Product Manual

Page 1
1. Introduction
The Coag-Sense
®
Prothrombin Time (PT)/INR
Monitoring System
Intended Use
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 International Normalized Ratio (INR)
units. It uses fresh capillary whole blood. It is intended for use by health
care professionals at the point of care to monitor patients who are on
warfarin-type (coumarin) anticoagulation therapy. 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.