BV200 Plasma Viscometer Mk2/3 Customer User Manual Overview The Benson Viscometers Ltd BV200 clinical viscometer is a capillary viscometer for in vitro use in the laboratory, designed and calibrated to measure the viscosity of human (or animal) blood plasma and other clinical fluids. The BV200 is manually loaded and unloaded with blood samples and reagent tubes. The operation is automated so that it measures patient samples and carries out automated check quality controls every ten patient samples without manual intervention offering a walk away operation. It is intended for use in clinical laboratories by trained laboratory professionals testing potentially high- risk blood samples, so it is designed to handle bio-hazardous materials safely. All equipment is manufactured, produced and supplied by Benson Viscometers Ltd, in the UK. Only reagents and viscometer cleaning products that are produced and supplied by Benson Viscometers are to be used with the analyser. The key clinical applications are in the identification and monitoring of chronic inflammatory conditions, for example rheumatoid arthritis and in the monitoring of malignancies of the immune system, e.g. myeloma and to determining hyperviscosity. Contents 1. Company Contact Information ......................................................................................................... 2 2. Viscometer Specification ................................................................................................................. 3 3. Health and Safety Warnings ............................................................................................................ 9 4. System Overview........................................................................................................................... 18 5. Draft Standard Operating Procedure (SOP) ................................................................................. 20 6. User Maintenance ......................................................................................................................... 23 7. Quick Start Guide .......................................................................................................................... 47 8. Barcode Reader Programming ...................................................................................................... 49 9. Reagents and Samples ................................................................................................................. 50 10. Zero run time: High value viscosity determination on the BV200 ................................................ 51 11. Plasma Viscosity Clinical Interpretation ........................................................................................ 52 Issue 9th Sep 2020 - Rev 1.8 Page 1 of 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual 1. Company Contact Information For all Enquiries please call us on 01646 650065 or e-mail: [email protected] Benson Viscometers Ltd Benson Viscometers Ltd Unit H – North Estate 13 Greenwich Business Park Withybush Road Greenwich Close Haverfordwest Ipswich SA62 4BS Suffolk IP3 0DD Registered Office Benson Viscometers Ltd. Croft Quarry West Williamston Pembrokeshire SA68 0TN Issue 9th Sep 2020 - Rev 1.8 Page 2 of 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual 2. Viscometer Specification 2.1. Operating Environment Conditions The BV200 viscometer is designed to be used in a clinical laboratory. UK Configuration 230 - 240 volt 50Hz A/C single-phase mains electricity Voltage US Configuration 110 - 120 volt 50/60Hz A/C single-phase mains electricity There are 3 electrical connection points on the BV200: Input/output Main IEC input socket Electrical RS232 (Male) connection for communication with the PC Connections RS232 (Female) connection for communication with the pump assembly sensors. There are 3 non-electrical connection points on the side of the Input/output BV200 Non-Electrical 4mm tube push fit connector for the wash bottle Connections 5mm tube push fit connector for the vacuum regulator 6mm tube push fit connector for the waste bottle Current 3 amps peak Operational 10-27°C. temperature The system heats up the sample to 37°C during testing Humidity 20-70% Normal atmospheric pressure (1 atm). Atmospheric The equipment is not affected by static atmospheric pressure, but pressure may be influenced by changing atmospheric pressure, which will require the system to be recalibrated – this can be done automatically or manually, depending on customer preferences. Vibration Vibrating equipment such as centrifuges may significantly affect Viscometer the performance of the equipment. It is strongly recommended Specification that such equipment is not placed on the same bench as the BV200 viscometer. Issue 9th Sep 2020 - Rev 1.8 Page 3 of 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual 2.2. Supply Connection UK Configuration -The BV200 viscometer is connected to the 230 volt mains supply via a 5 Amp fused IEC cable (supplied). The UK plug is plugged in to any mains outlet with the ratings above and the IEC connector is then inserted into the power socket on the left side of the unit. US Configuration - The BV200 viscometer is connected to the 115 volt mains supply via an IEC cable (supplied), the plug is plugged to any mains outlet with the ratings above and the IEC connector is then inserted into the power socket on the left side of the unit. 2.3. Electrical Protection The „AT‟ power supply unit (PSU) BV200 240-volt mains input viscometer (UK) is fitted with and protected by a 5-amp fuse located in the 3 pin mains plug of the viscometer input cable. The 36-volt PSU, BV200 240-volt mains input viscometer (UK) is fitted with and protected by a 5-amp fuse located in the 3 pin mains plug of the viscometer input cable. The 36-volt PSU viscometer is protected by two 3.15-amp fuses located in the IEC inlet socket. The viscometer is also protected by an over voltage protection circuit located within the 36 volt PSU. The BV200 110 – 120 volt mains input viscometer (US) is fitted with a 36 volt PSU protected by two 3.15 amp fuses located in the IEC socket. The viscometer is also protected by an over voltage protection circuit located within the 36 volt PSU The BV200 240 volt viscometer (UK) vacuum pump bases are protected by a 1 amp fuse located in the plug of the pump base input cord. The pump base assembly mains plug is the disconnecting device and should be plugged into a socket such that it is identifiable and easily reached. For the BV200 pump bases using a “Rocker” type vacuum pump (silver) the BV200 also has a power on/off switch at the rear of the pump unit. 2.4. Protective Conductor Earthing Point The protective conductor earthing point is connected to the IEC socket which connects to the mains socket earth via the IEC cable (supplied). The earthing point is located on the inside of the case on the left side panel above the IEC socket. All side panels are connected to the protective conductor earthing point to ensure the equipment is fully grounded. Issue 9th Sep 2020 - Rev 1.8 Page 4 of 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual 2.5. Accessories Pump assembly consists of: CA B85 Vacuum Pump or R 300 Vacuum pump Vacuum Regulator Pump Assembly Wash and Waste Bottle 4mm 5mm 6mm and 8mm connection hoses Grey PVC base plate with built in liquid level sensors A computer (PC) that consists of: Monitor PC Computer Keyboard Mouse 2.6. Physical Data Analyser 35 Kg Weight Base unit 9 Kg Analyser 42cm high x 55cm wide x 57cm deep Size Base unit 40cm high x 35cm wide x 30cm deep Issue 9th Sep 2020 - Rev 1.8 Page 5 of 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual 2.7. Performance Characteristics Linear Range The viscometer has a linear range from 0.89 – 9.99mPa.s Imprecision / To minimise imprecision the viscometer is calibrated and Uncertainty / quality control checked with standards that are fully traceable Repeatability and to the British National Physical Laboratory (BNPL), Reproducibility Teddington, England. The BNPL uncertainty data is available on request. Instrument uncertainty is a measurement of its accuracy. When a patient sample is presented at the test point, the barcode of the sample will be read by the barcode reader and the sample will then progress to be tested. If the result of this sample is outside the preconfigured limits (default 1.4- 2.0 mPa.s) the sample will automatically be retested. If the result of the second test is within ± 5% of the first test carried out on the sample, the initial result will be accepted by the viscometer and is then transmitted (pending approval if set up for manual sign off). This also ensures viscometer result repeatability The second result is stored in the viscometer but marked as void for LIMs and it is not transmitted. The 1.6mPa.s check control (is measured every ten patient samples), the control 2.5, control 4.0 and the high and low calibrator reagents have their plasma viscosity (PV) value encoded within the barcode on their tubes. When these reagents are presented to the analyser, their barcode is read and the reagent is tested. In the case of the high and low calibrator reagents, this is an optional functionality and requires configuration. The result of the reagent test is compared to the value encoded for that reagent and if it is within ± 5% of that value, the analysis is accepted. An uncertainty report for the check and the control 2.5 is available within the results menu. In the UK, The National External Quality Assessment Service (NEQAS)