IVD
For self-testing.
IMPORTANT:
Please read this information and your OneTouch® Vita™
User’s Handbook before using OneTouch® Vita™ Control Solution.
Intended Use
For use with the OneTouch® Vita™ Blood Glucose Meter and Test Strips
to check
that the meter and test strips are working together properly
and that you
are performing the test correctly.
Summary and Explanation
OneTouch® Vita™ control solution contains a known amount of glucose that
reacts with OneTouch® Vita™ Test Strips. The test result you obtain should fall
within the range of results printed on the vial of the test strips you are using.
m
CAUTION:
Control solution ranges printed on the test strip vial are
for control solution only.
It is not a recommended range for your blood
glucose level.
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WARNING:
Keep the meter and testing supplies away from young
children. Small items are choking hazards.
Do a control solution test:
To practise the test process, instead of using blood.
•
Once a week.
•
Whenever you open a new vial of test strips.
•
If you suspect that the meter or test strips are not working properly.
•
If you have had repeated unexpected blood glucose results.
•
If you drop or damage the meter.
•
A control solution test that is within the expected range printed on the test
strip vial will tell you the meter and test strips are working together and you
are doing the test properly.
Test Procedure
Carefully read the instructions in your User’s Handbook on how to perform
a control solution test.
Composition
Control solution consists of glucose in water (0.11% for OneTouch® Vita™
Control Solution) with buffers and stabilisers, a viscosity adjusting agent,
a preservative, and a dye.
Each vial contains enough solution for a minimum of 75 tests.
Important Safety Information
Use only OneTouch® Vita™ control solution with the OneTouch® Vita™
•
Meter. Write the use-by date (date opened plus 3 months) in the space
provided on the bottle label when you first open it.
Do not
•
use after the expiry date (printed on bottle label) or use-by date,
whichever comes first.
Control solution tests must be done at room temperature (20–25 °C).
•
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CAUTION:
Do not
swallow control solution; it is not for human
consumption.
Do not
apply control solution to the skin or eyes, as
it may cause irritation.
Control Solution
AW 06529201A
