Glucose Control Solution
Package Insert
REF 24121 MODEL OGC-211
English
Control Solution
Package Insert
Meter
Test Strips
Consult instructions for
use
Use by
MODEL
Model Number
In vitro diagnostic medical
device
Lot Number
Control Range
Temperature limit
Manufacturer
Catalogue number
Authorized representative in the European Community
Number: 1151434801
Effective Date: 20xx-xx-xx
MDSS GmbH
Schiffgraben 41
30175 Hannover, Alemania
ACON Laboratories, Inc.
5850 Oberlin Drive, #340
San Diego, CA 92121, USA
www.aconlabs.com
Manufacturer
0123
PRINCIPLE AND INTENDED USE
The GIMA Control Solution contains a known concentration of glucose. It is used to confirm that your
GIMA Test Strips are working properly when used with GIMA Blood Glucose Meter to confirm that you
are performing the test correctly.
You should perform a quality control test:
Before you first use your meter to familiarize yourself with its operation.
Before using a new vial of test strips.
When you suspect that the meter or test strips are not working properly.
When you suspect that your test results are inaccurate, or if they are inconsistent with how you feel.
If you suspect your meter is damaged.
At least once a week.
After cleaning your meter.
Three levels of control solution are available labeled Control Solution 0, Control Solution 1 and Control
Solution 2. Control Solution 1 is sufficient for most all self-testing needs. If you think your meter or strips
may not be working correctly, you may also want to do Control Solution 0 or Control Solution 2 tests.
Control Solution 0 contains less than 0.1% glucose (active ingredient), Control Solution 1 contains less
than 0.2% glucose (active ingredient) and Control Solution 2 contains less than 0.4% glucose (active
ingredient), all with preservatives in an aqueous based mixture.
Store the control solution at room temperature, 2-35 °C (36-95 °F).
Do not refrigerate or freeze.
If the control solution is cold, do not use until it has warmed to room temperature.
Use before the unopened expiration date that is shown on the bottle.
Note: All expiration dates are printed in Year-Month-Date format.
Each bottle of control solution can be used for 6 months after you first open it. Record this opened
expiration date on the bottle label.
For in vitro diagnostic use. The control solution is for testing only outside the body. Do not swallow or
inject. For self-testing and professional use.
Shake well before using.
Control solution tests are specified to be accurate only when tested between 10 and 40 °C (50 - 104 °F).
The control ranges shown on the test strip vial are not a recommended range for your blood glucose
level. Your personal blood glucose target ranges should be determined by your diabetes healthcare
professional.
Do not touch the end of the test strip to the control solution bottle. This could cause contaminants to
enter the control solution bottle.
Use only GIMA brand control solution with your GIMA meter and GIMA Test Strips.
MATERIALS REQUIRED BUT NOT PROVIDED
COMPOSITION
STORAGE AND HANDLING
PRECAUTIONS
MATERIALS PROVIDED
1. Insert a new test strip to turn on the meter. Refer to your meter’s User’s Manual details on how to
record the result as a quality control test and for further details on operating the meter.
2. Shake the control solution bottle thoroughly.
3. Squeeze the control solution bottle gently and discard the first drop. If the tip clogs, tap the tip gently
on a clean, hard surface, shake again, and then use.
4. Squeeze out a second small drop on a clean nonabsorbent surface. Touch the sample tip of the test
strip to the control solution drop and ensure the strip get sufficient sample.
Notes: Do not apply control solution to the test strip directly from the bottle.
If you applied the control solution sample but do not see the starting of the count down, you
may reapply a second drop within 3 seconds.
5. Read the result from the meter display.
Control solution test results should be within the control range. The ranges for CTRL 0, CTRL 1 and
CTRL 2 are displayed on the test strip vial (or on the foil pouch). For confirmation of results, Control
Solution 0 tests should fall within the CTRL 0 range, Control Solution 1 tests should fall within the
CTRL 1 range, and Control Solution 2 tests should fall within the CTRL 2 range. If the test results with
control solution fall within the specified control range, it indicates your Blood Glucose Monitoring System
is working properly and you are performing the procedure correctly.
If the control solution test results do not fall within the respective ranges:
Check the expiration date of the test strip and control solution. Discard any expired test strips or
control solution.
Confirm the temperature in which you are testing is between 10 and 40 °C (50 - 104 °F).
Make sure that the test strip vial and the control solution bottle have been tightly capped.
Confirm that you are using GIMA brand control solution.
Make sure that you followed the test procedure correctly.
After checking all of the conditions listed above, repeat the control solution test with a new test strip. If
your results still fall outside the range indicated on the test strip vial label or on the foil pouch, your meter
may not be working properly. DO NOT use the system to test blood. Contact your dealer for help. For
complete instructions, please refer to the User’s Manual included with your meter. For additional
questions or issues with this product, please contact your dealer for help.
INSTRUCTIONS FOR USE
EXPECTED RESULTS
INDEX OF SYMBOLS
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