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iLine microsystems microINR link - User Manual

iLine microsystems microINR link
222 pages
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© 2020 iLine Microsystems. microINR is trademark of iLine Microsystems.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG,
Inc. and any use of such marks by iLine Microsystems is under license.
IND0001AA - Rev 2020-05
Paseo Mikeletegi, 69
20009 Donostia - Gipuzkoa (SPAIN)
www.ilinemicrosystems.com
iLine Microsystems S.L.
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technology
Instructions for use
Instrucciones de uso
Bedienungsanleitung
Gebruiksaanwijzing
Istruzioni per l’uso
Instructions d’utilisation
Instruções de utilização
Návod k použití
Navodila za uporabo
link
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Charge completely the battery of the Meter before its first use.
Cargue la batería del Monitor por completo antes del primer uso.
Carregue totalmente a bateria do Monitor antes da sua primeira utilizaçao.
De batterij van de meter moet vóór het eerste gebruik volledig worden opgeladen.
Caricare completamente la batteria del dispositivo prima del suo primo utilizzo.
Charger complétement la batterie de l’appareil avant la première utilisation.
Laden Sie die Batterie des Messgeräts vor dem ersten Gebrauch vollständig auf.
Před prvním použitím měřícího přístroje baterii zcela nabijte.
Pred prvo uporabo baterijo Merilnika napolnite v celoti.
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Table of Contents

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iLine microsystems microINR link Specifications

General IconGeneral
Sample TypeCapillary whole blood
ConnectivityBluetooth
Operating Temperature15°C to 35°C
Intended UseMonitoring of oral anticoagulation therapy
MeasurementProthrombin Time (PT) / International Normalized Ratio (INR)
Sample Volume10 μL
Measuring Range0.8 – 8.0 INR
Power SourceRechargeable battery
Measurement Time1 minute
Battery LifeApproximately 100 tests
Dimensions150 mm x 75 mm x 30 mm

Summary

Introduction and Intended Use

Intended Use

The microlNR System is intended to monitor oral anticoagulation therapy (OAT) with vitamin K antagonist drugs.

Before Starting to Use the System

Guide to handling and use of the microlNR Link Meter, including reading Chip instructions.

General Safety Warnings

Provides safety warnings and information on correct use of the microlNR System.

Safety Information Details

Infection Risk Control

Guidelines for healthcare professionals on preventing infection transmission during testing.

Wireless Technology

Information on the microlNR Link Meter's Bluetooth communication capabilities and RF energy.

Electromagnetic Compatibility and Electrical Safety

Details compliance with EMC and electrical safety standards for the microlNR Link Meter.

System Principles

Oral Anticoagulant Therapy

Explains oral anticoagulant therapy, monitoring, and the role of PT and INR.

Prothrombin Time and INR

Explains prothrombin time (PT) measurement and conversion to INR values.

Measuring Principle and Calibration

Measuring Principle

Explains the microfluidics technology of the microlNR Chip and how INR is determined.

Calibration

Details the calibration process of microlNR Chips using WHO standards.

microlNR System Components

Kit Description

Lists the components included in the microlNR Link kit, excluding microINR Chips.

Meter Parts

Identifies the physical components of the microlNR Link Meter device.

Charging the Meter

Provides instructions for recharging the Meter's lithium battery via USB.

System Settings and Controls

Setting Time and Date

Instructions on how to set and adjust the Meter's time and date for accurate chip expiration.

Patient Identification

Explains how to optionally record a Patient Identification (PID) with test results.

Quality Control

Quality Control Procedures

Details the internal and on-board quality control checks performed by the Meter and Chip.

Conducting the Test - Preparation

Preparing Materials

Lists the essential materials required for conducting an INR test with the system.

Measurement Procedure Start

Guide on how to turn on the Meter, insert the Chip, and start the measurement process.

Conducting the Test - Procedure

Measurement Procedure

Step-by-step guide on how to conduct the test, obtain sample, and interpret results.

Obtaining Blood Sample

Detailed steps for correctly obtaining and applying a capillary blood sample for testing.

Interpreting Results

Explains how to read and understand the INR results displayed by the Meter.

Limitations and Memory

Limitations of Use

Outlines the restrictions and conditions that may affect the performance or accuracy of the microlNR System.

Memory Functionality

Information on how the Meter stores test results and how to access them.

Bluetooth Connectivity

Bluetooth Functionality

Overview of the Meter's wireless Bluetooth communication capabilities.

Configurable Features

Details the configurable settings for the Meter's wireless Bluetooth communication.

Bluetooth Menu

Instructions on how to access and navigate the Meter's Bluetooth menu.

Device Pairing and Unpairing

Device Pairing

Step-by-step guide on how to pair the microlNR Link Meter with a compatible device.

Device Unpairing

Instructions on how to remove the pairing between the microlNR Link Meter and a connected device.

Data Transfer and Results

Transferring Data

Explains how test results are automatically sent to a paired device.

Sending All Results

Instructions on how to manually send all stored test results from the Meter.

Cleaning and Disinfecting

Cleaning and Disinfection Procedures

Essential procedures for cleaning and disinfecting the Meter to ensure safety and proper operation.

Error Guide

Error Messages and Solutions

A comprehensive guide listing error codes, their probable causes, and suggested solutions.

Additional Information

Specifications

Technical specifications of the microlNR Link Meter, including dimensions, power, and operating conditions.

Warranty

Details the warranty coverage and limitations for the microlNR system.

Technical Service

Information on obtaining technical support and authorized repairs for the system.

Symbols

Explanation of the various symbols used on the Meter's screen and in the manual.

Glossary

Glossary

Definitions of key terms and technical vocabulary used throughout the manual.

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