Glucose Control Solution
Package Insert
G123-12C
English
Control Solution
Package Insert
Meter
Test Strips
Consult instructions for
use
Use by
Authorized
Representative
For in vitro
diagnostic use only
Lot Number
Control Range
Store between 5-30°C
Manufacturer
Catalog #
Number: 1150884501
Effective date: 2016-xx-xx
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
0123
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego, CA 92121, USA
www.acondiabetescare.com
The On Call® Plus II Glucose Control Solution contains a known concentration of glucose. It is used
to confirm that your On Call® Plus II Blood Glucose Test Strips are working properly together with On
Call® Plus II Blood Glucose Meter, On Call® Plus Blood Glucose Meter or On Call® EZ II Blood Glucose
Meter and 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 box 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 level 0 or level 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, 5-30°C (41-86°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 format. 2014-01 indicates January, 2014.
Each bottle of control solution can be used for 6 months after you first open it. The control solution
will expire 6 months after the bottle is opened for the first time. 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.
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 On Call® Plus II brand control solution with On Call® Plus II test strips when the test strips are
tested with On Call® Plus meter, On Call® Plus II meter or On Call® EZ II meter.
1. Power on the meter by inserting a new test strip. 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.
PRINCIPLE AND INTENDED USE
COMPOSITION
STORAGE AND HANDLING
MATERIALS REQUIRED BUT NOT PROVIDED
INSTRUCTIONS FOR USE
PRECAUTIONS
MATERIALS REQUIRED
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. If the audio option is turned on, the meter will beep to indicate
a sufficient sample has been applied.
Notes: Do not apply control solution to the test strip directly from the bottle.
If the control solution sample does not completely fill the check window, do not add a
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 box). 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. Make sure that neither the test strip
Confirm the temperature in which you are testing is between 10 and 40°C.
Make sure that the test strip vial and the control solution bottle have been tightly capped.
Make sure the code number on the vial (or on the foil pouch) of test strips you are using matches
Confirm that you are using On Call® Plus II 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 box), 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.
second drop. Discard the test strip and start over with a new test strip.
EXPECTED RESULTS
vial nor the control solution bottle has been opened for more than 6 months. Discard any expired
test strips or control solution.
the code number stored in the meter memory.
INDEX OF SYMBOLS
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