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Whole Blood Coagulation Analyzer

UMDNS GMDN
16749 Analyzers, Point-of-Care, Whole Blood, Coagulation 56689 Laboratory coagulation analyser IVD,
automated

Other common names:


Thromboelastograph, thrombometer; Analyser, laboratory, haematology, coagulation, automated

Health problem addressed


Core medical equipment - Information

Devices that measure the clotting mechanisms of hemostasis;


used primarily to detect clotting deficiencies related to
thromboembolytic disease, thrombocytopenia, impaired
liver function, hemophilia, von Willebrand disease, and other
conditions. They are also used to monitor the effect of drugs
such as heparin, oral anticoagulants, and thrombolytic and
antiplatelet agents on whole blood, as well as the effects of
blood component therapy.

Product description
Handheld device or benchtop device, sometimes placed on a
cart, with a display (usually LCD), a keypad to enter information,
and a slot to insert a test strip or sample tube. Some models
may have alarms, memory functions, touchpens, USB ports to
transfer data to a computer, and/or a small storage compartment
for reagents. Use and maintenance
User(s): Medical staff
Principles of operation Maintenance: Laboratory technician;
One of three methods may be used: Mechanical impedance biomedical or clinical engineer
uses blood viscosity changes to determine clotting time.
Instruments using the photometric principle monitor changes Training: Initial training by manufacturer and
in the specimen’s optical density to detect the beginning of clot manuals
formation. The electromagnetic uses a magnet in the test tube
aligned with a magnetic detector in the cuvette and remains Environment of use
locked in position with the detector while the test tube rotates. Settings of use: Hospital, patient bedside,
When a clot forms, it entangles the magnet, breaking the physician office, clinical laboratory, home
electromagnetic coupling and allowing the magnet to rotate
Requirements: Line power, biohazard disposal
with the tube, terminating the test.

Operating steps Product specifications


Whole blood samples are placed in tubes, on reaction cuvettes, Approx. dimensions (mm): 200 x 150 x 300
or on test strips, and loaded into the analyzer. The operator may Approx. weight (kg): 1-10
select the tests being performed on the sample using a keypad
Consumables: Reagents (cartridges, test
or connected computer.
strips, etc.), reaction cuvettes
Reported problems Price range (USD): 648 - 46,000
Operators should be aware of the risk of exposure to potentially Typical product life time (years): 5-8
infectious bloodborne pathogens during testing procedures and
Shelf life (consumables): Reagents: 2 years
should use universal precautions, including wearing gloves, face
shields or masks, and gowns.
Types and variations
Handheld, portable, benchtop; some models
may also test platelet function

© Copyright ECRI Institute 2011 (not including the GMDN code and device name).
http://www.who.int/medical_devices/en/index.html Reproduced with Permission from ECRI Institute’s Healthcare Product Comparison System.
© Copyright GMDN Agency 2011. GMDN codes and device names are reproduced with permission from the GMDN Agency.

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