
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 eectiveness
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 eective
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