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PRECAUTIONS
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Intended Use
For Self-testing: GlucoDr Plus Blood Glucose Monitoring System is for quantitative blood glucose testing
in fresh capillary whole blood drawn from the fingertips, palm, arm, thigh, and calf. The GlucoDr Plus Blood
Glucose Monitoring System is for testing outside the body (in vitro diagnostic use). The GlucoDr Plus Blood
Glucose Monitoring System is intended for use by diabetic lay users for self testing to improve management
of their blood glucose level. The GlucoDr Plus Blood Glucose Monitoring System should not be used for the
diagnosis of or screening of diabetes mellitus, or for neonatal use.
For professional use: GlucoDr Plus Blood Glucose Monitoring System is for quantitative blood glucose
testing in venous, arterial whole blood and fresh capillary whole blood drawn from the fingertips, palm,
arm, thigh, and calf. The GlucoDr Plus Blood Glucose Monitoring System is for testing outside the body (in
vitro diagnostic use). The GlucoDr Plus Blood Glucose Monitoring System is intended for use by healthcare
professionals to improve management of patient's blood glucose level. The GlucoDr Plus Blood Glucose
Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus, or for
neonatal use.
Test Principle
The blood sample is drawn into the test strip's reaction chamber through capillary action. Glucose in the
sample reacts with glucose dehydrogenase and mediator in the test strip. This reaction creates electrical
currents. The electrical currents produced are proportional to the glucose concentration in the blood
and converted to the equivalent glucose concentration values calculated based on the algorithm
programmed in GlucoDr Plus Meter.
Precautions for Use
- The GlucoDr Plus Meter is designed for use with GlucoDr Plus Test Strips
(manufactured by All Medicus Co., Ltd.) only.
- The GlucoDr Plus Blood Glucose Monitoring System is calibrated to produce values equivalent to results
on plasma specimens obtained from a laboratory analyzer (YSI 2300 STAT Plus).
- The GlucoDr Plus Blood Glucose Monitoring System should not be used for the diagnosis of diabetes.
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