Dexcom G5 mobile User Manual page 20

and contraindications are and what to do to keep you safe and the system in proper
working order.
Safety Statements are broken down into two major categories. First, general CGM system
Warnings—reviews warnings and precautions you take with most CGM systems—and
second, Hardware/Software Warnings and Precautions list warnings and precautions specific
to the Dexcom G5 Mobile CGM System components.
Indications and Contraindications
Indications
What are the Dexcom G5 Mobile CGM System indications? Well, in technical terms, the
indications are:
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System is a glucose
monitoring system indicated for detecting trends and tracking patterns in persons (age 2
years and older) with diabetes. The system is intended for single patient use and requires
a prescription.
The Dexcom G5 Mobile CGM System is indicated for use as an adjunctive device
to complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G5 Mobile CGM System aids in the detection of episodes of hyperglycemia
and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may
minimize these excursions. Interpretation of the Dexcom G5 Mobile CGM System results
should be based on the trends and patterns seen with several sequential readings over time.
In Layman's Terms
But what does that mean? Indications are the who, what, and why of the Dexcom G5 Mobile
CGM System.
Who
The Dexcom G5 Mobile CGM System is a single patient use device (meaning you can't share
the components with others) for people 2 years or older with diabetes.
What
The Dexcom G5 Mobile CGM System is a prescription-only glucose monitoring device.
Dexcom G5 Mobile CGM System tracks your glucose patterns and detects trends. Working
with your home blood glucose (BG) meter, the system is meant to complement, not replace,
your BG meter.
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
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