Sinocare iCan i3 - Intended Purpose; User Safety

CGM User Guide
Section 1: System Overview 10
1.2 Intended Purpose
The Continuous Glucose Monitoring System is a real time, continuous
glucose monitoring device indicated for the management of diabetes
for adult people (age 18 and older). It is intended to replace ngerstick
blood glucose testing for diabetes treatment decisions.
The CGM also detects trends and tracks patterns, and aids in the
detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments. Interpretation of the
System results should be based on the glucose trends and several
sequential readings over time.
The CGM can be used in conjunction with smart devices with
corresponding application where the user manually controls actions for
therapy decisions.
1.3 User Safety
This section includes important safety information such as indications,
contraindications, safety warnings, potential adverse reactions, and
how to protect the system from radiation exposure damage.
1.3.1 Contraindications
• Do not use the iCan i3 CGM if you are pregnant, on dialysis,
implanted with a pacemakers or critically ill. It is not known how
di󰀨erent conditions or medications common to these populations
may a󰀨ect performance of the system. iCan i3 CGM results may be
inaccurate in these populations.