Dexcom G5 - Safety Statements

Dexcom G5 Mobile System User Guide
16Indications for Use and Safety Statement
Safety Statement
A Safety Statement is a brief statement of the system’s indications, contraindications (when
to avoid using it), relevant warnings, and precautions. The Safety Statements are meant to
keep you and the system safe while using the system:
1) Indications
How, for what purposes, and under what circumstances you should use the system.
Indications let you know who should use the system and when. Indications are the who,
what, and why of the system.
2) Contraindications
Contraindications let you know when not to use the system. If used during these situations,
you may hurt yourself or the system, 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 system, their consequences, and how to avoid danger.
4) Precaution
Special steps you need to take while using the system preventing minor or moderate injury
to either you or the system.
2.3 Safety Statements
This user guide presents Safety Statements two ways:
1. In this chapter’s Overview of Safety Statements
– Lists all Safety Statements
– Includes a section reviewing how the statements are formatted
2. Within each chapter
– Lists only those statements applicable to that specific chapter
Chapter’s Safety Statements
Each chapter will list all applicable indications, contraindications, precautions, and warnings.
Some chapters will have multiple Safety Statements; others have none. Safety Statements
are located toward the beginning so you can keep them in mind as you learn about that
chapter’s topic. The same statement may be repeated throughout the user guide. It’s
important to recognize which factors could prevent the system from working correctly, or
even harm you.