OneTouch VITA - CONTROLE SOLUTION, VITA - CONTROL SOLUTION REV 3-2008, VITA User Handbook Manual

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.

m 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).•

m 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

Storage and Handling

Close the vial tightly immediately after use and store at room temperature below 30 °C. Do not refrigerate.

Expected Results

At room temperature, control solution test results should fall within the expected range printed on the test strip
vial label about 95% of the time.

If test results fall outside the expected range, read the notes in the bulleted list below and then repeat the control
solution test with a new test strip. Results outside the expected range may indicate:

Failure to follow all the instructions for performing a control solution test described in your User’s Handbook. •

Control solution is contaminated or past its expiry or use-by date. •

Test Strip is damaged or past its expiry or use-by date.•

Control solution test was performed outside the correct temperature range (20–25 °C).•

Control solution was too warm or too cold.•

The result was not matched with the correct control range on the test strip vial.•

A problem with the meter.•

m CAUTION: If you continue to get control solution test results that fall outside the range printed on the test
strip vial, do not use the meter, test strips, or control solution. Contact Customer Service on 0800 121 200 (UK)
or 1800 535 676 (Ireland).

OUR COMMITMENT TO YOU

Our goal is to provide you with quality health care products and dedicated customer service. If you are not
fully satisfied with this product, or if you have questions about the use of any LifeScan product, please call us
on 0800 121 200 (UK) or 1800 535 676 (Ireland).

Description of Symbols

For a complete description of all symbols used, refer to the User’s Handbook that came with your system.

© 2008 LifeScan, Inc. Rev. date: 03/2008 AW 06529201A

LOT

LifeScan, Inc.
Milpitas, CA 95035 U.S.A.

LifeScan Regulatory Affairs Europe
Division of Ortho -Clinical Diagnostics France
1, rue Camille Desmoulins
92787 Issy-les-Moulineaux, Cedex 09
France

0344

Symbols:

Distributed by:
LifeScan UK/Ireland,
A div. of Ortho-Clinical Diagnostics,
Johnson & Johnson,
50 - 100 Holmers Farm Way,
High Wycombe, Bucks HP12 4DP
United Kingdom
www.LifeScan.co.uk

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