iLine microsystems microINR Instructions For Use Manual
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iLine microsystems microINR Instructions For Use Manual

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iLine Microsystems S.L.
Paseo Mikeletegi, 69
20009 Donostia - Gipuzkoa (SPAIN)
www.ilinemicrosystems.com
© 2021 iLine Microsystems. All rights reserved. Made in Spain. This product
is covered by patent technology EP2201365(B1). iLine Microsystems and
microINR are registered trademarks of iLine Microsystems S.L.
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Instructions for use

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Summary of Contents for iLine microsystems microINR

  • Page 1 Microsystems S.L. Paseo Mikeletegi, 69 20009 Donostia - Gipuzkoa (SPAIN) www.ilinemicrosystems.com © 2021 iLine Microsystems. All rights reserved. Made in Spain. This product is covered by patent technology EP2201365(B1). iLine Microsystems and microINR are registered trademarks of iLine Microsystems S.L.
  • Page 2 Microsystems. The information contained in these instructions for use was correct at the time of printing. However, iLine Microsystems reserves the right to introduce changes to the specifications, equipment and maintenance procedures of the system at any time, without prior notification. Any substantial changes will be added to the next revision of these instructions for use.

  • Page 3: Table Of Contents

    CONTENTS Test Result and Assay End INTRODUCTION Turning the Meter Off INTENDED USE COLLECTION AND TESTING THE BLOOD SAMPLE BEFORE USING THE microINR® SYSTEM INTERPRETING THE RESULTS Important information LIMITATIONS OF USE Important information for healthcare professionals MEMORY ORAL ANTICOAGULANT THERAPY...

  • Page 4: Introduction

    These instructions for use will guide you on the handling and use of the microINR Meter, please, read them as well as the Important information regarding the correct use of the system instructions for use of the microINR Chip completely.

  • Page 5: Important Information For Healthcare Professionals

    (EMC) requirements according to IEC 60601-1-2. Important information for Healthcare professionals See EMC/Electrical Safety Compliance Information in Annex I. The microINR System can be used at physicians’ offices and CLIA categorization anticoagulation clinics, as well as in home settings, whereas it...

  • Page 6: Measuring Principle

    Ratio, by using a specific equation. 2. microINR® SYSTEM 1.4 MEASURING PRINCIPLE 2.1 DESCRIPTION OF THE microINR® KIT The technology used by the microINR System is based on the The microINR kit includes: microfluidics of the microINR Chip. - Case The Chips contain human recombinant thromboplastin as reagent.

  • Page 7: Parts Of The Microinr® Meter

    2.2 PARTS OF THE microINR® METER Do not change the battery. Do not store microINR Meter near a heat source since MINI USB CONNECTION it could result in battery swelling, leak or malfunction. For battery replacement or Meter repairs, the equipment must be sent to the manufacturer.

  • Page 8: Quality Control

    Then, On-Board Controls provide a quality control check for each individual microINR Chip used with the microINR Meter. microINR System has been designed to detect errors prior to and during the test in order to prevent inaccurate INR results through a multi-level strategy.

  • Page 9: Inserting The Chip

    Once this temperature is reached: Hold the Chip by the yellow part so that the - The device emits an audible signal “microINR” logo can be read correctly. Insert (beep tone). the Chip into the slot and push it until it stops.

  • Page 10: Test Result And Assay End

    • After the beep tone, gently remove the finger trying to leave Test Result and Assay End a small amount of blood at the Chip’s entry channel. • The measurement • Wait until the INR result is displayed on the screen. is performed, and If you apply the sample and no sound is emitted, this means the Meter displays...

  • Page 11: Turning The Meter Off

    Turning the Meter Off creams, etc.), lotions or sweat on the fingerstick area or the blood sample may cause incorrect results. There are two ways to turn the Meter off: Before lancing the finger, it is convenient to warm • The Meter turns off automatically after hands.

  • Page 12: Interpreting The Results

    Chip. 3.4 INTERPRETING THE RESULTS The results are shown as International Normalized Ratio (INR) units. The microINR System’s results range between 0.8 and 4.5. If you obtain a result out of the Samples must be applied immediately after collection, measuring range, since blood clotting does naturally occur upon fingerstick.

  • Page 13: Limitations Of Use

    The microINR Meter can store up to 199 results. Each result is stored with the date and time of the test. When conducting a Results are unexpected when they do not match the test, if there is no free storage space, the oldest result will be patient´s symptoms (i.e., hemorrhages, bruises, etc.).

  • Page 14: Cleaning And Disinfecting

    All these materials can easily be found and purchased on Sani-Cloth® wipe internet. and clean the • Super Sani-Cloth® Germicidal Disposable Wipes microINR Meter (EPA reg. no. 9480-4) (all areas) for 10 seconds and • Lint-free cloth dispose the wipe.

  • Page 15: Warnings When Cleaning-Disinfecting

    • Verify that the gauze or wipe is just moist, not soaked. Make these critical areas. sure that no liquid enters the Meter or the Chip insertion 4. Allow the microINR Meter to air dry area or USB port. thoroughly for 10 minutes before •...

  • Page 16: Error Guide

    Make sure you do not block the Chip’s entry channel and you are applying a sufficient amount of blood. Gently remove the finger after the blood application. Go to section 3.3 of the microINR Meter instructions. Verify proper Chip storage conditions (see microINR Chip instructions).
  • Page 17 The device has been hit or moved abruptly Do not hit/touch or move the Chip or Meter during the test. during the test. Verify proper Chip storage conditions (see microINR Chips instructions). Chip damaged. Wrong application of the blood sample or Repeat the test with a new Chip.

  • Page 18: Additional Information

    • Memory: 199 results / error messages with their date and time. • Power supply: 7.3 SOFTWARE LICENSES - Battery: Lithium 2400mAh/2800mAh; 3.7V. Consumption: 1 A - Power supply: Only use the charger provided with microINR This product incorporates software modules developed under Meter. Model Number GTM96060-0606-1.0. open source licenses.

  • Page 19: Symbols

    7.5 SYMBOLS TEST RESULTS IN INR DATE UNITS OR ERROR CODE. (MONTH : DAY : YEAR) TIME “Manufacturer” (HOURS : MINUTES). A: AM “Serial number” P: PM ”Catalogue number” BLINKING “Consult the instructions for use” INDICATES “APPLY SAMPLE”. “In-vitro diagnostic medical device” THE RESULT IS ABOVE OR BELOW ”Direct current”...

  • Page 20: Glossary Of Terms

    Prothrombin time (PT): Coagulation test in which for the INR test. coagulation is induced by exposing a blood sample to a Entry channel: Slot on the bottom of the microINR Chip that thromboplastin reagent material. receives the blood. Quality control: Procedures intended to assure that the...

  • Page 21: Annex I. Emc/Electrical Safety Compliance Information

    - guidance ±2 kV DM ±2 KV DM Electromagnetic emissions (line-to-earth) (line-to-earth) Surge The microINR System is intended for use in the electromagnetic IEC 61000-4-5 ±1 kV CM ±1 KV CM environment specified below. microINR System’s users should (line-to-line) (line-to-line) check that it is used in such an environment.
  • Page 22 The user of the microINR System can help prevent electromagnetic interference by maintaining a minimum distance between other portable/mobile RF communications equipment (transmitters) and the microINR System at least 30 cm (about 12 inches). Immunity to proximity fields from RF wireless communications equipment:...

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