Introduction; Intended Use; Before Using The Microinr® System; Safety Instructions - iLine microsystems microINR expert Instructions For Use Manual

1. INTRODUCTION

1.1 INTENDED USE

The microINR system (Expert), consisting of the microINR Expert meter and the microINR Chips, is intended
to monitor oral anticoagulation therapy (OAT) with vitamin K antagonist drugs. The microINR system (Expert)
determines quantitative prothrombin time (PT) - INR (International Normalized Ratio) units with fresh
capillary blood obtained by fingersticking.
The microINR Expert meter is a medical device for in-vitro diagnostics intended for multiple-patient use by
professional healthcare providers.
1.2 BEFORE USING THE microINR® SYSTEM
These Instructions for Use provide guidelines on handling and use of the microINR Expert meter. Please read
them and the Instructions for Use of the microINR Chips carefully before using the device. There is a USB
flash drive containing these instructions in various languages among the items provided with this meter.
Make sure you also read the instructions of the disposable lancets and/or lancing device used to obtain the
capillary blood sample. These products are not provided with microINR Expert meter.
The term "microINR Expert meter" refers to the reader device.
The term "microINR Chips" refers to the test strips intended to be used exclusively with microINR meters
(microINR, microINR Link and microINR Expert meters).
The microINR system (Expert) refers both to the microINR Expert meter and the test strips (microINR Chips)
and it is intended to be used for near-patient testing and not for self-testing.
Keep these instructions in a convenient place near the microINR Expert meter and refer to them if you have
any queries about proper operation of the system.
The microINR Expert meter is equipped with a touchscreen that displays information and icons about the
meter usage and test results. Users can work with this touchscreen while wearing latex or nitrile gloves.
Throughout these instructions the names of the on-screen options are shown as bold text.
The microINR Expert meter can communicate with a Data Management System (DMS) through wireless
technology (Wi-Fi or Bluetooth) or hard-wired ethernet through the ethernet adaptor (available separately).
The data handling function may vary depending on the particular Data Management System (DMS). Please
contact your local distributor for further information on the DMS compatible with the meter and configuration
required for connection.
You will find a terminology index at the end of these Instructions for Use.

Safety Instructions

This section describes the system safety-related messages and information and how they are presented in
these Instructions for Use.
General Safety Warnings
You will find safety warnings and information on proper use of the microINR system (Expert) throughout
this document.
This warning symbol indicates a potential hazard that could result in death, injury or harm to the
patient or user if the procedures and instructions contained herein are not strictly followed.
This precaution symbol indicates a hazard that could damage the equipment and cause data loss if
the procedures and instructions contained herein are not strictly followed.
Important information regarding proper use of the system that does not affect the safety of the patient
or the integrity of the device is displayed on a blue background.
02