User's Manual

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Important Information:Read this First!
To receive safe and optimum system benefits, please read the
entire manual contents before using the system. Please note the
following instructions:
• Do not use the system for the diagnosis of diabetes without the
guidance of a healthcare professional or for testing newborns.
• Use only fresh capillary whole blood samples for testing.
• Alternative site and fingertip test results may differ significantly
due to rapid change in the glucose level post meal, insulin
injection or exercise.
The following chart explains the symbols you’ll find in the CareSens
LINK User Manual, product packaging, and product inserts.
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Important Information
• The CareSens LINK blood glucose monitoring system is intended for
self-testing outside the body (in vitro diagnostic use).
• The glucose in the blood sample mixes with special chemicals on the
test strip where to produce a small electrical current. The CareSens
LINK meter detects this electrical current and measures the amount
of glucose in the blood sample.
• The CareSens LINK blood glucose meter is designed to minimize
code related errors in monitoring by using the no-coding function.
• The CareSens LINK blood glucose meter should be used only with
the CareSens LINK strip.
• The average hematocrit range is between 30 and 50%. However,
people with severe anemia, pregnant women and newborns may
have higher hematocrit and this can affect the test results.
• Very high (60% or more) or very low (20% or less) hematocrit can
lead to incorrect test results.
• A glucose value of less than 70 mg/dL (3.9 mmol/L) may indicate
hypoglycemia and a value of more than 240 mg/dL (13.3 mmol/L)
may indicate hyperglycemia.
If you need assistance, please contact your authorized i-SENS sales
representative or visit www.i-sens.com for more information.
For in
vitro diagnostic use
This product fulfills the requirements for Directive 98/79/
EC on in vitro diagnostic medical devices.
Cautions for safety and optimum product use
Consult instruction for use
Manufacturer
Authorized representative
Do not reuse.
Batch code
Do not discard this product with other household-type
waste
Serial number
0123
Use by
Temperature limitations