Roche CoaguChek Vantus - Intended Use of the CoaguChek Vantus System

9
Introduction
Before you start
Intended use
The CoaguChek
®
Vantus System measures an
INR (International Normalized Ratio) based
on a prothrombin time (PT) response to
monitor the effect of a therapy with vitamin
K antagonists by using the CoaguChek XS
®
PT Test strips. The CoaguChek Vantus System
uses fresh capillary whole blood from a nger
stick.
The system is intended for properly selected
and suitable trained users on the prescription
of the treating doctor.
Users should be stabilized on anticoagulation
with vitamin K antagonists for at least 6 weeks
prior to single patient self-testing with the
CoaguChek Vantus System.
The CoaguChek Vantus System is intended
for single patient self-testing only for adults,
age 22 years and older.
Introduction
CoaguChek Vantus User’s Manual, version 1.0