OneTouch VITA - TEST STRIPS Manual

Test Strips
For self-testing.
IVD
IMPORTANT: Please read this information and your OneTouch®
Vita™ User's Handbook before using OneTouch® Vita™ Test Strips.
Do not use your OneTouch® Vita™ Test Strips if your vial is open
or damaged in any way as this could lead to error messages
or inaccurate blood glucose values. Call 0800 121 200 (UK) or
1800 535 676 (Ireland) immediately if the test strip vial is open or
damaged, or if these instructions or your meter results seem unclear.
Intended Use
OneTouch® Vita™ Test Strips are used with the OneTouch® Vita™ meter
for quantitatively measuring glucose in fresh capillary whole blood.
OneTouch® Vita™ Test Strips and meter are for use in fingertip, palm,
and forearm testing.
Storage and Handling
• S tore the test strip vial in a cool dry place below 30°C (86°F). Do not
refrigerate. Keep away from direct sunlight and heat. Exposure to
temperatures and/or humidity outside the required storage conditions
may result in inaccurate readings.
• S tore your test strips in their original vial only. To avoid damage or
contamination, do not transfer test strips to any other container.
• Do not open the test strip vial until you are ready to test. Only open
vial when removing strips.
• A fter removing a test strip from the vial, immediately close the vial lid
tightly. Use each test strip immediately after removing it from the vial.
• D o not use test strips from any vial that is damaged or has been left
open to air.
• W rite the use-by date (date opened plus 6 months) on the vial label
when you first open it.
• D o not use after the expiry date (printed on vial label) or use-by date,
whichever comes first.
• A void getting dirt, food, or liquids on the test strip. With clean, dry
hands, you may touch the test strip anywhere on its surface.
• Do not bend, cut, or alter the test strip in any way.
• T est strips are for single use only. Never re-use a test strip that has
had blood or control solution applied to it.
• M ake sure your meter and test strips are about the same temperature
before you test.
• A pply only OneTouch® Vita™ Control Solution or a blood sample to the
test strip.
• A fter performing a test, do not return the used test strip to the vial.
WARNING: Keep the test strip vial away from children; test
strips are a choking hazard. Do not swallow test strips. The test
strip vial may contain drying agents that are harmful if inhaled or
swallowed and may cause skin or eye irritation. Do not ingest or
swallow any items.
Blood Glucose Test Procedure
For instructions on performing a blood test (including blood sample
collection) and the range of expected blood glucose values, refer to the
User's Handbook that came with your system.
Test Results
The OneTouch® Vita™ Meter displays results between 1.1–33.3 mmol/L
(20 and 600 mg/dL). Refer to the User's Handbook for the range of
expected blood glucose values.
Low Glucose Values
If your test result is below 1.1 mmol/L (20 mg/dL), a warning message
will appear indicating a low glucose level. This may indicate severe
hypoglycaemia (low blood glucose). Treat this condition immediately,
according to your health care professional's recommendations.
Although this message could be due to a test error, it is safer to treat first
and then do another test.
High Glucose Values
If your test result is above 33.3 mmol/L (600 mg/dL), a warning message
will appear indicating a high glucose level. This may indicate severe
hyperglycaemia (high blood glucose). You should re-test your glucose
level. If the message appears again, call your health care professional
immediately.
If You Get Unexpected Results
If your blood glucose result is below 3.9 mmol/L (70 mg/dL), indicating
low blood glucose, or above 10.0 mmol/L (180 mg/dL), indicating high
blood glucose, you should contact your health care professional and
follow their advice on treatment.
results, check your system with control solution. If you are experiencing
symptoms that are not consistent with your blood glucose test results
AND you have followed all instructions described in your User's
Handbook, call your health care professional. Never ignore symptoms or
make significant changes to your diabetes control programme without
speaking to your health care professional.
Checking the System
Use only OneTouch® Vita™ Control Solutions
A control solution test is performed to check that the meter and test
strips are working together properly and that you are performing the
test correctly. For instructions on how and when to check the system
by performing a control solution test, refer to the User's Handbook that
came with your system.
Limitations of the Procedure
OneTouch® Vita™ Test Strips give accurate results when the following
restrictions are observed:
• Do not use for the diagnosis of diabetes or for testing newborn
babies.
• T est strips are for single use only. Do not re-use.
• T he test strips are specific to D-glucose and do not react with other
sugars that may be present in blood.
• U se only fresh capillary whole blood. Do not use serum or plasma.
• H aematocrit is the percentage of red blood cells in the blood.
Extremes in haematocrit may affect test results.
below 30% may cause falsely high readings and haematocrit levels
over 55% may cause falsely low readings. If you do not know your
haematocrit level, consult your health care professional.
• O neTouch® Vita™ Test Strips may be used at altitudes up to 3048
meters (10,000 feet) without an effect on test results. Accurate results
have been demonstrated in clinical studies performed at altitudes up
to 1609 meters (5,280 feet) and in studies simulating altitudes up to
3048 meters (10,000 feet).
Health care professionals—please note these additional procedural
restrictions:
• F resh capillary blood may be collected in heparin-containing test
tubes if the blood is used within 10 minutes. Do not use other
anticoagulants or preservatives.
• I nterferences: Paracetamol, salicylates, uric acid, ascorbic acid
(vitamin C), and other reducing substances (when occurring in normal
blood or normal therapeutic concentrations) do not significantly
affect results. However, abnormally high concentrations in blood may
cause inaccurately high results.
• P atients undergoing oxygen therapy may yield falsely low results.
• T est results may be falsely low if the patient is severely dehydrated, in
shock, or in a hyperosmolar state (with or without ketosis). Critically ill
patients should not be tested with blood glucose meters.
• H yperlipidaemic samples: Cholesterol levels up to 18.1 mmol/L
(700 mg/dL) and triglycerides up to 33.9 mmol/L (3000 mg/dL) do
not affect the results. Grossly hyperlipidaemic patient samples have
not been tested and are not recommended for testing with the
OneTouch® Vita™ Meter.
Test Principle
The OneTouch® Vita™ system is plasma-calibrated to allow easy
comparison of results with laboratory methods. Glucose in the
blood sample mixes with special chemicals on the test strip and a
small electrical current is produced. This current is measured by the
OneTouch® Vita™ Meter and displayed as your blood glucose result.
The strength of this current changes with the amount of glucose in
the blood sample.
Reagent Composition
Each test strip contains: Glucose oxidase (Aspergillus niger) ≥ 0.08 IU;
ferricyanide ≥ 22 µg; other ingredients (buffer, etc.). The test strip vial
contains a drying agent.
Performance Characteristics
The performance of OneTouch® Vita™ Test Strips has been evaluated
both in laboratory and in clinical tests.
Measurement Range: The measurement range of the OneTouch® Vita™
System is 1.1–33.3 mmol/L (20 to 600 mg/dL).
System Accuracy: Diabetes experts have suggested that glucose meters
should agree within 0.8 mmol/L (15 mg/dL) of a laboratory method
when the glucose concentration is lower than 4.2 mmol/L (75 mg/dL),
If you continue to get unexpected
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Haematocrit levels
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