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PRINCIPLE AND INTENDED USE
®
The On Call
Plus Glucose Control Solution contains a known concentration of glucose. It is used to
®
confirm that your On Call
Plus Blood Glucose Test Strips and On Call
are working together properly 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.
•
When 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.
Two levels of control solution are available labeled Control Solution 1 and Control Solution 2. Control
Solution 1 is sufficient for most self-testing needs. If you think your meter or strips may not be
working correctly, you may also want to do a level 2 test.
Control Solution 1 contains less than 0.2% glucose (active ingredient) and Control Solution 2 contains less
than 0.4% glucose (active ingredient), both with preservatives in an aqueous based mixture.
STORAGE AND HANDLING
•
Store the control solution at room temperature, 59-86°F (15-30°C).
•
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. 2013-01 indicates January, 2013.
•
Each bottle of control solution can be used for 3 months after you first open it. The control
solution will expire 3 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 59 and 104°F
(15-40°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 only On Call
Plus brand control solution with your On Call
Plus brand test strips.
MATERIALS PROVIDED
• Control Solution
Please contact Customer Support at 1-800-838-9502 for more information on obtaining a control
solution kit.
Glucose Control Solution
Package Insert
English
®
Plus Blood Glucose Meter
COMPOSITION
PRECAUTIONS
®
Plus brand meter and On Call
• Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
• 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.
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
second drop. Discard the test strip and start over with a new test strip.
5. Read the result from the meter display.
Control solution test results should be within the control range. The ranges for both (CTRL 1 and CTRL 2)
are displayed on the test strip vial. For confirmation of results, 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 vial nor the control solution bottle has been opened for more than 3 months. Discard any
expired test strips or control solution.
•
Confirm the temperature in which you are testing is between 59 and 104°F (15-40°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 of test strips you are using matches the code number
stored in the meter memory.
•
Confirm that you are using On Call
•
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, your meter may not be working
properly. DO NOT use the system to test blood. Contact Customer Support at 1-800-838-9502 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 Customer Support at 1-800-838-9502, 24 hours
a day, 365 days a year.
®
•
Test Strips
INSTRUCTIONS FOR USE
EXPECTED RESULTS
®
Plus brand control solution.
ACON Laboratories, Inc.
10125 Mesa Rim Road
San Diego, CA 92121, USA
Customer Support: 1-800-838-9502
www.acondiabetescare.com
Number: 1150591603
Effective data: 2013-04-08