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9
Intended Use
This system is intended for use outside the body (
in vitro
diagnostic use) by people with diabetes at home and by health
care professionals in clinical settings as an aid to monitoring the
effectiveness of diabetes control. It is intended to be used for the
quantitative measurement of glucose (sugar) in fresh whole blood
samples (from the finger, palm, forearm and upper arm).
It should not be used for the diagnosis or screening of diabetes, or
testing on newborns.
Professionals may test with capillary and venous blood sample; home
use is limited to capillary whole blood testing.
PLUS Talking
“
speaks
”
aloud with step by step instructions to guide
you through the process of blood glucose testing.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip.
The meter measures the current, calculates the blood glucose level,
and displays the result. The strength of the current produced by the
reaction depends on the amount of glucose in the blood sample.
Summary of Contents for PLUS Talking
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