BENSON BV200 Customer User Manual

Plasma viscometer

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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

Company Contact Information ......................................................................................................... 2

Viscometer Specification ................................................................................................................. 3

Health and Safety Warnings ............................................................................................................ 9

System Overview........................................................................................................................... 18

Draft Standard Operating Procedure (SOP) ................................................................................. 20

User Maintenance ......................................................................................................................... 23

Quick Start Guide .......................................................................................................................... 47

Barcode Reader Programming ...................................................................................................... 49

Reagents and Samples ................................................................................................................. 50

10. Zero run time: High value viscosity determination on the BV200 ................................................ 51

11. Plasma Viscosity Clinical Interpretation ........................................................................................ 52

Issue 9

Sep 2020 - Rev 1.8

Page 1 of 53

Table of Contents

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Summary of Contents for BENSON BV200

Page 1: Table Of Contents
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.
Page 2: Company Contact Information
BV200 Plasma Viscometer Mk2/3 Customer User Manual Company Contact Information For all Enquiries please call us on 01646 650065 or e-mail: info@bensonviscometers.com Benson Viscometers Ltd Benson Viscometers Ltd Unit H – North Estate 13 Greenwich Business Park Withybush Road Greenwich Close...
Page 3: Viscometer Specification
BV200 Plasma Viscometer Mk2/3 Customer User Manual 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...
Page 4 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.
Page 5 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...
Page 6 BV200 Plasma Viscometer Mk2/3 Customer User Manual 2.7. Performance Characteristics The viscometer has a linear range from 0.89 – 9.99mPa.s Linear Range Imprecision / To minimise imprecision the viscometer is calibrated and Uncertainty / quality control checked with standards that are fully traceable...
Page 7 ± 0.09 % 10 to 30 ± 0.12 % The chart above shows the BV200 viscometer test linearity from 0.89 to 9.99 mPa.s. The PV was measured at 37℃ but reported at 25°C Issue 9 Sep 2020 - Rev 1.8...
Page 8 BV200 Plasma Viscometer Mk2/3 Customer User Manual The chart above shows the BV200 viscometer test linearity from 0.69 to 6.34 mPa.s. The PV was measured at 37℃ and reported at 37C. Issue 9 Sep 2020 - Rev 1.8 Page 8 of 53...
Page 9: Health And Safety Warnings
BV200 Plasma Viscometer Mk2/3 Customer User Manual Health and Safety Warnings The following are recommendations for safe operating of the BV200 Viscometer. They should be used in conjunction with your local Health and Safety procedures. 3.1. Symbols used within this documentation...
Page 10 BV200 Plasma Viscometer Mk2/3 Customer User Manual 3.2. General Warnings Type of Warning Precaution Blood samples deteriorate with time Blood samples for plasma viscosity testing can and incorrect storage temperature be used for up to 7 days. It is recommended the plasma sample be separated from the whole blood.
Page 11 General use of the Viscometer for Please follow the instructions provided in this measuring viscosity on Blood Plasma document when using the BV200, failure to follow these instructions could cause harm, injury or illness. The company cannot be held responsible for any unwanted effects that arise from misuse.
Page 12 BV200 Plasma Viscometer Mk2/3 Customer User Manual 3.3. Electrical Warnings Type of Warning Precaution Electrical supply Although fully tested before shipping it is advisable that you have your viscometer checked by a competent electrical contractor before use. Electrical Power Supply Cord Do NOT replace the detachable MAINS supply cords with an inadequately RATED cord.
Page 13 BV200 Plasma Viscometer Mk2/3 Customer User Manual Type of Warning Precaution Do not subject the PC or The PC is not rated to be used in wet/humid Viscometer to wet or humid conditions. As a guide please see lab conditions conditions.
Page 14 We do not recommend the viscometer is moved or relocated by anyone other than a trained Benson Viscometer engineer. Type of Warning Precaution The Viscometer main unit weighs 35kg The BV200 is too heavy for a single person. Packaging There is no standard packaging provided with the viscometer.
Page 15 3.7. Transport considerations There is no standard packaging for the BV200. The unit is normally delivered by Benson Viscometers engineers. Be aware that the unit is heavy (35Kg) and should be regarded as a 2-person lift.
Page 16 Two persons are required to move a BV200 viscometer – each should stand either side of the instrument with one hand under the sample rack and other under the main BV200 body, it is good practice to slide the instrument forward so the front 20-25cm over hangs...
Page 17 RF sources), as these can interfere with the proper operation. 3.12. IVD Statement The BV200 is an IVD (In Vitro Diagnostic) device for use in a clinical laboratory environment. It is not a personal self-testing device. 3.13. Disposal or Decommissioning of the Viscometer...
Page 18: System Overview
System Overview 4.1. Principle The Benson automated plasma viscometer uses a regulated vacuum to pull fluid samples through a calibrated capillary tube to determine a fluids viscosity. The precise time of the fluid passage between two predetermined positions and the capillary tube is measured and the fluid viscosity calculated.
Page 19 BV200 Plasma Viscometer Mk2/3 Customer User Manual 4.3. Pump base 4.4. Viscometer Issue 9 Sep 2020 - Rev 1.8 Page 19 of 53...
Page 20: Draft Standard Operating Procedure (Sop)
BV200 Plasma Viscometer Mk2/3 Customer User Manual Draft Standard Operating Procedure (SOP) 5.1. Before operating the viscometer Empty and rinse the 4 litre waste bottle. Empty and rinse the condensation bottle. Ensure the wash container is emptied, rinsed and then refilled daily with fresh wash.
Page 21 BV200 Plasma Viscometer Mk2/3 Customer User Manual If the second check is not validated the viscometer will either STOP or automatically RECALIBRATE, depending on the choice of configuration. The „STOP‟ (manual calibration) option is recommended, since it allows the operator to investigate and carry out possible local maintenance if required.
Page 22 The system will then remain ready for immediate use following the required maintenance. All spare parts and consumables must be supplied directly from Benson Viscometers Ltd. Issue 9 Sep 2020 - Rev 1.8...
Page 23: User Maintenance
Do not routinely use Sodium Hypochlorite or bleach products. A trained user is required to perform the following daily, weekly and monthly maintenance. For all other maintenance issues please contact Benson Support. 6.1. Daily Maintenance From the status menu located at the top centre of the screen, click in the box below the “Daily”...
Page 24 BV200 Plasma Viscometer Mk2/3 Customer User Manual Follow the on-screen instructions to empty/refill the waste and wash bottles The waste container and contents should be considered a biohazard. It is recommended that Benson Viscometer cleaning agents are used. a. When using Benson Viscometers cleaning agents i.
Page 25 BV200 Plasma Viscometer Mk2/3 Customer User Manual b. It is recommended that Benson Viscometer cleaning agents are used, however, when not using Benson Viscometers cleaning agents. i. Tick the box “Disable Wash Additive barcode check at this time” ii. Enter initials iii.
Page 26 When complete select “Click to Proceed” b. It is recommended that Benson Viscometer cleaning agents are used. However, when not using Benson Viscometers barcoded cleaning agents you will need to seek approval to override this feature from a Senior within the laboratory. This can be completed as per the below instructions.
Page 27 BV200 Plasma Viscometer Mk2/3 Customer User Manual a. When complete select “Click to Finish”. The viscometer will then process the Enzyme and Steriliser tubes. Note: This process takes approximately 25 minutes to complete Issue 9 Sep 2020 - Rev 1.8...
Page 28 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.2. Weekly maintenance Click in the “Weekly” days or due area from the cleaning activities section in the top bar or from the maintenance manu. Follow the on-screen instructions to remove and clean the washpot a.
Page 29 Follow the on-screen instructions to inspect and clean the probe Always remove the probe from the cassette before cleaning. You will need a Benson probe cleaning rod, a cloth soaked in a sterilisation fluid and a plastic tube cover guard for the probe.
Page 30 BV200 Plasma Viscometer Mk2/3 Customer User Manual a. Instructions: i. Starting position. Remove the probe from the cassette using the probe removal tool. ii. Clean the capillary with the cloth soaked in sterilisation fluid. iii. Under running water take the probe, and gently insert the probe cleaning rod into the top.
Page 31 BV200 Plasma Viscometer Mk2/3 Customer User Manual b. When complete select “Click to Proceed” Follow the on-screen instructions to check and adjust the capillary When looking at the aspiration hole, identify how much of the capillary is visible and is occupying the hole. Ideally, the capillary should only just be visible as in the top picture below.
Page 32 BV200 Plasma Viscometer Mk2/3 Customer User Manual Follow the on-screen instructions to check and clean the waste bottle cap with a cloth soaked in laboratory sterilisation fluid. Some staining of the rubber seal is normal and acceptable. a. When completed select “Click to Proceed”...
Page 33 It is recommended that Benson Viscometer cleaning agents are used. However, in the event Benson Viscometers cleaning agents are not used, you will need to seek approval to override this feature from a Senior within the laboratory. This can be completed as per the below instructions.
Page 34 BV200 Plasma Viscometer Mk2/3 Customer User Manual Follow the on-screen instructions for Decontamination Clean Stage 1 once a. When complete select “Press here to continue” Follow the on-screen instructions for Stage 2 a. When complete select “Press here to continue”...
Page 35 BV200 Plasma Viscometer Mk2/3 Customer User Manual Follow the on-screen instructions for Stage 7 Note: You do not need to empty and refill the wash and waste bottle if already completed as part of the weekly maintenance above a. When complete select “Press here to continue"...
Page 36 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.3. Monthly maintenance Click in the “Monthly” cleaning from the top bar Follow the on-screen instructions to clean the carriages a. When complete select “Click to Proceed” Issue 9 Sep 2020 - Rev 1.8...
Page 37 BV200 Plasma Viscometer Mk2/3 Customer User Manual Please remove the three stage side panels using the black finger screws. Inspect the sump filter and clean as required. Follow the on-screen instructions to rinse the base a. To drain the fluid from the base area, open the “Sump Drain” by clicking on the Sump Drain button.
Page 38 BV200 Plasma Viscometer Mk2/3 Customer User Manual Follow the on-screen instructions and add any additional notes Issue 9 Sep 2020 - Rev 1.8 Page 38 of 53...
Page 39 Do not routinely use bleach products when cleaning/decontaminating the viscometer as this can impact the serviceability of the viscometer system components. We recommend using Benson Viscometers barcoded decontamination additive, shown below. From the Maintenance Menu on the main screen select do Decontamination Clean The following popup will be displayed, with the following text:- Add the barcoded decontamination additive to 118ml of demineralised.
Page 40 Decontamination bottle cap tube adaptor and re-connect to the Wash Bottle. Pour approx. 100ml of tap water into the carriage area near the front of the BV200 unit, so it drips down into the drainage channels below the carriages to flush the sump valve.
Page 41 BV200 Plasma Viscometer Mk2/3 Customer User Manual Once complete click the Press here to continue button Issue 9 Sep 2020 - Rev 1.8 Page 41 of 53...
Page 42 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.5. Enzyme Cleaning How to Prepare Enzyme Cleaning Fluid Mix 3 drops of the enzyme cleaner concentrate with 4 ml of de-ionised water (1:50 ratio) in a sample tube with an enzyme label. Replace the cap and mix well. Remove the cap and introduce the tube to the viscometer along with the steriliser tube (see below) to complete the daily maintenance.
Page 43 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.6. Steriliser Cleaning How to Prepare Steriliser Cleaning Fluid Mix 4 drops of the Steriliser Additive concentrate with 4 ml of de-ionised water (1:20 ratio) in a sample tube with a Steriliser label. Replace the cap and mix well.
Page 44 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.7. Probe to Washpot Seal Test To ensure optimal washpot seal performance following the weekly maintenance, please follow the instructions below: Ensure the viscometer is switched on and in a ready for operation state...
Page 45 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.8. Drain Line Filter Cleaning Remove the inline filter from the drain line between the washpot and the drain valve. Remove the 3mm (black tail) tubing and connector from the cassette cleaning syringe.
Page 46 BV200 Plasma Viscometer Mk2/3 Customer User Manual 6.9. Short volume samples Low volume, „short samples‟ can be tested on the BV200 Viscometer. Here are some solutions used by different laboratories depending on the tube type and consumables available. For 75 x 13 ml tubes transfer only a small amount of plasma 0.4 to 0.5 ml (maximum) to a 1.5 ml hanging cup or 1.5 ml mini tube using a Pasteur.
Page 47: Quick Start Guide
Become familiar with calibration High (2.00), Low (1.32), and Check (1.67) run times  Calibrate with the calibrator caps OFF, note any large variations or swings in gradient and offset  BV200 gradient will normally be between 6.0 and 8.0 Issue 9 Sep 2020 - Rev 1.8 Page 47 of 53...
Page 48 BV200 Plasma Viscometer Mk2/3 Customer User Manual 7.6. Decontamination  Add the 7ml barcoded decontamination additive to 118ml of demineralised water.  Mix the 125 ml of „decontamination fluid‟ in the Decontamination bottle  Attach to the wash bottle tubing and follow the on screen instructions ...
Page 49: Barcode Reader Programming
BV200 Plasma Viscometer Mk2/3 Customer User Manual Barcode Reader Programming The Viscometer contains a laser – it is only low level, used to read barcodes. Do not stare into the beam. It is a class 2 laser product with a maximum output radiation of 1 mW.
Page 50: Reagents And Samples
BV200 Plasma Viscometer Mk2/3 Customer User Manual Reagents and Samples All calibration fluids are supplied by Benson Viscometers Ltd. and should be stored out of direct sunlight in the laboratory at ambient room temperature. 9.1. Check Control 12 dip units per Sarstedt 2.7 tube (contains glycerine and Sodium Azide -Toxic) Shelf life: 1 year from fill date - the expiry date is shown on the box and on the tube.
Page 51: Zero Run Time: High Value Viscosity Determination On The Bv200
1.90 and 2.10. for the high (2.0mPa.s) calibrant. With the vacuum set as above the detectable viscosity range of the BV200 can be between 0.6 mPa.s and 10 mPa.s. reported at 25°C. To test higher viscosities, it is necessary to increase the vacuum that is used to draw the thicker sample through the capillary in the cassette.
Page 52: Plasma Viscosity Clinical Interpretation
BV200 Plasma Viscometer Mk2/3 Customer User Manual 11. Plasma Viscosity Clinical Interpretation Plasma viscosity changes when plasma protein concentrations are altered. The major influences on plasma viscosity are exerted by fibrinogen and immunoglobulins. Fibrinogen responds as an acute phase reactant and is raised in the initial stages of any inflammatory response. In infection, the initial response is followed by an increase in immunoglobulin which will maintain a high plasma viscosity.
Page 53 BV200 Plasma Viscometer Mk2/3 Customer User Manual * If a patient has recently had a high volume of intravenous fluid administered this may alter the patients viscosity result. For example, some plasma expanders may give erroneous low values, whilst some parenteral fluids may give erroneous high values.

BENSON BV200 Customer User Manual

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Summary of Contents for BENSON BV200

Table of Contents