Indications For Use And Safety Statement; Introduction; Important User Information - Dexcom G5 mobile User Manual

Chapter 2
Getting Started:

Indications for Use and Safety Statement

2.1 Introduction

We want the Dexcom G5 Mobile CGM System to be a valuable tool in your diabetes
management. Like any system, there are steps to take to get the most out of it. As
excited as you are about getting started, did you know if you just took a medication
with paracetamol/acetaminophen maybe you should wait? Did you know taking
paracetamol/acetaminophen is contraindicated?
In this chapter, you will learn about some key areas that might prevent you from having the
best CGM experience, or, if you are not careful, might even harm you or the system. You will
even learn what a contraindication is!

2.2 Important User Information

Each part of your system has instructions including indications, contraindications, warnings,
precautions, and other important user information. Please review the instructions for each
part of the system in this user guide before using any of the Dexcom G5 Mobile CGM System.
This chapter is important to read. It helps you use the Dexcom G5 Mobile CGM System safely
and covers:
• What is a Safety Statement?
○ Telling the difference between an indication and a contraindication
○ Explaining why warnings are so important
○ Defining precautions
• Safety Statement Overview
Let us start with definitions, and then review the Safety Statements broken down into the
system's components.
Safety Statement
A Safety Statement is a brief statement of the Dexcom G5 Mobile CGM System's indications,
relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety
Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement 9