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1.1. Intended use
1. Intended use、Model、Applicable strip、Test Principle
The meter is used with test strip to quantitatively measure
glucose (sugar) in fresh capillary whole blood samples drawn
from the fingertip. The System may not be used for neonates.
The System is intended for at-home use outside the body
(self-testing) and for use by healthcare professionals in clinical
settings in order to assist in the management of diabetes. This
System is not for use in diagnosis or screening of diabetes
mellitus.
1.2 Model
真睿TRUE METRIX GO
1.3 Applicable test strip
TRUE METRIX blood glucose test strip
1.4 Test Principle
The Test Strip is a plastic strip containing chemicals and
electrodes. When inserted into meters, glucose is measured
using amperometric technology employing a glucose
dehydrogenase-FAD reaction. When whole blood or control
solution is drawn into the Sample Tip of the test strip, glucose
in the sample reacts with the chemicals and produces an
electrical current. The meter measures the current and
calculates the amount of glucose. The result is displayed as a
plasma value.