iLine microsystems GPC0001AD MicroINR Semi-Automatic Coagulation Analyzer User Guide

iLine microsystems GPC0001AD MicroINR Semi-Automatic Coagulation Analyzer

BEFORE STARTING

•  Read the microINR Meter and Chips instructions for use completely.
•  Read also the instructions for use of the disposable lancets

The instructions for use will guide you on the handling and use of the microINR System.

CHARGING THE microINR® METER
The microINR Meter uses lithium batteries (like cellphones). Charge the battery completely before using the Meter for the first time. The recommended charging time is approximately 3 hours. To charge the Meter, connect the charger provided with the kit to the mini-USB port of the Meter.

SETTING TIME & DATE
Check that the time and date are correct, as it is necessary for the Chips’ expiration date determination. Meter’s time and date are set during the manufacturing process, so you probably will not need to modify them. If necessary, please follow the steps described in section 2.4 of the Meter’s instructions for use to adjust the time and date.

GETTING READY FOR THE TEST

Prepare all items needed for the testing:

•  microINR Meter
•  microINR Chips
•  Disposable lancets
•  Means for skin cleaning
•  Gloves

The fingerstick area must be clean, free of contaminants and completely dry. We recommend washing patient’s hands with warm soapy water and drying them thoroughly.
It is convenient to warm hands. There are several techniques that can be used for that porpuse as keeping hands below the waist or massaging the fingertip softly.

TESTING

Insert the Chip
Remove a Chip from its pouch and hold it by the yellow part so that the “microINR” logo can be read correctly. Insert the Chip into the slot and push it
until it stops. The Meter will turn on automatically.

Warming up

A flashing hourglass appears on the screen. Wait for the Meter to be ready for testing, while preparing hands for the fingerstick. Make sure the puncture site is warm and fingertip clean. The Meter is ready when:

•  The Meter emits an audible signal (beep tone).
•  The drop symbol begins to flash on the display.
• An 80-second countdown appears.
•  The Chip emits a steady light.

Applying the blood sample

1.  Place the lancet firmly against the fingertip and activate it. Massage the finger to bring blood to the finger tip and gently press to help form a drop of blood.

2.  Make sure to obtain a spherical and properly sized drop, equivalent to a teardrop. Do not press the fingerstick site or let the drop of blood spread on the finger.

3. Apply the drop of blood to the Chip immediately. Put the drop in contact with the Chip’s entry channel.
   The Meter emits a beep tone when it detects that the sample volume is enough. The drop symbol stops flashing and the countdown disappears.

4. After the beep tone, gently remove the finger, trying to leave a small amount of blood at the Chip’s entry channel.

Result & Assay end
Wait until the INR result appears.
Dispose of the used Chip, lancet and gloves according to your institution´s infection control policy and the appropriate local regulations. The Meter automatically turns off after approx. 3 minutes of inactivity or by pressing the left button (EXIT), holding it for 3-4 sec.

MEMORY
The results are automatically stored in the Meter’s memory. To check previous results, follow the directions described in section 4 of the Meter’s instructions for use.

CLEANING / DISINFECTION

The FDA recommends that Point-Of-Care testing devices used with multiple patients be properly cleaned and disinfected after every use. Clean the Meter to remove visible dirt before disinfecting.
Please follow the cleaning and disinfecting procedure described in section 5 of the Meter’s instructions for use.

TIPS FOR A CORRECT SAMPLE APPLICATION

•  Make sure the blood drop has a spherical shape and is large enough, like a teardrop, before appling the sample to the Chip.
•  After obtaining that blood drop, immediately apply it on the Chip.
•  Do not touch the Chip or block the entry channel with the finger during the application.
•  Apply the sample on a single attempt. Never add more blood to the Chip.
•  A sufficient amount of blood will have been applied once the meter emits a beep tone and the blood drop symbol and the countdown disappear on the display. After that, remove the finger gently, trying to leave a small amount of blood at the Chip’s entry channel.

ALSO REMEMBER…

•  Use any technique recommended in this guide to warm hands, until the fingerstick area has a slightly reddish color.
•  The fingerstick area must be clean, free of contaminants and completely dry. Any alcohol, creams, lotions or sweat in the area may cause incorrect results.
•  Do not use the Chip if you detect that the Chip is defective or its pouch is opened or damaged.
•  The Meter must be placed on a flat and steady surface. Do not move the Meter or the Chip until the test is over.
•  Do not shake the Meter or let it fall.
•  Do not manipulate the Meter or the Chip with wet or dirty hands/gloves.
•  Do not fingerstick until the 80-second countdown starts.
•  Use any finger for fingersticking.
•  Do not squeeze or “milk” the fingerstick area. Do not let the drop of blood spread on the finger.
•  If you get an error message, follow the steps described on the “Error Guide” section of the Meter’s instructions for use.
•  If you need to repeat the test, perform the fingerstick on a different finger with a new lancet and a new Chip.

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.

References

• iLine – iLine Microsystems

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