BENSON BV200 User manual

BV200 Plasma Viscometer Mk2/3 Customer User
Manual
Issue 9th Sep 2020 - Rev 1.8 Page 1 of 53
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

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Manual
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1. Company Contact Information
For all Enquiries please call us on 01646 650065
or e-mail: [email protected]
Benson Viscometers Ltd
Unit H –North Estate
Withybush Road
Haverfordwest
SA62 4BS
Benson Viscometers Ltd
13 Greenwich Business Park
Greenwich Close
Ipswich
Suffolk
IP3 0DD
Registered Office
Benson Viscometers Ltd.
Croft Quarry
West Williamston
Pembrokeshire
SA68 0TN

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2. Viscometer Specification
2.1. Operating Environment Conditions
The BV200 viscometer is designed to be used in a clinical laboratory.
Voltage
UK Configuration
230 - 240 volt 50Hz A/C single-phase mains electricity
US Configuration
110 -120 volt 50/60Hz A/C single-phase mains electricity
Input/output
Electrical
Connections
There are 3 electrical connection points on the BV200:
Main IEC input socket
RS232 (Male) connection for communication with the PC
RS232 (Female) connection for communication with the
pump assembly sensors.
Input/output
Non-Electrical
Connections
There are 3 non-electrical connection points on the side of the
BV200
4mm tube push fit connector for the wash bottle
5mm tube push fit connector for the vacuum regulator
6mm tube push fit connector for the waste bottle
Current
3 amps peak
Operational
temperature
10-27°C.
The system heats up the sample to 37°C during testing
Humidity
20-70%
Atmospheric
pressure
Normal atmospheric pressure (1 atm).
The equipment is not affected by static atmospheric pressure, but
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
Viscometer
Specification
Vibrating equipment such as centrifuges may significantly affect
the performance of the equipment. It is strongly recommended
that such equipment is not placed on the same bench as the
BV200 viscometer.

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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.

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2.5. Accessories
Pump Assembly
Pump assembly consists of:
CA B85 Vacuum Pump or R 300 Vacuum pump
Vacuum Regulator
Wash and Waste Bottle
4mm 5mm 6mm and 8mm connection hoses
Grey PVC base plate with built in liquid level sensors
PC
A computer (PC) that consists of:
Monitor
Computer
Keyboard
Mouse
2.6. Physical Data
Weight
Analyser
35 Kg
Base unit
9 Kg
Size
Analyser
42cm high x 55cm wide x 57cm deep
Base unit
40cm high x 35cm wide x 30cm deep

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2.7. Performance Characteristics
Linear Range
The viscometer has a linear range from 0.89 –9.99mPa.s
Imprecision /
Uncertainty /
Repeatability and
Reproducibility
To minimise imprecision the viscometer is calibrated and
quality control checked with standards that are fully traceable
to the British National Physical Laboratory (BNPL),
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) confirms result reproducibility by a monthly
analytical monitoring service producing an independent audit
for all participating laboratories.
Interference
There are no known interferences with the plasma viscosity
result.
* Please see Interpretation of Results for further information.
Carryover
Under normal conditions the carryover between samples,
calibrators and controls should be <0.01mPa.s.

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2.8. Uncertainties and Linearity
Viscosity Range
Dynamic Viscosity mPa.s (cP)
0.3 to 7.4
± 0.07 %
7.4 to 10
± 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

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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.

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3. 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
Symbol
Meaning
Caution –consult the documentation for more information on the
warning
This symbol is essentially a safety symbol and should be used to
highlight the fact that there are specific warnings or precautions
associated with the device, which are not otherwise found on the label
Potentially deadly –treat with extreme caution
Toxic –treat with extreme caution
Biological Hazard –treat with extreme caution
Gloves must be worn
Harmful –treat with extreme caution
Laser Reader –treat with extreme caution
Biological Waste –treat with extreme caution
Electrical items –possibility of electrical shock
Anti-static electrical items which can be damaged by static electricity

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3.2. General Warnings
Type of Warning
Precaution
Blood samples deteriorate with time
and incorrect storage temperature
Blood samples for plasma viscosity testing can
be used for up to 7 days. It is recommended the
plasma sample be separated from the whole
blood. Plasma samples should be stored at
ambient room temperature and should never be
stored in a fridge or freezer. If plasma is stored in
a fridge, cryoproteins will precipitate out of the
fluid leading to incorrect results.
Blood products can carry blood borne
infection.
All operators are required to be trained in
handling contaminated blood products.
Always wear properly fastened protective
laboratory clothing when operating the
equipment - this is especially true of wearing
protective gloves.
The Anti-Biological Growth Reagent
is toxic if undiluted
The anti-biological growth reagent used
comprises 0.02% Sodium Azide in the LOW,
HIGH, and CHECK reagents, so is not toxic at
this level but users should be aware of the
hazard.
All those who are likely to come into contact with
this reagent should take the precautions listed in
the MSDS supplied with the support
documentation.
The cassette probe is sharp and
should always be considered as a
Biohazard
Avoid all contact with the probe tip.
Wear surgical gloves whenever handling the
cassette and probe.
Fit probe guards when removing the cassette
and ensure probe guards are fitted at all times
the probes are not installed in the viscometer,
apart from when it is being cleaned.
The Viscometer contains moving
parts
Never operate with loose fitting clothing - always
wear properly fastened protective laboratory
clothing when operating the equipment
Long hair should be restrained.
During operation never have the plastic door to
the cassette open.
Never operate the viscometer with the main front
hinged cover up.

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Type of Warning
Precaution
The Viscometer contains a laser
reader
The laser reader beam used by viscometer
barcode readers has a low power output.
Do not look directly into the beam.
The laser is a class 2 product with a maximum
output radiation of 1 mW. The emitted
wavelength is 630-680 nm to IEC 825-1 (1993)
Waste bottle for the Viscometer
contains Biohazard products
The Waste bottle and its contents should be
treated as hazardous and handled according to
your organisation's health and safety policy.
When carrying out the scheduled sterilise
maintenance process on the waste bottle, always
wear suitable safety clothing as indicated in your
organisation‟s health and safety policy.
In the UK it is recommended to follow the
Committee of Substances Hazardous to Health
(COSHH) requirements for the chemicals used in
your organisation.
General use of the Viscometer for
measuring viscosity on Blood Plasma
Please follow the instructions provided in this
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.

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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. An
adequately rated cord should comply with the
following:
UK - IEC (C13)/US-IEC (C13)
HO5VV-F 3G 1.0mm² Cores
Fitted with 5amp fuse (UK only)
GTSA-3 N1458
The unit must not be operated with
the hinged front cover up.
Never operate the equipment with any of the
cover(s) raised up or removed.
Cleaning the viscometer with water
could increase the hazard of an
electric shock.
Only trained operators should clean the
viscometer.
Cleaning fluid should never be used near the
electrical components of the system especially
those behind the lift-up hinged front cover of the
viscometer. It is perfectly safe to clean the stage
and drive mechanism underneath –normally done
as part of the monthly cleaning activities.
If incorrect actions are taken, there
is a risk of electric shock during
maintenance.
Only trained personnel are permitted to maintain or
repair the viscometer.
Before opening any covers always disconnect from
the power supply unless the power is required for
diagnosis.
Circuit boards are used in the
viscometer. They can be damaged
by static electricity.
Touch an earth point immediately before
attempting to handle a circuit board.
Keep any circuit board in an electrostatic bag when
not in use/fitted.

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Type of Warning
Precaution
Do not subject the PC or
Viscometer to wet or humid
conditions.
The PC is not rated to be used in wet/humid
conditions. As a guide please see lab conditions
for use in this document.
Vacuum Pump will not start when
powered up.
Do not leave the vacuum pump powered on if it
does not start. There may be residual vacuum
retained in the waste bottle and the pump may fail
to start. The vacuum pump may overheat causing
a hot paint or electrical smell. If the vacuum pump
does not start immediately, disconnect the power
and release the residual pressure in the waste
bottle. If the pump still fails to start, switch it off at
the plug and contact the Benson Viscometers
support desk.
3.4. Cleaning Warnings
Type of Warning
Precaution
When removing and handling a
cassette it must be considered to be
a Biohazard
Always switch the analyser off before
removing/replacing the cassette.
Always decontaminate a used cassette and
probe after changing the cassette. Gloves, safety
goggles and a lab coat should be worn as a
minimum.
Always fit the plastic sleeve to the probe as soon
as possible after removing the cassette from the
viscometer.
Waste from the Viscometer contains
small amounts of blood products.
The waste bottle and its contents should be
treated as though it contains blood products and
handled according to your organisation's health
and safety policy. Gloves, safety goggles and a
lab coat should be worn as a minimum.
When adding sterilising agent(s) to the waste,
always wear safety clothing as indicated in your
organisations health and safety policy.
In the UK it is recommended to follow Committee
of Substances Hazardous to Health (COSHH)
requirements of the chemicals used in your
organisation.

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3.5. Maintenance Warnings
Type of Warning
Precaution
There is a risk of electric shock
during maintenance.
Only trained personnel are permitted to maintain
or repair the viscometer. These personnel must
not access any parts with mains voltages.
Before opening any covers always disconnect
from the power supply unless the power is
required for diagnosis.
Only qualified electricians are permitted to work
on parts which could have lethal voltages.
Blood Products are Biohazard liquids
All those maintaining the viscometer are required
to be instructed on the precautions to avoid
becoming infected by blood products.
The Anti-Biological Growth Reagent
is toxic if undiluted
The anti-biological growth reagent used
comprises 0.02% Sodium Azide in the LOW,
HIGH, and CHECK reagents, so is not toxic at
this level but users should be aware of the
hazard.
All those who are likely to come into contact with
this reagent should take the precautions listed in
the MSDS supplied with the support
documentation.
3.6. Moving/Positioning the Viscometer
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.
Care is needed when moving the viscometer
to ensure no damage occurs to it.

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Type of Warning
Precaution
Positioning the Viscometer
The viscometer must be positioned so that it is
possible to operate the disconnecting device
(green switch on side of unit, or mains plug
switch).
The viscometer must not be located where
vibration can affect its operation e.g. where a
centrifuge is on the same bench or on a
neighbouring connected bench.
The viscometer should be located in an
environment which has a constant
temperature and as per the operating
environment conditions earlier in this
document.
Do not locate the viscometer next to an
opening window or in direct sunlight as
temperature variations can affect result
repeatability.
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.
The analyser is heavy –35Kg
and should not be lifted by 1 person
It is recommended that you contact the Benson Viscometers Support Desk where we can offer
a costed viscometer relocation service to decontaminate, decommission and relocate with
minimal local assistance, then set-up and fully re-commission the viscometer including a fully
documented and certificated acceptance procedure, leaving the viscometer in a ready to use
condition.

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Benson Viscometers will move the unit safely using the following instructions:
Safely remove all connections to the BV200 consisting of:1.
a. 2 x grey communications cables
b. 3 x clear waste and vacuum tubes
c. 1 x power cable
Ensure all standard and patient tubes are removed from the viscometer2.
Ensure all doors and panels are closed and secured with screws where appropriate3.
There are no feet/castors on the bottom of the instrument so care must be taken when4. lifting and placing so as to not trap fingers.
Two persons are required to move a BV200 viscometer –each should stand either side5. 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
the work surface, a hand can then be placed underneath and gently lift the front of the
instrument up so that the hand to support the rear of the unit can then be placed under
the instrument.
Benson Viscometers will then safely relocate the viscometer to the required location6. and connect and commission the analyser.
Once commissioned, Benson Viscometers will carry out an acceptance procedure and7. supply a documented acceptance report before testing patient samples can be
commenced.
3.8. Cassette and probe warnings
The cassette is delivered to sites using a hard case with foam cassette shaped cut-outs. This
should have a caution and a biohazard sign on it. The case will arrive with a security tie and
test security seal label. The security tie and label should not be broken until such time as the
cassette is required for use. A test certificate is enclosed confirming calibration and
performance.
Cassette probes are sharp
The cassette should be regarded as a biohazard.
3.9. Circuit Boards Warnings
The circuit boards within the BV200 should be regarded as
sensitive to static.
When printed circuit boards are being transported, it is recommended that they are wrapped in
an antistatic bag with a static warning label on it. A suitable strong well-padded container or box
should be used.

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3.10. Barcode Reader Warnings
The barcode reader contains a laser reader. Do not look directly at the beam. It is a class 2
laser product with a maximum output radiation of 1 mW. The emitted wavelength is 630-680
nm to IEC 825-1 (1993)
The barcode reader contains a laser reader.
3.11. EMC Statement
The BV200 complies with the emission and immunity requirements described in documents
IEC61326-1 and 61326-2-6.
The device is classified as Group 1 Class A, as specified in CISPR 11:2009, Clause 5. It does
not emit any dangerous or significant RF energy. As a precaution however, the following
phrase is brought to the users‟ attention:
“This equipment has been manufactured and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take measures to
mitigate the interference.”
As a general precaution, the electromagnetic environment should be evaluated prior to
operation of the equipment. If in doubt, please consult the Benson Support Desk.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional 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
Type of Warning
Precaution
The Viscometer and its
component parts are to be
considered a Biohazard
A viscometer or any part or sub component must be
decontaminated before transporting or disposal.
Benson Viscometers is committed to the WEEE
Directive and as such will decommission,
decontaminate, collect and, when suitable will
recycle viscometer components that are useful and
serviceable.
Please contact the Benson Viscometers Support
Desk for more information.
The Anti-Biological Growth
Reagent is toxic if undiluted
The anti-biological growth reagent used comprises
0.02% Sodium Azide in the LOW, HIGH, and
CHECK reagents, so is not toxic at this level but
users should be aware of the hazard.
Before disposal, the viscometer must be cleaned
and certified as free of toxic contamination. This also
applies to any parts being disposed of.

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4. 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.
4.2. Viscometer system overview

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4.3. Pump base
4.4. Viscometer

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5. Draft Standard Operating Procedure (SOP)
5.1. Before operating the viscometer
Empty and rinse the 4 litre waste bottle.1.
Empty and rinse the condensation bottle.2.
Ensure the wash container is emptied, rinsed and then refilled daily with fresh wash.3. Wash = 2 litre distilled or de-ionised water with 1 barcoded wash additive.
All viscometer covers and panels should be fitted and closed.4.
The control vac regulator (sample vacuum) should be between -0.4 and -0.45 bar.5.
Do not adjust the regulator unless followed by a full manual calibration6.
The vacuum on the waste bottle vac gauge should be a minimum of -0.7 bar.7. (70% vacuum).
Make sure the cap on the waste bottle is fully tightened and the air tubes are fully8. plugged in.
5.2. To test centrifuged EDTA plasma samples
-Ensure all samples to be tested are fully centrifuged (note –controls do not need to
be centrifuged)
-Allow all samples and calibrators to stabilise their temperature to room
temperature before testing. This will take longer if samples have arrived by post or
from a courier.
-Do not store PV samples in a fridge. Plasma samples should be stored at room
temperature and should never be stored in a fridge. If plasma is stored in a fridge,
cryoproteins will precipitate out of the fluid, leading to incorrect results.
-All calibration and patient sample tubes should be inserted so that the bar code
labels are aligned with the marker on the carriage tube holder.
-All tubes must be fully pressed down in the holder to avoid tube crashes in the test
area.
Insert a charged CHECK tube with cap on in the first green holder1.
Place centrifuged sample tubes into the black holders, starting after the first CHECK2. tube.
Insert a charged CHECK tube in each green tube holder as the viscometer is filled.3.
Insert a charged CHECK tube in the green tube holder after the last patient sample.4.
Note: If a known High-Risk sample/s are tested (run as a batch), follow it with a
viscometer STERILISER tube placed before the stop flag.
Insert a „stop flag‟ behind the last CHECK tube.5.
To start sample analysis, left-click on the viscometer screen button marked „Start‟. Top 6. left
Samples and CHECK calibrators may be added at any time. Move the stop flag to the7. end of the sample line.
The viscometer can be set to automatically retest a CHECK which has not been8. validated.