Limitations
Do not use for diagnosis of or screening for diabetes mellitus.
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The system should not be used to test neonates.
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Do not test samples other than fresh capillary whole blood
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obtained from the fingertip.
Do not use the system at altitudes above 10,000 feet
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(3,000 meters).
Do not use when hematocrit is outside the acceptable
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hematocrit range for testing of 20 % to 55 %.
Severe dehydration (excessive water loss) may cause
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inaccurate results. If you believe you are suffering from severe
dehydration, consult your healthcare professional immediately.
For in vitro diagnostic use only.
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Critically ill patients should not be tested with this device.
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Inaccurate results may occur in severely hypotensive
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individuals or patients in shock.
Incorrect result may occur in individuals who are dehydrated.
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The meter and lancing device are for single patient use. Do not
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share these items with anyone, including other family members!
Do not use on multiple patients!
Do not reuse; each test strip is for single use only.
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Do not use when humidity is higher than 90 % and lower than
•
10 %, as extremes in humidity may affect results.
For single patient use only.
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For over-the-counter use.
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8 www.i-sens.com