Dexcom 9588 User Manual

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Page 1

Dexcom G5x Mobile System User Guide

Table of Contents

®"

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Dexcom G5x System User Guide

Glossary

Table of Contents

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1.1"Introduction"...................................................................................."14"

1.2"Self-Paced"Resources"......................................................................"15"

1.3"Your"Dexcom"Account"....................................................................."18"

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2.1"Introduction"...................................................................................."20"

2.2"Important"User"Information"............................................................"20"

2.3"Safety"Statements"..........................................................................."21"

2.4"Overview"of"Safety"Statements"......................................................."23"

2.5"General"CGM"System"Warnings"......................................................"25"

2.6"Calibration"Warning"and"Precautions"............................................."27"

2.7"System/Hardware/Software"Warnings"and"Precautions"................"28"

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3.1"Risks"................................................................................................"37"

3.2"Benefits"..........................................................................................."39"

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4.1"System"Description"........................................................................."42"

4.2"Safety"Statement"............................................................................."42"

4.3"The"G5x"..........................................................................................."44"

4.4"What’s"New"to"the"G5x?"................................................................."46"

4.5"System"Information"........................................................................."47"

4.6"System"Components"......................................................................."47"

4.7"Smart"Device"Overview"..................................................................."57"

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5.1"Introduction"...................................................................................."59"

5.2"Safety"Statement"............................................................................."59"

5.3"Why"Different"Monitoring"Methods?"............................................."60"

5.4"App".................................................................................................."61"

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Glossary

5.5"Dexcom"Receiver"............................................................................."74"

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6.1"Overview"........................................................................................."81"

6.2"Safety"Statements"..........................................................................."82"

6.3"Prepping"for"Sensor"Insertion"........................................................."85"

6.4"Choosing"Your"Insertion"Site"..........................................................."88"

6.5"Inserting"Your"Sensor"......................................................................"90"

6.6"Attaching"Your"Transmitter"............................................................."94"

6.7"Loose"Transmitter"Holder"..............................................................."97"

6.8"Starting"Your"Sensor"Session"..........................................................."97"

6.9"Receiver"Bluetooth"Tips"................................................................."102"

6.10"Sensor"Session"Warmup".............................................................."106"

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7.1"Introduction".................................................................................."108"

7.2"Safety"Statements"........................................................................."109"

7.3"Calibration"Overview"....................................................................."111"

7.4"When"to"Calibrate"........................................................................."113"

7.5"Calibration"Notifications"..............................................................."114"

7.6"Preparing"for"Calibration"..............................................................."118"

7.7"Ready?"Set?"Calibrate!".................................................................."119"

7.8"Calibration"Errors".........................................................................."126"

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8.1"Introduction".................................................................................."129"

8.2"Safety"Statements"........................................................................."129"

8.3"Ending"Your"Sensor"Session".........................................................."130"

8.4"Remove"Sensor,"Transmitter,"and"Transmitter"Holder"................."145"

8.5"End"of"Transmitter"Battery"............................................................"148"

8.6"Pair"New"Transmitter"...................................................................."151"

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9.1"Introduction"to"Home"Screens"......................................................"161"

9.2"Safety"Statements"........................................................................."161"

9.3"Overview"of"Home"Screen"............................................................."163"

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Apple"Today"View"Widget"..................................................................."171"

9.4"Rate"of"Change"Arrows"................................................................."181"

9.5"Error"Messages".............................................................................."182"

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10.1"Introduction"................................................................................"189"

10.2"What"Is"an"Event?"......................................................................."189"

10.3"Entering"Events"..........................................................................."198"

10.4"Viewing"Events"............................................................................"207"

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11.1"Introduction"................................................................................"209"

11.2"Safety"Statements"......................................................................."210"

11.3"Alarm"and"Alerts"........................................................................."213"

11.4"Alarm"and"Alerts"Screens"............................................................"215"

11.5"App:"Alarm/Alert"Recommended"Settings".................................."221"

11.6"Receiver:"Default"Beeps"and"Vibrations"......................................"222"

11.7"Clearing"Alarm/Alerts".................................................................."226"

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12.1"Introduction"................................................................................"229"

12.2"Safety"Statement"........................................................................."229"

12.3"Changing"app"Alarm"and"Alerts"..................................................."230"

12.4"Changing"Receiver"Alarm"and"Alerts"..........................................."243"

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13.1"Introduction"................................................................................"253"

13.2"Receiver"Warranty"Information".................................................."253"

13.3"Transmitter"Warranty"Information"............................................."256"

13.4"Dexcom’s"Obligations"Under"the"Limited"Warranty"..................."257"

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14.1"Introduction"................................................................................"260"

14.2"Basic"Maintenance"......................................................................"260"

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14.3"Storage"........................................................................................"268"

14.4"Checking"app"and"Receiver"Information"....................................."269"

14.5"System"Disposal".........................................................................."270"

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15.1"Introduction"................................................................................"272"

15.2"Safety"Statement"........................................................................."272"

15.3"Going"Through"Security"..............................................................."273"

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16.1"Dexcom"Technical"Support"Team"................................................"276"

16.2"Dexcom"Patient"Care"Team"........................................................."277"

16.3"Dexcom"Sales"Support"Team"......................................................."278"

16.4"Corporate"...................................................................................."279"

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17.1"Device"Performance"Characteristics"..........................................."280"

17.2"Product"Specifications"................................................................."325"

17.3"FCC"Requirements"......................................................................."334"

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18.1"Introduction"................................................................................"336"

18.2"Safety"Statements"......................................................................."336"

18.3"Troubleshooting".........................................................................."337"

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20.1"Learning"About"Dexcom"Share"...................................................."357"

20.2"Dexcom"Share"Overview"............................................................."363"

20.3"Risks"and"Benefits"......................................................................."366"

20.4"Safety"Statement"........................................................................."367"

20.5"Setting"Up"Dexcom"Share"............................................................"371"

20.6"Using"Dexcom"Share"..................................................................."380"

20.7"Dexcom"Follow"App"...................................................................."386"

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Dexcom G5x System User Guide

Glossary

20.8"Troubleshooting".........................................................................."389"

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Dexcom G5x System User Guide

Glossary

GETTING STARTED

• Glossary

• Getting Started

• Indications for Use and Safety Statement

• Risks and Benefits

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Dexcom G5x System User Guide

Glossary

A1C

Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you’re managing your diabetes. The A1C test result reflects your average blood sugar level for the past two to three months.

Accessory Device

Hardware, connected to your smart device by

Bluetooth

, you use to get easy access to some of

its features. For example,

Bluetooth

headset,

Apple watch, or smart watch.

Also called wearables.

Alternative Site Testing

Using a blood sample from non-fingertip (alternative) sites such as the palm, forearm, or upper arm for meter readings.

Do not use alternative site testing to calibrate the Dexcom G5

x CGM System (G5x), only use

fingerstick measurement.

App

A self-contained program or piece of software designed to fulfill a particular purpose; an application, especially as downloaded by a user to a smart or mobile device.

The Dexcom G5® Mobile app (app) was developed as a display for continuous glucose monitoring.

Apple Watch®

Accessory device for iPhone®.

Blood Glucose (BG)

An abbreviation of blood glucose. Blood glucose

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Dexcom G5x System User Guide

Glossary

(BG) value is the amount of glucose in the blood measured by a BG meter.

Blood Glucose Meter/Meter/BG Meter

A medical device used to measure how much glucose is in the blood.

Calibration

A comparison or measurement between your meter’s fingerstick BG values and the sensor’s interstitial fluid glucose readings. Although blood and interstitial fluids are similar, glucose concentration is higher in your blood. Calibration allows alignment between your sensor and meter readings.

When you calibrate, you take a fingerstick measurement from your meter then enter the value into your receiver or smart device. The system uses that value to verify that the sensor glucose reading is on track.

Continuous Glucose Monitoring (CGM)

A system that uses a sensor inserted under the skin to check glucose levels in interstitial fluid. A transmitter sends sensor glucose readings to a display device.

Users must confirm glucose levels with a BG meter before making a change in treatment.

Contraindication

A safety statement outlining specific situations where the system should not be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit.

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Dexcom G5x System User Guide

Glossary

Hyperglycemia

High BG. Same as “high” or high blood sugar. Hyperglycemia is characterized by an excess of glucose in the bloodstream.

It’s important to treat hyperglycemia. If left untreated, hyperglycemia can lead to serious complications.

The default High Glucose Alert in the G5x is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemic setting for you.

Hypoglycemia

Low BG. Same as “low” or low blood sugar. Hypoglycemia is characterized by a low level of glucose in the bloodstream.

It’s important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications.

The default Low Glucose Alert in the G5x is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you.

Indications

A condition making a particular treatment or procedure advisable. How, for what purposes, and under what circumstances you should use the G5x. Indications let you know who should use the G5x and when.

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Dexcom G5x System User Guide

Glossary

The International Electrotechnical Commission (IEC) is a nonprofit, non-governmental, international organization created to produce safety standards for electronics. One of the safety standards it designed is the Ingress Protection (IP) Marking, which classifies and rates how protected an electronic device is against dust, water, accidental contact, etc.

IP ratings are numerical, with the number based on the conditions the electronic device comes across.

An IP22 rating lets you know your electronic device won’t allow you to stick your fingers in it and won’t get damaged or be unsafe during specific testing with water dripping down.

An IP28 rating tells you your electronic device won’t let you stick your fingers in it and is safe for long-term immersion in liquid up to a specified pressure.

Jailbroken

The removal of limitations and security measures set by the manufacturer on a smart device. The removal poses a security risk, and data may become vulnerable.

Do not use, install, or run the Dexcom G5 Mobile app on a jailbroken smart device. The app may not work correctly on a jailbroken smart device.

Landscape

When your smart device is oriented sideways.

mg/dL

Milligrams per deciliter. The standard unit of measure for glucose readings in the United States.

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Dexcom G5x System User Guide

Glossary

Portrait

When your smart device is oriented vertically.

Precaution

A safety statement regarding any special care to be exercised by you or your healthcare professional for the safe and effective use of the G5x.

Radio-frequency (RF) transmission used to send glucose information from the transmitter to the receiver or smart device. Also used to send calibration data from the receiver or smart device to the transmitter.

Safety Statement

A statement of the intended uses of G5x and relevant warnings, precautions, and contraindications.

Sensor Session

The seven-day monitoring period after inserting a new sensor.

During this time frame, your glucose is being monitored and reported every five minutes, with data being sent to your display device(s).

Smart/Mobile Device

Electronic device that can be wirelessly connected to networks over Wi-Fi,

Bluetooth

, or a

cellular data connection (3G, 4G, etc.

Examples are smartphones, tablets, and smart watches.

Today View

Swipe down to access information and notifications on your iPhone, iPad®, and iPod®.

Warning

A safety statement letting you know the following feature has important hazard information.

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Dexcom G5x System User Guide

Glossary

Describes serious and life-threatening circumstances of using the G5x, their consequences, and how to avoid the hazard.

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

Chapter 1

Getting Started:

Beginning Your Dexcom G5®x Continuous Glucose Monitoring System (G5x) Journey

1.1 Introduction

Welcome to the G5x family!

We are excited you chose us to partner with you in your journey to manage your diabetes. As a continuous glucose monitoring (CGM) device, the G5x allows you to break free from constant fingersticks. But how do you use the G5x? What are its features? Do you need to avoid anything?

Where do you even begin?

This chapter is the first step to answering these and many other questions.

After this chapter, you will be able to:

•

Describe different training resources

•

Locate tutorials about using the G5x in your diabetes management

•

Find G5x’s step-by-step instructions

•

Recall how to use the user guide

•

Explain why you need a Dexcom® account

We have numerous resources available to help you get the most out of your G5x. Between our self-paced training resources and our friendly and knowledgeable Dexcom customer support teams, help is always available.

First Things First - Learning How to Learn

Knowing about the G5x is your first step in creating a successful CGM experience. Before using it, learn about it.

You have numerous self-paced resources, helping you get to know the G5x:

1. Tutorials

2. Getting Started Guide

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

3. User Guide

No matter which resource(s) you select, make sure you review them prior to using your new CGM system.

1.2 Self-Paced Resources

Tutorials

Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in your daily diabetes management. The following is a list of tutorials and how to access them.

Online Tutorials

First Steps With Your Dexcom CGM

Designed for those who have never used a Dexcom CGM. This tutorial covers what to expect in your first week and includes links to step-by-step videos on how to insert your sensor, calibrations, ending a sensor session, etc.

Next Steps With Your Dexcom CGM

Just finished First Steps or already familiar with how a CGM can benefit you? This tutorial covers looking at trends and introduces some advanced features including our reporting tools.

Accessing Online Tutorials:

From dexcom.com homepage, click

Support

Once you have viewed the online tutorials, you should be pretty comfortable with what CGMs do and how the G5x can help you.

Offline Tutorials

You don’t need to be tied to the Internet to view our instructional tutorials, they’re also available offline.

Accessing Offline Tutorials:

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

USB Card in the receiver package.

Guides

Getting Started Guide (GSG)

The G5x GSG complements the tutorials by providing the same step-by-step instructions in a booklet form or within the app.

One of the great things about the GSG is you can use it in conjunction with the videos, taking notes as you go!

Accessing the GSG:

Booklet in the receiver package.

Both the tutorial and the GSG give you a brief look at the G5x. But what if you want more detailed information?

User Guide

Your G5x reference book!

This user guide gives you the most extensive overview of the system, detailing features, important safety information, and so much more.

To download an eBook of the user guide or request a printed user guide, visit dexcom.com/guides.

The G5x user guide is grouped into six separate parts:

Part 1:

Getting Started

•

Glossary

•

Getting Started

Learning how to learn about the G5x

Registering at dexcom.com

•

Indications for Use and Safety Statement

•

Risks and Benefits

Part 2:

Let’s G5x! The Basics

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

•

Introduction to the G5x

•

Initial Setup

•

Starting a Sensor Session: Inserting the Sensor and Attaching Transmitter

•

Calibration

•

Ending a Sensor Session and Transmitter Session

Part 3:

Next Steps - Getting the Most out of Your G5x

Once you are up and running, how you can maximize the G5x features:

•

Reading Trend Graph Screens and Recognizing Trends

•

Events

•

Alarm and Alerts

•

Sounds for Alarm, Alerts, and System Messages

Part 4:

Everything Else G5x

•

Warranty

•

G5x Maintenance

•

Travel Tips

•

Customer Service Contacts

•

Technical Information

•

Troubleshooting

•

Symbols on Package Labels

At the end of your G5x user guide, Part 5, is the user guide for Dexcom

™.

Part 5:

Sharing Is Caring

•

Dexcom

What Is Dexcom

Setting Up Dexcom

How to Use Dexcom

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

Your Followers

Troubleshooting

Part 6

•

Index for G5x System and Dexcom

How to Use Your User Guide

All chapters in the G5x user guide are laid out the same way:

The beginning of each chapter lists what you’ll be able to do after you have finished, after that, any applicable safety statements you need to know, followed by the chapter’s content. At the end, there’s a recap of what was covered and what’s in the next chapter.

1.3 Your Dexcom Account

You’ll need a username and password to set up the G5 Mobile app (app) and for reordering.

If you haven’t already done so, go to dexcom.com and set up your own account.

Or, if you prefer, the app walks you through creating your log-in credentials as part of your initial app setup.

Summary

Now You Can:

•

Describe different training resources

•

Locate tutorials about using the G5x

•

Find step-by-step instructions for the G5x

•

Recall how to use the user guide

•

Explain why you need a Dexcom® account

What’s Next?

Now you are familiar with how to use this user guide and where to go for help.

Throughout the user guide you’ll see color-coded boxes containing Safety Statements. The next chapter, Indications for Use and Safety Statement, lists all Safety Statements along with how to read and interpret them.

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Dexcom G5x System User Guide

Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey

Next you’ll learn about when and how to use the G5x safely.

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Dexcom G5x System User Guide

Chapter 2

Getting Started:

Indications for Use and Safety Statement

2.1 Introduction

We want the G5x 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 Tylenol®, maybe you should wait? Did you know taking Tylenol is contraindicated?

In this chapter, you’ll learn about some key areas that might prevent you from having the best CGM experience, or, if you’re not careful, might even harm you or the system. You’ll 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 the G5x.

This chapter is important to read. It helps you use the G5x safely and covers:

• What is a Safety Statement?

o Telling the difference between an indication and a

contraindication

o Explaining why warnings are so important

o Defining precautions

• How to read a chapter’s Safety Statement

• Overview of Safety Statements

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Dexcom G5x System User Guide

Let’s start with definitions, look at a Safety Statement example used throughout the User Guide, and then review the Safety Statements broken down into the system’s components.

Safety Statement

A Safety Statement is a brief statement of the G5x’s indications, relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety Statements are meant to keep you and the system safe while using the G5x:

1) Indications

How, for what purposes, and under what circumstances you should use the G5x. Indications let you know who should use the G5x and when. Indications are the who, what, and why of the G5x.

2) Contraindications

Contraindications let you know when

not

to use the G5x. 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 G5x, their consequences, and how to avoid danger.

4) Precaution

Special steps you need to take while using the G5x, preventing minor or moderate injury to either you or the system.

2.3 Safety Statements

This user guide presents Safety Statement two ways:

1. In this chapter’s Overview of Safety Statements

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o Lists all Safety Statements

o Includes a section reviewing how the statements are formatted

2. Within each chapter

o Lists only those statements applicable to that specific chapter

Chapter’s Safety Statements

Each chapter will list all applicable indications, contraindications, warnings, and precautions.

Some chapters will have multiple Safety Statements; others have none. Safety Statements are located toward the front 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.

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

Italicized

3. Why

a. A statement of the potential harm

4. Consequences

a. What could happen if you don’t follow the instructions

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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) 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.

Safety Statements are broken down into two major categories. First, general CGM system Warnings which review warnings and precautions you take with most CGM systems—and second, Hardware/Software Warnings and Precautions which list warnings and precautions specific to the G5x components.

Indications and Contraindications Indications

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What are the G5x indications? Well, in technical terms, the indications are:

The Dexcom G5x Continuous Glucose Monitoring (CGM) System (G5x) is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. The system is intended for single patient use and requires a prescription.

The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the system results should be based on the trends and patterns seen with several sequential readings over time.

In Layman’s Terms

But what does that mean? Indications are the who, what, and why of the G5x.

Who

The G5x is a single patient use device (meaning you can’t share the components with others) for people age 2 years and older with diabetes.

What

The G5x is a prescription-only glucose-monitoring device. G5x tracks your glucose patterns and detects trends. Working with your home blood glucose (BG) meter, the system is meant to complement, not replace, your BG meter.

Why

The CGM system’s trend and pattern information, its glucose Alarm/Alerts, combined with your meter’s actual BG value, can help you manage your diabetes.

By identifying low and high glucose level periods, the G5x allows you to take action when needed and create long-term management strategies with your healthcare professional. Using trend information to see your highs and lows helps you stay inside your target range.

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The G5x’s trend and pattern information is based on a series of sensor glucose readings taken over a period of time.

Work with your healthcare professional and create a game plan on how to best use your trend and pattern information in managing your diabetes.

Contraindications

Contraindications let you know when

not

to use the G5x; you may hurt yourself or damage the system. Remember, if used during certain situations, the risk of use may clearly outweigh any potential benefit. Within the chapters, contraindications are in purple boxes.

MRI/CT/Diathermy

Don’t wear the system (sensor, transmitter, and receiver) before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or highfrequency electrical heat (diathermy) treatment.

The system hasn’t been tested during MRI, CT scans, or with diathermy treatment. Magnetic fields and heat could damage the components, stopping sensor glucose readings or Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert notifications, you might miss a severe low or high glucose event.

Medications

Taking medications with acetaminophen (such as Tylenol or Excedrin® Extra Strength) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person.

2.5 General CGM System Warnings

Warnings

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Warnings outline important hazard information, describing any serious and/or life-threatening situations, their consequences, how to avoid danger while using the system and how to protect the G5x from harm.

Review Training Materials

Thoroughly review the training materials included with your system before using.

Incorrect use could lead you to misunderstand system information or might affect its performance and you might miss a severe low or high glucose event.

Treatment Decisions

The system does not replace your BG meter.

When making treatment decisions, such as the amount of insulin you need, only use your BG value. Don’t use the G5x sensor glucose readings because they can be different from your BG value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.

Don’t Ignore Low/High Symptoms

If your sensor glucose readings don’t match your symptoms, measure your BG with a fingerstick. You may miss a severe low or high glucose event.

Who Shouldn’t Use

The system was not evaluated for the following persons:

• Pregnant women

• Persons on dialysis

Do not use the Dexcom G5x System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.

The system’s accuracy hasn’t been tested in people falling into these groups and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event.

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2.6 Calibration Warning and Precautions

Calibration is the process of making sure your sensor continues to be accurate. Your sensor doesn’t automatically know what your glucose levels are—you have to teach your system what a given BG value is by entering in a KNOWN glucose value from your BG meter.

Warning

Calibrate on Schedule

Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, resulting in you missing a severe low or high glucose event.

Precautions

Be Accurate, Be Quick

Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick.

Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance, resulting in you missing a severe low or high event.

Significant Glucose Rate Changes

Don’t calibrate when your BG is changing at a significant rate: more than 2 mg/dL per minute.

Look for rate of change arrows on your display device screen and don’t calibrate when you see:

• A single arrow, pointing up

o Rising 2-3 mg/dL each minute

• Two arrows pointing up

o Rising more than 3 mg/dL each minute

• Single arrow pointing down

o Falling 2-3 mg/dL each minute

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• Two arrows pointing down

o Falling more than 3 mg/dL each minute

Calibrating during a significant rise/fall of your BG may affect accuracy of sensor glucose readings, resulting in you missing a severe low or high glucose event.

Fingerstick Only

Only use fingerstick measurements from your BG meter for calibration.

Alternative site BG values from your arms, palm of your hand, etc., may be different and less accurate than your fingerstick BG values. Using alternative sites for calibration might affect sensor performance, resulting in you missing a severe low or high glucose event.

Prior to Startup Calibration: Data/Alarm/Alert

After starting a new sensor session, until completing your startup calibrations you won’t receive any sensor information such as readings, Alarm or Alerts. Without these, you may miss a severe low or high glucose event.

Continue to take fingerstick measurements during a new sensor warmup period.

Now that we have reviewed common CGM Safety Statements, let’s focus on the G5x components.

2.7 System/Hardware/Software Warnings and Precautions

In this section, you will learn how to safely use the G5x’s hardware and software. Some sections have either Precautions or Warnings, others will have both.

Sensor/Transmitter Holder Warnings and Precautions

Warnings

Sensor Breaking Off

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On rare occasions, the sensor wire may break or detach from the transmitter holder.

Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department, toll free at 1.888.738.3646

If a sensor wire breaks under the skin with no portion of it visible, don’t remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.

Placement

Do not insert the sensor component of the system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the system is not approved for other sites.

The system has not been tested in other areas and may not work properly if inserted in other areas.

Storage

During a sensor’s shelf life, store it between 36° F-86° F. While you don’t need to keep your sensor in a refrigerator, you can as long as the refrigerator is between 36° F-86° F.

Never store sensors and/or sensor packages in a freezer.

Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect, resulting in you missing a severe low or high glucose event.

Precautions

Expiration Date

Don’t use expired sensors. Before inserting, always check the package label for the expiration date using the YYYY-MM-DD format.

If past the expiration date, don’t use because the sensor glucose readings might not be accurate, resulting in you missing a severe low or high glucose event.

Sensor Package

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Don’t use sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection.

Clean and Dry Before Using

Before opening the sensor package, wash your hands with soap and water, then dry. If your hands are dirty while inserting the sensor, you may contaminate the insertion site and get an infection.

Before sensor insertion, clean the skin with alcohol wipes to prevent infections. Don’t insert the sensor until the cleaned insertion site is dry, and free from any lotions or perfumes.

If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking and falling off.

Sensor Placement

Don’t insert the sensor where bones are close to the skin’s surface (for example, over your ribs or hip bones). If you insert the sensor in these areas, you may feel excessive pain or damage your sensor.

Don’t remove the safety guard before placing the applicator on the skin. If you remove the safety guard first, you may accidentally deploy the needle and hurt yourself. Change the site where you place the sensor with each new

insertion. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.

Sensor placement is important. Choose a site:

• At least 3 inches from insulin pump infusion set or injection site

• Away from waistband, scarring, tattoos, irritation

• Unlikely to be bumped or pushed

Insertion in these areas might affect sensor performance, resulting in you missing a severe low or high glucose event.

Transmitter Warnings and Precautions

Warnings

Inspect Transmitter

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If your transmitter is damaged or cracked in any way, don’t use it. Damaged components could create an electrical safety hazard or malfunction, which might cause electrical shocks.

Choking

The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or allow children to play with it.

Precautions

Reusable: Don’t Throw Away

When ending a session, don’t throw away the transmitter.

The transmitter is reusable and can be used in multiple sensor sessions. Keep using it until the system notifies you the transmitter battery is about to expire.

Don’t Share Your Transmitter

Never share your transmitter with another person. The system is a prescription-only medical device and is meant, or indicated, for your use only.

Your transmitter is tied to

your

readings. If used by someone else, your reports, Alarm and Alerts, etc., would be wrong, resulting in you missing a severe low or high glucose event.

System Precautions

Next are precautions for the receiver, transmitter, sensor, and the system.

Precautions

Use Correct Transmitter, Receiver, and Sensor

The G5x transmitter must be used with the G5x Sensor and is not interchangeable with the Dexcom G5®Mobile/G4® PLATINUM Sensor. The G5x transmitter is compatible with the G5 Mobile receiver.

The G5x transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver.

System Accuracy

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System accuracy may be affected when your glucose is changing at a significant rate such as during exercise or after a meal.

Significant glucose rise/fall rates:

• Rising 2-3 mg/dL each minute

• Rising more than 3 mg/dL each minute

• Falling 2-3 mg/dL each minute

• Falling more than 3 mg/dL each minute

Airport Scanners

Be aware of airport body scanners and baggage x-rays when you travel. Do not place any part of the G5x system in the baggage x-ray machine or body scanner. Ask for visual inspection instead:

• Baggage x-ray machine: Instead of putting any part of your G5x through the baggage x-ray, ask the TSA officers to visually inspect it.

• Body scanner: When you are wearing your G5x, request handwanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner. AIT is also called millimeter wave scanner.

The system has not been tested in x-rays or AIT body scanners, and it is unknown if exposure to x-rays or AIT body scanners can affect the system performance and result in you missing a severe low or high glucose event.

It is safe to wear the system through the walk-through metal detector or handwanding. If you are unsure of whether the airport scanner is a metal detector, an AIT body scanner or an x-ray, ask the TSA officer or request hand-wanding or full-body pat-down.

Receiver and Smart Device Precautions

The Dexcom receiver and your smart device share some warnings and precautions.

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Precautions

Communication Range

Do not separate the transmitter from the receiver or smart device by more than 20 feet. The transmission range from the transmitter to receiver or smart device is up to 20 feet without obstruction.

Types of obstruction differ and not all have been tested. Obstructions can include water, walls, metal, etc. If your transmitter and display device(s) are more than 20 feet from each other or are separated by an obstruction, they might not communicate, resulting in you missing a severe low or high glucose event.

As with any wireless device, water in reducing the communication distance. This applies to the transmitter and display devices. Take special care when swimming, taking a bath, or getting into a hot tub.

Setting Alarm/Alert Notifications

When using both a receiver and a smart device, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alerts, causing you to miss a severe low or high glucose event.

Using an accessory device (like a smart watch) might override your smart device sounds. Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device. After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarms or Alerts on the smart device.

Is It On?

If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts. Make sure they are turned on; otherwise you won’t get sensor glucose readings or Alarm or Alerts, causing you to miss a severe low or high glucose event.

Smart Device Warnings

Next are warnings for just your smart device.

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Warnings

Smart Device Settings

The app can’t override your smart device’s internal settings. Also, accessory devices (like a smart watch or other wearable smart devices) might override your smart device’s Alerts and Alarm.

To receive Alarm or Alerts you must:

1. Make sure app Notifications are turned on in the

Setting’s

menu.

2. Verify app hasn’t been shut down.

3. Turn

Bluetooth®

on.

4. Turn off

Do Not Disturb

(if available on your smart device).

5. Restart app after device is restarted.

6. Set

Volume

at a level you can hear.

7. Do not close app, always run app in the background.

8. Make sure accessory devices do not override your smart device settings.

If your settings are incorrect, you might miss a severe low or high glucose event.

App Alarm/Alert vibrations aren’t any different from other vibrating apps on your smart device. Medical device apps, like this app, don’t have any special priorities over your smart device’s features. G5 Mobile app notifications or Alerts may sound or feel the same as notifications from another app. The only way to know is to look at the screen.

Did You Miss an Alarm or Alert?

An Alarm or Alert can’t be heard through your smart device’s speakers if headphones are plugged in.

Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert, causing you to miss a severe low or high glucose event.

Receiver Warning and Precaution

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Warning

Don’t Use Damaged Goods

If your receiver is damaged or cracked, don’t use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks.

Avoid Strangulation

Use USB cable only as directed and store safely. Misuse of the USB cable can present a strangulation risk.

Precaution

Test Receiver

If your receiver gets wet or dropped, make sure the speaker and vibrations still work. To check, either plug it in, turn it on, or go to the

Profiles

menu and

select

Try It

. If it doesn’t vibrate and beep, contact Technical Support.

If the vibration motor and/or speaker on your receiver aren’t functioning properly you may miss a severe low or high Alarm/Alert. Use the app on your smart device until this issue is resolved

Keep Receiver Clean and Dry

Keep the USB port cover on the receiver closed whenever the USB cable is not attached and do not submerge in water.

If dirt or water gets into the USB port, the receiver could become damaged and stop displaying readings or providing Alerts; you might miss a severe low or high glucose event.

Caution

U.S. law restricts the sale of the G5x to sale by or on order of a physician.

Summary

Now You Can:

• Define a Safety Statement

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• Explain the difference between an indication and a contraindication

• Describe the importance of warnings

• Describe what a precaution is

• Correctly read a chapter’s Safety Statement

• Provide an overview of Safety Statements by category

What’s Next?

In our next chapter, you will learn about the risks and benefits of using the G5x.

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Chapter 3

Getting Started:

Risks and Benefits

When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are so you can better understand the pros and cons of CGM and the G5x.

First, let’s review some possible risks.

3.1 Risks

There are some risks with using real-time CGM.

Not Receiving Alarm/Alerts

If you aren’t getting your CGM Alarm/Alerts, you run the risk of not knowing you are having a severe glucose low or high.

Some hardware issues preventing Alarm/Alerts:

• Alert function is turned off

• Transmitter or display device is out of range

• Display device isn’t showing sensor glucose readings

• Display device battery is dead

• Unable to hear Alarm/Alerts or feel vibration

• Speaker or vibration motor not working

• App not running in the background

• Smart device is on

Do Not Disturb

or Silent Mode

See Troubleshooting in Chapter 18 or recommended settings in Chapter 11 for more information.

Different Devices May Give Different Numbers

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The sensor glucose reading can be different from your meter’s BG value.

If the sensor’s glucose reading is higher than your meter’s BG value, you may miss a Low Alert. As an example, your last sensor glucose reading was 82 mg/dL, whereas your meter BG value shows 78 mg/dL. If your Low Alert is set at 80 mg/dL, you won’t receive an alert because the sensor glucose reading is 82 mg/dL.

If you’re not receiving an Alarm/Alert, and not taking fingerstick measurements, you may be unaware of low or high glucose levels.

Sensor Insertion Risks

Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain, or skin irritations (for example, redness, swelling, bruising, itching, scarring, or skin discoloration). The chance of this happening is low. The G5x uses a different applicator than older systems. The G5x clinical studies showed slight redness and swelling occurring only in a few patients. Different people may have different skin sensitivity to the sensor adhesive. If skin irritation is seen, follow up with your healthcare professional on ways or tips to reduce or avoid sensor site irritation.

With any sensor, if you don’t follow the instructions for sensor insertion, there is a chance you may mistakenly insert the sensor before you are ready. Be careful to ensure you place the sensor on your sensor insertion site

before

taking off the safety guard.

After

placing the applicator on the body, fold and

break the safety guard.

The safety guard can be a choking hazard. Carefully throw it away, especially if around children.

During Dexcom’s G5x clinical studies, no sensor wires broke; however, there is a remote chance a sensor wire could break or detach and remain under your skin. Sterile broken sensor wires usually don’t pose a significant medical risk.

If a sensor wire breaks off or detaches and remains under your skin, contact your healthcare professional and call Dexcom’s Technical Support toll free, 24/7, at 1.888.738.3646 or toll at 1.858.200.0200 within 24 hours.

Those are the risks, let’s now review the benefits!

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3.2 Benefits

Daily habits impact your BG levels. With the G5x, you can track how your exercise, carbs, stress levels, medication, or illness influences your glucose levels.

Knowing Your Trends

Providing sensor glucose readings every five minutes, for up to seven days, the G5x helps you detect trends and patterns. Trend information reveals where your glucose is now, where it’s been, where it’s heading, and how fast it’s changing.

Understanding your trends allows you to take proactive action, helping you avoid dangerously low or high glucose values.

Using Dexcom

(see Part 5) allows friends and family, your Followers, to monitor your glucose activity, adding another layer of support and peace of mind.

Simplified Sensor Insertion

The redesigned G5x sensor applicator allows you to insert a sensor with fewer steps while using just one hand. Fewer steps simplify the insertion process.

Helping Your Diabetes Management

Wearing the G5x on a consistent and ongoing basis helps you manage your diabetes. The Alarm/Alerts features (see Chapter 11) keep you aware of your glucose levels. Alerts notify you when your glucose goes outside your target range or is rapidly falling or rising, letting you take action before you get too low or too high. The Urgent Low Glucose Alarm lets you know when you are dangerously or urgently low, going below 55 mg/dL. By taking corrective measures, you reduce the time spent in your low/high range, while increasing time in your target range (Garg, S. Z., 2006) (Battelino, T., 2011).

Real-time CGM can help improve your A1C as well as improve the quality of your glucose control. If you are at or below 7%, using a CGM such as the G5x helps reduce hypoglycemia (Tamborlane, W. V., 2008).

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Lowering your A1C, increasing your time in your target range while decreasing time in low/high BG range is believed to reduce your risk of diabetes-related complications (Ohkubo, Y., 1995).

In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, 2010).

What’s Next?

You’ve read the Safety Statements, reviewed the risks and benefits; now let’s take a look at Dexcom’s G5x!

References:

Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011). Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes.

Diabetes Care

, 34(4), 795-800.

Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., & Jovanovic, L. (2006). Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor: A Randomized Controlled Trial.

Diabetes Care

, 29(1), 44-50.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010). Quality-of-Life Measures in Children and Adults With Type 1 Diabetes.

Diabetes Care

, 33(10), 2175-2177.

Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., & Shichiri, M. (1995). Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in Japanese Patients With Non-insulindependent Diabetes Mellitus: A Randomized Prospective 6-year Study.

Diabetes Research and Clinical Practice

, 28(2), 103-117.

Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... & Xing, D. (2008). Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes.

The New England Journal of

Medicine,

359(14), 1464-1476.

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LET’S G5x! THE BASICS

• Introduction to the G5x

• Initial Setup

• Starting a Sensor Session: Inserting the Sensor and Transmitter

• Calibration

• Ending a Sensor Session and Transmitter Session

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Chapter 4

Let’s G5x! The Basics:

What Is the G5x?

4.1 System Description

Now it’s time to get an overview of the the Dexcom G5x.

After this chapter, you’ll be able to:

• Explain the G5x

• Describe options to view trends

• Locate your historical readings

• Recognize system components

• Explain each part’s function

4.2 Safety Statement

While you can use the G5 Mobile receiver with the G5x, you can’t use the sensor or transmitter from previous generations. If the transmitter or sensor box says “G5 Mobile” or “G4 PLATINUM,” don’t use them with the G5x.

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Warning

Don’t:

The system was not evaluated for the following persons:

•

Pregnant women

•

Persons on dialysis

Don’t use the system in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.

Consequences: The system’s accuracy hasn’t been tested in people falling into these groups, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event.

Precaution

: The G5x transmitter must be used with the G5x Sensor and is not

interchangeable with Dexcom the G5®Mobile/G4

PLATINUM Sensor.

The G5x transmitter is compatible with the G5 Mobile receiver.

Why: The G5x transmitter and G5 receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver.

Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event.

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G5x-Compatible Components

G5x System Components

Components Not Compatible with G5x

G5x Sensor G5x Transmitter G5 Mobile Receiver

G5 Mobile App

G5 Mobile/G4 PLATINUM Sensor G5 Mobile Transmitter G4 PLATINUM Transmitter G4 PLATINUM Receiver with Share

G4 PLATINUM Receiver

4.3 The G5x

The G5x is a medical device you use on yourself. It allows you to continually see your sensor glucose readings, updated every five minutes for up to 7 days, without the bother of taking constant fingerstick measurements. A single-use sensor inserted under your skin measures your sensor glucose readings. A reusable transmitter sends your data to your display device.

The G5x provides personalized trend Alerts, notifying you to proactively react when your glucose levels are getting too low or too high. Dexcom provides web-based reports reflecting your glucose trends and patterns. Share the reports with your healthcare professional when developing your diabetes management treatment plans.

Some users of the G5x System may need a caregiver involved in their care. Please consult your physician for guidance.

Options to View Your Trends

The G5x transmitter works with a number of display devices, giving you flexibility to use what’s best for you, your situation, or your lifestyle.

1. Receiver

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2. G5 Mobile app (app) on your smart device

While the system works with different smart devices, they’re not interchangeable during a sensor session, so before starting one, select which smart device you want to use and stick with it throughout your session. You can’t use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session.

The G5x is the first CGM system where a smart device acts as a receiver. For a list of current devices and operating systems, go to: dexcom.com/compatibility.

Chapter 5 covers how to set up your smart device with the app.

The primary difference between the receiver and app is not the information they give you, but how that information is presented. The following are some of the shared CGM data and system information features.

Tracking Real-Time CGM Data

The receiver and app give you the ability to track your glucose trends in a number of different ways. Each device’s home screen opens to your glucose trend screen.

Viewing Glucose Levels

The receiver and app share many of the same glucose-monitoring features. Your glucose values are color-coded to highlight what zone you are in, allowing you, at a glance, to see what your levels are.

Color-coded glucose levels:

• Red - Low

• Gray - Within your target range

• Yellow – High

Trend Arrows

Glucose levels are not just about the numbers. The G5x includes trend arrows so you know the speed and direction of your glucose, allowing you to proactively react before your glucose gets too high or too low.

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Alarm/Alerts

Being warned when your glucose value is too high or too low, falling or rising too quickly, or trending toward a severe low or high is very important. Warnings in the form of Alerts or an Alarm help you avoid getting too low or too high. Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds, vibrations, and screens.

There are a number of Alerts, but only one Alarm: when your glucose level dips below 55 mg/dL. Some customization options are available and are part of the setup process for the receiver and smart device.

In Chapter 11, you can learn more about the Alarm and Alerts feature.

Viewing Your Glucose Values

The G5x allows you to see your last 1-3-6-12-24 hours of your sensor glucose readings. On the receiver, from the home screen, press

Up/Down

Arrows

to view. On a smart device, hold upright in

portrait

mode to see the

most recent three hours; turn sideways to

landscape

mode to view your

glucose levels over the last 1-3-6-12-24 hours.

Go to Chapter 9 to learn more about viewing your glucose trends.

4.4 What’s New to the G5x?

Dexcom’s G5x has features not found in our previous generations. They include:

•

G5x sensor applicator

•

Redesigned transmitter and transmitter holder

G5x Sensor Applicator

Inserting a sensor has never been easier! The redesigned G5x sensor applicator allows you to insert a sensor with just one hand. Just peel away the adhesive’s backing, place the applicator on your body, fold and break off the safety guard, and push the applicator’s button. For detailed steps on sensor insertion, see Chapter 6.

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Redesigned G5x Transmitter Holder and Transmitter

The redesigned transmitter and its holder enjoy a lower profile. The transmitter snaps into the newly designed holder and, with its new breakaway feature, snaps out for easy transmitter removal. For more information on how to attach the transmitter, go to Chapter 6. After a sensor session has ended, see Chapter 8 for its removal.

4.5 System Information

The receiver and app also keep you informed on the system’s status. Technical notifications provide information about your sensor session and about the system’s hardware. Each chapter provides a table of the notifications, system, and error messages applicable to its subject. As an example, the calibration chapter will review all calibration messages you may see.

Now that you know what the G5x does and what’s new, let’s open your G5x packages, see what’s inside, and review each item.

4.6 System Components

Package

The G5x comes to you in a number of boxes; after opening, keep the packaging until you are no longer using its contents.

G5x System Component Packaging

Sensor

Sensor package

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Single use sensor(s)

Sold separately.

Comes in a sterile pack.

Insert

Transmitter

Transmitter package

Reusable transmitter

Receiver

Receiver package

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Receiver

Receiver’s USB charging and download cable

Receiver

AC power adapter Welcome Card

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Getting Started Guide

Training Checklist attached to Getting Started Guide

Training Tutorial USB Card

Overview of System Components

This section is meant as a quick overview of each part; specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 17.

The G5x is comprised of four key parts:

1. Applicator with single use sensor

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2. Reusable transmitter

3. Rechargeable receiver

4. G5 Mobile app

G5x optional:

Dexcom

Sensor Applicator Overview

After removing the backing from the adhesive patch on the back of the sensor applicator, place the applicator on your skin and remove the safety guard. Push the orange button to insert the sensor wire and release the transmitter holder.

The sensor wire is made of silver and platinum with polymer membranes. Once inserted, the thin and flexible wire measures your glucose levels in the fluid between your cells (interstitial fluid) for up to seven days.

This section is meant as a quick overview. More information on using and inserting the applicator, sensor, and sensor wire can be found in Chapter 6.

Figure 1. G5x Sensor Applicator and Transmitter Holder

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Applicator and Transmitter Holder

What it’s called

What it does

Applicator

Contains small insertion needle and sensor wire.

Inserts sensor wire under the skin.

Disposable, for single use only.

Removed after insertion.

Safety Guard

Keeps all moving parts in place before insertion.

Prevents accidental sensor insertion.

Fold and break to remove.

Button

Press to insert sensor wire and release transmitter holder.

Transmitter Holder

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Transmitter Holder

Holds sensor wire and transmitter in place.

Water resistant when transmitter is properly installed.

Discarded after sensor session.

Adhesive Patch

Keeps transmitter holder attached to your skin.

Sensor Wire

Measures glucose levels in the fluid between your cells (interstitial fluid).

Attached to transmitter holder once inserted under skin.

Discarded with holder after session.

Transmitter Overview

Figure 2. G5x Transmitter Front and Back

Please Note: Pictures above are representational only; your transmitter may look different.

Snapping into the transmitter holder, the gray plastic transmitter wirelessly sends your glucose information to your display devices—receiver and/or smart

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device. If you have a new transmitter, open the package when you are ready to use it.

Transmitter features:

•

Reusable

Do not discard after sensor session.

Only for you, don’t share transmitter.

•

Water resistant

•

Can transmit data to your display devices for up to 20 feet

Range is less if you are in or under water.

•

Battery lasts approximately three months

Receiver or smart device notifies you when battery is running low.

•

Transmitter’s serial number is on the back

More transmitter features and insertion information are in Chapter 6.

Now that you are familiar with the sensor applicator and transmitter, let’s review the receiver.

Receiver

The receiver is a small hand-held device. Your receiver, along with your smart device, shows your sensor glucose readings, trend graphs, and trend arrows, and notifies you when your glucose is too high or too low or if there is something you should be aware of or need to do.

The receiver is neither water resistant nor waterproof

and can get damaged if moisture gets inside, so keep it away from any liquids and very high humidity as well as dirt and dust. Keeping the micro USB port closed helps prevent damaging fluids and dust from getting inside the receiver. If your receiver does get wet or dirty, test it to make sure the speaker and vibrations still work (see Chapter 12).

If your receiver isn’t charged, see Chapter 14 for charging your receiver’s battery.

If you want to use the receiver along with a smart device, you need to set them up separately.

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Remember, you can’t use a combination of smart devices during a sensor session; select just one.

Receiver Overview

What you see

What it’s called

What it does

Receiver

Provides data about your glucose trends via screen display, sounds, and vibration.

Micro USB Port

Plug

USB cable

into

port

for

recharging.

USB Port Door

USB port door

after

removing

USB cable

to keep

receiver clean and dry.

Micro USB Cable

Plug into

receiver

to charge

battery.

Don’t plug into a computer port to charge.

Battery can only be charged using the adapter/wall charger.

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What you see

What it’s called

What it does

Wall Charger

Plug

USB cable

into

adapter/wall charger.

Plug

wall charger

into an electrical outlet to charge receiver’s battery.

Don’t block access to the charger.

Display Screen

Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status.

Change settings on Menu screen.

Speaker

Allows you to hear your Alarm/Alerts sounds.

Navigation Wheel

Arrows and button to help you navigate through the receiver’s menu options and choose features.

Select Button

Press to select menu option.

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What you see

What it’s called

What it does

Left Arrow

Press to go back to last item/screen or home screen.

Right Arrow

Press to highlight next item.

Up/Down Arrows

Press to scroll up or down to select menu items or set values.

Press to scroll back and forth from the 3-hour trend graph to the 1-6-12-24 views.

4.7 Smart Device Overview

The app was created to work with your smart device, giving you even more options in monitoring your glucose trends and patterns. The app is similar to all other apps.

This user guide is not meant to show you how to use your smart device. Please contact your smart device support or read your smart device’s user guide for assistance.

Summary

Now You Can:

• Explain the G5x

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• Describe options to view trends

• Locate your historical readings

• Recognize system components

• Explain each part’s function

Next Steps

Your next step in getting started with the G5x is selecting how to continuously receive your sensor glucose readings: using the app, the receiver, or a combination.

Our next chapter helps you set up both!

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Set up Your Display Devices

Chapter 5

Let’s G5x! The Basics:

Set Up Your Display Devices

5.1 Introduction

In the previous chapter, you received a high level overview of the G5x and learned you can monitor your glucose levels with different display devices. Now it’s time to set up your app and your receiver.

After this chapter, you will be able to:

• Create a Dexcom username and password

• Download the app

• Set up the app with the recommended settings

• Successfully set up your receiver

5.2 Safety Statement

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Set up Your Display Devices

Precaution

: The G5x transmitter must be used with the G5x Sensor and is not

interchangeable with the Dexcom G5® Mobile/G4

PLATINUM Sensor.

The G5x transmitter is compatible with the G5 Mobile receiver.

Why: The G5x transmitter and G5 receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver.

Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event.

G5x-Compatible Components

G5x System Components

Components Not Compatible with G5x

G5x Sensor G5x Transmitter G5 Mobile Receiver

G5 Mobile App

G5 Mobile/G4 PLATINUM Sensor G5 Mobile Transmitter G4 PLATINUM Transmitter G4 PLATINUM Receiver with Share

G4 PLATINUM Receiver

5.3 Why Different Monitoring Methods?

Your convenience!

By offering two separate monitoring systems, the app or receiver, you can choose to monitor your glucose levels in the handiest method at that moment. Forgot your receiver at home? Use your smart device! Battery died on your smart device? Smart device memory full? Your receiver has you covered!

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Set up Your Display Devices

With the exception of Dexcom

, the primary difference between the two

monitoring systems is not the data itself, but how it’s presented.

The next section walks you through the initial setup for the app. To set up the receiver, go to Section 5.5. If you want to use both the app and the receiver, you need to setup each individually.

Once you have completed the initial setup, you’re one step closer to beginning your sensor session!

5.4 App

Before starting your first sensor session, pick the smart device you want to use. As mentioned in the previous chapter, you can use the receiver with one smart device during a session; however, you can’t use multiple smart devices during the same session.

While your smart device can have the app installed, part of your initial setup is entering the transmitter’s serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you won’t be able to complete the setup process.

Suggested Smart Device Settings

Bluetooth

is designed for wireless communication between devices (unlike Wi-Fi®, which wirelessly connects devices to the Internet). Your transmitter communicates to your app via

Bluetooth

Smart! Before beginning, make

sure your smart device’s

Bluetooth

is available and turned on.

Refer to your smart device’s user guide if you have questions on how to change your smart device settings.

• While checking your

Bluetooth

settings, check to see

Silent

and

Not Disturb

are off. Your app does not override these settings; if you

have them on, you will miss Alarm/Alerts

• After verifying all your settings are correct, there is one more thing to check. Make sure your smart device’s

Volume

is loud enough for you

to hear any Alarm/Alerts

• Make sure your smart device settings allow your Alarm/Alerts to always show on your lock screen

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Set up Your Display Devices

• For information on how to set the above settings, see your smart device’s user guide. Once you have verified your smart device’s settings are right, the next step is installing the app

• The app needs to be open and running in the background. This may drain your smart device’s battery; make sure you check its battery is charged

• Don’t change your smart device’s time because it can make the time on the trend screen wrong and the app may stop displaying data

If your smart device is broken or lost, use your receiver until it’s fixed or replaced.

App Installation

Installing the app is easy! Simply download the Dexcom G5 Mobile app from your smart device’s store. However, if your smart device has been jailbroken, do not install the app.

For information on how to install an app, see your smart device’s user guide.

Initial App Setup

Setting up your app is easy! You’ll need your Dexcom account

username

and

password

, along with your

transmitter box

. Once inside, simply follow the setup wizard instructions. The setup wizard walks you through safety information, recommended settings, entering transmitter SN, setting your high/low glucose levels, and receiving CGM notifications.

Your initial setup will require a Dexcom username and password. You can create them by tapping

within the app, or by going to dexcom.com.

From Your Web Browser:

1. Go to dexcom.com.

2. Click

My Account

at top right of page

• If no

My Account

, click green menu bars at top left

• Click

My Account

3. Click

Create a Dexcom Account

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Set up Your Display Devices

But what if you are unclear about a step?

The app has notifications allowing you to get more information. If you are unsure of something during your initial setup process, look at the screen for additional information notifications. Informational notifications include, but aren’t limited to:

I don’t understand, Learn More,

Question Mark

. Tap your

informational notification

to get more information.

To close out of the information notification, tap the X in the upper right-hand corner.

Initial App Setup

Step

What you see

What you do

Introductory Screens

Tap

app

icon to open app.

Introductory Screens

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Set up Your Display Devices

Swipe through introductory screens or tap

Enter existing

username

and

password

Need a Dexcom username and password?

Tap

Complete

Username/Password

fields

Tap

once.

Introductory Screens

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Set up Your Display Devices

Tap

Let’s Get Started.

The next screens are the Terms of Use, safety warnings, contraindications, and the recommended settings.

Once each screen is read, tap the

appropriate answer

to move forward.

Tap

Full Safety Statement

or, when

applicable,

I don’t understand

to get more

information.

Setting Up Your App Alarm/Alerts and Basic Settings

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Set up Your Display Devices

Set your Low Glucose Alert.

Default is 80 mg/dL.

Scroll to select another amount.

Tap

Save

to move forward.

Once your Low Glucose Alert is set, you’ll receive an Alert notification if your glucose dips below your set amount.

Set your High Glucose Alert.

Default is 200 mg/dL.

Scroll to select another amount.

Tap

Save

to move forward.

Once your High Glucose Alert is set, you’ll receive an Alert notification if your glucose rises above your set amount.

Setting Up Your App Alarm/Alerts and Basic Settings

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Set up Your Display Devices

Make sure you get your Alarm/Alerts notifications.

Tap the

appropriate response

to move

forward and set your notifications.

Tap OK to receive Alarm/Alerts notifications.

Setting Up Your App Alarm/Alerts and Basic Settings

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Set up Your Display Devices

The next screens provide suggestions for device volume,

Do Not Disturb

, and other

basic settings.

Tap

appropriate answer

to move forward.

Connecting/Pairing Transmitter With App

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Set up Your Display Devices

Tap

Verify

Bluetooth

is on.

The app will check to see if

Bluetooth

turned “on.”

Connecting/Pairing Transmitter With App

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Set up Your Display Devices

12a

Turn transmitter box upside down on a flat surface with barcodes facing up.

Center longest barcode within green brackets.

For information on how to pair transmitter after initial setup, see Chapter 8.

12b

Center longest barcode within green brackets.

Tap

Take Photo

Connecting/Pairing Transmitter With App

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Set up Your Display Devices

12c

Check mark confirms successful transmitter SN scan.

13a

If unable to use app’s scanning device:

Tap

Enter transmitter SN by hand

Connecting/Pairing Transmitter With App

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Set up Your Display Devices

13b

Use keyboard to enter transmitter SN.

Confirm correct SN .

Tap

Save

Insert sensor and attach transmitter following video’s instructions.

See Chapter 6 for more information.

Connecting/Pairing Transmitter With App

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Set up Your Display Devices

Wait up to 30 minutes for smart device and transmitter to connect.

At notification, Tap

Pair

to pair app with

smart device.

Connecting/Pairing Transmitter With App

Make sure your transmitter and smart device have paired before starting your sensor session

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Set up Your Display Devices

Tap the

Sensor warmup

circle to start

your two-hour sensor warmup.

When you see the sensor warmup timer, your initial setup is complete.

Congratulations!

If you have any issues setting up the G5 Mobile app, always contact Technical

Support (available 24/7) at:

• [email protected]

• Toll free: 1.888.738.3646

• Toll call: 1.858.200.0200

If you are having problems with your smart device, contact your smart device’s support line.

After completing your initial app setup, set up the receiver or go to Chapter 6 to start your initial sensor session.

5.5 Dexcom Receiver

In the previous chapter, you learned about the receiver’s components. The following is a refresher to help in your initial setup.

Display Screen:

• Trend screen

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Set up Your Display Devices

• Menu selection screen

Navigation Wheel:

• Select

o Button in the middle of the navigation wheel

! Center button does not say “Select”

o Press to:

! Turn on receiver

! Select options/features

! Accept changes

! Move forward through menus/features

• Up/Down

o Scroll through trend screens

o Highlight menu items

o Change values

• Left

o Go back to last item or screen

• Right

o Go to next item or screen

Initial Setup of the Dexcom Receiver

Press

Select

to turn receiver on.

The first screen you see is the startup screen with ascending green bars. Once complete, a setup wizard guides you through the initial setup steps. Don’t be worry if your receiver buzzes or makes other sounds during this process.

After your initial setup is complete, you won’t see the setup wizard again. Your settings can always be adjusted using menu options.

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Set up Your Display Devices

How you complete your initial setup differs between the receiver and your smart device; however, the data is the same.

Setup Wizard Notifications:

• Time/Date

• Transmitter Serial Number

o Back of transmitter

o Back of transmitter’s box

• Setting Low Glucose Alert

• Setting High Glucose Alert

Before starting a session, you may want to check the receiver’s battery level. If it is less than half, go to Chapter 4 for charging instructions.

Initial Receiver Setup

Step

What you see

What you do

Initial Screens

Press

Select

to turn receiver on.

Wait.

Time/Date

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Set up Your Display Devices

Press

Up/Down Arrow

to change year.

Press

Right Arrow

to move forward.

Press

Up/Down Arrow

to change month.

Press

Right Arrow

Press

Up/Down Arrow

to change day.

Press

Right Arrow

to move to time.

Time/Date

Press

Up/Down Arrow

to change hour.

Press

Right Arrow

Press

Up/Down Arrow

to change

minutes.

Press

Right Arrow

Press

Up/Down Arrow

to select AM/PM.

Press

Select

to save and close.

NOTE: After initial setup, if battery is drained, receiver will vibrate once and you will need to reset date and time.

Transmitter

Turn

transmitter box

upside down to

locate SN number.

For information on how to pair transmitter after initial setup, see Chapter 8.

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Set up Your Display Devices

If transmitter package isn’t available:

• SN is on transmitter’s back

Press

Up/Down Arrows

to select and

enter transmitter SN.

Press

Right Arrow

to move to next digit.

Press

Select

to save and close.

Setting Low Alert

System default is at 80 mg/dL.

Press

Select

to save at present levels

and close.

To change value:

Press

Up/Down Arrows

to change value

at 5 mg/dL increments.

Press

Select

to save and close.

Setting High Alert

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Set up Your Display Devices

System default is at 200 mg/dL.

Press

Select

to save at present levels

and close.

To change value:

Press

Up/Down Arrows

to change value

at 10 mg/dL increments.

Press

Select

to save and close.

These steps are enough to get you going; now you can start your sensor session!

Summary

Now You Can:

• Create a Dexcom username and password

• Download the Dexcom G5 Mobile app

• Set up app with the recommended settings

• Successfully set up your receiver

What’s Next?

Now that you have completed setting up your app and/or the receiver, your next step is starting a sensor session.

No matter what monitoring method you choose, starting a sensor session is the same:

1. Inserting the sensor.

2. Attaching the transmitter.

3. Pairing the transmitter to your device.

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Set up Your Display Devices

4. Two-hour sensor warmup.

5. Startup calibrations.

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Calibration

Chapter 6

Let’s G5x! The Basics:

Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and Starting Your Session

6.1 Introduction

Now that your display devices are set up, you’re ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the G5x sensor insertion video to get a better understanding of the process.

There are three ways to get the sensor insertion video:

1. Through the app

2. On the USB card in your receiver package

3. Online at dexcom.com: a. Top of page, click

Support

After inserting the sensor, start the sensor warmup on your smart device and receiver. The sensor warmup takes approximately two hours; during this time your body is getting used to the new sensor, allowing for more accurate sensor glucose readings. Once the two-hour sensor warmup has passed, you enter two back-to-back fingerstick measurements to calibrate the sensor’s glucose readings with your fingerstick measurements (Calibration is covered in the next chapter).

Make sure you give yourself enough time to finish the startup session. Remember your smart device’s

Bluetooth

needs to pair with the transmitter, adding up to 30 minutes to your wait time. Good news is you don’t need to sit around waiting: as long as you have your display device near, you can go about your day running errands, gardening, personalizing the G5x settings, whatever you choose during that time frame.

Keep your display device(s) handy during the warmup period—it shows how much time has passed, notifying you with beeps and an icon when your sensor session is ready for its startup calibrations.

After this chapter you will be able to:

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• Identify sensor applicator features

• Properly prepare for sensor insertion

• Choose the best location to insert your sensor

• Correctly insert your sensor

• Prepare transmitter for placement

• Correctly attach transmitter to transmitter holder

• Outline what happens during the sensor warmup

• Identify countdown icon

6.2 Safety Statements

Following are some important Precautions and Warnings to review; we want to make sure you and the system are safe before starting a sensor session.

Warning

Don’t:

If a sensor breaks under the skin with no portion visible above the

skin, don’t remove it.

Do:

Contact your healthcare professional if you have redness, swelling, or

pain at the insertion site.

Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department:

Email: [email protected]

Toll free: 1.888.738.3646

Toll call: 1.858.200.0200

Why: Sensors may fracture on rare occasions.

MRI with broken wire

For patients undergoing an MRI with a retained wire broken off from a G5x sensor, in-vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire and imaging artifacts were limited to the area around the wire.

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Warning

Do:

During a sensor’s shelf life, store it between 36° F-86° F.

Why: Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect.

Never store sensors and/or sensor packages in the freezer.

Consequences: Missing a severe low or high glucose event.

Warning

Don’t:

Insert the sensor component of the system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years).

Why: The placement and insertion of the sensor component of the system is not approved for other sites.

Consequences: The system has not been tested in other areas and

may not work properly if inserted in other areas.

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Warning

Don’t:

Use the system sensor glucose readings for treatment decisions.

Do:

When making treatment decisions, such as the amount of insulin you

need, only use your BG value from your BG meter.

Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meter’s BG values.

Consequences: If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.

Precaution

Don’t:

Insert the sensor where bones are close to the skin’s surface (for

example, over your ribs or hip bones).

Why: If you insert the sensor in these areas, you may feel excessive pain or damage your sensor.

Precaution

Do:

Change the site where you place the sensor with each new insertion.

Sensor placement is important. Choose a site:

•

At least 3 inches from insulin pump infusion set or injection site

•

Away from waistband, scarring, tattoos, irritation

•

Unlikely to be bumped or pushed

Why: Using the same site too often might not allow the skin to heal. Also, insertion in these areas might affect sensor performance.

Consequences: Missing a severe low or high glucose event.

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Precaution

Don’t:

Use sensor if its sterile package has been damaged or opened.

Why: Make sure the sterile sensor pack has not been damaged or previously opened. If opened or damaged, sensor may be unsterile.

Consequences: Using a non-sterile sensor might cause an infection.

Precaution

Don’t:

Don’t remove the safety guard before placing the applicator on the

skin.

Why: If you remove the safety guard first, you may accidentally deploy the needle and hurt yourself.

Precaution

Don’t:

Get dirt or water in the receiver’s USB port or submerge in water.

Why: If dirt or water gets into the USB port, the receiver could become damaged and stop displaying readings or providing Alerts.

Consequences: You might miss a severe low or high glucose event.

6.3 Prepping for Sensor Insertion

Before inserting a sensor, make sure you have everything you need. Some items are included in your G5x packages, others are not.

Included in Your G5x Packages

For sensor insertion, you need the sensor and transmitter.

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Sensor Applicator

Inside Sensor Box

What you see

What it is

Sterilized applicator and sensor tray with important label information.

Check

expiration

date.

Do not use if it is past the expiration date.

Open when ready to use.

Single use sensor applicator.

Knowing what each applicator piece does helps you successfully insert your sensor. Chapter 4, Section 4.6 gave you an overview of the sensor applicator.

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Figure 3. G5x Sensor Applicator and Transmitter Holder

The following table reviews the sensor applicator components in order of use.

Sensor Applicator Components

Order of Use

Name

What it does

Adhesive Patch

Keeps transmitter holder securely on your skin.

Safety Guard

Prevents applicator from inserting sensor wire before you are ready.

Applicator

Inserts sensor under your skin.

Transmitter Holder

Holds sensor wire in place under skin.

Holds transmitter.

Transmitter

Transmitter Box

What you see

What it is

Bottom of box with important label information.

Keep box until transmitter battery dies.

Please Note: Picture is representative only; your transmitter box may look different.

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Reusable transmitter.

Please Note: Picture is representative only; your transmitter may look different.

In the previous chapter, you entered your transmitter SN into your display devices and made sure your smart device and/or receiver connected with the transmitter. You won’t be able to start a sensor session if your transmitter isn’t paired with your receiver and/or smart device.

Not included in packages:

1. Alcohol wipes

2. Your BG meter

3. Your test strips

Before starting, check your BG meter; make sure it’s in good working order following manufacturer’s directions and the meter’s date and time match your display device’s date and time.

Make sure test strips haven’t expired and work with your meter.

Before removing the sensor applicator from its sterile pack, determine the best place to insert your sensor.

6.4 Choosing Your Insertion Site

Choose a place on your belly (or if user is between the ages of 2 and 17, upper buttocks) to insert the sensor; the site should be either above or below your belt line. The best areas are usually flat, “pinchable,” and free from where rubbing can occur (along the waistband, seat belt strap, or where you lie when sleeping).

For more help on ideal sensor insertion sites, contact your healthcare professional.

Insertion Sites

Location

Where it is

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Front of body (belly area) for ages 2 years and older.

If user is between the ages of 2 years and 17:

Back of body (upper buttocks)

Do:

• Remove the sensor applicator and attached transmitter holder from its sterile pack only at time of use

• Place at least 3 inches from your insulin pump infusion set or injection site

• If needed, shave the area so adhesive patch sticks securely

• Make sure area is clean and free of lotions, perfumes, medications

Don’t:

• Never use same site repeatedly for sensor insertion

• Never use same site for 2 sensor sessions in a row

If you have concerns about the transmitter holder not sticking, before inserting your sensor, you can make the sensor site stickier to help ensure the transmitter holder does not peel up.

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Optional Site Preparation

Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion site preparation to help keep your transmitter holder attached. Apply the skin adhesive after you selected and cleaned your insertion site. Create an empty sideways oval, making sure you don't get any skin adhesive inside the oval. . Let the oval dry based on skin adhesive manufacture’s instructions. Once dry, your skin may feel slightly sticky.

See Step 3 in the next table for directions.

NOTE: Contact your healthcare professional for specific questions regarding the use of medical tape, barrier wipes, and/or other adhesives as it relates to your use of Dexcom CGM.

6.5 Inserting Your Sensor

You’ve collected all of the needed items to begin a sensor session, viewed the tutorials, reviewed the sensor applicator, and prepped the transmitter holder site. You’re now ready to insert your sensor!

Inserting Sensor

Step

Picture

What you do

Preparation

Wash and dry your hands.

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Clean

insertion site

with alcohol wipe.

Let dry.

Optional Step: Skin Adhesive

Create a empty sideways

oval

on the

skin

•

Do not get any skin adhesive inside the oval

•

Let skin adhesive dry (see manufacturer’s instructions)

•

Insert sensor on clean skin at the center of the oval

Preparation

Check

pack

. Is it damaged or already

opened?

• If yes, do not use

Peel

lid

off of sensor pack

Keep

sensor packaging

until sensor

session is complete.

Attaching Transmitter Holder

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Place hand over

pack’s

opening

Gently roll

pack

so applicator falls out

and rests in the palm of your hand.

Closely inspect

sensor applicator

, to

check it has not been damaged.

Remove Adhesive Backing

2-step process:

1. Remove

large tab

covering

adhesive patch.

2. Remove

small tab.

Don’t touch adhesive after removing backing.

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Inserting Sensor Wire and Transmitter Holder

Place

applicator

horizontally, not

vertically, on skin.

Firmly press down, sticking

adhesive

patch

to your skin.

Fold and break

safety guard.

Throw

safety guard

away.

Push

button

to insert sensor.

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Release

button

and remove

applicator.

Throw out

applicator

following local guidelines for disposal of bloodcontacting components.

What’s left on your skin?

• Sensor wire

• Transmitter holder

You have successfully inserted the sensor! Now the transmitter holder and sensor wire are attached to your body.

Having problems?

If it’s the first time inserting a sensor, you may have questions or need help. If you do, please contact Technical Support (available 24/7) at:

• [email protected]

• Toll free: 1.888.738.3646

• Toll call: 1.858.200.0200

The next step is attaching your transmitter to the transmitter holder.

6.6 Attaching Your Transmitter

Now that you have inserted your sensor, you need to attach your transmitter.

Since the transmitter is reusable, you don’t need a new one every time you start a sensor session. Keep your current session’s transmitter box. The bottom label has important information you may need after you’ve attached the transmitter. Once the transmitter has been attached, you can’t remove it

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until your session is over. Chapter 8 reviews when and how to remove your transmitter.

Before attaching your transmitter, check you’ve entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitter’s SN number during initial setup. See Chapter 8 for pairing your transmitter after the startup wizard

Attaching Transmitter

Step

Picture

What you do

Remove

transmitter

from box only when

you are ready to insert it.

Keep box.

Get alcohol wipe.

Wipe back of

transmitter

with alcohol

wipe.

Let dry for 2-3 minutes.

Do not let the back of transmitter touch your skin.

Do not scratch transmitter’s back; this can harm the waterproof seal.

Do not touch metal dots on transmitter’s bottom.

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Hold

transmitter’s round end

Slide

transmitter’s narrow tip

into slot at

the narrow end of transmitter holder.

Step

Picture

What you do

Press down firmly on

round end

of the

transmitter until it clicks into place.

Move fingers around top of

adhesive

patch

three times to secure tape.

You’re almost done starting your sensor session!

Inserting the sensor, attaching the transmitter, and the two-hour sensor warmup are the same, regardless of whether you use the receiver or app.

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The remaining steps vary from app to receiver:

1. Letting your device know you need to start the sensor warmup.

2. Following your warmup countdown.

6.7 Loose Transmitter Holder

The transmitter holder should be able to stay on your skin using its own adhesive.

If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support.

• Tape over white adhesive patch on all sides for even support

• Don’t tape over the transmitter or any plastic parts of the transmitter

holder

• Don’t tape under transmitter holder

• Don’t leave any substance on the skin where you insert the sensor

Figure 4. The Right Way to Use Tape for Extra Support

Image is representational only. Your transmitter may look different.

6.8 Starting Your Sensor Session

If you choose to use both the receiver and the app, each system requires individual setups (see Chapter 5).

After pairing the transmitter to your display device(s), inserting your sensor, and attaching the transmitter to the transmitter holder, your next step is telling

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your device(s) you want to start a sensor session. Transmitters are reusable; pairing is required only when using a new transmitter.

During the warmup period, neither device will provide any sensor glucose readings. Your sensor glucose readings begin after the two-hour sensor warmup has passed and you entered the two startup calibration BG values into either the smart device or the receiver.

We’ll first review starting the sensor session for the app.

Dexcom App: Starting a Session

Step

What you see

What you do

Wait for

Pair Successful

notification.

Tap

green checkmark

in black square.

Tap

sensor warmup

circle to start your

two-hour sensor warmup.

NOTE: You will NOT get any sensor glucose readings, Alarm/Alerts during your two-hour sensor warmup period.

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Wait.

Screen provides countdown to sensor warmup. The orange dashes darken as the countdown moves forward.

Keep

smart device

within 20 feet of transmitter during the sensor warmup period.

Step

What you see

What you do

Locked screen.

Startup calibration

notification tells you

when warmup is complete.

Chapter 7 covers calibrating.

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100

Startup calibration

notification tells you

when warmup is complete.

Sensor warmup is complete.

You’re ready to calibrate!

Receiver: Starting a Session

Step

What you see

What you do

Press

Select

to turn on receiver.

Step

What you see

What you do

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