System Description - CoaguSense Coag-Sense Prothrombin Time PT/INR Self-Test User's Manual

®
Prothrombin Time (PT)/INR Monitoring System Self-Test User's Manual
Coag-Sense

2. System Description

The Coag-Sense Self-Test PT/INR Monitoring System is used
for measurement of Prothrombin Time (PT) in fresh, capillary
whole blood. The Coag-Sense system is intended for use
outside the body by people taking warfarin or other oral
anticoagulant (blood thinning) therapy who need to monitor
clotting time.
The meter performs a self-test when it is first turned on. If there
are any problems with the meter, an error message is shown on
the display. Refer to the "Troubleshooting" section of this manual
or contact Tech Support. A test strip is inserted and heated in the
meter prior to sample application.
The strip contains a tiny wheel with spokes that pull the sample
into the reaction well. The spokes quickly and completely mix the
sample with the clot initiating component of the test strip.
The PT time is determined from when (a) the sample is drawn
into the reaction well of the test strip and detected by a beam of
light until (b) a clot forms and interrupts a beam of light. The PT
result is converted to an INR (International Normalized Ratio)
using the calibration data stored in the meter. INR is a
mathematical correction of the PT result that adjusts for
sensitivity differences among different PT systems.
The meter continues to check every feature of its operation
through a system of self-checks.
Page 6 For In Vitro Diagnostic Use CoaguSense, Inc.