Product Manual

Page 1
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.