BE Coagulator User manual
Instruction Manual
Edition: April 2005 V1
Kommanditgesellschaft Behnk Elektronik GmbH & Co., Hans-Boeckler-Ring 27, D-22851 Norderstedt
Tel.: +49 (40) 529-861-0 Fax: +49 (40) 524-1094 E-mail: behnk@behnk.de Internet: www.behnk.com
General Safety Information
All biological substances should be regarded as a potential source
of infection!
Wear gloves when handling blood, blood samples and objects
contaminated by blood!
DANGER! Strictly follow the existing regulations pertaining to the handling and
manipulation of reagents for laboratory use and blood samples!
IMPORTANT! This instrument shall only be operated by trained specialists, who have been
instructed and trained in procedures using in-vitro-diagnostica.
They must be familiar with the Instructions for Use and be able to work
accordingly in order to fully utilise the capabilities of the COAGULATOR.
IMPORTANT! This product is an in vitro diagnostic medical device. It complies with the
requirements of the directive 98/79/CE and the standards mentioned in the
certificate supplied with it. These requirements and limits are designed to
provide adequate protection against unwanted interference in home, office
and industrial environments.
This product generates and uses high-frequency energy and may radiate such
energy if the product is not installed and operated as detailed in these
instructions.
We recommend that you observe the different warnings on the instrument
itself and mentioned in the documentation supplied.
Caution! Follow all warnings and notes affixed to the instrument or mentioned in the
instructions.
Caution! Intervention in and modification of the product, not explicitly approved by the
equipment manufacturer, may result in a loss of functionality. The costs for
necessary repairs are to be borne by the user.
Caution! The equipment manufacturer is not liable for any damage resulting from
disregard of the specifications stated in these instructions, damage caused by
handling of reagents and biological fluids or other action with the product not
in conformity with these instructions.
Caution! Data processing equipment connected to the instrument, such as personal
computers or printers, must conform to the EN 60950 or UL 1950 standard,
respectively.
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Table of contents
General Safety Information...........................................................................................................................................1
Table of contents..........................................................................................................................................................2
Warning notes...............................................................................................................................................................3
Graphic Symbols ..........................................................................................................................................................3
Unpacking the COAGULATOR ....................................................................................................................................4
Location........................................................................................................................................................................4
Installation.....................................................................................................................................................................5
Use ...............................................................................................................................................................................6
Functions of the COAGULATOR..................................................................................................................................6
The COAGULATOR .....................................................................................................................................................7
The COAGULATOR (layout)........................................................................................................................................8
The Measuring System.................................................................................................................................................9
Ball function................................................................................................................................................................10
Starting .......................................................................................................................................................................11
Turning the COAGULATOR OFF...............................................................................................................................11
Incubation timer..........................................................................................................................................................12
Preparation.................................................................................................................................................................12
Conducting an Analysis..............................................................................................................................................13
Reagent Use...............................................................................................................................................................14
Evaluation / Reference Curves...................................................................................................................................14
Quality Control............................................................................................................................................................14
Fibrinogen determinations according to Clauss.........................................................................................................14
Error description .........................................................................................................................................................15
Operational check.......................................................................................................................................................16
Cleaning......................................................................................................................................................................16
Maintenance...............................................................................................................................................................16
Technical data ............................................................................................................................................................17
Dimensions.................................................................................................................................................................17
Operating conditions...................................................................................................................................................17
Sample volumes.........................................................................................................................................................17
Accessories ................................................................................................................................................................17
Spare parts.................................................................................................................................................................17
Glossary......................................................................................................................................................................18
Reagent Distribution...................................................................................................................................................19
Declaration of conformity............................................................................................................................................20
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Warning notes
These instructions contain the information necessary for installation and operation of the COAGULATOR.
Caution! It is recommended that the user conscientiously reads and understands these
instructions to fully utilise the capabilities of the COAGULATOR !
Meaning of the warnings used in these instructions.
DANGER! This information is for your own safety.
CAUTION! Information for optimal COAGULATOR use.
Read and follow this information before using the COAGULATOR.
Graphic Symbols
Symbol Explanation
Direct current (DC)
IEC 417
Alternating current (AC)
IEC 417
Direct or alternating current
IEC 417
Ground terminal
IEC 417
Protective isolation protection class II
I
IEC 417
ON (mains switch)
IEC 417
OFF (mains switch)
IEC 417
Warning of a danger area
(Caution, observe documentation)
Black symbol on yellow background, ISO 3864
Warning of dangerous high voltage
Black symbol on yellow background, ISO 3864
Black symbol on yellow background, DIN EN 563
Warning of a biological hazard
Warning of a hot surface
Black symbol on yellow background, 90/379/EEC
Page 3 of 20
Unpacking the COAGULATOR
Check the packaging for any signs of shipping damage.
Caution! If packaging or contents is damaged, put a claim in with the freight forwarder and notify
the equipment manufacturer or your dealer.
Open the packaging and remove the accessories and the instrument.
Make sure the contents are complete.
The following items are standard accessories for the COAGULATOR:
- 500 Cuvettes
- 500 Balls
- 50 Reagent containers 20mm
- 1 Bottle of Kaolin suspension 50ml
- 1 Mains cable
- 1 Ball dispenser
- 1 Instruction manual
Keep the original packaging for possible later transport.
Caution! Direct or indirect damage to the instrument caused by using improper packaging during
shipment, is not covered by the equipment manufacturer's liability or warranty.
Location
Select a location where the instrument is not exposed to direct sunlight, excess heat, humidity, dust and
vibrations.
To ensure that the measuring block's temperature control (37°C) can work properly, the room temperature
should be between 17°C and 28°C.
Place the instrument in a position that allows unhindered access to the power outlet at any time.
Caution! Do not install next to water fixtures, baths, sinks, etc.
Also do not place near centrifuges, washers, dishwashers, etc.
Avoid close proximity to radiators or other sources of heat, etc.
Page 4 of 20
Installation
Place the instrument on a sturdy, level surface and plug the mains cable into a power outlet.
DANGER! The mains voltage must coincide with the technical specifications of the instrument.
The mains circuit must have adequate fuse protection.
The instrument must be connected to a properly grounded outlet. Only was removed
If in doubt about mains voltage or the circuit in general, contact a qualified electrician.
Caution! Do not connect other electrical appliances which may cause interference with the circuit.
Do not set up the instrument near electrical appliances causing electric interference
(appliances bearing no CE-label).
Avoid connection to circuits where other appliances consume large amounts of current
(for example centrifuges) or which turn on and off frequently (for example refrigerator,
water bath, etc.).
Ensure that other persons can not step on or trip over the power cord.
All connections to the instrument should be made with the instrument turned OFF.
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