Before Starting
7
Indications for Use
The 2in1. SMART Blood Glucose Monitoring System is intended
for the quantitative measurement of glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertips,
forearm, upper arm, hand, thigh or calf as an aid in monitoring
the effectiveness of diabetes management at home by patients
with diabetes. The 2in1. SMART Blood Glucose Monitoring
System is intended to be used by a single patient and should
not be shared with any other person. 2in1. SMART System is for
self-testing outside the body (diagnostic use) by people with
diabetes at home as an aid to monitoring for the effective of
diabetes control. The 2in1. SMART Blood Glucose Monitoring
System should not be used for the diagnosis or screening of
diabetes without the guidance of a healthcare professional or
for testing newborns. Alternative site testing should be done
only during steady-state (when glucose level is not changing
rapidly).
The 2in1. SMART Blood Glucose Monitoring System is intended
to be used by the Apple iPhone 3GS, iPhone 4, iPhone 4S, iPod
touch 4th generation, iPad and iPad 2.
Test Principle
The 2in1. SMART System is based on detection of a small
electrical current variation, which produced by the reaction of
glucose in the blood sample with the reagents on the strip. This
current is varied by the amount of glucose in the blood sample.
The current variation is calculated to glucose concentration of
sample.
