iLine microsystems microINR User Manual

02
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
The microINR Meter is intended to be used exclusively with the
microINR Chips manufactured by iLine Microsystems.
Before starting to use the microINR system, read these
instructions for use completely, as well as the instructions for
use of the microINR Chip. Also, do not forget to read the
instructions for use of the lancing device and lancets used to
obtain the capillary blood sample.
Keep these instructions for use near the microINR system and
refer to them if you have any questions about proper
operation of the system.
Users of the microINR system (patients and healthcare
professionals) must receive proper training before
starting to use the system.
Before starting to use the microINR system, verify the
compatibility between the soware version of your Meter and
the reference of the Chips you are going to use.
REF SOFTWARE VERSION*
CHA0025AA All soware versions
CHB0025AA >07:03
*The soware version appears at the top of
the display, immediately aer turning the
Meter on. If you cannot read the version,
repeat the attempt by turning the Meter off
and on again.
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 damage of 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.
1. INTRODUCTION

iLine microsystems microINR Specifications

General

Brand	iLine microsystems
Model	microINR
Category	Measuring Instruments
Language	English