medisana MediTouch-2 mg-dL Blood glucose monitor incl.starter set User Manual

: June 4, 2024
: medisana

Table of Contents

Intended purpose
PRECAUTIONS
Instructions for use
Test results
References
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GB Control solution for self-testing

Explanation of symbols

This instruction manual is for this blood glucose control solution. It contains important information about starting up and operation. Read the instruction manual thoroughly. Non-observance of these instructions can result in serious injury or damage to the device.

| use only)
---|---
| Control solution
**LOT**| LOT number
**REF**| Catalogue number
| Storage temperature limitation
| Manufacturer
| Use by
| Discard 3 months after opening

This blood glucose control solution corresponds to the requirements of the EU guidelines 98/79 for in vitro diagnostics and bears the CE marking (conformance label) CE 0483.

Intended purpose

The control solution Meditouch 2 from medicine, art. 79039 is sufficient for the examination of the blood glucose measurement device and the test strips. It is intended for self-testing. The control solution is for external (in vitro) use only, together with the test strips and the measurement device Meditouch 2. g The control solution corresponds to the direction 98/79/EC, attachment IV.3 for in vitro diagnostics. The conformity with the above- mentioned direction has been confirmed by company mdc Medical devices certification GmbH.

PRECAUTIONS

The control solution for Meditouch 2 from medicine is only intended for external (in vitro) diagnostic use!
The control solution is NOT suitable for consumption or injection!
Only use the medicine control solution for testing with the MediTouch 2 test strips and the MediTouch 2 device!
Do NOT freeze the control solution!

Instructions for use

Write the opening date on the label of the container. The control solution can be used for approx. three months after opening the container or until the expiry date, whichever comes first.
Do not use the control solution after the expiry date.
The ambient temperature for using the control solution should lie between 10 °C – 40 °C (50 °F – 104 °F).
The temperatures for storing and transporting the control solution should lie between min 2 °C and max 30 °C (35.6 °F – 86 °F). Do not store the solution in the refrigerator and do not freeze it.
Shake the bottle with the control solution well before you open it.
Wipe away the first drop with a clean cloth and use the second drop to ensure you get a good sample for a precise reading.
To ensure the control solution does not get contaminated, wipe the remaining solution on the tip of the container with a clean cloth before closing it again. i
The control solution may stain your clothing. If this is the case, rinse the soiled clothing immediately in water and detergent.
Do not put any excess control solution back into the container.
Close the container carefully after every use.

Chemical Substances
The control solution for Meditouch 2 from medicine contains the following reagent:
0.12 (w/w) D-Glucose
99.88 (w/w) Non-reactive ingredients

Test results

If the reading of your test falls within the expected range printed on the test strips vial label, then the test strip and the glucose meter are working together correctly. The results of your blood glucose tests will be reliable. g
If the reading falls outside the expected range, your meter may not be working properly. In this case, check the following:

Have the control solution or test strips been used after their expiration date? Has the control solution been contaminated?
Did you forget to replace the cap on the vial of the control solution or test strips?
Did you follow the instructions for the control solution, art? 79039, test strips (art. 79038 / 79040) and device (art. 79030 / 79034) thoroughly to achieve a correct test procedure?

Repeat the test according to the instructions given with the proper control solution and test strips. If the reading is still not acceptable, contact the service center.
You can find out which is your responsible service center from your supplier

medisana GmbH
Carl-Schurz-Str. 2 41460 NEUSS
Germany
Email:[email protected]
Internet:www.medisana.com