Introduction - CoaguSense Assure PT Care Prothrombin Time User Manual

1. Introduction

®
Assure PT Care Prothrombin Time (PT)/INR
Monitoring System
Intended Use
®
The Assure PT Care 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.
Anticoagulation Medication:
Oral anticoagulation medications are typically prescribed to patients to avoid
unwanted clots. The patient's blood clotting time must be monitored to ensure that
their dosage is correct.
Oral anti-coagulation medication is prescribed to patients with acute and chronic
conditions including, but not limited to: congestive heart failure, atrial fibrillation,
prosthetic heart valve, myocardial infarction, joint replacement, deep vein
thrombosis, pulmonary embolism, thrombotic stroke, coronary artery disease,
venous thromboembolism and cancer.
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