Overview Of Safety Statements; Indications For Use - Dexcom G5 mobile User Manual

Statements are meant to keep you and the system safe while using the Dexcom G5 Mobile
CGM System:
1) Indications
How, for what purposes, and under what circumstances you should use the Dexcom G5
Mobile CGM System. Indications let you know who should use the Dexcom G5 Mobile
CGM System and when. Indications are the who, what, and why of the Dexcom G5 Mobile
CGM System
2) Contraindications
Contraindications let you know when not to use the Dexcom G5 Mobile CGM System. If
used during these situations, you may hurt yourself or the system, and the risk of use
clearly outweighs the benefit.
3) Warning
Important hazard information: Describes serious or life threatening circumstances to stay
away from while using the Dexcom G5 Mobile CGM System, their consequences, and how
to avoid danger.
4) Precaution
Special steps you need to take while using the Dexcom G5 Mobile CGM System, preventing
minor or moderate injury to either you or the system.

2.3 Overview of Safety Statements

This section provides a review of all of the Safety Statements outlining the type of Safety
Statement, an action, a statement of potential harm, and consequences. Here you will learn
what indications and contraindications are and what to do to keep you safe and the system in
proper working order.

Indications for Use

The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring
system indicated for the management of diabetes in persons age 2 years and older. The
Dexcom G5 Mobile CGM System is designed to replace fingerstick blood glucose testing for
diabetes treatment decisions.
Interpretation of the Dexcom G5 Mobile CGM System results should be based on the glucose
trends and several sequential readings over time. The Dexcom G5 Mobile CGM System also
aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute
and long-term therapy adjustments.
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
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