User Manual

Page 4 of 27
SETUP REQUIREMENTS
The iHealth Wireless Smart Gluco‐Monitoring System (BG5) is designed to be used with the following
iPod Touch ,iPad, iPhone models:
iPod Touch 4
iPod Touch 5
iPhone 4S
iPhone 4
iPhone 5
iPad2
iPad3
iPad4
iPad Mini
The iOS version of these devices should be V5.0 or higher.
INTENDED USE
The iHealth Wireless Smart Gluco‐Monitoring System (BG5) should be used for:
• Quantitative measurement of glucose in fresh capillary whole blood samples drawn from
the fingertip, palm, forearm, upper arm, calf or thigh
• Single person measurement only and should not be shared
• Self‐testing outside the body (in vitro diagnostic use) by people with diabetes at home as
an aid to monitor the effectiveness of diabetes control
The iHealth Wireless Smart Gluco‐Monitoring System (BG5) should not be used for the diagnosis of
or screening for diabetes, or for neonatal use.
Alternate Site Testing (AST) should be done only during steady – state times when glucose levels are
not changing rapidly.
Control Solutions are intended for use with the Wireless Smart Gluco‐Monitoring System (BG5).
Control Solutions can be used to check that the glucose meter and test strips are working properly
and that the measurement is accurate. These Control Solutions contain a known amount of glucose,