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vertex
diagnostics
9
GETTING STARTED
Intended Use
The system is intended for use outside the body (in vitro
diagnostic use). It should be used only for testing glucose
(sugar) and only with fresh capillary whole blood samples
(from the finger, the palm, the forearm, the upper arm, the
calf and the thigh). The system is intended for use in the
home and in clinical settings. It should not be used for the
diagnosis of diabetes or for the testing of newborns.
AST in this system can be used only during steady-state
blood glucose conditions described in the section of “About
AST”.
This system contains a speaking functionality which pro-
vides step by step instructions to aid visually impaired per-
sons.
Principle of Measurement
The test 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 and displays the
corresponding blood glucose level. The strength of the cur-
rent produced by the reaction depends on the amount of
glucose in the blood sample.
