Dexcom 9588 G5x Transmitter User Manual

Dexcom, Inc. G5x Transmitter

User Manual

Download:
Mirror Download [FCC.gov]
Document ID	2994928
Application ID	lxIHmK+xsQ0nqLzK7dYyzw==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	462.5kB (5781304 bits)
Date Submitted	2016-05-18 00:00:00
Date Available	2016-11-10 00:00:00
Creation Date	2016-05-13 22:45:58
Producing Software	CVISION Technologies
Document Lastmod	2016-05-18 12:39:54
Document Title	Microsoft Word - LBL013726 Rev 003 G5x Adjunctive User Guide US .docx
Document Creator	PdfCompressor 6.0.181

®
Dexcom G5x Mobile System User Guide
Table of Contents
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table of Contents
Glossary ..................................................................................................8
Chapter 1 .............................................................................................. 14
Beginning Your Dexcom G5®x Continuous Glucose Monitoring System
(G5x) Journey........................................................................................ 14
1.1 Introduction .................................................................................... 14
1.2 Self-Paced Resources ...................................................................... 15
1.3 Your Dexcom Account ..................................................................... 18
Chapter 2 .............................................................................................. 20
Indications for Use and Safety Statement ............................................. 20
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
Chapter 3 .............................................................................................. 37
Risks and Benefits ................................................................................. 37
3.1 Risks ................................................................................................ 37
3.2 Benefits ........................................................................................... 39
Chapter 4 .............................................................................................. 42
What Is the G5x? .................................................................................. 42
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
Chapter 5 .............................................................................................. 59
Set Up Your Display Devices .................................................................. 59
5.1 Introduction .................................................................................... 59
5.2 Safety Statement............................................................................. 59
5.3 Why Different Monitoring Methods? ............................................. 60
5.4 App .................................................................................................. 61
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
5.5 Dexcom Receiver............................................................................. 74
Chapter 6 .............................................................................................. 81
Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and
Starting Your Session ............................................................................ 81
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
Chapter 7 ............................................................................................ 108
Calibration .......................................................................................... 108
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
Chapter 8 ............................................................................................ 129
Ending Your Sensor Session and Transmitter Session .......................... 129
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
Chapter 9 ............................................................................................ 161
Home Screen, Rate of Change Arrows, and Errors ............................... 161
9.1 Introduction to Home Screens ...................................................... 161
9.2 Safety Statements ......................................................................... 161
9.3 Overview of Home Screen............................................................. 163
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Apple Today View Widget ................................................................... 171
9.4 Rate of Change Arrows ................................................................. 181
9.5 Error Messages.............................................................................. 182
Chapter 10 .......................................................................................... 189
Daily Events Affect Your Glucose Trends and Patterns ........................ 189
10.1 Introduction ................................................................................ 189
10.2 What Is an Event? ....................................................................... 189
10.3 Entering Events ........................................................................... 198
10.4 Viewing Events ............................................................................ 207
Chapter 11 .......................................................................................... 209
Sensor Glucose Alarm and Alerts ........................................................ 209
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
Chapter 12 .......................................................................................... 229
Next Steps: ......................................................................................... 229
On the Go With G5x: Customizing Your Alarm and Alerts .................... 229
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
EVERYTHING ELSE G5x................................................................... 252
Chapter 13 .......................................................................................... 253
Warranty: The Fine Print ..................................................................... 253
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
Chapter 14 .......................................................................................... 260
How to Take Care of Your G5x ............................................................ 260
14.1 Introduction ................................................................................ 260
14.2 Basic Maintenance ...................................................................... 260
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
14.3 Storage ........................................................................................ 268
14.4 Checking app and Receiver Information ..................................... 269
14.5 System Disposal .......................................................................... 270
Chapter 15 .......................................................................................... 272
On the Go With G5x: Getting Through Security ................................... 272
15.1 Introduction ................................................................................ 272
15.2 Safety Statement......................................................................... 272
15.3 Going Through Security ............................................................... 273
Chapter 16 .......................................................................................... 276
Need Help? You’re Not Alone! ............................................................ 276
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
Chapter 17 .......................................................................................... 280
Technical Information ......................................................................... 280
17.1 Device Performance Characteristics ........................................... 280
17.2 Product Specifications ................................................................. 325
17.3 FCC Requirements ....................................................................... 334
Chapter 18 .......................................................................................... 336
Troubleshooting ................................................................................. 336
18.1 Introduction ................................................................................ 336
18.2 Safety Statements ....................................................................... 336
18.3 Troubleshooting .......................................................................... 337
Chapter 19 .......................................................................................... 353
Symbols on Package Labels ................................................................. 353
SHARING IS CARING ...................................................................... 356
Chapter 20 .......................................................................................... 357
Dexcom Share® ................................................................................... 357
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
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
20.8 Troubleshooting .......................................................................... 389
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1
GETTING STARTED
•
Glossary
•
Getting Started
•
Indications for Use and Safety Statement
•
Risks and Benefits
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
(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
Dexcom G5x System User Guide
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.
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
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.
10
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
IP
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.
Dexcom G5x System User Guide
11
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
RF
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®.
W arning
A safety statement letting you know the following
feature has important hazard information.
Dexcom G5x System User Guide
12
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Describes serious and life-threatening
circumstances of using the G5x, their
consequences, and how to avoid the hazard.
Dexcom G5x System User Guide
13
Glossary
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
14
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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:
Dexcom G5x System User Guide
15
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
o 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
Dexcom G5x System User Guide
16
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
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
Share®™.
Part 5: Sharing Is Caring
•
Dexcom Share
o What Is Dexcom Share?
Setting Up Dexcom Share
How to Use Dexcom Share
Dexcom G5x System User Guide
17
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
o
Your Followers
Troubleshooting
Part 6
•
Index for G5x System and Dexcom Share
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
W hat’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.
Dexcom G5x System User Guide
18
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Next you’ll learn about when and how to use the G5x safely.
Dexcom G5x System User Guide
19
Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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?
Telling the difference between an indication and a
contraindication
Explaining why warnings are so important
Defining precautions
•
How to read a chapter’s Safety Statement
•
Overview of Safety Statements
Dexcom G5x System User Guide
20
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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) W arning
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
Dexcom G5x System User Guide
21
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
o
Lists all Safety Statements
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
•
W ARNING-Red
•
PRECAUTION-Blue
•
INDICATION-Green
•
CONTRAINDICATION-Purple
2. Do’s/Don’ts
a. An action you should or should not take
b. Italicized
3. Why
a. A statement of the potential harm
4. Consequences
a. What could happen if you don’t follow the instructions
Dexcom G5x System User Guide
22
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The following is an example of a chapter’s Safety Statement and how to read
it.
W arning
Do: Calibrate at least once every 12 hours
W hy: 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 W arning, 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 W hy 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
Dexcom G5x System User Guide
23
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
24
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
25
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
W ho 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.
Dexcom G5x System User Guide
26
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
•
Two arrows pointing up
•
Rising 2-3 mg/dL each minute
Rising more than 3 mg/dL each minute
Single arrow pointing down
Falling 2-3 mg/dL each minute
Dexcom G5x System User Guide
27
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
Two arrows pointing down
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
Dexcom G5x System User Guide
28
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
29
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
30
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
31
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
32
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
33
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
34
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
35
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
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
W hat’s Next?
In our next chapter, you will learn about the risks and benefits of using the
G5x.
Dexcom G5x System User Guide
36
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
37
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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!
Dexcom G5x System User Guide
38
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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 Share (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).
Dexcom G5x System User Guide
39
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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).
W hat’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.
Dexcom G5x System User Guide
40
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2
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
Dexcom G5x System User Guide
41
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
42
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
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
Do : 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.
W hy: 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.
Dexcom G5x System User Guide
43
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
G5x-Compatible Components
G5x System Components
Components Not Compatible with
G5x
G5x Sensor
G5 Mobile/G4 PLATINUM Sensor
G5x Transmitter
G5 Mobile Transmitter
G5 Mobile Receiver
G4 PLATINUM Transmitter
G5 Mobile App
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
Dexcom G5x System User Guide
44
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
45
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
46
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
47
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Single use sensor(s)
Sold separately.
Comes in a sterile pack.
Insert
Transmitter
Transmitter package
Reusable transmitter
Receiver
Receiver package
Dexcom G5x System User Guide
48
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Receiver’s USB charging and download cable
Receiver
AC power adapter
Welcome Card
Dexcom G5x System User Guide
49
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
50
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2. Reusable transmitter
3. Rechargeable receiver
4. G5 Mobile app
G5x optional:
Dexcom Share
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
Dexcom G5x System User Guide
51
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Applicator
Disposable, for single use only.
Removed after insertion.
Keeps all moving parts in place before insertion.
Safety Guard
Prevents accidental sensor insertion.
Fold and break to remove.
Button
Press to insert sensor wire and release transmitter
holder.
Transmitter Holder
Dexcom G5x System User Guide
52
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Holds sensor wire and transmitter in place.
Transmitter Holder
Water resistant when transmitter is properly
installed.
Discarded after sensor session.
Adhesive Patch
Keeps transmitter holder attached to your skin.
Measures glucose levels in the fluid between your
cells (interstitial fluid).
Sensor Wire
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
Dexcom G5x System User Guide
53
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
device. If you have a new transmitter, open the package when you are ready
to use it.
Transmitter features:
• Reusable
o Do not discard after sensor session.
o Only for you, don’t share transmitter.
Water
resistant
•
• Can transmit data to your display devices for up to 20 feet
o Range is less if you are in or under water.
• Battery lasts approximately three months
o 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.
Dexcom G5x System User Guide
54
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Close USB port door after
removing USB cable to keep
receiver clean and dry.
Plug into receiver to charge
battery.
Micro USB
Cable
Don’t plug into a computer
port to charge.
Battery can only be charged
using the adapter/wall
charger.
Dexcom G5x System User Guide
55
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What it’s called
What it does
Plug USB cable into
adapter/wall charger.
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
Dexcom G5x System User Guide
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.
56
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Press to scroll up or down
to select menu items or set
values.
Up/Down
Arrows
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
Dexcom G5x System User Guide
57
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
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!
Dexcom G5x System User Guide
58
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
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.
Dexcom G5x System User Guide
59
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Do : 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.
W hy: 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
G5 Mobile/G4 PLATINUM Sensor
G5x Transmitter
G5 Mobile Transmitter
G5 Mobile Receiver
G4 PLATINUM Transmitter
G5 Mobile App
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!
Dexcom G5x System User Guide
60
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
With the exception of Dexcom Share, 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 Do
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
Dexcom G5x System User Guide
61
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
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 Sign Up 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
Dexcom G5x System User Guide
62
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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, or 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
Dexcom G5x System User Guide
63
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2
Swipe through introductory screens or
tap Log In.
Enter existing username and password
OR
Need a Dexcom username and
password?
Tap Sign Up.
Complete Username/Password fields.
Tap Login once.
Introductory Screens
Dexcom G5x System User Guide
64
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
4
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
Dexcom G5x System User Guide
65
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
66
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
8a
8b
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
Dexcom G5x System User Guide
67
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
9
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
Dexcom G5x System User Guide
68
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
10
Tap Next.
Verify Bluetooth is on.
11
The app will check to see if Bluetooth is
turned “on.”
Connecting/Pairing Transmitter With App
Dexcom G5x System User Guide
69
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Turn transmitter box upside down on
a flat surface with barcodes facing up.
12a
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
Dexcom G5x System User Guide
70
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
12c
13a
Check mark confirms successful
transmitter SN scan.
If unable to use app’s scanning device:
Tap Enter transmitter SN by hand.
Connecting/Pairing Transmitter With App
Dexcom G5x System User Guide
71
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Use keyboard to enter transmitter SN.
13b
Confirm correct SN .
Tap Save.
14
Insert sensor and attach transmitter
following video’s instructions.
See Chapter 6 for more information.
Connecting/Pairing Transmitter With App
Dexcom G5x System User Guide
72
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
15
16
W ait 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
17
Dexcom G5x System User Guide
Make sure your transmitter and smart
device have paired before starting your
sensor session
73
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Tap the Sensor warmup circle to start
your two-hour sensor warmup.
18
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:
•
TechSupport@dexcom.com
•
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
Dexcom G5x System User Guide
74
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
Menu selection screen
Navigation Wheel:
•
Select
Button in the middle of the navigation wheel
Press to:
•
Center button does not say “Select”
Turn on receiver
Select options/features
Accept changes
Move forward through menus/features
Up/Down
Scroll through trend screens
Highlight menu items
Change values
Go back to last item or screen
•
Left
•
Right
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.
Dexcom G5x System User Guide
75
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Back of transmitter
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.
W ait.
Time/Date
Dexcom G5x System User Guide
76
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
3b
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.
4a
For information on how to pair transmitter
after initial setup, see Chapter 8.
Dexcom G5x System User Guide
77
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If transmitter package isn’t available:
4b
4c
•
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.
5a
Press Select to save at present levels
and close.
To change value:
5b
Press Up/Down Arrows to change value
at 5 mg/dL increments.
Press Select to save and close.
Setting High Alert
Dexcom G5x System User Guide
78
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
System default is at 200 mg/dL.
6a
Press Select to save at present levels
and close.
To change value:
Press Up/Down Arrows to change value
at 10 mg/dL increments.
6b
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
W hat’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.
Dexcom G5x System User Guide
79
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
4. Two-hour sensor warmup.
5. Startup calibrations.
Dexcom G5x System User Guide
80
Set up Your Display Devices
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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:
Dexcom G5x System User Guide
81
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
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.
W arning
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: TechSupport@dexcom.com
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
W hy: 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.
Dexcom G5x System User Guide
82
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W ar nin g
D on ’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).
W hy : The placement and insertion of the sensor component of the
system is not approved for other sites.
C on se qu e nc es : The system has not been tested in other areas and
may not work properly if inserted in other areas.
W arning
Do: During a sensor’s shelf life, store it between 36° F-86° F.
W hy: 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.
Dexcom G5x System User Guide
83
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
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.
W hy: 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).
W hy: 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
W hy: 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.
Dexcom G5x System User Guide
84
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Don’t: Use sensor if its sterile package has been damaged or opened.
W hy: 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.
W hy: 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.
Dexcom G5x System User Guide
85
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
86
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
87
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
Where it is
88
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
89
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
W ash and dry your hands.
90
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2
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
Dexcom G5x System User Guide
91
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
5
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.
Dexcom G5x System User Guide
92
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
10
Dexcom G5x System User Guide
Push button to insert sensor.
93
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Release button and remove
applicator.
Throw out applicator following local
guidelines for disposal of bloodcontacting components.
11
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:
•
TechSupport@dexcom.com
•
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
Dexcom G5x System User Guide
94
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
W ipe 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.
Dexcom G5x System User Guide
95
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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.
Dexcom G5x System User Guide
96
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Dexcom G5x System User Guide
97
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
W ait for Pair Successful notification.
Tap green checkmark in black square.
Tap sensor warmup circle to start your
two-hour sensor warmup.
Dexcom G5x System User Guide
NOTE: You will NOT get any sensor
glucose readings, Alarm/Alerts during
your two-hour sensor warmup period.
98
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W ait.
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.
Dexcom G5x System User Guide
99
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
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
Step
What you do
Press Select to turn on receiver.
What you see
Dexcom G5x System User Guide
What you do
100
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Make sure receiver and transmitter are
connected/paired before starting sensor
session.
Check receiver 10 minutes after starting
for Bluetooth icon.
•
Solid: Connected/paired
•
Blinking: Searching/not paired
Don’t start a sensor session until they are
paired.
Once connected/paired:
Press Select to go to the Main Menu
Press Down Arrow to highlight Start
Sensor.
Press Select to start new sensor
session.
NOTE: After sensor starts, Start Sensor
option disappears.
Dexcom G5x System User Guide
“Start Sensor” progress bar confirms twohour sensor warmup.
Keep your receiver within 20 feet during
the warmup period.
101
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver returns to the trend graph
screen.
Step
What you see
What you do
W ait.
Screen provides countdown of the twohour sensor warmup.
Sensor warmup is complete.
You’re ready to calibrate!
6.9 Receiver Bluetooth Tips
Your transmitter and receiver begin communicating once you start a sensor
session. After approximately 30 minutes, if the Bluetooth symbol is solid, and
not blinking, your transmitter and receiver are talking to each other.
•
If blinking, Bluetooth is looking for your transmitter
Make sure your transmitter and receiver are within 20 feet of
each other
Dexcom G5x System User Guide
102
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
o
Don’t start a sensor session until they are paired.
If the Bluetooth icon isn’t on the receiver and the Signal Loss icon appears in
the receiver’s upper right corner of the status bar, they’re not communicating.
No Communication Between Transmitter and Receiver
Step
What you see
What you do
Check correct transmitter SN is in
receiver.
•
SN is on the label on bottom of
transmitter box
Press Select to go to Main Menu.
Dexcom G5x System User Guide
Press Down Arrow to Settings.
Press Select.
Press Down Arrow to Transmitter.
Press Select.
103
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Press Select.
Check correct transmitter SN is in
receiver.
•
SN is on the label on bottom of
transmitter box
Compare SN in receiver to SN on
transmitter box.
If correct, call our 24/7 Technical Support
department, toll free at 1.888.738.3646
or toll at 1.858.200.0200 for help.
Press Select to exit screen.
Press Left Arrow twice to go to Main
Menu.
If Wrong SN Entered
Dexcom G5x System User Guide
Press Left Arrow twice to go to Main
Menu.
104
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
If sensor session has started, to correct
the transmitter SN, you must stop the
sensor session.
Press Down Arrow to Stop Sensor.
Press Select.
Press Select to stop session.
If Wrong SN Entered
W ait for sensor session to end.
From Main Menu:
10
Press Down Arrow to Settings.
Press Select.
Dexcom G5x System User Guide
105
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
11
12
What you do
Press Down Arrow to Transmitter.
Press Select.
Highlight Transmitter SN.
Press Select.
Enter correct SN using Up/Down Arrow.
Press Up/Down Arrow to select and
enter transmitter SN.
13
Press Right Arrow to move to next digit.
Press Select to save and close.
Press Left Arrow twice to return to Main
Menu.
Start Sensor Session.
14
Press Up/Down Arrow to highlight Start
Sensor.
Press Select.
6.10 Sensor Session Warmup
Dexcom G5x System User Guide
106
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The sensor takes about two hours to adjust to your body. While you are in the
sensor warmup period, you can customize your settings. Chapter 12 steps
you through how to personalize your G5x display devices.
Once the sensor warmup is complete, you’re ready to enter your startup
calibrations! The next chapter shows you how.
Summary
Now You Can:
•
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
•
Properly attach transmitter to transmitter holder
•
Outline sensor warmup
•
Identify countdown icon
W hat’s Next?
The next chapter guides you through the calibration steps.
Dexcom G5x System User Guide
107
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 7
Let’s G5x! The Basics:
Calibration
7.1 Introduction
In the previous chapter, you learned how to insert your sensor, transmitter,
and start a new sensor session. You’re now ready to begin your last step
before getting your sensor glucose readings: Calibration.
This chapter reviews not just your startup calibration, but also update
calibrations required throughout your sensor session.
After this chapter, you will be able to:
•
•
•
Calibration overview
Define calibration
Explain the importance of calibration
Identify steps to ensure a successful calibration
Recognize steps in taking accurate BG measurement
Identify the correct BG site for calibrations
Prepare finger for fingerstick measurement
Determine if you should/should not calibrate
Recognize when you can enter a fingerstick measurement for
calibration
Recognize when you shouldn’t enter a fingerstick
measurement for calibration
Determine if you need to calibrate outside of the normal
calibration requirements
•
Initiate startup calibration
•
Perform update calibrations
Dexcom G5x System User Guide
108
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
•
Correctly enter your fingerstick measurement
In the app
In the receiver
Identify calibration errors
7.2 Safety Statements
Contraindication
Don’t: Take medications containing acetaminophen while wearing the
sensor.
W hy: 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 sensor inaccuracy:
1. Depends on amount of acetaminophen active in your body.
2. May be different for each person.
Consequences: Without correct readings you might miss a severe low or
high glucose event.
W arning
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..
W hy: 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.
Dexcom G5x System User Guide
109
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
Do: Calibrate at least once every 12 hours.
W hy: Calibrating less often than every 12 hours might cause sensor
glucose readings to be inaccurate.
Consequences: Missing severe low (hypoglycemia ) or high
(hyperglycemia) glucose event.
Precaution
Do: Look for rate of change arrows on your display device screen. Trend
arrows help you determine if you can calibrate now or should wait.
Don’t: Calibrate when your BG is changing at a significant rate: more than
2 mg/dL per minute.
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
• Two arrows pointing down
o Falling more than 3 mg/dL each minute
W hy: Calibrating during a significant rise/fall of your BG may affect
accuracy of sensor glucose readings.
•
Consequences: You may miss a severe low or high glucose event.
Dexcom G5x System User Guide
110
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Do: Enter the exact BG value displayed on your BG meter within five
minutes of a fingerstick.
W hy: Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor performance.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: Only use fingerstick measurements from your BG meter for
calibration.
Don’t: Use alternative site BG values from your arms, palm of your hand,
etc.
W hy: Alternative site BG values may be different and less accurate than
your fingerstick BG values.
Consequences: You may miss a severe low or high glucose event.
7.3 Calibration Overview
What Is a Calibration?
As you learned earlier, the sensor glucose readings come from measuring the
glucose fluids found between your cells (interstitial fluids). Although blood and
interstitial fluids are similar, sensor glucose readings can be different between
your fingerstick and your CGM. Calibration provides a comparison, or
measurement, between your meter’s fingerstick measurement and the
sensor’s glucose readings, allowing alignment between the sensor and meter.
Your BG meter “teaches” the sensor your glucose values through calibration.
Just like a clock can need adjusting—calibrations allow your CGM to adjust to
your body.
Dexcom G5x System User Guide
111
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Why Is Calibrating Important?
Calibrations are a must to make sure the CGM system is performing at its
best.
By calibrating when the system notifies you that a calibration is due, the G5x
uses your meter’s BG value to make sure the sensor glucose readings remain
accurate throughout your session.
How Do I Calibrate?
Take a fingerstick measurement from your meter, and simply enter the
meter’s BG value into one of your display devices. This chapter lets you know
what precautions you need to take before taking your BG meter value, then
entering your data. Up to now, you needed to enter information such as Alerts,
transmitter SN, etc., separately for the receiver and smart device. Calibration
is different. You only need to enter calibrations into one device.
Don’t enter your BG values into both devices: enter into either your app or the
receiver. If you enter your meter’s BG value into your receiver, it takes about
five minutes for your sensor glucose readings to begin. In approximately ten
minutes, you can view the readings in the other display device.
How Often Do I Calibrate?
There are three primary “must do” calibration events, each with its own
notifications:
1. Two startup calibrations once your warmup session is complete.
2. Update calibrations done twice daily, once every 12 hours.
3. When you’re notified.
If you receive a calibration notification outside of your scheduled calibration
schedule, either the system doesn’t accept your most recent calibration or
your meter’s BG value is very different from the sensor’s glucose reading.
Don’t worry about keeping track of the time between calibrations; the system
will notify you when you are ready for another.
Dexcom G5x System User Guide
112
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Now that you have an overview of calibration, let’s review some
contraindications, warnings, and precautions you need to know and follow
before you calibrate.
7.4 When to Calibrate
Calibrating on a regular schedule aligns your sensor glucose readings with
your meter’s BG values. Without calibrations, your sensor may be inaccurate,
and as a result, so will your display device’s sensor glucose readings, Alerts,
and notifications, etc.
There are important times when you must calibrate:
1. Startup Calibration: two hours after you insert your sensor.
2. 12 Hour Update Calibration: every 12 hours after two-hour startup
calibration.
3. When system notifies you.
With calibration notifications, your sensor and display device help you keep
your calibration schedule on track. If your BG values are not between 40-400
mg/dL, the system won’t accept your calibration. Wait until you are within the
40-400 mg/dL range before entering your BG values.
Startup Calibration: Sensor Startup Completed
1. At notifications (see next table) enter two back-to-back fingerstick
measurements into just one device.
2. No need to do startup calibrations twice.
a. Calibration data flows between the receiver and your app.
b. Five minute reporting delay between devices.
3. First update calibration is 12 hours after your startup calibration.
Update Calibration
Enter an update calibration every 12 hours after your initial calibration. Below
is a sample calibration schedule. As you can see from the calendar’s BG
meters, you:
1. Inserted your sensor and entered initial two calibrations on Monday at
10 AM.
Dexcom G5x System User Guide
113
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2. Entered update calibrations at 10 PM that night.
3. For the rest of the seven-day sensor period, you enter update
calibrations at 10 AM and 10 PM.
Figure 5. Example Minimum Calibration Schedule During Seven-Day Sensor Session
Update calibrations are typically 12 hours since your last calibration; however,
they can be sooner. As an example, if you know your next calibration is due at
10 PM, but you want to go to bed at 9 PM, you can do the calibration before
bedtime, resetting the 12-hour count down.
1. Enter one fingerstick measurement at least every 12 hours.
2. Display devices provide calibration prompts.
3. You may be prompted to enter additional fingerstick measurements
as needed.
7.5 Calibration Notifications
Sensor Session Startup Calibration Notifications
Dexcom G5x System User Guide
114
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Once your two-hour sensor warmup is complete, your display device tells you
it’s time to enter the first of your two back-to-back startup calibrations. Once
the system has accepted your BG values, your glucose readings begin. If you
don’t enter your BG values right away, the system reminds you every 15
minutes. Remember, use only your BG meter for calibrations, and never enter
values from your CGM.
Startup Calibration Notifications
Device
What you see
What it
means
What you
do
First Calibration
Smart
Device: Lock
Screen
Sensor
warmup is
complete.
Smart
Device: In
App
Dexcom G5x System User Guide
Ready for first
of two startup
calibrations.
Follow steps
in Section 7.6
and 7.7.
Immediately
prepare for
next
calibration.
115
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Device
What you see
What it
means
What you
do
Sensor
accepted first
calibration.
Follow steps
in Section 7.6
and 7.7.
Ready for
second BG
meter value.
Next
calibration in
12 hours.
Second Calibration
Smart
Device: Lock
Screen
Smart
Device: In
App
Dexcom G5x System User Guide
116
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Your sensor glucose readings begin in approximately five minutes once the
device(s) accepts your calibrations.
Update Calibration Notifications
Once your startup calibration is done, your update calibration schedule
begins.
The steps to enter your update calibrations are the same as your startup
calibration, including only entering values in one display device. The only
difference is, with update calibrations, enter your BG meter value just once.
The default BG value is your current reading if available or 120 mg/dL.
Like the reminders you received with your startup calibration, if you don’t enter
your BG meter values right away, the system notifies you every 15 minutes.
Update Calibration Notifications
Device
What you see
Smart
Device: Lock
Screen
Smart
Device:
In App
Dexcom G5x System User Guide
What it means
What you do
Enter update
calibration.
Follow steps
in Section 7.6
and 7.7 to
calibrate.
If message
doesn’t go
away:
• System didn’t
accept
calibration
Immediately
prepare for
next
calibration.
117
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
• BG values
are very
different from
sensor
glucose
readings
Tap Message to clear notification on your smart device. To clear a notification
on your receiver, press Select.
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide, with the exception of your regular 12-hour update calibration,
beep/vibration notifications to let you know it’s time to calibrate or if there was
a system calibration error.
For more information on setting your sound/vibration notifications and how to
clear them, please see Chapter 9.
Smart Device
Calibration notifications will Alert you with a triple beep if your smart device is
not on Silent or Do Not Disturb.
Receiver
The receiver Alerts you with an initial vibration for calibration notifications. If
not cleared, you receive a vibrate/beep every five minutes until confirmed.
7.6 Preparing for Calibration
Your sensor depends on you to help make its sensor glucose readings
accurate. If you don’t prepare properly for the calibration, your sensor may not
provide you with the most accurate sensor glucose readings.
Nine Steps to Successful Calibration:
Do:
Dexcom G5x System User Guide
118
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1. Wash and dry your hands before staking a fingerstick measurement.
2. Always use the same meter you routinely use to measure your BG.
a. BG meter and strip accuracy vary between meter brands.
b. Switching within a session might cause sensor glucose
readings to be less accurate.
3. Follow meter’s instructions exactly when taking your fingerstick
measurement.
4. Verify test strips are current and, if required, coded correctly with
meter.
5. Check: Is Bluetooth on?
a. If off, can’t calibrate
6. Use fingerstick BG values only.
a. Other sites are not as accurate.
b. Must enter within five minutes of taking BG meter value.
c. Enter exact BG value from your meter for each calibration.
Don’t:
7. Don’t take acetaminophen-containing medication during your session
(for example, Tylenol).
a. See your healthcare professional to better understand how
long acetaminophen is active in your body.
8. Don’t calibrate if your BG values are under 40 mg/dL or over 400
mg/dL.
a. If BG value is outside of this range, receiver doesn’t
understand these values and won’t calibrate.
i. You must wait until your BG is in the range to
calibrate.
9. Don’t calibrate if trend arrows are going straight up or down
a. Glucose is changing too quickly for an accurate calibration.
Be safe—if BG is low, first treat low blood sugar, and then calibrate.
7.7 Ready? Set? Calibrate!
You’ve followed the nine steps above, have a valid BG value from your meter,
and your display device keeps alerting you: Calibrate! Calibrate! Calibrate!
Remember:
Dexcom G5x System User Guide
119
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
You don’t have to take a fingerstick measurement for each display device
when calibrating. Once you enter the reading into one, data is pushed to the
other within ten minutes.
Next are steps to enter your calibrations using the app, followed by the steps
for entering your calibrations into the receiver.
Startup Calibration in the App
Step
What you see
What you do
Additional Info
Tap circle.
Startup
calibration: Enter
two back-to-back
meter BG values.
Update
calibration: Enter
one meter BG value.
Dexcom G5x System User Guide
120
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Enter meter’s BG
value using number
pad.
Tap Save.
Additional Info
Double-check your
numbers.
Entering wrong
values, or values
taken more than five
minutes ago, can
affect the sensor’s
accuracy.
Verify value is
correct.
Tap Save.
If not correct:
Tap Cancel.
Reenter correct
value.
Dexcom G5x System User Guide
121
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Tap circle to enter
your second BG
value.
Follow steps 2-3
and enter second
reading.
Meter icon has no
calibration
notification.
Calibration
accepted.
Dexcom G5x System User Guide
Additional Info
Your calibration was
successful.
122
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Additional Info
W ait for next
calibration
notification in 12
hours.
Default Home trend
screen.
Calibration
accepted.
Startup Calibration W ith Your Receiver
Step
What you see
Dexcom G5x System User Guide
What you do
Additional Info
Press Select to turn
on receiver.
You won’t see
calibration
notifications when
receiver screen is
black.
Press Select again
for Main Menu.
123
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Additional Info
Press Up/Down
Arrow.
Highlight Enter
BG.
Press Select.
Press Up/Down
Arrow to change
numbers.
Stop at meter’s BG
value.
Press Select.
4a
Verify BG value is
correct.
If correct:
Press Select.
Dexcom G5x System User Guide
Sensor default
reading is 120
mg/dL.
If sensor glucose
reading is within the
last 15 minutes,
screen will show
sensor’s actual
reading.
If Select is not
pressed:
•
Receiver
times out
•
BG level isn’t
recorded
124
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Verify BG value is
correct.
If incorrect:
4b
Press Right Arrow
to Cancel.
Press Select.
Additional Info
Cancel and reenter
BG value.
Fingerstick
measurement must
be within the last
five minutes.
Reenter BG value.
“Thinking” screen.
Wait.
Immediately take
another meter
reading.
Enter meter’s BG
value.
Dexcom G5x System User Guide
BG value is
accepted.
First calibration
accepted.
Time for second
calibration.
125
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Additional Info
W ait for next
calibration
notification in 12
hours.
Default trend
screen.
Calibration(s)
accepted.
7.8 Calibration Errors
Before or during your calibration process, your display device may show error
notifications. If the notifications don’t go away after 15 minutes, refer to
Chapter 18, Troubleshooting.
Calibration Error Notifications
Device
What you see
What it means
Smart
Device:
In App
W ait 10-15
minutes.
Sensor can’t
calibrate now.
Receive
Dexcom G5x System User Guide
What you do
Retake fingerstick
measurement at
notification.
Enter BG value.
126
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Smart
Device:
In App
System didn’t
accept recent
calibration.
Receive
What you do
Additional
calibration needed
immediately.
Calibrate.
No sensor glucose
readings.
Approximately five minutes after entering your second BG meter value, your
display device(s) will start providing sensor glucose readings and glucose
level trends. While each display device may have different ways of presenting
sensor glucose readings and trends, the meanings are the same.
Fingerstick measurements entered into one device will be available in the
other approximately ten minutes after entering data.
Summary
Now You Can:
•
•
•
Calibration overview
Define calibration
Explain the importance of calibration
Identify steps to ensure a successful calibration
Recognize steps required to take accurate BG measurements
Identify the best BG site for calibrations
Prepare finger for fingerstick measurement
Determine if you should/should not calibrate
Dexcom G5x System User Guide
127
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
o
Recognize when you can enter BG meter values
Recognize when you should not enter BG meter values
Determine if you need to calibrate outside of the normal
calibration guidelines
•
Initiate startup calibration
•
Perform update calibrations
•
Correctly enter your fingerstick measurement
•
App
Receiver
Identify calibration errors
W hat’s Next?
In the next chapter, you’ll learn how to end a typical seven-day sensor
session, what to do if you need to end your sensor session early, along with
how to remove the transmitter and determining if you need to replace it.
Dexcom G5x System User Guide
128
Calibration
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 8
Let’s G5x! The Basics:
Ending Your Sensor Session and Transmitter Session
8.1 Introduction
G5x sensor sessions last seven days. This chapter reviews what you should
expect when your session is about to expire, and removing the sensor and
transmitter. It also covers how to determine if you need to end your session
early.
After this chapter, you will be able to:
•
Identify replace sensor notifications at the end of a seven-day sensor
session
•
Recognize when you have to end a sensor session early
•
Successfully end a sensor session early
•
Remove your transmitter holder with transmitter attached
•
Separate transmitter from its holder
•
Determine if transmitter can be used for another sensor session
•
Pair a new transmitter
Identify how you can prevent sensor session failures
To keep up with your glucose trends, it’s important to begin a new sensor
session as quickly as possible. After a sensor session ends, the sensor stops
taking your sensor glucose readings. You won’t get your trends, nor will you
get any Alarm or Alerts.
Before stopping a session and removing the transmitter and its holder, review
the following safety statements to make sure you don’t harm yourself.
8.2 Safety Statements
Dexcom G5x System User Guide
129
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
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: TechSupport@dexcom.com
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
W hy: 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.
Precaution
Don’t: When ending a session, don’t throw away the transmitter.
Do: Keep using it until the system notifies you the transmitter battery is
about to expire.
W hy: The transmitter is reusable and can be used in multiple sensor
sessions.
8.3 Ending Your Sensor Session
There are different ways your session might end.
Dexcom G5x System User Guide
130
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The most common is your sensor’s typical seven-day time frame ended. The
second is ending the sensor session early. You may end a session early
based on a personal decision, or, on rare occasions, the receiver or app
detects sensor issues and notifies you to end the session.
Let’s review ending a normal session first; later in this chapter we’ll review the
notifications for ending the session early.
Ending Your Seven-Day Sensor Session
Just like other notifications, your sensor session ending notifications need
clearing:
•
App
•
Tap screen
Receiver
Press Select
End of Seven-Day Sensor Session Notifications
Ending Sensor Session Notifications
Device
What you see
What it means
At Six Hours
Dexcom G5x System User Guide
131
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Smart
Device: Lock
Screen
Notifications begin when sensor
session has only six hours left.
Clock will count down until
session has ended.
Smart
Device:
In App
Continue to get sensor glucose
readings.
Receiver
Device
What you see
What it means
At Two Hours
Dexcom G5x System User Guide
132
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Smart
Device: Lock
Screen
Two hours remain on your
current sensor session.
Smart
Device:
In App
Continue to get sensor glucose
readings.
Receiver
Device
What you see
Dexcom G5x System User Guide
What it means
133
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
At Thirty Minutes
Smart
Device: Lock
Screen
Smart
Device: In
App
Thirty minutes remain.
Continue to get sensor glucose
readings.
Receiver
Dexcom G5x System User Guide
134
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Session Ended
Smart
Device: Lock
Screen
What
see
Session has ended.
App
Smart
Device: In
App
Tap screen’s “?” for steps to:
•
•
Remove sensor
Insert new sensor
Receiver
Press Select to clear.
Receiver
Dexcom G5x System User Guide
135
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Session Stopped
Smart
Device: Lock
Screen
N/A
Sensor session has stopped.
App
•
Smart
Device:
In App
•
No sensor glucose
readings
Notifications for new
session
Receiver
No sensor glucose readings
Receiver
•
Straight line on trend
graph
•
Dashed lines on status
bar
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide beep/vibration notifications to remind you your sensor session will end
in 30 minutes, it has just ended, or your sensor failed and you need to start a
new session. Remember, if your smart device is on Silent or Do Not Disturb,
you won’t get any sound notifications.
For more information on setting your sound/vibration notifications, please see
Chapter 9.
Smart Device
Your smart device notifications you with a triple beep. If not cleared, you
receive the triple beep twice, five minutes apart.
Receiver
Dexcom G5x System User Guide
136
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The receiver alerts you with an initial vibration notification. If not cleared, you
receive a vibrate/beep twice, five minutes apart.
Once a sensor session has expired, you are ready to start your new session!
If you’re not sure what to do, the app will provide instructions, or you can refer
to the Getting Started Guide, online tutorials, or Chapter 6 in this user guide.
Ending Your Sensor Session Early
For personal reasons, you may want to force quit a sensor session early (for
example, you’re getting an MRI and need to remove all parts of the system).
Or, occasionally, the app or receiver may detect something is wrong with your
sensor and let you know it’s stopping the current session.
This may be caused by a number of reasons:
1. Unresolved calibration issues.
2. Error symbol does not go away.
3. Wait symbol does not go away.
4. Sensor is coming out of the body (for example, the adhesive is
peeling off).
You’ll receive error notifications leading to a new sensor session. If you see
error notifications, before stopping a sensor session early, always contact
Technical Support (available 24/7) at:
•
Email: TechSupport@dexcom.com
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
When your display device has system errors, you may not receive any sensor
glucose readings and you should not calibrate.
Notifications to End Sensor Session Early
System Notifications
Device
What you see
Dexcom G5x System User Guide
What it means
137
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Smart
Device: Lock
Screen
Sensor issues detected.
Smart
Device:
In App
Session ends automatically.
No:
•
•
Sensor Glucose
Readings
Alarm/Alerts
Replace sensor.
Receiver
Device
What you see
Smart
Device: Lock
Screen
Dexcom G5x System User Guide
What it means
Wait up to three hours while the
system autocorrects.
138
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Smart
Device:
In App
What it means
Check transmitter—is it properly
inserted into transmitter holder?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
•
Contact Dexcom
Technical Support
Receiver
Smart
Device: Lock
Screen
Smart
Device:
In App
Wait up to three hours while the
system autocorrects.
Check transmitter—is it properly
inserted into transmitter holder?
Make sure you haven’t taken
acetaminophen.
If not corrected after 3 hours:
Receiver
•
Contact Dexcom
Technical Support
The G5x knows when a typical seven-day sensor session is over,
automatically ending the session in each display device. However, if you need
to end the session early, you need to let the system know by manually
stopping the sensor session.
Dexcom G5x System User Guide
139
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
While the end result is the same (ending a sensor session), the steps differ
between the app and receiver. If you’re using both, no need to stop the sensor
session in each: the other display will see the session has stopped.
Let’s first look at how to end a sensor session in the app, then the receiver.
App: Ending a Sensor Session Early
Step
What you see
What it means
What you do
Access Main Menu.
Tap Main Menu
icon.
Dexcom G5x System User Guide
140
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Ends sensor
session.
During session:
Stop Sensor
option
appears
Not in active
session:
•
•
Dexcom G5x System User Guide
Tap Stop Sensor.
Start Sensor
option
appears
141
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Blue ? icons provide
additional
information.
Tap Stop Sensor.
Confirms sensor
session has ended.
Ready for new
session.
Remove sensor.
Insert new sensor.
Tap green circle
when ready for new
session.
Receiver: Ending a Sensor Session Early
Step
What you see
What it means
What you do
Go to Main Menu.
Press Select.
Dexcom G5x System User Guide
142
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
Ends sensor
session.
During session,
Stop Sensor option
appears.
Thinking screen.
Confirms you want
to stop sensor.
Return to Main
Menu.
What you do
Press Down Arrow
to Stop Sensor.
Press Select.
W ait
Press Select.
Ready to start a new
session.
Remove sensor.
Not in active
session, Start
Sensor option
appears.
Press Select to
Start Sensor when
ready for new
session.
Insert new sensor.
Temporarily Shut Down Receiver
Dexcom G5x System User Guide
143
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
To save on its battery, you can temporarily shut down the receiver. When shut
down, your receiver and transmitter no longer communicate and you will not
get any Alarm or Alerts although your sensor session remains active.
Shutting down the receiver does not extend your sensor session past the
seven days; it only stops the receiver from communicating with the
transmitter. Your sensor session will stop seven days after you started the
session.
Receiver: Temporary Shutdown
Step
What you see
What it means
What you do
Go to Main Menu.
Press Select.
Ends sensor
session.
During session,
Stop Sensor option
appears.
Confirms you want
to shut down.
Press Down Arrow
to Stop Sensor.
Press Select.
Press Select.
Shuts down
receiver.
Press Select to turn the receiver back on. It may take up to 20 seconds for
the receiver to turn on.
Preventing Sensor Failures
Dexcom G5x System User Guide
144
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Sensor failures can happen when your display device doesn’t receive your
sensor’s glucose readings. While it is rare to have a sensor failure, there are
preventative steps you can take.
Help prevent sensor failures by checking:
1. Sensor hasn’t expired.
2. Transmitter is snapped securely into its holder.
3. Transmitter holder isn’t dislodged or adhesive isn’t peeling.
4. Nothing is rubbing against transmitter holder (for example, seat belts).
5. You selected a good insertion site (see Chapter 6).
6. Insertion site is clean and dry before sensor insertion.
8.4 Remove Sensor, Transmitter, and Transmitter
Holder
The app and receiver are ready for a new session! However, before you can
start a new sensor session, you need to end the current sensor session, and
remove the old sensor and transmitter.
Removing Transmitter Holder and Sensor
Think of the transmitter as being part of the transmitter holder. Do not remove
the transmitter before removing the transmitter holder from your body.
To remove the transmitter holder:
1. Gently peel transmitter holder adhesive patch from skin.
a. Sensor wire comes out with transmitter holder.
2. Separate the transmitter from the transmitter holder.
3. Discard the transmitter holder following your local waste management
regulations for disposing of blood-contacting parts (sensor and
transmitter holder).
Removing Transmitter From Its Holder
Remember, your transmitter is reusable, don’t throw it away until its battery
has died. With a battery life of 90 days, use the same transmitter over a
number of sensor sessions. You’ll receive notifications as it nears the end of
its battery life.
Dexcom G5x System User Guide
145
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Before reusing the transmitter in your new sensor session, remove it from the
old transmitter holder.
Removing Sensor, Transmitter, and Transmitter Holder
Step
Picture
What you do
Grasp end of adhesive patch.
Peel adhesive patch up and away from
your body like a bandage, removing sensor,
transmitter, and its holder.
NOTE: Do not remove the transmitter while
the adhesive patch is on your skin.
Hold transmitter holder in your hand.
Bend and break latch, releasing the
transmitter.
Dexcom G5x System User Guide
146
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
What you do
Hold ridged side
Pull transmitter straight out
Keep transmitter to use with next sensor.
Throw away adhesive patch, transmitter
holder, and sensor following your local
guidelines for disposal of blood-contacting
components.
After removing your sensor and taking the transmitter out of the transmitter
holder, you’re ready to begin a new sensor session. The transmitter’s battery
is good for up to three months. If you haven’t received your final seven-day
transmitter battery life warning, you can reuse the transmitter for your next
session.
Remember:
1. Never use same spot repeatedly for sensor insertion.
Dexcom G5x System User Guide
147
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2. Never use same site for 2 sensor sessions in a row.
8.5 End of Transmitter Battery
How do you know if your transmitter’s battery will last through your next
session?
System messages help you determine if your transmitter’s battery will last
through your next seven-day session. Starting at three weeks prior to the end
of its battery life, the messages count down the transmitter’s battery until it
has only seven days. If the transmitter battery has seven days or less
remaining, you won’t be able to start a new session.
Transmitter Battery Messages
Device
What you see
What it means
Smart
Device: Lock
Screen
Transmitter battery will expire in
three weeks.
Smart
Device: In
App
Dexcom G5x System User Guide
148
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
What you see
What it means
Receiver
Device
Smart
Device: Lock
Screen
Smart
Device: In
App
Transmitter battery will expire in
two weeks.
Order a new transmitter.
Receiver
Dexcom G5x System User Guide
149
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Smart
Device: Lock
Screen
Smart
Device: In
App
Transmitter battery will expire in
one week.
Order a new transmitter.
Receiver
To make sure you have a transmitter that’s ready for a new sensor session,
you may want to reorder a new one at.dexcom.com/order, by calling
Customer Service (see Section 16.1), or through the channels you used
before, at your first low battery notification.
Sound/Vibration Notifications
In case you can’t look at your screen, both the smart device and receiver
provide beep/vibration notifications to tell you your transmitter’s battery is low
or the transmitter failed. Remember, if your smart device is turned on to Silent
or Do Not Disturb, you won’t get any sound notifications.
Dexcom G5x System User Guide
150
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
For more information on setting your sound/vibration notifications and how to
clear them, please see Chapter 9.
Smart Device
Your smart device notifies you with a triple beep. If not cleared, you receive
the triple beep twice, five minutes apart.
Receiver
The receiver alerts you with an initial vibration notification. If not cleared, you
receive a vibrate/beep twice, five minutes apart.
8.6 Pair New Transmitter
Once the transmitter battery has died, before starting a new sensor session,
you need to pair your new transmitter with your display device(s). In Chapter 5
you learned how to pair your transmitter using the set up wizard. But how do
you pair a new transmitter once your display device is setup?
Pair the transmitter before inserting the sensor, putting the transmitter in the
transmitter holder, and starting a new sensor session.
App
Step
Picture
What you do
Tap Menu icon
Dexcom G5x System User Guide
151
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
What you do
Tap Settings
Tap Transmitter
Dexcom G5x System User Guide
152
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
What you do
Tap Pair New
If you still have transmitter package:
5a
Turn transmitter box upside down on a
flat surface with barcodes facing up.
Dexcom G5x System User Guide
153
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
5b
What you do
Center longest barcode within green
brackets.
Tap Take Photo
5c
Check mark confirms successful transmitter
SN scan.
Dexcom G5x System User Guide
154
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
6a
What you do
If unable to use app’s scanning device:
Tap Enter transmitter SN by hand.
Use keyboard to enter transmitter SN.
6b
Confirm correct SN .
Tap Save.
Dexcom G5x System User Guide
155
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
What you do
W ait up to 30 minutes for smart device and
transmitter to connect.
At notification, Tap Pair to pair app with
smart device.
Before inserting the transmitter into its
holder and starting a new sensor session,
make sure your smart device and
transmitter are paired
Dexcom G5x System User Guide
156
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Step
Picture
5a
What you do
Press Left Arrow twice to go to Main Menu.
Press Down Arrow to Settings.
Press Select.
Press Down Arrow to Transmitter.
Press Select.
Highlight Transmitter SN.
Press Select.
Turn transmitter box upside down to
locate SN number.
Dexcom G5x System User Guide
157
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
Picture
What you do
If transmitter package isn’t available:
5b
•
SN is on transmitter’s back
Enter correct SN using Up/Down Arrow.
Press Up/Down Arrow to select and enter
transmitter SN.
Press Right Arrow to move to next digit.
Press Select to save and close.
Press Left Arrow twice to return to Main
Menu.
Make sure receiver and transmitter are
connected/paired.
Check receiver 10 minutes after starting for
Bluetooth icon.
•
Solid: Connected/paired
•
Blinking: Searching,/not paired
Don’t insert the transmitter into its holder or
start a new sensor session until they are
paired.
Summary
Now You Can:
•
Identify replace sensor notification at the end of a seven-day sensor
session
Dexcom G5x System User Guide
158
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
Recognize when you have to end a sensor session early
•
Successfully end a sensor session early
•
Identify how you can prevent sensor session failures
•
Remove your transmitter holder with transmitter attached
•
Separate transmitter from transmitter holder
•
Determine if transmitter can be used for another sensor session
•
Pair new transmitter
W hat’s Next?
Congratulations, you have the basics down!
You can set up your app and receiver, start a sensor session, calibrate, as
well as end your sensor session and know when to replace your transmitter.
But the G5x can do much more!
In the next part, Part 3: Next Steps, you will learn how to get the most out of
your G5x.
Dexcom G5x System User Guide
159
Ending Your Sensor Session and Transmitter Session
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
3
NEXT STEPS - GETTING THE MOST
OUT OF YOUR G5x
•
Reading Trend Graph Screens and Recognizing Trends
•
Events
•
Alarm and Alerts
•
Sounds for Alarm, Alerts, and System Messages
Dexcom G5x System User Guide
160
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 9
Next Steps:
Home Screen, Rate of Change Arrows, and Errors
9.1 Introduction to Home Screens
In the previous chapter, you learned about calibrations: why they are
important and how to do them. Within five minutes of your final startup
calibration your sensor glucose readings begin!
In this chapter, you’ll learn three things. First, reading the home screen,
second, identifying your sensor glucose readings and trends: What do they
mean? What’s the best way to use trend information? And third, what you do if
you aren’t getting your sensor glucose readings.
The purpose of this chapter isn’t to tell you how to react to your trends but to
help you recognize where your glucose was and where it’s going. Your
healthcare professional can help you with your questions on what actions to
take based on your glucose trends.
After this chapter, you’ll be able to:
•
Recognize home screen icons
•
Locate sensor glucose reading
•
Explain sensor glucose target range
•
Recognize the importance of gray, yellow, and red colors
•
Identify Low/High Glucose Alert levels on your trend graph
•
Describe when you receive a High or Low sensor glucose reading
•
Change trend graph views
•
Cite differences between rate of change arrows
•
Recognize error messages
9.2 Safety Statements
Dexcom G5x System User Guide
161
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Take a moment and read the safety statements. If not followed, your sensor
glucose readings and trends may be less accurate, and you may miss
important High or Low Glucose Alerts.
Contraindication
Don’t: Take medications with acetaminophen while wearing the sensor.
W hy: 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 sensor inaccuracy:
• Depends on amount of acetaminophen active in your body.
• May be different for each person.
Consequences: Without correct readings you might miss a severe low or
high glucose event.
W arning
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..
W hy: 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.
Dexcom G5x System User Guide
162
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
Don’t: Ignore symptoms of high and low glucose.
Do: If your sensor glucose readings don’t match your symptoms, measure
your BG with a fingerstick.
W hy: Your sensor glucose readings may not be accurately reading your
glucose.
Consequences: You may miss a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each.
W hy: If you set up one device and then use another device with different
settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
W hy: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device causing you to miss severe low or high glucose
event.
9.3 Overview of Home Screen
Regardless of your display device, the home screen shows your current
sensor glucose value, glucose trend, rate of change arrow, and CGM system
Dexcom G5x System User Guide
163
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
status. While the screen does look different between the receiver, smart
devices, along with the Apple Today View, and Apple Watch the information
and color-coding are the same.
No matter how you hold it, the receiver’s view does not change. The app,
however, has two ways to view data based on how you hold your smart
device:
1. Vertically in portrait: 3-hour trend information with task bar.
2. Horizontally in landscape: 1, 3, 6, 12, or 24-hour trend information
without task bar.
This section first familiarizes you with the app’s home screen, the Apple
Today View, then the receiver’s home screen, and last with the Apple Watch
home screen. In other chapters, you’ll see how to use the icons or use the
navigation wheel to enter data or make system changes.
App Home Screen
The app’s home screen has two main sections:
1. Status/Task Bar
a. Status Bar reflects status of smart device’s system.
i. Battery, Bluetooth, etc.
b. Task Bar allows you to change settings, enter data, etc.
2. Glucose Information
a. Reflects sensor glucose readings and trends.
Status and Task Bar
Task Bar
Glucose
Information
Dexcom G5x
System User
Guide
164
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Figure 6. Example App Home Screen on Smart Device
App Task Bar
App
Name
What it means
What you do
Displays signal
strength, time,
Bluetooth, and
battery level.
Time:
Status Bar: Information Only
Status Bar
Changes are
made using
smart device
settings, not in
the app.
May look
different
depending on
your smart
device/carrier.
Check smart
device and
receiver show
same time.
Bluetooth:
Check Bluetooth
is on.
Battery:
App can use up
battery—Check
you are
charged.
Task Bar: Complete Tasks
Dexcom G5x System User Guide
165
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
App
Name
What it means
What you do
Tap Main Menu
icon to access:
•
•
•
•
Alerts
Settings
Help
Start/Stop
Sensor
Main Menu
Goes to other
options.
BG Meter
with red
circle and
number
Calibration
Notification.
Tap icon and
enter fingerstick
BG value (see
Chapter 7).
BG Meter
without red
circle
No need to
calibrate.
Do nothing.
Tap icon to
enter data for:
Event
Enter different
events capturing
activities
affecting your
glucose.
• Carbs
• Insulin
• Exercise
• Health
(See Chapter
10).
Dexcom G5x System User Guide
166
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
App
Name
Dexcom
Share
Dexcom
Share
What it means
Dexcom Share
is available only
on the app.
Gray icon
means Share is
not active.
Once activated,
Dexcom Share
icon is colored.
What you do
Tap icon to
activate (see
Part 5).
Do nothing.
Tap icon to
access Dexcom
Share.
Glucose Information
App: Portrait
App: Landscape
What it means
Home Screen
In Landscape mode,
Tap the trend view
you want to see at
the top of the screen:
1, 3, 6, 12, or 24-hour
historical trend views.
Dexcom G5x System User Guide
167
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
App: Portrait
App: Landscape
What it means
Number: Most
recent sensor
glucose reading.
Shown in milligrams
per deciliter (mg/dL).
• Yellow: At or
above target
• Gray: Within
range
• Red: At or below
target
Historical
Readings
Turn smart device to
Landscape mode.
N/A
Tap time shows time
frame’s sensor
glucose reading.
Slide finger across
screen to view rest of
day’s sensor glucose
readings.
Dexcom G5x System User Guide
168
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
App: Portrait
App: Landscape
What it means
Rate of Change
Arrow
N/A
Direction and number
of arrows show
sensor glucose
change rate.
Sensor Glucose
Reading Range
Shows between 40400 mg/dL.
Dexcom G5x System User Guide
169
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
App: Portrait
App: Landscape
What it means
W ithin Glucose
Range and Alert
Levels
• Yellow: High
Alert level
• Gray: Within
range
• Red: Low Alert
level
Trend Graph Time
Frame
Default is most recent
3 hours.
Turn smart device to
Landscape mode for
most recent 1, 3, 6,
12, and 24-hour
readings.
Dexcom G5x System User Guide
170
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Apple Today View Widget
Check your CGM on your smart device without opening the app, even when
the smart device is locked. Swipe down from the top edge of your smart
device to find the Dexcom widget in your Today view; the widget installs when
you install the app. (See your smart device instructions for customizing your
Today view.)
Apple Today View
Apple Today View
Name
What it does
What you do
Glucose Information
Displays your
glucose
information:
Glucose
Information
Dexcom G5x System User Guide
•
Current
glucose
number
•
Direction
your
glucose is
heading
•
Graph of
glucose
trend
Review and take
appropriate
action.
171
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Apple Today View
Name
What it does
What you do
Shows most
recent sensor
glucose reading.
Color of circle
changes:
Sensor
Glucose
Reading
• Yellow: At
or above
target
Take
appropriate
action.
• Gray: Within
target range
• Red: At or
below target
Trend Arrow
Dexcom G5x System User Guide
Shows direction
and speed your
glucose is
changing.
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
172
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Apple Today View
Name
What it does
What you do
Graph of your
recent glucose
readings
between 40 and
400 mg/dL.
Glucose target
range Alert
settings:
Historical
Readings
•
Yellow Line:
High Alert
setting
•
Gray: Target
range
•
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
Red Line:
Low Alert
setting or, if
that’s
disabled, 55
mg/dL
(Urgent Low
Glucose
Alarm)
Receiver Home Screen
This section gets you familiar with the receiver’s home screen. In other
chapters, you’ll see how to enter data or make system changes.
Dexcom G5x System User Guide
173
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver Home Screen
Unlike your smart device screens, the receiver’s screen is not interactive; all
notifications are for information only. To make changes or enter data in the
receiver, press Select and go to the Main Menu.
The receiver’s home screen has two main sections:
1. Status Bar
a. Reflects glucose trends, readings, status of receiver’s system
(e.g., battery level).
2. Glucose Information Trend Graph
a. Reflects sensor glucose readings and trends.
This section will get you familiar with the receiver’s home screen. In other
chapters, you’ll see how to use the navigation wheel to enter data or make
system changes.
Status Bar
Glucose
Information
Figure 7. Home Screen on Receiver
Dexcom G5x System User Guide
174
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Status Bar
Receiver
Name
Status Bar
What it does
What you do
Provides at-aglance
information
about the
receiver,
system, or you.
Review and take
appropriate
action.
Icons will
change based
on current data.
Battery
Shows battery
level.
Bluetooth
Shows
Bluetooth
connection is
working.
Dexcom G5x System User Guide
When low, plug
micro USB
cable into
receiver.
Plug USB into
the adapter and
then into
electrical outlet.
Do nothing.
Receiver’s
Bluetooth is
always on.
175
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Name
Sensor
Glucose
Reading
Trend Arrow
What it does
Shows most
recent sensor
glucose reading.
Color of status
bar changes:
• Yellow: At
or above
target
• Gray: Within
target range
• Red: At or
below target
Shows direction
and speed your
glucose is
changing.
Far right.
Status Area
Dexcom G5x System User Guide
Error icons and
calibration
notifications.
What you do
Take
appropriate
action.
Review and take
appropriate
action based on
fingerstick BG
value.
Take
appropriate
action.
176
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Glucose Information
Receiver
What it does
Home screen.
Number: Most recent sensor glucose reading.
Shown in milligrams per deciliter (mg/dL). Color of
status bar changes:
•
•
•
Yellow: At or above target
Gray: Within target range
Red: At or below target
Historical Readings
Default is most recent 3 hours.
Press Up/Down Arrows to access 1, 3, 6, 12, or 24hour trend views.
Rate of Change Arrow
Direction and speed of your glucose changes.
Dexcom G5x System User Guide
177
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
What it does
Sensor Glucose Reading Range
Shows between 40-400 mg/dL.
Glucose target range Alert settings.
•
•
•
Yellow: High Alert setting
Gray: Target range
Red: Low Alert setting
Now that you’re familiar with the basic layout of the trend graph screen, can
locate readings, identify color-coding, and view time frames, let’s take a closer
look at the rate of change arrows.
Apple Watch Home Screen
This section gets you familiar with the Apple Watch home screen.
Like your smart device, your Apple Watch has a touchscreen.
Dexcom G5x System User Guide
178
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Apple Watch
Receiver
Name
What it does
What you do
Displays your
glucose
information:
Apple Watch
Home
Screen
Sensor
Glucose
Reading
Dexcom G5x System User Guide
•
Current
glucose
number
•
Direction
your
glucose is
heading
•
Graph of
glucose
trend
Shows most
recent sensor
glucose reading.
Review and take
appropriate
action.
Take
appropriate
action.
179
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Receiver
Name
Trend Arrow
What it does
What you do
Shows direction
and speed your
glucose is
changing.
Review and take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
Graph of your
recent glucose
readings
between 40 and
400 mg/dL.
Glucose target
range Alert
settings:
Historical
Readings
•
•
•
Dexcom G5x System User Guide
Yellow: High
Alert setting
Gray: Target
range
Red: Low
Alert setting
or, if that’s
disabled, 55
mg/dL
(Urgent Low
Glucose
Alarm)
Review 3-hour
trend graph; no
other views are
available. Take
appropriate
action based on
fingerstick BG
value.
(See Chapter 9)
180
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
9.4 Rate of Change Arrows
Not sure of how your sensor glucose readings are trending?
Rate of change arrows show the speed and direction of your glucose trends
based on the last several sensor glucose readings. Arrows and the trend
graph help you know when to take action before you are too high or too low.
However, before doing anything, think about your most recent insulin dosing,
food intake, overall trend graph, and current BG value. Don’t overreact to
the arrows. Remember the arrows don’t reflect your latest reading: they
reflect a combination of recent readings.
Rate of Change Arrows
App
Receiver
What your glucose is doing
Steady
Changing:
•
Less than 1 mg/dL each minute
Up to 15 mg/dL in 15 minutes
Slowly Rising or Falling
Changing:
•
1-2 mg/dL each minute
Up to 30 mg/dL in 15 minutes
Rising or Falling
Changing:
•
2-3 mg/dL each minute
Up to 45 mg/dL in 15 minutes
Dexcom G5x System User Guide
181
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Rapidly Rising or Falling
Changing:
•
More than 3 mg/dL each minute
More than 45 mg/dL in 15 minutes
System can’t calculate the speed and
direction of your glucose change.
There are a number of reasons why you may not get rate of change arrows:
•
You just started your sensor session
•
No sensor glucose readings over the last few minutes
9.5 Error Messages
Sometimes the transmitter or sensor isn’t communicating with the display
device, causing you not to get your sensor glucose readings or rate of change
arrows. Each device notifies you when there is an issue; however, the
notifications look different.
Before the system can move forward, you need to address the error.
App
1. If screen is locked:
a. Swipe message to go to app.
2. Within app:
a. Read message.
i. Tap Question Marks for more information and follow
steps as appropriate.
Receiver
1. Press Select to clear message.
You will not get any sensor glucose readings or rate of change arrows on
either display device until the error is resolved. Check with your BG meter to
monitor your glucose during these error periods.
Error Messages
Dexcom G5x System User Guide
182
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What you do
Bluetooth Is Out of Range
Smart
Device:
Lock Screen
Make sure there are no
obstructions, such as a wall or
water between your transmitter and
your display device.
Smart
Device:
In App
Move within 20 feet of display
device.
Wait up to 30 minutes while
transmitter restores communication.
Receiver
Bluetooth Off
Smart
Device:
Lock Screen
Smart device:
1. Exit app.
Smart
Device:
In App
2. Tap Settings.
3. Tap Bluetooth.
4. Turn Bluetooth on.
Receiver
N/A; Bluetooth is
always on.
Dexcom G5x System User Guide
183
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What you do
Not Getting Sensor Glucose Reading
Smart
Device:
N/A
Lock Screen
Smart
Device:
In App
Check—Are you:
•
N/A
•
•
Receiver
•
Within 20 feet of your
display device?
In your two-hour warmup
period?
Outside of your calibration
schedule?
In a sensor session?
System Found Temporary Sensor Issue
Smart
Device:
N/A
Don’t calibrate.
Lock Screen
System may correct problem on its
own and display sensor glucose
readings again.
Smart
Device:
In App
If notification stays for three hours:
Dexcom G5x System User Guide
•
Contact Technical Support
(see Section 16.1).
184
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What you do
Receiver
Transmitter and Sensor Not Communicating
Smart
Device:
N/A
Wait three hours while the
transmitter tries to fix the error.
Lock Screen
Do not enter calibrations during this
time.
Smart
Device:
In App
Make sure your transmitter is
properly inserted into the
transmitter holder.
If not corrected:
•
Receiver
•
•
Contact Technical Support
(see Section 16.1)
Remove sensor
Insert new sensor
Calibration Required
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
Error in calibrating.
Verify you did not enter a BG
reading outside the range of 40-400
185
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What you do
mg/dL.
Enter another BG meter value.
Smart
Device:
In App
Receiver
Calibration Error
Smart
Device:
N/A
Lock Screen
Smart
Device:
In App
Wait 15 minutes.
Enter a BG meter value.
If error screen still appears, enter
one more BG meter value.
Wait 15 minutes.
If no sensor glucose readings
appear on the display, the sensor
needs to be replaced.
Contact Technical Support
(available 24/7) at:
•
TechSupport@dexcom.co
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
Receiver
Dexcom G5x System User Guide
186
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What you do
Display Devices and Transmitter Not Communicating
Smart
Device:
App/Receiver
Lock Screen
Wait 10 minutes.
Smart
Device:
In App
Move display device and transmitter
within 20 feet of each other without
obstruction (walls or water).
Wait up to 30 minutes.
In app (if not resolved):
Receiver
•
Tap Settings.
•
Tap Bluetooth.
•
Turn Bluetooth Off and On.
If error messages don’t go away after you followed necessary steps, and you
aren’t getting sensor glucose readings, contact Technical Support (see
Section 16.1).
Now You Can:
•
Recognize home screen icons
•
Locate sensor glucose reading
•
Explain glucose target range
•
Recognize the importance of gray, yellow, and red colors
•
Identify Low/High Glucose Alert setting lines
•
Describe when you receive a high or low sensor glucose reading
•
Change trend graph hours view
•
Cite differences between rate of change arrows
Dexcom G5x System User Guide
187
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
Recognize error messages
W hat’s Next?
By now you have a pretty good understanding of how your trends look on the
different display devices, but did you know what you do can affect your trends
and patterns? It’s important to track actions or well-being to better understand
that what you do or how you feel can change your trends.
In the next chapter, you will learn how to enter Events into your G5x.
Dexcom G5x System User Guide
188
Home Screen, Rate of Change Arrows, and Errors
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 10
Next Steps:
Daily Events Affect Your Glucose Trends and Patterns
10.1 Introduction
Your daily activities can impact your glucose trends and patterns. In the
previous chapter, you learned how to read your glucose trend screens; in this
chapter, you learn how to enter situations, or “Events.” By tracking Events,
you can determine how certain actions or circumstances affect your glucose
levels.
After this chapter, you’ll be able to:
•
Define Event
•
Describe each Event
•
Create Events
•
App
Receiver
Recognize Event markers on app
Describe how Event markers are different in portrait and
landscape view
•
Describe how to view Events entered via your receiver
•
View Event markers on your smart device
10.2 What Is an Event?
Did you take a walk after lunch today? Did you go to happy hour with your coworkers and have a beer? Are you feeling stressed? Did you catch your kid’s
sniffles? How much insulin did you take for your dinner meal? These are all
Events that can raise or lower your blood sugar.
Dexcom G5x System User Guide
189
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
An Event is an action or situation affecting your glucose levels. With the G5x,
you have the ability to enter your daily Events, helping you track their effect on
your glucose trends. Once entered into the smart device or receiver, Events
can be viewed in Dexcom reports. The reports help you review how each
Event influenced your glucose trends. You can use the reports with your
healthcare professional to create a game plan in managing your diabetes.
Even though they differ on how to enter an Event and time, the app and
receiver have the same Event categories and subcategories. Later in this
chapter, you’ll learn how to enter Events in each device.
Event Categories
There are four main Event categories:
1. Carbs
2. Insulin
3. Exercise
4. Health
The fourth category, Health, has more options:
•
Illness
•
Stress
•
Feel High
•
Feel Low
•
Cycle
•
Alcohol
The following table provides more detail on each type of Event.
Dexcom G5x System User Guide
190
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Events Menu
Device
What you see
What it means
What you do
Carbs
Smart
Device:
In App
How many grams
did you just eat?
Receiver’s screen
reflects last
number entered.
Enter Carb
grams per snack
or meal, up to
250 grams.
Receiver
Dexcom G5x System User Guide
191
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
What you do
Insulin
Smart
Device:
In App
Receiver’s screen
reflects last
number entered.
Enter insulin
units for each
dose, up to 250
units.
Can’t enter type
of insulin, only
dosage.
Receiver
Dexcom G5x System User Guide
192
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
What you do
Exercise
Smart
Device:
In App
Default is 30
minutes.
Select each
exercise’s
intensity level
and duration.
Enter intensity
and duration.
Type of exercise
isn’t an option.
Receiver
Dexcom G5x System User Guide
193
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
What you do
General wellbeing.
Enter different
health Events
(see following
Health Events
Menu table).
Health
Smart
Device:
In App
Receiver
Dexcom G5x System User Guide
194
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
What you do
Event time.
For each
separate Event,
enter date/time
Event began.
Event Time
Smart
Device:
In App ice
Receiver
As mentioned in the last table, Health has a series of Events. Tell the system
how you are feeling, if you had a drink, if you’re having low or high BG
symptoms, etc. You select the Event: no amounts are entered, just date and
time.
Dexcom G5x System User Guide
195
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Health Events Menu
Device
What you see
What it means
Health Main Menu
Smart
Device:
In App
Use Health Main Menu to access
selections.
Receiver
Dexcom G5x System User Guide
196
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
What it means
Health Main Menu
Illness
Smart
Device:
In App
Have a cold, flu, or any other
temporary illness affecting your wellbeing?
Stress
Are you under stress? Feeling
anxious?
High Symptoms
Feel high BG symptoms?
Low Symptoms
Feel low BG symptoms?
Cycle
Receiver
Have you started your menstrual
cycle?
Alcohol
Had a glass of wine, beer, or cocktail?
You can have multiple Events in a single day, or even during the same time
frame and enter them all in at the same time. As an example, you’re running
late because of traffic (Stress) and quickly swing by a drive-thru to get lunch
(Carbs of 85 grams).
Dexcom G5x System User Guide
197
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
For your convenience (and safety!), no need to stop everything and enter your
Events as they are happening. When you have a moment, you can enter your
Events retroactively in your app or receiver.
Events are entered as individual occurrences: don’t enter daily totals, enter
each Event separately.
In the next section, you will learn how to enter Events, first in your smart
device, then in your receiver.
10.3 Entering Events
You probably will enter Events in the display device you use most often;
however, you should know how to enter Events into each.
First, let’s look at how to enter Events in a smart device, then in the receiver.
When using Dexcom Share, you can allow your Followers to see your Event
entries. For more Dexcom Share information, please see Part 5.
Entering Events: Smart Device
In the app, Events are just a tap away! The Event icon, a running man, is on
the app’s home screen task bar in portrait mode (remember, you don’t have
the task bar in landscape).
Entering Events for the Carbs, Insulin, Exercise, and Health categories follows
the same steps. If you can enter a Carbs Event, you can enter an Insulin
Event. To enter Events, we’ll use the above scenario. The following table
shows how to enter Carbs (drive-thru lunch) and Stress (traffic jam) Events.
Entering Events: App
Step
What you see
What you do
Enter Carbs Event
Dexcom G5x System User Guide
Tap Running Man.
198
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Tap Carbs.
Enter Carbs Event
Using the above example, add up all
carb grams from lunch.
Enter “85” using keypad.
Tap Done.
Dexcom G5x System User Guide
199
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
4
Tap Event Time.
Enter Carbs Event
Dexcom G5x System User Guide
Scroll and select date and time.
Tap Done.
200
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
6
Tap Save or Cancel.
Enter Health Event - Stress
Dexcom G5x System User Guide
Tap Events icon.
201
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
8
Dexcom G5x System User Guide
Tap Health.
202
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Enter Health Event - Stress
10
Tap Stress.
Tap Done.
Tap Event Time.
Enter Health Event - Stress
Dexcom G5x System User Guide
203
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
11
12
Scroll and select date and time.
Tap Done.
Tap Save or Cancel.
View Events
13
Dexcom G5x System User Guide
Trend graph shows events.
Turn to landscape to see more
204
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The receiver and app don’t talk to one another. If you enter an Event only into
the receiver, while the information will appear on Dexcom reports, you won’t
get an Event marker on your app’s trend screen.
The app has Event markers on its screen, but the receiver doesn’t.
However, there may be times when you want or need to enter Events on the
receiver.
Entering Events: Receiver
While the Event data is the same between display devices, the flow is not the
same, including how to enter the Event’s date and time. The following table
reviews how to enter the same Carbs/Stress Event data from the previous
scenario: Carbs at 85, and a Stress Event.
Entering Events: Receiver
Step
What you see
What you do
Enter Carbs Event
Default screen
Press Select to go to Main Menu.
Press Down Arrow until Events is
highlighted.
Press Select.
Dexcom G5x System User Guide
205
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
3
Highlight Carbs.
Press Select.
Add up all carb grams from lunch.
Arrow up to “85.”
Press Select.
Enter Carbs Event
Press Left/Right Arrows to change time
and date.
•
Left: Backwards
•
Right: Forward
Press Select.
Confirmation screen.
Press Select.
Enter Health Event - Stress
Dexcom G5x System User Guide
206
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
7
Press Down Arrow until Health is
highlighted.
Press Select.
Press Down Arrow to Stress.
Press Select.
Enter Health Event - Stress
Press Left/Right Arrows to change time
and date.
•
•
Left: Backward
Right: Forward
Press Select.
Verify information is correct.
10
Press Left/Right Arrows to highlight
field.
Press Up/Down Arrows to change
numbers.
Press Select to save.
10.4 Viewing Events
Dexcom G5x System User Guide
207
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Events entered into your receiver can only be viewed on a Dexcom report;
there are no markers on your receiver’s screen.
On your smart device, turn to landscape to view your Event markers. A single
small square marks all Events entered on your smart device. Slide your finger
across the screen or tap the square to get your Event’s information.
App: Viewing Events
Landscape
What it does
Landscape Only
Show Event details.
What you do
Landscape Only
Slide finger across
screen.
Once your Share Follower’s access your trend screen, they too will be able to
view your Events. See Part 5 for more information.
Summary
Now You Can:
•
•
•
•
Define Event
Describe each Event
Create an Event
o App
o Receiver
Recognize Event markers on the app
o Describe how Event markers are different in portrait and
landscape view
W hat’s Next?
In the next chapter, you will learn about how your Alarm and Alerts help you
monitor your glucose levels. You’ll also learn how you know when your
system loses its signal and stops communicating.
Dexcom G5x System User Guide
208
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 11
Next Steps:
Sensor Glucose Alarm and Alerts
11.1 Introduction
Monitoring your glucose trends is critical in managing your diabetes. But what
happens if you’re driving, in a meeting, at the movies, and can’t, or don’t want
to, keep looking at your display device?
The G5x understands there are times when you can’t look at your receiver or
smart device; however, you still need to know critical glucose trends or if
you’re not getting your sensor glucose readings.
This chapter reviews the sensor glucose Alarm and Alerts based on your
sensor glucose readings, allowing you to proactively manage your glucose
trend levels and make sure your transmitter is communicating with your
display device.
In the next chapter, you’ll learn how to customize the Alarm and Alerts.
After this chapter you will be able to:
• Define an Alarm
• Define an Alert
• Identify the different types of Alerts
• Describe the difference between an Alarm and an Alert
• Recognize different Alarm/Alert notifications and sounds
• Determine if signal loss is preventing you from getting an Alarm or
Alert
• Describe recommended app settings
• Successfully clear an Alert
o App
o Receiver
Your trending information is one of the greatest benefits of the G5x. It’s
important to focus on your trends and rate of change arrows, rather than the
exact number of your glucose reading.
Dexcom G5x System User Guide
209
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
11.2 Safety Statements
The Alarm and Alerts were designed to keep you safe, helping you avoid
severe lows and highs or missing your readings. The following safety
statements help ensure you get your Alerts and Alarm.
W arning
Do: Verify that your smart device’s internal settings let you receive Alarm
and Alerts.
To receive Alarm/Alerts you must:
1. Make sure Dexcom G5 Mobile app Notifications are turned
on in your smart device settings
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
W hy: The app cannot 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 Alarm, Alerts, and notification settings.
Consequences: If your settings are incorrect, you might miss a severe
low or high glucose Alarm or Alerts.
Dexcom G5x System User Guide
210
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
Don’t: Assume the app Alarm/Alert vibrations are different from other
vibrating apps on your smart device.
Do: Look at the screen of your smart device and check to see if the sound
or vibration is from the G5 Mobile app.
W hy: Medical device apps, like this app, don’t have any special priorities
over your smart device’s features. App notifications or alerts may sound or
feel the same as notifications from another app.
Consequences: You might miss a severe low or high glucose event.
W arning
Do: Make sure you unplug your headphones from your smart device when
you are done using them.
W hy: An Alarm or Alert can’t be heard through your smart device’s
speakers if headphones are plugged in.
Consequences: You might not hear an Alarm or Alert, causing you to
miss a severe low or high glucose event.
Precaution
Don’t: Separate the transmitter from the receiver or smart device by more
than 20 feet.
W hy: The transmission range from the transmitter to receiver or smart
device is up to 20 feet without obstruction. If your transmitter and display
device(s) are more than 20 feet apart or are separated by an obstruction,
they might not communicate.
Types of obstruction differ and not all have been tested. Obstructions can
include water, walls, metal, etc.
Dexcom G5x System User Guide
211
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
As with any wireless device, water is often the biggest culprit in reducing
communication distance. This applies to the transmitter and display
devices. Take special care when swimming, taking a bath, or getting into a
hot tub.
Consequences: Missing a severe low or high glucose event.
Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each.
W hy: Settings are specific to each display device and don’t carry over to
other devices. If you set up one device and then use another device with
different settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
W hy: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device, causing you to miss severe low or high glucose
event.
Dexcom G5x System User Guide
212
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Do: Make sure the receiver and smart device are turned on.
W hy: If the receiver or smart device is turned off (Shut Down), it will not
display sensor information, Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
11.3 Alarm and Alerts
As part of managing your diabetes, you learned how to read your trend screen
and how to enter Events. In this chapter, you’ll learn how Alarm and Alerts can
keep you safe from severe lows or highs.
Depending on your display device, you can customize how you receive your
Alarm or Alerts.
What Is an Alarm?
While there are a variety of Alerts, there is just one Alarm: the Urgent Low
Glucose Alarm (Alarm), is set at 55 mg/dL. The Alarm will repeat every 5
minutes until you clear the Alarm (see Chapter 12 on how to customize the
sounds). If you clear the Alarm and your sensor glucose readings don’t go
over 55 mg/dL in the next 30 minutes, you get another Alarm.
Unlike Alerts, the Urgent Low Glucose Alarm setting can’t be changed or
turned off. Think of it as a safety net: your glucose level is dangerously low—
pay attention now!
What Are Alerts?
An Alert is a message telling you your glucose trend levels need attention.
Low/High Glucose Alerts tell you when your sensor glucose readings are
outside your target glucose ranges. Think of them as an FYI: You need to
know what’s happening. Rising/Falling Alerts tell you your glucose levels are
changing quickly. Their default settings are Off (see Chapter 12 on how to turn
them on).
Dexcom G5x System User Guide
213
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Alerts message you with vibrations (vibrations not available on all smart
devices), visual notifications, sounds, or a combination of all three.
Unlike the Alarm, you can customize your different Alert’s target range (see
Chapter 12).
During your initial setup, you establish your Low/High Glucose Alert levels. As
mentioned before, this chapter is a review of the Alarm and Alerts,
recommended smart device settings, and the receiver’s default Alert settings.
Chapter 12 will show you how to change their settings: customize glucose
levels notifications, how you are notified, and in some cases, how often you
get notified. The following are the defaults.
Default Alerts
Low/High Glucose Alerts
Your Low/High Glucose Alerts have the same color-coding as your trend
graph screen:
1. Red: Glucose levels are below your low threshold.
a. Default setting of 80 mg/dL.
2. Gray: Glucose levels are within your Low/High Glucose Alert levels.
a. No Alerts.
3. Yellow: Glucose levels are above your high threshold.
a. Default setting of 200 mg/dL.
Rise Rate/Fall Rate/Repeat Alerts
Rise Rate and Fall Rate Alerts warn you when your glucose levels are
changing rapidly, either down or up, and look similar to the rate of change
arrows. Repeat Alerts let you know if your sensor glucose readings continue
to be above or below your Alert levels.
Glucose Level Alerts
1. Rise Rate
a. Default setting is Off—No Alert.
Dexcom G5x System User Guide
214
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
b. Need to change settings to receive Rising Alert.
2. Fall Rate
a. Default setting is Off—No Alert.
b. Need to change settings to receive Falling Alert.
3. Repeat
a. Default setting is Off—No Alert.
b. Need to change settings to receive Repeat Alert.
Signal Loss Alert
Signal Loss tells you when you and the transmitter are too far from your
display device or something is blocking your transmitter signal, causing you
not to get sensor glucose readings. The default setting for Signal Loss is On.
Now you have the basics for the G5x Alarm/Alerts features. Next, you will
learn about each Alarm/Alert in more detail.
11.4 Alarm and Alerts Screens
When you fall within an Alarm or Alert target range, your display device will tell
you. As mentioned in previous chapters, you won’t get any Alarm or Alerts
within five minutes of calibration.
Let’s first review how the information is presented visually across the devices.
While the Alarm/Alerts notifications look different on the display devices, they
reflect the same information.
After notifications, we’ll separately review the vibration and audible
Alarm/Alerts for app and receiver.
Urgent Low Glucose Alarm
Device
What you see
Dexcom G5x System User Guide
What it means
215
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Smart
Device:
Lock Screen
Sensor glucose reading at or
below 55 mg/dL.
Smart
Device:
In App
Shows last glucose value.
Arrows reflect rate of change.
Check BG meter to make
treatment decisions.
Receiver
Low/High Glucose Alerts
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Sensor glucose reading at or
below your Low Glucose Alert
level.
216
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Shows most current sensor
glucose reading.
Arrows reflect rate of change.
Can be set to repeat between
15 minutes to 4 hours.
Smart
Device:
In App
Check your BG meter to make
any treatment decisions.
Receiver
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Sensor glucose reading at or
above your High Glucose Alert
level.
217
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Shows most current sensor
glucose reading.
Arrows reflect rate of change.
Can be set to repeat between
15 minutes to 4 hours.
Smart
Device:
In App
Check BG meter to make
treatment decisions.
Receiver
Rise Rate/Fall Rate Alerts
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Sensor glucose readings
rising quickly.
218
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Number of arrows
shows how fast
(2 mg/dL/min;
3+ mg/dL/min) glucose
is rising.
Check BG meter to
make any treatment
decisions.
Smart
Device:
In App
Receiver
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Sensor glucose readings
falling quickly.
219
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Number of arrows
shows how fast
(2 mg/dL/min;
3+ mg/dL/min) glucose
is falling.
Check BG meter to
make any treatment
decisions.
Smart
Device:
In App
Receiver
Signal Loss Alert
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Your display device and
transmitter are not
communicating.
220
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Smart
Device:
In App
You will not receive
glucose readings or
Alarm/Alerts.
Check BG meter to
check your glucose and
make any treatment
decisions.
Receiver
11.5 App: Alarm/Alert Recommended Settings
The receiver is a standalone medical device and used solely to monitor your
glucose trends.
The app can’t override your smart device’s general settings:
•
•
•
•
•
•
When your smart device is on Silent, you’ll still receive Alarm/Alerts
visual notifications and messages, but not vibrations if you haven’t
adjusted your smart device settings
Some smart devices don’t have a Vibration feature, so you won’t get
any vibration notifications
When your ringer’s volume is low, you may not hear an Alarm or Alert
When your smart device is in Do Not Disturb mode, you won’t receive
any Alarm/Alerts. The app can’t override the Do Not Disturb setting
If you don’t enable your G5 push Notifications settings during setup,
you won’t get any Alarm/Alerts
Check in Settings under Notifications on how your Alarm/Alerts are
prioritized
For information on smart device settings, see your smart device’s instructions.
Dexcom G5x System User Guide
221
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If you are concerned about missing an Alarm or Alert (for example, due to
smart device settings, app shutting off due to lack of storage, low smart device
battery, etc.), bring your receiver with you.
11.6 Receiver: Default Beeps and Vibrations
The receiver’s Alarm/Alerts are vibrations and a beep, or a series of beeps,
based on the Alarm or Alert. Beeps and vibrations are preprogrammed into
the receiver, and unlike the smart device, the volume can’t be changed.
In Chapter 12 you’ll learn how to adjust the volume and intensity of your
Alarm/Alerts.
The following is a table of the receiver’s default beep and vibration patterns. If
you clear the Alert’s initial vibration, you won’t get any beeps or sounds unless
you’ve turned on the Repeat Alert.
In the next section, you’ll learn how to clear the Alarm/Alerts.
Urgent Low Glucose Alarm
What you see
Beeps and vibration
Initial Default Alert:
Vibrates 4 times.
After 5 Minutes:
Vibrates/beeps 4 times every 5 minutes until cleared
or sensor glucose readings go above Alarm level.
After 30 Minutes:
After clearing Alarm, continues to notify if sensor
glucose readings remain at or below Alarm level.
Low/High Glucose Alerts
What you see
Dexcom G5x System User Guide
Beeps and vibration
222
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Initial Default Alert:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until
cleared.
Trend screen will continue to reflect Alert until
sensor glucose readings go above Alert level.
Initial Default Alert:
Vibrates 2 times.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until
cleared.
Trend screen will continue to reflect Alert until
sensor glucose readings go below Alert level.
Rise Rate/Fall Rate Alerts
What you see
Dexcom G5x System User Guide
Beeps and vibration
223
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 2 times, 2 sounds.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until cleared
or sensor glucose reading drops below Alert level.
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until cleared
or sensor glucose reading rises above Alert level.
Low Repeat/High Repeat
What you see
Dexcom G5x System User Guide
Beeps and vibration
224
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 3 times.
After 5 Minutes:
Vibrates/beeps 3 times every 5 minutes until cleared.
Will re-Alert if sensor glucose readings drop at or
below 55 mg/dL.
Initial Default Alert:
None/Off.
After Setting Change:
Vibrates 2 times.
After 5 Minutes:
Vibrates/beeps 2 times every 5 minutes until cleared.
Signal Loss Alert
What you see
Dexcom G5x System User Guide
Beeps and vibration
225
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Initial Default Alert:
On.
After Setting Change:
Vibrates 1 time.
After 5 Minutes:
Vibrates/beeps 1 time every 5 minutes for a total of 6
times if not cleared.
After 6 times it will not Alert again.
11.7 Clearing Alarm/Alerts
Alerts require you to acknowledge and clear them. How this is done depends
on your display device. If using both display devices, you’ll need to clear each
separately.
Due to its medical importance, the Alarm is more persistent than an Alert.
Even after acknowledging and clearing an Alarm, if your sensor’s glucose
readings remain at or below 55 mg/dL, the Alarm will sound every 30 minutes
until readings are above 55 mg/dL.
Clearing Your Smart Device
Device
What you see
Smart
Device:
Lock Screen
Dexcom G5x System User Guide
What it means
Slide Alarm or Alert to
access app.
226
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Smart
Device: In
App
Tap OK to accept Alarm
or Alert.
Clearing Your Receiver
What you see
What you do
Press Select.
Once an Alert is cleared, you won’t receive the same Alert unless you hit the
Alert’s target range again. Your Alarm will repeat even after clearing if your
glucose levels do not return to your target range.
Summary
Now You Can:
•
•
•
•
•
Define an Alarm
Define an Alert
Identify the different types of Alerts
Describe the difference between an Alarm and an Alert
Recognize different Alarm/Alert notifications and sounds
Dexcom G5x System User Guide
227
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
•
•
Determine if signal loss is preventing you from getting an Alarm/Alert
Describe recommended app settings
Successfully clear an Alert on
o App
o Receiver
W hat’s Next?
Up to now, you have learned about the Alarm or Alert default settings. But
what do you do if you want to decrease the High Glucose Alert setting, or you
want to continue getting a Low Glucose Alert if your glucose levels don’t
improve, even though you cleared the message?
How do you make your Alarm/Alerts fit your needs?
Dexcom G5x System User Guide
228
Sensor Glucose Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 12
Next Steps:
On the Go With G5x: Customizing Your Alarm and
Alerts
12.1 Introduction
The receiver and app come with default glucose Alert level settings, but
perhaps they don’t reflect the glucose level that works best for you.
Perhaps you’re in a meeting and can only clear an Alert, yet want to make
sure your Alert repeats, or continues, until you’re able to take corrective
measures. Maybe you’d like to get a Rising/Falling glucose Alert, but their
settings are off by default. How do you turn them on?
In this chapter, you’ll learn how to personalize your Alarm and Alerts tones
and glucose levels.
After this chapter you will be able to:
•
•
•
Customize your glucose trend Low/High Glucose Alert notifications
o App
o Receiver
Adjust Alarm sound notification
Use receiver’s Advanced Alerts
o Low/High Repeat
o Rise/Fall Alerts
o Signal Loss
Each display device has customization options; however, the setup flow is
different. Before making any changes to your Alert levels, talk with your
healthcare professional.
First, let’s take a look at personalizing your app Alarm and Alerts, and then
we’ll review the same process for the receiver.
12.2 Safety Statement
G5x System User Guide
229
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Do: When using both a receiver and a smart device, you must set your
settings separately in each.
W hy: Settings are specific to each display device and don’t carry over to
other devices. If you set up one device and then use another device with
different settings, you might not get an Alarm or Alerts.
Consequences: You may miss a severe low or high glucose event.
Precaution
Do: After connecting any accessories, make sure that the smart device
settings allow you to continue receiving Alarm or Alerts on the smart device.
W hy: Using an accessory device (like a smart watch) might override your
smart device sounds.
Consequences: Alarm or Alerts might vibrate or be heard on the accessory
instead of your smart device, causing you to miss severe low or high glucose
event.
12.3 Changing Alarm and Alerts
App Screen Overview
The Alerts Main Menu lists all customizable Alarm and Alerts and their current
settings. Part of your initial setup included setting your Low/High Glucose
Alerts. In this chapter, you’ll learn how to change them.
Before learning how to change your settings, let’s review the app’s Alerts Main
Menu screen.
G5x System User Guide
230
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Customizing Alerts: App Alarm/Alerts Screen Overview
Step
What you see
Step
What you see
What it means
What you do
Access Main Menu.
Tap Main Menu
icon.
What it means
What you do
G5x System User Guide
231
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Access Alerts Main
Menu.
Tap Alerts.
All customizable
Alarm and Alerts.
Current Alert
settings.
All Alerts have:
•
•
•
Tap Alarm/Alert you
want to change.
On/Off switch
Notify me
options
Sound options
G5x System User Guide
232
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
“?” explains:
•
•
•
Each
Alarm/Alert
Message
options
Recommended
settings
Tap “?” for
Alarm/Alert
information.
Urgent Low Glucose
Alarm:
•
•
•
Preset at
55 mg/dL and
cannot be
changed
Repeat preset
at 30 minutes
and can’t be
changed
Sound is the
only change
option
Tap Sound to
change sound.
Steps to Customize App Alarm/Alerts
G5x System User Guide
233
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Although the results will vary depending on the Alarm or Alert you are
customizing, the steps to change your Alerts are the same:
From app’s Main Menu:
1. Tap Alerts.
2. Tap the Alert you want.
a. Tap On or Off switch to turn on desired Alerts.
3. Tap Notify me.
a. Change the Alert glucose level (mg/dL).
i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap Save.
4. Tap Repeat.
a. Change the amount of time you want between your High/Low
Glucose Alerts if your sensor glucose readings continue to be low
or high.
i. Scroll selection wheel, find your desired Alert level.
ii. Tap to highlight.
iii. Tap Save.
5. Tap Sound.
a. Assign a different sound to each Alarm or Alert.
i. Scroll selection wheel, find your desired sound.
ii. Tap to highlight.
iii. Tap back arrow.
In this following example, we’ll change the High Alert level from 200 mg/dL to
190 mg/dL, repeating every hour if you continue to stay high, with a Door Bell
sound.
Customizing Alerts: App
Step
What you see
What it means
What you do
Access Main Menu.
Tap Main Menu
icon.
Access Alerts Main Menu
G5x System User Guide
234
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Access Alerts Main
Menu.
Tap Alerts.
Changing an Alert
G5x System User Guide
235
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
3
Access High Alert
settings (mg/dL).
Shows High Alert
options and current
settings.
Tap High mg/dL.
Check High Alert is
On.
•
•
On - Orange
Off - Gray
Changing an Alert
G5x System User Guide
236
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If Off:
Won’t get Alerts if
Off.
Change High Alert
(mg/dL).
Slide to On.
•
On - Orange
•
Off - Gray
Tap Notify Me
Above.
Changing an Alert
G5x System User Guide
237
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
7
Change glucose level
from current level
(mg/dL).
Scroll selection
wheel.
Stop at 190 mg/dL.
Saves new High Alert
glucose level
(mg/dL).
Returns to High
Glucose Alert screen
options.
Tap Save.
Notify Me Above set
at 190 mg/dL.
Changing an Alert
G5x System User Guide
238
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
9
Changes how often
your High Alert
repeats after initial
Alert and
confirmation.
Tap Repeat.
Repeats only if you
are above your high
glucose level.
10
Change the current
repeat setting.
Can select in 5minute steps (range
15 minutes-4 hours).
Scroll selection
wheel.
Stop at 1 hour.
Changing an Alert
G5x System User Guide
239
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Saves your new
repeat timing.
11
Returns to High
Glucose Alert screen
options.
Tap Save.
Repeat shows how
often you’ll get
notified.
12
Customize Alert
sound.
Tap Sound.
Changing an Alert
G5x System User Guide
240
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
13
14
Change current
sound setting.
Saves your new Alert
sound.
Returns to High
Glucose Alert Menu.
Tap Door Bell.
Tap Sound again to
hear sound sample.
Tap back arrow.
Changing an Alert
G5x System User Guide
241
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
15
Return to Main Menu.
16
Return to trend
screen.
Tap “X”.
Tap Menu icon
Or
Swipe right.
Any changes to the app will not carry over to the receiver. If using both, make
the same changes in the receiver you made in your smart device. If you don’t,
you may miss an Alarm or Alert.
G5x System User Guide
242
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
12.4 Changing Receiver Alarm and Alerts
You’ll notice a flow difference between the app and the receiver when
personalizing your Alarm/Alerts. With the app, all Alert adjustments are made
from one screen, whereas in the receiver, you make changes in different
screens.
Unlike the app, you change your receiver’s tones (known as Profiles) through
a number of different screens in the Profiles menu.
Profiles
Profiles determine the sound and volume of your Alarm and Alerts.
As mentioned in the previous chapter, the receiver uses a series of
beeps/vibrations for an Alarm or Alert. The receiver doesn’t have the same
variety of tones as the app; however, you can adjust their volume. While the
receiver doesn’t have a silent mode, selecting Vibrate will replace audible
beeps with quiet vibrations. The only exception is the Alarm: the Urgent Low
Glucose Alarm can’t be turned off.
Changes made in Profiles are applied to all of the receiver’s Alarm/Alerts. If
you choose Soft (see next table), all Alerts are in Soft mode. In Chapter 11,
you learned how many beeps each Alarm/Alert has.
Normal is the default setting for your receiver sound Profiles.
Attentive uses a rising or falling melody instead of beeps.
The receiver first vibrates when sending you an Alarm or Alert. If you clear the
Alarm/Alert at the first vibration by pressing the Select button on your
navigation wheel, you won’t get any Alarm/Alert tones. If you would like to
continue to get your Alarm or Alert after clearing, later in this chapter you’ll
learn about setting up Repeat Alerts.
HypoRepeat is very similar to the Normal Profile, but keeps repeating the
Urgent Low Glucose Alarm every 5 seconds until your sensor glucose value
rises above 55 mg/dL or you confirm by pressing the Select button.
The next table lists the different sound Profiles, starting with the quietest,
working its way up to the loudest.
G5x System User Guide
243
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Alarm/Alert Sound Profiles: Receiver
Icon
Profile name
Notification description
Vibration only.
Vibrate
Soft
Normal
Only sound is your receiver vibrating.
Vibrate is not available for the Urgent Low
Glucose Alarm.
Lower volume beeps.
Medium volume beeps.
Default Profile.
No beeps.
Attentive
Rising melody for High and Rising Alerts
Dropping melody for Low and Falling Alerts
Medium volume beeps.
Urgent Low Glucose Alarm only.
HypoRepeat
Repeats Urgent Low Alarm every 5 seconds
until sensor glucose reading rises above
55 mg/dL or is confirmed.
Try It
Sample Profile setting before selecting.
G5x System User Guide
244
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
After choosing your sound Profile, changing it is just a few steps away!
Change your Profile throughout the day depending on what lies ahead: In a
meeting? Select Vibrate. Going to a ball game after work? Select Attentive.
The next table shows how to change a sound Profile, then sample how it
sounds.
Customizing Sound Profile: Receiver
Step
What you see
What it means
What you do
Go to Main Menu.
Press Select.
Access second Main
Menu screen.
Profiles adjusts
volume of
Alarm/Alerts.
Choose sound
Profile.
Check mark shows
current Profile.
G5x System User Guide
Press Down Arrow.
Profiles on second
screen.
Press Up/Down
Arrow.
Stop at Profiles.
Press Select.
Press Up/Down
Arrow.
Stop at desired
Profile.
Press Select.
245
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
To sample sound:
Press Down Arrow.
Stop at Try It.
Hear selected Profile.
Press Select to
play the sound.
To exit Profiles:
Press Left Arrow to
Main Menu.
Repeat steps 2-5 to
change Profile.
N/A
Repeat as needed.
To exit Profiles:
Press Left Arrow to
Main Menu.
Profiles allow you to change your Alarm and Alerts tones. The Alerts menu
gives you options for personalizing your glucose level Alerts, repeating Alerts,
turning on your Rise/Fall Alerts, and turning on your Signal Loss Alert.
Alerts Main Menu
Low/High Alert option lets you adjust your low/high glucose Alert level
(mg/dL).
Advanced gives you options to turn on Low/High Repeat, Rise/Fall Alerts, and
Signal Loss Alert.
Low/High Repeat
In the previous chapter, you learned clearing an Alert stops it from repeating.
If you want to continue to be re-Alerted until your glucose levels are back in
your target range, turn on the Repeat option.
Rise/Fall Rate
G5x System User Guide
246
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Your trend screen provides visual cues letting you know your sensor glucose
readings are falling or rising rapidly.
Constantly looking at your screen may not be practical. You can customize
your Rise/Fall Alert with vibrations or beeps letting you know when your
glucose is rising or falling (2 mg/dL/min or 30 mg/dL up or down in 15 minutes)
or rising or falling rapidly (3 or more mg/dL/min or 45 mg/dL or more up or
down in 15 minutes).
The default setting for Repeat and Rise/Fall Rate is Off.
It’s important you discuss your Alert settings with your healthcare
professional.
Signal Loss
Signal Loss Alert tells you when your transmitter and receiver aren’t
communicating. Set the Signal Loss Alert and get notified if your sensor
glucose readings have stopped due to a signal loss anywhere from 20 to 200
minutes.
The default setting for Signal Loss is On.
Steps to Customize Receiver Alarm/Alerts
Using the same example from changing your app Alerts, let’s change the
receiver’s High Alert notification level from 200 mg/dL to 190 mg/dL, repeating
every 60 minutes.
Follow the same steps turning on the Rise/Fall Alerts, and adjusting your Low
Alerts.
Customizing Alerts: Receiver
Step
What you see
What it means
What you do
Change High Alert Level
G5x System User Guide
247
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Go to Main Menu.
Press Select.
Alerts option from the
Main Menu.
Press Down Arrow.
Enter Alerts menu
option.
Alerts option menu.
Lists different Alerts:
High/Low/Advanced
(Repeat, Rise/Fall,
Signal Loss) Alerts.
Stop at Alerts.
Press Select.
Press Up/Down
Arrow.
Stop at High Alert.
Press Select.
Change High Alert Level
Alert’s current
settings.
Change your current
High Alert level.
G5x System User Guide
Press Down Arrow.
Stop at Level.
Press Select.
248
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Current setting.
Use Up/Down
arrows to change
your High Alert level
(mg/dL).
Stop at 190 mg/dL.
Saves new High Alert
level.
Press Select.
Return to Alerts
Menu.
Press Down Arrow.
To exit:
Press Left Arrow.
Turn On Repeat
Alerts Menu.
Press Down Arrow.
Choose Advanced to
get to Repeat Alert.
Stop at Advanced.
Enter Advanced Alert
options.
Press Select on
Advanced.
Turn On Repeat
G5x System User Guide
249
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Main Advanced
screen.
Set Repeat Alerts.
Turn on Rise/Fall
Rate Alerts.
10
Initial screen shows
current repeat
minutes.
Change time frame in
5-minute increments.
11
12
Changed Repeat
time for High Alert.
Change completed.
Return to Alerts
Menu.
Arrow to High
Repeat.
Press Select.
Press Up/Down
Arrow.
Stop at 60 minutes.
Press Select.
To exit:
Press Left Arrow.
It doesn’t matter which device you first use to customize your Alarm/Alert
settings; the key is to make sure you make the same changes in both or you
may miss an Alarm or Alert.
Summary
Now You Can:
G5x System User Guide
250
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
Customize your glucose trend Low/High Alerts in
o App
Receiver
•
Adjust Alarm Profiles
•
Set up receiver’s Advanced Alerts
o Low/High Repeat
Rise/Fall Rate
Signal Loss
W hat’s Next?
Believe it or not, you are becoming a pro at using your G5x! You’ve set up the
app and receiver, started a session, calibrated, followed your glucose trends,
paid attention to your Alarm/Alerts notifications, and ended a session!
The next chapters begin our fourth part of the user guide: information you
need to know, but unlike the previous chapters, typically not part of your dayto-day G5x experience.
The next part, Part 4: Everything Else G5x, reviews the technical
specifications, the warranty, how to take care of the G5x components, going
through security when traveling, contacting the Help Desk, Troubleshooting
information, and symbols on system components and packages.
G5x System User Guide
251
On the Go With G5x: Customizing Your Alarm and Alerts
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
4
EVERYTHING ELSE G5x
•
Warranty
•
G5x Maintenance
•
Travel Tips
•
Customer Service Contacts
•
Technical Information
•
Troubleshooting
•
Symbols on Package Labels
Dexcom G5x System User Guide
252
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 13
Everything Else G5x:
Warranty: The Fine Print
13.1 Introduction
Sometimes stuff happens. Dexcom has you covered!
The following is our warranty information outlining what we do cover, what we
don’t, and for how long. First the receiver’s limited warranty information, then
the transmitter’s limited warranty information.
13.2 Receiver Warranty Information
G5x’s Limited Warranty
What’s Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser
(“you” or “Purchaser”) that the Dexcom receiver (the “receiver”) is free from
defects in material and workmanship under normal use (“Limited Warranty”)
for the period starting from the shipment date and continuing for a year
following the shipment date (“Warranty Period”):
Dexcom receiver: 1 year from shipment date
NOTE: If you received this receiver as a replacement for an in-warranty
receiver, the Limited Warranty for the original receiver shall continue for the
Warranty Period on the original receiver, but the replacement is not subject to
any other warranty.
What’s Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM
system in accordance with the documentation provided by Dexcom. You are
not permitted to use the CGM system otherwise. You understand that
misusing the CGM system, improperly accessing it or the information it
Dexcom G5x System User Guide
253
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
processes and transmits, “jailbreaking” your CGM system or cell phone, and
taking other unauthorized actions may put you at risk, cause the CGM system
to malfunction, is not permitted and voids your Limited Warranty.
This Limited Warranty does not cover:
1. Defects or damage resulting from accident, misuse, abuse, neglect,
unusual physical, electrical or electromechanical stress, modification
of any part of the product, or cosmetic damage.
2. Equipment with the ID number removed or made illegible.
3. All surfaces and other externally exposed parts that are scratched or
damaged due to normal use.
4. Malfunctions resulting from the use of the receiver in conjunction with
accessories, ancillary products, and peripheral equipment, whether
hardware or software, not furnished or approved by Dexcom.
5. Defects or damage from improper testing, operation, maintenance,
installation, or adjustment.
6. Installation, maintenance, and service of products or services other
than the CGM system (which may be subject to a separate limited
warranty), whether provided by Dexcom or any other party; this
includes your cell phone or smart device and your connection to the
Internet.
7. Equipment which has been taken apart physically or which has had
any of its software accessed in any unauthorized manner.
8. Water damage to the receiver.
a. Receiver is not water resistant.
b. Do not get the receiver wet at any time.
Dexcom’s Obligations Under the Limited Warranty
During the Warranty Period, Dexcom will replace, without charge to
purchaser, any defective G5 Mobile receiver.
To return, you must send the receiver to an authorized Dexcom Technical
Support Department. Make sure you package the receiver adequately for
shipping.
Dexcom G5x System User Guide
254
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The return package needs to include:
1. Receiver
2. Sales receipt or comparable substitute proof of sale showing the date
of purchase
3. Receiver’s serial number
4. Seller’s name and address
Call Dexcom Technical Support Department for delivery
information help:
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
Upon receipt, Dexcom will replace the defective receiver.
If Dexcom determines the receiver isn’t covered by this Limited Warranty,
Purchaser must pay all shipping charges for the receiver’s return by Dexcom.
Limits on Dexcom’s Warranty and Liability Obligations
The Limited Warranty described above is the exclusive warranty for the
receiver, and in lieu of all other warranties, expressed or implied, either in fact
or by operation of law, statutory or otherwise.
Dexcom expressly excludes and disclaims all other warranties, including
without limitation any warranty of merchantability, fitness for a particular
purpose, or non-infringement, except to the extent prohibited by applicable
law.
Dexcom shall not be liable for any special, incidental, consequential, or
indirect damages, however caused, and on any theory of liability, arising in
any way out of the sale, use, misuse, or inability to use, any G5x or any
feature or service provided by Dexcom for use with the G5x.
These limits on Dexcom’s warranty and liability obligations apply even if
Dexcom, or its agent, has been advised of such damages and notwithstanding
any failure of essential purpose of this Limited Warranty and the limited
remedy provided by Dexcom.
Dexcom G5x System User Guide
255
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
This Limited Warranty is only provided to the original Purchaser and can’t be
transferred to anyone else, and states Purchaser’s exclusive remedy.
If any portion of this Limited Warranty is illegal or unenforceable by reason of
any law, such partial illegality or enforceability shall not affect the
enforceability of the remainder of this Limited Warranty. This Limited Warranty
will be enforced to the maximum extent permitted by law.
13.3 Transmitter Warranty Information
G5x Transmitter Limited Warranty
What’s Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser
that the G5x transmitter is free from defects in material and workmanship
under normal use for the period commencing on the date of first use by the
original purchaser (the “Date of First Use”) and expiring three (3) months
thereafter; provided, that, the Date of First use occurs within five (5) months of
the date of shipment (or disbursement) of the transmitter to the original
purchaser.
NOTE: If you received this transmitter as a replacement for an in-warranty
transmitter, the Limited Warranty for the original transmitter shall continue for
the Warranty Period on the original transmitter, but the replacement is not
subject to any other warranty.
What’s Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM
system in a timely manner and in accordance with the documentation
provided by Dexcom. You are not permitted to use the CGM system
otherwise. You understand that misusing the CGM system, improperly
accessing it or the information it processes and transmits, “jailbreaking” your
CGM system or cell phone, and taking other unauthorized actions may put
you at risk, cause the CGM system to malfunction, is not permitted and voids
your Limited Warranty.
This Limited Warranty does not cover:
Dexcom G5x System User Guide
256
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1. Defects or damage resulting from accident, misuse, abuse, neglect,
unusual physical, electrical or electromechanical stress, modification
of any part of the product, or cosmetic damage.
2. Equipment with the ID number removed or made illegible.
3. All surfaces and other externally exposed parts that are scratched or
damaged due to normal use.
4. Malfunctions resulting from the use of the transmitter in conjunction
with accessories, ancillary products, and peripheral equipment,
whether hardware or software, not furnished or approved by Dexcom.
5. Defects or damage from improper testing, operation, maintenance,
installation, or adjustment.
6. Installation, maintenance, and service of products or services other
than the CGM system (which may be subject to a separate limited
warranty), whether provided by Dexcom or any other party; this
includes your cell phone or smart device and your connection to the
Internet.
7. Equipment which has been taken apart physically or which has had
any of its software accessed in any unauthorized manner.
8. Water damage to transmitter.
a. Beyond specifications listed in G5 Mobile’s user guide.
b. Your options to get the user guide:
i. Download or view: dexcom.com/guides
ii. Online request form to receive free printed copy:
dexcom.com/guides
iii. Request a free copy by mail
iv. Request a free copy by phone:
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
v. Located on dexcom.com.
13.4 Dexcom’s Obligations Under the Limited Warranty
During the Warranty Period, Dexcom will replace, without charge to
purchaser, any defective G5x transmitter.
Dexcom G5x System User Guide
257
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
To return, you must send the transmitter to an authorized Dexcom Technical
Support Department. Make sure you package the transmitter adequately for
shipping.
The return package needs to include:
1. Transmitter
2. Sales receipt or comparable substitute proof of sale showing the date
of purchase
3. Transmitter’s serial number
4. Seller’s name and address
Call Dexcom Technical Support Department for delivery information or help:
•
•
Toll free: 1.888.738.3646
Toll call: 1.858.200.0200
Upon receipt, Dexcom will replace the defective transmitter.
If Dexcom determines this Limited Warranty doesn’t cover the transmitter,
Purchaser must pay all shipping charges for the transmitter’s return by
Dexcom.
Limits on Dexcom’s Warranty and Liability Obligations
The Limited Warranty described above is the exclusive warranty for the
transmitter, and in lieu of all other warranties, expressed or implied, either in
fact or by operations of law, statutory or otherwise.
Dexcom expressly excludes and disclaims all other warranties, including
without limitation any warranty merchantability, fitness for a particular
purpose, or non-infringement, except to the extent prohibited by applicable
law.
Dexcom shall not be liable for any special, incidental, consequential, or
indirect damages, however caused, and on any theory of liability, arising in
any way out of the sale, use, misuse, or inability to use, any G5x or any
feature or service provided by Dexcom for use with the G5x.
These limits on Dexcom’s warranty and liability obligations apply even if
Dexcom, or its agent, has been advised of such damages and notwithstanding
any failure of essential purpose of this Limited Warranty and the limited
remedy provided by Dexcom.
Dexcom G5x System User Guide
258
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
This Limited Warranty is only provided to the original Purchaser and can’t be
transferred to anyone else, and states Purchaser’s exclusive remedy.
If any portion of this Limited Warranty is illegal or unenforceable by reason of
any law, such partial illegality or enforceability shall not affect the
enforceability of the remainder of this Limited Warranty.
This Limited Warranty will be enforced to the maximum extent permitted by
law.
Dexcom G5x System User Guide
259
Warranty: The Fine Print
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 14
Everything Else G5x:
How to Take Care of Your G5x
14.1 Introduction
There are not a lot of moving parts in the G5x, so maintenance is relatively
simple:
•
Keep it clean
•
Keep display device(s) dry and protected
•
Use accessory parts, like the USB cable, etc., included with the
system
•
Store according to each piece’s instructions
This chapter covers only Dexcom parts (sensor, transmitter, and receiver).
Follow the manufacturer’s instructions when caring for your smart device.
After this chapter, you will be able to:
1. Demonstrate proper maintenance
a. Sensor applicator
b. Transmitter
c. Receiver
d. Receiver battery
e. Accessories
2. Identify the best storage methods
a. Sensor applicator
b. Transmitter
c. Receiver
3. Check app and receiver information
4. Safely dispose of system components
a. Sensor
b. Transmitter
c. ReceiverX
Dexcom G5x System User Guide
260
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
14.2 Safety Statements
Following are some important Warnings and Precautions to review. This
information helps you take care of your system so it can take care of you.
Warning
Do: Inspect your transmitter.
Don’t: Use your transmitter if it is damaged or cracked in any way.
W hy: Damaged components could create an electrical safety hazard or
malfunction.
Consequences: Electrical safety hazard or malfunction could cause
electrical shocks.
Warning .
Don’t: Use your receiver if it is damaged or cracked in any way.
W hy: Damaged components could create an electrical safety hazard or
malfunction.
Consequences: Electrical safety hazards or malfunctions could cause
electrical shocks.
Precaution
Don’t: Never get dirt or water in the receiver’s USB port or submerge in
water.
W hy: 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.
Dexcom G5x System User Guide
261
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Don’t: Use expired sensors. Before inserting, always check the package
label for the expiration date using the YYYY-MM-DD format.
W hy; If past the expiration date, the sensor glucose readings might not be
accurate.
Consequences: Missing severe low or high glucose event.
Precaution
Don’t: Share your transmitter with another person.
W hy: The system is a prescription-only medical device and is meant, or
indicated, for your use only.
Consequences: 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.
Dexcom G5x System User Guide
262
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Do: 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.
W hy: If your receiver gets wet or dropped, the speaker and vibrations may
not work.
Consequences: 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
14.3 Basic Maintenance
14.2 Basic Maintenance
Sensor Applicator
1. Keep in sterile package until ready for use.
2. Check package label for expiration date.
a. Expiration date format is YYYY-MM-DD (year-month-day)
format.
b. Don’t use if past expiration date.
i. May provide inaccurate sensor glucose readings.
ii. May be unsterile.
Transmitter
1. Keep in box until ready for use.
Dexcom G5x System User Guide
263
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
a. Check transmitter and don’t use if damaged.
2. Transmitter is reusable, but only by the same person.
a. Never share transmitter with anyone.
3. Between uses, clean outside of the transmitter with damp cloth or
alcohol wipes. Let dry before use or storage.
4. When not in use:
a. Protect transmitter by returning it to its packaging or another
safe place.
b. Store between 32° F-113° F.
Receiver
1. Check receiver casing; if it’s cracked or damaged, don’t use. Do not
open it. There are no serviceable parts inside.
a. May get an electric shock.
2. Keep receiver dry—it is only splash resistant.
a. Don’t submerge in liquid.
b. Don’t spill fluids on receiver.
3. Keep battery charged.
a. Only use Dexcom USB charging/download cable.
4. Keep the micro USB port cover closed if not using USB cable.
a. Prevents fluid from getting inside receiver.
Charging Receiver’s Battery
The receiver’s status bar lets you see its battery level and notifications you
when the battery is getting low. While the receiver is being charged, you will
continue to get your sensor glucose readings if the transmitter and receiver
are within 20 feet of each other.
Each charge lasts approximately three days. If your receiver’s battery was
drained, after charging, you may need to reset its time and date. If this is
required, the system tells you to reset and takes you to the time/date setting
screens.
Dexcom G5x System User Guide
264
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Charging Receiver Battery
Step
What you see
What it means
What you do
Low Battery
Charge your battery.
Open USB port
door.
Micro USB Port
Dexcom G5x System User Guide
Plug USB cable
into port for
recharging.
265
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Plug into receiver to
charge battery.
Don’t plug into a
computer port to
charge.
Micro USB Cable
Don’t use an
external USB hub; it
doesn’t provide
enough power to
charge battery.
Battery can only be
charged using the
adapter/wall
charger.
Charge battery
before each new
sensor session.
Plug USB cable
into adapter/wall
charger.
Wall Charger
Plug wall charger
into an electrical
outlet to charge
receiver’s battery.
Don’t block access
to the charger.
Dexcom G5x System User Guide
266
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Battery Charging
Keep charging until
battery icon is solid.
Battery Charged
Disconnect wall
charger from outlet
when fully charged.
Remove USB
cable from receiver.
USB Port Door
Close USB port
door after removing
USB cable to keep
receiver clean and
dry.
Accessories
1. Only use Dexcom-supplied parts (including cable and charger).
a. Use of non-Dexcom supplied parts may affect safety and
performance.
2. Insert cable only as directed.
a. Do not force cable in place.
Dexcom G5x System User Guide
267
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
3. Look at cable for signs of wear and tear. Do not use if worn or
damaged.
There is no repair service available for any G5x parts.
If you experience problems, report the issue to Technical Support (available
24/7) at:
•
TechSupport@dexcom.com
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
14.4 Storage
Storing your G5x correctly helps prevent system failures.
Sensor Applicator
1. Keep the sensor applicator in its sterile packaging until you are ready
to use it.
2. Store at temperatures between 36° F-86° F.
a. Storing outside of this range may cause inaccurate sensor
glucose readings.
b. May store in refrigerator if it’s within this temperature range.
c. Sensors should not be stored in freezer.
3. Store at humidity levels between 10%-90% relative humidity.
Transmitter
1. Keep transmitter protected when not in use.
2. Store at temperatures between 32° F-113° F.
3. Store at humidity levels between 10%-95% relative humidity.
Receiver
1.
2.
3.
4.
Keep receiver protected when not in use.
Fully charge the battery before storing for over 3 months.
Store at temperatures between 32° F-104° F.
Store at humidity levels between 10%-95% relative humidity.
Dexcom G5x System User Guide
268
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
14.5 Checking app and Receiver Information
You can check your app or receiver for information about your CGM system at
any time.
Dexcom G5x System User Guide
269
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
CHECKING YOUR APP & RECEIVER SOFTW ARE
VERSION
You can check your app or receiver for information about your CGM
system at any time.
Receiver
1. From the Settings menu, press Up or Down arrows to scroll to
“Device Info.”
2. Press Select. Information about your sensor session and system
will show
App
1. From Main Menu, tap Settings.
2. Tap Device Info.
Available Inform ation
•
•
•
•
•
•
•
Insertion Time
Last Calibration
Transmitter Battery
Transmitter Serial Number
Part Number
Part Revision
Software Number
14.5 System Disposal
Dexcom G5x System User Guide
270
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Different municipalities have different requirements when throwing away
electronics (receiver and transmitter) and parts that have come in contact with
blood or other bodily fluids (sensor).
Consult your area’s local waste management authorities for proper disposal
instructions.
Taking care of your G5x is pretty easy. In the next chapter, “On the Go With
G5x: Getting Through Security” you’ll learn how simple it is to travel the world
with your G5x!
Dexcom G5x System User Guide
271
How to Take Care of Your Dexcom G5x Mobile CGM System
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 15
Everything Else G5x:
On the Go With G5x: Getting Through Security
15.1 Introduction
G5x can be a great travel companion; you can go through metal detectors, be
handwanded, and even keep your receiver on during your flight.
This chapter covers only the G5x. It doesn’t cover steps you need to take
when traveling with your smart device. See your smart device’s instructions
for use to learn how to travel with it.
After this chapter, you will be able to:
• Explain proper procedure if you prefer a full-body pat-down
• Describe steps needed for a TSA officer to inspect G5x components
• Identify when your display device(s) can be on during a flight
• Contact TSA directly with your security questions
15.2 Safety Statement
G5x System User Guide
272
On the Go With Dexcom G5x Mobile CGM System: Getting Through Security
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Precaution
Don’t: Place any part of the G5x in the baggage x-ray machine or body
scanner.
Do: Ask for visual inspection instead:
•
•
Baggage x-ray machine: Instead of putting any part of your G5 Mobile
through the baggage x-ray, ask the TSA officer to visually inspect it.
Body scanner: When you are wearing your G5 Mobile, 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.)
W hy: 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.
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.
Consequences: Missing a severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
15.3 Going Through Security
Walk-Through Metal Detectors
Transmitter and Sensor
No worries about wearing your transmitter and sensor when going through
security.
Go through walk-in metal detectors or, if you prefer, be handwanded without
worrying about damaging your transmitter or sensor.
G5x System User Guide
273
On the Go With Dexcom G5x Mobile CGM System: Getting Through Security
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If you’re concerned or uncomfortable about walking through the metal
detector, the Transportation Security Administration (TSA) requests you tell
the Security Officer that you’re wearing a continuous glucose monitor and
want a full-body pat-down with a visual inspection of your sensor and
transmitter.
Let the Security Officer know the sensor can’t be removed because it’s
inserted under the skin.
X-Ray Machines
Receiver, Extra Sensors
Don’t put your components through x-ray machines.
Before your screening process begins, ask the TSA Officer to perform a visual
inspection of the receiver and your extra sensors. Place all components in a
separate bag before handing over to the Security Officer.
For other medical supplies, such as medications, meters, and strips, check
manufacturer’s instructions or the TSA website.
Body Scanners
Use of advanced imaging technology (AIT) body scanners, like millimeter
wave scanners, has not been studied, and we therefore recommend handwanding or full-body pat-down and visual inspection in those situations.
In the Plane
To use your smart device, receiver, or both to get sensor glucose information
while in the plane:
• Smart device: When you switch to airplane mode, keep Bluetooth on
• Receiver: Keep receiver on
Contact your airline for their policies.
Technical Information
G5x System User Guide
274
On the Go With Dexcom G5x Mobile CGM System: Getting Through Security
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The G5x System is an M-PED (Medical-Portable Electronic Device) which
meets the FAA RTCA/DO-160 edition G section 21, Category M. It can be
used on aircraft according to the directions provided by the operator of the
aircraft..
Any M-PED that meets this standard in all modes may be used onboard the
aircraft without any further testing by the operator.
This device can withstand exposure to common electrostatic discharge (ESD)
and electromagnetic interference (EMI).
Still Have Questions?
Visit the TSA’s website if you have any questions or concerns at tsa.gov.
Email: TSA-ContactCenter@tsa.dhs.gov
Phone: 1.866.289.9673
G5x System User Guide
275
On the Go With Dexcom G5x Mobile CGM System: Getting Through Security
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 16
Everything Else G5x:
Need Help? You’re Not Alone!
Dexcom has three support teams to help you, each with their own specialty:
•
•
•
Dexcom Technical Support Team
Dexcom Patient Care Team
Dexcom Sales Support Team
16.1 Dexcom Technical Support Team
The Dexcom Technical Support Team helps you with all CGM system-related
issues as well as software-related issues. They provide replacement units,
resolve technical issues and take product complaints.
Dexcom Technical Support does not offer medical advice.
By Email
Email: TechSupport@dexcom.com
If you prefer to email, to help us help you best, include the following
information in your email:
•
•
•
•
•
•
•
•
•
Name of patient
Patient’s date of birth
Description of technical problem
When the problem happened (date and time)
Patient’s address
Patient’s phone number
Item SKU number and description (for example, name of the device)
Lot number and/or serial number(s) of affected device(s) (for
example, sensor)
Your preferred contact method and information so Dexcom can reach
Dexcom G5x System User Guide
276
Need Help? You’re Not Alone!
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
you if needed. For example: by phone 555-555-5555 after 5 PM
Pacific Time
By Phone
Available 24 hours a day, 7 days a week
Dexcom Technical Support phone numbers:
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
16.2 Dexcom Patient Care Team
The Dexcom Patient Care Team is a group of Certified
®
Diabetes Educators (CDE ) and Registered Nurses
(RNs) offering you customer care and individualized
education services around Dexcom CGM.
Your Dexcom Patient Care Team provides education and support throughout
your CGM experience, such as:
•
•
•
•
•
Initial CGM product training
Ongoing Dexcom product education (for example, how to use a
specific feature)
How to maximize Dexcom CGM use
Dexcom CGM reporting software and features
How to review and understand Dexcom CGM reports
By Email
Email: patientcare@dexcom.com
Dexcom G5x System User Guide
277
Need Help? You’re Not Alone!
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If you prefer to email, to help us help you best, include the following
information in your email:
•
•
•
•
Name of patient
Patient’s date of birth
Contact phone number
Reason for inquiry or education needed
For additional Dexcom CGM education, check the Dexcom website:
dexcom.com/web-based-education
By Phone
Available Monday-Friday 5:30 AM-8:00 PM PST (subject to change)
Toll Free: 1.888.738.3646
Toll Call: 1.858.200.0200
16.3 Dexcom Sales Support Team
Inside Sales Support Team
For help with:
•
•
•
•
First-time orders
Re-orders
Tracking shipments
Locating a local Dexcom representative
By Internet
Dexcom online store: dexcom.com/order
By Email
Email: CustomerService@dexcom.com
Dexcom G5x System User Guide
278
Need Help? You’re Not Alone!
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
By Phone
Dexcom Inside Sales Support phone numbers:
Toll Free: 1.888.738.3646
Toll Call: 1.858.200.0200
By Fax
1.877.633.9266
16.4 Corporate
Dexcom Website:
dexcom.com
Dexcom Address:
6340 Sequence Drive
San Diego, CA 92121
Dexcom G5x System User Guide
279
Need Help? You’re Not Alone!
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 17
Everything Else G5x:
Technical Information
17.1 Device Performance Characteristics
NOTE: We recommend that you review the information in this chapter with
your healthcare professional to understand how well the G5 Mobile performs.
The G5 Mobile (the System) uses a glucose sensor to continuously measure
and monitor your glucose levels. The sensor is “calibrated” using a
commercially available BG meter. Once calibrated, the System reports
glucose readings up to every 5 minutes. The System was evaluated in clinical
studies in which System readings were compared to BG values to assess its
performance and how well the System readings compared to a laboratory test
method that measures BG values. Additionally, subjects performed selfmonitoring BG meter tests at home to assess the System performance in a
real use environment.
Although the performance characteristics of the System are presented in the
following, there is no commonly accepted statistical approach for capturing
performance of continuous glucose monitors (CGMs), such as the G5 Mobile.
Clinical Study Overview
The System performance was evaluated in four separate prospective clinical
studies. Two studies included adults, and two studies included pediatrics. In
the following sections and tables, the studies will be identified as follows:
Adult Studies (18 years and older)
Original Adult Study: the receiver included software version SW10050
Software 505 Adult Study: the receiver included software version
SW10505
Pediatric Studies (2 to 17 years)
Dexcom G5x System User Guide
280
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Original Pediatric Study: the receiver included software version
SW10050
Software 505 Pediatric Study: the receiver included software version
SW10505
The G5 Mobile incorporates the algorithm from software version SW10505
and has a new software number.
Overview of Adult Studies
The System performance for adults was evaluated in two separate
prospective clinical studies: Original Adult Study (software SW10050) and
the Software 505 Adult Study (software SW10505). Differences between
the studies include the number of subjects enrolled, the number of Systems
worn by each participant, the SMBG meter used, and the number of clinic
days each subject participated in during the study. An overview of each study
is provided here.
The Original Adult Study enrolled 72 subjects, and the Software 505
Adult Study enrolled 51 subjects. All subjects had Type 1 or Type 2 diabetes
mellitus, and required insulin or oral medication to manage their diabetes. In
the Original Adult Study, 83% of subjects had Type 1 diabetes, and 17% of
subjects had Type 2 diabetes. In the Software 505 Adult Study, 86% of
subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes. Both
studies included subjects greater than 18 years of age.
Subjects in both studies used the System for seven days. In the Original
Adult Study, thirty-six subjects each wore 2 sensors; in the Software 505
Adult Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensor was calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours). In the Original Adult Study, subjects
®
®
®
used the LifeScan OneTouch Ultra 2 meter and in the Software 505
®
Adult Study, subjects used Bayer’s CONTOUR NEXT USB meter.
In the Original Adult Study, all subjects were evaluated in a controlled clinic
environment on all three clinic days: Day 1, Day 4, and Day 7 of the 7-day
wear period. In the Software 505 Adult Study, subjects were evaluated in
one of the three clinic days so there are fewer data samples than in the
Original Adult Study. While using the System in the clinic, subjects had their
BG measured every 15 minutes with a reliable laboratory method, the Yellow
Dexcom G5x System User Guide
281
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is
referred to as the “YSI.” Readings from the System were reported every 5
minutes and paired with YSI values in order to characterize how well the
System readings agreed with laboratory standard BG results. The remainder
of the study took place at home, and the System performance was also paired
with the comparative meter results, referred to as the “SMBG.”
Overview of Pediatric Studies
The System performance for children and adolescents was evaluated in two
separate prospective clinical studies: the Original Pediatric Study
(SW10050) and the Software 505 Pediatric Study (SW10505).
Differences between the studies include the number of subjects enrolled, the
number of Systems worn by each participant, the SMBG meter used, the
length of time subjects were evaluated in a controlled clinic environment and
whether or not subjects ages 13-17 had their glucose levels intentionally
manipulated during the study. An overview of each study is provided here.
The Original Pediatric Study enrolled 176 subjects, with 16% of subjects
younger than 6-years old, and the Software 505 Pediatric Study enrolled
79 subjects, with 20% of subjects younger than 6-years old. All subjects had
Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to
manage their diabetes. In the Original Pediatric Study, about 99% of
subjects had Type 1 diabetes and 1% had Type 2 diabetes. In the Software
505 Pediatric Study, all subjects had Type 1 diabetes. Sensors were
inserted in either the abdomen or upper buttocks.
Subjects in all studies used the System for seven days. In the Original
Pediatric Study, all subjects wore 2 sensors; in the Software 505
Pediatric Study, all subjects wore 1 sensor only. Throughout the 7-day wear
period, the sensors were calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours), using self-monitoring BG (SMBG) meter
®
®
values. The Original Pediatric Study used the LifeScan OneTouch
®
Verio IQ meter; the Software 505 Pediatric Study used Bayer’s
®
CONTOUR NEXT USB meter.
All subjects were evaluated in a controlled clinic environment on Day 1, Day 4,
or Day 7 of the 7-day wear period. While using the System in the clinic,
subjects provided at least two fingerstick measurements per hour, and
Dexcom G5x System User Guide
282
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
subjects ages 6-17 also provided venous blood for comparison to a laboratory
method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer.
This instrument is referred to as the “YSI.” In the Original Pediatric Study,
subjects’ glucose levels were not intentionally manipulated during this study;
in the Software 505 Pediatric Study, subjects ages 13-17 had their
glucose levels intentionally manipulated during the clinic session. Readings
from the System were reported every 5 minutes and paired with YSI values
collected every 15 minutes in order to characterize how well the System
readings agreed with laboratory standard BG results. The remainder of the
study took place at home, and the System performance was also paired with
the comparative meter results, referred to as the “SMBG.”
Dexcom G5x System User Guide
283
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 1-A. System Agreement to YSI W ithin CGM Glucose
Ranges (Adult)
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
Original
9152
71%
82%
92%
3%
Software 505
2263
86%
93%
98%
1%
Original
512
67%
78%
88%
6%
Software 505
120
89%
94%
98%
0%
Original
781
73%
85%
94%
2%
Software 505
226
91%
96%
99%
0%
Original
3853
67%
78%
91%
3%
Software 505
738
84%
92%
98%
1%
Original
2784
72%
84%
93%
4%
Software 505
798
86%
93%
98%
1%
Original
775
82%
91%
97%
2%
Software 505
229
86%
94%
98%
1%
Original
447
74%
84%
91%
5%
Software 505
152
80%
92%
97%
0%
CGM
Glucose
Range
(mg/dL)
Study
Overall
40-60
61-80
81-180
181-300
301-350
351-400
CGM readings are within 40-400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
284
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 1-B. System Agreement to YSI Within CGM Glucose
Ranges (Pediatric)
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
Original
2922
55%
68%
85%
7%
Software 505
2262
81%
91%
96%
2%
Original
19
63%
74%
79%
21%
Software 505
86
54%
74%
91%
3%
Original
76
61%
82%
92%
4%
Software 505
142
77%
82%
90%
3%
Original
1155
56%
69%
84%
6%
Software 505
805
78%
88%
97%
1%
Original
1380
55%
68%
85%
7%
Software 505
957
89%
96%
99%
1%
Original
206
48%
62%
80%
11%
Software 505
209
81%
91%
94%
5%
Original
86
48%
61%
79%
12%
Software 505
63
64%
81%
83%
8%
CGM
Glucose
Range
(mg/dL)
Study
Overall
40-60
61-80
81-180
181-300
301-350
351-400
CGM readings are within 40-400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
285
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Agreement Relative to YSI
Agreement between the System and BG values is characterized using paired
System and YSI values. The System and YSI results were compared by
pairing the YSI BG value to a System glucose reading that occurred
immediately after the YSI was collected.
The agreement of the System to BG value was assessed by calculating the
percentage of System readings that were within 15%, 20%, 30% and greater
than 40% of the YSI values. For readings less than or equal to 80 mg/dL the
absolute difference in mg/dL between the two glucose results was calculated.
For values greater than 80 mg/dL the absolute percent difference (%) from the
YSI values was calculated. The percentages of total readings within 15 mg/dL
or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% or greater than 40 mg/dL or 40%
are provided in Table 1-A and 1-B. The tables are categorized within CGM
glucose ranges. When you see a CGM reading on your receiver, this table
shows you how likely that reading matches your BG level (measured by YSI in
the study).
For example, in the SW10505 Adult Study (Table 1-A), the total number of
data pairs considered in the analysis was 2263. Of these, 93% of the System
readings fall within ± 20 mg/dL of the YSI BG values ≤ 80 mg/dL and within ±
20% of YSI BG values > 80 mg/dL.
Dexcom G5x System User Guide
286
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 2-A. Number and Percentage of YSI Values When CGM
Readings Are “LOW” or “HIGH” (Adult)
YSI mg/dL
CGM
Readings
Study
Original
“LOW”
CGM-YSI
Pairs
< 55
< 60
< 70
< 80
≥ 80
66
84
123
142
13
Cumulative
Percent
42%
54%
79%
92%
8%
11
16
17
18
61%
89%
94%
100%
0%
Software
Cumulative
505
Percent
Total
155
18
YSI mg/dL
CGM
Readings
Study
Original
“HIGH”
CGM-YSI
Pairs
> 340
> 320
> 280
> 240
≤ 240
189
220
238
246
Cumulative
Percent
76%
89%
96%
99%
1%
40
43
45
45
89%
96%
100%
100%
0%
Software
Cumulative
505
Percent
Total
248
45
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
287
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 2-B. Number and Percentage of YSI Values When CGM
Readings Are “LOW” or “HIGH” (Pediatric)
YSI mg/dL
CGM
Readings
Study
Original
“LOW”
CGM-YSI
Pairs
< 55
< 60
< 70
< 80
≥ 80
13
Cumulative
Percent
0%
0%
0%
0%
100%
10
15
19%
31%
63%
94%
6%
Software
Cumulative
505
Percent
Total
13
16
YSI mg/dL
CGM
Readings
Study
Original
“HIGH”
CGM-YSI
Pairs
> 340
> 320
> 280
> 240
≤ 240
38
51
68
69
Cumulative
Percent
54%
73%
97%
99%
1%
14
19
22
23
58%
79%
92%
96%
4%
Software
Cumulative
505
Percent
Total
70
24
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Agreement When CGM Reads “LOW” or “HIGH”
The System reports glucose readings between 40 and 400 mg/dL. When the
System determines the glucose reading is below 40 mg/dL, it displays “LOW”
in the Receiver Status Box. When the System determines that the glucose
level is above 400 mg/dL, it displays “HIGH” in the Receiver Status Box.
Dexcom G5x System User Guide
288
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Because the System does not display glucose values below 40 mg/dL or
above 400 mg/dL, the comparisons to the actual BG levels (as determined by
the YSI analyzer) when CGM is classified as “LOW” or “HIGH” are included
separately in Table 2-A and 2-B. The tables include the numbers and the
cumulative percentages when YSI values were less than certain glucose
levels (for “LOW”), and when YSI values were greater than certain glucose
levels (for “HIGH”).
For example, in the Software 505 Adult Study (Table 2-A), when the
System displayed “LOW” (18 occasions), 100% (18 out of 18) of the YSI
values were less than 80 mg/dL, and 94% (17 out of 18) of the YSI values
were less than 70 mg/dL. When the System displayed “HIGH” (45 occasions),
100% (45 out of 45) of the YSI values were greater than 240 mg/dL, and
100% (45 out of 45) of the YSI values were greater than 280 mg/dL.
Dexcom G5x System User Guide
289
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 3-A. Concurrence of CGM Readings and YSI Values
(Original Adult Study)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
CGM
(mg/dL)
< 40
4060
6180
81120
121160
161200
201250
251300
301350
351400
400
Number
of Paired
CGM-YSI
< 40
6%
48%
37%
7%
1%
0%
0%
0%
0%
0%
0%
155
40-60
4%
49%
36%
11%
1%
0%
0%
0%
0%
0%
0%
512
61-80
0%
22%
51%
24%
1%
0%
0%
0%
0%
0%
0%
781
81-120
0%
2%
17%
66%
13%
1%
0%
0%
0%
0%
0%
1706
121-160
0%
0%
1%
25%
60%
13%
2%
0%
0%
0%
0%
1492
161-200
0%
0%
0%
2%
28%
53%
16%
2%
0%
0%
0%
1240
201-250
0%
0%
0%
0%
3%
21%
51%
21%
3%
1%
0%
1181
251-300
0%
0%
0%
0%
0%
4%
19%
49%
24%
3%
0%
1018
301-350
0%
0%
0%
0%
0%
0%
3%
28%
51%
16%
1%
775
351-400
0%
0%
0%
0%
0%
0%
3%
10%
43%
38%
7%
447
> 400
0%
0%
0%
0%
0%
0%
1%
6%
21%
57%
15%
248
Dexcom G5x System User Guide
290
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 3-B. Concurrence of CGM Readings and YSI Values
(Software 505 Adult Study)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
CGM
(mg/dL)
< 40
4060
6180
81120
121160
161200
201250
251300
301350
351400
400
Number
of Paired
CGM-YSI
< 40
6%
83%
11%
0%
0%
0%
0%
0%
0%
0%
0%
18
40-60
2%
74%
22%
3%
0%
0%
0%
0%
0%
0%
0%
120
61-80
0%
19%
68%
13%
0%
0%
0%
0%
0%
0%
0%
226
81-120
0%
0%
19%
72%
8%
1%
0%
0%
0%
0%
0%
347
121-160
0%
0%
0%
17%
72%
11%
0%
0%
0%
0%
0%
246
161-200
0%
0%
0%
0%
25%
59%
16%
0%
0%
0%
0%
286
201-250
0%
0%
0%
0%
0%
16%
70%
13%
1%
0%
0%
376
251-300
0%
0%
0%
0%
0%
2%
16%
61%
14%
7%
0%
281
301-350
0%
0%
0%
0%
0%
0%
2%
28%
59%
10%
1%
229
351-400
0%
0%
0%
0%
0%
0%
0%
4%
47%
45%
5%
152
> 400
0%
0%
0%
0%
0%
0%
0%
0%
20%
38%
42%
45
Dexcom G5x System User Guide
291
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 3-C. Concurrence of CGM Readings and YSI Values
(Original Pediatric Study)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
CGM
(mg/dL)
Number
351> 400 of Paired
400
CGM-YSI
< 40
4060
6180
81120
121160
161200
201250
251300
301350
< 40
0%
0%
0%
54%
31%
15%
0%
0%
0%
0%
0%
13
40-60
0%
21%
58%
16%
5%
0%
0%
0%
0%
0%
0%
19
61-80
0%
21%
45%
30%
4%
0%
0%
0%
0%
0%
0%
76
81-120
0%
1%
20%
66%
12%
1%
0%
0%
0%
0%
0%
338
121-160
0%
0%
1%
36%
54%
7%
1%
0%
0%
0%
0%
511
161-200
0%
0%
0%
4%
40%
48%
6%
1%
0%
0%
0%
596
201-250
0%
0%
0%
1%
9%
44%
41%
5%
0%
0%
0%
658
251-300
0%
0%
0%
0%
2%
7%
50%
36%
3%
0%
2%
432
301-350
0%
0%
0%
0%
0%
2%
18%
59%
21%
0%
0%
206
351-400
0%
0%
0%
0%
0%
0%
3%
28%
50%
16%
2%
86
> 400
0%
0%
0%
0%
0%
0%
1%
14%
41%
36%
7%
70
Dexcom G5x System User Guide
292
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 3-D. Concurrence of CGM Readings and YSI Values
(Software 505 Pediatric Study)
YSI (mg/dL)
Row Percentage of Matched Pairs in Each CGM Glucose Range
CGM
(mg/dL)
Number
351> 400 of Paired
400
CGM-YSI
< 40
4060
6180
81120
121160
161200
201250
251300
301350
< 40
6%
25%
63%
6%
0%
0%
0%
0%
0%
0%
0%
16
40-60
0%
33%
60%
6%
1%
0%
0%
0%
0%
0%
0%
86
61-80
0%
8%
64%
26%
2%
0%
0%
0%
0%
0%
0%
142
81-120
0%
1%
15%
69%
13%
1%
1%
0%
0%
0%
0%
314
121-160
0%
0%
0%
15%
66%
18%
1%
0%
0%
0%
0%
313
161-200
0%
0%
0%
1%
18%
66%
15%
0%
0%
0%
0%
355
201-250
0%
0%
0%
0%
1%
17%
68%
14%
0%
0%
0%
444
251-300
0%
0%
0%
0%
0%
0%
26%
58%
16%
0%
0%
336
301-350
0%
0%
0%
0%
0%
0%
4%
40%
46%
9%
0%
209
351-400
0%
0%
0%
0%
0%
0%
3%
14%
62%
21%
0%
63
> 400
0%
0%
0%
0%
0%
0%
4%
13%
29%
38%
17%
24
Concurrence of System and Laboratory Reference
Table 3-A (Original Adult Study), 3-B (Software 505 Adult Study), 3-C
(Original Pediatric Study) and 3-D (Software 505 Pediatric Study) are
categorized by ranges of CGM glucose readings. These tables describe, for
each range of CGM glucose readings, what percentage of paired YSI values
were in the same glucose range (shaded) or in glucose ranges above and
below the paired CGM readings. For example, based on the Software 505
Dexcom G5x System User Guide
293
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Adult Study, when CGM readings are within 81 to 120 mg/dL, you can expect
your BG levels are within 81 to 120 mg/dL 72% of time.
Table 4-A. System Difference to YSI W ithin CGM Glucose Ranges
(Adult)
CGM
Glucose
Range
(mg/dL)
Overall
*40-60
Study
Number of
Mean
Median
Paired
Percent
Percent
CGM-YSI Difference Difference
Mean
Median
Absolute
Absolute
Percent
Percent
Difference Difference
Original
9152
2.9%
1.7%
13.3%
9.8%
Software 505
2263
2.5%
2.4%
9.0%
7.0%
Original
512
-10.0
-8.2
13.5
9.7
Software 505
120
-3.3
-2.1
6.9
4.8
Original
781
-2.4
-0.4
11.4
8.6
Software 505
226
0.8
1.4
6.7
5.4
Original
3853
4.8%
3.0%
13.8%
9.8%
Software 505
738
3.9%
4.1%
9.6%
8.2%
Original
2784
2.1%
0.0%
11.9%
9.2%
Software 505
798
0.6%
0.4%
8.0%
6.1%
Original
775
3.8%
2.8%
9.8%
7.9%
Software 505
229
4.1%
3.4%
8.0%
5.8%
Original
447
10.4%
7.7%
12.8%
9.1%
Software 505
152
7.2%
6.3%
9.2%
7.2%
*61-80
81-180
181-300
301-350
351-400
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
294
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
*For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included
instead of percent differences (%).
Dexcom G5x System User Guide
295
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 4-B. System Difference to YSI W ithin CGM Glucose Ranges
(Pediatric)
CGM
Glucose
Range
(mg/dL)
Study
Number of
Mean
Median
Paired
Percent
Percent
CGM-YSI Difference Difference
Mean
Median
Absolute
Absolute
Percent
Percent
Difference Difference
Original
2922
13.5%
11.6%
17.4%
13.5%
Software 505
2262
1.8%
1.2%
10.4%
7.9%
Original
19
-18.1
-9.1
19.2
9.1
Software 505
86
-15.3
-13.2
16.1
13.2
Original
76
-3.7
-2.3
13.4
10.6
Software 505
142
-4.8
-1.0
11.8
7.7
Original
1155
11.9%
9.7%
17.0%
13.0%
Software 505
805
1.9%
0.7%
10.6%
8.1%
Original
1380
14.8%
12.4%
17.4%
13.3%
Software 505
957
2.2%
1.0%
8.1%
6.5%
Original
206
19.2%
15.9%
19.4%
15.9%
Software 505
209
7.8%
6.5%
11.0%
7.9%
Original
86
18.5%
15.5%
19.1%
15.5%
Software 505
63
14.9%
11.6%
15.2%
11.6%
Overall
*40-60
*61-80
81-180
181-300
301-350
351-400
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included
instead of percent differences (%).
Dexcom G5x System User Guide
296
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Dexcom G5x System User Guide
297
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Accuracy Relative to YSI
Accuracy between matched pairs was also estimated by calculating the
percent difference between the System reading and the YSI value. For
example, if the YSI value is 100 mg/dL and the System reading is 90 mg/dL, a
10% difference between the System and the YSI is reported. The System and
YSI values were compared by pairing the System reading that fell immediately
after the YSI value was collected.
In the example above, the System reading is less than the YSI value, so the
percent difference reading is negative. The mean percent difference is the
average of all positive and negative percent differences between the two
devices; it tells you if the System reads higher or lower on average than the
YSI within each glucose range.
Another estimate used to show the accuracy of the System is the absolute
percent difference. The absolute percent difference tells you the percent
difference or “distance” between the System and YSI values, but does not tell
you whether the System is reading, on average, higher or lower than the YSI
laboratory standard. The mean absolute percent difference is the average
“distance” (regardless if positive or negative) between System readings and
YSI values.
Accuracy measures in differences for both the Original Adult and Software
505 Adult Studies are summarized in Table 4-A. Accuracy measures in
differences for both the Original Pediatric and Software 505 Pediatric
Studies are summarized in Table 4-B. Table 4-A and 4-B are categorized
within CGM glucose ranges.
For example, in the Software 505 Adult Study (Table 4-A), overall, on
average, the System reads 2.5% different (Mean Percent Difference) than the
reference and 9.0% absolute different (Mean Absolute Difference) than the
reference values. The Median Percent Difference shows that half of the time
the System reads 2.4% or less than the YSI BG values and the Median
Absolute Percent Difference shows that half of the time the System reads
about 7.0% or less than the YSI BG values.
Dexcom G5x System User Guide
298
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 5-A. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)
Hypoglycemia
Alert Level
(mg/dL)
55
60
70
80
90
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
Original
50%
50%
71%
29%
Software
505
71%
29%
68%
32%
Original
64%
36%
75%
25%
Software
505
85%
15%
83%
17%
Original
79%
21%
83%
17%
Software
505
92%
8%
91%
9%
Original
87%
13%
86%
14%
Software
505
95%
5%
90%
10%
Original
90%
10%
89%
11%
Software
505
96%
4%
94%
6%
Study
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
299
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 5-B. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6 17 Years)
Hypoglycemia
Alert Level
(mg/dL)
55
60
70
80
90
100
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
Original
0%
100%
0%
100%
Software
505
22%
78%
75%
25%
Original
11%
89%
25%
75%
Software
505
42%
58%
78%
23%
Original
47%
53%
50%
50%
Software
505
68%
32%
75%
25%
Original
55%
45%
55%
45%
Software
505
86%
14%
91%
9%
Original
69%
31%
62%
38%
Software
505
90%
10%
93%
7%
Original
75%
25%
62%
38%
Software
505
91%
9%
93%
7%
Study
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
300
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 5-C. Hypoglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages
2-5 Years)
Hypoglycemia
Alert Level
(mg/dL)
55
60
70
80
90
100
True
Alert
Rate
False
Alert
Rate
Hypoglycemia
Detection Rate
Hypoglycemia
Missed
Detection Rate
Original
3%
97%
57%
43%
Software
505
25%
75%
100%
0%
Original
11%
89%
62%
38%
Software
505
20%
80%
100%
0%
Original
29%
71%
77%
23%
Software
505
20%
80%
100%
0%
Original
35%
65%
85%
15%
Software
505
61%
39%
100%
0%
Original
51%
49%
89%
11%
Software
505
78%
22%
100%
0%
Original
64%
36%
91%
9%
Software
505
82%
18%
100%
0%
Study
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Low and High Glucose Alerts
Dexcom G5x System User Guide
301
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The ability of the System to detect high and low glucose levels is assessed by
comparing System results to YSI results at low and high BG levels and
determining if the Alert may have sounded. The System and YSI values were
compared by pairing the System reading that occurred immediately after the
YSI value was collected. We suggest that you ask your doctor what Alert
settings would be best for you.
The Low Glucose Alert
Estimates of how well the adjustable Low Glucose Alert performs are
presented in Table 5-A, 5-B and 5-C. Table 5-A represents the hypoglycemic
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
5-B represents the Alert evaluation within 15 minutes of the YSI value for a
subset of the pediatric population—subjects age 6 to 17 years who had YSI
measurements every 15 minutes. Table 5-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hypoglycemia Alert Rate
The Alert Rate shows how often the Alert is right or wrong. The True Alert
Rate is the % of time the device alarmed when the BG level was at or below
the Alert setting within 15 or 30 minutes before or after the device alarmed.
The False Alert Rate is the % of time the device alarmed when the BG level
was above the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the Low Glucose Alert to 70 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be low? In the
Software 505 Adult Study (Table 5-A), when your Alarm sounds, you can
expect your blood sugar to be below 70 mg/dL approximately 92% of the time
and above 70 mg/dL approximately 8% of the time within the 15 minute period
before or after your Alarm sounds.
Dexcom G5x System User Guide
302
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Hypoglycemia Detection Rate
The Detection Rate shows how often the device recognizes and Alerts you to
an episode of hypoglycemia or how often it misses such an event. The
Hypoglycemia Detection Rate is the % of time the BG level was at or below
the Alert setting and device alarmed within 15 or 30 minutes before or after
the BG was at or below the Alert settings. The Hypoglycemia Missed
Detection Rate is the % of time the BG was at or below the Alert setting, but
the device did not alarm within 15 or 30 minutes before or after the BG was at
or below the Alert setting.
For example, if you set the Low Glucose Alert to 70 mg/dL, how often will your
Alarm Alert you if your BG goes below 70 mg/dL? In the Software 505
Adult Study (Table 5-A), when your blood sugar goes below 70 mg/dL, you
can expect your alarm to sound 91% of the time and not to sound
approximately 9% of time within the 15 minute period before or after your
blood sugar goes below 70 mg/dL.
Dexcom G5x System User Guide
303
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 6-A. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Adult)
Hyperglycemia
Alert Level
(mg/dL)
120
140
180
200
220
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed
Detection Rate
Original
95%
5%
98%
2%
Software
505
98%
2%
100%
0%
Original
94%
6%
97%
3%
Software
505
97%
3%
99%
1%
Original
92%
8%
97%
3%
Software
505
97%
3%
99%
1%
Original
92%
8%
97%
3%
Software
505
96%
4%
98%
2%
Original
91%
9%
95%
5%
Software
505
94%
6%
98%
2%
Study
Original
91%
9%
94%
6%
240
Software
505
93%
7%
95%
5%
Original
82%
18%
86%
14%
300
Software
505
86%
14%
90%
10%
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
304
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 6-B. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6 17 Years)
Hyperglycemia
Alert Level
(mg/dL)
Study
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection
Rate
Hyperglycemia
Missed
Detection
Rate
Original
91%
9%
98%
2%
120
Software
505
98%
2%
99%
1%
Original
87%
13%
99%
1%
140
Software
505
97%
3%
98%
2%
Original
75%
25%
99%
1%
180
Software
505
94%
6%
98%
2%
Original
71%
29%
98%
2%
Software
505
94%
6%
97%
3%
Original
67%
33%
97%
3%
Software
505
93%
7%
96%
4%
Original
62%
38%
96%
4%
Software
505
88%
12%
94%
6%
Original
43%
57%
93%
7%
Software
505
69%
31%
84%
16%
200
220
240
300
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
305
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 6-C. Hyperglycemia Alert and Detection Rate Evaluation in
Reference to SMBG 30 Minutes Before and After (Pediatric, Ages
2-5 Years)
Hyperglycemia
Alert Level
(mg/dL)
120
140
180
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed
Detection Rate
Original
92%
8%
98%
2%
Software
505
97%
3%
99%
1%
Original
90%
10%
98%
2%
Software
505
98%
2%
100%
0%
Original
87%
13%
96%
4%
Software
505
99%
1%
93%
7%
Study
Original
85%
15%
96%
4%
200
Software
505
98%
2%
93%
7%
Original
81%
19%
95%
5%
220
Software
505
100%
0%
97%
3%
Original
80%
20%
95%
5%
240
Software
505
99%
1%
98%
2%
Original
71%
29%
90%
10%
300
Software
505
95%
5%
96%
4%
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
306
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The High Glucose Alert
Estimates of how well the adjustable High Glucose Alert performs are
presented in Table 6-A, 6-B and 6-C. Table 6-A represents the hyperglycemia
Alert evaluation within 15 minutes of the YSI value in the adult studies. Table
6-B represents the Alert evaluation within 15 minutes of the YSI value for a
subset of the pediatric population—subjects age 6 to 17 years who had YSI
measurements every 15 minutes. Table 6-C represents the Alert evaluation
within 30 minutes of an SMBG reading for 2- to 5-year-old subjects in the
pediatric studies.
Hyperglycemia Alert Rate
The Alert Rate shows how often the Alert is right or wrong. The True Alert
Rate is the % of time the device alarmed when the BG level was at or above
the Alert setting within 15 or 30 minutes before or after the device alarmed.
The False Alert Rate is the % of time the device alarmed when the BG level
was below the Alert setting within 15 or 30 minutes before or after the device
alarmed.
For example, if you set the High Glucose Alert to 200 mg/dL and your Alarm
sounds, how often can you expect your blood sugar to actually be high? In the
Software 505 Adult Study (Table 6-A), when your Alarm sounds, you can
expect your blood sugar to be at or above 200 mg/dL approximately 96% of
the time and not be above 200 mg/dL approximately 4% of the time within the
15 minute period before or after your Alarm sounds.
Hyperglycemia Detection Rate
The Detection Rate shows how often the device recognizes and Alerts you to
an episode of hyperglycemia or how often it misses such an event. The
Hyperglycemia Detection Rate is the % of time the BG level was at or above
the Alert setting and the device alarmed within 15 or 30 minutes before or
after the BG was at or above the Alert settings. The Hyperglycemia Missed
Detection Rate is the % of time the BG was at or above the Alert setting, but
the device did not alarm within 15 or 30 minutes before or after the BG was at
or above the Alert setting.
Dexcom G5x System User Guide
307
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
For example, if you set your High Glucose Alert to 200 mg/dL, how often will
your Alarm Alert you if your BG goes at or above 200 mg/dL? In the
Software 505 Adult Study (Table 6-A), when your blood sugar goes above
200 mg/dL, you can expect your Alarm to sound 98% of the time and not to
sound approximately 2% of time within the 15 minute period before or after
your blood sugar goes above 200 mg/dL.
Dexcom G5x System User Guide
308
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1
Table 7-A. Percentage of System Readings W ithin YSI Values
W ith Data Stratified in 2-Hour Increments After Calibration (Adult)
Number
of Paired
CGM-YSI
Percent
Within
15/15%
YSI
Percent
Within
20/20%
YSI
Percent
Within
30/30%
YSI
Percent
Greater
than
40/40%
YSI
Original
1929
78%
88%
96%
2%
Software 505
469
93%
97%
99%
0%
Original
1516
69%
81%
91%
4%
Software 505
389
90%
97%
99%
0%
Original
1547
69%
79%
91%
5%
Software 505
383
85%
91%
97%
2%
Original
1520
68%
79%
92%
3%
Software 505
380
79%
90%
97%
2%
Original
1555
71%
82%
92%
4%
Software 505
347
83%
92%
98%
0%
Original
1068
65%
77%
91%
4%
Software 505
295
80%
90%
98%
0%
Original
17
65%
76%
82%
12%
Software 505
--
--
--
--
Time from
Calibration
Study
0-2 hours
2-4 hours
4-6 hours
6-8 hours
8-10 hours
10-12 hours
12-14 hours
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
309
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1
Table 7-B. Percentage of System Readings W ithin YSI Values
W ith Data Stratified in 2-Hour Increments After Calibration
(Pediatric)
Time from
Calibration
0-2 hours
2-4 hours
4-6 hours
6-8 hours
8-10 hours
10-12 hours
12-14 hours
Study2
Percent
Number of
within
paired
15/15%
CGM-YSI
YSI
Percent
Percent
Percent
greater
within
within
than
20/20% YSI 30/30% YSI
40/40% YSI
Original
648
65%
75%
87%
7%
Software 505 545
83%
91%
97%
1%
Original
649
51%
67%
86%
7%
Software 505 460
72%
89%
96%
2%
Original
630
51%
61%
80%
10%
Software 505 428
77%
88%
95%
2%
Original
409
52%
68%
85%
5%
Software 505 325
88%
92%
94%
3%
Original
296
53%
69%
84%
7%
Software 505 305
86%
93%
97%
1%
Original
253
58%
74%
89%
5%
Software 505 198
89%
94%
98%
0%
Original
32%
38%
65%
22%
100%
100%
100%
0%
37
Software 505 1
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
310
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate performance
of the System over a 12-hour calibration period, Systems were evaluated to
verify that performance remains consistent over the 12-hour calibration period.
Systems were evaluated in 2-hour increments after calibration. Performance
was estimated at each 2-hour interval and stratified by glucose values by
calculating the percentage of System readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% and greater than 40 mg/dL
or 40% of the YSI values in Table 7-A and 7-B.
Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time )
- (Adult)
Day
of
Wear
Day
Day
Day
Study
Percen
Number
Mean
Median Percen Percen Percen
of
Absolute Absolute
Greater
Paired Percent
Percent Within Within Within
than
CGM- Differenc Differenc 15/15% 20/20% 30/30%
40/40%
YSI
es
es
YSI
YSI
YSI
YSI
Original
3023
16.7%
13.2%
59%
71%
86%
6%
Software
505
680
10.7%
7.9%
77%
84%
96%
2%
Original
3108
11.4%
8.2%
77%
87%
95%
2%
Software
505
777
8.0%
6.4%
89%
96%
99%
0%
Original
3021
11.9%
8.9%
76%
87%
95%
2%
Software
505
806
8.5%
7.2%
90%
97%
99%
0%
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
311
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
1
Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time )
- (Pediatric, Ages 6-17 Years)
Day
of
Wear
Day
Day
Day
Study
Percen
Number
Mean
Median Percen Percen Percen
of
Absolute Absolute
Greater
Paired Percent
Percent Within Within Within
than
CGM- Differenc Differenc 15/15% 20/20% 30/30%
40/40%
YSI
es
es
YSI
YSI
YSI
YSI
Original
1016
21.2%
15.8%
48%
61%
78%
15%
Software
505
740
12.7%
8.5%
75%
83%
91%
4%
Original
810
16.0%
13.9%
52%
66%
87%
3%
Software
505
795
8.1%
6.7%
89%
97%
100%
0%
Original
1096
15.1%
11.3%
63%
76%
89%
4%
Software
505
727
10.4%
8.4%
80%
91%
98%
1%
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
312
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over
Time ) - (Pediatric, Ages 2-17 Years)
Day
of
Wear
Day
Day
Day
Day
Day
Day
Day
Study
Percen
Number
Mean
Median Percen Percen Percen
of
Absolute Absolute
Greater
Paired Percent
Percent Within Within Within
than
CGM- Differenc Differenc 15/15% 20/20% 30/30%
40/40%
SMBG
es
es
SMBG SMBG SMBG
SMBG
Original
3216
18.8%
14.2%
53%
65%
81%
10%
Software
505
893
14.8%
10.7%
64%
79%
91%
5%
Original
2148
16.2%
12.4%
60%
74%
87%
6%
Software
505
436
13.2%
10.4%
69%
81%
95%
3%
Original
1977
15.2%
11.0%
63%
76%
89%
5%
Software
505
441
13.8%
11.3%
66%
77%
91%
2%
Original
2830
14.0%
10.9%
66%
79%
91%
4%
Software
505
850
10.7%
8.5%
79%
91%
97%
1%
Original
1768
15.4%
10.7%
67%
78%
90%
5%
Software
505
374
11.4%
8.7%
74%
86%
96%
1%
Original
1704
14.3%
9.8%
68%
79%
90%
4%
Software
505
410
12.3%
9.2%
72%
80%
93%
2%
Original
2675
12.4%
9.2%
72%
83%
94%
3%
Software
505
860
11.3%
8.6%
79%
90%
96%
2%
CGM readings are within 40 to 400 mg/dL, inclusive.
Dexcom G5x System User Guide
313
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
2
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
314
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Sensor Stability
Relative to YSI
Sensors can be worn for up to 7 days. Performance was estimated by
calculating the percentage of System readings within 15 mg/dL or 15%, 20
mg/dL or 20%, 30 mg/dL or 30% , 40 mg/dL or 40% and greater than 40
mg/dL or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and
end (Day 7) of the System lifecycle. The average and median of the absolute
percent differences are included in Table 8-A and 8-B showing consistent
accuracy and sensor stability over the 7-day life of the sensor.
Relative to SMBG (Pediatric Study)
Performance was also estimated by calculating the percentage of system
readings within various percentages of the SMBG values at each day of the
sensor wear period (Table 8-C). The average and median of the absolute
percent differences are included in the table.
Precision of System Readings
A subset of subjects wore two Systems at the same time. This was to look at
how similarly two Systems function on the same subject (sensor precision).
Precision was evaluated by comparing the glucose readings from the two
Systems worn on the same subject at the same time.
In the Original Adult Study, 36 subjects wore two Systems. Results showed
that System readings from the two sensors generally agreed with each other
within 9% (absolute percent difference) with a 7% coefficient of variation. In
the Original Pediatric Study, all subjects wore two Systems. Results
showed that System readings from the two sensors generally agreed with
each other within 10% (absolute percent difference) with a 7% coefficient of
variation. Only one System was worn in the Software 505 Adult and
Software 505 Pediatric Studies, so precision data was not collected.
Sensor Life
Dexcom G5x System User Guide
315
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Sensors may be worn for up to 7 days (168 hours). To estimate how long a
sensor will work over 7 days, all sensors worn were evaluated to determine
how many days/hours of readings each sensor provided.
In the Original Adult Study, 108 sensors were evaluated. Ninety-four
percent (94%) of the sensors lasted until Day 7 (145-168 hours). There were 6
(6%) sensors that ended early, four of which lasted more than 3 days.
In the Software 505 Adult Study, 51 sensors were evaluated. Ninety-eight
percent (98%) of the sensors lasted until Day 7 (145-168 hours). There was 1
(2%) sensor that ended early, which lasted until day 5 of the sensor wear.
In the Original Pediatric Study, 351 sensors were evaluated. Eighty-five
percent (85%) of the sensors lasted until Day 7 (145-168 hours).
In the Software 505 Pediatric Study, 77 sensors were evaluated. Ninetyfour percent (94%) of the sensors lasted until Day 7 (145-168 hours).
Table 9-A. Number of Readings Provided by Each Sensor Over 7
Days (Adult)
% of Total Possible
Readings Provided
0-25%
26-50%
51-75%
76-100%
Total Readings
Provided
(Min-Max)
% of Systems Providing
That Number of
Readings
Original
167-491
2%
Software 505
0%
Original
719-914
4%
Software 505
856-856
2%
Original
1267-1267
1%
Software 505
1253-1253
2%
Original
1811-1992
94%
Software 505
1497-1992
96%
Study
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
316
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 9-B. Number of Readings Provided by Each Sensor Over 7
Days (Pediatric)
% of Total Possible
Readings Provided
Total Readings
Provided
(Min-Max)
% of Systems Providing
That Number of
Readings
Original
103-427
3%
Software 505
60-223
4%
Original
569-954
3%
Software 505
877-891
3%
Original
1006-1484
9%
Software 505
1131-1342
3%
Original
1518-1992
86%
Software 505
1623-1990
91%
Study
0-25%
26-50%
51-75%
76-100%
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
317
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 10-A. System Readings Within Wear Days (Adult)
Statistic
Mean
Median
Standard
Deviation
Study
Day 1 Day 2 Day 3 Day 4
Day 5 Day 6 Day 7
All
Days
Original
98%
98%
98%
98%
97%
99%
95%
97%
Software
505
98%
99%
98%
98%
96%
99%
97%
98%
Original
100%
100%
100%
100%
100%
100%
100%
100%
Software
505
99%
100%
100%
100%
100%
100%
100%
100%
Original
5%
3%
9%
8%
10%
3%
11%
8%
Software
505
3%
2%
8%
11%
15%
2%
13%
9%
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
A total of 108 sensors were included with the Original Study and 51 sensors were
included with the Software 505 Study.
Dexcom G5x System User Guide
318
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 10-B. System Readings Within Wear Days (Pediatric)
Statistic
Mean
Median
Standard
Deviation
Study
Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
All
Days
Original
97%
96%
96%
95%
94%
94%
92%
95%
Software
505
96%
96%
95%
96%
93%
95%
93%
95%
Original
99%
99%
99%
99%
99%
99%
98%
99%
Software
505
99%
98%
99%
99%
97%
97%
98%
98%
Original
6%
10%
9%
12%
14%
14%
17%
12%
Software
505
9%
6%
12%
10%
15%
7%
12%
11%
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
A total of 108 sensors were included with the Original Study and 77 sensors were
included with the Software 505 Study.
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes, or up to
288 readings per day. For a variety of reasons, the System may not display a
glucose reading and readings are “skipped.” Table 9-A and 9-B estimate the
number of readings you can expect to receive from the System over the entire
7-day period after calibration. Table 10-A and 10-B show the number of
readings you can expect to receive from the System within each system wear
day.
For the Software 505 Adult Study (SW10505), 96% of Systems provided
between 1497 and 1992 valid glucose readings (or more than 75% of the
expected number of readings) as seen in Table 9-A. Adjusted within each
system wear-day, the System in the Software 505 Adult Study provided an
average of 98% of all expected glucose readings (288) as seen in Table 10-A.
Dexcom G5x System User Guide
319
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 11-A. System Agreement to SMBG Within CGM Glucose
Ranges (Adult)
Number
of Paired
CGMSMBG
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
Greater
than
40/40%
SMBG
Original
7508
69%
81%
94%
2%
Software
505
2992
77%
87%
96%
1%
Original
731
75%
84%
92%
4%
Software
505
221
73%
80%
87%
7%
Original
968
78%
86%
95%
1%
61-80
Software
505
336
77%
85%
95%
1%
Original
3141
65%
78%
93%
2%
81-180
Software
505
1362
74%
85%
96%
1%
Original
1960
68%
81%
94%
3%
181-300
Software
505
826
80%
90%
97%
1%
Original
450
77%
88%
98%
1%
301-350
Software
505
161
83%
93%
99%
0%
Original
258
75%
85%
95%
2%
351-400
Software
505
86
90%
93%
98%
1%
CGM
Glucose
Range
(mg/dL)
Overall
40-60
Study
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
320
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 11-B. System Agreement to SMBG Within CGM Glucose
Ranges (Pediatric)
CGM
Glucose
Range
(mg/dL)
Overall
40-60
61-80
81-180
181-300
301-350
351-400
Number
of Paired
CGMSMBG
Percent
Within
15/15%
SMBG
Percent
Within
20/20%
SMBG
Percent
Within
30/30%
SMBG
Percent
Greater
than
40/40%
SMBG
Original
16,318
64%
76%
89%
5%
Software 505
4264
73%
84%
94%
2%
Original
487
44%
55%
68%
19%
Software 505
240
54%
71%
86%
7%
Original
1340
59%
70%
85%
7%
Software 505
399
64%
76%
92%
2%
Original
7084
62%
74%
90%
5%
Software 505
1650
72%
84%
95%
2%
Original
5627
69%
80%
90%
5%
Software 505
1526
79%
89%
97%
2%
Original
1176
65%
77%
90%
4%
Software 505
319
72%
83%
94%
2%
Original
604
58%
72%
86%
6%
Software 505
130
69%
79%
86%
8%
Study
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
Dexcom G5x System User Guide
321
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 12-A. System Difference to SMBG Within CGM Glucose
Ranges (Adult)
CGM
Glucose
Range
(mg/dL)
Study
Number
of Paired
CGMSMBG
Mean
Median
Percent
Percent
Difference Difference
Mean
Median
Absolute
Absolute
Percent
Percent
Difference Difference
Original
7508
-0.4%
-1.4%
14.0%
11.0%
Overall
Software
505
2992
-2.6%
-2.7%
11.3%
8.6%
Original
731
-9.3
-8.0
11.7
8.0
*40-60
Software
505
221
-10.3
-6.0
13.0
8.0
Original
968
-1.0
1.0
10.7
8.0
*61-80
Software
505
336
-4.0
-2.0
10.1
7.0
Original
3141
1.4%
0.0%
14.2%
11.0%
81-180
Software
505
1362
-2.6%
-3.1%
11.4%
8.9%
Original
1960
-0.7%
-2.8%
13.0%
10.3%
181-300
Software
505
826
-1.4%
-2.0%
9.5%
7.4%
Original
450
-0.7%
-2.6%
10.5%
8.6%
301-350
Software
505
161
-0.0%
0.0%
8.3%
6.0%
Original
258
5.0%
3.0%
11.9%
8.6%
351-400
Software
505
86
3.9%
3.2%
8.1%
6.7%
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent
differences (%).
Dexcom G5x System User Guide
322
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table 12-B. System Difference to SMBG Within CGM Glucose
Ranges (Pediatric)
CGM
Glucose
Range
(mg/dL)
Study
Number
of Paired
CGMSMBG
Mean
Median
Percent
Percent
Difference Difference
Mean
Median
Absolute
Absolute
Percent
Percent
Difference Difference
Original
16,318
2.2%
0.9%
15.3%
11.1%
Overall
Software
505
4264
-0.7%
-1.1%
12.5%
9.5%
Original
487
-22.1
-17.0
23.9
18.0
*40-60
Software
505
240
-15.9
-14.0
16.9
14.0
Original
1340
-11.8
-8.0
17.0
11.0
*61-80
Software
505
399
-7.8
-6.0
13.7
10.0
Original
7084
1.1%
-1.0%
15.4%
11.4%
81-180
Software
505
1650
-1.2%
-2.6%
12.1%
9.5%
Original
5627
5.7%
3.4%
13.5%
9.5%
181-300
Software
505
1526
1.7%
0.9%
10.1%
7.7%
Original
1176
9.6%
7.2%
14.2%
10.4%
301-350
Software
505
319
6.7%
5.9%
11.8%
8.9%
Original
604
12.7%
10.2%
16.1%
11.9%
351-400
Software
505
130
12.0%
8.9%
15.7%
10.6%
CGM readings are within 40 to 400 mg/dL, inclusive.
Both sets of study data are presented and are labeled as Original (SW10050) or
Software 505 (SW10505).
*For CGM ≤ 80 mg/dL, the differences in mg/dL are included instead of percent
differences (%).
Dexcom G5x System User Guide
323
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Agreement and Accuracy Relative to SMBG
Agreement between the System and BG values is also characterized using
paired System and SMBG results (Table 11 to 12). The System and SMBG
values were compared by pairing the comparative SMBG value to a System
glucose reading that occurred immediately after the SMBG was collected.
These results characterize the performance that subjects expect during realtime use of the System in their daily diabetes management when comparing
the System readings to their home BG meter results. For readings less than or
equal to 80 mg/dL, the absolute difference in mg/dL between the two glucose
results was calculated. For values greater than 80 mg/dL, the absolute
percent difference (%) from the SMBG values was calculated. The
percentages of total readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30
mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then
calculated.
For example, if the System reads 100 mg/dL, it is between 81-180 mg/dL
range and you can expect the System readings to be within 20% of the SMBG
values 85% of the time for the Software 505 Adult Study, as seen in Table
11-A.
Overall, the System in the Software 505 Adult Study reads, on average,
2.6% lower (Mean Percent Difference) than SMBG values and 11.3%
absolute different (Mean Absolute Percent Difference) than the SMBG values.
The Median Percent Difference shows that half of the time the System reads
lower in 2.7% or less than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the System reads about 8.6% or less
different than SMBG values, as seen in Table 12-A.
Adverse Events
No serious adverse events or device-related serious adverse events occurred
during the studies. Mild to moderate skin irritation, such as erythema or
edema, occurred at the sensor needle insertion area or around the adhesive
area. No infection, bruising, or bleeding occurred at the sensor needle
insertion area or the adhesive area.
Dexcom G5x System User Guide
324
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
17.2 Product Specifications
The G5x is intended for single patient use in the home environment and
requires a prescription.
Use of accessories, transducers, and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Do not touch the metal connectors on the bottom of the transmitter and other
open connectors on the receiver, charging cable, and charger.
Sensor Product Specifications
Glucose Range
40-400 mg/dL
Sensor Life
Up to 7 days
Calibration
Commercially available BG meter
Calibration Range
40-400 mg/dL
Storage
/Operational/Transport
Conditions
Temperature: 36° F-86° F
Humidity: 10%-90% RH
Sterilization
Sterile by radiation
Transmitter Product Specifications
Part Number
9445-01
Length: 1.5 inches
Dimensions
(Including Transmitter Width: 0.9 inches
Holder)
Thickness: 0.5 inches
Weight (Including
Transmitter Holder)
Dexcom G5x System User Guide
0.3 ounces
325
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Part Number
9445-01
Power Supply
Lithium manganese dioxide/Organic electrolyte battery (not
replaceable)
Operational
Conditions
Ambient temperature is 10° C-42° C (50° F-107.6° F)
Equilibrium temperature of less than 0.5° C (0.9° F) above ambient
Humidity: 10%-95% RH
Storage /Transport
Conditions
Temperature: 32° F-113° F
Operating Altitude
-1300 feet to 13,800 feet
Limited Warranty
3 months
Moisture Protection
Humidity: 10%-95% RH
IP28: Protection against insertion of large objects and immersion in
water for up to 8 feet for 24 hours
Protection against submersion in water
Protection Against
Electrical Shock
Dexcom G5x System User Guide
Type BF applied part
326
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Transmitter Performance Characteristics
Parameter
Performance Characteristic
TX/RX Frequencies
2.402-2.480 GHz
Bandwidth
1.02 MHz
Maximum Output Power
1.0 mW EIRP
Modulation
Gaussian Frequency-Shift Keying
Data Rate
1 Mbps
Data Communication Range 20 feet
The Dexcom G5x CGM System is safe for use on U.S. commercial airlines.
The G5x System is an M-PED (Medical-Portable Electronic Device), which
meets the FAA RTCA /DO-160 edition G section 21, Category M. It can be
used on aircraft according to the directions provided by the operator of the
aircraft.
This device can withstand exposure to common electrostatic discharge (ESD)
and electromagnetic interference (EMI).
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The transmitter (P/N 9445-01) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
transmitter should ensure that it is used in such an environment.
Dexcom G5x System User Guide
327
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Transmitter Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test
Level
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Transmitter
Compliance Level
Electromagnetic
Environment
Guidance
± 8 kV Contact
± 15 kV Air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
30 A/m
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
± 8 kV Contact
± 15 kV Air
Power Frequency
(50/60 Hz)
Magnetic Field
30 A/m
IEC 61000-4-8
Receiver Product Specifications
Part Number
MT22719
Reading Frequency
Every 5 minutes
Length: 4.0 inches
Dimensions
Width: 1.8 inches
Thickness: 0.5 inches
TX/RX Frequencies
2.402-2.480 GHz
Bandwidth
1.22 MHz
Maximum Output Power 2.5 mW EIRP
Modulation
Gaussian Frequency-Shift Keying
Data Rate
1 Mbps
Dexcom G5x System User Guide
328
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Weight
2.4 ounces
Receiver Input
5V DC, 1A
Power Supply
MT21255
Communication Range
20 feet
Memory Storage
30 days of glucose data
7 days of tech support data
Re-Chargeable Battery
Use
3 days
3 hours wall outlet
The device behaves normally while being charged
Charging Time
Do not hold the receiver while charging for over a minute
There are no risks to connecting any part of the system to an MSO
(Multiple Socket Outlet)
Storage/Operational/Tra Temperature: 32° F-104° F
nsport Conditions
Humidity: 15%-95% RH, (Storage 10%-95% RH)
Operating Altitude
-1300 feet to 13,800 feet
Medium Priority Alarm
Audible Output
50 dBa at 1 meter
Moisture Protection
IP22: Vertically falling drops
Protection against insertion of large objects and dripping water
Limited Warranty
1 year
Control Classification
Class II equipment
No cleaning methods are recommended or tested for the receiver. The
warranty life of the receiver is 1 year. The service life for the accessories is
noted to be up to 1 year. If you have difficulty reading your receiver in bright
sunlight, you may need to seek a shady location. Do not connect the receiver
to any equipment not specified in IFU.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Dexcom G5x System User Guide
329
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The receiver (MT22719) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
receiver should ensure that it is used in such an environment.
Receiver Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test
Level
Transmitter
Compliance
Level
Electromagnetic
Environment Guidance
± 8 kV Contact
± 15 kV Air
± 8 kV Contact
± 15 kV Air
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%.
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Surge
IEC 61000-4-5
Voltage Dips,
Short
Interruptions and
Voltage
Variations on
Power Supply
Input Lines
IEC 61000-4-11
± 2 kV for power supply
± 2 kV for power supply Mains power quality should be that
lines
of a typical commercial or hospital
lines
± 1 kV for input/output
environment.
Not applicable
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
0% UT for 1 cycle
0% UT for 1 cycle
0% UT for 0.5 cycle at
8 phase angles
0% UT for 0.5 cycle at
8 phase angles
Mains power quality should be that
of a typical commercial or hospital
70% UT (30% dip in Ut) 70% UT (30% dip in UT) environment.
for 25 cycles
for 25 cycles
0% UT for 250 cycles
0% UT for 250 cycles
IEC 60601-1-11
Power Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Dexcom G5x System User Guide
330
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Dexcom G5 Mobile System is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
Dexcom G5 Mobile System should ensure that it is used in such an
environment.
System Electromagnetic Immunity Specifications
Immunity Test
Conducted RF
IEC 61000-4-6
(Receiver only)
IEC 60601 Test
Level
Transmitter
Compliance
Level
3 Vrms
150 kHz to 80 MHz
6 Vrms
Electromagnetic
Environment Guidance
Floors should be wood,
concrete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Recommended Separation
Distance
d = 1.2 √P 150 kHz to 80 MHz
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.5 GHz
Radiated RF
IEC 61000-4-3
10 V/m at 80 MHz to
2700 MHz (AM
Modulation)
10 V/m
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey
should be less than the
compliance level in each
frequency range .
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Dexcom G5x System User Guide
331
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the
location in which the G5 Mobile System is used exceeds the applicable RF compliance
level above, the G5 Mobile System should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the G5 Mobile System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than
10 V/m.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The G5 Mobile System is intended for use in the electromagnetic environment
specified in the next table. The customer or the user of the G5 Mobile System
should ensure that it is used in such an environment.
Electromagnetic Emissions Specifications
Immunity Test
Compliance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Dexcom G5x System User Guide
Electromagnetic Environment Guidance
Group 1
The G5 Mobile System uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
Class B
The G5 Mobile System is suitable for use in all
establishments including domestic and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
332
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Recommended Separation Distances Between Portable and Mobile
RF Communications Equipment and the Receiver
The receiver is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the
receiver can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications
equipment (transmitters) and the receiver as recommended in the next table,
according to the maximum output power of the communications equipment.
Portable and mobile RF equipment include: baby monitors, Bluetooth wireless
headsets, wireless routers, microwave ovens, laptops with internal Wi-Fi
adapters, GSM cell phones, RFID scanners and hand-held security metal
detector often used by security screeners.
Minimum Recommended Distance Between Other RF Transmitters
and the Dexcom Transmitter/Receiver
Rated Maximum
Output Power of
Transmitter (W)
Separation Distance According to Frequency of Transmitter
(m)
150 kHz to 80 MHz 80 MHz to 800 MHz
½
½
d = 1.2 P
d = 1.2 P
800 MHz to 2.5
GHz
d = 2.3 P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
½
For transmitters rated at a maximum output power not listed above, the recommended
separation distance (d) in feet can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic
Dexcom G5x System User Guide
333
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
propagation is affected by absorption and reflection from structures, objects and
people.
USB Charging/Download Cable* Specifications
Part Number
MT20655
Input/Output
5V DC, 1A
Type
USB A to USB micro B
Length
3 feet
*The power supply/charger can be connected to the USB charging/download cable for
charging using an AC power outlet. Misuse of the USB cable can present a
strangulation risk. Isolation of system is by disconnecting charger from wall.
Power Supply/Charger Specifications
Part Number
MT21255
Class
II
Input
AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100 Vac
DC Output
5V DC, 1A (5.0 Watts)
17.3 FCC Requirements
The transmitter and receiver covered by this user guide have been certified
under FCC ID:
•
•
G5x Transmitter: PH29588
G5 Mobile receiver: PH29496
Although the transmitter and receiver have been approved by the Federal
Communications Commission, there is no guarantee that they will not receive
interference or that any particular transmission from either device will be free
from interference.
Compliance Statement (Part 15.19)
This device complies with Part 15 of the FCC Rules.
Dexcom G5x System User Guide
334
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Operation is subject to the following two conditions:
1. This device may not cause harmful interference, and
2. This device must accept any interference received, including
interference that may cause undesired operation.
Warning (Part 15.21)
Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. No
modification of the equipment is allowed as it could create an unsafe
condition.
FCC Interference Statement (Part 15.105 (b))
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
This portable transmitter with its antenna complies with FCC/IC RF exposure
limits for general population/uncontrolled exposure.
Dexcom G5x System User Guide
335
Technical Information
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 18
Everything Else G5x:
Troubleshooting
18.1 Introduction
Transmitter holder not sticking? Notification won’t go away? Not getting your
sensor glucose readings? Don’t know when to replace your transmitter? This
chapter will help you figure it out!
Troubleshooting sections are categorized by function or system component.
The solutions here are meant to be brief and not all-inclusive; some have
audible notifications, and others don’t. When more detailed answers or
preventative measures are in a chapter, you’ll get a brief explanation here,
and then get directed to the applicable chapter and section.
After looking at the troubleshooting chapter, are you still not sure what to do?
Or maybe your problem is hardware (for example, receiver or transmitter
failure).
If your problem is not found here, follow the steps listed on your app screen,
or call Technical Support.
If any of these errors continue and the instructions don’t resolve the issue,
please contact Technical Support (available 24/7) at:
•
TechSupport@dexcom.com
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
18.2 Safety Statements
Following are the Safety Statements for the Troubleshooting chapter.
Dexcom G5x System User Guide
336
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
W arning
Do: Calibrate at least once every 12 hours.
W hy: Calibrating less often than every 12 hours might cause sensor
glucose readings to be inaccurate.
Consequences: Missing severe low (hypoglycemia) or high
(hyperglycemia) glucose event.
Precaution
Do: Enter the exact BG value displayed on your BG meter within five
minutes of a carefully performed fingerstick.
W hy: Entering the wrong BG values, or waiting more than five minutes
before entry, might affect sensor performance.
Consequences: Missing a severe low or high glucose event.
Precaution
Don’t: Separate the transmitter from the receiver or smart device by more
than 20 feet.
W hy: The transmission range from the transmitter to receiver or smart
device is up to 20 feet without obstruction. If your transmitter and display
device(s) are more than 20 feet apart or are separated by an obstruction,
they might not communicate.
Types of obstruction differ and not all have been tested. Obstructions can
include water, walls, metal, etc.
As with any wireless device, water is often the biggest culprit in reducing
communication distance. This applies to the transmitter and display
devices. Take special care when swimming, taking a bath, or getting into a
hot tub.
Consequences: Missing a severe low or high glucose event.
18.3 Troubleshooting
Dexcom G5x System User Guide
337
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
No Alarm/Alerts
Device
What you see
Problem
What you do
See Chapter 11.
Smart
Device:
In app
Not receiving
Alarm/Alerts
Check
Alarm/Alerts, sound
and/or vibrations
notifications are
turned on.
Check your smart
device is not on
Silent or Do Not
Disturb (if
applicable).
Receiver
Sensor Glucose Readings
Device
What you see
BG
Meter
Dexcom G5x System User Guide
Problem
What you do
Sensor
readings and
BG meter
glucose values
often don’t
show the same
numbers.
See Chapter 7.
Differences are not
uncommon.
Readings from different
body fluids reflect
different numbers:
338
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
Meter - from blood
Sensor - from
interstitial fluid
Smart
Device:
In app
20/20 Rule:
If the meter shows 80
or less, CGM should
read within ± 20 points.
If the meter shows 80
or above, the CGM
should read ± 20%.
Example: a 202 mg/dL
sensor reading and a
188 mg/dL glucose
meter value = a 7%
difference (this is still
considered accurate).
Receiver
Outside of 20/20
rule:
Calibrate again.
Device
What you see
Problem
What you do
See Chapter 9.
Smart
Device:
In app
Not getting
sensor glucose
readings.
W ait.
System will often
resolve itself.
Check transmitter—is it
properly inserted into
Dexcom G5x System User Guide
339
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
the transmitter holder?
Make sure you haven’t
taken acetaminophen.
Don’t calibrate. Use BG
meter for BG reading.
Receiver
If this continues for
more than 3 hours,
contact Technical
Support (see Chapter
16.:
See Chapter 9.
W ait
Smart
Device:
In app
System will often
resolve itself.
Not getting
sensor glucose
readings.
Receiver
Dexcom G5x System User Guide
Check transmitter—is it
properly inserted into
transmitter holder?
Make sure you haven’t
taken acetaminophen.
Don’t calibrate.
If this continues for
more than 3 hours, call
Technical Support (see
Chapter 16):
340
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
See Chapter 9.
Don’t calibrate.
Smart
Device:
In app
Verify display device
and transmitter are
within 20 feet of each
other without
obstruction.
System display
device and
transmitter not
connecting.
Receiver
No sensor
readings,
Alarm/Alerts or
notifications
until error is
fixed.
Wait up to 30 minutes.
Don’t calibrate. Use BG
meter for BG reading.
More than 30 minutes?
App (if not
resolved):
•
Go to Settings.
•
Tap Bluetooth.
•
Turn Bluetooth
Off and On.
App/Receiver:
If this continues for
more than 3 hours,
contact Technical
Support (see Chapter
16).
See Chapter 7.
Smart
Device:
In app
Dexcom G5x System User Guide
No sensor
glucose
readings
W ait up to 2 hours.
System is counting
down to when you do
your startup calibration.
341
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
Receiver
Applicator
Picture
Problem
What you do
Can’t push
in orange
button.
After placing on body, make sure safety
guard is removed.
Hurts when
the needle
fires.
Smaller
adhesive
patch won’t
come off.
Dexcom G5x System User Guide
Fold and break away guard.
Make sure your application site is not
directly over a bone.
Use an area of your belly with less scar
tissue or irritation.
Lift up the tab of the label.
342
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Picture
Problem
What you do
See Chapter 6.
Transmitter
holder
won’t stick.
Put medical tape over transmitter
holder’s white adhesive patch (e.g.,
Blenderm).
Don’t place tape over the transmitter.
Dexcom G5x System User Guide
343
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Picture
Problem
What you do
Don’t panic!
Remove applicator and adhesive patch:
1. Gently pull applicator up until
you see adhesive patch
2. Using your finger or thumb, hold
front edge of patch and peel
from skin
Applicator
doesn’t
come off
after
pushing
button
3. While holding adhesive patch’s
front edge, gently rock back
applicator, away from your
body.
Check insertion site to make sure
the sensor isn’t left on the skin.
Don’t try to reuse applicator.
Call Customer Service.
Dexcom G5x System User Guide
•
Toll free: 1.888.738.3646
•
Toll call: 1.858.200.0200
344
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Hardware Error
Device
What you see
Problem
What you do
See Chapter 4.
Receiver
Won’t turn on:
Battery dead.
Charge receiver using
electrical outlet, not
computer/laptop.
Full charge may take up
to five hours.
See Chapter 4.
Reset receiver.
Connect receiver to
charger.
Receiver
After full
charge
session:
Won’t turn on.
Insert end of paper clip
into small circular hole
on receiver’s back.
Push down on paper
clip.
Receiver will vibrate.
Processing screen
appears.
Charge receiver.
Receiver
Dexcom G5x System User Guide
Receiver low
battery.
See Chapter 4.
Charge receiver.
345
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
See Chapter 16.
W rite down error code.
(Screen may show other
codes.)
Call Technical Support:
Receiver
Corrupted
database.
•
Toll free:
1.888.738.36
46
•
Toll call:
1.858.200.02
00
Notification: Vibrates
one time for four
seconds and four beeps.
See Chapter 16.
Do nothing.
Receiver
System
recovery.
Receiver is able to
continue to work and
recover from an error.
app: Tap OK to clear
Alert.
Receiver: Press Select
to clear Alert.
Dexcom G5x System User Guide
346
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
No Bluetooth.
See Chapter 5.
No sensor
readings,
Alarm/Alerts
or notifications
until error is
fixed.
Smart
Device:
In app
Go to smart device’s
Settings.
Make sure Bluetooth is
On.
If problem persists,
please contact device’s
manufacturer.
Calibration Error
Device
What you see
Problem
What you do
See Chapter 7.
BG
Meter
System will not
accept
calibration if
outside of the
40-400 mg/dL
range.
Smart
Device:
In app
System didn’t
accept recent
calibration (see
Sensor
Glucose
Readings
troubleshooting
Dexcom G5x System User Guide
W ait until your glucose
is between 40-400
mg/dL.
Calibrate only when
your BG meter values
are between 40-400
mg/dL.
See Chapter 7.
app:
Tap question mark to
get more information.
OR
Follow instructions
347
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
for a possible
reason).
below.
No sensor
readings,
Alarm/Alerts or
notifications
until error is
fixed.
W ait 15 minutes.
app/Receiver:
Enter 1 calibration.
If error screen still
appears enter 1 more
BG meter value.
W ait 15 minutes.
Receiver
If no sensor glucose
readings display on the
smart device or
receiver, the sensor
needs to be replaced.
Contact Technical
Support (see Section
16.1) to report error:
Device
What you see
Dexcom G5x System User Guide
Problem
What you do
348
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
See Chapter 7.
W ait 15 minutes.
Enter 1 BG meter
value.
W ait 15 more minutes.
Smart
Device:
In app
If error screen still
appears enter 1 more
BG meter value.
W ait 15 minutes.
System didn’t
accept recent
calibration.
If no sensor glucose
readings appear on the
display, the sensor
needs to be replaced.
Call Technical Support
(see Section 16.1) to
report error:
Receiver
•
TechSupport@dex
com.com
•
Toll free:
1.888.738.3646
•
Toll call:
1.858.200.0200
Transmitter Error
Device
What you see
Dexcom G5x System User Guide
Problem
What you do
349
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
See Chapter 16.
Smart
Device:
In App
Transmitter not
working.
Sensor session
automatically
stopped.
No sensor
readings,
Alarm/Alerts or
notifications
until transmitter
is replaced
Receiver
Make sure transmitter
is snapped into sensor
pod
Contact Technical
Support:
•
TechSupport@dex
com.com
•
Toll free:
1.888.738.3646
•
Toll call:
1.858.200.0200
Use BG meter for BG
reading.
You won’t get
additional Alerts after
clearing.
Device
What you see
Smart
Device:
In App
Dexcom G5x System User Guide
Problem
What you do
Pairing failed
See Chapter 6.
Transmitter
and sensor not
connected.
Sensor may not be
inserted correctly.
Insert a new sensor.
For a replacement,
350
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
No sensor
readings,
Alarm/Alerts or
notifications
until transmitter
is paired.
Receiver
Device
Problem
What you see
Problem
What you do
contact Tech Support
at:
•
TechSupport@dex
com.com
•
Toll free:
1.888.738.3646
•
Toll call:
1.858.200.0200
What you do
See Chapter 16.
Contact Technical
Support:
Smart
Device:
In App
Dexcom G5x System User Guide
Transmitter
Low Battery
•
TechSupport@dex
com.com
•
Toll free:
1.888.738.3646
•
Toll call:
1.858.200.0200
351
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Device
What you see
Problem
What you do
Receiver
Dexcom G5x System User Guide
352
Troubleshooting
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 19
Everything Else G5x:
Symbols on Package Labels
The following symbols may be found on the sensor, transmitter, and receiver
package labels. These symbols tell you about the proper and safe use of the
Dexcom G5x System.
Some of these symbols may not have meaning in your region, and are listed
for informational purposes only. This table shows what each symbol means.
Alternating Current
EC REP
Authorized
Representative in the
European
Community
Batch/Lot Number
Bluetooth
Caution
Class II Equipment
Date of Manufacture
Direct Current
Do Not Reuse
Electrical Equipment
Designed Primarily
for Indoor Use
Dexcom G5x System User Guide
Do Not Use If
Package Is
Damaged
European Union
WEEE Directive
2012/19/EU
353
Symbols on Package Labels
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Humidity Limitation
Input
IP22: Protection
Against Insertion of
Large Objects and
Dripping Water
IP28: Protection
Against Insertion of
Large Objects and
Immersion in Water
Keep Dry
Manufacturer
Marking Certifies
Device Meets
European Council
Directive 93/42/EEC
MR Unsafe
Non-Ionizing
Radiation
Prescription
Required
Refer to Instruction
Manual/Booklet
Ship By Date
Temperature
Limitation
SN
STERILE R
Serial Number
Sterile by Radiation
Type BF Applied
Part
Use By Date
Dexcom G5x System User Guide
354
Symbols on Package Labels
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Dexcom G5x System User Guide
355
Symbols on Package Labels
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
5
SHARING IS CARING
•
Dexcom Share
G5x System User Guide
®
356
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 20
Sharing is Caring:
Dexcom Share®
20.1 Learning About Dexcom Share
Glossary
Airplane Mode
A setting on a smart device where wireless features
are disabled in order to comply with airline
regulations.
Application or
App
A software program, such as the Dexcom G5 Mobile
app and the Dexcom Follow app, designed to run on
a smart device.
App Store
Internet store for downloading applications to a
smart device.
Blood Glucose
Meter
A device used to measure how much glucose is in
the blood.
BG Value
The measurement of glucose in the blood.
Bluetooth
A wireless technology that allows devices to
wirelessly communicate with each other.
Default
A manufacturer’s preset option for a device setting.
Delay
Amount of set time that passes before a notification
is sent to a Follower.
G5x System User Guide
357
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Dexcom Follow
App
Gets the Sharer’s glucose information and
notification data from the Dexcom Share Cloud.
Dexcom G5
Mobile App
Receives glucose information from the G5x
transmitter. Sends glucose information to the
Dexcom Cloud using an Internet connection.
Dexcom G5x
Sensor
The Dexcom G5x System part that includes an
applicator and sensor wire.
Dexcom G5x
System
CGM system made of a sensor, transmitter, and
smart device/receiver.
Dexcom G5x
Transmitter
The G5x System part that wirelessly sends glucose
information to the app.
Dexcom Share
A secondary notification system using the following
parts:
Dexcom Share
Cloud
G5x System User Guide
•
G5x
•
Bluetooth wireless technology
•
Sharer’s smart device
•
App
•
Internet
•
Follower’s smart device
•
Dexcom Follow app
A secure online storage server where Dexcom
Share feature information is stored and then shared
with Followers.
358
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Do Not Disturb
A setting on a smart device where all incoming calls,
Alerts, and notifications are silenced.
Do Not Disturb can be set to specific times and can
be set to allow exceptions (people who can disturb
you).
Follower
A person that gets the Sharer’s shared information
in the Dexcom Follow app.
Follow
Dashboard®
On the Dexcom Follow app, the Follow Dashboard
shows the glucose information of up to five (5)
Sharers.
Follower’s Smart
Device
Runs the Dexcom Follow app.
G5 Mobile/G4
PLATINUM
Sensor
G5 Mobile part that includes an applicator and
sensor wire.
G5 Mobile
System
CGM system made of a sensor, transmitter, and
smart device/receiver.
G5 Mobile
Transmitter
G5 Mobile part that wirelessly sends glucose
information to the G5 Mobile app.
G5 Mobile App
Receives glucose information from the G5
transmitter. Sends glucose information to the
Dexcom Share Cloud using an Internet connection.
G5x System User Guide
359
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Hyperglycemia
High BG. Same as “high.”
The default High Glucose Alert in the G5x is set to
200 mg/dL.
Consult your healthcare professional to determine
the appropriate hyperglycemia setting for you.
Hypoglycemia
Low BG. Same as “low.”
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.
Invite/Follow
Invitation Email
An email request for a person to download the
Dexcom Follow app and get the Sharer’s shared
information.
Jailbroken
The removal of limitations set by the manufacturer
on a smart device.
Do not use jailbroken smart devices with Dexcom
Share.
mg/dL
Milligrams per deciliter. The standard unit of
measure for sensor glucose information in the
United States.
Mobile Data
Connections
Cellular networks, such as 3G, 4G, and LTE™, used
by a smart device to access the Internet.
No More Data
Notification
Notifies the Follower when the Sharer is unable to
share glucose information.
G5x System User Guide
360
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Notification
A visual message that appears on the screen of the
Follower’s smart device. Notifications may also
include a sound, depending on the smart device’s
settings.
Not Sharing
When the Sharer chooses to temporarily not share
glucose data with the Follower.
Obstruction
An object that stops the wireless communication
between devices, such as wall thickness or radio
waves.
Profile
Located in Follow Dashboard and displays the
Sharer’s glucose information, trend arrow, and
profile picture.
Range
Maximum distance two devices can communicate
wirelessly without obstruction.
Real-Time CGM
Data the Sharer receives on the G5 Mobile app.
Although your Dexcom Follow app might be similar
to what you see on your G5 Mobile app, it cannot be
considered real-time because there are layers of
communication between the Dexcom G5 Mobile app
and the Dexcom Follow app.
Repeat
Amount of time the Follower chooses before he/she
wishes to receive a repeat notification.
Sensor Glucose
Reading
A glucose measurement taken by the G5x.
G5x System User Guide
361
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Sharer
The person who uses the Dexcom Share app..
Sharing
The act of electronically transmitting glucose
information from the Sharer’s smart device to the
Follower’s smart device.
Simultaneous
Voice and Data
The ability to make a phone call and access the
Internet on the same cellular connection at the
same time.
Smart Device
A cordless (unless charging), mobile (easily
transportable), connected (via Wi-Fi, 3G, 4G, etc.)
electronic device that can operate the G5 Mobile
app or the Dexcom Follow app.
Examples of smart devices are smartphones or
tablets.
For a list of compatible smart devices, see
dexcom.com/compatibility.
Standard Home
Glucose
Monitoring
Self-monitoring of BG using blood taken from the
finger and a BG meter.
Trend Arrow
The arrow next to the Sharer’s glucose value,
located on the Sharer’s profile on the Dexcom
Follow app.
This is the same trend arrow that is found on the
Dexcom receiver.
G5x System User Guide
362
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Trend Graph
Displays the pattern of the Sharer’s glucose
information.
W i-Fi or Wireless
Internet
A technology that allows electronic devices to
wirelessly access the Internet. These networks can
include your home Internet or one found at a public
location.
20.2 Dexcom Share Overview
Dexcom Share is a feature within the G5 Mobile app. It allows for remote
monitoring of G5x data from one person, the Sharer, to another person, the
Follower.
Dexcom Share includes:
•
•
•
•
•
•
G5x CGM System
Sharer’s smart device
App
Internet connection
Follower’s smart device
Dexcom Follow app
You cannot use the Share feature with the receiver.
Once the Sharer activates the Share feature in their app, the smart device
transfers sensor glucose readings to the Dexcom Share Cloud using either
Wi-Fi or a cellular data plan. Then, the sensor glucose readings are sent from
the Dexcom Share Cloud to the Follower’s smart device using Wi-Fi or the
Follower’s cellular data plan.
G5x System User Guide
363
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Figure 8. Sharing
The Sharer must be within 20 feet of his/her smart device in order to send
data to the Follower or it will not work.
G5x System User Guide
364
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Dexcom Share Parts
Sharer’s smart device*
Follower’s smart device*
G5 Mobile app
Dexcom Follow app
G5x transmitter*
G5x sensor*
Internet/Wi-Fi or mobile data service/3G/4G/LTE*
Bluetooth
*Must be purchased separately.
A list of compatible devices can be found at dexcom.com/compatibility.
G5x System User Guide
365
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Conditions Affecting Use
Once sharing is active, make sure the Sharer’s and Follower’s smart device
settings are not altered.
Make sure the Sharer’s and Follower’s smart devices have:
•
•
•
Enough battery power to maintain sharing
An active Internet connection
Notifications turned on. If turned off, Follower won’t receive any
notifications
Dexcom recommends charging the smart device while sharing.
20.3 Risks and Benefits
Risks
Dexcom Share is a feature of the G5x. The main risks involved with using the
Dexcom Share feature are based on misunderstanding its purpose.
Remember that the Dexcom Share feature in the G5x is a secondary
notification feature, not a real-time remote monitoring system.
With using the Dexcom Share feature, there are three distinct parts of glucose
monitoring:
1. BG meter—use this to make any treatment decisions.
2. G5x—Use the G5x to complement, but not replace, information
obtained from the BG meter. It detects glucose trends and tracks
glucose patterns.
3. Dexcom Share —This is an optional add-on to the G5x that can
share glucose information and notifications with up to five (5) other
people. Shared sensor glucose readings and information can add
another level of awareness.
Using the wrong glucose information for treatment decisions could lead to low
or high glucose. BG values from a BG meter may differ from the information
displayed on the Dexcom Follow app. All treatment decisions should be made
using a BG value from your meter, not the glucose information displayed on
the Dexcom Follow app.
G5x System User Guide
366
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Followers who are concerned by notifications on the Dexcom Follow app
should contact Sharers and remind them to check their BG with a BG meter
before driving a car or making any treatment decisions, such as taking insulin
or eating fast-acting carbohydrates.
Sharers should not rely on Followers to notify them about low or high glucose.
Any problems with smart device(s), Bluetooth, wireless Internet connection,
mobile data connection, Dexcom Share Cloud, or not being in the
communication range could cause data to not be shared with the Follower. In
addition, if the Delay setting is too long, the Follower might not be aware of
glucose level changes in a reasonable time. Therefore, the Dexcom Share
feature should be used only to give a secondary level of awareness and
should not be expected to always communicate and transfer sensor glucose
readings and information.
Benefits
Patients usually respond when their continuous glucose monitoring (CGM)
systems notify them.
However, experts advise that an additional CGM Alert to another person may
be helpful in increasing the detection of low glucose or high glucose values,
especially at night. The Dexcom Share feature enables this additional
awareness, even when the Sharer and Follower are not in the same place.
The Dexcom Share feature may provide improved quality of life and greater
peace of mind to patients, their caregivers, and their support team by allowing
the G5x Alerts, Alarms, and trend graphs to be checked remotely.
20.4 Safety Statement
Intended Use
The purpose of Dexcom Share Direct Secondary Displays is to notify another
person, the Follower, of the patient’s Dexcom Continuous Glucose Monitoring
(CGM) System sensor glucose information.
The Secondary Displays is intended for providing secondary notification of a
continuous glucose monitoring system and does not replace real time
G5x System User Guide
367
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
continuous glucose monitoring (G5x) or standard home BG monitoring. The
Dexcom Share Direct Secondary Displays is not intended to modify or analyze
data received from the continuous glucose monitoring system, nor is it
intended to instruct, or to transmit information to the continuous glucose
monitoring system.
The Dexcom Share Direct Secondary Displays is not intended to serve as a
replacement for a primary display device for a continuous glucose monitoring
system. The Dexcom Share Direct Secondary Displays is not intended to
receive information directly from the sensor or transmitter of a continuous
glucose monitoring system.
Important User Information
Please review the indications, contraindications, warnings, precautions,
cautions and other important information in the G5x user guide. Dexcom
Share is a feature of the G5x.
If you do not have the G5x user guide, you can view it on dexcom.com or call
1.888.738.3646 to request a copy. Availability hours: Monday-Friday, 6 AM6 PM PST. Please contact your healthcare professional during hours the line is
unavailable.
Contraindications
Do not bring the smart device (e.g., mobile phone, tablet computer) into a
room containing medical equipment such as Magnetic Resonance Imaging
(MRI), Computed Tomography (CT), or diathermy.
These smart devices have not been tested with this equipment. Exposure to
these types of equipment could heat and damage the smart devices so that
they are unable to send or receive glucose information.
Warnings
Dosing decisions should not be made based on this device. The user should
follow instructions on the continuous glucose monitoring system.
This device is not intended to replace self-monitoring practices advised by a
physician. Dexcom Share does not work alone. Dexcom Share does not
G5x System User Guide
368
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
replace G5x and requires Share to be turned “On” to communicate glucose
information to the Follower.
You cannot use Dexcom Share to make treatment decisions, such as how
much insulin to take. Dexcom Share does not replace a BG meter. Always use
the values from a BG meter for treatment decisions.
BG values may differ from the sensor glucose information. Using the sensor
glucose information for treatment decisions could lead to low or high BG
values.
Precautions
Do not use Dexcom Share as the main source of CGM glucose trend
information. Use the Dexcom receiver as the main device to track sensor
glucose information, notifications and Alarms.
At times, the patient will be unable to share data using Dexcom Share, and
the Follower might miss helping the patient in the event of low or high BG
values. Do not rely solely on the Follower to notify the patient of low or high
glucose events or other important information. At times, the Follower may not
receive data, and the patient will not be notified of this fact.
When using Dexcom Share, make sure Share is turned “On.” If not, the
patient will be unable to share data, and the Follower might miss helping the
patient in the event of low or high BG values. If the patient’s smart device
does not have a connection or loses the connection, the patient will be unable
to share data, and the Follower might miss helping the patient in the event of
low or high BG values.
Do not use Dexcom Share unless both the patient’s and Follower’s smart
devices have active Internet connections in order to share data. If either the
patient or the Follower does not have a connection, loses their connection,
turns off the connection (“Airplane Mode”) or if the smart device is in Do Not
Disturb mode, the patient will be unable to share data and the Follower might
miss helping the patient in the event of low or high BG values. To check this,
make sure that the Follower’s smart device can receive text messages. Follow
notifications and text messages work by a similar process.
Make sure the patient’s and Follower’s smart devices have charged batteries
or are connected to electrical outlets. If the smart device shuts down due to
G5x System User Guide
369
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
low battery, the patient will be unable to share data, and the Follower might
miss helping the patient in the event of low or high BG values.
If the patient’s smart device is powered off or restarted, make sure the app is
reopened after the smart device is turned back on in order to resume sharing.
If the app is not reopened, the patient will be unable to share data, and the
Follower might miss helping the patient in the event of low or high BG values.
Do not turn off sounds in the Follower’s smart device at any time that he or
she wants Follow notifications to be heard. The smart device settings override
the Dexcom Follow app, and all notifications will be silent even if the Follower
has selected a Dexcom Follow app notification sound. If the smart device has
a vibrate feature and vibrate is On, the Dexcom Follow app notifications will
only vibrate.
Check the delay settings on the patient’s smart device to make sure they are
not too long. The Follower will not receive notifications until after the time
period in the delay has passed, and the Follower might miss helping the
patient in the event of low or high BG values if the delay is too long.
The patient should not choose to “Not Share” with the Follower at any time
when he or she wants the Follower to get notifications. During the time the
patient chooses to “Not Share,” the Follower will not receive notifications and
might miss helping the patient in the event of low or high BG values.
Check the Dexcom Follow app’s trend graph if the Follower’s smart device
has been off or if there is no data connection (for example, Internet/Wi-Fi or
mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane
Mode, or smart device touch is placed in Do Not Disturb mode). When the
smart device is turned back on, the Follower will only receive the most recent
notification and might miss helping the patient in the event of prior low or high
BG values.
Sharers and Followers should check whether their cellular service carriers
support voice and data at the same time (simultaneous voice and data). If
their carriers do not support simultaneous voice and data, the app may not be
able to share glucose readings and the Dexcom Follow app may not be able
to receive notifications or glucose readings during phone calls. Dexcom Share
will resume sharing after the phone call has ended, and the Follower will
receive any waiting notifications after the phone call has ended.
G5x System User Guide
370
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
20.5 Setting Up Dexcom Share
Dexcom Share Description
W hat Dexcom Share does:
•
•
•
Connects your smart device with your Follower’s smart device via
either a Wi-Fi or mobile data connection (connect to Wi-Fi through a
secured network to maintain data security)
Invites and sends Followers your setting recommendations
Displays the status of your smart device, and the Dexcom Share
Cloud
o Confirms your sensor glucose readings are being shared with
your Follower(s)
W hat Dexcom Share does not do:
•
Lets you know when the Follower is not receiving your sensor glucose
readings and information
Tips
•
•
•
Read the rest of the G5x user guide before using Dexcom Share
Always confirm information with a BG meter before making treatment
decisions
Check the status screen after turning Dexcom Share “On” on the
smart device to make sure it is working
Installing the App
Step
What you see
G5x System User Guide
What you do
371
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Download the G5 Mobile app from your app
store.
See your smart device’s user manual for
instructions.
Download the app to use Dexcom Share.
Launch the app.
Set up your smart device (see Chapter 5)
before sharing.
Once your app has been set up, activate
Dexcom Share.
A series of screens walk you through the Dexcom Share features, highlighting
important information.
Activating Your Share Feature
Step
What you see
G5x System User Guide
What it means
What you do
372
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
Activates
Dexcom Share.
G5x System User Guide
If Dexcom Share
icon is gray, your
Share feature
has not been
turned on.
Dexcom Share
Welcome
Screen.
What you do
Tap Dexcom Share
icon in the upper right
corner of your smart
device’s home screen.
Read screen.
Tap Next when done.
373
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
Message about
Internet access.
Tap Next.
How to know you
are sharing your
data.
Tap Next.
G5x System User Guide
374
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What it means
What you do
How to know
your Follower is
not getting your
sensor data.
Tap Let’s Get Started to
move on and invite your
Followers.
Inviting Followers
Step
What you see
G5x System User Guide
What you do
Tap Invite Followers to set up your
Followers.
375
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Enter the Follower’s nickname and email
address.
Confirm Follower’s email address.
The Follower will get a Follow Invitation
email.
Make sure the Follower can access this
email account from their smart device.
Tap Next.
G5x System User Guide
376
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Slide Allow Trend Graph View’s On/Off
switch if you want Follower to see your trend
graph.
Tap Next.
Turned Off: Follower sees only your sensor
glucose reading and trend arrow.
Turned On: Follower sees your sensor
glucose reading, trend arrow, and trend
graph.
G5x System User Guide
377
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Choose if your Follower gets your Urgent
Low, Low, and High Glucose Alarm/Alerts.
Choose if you want your Follower to get
notifications if they are not receiving your
sensor glucose readings.
Select what Alarms/Alerts your follower gets
and how long you are low/high or not sharing
data (for example, if you want your Follower
to know when your glucose is above 200
mg/dL for more than 2 hours, you can set up
notifications in the Follower’s Settings
menu).
Tap Save for each Follower Setting “Save.”
Tap Next when done.
G5x System User Guide
378
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step
What you see
What you do
Before Follower invitation is sent, review the
Summary screen.
Tap Send Invitation.
After sending invitation, you cannot adjust
the Follower’s settings.
To add more Followers:
Tap Followers on the Share Status screen.
Invite up to a total of five (5) Followers.
G5x System User Guide
379
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
20.6 Using Dexcom Share
Dexcom Share Status
You can look at the Dexcom Share icon on your home screen to see if
Dexcom Share is working. After turning Dexcom Share on, check its status.
Share icon
Figure 9. Share Status
Dexcom Share Status Icons
Status tab
What it is
The Share icon is in color when Dexcom Share is
sending sensor glucose readings and information.
G5x System User Guide
380
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Status tab
What it is
The Share icon is dark gray with a red circle when
Dexcom Share is not working.
The Sharer should tap on the dark gray Share icon
when Share is not working to get further information
about the error.
The Share icon is light gray when Dexcom Share has
not been activated.
The Sharer should tap the light gray icon to get started
using Dexcom Share.
When a device or connection is not working, Dexcom Share will not work. The
Sharer will not be able to send sensor glucose readings and data to
Follower(s).
Troubleshooting Status Issues
The Dexcom Share status bar is a useful tool. It can help identify if there is a
problem and Dexcom Share is not working. The following table provides
troubleshooting tips for the Share status bar.
G5x System User Guide
381
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
On/Off Switch Turns sharing on
or off
Sharing Status
Bar - Status of
sharing your
sensor glucose
readings with your
Followers
Follower List - Add
Followers and lists
status of Followers.
Figure 10. Dexcom Share Screen
NOTE: Whether or not Dexcom Share is working and the Followers are
receiving glucose Alarm/Alerts, you must always refer to your G5x display
device for your sensor glucose readings and Alerts.
All treatment decisions must be based on your BG value from your BG meter.
Dexcom Share Status Issues
What you see
What it means
What you do
Green check mark:
All connections are
working.
G5x System User Guide
N/A.
382
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What it means
What you do
The Sharer should:
Issue with:
•
Sharer’s
CGM data
•
Sharer’s
smart device
•
Verify there is a
glucose value on the
smart device
•
Be sure the
transmitter is in range
of the smart device
•
Tap on blue “?” to
learn more about how
to troubleshoot this
issue
•
Allow up to 10
minutes for their
status to turn green
and a green check
mark to appear
If the Sharer continues to see
this, the Sharer should turn
off Share and then turn it
back on.
G5x System User Guide
383
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
What you see
What it means
What you do
The Sharer should:
•
Verify their Wi-Fi or
cellular connection is
ON
•
Be sure they are in
an area that has
cellular reception
•
Not be on a voice call
•
Be sure they can
access the web via a
browser
•
Check later or follow
up with their Internet
connectivity provider
•
Tap on blue “?” to
learn more about how
to troubleshoot this
issue
Issue with:
•
Sharer’s
Internet
connection
•
Dexcom
Share Cloud
Followers List
The Followers list allows the Sharer to manage his/her Followers.
In the Followers list the Sharer can:
•
•
•
Invite a new Follower
See the status of Followers that have been invited
Glance at what options the current Followers have
G5x System User Guide
384
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Icon/Status
What you see
What it means
Invite a new Follower.
Follower is set to get notifications from Sharer.
Follower is able to view Sharer’s trend graph.
Follower did not accept Sharer’s Follow Invitation
email within 7 days.
Sharer can invite Follower again by tapping on the +
icon in the top right corner of the screen.
Follower has been sent a Follow Invitation email but
has not accepted it yet.
Sharer stopped sharing with Follower.
Follower will not get any of the Sharer’s glucose
information, Alarm/Alerts, or trend graph updates.
Editing/Removing Followers
Tap on a Follower to edit the Follower’s profile (nickname or ability to view
trend graph) or remove a Follower. Remove a Follower by tapping “Remove
Follower.” Once removed, the Follower won’t get glucose information or
Alarm/Alerts.
NOTE: The Sharer cannot change any Follower settings after the Follow
Invitation email has been sent.
G5x System User Guide
385
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Stop Sharing
The Sharer can swipe the On/Off switch to temporarily stop glucose
information and Alarm/Alerts from being sent to Followers. Sharing stops until
the Sharer turns the On/Off Switch back on.
For reasons of safety and intended use, the Follower will get a message
telling them the Sharer’s data was set to Not Sharing. The Follower’s
dashboard will show the Sharer has stopped sharing glucose information.
20.7 Dexcom Follow App
Dexcom Follow App Description
The Dexcom Follow app is a separate app from the G5 Mobile app. Your
Followers only need to download and install the Dexcom Follow app.
W hat the Dexcom Follow App does:
•
•
•
Allows Follower to view Sharer’s glucose information
Allows Follower to get Alarm and Alerts
Allows Follower to view Sharer’s trend graph
W hat the Follower app does not do:
•
•
Provide treatment advice
Interact with the G5 Mobile app
Receiving Dexcom Follow Invitation Email
After getting the Sharer’s Follow invitation by email, the Follower sets up
his/her smart device.
Glucose Alarm and Alerts
A glucose notification is a visual message saying “Glucose notification from
[Sharer’s name]” that appears on the screen of the Follower’s smart device.
The notification may include sounds, depending on the smart device’s
settings.
Types of notifications the Follower gets:
G5x System User Guide
386
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
•
•
•
Low Sensor Glucose Reading
Urgent Low Glucose Alarm (< 55 mg/dL)
High Sensor Glucose Reading
Followers can change some of the initial settings to fit their needs. Followers
cannot change the Sharer’s permission settings to see the trend graph.
Sharer Status Changes That Notify the Follower
Some Sharer status changes will notify the Follower:
•
•
•
Not Sharing—Sharer decides to temporarily stop sharing
Removed by Sharer—Sharer removes Follower
No More Data—Active glucose sharing is stopped for any reason,
other than the Sharer turning Share “Off”
o Follower should contact Sharer for more information about
the data interruption
G5x System User Guide
387
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
The Follower Dashboard
If the Sharer doesn’t allow the Follower to see the trend graph, he/she will
only see the glucose reading and trend arrow.
Sharer’s picture
Sharer’s glucose reading
and trend arrow
How long ago
the Sharer’s
glucose reading
and trend arrow
were last updated
Figure 12. Follower Information
G5x System User Guide
388
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
If you choose to have your Followers see your trend graph, they see:
Sharer’s name
Notification settings
Home icon
Sharer’s
glucose
reading
Trend arrow
Time
duration
setting of
3, 6, 12 or
24 hours
Trend graph
Glucose range
(between high
and low alerts)
20.8 Troubleshooting
Dexcom Share Troubleshooting
Troubleshooting Status—See the Troubleshooting Status Issues portion of
Section 20.6.
Figure 14. Sharing Status Troubleshooting
G5x System User Guide
389
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Sharing Checklist
To share, make sure:
• Your smart device works with the G5 Mobile app
o To see a list of supported smart devices and operating
systems, go to: dexcom.com/compatibility
• The app is open or running in the background
• Your smart device has an active Internet connection (Wi-Fi, 3G, 4G,
LTE)
o Check to see if the Internet connection is working by trying to
open a web page on the smart device
• If on a phone call using your smart device, your CGM information may
not upload into the Share Cloud while on your call
• Airplane Mode is turned off
• Do Not Disturb is turned off
• Smart device sound is on in order to hear notifications
• Smart device is sufficiently charged or charging
• Smart device is within 20 feet of the transmitter
• Smart device has 35 MB of available memory
•
Refer to the smart device user manual for further instructions.
Tips
•
•
Read the G5x user guide before using the Dexcom Share feature
Always confirm information with a BG meter before you make
treatment decisions
G5x System User Guide
390
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
| Sample Index (note,
pagination is wrong)
Warning and Precautions 6
Change Low/High Alerts 44
Choose Display Device 18
Components
Applicator and Sensor 17
Display Devices 17
Transmitter 17
Adhesive
Adhesive won’t stick 51
Optional use 30
Customer Service 60
Alarm or Alerts
Change Low/High Alerts 44
Rise Rate, Fall Rate, and Signal Loss Alerts
44
Urgent Low Glucose Alarm 44
Ending Sensor Session Early 42
End Sensor Session 40
Enter Initial BG Meter Values 36
Enter Initial BG Meter Values 22
Enter Update Calibration 23
Install App 21
View Home Screen 24
Fall Rate 44
Fingerstick 7
App
Hourglass 46
Benefits 15
Calibration
Entering initial BG in app 22
Enter update BG readings in app 12 Hours
23
Tips for Entering BG Meter Values 23
G5x System User Guide
Indications for Use 5
Install App 21
MRI/CT/Diathermy 5
391
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
P
Receiver Warning and Precaution 11
System Precautions 10
Transmitter Warnings and Precautions 9
Precautions 7, 8, 10, 11, 13
Sensor
Ending Sensor Session Early 43
End Sensor Session 40
Insert Sensor 29
Question Marks 46
Receiver
Confirm Transmitter and Receiver
Communication 35
Ending Sensor Session Early 43
Enter BG Meter Values Every 12 Hours 37
Enter Initial BG Meter Values 36
Receiver Setup 27
Set Up Alert Sounds 34
Start Sensor 33
Trend Arrows 39
View Receiver Trend Screen 38
Rise Rate 44
Risks and Benefits
Benefits 15
Risks 14
Signal Loss 44
System Overview
Choose Display Device 18
Components 17
Applicator and Sensor 17
Display Device(s) 17
Transmitter 17
Training Options 4
Transmitter
Attach Transmitter 32
Errors 49
Remove 40
Travel 58
Trend Arrows
App 25
Receiver 39
Safety Statement
Calibration Warning and Precautions 6
Contraindications 5
Indications for Use 5
Trend Graph
App 25
Receiver 39
Troubleshooting
Adhesive 51
G5x System User Guide
392
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Applicator 52
Calibration Errors 48
Sensor Glucose Readings 45
Transmitter Errors 49
Urgent Low Glucose Alarm 44
Warnings 6, 8, 9, 12, 13
Warranty
Receiver Warranty Information 53
Transmitter Warranty Information 55
G5x System User Guide
393
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
© 2016 Dexcom, Inc. All rights reserved.
Covered by patents: dexcom.com/patents.
Dexcom, Dexcom G4 PLATINUM, G5, Dexcom G5, Dexcom G5 Mobile,
Dexcom G5x, G5x, Dexcom G5x CGM System, Dexcom Share, Dexcom Care
are either registered trademarks or trademarks of Dexcom, Inc. in the United
States and/or other countries. Bluetooth is a registered trademark owned by
Bluetooth SIG. All other product or company names that may be mentioned in
this publication are trade names, trademarks or registered trademarks of their
respective owners
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
Web: dexcom.com
Phone: 1.858.200.0200
Tech Support: 1.888.738.3646
LBL013726 Rev 003 / MT23637
G5x System User Guide
394
Sharing is Caring
PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : Yes
XMP Toolkit                     : Adobe XMP Core 5.6-c015 81.157285, 2014/12/12-00:43:15
Create Date                     : 2016:05:13 22:45:58Z
Creator Tool                    : Word
Modify Date                     : 2016:05:13 15:49:04-07:00
Metadata Date                   : 2016:05:13 15:49:04-07:00
Keywords                        : 
Producer                        : Mac OS X 10.11.4 Quartz PDFContext
Format                          : application/pdf
Title                           : Microsoft Word - LBL013726 Rev 003 G5x Adjunctive User Guide US .docx
Document ID                     : uuid:3c4c100a-96db-2748-958a-c3774a7822cc
Instance ID                     : uuid:13a78633-d4df-7c4a-b8c3-b1c2d4ef08bd
Page Count                      : 394
Creator                         : PdfCompressor 6.0.181

EXIF Metadata provided by EXIF.tools

Dexcom 9588 G5x Transmitter User Manual

Dexcom, Inc. G5x Transmitter

User Manual

FCC ID Filing: PH29588

Navigation menu

Namespaces

Views

Navigation