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1. Introduction
The Coag-Sense
®
Prothrombin Time (PT)/INR
Monitoring System
Intended Use
For self-test users, the Coag-Sense® Prothrombin Time (PT) / INR
Monitoring System is an in vitro diagnostic device that provides
quantitative prothrombin time (PT) results, expressed in seconds
and INR units. It uses fresh capillary whole blood.
The device is intended for use by properly selected and suitably
trained patients or their caregivers on the order of the treating
physician to monitor patients who are on anticoagulation therapy.
Patients should be stabilized on warfarin-type (coumarin)
anticoagulation therapy prior to self- testing.
The device is not intended to be used for screening purposes.
Importance of PT/INR Monitoring
Blood-Clotting Time:
The rate at which blood clots is measured in units is called
International Normalized Ratio (INR). It is very important for
patients to stay within their individual target INR range. If the INR
is too low, the risk of blood clots increases. If the INR is too high,
the risk of hemorrhaging increases. The patient‟s physician will
determine the most appropriate INR range for the patient,
depending upon the patient‟s indication and how they respond to
the oral anticoagulants.
