Overview
The iHealth Align Gluco-Monitoring System (BGL) and iHealth Wireless Smart Gluco-Monitoring System (BGS) are designed for self-testing of glucose levels in fresh capillary whole blood samples.
Components
Both systems consist of a glucose meter, blood glucose test strips (EGS-2003), and a mobile application (iHealth Gluco-Smart App).
Intended Use
The systems are intended for use by people with diabetes at home to monitor the effectiveness of diabetes control. They should not be used for diagnosis or screening of diabetes, or for neonatal use.
Special Conditions
Users should not share the device, and it is not intended for use in healthcare or assisted-living settings. Alternative site testing should be done only during steady-state times.
Manual:
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