Introduction; Intended Use; Before Starting To Use The; Microinr® System - iLine microsystems microINR link Instructions D'utilisation

1. INTRODUCTION

1.1 INTENDED USE

The microINR System is intended to monitor oral
anticoagulation therapy (OAT) with vitamin K antagonist drugs.
The microINR System determines quantitative prothrombin
time (PT) in INR (International Normalized Ratio) units with
fresh capillary blood performed by fingersticking.
The microINR System is a medical device for in-vitro
diagnostics intended for professional and self-testing use.

1.2 BEFORE STARTING TO USE THE

microINR® SYSTEM
These instructions for use will guide you, with comprehensive
information, on the handling and use of the microINR Link
Meter. Please, read them as well as the instructions for use of
the microINR Chip carefully. Furthermore, do not forget to read
the instructions for use of the disposable lancets and/or
lancing device used to obtain the capillary blood sample.
The microINR Link Meter refers to the reader device.
The microINR Chips refer to the test strips, intended to be used
exclusively with the microINR or microINR Link Meters.
The microINR System refers to reader (microINR or microINR
Link Meters) and the strips (microINR Chips).
The microINR Link Meter can communicate through wireless
Bluetooth technology to a software or smartphone application
(App). Please, inform yourself on the correct use of this
software or app.
Keep these instructions for use near the microINR Link Meter
and refer to them if you have any questions about proper
operation of the system.
At the end of these instructions you will find a glossary.
Self-testing or self-management of vitamin K antagonists
may only be prescribed by a doctor.
Users of the microINR System (patients and healthcare
professionals) must receive proper training before
starting to use the system.

Safety Information

General Safety Warnings
Throughout these instructions for use you will find safety
warnings and information on the correct use of the microINR
System.
This warning symbol indicates a possibility of danger
which could result in death, injury or harm to the
patient or user if the procedures and instructions for
use are not strictly followed.
This precaution symbol indicates the possibility of
deteriorating or damaging the equipment and losing
data, if the procedures and instructions for use are not
strictly followed.
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