Indications For Use; Chapter 2: Safety Statements - Dexcom G6 Pro User Manual

Chapter 2: Safety Statements

2.1 Indications for Use

The Dexcom G6 Pro Continuous Glucose Monitoring System (Dexcom
G6 Pro System) is a real time continuous glucose monitoring device
indicated for the management of diabetes in persons age 2 years
and older in a home environment while under the supervision of
a healthcare professional. The Dexcom G6 Pro System is intended
to replace fingerstick blood glucose testing for diabetes treatment
decisions. Interpretation of the real-time Dexcom G6 Pro System
results should be based on the glucose trends and several sequential
readings over time.
The Dexcom G6 Pro System may also be used as a retrospective
glucose recording device indicated for assessing glycemic variability in
persons age 2 years and older in a home environment while under the
supervision of a healthcare professional. Retrospective interpretation
of data recorded by the Dexcom G6 Pro System should be conducted
solely by a healthcare professional.
The Dexcom G6 Pro System aids in detecting glucose excursions
facilitating care plan adjustments. The Dexcom G6 Pro System is also
intended to interface with digitally connected devices. The Dexcom
G6 Pro System can be used alone or in conjunction with these digitally
connected medical devices for managing diabetes or assessing
glycemic variability.
Warning
Failure to use the G6 Pro and its components according to the
instructions for use and all indications, contraindications, warnings,
precautions, and cautions may result in missing a severe hypoglycemia
(low blood glucose) or hyperglycemia (high blood glucose) occurrence
and/or making a treatment decision that may result in injury.
G6 Pro User Guide
Chapter 2: Safety Statements
9