Safety Statement; Intended Use; Important User Information - Dexcom G5 Mobile User Manual

Chapter 1

Safety Statement

1.1 Intended Use

The purpose of Dexcom Share Secondary Displays is to notify another person, the
Follower, of the patient's Dexcom Continuous Glucose Monitoring (CGM) System
sensor glucose information.
The Secondary Display is intended for providing secondary notification of a
continuous glucose monitoring system and does not replace real time continuous
glucose monitoring (Dexcom G5 Mobile CGM System) or standard home blood
glucose meter. The Dexcom Share Secondary Displays is not intended to modify or
analyze data received from the continuous glucose monitor system. Nor is it intended
to instruct, or to transmit information to the continuous glucose monitor system.
The Dexcom Share Secondary Displays is not intended to serve as a replacement for
a primary display device for a continuous glucose monitoring system. The Dexcom
Share Secondary Displays is not intended to receive information directly from the
sensor or transmitter of a continuous glucose monitoring system.

1.2 Important User Information

Please review the indications, contraindications, warnings, precautions, cautions
and other important information in the Dexcom G5 Mobile CGM System User Guide.
Dexcom Share is a feature of the Dexcom G5 Mobile CGM System.
Contraindications
Do not bring the smart device (e.g., mobile phone, tablet computer) into a room
containing medical equipment such as Magnetic Resonance Imaging (MRI),
Computed Tomography (CT), or diathermy.
These smart devices have not been tested with this equipment. Exposure to these
types of equipment could heat and damage the smart devices so that they are unable
to send or receive glucose information.
Warnings
Treatment decisions should not be made based on the secondary display. The user
should follow instructions on the continuous glucose monitoring system.
This device is not intended to replace self-monitoring practices advised by a
physician. Dexcom Share does not work alone. Dexcom Share does not replace
the Dexcom G5 Mobile CGM System and requires Share to be turned "On" to
communicate glucose information to the Follower.
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Dexcom Share Follow User Manual