3.7. Use only hardware and software ac- cessories made specifically for the instrument.

3.8. Do not expose the instrument to drafts or operate the instrument in direct sunlight. Do not operate the instrument at tempera- tures below 59°F (15°C) or above 80.6°F (27°C), and do not allow prolonged expo- sure to high humidity.

3-1 QuickScan Touch FOUR - Hazards

Section 4 - Hazards 4.1. If the instrument is used in a man- ner not specified by this manual, the protection provided by equipment design may be impaired. 4.2. Do not move the scanner until it is prepared for moving. See the scanner owner’s guide for instructions on moving the scanner. Failure to do so may result in damage to the scanner. 4.3. These devices contain high voltag- es, which can be extremely dangerous. Turn off the system power, disconnect the main power cord and use extreme care when attempting disassembly for cleaning, repair or adjustments. Do not operate any instrument with the cover off unless in- structed to do so by a qualified service technician directly representing Helena La- boratories, its subsidiaries, or its distributors. 4.4. Do not attempt to operate the in- strument unless the power cords are plugged into grounded wall outlets of the proper voltage and frequency. This infor- mation is contained on the serial number plate located on the back of the instru- ment’s components. 4.5. Do not lubricate the instrument.

4-1 QuickScan Touch FIVE - Installation 1691 QuickScan Touch, Export Version Section 5 - Installation I: WARNING: Read sections three, Pre- 1 QuickScan Touch Software CD cautions and Limitations, and four, 1 NDDC Plate Hazards, before attempting to move, 1 10 Step Optical Density Step Tablet install, or operate the instrument. 1 USB Hardlock Key 1 QuickScan Touch Operator’s Manual 5.1. Unpacking and Inspection 1 Mouse Pad 2 USB Cables 1. Check all shipping containers for signs 1 Scanner Bed Template of damage. If damage is found, immedi- ately notify the shipping carrier. 1692 QuickScan Touch, Export Version II: 2. Carefully unpack the instrument’s compo- 1 QuickScan Touch Software CD nents and remove them from the shipping 1 NDDC Plate cartons. If possible, the packing material 1 10 Step Optical Density Step Tablet should be removed undamaged to facilitate 1 USB Hardlock Key repacking the instrument if it becomes nec- 1 QuickScan Touch Operator’s Manual essary. 1 QuickScan Touch Field Installation Form 1 QuickScan Touch Scanner 3. Remove the plastic wrappings from the 1 Transparency Lid components. If scissors are used to cut 1 USB Cable the plastic or binding tape, take care not to 1 Power Cord scratch the components. 1 Owner’s Guide 4. Inventory all items (refer to the packing 1 Mouse Pad 2 USB Cables lists for a complete list of materials). If any parts are missing, recheck the packing 1672 Monitor, Flat Screen: materials before notifying Helena Labora- 1 color Flat screen monitor tories. 1 Interface Cable 1 Power cord Table 5-1 Inventory 1695 Monitor, Flat Screen Touch 1690 QuickScan Touch: 1 Color Flat Screen Monitor 1 QuickScan Touch Software CD 1 Interface Cable 1 NDDC Plate 1 USB Cable 1 10 Step Optical Density Step Tablet 1 Power Cord 1 USB Hardlock Key 1 QuickScan Touch Operator’s Manual 1693 Printer, Inkjet: 1 QuickScan Touch Field Installation Form 1 Color Inkjet Printer 1 QuickScan Touch Computer 1 Magenta Ink Cartridge 1 Mouse 1 Cyan Ink Cartridge 1 Keyboard with interface cable 1 Yellow Ink Cartridge 1 Power Cord 1 Black Ink Cartridge 1 QuickScan Touch Scanner 1 Power Cord 1 Transparency Lid 1 Owner’s Guide 1 USB Cable 1694 Printer, Laser: 1 Power Cord 1 Color Inkjet Printer 1 Owner’s Guide 1 Magenta Toner Cartridge 1 Mouse Pad 1 Cyan Toner Cartridge 2 USB Cables 1 Yellow Toner Cartridge

5-1 QuickScan Touch FIVE - Installation 1 Black Toner Cartridge However, if the operator experiences difficul- 1 Power Cord ty in operation, it may be necessary to install 1 Owner’s Guide an isolation transformer. Transformer speci- 1422 Printer, Laser: fications are available from Helena 1 Black and White Laser Printer Laboratories. 1 Toner Cartridge 4. Do not select a location that places the 1 Power Cord instrument near a strong source of elec- 1 Owner’s Guide tromagnetic interference, such as a

centrifuge, x-ray machine, etc. Table 5-2 System Requirements 5.3. Component Interface and Power ▪ Computer - IBM compatible PC, Pentium Connections 2 GHz or higher, minimum 2 GB of RAM, 1. Check each component to make sure SVGA, minimum 200GB hard drive space, that each has the same power rating (110 Microsoft ® Windows ® 7 operating systems to 120 VAC or 220 to 240 VAC). This in- (if network and/or internet connections will formation is located on the back of each be used, the use of the latest security component. patch and service pack is recommended), CD drive, and optional CD/RW drive. 2. Check to ensure that the power switch- es are off on the instrument’s components. ▪ Scanner - Perfection V700/750 or V800/850. 3. When inserting interface cables into connectors, make sure that they are firmly ▪ Printer - any printer supported by Win- seated. dows. ▪ Monitor - any monitor supported by Win- 5.3.1. Computer dows. 1. Record the computer’s serial number located on the back of the computer for 5.2. Select Instrument Location use later. 1. Select an environment free of drafts, direct 2. On the white Helena label containing a sunlight, excessive humidity and dust, and handwritten system serial number, located large temperature fluctuations. Ambient tem- on the computer, write your Helena cus- perature should be from 59° - 80.6°F (15° - tomer number. 27°C). 3. Place the computer in the center of the 2. Select an area with enough space to area designated for the instrument. Keep place the instrument’s components. in mind you will need access to the back of 3. Select a location close to the needed wall the computer to interface it with the other outlets. Grounded wall outlets must be of components. the proper voltage and frequency as de- 4. Plug the female end of the computer’s scribed on the serial plates located on the power cord into the back of the computer. back of the instrument’s components. The wall outlets should not be on the same cir- 5.3.2. Printer cuit as any large load device such as a refrigerator, compressor, centrifuge, etc. 1. Record the printer’s serial number lo- The instrument’s circuitry contains filters to cated on the back of the printer for use reduce the effect of line voltage fluctuations. later.

5-2 QuickScan Touch FIVE - Installation 2. Place the printer relative to the comput- the top USB port on the back of the com- er. puter as shown in (Figure 5-1). Unlock the scanner per the instructions included in the 3. Plug the provided Key into the bottom scanner owner’s guide. USB port on the back of the computer as shown in Figure 5-1. 6. If needed, plug the female end of the scanner’s power cord into the back of the 4. Plug the printer interface cable into the scanner. back of the printer (Figure 5-1). 5. Plug the other end of the printer inter- 5.3.4. Monitor face cable into one of the two USB ports 1. Record the monitor’s serial number lo- on the back of the computer as shown in cated on the back of the monitor for use (Figure 5-1). later. 6. Plug the female end of the printer’s 2. Place the monitor relative to the com- power cord into the back of the printer puter. 7. For information on installing and remov- 3. Plug the female end of the monitor’s ing toner or ink cartridges and on loading power cord into the back of the monitor. printer paper, see the printer owner’s guide. 4. If needed, plug the monitor's interface cable into the matching receptacle on the Note: For the V700/750 scanner, only use back of the monitor. the scanner driver provided in the Helena software kit (8PF68010) and not the Ep- 5. Plug the monitor’s interface cable into son driver that is included in the scanner the matching receptacle on the back of the box. computer. Hand tighten the thumbscrews. Note: For the V800/V850 scanner, use the 5.3.5. Keyboard Epson scanner driver. 1. Place the keyboard relative to the com- 5.3.3. Scanner puter. 1. Record the scanner’s serial number lo- 2. Plug the keyboard cable into the match- cated on the back of the scanner for use ing connector on the back of the computer. later. 5.3.6. Mouse 2. On the white Helena labels containing a handwritten system serial number, one lo- 1. Place the mouse relative to the comput- cated on the scanner and one on the er. transparency lid, write your Helena cus- 2. Plug the mouse cable into the recepta- tomer number. cle on the back of the computer. 3. Attach the transparency lid to the scan- ner per the instructions included in the 5.3.7. Power Connections scanner owner’s guide. Once each component is interfaced and 4. Place the scanner relative to the com- has its power cord, plug each power cord puter. into a grounded wall outlet of the proper voltage and frequency. This information 5. Connect the USB cable to the scanner. can be found on the serial number plates Connect the other end of the USB cable to located on the back of the instrument’s

5-3 QuickScan Touch FIVE - Installation components. Do not turn the power on at these instructions. Any instruction to “se- this time. lect” something can be completed using the mouse. 5.4. Powering Up and Scanner Parameter Installation 5.5.2. Keyboard The keyboard is used to enter information 5.4.1. Components and in some areas to make selections. With the components interfaced with the Any word displayed on the screen contain- computer, turn each of the power switches ing an underlined letter, for example on for the scanner, printer and monitor. Setup, can be accessed by simultaneously The QuickScan Touch software will auto- pressing the Alt key and the underlined matically setup all of the components for letter key. In this manual, any keys listed operation once the computer power is on. with hyphens between them, for example, For additional information, refer to each Alt-S, need to be pressed simultaneously. component owner’s guide. On most screens, you can also access an area by pressing the Tab key until the de- 5.4.2. Computer sired area is indicated. The up, down, left, Once the scanner, printer and monitor are and right arrow keys can be used in areas powered on, and then turn on the comput- where information is entered either to er’s power switch. The Windows program scroll through the areas available to enter opens and displays the QuickScan Touch information or to position your cursor with- icon. in an indicated area.

5.4.3. Opening/Starting Software 5.5.3. Displays and Manual Select the QuickScan Touch icon. If the In understanding this manual, keep the fol- main menu appears on the monitor, the lowing things in mind: system is operating correctly. If an error “Click” or “double click” - refers to the in- message appears instead, refer to section structions given in section 5.5.1. 10.2, Troubleshooting. “Field” - is the area into which information 5.5. Helpful Hints is entered. “Cursor” - refers to the location entered 5.5.1. Mouse information will be placed and is most of- The mouse may be used to make selec- ten indicated by a white arrow or a symbol tions and indicate where information is to resembling a black Roman numeral one,1. be entered. Move the white arrow, or a “Drop down menu” or “drop down list” - re- symbol resembling a black Roman numer- 1 fers to a list of options available for your al one, , around the screen to the desired selection. A field has a drop down menu selection or location by moving the mouse or list when the right side of the field has a over the mouse pad. With the white arrow square containing an arrow. You can ac- over the desired area, click the button lo- cess the drop down menu/list by clicking cated on the left of the mouse. Clicking on the arrow or the field. this button is required to select some options. In this manual, any statement to “Highlight” or “highlighted” - refers to the “click” or “double click” an area refers to information currently selected and is dis-

5-4 QuickScan Touch FIVE - Installation played as white text with a blue back- 5.6. Verification of Functionality ground. After reading and understanding the Oper- “Slide” or “slide bar” - refers to when the ator’s Manual, complete the applicable display allows you to use either your section of the Field Installation Verification mouse or your arrow keys to move an in- Form QuickScan Touch as the following dicator bar in order to define the desired steps are performed: setting or access additional fields. 1. Record on the verification form the seri- In this manual, Italic text refers to the dis- al numbers of each component recorded in play and bold text refers to keyboard keys. section 5.3. Note: With the “touch screen” monitor in 2. Record the software version and serial conjunction with the QuickScan Touch number. Refer to section 7.8.1 for instruc- software, the operator may “touch” or “tap” tions on obtaining the software the icons shown on the screen instead of information. using a mouse. Tapping text blocks (where 3. Enter the QC values; see section 6.8 . information needs to be added) will bring Perform a calibration QC; see section 8-1. up an onscreen keyboard that can be used Printout the QC results and include the in place of a normal keyboard. Refer to the printout with the Verification Form. monitor’s specific operator’s manual for more details. Hot keys should not be ena- 4. Return the Verification Form as instruct- bled or used on the touch screen itself, ed on the form. only on the physical keyboard. Refer to section 10.1.3, page 10-2 for information 5.7. Programming Setup on cleaning and maintenance of the The QuickScan Touch software is ready to touchscreen. operate once the desired test(s) and the worklist(s) are setup. Setup instructions are in Section 6 - User Setup.

5-5 QuickScan Touch FIVE - Installation

Figure 5-1 Back view of computer

5-6 QuickScan Touch SIX - User Setup and any name may be typed in without the Section 6 - User Setup use of a password. WARNING: Patient Overlays may be as- 5. User Setup is accessed by selecting Ed- signed automatically in Test Setup, in Pre- it on the Figure 6-1 and, from the drop Scan Setup, or at the level of the scan. Pa- down menu, selecting User Setup . Note tient overlays may also be manually selected that Setup will not be accessible if the user and pasted. Patient Overlays are labeled with name in use does not have permission to patient identification, demographics, and change the setup. When User Setup is se- results. It is recommended that patient identi- lected, a menu appears with the following fication be reviewed on each overlay . choices: Patient Demographics, Tests, Note: For information on the optional Track- Worklists, Comments / Interpretations, ing software, see Section 14. Reports, Import / Export, Sample Handler, Quality Control, and Users and Passwords Note: For information on the optional V8 (Figure 6-3). Interface, see Section 13. 6. The options listed in User Setup are de- Note: SPIFE 4000 worklists can now be scribed in brief below. opened and edited on the QuickScan Touch; however, overlays may not be applied as the a. Patient Demographics : Allows the us- tests are different. er to set up demographic labels for all tests. (See Section 6.1). 1. Turn the power on for the instrument and computer. b. Tests: Allows the user to set up new ® ® tests, edit existing tests, or delete tests. 2. The Microsoft Windows program (See Section 6.2). opens and displays the QuickScan Touch icon. Double-click the icon. c. Worklists: A worklist defines the op- eration to be performed, and the disposition a. If the system detects no setup er- of the data. A user may simply use the rors, the Sign In window appears. (Figure default worklist template, or create a unique 6-2) worklist design designated for use with a b. If an error message appears, refer to specific test. Under this menu, the user can the message, and perform the actions sug- set up a new worklist template for a specific gested in the message. For further test, or edit an existing worklist template. assistance, or if the error recurs, record the That worklist template worklist will always message and call Helena Laboratories for be used for the designated test, although further assistance. Also see Table 10-2. some parameters may later be altered per scan. (See Section 6.3) 3. Note that access to the software can be controlled by setting up individual user d. Comments / Interpretations: Allow the names and passwords each with specific user to create and edit a menu of com- software access. (See Section 6.9). ments for each test. The user may also set up criteria by which data can be interpreted 4. Enter the appropriate User name and and commented upon automatically. (See Password and select Sign In. Section 6.4). Note: User Names and Passwords are e. Reports: Allows the user to define the case sensitive. If no security levels have contents and appearance of patient reports. been added, the window will still appear (See Section 6.5)

6-1 QuickScan Touch SIX - User Setup f. Import / Export: Allows the user to set up parameters for importing and exporting data. (See Section 6.6) g. Sample Handler : Allows the user to set connection parameters for the Electro- phoresis Sample Handler (ESH). (See Section 6.7) h. Quality Control : Allows the user to set up and track the NDDC information. (See a. Label - enter or select from the drop Section 6.8) down list the desired label. Some com- i. Users and Passwords: Allows the user mon labels include: Patient Name, Patient to add new users, and define levels of op- ID, Birthdate, Sex, Date Drawn, Time eration by user . (See Section 6.9) Drawn , and Tech ID.

6.1. Patient Demographics b. ASTM Field Number: Field Name - use the drop down list of ASTM de- The demographic labels common to all mographics to assign the applicable ASTM tests are set up in Patient Demographics . demographic. Note that the ASTM field Demographics that will vary based on the numbers may be reassigned to field type of test (for example, Total is a demo- names as desired to accommodate the graphic often best designated as a test needs of the user’s information system. specific demographic) are set up as part of each individual test. c. OK – select to accept and saves the changes made to the demographic. 1. From the main menu, select Edit and then User Setup. d. Cancel – select to reject and delete the changes made. A Confirm Cancel 2. From the QuickScan Touch Setup win- prompt is displayed. Select Yes to contin- dow, select Patient Demographics (Figure ue or No to return the Edit Demographic 6-3).This window displays all the current window. demographic labels as well as options to Edit, Add, Delete, Move Up, Move Down , 4. Add - To add a patient demographic, and Print. There is also a box in which to select Add. The Add Demographic win- designate the Key Identifier. dow opens. Note: For the Key Identifier, select a unique identifier such as a medical record number. PATIENT NAME IS NOT A UNIQUE IDENTIFIER. 3. Edit - To edit an existing demographic, select the demographic label to be altered and then select Edit. The Edit Demo- graphic window opens. a. Label - enter or select from the drop down list the desired label.

6-2 QuickScan Touch SIX - User Setup b. ASTM Field Number: Field Name - a. OK - to save all the changes made use the drop down list of ASTM de- and exit, select OK. mographics to assign the applicable ASTM b. Cancel - to exit without saving any demographic. Note that the ASTM field changes made, even those made to differ- numbers may be reassigned to field ent portions of setup, select Cancel. names as desired to accommodate the needs of the user’s information system. i. If changes were made, a Confirm Cancel prompt is displayed. c. OK – select to accept the changes made to the demographic. 1) To exit without saving chang- es, select Yes. d. Cancel – select to reject the changes made. A Confirm Cancel prompt is dis- 2) To save changes, select No played. Select Yes to continue or No to in response to the prompt and then select return the Edit Demographic window. OK .

5. Delete - To delete a demographic, se- 6.2. Tests lect the demographic Label to be deleted and then select Delete. 1. From the main menu, select Edit and then User Setup. a. A Confirm Delete prompt displays. 2. From the QuickScan Touch Setup win- i. Select Yes to delete the demo- dow, select Tests. The window displays graphic. the existing tests. (Figure 6-4). ii. Select No to retain the demo- 3. Edit - To edit an existing test, highlight graphic. the needed test and select Edit . The Edit 6. Move Up – moves a demographic label Test window appears containing the test up in the list of demographics. Select the name and its current parameters. See demographic label to be moved and then sections 6.2.1 through 6.2.6 for instruc- select Move Up. tions on using this window. 7. Move Down – moves a demographic Note: Once a test has been edited and label down in the list of demographics. Se- saved, the new test will overwrite the origi- lect the demographic label to be moved nal test. and then select Move Down. 4. Add - To add a new test, select Add and 8. Key Identifier – is any Patient Demo- the Add Test window displays. (See sec- graphic that is unique to each patient, such tion 6.2.1 for further detail.) as the patient’s name or patient’s ID num- Note: The Edit Test and Add Test win- ber. It will be the first column in the dows use the same window for entering worklist. The Key Identifier should be the information concerning test setup. first demographic entered. 5. Delete - To delete an existing test, high- Note: Once a key identifier has been se- light the needed test and select Delete . A lected, it should not be changed as this Confirm Delete prompt displays: can cause retrieval problems. a. Select Yes to delete the test. 9. Once all the demographics have been set up as desired: b. Select No to retain the test. 6. Print – The Print Settings window ap- pears allowing the user to select the

6-3 QuickScan Touch SIX - User Setup desired printer, print range, and number of Note : do not name the test until after click- copies. ing on the Default Settings button as the 7. Export – A named test with settings may Default Settings button will clear the test be exported to a file for use in another name . QuickScan Touch system. Select Export to 2. Test Name - may be entered/altered as export the test settings. Select a file name needed. The test name will automatically and source in which to save the test. The include the maximum number of samples test will be saved as a Test Export File and the stain type the test is setup to use (.xtf) and can only be opened in the plus the name entered in this field. Each QuickScan Touch software. Note that the test setup must have a unique Test Name . gel image and Scan Location in Test Set- Note that for Cholesterol Profiles to have up is not exported with the test settings. access to the Auto Edit and Report Total 8. Import – Select to import test setting LDL features, the test name must include from another file or location. Select the "Chol". Additionally, for Serum Proteins to folder and file name and click on Open. have access to the Restricted Bands fea- Select the desired test file. The test file ture in the edit mode, the test name must will be a Test Export File (.xtf) and can on- include either "Proteins" or "SPE". ly be opened in the QuickScan Touch 3. On the same screen there are five addi- software. tional tabs; Gel Properties , Scan Settings , Scan Locations , Fractions/Ratios/Ranges , 9. Once the test has been set up and/or and Patient Demographics. E ach tab con- altered as desired: tains menus for setting up test-specific a. OK - to save all the changes made parameters. and exit, select OK. b. Cancel - to exit without saving any 6.2.2. Gel Properties changes made, even those made to differ- 1. Select the Gel Properties tab (Figure 6- ent portions of setup, select Cancel. 6) and the following information will be as i. If changes were made, a Confirm follows: Cancel prompt displays. a. Scan Lanes per Row –may be from 1) To exit without saving chang- 1 to 20. es, select Yes. b. Scan Lanes per Sample – may be 2) To save changes, select No from 1 to 6. in response to the prompt and then select c. Rows per Gel – may be from 1 to 5. OK. d. Stain Type – includes Acid Blue , Ac- 6.2.1. Test Type and Test Name id Violet , Amido Black , Fat Red 7B , Fetal Tek , and Ponceau S , and should only 1. Test Type – On the Add Test window, need customizing when entering a user- use the drop down list to select the appro- defined test. The stain type selected priate test type (Figure 6-5). The user may should match the color of the pattern either choose to enter de novo settings, or scanned, with the exception of L/S or Fetal click Default Settings choose from a drop Tek plates. These plates should always down list of available default test settings be scanned using the “Fetal-Tek” stain for that test type. type, as the correct scanner calibration pa- rameters are programmed using this

6-4 QuickScan Touch SIX - User Setup setting. Note that for Titan Gel Serum Pro- tein gels, for better correlation with other 6. Auto Edit - only available for tests Helena densitometers, select Acid Blue with "Chol" in the test name. Note that if stain instead of Amido Black . not selected in setup, Auto Edit is available for selection in the Edit mode. As an aid to 6.2.3. Scan Settings scanning, the auto edit program applies curvilinear analysis to the scans and Select the Scan Settings tab (Figure 6-7) marks the fractions appropriately. Only the and the following information will be as fol- fractions present will have fraction labels lows: displayed or printed. The auto edited pat- 1. Resolution – Choose from 200, 400, tern may be modified by inserting a 600 , 800 , or 1200 dpi. A resolution of 200 fraction mark but doing so loses the label dpi is recommended for routine use and identity so that all fractions labels will be for clinical use. An increase in dpi will not used in order. With Auto Edit in use, be visually apparent on a standard high scans should be reviewed and can be resolution monitor without greatly enlarg- edited, as needed. ing the gel image. Gel images scanned in higher dpi require greater storage, and a a. Auto Edit Settings - select and large number of high resolution gels in the the Auto Edit Settings window displays worklist folder may result in slowing of the and allows for selection of the following.

system. i. Force Lp(a) Fraction - selection of 2. Sequence - can be altered by entering this feature provides for automatic marking the sample positions needed, separating of an Lp(a) fraction, based on the position the position numbers with a comma and/or of the Lp(a) in the Reference. If no Lp(a) designating a set of positions with a hy- is found during auto edit. In order to keep phen. For example 3, 5, 8-12, 15, 20 Lp(a) values on the report, the software 3. Aperture Size - may be from 1 to 12 , marks automatically this small amount of see Section 9.6 for the measurement that Lp(a) based on an amount indicated by the corresponds to each aperture setting. Lp(a) area on the reference. Note: 4. Smooth - Do not select unless proce- This feature is based on the absolute position of the Lp(a) on the reference. An dure recommends otherwise; the graph will not be smoothed. With Smooth se- appropriately labeled and marked reference lected, set the Smoothing Level to a value scan must be on the worklist. These scans from 1 to 10 , with 1 being minimal smooth- must always be reviewed because faulty fraction marking can compromise not only ing and 10 being maximum Lp(a) values but also HDL quantitation. smoothing. Smoothing will affect the re- sults. Increasing the smoothing level 7. Report Total LDL - is only available decreases the background noise and low- when "Chol" is in the Test Name . Select ers smaller fractions. Smoothing could this feature for the results to include the affect small monoclonals. Total LDL value of Lp(a) plus LDL. 5. Auto Interpretation - enables automatic 8. Report Total non-HDL – Is the Total interpretation of the scan results and re- cholesterol minus whatever the value of quires user-defined interpretations be HDL is.

setup. 9. Patient Overlay 1 - select to have a pa- tient’s scan, shown in pink, overlaid on the

6-5 QuickScan Touch SIX - User Setup current scan. An IFE image may be se- fects only the appearance of the scan im- lected as one or both patient overlays; the age when displayed and printed and does image will be shown as an overlay thumb- not affect the quantitation. nail. Select Overlay 1 Auto Selection 12. Gain Settings and choose from the following: a. Gain Mode : a. Limit search to the previous days – search from any number of previous days i. Auto - the maximum fraction am- plitude is set to 100% of the graph height b. Test - select from any available test with the rest of the fraction heights propor- c. Scan – choose from Most recent, tional to it. Note that Serum Proteins are Next most recent, Prior oldest , and Oldest . usually scanned in auto gain. ii. Manual - the fraction amplitude is proportional to concentration and is the gain of choice for light patterns such as urines. This option is selected because an auto-scanned sample that is light will show many fractions. With Manual gain select- ed, Auto Scale is accessible in the Edit mode for use if a specific pattern over ranges because that pattern is not light. Patterns of varying intensity are usually scanned in Manual gain, for example, 10. Patient Overlay 2 - select to have a Urine Proteins and CK Isoenzymes. second patient’s scan, shown in blue, overlaid on the current scan. Select Over- 1) Manual Gain - is set in a lay 2 Auto Selection Settings and choose range of 0.0 Min to 10.0 Max , in 0.1 incre- from the following: ments. Set using the slide bar accessible only when Manual is selected. Adjust the a. Limit search to the previous days – slide bar as needed to achieve the desired search from any number of previous days amplitude with the highest peak at the de- b. Test - select from any available test. sired level when scanned. Start at a c. Scan – choose from Most recent, manual gain of five and increase or de- Next most recent, Prior oldest , and Oldest. crease gain as needed. Note that Manual Gain should be selected for Urine gels in order to minimize noise 13. Fraction Detection a. Sensitivity - sets the “sensitivity” of the instrument to +/- slope changes when detecting fractions. Set, using the slide bar, within a range of 0.0 Min to 10.0 Max , in 0.1 increments. A sensitivity of zero turns off the auto fraction selector thus causing no fraction marks on the scan. 11. Image Contrast - is set, using a slide Start at a sensitivity of four and increase or bar, in a range of -10.0 Lighter to 10.0 decrease as needed. Darker , in 0.2 increments. The setting af-

6-6 QuickScan Touch SIX - User Setup b. Forced Fractions - scanning using 14. Save gel image – check to save the the Float or Fixed option is based on the gel image with the worklist. assumption that the scan distance is the 15. Do pre-scan setup – check to include a same for all rows. Any pattern may be pre-scan setup before the plate is named Reference to serve as a fraction scanned. mark guide as long as it is scanned before the scans to which it will be used. If using 16. Default Settings – will restore all manu- Float or Fixed, it is recommended that a facturers original test settings to the representative sample of each row be selected test. identified as "Reference". 17. Once the test has been set up and/or i. No - select to pick fractions based altered as desired: only on pattern slope change. a. OK - to save all the changes made ii. Float - select for fraction marks and exit, select OK. based on the pattern slope only if they oc- b. Cancel - to exit without saving any cur within a window around the Reference changes made, even those made to differ- fraction marks. If no fraction marks appear ent portions of setup, select Cancel. in the window, a mark is forced at the Ref- erence fraction mark location. If selected, i. If changes were made, a Confirm a sample will need to be labeled Refer- Cancel prompt displays. ence for each gel and will need to be 1) To exit without saving chang- scanned prior to any sample for which it es, select Yes. will be the overlay. If Float is selected, then to more clearly see the impact on the 2) To save changes, select No scan, set the Worklist to Overlay Refer- in response to the prompt and then select ence on the Display and/or Print Settings. OK. An example of a use for the float feature is 6.2.4. Scan Locations to force 5 fractions on a Urine Protein when a Serum is used as the Reference. To set up the scan begin and end posi- iii. Fixed - select to use the same tions and the sample to sample step over fraction locations as those of a previously positions, proceed as follows. scanned Reference. If selected, a sample 1. Open the scanner lid. will need to be labeled Reference for each 2. Position the gel on the scanner: If scan- gel and will need to be scanned prior to any ning a Helena gel with a round and an sample for which it will be the overlay. The obround hole, place the round hole over Fixed fractions feature is useful when the the right pin on the scanner and the software would not normally insert marks obround hole over the left pin. If scanning where the operator desires. If Fixed is se- a gel with no holes, place the gel so that lected, then to more clearly see the impact the first sample is on the right, back corner on the scan, set the Worklist to Overlay of the scanner with the samples oriented Reference on the Display and/or Print Set- left to right. If needed the gel may be tings. This feature requires there be no taped down to the scanner bed to make it pattern shift between the reference and the lie flat. patterns. For this reason, either No or Float is usually the preferred choice. 3. Close the lid.

6-7 QuickScan Touch SIX - User Setup 4. Select Update Image . The scanner i. If changes were made, a Confirm scans the gel and the message “Scanning Cancel prompt displays. in Progress” displays until an image of the 1) To exit without saving chang- gel displays (Figure 6-8 and 6-9). For es, select Yes. each row of the gel there is a green scan begin line, a red scan end line, a blue line 2) To save changes, select No to indicate the first sample position on the in response to the prompt and then select row, and a purple line to indicate the last OK sample position on the row. 6.2.5. Fractions / Ratios / Ranges 5. For each row, use the mouse to move the green lines to the front of the pattern to 1. Unit of Measure (Figure 6-10) set the scan begin and the red lines to the a. Fractions - can contain up to 10 other end of the pattern to set the scan characters. Fractions may be any unit, ex- end. These lines should never overlap. cept percent. For example, units may be 6. For each row, use the mouse to set the g/L, g/mL, U/L, U/dL, etc. sample step over by placing the blue lines b. Total - is only available with Im- on the center of the samples located on munofixation Electrophoresis (IFE) Test the left of the window (the first sample) Type selected. This feature gives the use and placing the purple lines on the center the option of using a different unit of of the samples located on the right of the measurement for immunoglobulins. It may window (the last sample). This operation be any unit for proteins except percent. defines the distance from one sample to For example, immunoglobulin levels may the next. The purple line must be centered be measured as g/L, g/mL or other units. in the last sample position regardless of This field can contain up to 10 characters. the number of samples in the row. c. Decimal Places - select the desired 7. The QuickScan Touch software will use number of decimal places for numeric re- the position of these lines to automatically sults. Options are, 0, 1, or 2. calculate the space between each sample. This calculation is used to automatically 2. Restricted Bands setup the scanner so that all future scans a. Label - enter a label, of up to 12 of the same type test gel will use this as a characters (for example M-Spike or M- preset scan begin, end and sample step Protein) for use when a restricted band is over. marked. 8. Default Settings – will restore all manu- b. Marking Method – using the facturers original test settings to the dropdown menu, select from Sliced, selected test. Skimmed , and Sliced or Skimmed . 9. Once the test has been set up and/or 3. Label – enter a label for each of the fol- altered as desired: lowing as needed. a. OK - to save all the changes made a. Ratio 1 and 2 and exit, select OK. b. Total b. Cancel - to exit without saving any c. Fraction 1, 2, 3, 4, 5, 6, 7, 8, 9, and changes made, even those made to differ- 10 ent portions of setup, select Cancel.

6-8 QuickScan Touch SIX - User Setup 4. Ratio Assignment 1 and 2 – for each of be selected. If the range is age specific, the following, indicate the ratio assign- put no letter in the sex field. ments as Numerator , Denominator , or 2) Age Low and Age High - may leave the space blank, to indicate it is nei- be used for an age range. Place the lower ther. Each may be part of one, two or no limit, from 0 to 125, in the Age Low field ratios. and then select either Year(s) , Month(s) , a. Total or Day(s) from the drop down list in the b. Fraction 1, 2, 3, 4, 5, 6, 7, 8, 9, and field to the right. Place the upper limit, 10 from 0 to 125, in the Age High field and select either Year(s) , Month(s) , or Day(s) 5. Range Set A, B, C, D, E, F, G, H, and I from the drop down list in the field to the – are the nine available reference ranges. right. When using control ranges, the patient 3) Clear – select to clear all en- reference range is usually placed in range A, because this is the default range. If a tries made for Sex/Age Characteristics. patient’s demographic data do not meet iii. OK the specific criteria for another range set, iv. Cancel then Range set A is automatically used for that patient. b. Ratio 1 and 2 a. Edit Range Set i. Edit Total Range i. Type - Patient , Normal Control , 1) Low Limit and High Limit – Abnormal Control . Note that Normal and enter the low and high limits. Abnormal Control can only be used once 2) Clear Range – select to clear per set of reference ranges. And if used, the limits. then a sample must be designated Normal or Abnormal as appropriate. 3) OK 4) Canc el c. Total i. Edit Total Range 1) Low Limit and High Limit – enter the low and high limits. 2) Clear Range – select to clear the limits. 3) OK ii. Sex / Age Characteristics - only 4) Cancel available with Patient selected. d. Fraction 1, 2, 3, 4, 5, 6, 7, 8, 9, and 1) Sex - may contain only one 10 character and is often used as the index for selection of range. For example, use i. Percent Range M, for male, or F, for female. The corre- 1) Low Limit and High Limit – sponding letter must be entered as sex enter the low and high limits. when filling in patient demographics on the patient information window or range A will

6-9 QuickScan Touch SIX - User Setup 2) Clear Range – select to clear mographics to assign the applicable ASTM the limits. demographic. 3) OK c. OK – select to accept the changes 4) Cancel made to the demographic. ii. Units Range – The default Unit of d. Cancel – select to reject the changes Measure in the box labeled Fractions is made. gm/dl. When a different Unit of Measure is i. A Confirm Cancel prompt display. entered then the column labeled Units is 1) Select Yes to continue or renamed with the new Unit of Measure. 2) No to return the Edit Demo- 1) Edit Fraction Range graphic window. 2) Low Limit and High Limit – 2. Add - To add a patient demographic, enter the low and high limits. specific to this test, select Add. The Add 3) Clear Range – select to clear Demographic window opens. the limits. a. Label - enter or select from the drop a) OK down list the desired label. b) Cancel b. ASTM Field Number: Field Name - use the drop down list of ASTM de- 6.2.6. Patient Demographics mographics to assign the applicable ASTM Demographics entered under the de- demographic. mographics tab in test setup are specific c. OK – select to accept the changes only to the specific test currently opened. made to the demographic. While entering these test specific de- d. Cancel – select to reject the changes mographics, a list appears of the demographics previously entered under made. Patient Demographics from the Main i. A Confirm Cancel prompt display. Menu. One can also create and label new 1) Select Yes to continue or demographic fields. 2) No to return the Edit Demo- 1. Edit - To edit an existing demographic, graphic window. select the demographic Label to be altered and then select Edit (only test specific de- 3. Delete - To delete a test specific demo- mographics can be edited here). The Edit graphic, select the demographic Label to Demographic window opens, displaying all be deleted and then select Delete. the fields entered from the Main Menu. a. A Confirm Delete prompt displays: a. Label - enter or select from the drop i. Select Yes to delete the demo- down list the desired label. Some com- graphic. mon labels include: Patient Name, Patient ID, Birthdate, Sex, Date Drawn, and Time ii. Select No to retain the demo- Drawn. graphic. b. ASTM Field Number: Field Name - 4. Move Up - To have a demographic label use the drop down list of ASTM de- display sooner in the list of demographics, select the desired label to be moved and then select Move Up.

6-10 QuickScan Touch SIX - User Setup 5. Move Down - To have a demographic 5. Add - To add a worklist template, select label display later in the list of de- Add . See Sections 6.3.1 through 6.3.4 for mographics, select the desired label to be instructions on using this window. moved and then select Move Down. 6. Naming and assigning 6.3. Worklists a. To assign a worklist template to a The worklist template setup defines the specific test, the template must share the operation to be performed and the disposi- name of the test, followed by the word tion of the data. The physical layout of a “Scan.” The full name of the test must be worklist, Display, Print, and Export Set- included within the template name, and tings may be modified and a template must be spelled correctly. If there are mul- created, much in the same way a report is tiple templates that share the test name, created. If a test and a worklist template the first template will be applied automati- share the same (case sensitive) name, cally. Any template may be manually then that worklist template will be used as applied if specifically designated by the user by using the New Worklist function. the default worklist for that test. The work- list template must also include the word 7. Delete - To delete an existing worklist “scan” following the name of the test. A template, highlight the needed worklist and specific worklist template may also be se- select Delete . A Confirm Delete prompt lected and applied any time a new worklist displays: is created by the user. a. Select Yes to delete the worklist 1. From the main menu, (select Edit and template. then User Setup. b. Select No to retain the worklist tem- 2. From the QuickScan Touch Setup win- plate. dow, select Worklists (Figure 6-11). The 8. Print – To print the existing worklist. window displays where worklists will be From Printer Settings window select the stored and allows access to the currently needed printer properties, print range, and setup worklist templates . number of copies. Note: It is NOT recommended to alter the 9. Export – Allows the user to export a default setup files, however it is recom- worklist template. Click on Export, name mended to backup all User Settings to the the template file, and designate the folder. computer hard drive, and also to an exter- The file will be saved as an Worklist Tem- nal device. plate Export .XWF) 3. There are two templates present, the 10. Import - Allows the user to import a Default Scan, (Figure 6-12) and Edit. Note worklist template. Click on Import, name that any edits to the Default Scan Tem- the template file, and designate the folder. plate will be applied to every new worklist The file will be saved as an Worklist Tem- created. plate Import .XWF) 4. Edit - To edit an existing worklist tem- 11. Once all the worklist templates have plate, highlight the needed worklist been setup and/or altered as desired: template and select Edit . See Sections 6.3.1 through 6.3.4 for instructions on us- a. OK - to save all the changes made to ing this window. setup and exit setup, select OK.

6-11 QuickScan Touch SIX - User Setup b. Cancel - to exit setup without saving 1. Overlays - if not already selected, select any changes made, even those made to Overlays to access the options available: different portions of setup, select Cancel. a. Overlay Unedited - select to have the i. If changes were made, a Confirm unedited pattern, shown in green, overlaid Cancel prompt is displayed. on the sample pattern. This feature allows 1) To exit without saving chang- the user to see the cumulative effect of any es, select Yes. editing. 2) To save changes, select No b. Overlay Reference - select to have in response to the prompt and then select the reference pattern, shown in yellow, OK. overlaid on the sample pattern. If select- ed, a sample will need to be labeled Note: The following sections include direc- Reference for each gel and will need to be tion of adding or editing scans. The Edit listed prior to any sample for which it will screen can be displayed by clicking the be the overlay. The sample may be la- Edit button on the Worklist menu. The Edit beled Reference before or after the run. Worklist Template is displayed with the fol- This feature is a useful tool to aid in mark- lowing options. ing fractions on a sample that is not well delineated. 6.3.1. Template Name c. Overlay Patient 1 - select to have a Template Name – Enter (or edit) the de- patient’s scan, shown in pink, overlaid on sired worklist template name (Figure 6-12). the current scan. An IFE image may be For a worklist template to be used as the selected as one or both patient overlays; default template for a specific test, the the image will be shown as an overlay template name must be exactly the same thumbnail. as the test name, followed by the word “scan.” For example, a test might be d. Overlay Patient 2 - select to have a named “Special Serum Proteins,” and the second patient’s scan, shown in blue, worklist template would then be “Special overlaid on the current scan. Serum Proteins Scan.” Otherwise, the de- e. Show Overlay Thumbnails – select fault worklist template will be used to show thumbnails of overlays.

6.3.2. Display Settings i. Up to two overlay thumbnails may be displayed Select the Display Settings window. (Fig- ures 6-12 to 6-14) ii. IFE images may be displayed as Overlay Thumbnails. WARNING: Patient Overlays may be as- signed automatically in Test Setup, in Pre- f. Show Reference Delimiters Scan Setup, or at the level of the scan. Pa- g. Show Patient 1 Delimiters tient overlays may also be manually selected and pasted. Patient Overlays are h. Show Patient 2 Delimiters labeled with patient identification, de- 2. Results - select to access the options mographics, and results. It is available: recommended that patient identification be a. Display Percent – select to include reviewed on each overlay. the percent in the display.

6-12 QuickScan Touch SIX - User Setup b. Display Units – select to include the Graphics , Results , Ranges , and Com- units in the display. If in use, a total de- ments ). mographic is required. b. File - once selected the following op- c. Display Integrals – select to include tions are available (and are explained the integrals in the display. If in use, sam- below) : File Information , Patient Infor- ples must be scanned in manual gain. mation , and Results . These integrals are arbitrary amounts 3. File Information – used in rough comparison of amounts of material and are altered as soon as the a. Save in – click the icon on the right gain is altered. of the text box to select a location. d. IFE – for IFE only b. File name – enter a file name of characters. i. Display units – for IFE only. Select to include the units in the display. c. Include Column Headers – select to include. 3. Ranges – the options available depend on selections made in Results. Select as d. Delimiter – choose from Tab, Space, needed. Comma, Semicolon , or Other . a. Display Percent Range 4. Patient Information – is available with three options. Select one of the following: b. Display Units Range a. Don’t Export c. Display Ratio Range b. Export Key Identifier Only d. Flag Percent Out c. Export All Patient Information e. Flag Units Out 5. Graph – only available with the Host f. Flag Ratio Out Computer option. g. IFE – for IFE only a. Export Graph – click to include i. Display Units Range graph. ii. Flag Units Out 6. Results – select as needed a. Export Percent – select to export 6.3.3. Export Settings percent Select the Export Settings icon window b. Export Units - requires that a total (Figure 6-15) appears. If planning on using the host computer option, insure it is ena- demographic exist bled in Import / Export , Section 6.6. c. Export Integrals - requires that sam- 1. Automatically export after scanning. – ples are scanned in manual gain. These select to have the worklist export once a integrals are arbitrary amounts used in scan is complete. rough comparison of amounts of material and are altered as soon as the gain is al- 2. Destination - select one of the following: tered. a. Host Computer - once selected the 7. Ranges – select as needed. following options are available (and are explained below) : Patient Information , a. Export Percent Range b. Export Units Range

6-13 QuickScan Touch SIX - User Setup c. Export Ratio Range b. Number of Copies - select number of d. Flag Percent Out copies to be printed at once. e. Flag Units Out 3. Patient Information - Select one of the following: f. Flag Ratio Out a. Print Key Identifier Only – select to 8. Export Comments – click to include have only the demographic classified as comments. Key printed. 9. OK - to save all the changes made and b. Print All Patient Information - select exit, select OK. to have all the demographics printed. 10. Cancel - to exit without saving any 4. Overlays - Note that if a color printer is changes made, select Cancel. not in use, including the Overlay(s) on the a. If changes were made, a Confirm reports may make the reports difficult to Cancel prompt displays. read. Select as needed: i. To exit without saving changes, a. Overlay Unedited - select to have select Yes. the unedited pattern overlaid on the edited pattern. ii. To save changes, select No in response to the prompt and then select b. Overlay Reference - select to have OK. the reference pattern overlaid on the sam- ple pattern. If selected, a sample will need 6.3.4. Print Settings to be labeled Reference for each gel scanned. 1. Automatically print after scanning. – se- lect to have the worklist print once a scan c. Overlay Patient 1 - select to have a is complete. patient’s scan overlaid on the current scan. d. Overlay Patient 2 - select to have a second patient’s scan overlaid on the cur- rent scan. e. Print Overlay Thumbnails f. Print References Delimiters g. Print Patient 1 Delimiters h. Print Patient 2 Delimiters Note: Can print up to two overlay thumb- nails and an IFE image can be printed as an Overlay thumbnail. 2. Report - if not already selected, select Report to access the options available: 5. Results - Select as needed: a. Print Percent – select to print per- a. Report - from the drop down list se- cent. lect one of the reports. The list consists of all the currently setup reports (section b. Print Units - requires that a total de- 6.5.1). mographic exist.

6-14 QuickScan Touch SIX - User Setup c. Print Integrals -Integrals are unit-less 6.3.5. Worklist Appearance values that represent the area under the The appearance may be altered for cer- graph curve and are dependent upon the tain components on the worklist, such as gain used when scanning. altering the background color of the d. IFE graph. Right clicking on the component i. Print Units - allows printing immu- will open the settings window with all the nological totals as part of the IFE report. applicable options. 6. Ranges - The options accessible de- 6.3.6. OK and Cancel pend on which selections are made in 1. OK - To accept the additions/changes Results , and/or on selections made within made to the worklist and return to the User Ranges. Select as needed: Setup window, select OK. a. Print Percent Range 2. Cancel - to exit to the User Setup win- b. Print Units Range dow without saving any changes made, c. Print Ratio Range select Cancel. d. Flag Percent Out a. If changes were made, a Confirm Cancel prompt displays. e. Flag Units Out i. To exit without saving changes, f. Flag Ratio Out select Yes. g. IFE ii. To save changes, select No in i. Print Units Range response to the prompt and then select OK. ii. Flag Units Out 7. Levey-Jennings Graph - Select either: 6.4. Comment / Interpretation Note: a. Plot Percent - select to plot using the When creating parameters in User setup Reference Range Percent Range. Setup for Auto Interpretation and com- ments associated with those parameters, a b. Plot Units - select to plot using the single test must be designated. The Auto setup Reference Range Units Range. Interpretation and any associated com- 8. OK - to save all the changes made and ments will not be accessible from a scan of exit, select OK. a different test, unless the operator returns to Comments / Interpretations in User Set- 9. Cancel - to exit without saving any up and changes the test designation. changes made, select Cancel. 1. From the main menu, select Edit and a. If changes were made, a Confirm then User Setup. Cancel prompt displays. 2. From the QuickScan Touch Setup win- i. To exit without saving changes, dow, select Comments / Interpretation select Yes. (Figure 6-16). The right side of the window ii. To save changes, select No in allows access to the currently setup com- response to the prompt and then select ments and interpretations. OK. 3. Folder where comments and interpreta- tions will be stored – Indicate the desired

6-15 QuickScan Touch SIX - User Setup folder location by using the Search for ii. Interpret Based on - select either folder icon and choosing from the drop Percent or Units. down menu or typing the location using the iii. The Fraction Labels setup for the keyboard. test selected display horizontally across 4. E dit - To edit an existing comment and the window to allow for their use as inter- interpretation, highlight the needed com- pretation criteria. For each of the labels, ment and select Edit and the Edit select one of the following: Comment / Interpretation window displays. 1) Not a Factor Note : See the instructions for the Add 2) Absent (< 0.0) A - enter the Comment and Interpretation window to desired absent threshold of from 0.0 to use this window. 99.9. Whatever value is set here, any val- 5. Add - To add a comment and interpreta- ue less than it will be viewed as a zero. tion, select Add and the Add Comment 3) Decreased and Interpretation window (Figure 6-17) displays. 4) Normal to Decreased a. Label - enter or edit the label for the 5) Normal comment. The label can contain unlimited 6) Normal to Elevated characters. The label is not displayed or printed as part of the test results, but is 7) Elevated used by the operator to identify the saved iv. Pattern Characteristic - an op- comments. Keep in mind when assigning tional text description of the appearance of Labels, that when viewing the list of avail- the scan. For example if the valley be- able comments, the list is presented tween the Alpha 2 fraction and the Beta alphabetically. Thus, it may be helpful to fraction was missing, the pattern charac- use this feature to group together com- teristic might be “Alpha 2 / Beta bridge”. ments that relate to the same tests, for Interpretations can be retrieved by pattern example SPE Normal and SPE Polyclonal. characteristic. Only pattern characteristics b. Text - use the keyboard to enter or for interpretations with a test designation edit the comment that can contain an un- the same as the scan test will be listed as limited amount of characters. available for the scan. c. Auto Interpretation - select to desig- d. OK – select to accept the changes nate the comment as an Auto made to the comment or interpretation. Interpretation . (Figure 6-18) Note that the e. Cancel – select to reject the changes test for which the auto interpretation is to made. A Confirm Cancel prompt display. be used must be setup to use reference Select Yes to continue or No to return the ranges of units and/or percent, and must Add Comment and Interpretation window. have auto interpretation selected for use. With Auto Interpretation selected, the fol- 6. Delete - To delete an existing test, high- lowing is accessible: light the needed comment and select Delete . A Confirm Delete prompt displays: i. Test - using the drop down list, select a test. The contents of the list are a. Select Yes to delete the comment based on the currently setup tests. and interpretation.

6-16 QuickScan Touch SIX - User Setup b. Select No to retain the comment and It is recommended that when creating a interpretation. new report, that the Default report is 7. Print – Select to print the comment. The Copied then the Copy is edited and re- Printer Setup window appears allowing the named. Once the Default report has user to select the desired printer, print been modified, the Default cannot be range, and number of copies. reset. 8. Export – Select to export the comment b. Add - To create a new report, select Add . The Add Report window displays. to another file location. 9. Import – Select to import the comment c. Copy - To copy a currently setup re- from another file location, including a flash port, highlight the needed report and select Copy. The report is copied and added to drive, network, etc. the end of the report list. The new report 10. Once all the comments and interpreta- may then be opened and edited if desired. tions have been setup and/or altered as d. Delete - To delete a report, highlight desired: the needed report and select Delete . A a. OK - To save all the changes made Confirm Delete prompt displays. to setup and exit setup, select OK. i. Select Yes to delete the report. b. Cancel - To exit setup without saving ii. Select No to retain the report. any changes made, even those made to different portions of setup, select Cancel. e. Print – Select to print the selected report. The Printer Setup window appears i. To exit without saving chang- es, select Yes . allowing the user to select the desired printer, print range, and number of copies. ii. To save changes, select No in f. Export – Select to export the com- response to the prompt and then select OK. ment to another file location. g. Import – Select to import the com- 6.5. Reports ment from another file location. Note: 6.5.1. Reports Setup Use Sections 6.5.1.1 – 6.5.1.5 to either Add or Edit a report. 1. From the main menu select Edit and then User Setup. 6.5.1.1. Report Name 2. From the User Setup window, select Report Name - Enter the desired name. Reports (Figure 6-19) . The right side of This name is only used for quick identifica- the User Setup window allows access to tion of the report and is not printed on the the existing reports, any other currently report; however, all reports must have a setup reports. name. 3. From this window, select one of the fol- 6.5.1.2. Paper Size lowing actions: Size - Select from the four available paper a. Edit -To alter a previously setup re- sizes. Note that if the report currently con- port, highlight the needed report and select tains components and the Size is altered, Edit . The Edit Report window opens and some or part of the components may not the report is ready for editing.

6-17 QuickScan Touch SIX - User Setup be accessible in this window and will not d. Graph - select to include an image of printout. graph. e. Overlay Info - select to include a 6.5.1.3. Orientation legend of any overlays included. The leg- Orientation - Set the paper orientation to end only prints if the Print Settings specify. either Portrait or Landscape. Note that if f. Results - results will display in the the report currently contains components and the Orientation is altered, some or part format selected earlier in Section 6. of the components may not be accessible g. Comments - once the position for in this window and will not printout. this component is selected, right click on the box and select Settings . The Com- 6.5.1.4. Add ments 1 Presentation Settings window 1. Add – Click on the location within the displays. Only the header name can be report the selected component needs to entered at this point, but the appearance appear. of the comment can still be altered. Once entered, select Ok and the comment is 2. Right click to access the drop down placed on the report. The comment may menu of components available to add and need to be resized for all the text to display select one. Note that each component ap- and/or for the text to wrap as desired. pears with a gray frame around it. The top left corner is used to move the component h. Text - once the position for this com- location around the report. The bottom ponent is selected, right click on the box right corner is used to resize the width and select Settings . The Text 1 Presenta- and/or height of the component when the tion Settings window displays. Use this mouse cursor is moved over it. window to enter the desired text. Once entered, select Ok and the text component is placed on the report. The text compo- nent may need to be resized for all the text to display and/or for the text to wrap as desired. i. List - once the position for this com- ponent is selected, right click on the box and select Settings . The List 1 Presenta- 3. The components available through Add tion Settings window displays. Click to are as follows (Figure 6-19): Print Statistics and change the font and a. Scan Identifier - includes the name color of the report elements. Once en- of the test, the sample number, and the tered, select Ok and the component is date and time the sample was scanned. placed on the report. b. Patient Info - includes the demo- j. Chart – select this to include the graphic labels and entered patient Levey-Jennings report. information. Note that the Print Settings k. Bar code – select this to include the selected determine if all or only the Key bar code. demographic print. l. Picture – select this to include a pic- c. Image - select to include an image of ture from file. the scan. m. Line – select to add a line.

6-18 QuickScan Touch SIX - User Setup Note: See Section 6.5.1.5 for a more de- c. Effects - select Bold , Italic and/or tailed description of the available Underline as needed components and their features. 4. Color - Use the pop up list to select the desired color. 6.5.1.5. Settings 1. Settings - Position the mouse cursor 6.5.1.6. Patient Info over the component, right click and select 1. Scan Assignment - For single scan re- Settings. Depending on the component ports, this should be set to 1. To create selected, the window displays. For infor- multi-scan reports, include multiple Patient mation on moving and/or resizing a info components and set the first to 1, the component, see section 6.5.1.4. second to 2, etc. 2. Once all the components have been 2. Overlay Assignment - To assign this setup and/or altered as desired. component to a patient overlay scan, set a. OK - To save all the changes made this to 1 for patient overlay 1 or 2 for pa- to setup and exit setup, select OK. tient overlay 2. The patient info for the specified overlay will be printed. b. Cancel - To exit setup without saving any changes made, even those made to 3. Components - Highlight the component different portions of setup, select Cancel. needing modification and then use Color and/or Font Settings to modify. i. If changes were made, a Confirm Cancel prompt displays. a. Label 1) To exit without saving chang- b. Demographic es, select Yes. 4. Font Settings 2) To save changes, select No a. Name – use the drop down list to se- in response to the prompt and then select lect the desired font name. OK. b. Size - use the drop down list to se- lect the desired font size. 6.5.1.5.1. Scan Identifier c. Effects - select Bold, Italic and/or 1. Scan Assignment - For single scan re- Underline as needed. ports, this should be set to 1. To create 5. Color - Use the pop up list to select the multi-scan reports, include multiple Scan Identifier components and set the first to 1, desired color. the second to 2, etc. 6.5.1.7. Image 2. Overlay Assignment – To assign this 1. Scan Assignment - For single scan reports, component to a patient overlay scan, set this should be set to 1. To create multi-scan this to 1 for patient overlay 1 or 2 for pa- reports, include multiple Image components tient overlay 2. The scan identifier for the and set the first to 1, the second to 2, etc . specified overlay will be printed. 3. Font Settings a. Name – use the drop down list to se- lect the desired font name. b. Size - use the drop down list to se- lect the desired font size.

6-19 QuickScan Touch SIX - User Setup 2. Overlay Assignment – To assign this 6.5.1.9. Overlay Info component to a patient overlay scan, set 1. Scan Assignment - For single scan re- this to 1 for patient overlay 1 or 2 for pa- ports, this should be set to 1. To create tient overlay 2. The image for the specified multi-scan reports, include multiple Over- overlay will be printed . lay Info components and set the first to 1, 3. Border - Select to place a border the second to 2, etc. around the component. 2. Components – Highlight the component 4. Border Width - Select from 3 different needing modification and then use Color widths to border the image. and/or Font Settings to modify.

6.5.1.8. Graph a. Header 1. Scan Assignment – For single scan re- b. Thumbnail Label ports, this should be set to 1. To create c. Graph Outline multi-scan reports, include multiple Graph components and set the first to 1, the sec- d. Graph Fill ond to 2, etc . e. Fraction Delimiter 2. Overlay Assignment – To assign this f. Restricted Band Delimiter component to a patient overlay scan, set this to 1 for patient overlay 1 or 2 for pa- 3. Font tient overlay 2. The graph for the specified a. Name – use the drop down list to se- overlay will be printed. lect the desired font name. 3. Options b. Size - use the drop down list to se- a. Border - select to place a border lect the desired font size. around the component. c. Style - select Bold , Italic and/or Un- b. Border Width - select from 3 different derline as needed. widths to border the image. 4. Color - Use the pop up list to select the 4. Components - Highlight the component desired color. needing modification and then use Color to modify. 6.5.1.10. Results a. Graph Outline 1. Scan Assignment - For single scan re- ports, this should be set to 1. To create b. Graph Fill multi-scan reports, include multiple Results c. Unedited Overlay components and set the first to 1, the sec- d. Reference Overlay ond to 2, etc. e. Patient Overlay 1 2. Overlay Assignment – To assign this f. Patient Overlay 2 component to a patient overlay scan, set this to 1 for patient overlay 1 or 2 for pa- g. Fraction Delimiter tient overlay 2. The results for the h. Restricted Band Delimiter specified overlay will be printed. 5. Color - Use the pop up list to select the 3. Components – Highlight the component desired color . needing modification and then use Color and/or Font Settings to modify. a. Header

6-20 QuickScan Touch SIX - User Setup b. Label b. Size - use the drop down list to se- c. Results In lect the desired font size. d. Results Out c. Style - select Bold , Italic and/or Un- derline as needed. e. Range 7. Color - Use the pop up list to select the 4. Font desired color a. Name – use the drop down list to se- lect the desired font name. 6.5.1.11.1. Text 1. Border - Select to place a border around b. Size - use the drop down list to se- the component . lect the desired font size. 2. Border Width - Select from 3 different c. Style - select Bold , Italic and/or Un- derline as needed. widths to border the image. 5. Color - Use the pop up list to select the 3. Font desired color. a. Name – use the drop down list to se- lect the desired font name. 6.5.1.11. Comments b. Size - use the drop down list to se- 1. Scan Assignment - For single scan re- lect the desired font size. ports, this should be set to 1. To create c. Style - select Bold , Italic and/or Un- multi-scan reports, include multiple Com- derline as needed. ments components and set the first to 1, 4. Color - Use the pop up list to select the the second to 2, etc. desired. 2. Overlay Assignment – To assign this 5. Justify - Select the text and choose from component to a patient overlay scan, set left, right, or center justify. this to 1 for patient overlay 1 or 2 for pa- tient overlay 2. The comments for the 6. Cut – Highlight the text and choose to specified overlay will be printed . cut the selected text. 3. Header – Select to have a header dis- 7. Copy - Highlight the text and choose to played. If enabled, the header text can be copy the selected text entered in the edit box to the right. 8. Paste - Select the appropriate location 4. Word Wrap – Select to have text wrap for the text and choose to paste. the width of the box. 9. Undo – Select the arrow to undo the last 5. Components – Highlight the below change. component needing modification and then use Color and/or Font Settings to modify. 6.5.1.12. List a. Header 1. Statistics are automatically included as part of a list report (Figure 6-20) b. Comment 2. Components - Highlight the component 6. Font needing modification and then use Color a. Name – use the drop down list to se- and/or Font Settings to modify. lect the desired font name. a. Test Name b. Header

6-21 QuickScan Touch SIX - User Setup c. Label 6.5.1.14. Barcode d. Result In Note: If using a barcode type with a check- e. Result Out sum, verify that the checksum digits in the laboratory information system are scanned 3. Font and interpreted in the same manner as the a. Name – use the drop down list to se- Quick Scan Touch, and with any bar code lect the desired font name. scanner. Incorrect patient identification may occur if bar code numbers are not read in an b. Size - use the drop down list to se- identical manner. lect the desired font size. c. Style - select Bold , Italic and/or Un- 1. A barcode may be printed on a report derline as needed. 2. Scan Assignment – For single scan re- 4. Color - Use the pop up list to select the ports, this should be set to 1. To create desired color of the selected component. multi-scan reports, include multiple Com- ments components and set the first to 1, 5. Background Color – Use to change the the second to 2, etc. background color of the selected compo- nent 3. Overlay Assignment – To assign this component to a patient overlay scan, set 6.5.1.13. Chart this to 1 for patient overlay 1 or 2 for pa- tient overlay 2. The comments for the 1. Components – Highlight the component specified overlay will be printed needing modification and then use Color and/or Font Settings to modify. 4. Barcode Type – select from one of the below. a. Header a. Code 39 b. Fraction / Units b. Interleaved 2 of 5 c. Range c. Code 128 d. Date Scanned d. Codabar e. Times Scanned e. UPC-A f. Results In f. UPC-E g. Results Out g. EAN-13 2. Font h. EAN-8 a. Name – use the drop down list to se- lect the desired font name. 5. Include checksum in bar code – Select to include on report. b. Size - use the drop down list to se- lect the desired font size. 6. Bar Code Prefix - add prefix here. c. Style - select Bold , Italic and/or Un- 7. Bar Code Suffix – Add suffix here. derline as needed. 8. Bar Code Label Font 3. Color - Use the pop up list to select the a. Name – use the drop down list to se- desired color. lect the desired font name. 4. Background Color – Use the pop up list to change the color of the background.

6-22 QuickScan Touch SIX - User Setup b. Size - use the drop down list to se- performance of the software. If enabled, lect the desired font size. the Setup Host Computer Interface op- c. Style - select Bold , Italic and/or Un- tions will not be grayed out. derline as needed 2. Port - Select COM1 or COM2 9. Bar Code Label Color - Use the pop up 3. Baud Rate – Select 1200, 2400, 4800, list to change the color of the bar code. 9600, 14400, or 19,200. 4. Data Bits- Select 7 or 8. 6.5.2. Picture 5. Stop Bits – Select 1 or 2. 1. A picture or image (For example, a logo) may be added to a report form.) 6. Parity - Select none, odd, or even. 2. Right Click on the report and click Add. 7. Protocol – Select None, XON-XOFF , or Select Picture from the drop down menu. ASTM 3. A blank square will appear on the re- 8. Create Communication Log – When en- port form. Right click on the square and abled, a record is kept of all click on Settings, to locate a folder in communication. The log is accessible which the desired *.bmp picture file may from the main menu; see Section 7.7.2. be found. Click on Open to add the image. This option should only be enabled for troubleshooting purpose and should not be 4. Position and size may also be altered. left enabled during normal instrument op- 6.5.2.1.1. Line eration. 1. Line Style – Use the dropdown menu to 9. Print – Select to print the selected re- select from a variety of line styles. port. The Printer Setup window appears allowing the user to select the desired 2. Line color - Use the pop up list to printer, print range, and number of copies. change the color of the line. 6.7. Sample Handler 6.6. Import / Export 1. Electrophoresis Sample Handler con- 6.6.1. Import / Export nected – Select if a Helena Electrophoresis Sample Handler is con- For additional information, see Section 12 nected to the system (Figure 6-23) - Communication Specifications . 2. Setup options – Port, Baud Rate, Data 1. From the main menu select Edit and Bits, Stop Bits, Parity, and Protocol from then User Setup. Section 6.6.1.1. 2. From the User Setup window, select 3. Positive Sample Identification - select if Import / Export (Figure 6-22). the Helena Electrophoresis Sample Han- 6.6.1.1. Setup dler will be used for Positive Sample Identification. Both the QuickScan Touch 1. Select Enable Host Computer Commu- and the Electrophoresis Sample Handler nication if the instrument is to be parameters must match. interfaced to a host computer. If the in- strument is not interfaced to a host 4. Create communication log – When en- computer, it is recommended that this op- abled, a record is kept of all tion be unchecked to improve communication. The log is accessible

6-23 QuickScan Touch SIX - User Setup from the main menu. This option should c. QC History - set the Maximum num- only be enabled for troubleshooting pur- ber of QC scans to keep pose and should not be left enabled d. Print - Select to print the selected during normal instrument operation. report. The Printer Setup window appears 5. Print - Select to print the selected re- allowing the user to select the desired port. The Printer Setup window appears printer, print range, and number of copies. allowing the user to select the desired 4. Once all the components have been printer, print range, and number of copies. setup and/or altered as desired. 6. Once all the components have been a. OK - To save all the changes made setup and/or altered as desired. to setup and exit setup, select OK. a. OK - To save all the changes made b. Cancel - To exit setup without saving to setup and exit setup, select OK. any changes made, even those made to b. Cancel - To exit setup without saving different portions of setup, select Cancel. any changes made, even those made to i. If changes were made, a Confirm different portions of setup, select Cancel. Cancel prompt displays. i. If changes were made, a Confirm 1) To exit without saving chang- Cancel prompt displays. es, select Yes. 1) To exit without saving chang- 2) To save changes, select No es, select Yes. in response to the prompt and then select 2) To save changes, select No OK. in response to the prompt and then select 5. QC history data files are stored in the OK. folder 'C:\Program Data\Helena Laborato- ries\QuickScan Touch\QC'. QC scans are 6.8. Quality Control not archived with worklists, or saved with 1. From the main menu select Edit and the Backup Settings function. To backup then User Setup . or archive QC scans, locate the folder 'C:\Program Data\Helena Laborato- 2. From the User Setup window, select ries\QuickScan Touch\QC’ and copy to a Quality Control (Figure 6-24.). The Quality thumb drive or network Control window displays. Setup as the fol- lowing describes: 6.9. Users and Passwords 3. Entering the Neutral Density Densitom- 1. From the main menu select Edit and eter Control (NDDC ) information: then User Setup . a. Identifying Number – enter an identi- 2. From the User Setup window, select fying number to save the scan to. Users and Passwords ( Figure 6-25). b. Neutral Density Densitometer Con- 3. Edit – To edit an existing user, highlight trol (NDDC) - enter the information the needed user and select Edit and the contained on the card supplied with the Edit User window displays. See the in- Neutral Density Densitometer Control structions for the Add User window to use (NDDC) as follows on the Quality Control this window. Screen.

6-24 QuickScan Touch SIX - User Setup 4. Add - To add a new user, select Add e. Cancel – select to reject the changes and the Add User window (Figure 6-25) made. A Confirm Cancel prompt display. displays. Select Yes to continue or No to return the Add User window. a. User name – enter the desired user name. 5. Delete - To delete an existing user, highlight the needed user and select De- b. Password – enter the desired pass- lete . A Confirm Delete prompt displays. word. a. Select Yes to delete the user. NOTE: Passwords are case-sensitive. b. Select No to retain the user c. This user has rights to – select each of the following which apply to the user be- 6. Print - Select to print the selected report. ing setup: The Printer Setup window appears allow- i. Edit patient information ing the user to select the desired printer, print range, and number of copies ii. Edit scans 7. Once all the users have been setup iii. Export and/or altered as desired: iv. Print a. OK - To save all the changes made v. Delete scans to setup and exit setup, select OK. vi. Change worklist settings b. Cancel - To exit setup without saving any changes made, even those made to vii. Change setup different portions of setup, select Cancel . viii. Setup users (this option is only i. If changes were a Confirm Cancel available if Change Setup has been se- prompt displays. lected. 1) To exit without saving chang- ix. Change calibration es, select Yes. x. Clear log files 2) To save changes, select No d. Ok - select to accept the changes in response to the prompt and then select made to the user. OK .

6-25 QuickScan Touch SIX - User Setup

Figure 6-1 Main Menu

Figure 6-2 Sign-In Menu

6-2 QUICKSCAN Touch SIX - User Setup

Figure 6-3 User Setup, Demographics

6-27 QUICKSCAN Touch SIX - User Setup

Figure 6-4 User Setup, Tests

6-28 QUICKSCAN Touch SIX - User Setup

Figure 6-5 Test Setup, Test Types

6-28 QUICKSCAN Touch SIX - User Setup

Figure 6-6 Test Setup, Gel Properties

6-29 QUICKSCAN Touch SIX - User Setup

Figure 6-7 Test Setup, Scan Settings

6-32 QUICKSCAN Touch SIX - User Setup

Figure 6-8 Test Setup, Scan Locations, IFE

6-33 QUICKSCAN Touch SIX - User Setup

Figure 6-9 Test Setup, Scan Locations, SPE

6-34 QUICKSCAN Touch SIX - User Setup

Figure 6-10 Test Setup, Fractions/ Ratios/Ranges

6-35 QUICKSCAN Touch SIX - User Setup

Figure 6-11 Worklist Template Setup

6-35 QUICKSCAN Touch SIX - User Setup

Figure 6-12 Worklist Template Setup

6-36 QUICKSCAN Touch SIX - User Setup

Figure 6-13 Worklist Template Setup, Overlays

6-37 QUICKSCAN Touch SIX - User Setup

Figure 6-14 Display Settings, Ranges

6-38 QUICKSCAN Touch SIX - User Setup

Figure 6-15 Export Setting – Worklist Template

6-39 QUICKSCAN Touch SIX - User Setup

Figure 6-16 User Setup, Comments

6-40 QUICKSCAN Touch SIX - User Setup

Figure 6-17 User Setup, Comment / Interpretation

6-41 QUICKSCAN Touch SIX - User Setup

Figure 6-18 Setup, Auto Interpret

6-42 QUICKSCAN Touch SIX - User Setup

Figure 6-19 User Setup: Reports

6-43 QUICKSCAN Touch SIX - User Setup

Figure 6-20 Report Setup, List Report

6-44 QUICKSCAN Touch SIX - User Setup

Figure 6-21 Reports Setup: Levey Jennings

6-45 QUICKSCAN Touch SIX - User Setup

Figure 6-22 User Setup, Import/Export

6-46 QUICKSCAN Touch SIX - User Setup

Figure 6-23 User Setup, Sample Handler

6-47 QUICKSCAN Touch SIX - User Setup

Figure 6-24 User Setup, Quality Control

6-48 QUICKSCAN Touch SEVEN – Operating Instructions

Figure 6-25 User Setup, Add User

6-0 QUICKSCAN Touch SEVEN – Operating Instructions be backed up and archived pe- Section 7 - Operating Instructions riodically, both to an archive CAUTION: Do not attempt to operate folder, as well as to a remote this instrument until you have read and location . understood this manual. 7.1.1.1. Create a New Worklist If the system has not been setup, go through all of section six before proceed- 1. Under File, select the New ing. Proceeding without completing worklist item or click on the new setup may result in difficulty completing worklist icon and create a the instructions contained in this section. new worklist. A dialog box opens If the system is turned off, turn the power in which the user is prompted to on for the scanner, printer, and monitor select a worklist template. and then the computer. The Microsoft ® 2. Select the desired worklist Windows ® program opens and displays template. the QuickScan Touch icon. Select the 3. An empty worklist opens, with icon. Take care to select the icon only a dialog box. Label the new once. Opening multiple copies may cor- worklist. rupt files. If the main menu (Figure 7-1) appears on the monitor, the system is 4. Select the Enter Patient Info operating correctly. If an error message icon, and select the desired appears instead or the instrument does test when prompted. not perform as described in this manual, refer to Section 10 and contact Helena 5. Enter the patient data either Laboratories. manually or by importing patient data. (Section 7.2). 7.1. Summary Instructions Note that imported data will Use these instructions only after reading overwrite any manually en- the detailed instructions in the rest of tered data. If additional section seven. These instructions sum- manually entered data is de- marize operations required for a typical sired, add the information after scan. Detailed instructions begin in Sec- importing demographics tion 7.3. 7.1.1.2. Automatic Creation of 7.1.1. Summary for worklists Worklist The number of worklists that may be creat- Worklists will be automatically ed, stored, and archived in the QuickScan created by scanning a gel, and Touch software is essentially unlimited (by open on the screen. The worklist disc memory alone.) Worklists are auto- will be identified by date, time, and matically created by scanning a plate, or test, and user may choose to cre- may be created prior to scanning using the ate a label by right clicking over New or Open functions. All worklists are the gel image, selecting Worklist, automatically saved into the default worklist then Worklist label. folder C:\Program Data\Helena Laborato- ries\Quick Scan Touch\Worklists . It is strongly recommended that worklists

7-1 QUICKSCAN Touch SEVEN – Operating Instructions 7.1.1.3. Scanning 3. Worklists may be sorted by la- 1. Open the scanner lid. bel, date, gel ID or number of scans. 2. Position the gel on the scanner: If scanning a Helena gel with a round and 4. Search criteria for worklists in- an obround hole, place the round hole clude worklist label, test, Gel ID, over the right pin on the scanner and and timeframe. the obround hole over the left pin. If 5. Enter the desired parameters scanning a gel with no holes, place the and click Apply . gel so that the first sample is on the 6. Highlight the desired worklist right, back corner of the scanner with and click Open . the samples oriented left to right. If needed the gel may be taped down to 7.1.2. Editing Summary the scanner bed to make it lie flat. 1. The user may begin to edit the 3. Close the lid and select the Scan scans when the worklist opens icon. and scans are displayed. There 4. If it is necessary to correct scan posi- are three ways in which the user tions, select the Scan and Pre-Scan may edit the scans. setup . (Section 6.2.4) If desired, most 2. With the scan(s) displayed, Scan Settings, display, print, and export click on the desired scan and do options can be altered temporarily using one of the following: the Pre-Scan Setup option. The gel is rescanned and displayed with the col- a. Use the icons across ored alignment lines. Use the colored the top of the screen. lines to correct the scan position, and b. Place the arrow over click on Scan Sample.. This change is the scan, right click the for this particular scan only. It does not mouse and select the func- permanently change Scan Begin and tion to be performed Scan End settings. c. Use the editing hot- 5. Edit, print, and/or export scan(s) will keys occur as programmed in Worklist Setup (Section 6.3) or Pre-Scan options, and d. Select and perform the may be modified for each individual desired editing actions scan. e. Exit edit when scan ed- iting is complete. 7.1.1.4. Summary for Open Worklist 7.1.3. Saving and Exporting 1. Select the Open Worklist icon or Summary menu item. A menu appears in which 1. Select Export Scan(s), as de- the user may designate a folder in which to search and search criteria . sired. . 2. The worklist folder will be open by de- 2. Scans are automatically saved fault, and all worklists in the folder will to the worklist folder. Edits are be listed in reverse chronological order. saved in real time.

7-2 QUICKSCAN Touch SEVEN – Operating Instructions 3. After completing all scan edits, the lays, Results Ranges and Levey- user may choose to export an individual Jenning Chart. Enter the appro- scan or the entire worklist by clicking on priate parameters and select OK. the Export Icon (5 th icon on the left 3. With the desired scans indi- at the top of the screen). An export cated, select Print. scans menu opens with a list of all 4. A worklist may be setup to au- scans in the worklist. At the bottom of tomatically perform the print the menu are options to Select All, Ex- function. Automatic printing is port Setting, Export, and Cancel. If the not recommended as reports will user did not set up export options in print immediately after scanning, Setup or Pre-Scan, they may click on prior to review or edit. Export Setting and enter export criteria. 4. A worklist may be setup to automati- 7.2. File cally export results, however, this is not To access the options in File , on recommended as the export will take the main menu (Figure 7-1) select place immediately after scanning and File . The options are discussed in thus prior to review and archive. Re- the order they appear in the File sults may be exported to the host drop down list; however, which computer (LIS system) or to a text file) options are accessible at any giv- Note that the Export function exports en time depends on which worklist numeric results only. is active and user privilege. An option is accessible with the se- 7.1.4. Archive lected worklist through the File The Archive function may be used to drop down list, when it is shown in save scans from the worklist folder to black text and through the appli- another location, including a network or cable icon, when it is shown in flash drive. The Archive function will color. save the actual scan and gel image (if enabled) but Archived worklist files may only be opened and interpreted by QuickScan Touch software.

7.1.5. Gel Image Gel Image files are saved as image files (bitmap by default) and may be opened by most image viewing software. 7.2.1. New Worklist From the main menu, select the 7.1.6. Print New worklist item under File, or 1. To manually print reports, select the click on the new worklist icon Print Scan(s) icon (9 th icon from the left and create a new worklist. at the top of the screen). 1. New worklist: A dialog box 2. As needed, select Print Settings. A opens in which a list of all previ- menu opens giving the user choices to ously setup worklist templates select Report, Patient Information, Over- appears.

7-3 QUICKSCAN Touch SEVEN – Operating Instructions 2. The user is prompted to select a nection is enabled. Right click on worklist template. the patient information screen, 3. Select the desired worklist template. and select All Patients. The sample identifiers will be added 4. An empty worklist opens, with a dia- to a list as they are imported from log box. Label the new worklist. the ESH. When all identifiers are 5. Select Edit, and Patient Info, or click added, click on Import Patient In- formation, and the demographic on the patient icon , and select the information is imported from the desired test when prompted Host Computer. 11. To import multiple patients simultaneously, the user may create a task list in the Host Computer. To create a task list, patients must be assigned se- quential sample identifiers in the Host computer, (for example, pa- tients 1,2,3,4 and 5) Click on All 6. The worklist may be closed and used patients, then Import, then enter later, or patient information may be the sequence of patient IDs. (For added at this point. examples, (1-5)) into the “Add 7. Patient data may be manually typed Identifier” box. in, or imported. To manually enter data, type in the desired information. 7.2.2. Positive Patient Identity/ Electronic Sample Handler 8. To import data, the lab information system must be connected, and the 1. In order to take advantage of host computer import/export communi- positive patient Identity with the cation settings enabled. use of the ESH (also see the manual for the Electronic Sample 9. Right click on the patient information Handler), ensure that the sample screen. hander connection with the ESH 10. To import a single patient, select the is enabled, and that the commu- patient row, click on import, scan or type nication settings in the ESH are in the patient identifier, then click “import identical to those in the patient information.” To import multiple QuickScan Touch software. (Sec- patients, click on All Patients, then Im- tion 6.7) port. Scan in one barcode at a time into 2. The host computer connect the sample identifier box, clicking on must also be enabled. To import “Add sample identifier” after each addi- patient information into the tion. When all identifiers are added, QuickScan Touch, sample identi- click on Import Patient Information, and fiers are imported from the ESH the demographic information is imported to the QuickScan Touch, and the from the Host Computer. To import a patient information is imported list of patients, ensure that the Electron- from the Lab Information system ic Sample Handler (ESH) has completed sampling, and that the con-

7-4 QUICKSCAN Touch SEVEN – Operating Instructions (Host Computer) to the Quick Scan information. Importing empty data Touch. fields will erase manually entered 3. Ensure that the sample tubes are ap- data. propriately bar-code labeled, and that 7.2.3. Open the sample tray barcode is scanned. Sample the tubes per ESH procedure . 1. To open a previously created worklist, from the Main Menu se- 4. When the ESH is finished sampling, lect File, then Open, or select the the operator may choose to either cre- ate a new worklist, or open a previously Open Worklist icon. A menu existing worklist as long as the worklist appears where the user may des- was created with the test entered on the ignate a folder in which to search ESH. Open the patient information and search criteria. screen, and right click on the screen, 2. The worklist folder will open by and select All Patients, then Import. default, and all worklists in the 5. The Import All patient information dia- folder are listed in reverse chron- log box opens. There is a space at the ological order. top to “Add Identifier” and a larger box 3. Worklists may be sorted by la- at the bottom with options to Import Pa- bel, date, gel ID or number of tient Information, Import Patient scans. Identifiers, and Clear All. 4. Search criteria for worklists in- 6. Select Import Patient Identifiers. The clude worklist label, test, Gel ID, Sample Identifiers (bar code numbers) and timeframe. Any one or com- are imported from the ESH into the low- bination of search parameters er section of the import screen. If a bar may be applied. Clear may be code was not read, there will be a blank used to clear parameters. space. 5. To open worklists from the ar- 7. Click Import patient information. The chive, the “Look in” folder may be patient information is imported into the altered to search any folder, such worklist, and the sample identifiers are as the archive folder, flash drive, deleted from the box. There will be a or network. blank space for a missing tube or un- read barcode. Note that worklists retrieved from the archive will not be 8. Missing demographics may either be saved to the worklist folder au- typed into the patient information screen tomatically. manually, or the operator may right click on the blank row, click on patient, im- 6. To move a worklist back to the port, and scan or type in the barcode worklist folder, the Archive func- and import a single patient. Of note, tion must be used. manually entered information appears in 7. Enter the desired parameters italics. and click Apply. Highlight the desired worklist and click Open. Note that any information imported over The Open button must be manually typed information will over write touched or clicked; clicking Enter pre-existing information - even missing will not open the worklist.

7-5 QUICKSCAN Touch SEVEN – Operating Instructions 7.2.4. Find 5. Across from the Search for pa- 1. A scan may also be located using the rameter is the in icon. This icon Find feature. To retrieve a scan select gives the user the option to either select File and then Find or select choose an area with in the scan to search for a Key Demographic the Find icon (the fourth icon). or All Demographics . The user may click the down arrow to change the Demographic. Note: The default demographic is Key Demographic 6. Under the Search for parame- ter is the Test parameter. This gives the user the option to choose a specific test to search in. The user simply clicks on the down arrow located on the right and highlight the test to search for a scan. 2. A window opens giving the user op- 7. Under test is a search parame- tions to enter different search ter labeled Gel Identifier . Under parameters and a location to search for this parameter the user is able to the scan. It contains the fields Look in , narrow the search by entering a Search for , Test , Gel Identifier , match- specific Gel Identifier . The user ing criteria, and date range. may click the down arrow located 3. The first search parameter on the on the right hand side or typing it Find Scan menu is labeled Look in. This in the space provided. parameter tells the software where to 8. Under Gel Identifier is a group start searching for the scan. To the right of small boxes the user may of the Look in parameter is an icon of a check to narrow the search to little folder with a magnifying glass. This specific criteria. For instance, the icon may be clicked to change the area user may tell the software to or folder the software will search for the Match whole words only, Match scan. case, Must be normal, Must be Note: The default folder is the pathological, or Must be re- QuickScan Touch worklist folder . viewed. 4. The next parameter is the labeled 9. The last area the user may use Search for . In this parameter the user for a search criterion is the Date, may enter a Key ID, a control, or what- which is located under the Gel ever demographic he/she is searching Identifier and search boxes. The for. On the right side of the Search for user may enter a date range in space is a down arrow icon. The user this search criterion or simply may click the down arrow icon and se- type it in the space provided. lect a reference, normal, or abnormal. 10. At the bottom of the Find Scan Menu are three buttons la-

7-6 QUICKSCAN Touch SEVEN – Operating Instructions beled Search , Clear , and Cancel . After 3. The user may enter search cri- the user has entered the entire search teria to find a specific worklists by criteria needed, click on Search . entering information in Label , 11. The user may use Clear to clear all Test , Gel Identifier , and Date . previous search criteria or Cancel to Use the drop down arrows and cancel the search all together. highlight or type in the infor- mation needed for the search. Note: If only default criteria are entered, Click on Apply to start the search all scans from all worklists will appear in or Clear to clear all parameters. Clear. Note: The default Look in folder 12. The contents of a worklist need not is the worklist folder. Leaving La- be cleared prior to scanning. Unlimited bel, Test, Gel Identifier and Date, worklists may be created and stored. blank will give the user all the (Storage is limited by computer memory worklists contained in the folder only. to date . 13. Worklists are automatically saved in 4. After selecting the desired the worklist folder, and may be archived worklist(s), choose the location as desired.) Each time a gel is where the files will be archived scanned, a new worklist is generated. using the drop down menu in the 14. A worklist must be open for the icon Save to box. The user also has to function. the option of deleting the files af- ter archiving by checking the 15. From the Main Menu, select the Delete worklist after archiving op- tion. Clear icon – sixth icon at the top of the screen or click on File , then Clear . 5. Select Archive to save work- lists or Cancel to cancel the 16. A warning will appear for the user to action without archiving worklists. confirm the worklist clearing. 6. QC history data files are stored Note: Worklists need not be cleared to in the folder 'C:\Program Da- scan new gels, as an unlimited number ta\Helena of new worklists may be created and Laboratories\QuickScan stored . Touch\QC'. QC scans are not ar- chived with worklists, or saved 7.2.5. Archive with the Backup Settings func- 1. From the main menu, select File and tion. To backup or archive QC Archive . The Archive Worklist window scans, locate the folder will appear . 'C:\Program Data\Helena Labora- tories\QuickScan Touch\QC’ and 2. The user has the option to choose the copy to a thumb drive or network. location where the software will search for the scan or worklist in the field la- 7.2.6. Delete beled Look in . Use the look in icon to the right of the blank space provided 1. From the main menu (Figure 7 (icon with a folder with a magnifying 1), select File and Delete . The glass).

7-7 QUICKSCAN Touch SEVEN – Operating Instructions Delete Worklist window will appear. b. Red indicates the scan does 2. The user may enter search criteria to not have the proper number of frac- find a specific worklist(s) by entering in- tions and/or one or more fraction is formation in Label, Test , Gel Identifier , out of range. and Date . Use the drop down arrows c. Yellow indicates the scan has and highlight or type in the information been viewed in the edit mode; needed for the search. Click on Apply however, still does not have the to start the search or Clear to clear all proper number of fractions and/or parameters. one or more fraction is out of 3. A list of matching worklists will ap- range . pear. The user may select one or more 7.2.7.1. Print Settings worklists, or may use the Select All but- ton at the bottom of the screen. After From the Print Scans window, selecting the desired worklist(s), click select Print Settings to alter the Delete . A confirmation prompt will ap- contents of the report from the pear prior to deletion. Select Yes or Yes currently setup parameters. The to All to proceed. following print related settings are 4. A confirmation prompt will appear pri- listed; Report, Patient Information, or to deletion. Overlays, Results, Ranges , and Levey-Jennings Chart . 7.2.7. Print Scans 7.2.7.2. Report 1. Open or select the worklist containing the scans to be printed. From the main 1. Report - from the drop down menu (Figure 7-1), either select File and list, select one of the reports shown. The list consists of all the Print or select the Print icon (the currently setup reports, (section ninth icon at the top of the screen). The 6.5.1). Print option is only accessible with a worklist open. 2. A Print Scans Menu opens in the cen- ter of the screen with a colored square, Key ID, Test name, Gel ID, sample number date and time scanned and test , and Gel ID . Across the bottom of the menu are the buttons Select All, Print Settings, Printer Setup, Print , and Can- cel . 3. The color of the square represents the following: 2. Number of Copies - from one a. Blue, indicates the scan has the to one hundred copies may be proper number of fractions and all the printed at once. fractions are within range values.

7-8 QUICKSCAN Touch SEVEN – Operating Instructions 7.2.7.3. Patient Information a. Print Percent 1. Patient Information - Print Key Only - b. Print Units select to have only the demographic c. Print Integrals classified as Key printed. d. Print IFE Units 2. Print All - select to have all the de- mographics printed. 7.2.7.6. Ranges 3. Overlay – available with List and 1. Ranges – The options acces- Levey-Jennings Report Types: sible depend on which of the 4. Unedited - select to have the unedit- Report Types is selected, on se- ed pattern overlaid on the edited lections made in Results, and/or pattern. on selections made within Rang- es. Select as needed: 7.2.7.4. Reference a. Print Percent Range 1. Reference - select to have the refer- b. Print Units Range ence pattern, overlaid on the sample pattern. If selected, a sample will need c. Print Ratio Range to be labeled Reference for each gel d. Print IFE Range scanned (Section 6.2.3). e. Flag Percent Out 2. Print Reference Delimiters - select to have fraction marks printed on the ref- f. Flag Units Out erence overlay. g. Flag Ratio Out 3. Patient 1 - select to have a patient’s h. Flag IFE Out scan overlaid on the current scan (Sec- tion 6.2.3). 7.2.7.7. List Reports 4. Patient 2 - select to have a second List reports do not print ranges or patient’s scan overlaid on the current report marked restricted bands. scan (Section 6.2.3). List reports report 5 fractions, 5. Print Patient 1 or 2 delimiters – Select and are intended primarily for to have fraction marks printed on patient statistical purposes. Integrals overlays. are not printed on list reports. 6. Print Overlay Thumbnails – prints the 7.2.7.8. Levey-Jennings overlay thumbnail when at least one Graph Overlay is selected. Legend is included 1. Levey-Jennings Graph - ac- for identifying the overlays. cessible only with a Levey- 7.2.7.5. Results Jennings Report Type selected. Select either: 1. Results – The options accessible de- pend on which of the Report Types is a. Plot Percent - select to plot selected, except for a scan worklist with using the Reference Range Per- an IFE test selected, and then only the cent Range. last option is available. Select as need- ed:

7-9 QUICKSCAN Touch SEVEN – Operating Instructions b. Plot Units - select to plot using the 7.2.7.12. Print and Cancel Reference Range Units Range. 1. Print - with all the desired Note : A Levey-Jennings chart will only scans selected, select to print the print results that are of the same test highlighted scans. name and test version. If edits made to 2. Cancel - select to exit without a test (such as updating ranges or printing. changing test options) results from both versions of the test cannot be included 7.2.8. Export in a single chart. 7.2.8.1. Export Settings 7.2.7.9. Ok and Cancel 1. With a worklist open, to export 1. Ok - select to exit the window and scans, from the main menu either save the selections made. select File and Export Scan(s) or 2. Cancel - select to exit the window select the Export Scan(s) icon without saving any selections. (the fifth icon). 7.2.7.10. Select Scans to Print 2. The Export Scans window dis- 1. Select Scans to Print. plays listing all the scans within the worklist in use. The list of 2. To select all of the scans listed, Se- scans contains key demographic, lect All. the test name, the Gel ID, the 3. To select a specific scan listed, click sample number, the date and on the desired scan to highlight it. To time scanned, and a colored make additional selections, simultane- square. The color of the square ously press the Ctrl key on the keyboard represents the following: and click on the desired scan. Repeat, a. Blue indicates the scan has as needed, to highlight all the desired the proper number of fractions and scans . all the fractions are within range values. 7.2.7.11. Printer b. Red indicates the scan does 1. Select Printer Setup not have the proper number of frac- a. Name – from the drop down list se- tions and/or one or more fraction is lect the appropriate printer. out of range. b. Properties c. Yellow indicates the scan has been viewed in the edit mode; c. Status however, it still does not have the d. Type proper number of fractions and/or e. Where - is automatically entered one or more of the fraction is out of based on the Printer Name selected. range. f. Comment - comments regarding d. There are options at the bot- printer. tom of the screen to Select All, Export Settings, Export, and Can- cel.

7-10 QUICKSCAN Touch SEVEN – Operating Instructions 7.2.8.2. Destination 7.2.8.5. Host Computer The user may elect to export data to a 7.2.8.6. Patient Information - file or to the Host computer. Unless See Above Host Computer communications are en- abled under the Import/Export options in User Setup, the default destination is to a file. If the Host Computer connected is enabled, select either Host Computer or File.

7.2.8.3. Patient Information 1. File - if selected then the following op- tion is accessible under File Information: 2. Save In – drop down folder allows user to choose a destination to save file.

3. File Name - enter a file name and ex- tension. For example, an Excel file 7.2.8.7. Export Graph would be entered as “.xls”. Note: The This section is only accessible file must have an extension to open. when Host Computer is selected The extension .txt is the default and will and is not accessible for a scan work in Excel. To open a txt file in Excel worklist with an IFE test select- the data must be imported into Excel. ed). Numerical graphical data Refer to the Excel Help for instructions only is exported. appropriate to each software version 4. Column Header - check if user wants 7.2.8.8. Comments a column header. This section is only accessible 5. Delimiter - Tab, Space, Comma, or when Host Computer is selected. Semicolons may be used as delimiters. 7.2.8.9. Results 6. Results - Data exported to a file may The last option is only available be exported as percent, units, or inte- for a scan worklist with an IFE test grals. selected. Select as needed: Note that data exported to a file does 1. Export Percent not include ranges or flags, and re- 2. Export Units stricted bands are NOT exported. 3. Export Integrals 7.2.8.4. Patient Information- Select one 4. Export IFE Units of the following 1. Export All 7.2.8.10. Ranges 2. Export Key Only This section is only accessible when Host Computer is selected. 3. Don't Export The options accessible depend on selections made in Results and/or within Ranges . Select as needed:

7-11 QUICKSCAN Touch SEVEN – Operating Instructions 1. Export Percent Range 2. Backup Setup - A Folder is de- 2. Export Units Range scribed where backup files are located. The default file is in the 3. Export Ratio Range Program Data QuickScan Touch 4. Export IFE Range folder. Change the folder desti- nation to Backup settings to a 5. Flag Percent Out network, flash drive or other des- 6. Flag Units Out tination. Click OK to backup User Settings. 7. Flag Ratio Out NOTE: IT IS STRONGLY 7.2.8.11. Ok and Cancel RECOMMENDED THAT USER SETTINGS ARE BACKED UP 1. Ok - select to exit the window and AFTER INSTALLATION, AND save the selections made. PERIODICALLY, BOTH TO THE 2. Cancel - select to exit the window DEFAULT DESTINATION AND TO without saving any selections. A DIFFERENT LOCATION!

7.2.8.12. Select Scans to Export 7.2.9. Backup Calibration 1. To select all of the scans listed, select Backup Calibration - A Folder is Select All. described where backup calibra- 2. To select a specific scan listed, click tion files are located. The default on the desired scan to highlight it. To file is in the Program Data make additional selections, simultane- QuickScan Touch folder. ously press the Ctrl key on the keyboard Change the folder destination to and click on the desired scan. Repeat, Backup calibration to a network, as needed, to highlight all the desired flash drive or other destination. scans. Click OK to backup calibration settings. 7.2.8.13. Export and Cancel 7.2.10. Restore 1. Export - With all the desired scans se- lected, select Export to export the 1. Restore - User Settings and highlighted scans. The export destina- Calibration may be restored with tion selected determines which of the this feature. From the Main following occurs: Menu select File, then Restore. a. Host Computer - the scan(s) is ex- 2. Restore Setup - A Folder may ported and the Export window closes. be designated from which to re- store Setup files. The default b. File - the scan(s) is exported and folder is in the Program Data the Export window closes. QuickScan Touch folder. If one wishes to restore settings from 7.2.8.14. Backup another location, the folder may 1. Backup - User Settings and Calibra- be changed to a network, flash tion may be backed up with this feature. drive or other destination. Click From the Main Menu select File, then OK to restore User Settings. The Backup. Restore Settings function may be

7-12 QUICKSCAN Touch SEVEN – Operating Instructions used to transfer User Settings from an- other instruments by backing up settings to a flash drive from one instrument, and restoring files from the flash drive to the second instrument. 3. Restore Calibration - Calibration Set-

tings may be restore in the same manner as above. 3. The Patient Information win- dow displays. 7.2.11. Sign out 7.3.2. Demographic Labels From the Main Menu, select File, then Sign Out to log out of the software. A 7.3.2.1. Columns confirmation prompt will appear. A new 1. The titles of each column in user must then either sign in or exit the the table are the demographic la- program. bels assigned in setup (These include any test specific de- 7.2.12. Exit mographics (Section 6.2.6) To exit the QuickScan Touch software, applicable to the test attributed to from the main menu (Figure 7-1) either the worklist in use). The first col- select File and then Exit or select the X umn is always the demographic at the top right of the main menu. Note designated as the Key identifier. that any worklists open when the soft- 2. The column width may be ad- ware is exited will be open when the justed. Place the cursor on the software is reopened. line separating the column to be adjusted and the next column. 7.3. Edit Patient Information Click and hold the left button on 7.3.1. Patient Information Window the mouse while moving the mouse left or right as needed to resize the column. When the de- 1. Open or select a scan worklist. If pa- sired width, release the button. tient information has been imported Use caution not to resize a col- automatically from the ESH, it is rec- umn so narrow that it is not ommended that the patient data is visible or appears to be removed. reviewed to ensure that all bar codes labels were read and imported 7.3.2.2. Rows 2. To enter patient demographic infor- The titles of each row in the table mation, with a scan open, either touch are 1 through the total number of or select Edit from the main menu either samples the test attributed to the select Edit and then Patient Info, or se- worklist in use specifies (section 6.2.6 ) lect the Enter Patient Info icon (the seventh icon from the left). 7.3.2.3. Reference Often, the first sample is used as the Reference sample. The Ref-

7-13 QUICKSCAN Touch SEVEN – Operating Instructions erence may be labeled manually, by rect them. Repeat until all patient clicking Ctrl-R in the Key ID field. Con- information is entered. Imported firm the cursor is in the row one, column data will over-write and hand writ- one field, Ctrl R or right click the mouse. ten data, and an imported blank The reference scan may be labeled be- field will erase any manually fore or after scanning, or at any time. typed data. More than one scan may be labeled ref- erence, and all scans following that 7.3.2.6. Import Patient labeled scan will use the reference scan Patient information can also be that is closest behind. For example, a entered by scanning the barcode reference may be designated at the be- for the patient sample. Select the ginning of each row, to be applied to Key ID column in the designated each row. patient row and right click. A drop down menu lists the options 7.3.2.4. Controls Undo, Demographic Patient, All A control or patient scan may also be Patients, and Close. Select Pa- labeled as a reference. When desig- tient, then Import. A dialog box nated as the reference, the control can opens where the user may scan then be used for forced fractions or as a the barcode into the Sample reference overlay. Samples scanned Identifier box, then Import the Pa- following the reference may be dis- tient information. played and/or printed with the reference overlay. If using a normal and/or ab- 7.3.2.7. Positive Patient ID normal reference range, label the 1. If the Positive Patient ID fea- sample Reference Normal or Reference ture is in use (section 6.6.1.1), Abnormal, as applicable. the worklist label, date and time the worklist was created/ 7.3.2.5. Entering Patient Data scanned, Gel ID and worklist la- 1. With row 1 most likely the Reference, bel is displayed on the top of the enter patient information beginning in window. When the scanning be- the first field of row 2. Enter the pa- gins, the instrument will request tient information in the row that the gel ID. corresponds to the patient sample on Data imported automatically the gel and in the column that corre- from the Sample Handler using sponds with the demographic label Positive Patient ID will appear assigned to the column. in regular font, manually im- 2. To move through a row entering in- ported or entered data will formation, press Tab after each entry appear in italics and Tab or Enter at the end of the row. 2. Note that if patient identifica- The arrow keys move the cursor up, tion and sample ID (barcoded down, left and right within the patient in- labels) have been imported, the formation window. For large moves, sample ID will remain associated use the mouse, scroll up or down, with the scan, even if the identifi- and/or the Page Up and Page Down cation is manually overwritten. keys. Errors can be typed over to cor- For example, if the user were to

7-14 QUICKSCAN Touch SEVEN – Operating Instructions attempt to change a patient ID from the 4. Cut - select to have infor- patient ID imported by manually (for ex- mation in the column removed. ample, if the incorrect label had been (Hot-Key: Ctrl + X). applied) the originally bar code number 5. Copy - select to have the indi- would remain associated with the scan cated column of patient when exported. information copied to clip board 3. If attempted to overwrite positive (Hotkey: Ctrl +C). patient ID, the user MUST reimport 6. Paste - select to have the pa- data by rescanning the correct bar- tient information that has been code and reimporting the correct cut or copied entered into the in-

information. dicated column (Hotkey: Ctrl + V. 7.3.2.8. Patient Information 7. Select - used to highlight pa- With the curser in the appropriate row, tient information in a column Right click the mouse. A window opens (Hotkey: Ctrl +S). displaying five icons: Undo, Demo- 8. Delete - select to have the in- graphic, Patient, All Patients, and Close dicated patient information Menu. deleted. (Note: information must be highlighted before it can be 7.3.2.9. Undo deleted). Hotkey Ctrl +D. Undoes the last task the user performs. 9. Reference - select to desig- (Hot Key Ctrl + Z). nate a sample as a Reference sample (Hot-Key: Ctrl + R). 7.3.2.10. Demographics 10. Normal - select to designate 1. Right Click on Demographics. An- a sample as a Normal sample other window opens that contains (Hot-Key: Ctrl + N). fourteen tabs located on the side of the first window. 11. Abnormal - select to desig- nate a sample as an Abnormal 2. Find – is used to search for patients sample. within the worklist. The user may enter criterion from any demographic within 12. Today’s Date - select to enter the worklist. Right click mouse, highlight today’s date in the indicated field. Demographic, and highlight Find (or Ctrl 13. Yesterday’s Date - select to + F). Enter information in Search for, enter yesterday’s date in the indi- check the box Match whole words only cated field. or Match case. Click Find or Cancel. 14. Paste to the following - select (Section 6.2.6) If the information is found in the worklist, the cursor will to have the indicated demograph- move to its location and highlight it. If ic, for example Tech ID, entered the information cannot be found, a mes- into all the fields under the indi- sage will appear No instance was found. cated field (Hot-Key: Ctrl + W). 3. Find again - used to find other in- 15. Increment and Paste to the following - select to have the in- stances of the previously found data in the worklist (Hot-Key: F3). dicated numeric demographic entered into all the fields under

7-15 QUICKSCAN Touch SEVEN – Operating Instructions the indicated field increased by one in imported from the ESH to the each field. For example if the indicated QuickScan computer, and then field contains the number 123, the next the patient information is import- would be 124, then 125, and so on (Hot- ed and exported from a direct Key Ctrl + I). connection with the LIS.

7.3.2.11. Patient Allows user to insert patient information into the entire row for a single patients. Within Patient there are five icons: Cut, Copy Paste, Delete, and Import. 7.3.2.12. All Patients Allows user to insert patient infor- mation into the entire row for multiple patients simultaneously. Within Patient there are five icons: Cut, Copy Paste, Delete, and Im- port.

1. Cut - cuts the entire row of patient in- formation (Hot-Key: Ctrl + Alt+X). 2. Copies the entire row of patient in- formation to the clip board (Hot-Key: Ctrl + Alt + C.) 3. Paste - Pastes the entire row of pa- tient information (Hot-Key: Ctrl + Alt+V). 4. Delete - Deletes the entire row of pa- 7.3.2.13. All Patients: Import tient information (Ctrl+Alt+D). 1. Sample Handler : Imports all 5. Import - if enabled in setup, and con- Sample Identifiers from the Sam- nected to the Host Computer Laboratory ple Handler. Information System (LIS)) a complete set of demographic data for that patient 2. Click All Patients , then Im- may be imported. Select import, and a port . A menu opens with a small dialog box opens where the user may box at the top. Sample Identifiers scan a barcode into the Sample Identifi- are imported from the ESH. er box, then then click Import the Patient 3. The user then clicks Import information. The Key ID is imported, Patient Information , and the Pa- then the box closes, and the patient in- tient IDs are imported from the formation is imported from the LIS. LIS into the menu. 6. In the QuickScan Touch software, the 4. The menu closes, and the pa- patient data is not directly imported from tient information had been the ESH; the “Sample Identifiers” are

7-16 QUICKSCAN Touch SEVEN – Operating Instructions imported into the worklist (Hot-Key: Patient Identifiers , and click on Ctrl+Alt+M) Add Patient. 5. If a barcode was not read, a blank 18. The specific sequence will space will appear in the sample identifi- appear in the sample identifier list ers as they are imported, and a below. (for example 1-60) click corresponding blank row will appear in Import Identifiers. the patient information list. 19. The Patient Information im- 6. Task List: More than one patient may ports from the LIS Task list. be imported simultaneously from the 20. Click on the Red X to close Host Computer through the use of a the Patient Information screen. task list. 21. Scan the plate. 7. Positive patient identity is not appli- cable. Note: If using an ESH, the Import Patient Info will be greyed out and 8. To use a task list one must create a not available. list of patients in the Host Computer in the same sequence that samples will be applied to the plate. Sample identifiers must be in sequential order. (for exam- ple, 1-60). 9. From the Main Menu , click on create a New Worklist (from the Icon or File, New Worklist). 10. Select a worklist template when prompted (example Default). 11. A small box opens for the user to enter a Worklist label and click OK. 12. Select the Patient Icon at the top of the screen.

13. The user is prompted to select a test. Select test and the Patient Infor- 7.3.2.14. Print mation Menu opens. Print - when selected, the Print 14. With the cursor in position one, right Patient List window displays. Se- click on the mouse and another menu lect a Printer from the drop down opens. list and indicate the Number of Copies needed. Select Print to 15. Scroll down to All Patients and se- print the list. Select Cancel to ex- lect Import. it without printing. 16. Another menu opens where the user may enter patient sample identifiers. 7.3.2.15. Delete 17. Enter the desired sequence of sam- Delete - select and the Alert, “Are ple identifiers (for example 1-60) under you sure you want to delete all patient information” appears. Se-

7-17 QUICKSCAN Touch SEVEN – Operating Instructions lect Yes or Yes to All to clear all the pa- the Undo or Restore feature. tient information. Select No to exit See section 7.3.2.9 for additional without clearing the patient information. information.

7.3.2.16. OK 7.4.2. Auto Edit OK - When all the patient information is 7.4.2.1. Application entered, select Ok to return to the work- list. 1. The Auto Edit function may be used to automatically edit the 7.4. Edit Scans scan based on a reference over- lay. 7.4.1. Navigation 2. Auto Edit may be accessed by 1. A scan displayed in an open worklist window includes the scan, image, and touching or clicking the icon th any demographics, fractions, overlay (10 from the left) or by right thumbnails, and comments associated clicking on the scan and access- with the scan. In the upper left corner of ing the pull down menus. the screen there is a space where the 3. Auto Edit is only accessible image of the gel may be displayed (if when the name of the test in use Save Gel Image is enabled). contains "Chol" and only if Auto 2. To select a scan for editing, the user Edit was not already applied. (For may click on the image of the gel locat- example if Auto-Edit was already ed in the top left side of the screen and selected in the test setup or Pre- select the number of the scan. Scan Setup, the edits would have already been applied). 3. A scan may also be selected for edit- ing by selecting a thumbnail image 4. Auto Edit is based on the ab- located in the bottom left corner of the solute position of the Lp(a) on the screen. reference. Optimally a reference is included on each row of sam- 4. To move between the scans in the ples. These scans must always worklist, click on the thumbnail or the be reviewed because faulty frac- gel image located on the left hand side tion marking can compromise not of the screen. only Lp(a) values but also HDL 5. Scans may be edited by use if the quantitation. On some occasions, touch screen, icons, right clicking on the the HDL may be very low in value scan and accessing the pull down men- or may move faster causing the us, or with hot keys. software to eliminate the HDL. Any sample without HDL should 6. Note that moving the cross hair caus- be manually edited. To do so, use es a corresponding move in the the Restore function to remove the indicator bar on the display of the sam- automatic edits. ple. 5. Note that with this version of 7. Once an edit function is performed, software, if Auto Edit is in use, List the last function or all functions per- /Statistics report types cannot be formed can be undone by using either printed .

7-18 QUICKSCAN Touch SEVEN – Operating Instructions 7.4.3. Auto Edit Settings use the hot-key Ctrl+Ins. A frac- 1. There are two Auto Edit Settings, Au- tion delimiter appears on the to Edit, and Auto Edit with Force Lp(a). graph at that point and the frac- To access Auto Edit Settings, right click tion data is automatically on the scan and access Auto Edit, Auto recalculated when editing causes Edit Settings from the pull down menu, a change in values. or click Ctrl-S. Select the box next to 7.4.6. Delete Fraction Force Lp(a) to enable or disable this op- tion. Delete is only available when at least one fraction is present. To 2. Cholesterol Auto Edit , Force Lp(a) delete a fraction mark, place the Fraction - selection of this feature pro- cursor near the fraction mark to vides for automatic marking of an Lp(a) be removed and select the delete fraction, based on the Reference. In or- der to keep Lp(a) values on the report, icon (icon with the negative the software marks automatically this sign), or right click the mouse se- small amount of Lp(a) based on an lect Delimit Bands- Delete amount indicated by the Lp(a) area on Fraction. The user may also use the reference. the hot-key: Ctrl+Del. The clos- Note: With Auto Edit in use, scans est fraction mark is deleted and should be reviewed and edited, as need- the fraction data is automatically ed, to evaluate the auto edit recalculated when editing causes performance . a change in values.

7.4.4. Delimit Bands 7.4.7. Force Fraction Right click on the scan to access Delimit Fractions are automatically Bands, which provides access to Frac- marked by the software based on tions, Restricted Bands and Auto Edit detection of change in the slope (for Cholesterol tests). The user may al- in the pattern. The position of so use the individual icons. fractions can also be modified based on the reference overlay, if 7.4.5. Insert Fraction present, and edited. There are 1. Although the QuickScan Touch pro- three options for fraction place- gram will automatically place fraction ment. Use the menu item or icon marks where the software detects a to access these options. change in the slope of the scan, the us- er MUST review and edit every scan . 7.4.8. No 2. Up to 10 fractions may be inserted. Fraction marks are placed based To indicate a fraction, place the cursor on the individual scan without re- on the appropriate location on the scan gard to the reference overlay. and select the Insert icon (icon (Recommended). with the plus sign), or right click the 7.4.9. Float mouse-highlight Delimit Bands and se- lect Insert Fraction. The user may also Fraction marks are based on both the individual scan, but will

7-19 QUICKSCAN Touch SEVEN – Operating Instructions also be guided by the reference overlay. now be identified by number. To relabel the fraction, highlight the 7.4.10. Fixed label from the unused box, and Scans will be edited with fraction delim- click on the arrow pointing left. iters in the exact position as the To label an unlabeled fraction, reference delimiters. highlight the blank space in the “Labeled” column, select the de- 7.4.11. Fraction Identification sired label from the “Unused Label” column, and click the ar- With the Fraction ID feature, the user row pointing left. Note that the may renumber or relabel fractions order of fraction labeling can be based on labels assigned in User Setup. altered as well. With the Touch or Select the Fraction ID Note: If using this feature in icon (13 th from the left “ID”) or right combination with Auto Interpreta- click on the scan, select Delimit Bands, tion, keep in mind that the correct then Fraction Identification to access number of fractions must be la- this feature. beled in test setup, auto- interpretation, and marked in or- 1. Before using this feature, be sure der for auto-interpretation criteria to mark the correct number of frac- to be appropriately applied. tions. 7.4.15. Clear 7.4.12. Fraction Number Select Clear to remove all frac- A menu opens with a list of all fractions tion labels and replace with for the selected scan identified by num- numbers. ber and label (if available) to the right. Up to 10 fractions may be marked on a 7.4.16. OK scan. 0 to 10 fraction labels may be as- signed in Test Setup. The list will Select OK to apply and save include as many fractions as marked. changes.

7.4.13. Unused Labels 7.4.17. Cancel On the right hand side of the menu, Select Cancel to exit without there is a column for unused fraction la- making changes. bels. If there are fewer marked fractions 7.4.18. Reset than labels identified in test setup, addi- tional labels are listed in this box. Select Reset to reset all fraction labels to original labels. 7.4.14. Fraction Labeling 7.4.19. Mark Sliced Restricted There are two arrows between the col- Band umns. To remove an undesired label from a fraction, select the label then 1. The Restricted bands features click on the arrow pointing towards the - are only available when the right. The label will be moved into the name of the test in use contains unused column, and the fraction will "Proteins" or "SPE". There are now two marking methods avail-

7-20 QUICKSCAN Touch SEVEN – Operating Instructions able in the QuickScan Touch software, Thus any protein would appear to Sliced, and Skimmed. Up to ten re- have been obscured by a normal stricted bands in total may be marked. background is not included in the Traditionally, restricted bands/ M- total M-protein measurement. To proteins have been marked using the indicate a band, touch the screen “Sliced” method, as seen below. or place the cursor on the appro- 2. The Sliced marking method will in- priate location on the scan and clude in the measurement all protein select Mark skimmed restricted between the two marks, from the peak band icon User may also of the scan to the baseline, which most right click the mouse, select De- likely includes some element of normal limit Bands- Mark Skimmed baseline protein. To indicate a band, Restricted Band, or use the hot- touch the screen or place the cursor on keys: Ctrl+Alt+M for skimmed. the appropriate location on the scan and select Mark sliced restricted band icon. The user may also right click the mouse, select Delimit Bands- Mark Sliced Restricted Band, or use the hot- keys: Ctrl+M for Sliced.

7.4.21. Unmark Touch the screen or place the cursor between the band marks needing deletion and select Un-

mark . 7.4.20. Mark Skimmed Restricted Band 7.4.22. Reposition Delimiter 1. The Restricted bands features- are 1. To adjust the position of a de- only available when the name of the test limiter, touch or click on the 17 th in use contains "Proteins" or "SPE". There are now two marking methods icon then touch or use the available in the QuickScan Touch soft- cursor to click and drag one of ware, Sliced, and Skimmed. Up toten the delimiters to the desired loca- restricted bands combined may be tion. marked. 2. With very small bands, the au- 2. The Skimmed method includes only tomatic marking feature may not the portion of the marked protein that is be able to recognize the band. above what is estimated to be above the NOTE: It is extremely important predicted normal tracing of the scan. the total M–protein measurement

7-21 QUICKSCAN Touch SEVEN – Operating Instructions method is CONSISTENT over time. Correction. The Mark Baseline, EVERY OPERATOR MUST MARK Cancel Baseline, and Apply RESTRICTED BANDS USING THE baseline functions are the 12 th , SAME TECHNIQUE, AND EVERY 11 th and 10 th icons from the right PATIENT’S RESULTS MUST BE REPORTED USING THE SAME respectively) . TECHNIQUE IN WHICH THEY WERE 2. Mark - Place the cursor in the PREVIOUSLY REPORTED. Treatment desired location of the new base- of many conditions is based on the line and then select Mark. A change in M-protein, thus any change in straight, horizontal line is then measurement technique may produce placed at the specified location what appears to be an artificial change, indicating the new baseline. and has the potential to affect treatment. 3. Unmark - Once Mark is used, It is HIGHLY RECOMMENDED to dis- Unmark becomes available. Se- cuss changes in marking methods with lect Unmark to remove the line pathologists and treating clinicians . indicating the new baseline . 7.4.23. Delete Area 4. To create a non-linear base- 1. An area of the scan may be deleted if line, place the cursor on another necessary. To access this function, ei- location and again select Mark. ther right click on the scan and select The line indicating the new base- the delete function, or use the 13 th , 14 th , line is drawn between the marked th locations. Repeat until the base- and 15 icon from the left. . line is indicated as desired . 2. Mark - Place the cursor on one side 5. Apply - With the baseline of the area needing deletion and then marked as desired, select Apply. select Mark. The pattern is readjusted so the 3. Unmark - Once Mark is used, Unmark baseline is a straight line and the is accessible. Select if the location numeric data reflects the change . marked is incorrect. Note: Baseline correction is NOT 4. Apply - Once Mark is used, Apply be- recommended for routine use in comes accessible. Place the cursor on most electrophoretic patterns, as the other side of the area needing dele- removing baseline “noise” may in tion and then select Apply. The area fact be deleting true results. between and above the marks is delet- ed. Repeat as needed. 7.4.25. Auto Scale Auto Scale may be accessed ei- 7.4.24. Baseline Correction ther by right clicking on the scan, 1. The Baseline Correction feature may and selecting the Appearance be used if the baseline needs to be item, or by selecting the icon. moved or if the pattern has a non-linear baseline due to irregularities in back- . Auto scale is only accessi- ground intensity. To access this feature ble when the pattern has been one may either use the icons or right scanned in manual gain. When click on the scan and select Baseline Auto Scale is selected, the pat-

7-22 QUICKSCAN Touch SEVEN – Operating Instructions tern is adjusted to full scale as if it had protein scan, or 5 th from the left been scanned in auto gain . on an IFE scan). Hot key: Ctrl + I 2. The default setting for image 7.4.26. Smooth contrast is selected during Test 1. This feature can be accessed either setup or Pre-Scan Setup (Section by right clicking on the scan, and select- 6.2.3) and can be altered, using ing the Appearance item then Smooth, the slide bar, to adjust from Lighter to Darker. The setting af- or by selecting the icon: The fects only the displayed image of Smooth window displays. Select the the scan and does not affect the desired Smooth setting of 1 through 10. results. To reset to the default Select Ok and the Edit Scan(s) window setting, select Reset. displays with the scan smoothed as in- dicated. Select Cancel to exit without 7.4.29. Negative Image-IFE scans smoothing. As an aid to viewing IFE scans 2. Smoothing, in most cases, is not electronically, a negative image recommended. Smoothing DOES af- may be viewed simultaneously fect results . with a positive image (Hot key: Ctrl + N). See Section 7.4.39 3. Increasing the smoothing level de- The contrast may be adjusted creases the background noise and from -10 to +10, and will be ad- lowers smaller fractions . justed in both the positive and 4. Smoothing may affect quantitation negative images at the same of small monoclonals. time. Select OK to close the view of the negative image. 7.4.27. Zoom 7.4.30. Calculate Total LDL This feature can be accessed either by right clicking on the scan, and selecting This feature is available for Cho- the Appearance item, or by clicking on lesterol Tests, and will calculate the total LDL; Lp(a) + LDL. To the icon . Use the slide bar to en- access this feature, touch or click large or reduce the pattern from 1x to on the Lp(a) + LDL icon (7 th from 10x , in increments of 0.1. The final the right) or right click on the magnification is shown in red in the right scan. bottom corner of the pattern. Zoom does not affect printed results . 7.4.31. Calculate Total non-HDL This feature is available for Cho- 7.4.28. Image Contrast lesterol tests and will calculate 1. Image Contrast can be accessed ei- the total non-HDL fraction (LDL + ther by right clicking on the scan, and VLDL + Lp(a). To access this selecting the Appearance item, or by feature, either enable in Setup, or touching/selecting the Image Contrast click on the icon (6 th from left).

Icon (8 th from the left on a serum

7-23 QUICKSCAN Touch SEVEN – Operating Instructions 7.4.32. Overlays 7.4.32.3. Reference Overlay WARNING: Patient Overlays may be 1. Select Reference to overlay a assigned automatically in Test Setup, in previously scanned reference Pre-Scan Setup, or at the level of the pattern on the scan. This makes scan. Patient overlays may also be a comparison of the patient to a manually selected and pasted. Patient reference very easy. A reference Overlays are labeled with patient identi- scan must be identified on the fication, demographics, and results. It is worklist and located prior to the recommended that patient identification scan in which the overlay is to be be reviewed on each overlay displayed. The reference scan may be labeled at any time, in- Overlays allows for overlaying Un- cluding after the gel has been edited, Reference and/or Patient scans. scanned. The reference appears One or two patient overlays may be ap- in yellow over the sample, which plied. is in red. 2. Adjust - Once Reference is se- 7.4.32.1. Viewing/Printing Overlays lected, the Adjust slide bar In order to view/print overlays, the Dis- becomes available. Use the slide play/Print settings must be enabled as bar to position the overlay on the desired. Settings may be enabled or scan as desired. disabled in User Setup under Test Set- up, Worklist Template Setup, Report Setup, or in Pre-Scan Settings Display and Print Settings may also be altered at the level of the scan. Select the Dis-

play icon, or the Print icon, or use the drop down menu under File to access these options. Options include Display/Print Unedited, Reference, Pa- tient 1, Patient 2, Overlay of Thumbnail Images, and display of delimiters . Alter- natively, (Hot Key: Ctrl + O) may be used.

7.4.32.2. Unedited Under Overlay, Select Unedited. A green line will appear tracing the outline of the original scan. Once an editing 7.4.32.4. Patient Overlay 1 function, which alters the pattern's ap- and/or 2 pearance, is performed, the green line 1. Patient Overlays may be as- will remain in the same location as the signed automatically in Test original scan, shown relative to the edit- Setup, in Pre-Scan Setup, or at ed scan, appearing in red. the level of the scan. Patient overlays may also be manually

7-24 QUICKSCAN Touch SEVEN – Operating Instructions selected and pasted. Patient Overlays are labeled with patient identification, demographics, and results. It is rec- ommended that patient identification be reviewed on each overlay . 2. Click on the thumbnail image of the patient overlay to view the full, original scan results, demographics, and com- ments . 3. Note that IFE scans can be used as patient overlays using the following steps; however, patient overlays cannot be applied to IFE scans. 4. Select Overlay, then select either 1 or 2 to overlay a saved patient pattern.

5. A window opens with a check box to enable the patient overlay and the op- 7.4.32.6. Clear tions Auto Select , Clear, Position Adjust, 1. To remove the patient overlay and Cancel. currently applied, select Clear. An automatically applied Overlay 7.4.32.5. Auto Select will remain in place unless Auto Select Criteria may be entered in cleared, even if the selection cri- Test Setup, Pre-scan Setup, or by se- teria are altered. lecting Patient Overlay on the scan. If 2. With a patient overlay select- Auto Select criteria have been entered ed, the Adjust slide bar becomes in Setup, the criteria may be viewed by available. Use the slide bar to clicking on Auto Select. Enter the time position the overlay on the scan frame in which to search (1-365 days) as desired. Auto Overlay: To up- the test, and Oldest, Prior Oldest, Next date and apply changes to Most Recent, or Most Recent. The scan Overlay search criteria, either which best fits the matching criteria is close and reopen the worklist, or applied. use the Auto Overlay feature. Note: the scan that best matches the Right click on the area of the Gel criteria may be altered as patient sam- Image, select scan, then Select ples are repeated. For example, the Auto Overlay, or click Ctrl O. Most Recent overlay will change each Copy and Paste Overlay. time a new sample is scanned. The up- 3. An Overlay may also be ap- date will take place whenever a worklist plied manually. The pattern can is closed and reopened, or by using the be from the same patient or a dif- Auto Overlay function. (Ctrl-O, or right ferent patient. click on the Gel Image area, select Scan, and select Auto Overlay .

7-25 QUICKSCAN Touch SEVEN – Operating Instructions 7.4.32.7. Copy and paste from sample number, and Date and worklist Time Scanned. From the list, se- 1. Any overlay may be selected from lect the scan that is to be used as any worklist by selecting and right click- the overlay, and click on the ing on the thumbnail of the scan, Paste to Patient Overlay 1 or 2 located at the lower left corner of the button. worklist. Select the Scan option, then 7.4.32.9. View Overlay Copy. Next, select the scan in which the overlay is to be applied, right click Right click on the Patient Overlay on the thumbnail image of the scan, se- to open a screen displaying the lect Scan, then Paste, and Paste to original overlaid scan, with im- Patient Overlay 1 or 2 . age, scan, results, demographics, and comments. 2. Patient overlays may be automatically applied or manually cut and pasted from Note: Patient Overlay matching any worklist criteria is based on date and time of the worklist, rather than scan. 3. To select a scan to use as a patient For example, if “Most Recent” is overlay, left click on the desired scan. used as a matching criteria, and a Then right click on that same scan and patient scan has been copied and a menu containing Copy and Paste dis- pasted to a second worklist, the plays. Left click on Copy. To place the scan from the most recent worklist indicated patient overlay on the desired will be pasted. Patient Overlay scan, left click on the scan to receive thumbnails are labeled by Key ID the patient overlay. Then right click on and Date and Time Scanned. For that same scan and a menu containing further demographics, click on the Copy and Paste displays. Left click on thumbnail . Paste . Note that when manually pasting a 7.4.33. Auto Interpretation patient overlay, positive patient iden- tity is NOT applicable, and it is the 7.4.33.1. Auto Interpretation: user’s responsibility to ensure that the desired overlay is applied . The user may elect to enter cus- 7.4.32.8. Find and Paste Patient tomized comments based on Overlay user-specified criteria. Com- ments are then applied to scans A Patient Overlay may also be manually with results meeting the specified located and pasted to a scan using the criteria. Criteria must be entered find feature. Select the Scan in which in Setup, and assigned to a spe- the overlay is to be pasted. From the cific test. Note that the test for Main Menu, select File, then Find, or which the auto interpretation is to be used must be setup to use use the icon . Enter the criteria in reference ranges of units and/or which to locate the desired scan, and a percent, and must have auto in- list of scans will be displayed, described terpretation enabled in Test by worklist name, Key ID, Test, Gel ID, Setup, Pre-Scan Setup, or ena-

7-26 QUICKSCAN Touch SEVEN – Operating Instructions bled at the level of the screen by select- bottom of the window are the Op- tions: Open, OK, and Cancel. ing the AI icon. See section 6.4 Comments/Interpretation for further in- 2. To manually enter a free-text formation . comment, type the comment into the blank space, and click OK. Note: If creating stored comments as well as Auto Interpretation comments 3. To add a comment from those ensure the comments do not contain the added in User Setup, select same wording/text. Similar wording will Open. The Open Comment win- cause the stored comment not to be ap- dow opens. The window lists plied correctly. Available Comments (all the cur- rently setup comments by label) 7.4.33.2. Pattern Characteristics and the highlighted comments contents to the right of the list. 1. Pattern Characteristics may also be To select a comment, highlight used as optional descriptions to de- the desired comment and select scribe the appearance of a scan. Select. The text will appear the Multiple pattern characteristics may be large box on the upper right cor- entered in User Setup to be available for ner. Click Open to apply, and application to a scan with numeric re- Cancel to exit the screen. Re- sults that might meet the same Auto peat as needed to include all the Interpretation criteria. (Section 6.4). For desired comments. Clicking example, a scan with a high gamma Open more than once will add fraction may appear monoclonal, poly- the comment more than once. clonal, or oligoclonal. 4. Comments may be removed 2. Select Pattern Characteristics under by manual deletion from the the Auto Interpretation criteria to view comment. (Auto Interpretation the list of available/ applicable Pattern comments must be cleared). Characteristics for a scan. A window displays which contains None and any 5. To apply the comments as pattern characteristics setup for the test displayed, select Ok. in use (section 6.4).Select the desired 6. To exit without changing the pattern characteristic and select OK. To comments, select Cancel. If any exit without making a selection, select comments have been add- . Cancel ed/altered, then a Confirmation Cancel prompt displays. To exit 7.4.34. Comments without changing the comments, 1. Touch, or select the Comments icon select Yes. To return to the Add Comments window, select No. (third from left- the picture of quota- tion marks), or right click on the scan, 7.4.35. Restore and select Comments, or elect Ctrl-Alt-C from the scan window to access the Touch or select the first icon from Comments feature. Alternatively, (Hot Key: Ctrl + C) may be used. A menu the right, click Ctrl-alt-R, or box opens with a blank space. At the right click on the scan and select Restore to return the pattern to

7-27 QUICKSCAN Touch SEVEN – Operating Instructions its appearance prior to all editing. Edit- 7.4.39. Negative Image-IFE scans ing may then need to be repeated. 1. As an aid to viewing IFE scans electronically, a negative image 7.4.36. Undo may be viewed simultaneously Touch or select the second to last icon with a positive image. To access this feature, right click on the on the left, Ctrl-Z, or right click on scan and select Negative Image, the scan and select Undo to undo the or touch/click on the Negative last editing function performed and re- turn the pattern to its appearance prior Image icon. (4 th from the to the most recent editing function per- right on an IFE scan.) formed .

7.4.37. Edit IFE Scans

7.4.37.1. Indicator Tool An indicator bar appears over the scan to aid in viewing. To move the indicator bar up or down, use the mouse to place the white arrow on the indicator bar. Press and hold the button on the left

side of the mouse. Move the mouse, which moves the indicator bar, to the 2. A window opens with a nega- desired location, and then release the tive image of the IFE scan, and button. the options to adjust the image contrast. The contrast may be 7.4.38. Image Contrast adjusted from -10 to +10, and will be adjusted in both the positive 1. Image Contrast may be accessed ei- and negative images at the same ther by right-clicking on the scan, and time. Select OK to close the view selecting the Appearance item, or by of the negative image. touching/selecting the Image Contrast th Icon (8 from the left on a serum protein 7.4.40. Immunototals scan, or 5 th from the left on an IFE scan). Note: If positive patient identity is NOT enabled, AND a DIFFERENT 2. The default setting for image contrast patient ID is imported into the same is selected during Test setup or Pre- sample/scan, IFE Immunototals data Scan Setup. (Section 6.2) Image Con- will NOT automatically be erased trast can be altered, using the slide bar, and overwritten. In this instance, the to adjust from Lighter to Darker . The Immunototal must be manually setting affects only the displayed image deleted or cleared prior to importing of the scan and does not affect the re- new demographics (See 7.4.40.4), sults. To reset to the default setting, select Reset . 1. Immunototals allows for enter- ing total immunoglobins. Touch or select the Immunototal icon,

7-28 QUICKSCAN Touch SEVEN – Operating Instructions has two holes, then place the (Third from the right) or right click round hole in the gel over the on the scan and select Immunototals right pin in the scanner and the (Hot key: Ctrl + T). The Immunoglobulin obround hole over the left pin. If Totals window displays: the gel has no holes, place the gel so that the first sample in on 2. The window contains labels and the right, back corner of the spaces for Immunototals, and total pro- scanner with the samples orient- tein (if not selected as a demographic ed left to right. If needed the gel during test setup). may be taped down to the scan- 3. Enter the totals, as needed, using the ner bed to make it lie flat. The keyboard. Each total may be from 0.0 agarose side of the gel should be to 99999.0 up. Close the lid. 4. To remove all the displayed totals, 2. Once the gel is in the scanner, select Clear and Yes in response to the the user may begin scanning by prompt. touching or selecting the Scan 5. Once the totals are as needed, select icon (first from the Ok and the Edit Scan(s) displays. left) or the Scan option from the 6. To exit without entering or altering the menu at the top of the screen. totals, select Cancel. If any alterations 3. If there is no worklist open at where made, an Alert prompt is dis- the time of scanning, the user will plays. To exit without applying the be asked to designate a test. changes, select Yes. To return the Im- munoglobulin Totals window, select No. 4. If positive patient Identity is enabled, the user will be prompt- 7. Comments - functions the same as ed to type in or scan the Gel ID Comments on non-IFE edit windows. number. By clicking OK without 8. Auto Interpretation and Pattern Char- entering a Gel ID number, the gel acteristics functions the same from this will still be scanned, but no pa- edit window as from non-IFE edit win- tient information will be imported. dows. This function will be added in a 5. When a gel is scanned, the future version of software. window displays “Scanning in Progress.” If Pre-scan Setup is 7.5. Scanning Gels not enabled, the worklist contain- ing all scans will open 7.5.1. Scan immediately after scanning. To aid in the scanner’s function, re- member to keep the scanner lid closed, 7.5.2. Pre-Scan Setup not to place objects on the glass sur- Pre-Scan Setup may be enabled face, other than items to be scanned, either in Test Setup, or before and to keep all the scanner’s glass sur- rescanning a gel such that a win- faces clean at all times. Failure to do so dow opens after imaging the gel, may compromise results. but prior to scanning. This gives 1. To position the gel, open the lid and the user the opportunity to adjust place the gel on the scanner. If the gel

7-29 QUICKSCAN Touch SEVEN – Operating Instructions Scan locations, Scan Settings, and 7.5.2.2. Scan Settings Worklist Settings . 1. Scan Settings may be altered in Pre-Scan Setup in a manner similar to Test Settings in User Setup . 2. Scan Settings contains the currently setup settings for the test and worklist in use. Only al- 7.5.2.1. Scan Locations ter those parameters that need to 1. Select this option to display an image be changed from the setup set- of the gel and the scan begin and end tings (the changes will only apply lines. The scan position can be tempo- to the worklist for this scan). rarily adjusted if needed. Note that if a test repeatedly needs scan parameters 7.5.2.3. Scan Sequence and/or scan position adjusted, the test Scan Sequence can be altered setup may need to be altered (see sec- by entering the sample positions tion 6.2). needed, position numbers with a 2. For each row of the gel there will be a comma and/or designating a set green scan begin line and a red scan of positions with a hyphen. For end line. In addition, there will be a blue example 3, 5, 8-12, 15, 20. line, indicating the first sample position on a row, and a purple line, indicating 7.5.2.4. Scan Aperture the last sample position on a row, for Scan Aperture may be from 1 to each row of samples. 12, see section 9 for the meas- 3. For each row, use the mouse to move urement that corresponds to the green lines to the front of the pattern each aperture setting. to set the scan begin and the red lines 7.5.2.5. Smooth to the other end of the pattern to set the scan end. Smooth - Do not select unless procedure recommends other- 4. For each row, use the mouse to set wise; the graph will not be the sample step over by placing the blue smoothed. With Smooth select- lines on the center of the samples locat- ed, set the Smoothing Level to a ed on the left of the window (the first value from 1 to 10, with 1 being sample) and placing the purple lines on minimal smoothing and 10 being the center of the samples located on the maximum smoothing. Smoothing right of the window (the last sample). does affect the results. Increas- 5. This operation defines the distance ing the smoothing level from one sample to the next. The pur- decreases the background noise ple line must be centered in the last and lowers smaller fractions. sample position regardless of the num- Smoothing could affect small ber of samples in a row. The monoclonals . QuickScan software will use the position of these lines to automatically calculate the space between each sample.

7-30 QUICKSCAN Touch SEVEN – Operating Instructions 7.5.2.6. Auto Interpretation Manual Gain should be selected See Section 6.2 for Urine gels in order to mini- mize noise. 7.5.2.7. Auto Edit/Auto edit Settings 7.5.2.12. Fraction Detection See Section 6.2 See Section 6.2 7.5.2.8. Report Total LDL Report Total non HDL 7.5.2.13. Sensitivity Sensitivity - sets the “sensitivity” See Section 6.2 of the instrument to +/- slope 7.5.2.9. Overlays and Auto Settings changes when detecting frac- tions. Set, using the slide bar, See Section 6.2 within a range of 0.0 Min to 10.0 Max, in 0.1 increments. A sensi- 7.5.2.10. Image Contrast tivity of zero turns off the auto See Section 6.2 fraction selector thus causing no fraction marks on the scan. 7.5.2.11. Gain Mode 7.5.2.14. Forced Fractions 1. Auto - the maximum fraction ampli- tude is set to 100% of the graph height 1. No - select to pick fractions with the rest of the fraction heights pro- based only on pattern slope portional to it. change . 2. Manual - the fraction amplitude is 2. Float - select for fraction marks proportional to concentration and is the based on the pattern slope only if gain of choice for light patterns such as they occur within a window urines. This option is selected because around the Reference fraction an auto-scanned sample that is light will marks. If no fraction marks ap- show many fractions. With Manual gain pear in the window, a mark is selected, Auto Scale is accessible in the forced at the Reference fraction Edit mode for use if a specific pattern mark location. If selected, a over ranges because that pattern is not sample will need to be labeled light. Patterns of varying intensity are Reference for each gel and will usually scanned in Manual gain, for ex- need to be scanned prior to any ample, Urine Proteins and CK sample for which it will be the Isoenzymes. overlay. 3. Manual Gain - is set in a range of 0.0 3. Fixed - select to use the same Min to 10.0 Max, in 0.1 increments. Set fraction locations as those of a using the slide bar accessible only when previously scanned Reference. If Manual is selected. Adjust the slide bar selected, a sample will need to as needed to achieve the desired ampli- be labeled Reference for each tude with the highest peak at the gel and will need to be scanned desired level when scanned. Start at a prior to any sample for which it manual gain of five and increase or de- will be the overlay. crease gain as needed. Note that

7-31 QUICKSCAN Touch SEVEN – Operating Instructions 7.5.2.15. Worklist Settings 7.5.4. Rescan 1. Worklist Settings may be altered in a To rescan the gel and attribute it manner similar to Worklist Template to the demographic content of the Setup (Section 6.3). current worklist, select Scan with 2. Display Settings - select and the Dis- the current worklist open. A play Settings window displays. Use this prompt will appear as to whether window to customize the appearance of the scan is a rescan. Rescanning the window displayed once scanning is a plate will remove edits for each complete. sample selected for rescanning. 3. Print Settings - select and the Print 7.6. Quality Control Settings window displays. Use this win- dow to customize the print related 7.6.1. See Section 6.8 for QC settings. These settings will be used Setup whether printing occurs automatically or at operator request. Automatic printing To perform QC using the NDDC is not recommending as printing will oc- and OD Step Tablet and/or to cur prior to operator review. See manage previous QC results, section 6.3 for additional information on touch or Select Maintenance, this window. then Quality Control. The Quality Control Window will open. 4. Export - select to automatically export scans. Whether or not Export is select- 7.6.2. Quality Control History ed, scans can be exported at operator request. Automatic export is not rec- The window displays a history of ommending as export will occur prior to all QC scans, listed by the NDDC operator review. See section 6.3 for ad- identifying number, Date and ditional information on this window. Time Scanned, and User ID. The number of scans stored is set in 5. Save - Save is not listed as an option QC Setup. (Section 6.8). There in the QuickScan Touch software as all are options to Scan, View, Print, scans are automatically saved in the Delete, and Close. View, Print, worklist folder. and Delete are only available if there have been previous scans 7.5.3. Scan Samples stored. 1. When all desired options have been reviewed and/or selected in Pre-Scan setup, click on Scan Samples. 2. Select Scan Samples to finish scan- ning the gel after Pre-Scan Setup settings have been viewed and/or edit- ed.

7-32 QUICKSCAN Touch SEVEN – Operating Instructions 7.6.3. Scan 4. Verify that there is no debris 1. Select Scan to QC using the on the NDDC plate, and that the NDDC/OD Step Tablet. The message NDDC plate is not scratched or “Place the QC Plate in the scanner, click otherwise damaged. ‘OK’ to continue ” displays. 5. Optics alignment or instrument servicing may be required. Con- tact Helena Laboratories for assistance .

2. Open the scanner lid and place the NDDC plate in the scanner. The round hole in NDDC/OD Step Tablet is aligned over the right pin in the scanner and the obround hole over the left pin. Close the lid. 3. Select OK and “Scanning in Pro- gress” displays. The NDDC results are 7.6.5. View automatically compared to and dis- played with the Assayed Value and Select a scan from the history of Expected Range entered in setup. saved scans and click View to view the QC scan. The selected 4. The OD Step Tablet shows proper scan opens. There is an option linearity when, on the QC printout, a to print the individual scan from straight line can be drawn which con- this screen. It is recommended nects the vertical points from the bottom that a permanent record of the step through at least 6 steps. QC results be kept.

7.6.4. Troubleshooting 7.6.6. Print 1. If the results are not acceptable, trou- From the Quality Control History bleshooting may proceed as follows. window, the user may print a re- 2. Verify that the lid is completely closed port containing all previously run and repeat the scan. If the lid is not and saved scans. Each scan is completely closed, fewer than the appli- recorded by NDDC registration cable number of distinct steps on the number, date and time scanned, OD Step Tablet may be presented. User ID, and each of the five NDDC fraction results. The re- 3. Clean all the glass surfaces in the port also includes, for each of the scanner with a standard glass cleaner five NDDC fractions, the mean, and a lint free tissue. Repeat the scan. standard deviation, and coeffi- cient of variation. It is

7-33 QUICKSCAN Touch SEVEN – Operating Instructions recommended that a permanent record b. Reference - select to have of the QC results be kept. the reference pattern, shown in blue, overlaid on the sample pat- 7.6.7. Delete tern, shown in red. If selected, a Select Delete to Delete the selected QC sample will need to be labeled scans. A confirmation prompt displays. Reference for each gel scanned Select Yes to exit and delete the select- (section 7.11.2). ed QC, or No to exit without deleting c. Patient 1 - select to have a QC . patient’s scan overlaid on the cur- rent scan (section 7.3.22) 7.6.8. Close d. Patient 2 - select to have a Select Close to close the QC window. second patient’s scan overlaid on Scans are automatically saved up to the the current scan (section 7.3.22) limit set in QC Setup. When the total 3. Results - select as needed: number of scans to be saved exceeds the limit established in QC Setup, the a. Display Percent oldest scan will be deleted as new b. Display Units scans are saved. c. Display Integrals 7.6.9. Delete d. Display IFE Units - is the on- ly option available with an IFE test Select Delete to delete the indicated QC is selected. scan. 4. Ranges - the options available 7.6.10. Exit depend on selections made in Results and within Ranges. Se- To exit the QC window select the X lo- lect as needed: cated on the top right of the window . a. Display Percent Range 7.7. View b. Display Units Range c. Display Ratio Range 7.7.1. Display Options/Set Display Options d. Display IFE Range 1. Either select View and Display Options e. Flag Percent Out or select the Set Display Options icon f. Flag Units Out (the eighth icon). The Display Settings g. Flag Ratio Out window (Figure 6-14) displays. This window allows for the display parameters h. Flag IFE Out for the indicated worklist to be temporari- 5. Cancel - select to exit the win- ly altered. dow without altering the display 2. Overlay - is not available for a scan settings. worklist with an IFE test selected. Select 6. OK - select to exit the window as needed: and implement any altered display a. Unedited - select to have the uned- settings. ited pattern overlaid on the edited pattern.

7-34 QUICKSCAN Touch SEVEN – Operating Instructions 7.7.2. Communication Logs be connected, and the following There are three types of logs that may must be active/ enabled: be maintained in the QuickScan Touch 2. Sample Handler Connection software. The logs may be useful for Enabled in Setup, Import/ Export. diagnostic purposes in case of importing 3. Sample Handler log created in or exporting difficulties, error reporting, Setup. or a record of users . 4. From the Main Menu, Touch or 7.7.2.1. Sign In Log Click on View, then Communica- Under View, select the Sign In Log to tions, then select Sample view a list of each user and the date and Handler. time of sign in and sign out. 5. A window opens with a list of all the incoming and outgoing 7.7.2.2. Host Communications communications with the Sam- 1. The Communications log can be very pler Handler. This log may be useful in troubleshooting importing and very useful in troubleshooting dif- exporting failures of patient data and re- ficulties with importing patient sults. To be able to access the Host identifiers. The following options Computer Communications log, the are listed. Host Computer must be connected, and a. Clear - to clear the the following must be active/ enabled : communications log. a. Host Computer Connection b. Print - to print the Enabled in Setup, Import/ Export. Sample Handler log. b. Communication log created in c. Close – to close the Setup window. c. From the Main Menu, Touch or Click on View, then Communica- 7.7.2.5. Error Log tions, then select Host Computer . 1. Select View and Error Log. The Error Log window displays . 7.7.2.3. Communications Log 2. The Error log maintains a list 1. A window opens with a list of all the of all reportable errors. The log incoming and outgoing communications may be cleared or printed. This with the Host Computer, and the options log provides useful information to listed below. a Helena technical or service rep- a. Clear - to clear the communi- resentative in the case of cations log. dysfunction . b. Print - to print the log. 7.7.3. List of Open Worklists c. Close – to close the window. With multiple worklists open, to select a worklist for use, select 7.7.2.4. Sample Handler Log Windows and click on the desired 1. To be able to access the Sample worklist. Note that check in the Handler Log, the Sample Handler must box to the left of each worklist in-

7-35 QUICKSCAN Touch SEVEN – Operating Instructions dicated which worklist is currently active. a. Scan components may Note : If the cursor does not appear to also be altered on the display respond, the active window may be be- by clicking and dragging indi- hind the displayed window, Click Enter to vidual elements. For correct . example, the image of the sample may be enlarged. 7.8. Help 3. Label

7.8.1. About a. The scan itself is la- beled across the top with the 1. Select Help and About to display a Test Name, Gel number, window containing the current software sample number, date, and version and system serial number. time scanned. 2. The system serial number should be the same as the handwritten serial 7.10.2. Thumbnails number on the Helena labels located on 1. With a worklist open, thumb- the computer, scanner, and transparen- nail images are displayed at the cy lid. bottom right of the screen. The scans for the selected thumbnail 7.8.2. OK will be displayed. Thumbnails OK - select to exit the window. may be scrolled through with the arrow keys, mouse, or touch 7.9. Worklists screen. Resize the window con- taining the thumbnails as desired There are three components to an open to display scans in rows or col- worklist, the scan, the thumbnails, and umns. the Gel Image (if enabled). The open worklist is labeled along the top of the 2. Touch or click on the thumb- screen by the worklist name, date nail to select the desired scan. scanned, time scanned, test, and Gel 3. Each thumbnail is labeled by number . the key identifier information, and a colored square indicated its 7.10. Scans status. Blue, indicates the scan 7.10.1. Scan Components has the proper number of frac- tions and all the fractions are 1. Resizing within range values. Red indi- a. Scan components may be cates the scan does not have the added, resized, or removed as de- proper number of fraction and/or sired by creating custom worklist one or more fraction is out of templates. The default worklist range. Yellow indicates the scan scan components are the de- has been viewed in the edit mographics, image of the sample, mode; however, it still does not scan, results, space for overlays, have the proper number of frac- and comments. tions and/or one or more of the fraction is out of range. 2. Relocating

7-36 QUICKSCAN Touch SEVEN – Operating Instructions 4. Using the Scan option, individual available scans and overlay selec- scans may be searched for within the tion criteria. worklist. Right click on the Gel Image j. Scan Properties: The area and select Scan. The following op- following may be located by tions appear: Find, Find Again, Cut, right clicking on the Gel Im- Copy, Paste, and Delete. age Area and selecting Scan 5. Find Properties. a. Search for : Enter in a partial i. Test name and serial or complete demographic. number of test . b. Match whole words only : must ii. Sample Identifier - Sam- enter the complete ID or demo- ple ID from the bar code tube of the graphic. Sample Handler if positive Patient c. Match Case Identity was enabled d. Find Again : Find the next in- iii. Gel Identifier - ID number stance of gel. e. Cut iv. Sample Number - Sam- ple lane number of specific patient i. Cut a scan from a worklist. The to indication position on the gel. scan may be pasted to the same worklist, v. Scanned: Date, Time, or to another worklist. A scan may not be cut and pasted as an overlay. A scan User ID. may not be pasted twice to the same vi. Rescanned: Date, Time, worklist. User ID.3 f. Copy vii. Reviewed: Date, Time, i. Copy a Scan from the worklist. User ID. The scan may not be pasted to the same viii. Edited: Date, Time, Us- worklist. The scan may be pasted to an- er ID of most recent edit. other worklist, or as an overlay to the ix. Scan Resolution: (DPI of same or other worklist. A scan may not scan. 200, 400, 600, 800, or 1200, be pasted twice to the same worklist selected during test setup) g. Paste x. Scanned Status (OK or i. Only active if a scan has been error). copied or cut. A cut scan may not be pasted as an overlay) or a scan may 7.10.3. Gel Image Properties pasted to the end of a worklist. Two cop- 1. In the upper left corner of the ies of the same scan cannot be pasted to displayed worklist, there is an ar- the same worklist. ea for the Gel Image to be h. Delete displayed, if enabled in Test Set- up. Right clicking on this area i. Auto Overlay reveals several options. Worklist, i. Auto overlay may be used to ap- Gel Image, Scan, and Close. If ply overlays based on the most currently the Gel Image was not saved,

7-37 QUICKSCAN Touch SEVEN – Operating Instructions there is a blank gray space in this area be written manually on the gel it- with a message “Gel image not availa- self, or noted in the name of the ble. “ The Gel Image option is grayed file. out and not accessible when the screen 4. Users are welcome to save is clicked on. and email gel images to Helena 2. Worklist Label - Right click on the im- Technical Services for trouble- age of the gel, and select Worklist to shooting purposes. add a specific label, to view, or to edit 5. Scan Navigation using Gel Im- the worklist label. Note that the worklist ages. label may be free text, and is not the same as the Gel ID number. Every a. If the Save Gel Image worklist may be individually named . feature is enabled, an image of the entire gel will be dis- 7.10.4. Worklist Properties played above the thumbnails Right click on the image on the gel, se- in the upper right corner of lect Worklist, and then Worklist the screen. This image may Properties. A screen opens which dis- be resized as desired by plays the worklist label, Date and Time clicking and dragging. The created, Worklist Template used, Loca- sample lane of the currently tion or folder that the worklist is stored selected scan will be identi- in, Test name and serial number, Gel fied on the gel image. A ID, and the number of completes scans scan may be select by touch- in the worklist. Click OK or the X in the ing the displayed sample, or clicking with the mouse. upper right corner to exit .

7.10.5. Gel Image 7.11. Tips Note: If Save Gel Image is enabled, the 7.11.1. Scanning gel image is automatically saved and ar- 1. The contents of a worklist chived with the worklist. The Save As need not be cleared prior to and Print options discussed here refer to scanning. Unlimited worklists saving the gel image outside of the may be created and stored. QuickScan Touch software. (Storage is limited by computer 1. Right click on the Gel Image if availa- memory only Worklists are auto- ble. There are options to Print or Save. matically saved in the worklist 2. Print: Select a printer, and print. folder, and may be archived as desired.) Each time a gel is 3. Save As: To save the gel as a bitmap scanned, a new worklist is gen- file, click on Gel Image, then Save. A erated. menu appears where the user may des- ignate a name for the file, and 2. To remove water spots on the destination. The image may be saved gel, use an alcohol prep pad or to any folder, include a flash drive, net- water and wipe off the back of work, etc. The image will be saved the gel. exactly as the gel appears, such that 3. Any external flaw, for example any identifying information must either a spot of stain, located on the gel

7-38 QUICKSCAN Touch SEVEN – Operating Instructions within the area to be scanned will be 2. Noise is best corrected in the visible on the scan image displayed in edit mode using the delete area the Edit mode. The operator can then feature and not by smoothing. determine if the flaw can be safely re- 3. Do not use smoothing unless moved in the Edit mode or if the scan is the procedure recommends. unusable. Smoothing does affect results. Increasing the smoothing level 7.11.2. Edit decreases the background noise 7.11.2.1. Reference Ranges and and lowers smaller fractions. Reference Overlays Smoothing could affect small paraprotein spikes. 1. If using normal and/or abnormal con- trol ranges, the applicable sample(s) 7.11.4. Urine and Serum Proteins must be designated as Reference Nor- mal or Reference Abnormal in order for 1. Gels containing both urine and the correct range to be used. serum protein samples can be scanned on the QuickScan 2. The use of a Reference Overlay is Touch. Setup the tests and recommended as an aid when scans worklists for urine proteins and are displayed. Note that viewing, print- for serum proteins. The gel may ing and exporting overlay information be scanned twice, creating two are each separate setup selections. worklists. 3. Scanning using the float or fixed op- 2. Open or create a serum pro- tion is based on the assumption that the tein worklist, enter the applicable scan distance is the same for all rows. patient information, use Scan Any pattern may be named Reference Settings to specify the sequence to serve as a fraction mark guide as of the serum protein samples on long as it is scanned before the scans to the gel, and scan the gel. Then, which it will be used. It is recommended without moving the gel, open or that a representative sample of each create a urine protein worklist, row be identified as Reference. enter the applicable patient in- 4. Any scan(s) designated as Reference formation, and use Scan Settings must be scanned prior to the scans for to specify the sequence of the which it is the reference. This can be urine protein samples on the gel, accomplished either by placing the ref- and scan the gel. erence sample(s) on the gel before the 3. When scanning urine protein applicable samples or by setting the gels it may be helpful to use a se- scan sequence to scan the reference rum protein as a reference sample(s) position and then the appli- overlay because the urine protein cable sample positions (section 6.2.3). samples may be too low to de- termine the fraction area. This is 7.11.3. Editing also an opportune time to use 1. The best guide to the interpretation of fixed fractions. scans, especially scans with results that are out of range, is physical examination of the gel.

7-39 QUICKSCAN Touch SEVEN – Operating Instructions 7.11.5. Cholesterol profiles 2. Ensure that the stain type se- Cholesterol profile scans using the auto lected for the Fetal Tek plates is edit feature should be reviewed and “Fetal-Tek.” This will ensure that manually edited as needed. the correct scanning calibration parameters are applied. 7.11.6. QuickGel 3. When editing a Fetal-Tek 1. For QuickGel IFE gels, Test Setup plate, baselining to remove back- must include the following: Test Proper- ground is NOT recommended. ties - Rows per Gel set to 2; Scan lanes Studies have shown that a badly per Row set to 6, Scan lanes per sam- charred plate cannot be salvaged ple set to 6. Scan Setup; through editing due to the une- Scan Positions set the two sets of scan venness of background charring. position lines so that the lines identified If the control samples are out of as A are located on the top and define range, the plate should be re- channels one through six for sample charred or rerun. one, B are located on the bottom, left 4. If there are more or less than 7 and define channels one through six for lanes on a Fetal Tek Plate, then sample two. the scan settings must be altered 2. For all other QuickGels, Test Setup accordingly. This may be ac- must include Rows per Gel set to 4 and complished in two ways. Sample Applications per Row set to 5. 5. The scan lanes per row may 3. If scanning a QuickGel with fewer be altered in Gel Properties with rows and/or samples per row, use the the scan begin and end lines re- Pre-Scan window to alter the sequence set to accommodate the new of samples scanned. Alternatively, the number of lanes. user may scan the entire plate and de- 6. If there are fewer lanes per lete any “empty” samples. plate (for example, if the plate contains 6 lanes rather than 7) 7.11.7. Fetal Tek then the user may elect to scan 1. When scanning Fetal Tek plates, be- an empty area as a lane in pre- cause it is difficult to see the lines scan setup. through the silica, it is recommended that the scan begin and end positions 7.11.8. IFE are marked on the plate with a marker in Note that when scanning an IFE the glass area on either side. Then gel, scan from the gamma end to place the marked plate so that the pre- the albumin end. adsorption area is on the left of the scanner with the silica layer facing up so 7.11.9. Hemoglobins that the first sample is in the proper po- Smoothing is not recommended sition. Place the green scan-begin line when scanning Hemoglobin to the right of the second major band, plates. which is Sphingomyelin (S) and the red scan-end line on the preadsorbant side of the first large band, which is Lecithin (L).

7-40 QUICKSCAN Touch SEVEN – Operating Instructions 7.11.10. Patient Overlays/Reports 1. To print a report with multiple patient results (for example, a Serum Protein and IFE scan, select a report setup to print overlays, for example the Standard profile report. 2. Designate the desired IFE scan as the patient overlay 1 for the desired Se- rum Protein scan. 3. When the Serum Protein scan is printed using the Profile Report, the IFE image used as the Patient Overlay will appear as well as the results. 4. Refer to Section 6.5 or contact Hele- na for further information on how to create unique reports that may contain multiple test types and gel images.

7.11.11. Results For a complete discussion of results and their interpretation, refer to the following sections of the procedure supplied with the reagents: Instruments, Evaluation of Bands, Stability of End Product, Results, Expected Values, Performance Charac- teristics, and Interpretation of Results.

7-41 QUICKSCAN Touch SEVEN – Operating Instructions

Figure 7-1 Main Menu

Figure 7-2 New Worklist

7-42 QUICKSCAN Touch SEVEN – Operating Instructions

Figure 7-3 Label Worklist

7-43 QUICKSCAN Touch EIGHT - Test Functions and Quality Control 8.3.2. 10 Step Optical Density (OD) Step Section 8 - Test Functions and Quality Tablet Control 1. The OD Step Tablet checks linearity 8.1. Tests and analog response of the visible light source and detector 1. The instrument automatically performs a self-test any time the power is turned 2. A list of the quantitative ranges for the on. Should an error message appear on NDDC bands should have been entered the display, see section 10-2. during QC setup. 2. Refer to the appropriate owner’s guide 3. To QC using the NDDC and OD Step for tests of the monitor and printer. Tablet and/or to manage previous QC re- sults, either select Maintenance and then 8.2. Quality Control Quality Control. The QC window displays. A list of all saved QC scans is displayed, 8.2.1. Controls with the options to view, Print, Scan, De- lete, and Cancel. 1. On every gel, Helena Laboratories normal control should be run in scan posi- 8.3.3. QC Main Menu tion 1 and/or abnormal control in the last position, and samples in between. The control data should be compared to the ranges printed on the assay sheet provid- ed with the control. Keep a permanent record of the results. 2. Each laboratory should establish its own reference ranges of expected values for the procedures in use. Refer to the electrophoresis procedure supplied with the reagents for further information. 1. The History of all saved QC scans is available from the main QC menu. The 3. It is recommended that each laboratory availability of previous QC results is de- set up an effective quality control program pendent upon selections made in setup based on licensing requirements. The list of previous results includes the 8.3. Instrument Performance Check NDDC registration number and the date and time the QC was run. Highlight the 8.3.1. Neutral Density Densitometer desired QC and select from the following: Control (NDDC) 2. View - A single scan may be selected The QC plate contains a Neutral Density from the list for view. Densitometer Control (NDDC) containing 5 bands of known quantitation, and a 10 Step Optical Density (OD) Step Tablet with an OD Range of .05 to 3.05 in .30 in- crements. Scan the QC plate at frequent, regular intervals .

8-1 QUICKSCAN Touch EIGHT - Test Functions and Quality Control 4. The NDDC results are automatically compared to and displayed with the As- sayed Value and Expected Range entered in setup. Out of range values are indicat- ed by a plus or minus on the display and report. 5. The OD Step Tablet shows proper line- arity when, on the QC printout, a straight line can be drawn which connects the ver- tical points from the bottom step through at least six peaks .

8.3.5. Unacceptable results If the results are not acceptable: 1. Verify that the lid is completely closed 3. Print is available with a single QC and repeat the scan. If the lid is not com- scan/NDDC result displayed. Select and pletely closed, fewer than the applicable the Print QC Results window displays. As number of distinct steps on the OD Step needed, select the appropriate Printer and Tablet may be presented. Number of Copies. Select Print to print 2. Clean all the glass surfaces in the the scan. Select Cancel to exit without scanner with a standard glass cleaner and printing. It is recommended that a perma- a lint free tissue. Repeat the scan. nent record of the QC results be kept. 3. Optics alignment or instrument servic- 4. Delete - Delete to delete the indicated ing may be required. Contact Helena QC. Select Delete and Alert displays. Laboratories for assistance. Select Yes to exit and delete the selected QC scan, or No to exit without deleting the 8.3.6. Print scan. Print - From the main QC window, the 8.3.4. Scan Print function may be used to print a re- port containing all previously run QC. The 1. To run a new QC scan using the report includes for each previously run QC NDDC/OD Step Table, select Scan, click the NDDC registration number, the date on Maintenance, then QC, then Scan.. and time of the run, and each of the five The message “ Place the QC Plate in the NDDC fraction results. The report also in- scanner, click ‘OK’ to continue ” displays. cludes, for each of the five NDDC 2. Open the scanner lid and place the QC fractions, the mean, standard deviation, plate in the scanner. The round hole in and coefficient of variation, determined the QC plate is aligned over the right pin from the results of each previously run in the scanner and the obround hole over QC. Select Print , the report prints and the the left pin. Close the lid. display returns to the QC History window. 3. Select OK and “Scanning in Progress” Select Cancel to return to the window displays. without printing.

8-2 QUICKSCAN Touch EIGHT - Test Functions and Quality Control 8.3.7. Delete From the main QC window, use the delete function to delete the indicated QC. Se- lect Delete and Alert displays. Select Yes to exit and delete the selected QC, or No to exit without deleting QC .

8.3.8. Cancel Cancel - select to exit the QC History win- dow.

8.3.9. Exit To exit the QC window, select the X locat- ed on the top right of the window.

8-3 QUICKSCAN Touch NINE - Performance Specifications ments/Interpretations, Print Auto Interpre- Section 9 - Performance Specifications tation, Print User-Defined Text (Headers, Footers, etc.), Print Picture, Bar Code, 9.1. General Specifications List/Statistics, Profile, Reports Print Se- Tests: lected Demographics, Levey-Jennings Reports Select Graph Size Serum Proteins, Urine Proteins, Alkaline Import /Export Parameters: Hemoglobins, Alkaline Phosphatase, Cho- lesterol Profile, CK, LD, IFE, L/S and Communication Parameters including Lipoproteins XON-XOFF and ASTM Protocol, and Posi- User-Programmable: tive Sample Identification, Exporter Information, Export Demographics, Export Test Parameters: Graph, Export Comments, Export Auto In- terpretations, Export IFE Interpretation, Test, Test Name, Scan Sequence, Gel Export Percent, Export Units, Export Inte- Stain Type, Immunofixation Electrophore- grals, Export IFE Units, Export Ratio sis, Sample Image Color Intensity, Range, Export Ranges, Export File Name Aperture, Gain Mode, Fraction Detect Sen- and Delimiter, and ASTM Fields, Host sitivity, Forced Fractions, Smoothing, Unit Computer and Sample Handler Communi- of Measure, Total Unit of Measure, Deci- cation logs. mal Places, (Cholesterol Profile only) Auto Edit and Report Total LDL (Lp(a) + LDL), Additional User-Programmable Selec- Report total non-HDL (Total cholesterol – tions: HDL), Auto Interpretation, Combine Split Beta, Test Specific Demographics, Chan- System Demographic Labels, Comments nel Width, Scan Positions, Fraction Labels and Interpretations, QC, Date and Time, and Ratios, Ratio Labels and Limits, Re- Printer, and Users and Passwords for Set- stricted Band Label, Restricted band up marking method (Skimmed or Sliced) and Media Types: Reference Ranges. Display Parameters: Agarose and cellulose acetate gels Maximum Sample Size: Display Scans, Overlay, Overlay Thumb- nails, Overlay Delimiters, Display Percent, 5 x 5 in. (12.7 x 12.7 cm) Display Units, Display Ranges, Display In- tegrals. Input Power: Report Parameters: 120 VAC, 50/60 Hz, 1000 Watts

Report Label, Type of Report, Scans per 240 VAC, 50/60 Hz, 1000 Watts Report, Paper Size and Orientation, Num- Leakage Current: ber of Copies, Print Scan Identifier, Print Patient Information, Print Sample Image, Less than 5 mA Print Graph, Print Overlay Legend, Overlay Reference, Patient(s), Unedited on Graph, Dimensions Height x Width x Depth: Print IFE Overlay, Print IFE information, Computer, Monitor, and Keyboard: Scan Status, Print Results, Print Com-

9-1 QUICKSCAN Touch NINE - Performance Specifications 22 x 18 x 24 in. (56 x 48 x 61 cm) and denominator of zero, one, or two rati- os. Scanner:

≤ 8 x 13 x 22 in. (20 x 33 x 56 cm) 9.2.2. Programming Worklists Choose how scans are displayed, whether Printer: to edit, print, or export data to an external 10 x 14 x 14 in. (26 x 36 x 36 cm) source. Total Weight: 104 lbs (47 kg) 9.2.3. Programming Report Style Environment: 15° to 27°C (59° to 80.6°F) The title, report type, the quantity of scans Complete specifications for the scanner, per report, the paper size and orientation, monitor and printer can be found in their scan identifier, patient demographics, respective owner’s guide. sample image, graph, overlay legend, scan status, results, comments, auto interpreta- 9.2. User Programming tion, text, pictures, lines, overlays, barcodes, Levey-Jennings Graph plots, Although QuickScan Touch is factory pro- ranges, and number of copies can be se- grammed for each default test, the user lected. may modify instrument operation. 9.2.4. Programming Patient 9.2.1. Programming Test Demographics Unit of Measure: Any units, such as Determine what information is to be includ- mg/dL, mg/24hrs, g/L, or U/L. ed in the patient data, and the order in Ratio Names: Any name for one or two which it will appear. Include essentially un- ratios. limited demographic labels (such as Patient Name, ID Number, Patient Age, Sensitivity: Set sensitivity for optimal re- Patient Sex, etc.). sults for each test. Forced Fractions: Choose to have fraction 9.2.5. Programming Comments marks “fixed” at the same location as that You can write and save comments. Saved of the Reference, “floating” (left where they comments can be recalled and used with occur if within a window around Reference other comments in any patient files. Auto fraction marks or, if none occur in window, interpretation comments based on user de- put at the Reference fraction mark posi- fined parameters may be programmed and tion), or forced fractions “off”. applied. Reference Ranges: Normal ranges (de- termined from previous runs) assigned for 9.3. Editing total and each fraction. Can have ranges Choose whether or not to edit each scan based on age or sex. before storing, printing, or exporting the Fraction Names: Up to 10 labeled frac- data. Editing features include: restoring tions. the graph to an unedited form, automatical- ly editing a pattern, automatically setting Ratios, Numerator and Denominator: De- the scale to bring all peaks onto the graph, note which fractions are in the numerator overlaying a reference pattern on the graph, aligning the reference with the sam-

9-2 QUICKSCAN Touch NINE - Performance Specifications ple, adding comments, inserting or deleting 9 5 x .1 fraction marks, marking restricted bands using the skimmed or sliced method, delet- 10 5 x .25 ing an area from the pattern, baseline adjustment, overlaying an unedited pattern 11 5 x .5 on a edited pattern, overlaying other pa- tient patterns, and smoothing a pattern. 12 12.18 x 12.18 Scan Length: 9.4. File Retrieval Determine what information the computer Variable from 0.01 to 221.5 mm will search for when retrieving files. The Zeroing: selections are similar to Patient De- mographics. Automatic Light Source: 9.5. Automatic Data Analysis, Each Scan Cold Cathode Fluorescent (white light) Analog curve, fractions, percent, units, in- Light Detectors: tegrals, one or two ratios, fractions, integrals, high and low indicators when CCD Array outside normal ranges, and total. Optical Density Linearity: 9.6. Densitometer Specifications 0.05 to 3.05 OD - Epson Expression scanner Scanning Parameters: model V700 Gain: Automatic or Manual Over range: > 100% of full scale Operating System: Optics Mode: *Microsoft ® Windows ® 7

Visible Transmittance (white light)

Aperture Sizes (mm): *Windows is a registered trademark of Microsoft Inc. 1 1 x .1

2 2 x .2

3 3 x .3

4 4 x .4

5 6 x .6

6 7 x .7

7 8 x .8

8 2.5 x .25

9-3 QUICKSCAN Touch TEN - Maintenance, Troubleshooting, and Warranty 10.1.3. Cleaning Touchscreen Monitor Section 10 - Maintenance, Troubleshooting, and Warranty The QuickScan Touch touchscreen moni- tor is designed for medical use. Turn off This section describes routine operator and unplug the monitor prior to cleaning. maintenance procedures. For instrument The monitor may be cleaned using a calibration or for maintenance not de- clean, soft, cloth. Apply a non-abrasive scribed in this manual, call Helena cleaner to the cloth prior to cleaning the Laboratories for assistance. screen. Handle the touchscreen with 10.1. Maintenance care, without applying any stress to the cables. WARNING: The QuickScan Touch is factory lubricated. Do NOT lubricate the Do not use any vinegar based or abra- instrument. sive cleaners on the monitor. NOTE: No daily maintenance is re- Other cleaners than may be used include; quired. Quaternary ammonium (Virex, PDI Sani- 10.1.1. General Cleaning cloth HB), Bleach 5.25% or 6.25% at (1:10 dilution-1:100), or Quaternary ammonium Visually inspect and clean the QuickScan in combination with 70% alcohol (iso or Touch once a month. ethanol) (PDI Sanicloth or PDI Super San- TURN OFF THE POWER AND UNPLUG icloth). THE POWER CORDS BEFORE PROCEEDING. Should an instrument be 10.2. Troubleshooting contaminated by blood or blood deriva- tives, spray any contaminated surface with When using the QuickScan Touch software, a commercial virucidal and germicidal error messages may appear. If corrective agent. Observe where the specimens are action is not obvious, call Helena Laborato- used inside the instrument and confine ries for assistance. For system problems, cleaning to that area. Wipe up the residue. refer to the following table. If the recom- These materials contain alcohol, which is mended solutions should fail to solve a corrosive to metal surfaces. problem, call Helena Laboratories for assis- tance. Also, refer to the component owner’s Clean outer surfaces and any spills with a guide for troubleshooting procedures. damp soft cloth or sponge. Do not use cor- rosive or abrasive cleansers. Dry the unit before plugging the power cord in.

10.1.2. Cleaning Scanner Glass If the glass appears soiled or dusty, clean with a standard glass cleaning solution and a lint free tissue. All glass surfaces in the scanner must be kept clean for best opera- tion.

10-1 QUICKSCAN Touch TEN - Maintenance, Troubleshooting, and Warranty

Table 10-1 Troubleshooting PROBLEM POSSIBLE CAUSE SOLUTION Error message appears Refer to the message Perform actions in message; if re- curs, record the message and call Helena Laboratories for assistance. Power switch on, no power Power cord not plugged in Plug in power cord. Bad wall outlet Use another outlet. Not all Setup Options availa- Hard lock key not inserted or Check for dark blue flash drive in- ble poorly seated serted into USB port. Restart software No display (dark screen) Brightness turned down Turn up brightness on display, see monitor owner’s guide. Display power switch off Turn on display power switch. Unable to scan, scan icon Hard lock key not inserted or Check for dark blue flash drive in- not accessible poorly seated serted into USB port. Restart software Unable to scan, scan icon Scanner not connected Connect scanner. Restart soft- not accessible ware No presentation on display Loose interface or power cable Push cable connections in fully. Defective interface cable Call Helena Laboratories. Sample Identifiers not import- Closure of Import Identifier Win- Reimport ing from ESH dow before import complete Sample Identifiers not import- Comm port set to “Auto” Work with IT and have Comm ing from ESH ports given appropriate assign- ments Sample Identifiers not import- Sample Handler connection disa- Ensure connection physically ing from ESH bled sound, enable in User Setup Sample Identifiers not import- Communications settings be- Review Comm Settings ing from ESH tween Sample Handler and QuickScan Touch not identical Sample Identifiers not import- Loose or faulty connection Check Connections ing from ESH Sample Identifiers not import- Bar codes not read Check labels ing from ESH Check position of labels/ tubes in ESH Sample Identifiers not import- Incorrect Gel ID Rescan/confirm ID ing from ESH Sample Identifiers not import- Bar Code reader failure Call Helena Laboratories ing from ESH No printout is produced Did not select Print Select Scan Options, select Print, select a Printer, a Report, Number of copies, and OK. No printout is produced Loose interface cable Push cable connections in fully. No printout is produced Paper installed improperly Reinstall paper. No printout is produced Defective interface cable Replace cable. No printout is produced Improper printer setup Refer to printer owner’s guide for settings.

10-2 QUICKSCAN Touch TEN - Maintenance, Troubleshooting, and Warranty

No printout is produced Printer off-line but printout Leave printer on-line during requested operation. Poor quality printout Needs toner/ink Replace toner/ink cartridge. Other problem Refer to printer owner’s guide. No response to keystrokes Cable disconnected Firmly insert keyboard or mouse or mouse movement plug into receptacle on back of computer. No response to keystrokes Mouse located on screen behind Click Enter or mouse movement active screen No response to keystrokes Undetermined cause Press Alt-Ctrl-Del key to reset pro- or mouse movement gram (unsaved data will be lost). No response to keystrokes Undetermined cause Call Helena Laboratories. or mouse movement No response to touch screen Undetermined cause Use mouse/ keyboard/hotkeys Call Helena Laboratories No fraction marks on pat- Float or Fixed Fraction detection Put Reference as key identifier terns in use and/or scan first No fraction marks on pat- Fraction detection/sensitivity set Increase fraction sensitivity to de- terns to zero sired level.

Restricted band not marked/ Selected marking method not en- Check test setup marked incorrectly abled Band too small for automatic Mark manually marking Control and/or NDDC out of Power surge Call Helena Laboratories. range Control and/or NDDC out of Damaged plate Examine plate. Replace as need- range ed Control and/or NDDC out of Dirty NDDC plate Gently remove debris with dry lint range free tissue. Control and/or NDDC out of Scanner not calibrated, calibrated Call Helena Laboratories. range incorrectly Control and/or NDDC out of Scanner lamp failure Call Helena Laboratories. range Scan image and scan lines Scan lines setup incorrectly in Review scan image in test setup. (begin/end and step-over test setup, incorrect plate/test se- lines) do not line up lection Ranges not displayed Display not enabled Enable display

Ranges not displayed Ranges not entered in Setup Check test setup Ranges not printed Print Ranges not enabled Select 'print ranges' (units or per- cent) in print settings Ranges not printed Ranges not entered in Setup Check test setup

Ranges not printed Range values are not printed on Normal function List Reports Ranges not exported Export Ranges not enabled Enable export

10-3 QUICKSCAN Touch TEN - Maintenance, Troubleshooting, and Warranty

Ranges not exported Ranges not entered in Setup Check test setup Range values are not exported to file destination Ranges not exported Range values are not exported to Normal function file destination Barcode on report not printed Undetermined Cause Attempt to reprint Barcode on report not printed Incorrect type Check bar code type in setup Barcode on report not printed Incorrect format Ensure correct bar code format Units not calculated Total demographic not set up Check test setup

Units not calculated Total value not entered Enter correct total Auto interpretation not ap- Auto interpretation not enabled Review test setup, pre-scan setup plied Auto interpretation not ap- Units not entered Verify units plied Auto interpretation not ap- Ranges not entered Review test setup, plied Auto interpretation not ap- Incorrect number of fractions Edit scan plied Auto interpretation not ap- Auto Interpretation criteria not Check comment setup plied entered in Setup/ not entered for Check test setup designated test. Patient Overlay not applied No matching overlay available Use Find function to search for patient scans by Key ID Patient Overlay not applied Overlay Display not enabled Check Display criteria Patient Overlay not applied Incorrect Overlay criteria entered Check overlay search criteria No Lp(a) when forced Reference scan must be labeled Check patient info screen and label reference. reference No Lp(a) when forced Lp(a) must be marked Check reference overlay No Lp(a) when forced Auto Edit must be enabled. Check auto edit No Lp(a) when forced Force Lp(a) setting must be on Restore, then check auto edit criteria

10-4 QUICKSCAN Touch TEN - Maintenance, Troubleshooting, and Warranty 10.3. Warranty Helena Laboratories warrants its products to meet Helena’s published specifications and to be free from defects in materials and workmanship. Helena’s liability under this contract or otherwise shall be limited to replacement or refund of any amount not to exceed the purchase price attributable to the goods as to which such claim is made. These alternatives shall be the buyer’s ex- clusive remedies. In no case will Helena Laboratories be liable for consequential damages even if Helena has been advised as to the possibility of such damages. The foregoing warranties are in lieu of all warranties expressed or implied, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. In no event will Helena Laborato- ries be liable for indirect, incidental or consequential damages; the original user's remedies being limited to repair or re- placement at the manufacturer's option. All software and driver disks provided with this instrument must be retained and be accessible in the sleeves provided at the end of this manual for the warranty to be valid. Warranty Duration This warranty is provided to the original purchaser for six months from date of sale. Warranty Exclusions WARNING! Do not use the QuickScan Touch for any purpose other than that de- scribed in this manual. Modification of the software or the use of the QuickScan Touch computer to run other programs may affect the operation and reliability of the instrument. Helena Laboratories is not liable for any consequential damages should the customer choose to ignore this warning.

10-5 QUICKSCAN Touch ELEVEN - Symbology

Section 11 - Symbology NOTE: The following symbols may be used in this manual, or on the instrument, to provide information necessary to the user, if applicable.

Caution, electric shock hazard, high voltages capable of causing personal injury - shut down the instrument and unplug the power cord before touch- ing - do not operate with the cover(s) removed

Caution, heat hazard - allow heated components to cool before handling

Caution, general hazard - see Precautions and Hazards (Sections 3 and 4) of Operator’s Manual before proceeding

Direct current

Alternating current

Both direct and alternating current

Ground (earth) terminal

Protective conductor terminal (grounded conductors)

Frame or chassis terminal

Equipotentiality (conductor with all parts at a single potential)

On (power switch)

Off (power switch)

11-1 QUICKSCAN Touch ELEVEN - Symbology

Equipment protected throughout by double insulation or reinforced insula- tion (equivalent to Class II of IEC 536)

11-2 QUICKSCAN Touch TWELVE – Communication Specifications The protocol used by the QuickScan Section 12 - Communication Touch software is user selectable (see Specifications section 6.6). Listed below are the proto- INTERFACE SPECIFICATIONS: col options available. The QuickScan Touch import/export in- No Protocol: terface conforms to the EIA standard RS- Data is transmitted and received as 332C and is configured as a DTE (Data ASCII text with no flow control or error Terminal Equipment). Only RECEIVE checking/ correction. This option is not DATA, TRANSMIT DATA and SIGNAL recommended unless the QuickScan COMMON lines are used. The baud rate Touch is to be connected to a terminal. is user selectable at 1200, 2400, 4800, 9600, 14400, or 19200. The number of XON-XOFF Flow Control: data bits may be set at 7 or 8 and the Data is transmitted and received as ASCII number of stop bits may be either 1 or 2. text and XON/XOFF (ASCII codes 17 and Parity may be set to none, even odd, 19) handshaking is used to control data flow. mark, or space. Protocol options include When importing, the QuickScan Touch no protocol, XON-XOFF flow control, or software will transmit an XOFF character ASTM protocol. The QuickScan Touch when its communications buffer becomes does not order the tests. three quarters full. Data transmission should stop at this point. The QuickScan MECHANICAL SPECIFICATIONS: Touch software will process the data in the 9 pin D-shell connector (male): buffer and when it becomes half empty, an XON character will be transmitted and data Pin Description transmission can resume. When exporting, the QuickScan Touch will recognize an 1 receive line detect XOFF character and stop transmission until an XON character is received. There is no 2 receive data* error checking or correction when using this 3 transmit data* protocol. ASTM Protocol (E1381-95 and E1394- 4 data terminal ready 97): 5 signal common* This protocol provides procedures for link connection and release, delimiting and 6 data set ready synchronism, sequence control, error de- tection and error correction. Data is 7 request to send transmitted and received as ASCII text and some restrictions are placed on 8 clear to send which characters can be used in the data content. The restricted characters are: 9 ring indicator , , , , *only these lines are used by the QuickScan , , , , Touch software. , , , , , COMMUNICATIONS PROTOCOL: , and .

12-1

QUICKSCAN Touch TWELVE – Communication Specifications There are three distinct phases in trans- tention occurs. Contention is resolved as ferring information between the follows. Upon receiving a reply of QuickScan Touch and the computer sys- to its transmitted , the tem. In each phase, one system directs computer system must stop trying to the operation and is responsible for conti- transmit, it must prepare to receive. nuity of the communication. The three When the next is received, it re- phases assure the actions of sender and plies with an or receiver are coordinated. The three depending on its readiness to receive. phases are Establishment, Transfer, and Transfer Phase Terminate. During the transfer phase, the sender Establishment Phase transmits information to the receiver. The Establishment phase determines the The transfer phase continues until all in- direction of information flow and prepares formation has been sent. the receiver to accept information. The Information is sent in frames, each frame sender notifies the receiver that information contains a maximum of 247 characters is available. The receiver responds that it is (including frame overhead). Records or prepared to receive before information is data that are longer than 240 characters transmitted. A system which does not have are divided between two or more frames. information to send normally monitors the A frame is one of two types, an interme- data link to detect the establishment phase. diate frame or an end frame. It acts as a receiver, waiting for the other system. Intermediate frames terminate with the characters , checksum, and The system with information available . End frames terminate with the char- initiates the establishment phase. After acters , checksum, and . the sender determines the data link is in The frame structure is illustrated below: a neutral state, it transmits the character to the intended receiver. Upon Intermediate Frame: receiving the , the receiver pre- FN “data” C1 C2 pares to receive information. All other End Frame: characters are ignored. It replies with FN “data” C1 C2 the character to signify it is ready. With this sequence of events, the Where: - Start of text transmission character establishment phase ends and the trans- fer phase begins. FN - single digit frame number “0” to “7” A receiver that cannot immediately re- “data” - data content ceive information, replies with the C1 - first character of checksum character. Upon receiving the , “0” - “9” & “A” - “F” the sender must wait at least 10 seconds before transmitting another . C2 - second character of checksum Should both systems simultaneously “0” - “9” & “A” - “F” transmit an , the data link is in - end of transmission block character contention. The QuickScan Touch has - end of text transmission character priority to transmit information when con-

12-2

QUICKSCAN Touch TWELVE – Communication Specifications - carriage return character 1 - Any character errors are detected - line feed character (parity error, framing error, etc.) The frame number is an ASCII digit rang- 2 - The frame checksum doesn’t match ing from “0” to “7”. The frame number the checksum computed on the received begins at “1” with the first frame of the frame. transfer phase. The frame number is in- 3 - The frame number is not the same as cremented by one for each new frame the last accepted frame or one higher transmitted. After “7”, the frame number (modulo 8). rolls over to “0”. A frame may be retransmitted up to 6 The checksum permits the receiver to times. If after 6 tries the frame has still detect a defective frame. The checksum not been successfully transmitted, the is encoded as two characters which are sender transmits an and regards sent after the or charac- the data link to be in the neutral state. ter. The checksum is computed by adding the binary values of the frame A reply of signifies the last frame characters, keeping the least significant was received successfully, the receiver is eight bits of the result. The checksum is ready to receive another frame, but is a transmitted as ASCII hexadecimal. request to the sender to stop transmit- ting. The sender does not have to stop The checksum is initialized to zero with transmitting after receiving the request. the character. The first character If it continues to transmit, there is a pos- used in computing the checksum is the sibility of overflowing the receiver’s frame number. Each character in the da- buffers. If the sender chooses to ignore ta is added to the checksum (modulo the , the receiver must retransmit 256). The computation for the checksum the request. does not include , the checksum characters, or the trailing and Termination Phase . The termination phase returns the data link After the frame is sent, the sender stops to the clear or neutral state. The sender transmitting until a reply is received. The notifies the receiver that all data has been receiver replies to each frame. A reply of sent. signifies the last frame was re- The sender transmits the charac- ceived successfully and the receiver is ter and then regards the data link to be in prepared to receive another frame. a neutral state. Upon receiving the A reply of signifies the last frame , the receiver also regards the da- was not received successfully and the ta link to be in the neutral state. receiver is prepared to receive the frame Timeouts again. Upon receiving the , the The sender and receiver both use timers sender retransmits the last frame with to detect loss of coordination between the same frame number. In this way, them. The timers provide a method for transmission errors are detected and au- recovery if the communication line or the tomatically corrected. A frame is not other device fails to respond. successfully received if any of the follow- ing occur:

12-3

QUICKSCAN Touch TWELVE – Communication Specifications During the establishment phase, the ASTM standard, if strict adherence to the sender sets a timer when transmitting the standard is required. . If a reply of an , General Information or is not received within 15 sec- onds, a timeout occurs and the sender Data is exchanged in records of different regards the link to be in the neutral state. types. Each record is introduced by field number 1 identifying the record type, and During the establishment phase, if the terminated by a carriage return. There computer (as receiver) detects conten- are 7 record types recognized by the tion, it sets a timer. If an is not QuickScan Touch: Header Record (H), received within 20 seconds, a timeout Patient Record (P), Test Order Record occurs and the receiver regards the link (O), Result Record (R), Comment Rec- to be in the neutral state. ord (C), Request Information Record (Q), During the transfer phase, the sender and the Terminator Record (L). sets a timer when transmitting the last NOTE: The record ID field is not case character of a frame. If a reply is not re- sensitive. ceived within 15 seconds, a timeout occurs. After a timeout, the sender Records are related to each other in a aborts transmission by proceeding to the definite hierarchy. At level zero is the termination phase. Header record and Terminator record. At level one is the Patient record and the During the transfer phase, the receiver Request-Information record. At level two sets a timer when first entering the trans- is the Test Order record. At level three is fer phase or when replying to a frame. If the Result record. Comment Records do a frame or is not received within not have an assigned level. A Comment 30 seconds, a timeout occurs. After a record always relates to the immediately timeout, the receiver discards the last preceding Patient, Order, or Result rec- incomplete record or set of data and re- ord. Therefore if a Comment record gards the link to be in the neutral state. were to follow a patient record (level 1), DATA TRANSFER FORMAT then the Comment record would be The QuickScan Touch software in gen- treated as a level 2 record. eral adheres to the ASTM Standard A sequence of patient records, order Specification for Transferring Information records, or result records at one level is Between Clinical Instruments and Com- terminated by the appearance of a rec- puter System. The only exception is the ord type of the same or higher level. format for transfer of patient information. Thus, a sequence of results for one pa- Because the QuickScan Touch software tient is terminated by the next patient allows user designation of the demo- record. graphic fields, and because the ASTM Each record is composed of fields which Standard defines the demographic fields are position sensitive and variable in and the order in which they will be length. Each field is separated by a field transmitted, deviation from the standard delimiter (the vertical bar, “|”). The posi- can occur. However, the end user can tion sensitivity requires that when the define the QuickScan Touch de- contents of a field are null, its corre- mographics to match those defined in the sponding field delimiter must be included

12-4

QUICKSCAN Touch TWELVE – Communication Specifications in the record to ensure that the i’th field When the QuickScan Touch receives a can be found by counting (i-1) delimiters. header record it only considers the first Delimiters are not included for trailing two characters to be significant, all other null fields; that is, if the tenth field was characters up to the carriage return will the last containing data, the record could be ignored. Therefore, the minimum terminate after the tenth field (with a car- characters the computer system needs riage return) and therefore would contain to transmit for the header record would only nine delimiters. be: A system may transmit a null value for a H| field because (1) it does not know the Patient Record value, (2) it knows the value is irrelevant to the receiving system, or (3) the value When importing data using ASTM, de- has not changed since the last transmis- mographic data will automatically be sion, or any combination thereof. assigned to an ASTM field based on the Because the sending system can use demographic label. The user may over- null values to indicate no change, a null ride this automatic assignment in Import / value does not overwrite existing data in Export setup. the receiving system. The transmission Graph Data Record of a double quote (ASCII 34) in a field tells the receiving system to replace any The QuickScan Touch will transmit the existing value with a null value. graph data in the following format: Each field may be composed of sub- M|1| test components. These sub-components name |yyyymmddhhmmsshs |ndata ^ are separated by a component delimiter d1,d 2,d 3,...d ndata |nfractions ^f1,f 2,f 3,...f nfraction (the caret, “^”). The component delimiter |nmspikes ^:m 11 :m 12 :m 21 :m 31 : m32 is used to separate data elements of test name - Name of test performed. fields of a hierarchical or qualifier nature. yyyymmddhhmmsshs - Date and Header Record time test was performed. The date is The header record must always be the transmitted with the year first, month first record in a transmission. When the second, and day last. hs=hundredths of QuickScan Touch transmits a header a second. record it will have the following format: ndata - The number of data points in H|\^&||HELQS3|Helena Laborato- the scan. There can be a maximum of ries^QuickScan Touch ^ serial 1100 scan data points.

number |P.O. Box 752 Beau- d1,d 2,d 3,... - Scan data points. mont^Texas^77704-0752^USA|Toll Free: 800-231-5663 Local: 409-842-3714 nfractions - Number of fractions for the scan. There can be a maximum of HELQS3 Password indicating the send- 10 fractions. ing instrument is a Helena QuickScan Touch. f1,f 2,f 3 - Location of fraction bounda- ries within the scan data. serial number – the serial number of the QuickScan Touch will be listed here. nmspikes - Number of m-spikes. There can be a maximum of 3 m-spikes.

12-5

QUICKSCAN Touch TWELVE – Communication Specifications

m11 :m 12 - Location of the m-spike R| n|^^^ test name ^ratio within the scan data. The first value is name |nnnn.nn |||||F||| the start boundary and the second value yyyymmddhhmmsshs is the end boundary. n - Sequence number. For the first Order Record result record, the value will be 1, for the The QuickScan Touch will transmit an second, 2, ... etc. order record immediately preceding any test name - Name of the test per- result records for a patient as required in formed. the ASTM specification. The format will fraction name - User defined fraction be as follows: name. O|1||gel id-sample number|^^^test ratio name - User defined ratio name name. test name - Name of the test per- type - Result type, will be one of the formed. following: % (percent), U (units), or I (in- gel ID – unique identifier. If using posi- tegrals). tive sample ID, this will be the bar code nnnn.nn - Fraction or ratio value. on the gel unit of measure - User defined unit of sample number – the position of the measure. If the result type is “I”, this field sample on the gel. will be null. The QuickScan Touch currently does not nnnn.nn-nnnn.nn - User defined ref- recognize test order records transmitted erence range. by the computer system. f - Result abnormal flag. Will be one Result Record of the following: L (low), N (normal), or H Each fraction and each ratio of a patient (high). scan will be transmitted as a separate yyyymmddhhmmsshs - Date and result record. If multiple results for each time the test was performed. The date is fraction are required, they will be trans- transmitted with the year first, month mitted in separate records. For example, second and day last. hs = hundredths of if the percent and units values of a frac- seconds tion are required, they will be transmitted in separate records. The QuickScan Touch does not recog- nize result records transmitted by the A fraction result will be transmitted in the computer system. following format: Comment Record R|n|^^^ test name ^fraction name ^type |nnnn. nn |unit of meas- The QuickScan Touch will transmit ure || nnnn.nnnnnn.nn |f||F||| comment records in the following format: yyyymmddhhmmsshs C|1|I|comment text|G A ratio result will be transmitted in the The comment record will be transferred following format: immediately following the order record.

12-6

QUICKSCAN Touch TWELVE – Communication Specifications The QuickScan Touch does not recog- 08:32:48:29 |--> nize comment records transmitted by the 08:32:48:51 |<-- 3O|1|001||^^^Serum Im- computer system. munofixation (IFE)A6 Request Information Record 08:32:48:52 |--> The QuickScan Touch can transmit a re- 08:32:48:74 |<-- 4R|1|^^^Serum Immuno- fixation quest to import patient demographics. (IFE)^IgG^U|5|mg/dl29 This request must be user initiated. The format will be as follows: 08:32:48:87 |--> 08:32:49:10 |<-- 5R|2|^^^Serum Immuno- Q|1|patient ID||||||||||D fixation patient ID - A user entered value (IFE)^IgA^U|6|mg/dl26 which the computer system will recog- 08:32:49:23 |--> nize as the identifier for a single patient 08:32:49:46 |<-- 6R|3|^^^Serum Immuno- or a group of patients. fixation (IFE)^IgM^U|7|mg/dl35 The QuickScan Touch does not recog- nize request information records 08:32:49:48 |--> transmitted by the computer system. The third field in the test order record Terminator Record contains the specimen ID, which is the identifying number sent in the query rec- The terminator record must be the last ord. This ties the test order record and record in a transmission. When the the following results records to the pa- QuickScan Touch transmits a terminator tient. In the above example the specimen record it will have the following format: ID is '001'. The test name in the order L|1| record and the result records must match exactly the test name in the QuickScan When receiving a terminator record, the Touch. In the example above, the test QuickScan Touch only considers the first name is 'Serum Immunofixation (IFE)'. character significant, all other characters The immunoglobulin name or fraction up to the carriage return will be ignored. name in the result record must also Importing External Data into QuickScan match exactly the immunoglobulin name Touch or fraction name in the QuickScan Touch. In the above example the immu- To import external data, such as IFE noglobulin names are 'IgG', 'IgA' and Immunoglobulins or Total Proteins, a test 'IgM'. The 'U' following the immunoglobu- order record and a result record for each lin names is required and indicates the external result needs to send immediate- values are unit values. The value for the ly following the patient record for which immunoglobulin or fraction follows the the external data applies. See the exam- name field. In the example above the ple below: value for IgG is 5, the value IgA is 6 and 08:32:48:15 |<-- the value for IgM is 7. The unit of meas- STX>2P|1|||PAT296862|Patterson^Helen||20030 ure follows the values and should also 121|F|black||||Alford^G.|9||4' match what is defined in the QuickScan 11"|129||||||20000000||176||||||||||507 Touch.

12-7

QUICKSCAN Touch THIRTEEN – V8 INTERFACE 2. Select the Sending to LIMS tab. Section 13 - V8 interface (optional) 3. Under Ethernet selection , there are This section details the steps required to options for TCP/IP , IP Address , and import Serum Protein results from the V8 Port . Clinical Capillary Electrophoresis system. Note: The IP address and Port will vary Note: Hemoglobin test results should with the configuration of the V8 and not be imported from the V8 Platinum QuickScan Touch setup. Helena Ser- software into the QuickScan Touch soft- vice will consult with the institution’s IT ware. The Platinum software excludes department to determine the correct in- portions of the curve from its calculations formation to be added . while the QuickScan Touch utilizes all data in its computations, therefore, the 4. Select Connect . final results will differ slightly on the two 5. Click OK to close and save the infor- software programs. mation.

13.1. Main Menu 13.3. Test Setup When the V8 interface is enabled, an 1. From the QuickScan Touch main Import V8 CE scans icon will be dis- menu, select Edit and then User Setup . played on the menu bar (Figure 13-1). 2. From the QuickScan Touch Setup Clicking on this icon will open a new win- window, select Tests. The window dis- dow to download scans imported from plays the existing tests. (Figure 6-4). the V8 (see Section 13.4). 3. Edit - To edit an existing test, high- 13.2. V8 Setup light the needed test and select Edit . The Edit Test window appears contain- 1. From the QuickScan Touch main menu, select Edit and then User Setup. ing the test name and its current parameters. See sections 6.2.1 through 2. From the QuickScan Touch Setup 6.2.6 for instructions on using this win- window, select V8 CE System. dow. 3. Connect the V8 system to the Note: Once a test has been edited and QuickScan Touch using an Ethernet ca- saved, the new test will overwrite the ble. Enable the V8 Capillary original test. Electrophoresis System connected op- Note: The Edit Test and Add Test win- tion by checking it. (Figure 13-2). dows use the same window for entering 4. Port – Select the necessary port. information concerning test setup. 5. Print – Select to print the information 4. Add - To add a new test, select Add for the port. and the Add Test window displays. (See section 6.2.1 for further detail.) 13.2.1. Platinum interface 5. Delete - To delete an existing test, 1. From the Platinum Main menu, select highlight the needed test and select De- File, then Customise. The Customisa- lete . A Confirm Delete prompt displays: tion window appears. a. Select Yes to delete the test.

13-5

QUICKSCAN Touch THIRTEEN – V8 INTERFACE b. Select No to retain the test propriate test type (Figure 13-3). The 6. The Print Settings window appears user may either choose to enter de novo allowing the user to select the desired settings, or click Default Settings printer, print range, and number of cop- choose from a drop down list of availa- ies. ble default test settings for that test type. Note : do not name the test until 7. Export – A named test with settings after clicking on the Default Settings may be exported to a file for use in an- button as the Default Settings button will other QuickScan Touch system. Select clear the test name. Export to export the test settings. Se- 2. Test Name - may be entered/altered lect a file name and source in which to save the test. The test will be saved as as needed. The test name will automat- a Test Export File (.xtf) and can only be ically include the maximum number of opened in the QuickScan Touch soft- samples and the stain type the test is ware. Note that the gel image and Scan setup to use plus the name entered in Location in Test Setup is not exported this field. Each test setup must have a unique Test Name . Additionally, for Se- with the test settings. rum Proteins to have access to the 8. Import – Select to import test setting Restricted Bands feature in the edit from another file or location. Select the mode, the test name must include either folder and file name and click on Open. "Proteins" or "SPE”. Select the desired test file. The test file 3. Capillary Electrophoresis – this must will be a Test Export File (.xtf) and can only be opened in the QuickScan Touch be enabled to create a test to import V8 software. test results in to the QuickScan Touch software. 9. Once the test has been set up and/or 4. After enabling the Capillary Electro- altered as desired: phoresis option from the previous step, a. OK - to save all the changes made three additional tabs will be displayed; and exit, select OK. CE Scan Settings , Fractions / Ratio / b. Cancel - to exit without saving any Ranges , and Patient Demographics. changes made, even those made to dif- Each tab contains menus for setting up ferent portions of setup, select Cancel. test-specific parameters. i. If changes were made, a Con- 13.3.2. CE Scan Settings firm Cancel prompt displays. 1. CE Analysis Name – must corre- 1) To exit without saving spond to the test name used in the V8. changes, select Yes. For Serum Proteins, spe should be used 10. 2) To save changes, select No in re- here. sponse to the prompt and then select 2. Auto Slope Correction – automatically OK corrects the slope. 13.3.1. Test Type and Test Name 3. Smooth - Do not select unless proce- dure recommends otherwise; the graph 1. Test Type – On the Add Test window, will not be smoothed. With Smooth se- use the drop down list to select the ap- lected, set the Smoothing Level to a

13-6

QUICKSCAN Touch THIRTEEN – V8 INTERFACE value from 1 to 10 , with 1 being minimal 7. Patient Overlay 2 - select to have a smoothing and 10 being maximum second patient’s scan, shown in blue, smoothing. Smoothing will affect the overlaid on the current scan. Select results. Increasing the smoothing level Overlay 2 Auto Selection Settings and decreases the background noise and choose from the following: lowers smaller fractions. Smoothing a. Limit search to the previous days – small monoclonals. could affect search from any number of previous 4. Auto Interpretation - enables auto- days matic interpretation of the scan results b. Test - select from any available and requires user-defined interpreta- test. tions be setup. c. Scan – choose from Most recent, 5. Auto Edit - only available for Next most recent, Prior oldest , and Old- tests with "Chol" in the test name. See est. Section 6.2.3 for more detail. 6. Patient Overlay 1 - select to have a patient’s scan, shown in pink, overlaid on the current scan. An IFE image may be selected as one or both patient over- lays; the image will be shown as an overlay thumbnail. Select Overlay 1 Au- to Selection Settings and choose from the following:

a. Limit search to the previous days – 8. Image – search from any number of previous days a. Simulate gel image – may be ena- bled to include a “simulated” gel image b. Test - select from any available that will be included with the worklist. test b. Stain Type – includes Acid Blue , c. Scan – choose from Most recent, Acid Violet , Fat Red 7B , and Ponceau S. Next most recent, Prior oldest , and Old- Since the gel image is being simulated, est. any stain may be selected. c. Image Contrast - is set, using a slide bar, in a range of -10.0 Lighter to 10.0 Darker , in 0.2 increments. The set- ting affects only the appearance of the scan image when displayed and printed and does not affect the quantitation 9. Default Settings – will restore all manufacturers original test settings to the selected test.

13-7

QUICKSCAN Touch THIRTEEN – V8 INTERFACE 10. Once the test has been set up user may highlight selected scans using and/or altered as desired: the mouse and Control key. a. OK - to save all the changes made b. Import – will import the scans into a and exit, select OK. worklist and prompt the user for a work- b. Cancel - to exit without saving any list name. changes made, even those made to dif- c. Clear – select to clear all scans ferent portions of setup, select Cancel. displayed i. If changes were made, a Confirm d. Cancel - to exit without saving any Cancel prompt displays. changes made. 1) To exit without saving Note: Do NOT attempt to manually im- changes, select Yes. port patients from the V8 or import the 2) To save changes, select No same patient from the same run more than once . If the same scan is imported in response to the prompt and then select OK. from the Platinum software multiple times, each scan will be viewed as a dif- 13.3.3. Fractions / Ratios / Ranges ferent scan with a different time and date stamp in the Quick Scan Touch Setup is identical in the original software . QuickScan Touch. See Section 6.2.5 for more information. 4. After selecting the scans, click the Import button. 13.3.4. Patient Demographics 5. When the New Worklist window ap- Setup is identical in the original pears, select either Default Scan or the QuickScan Touch. See Section 6.2.6 for desired template and click OK. more information. 6. Name the worklist and click OK again. 13.4. Importing scans from the V8 7. The scans are imported into the 1. On the main menu bar, click the Im- QuickScan Touch and displayed on the port V8 CE Scans icon . screen. A progress bar will alert the user the scans are being imported. 2. The Import V8 CE Scans window ap- pears. Any scans that have been 8. If when importing a scan from the V8, received from the V8 will be displayed the Total Protein result (set up as an in- here (Figure 13-4). The scans will be dependent result record and not a stored here until they are either import- demographic) is not imported from the ed or deleted. LIS, the QuickScan Touch software will allow the user to add the result by click- 3. Once the scans are imported into a ing the Edit Patient Info icon and then worklist, they will be linked with the test adding the total into the patient list. The specifically set up for the V8 (Section QuickScan Touch will not allow the user 13.3.2). to overwrite a total that has been a. Select All – may be used to select brought in from the LIS. all the scans shown. Alternatively, the

13-8

QUICKSCAN Touch THIRTEEN – V8 INTERFACE 9. The QuickScan Touch will not import scans with no results automatically. These results will have to be imported manually by the user. Note: When importing V8 scans, only one test should be designated as a CE test. Having multiple tests will have the QuickScan Touch use the first one it finds, which may not be the one the us- er selected.

13-9

QUICKSCAN Touch THIRTEEN – V8 INTERFACE

Figure 13-1 Main menu with V8 icon

Figure 13-2 Connecting the QST to the V8

13-1

QUICKSCAN Touch THIRTEEN – V8 INTERFACE

Figure 13-3 V8 Test Setup

Figure 13-4 Import V8 Scans

13-2

QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

and the Edit User window displays. See Section 14 - Tracking Software the instructions for the Add User window (optional) to use this window. The new tracking software available from 4. Add - To add a new user, select Add Helena Laboratories can be used for and the Add User window displays (Fig- tracking patient’s QuickScan Touch and ure 14-2). V8 results. Figure 14-1 displays the main a. User name – enter the desired us- menu with the new icons on the menu er name. bar. From here, scans can be sent to the Review folder where they are paired with b. Password – enter the desired other results on the same patient and password. collated historically. Once in the Review NOTE: Passwords are case-sensitive. folder, the pathologist or whomever is responsible for reviewing and interpreting c. This user has rights to – select each results can view the current results with of the following which apply to the user the patient’s historic results for faster in- being setup: terpretations. Once completed, the i. Edit patient information results can be sent to the accepted folder or sent back to the operator (re-edit) for ii. Edit scans additional work. Patient results can be iii. Export tracked throughout the various folders using the demographic field selected as iv. Print the “Key Identifier”. v. Delete scans All three folders ( Review, Re-Edit , and vi. Change worklist settings Accept ) will have the same layout. Any vii. Change setup associated scans will be displayed as thumbnails on the left hand side of the viii. Setup users (this option is on- screen in chronological order with the ly available if Change Setup has been oldest at the bottom. The thumbnail with selected. a blue background is the most recent ix. Change calibration scan. The thumbnail with the red back- ground is the “baseline scan”. All other x. Clear log files thumbnails will have a green back- xi. Review Option: ground. 1) Edit ‘Review’ worklist 14.1. User Setup Note: If users with permissions will be 1. From the main menu select Edit and created and utilized, Edit ‘Review’ work- then User Setup. list must be enabled to accept scans and send them to the Accept folder. 2. From the User Setup window, select Users and Passwords. d. Ok - select to accept the changes made to the user. 3. Edit – To edit an existing user, high- light the needed user and select Edit

14-1

QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE e. Cancel – select to reject the chang- ly displayed worklist (Figure 14-10). Se- es made. A Confirm Cancel prompt will lect All , Send , and Cancel buttons are be displayed. Select Yes to continue or displayed as well as the worklist name No to return the Add User window. and time/date stamp. 5. Delete - To delete an existing user, 4. Scans may be selected by using the highlight the needed user and select De- mouse and Ctrl and/or Shift key or by lete . A Confirm Delete prompt displays. clicking Select All . a. Select Yes to delete the user. 5. Once all the desired scans have been b. Select No to retain the user selected, click Send. 6. Print - Select to print the selected re- 6. A dialog box will be displayed alerting port. The Printer Setup window appears the user the scans are being imported to allowing the user to select the desired ‘Review’. printer, print range, and number of cop- ies 7. Once all the users have been setup and/or altered as desired. a. OK - To save all the changes made to setup and exit setup, select 7. Once complete, close the worklist. Do OK. NOT keep the original worklist open be- b. Cancel - To exit setup without fore attempting to access the same saving any changes made, even worklist in any other folders. Multiple those made to different portions of copies of the same open worklist can setup, select Cancel. cause EAccess violations. i. If changes were a Confirm Can- 8. When the worklist is closed, a pro- cel prompt displays. gress bar will appear and alert the user 1) To exit without saving the worklist is being saved. changes, select Yes. 2) To save changes, select No in response to the prompt and then se- lect OK .

14.2. Save Scans to Review Note: Only scans with a Patient Identifi- 1. From the main menu, select File then er (such as a name or Patient ID) will be Open to open the desired worklist. sent to Review. 2. With the worklist open, click the Save Note: Any scan that with the words Scans to Review Icon on the menu bar. Normal, Abnormal, Control, or Refer- ence will not be sent to the review folder and will be retained with the original 3. The Send Scans window will appear worklist . with all the scans listed from the current-

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE 14.3. Review folder f. Cancel – click to exit without saving 1. Click Review Icon on the menu bar. any changes . 14.3.1. Reviewing scans

On the main screen, the most recent 2. The Open Worklist ‘REVIEW’ folder is scan will be displayed on the left hand displayed, Figure 14-3. side with the other side of the main 3. The window contains the fields Look screen displaying any other scan that in , Test Type , Apply , Bar Code Reader , has been selected for comparison as Open , and Cancel . the “baseline scan” (Figure 14-4). All other associated scans are displayed as a. Look in - the user has the option to thumbnails along the left hand side ver- choose the location in which the software tically. will search for the scan or worklist in the field labeled Look in. Use the look in Once at least four or more scans are icon to the right of the blank space pro- stored, a “slide bar” is available at the vided (icon with a folder with a top left of the screen for quickly paging magnifying glass). through the scans to visually check dif- b. Test Type – use the drop down list ferences between them. to select from the test type contained in Only the newest scan will be able to be the folder. edited. Any other “accepted scans” as- c. Apply – click to apply the search sociated with it, will be locked to editing. parameters To unlock and “edit” any of the older d. Bar Code Reader – clicking this scans, the user will have to right click on opens the Patient Identifier box. Here, the scan’s thumbnail and select Scan , the user can enter the specific Gel Identi- Review , and then Edit Scan . The fier number to locate the worklist. QuickScan Touch will prompt the user Additionally, a test type can be selected and ask them, “ Are you sure you want from the dropdown menu. to edit? ” If Yes is selected, the most re- cent scan will be removed from the main screen (not from the thumbnails) so the older scan may be edited. The editing menu has the same features as any other editing menu available in the QuickScan Touch (see Section 7.4 for detailed instructions on editing scans). i. OK – to save all the changes Note: All patient information may be al- made and exit, select OK. tered except for the demographic that ii. Cancel – to exit without saving links the scans, whether it is a patient any changes made . name or patient ID. e. Open – click to open the selected worklist.

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE Once the editing is completed, clicking ii. Edit Scans – select to edit on any other thumbnail will relock the the scan. scan. c. Scan Properties – contains There are certain functions listed below the following information for the se- that aren’t available such as gel image , lected scan: Test, Sample Identifier, cut , copy , etc. These functions aren’t Gel Identifier, Sample Number, available inside the tracking software Scanned, Rescanned, Reviewed, folders and are only available in the Edited, Reviewer Id, Scan Resolu- original worklists processed on the tion , and Scan Status . QuickScan Touch . Only the available 6. Close Menu – select to close the options will be listed below. menu 1. Accept – click to send the scan to the Accept folder. 14.4. Re-Edit Folder 2. Re-Edit – click to send the scan to the 1. Click Re-Edit Icon on the menu bar. Re-Edit folder.

Note: If the users and passwords fea- ture is in use, the user must have the 2. The Open Worklist ‘RE-EDIT’ folder is “Review option” enabled in the permis- displayed, Figure 14-5. sion list from Section 14.1 to be able to 3. The window contains the fields Look send scans to the Accept folder. in , Test Type , Apply , Bar Code Reader , 3. To access thumbnail options, right Open , and Cancel . click on the desired scan a. Look in - the user has the option to choose the location in which the software 4. Worklist will search for the scan or worklist in the a. Worklist Label – name of the field labeled Look in. Use the look in icon worklist to the right of the blank space provided b. Worklist Properties – displays (icon with a folder with a magnifying the properties associated with the glass). scan. This includes Label, Date b. Test Type – use the drop down list Created, Template, Location, Test, to select from the test type contained in Gel Identifier , and Completed the folder. Scans . c. Apply – click to apply the search 5. Scan parameters a. Delete - is only available for d. Bar Code Reader – clicking this the most recent scan. Any other opens the Patient Identifier box. Here, scans cannot be deleted. the user can enter the specific Gel Identi- fier number to locate the worklist. b. Review - Additionally, a test type can be selected i. Select Baseline – select to from the dropdown menu. change the highlighted scan to the baseline scan for the group.

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE screen (not from the thumbnails) so the older scan may be edited. The editing menu has the same features as any other editing menu available in the QuickScan Touch (see Section 7.4 for detailed instructions on editing scans).

Note: i. OK – to save all the changes All patient information may be al- made and exit, select OK. tered except for the demographic that links the scans, whether it is a patient ii. Cancel – to exit without saving name or patient ID. any changes made . e. Open – click to open the selected Once the editing is completed, clicking worklist. on any other thumbnail will relock the scan. f. Cancel – click to exit without saving any changes There are certain functions listed below that aren’t available such as gel image , 14.4.1. Re-Editing scans cut , copy , etc. These functions aren’t available inside the tracking software On the main screen, the most recent folders and are only available in the scan will be displayed on the left hand original worklists processed on the side with the other side of the main QuickScan Touch. Only the available screen displaying any other scan that options will be listed below. has been selected for comparison as the “baseline scan” (Figure 14-6). All 1. Review – click to send the scan back other associated scans are displayed as to the Review folder. thumbnails along the left hand side ver- 2. Accept – click to send the scan to the tically. Accept folder Once at least four or more scans are Note: If the users and passwords fea- stored, a “slide bar” is available at the ture is in use, the user must have the top left of the screen for quickly paging “Review option” enabled in the permis- through the scans to visually check dif- sion list from Section 14.1 to be able to ferences between them. send scans to the Accept folder. Only the newest scan will be able to be 3. To access thumbnail options, right edited. Any other “accepted scans” as- click on the desired scan. sociated with it, will be locked to editing. 4. Worklist To unlock and “edit” any of the older scans, the user will have to right click on a. Worklist Label - name of the the scan’s thumbnail and select Scan , worklist. Review , and then Edit Scan . The b. Worklist Properties – displays QuickScan Touch will prompt the user the properties associated with the and ask them, “ Are you sure you want scan. This includes Label, Date to edit? ” If Yes is selected, the most re- Created, Template, Location, Test, cent scan will be removed from the main

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE Gel Identifier , and Completed of the blank space provided (icon Scans . with a folder with a magnifying 5. Scan glass). b. Test Type – use the drop a. Delete - is only available for down list to select from the test type the most recent scan. Any other contained in the folder. scans cannot be deleted. c. Apply – click to apply the b. Review - search parameters i. Select Baseline – select to d. Bar Code Reader – clicking change the highlighted scan to the this opens the Patient Identifier box. baseline scan for the group. Here, the user can enter the specific ii. Edit Scans – select to edit Gel Identifier number to locate the the scan. worklist. Additionally, a test type can be selected from the dropdown c. Scan Properties – contains menu. the following information for the se- lected scan: Test, Sample Identifier, Gel Identifier, Sample Number, Scanned, Rescanned, Reviewed, Edited, Reviewer Id, Scan Resolu- tion , and Scan Status . 6. Close Menu – select to close the menu i. OK – to save all the changes 14.5. Accept folder made and exit, select OK. Note: Once scans are accepted and in- ii. Cancel – to exit without saving cluded as part of the Accept folder, they any changes made . will be deleted from the original worklist e. Open – click to open the se- and retained in the Accept folder . lected worklist. 1. Click the Review Icon on the menu f. Cancel – click to exit without saving any changes bar. 14.5.1. Accepting scans 2. The Open Worklist ‘ACCEPT’ folder is displayed, Figure 14-7. On the main screen, the most recent scan will be displayed on the left hand 3. The window contains the fields Look side with the other side of the main in , Test Type , Apply , Bar Code Reader , screen displaying any other scan that Open , and Cancel . has been selected for comparison as a. Look in - the user has the op- the “baseline scan” (Figure 14-8). All tion to choose the location where other associated scans are displayed as the software will search for the scan thumbnails along the left hand side ver- or worklist in the field labeled Look tically. in. Use the look in icon to the right

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE Once at least four or more scans are b. Worklist Properties – displays stored, a “slide bar” is available at the the properties associated with the top left of the screen for quickly paging scan. This includes Label, Date through the scans to visually check dif- Created, Template, Location, Test, ferences between them. Gel Identifier , and Completed Scans . All patient Information is locked in the Accept folder. To unlock and “edit” any 3. Scan of the scans, the user will have to right a. Review - click on the scan’s thumbnail and select Scan , Review , and then Edit Scan . The i. Select Baseline – select to QuickScan Touch will prompt the user change the highlighted scan to the and ask them, “ Are you sure you want baseline scan for the group. to edit? ” If Yes is selected, the most re- ii. Edit Scans – select to edit cent scan will be removed from the main the scan. screen (not from the thumbnails) so the older scan may be edited. b. Scan Properties – contains the following information for the se- The editing menu has the same features lected scan: Test, Sample Identifier, as any other editing menu available in Gel Identifier, Sample Number, the QuickScan Touch (see Section 7.4 Scanned, Rescanned, Reviewed, for detailed instructions on editing Edited, Reviewer Id, Scan Resolu- scans). tion , and Scan Status . Note: All patient information may be al- 4. Close Menu – select to close the tered except for the demographic that menu. links the scans, whether it is a patient name or patient ID. 14.6. Message Flags Once the editing is completed, clicking Message flags can be created to mark on any other thumbnail will relock the scans. They are displayed in the com- scan. ments section of the scan. (Hot key: Ctrl There are certain functions listed below + F). that aren’t available such as gel image , 1. To create a message flag, from the cut , copy , etc. These functions aren’t Main Menu , select Edit then User Setup . available inside the tracking software folders and are only available in the 2. On the left hand side of the original worklists processed on the QuickScan Touch Setup window, select QuickScan Touch. Only the available User Message Flags (Figure 14-9). options will be listed below 3. The window displays 10 different 1. To access thumbnail options, right empty text boxes, each with a different click on the desired scan color as well as Clear All and Defaults buttons. 2. Worklist 4. To create a User Message Flag, click a. Worklist Label - name of the inside and white text box and type the worklist desired wording.

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE 5. Clear All – clears all the text from all the fields. 6. Defaults – fills in the text boxes with “User Message Flag” with a sequential number. 7. OK – select to accept, save the changes made to the flags, and close the User Setup window. 8. Cancel – select to reject, delete the changes made, and close the User Set- up window. 9. Flags may be added to individual scans in an opened worklist by clicking the message flag icon at the top of the screen.

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

Figure 14-1 Main Menu

Figure 14-2 Users and Passwords

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

Figure 14-3 Open Worklist in the Review folder

Figure 14-4 Review folder

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

Figure 14-5 Open Worklist in the Re-Edit folder

Figure 14-6 Re-Edit folder

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

Figure 14-7 Open Worklist in the Accept folder

Figure 14-8 Accept folder

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QUICKSCAN Touch FOURTEEN – TRACKING SOFTWARE

Figure 14-9 Accept folder

Figure 14-9 Sending Scans to Review

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QUICKSCAN Touch FIFTEEN - Index

Section 15 - Index

Forced Fractions , 6-7, 7-33 Overlay, 7-24, 7-35 Fixed , 6-7 Overlay Thumbnails , 6-13 A Float , 6-7, 7-32 Abnormal Control, 8-1 Fraction Detection Sensitivity , 6-6, 7-32 P Accept folder, 14-5 Fractions / Ratios / Ranges, 6-8 Aperture, 7-31 Parity, 12-1 ASTM, 12-1, 12-4, 12-5, 12-6 G Patient Information, 7-13 Auto Edit, 6-4, 7-18, 7-19, 10-4 Patient Overlay , 6-20 Settings , 6-5, 7-19 Gain Mode , 6-6 Powering Up Instrument, 5-4 Auto Interpretation , 6-5, 7-29 , 13-6 Auto, 6-6, 7-31 Preparation, 6-4, 13-6 Auto Scale, 7-29 Manual, 6-6, 7-31 Print, 7-35, 8-2 Graph, 6-15, 6-18, 6-20 Print Scans, 7-8 B Print Settings, 6-18, 7-32 H Printer, 5-3 Baseline Correction , 7-22 Protocol, 12-1 Help and About, 7-36 C Q I Calibration, 8-1 Quality Control, 6-1, 6-2, 6-24 CE Scan Settings, 13-6 Import, 12-5 Quality Control (QC), 6-25, 7-33 , 7-35, Cholesterol, 6-4, 7-19 Import / Export, 12-5 8-1, 8-2, 8-3, 14-1 Cleaning, 10-1 Importing scans from the V8, 13-8 Comment / Interpretation, 6-23, 7-28 Installation, 5-1 R Communication Specifications, 12-1 Inventory, 5-1 Computer, 5-2 Ranges, 6-13, 6-15 K Re-Edit Folder, 14-4 D Reference, 7-24, 7-35 Keyboard, 5-3 Reports, 6-1, 6-17 Delete, 7-35 Restore , 7-28 Fraction Delimiter, 7-19 Restricted Band , 6-20 Delimit Bands, 7-29 L Results, 7-35, 7-41, 8-2 Fractions, Restricted Bands and Laboratory Information Systems (LIS), Review folder, 14-2 Auto Edit, 7-19 7-16 Demographics, 6-1, 6-2, 6-4, 6-10, 13-6 Levey-Jennings, 6-15, 6-19 S Display Options, 7-35 Display Settings , 7-32 , 7-35 Save , 7-32 M Scan E Maintenance, 10-1 New Gel, 7-29 Message Flags, 14-7 Scan Identifier , 6-18 Edit , 6-5, 7-13 Message Options, 6-1 Scanner, 5-3 Patients, 7-13 Monitor, 5-3 Smooth, 7-29, 7-31 Scans, 7-23, 7-29 Mouse, 5-3 System Requirements, 5-2 Electrophoresis Sample Handler, 6-23, 6-24 T Exit, 7-13 N Export, 7-10, 7-32 Neutral Density Densitometer Control Tracking Software, 14-1 Scans, 7-10 (NDDC), 7-33, 7-34, 8-1, 8-2 Troubleshooting, 10-1

F O U File , 7-3, 7-10 Optical Density Step Tablet (OD Step Unit of Measure, 6-8 Force Lp(a) Fraction, 6-5, 7-19 Tablet), 7-33, 8-1, 8-2 Unpacking and Inspection, 5-1

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Users and Passwords, 6-1, 6-2 View, 7-35, 7-36, 8-2 worklist template, 6-1, 6-11, 6-12 Worklists, 6-1 V W Z V8 interface, 13-5 Warranty, 10-5 Verification of Functionality, 5-5 Windows , 7-36 Zoom, 7-29

QuickScan Touch

Catalog Numbers 1690, 1691, 1692 Software Version 1.3.9.0 Operator's Manual

For additional information, call Helena Laboratories at 800-231-5663, toll free.

Helena Laboratories P.O. Box 752 Beaumont, Texas 77704-0752

© July, 2017 D6500138E

Helena Laboratories, Corp. 07/17