User's Guide

3
1. Introducing Xprecia Prime™
About the Xprecia Prime™ system
The Xprecia Prime™ system is designed to monitor blood
coagulation. It measures the time it takes for a sample of blood to
clot and reports the result as an International Normalised Ratio
(INR). INR results can vary from test to test due to health conditions.
If it is too low, there is a greater than normal risk of blood clots
forming; if it is too high, there is a greater than normal risk of
bleeding.
Anticoagulant medication is a common treatment in patients
susceptible to blood clots. Blood clots can cause serious conditions,
such as deep vein thrombosis (a blood clot in the veins of the legs),
pulmonary embolism (a blood clot in the lungs), or a stroke (a blood
clot in a blood vessel in the brain). Anticoagulants are designed to
reduce potentially harmful blood clotting.
The Xprecia Prime™ system has been specifically designed to
monitor INR of patients undergoing anticoagulation therapy with
warfarin. Vitamin K is essential to the normal blood clotting
(coagulation) process; warfarin acts by making the body less
efficient at using vitamin K to make clotting factors (factor II, VII, IX
and X). INR is sensitive to changes in these factors so it is essential
that INR be monitored in patients taking warfarin. A higher dose of
warfarin might be necessary if the INR is too low; a lower dose if it is
too high.
Intended Use
The Xprecia Prime™ system is for determining the International
Normalised Ratio (INR, related to prothrombin time) during the
monitoring of oral anticoagulation therapy with warfarin (a vitamin K
antagonist) in fresh capillary whole blood. It is an in-vitro diagnostic
device intended for multi-patient use in professional healthcare
settings including point of care settings.