Overview Of Safety Statements - Dexcom G5 mobile User Manual

Within chapters, each color coded Safety Statement is in a box, broken down into
four sections:
1. Type of statement
a. Bold and color-coded
▪ WARNING-Red
▪ PRECAUTION-Blue
▪ INDICATION-Green
▪ CONTRAINDICATION-Purple
2. Do's/Don'ts
a. An action you should or should not take
b. Italicized
3. Why
a. A statement of the potential harm
4. Consequences
a. What could happen if you don't follow the instructions
The following is an example of a chapter's Safety Statement and how to read it.
WARNING
Do: Calibrate at least once every 12 hours.
Why: Calibrating less often than every 12 hours might cause inaccurate sensor
glucose readings.
Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) Alarm
or Alerts.
Since this is a WARNING, you know it covers important safety information. Italics are the
Do/Don't steps to follow: Calibrate at least once every 12 hours . Below the italics is a
statement explaining Why you need to follow the steps: Calibrating less often than every
12 hours might cause inaccurate sensor glucose readings. And finally what happens, or the
Consequences, if you don't: missing a severe low (hypoglycemia) or high (hyperglycemia)
glucose event.

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) listed in a narrative, not boxed, format. Here you'll learn what indications
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement 17