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

2.4 Overview of Safety Statements

This section provides a review of Safety Statements containing the same elements described
above (type of Safety Statement, an action, a statement of potential harm, and consequences)
but listed in a narrative, not boxed, format. Here you'll 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 (Dexcom G5 Mobile) is a
glucose monitoring system indicated for the management of diabetes in persons age 2 years
and older. The Dexcom G5 Mobile is designed to replace fingerstick blood glucose testing for
diabetes treatment decisions.
Interpretation of the Dexcom G5 Mobile results should be based on the glucose trends and
several sequential readings over time. The Dexcom G5 Mobile also aids in the detection of
episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy
adjustments.
The Dexcom G5 Mobile is intended for single patient use and requires a prescription.
Important User Information
Failure to use the Dexcom G5 Mobile and its components according to the instructions for
use and all indications, contraindications, warnings, precautions, and cautions may result
in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood
glucose) occurrence and/or making a treatment decision that may result in injury. If your
glucose alerts and readings from your Dexcom G5 Mobile do not match your symptoms or
expectations, use a fingerstick blood glucose value from your blood glucose meter to make
diabetes treatment decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G5 Mobile. Indications,
contraindications, warnings, precautions, cautions, and other important user information
can be found in the product instructions that are included with, or accompany, the Dexcom
G5 Mobile. Discuss with your healthcare professional how you should use the information
displayed on the Dexcom G5 Mobile to help manage your diabetes. The product instructions
contain important information on troubleshooting the Dexcom G5 Mobile and on the
performance characteristics of the system.
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
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