Dexcom 9433 Glucose Monitor User Manual LBL 010797 Rev01 Users Guide IUO indd

Download:
Mirror Download [FCC.gov]
Document ID	1372766
Application ID	qzL7DDdcLkCRsRCVFi4M1w==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	134.4kB (1679968 bits)
Date Submitted	2010-11-08 00:00:00
Date Available	2010-11-09 00:00:00
Creation Date	2010-09-30 13:20:41
Producing Software	Acrobat Distiller 9.3.2 (Windows)
Document Lastmod	2010-11-04 16:13:14
Document Title	LBL-010797 Rev01 Users Guide_ IUO.indd
Document Creator	PScript5.dll Version 5.2.2
Document Author:	jrichey

G4-Global Continuous
Glucose Monitoring System
CAUTION: Investigational device. Limited by Federal
(or United States) law to investigational use.
USER’S GUI DE
G4-Global Continuous
Glucose Monitoring System
IMPORTANT CONTACTS AND NUMBERS
DexCom Website:
www.DexCom.com
Your Transmitter ID Number:
Your Transmitter Expiration Date:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
Other Notes:
© 2010 DexCom, Inc. All rights reserved.
DexComTM, STS®, SEVEN®, DexCom DM®, DexCom Studio® Software, GVITM,
OpenChoiceTM, Take Control – Live Uninterrupted®, Live Uninterrupted®, Between the
LinesTM, SENSYNCTM, Stay Between the Lines®, DexCom Glucose Sensing™, Glucose
Sensor Company™ and Dex™ are trademarks of DexCom, Inc. All other trademarks and
copyrights are the property of their respective owners.
4 | Continuous Glucose Monitoring System
G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM
G4-Global Receiver
G4-Global Sensor
and Applicator
G4-Global
Transmitter
G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM
KIT CONTENTS:
• Transmitter
• Receiver Case
• Receiver
• User’s Guide
• DexCom Studio® Accessory Software • Quick Start Guide
• Receiver Charging Cable
NOTE: Sensors are sold separately. Commercially distributed blood glucose
meter required for use. Make sure to use the correct version of DexCom
Studio® with your G4-Global System. The G4-Global Sensor works with
the G4-Global family of products. The G4-Global Sensor, Transmitter and
Receiver are not backwards compatible with the SEVEN/SEVEN ® PLUS
Transmitter and Receiver.
The G4-Global Continuous Glucose Monitoring System is a
glucose-monitoring device indicated for detecting trends and tracking
patterns in adults (age 18 and older) with diabetes.
G4-Global System User’s Guide | 5
DexCom would like to thank you for purchasing the G4-Global Continuous
Glucose Monitoring System (G4-Global System)! When you use the G4-Global
System, you will see real-time continuous glucose readings every 5 minutes for
up to 7 days. These readings will help you detect trends and patterns in your
glucose levels. Glucose trends let you see where your glucose levels have been,
which direction your levels are headed, and how fast they may be rising
or falling.
The G4-Global System is made up of three technologies that all work together:
the Sensor, the Transmitter, and the Receiver. The Sensor is a disposable unit
that you insert into your abdomen (belly) to continuously monitor your glucose
levels for up to 7 days. The Transmitter is a reusable device that snaps into
the Sensor Pod. Your Transmitter will wirelessly send your Sensor-measured
glucose information to your Receiver. The Receiver is a hand-held device that
receives and displays your glucose information every 5 minutes.
The Receiver displays your current glucose reading and shows your glucose
trend information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour
periods. You will also see adjustable High and Low Glucose Alerts, and a Low
Glucose ALARM to tell you when you are outside of your target glucose levels.
Rise and Fall (Rate of Change) Alerts will let you know when your glucose levels
are changing fast.
You can use any FDA-cleared blood glucose meter for calibration on the
G4-Global System.
This User’s Guide describes how to use your G4-Global System from start to
finish of a continuous glucose monitoring session. Important safety information,
warnings, precautions, cautions, and contraindications of the G4-Global System
are described in the next few pages and throughout this guide. Be sure to read
this entire User’s Guide before beginning a continuous glucose monitoring
session.
6 | Continuous Glucose Monitoring System
INDICATION FOR USE
The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring
device indicated for detecting trends and tracking patterns in adults (age 18 and
older) with diabetes. The G4-Global System is intended for use by patients at
home and in health care facilities. The device is for prescription use only.
The G4-Global Continuous Glucose Monitoring System is indicated for use as
an adjunctive device to complement, not replace, information obtained from
standard home glucose monitoring devices.
The G4-Global Continuous Glucose Monitoring 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 G4-Global System results should be based on the trends
and patterns seen with several sequential readings over time.
IMPORTANT SAFETY INFORMATION
Read this entire guide before using your G4-Global Continuous Glucose
Monitoring System. If you do not understand something or have any questions,
please ask your Diabetes Management Team or another health care provider.
Contraindications, warnings, precautions, cautions, and other important
safety information can be found in this section and in boxes throughout your
G4-Global System User’s Guide. The Troubleshooting section (Chapter 9)
contains important information on troubleshooting your G4-Global System. The
Technical Information section (Chapter 11, Section 11.2) provides information on
the performance characteristics of the device.
CONTRAINDICATIONS
• The G4-Global System must be removed prior to Magnetic Resonance
Imaging (MRI).
• Use of acetaminophen-containing medications while the Sensor is inserted
may affect the performance of the device.
G4-Global System User’s Guide | 7
WARNINGS
• This device is not designed to replace a blood glucose meter. The G4-Global
System must be used with a blood glucose meter.
• Treatment decisions should not be based solely on results from the G4-Global
System. You must confirm results with fingerstick readings from a blood
glucose meter before making therapeutic adjustments.
• Symptoms related to low or high blood glucose levels should not be ignored. If
you have symptoms of low or high glucose, use fingerstick readings from your
blood glucose meter to check the G4-Global System results.
• You should update the G4-Global System calibration every 12 hours at a
minimum. The performance of the G4-Global System when calibrated less
frequently than every 12 hours has not been studied.
• Sensors may fracture on rare occasions. If a Sensor breaks and no portion of it
is visible above the skin, do not attempt to remove it. Seek professional medical
help if you have symptoms of infection or inflammation—redness, swelling or
pain—at the insertion site. If you experience a broken Sensor, please report
this to our Technical Support department.
• The G4-Global System is not approved for use in children or adolescents,
pregnant women or persons on dialysis.
• The safety and effectiveness of the G4-Global System has not been evaluated
for Sensor Probe insertion sites other than the skin of the abdomen.
PRECAUTIONS
• Always wash hands with soap and water before opening the Sensor package.
After opening the package, avoid touching the adhesive area.
• Before inserting the Sensor, always clean the skin at the Sensor insertion
location with a topical antimicrobial solution, such as isopropyl alcohol. Do not
apply the Sensor until the cleaned area is dry.
• Establish a rotation schedule for choosing each new Sensor location. Avoid
Sensor locations that are constrained by clothing, accessories, or subjected to
rigorous movement during exercise.
• Avoid injecting insulin or placing an insulin pump infusion set within 3 inches
(7.62 centimeters) of the Sensor.
8 | Continuous Glucose Monitoring System
• The Sensor is sterile in its unopened, undamaged package. Do not use any
Sensor if its sterile package has been previously damaged or opened.
• The Sensor has currently only been tested in adult persons with type 1 and
type 2 diabetes. The device has not been tested in children or adolescents,
pregnant women, or persons on dialysis.
CAUTION
U.S. federal law restricts the sale of the G4-Global System to sale by or on order
of a physician.
G4-Global System User’s Guide | 9
table of contents
G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM:
SYSTEM KIT CONTENTS
INTRODUCTION:
INDICATION FOR USE
IMPORTANT SAFETY INFORMATION
CHAPTER 1: THE G4-GLOBAL SYSTEM BASICS
1.1 Sensor Overview
1.2 Transmitter Overview
1.3 Receiver Overview
1.4 Moving Through the Receiver Screens
13
15
16
17
19
CHAPTER 2: G4-GLOBAL SYSTEM SET UP
2.1 The Set Up Wizard
2.2 Turning the Receiver On
2.3 Setting the Time and Date
2.4 Entering Your Transmitter ID
2.5 Changing Your High and Low Alerts
2.6 Charging Your Receiver Battery
23
25
26
27
28
29
31
CHAPTER 3: USING A SENSOR
3.1 Before You Start
3.2 Removing the Sensor From Its Packaging
3.3 Choosing an Insertion Site
3.4 Placing the Sensor
3.5 Sensor Insertion
3.6 Transmitter Attachment
3.7 Starting a Sensor Session
3.8 Transmitter and Receiver Communication
3.9 Sensor Startup Period
3.10 The G4-Global System and Water
3.11 Taping the Sensor Pod
33
35
37
37
38
39
40
42
42
44
44
44
CHAPTER 4: CALIBRATING YOUR G4-GLOBAL SYSTEM
4.1 Calibration Overview
4.2 How to Calibrate
45
47
48
10 | Continuous Glucose Monitoring System
4.3 Startup Calibration
4.4 Calibration Update
4.5 Re-Calibration
50
51
52
CHAPTER 5: CONTINUOUS GLUCOSE READINGS,
TRENDS, ALERTS AND ALARM
5.1 Glucose Readings
5.2 Glucose Trends
5.3 Glucose Alerts and Low Glucose ALARM
5.3.1 High Glucose Alert
5.3.2 Low Glucose Alert
5.3.3 Low Glucose ALARM
5.3.4 Rise and Fall Glucose rate Alerts
5.4 Glucose Status Area on Trend Graphs
5.4.1 Glucose Status Area Symbols
5.4.2 Missing Glucose Readings
5.4.3 System Glucose Errors
5.4.4 Out of range/No Antenna
5.5 Temporary Sensor Shut Down
55
58
61
62
63
64
65
65
67
67
68
69
70
71
CHAPTER 6: COMPLETING YOUR CONTINUOUS GLUCOSE
MONITORING SESSION
6.1 Removing a Sensor
6.2 Automatic Sensor Shut-Off
6.3 Early Sensor Shut-Off
6.3.1 Early Shut-Off – Sensor Failure
6.3.2 Manual Sensor Shut-Off – “Stop Sensor”
6.4 Transmitter Removal
73
75
76
77
77
77
79
CHAPTER 7: BASIC SETTINGS
7.1 The Settings Menu
7.1.1 Getting to the Settings Menu
7.1.2 Setting Your Receiver Date and Time
7.1.3 Entering Your Transmitter ID
7.1.4 Checking Information About Your Receiver
7.2 Setting Your Alerts
7.2.1 Factory Alert Settings
7.2.2 Getting to the Alerts Menu
7.2.3 Setting Glucose Alerts
81
83
83
83
84
86
87
87
89
89
G4-Global System User’s Guide | 11
CHAPTER 8: ADVANCED FEATURES - BEYOND THE BASICS
8.1 Activating Advanced Features
8.2 Diabetes Events
8.2.1 Selecting an Event
8.2.2 Setting the Date and Time for an Event
8.2.3 Carbohydrates
8.2.4 Insulin
8.2.5 Exercise
8.2.6 Health
8.3 DexCom Studio® Software
8.4 Rise and Fall Glucose Rate Alerts
8.5 Setting Other Alerts
8.6 Setting the Out of Range Alert
8.7 Setting a Snooze Time for Your High and Low Glucose Alerts
95
97
98
98
99
99
100
101
102
103
103
105
106
108
CHAPTER 9: TROUBLESHOOTING
9.1 Sensor Insertion Troubleshooting
9.2 Calibration Troubleshooting
9.2.1 Blood Drop Prompts
9.2.1.1 Types of Blood Drop Prompts
9.2.1.2 Status Area Symbols During Blood Drop Prompts
9.3 Sensor Failed Troubleshooting
9.4 Calibration Error Troubleshooting
9.5 Receiver and Cables Troubleshooting
9.6 Receiver and Transmitter Communication Troubleshooting
109
111
112
112
112
114
115
116
117
118
CHAPTER 10: TAKING CARE OF YOUR G4-GLOBAL SYSTEM
10.1 Maintenance
10.2 Storage
10.3 Cleaning and Disinfecting
119
121
122
122
CHAPTER 11: STUDY RESULTS
11.1 Pivotal Study Results
11.2 Product Specifications
11.3 FCC Requirements
125
127
145
154
CHAPTER 12: APPENDIX
Appendix I, Other Alerts
Appendix II, Receiver Screens and Prompts
Glossary
Symbols Used in Labeling
Index
155
157
160
164
166
168
12 | Continuous Glucose Monitoring System
chapter one
on
THE G4-GLOBAL SYSTEM BASICS
1.1 SENSOR OVERVIEW
The Sensor is the System component that continuously measures your glucose
levels. You will use a blood glucose meter to calibrate your glucose readings
measured by the Sensor. The Transmitter collects the Sensor readings and
sends them to the Receiver using wireless, radio frequency (RF) technology.
This happens every 5 minutes for up to 7 days.
The Sensor unit has an Applicator (needle, sensor, plastic housing), Sensor
Probe, and Sensor Pod. The Applicator includes a Safety Lock/Transmitter
Key to keep the needle in place until you are ready to insert. After taking
off the Safety Lock, you will insert the Sensor Probe just beneath the skin
(subcutaneous tissue) of your belly using a small needle inside the Applicator.
The needle is inserted just under the skin at an angle and carries the Sensor
Probe with it. After you insert the needle and Sensor Probe, you will pull
the needle back into the Applicator. This leaves the Sensor Probe behind to
continuously measure your glucose levels. The Applicator, with the needle
inside, is pulled off from the Sensor Pod and should be thrown away. Save the
Safety Lock/Transmitter Key because you can use it to remove the Transmitter
at the end of a continuous monitoring session.
The Sensor Probe lies underneath your skin at an angle and continuously
measures your glucose levels for up to 7 days. The Sensor Pod and Transmitter
(once snapped in) remain on your belly for the entire Sensor session. The
Sensor insertion site is similar to an insulin pump infusion site.
Plunger
Safety Lock/
Transmitter Release
Collar
Applicator
(needle/sensor probe inside)
Transmitter Latch
Sensor Pod
Release Tab
G4-Global System User’s Guide | 15
1
1.2 TRANSMITTER OVERVIEW
The Transmitter wirelessly sends your glucose information from the Sensor to
the Receiver. Once you insert the Sensor, you will snap the Transmitter into the
Sensor Pod using the Transmitter Latch. The same Transmitter is used when
you change Sensors.
The Transmitter battery will last about 6 months. As
the Transmitter nears the end of its battery life, it can
sometimes lose communication with the Receiver.
This can happen even if the Receiver and Sensor/
Transmitter are within 20 feet (6 meters) of each
other. The Transmitter (Low Battery) screen will first
appear when there are about 2 weeks of battery
life remaining. Press any Receiver button to clear
the ALARM. This ALARM will reappear every day for 2 weeks, or until the
Transmitter is replaced. Once the Transmitter battery has drained, you will need
to replace the Transmitter because it can no longer communicate (talk) to the
Receiver. You can easily set up a new Transmitter to talk with your Receiver
(see Chapter 2, Section 2.4).
HELPFUL HINTS:
• Your Transmitter is re-used for many Sensor uses.
• If you see the Out of Range Symbol
in the upper right corner of the
Trend Graph, your Transmitter and Receiver are no longer talking. This
can happen even when your Sensor/Transmitter and Receiver are within
20 feet (6 meters) of each other.
• The Receiver and Transmitter are designed and tested to withstand
common electromagnetic interference, including airport security systems.
Install Transmitter
in Sensor Pod
Transmitter Installed
Transmitter Latch
16 | Continuous Glucose Monitoring System
Remove
Transmitter Latch
1.3 RECEIVER OVERVIEW
The Receiver looks like a small MP3 player and shows your Sensor-measured
glucose information. The G4-Global Receiver only shows glucose readings in
the milligrams per deciliter (mg/dL) unit of measure. In the United States,
mg/dL is the standard unit used for glucose testing systems (i.e., blood glucose
meters). Please check with your Diabetes Management Team if you have
questions about the unit of measure displayed on your Receiver.
Keep the Receiver within 20 feet (6 meters) of the Sensor/Transmitter at
all times for your G4-Global System to work best. Good places to keep the
Receiver are on your belt in the Receiver case provided or in your pocket.
Most recent 5-minute
glucose reading
Trend Arrow
Time
High Glucose
Alert Setting
Low Glucose
Alert Setting
Plot of most
recent glucose
reading
Trend Graph Hours
EXAMPLE: 3-Hour Trend Graph Screen
G4-Global System User’s Guide | 17
1
There are 5 Receiver buttons to move you through the display screens that
control setup and operation. The screens display glucose readings and trend
graphs (“Trend Graphs”) and allow you to change your Receiver settings
(“Menu Screens”). You program your Receiver with a specific Transmitter ID
Number so your Receiver and Transmitter can talk with each other. Each time
you insert a new Sensor, you will need to notify the Receiver (see Chapter 3,
Section 3.8).
Each Sensor must be “calibrated” before glucose readings are displayed on the
Receiver. To calibrate, you manually enter fingerstick readings (see Chapter 4,
Section 4.1) from any FDA-cleared meter.
UP TOGGLE button
RIGHT
TOGGLE
button
SELECT button
LEFT
TOGGLE
button
18 | Continuous Glucose Monitoring System
DOWN
TOGGLE
button
1.4 MOVING THROUGH THE RECEIVER SCREENS
1. Turn the Receiver on by pressing the SELECT button.
2. The 3-Hour Trend Graph will appear.
a. The default screen is the 3-Hour Trend Graph,
but you may view glucose information for
shorter or longer periods by pressing the TOP
or BOTTOM TOGGLE button to see the 1-Hour,
6-Hour, 12-Hour, and 24-Hour Trend Graphs.
3. From any Trend Graph, press the SELECT button to display the Main Menu.
NOTE: Main Menu options take up more than one screen, and certain
options only appear at certain times.
a. Press the TOP or BOTTOM TOGGLE button to scroll through and highlight
different Menu options.
b. Press the SELECT button when the option you want is highlighted. You will
then enter that Menu.
c. Press the LEFT TOGGLE button to return to the previous Menu.
G4-Global System User’s Guide | 19
1
4. More information on Main Menu options can be found in the sections listed
below:
Menu
Purpose
User’s Guide
Reference
Trend
Graph
To display the Trend Graphs.
• The 3-Hour Trend Graph is the default screen
displayed whenever you turn the Receiver on.
Chapter 1
Start
Sensor
To start a new Sensor session.
• This option only appears if a Transmitter ID has
been entered and you are not in the middle of a
Sensor session.
Chapter 3
Enter BG
To enter your fingerstick blood glucose readings
for calibration.
Chapter 4
Events
To enter personal information about meals, insulin,
exercise, and health status.
Chapter 8
Alerts,
High/low
To change the settings for notifications of High and
Low Alerts from your Receiver.
Chapters
2 and 7
Alerts,
Rise/Fall
rate, Other,
and Out of
Range
To change the settings for notifications of Rise/Fall
Rate (Rate of Change) Alerts, Other Alerts and Out of
Range Alerts.
Chapter 8
Settings
To change the time, date and Transmitter ID number,
to look up your G4-Global System hardware and
software version numbers, to view Transmitter battery
status, last calibration value, Sensor insertion time,
and to enable Advanced features.
Chapters
2 and 7
Shutdown
To temporarily turn off all communications between
your Sensor, Transmitter and Receiver.
Chapter 5
Stop
Sensor
To end a Sensor session early.
• This option only appears when you are in the middle
of a Sensor session.
Chapter 6
See Appendix I, “Other Alerts”, for a list of prompt screens that may appear on
the Receiver during use.
20 | Continuous Glucose Monitoring System
THIS PAGE LEFT INTENTIONALLY BLANK
G4-Global System User’s Guide | 21
1
THIS PAGE LEFT INTENTIONALLY BLANK
22 | Continuous Glucose Monitoring System
chapter
pter two
G4-GLOBAL
LOBAL SYSTE
SYSTEM SETUP
This chapter will help you set up your G4-Global System. You
will want to read this chapter before you insert and start a new
Sensor session.
2.1 THE SETUP WIZARD
The Receiver Setup Wizard will guide you through the first-time setup of your
G4-Global system.
Before setting up your Receiver, remove the Transmitter from the box.
NOTE: In order to save battery life, the Transmitter is stored in a tray with a
small magnet attached. This prevents the Transmitter from turning on until it
is removed from the tray. The Transmitter will turn on 10 minutes after being
removed from the tray.
1. Turn your Receiver on by pressing the SELECT
button on the Receiver. When you turn the
Receiver on for the first time, the Setup Wizard will
help you get started by prompting you to enter the
following setup information:
2. Set the Time and Date
3. Enter your Transmitter ID
Your Transmitter ID can be found in any of the
following locations:
- On the Transmitter card located inside your
Global System Kit
- On the outside of the Transmitter box label
- Engraved on the back of the Transmitter itself
If you have difficulty locating your Transmitter ID, please contact DexCom
Technical Support.
G4-Global System User’s Guide | 25
2
4. Set your Low and High Glucose Alert Levels
The Setup Wizard is now completed. You will now need to insert a Sensor and
start a Sensor session to begin a continuous glucose monitoring session (see
Chapter 3).
NOTE:
• When using the Setup Wizard, the Low and High Glucose Alerts are
already turned on and are set to vibrate and beep. Only the Low Alert and
High Alert “levels” can be adjusted in the Setup Wizard. To make other
changes, see Section 2.5.
• See Sections 2.3, 2.4 and 2.5 and Chapter 7 for more information on
setting the time and date, entering Transmitter ID, and Low and High
Glucose Alerts from the Main Menu.
2.2 TURNING THE RECEIVER ON
1. Press the SELECT button to turn the Receiver on. The 3-Hour Trend Graph
will appear.
2. Press the SELECT button to display the Main Menu.
26 | Continuous Glucose Monitoring System
2.3 SETTING THE TIME AND DATE
1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to
“Settings” and press the SELECT button. Next, scroll to “Time/Date” and press
the SELECT button.
2. Check that the current date and time are correctly
set in the Receiver. Press the RIGHT TOGGLE
button to highlight each value in the date and
time. Then, press the TOP or BOTTOM TOGGLE
button to make any adjustments, and then press
the RIGHT TOGGLE button to move to the next
value. After choosing AM or PM, press the SELECT
button. You will return to the Settings menu.
G4-Global System User’s Guide | 27
2
2.4 ENTERING YOUR TRANSMITTER ID
Before you can use your G4-Global System, you must enter the Transmitter ID
into the Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on
the back of the Transmitter. Entering the ID will begin the unique wireless radio
frequency (RF) communication between the Transmitter and Receiver.
To enter the Transmitter ID, perform the following steps:
1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to
“Settings” and press the SELECT button. Next, scroll to “Transmitter ID” and
press the SELECT button.
NOTE: You can only enter your Transmitter ID when you are not in a Sensor
session. During a Sensor session, “Transmitter ID” will not appear as an
option on the Settings menu.
2. Starting with the first value, press the TOP
or BOTTOM TOGGLE button to make any
adjustment, and then press the RIGHT TOGGLE
button to move to the next value. After entering the
5th number, press the SELECT button. You will
return to the Settings menu.
Your Transmitter ID can be found in any of the
following locations:
- On the Transmitter card located inside your Global System Kit
- On the outside of the Transmitter box label
- Engraved on the back of the Transmitter itself
If you have difficulty locating your Transmitter ID, please contact DexCom
Technical Support.
28 | Continuous Glucose Monitoring System
2.5 CHANGING YOUR HIGH AND LOW ALERTS
High Alerts and Low Alerts provide information about your glucose levels and
trends. See Chapter 5, Section 5.3 for more information. You can turn the High
Alert and/or Low Alert on or off, and choose how the Alerts are delivered (vibrate
and beep, or vibrate only). You can also select the glucose value the Receiver
will use to trigger a High or Low Alert.
NOTE: The High and Low Alerts are already turned on when you turn the
Receiver on for the first time during Setup Wizard.
The options for setting both a High Alert and a Low Alert are the same. The
following steps will show you how to change your High Alert settings.
1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll
to “Alerts” and press the SELECT button. Next, scroll to “High Alert” or “Low
Alert” and press the SELECT button.
2. On the High Alert menu (example), press the TOP
or BOTTOM TOGGLE button to choose the “On/
Off” option. The High Alert is currently set to “On”.
If you do not want to receive this type of Alert press
the SELECT button to choose “Off”.
Example-High Alert menu
G4-Global System User’s Guide | 29
2
3. Next, on the High Alert menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Type” and press the SELECT button. Then,
choose “Vibrate Then Beep” or “Vibrate Only”
as your Alert delivery option, and press the
SELECT button.
- Vibrate Then Beep (vibrate, then a vibrate and a
beep every 5 minutes)
Example-High Alert
° High Alert Beep (a series of tones in ascending order, followed by a few
steady high tones)
° Low Alert Beep (a series of tones in descending order, followed by a few
steady low tones)
- Vibrate Only (vibrate every 5 minutes)
NOTE: Alerts can be acknowledged by pressing any button on the Receiver.
4. Next, on the High Alert menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Level” and press the SELECT button. Press
the TOP or BOTTOM TOGGLE button to enter
your Alert value (120 to 400 mg/dL in 10 mg/dL
increments for a High Alert and 60 to 100
mg/dL in 5 mg/dL increments for a Low Alert).
The starting value that first appears on this screen
is the default value of 200 mg/dL (High Alert) and
80 mg/dL (Low Alert), or the values you set in the
Setup Wizard.
Example-High Alert
You have the option to set a snooze time to re-alert you (see Chapter 8, Section
8.7, Setting a Snooze Time for Your High and Low Alerts).
30 | Continuous Glucose Monitoring System
2.6 CHARGING YOUR RECEIVER BATTERY
The Receiver battery is rechargeable like a cellular
phone. The rechargeable battery will last for about
3-5 days before you need to charge it with the
Receiver Charging Cable. Your rechargeable battery
life depends on how often you turn your Receiver on,
your Alert settings, and how often you enter Event
information using the Events feature. The Receiver
will tell you when the battery charge is low.
Low Battery
The Receiver Battery may be charged using one of the following options:
• Receiver charging cable for wall charging (cable included with kit)
• PC cable for computer charging (cable available separately)
It takes about 3 hours to fully charge an empty battery with the wall charger, and
about 5 hours when the Receiver is connected to a computer.
To recharge your battery, follow the instructions below:
1. Open the connection port cover on the right side of the Receiver. Plug the
Receiver end of the Receiver charging or PC cable into the connection port on
the Receiver.
2. Plug the other end of the cable to the wall outlet or to the USB port on your
computer, depending on the cable you are using.
3. The Battery Charging screen will appear on
the Receiver.
Battery Charging
4. After a few seconds the Trend Graph will reappear
with the Battery Charging Symbol
shown in the
upper left corner next to the Antenna Symbol .
G4-Global System User’s Guide | 31
2
5. As the battery charges, the Battery Symbol will begin to fill in (green). When
the battery is fully charged, the Battery Symbol will be completely filled in.
Start
Fully Charged
6. After the charge is complete, remove the cable from the Receiver and the wall
outlet or computer USB port.
HELPFUL HINTS:
• Charge your Receiver battery before each Sensor insertion. Periodically
check your battery level to make sure it has enough charge.
• If your battery drains and is not charged for about 6 months, the backup
battery might also drain. When this happens, you will need to reset your
Receiver time and date (see Section 2.3).
• Only use the DexCom battery charger provided in the Starter Kit. Do not
use any other battery charger.
32 | Continuous Glucose Monitoring System
chapter three
USING A SENSOR
To use your G4-Global Continuous Glucose Monitoring System
you will need a Sensor, a Transmitter, and a Receiver. You will
also need a blood glucose meter and test strips for calibration.
Once inserted and calibrated, the Sensor will continuously
measure and display your glucose readings for up to 7 days
(167 hours after the 1-hour Startup period). The following
sections will show you how to insert the Sensor and start a new
continuous glucose monitoring session.
3.1 BEFORE YOU START
 Wash your hands thoroughly.
 Make sure you charge your Receiver completely. See Chapter 2, Section 2.6
for directions.
 Check that the date and time are correct on the Receiver.
 If this is a new Transmitter, make sure the correct Transmitter ID Number has
been entered into your Receiver (See Chapter 2, Section 2.4).
 Check the expiration date on the Sensor, before you start, to make sure you
are not using an expired Sensor. The expiration date format is YYYY-MM-DD.
 Quality check (“QC”) your blood glucose meter per the manufacturer’s
instructions to make sure it is providing you the best readings for calibration
(e.g., check the code number and use the control solution if applicable).
 Clean the bottom of the Transmitter with a damp cloth or alcohol wipe, and
dry before you start a new Sensor session.
 Make sure your blood glucose meter and Receiver date and time match.
G4-Global System User’s Guide | 35
3
REVIEW THE SENSOR APPLICATOR
Review the Sensor Applicator picture below before using a new Sensor.
Plunger
Safety Lock/
Transmitter Release
Collar
Applicator
(needle/sensor probe inside)
Transmitter Latch
Sensor Pod
Release Tab
HELPFUL HINT: Always check the expiration date on the Sensor
packaging before opening the Sensor for use. Never use expired Sensors.
The expiration date format is YYYY-MM-DD.
The G4-Global Continuous Glucose Monitoring System is a
glucose-monitoring device indicated for detecting trends and tracking
patterns in adults (age 18 and older) with diabetes.
36 | Continuous Glucose Monitoring System
3.2 REMOVING THE SENSOR FROM ITS PACKAGING
The Sensor is sterile in its unopened, undamaged package. Do not
use any Sensor if its sterile package has been previously damaged
or opened.
• Carefully remove the Sensor from its packaging. Look closely at the Sensor to
make sure it is not damaged.
• The Applicator is a single use, disposable unit. The Safety Lock prevents you
from accidentally releasing the needle before you are ready.
3.3 CHOOSING AN INSERTION SITE
Establish a rotation schedule for choosing each new Sensor location.
Avoid Sensor locations that are constrained by clothing, accessories,
or subjected to rigorous movement during exercise.
Avoid injecting insulin or placing an insulin pump infusion set within
3 inches (7.62 centimeters) of the Sensor.
Choose a site on a fatty area of your belly to place the Sensor. You can choose
a site above or below your belt line. The best areas to insert your Sensor are
usually flat, “pinchable,” and free from where rubbing can occur (i.e., pant line,
seatbelts).
• Avoid areas with scarring, tattoos, or rough patches of skin from your insulin
injections or pump.
• Choose an area that is at least 3 inches (7.62 centimeters) from where you plan
to inject insulin or from where your pump infusion site is located.
• Avoid using the same spot repeatedly for Sensor insertion. Never use the same
site for 2 Sensor sessions in a row.
• You may need to shave the area where you plan to put the Sensor so that the
adhesive patch sticks securely.
• Make sure there are no traces of lotions, perfumes or medications on the area.
Clean the area first with an alcohol swab. Make sure the area is clean and
completely dry before you insert the Sensor.
G4-Global System User’s Guide | 37
3
3.4 PLACING THE SENSOR
1. After you have cleaned your skin, remove the adhesive backing from the
Sensor Pod. Hold the Sensor by the plastic Applicator and try not to touch the
sticky adhesive patch.
2. Place the Sensor on the area. You can place the Sensor flat facing to the
left or right of your belly button. Make sure the Sensor is placed in the same
direction shown in the picture below. You should not place the Sensor pointing
in the up or down direction.
Remove the Adhesive backing
Adhere the Sensor on the skin
3. After placing the Sensor, press firmly on and around the outside of the
adhesive patch to make sure it is flat.
a. Pressing the patch to remove any wrinkles should help it stick better.
b. Press firmly over the entire patch area.
4. Hold on to the Applicator. Then pull the Safety Lock/Transmitter Key straight
out away from the applicator, in the direction the arrow shows below.
Remove the Safety Lock/Transmitter Key
38 | Continuous Glucose Monitoring System
HELPFUL HINT: The Safety Lock also serves as the Transmitter Key that is
used later for Transmitter removal. Keep this piece to help you remove the
Transmitter at the end of a continuous glucose monitoring session. When
your glucose monitoring session is over, follow the steps in Chapter 6,
Section 6.4 to remove the Transmitter.
3.5 SENSOR INSERTION
Once you have placed the Applicator on your belly and removed the Safety Lock
(see Section 3.4), you are ready to insert the Sensor. Follow these 4 steps to
successfully insert your Sensor.
1. Hold down the Pod with one hand. With your other hand, place two fingers
above the collar on the barrel of the Applicator.
2. Place your thumb on the plunger. Push the plunger down completely. This
action inserts the needle and Sensor Probe under your skin.
When you are pushing down on the plunger, do not pull back on the collar.
“CLICK”
Push down the plunger – Insert the Needle and Sensor Probe
3. To remove the needle, keep holding the
Sensor Pod with one hand. With your other
hand, place two fingers under the collar.
Then pull the collar back towards your
thumb. Stop when you hear 2 “clicks” or
cannot pull back any more. This step pulls
the needle back into the Applicator and
keeps the Sensor Probe under your skin.
a. Remember to do this in the correct order:
push plunger down, then pull collar up.
“ 2 CLICKS”
Pull back the collar - Retract
the Needle
G4-Global System User’s Guide | 39
3
4. Squeeze the ribbed release tabs on the
sides of the Sensor Pod to remove the
Applicator. When you squeeze the front
release tabs, the back tabs will widen,
allowing you to pull off the Applicator.
After this step, only the Sensor Pod will
be left on your body.
a. Make sure the Transmitter Latch is
down (against your body) to remove
the Applicator.
Release the Applicator
5. The used Applicator can be thrown in the trash.
If you have any problems with insertion, save the Sensor and Applicator
and contact DexCom.
3.6 TRANSMITTER ATTACHMENT
The Transmitter wirelessly sends your Sensor glucose information to the
Receiver. Once you have inserted your Sensor, you will need to snap the
Transmitter into the Sensor Pod. Follow the steps below to attach your
Transmitter.
1. Clean and dry the bottom of the Transmitter with a damp cloth or an alcohol
wipe before every use.
a. Be careful not to touch the metal circles on the bottom of the Transmitter.
2. Place the Transmitter in the Sensor Pod with the flat side facing down.
3. Pull the Transmitter Latch over the Transmitter to snap the Transmitter into
place. The Transmitter should lie flat in the Sensor Pod. You should hear 2
“clicks.”
a. If you do not hear 2 clicks, the Transmitter might not be fully snapped in.
4. Make sure both sides of the Transmitter are secure inside the Sensor Pod.
a. Do this by sliding your first and second fingers under the edge of the
Sensor Pod (with your fingernails against your skin under the Latch).
b. Place your thumb on top of the Transmitter.
c. Then squeeze together to make sure the Transmitter has been snapped in.
40 | Continuous Glucose Monitoring System
5. Remove the Transmitter Latch by holding the end of the Latch and quickly
twisting off the Latch away from your body.
Install Transmitter
in Sensor Pod
Transmitter Installed
Remove
Transmitter Latch
Transmitter Latch
HELPFUL HINTS:
• Make sure you hear 2 clicks when you snap the Transmitter in place (see
Step 3). This helps ensure your device is water resistant (see Section 3.10).
• Make sure that you have entered the correct Transmitter ID into your
Receiver. See Chapter 2, Section 2.4 for instructions on how to enter the
Transmitter ID into your Receiver.
G4-Global System User’s Guide | 41
3
3.7 STARTING A SENSOR SESSION
After you have checked that your Transmitter and Receiver are talking, you need
to tell the Receiver that you have inserted a new Sensor.
To tell the Receiver that you have inserted a new Sensor, follow the steps below.
1. Press the SELECT button to turn the Receiver on.
2. From any Trend Graph, press the SELECT button to display the Main Menu.
3. Press the TOP or BOTTOM TOGGLE button to
scroll until you highlight “Start Sensor.”
4. Press the SELECT button to confirm the start of a
new Sensor session. The Start Sensor Processing
screen will appear to let you know your Sensor
session has begun.
5. Your Receiver will then return to the 3-Hour Trend
Graph.
HELPFUL HINTS:
• The Start Sensor menu option will now disappear from the Main Menu.
The option will only appear again after an active Sensor session ends.
• Each time you insert a new Sensor and press SELECT to start a new
Sensor session, you will start a new 1-hour Startup period.
3.8 TRANSMITTER AND RECEIVER COMMUNICATION
CONTRAINDICATION: The G4-Global System must be removed
prior to Magnetic Resonance Imaging (MRI).
42 | Continuous Glucose Monitoring System
Keep your Receiver within 20 feet (6 meters) of the Sensor/Transmitter for best
communication. To check that the Receiver and Transmitter are talking, press
the SELECT, LEFT or RIGHT TOGGLE button to see the Trend Graph.
Note the difference between the two Antenna Symbols below:
This Antenna Symbol shows that the Transmitter
and Receiver are talking.
This Out of Range Symbol shows the
Transmitter and Receiver are not talking.
If you see the Out of Range Symbol in the
upper right corner of the screen, then review the
following troubleshooting tips.
• Is the Receiver within 20 feet (6 meters) of your Sensor/Transmitter? If the
Receiver is not close enough, then move it within 20 feet (6 meters) of the
Sensor/Transmitter. Check in 5-10 minutes to see if the Antenna Symbol
appears and the Out of Range symbol
disappears.
• If the Receiver and Sensor/Transmitter are still not talking, then check to make
sure the correct Transmitter ID Number is entered into your Receiver (see
Chapter 2, Section 2.4).
• If the correct Transmitter ID has been entered into your Receiver and the
Receiver and Transmitter are still not talking, then contact DexCom.
HELPFUL HINTS:
The Transmitter and Receiver may lose communication at the following
times:
• When they are near metallic objects.
• While you are lying on a water bed.
• When you are using an electric blanket.
G4-Global System User’s Guide | 43
3
3.9 SENSOR STARTUP PERIOD
The Sensor needs a 1-hour Startup period. This is so the Sensor can get used
to its new insertion site. During the Startup period, check every so often to make
sure the Antenna Symbol
is in the upper left corner of the Trend Graph. Also
make sure your Receiver battery is fully charged.
When you press the SELECT button during the
Startup period to turn the Receiver display on,
your Trend Graph will include a 1-hour Countdown
Symbol
in the upper right hand corner.
Over time, the Countdown Symbol
will fill to
indicate that you are getting closer to initial calibration
time. See the pictures below for an example of what
this looks like.
Start [0-12]
[12-24]
[24-36]
[36-48]
Ready for
calibration
At the end of the 1-hour Startup period the Receiver will let you know that it is
time to calibrate your Sensor. Chapter 4 tells you how to calibrate your Sensor.
3.10 THE G4-GLOBAL SYSTEM AND WATER
Your Sensor (including the installed Transmitter) is water resistant when
showering, bathing, or swimming. The Sensor has been tested to be water
resistant when submerged for up to 3 feet (0.9 meters) for a maximum of 30
minutes. For added protection you can use a shower cover. The Receiver is not
water resistant. Do not get your Receiver wet at any time.
3.11 TAPING THE SENSOR POD
The Sensor Pod should stay securely attached using
its own adhesive. But, if the patch is peeling up, you
can use medical tape (such as BlendermTM) for extra
support. If you use tape, only tape over the white
adhesive patch on all sides for even support. Do not
tape over the Transmitter or any of the plastic parts of
the Sensor Pod. Do not tape under the Sensor Pod or
leave any substance on the skin where you insert the Needle.
44 | Continuous Glucose Monitoring System
chapter four
CALIBRATING YOUR G4-GLOBAL SYSTEM
The G4-Global System requires you to “calibrate” the Sensor
glucose readings to your blood glucose meter. The purpose
of calibration is to convert the measurement of glucose by the
Sensor into a reading similar to the one provided by your meter.
CONTRAINDICATION: Use of acetaminophen-containing
medications while the Sensor is inserted may affect the performance
of the device.
4.1 CALIBRATION OVERVIEW
When calibrating, you need to manually enter your fingerstick readings into the
Receiver. You can use any FDA-cleared blood glucose meter.
You will need to perform three types of calibration on your Receiver:
1. Startup Calibration
2. Calibration Update
3. Re-calibration
Startup Calibration happens at the end of the 1-hour Startup Period and takes 2
fingerstick readings. Calibration Update is a calibration that must be performed
every 12 hours (about 1 fingerstick reading, 2 times per day). The Receiver will
remind you when these calibrations are needed. Re-calibration may be required
if one of the fingerstick readings entered for Startup Calibration or Calibration
Update is not accepted by the Receiver.
The sections in this Chapter tell you how to calibrate your system. The sections
also describe Startup Calibration, Calibration Update, and how to Re-calibrate in
more detail.
HELPFUL HINT: Do not use alternative blood glucose site testing (blood
from your palm or forearm, etc.) for calibration. You must take your blood
glucose readings from your fingertips only for calibration.
G4-Global System User’s Guide | 47
4
4.2 HOW TO CALIBRATE
For Calibration, you must enter the exact fingerstick reading from your meter.
Readings must be between 40-400 mg/dL and must have been taken within the
past 5 minutes. Entering incorrect fingerstick readings, or fingerstick readings
that occurred more than 5 minutes ago, will affect device performance.
The steps below show you how to enter your fingerstick readings for calibration:
1. Take a fingerstick reading using your meter.
2. From any Trend Graph, press the SELECT button to display the Main Menu.
3. Use the TOP or BOTTOM TOGGLE button to scroll
until you highlight “Enter BG.”
NOTE: “Enter BG” will be the second Main Menu
option when you are not in the middle of a Sensor
session.
4. Press the SELECT button to choose this option.
You will see a screen with a blood drop and a
number in mg/dL units.
a. During initial calibration the Receiver will
default to the reading of 120 mg/dL as your
starting point.
b. If there has been a glucose reading in the past
15 minutes, the Enter BG screen will display
your current continuous glucose reading as your
starting point. Do not use the continuous glucose
reading for calibration. Use only fingerstick
readings from your meter.
48 | Continuous Glucose Monitoring System
5. To enter the fingerstick reading taken from your meter, press the TOP or
BOTTOM TOGGLE button until you find the correct reading and then press
the SELECT button.
a. Pressing the TOP or BOTTOM TOGGLE button lets you scroll by
1 mg/dL. To scroll faster, hold down the TOP or BOTTOM TOGGLE button.
6. Confirm that the fingerstick reading you entered is
correct.
a. If the fingerstick reading displayed is correct,
press the LEFT TOGGLE button to highlight
“OK” and then press the SELECT button.
b. If the fingerstick reading displayed is incorrect,
press the SELECT button (with “Cancel”
highlighted) to return to the Enter BG screen. Repeat the steps for
re-entering the correct reading.
c. If you do not press any button, the Receiver will “time out” and no
fingerstick reading will be entered.
7. The Enter BG Processing screen will appear to let
you know the fingerstick reading is being processed
for calibration.
8. For Startup Calibration, repeat these steps for the second fingerstick reading.
9. A glucose reading will appear on the Receiver right away, and glucose
readings will be updated every 5 minutes.
10. If readings do not appear immediately, see Chapter 9, Section 9.2.
G4-Global System User’s Guide | 49
4
HELPFUL HINTS:
• Make sure a glucose reading is displayed at the top of the Trend Graph,
or a Blood Drop Symbol is displayed in the top right corner of the Trend
Graph, before calibration.
• Only fingerstick readings between 40-400 mg/dL can be used for
calibration. If 1 or more of your readings entered was outside of this range,
the Receiver will not calibrate. You will have to wait to until your blood
glucose is in this range to calibrate.
• Always make sure the Antenna Symbol
is displayed in the upper left
corner of the Trend Graph before you enter fingerstick readings for
calibration.
• You should always use the same meter you routinely use to measure
your blood glucose to calibrate. Do not switch your meter in the middle of
Sensor session.
4.3 STARTUP CALIBRATION
One (1) hour after you start the Sensor session (see
Chapter 3, Section 3.7) the Receiver will tell you that
you need to calibrate. The Receiver will show the
Double Blood Drop Prompt. If your Alerts are set to
the factory default settings, the Receiver will also
vibrate and beep to tell you it is ready for calibration.
1. You can also set your Receiver to vibrate only (see
Chapter 8, Section 8.5).
Double Blood Drop Prompt
2. When you see this screen, press any Receiver button to clear the display.
3. Take 2 fingerstick readings with your meter and enter them into the Receiver
(see Section 4.2).
NOTE: Your fingerstick readings must be between 40 mg/dL and 400
mg/dL for calibration. The Receiver cannot use fingerstick readings outside
of this range for calibration.
50 | Continuous Glucose Monitoring System
HELPFUL HINTS:
• If your readings are less than 40 mg/dL or greater than 400 mg/dL, you
should determine if you should treat yourself first, and then calibrate when
it is convenient for you.
• If you choose to clear the Double Blood Drop
Prompt and calibrate later, the Blood Drop
Symbol will appear in the top right corner of
the Trend Graph.
• Once you clear the Double Blood Drop Prompt,
it will reappear every 15 minutes until you
successfully calibrate.
• Always make sure the Antenna Symbol
corner before you calibrate.
is visible in the upper left
4.4 CALIBRATION UPDATE
Calibration Update is required every 12 hours to make sure your Sensor
readings remain accurate and are close to your blood glucose meter readings.
You can enter any fingerstick readings you take during a Sensor session. If you
have not entered any fingerstick readings in the past 12 hours, the Receiver will
ask you for a fingerstick reading to update its calibration. The steps below show
you how to enter this calibration.
You must update G4-Global System calibration every 12 hours at
a minimum. The performance of the System when calibrated less
frequently than every 12 hours has not been studied.
You must enter the exact fingerstick reading that your blood glucose
meter displays. Enter all fingerstick readings for calibration within
5 minutes. Entering incorrect fingerstick readings, or fingerstick
readings that occurred more than 5 minutes ago, will affect device
performance.
G4-Global System User’s Guide | 51
4
1. If you see the Single Blood Drop Prompt shown
to the right, clear this display by pressing any
Receiver button. The Single Blood Drop Prompt
will not go away until you press a button.
Single Blood Drop Prompt
2. Take a fingerstick reading at this time. Enter this reading in the Receiver to
update calibration.
3. This screen will appear every 15 minutes until you enter a new fingerstick
reading that is accepted for calibration.
4. If this screen reappears shortly after you have entered a new fingerstick
reading, review Chapter 5, Section 5.4.
4.5 RE-CALIBRATION
When you enter a fingerstick reading for 12-Hour
Update Calibration (Section 4.3), the System checks
how well it is functioning compared to the blood
glucose meter. During each Calibration Update
attempt, the System may tell you that another
fingerstick reading is needed. This Re-calibration can
also be prompted during Startup Calibration. The
Single Blood Drop Prompt will appear (shown to the
right).
Single Blood Drop Prompt
You can clear this Screen by pressing any Receiver
button. The display will return to the Trend Graph. A
Blood Drop Symbol will appear on the top right of
the Trend Graph screen.
This Blood Drop Symbol tells you that the System
needs at least one more fingerstick reading. You will
not see glucose readings or trends, or get Alerts/Low
Glucose ALARM when the Blood Drop Symbol is
still displayed.
52 | Continuous Glucose Monitoring System
No glucose data
Awaiting Fingerstick
Reading (Blood Drop)
Symbol
You should take another fingerstick reading and enter it into the Receiver.
1. Your System should calibrate immediately.
2. After successful Re-calibration the System will display glucose readings,
trends and provide Alerts/Low Glucose ALARM again.
HELPFUL HINT: Refer to Section 8.4, “Error Code Troubleshooting,” if you
see the “15 Minute Calibration Error Screen” or the “1 Hour Calibration Error
Screen” on your Receiver during calibration.
15 Minute Calibration
Error screen
1 Hour Calibration
Error screen
G4-Global System User’s Guide | 53
4
THIS PAGE LEFT INTENTIONALLY BLANK
54 | Continuous Glucose Monitoring System
chapter five
CONTINUOUS GLUCOSE READINGS,
TREN
TRENDS, ALERTS AND ALARM
This chapter will teach you how to view your G4-Global System
continuous glucose readings and trend information. Once you
have successfully calibrated, the G4-Global Receiver will display
your glucose readings every 5 minutes. This will tell you how
your glucose levels are changing.
You must update G4-Global System calibration every 12 hours
at a minimum. The performance of the System when calibrated
less frequently than every 12 hours has not been studied. Use of
acetaminophen-containing medications while the Sensor is inserted
may affect the performance of the device.
Your blood glucose meter only gives your blood glucose level at one point in time
(like a still picture). However, the G4-Global System Trend Graphs and Trend
(Rate of Change) Arrows will help you understand the direction your glucose
level is moving (like a video camera).
The G4-Global Sensor sits in the fluid under your skin, not in your blood. The
Sensor calculates a glucose reading from this fluid when you calibrate your
System. So, the glucose reading you see on your Receiver may be about
5-10 minutes behind the fingerstick reading you get from your meter. If your
meter reading is above 80 mg/dL, the G4-Global System readings can be
10 – 20% different from your meter readings. If your meter reading is below 80
mg/dL, the G4-Global System readings can be up to 20 mg/dL different from
your meter readings.
It is important that you focus on the trends and rate of change on your Receiver,
rather than the exact glucose reading. The Trend Graphs and Arrows will help
you determine how fast your glucose level is rising or falling. Chapter 11, Section
11.2 tells you how closely your G4-Global System readings will be to a laboratory
analyzer in the doctor’s office.
Glucose Alerts and the Low Glucose ALARM are designed to help you stay
within your target glucose zones. Your Low and High Glucose Alerts, and Rise
and Fall (Rate of Change) Alerts can tell you when you fall outside of your target
glucose range. Your Alerts are personal tools that you can set (see Chapter 2,
Section 2.5), and are determined by you and your Diabetes Management
Team. Your Low Glucose ALARM can tell you when your glucose levels may be
reaching potentially dangerous low levels.
G4-Global System User’s Guide | 57
5
The G4-Global System also lets you enter information about your meals, insulin,
exercise, and health. That way you and your Diabetes Management Team
can view a bigger picture of your diabetes management plan. Your Diabetes
Management Team can transfer this information to the DexCom Studio®
Accessory Software to see how you are doing over a long period of time.
Treatment decisions should not be based solely on results from
the G4-Global System. You must confirm System readings with
a fingerstick reading on a blood glucose meter before making
therapeutic adjustments.
You must update G4-Global System calibration every 12 hours at
a minimum. The performance of the System when calibrated less
frequently than every 12 hours has not been studied.
5.1 GLUCOSE READINGS
Press any button on the Receiver to display the 3-Hour Trend Graph. This is the
default screen whenever you turn your Receiver on. The following information
will appear:
Most recent 5-minute
glucose reading
Trend Arrow
Time
High Glucose
Alert Setting
Low Glucose
Alert Setting
Plot of most
recent glucose
reading
Trend Graph Hours
EXAMPLE: 3-Hour Trend Graph Screen
58 | Continuous Glucose Monitoring System
• The G4-Global System reports glucose readings
from 40-400 mg/dL and updates glucose readings
every 5 minutes.
The glucose reading
is in milligrams per
deciliter (mg/dL) units.
The Receiver displays “LOW” when the most recent glucose reading is less than
40 mg/dL, and “HIGH” when the most recent glucose reading is greater than
400 mg/dL.
“Low”
Less than 40 mg/dL
“High”
Greater than 400 mg/dL
• Each “dot” on the Trend Graph is a glucose reading.
• Every Trend Graph shows the current time.
• The gray zone on the Trend Graphs indicates the area in between the High
Alert and Low Alert settings (see Chapter 2, Section 2.5 to change these
settings).
You can see Trend Graphs of your glucose information from the past 1-hour,
3-hour, 6-hour, 12-hour, and 24-hour periods by pressing the TOP or BOTTOM
TOGGLE button on your Receiver. Trend Graphs show you where your glucose
levels have been and where your glucose levels are headed.
G4-Global System User’s Guide | 59
5
(Scroll up from the 3-Hour Graph to reach the 1-Hour Graph)
1-Hour Trend Graph: The 1-Hour (1 Hr) Trend Graph shows
your current glucose reading and the last 1 hour of glucose
readings.
3-Hour Trend Graph: The 3-Hour (3 Hr) Trend Graph shows
your current glucose reading and the last 3 hours of glucose
readings (this is your default Trend Graph screen).
(Scroll down from the 3-Hour Graph to reach the 6-Hour Graph)
6-Hour Trend Graph: The 6-Hour (6 Hr) Trend Graph shows
your current glucose reading and the last 6 hours of glucose
readings.
(Scroll down from the 6-Hour Graph to reach the 12-Hour Graph)
12-Hour Trend Graph: The 12-Hour (12 Hr) Trend Graph
shows your current glucose reading and the last 12 hours of
glucose readings.
(Scroll down from the 12-Hour Graph to reach the 24-Hour Graph)
24-Hour Trend Graph: The 24-Hour (24 Hr) Trend Graph
shows your current glucose reading and the last 24 hours of
glucose readings.
60 | Continuous Glucose Monitoring System
5.2 GLUCOSE TRENDS
In addition to your current glucose reading and Trend
Graphs, Trend (Rate of Change) Arrows may appear
to show you how your glucose readings are changing.
The Trend Arrows appear to the right of your current
glucose reading.
Trend Arrows appear
here
This table shows the different Trend Arrows your Receiver will display:
Constant: Your glucose is steady (not increasing/decreasing more
than 1 mg/dL each minute)
Slowly rising: Your glucose is rising 1-2 mg/dL each minute
Rising: Your glucose is rising 2-3 mg/dL each minute
Rapidly rising: Your glucose is rising more than 3 mg/dL each minute
Slowly falling: Your glucose is falling 1- 2 mg/dL each minute
Falling: Your glucose is falling 2-3 mg/dL each minute
Rapidly falling: Your glucose is falling more than 3 mg/dL each minute
no arrow
No Rate of Change Information: The Receiver cannot always
calculate how fast your glucose is rising or falling
G4-Global System User’s Guide | 61
5
HELPFUL HINTS:
• Trend Arrows do not appear when there is
Missing Glucose Information (see Section 5.4).
If the
Symbol, the Wait Symbol , the Out
of Range Symbol , or the Blood Drop Symbol
appears in the upper right corner, the Trend
Arrows will not appear.
• If the Trend Arrow is missing, but you are
concerned that your blood glucose level may be rising or falling, take a
fingerstick test on your blood glucose meter to check your readings.
5.3 GLUCOSE ALERTS AND LOW GLUCOSE ALARM
The G4-Global System lets you create your own personal settings for how you
want the Receiver to tell you what is going on. The Low and High Glucose Alerts
will tell you when you fall outside of your target glucose range. Rise and Fall
(Rate of Change) Alerts let you know when your glucose levels are changing
fast (see Chapter 8, Section 8.4). The G4-Global System also features a
non-adjustable Low Glucose ALARM that will tell you when your glucose levels
may be reaching potentially dangerous low levels. In addition to the Alert screens
that appear on your Receiver display, you can also set High and Low Glucose
Alerts to notify you with vibrations and beeps. This feature can be helpful during
times when you are not able to test your blood glucose on your meter (such as
sleeping, driving, exercise, or long meetings).
62 | Continuous Glucose Monitoring System
5.3.1 HIGH GLUCOSE ALERT
When your G4-Global System readings are at or
above your High Alert level, the screen shown to the
right will appear. You can also set the Receiver to
beep and vibrate when this screen appears
(see Chapter 2, Section 2.5). The default level is set
at 200 mg/dL, but you can adjust this value.
High Glucose Alert set
at 200 mg/dL
When you set the High Glucose Alert, the level is
indicated by the top of the gray zone on the Trend
Graphs. (If the Low Glucose Alert is not set, the High
Glucose Level is indicated by a horizontal gray line.)
The Receiver will continue to alert you until you press
any Receiver button to clear the Alert, or until your
glucose readings drop below your High Glucose Alert
level. You can choose to have the Receiver re-alert
you every 15, 30 minutes or 1, 2, 3, 4, or 5 hours after
clearing the Alert, by changing your Snooze settings
(see Chapter 8, Section 8.7). Snooze settings for the
High Glucose Alert are only available if Advanced
features is turned on (see Chapter 8, Section 8.1).
High Glucose
Alert Setting
G4-Global System User’s Guide | 63
5
5.3.2 LOW GLUCOSE ALERT
When your G4-Global System readings are at or
below your Low Alert level, the screen shown to the
right will appear. You can also set the Receiver to
beep and vibrate when this screen appears
(see Chapter 2, Section 2.5). The default level is set
at 80 mg/dL, but you can adjust this value.
Low Glucose Alert set
at 80 mg/dL
When you set the Low Glucose Alert, the level is
indicated by the bottom of the gray zone on the Trend
Graphs. (if the High Glucose Alert is not set, the Low
Glucose Level is indicated by a horizontal gray line.)
The Receiver will continue to alert you until you press
any Receiver button, or until your glucose readings
rise above your Low Glucose Alert level. You can
choose to have the Receiver re-alert you every
15, 30 minutes or 1, 2, 3, 4, or 5 hours after clearing
the Alert, by changing your Snooze settings
(see Chapter 8, Section 8.7). Snooze settings for the
Low Glucose Alert are only available if Advanced
features is turned on (see Chapter 8, Section 8.1).
Low Glucose
Alert Setting
Symptoms related to low or high blood glucose levels should not
be ignored. If you have symptoms of low or high glucose, use
fingerstick readings from your blood glucose meter to check the
System results.
64 | Continuous Glucose Monitoring System
5.3.3 LOW GLUCOSE ALARM
The G4-Global System also has an automatic Low Glucose ALARM set at
55 mg/dL. This ALARM is a feature in addition to your personal Low and High
glucose Alerts. You cannot change or turn off this ALARM or its Re-ALARM
settings.
• When your glucose reading is at or below 55 mg/dL the Receiver will notify you
with 3 ALARMS (each 5 minutes apart) that beep/vibrate as follows:
- 1st ALARM: Vibrate
- 2nd ALARM: Vibrate, then a series of rapid descending tones followed by
3 constant tones. Series is repeated 3 times.
- 3rd ALARM: Vibrate, then a series of rapid descending tones followed by
3 constant tones. Series is repeated 3 times. (louder)
• The Receiver will vibrate and beep every 5 minutes after the 3rd ALARM if your
readings are still at or below 55 mg/dL, until you press any Receiver button to
clear it.
• For Low Glucose ALARMs the Receiver will display
the screen to the right.
• Re-ALARM: The Receiver will automatically notify
you again in 30 minutes after you press any
Receiver button to clear it, if your glucose readings
are still at or below 55 mg/dL.
Low Glucose ALARM
5.3.4 RISE AND FALL GLUCOSE RATE ALERTS
You can activate these Alerts (see Chapter 8, Section
8.4), to have the Receiver tell you if your glucose
readings are rising or falling fast.
You can set the Rise Rate (how fast you are going
up) to one of two different Rise Rate levels, or choose
to turn this Alert off. Depending on your selection,
you will be notified if your glucose level is rising
2 mg/dL or more each minute, or 3 mg/dL or more
each minute.
G4-Global System User’s Guide | 65
5
You can set the Fall Rate (how fast you are going
down) to one of two different Fall Rate levels, or
choose to turn this feature off. Depending on your
selection, you will be notified if your glucose level is
falling 2 mg/dL or more each minute, or 3 mg/dL or
more each minute.
If your glucose reading rises or falls at or above/below the Alert setting you
chose, the Receiver will display an Alert. You can also set the Alert to vibrate or
beep (see Chapter 8, Section 8.4). Two examples are shown below:
If you set your Fall Rate to 2 mg/dL per minute
and your glucose readings fall at this rate or
faster, the FALLING Single Arrow screen will
appear and vibrate/beep according to your
settings.
Example-Fall Alert
If you set your Rise Rate to 3 mg/dL per minute
and your glucose readings rise at this rate or
faster, the RISING Double Arrow screen will
appear and vibrate/beep according to your
settings.
NOTE: To set Rise and Fall Glucose Rate Alerts,
Advanced features must be turned on (see
Chapter 8, Section 8.1).
66 | Continuous Glucose Monitoring System
Example-Rapid Rise Alert
5.4 GLUCOSE STATUS AREA ON TREND GRAPHS
This device is not designed to replace a blood glucose meter. When
there is Missing Glucose Information, rely on fingerstick readings
from your blood glucose meter.
Symptoms related to low or high blood glucose levels should not be
ignored. If you have symptoms of low or high glucose, confirm them
with fingerstick readings from your blood glucose meter.
5.4.1 GLUCOSE STATUS AREA SYMBOLS
During your Sensor session the “Status Area” in the upper right hand corner of
the Trend Graph may display any of the information below.
Calibration
Needed
Glucose
Reading
Error
RF Error
A blood drop means your System requires you to enter another
fingerstick reading. You may need to enter a fingerstick reading for your
12-hour calibration, or the Receiver might need an additional fingerstick
reading to improve its calibration. (See Chapter 4, Section 4.2.)
Three question marks mean the Receiver does not understand the
Sensor signal. You should wait for more prompts and do not enter any
fingerstick readings when you see this symbol. (See Section 5.4.3.)
An antenna symbol with a line through it and a circle around it, means
the Sensor/Transmitter and Receiver are out of range. Make sure the
Receiver and Sensor/Transmitter are within 20 feet (6 meters) of each
other. (See Section 5.4.4.)
G4-Global System User’s Guide | 67
5
15 Minute
Calibration
Error
1 Hour
Calibration
Error
Wait
Means the Sensor cannot calibrate right now. If you see this screen,
enter at least 1 more calibration fingerstick reading after about
10-15 minutes. If the Sensor still cannot calibrate using this additional
fingerstick reading, the Sensor needs to be replaced. (See Chapter 8,
Section 8.4.)
Means the Sensor is not calibrating properly. If you see this screen, wait
about one hour and then enter at least 1 more fingerstick reading. If no
readings display on the Receiver after this additional fingerstick, the
Sensor needs to be replaced.
The single hourglass means the Receiver has detected a potential
problem with the Sensor signal. You should wait about 30 minutes for
more prompts. Do not enter any fingerstick readings when you see this
symbol.
5.4.2 MISSING GLUCOSE READINGS
At certain times, a notification symbol may appear in the Status Area of the
Trend Graph. These notifications are helpful in troubleshooting why glucose
readings do not appear on the Receiver. The table in the previous section shows
the symbols that might appear in the Status Area.
Missing Glucose Information can happen when:
1. The System needs another fingerstick reading for calibration because
the Sensor readings do not match the recent fingerstick reading you just
entered.
2. The Receiver does not understand the Sensor signal.
3. The Sensor/Transmitter and Receiver are out of range. Make sure the
Sensor/Transmitter and Receiver are within 20 feet (6 meters) of each other.
For calibration errors see Chapter 8. The following
sections will tell you what happens when the Receiver
does not understand the Sensor signal, and when
your Sensor/Transmitter and Receiver are out of
range. If your Receiver is not displaying glucose
information, look at the Status Area on the Trend
Graph.
Status Area
68 | Continuous Glucose Monitoring System
5.4.3 SYSTEM GLUCOSE ERRORS
Sometimes the G4-Global System may tell you that it
cannot provide a glucose reading. When this occurs
you will see 3 question marks (
) in the Status
Area.
Check the placement of your Sensor to make sure it
is still sticking securely to your skin. Also make sure
nothing is rubbing the Sensor Pod (i.e. clothing, seat
belts, etc.).
No Glucose Data
Check to see if the Transmitter is snapped in on both sides. This error can
happen when the G4-Global System detects problems with the glucose signal or
Sensor insertion area. Chapter 9 tells you how often you might expect to see this
error. Sometimes the G4-Global System can correct the problem and continue
providing glucose readings. However, if it has been 3 hours since your last
glucose reading appeared, contact Technical Support.
HELPFUL HINTS:
• If you see
in the Status Area of the Trend Graph, it is recommended
that you wait out this period of time. Do not calibrate your System during
this time.
• When you see
, taking fingerstick readings with your meter and
entering them does not help the System display more glucose readings.
Any fingerstick readings that you enter during
will be ignored by the
System.
• Wait until you see a Single Blood Drop in the Status Area before
entering a calibration value into your Receiver.
G4-Global System User’s Guide | 69
5
5.4.4 OUT OF RANGE/NO ANTENNA
• When you see the Out of Range Symbol
in the Status Area, this means the
Receiver has “missed” the last glucose reading sent by the Transmitter.
• If you see this Symbol, make sure the Receiver is
within 20 feet (6 meters) of the Sensor/Transmitter.
If not, move the Receiver closer and wait at least
5 minutes.
• Once you have moved the Receiver closer and
waited 5-10 minutes, the Out of Range Symbol
in the Status Area should disappear. The Antenna
Symbol
should reappear in the upper left corner,
and you should receive a glucose reading.
No Glucose Data
• If you are still having trouble receiving System readings because of this
problem, contact DexCom Technical Support.
HELPFUL HINTS:
• You can set an Out of Range Alert to notify you when the Receiver and
Sensor/Transmitter are not talking (see Chapter 8, Section 8.6). You can
also set the amount of time the Transmitter can be out of range before the
Receiver alerts you.
• The Sensor/Transmitter and Receiver may lose communication during the
following circumstances: while you are lying on a waterbed, while you are
near other metallic objects, or when you are using an electric blanket.
70 | Continuous Glucose Monitoring System
5.5 TEMPORARY SENSOR SHUT DOWN
There may be times when you want to temporarily shut down your Receiver.
Shutdown will stop all communication between the Transmitter and Receiver,
and will turn the Receiver off. You will not receive glucose readings or any Alerts/
Low Glucose ALARMs while the Receiver is shut down, but your current Sensor
session will remain in progress. Follow these steps to shut down your Receiver:
1. From the Main Menu, scroll to and highlight
“Shutdown”. Press the SELECT button.
2. Confirm that you want to shutdown your Receiver.
a. If you want to shutdown, press the LEFT
TOGGLE button to highlight “OK” and then press
the SELECT button.
b. If you want to cancel the shutdown, press the
SELECT button (with “Cancel” highlighted) to
return to the Main Menu.
3. To turn the Receiver back on and resume communication with the Transmitter,
press the SELECT button. It may take up to 20 seconds for the display to turn
back on.
HELPFUL HINTS:
• Remember that your Alerts and Low Glucose ALARM will not work when
the Receiver is shut down.
• Your Sensor session will stop 7 days after you start the Sensor session.
Shutting down the Receiver does not extend Sensor life beyond 7 days.
G4-Global System User’s Guide | 71
5
THIS PAGE LEFT INTENTIONALLY BLANK
72 | Continuous Glucose Monitoring System
chapter
hapter six
COMPLETING YOUR CONTINUOUS
GLUCOSE MONITORING SESSION
At the end of your Sensor session (or wear period), you will need
to remove the Sensor. Gently peel up the adhesive patch from
your skin (this will pull out your Sensor Probe). Then remove the
Transmitter from the Sensor and keep it for your next continuous
glucose monitoring session (see Section 6.4).
6.1 REMOVING A SENSOR
Your Sensor session will end on time when the Sensor expires (after 7 days).
You can also choose to end the session early, or it might end early (less than 7
days) due to a Sensor failure.
Once your Sensor session has ended, glucose
readings will no longer be shown on the Receiver.
The Trend Graphs will indicate that the Sensor
session has ended by displaying a red Stoplight
Symbol in the upper right corner.
A Stop Sign indicates
that your Sensor
session has ended
HELPFUL HINT: Remember to save your Transmitter after each Sensor
removal. The same Transmitter is used for each session until you have
reached the end of the Transmitter battery life. The Sensor can be thrown in
the trash.
G4-Global System User’s Guide | 75
6
6.2 AUTOMATIC SENSOR SHUT-OFF
The Receiver will tell you how much time you have remaining until your
G4-Global Sensor session is complete. The Sensor Expiration screen will
appear at 6 hours, 2 hours and 30 minutes before your 7-day session ends.
You can to set the Receiver to vibrate and/or beep with these displays if you
choose (see Chapter 8, Section 8.5). After the 6-hour, 2-hour, and 30-minute
reminders, you will still continue to receive glucose readings. You can clear any
of these screens by pressing any button on the Receiver. You must remove your
Sensor after the final Sensor Expiration screen (00:00:00) appears.
6-hour Sensor Expiration
Notification
30-minute Sensor Expiration
Notification
2-hour Sensor Expiration
Notification
Sensor Expiration Notification
End of session
Once the Replace Sensor Now screen appears, press any button on the
Receiver to clear this notification.
76 | Continuous Glucose Monitoring System
6.3 EARLY SENSOR SHUT-OFF
In some cases your Sensor session may end before you have completed a full
7-day period. You should review Chapter 11, Section 11.2 in this User’s Guide
to determine how often you should expect this to happen. Examples of why this
may occur are described below.
6.3.1 EARLY SHUT-OFF – SENSOR FAILURE
During a session the Receiver may detect a series
of issues with your Sensor signal where it can no
longer determine your glucose reading (see Chapter
9, Section 9.3). At this time the CGM session will end
and show the screen to the right.
If you see this screen then your continuous glucose
monitoring session has ended. Press any button on
the Receiver to clear this screen.
Sensor Failed Screen
6.3.2 MANUAL SENSOR SHUT-OFF – “STOP SENSOR”
To manually end your Sensor session, select “Stop
Sensor” from the Main Menu. This option will only
appear if you are in the middle of an active Sensor
session (you have already started a Sensor session
and the Sensor has not expired or failed). See
Chapter 6, and Chapter 9, Section 9.3.
With “OK” highlighted, press the SELECT button to
confirm that you want to stop the Sensor session.
G4-Global System User’s Guide | 77
6
The Stop Sensor processing screen will appear to let you know the Sensor
session is stopping. Once the session has stopped, a Red Stoplight Symbol
will appear in the upper right corner of the Trend Graph.
HELPFUL HINTS:
• If you removed your Sensor before stopping the Sensor session on the
Receiver, the Sensor Failed screen will appear automatically. You must
press SELECT before inserting a new Sensor. Look closely at the Sensor
to make sure it is not damaged.
• You cannot reverse the decision to stop a Sensor session after pressing
the SELECT button. Press the LEFT TOGGLE button to return to the Main
Menu if you do not want to stop the Sensor session.
78 | Continuous Glucose Monitoring System
6.4 TRANSMITTER REMOVAL
When you are ready to remove the Sensor, make sure to pull out the Sensor
Pod with the Transmitter still inside. Once the Sensor Pod is off your body, you
will need to remove the Transmitter. To do this you can use either of the two
methods below:
Method 1
The Safety Lock/Transmitter Key once removed from the Applicator (see
Chapter 3, Section 3.5) can be used as a tool to remove the Transmitter.
1. Place the Sensor Pod on a table.
2. Hold the rounded edge of the Transmitter Key.
3. Make sure the jagged edge of the Transmitter Key is facing down (the
direction away from the removal arrow) as shown below:
Transmitter Key
(from Applicator)
Sensor Pod with
Transmitter Key
snapped in
4. Insert the jagged edges so that they “hug” the Transmitter wings in the Sensor
Pod. Press the Transmitter Key down until you cannot press down anymore,
and the Transmitter wings will “pop” out of the Sensor Pod.
5. Remove the Transmitter and store it in a cool, dry place until your next glucose
monitoring session.
Method 2
If you did not save the Transmitter Key, you can simply use your pointer finger on
each hand and spread out the tabs at the back of the Sensor Pod (end closest to
the wings). The Transmitter wings will “pop” out of the Sensor Pod.
G4-Global System User’s Guide | 79
6
THIS PAGE LEFT INTENTIONALLY BLANK
80 | Continuous Glucose Monitoring System
chapterr seven
sev
BASIC SETTINGS
7.1 THE SETTINGS MENU
7.1.1 GETTING TO THE SETTINGS MENU
1. Press any button to turn on the Receiver. The 3-Hour Trend Graph will
appear.
2. Press the SELECT button to display the Main Menu.
3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to
“Settings” and press the SELECT button. The Settings menu will appear.
7.1.2 SETTING YOUR RECEIVER TIME AND DATE
1. From the Settings menu, press the TOP or
BOTTOM TOGGLE button to scroll to “Time/Date”
and press the SELECT button.
2. Check that the current date and time are correctly
set in the Receiver. Press the RIGHT TOGGLE
button to highlight each value in the date and time.
Then, press the TOP or BOTTOM TOGGLE button
to make any adjustments and then press the
RIGHT TOGGLE button to move to the next value.
After choosing AM or PM, press the SELECT
button. You will return to the Settings menu.
G4-Global System User’s Guide | 83
7
HELPFUL HINTS:
• The date in the Receiver is set at the factory to Pacific Standard Time
(PST).
• Make sure to set the correct date and time on your Receiver.
• When setting values for the time or date, press and hold the TOP or
BOTTOM TOGGLE button to scroll through the fields more quickly.
• You might need to reset the Receiver’s time and date if the rechargeable
battery is drained. If this happens, the Time Loss Alert will automatically
take you to the Time/Date Setting Screen.
7.1.3 ENTERING YOUR TRANSMITTER ID
Any time you switch to a new Transmitter and/or Receiver (as a replacement
to the Transmitter and Receiver that came in your kit) you must enter the
Transmitter ID into your Receiver. The Transmitter ID is a series of 2 letters and
5 numbers on the back of the Transmitter. Entering the ID will begin the unique
wireless radio frequency (RF) communication between the Transmitter and
Receiver.
NOTE: You can only set your Transmitter ID when you are not in a Sensor
session. During a Sensor session, “Transmitter ID” will not appear as an
option on the Settings menu.
To enter the Transmitter ID, perform the following steps:
1. From the Settings menu, press the TOP or
BOTTOM TOGGLE button to scroll to “Transmitter
ID” and press the SELECT button.
84 | Continuous Glucose Monitoring System
2. Starting with the first number (do not enter the first
2 letters), press the TOP or BOTTOM TOGGLE
button to make any adjustment and then press the
RIGHT TOGGLE button to move to the next value.
After entering the 5th number, press the SELECT
button. You will return to the Settings menu.
Your Transmitter ID can be found in any of the
following locations:
- On the Transmitter card located inside your G4-Global System Kit
- On the outside of the Transmitter box label
- Engraved on the back of the Transmitter itself
If you have difficulty locating your Transmitter ID, please contact DexCom
Technical Support.
G4-Global System User’s Guide | 85
7
7.1.4 CHECKING INFORMATION ABOUT YOUR RECEIVER
At any time you can check your Receiver for information about your G4-Global
System.
1. From the Settings menu, press the TOP or
BOTTOM TOGGLE button to scroll to “Device Info”
and press the SELECT button.
2. Information about your Sensor session and System will appear. Scroll down
to see all the information. Press the LEFT TOGGLE button to return to the
Settings menu.
Device Info:
• Insertion Time
• Last Calibration
• Transmitter Battery
• Transmitter ID
• Part Number
• Part Revision
• Software Version
• Software Revision
86 | Continuous Glucose Monitoring System
7.2 SETTING YOUR ALERTS
7.2.1 FACTORY ALERT SETTINGS
The G4-Global System is shipped from the factory with the following “default”
settings for Alerts. (See the table below.)
Screen
Alert Type
Default
Setting
Default Prompt
Vibrate/Beep
Default
Re-alert
Setting
High Alert
On200
mg/dL
Vibe then Beep
(vibrate first,
then 2 high
beeps and
vibrate)
None
(no Re-alerts
after pressing
any Receiver
button to clear)
Low Alert
On80 mg/dL
Vibe then
Beep (vibrate
first, then 3
low beeps and
vibrate)
None
(no Re-alerts
after pressing
any Receiver
button to clear)
Rise Alert
Off
Disabled (None)
None
(no Re-alerts
after pressing
any Receiver
button to clear)
G4-Global System User’s Guide | 87
7
Screen
Alert Type
Default
Setting
Default Prompt
Vibrate/Beep
Default
Re-alert
Setting
Fall Alert
Off
Disabled (None)
None
(no Re-alerts
after pressing
any Receiver
button to clear)
Other Alerts
(See Chapter
11, Appendix
1 for a
detailed list
of all “Other
Alerts.”)
On
Vibe then Beep
(vibrate first,
then medium
beep tone)
Depends on the
Alert Type (See
Chapter 12,
Appendix 1)
Out of Range
Alert
Off
Disabled (None)
Continues to
Re-alert you
until you come
back into range.
88 | Continuous Glucose Monitoring System
7.2.2 GETTING TO THE ALERTS MENU
1. Press the SELECT button to turn on the Receiver. The 3-Hour Trend Graph
will appear.
2. Press the SELECT button to display the Main Menu.
3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to
“Alerts” and press the SELECT button. The Alerts menu will appear.
7.2.3 SETTING GLUCOSE ALERTS
The High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert (see Chapter 5)
provide information about your glucose levels and trends. The following will
show you how to change the High Alert, Low Alert, Rise Rate Alert, and Fall
Rate Alert settings.
NOTE: To receive Rise Rate and Fall Rate Alerts, Advanced Features must
be turned on (see Chapter 8, Section 8.1).
G4-Global System User’s Guide | 89
7
High and Low Glucose Alerts
NOTE: The options for setting both a High Alert and a Low Alert are the
same.
The following steps will show you how to change your High Alert Settings.
1. From the Alerts menu, press the TOP or BOTTOM
TOGGLE button to select “High Alert” or “Low
Alert” and press the SELECT button.
2. On the High Alert menu (example), press the TOP
or BOTTOM TOGGLE button to choose “On/Off”.
The High Alert is currently set to “On”. If you do
not want to receive this type of Alert press the
SELECT button to choose “Off”.
Example-High Alert menu
3. Next, on the High Alert menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Type” and press the SELECT button. Then,
choose “Vibrate Then Beep” or “Vibrate Only” as
your alert delivery option, and press the SELECT
button.
- Vibrate Then Beep (vibrate, then a vibrate and a
beep every 5 minutes)
Example-High Alert
° High Alert Beep (a series of tones in ascending order, followed by a few
steady high tones)
° Low Alert Beep (a series of tones in descending order, followed by a few
steady low tones)
- Vibrate Only (vibrate every 5 minutes)
NOTE: Alerts can be acknowledged by pressing any button on the Receiver.
90 | Continuous Glucose Monitoring System
4. Next, on the High Alert menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Level” and press the SELECT button. Press
the TOP or BOTTOM TOGGLE button to enter
your Alert value (120 to 400 mg/dL in 10 mg/dL
increments for a High Alert and 60 to 100
mg/dL in 5 mg/dL increments for a Low Alert). The
starting value that first appears on this screen is
the default value of 200 mg/dL (High Alert) and
80 mg/dL (Low Alert), or the values you set in the
Setup Wizard.
Example-High Alert
You have the option to set a snooze time to re-alert you (see Chapter 8,
Section 8.7).
G4-Global System User’s Guide | 91
7
Rise and Fall Rate Alerts
NOTE:
• The options for setting both a Rise Rate Alert and a Fall Rate Alert are the
same.
• To use the Rise and Fall Rate Alerts feature, Advanced Features must be
turned on. (See Chapter 8, Section 8.1.)
The following steps will show you how to change your Fall Rate Alert settings.
1. From the Alerts menu, press the TOP or BOTTOM TOGGLE button to select
“Rise Rate” or “Fall Rate” and press the SELECT button.
2. On the Fall Rate menu (example), press the TOP
or BOTTOM TOGGLE button to choose “On/Off”.
Then, press the SELECT button to select “On”. If
you do not want to receive this type of Rate Alert
press the SELECT button to choose “Off”.
Example-Fall Rate menu
3. Next, on the Fall Rate menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Type” and press the SELECT button. Then,
choose “Vibrate Then Beep” or “Vibrate Only” as
your alert delivery option and press the SELECT
button.
- Vibrate Then Beep (vibrate, then a vibrate and a
beep every 5 minutes)
Example-Fall Rate
° Rise Rate Beep (a series of rapid ascending tones, repeated 3 times)
° Fall Rate Beep (a series of rapid descending tones, repeated 3 times)
- Vibrate Only (vibrate every 5 minutes)
NOTE: Alerts can be acknowledged by pressing any button on the Receiver.
92 | Continuous Glucose Monitoring System
4. Next, on the Fall Rate menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Level” and press the SELECT button. Then,
choose whether the alerts should be delivered
when your glucose levels are falling either
“2 mg/dL/min” (2 mg/dL or more per minute), or
“3 mg/dL/min” (3 mg/dL or more per minute). Press
the SELECT button.
Example-Fall Rate
When finished, press the LEFT TOGGLE button to return to the Alerts menu.
NOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert,
one arrow will appear on the screen when you receive an Alert. Two arrows
(meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or
Fall Rate Alert.
Example-Fall Rate Alert
Example-Rapid Rise Alert
G4-Global System User’s Guide | 93
7
THIS PAGE LEFT INTENTIONALLY BLANK
94 | Continuous Glucose Monitoring System
chapter eight
ADVANCED FEATURES
BEYOND THE BASICS
Advanced features allows you to do the following:
• Enter events related to your carbohydrate consumption, insulin usage,
exercise and overall health. Event information can be downloaded to a PC
along with your glucose readings and viewed using the DexCom Studio®
Accessory Software.
• Expand and customize the Alerts feature so that the Receiver can:
- notify you when and how fast your glucose levels are rising or falling
- deliver other Alerts according to your preference
- notify you when your Sensor/Transmitter and Receiver are out of range
8.1 ACTIVATING ADVANCED FEATURES
To use the Receiver’s Advanced features, the Advanced features setting must
be turned on.
1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll
to “Settings” and press the SELECT button. Next, scroll to “Advanced” and
press the SELECT button.
2. On the “Advanced” screen, press the SELECT
button to turn Advanced features On (or Off).
Press the LEFT TOGGLE button to return to the
Settings screen.
G4-Global System User’s Guide | 97
8
8.2 DIABETES EVENTS
With the G4-Global System you can enter meal, insulin, physical activity,
and health information. This information can help you and your Diabetes
Management Team review your glucose trends and patterns and may help you
make better decisions about your diabetes management plan. These events
can be downloaded to a PC along with your glucose readings and reviewed
later with the DexCom Studio® Accessory Software.
8.2.1 SELECTING AN EVENT
When Advanced features is turned on, “Events” will appear as an option on the
Main Menu.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Events” and press the SELECT button.
From the Events menu you can choose “Carbs”,
“Insulin”, “Exercise” or “Health”.
98 | Continuous Glucose Monitoring System
8.2.2 SETTING THE DATE AND TIME FOR AN EVENT
When you enter an event you will be prompted to check that the date and time
for that event are correct. The default date and time for events you enter is the
current date and time stored in the Receiver.
1. To change the date and time for an event, press
the RIGHT TOGGLE button to highlight each
value in the date and time. Then, press the
TOP or BOTTOM TOGGLE button to make any
adjustments and then press the RIGHT TOGGLE
button to move to the next value. After choosing
AM or PM, press the SELECT button. You will
advance to the Event confirmation screen.
NOTE: If you change the date or time for any event, it only applies to that
event and will not change the current date and time in your Receiver.
8.2.3 CARBOHYDRATES
The Carbs Event lets you enter the amount of carbohydrates you have
consumed, up to 250 grams for any particular date and time.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Carbs” and press the SELECT button.
2. Press the TOP or BOTTOM TOGGLE button to
enter your carb amount (0-250 grams), and press
the SELECT button. The number that first appears
on this screen will be the last number you entered
or the default amount of 50 grams.
G4-Global System User’s Guide | 99
8
4. Check that the date and time for this entry are correct.
5. Confirm the entry. Press the LEFT or RIGHT
TOGGLE button to choose either “OK” to confirm
this entry or “Cancel” to discard this entry, and
press the SELECT button. You will return to the
Events menu.
8.2.4 INSULIN
The Insulin Event lets you enter the amount of insulin you have taken, up to 250
units for any particular date and time. You can only enter an insulin amount, not
the type of insulin taken.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Insulin” and press the SELECT button.
2. Press the TOP or BOTTOM TOGGLE button to
enter your insulin amount (0-250 units), and press
the SELECT button. The number that first appears
on this screen will be the last number you entered
or the default amount of 10 units.
3. Check that the date and time for this entry are
correct.
4. Confirm the entry. Press the LEFT or RIGHT
TOGGLE button to choose either “OK” to confirm
this entry or “Cancel” to discard this entry, and
press the SELECT button. You will return to the
Events menu.
100 | Continuous Glucose Monitoring System
8.2.5 EXERCISE
The Exercise Event lets you enter the intensity (Light, Medium, or Heavy) and
duration (up to 360 minutes), for any particular date and time.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Exercise” and press the SELECT button.
2. Press the TOP or BOTTOM TOGGLE button to
enter your exercise intensity level, and press the
SELECT button.
3. Press the TOP or BOTTOM TOGGLE button to
enter your exercise duration (0-360 minutes), and
press the SELECT button. The number that first
appears on this screen is the default amount of
30 minutes.
4. Check that the date and time for this entry are
correct.
5. Confirm the entry. Press the LEFT or RIGHT
TOGGLE button to choose either “OK” to confirm
this entry or “Cancel” to discard this entry, and
press the SELECT button. You will return to the
Events menu.
G4-Global System User’s Guide | 101
8
8.2.6 HEALTH
The Health Event lets you enter episodes of Illness, Stress, High Symptoms,
Low Symptoms, Cycle (menstrual) or Alcohol consumption, for any particular
date and time.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Health” and press the SELECT button.
2. Press the TOP or BOTTOM TOGGLE button to
enter your health event, and press the SELECT
button.
3. Check that the date and time for this entry are correct.
4. Confirm the entry. Press the LEFT or RIGHT
TOGGLE button to choose either “OK” to confirm
this entry or “Cancel” to discard this entry, and
press the SELECT button. You will return to the
Events menu.
102 | Continuous Glucose Monitoring System
8.3 DEXCOM STUDIO SOFTWARE
The DexCom Studio® Accessory Software comes with your G4-Global
System. This software allows you to view trends and track patterns and create
customizable charts to display your glucose trends.
Change the date ranges to view long- or short-term patterns and trends. Plus,
you can use data from current and previous G4-Global System downloads and
save or print files that you can take to your next doctor visit.
For system requirements refer to the DexCom website (www.dexcom.com).
The DexCom Studio® Help File gives you more information on how to use this
software.
NOTE: To receive Rise and Fall Rate Alerts, Advanced Features must be
turned on.
8.4 RISE AND FALL GLUCOSE RATE ALERTS
Rate Alerts notify you when your glucose levels are rising (Rise Alert) or falling
(Fall Alert), and by how much. You can turn the Rise and/or Fall Rate Alert on or
off, and choose how the Alerts are delivered (vibrate and beep, or vibrate only).
You can also choose whether the Alert should be delivered when your glucose
is either rising or falling 2 mg/dL or more per minute, or 3 mg/dL or more per
minute.
When Advanced features is turned on, “Rise Rate” and “Fall Rate” will appear
as additional options on the Alerts menu. The options for setting both a Rise
Rate Alert and Fall Rate Alert are the same.
The following steps will show you how to change your Fall Rate Alert settings.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Rise Rate” or “Fall Rate” and press the
SELECT button.
G4-Global System User’s Guide | 103
8
2. On the Fall Rate menu (example), press the TOP
or BOTTOM TOGGLE button to choose “On/Off”.
Then, press the SELECT button to select “On”. If
you do not want to receive this type of Rate Alert
press the SELECT button to choose “Off”.
Example-Fall Rate menu
3. Next, on the Fall Rate menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Type” and press the SELECT button. Then,
choose “Vibrate Then Beep” or “Vibrate Only” as
your alert delivery option and press the SELECT
button.
- Vibrate Then Beep (vibrate, then a vibrate and a
beep every 5 minutes)
Example-Fall Rate
° High Alert Beep (a series of tones in ascending order, done in pairs)
° Low Alert Beep (a series of tones in descending order, done in pairs)
- Vibrate Only (vibrate every 5 minutes)
NOTE: Alerts can be acknowledged by pressing any button on the Receiver.
4. Next, on the Fall Rate menu (example), press
the TOP or BOTTOM TOGGLE button to choose
“Level” and press the SELECT button. Then,
choose whether the alerts should be delivered
when your glucose levels are falling either
“2 mg/dL/min” (2 mg/dL or more per minute) or
“3 mg/dL/min” (3 mg/dL or more per minute). Press
the SELECT button.
Example-Fall Rate
When finished, press the LEFT TOGGLE button to return to the Alerts menu.
104 | Continuous Glucose Monitoring System
NOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert,
one arrow will appear on the screen when you receive the Alert. Two arrows
(meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or
Fall Rate Alert.
Example-Fall Alert
Example-Rapid Rise Alert
8.5 SETTING OTHER ALERTS
The G4-Global System provides many other notifications. See Chapter 12,
Appendix I for a complete list of these “Other Alerts.”
When Advanced features is turned on, “Other Alerts” will appear as an additional
option on the Alerts menu. The default “Type” for all of the “Other Alerts” is
“Vibrate Then Beep”, a setting that will notify you with vibrations and a series of
rapid ascending then descending tones, when these Alerts occur. This setting
can be changed to “Vibrate Only” or “Silent”.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Other Alerts” and press the SELECT
button.
2. “Type” is highlighted. Press the SELECT button.
G4-Global System User’s Guide | 105
8
3. Press the TOP or BOTTOM TOGGLE button to
change “Vibrate Then Beep” to “Vibrate Only” or
“Silent” option and press the SELECT button.
When finished, press the LEFT TOGGLE button to
return to the Alerts menu.
8.6 SETTING THE OUT OF RANGE ALERT
The Out of Range Alert lets you know when the Sensor/Transmitter and
Receiver are not talking to each other. Typically, you should keep the Sensor/
Transmitter and Receiver within 20 feet (6 meters) of each other. When the
Sensor/Transmitter and Receiver are too far apart and are not talking, you will
not receive glucose readings from the Sensor.
When this happens, the Out of Range Symbol
will
appear in the upper right corner of the Trend Graph
and the screen to the right will appear. The amount of
time the devices are out of range will appear on the
Out of Range Alert screen.
When Advanced features is turned on, “Out of Range”
will appear as an additional option on the Alerts menu.
The default setting for the Out of Range Alert is off (“disabled”). But if you choose
to turn this Alert on, you can then set the Alert to either “Vibrate Then Beep” or
“Vibrate Only”. “Vibrate Then Beep” notifies you with vibrations and a series of
3 ascending tones, repeated 3 times, followed by 5 buzzers. You can also set
the amount of time (between 20 and 200 minutes) the Transmitter can be out of
range before the Receiver alerts you. If you go out of range, the Receiver will
continue to re-alert you until you come back in range again, or press any button
on the Receiver.
1. Press the TOP or BOTTOM TOGGLE button to
choose “Out of Range” and press the SELECT
button.
106 | Continuous Glucose Monitoring System
2. On the Out of Range menu, press the TOP or
BOTTOM TOGGLE button to choose “On/Off”.
Then, press the SELECT button to select “On”.
If you do not want to receive Out of Range Alerts
press the SELECT button to choose “Off”.
3. Next, on the Out of Range menu, press the TOP or
BOTTOM TOGGLE button to choose “Type” and
press the SELECT button. Then, choose “Vibrate
Then Beep” or “Vibrate Only” as your alert delivery
option and press the SELECT button.
4. Next, on the Out of Range menu, press the TOP or
BOTTOM TOGGLE button to choose “Time” and
press the SELECT button. Then, press the TOP or
BOTTOM TOGGLE button to choose the elapsed
time, after which the Receiver will alert you and
continue to re-alert you until you are back in range.
Press the SELECT button.
When finished, press the LEFT TOGGLE button to return to the Alerts menu.
G4-Global System User’s Guide | 107
8
8.7 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW
GLUCOSE ALERTS
You have the option to set a snooze time (every 15 minutes up to 5 hours) in
between High and Low glucose Re-alerts.
NOTE: To set a snooze time for your High and Low Alerts, Advanced
Features must be turned on.
TOGGLE button to choose “Snooze” and press the
SELECT button.
Example-High Alert
2. Press the TOP or BOTTOM TOGGLE button to
select the amount of time (in 15 minute increments)
in between the first Alert and Re-alerts. Press the
SELECT button. If you set the amount of time to
zero there will be no Re-alerts.
When finished, press the LEFT TOGGLE button to
return to the Alerts menu.
108 | Continuous Glucose Monitoring System
Example-High Alert
chapter nine
TROUBLESHOOTING
9.1 SENSOR INSERTION TROUBLESHOOTING
Sensor Insertion Difficulties
• I am having trouble taking out the Safety Lock/Transmitter Key:
- Make sure to pull straight out using the arrows on the Safety Lock as a guide.
- Do not wiggle back and forth.
• I am not able to pull the Collar up:
- Make sure the plunger is completely pressed down before pulling the
collar up.
- When pulling the Collar up you should hear 2 clicks.
- Try using more force when pulling the collar up.
• I am not able to remove the Applicator from the Sensor Pod:
- Pull the Collar all the way up. It should be very close
to the top of the Applicator.
- Make sure the Transmitter Latch is down before
squeezing the Release Tabs.
- Then squeeze the ribbed Release Tabs (on the
side), and lift the Applicator away from your body.
• Removing the Transmitter Latch is difficult:
Release the Applicator
- Hold the Sensor Pod down with one hand and twist the Latch with the other
hand to remove it.
- Do not try to snap it straight off.
Sensor Pod is Not Sticking Long Enough
• Do not use any cream or lotion on your skin where you attach the Sensor Pod.
• Clean the skin and make sure it is completely dry before you attach the Sensor
Pod. Do not leave any substance on the skin where the Needle inserts.
• You may use medical tape (such as BlendermTM) over the white adhesive patch
of the Sensor Pod, but do not place the tape over the Transmitter or the plastic
parts of the Sensor Pod.
The G4-Global Continuous Glucose Monitoring System is a glucosemonitoring device indicated for detecting trends and tracking patterns in
adults (age 18 and older) with diabetes.
G4-Global System User’s Guide | 111
9
9.2 CALIBRATION TROUBLESHOOTING
Prompts may appear during or shortly after you try to calibrate
your System. Review the following troubleshooting tips so that your calibration
is successful.
• Make sure you have inserted a Sensor and started a Sensor session
• Do not use expired Sensors
• Store Sensors at room temperature (see Chapter 9 for Maintenance and
Storage of your System)
• Make sure your meter readings are between 40 and 400 mg/dL before you
calibrate
• Quality check your blood glucose meter per the manufacturer’s instructions
9.2.1 BLOOD DROP PROMPTS
9.2.1.1 TYPES OF BLOOD DROP PROMPTS
This section describes the three blood drop symbols you will see. The next
section (Section 9.2.1.2) describes what to do when you see one of these
symbols.
Repeat Double Blood Drop Prompt
If Startup calibration is not successful, the Receiver
will continue to display this screen until you correct the
problem. If you have followed these steps and you still
receive the Double Blood Drop Prompt, then one of
the following errors has occurred:
• Both fingerstick readings you took and entered for
your first calibration were outside of the 40-400
mg/dL range, or
Double Blood Drop
Prompt
• The Receiver and Transmitter were not talking (Out of Range Symbol
appears in the Status Area) with each other at the time you took the 2
fingersticks entered for calibration, or
• The Receiver could not understand (
appears in the Status Area) your
Sensor signal at the time you entered the fingerstick readings for calibration.
112 | Continuous Glucose Monitoring System
Additional Startup Blood Drop Prompt
The Additional Startup Blood Drop Prompt (with
1 checked) means you need 1 more fingerstick
reading for Startup Calibration.
This screen will appear and the Receiver will make
a medium tone and vibrate once (if set to “Vibe
then beep”). The Receiver will continue to show the
Additional Startup Blood Drop Prompt screen every
15 minutes until the fingerstick reading is successfully
entered into the Receiver.
Additional Blood Drop
Prompt
Single Blood Drop Prompt
The Single Blood Drop Prompt means you need
1 more fingerstick reading to calibrate. This symbol
will appear when it is time for the 12-Hour Calibration
Update or if the Receiver needs another fingerstick
reading for Re-calibration.
• 12-Hour Update: The screen will prompt you again
every 15 minutes until a new fingerstick reading is
successfully entered.
Single Blood Drop
Prompt
• Additional fingerstick needed: The Receiver will vibrate and will make a sound.
The Receiver will notify you two more times (to enter a fingerstick), or until a
new fingerstick reading is successfully entered.
G4-Global System User’s Guide | 113
9
9.2.1.2 STATUS AREA SYMBOLS DURING BLOOD DROP
PROMPTS
If you are prompted repeatedly by the Double Blood Drop screen, Additional
Startup Blood Drop screen (1 checked), or the Single Blood Drop screen, make
sure you first check the Status Area on your Receiver before you take another
fingerstick reading. Then follow the steps below:
1. Clear the prompt from the Screen by pressing any button on the Receiver.
2. Check the Status Area in the upper right corner of your Receiver. You will
decide what to do based on the symbol that is shown in the Status Area:
a. If the Double Blood Drop Prompt Symbol
displayed:
is
• Take 2 more fingerstick readings if you are
prompted by the Double Blood Drop.
b. If the Additional Startup Blood Drop Prompt
Symbol
is displayed:
Double Blood Drop
• Take 1 more fingerstick reading if you are
Prompt
prompted by the Additional Startup or Single
Blood Drop. (Readings must be within 40-400 mg/dL).0
c. If the “Single” Blood Drop Symbol
prompt is displayed:
• Enter your fingerstick readings into the Receiver.
d. If
is displayed, your Receiver cannot
understand your Sensor signal. Do not take any
more fingerstick readings for calibration at this
time. Wait until you see one of the Blood Drop
Prompts and review Steps 1 and 2.
“Unknown Glucose
Reading” Symbol
114 | Continuous Glucose Monitoring System
e. If the Out of Range Symbol
is displayed, do not take any more fingerstick
readings for calibration at this time. Move the Receiver and Transmitter
so that they are within 20 feet (6 meters) of each other and wait at least 5
minutes.
1. Make sure your Transmitter ID is entered into the Receiver (see Chapter 2,
Section 2.4)
2. Make sure your Transmitter is fully snapped in
If you are still having problems with communication
review Chapter 5, Section 5.4.4. When you are
prompted with any of the Blood Drop Prompt screens
again, review the steps at the beginning of this
section to calibrate.
Out of Range Symbol
HELPFUL HINT: If you are still having trouble with G4-Global System
calibration (e.g., receiving repeated prompts) following these steps, contact
DexCom Technical Support at 1-888-SEVENGO (738-3646) for help.
9.3 SENSOR FAILED TROUBLESHOOTING
In some cases your Sensor session may stop before the end of a full 7-day
period. Follow the guidelines below to have the best results with your System.
• Do not use expired Sensors
• Store Sensors at room temperature (see Chapter 10, Section 10.2)
• Quality check your blood glucose meter
• Make sure your Transmitter is snapped in fully
• Make sure your Sensor Pod is not dislodged or peeling up
G4-Global System User’s Guide | 115
9
During use your System may detect problems that
make your Sensor unable to calculate glucose
readings (see Chapter 5, Section 5.4.3). At this time
the Sensor session will stop automatically and the
following screen will appear.
Sensor Failed Screen
9.4 CALIBRATION ERROR TROUBLESHOOTING
The screen to the right means your Sensor cannot
calibrate. If you see this screen, enter at least
1 more calibration fingerstick reading after about
10-15 minutes. If no readings are displayed after this
additional fingerstick, the Sensor may need to be
replaced.
If you clear this screen by pressing any button on the
Receiver, you will see this symbol (
) in the Status
Area.
15 Minute Calibration
Error Screen
The screen to the right tells you that the Sensor is
not calibrating correctly. If you see this screen, wait
approximately one hour. Then, enter at least 1 more
calibration fingerstick reading. If no readings are
displayed after this additional fingerstick, the Sensor
may need to be replaced.
If you clear this screen by pressing any button on
the Receiver, you will see this symbol (
) in the
Status Area.
1-Hour Calibration
Error Screen
Receiver Error Code
An error code displayed on your Receiver means the
Receiver may not be working properly. An example is
shown to the right:
Receiver Error Code
Screen
116 | Continuous Glucose Monitoring System
Note any code that may appear on the screen, and contact DexCom Technical
Support at 1-888-SEVENGO (738-3646). Continue to check blood glucose
readings using your meter.
System Recovery Check
This screen indicates that the System discovered an
error that it was able to fix itself. Press any button on
the Receiver to clear this display, and your continuous
monitoring session will continue.
System Recovery
Check Screen
9.5 RECEIVER AND CABLES TROUBLESHOOTING
Battery and Charging Difficulties
1. Remember to charge your Receiver battery.
a. The charge will last approximately 3-5 days, depending on how often you
turn on your Receiver, use the Alerts, and enter Events.
b. Make sure you are not pressing buttons by mistake if you carry the
Receiver in your pocket or bag.
c. Check the Battery image on your Trend Graphs to see how much charge is
left in the battery.
d. The Receiver takes about 3 hours to charge fully if using the wall charger,
and about 5 hours to charge fully using the USB charger.
2. Make sure the Charging Cable is fully inserted in the Receiver and in the
electrical outlet.
a. Pull the cable out carefully.
b. Only use DexCom cables.
3. If your battery drains and is not charged for a few weeks, the time and date
may be lost. When this happens, you will need to reset your Receiver’s time
and date (see Chapter 2, Section 2.3).
4. Only use the DexCom battery charger.
G4-Global System User’s Guide | 117
9
Alerts Not Working
1. Make sure you have not disabled the sound and/or vibrations for the Alerts.
Chapter 2, Section 2.5 explains how to change these Alert options.
2. Check to be sure that Advanced Features is turned on. If not, you will not
receive Rise and Fall Rate Alerts.
3. Remember “Vibe then Beep” will vibrate during the first alert and then will
beep during the re-alert. If you do not hear a sound during the first alert, this is
normal.
9.6 RECEIVER AND TRANSMITTER COMMUNICATION
TROUBLESHOOTING
This screen will appear once the Transmitter nears
the end of its battery life (see Chapter 1, Section 1.2).
Contact DexCom to order a new Transmitter.
Low Transmitter
Battery Screen
The screen to the right tells you that the Transmitter
is not working correctly. If you get this alert during
a Sensor session in progress, your Sensor session
will automatically stop. Note this alert and contact
DexCom Technical Support at 1-888-SEVENGO
(738-3646). Continue to check blood glucose
readings using your meter.
Transmitter Failed
Screen
118 | Continuous Glucose Monitoring System
chapter ten
chapt
TAKING CARE OF YOUR
G4-GLOBAL
G4-G
SYSTEM
10.1 MAINTENANCE
The G4-Global Receiver requires minimal maintenance. Keep the following tips
in mind:
Sensor and Transmitter
• Insert the Sensor only as directed.
• Snap the Transmitter completely into the Sensor Pod in the correct alignment.
• Calibrate the G4-Global Receiver every 12 hours as directed.
• Do not wear the Sensor/Transmitter in water deeper than 3 feet and do not
wear the Sensor/Transmitter in water for over 30 minutes.
• Remove the Sensor and Transmitter as directed.
• Wipe the Transmitter clean with a wet cloth or alcohol wipe between uses.
• Keep the Transmitter clean and protected when not in use.
Receiver
• Do not get the Receiver wet.
• Keep the Receiver in its carrying case or otherwise protected.
• Charge the Receiver when the battery gets low.
Accessories
• Insert cables only as directed. Only use cables intended for use with the
G4-Global Receiver. Do not force cables in place.
• Observe cables for signs of wear and tear.
• Maintain your fingerstick blood glucose meter as directed by the manufacturer.
• Only use DexCom-supplied parts (including cables and chargers). Use of other
parts might degrade safety.
G4-Global System User’s Guide | 121
10
10.2 STORAGE
Sensor
• Keep the Sensor in its sterile packaging until you are ready to use it.
• Do not insert Sensors past the expiration date printed on the Sensor
packaging.
• Storage Temperature should be 36°-77° F (2°-25° C) for the length of its shelf
life. You may store your Sensors in the refrigerator if it is within this temperature
range.
Transmitter
• Keep the Transmitter clean and protected when not in use.
• Transmitter Warranty is 6 months.
• Storage Temperature should be 32°- 113° F (0°- 45° C).
Receiver
• Keep the Receiver clean and protected when not in use.
• Receiver Warranty is 1 year.
• Storage Temperature should be 32°- 113° F (0°- 45° C).
• Store at Humidity levels between 10-95% Relative Humidity.
10.3 CLEANING AND DISINFECTING
WARNING: Review all contraindications, warnings, precautions and
detailed procedures in the User’s Guide before using the G4-Global
System.
PRECAUTION:
• Always disinfect and clean the Transmitter after removing it from the body/
patient.
• Always clean and/or disinfect the Receiver while it is DISCONNECTED
from any cables or electrical outlets.
122 | Continuous Glucose Monitoring System
NOTE:
• Always clean the Receiver and Transmitter after each use.
• Do NOT use bleach or acetone to clean the Receiver and Transmitter.
For Single-Patient Use
Cleaning
1. Use an alcohol wipe, or equivalent to clean the outside of the Receiver and
Transmitter. Avoid using wipes that contain adhesive properties. (e.g. Smith +
Nephew IV Prep™).
NOTE: Do NOT get the DexCom Receiver wet. Ensure the wipe is slightly
damp, but not wet enough to leave drops of liquid on the Receiver surface
(particularly the openings and buttons).
2. Place the Receiver and Transmitter on a clean, dry cloth and air dry for 2-3
minutes.
For Multi-Patient Use
Preparation
1. Use precaution when handling products worn by another person.
2. Wash hands thoroughly.
3. Wear personal protective equipment as appropriate (gloves, protective
goggles, gowns, etc.).
Disinfection
4. Wipe down the outer surface of each component with Steris® Coverage®
Spray TB Plus, or equivalent sterilant.
5. Allow contact time for 3 minutes at room temperature (20°C/68°F).
G4-Global System User’s Guide | 123
10
Cleaning
6. Use an alcohol wipe, or equivalent, to clean the outside of the Receiver and
Transmitter. Avoid using wipes that contain adhesive properties (e.g. Smith +
Nephew IV Prep™).
NOTE: Do NOT get the DexCom Receiver wet. Ensure the wipe is slightly
damp, but not wet enough to leave drops of liquid on the Receiver surface
(particularly the openings and buttons).
7. Verify that any signs of bodily fluids have been wiped away. The presence of
bodily fluids is rare.
8. Place the Receiver and Transmitter on a clean, dry cloth and air dry for 2-3
minutes.
9. When completely dry, place the Receiver and Transmitter in a sealed bag with
the cleaning method and date. For example:
NOTE: Include the following information in the Multi-Patient Use Disinfection
and Cleaning Record: Device Information, Date of Disinfection and Cleaning,
Method of Disinfection (e.g. disinfectant), and Method of Cleaning (e.g. 70%
or 99% IPA).
10. Dispose of gloves as biohazard waste and wash your hands immediately
after completing disinfection and cleaning of Receiver and Transmitter.
124 | Continuous Glucose Monitoring System
chapter
apter eleve
eleven
STUDY RESULTS
11.1 DEVICE PERFORMANCE
CHARACTERISTICS
Section
11.1
The
G4-Global Receiver
uses a glucose
Sensor toPivotal
continuously
measure
and
Placeholder
for G4-Global
Receiver
Study
Results
monitor your glucose levels. The Sensor is “calibrated” using your OneTouch®
Ultra® blood glucose meter (Auto Upload) or a FDA-cleared blood glucose meter
(using the OpenChoiceTM feature). Once calibrated, the G4-Global Receiver
reports glucose readings up to every 5 minutes. In a clinical study, G4-Global
Receiver readings were compared to blood glucose measurements in order
to assess its performance or how well the G4-Global Receiver measurements
compare to a laboratory method that measures blood glucose levels. Clinical
Study findings are presented below.
Although presentations to characterize performance of the G4-Global Receiver
are given below, there is no commonly accepted statistical approach for
capturing performance of continuous glucose monitors such as the G4-Global
Receiver. Performance may be best understood by viewing graphs called
“time-elapsed plots”. In these plots, the readings from the G4-Global Receiver
were recorded over time and were overlaid with readings taken at the same time
with a reference laboratory method. Three representative time-elapsed plots
are presented in this section (see Figures 2-3). They are examples of excellent,
average and poor G4-Global Receiver performance.
Participants enrolled in the clinical study and certain conditions of the study
tend to result in above average glucose control. This, in turn, may result in the
appearance that the G4-Global Receiver agrees with blood glucose levels
better than it does under typical conditions. The following are some examples of
why performance of the G4-Global Receiver might be idealized in this study.
• The average Hemoglobin A1c among the 53 participants was 7.4%. Many
people with diabetes have higher A1c levels, indicating poorer control of their
glucose levels.
• While subjects participated in the clinic portion of the study, they were more
limited in their activities than someone at home. They were also provided with
all their meals. Subjects who are more active, or with poor eating habits, may
create more challenging conditions for the G4-Global Receiver.
• Blood Glucose meters used in the study were well maintained. Because the
meter is used to calibrate the G4-Global Receiver, performance may be poorer
if the meter is not well maintained. It is important to carry out quality-control
checks on the meter and code the meter according to the manufacturer’s
instructions to optimize performance of the G4-Global Receiver.
G4-Global System User’s Guide | 127
11
Clinical Study Results
Section 11.1
ToPlaceholder
evaluate performance
of the G4-Global
Receiver,
53 participants
were
for G4-Global
Receiver
Pivotal
Study Results
enrolled in a clinical study conducted at 3 clinics. All participants had Type 1 or
Type 2 diabetes mellitus, and required insulin to manage their diabetes. About
81% of participants had Type 1 diabetes and about 19% had Type 2 diabetes.
Subjects ranged in age from 23 to 72 years old.
Participants used the G4-Global Receiver for approximately 7 days (each
participant wore 1 or 2 Sensors for 7 days.) Receivers were calibrated
approximately 2 times per day, on average, over the 7-day period using the
Lifescan® OneTouch® Ultra meter. Throughout the 7-day wear period, the
Receiver was calibrated the most on day 1, with an average of 3 fingersticks per
day (2 to start up and 1 in the evening), and was calibrated with an average of 2
fingersticks per day for days 2-7 (approximately every 12 hours).
All participants used the G4-Global Receiver in a controlled clinic environment
on Day 1, Day 4, or Day 7 of the 7-day wear period. The remainder of the study
took place at home. While using the G4-Global Receiver in the clinic 49 of
the 53 participants had their blood glucose measured every 15 minutes with
a reliable laboratory method, the Yellow Springs Instrument 2300 STAT Plus
glucose analyzer. This instrument is referred to as the “YSI.” Readings from
the G4-Global Receiver were paired with YSI readings in order to characterize
how well G4-Global Receiver results agreed with blood glucose results. For
the remainder of the study, participants used the G4-Global Receiver at home
and results were paired with OneTouch Ultra blood glucose meter results.
During Start-Up Calibration (see Chapter 4), all participants (100%) were able to
calibrate successfully after the 2 hour Start-up period. For Calibration Updates/
Re-Calibration (see Chapter 4) 97% of the time participants only needed one
attempt to update calibration. Two-percent (2%) of Calibration Updates required
a second attempt, and less than one-percent (<1%) of Calibration Updates
needed more than three attempts.
Agreement
Agreement between the G4-Global Receiver and glucose levels is
characterized using paired G4-Global Receiver and YSI results. The G4-Global
Receiver and YSI readings were compared by pairing the YSI blood glucose
reading to a G4-Global Receiver glucose reading that occurred approximately
5 minutes after the YSI reading was collected.
128 | Continuous Glucose Monitoring System
The agreement of the G4-GlobalSection
Receiver 11.1
to blood glucose levels was
assessed by calculating the percentage of G4-Global Receiver readings that
Placeholder
for G4-Global
Receiver
Pivotal
StudyFor
Results
were
within 20%, 30%,
and greater than
40% of the
YSI readings.
readings
less than or equal to 80 mg/dL the difference in mg/dL between the two glucose
readings was calculated. For readings greater than 80 mg/dL the percent
difference (%) from the YSI reading was calculated. The percentages of total
readings within 20 mg/dL or 20%, 30 mg/dL or 30%, or greater than 40 mg/dL
or 40% were then calculated. The total number of data pairs considered in this
analysis was 1,827. Results are shown in Table 1.
Table 1. Percentage of G4-Global Receiver Results Falling Within 20, 30,
and Greater Than 40 Percent of the Paired YSI Results, at Various Glucose
Concentrations
YSI
Readings
(mg/dL)
Number
of Paired
Readings
% of
G4-Global
Receiver
Readings
Within 20%*
% of
G4-Global
Receiver
Readings
Within 30%*
% of
G4-Global
Receiver Readings
Greater than
40%* of YSI
40-400
1827
76%
90%
5%
40-80
277
73%
87%
6%
81-180
801
74%
89%
5%
181-300
563
81%
93%
3%
301-400
186
75%
95%
2%
* For the 40-80 mg/dL range the absolute difference is presented as the difference in
mg/dL between the G4-Global Receiver and YSI, rather than the percent.
The G4-Global Receiver reports glucose concentrations between 40 and
400 mg/dL. When the G4-Global Receiver determines the glucose level is
below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the
G4-Global Receiver determines that the glucose level is above 400 mg/dL,
it displays “HIGH” in the Receiver Status Box. The ability of the G4-Global
Receiver to accurately report these occurrences is assessed by looking at the
actual blood glucose concentrations (as determined by the YSI analyzer) when
“LOW” or “HIGH” are reported.
G4-Global System User’s Guide | 129
11
• On 19 occasions, the G4-Global
Receiver11.1
indicated the glucose reading was
Section
less than 40 mg/dL and displayed “LOW”. Of these, the YSI blood glucose
Placeholder
forbelow
G4-Global
Results
readings
were never
40 mg/dLReceiver
and rangedPivotal
betweenStudy
43 mg/dL
up to 141
mg/dL.
• On 39 occasions, the G4-Global Receiver indicated the glucose reading
was greater than 400 mg/dL and displayed “HIGH”. Of these, the paired YSI
glucose reading was also above 400 mg/dL twelve (12) times. When the
G4-Global Receiver read more than 400 mg/dL, the range of the YSI blood
glucose readings at that time was 264-438 mg/dL.
LOW AND HIGH GLUCOSE ALERTS
The ability of the G4-Global Receiver to detect high and low glucose levels
(concentrations) is assessed by comparing G4-Global Receiver results to YSI
results at low and high blood glucose levels and determining if the alert may
have sounded. The G4-Global Receiver and YSI readings were compared by
pairing the G4-Global Receiver reading that occurred approximately 5 minutes
after the YSI reading was collected. There were 1,827 pairs of paired G4-Global
Receiver and YSI results evaluated. 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 the table on the next page. For example, the data in the table shows that if
you set the Low Glucose Alert to 70 mg/dL, the G4-Global Receiver will alert
you of a blood glucose measurement of 70 mg/dL or lower 57% of the time
within 5 minutes of reaching that blood glucose level (True Alert Rate). The table
also shows that at the same Alert setting (70 mg/dL), the Low Alert may not
alert you 44% of the time (“Missed Alert Rate***”) within 5 minutes of the blood
glucose reading. Also at the 70 mg/dL alert level, 46% of the time the G4-Global
Receiver may falsely alert you that your glucose level is at or less than 70 mg/dL
when your actual blood glucose level is above 70 mg/dL.
If you set the Low Glucose Alert to 90 mg/dL, the G4-Global Receiver should
alert you 73% of the time within 5 minutes of when your glucose levels are at
or below 90 mg/dL. The table also shows that at the same Alert setting (90 mg/
dL), the Low Alert may not alert you within ~5 minutes of the low blood glucose
event 27% of the time (“Missed Alert Rate***”).
130 | Continuous Glucose Monitoring System
Also at the 90 mg/dL alert level, Section
25% of the11.1
time the G4-Global Receiver may
falsely alert you that your glucose level is at or less than 90 mg/dL when your
Placeholder
forreading
G4-Global
actual
blood glucose
is aboveReceiver
90 mg/dL atPivotal
that time.Study Results
G4-Global System User’s Guide | 131
11
Section
Table 2. Hypoglycemic Alert Evaluation
11.1
Placeholder
for G4-Global
Study
Results
G4-Global
True Alert Receiver
False Pivotal
Alert
Missed
Alert
Receiver
Alert Level
Rate*
Rate**
Rate***
60 mg/dL
59 %
61 %
41%
70 mg/dL
57%
46 %
44 %
80 mg/dL
64 %
29 %
36 %
90 mg/dL
73 %
25 %
27 %
* True Alert Rate is the % of time when the blood glucose level was at or below the alert
setting and the alert sounded.
** False Alert Rate is the % of time when the device alarmed but the blood glucose level
was above the alert setting.
*** Missed Alert Rate is the % of time when the device failed to alarm when the blood
glucose level was at or below the alert setting.
The High Glucose Alert
Estimates of how well the adjustable High Glucose Alert performs are
presented in the table below. For example, if you set the High Glucose Alert
to 200 mg/dL, the G4-Global Receiver should alert you 81% of the time within
5 minutes when your blood glucose levels rise above 200 mg/dL (True Alert).
Additionally, 7% of the time when the alert sounds, the glucose level may
actually be below 200 mg/dL (False Alert) at this time.
132 | Continuous Glucose Monitoring System
Section
Table 3. Hyperglycemic Alert Evaluation
11.1
Placeholder for G4-Global Receiver Pivotal Study
Results
Missed
Alert
Alert Setting
True Alert Rate*
False Alert Rate**
140 mg/dL
92 %
6%
8%
180 mg/dL
84 %
6%
16 %
200 mg/dL
82 %
7%
18 %
220 mg/dL
80 %
8%
20 %
240 mg/dL
77 %
8%
23 %
300 mg/dL
59 %
27 %
41 %
Rate***
* True Alert Rate is the % of time when the blood glucose level was at or above the alert
setting and the alert sounded.
** False Alert Rate is the % of time when the device alarmed but the blood glucose level
was below the alert setting.
*** Missed Alert Rate is the % of time when the device failed to alarm when the blood
glucose level was at or above the alert setting.
Performance of High and Low Glucose Alerts at night comparing the
G4-Global Receiver to YSI data has not been established with the G4-Global
Receiver Sensor. During use of the G4-Global Receiver at home, the High
Alert was set to 200 mg/dL and the Low Alert was set to 80 mg/dL. Subjects
were asked to take a fingerstick each time a high or low glucose alert sounded.
The G4-Global Receiver and Meter readings were compared by pairing the
G4-Global Receiver reading that occurred on average 5 minutes after the
fingerstick meter reading was taken during home use. Analysis of the home
use data showed that when the G4-Global Receiver was above 200 mg/dL,
77% of the OneTouch Ultra meter readings were above 200 mg/dL (True High
Alert). When the G4-Global Receiver read below 80 mg/dL, 73% of the time the
OneTouch Ultra readings were below 80 mg/dL (True Low Alerts).
The G4-Global Receiver notified the subject that their glucose levels were
falsely below the Low Alert level 27% of the time and notified the subject that
their glucose levels were falsely above the High Alert level 23% of the time.
G4-Global System User’s Guide | 133
11
Section 11.1
Accuracy
between for
matched
pairs wasReceiver
also estimated
by calculating
the percent
Placeholder
G4-Global
Pivotal
Study Results
Accuracy
difference between the G4-Global Receiver reading and the YSI reading. The
G4-Global Receiver and YSI readings were compared by pairing the G4-Global
Receiver reading that fell approximately 5 minutes after the YSI reading was
collected. For example, if the YSI reading is 100 mg/dL and the G4-Global
Receiver reading is 90 mg/dL, a 10% difference between the G4-Global
Receiver and the YSI Laboratory machine is reported.
In the above example the G4-Global Receiver reading is less than the YSI
reading and so the percent difference reading is negative. The mean percent
difference is the average of all of the positive and negative percent differences
between the two devices compared and, therefore, tells you if the G4-Global
Receiver on average reads higher or lower than the YSI at each glucose range.
Another estimate used to tell you the accuracy of the G4-Global Receiver is
the absolute percent difference. The absolute percent difference tells you the
overall percent difference or “distance” between the G4-Global Receiver and
YSI readings, but does not tell you if the G4-Global Receiver 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 G4-Global Receiver readings and YSI readings. These accuracy
measures are summarized in Table 4 below and are based on 1,827 paired
glucose measurements:
Table 4. G4-Global Receiver and YSI Blood Glucose Accuracy by Glucose
Concentration
Glucose
Range
(mg/dL)
Number
of Paired
Readings
Mean
Percent
Difference
Median
Percent
Difference
Mean
Absolute
Percent
Difference
Median
Absolute
Percent
Difference
Overall
(40-400
mg/dL)
1827
-1%
-3%
16%
13%
40-80
277
13%
12%
25%
20%
81-180
801
-1%
-2%
15%
13%
181-300
563
-6%
-7%
13%
12%
301-400
186
-9%
-9%
13%
10%
134 | Continuous Glucose Monitoring System
Section
11.1 reads 13% higher than the
Table 4 shows that the G4-Global Receiver,
on average,
YSI at glucose levels of 40-80 mg/dL and reads 9% lower, on average, than the YSI at
Placeholder for G4-Global Receiver Pivotal Study Results
glucose concentrations of 301-400 mg/dL (Mean Percent Difference). The G4-Global
Receiver reads, on average, 25% different than the YSI at glucose levels of
40-80 mg/dL and, on average, 13% different than the YSI readings at glucose levels of
301-400 mg/dL (Mean Absolute Percent Difference). The Median Percent Difference
shows that 50% of the time the G4-Global Receiver reads approximately 3% less than
the YSI System and the Median Absolute Difference shows that 50% of the time the G4Global Receiver reads about 13% different then YSI blood glucose readings taken within
5 minutes.
Table 5. Clarke Error Grid Analysis
The Clarke Error Grid was used to determine if G4-Global Receiver results
are “clinically accurate.” The Clarke Error Grid divides a correlation plot into 5
zones, which are described in the table below.
Zone
Description
Clinically Accurate, would lead to correct treatment decisions
Would lead to benign decisions or no treatment
Would lead to overcorrection of normal glucose levels
Would lead to failure to be aware of and treatment of high or low glucose
levels
Would lead to inaccurate and “dangerous” treatment decisions
Results in zones A and B are considered “clinically acceptable”, in which you would most
likely make accurate treatment decisions or decide not to do treatment with the readings
provided, while results in zones C, D, and E can lead to dangerous treatment errors. The
Clarke Error Grid zones are labeled on a correlation plot in Figure 1. Each YSI result (on
the horizontal axis) is matched up with its corresponding G4-Global Receiver result (on
the vertical axis). A point is recorded where the two readings intersect. These results are
based on 1,827 paired data points recorded.
G4-Global System User’s Guide | 135
11
Figure 1.
Section 11.1
Clarke Error Grid, G4-Global Receiver Results Compared to YSI Results
Placeholder for G4-Global Receiver Pivotal Study Results
Point Error Grid Regions for All Site
The percentage of G4-Global Receiver results in the above graph are presented in
Table 6 on the next page according to the percentage of points falling within each zone
(A-E). Results are further broken down (stratified) according to the range of glucose
concentration.
YYY
YSI Reading
•••
G4-Global Receiver Glucose Reading
YYY
YSI Reading
•••
G4-Global Receiver Glucose Reading
136 | Continuous Glucose Monitoring System
Section 11.1
Placeholder for G4-Global Receiver Pivotal Study Results
YYY
YSI Reading
•••
G4-Global Receiver Glucose Reading
Table 6. Clarke Error Grid Analysis, Stratified by YSI Glucose Concentrations
Glucose Range
(mg/dl)
Total YSI –
G4-Global
Receiver Pairs
40-400
1,827
73%
23%
0%
4%
0%
40-80
277
57%
22%
0%
21%
0%
81-180
801
73%
27%
0%
N/A*
N/A*
181-300
563
81%
17%
0%
2%
0%
301-400
186
75%
23%
N/A*
2%
0%
* N/A means that the Clarke Error Grid does not consider the possibility of these zones in
that glucose range.
G4-Global System User’s Guide | 137
11
The Continuous Error Grid was also
used to11.1
determine if the G4-Global Receiver
Section
results are “clinically acceptable.” The Continuous Error Grid looks at how closely
for G4-Global
Receiver
Study
thePlaceholder
G4-Global Receiver
readings match
to the YSI Pivotal
Analyzer and
alsoResults
how closely
the G4-Global Receiver glucose rate of change (how fast the glucose rises or
falls) compares to the actual blood glucose rate of change measured by the YSI.
The data is evaluated in 3 zones: clinically accurate readings, benign errors, and
clinically inaccurate readings. See the table below for the G4-Global Receiver
accuracy by glucose range. There were 1,827 paired points evaluated.
Table 7. Continuous Error Grid Combined Point and Rate Rating Table
Hypoglycemia
(YSI<= 70 mg/dL)
(8% of the data)
Euglycemia
(70< YSI <=180 mg/dL)
(51% of the data)
Hyperglycemia
(YSI >180 mg/dL)
(41% of the data)
Accurate
Readings
61%
97%
94%
Benign Errors
1%
2%
2%
Inaccurate
Readings
39%
1%
5%
138 | Continuous Glucose Monitoring System
Calibrations Stability
Section 11.1
The
G4-Global Receiver
must be calibrated
every 12
hours. Study
To demonstrate
Placeholder
for G4-Global
Receiver
Pivotal
Results
performance of the G4-Global Receiver over a 12-hour calibration period, 71
Sensors were evaluated to verify that performance remains consistent over
the 12-hour calibration period. G4-Global Receivers were evaluated in 3-hour
increments after calibration. Performance was estimated at each 3-hour interval
and stratified by glucose concentrations by calculating the percentage of
G4-Global Receiver readings within 20%, 30% and greater than 40% of the YSI
readings. See the table below.
Table 8. Percentage of G4-Global Receiver readings within 20%, 30% and
40% of the YSI Laboratory reading with data stratified in 3-hour increments
after calibration across days 1, 4 and 7.
Time from
Calibration
and YSI
Glucose Range
(40-400 mg/dL)
Number
of Paired
Readings
% of
Readings
within 20%
of YSI
% of
Readings
within 30%
of YSI
% of
Readings
within 40%
of YSI
0-3 hours
1031
77%
91%
96%
3-6 hours
345
75%
91%
96%
6-9 hours
235
71%
88%
94%
9-12 hours
187
77%
88%
91%
G4-Global System User’s Guide | 139
11
Sensor Stability
Section 11.1
Sensors
can be worn
up to 7 days.Receiver
To verify thatPivotal
sensors Study
perform Results
consistently
Placeholder
forforG4-Global
over the 7-day period, 71 Sensors were evaluated across the 7-day wear
period. Performance was estimated by calculating the percentage of G4-Global
Receiver readings within 20%, 30% and >40% of the YSI readings at the
beginning (Day 1), middle (Day 4) and end (Day 7) of the G4-Global Receiver
lifecycle. Results are shown in the table below.
Table 9. G4-Global Receiver System Sensor Stability (Accuracy Over Time)
Day of Wear
(40-400
mg/dL)
Number
of Paired
Readings
% of Readings
within 20%
of YSI
% of Readings
within 30%
of YSI
% of Readings
within 40%
of YSI
Day 1
637
77%
91%
3%
Day 4
635
80%
94%
3%
Day 7
533
70%
86%
8%
Precision of G4-Global Receiver System Readings
In the same study, 18 of the subjects wore two G4-Global Receiver’. This was
done to look at how similarly two G4-Global Receiver’ on the same person
function (Sensor Precision). Precision was evaluated by comparing the glucose
readings from the two G4-Global Receiver’ worn on the same subject at the
same time. Results showed that G4-Global Receiver readings from the two
sensors generally agreed with each other within 15%.
140 | Continuous Glucose Monitoring System
Sensor Life
Section 11.1
During
the trial there
no Sensor insertion
problems
andStudy
SensorsResults
may be
Placeholder
forwere
G4-Global
Receiver
Pivotal
worn for up to 7 days (168 hours). To estimate how long a G4-Global Receiver
Sensor will work over 7 days, the 71 Sensors were evaluated to determine how
many Days (hours) of readings each Sensor provided. Table 10, below, displays
how long you can expect a Sensor to last after insertion. For example, 89% of
the sensors lasted more than 6 and up to the full 7 days (144-168 hours).
Table 10. Estimated G4-Global Receiver Sensor Life
Number of Days of Use (Hours)
Percentage of Sensors
1 (24 hours)
1%
2 (48 hours)
1%
3 (72 hours)
6%
4 (96 hours)
0%
5 (120 hours)
0%
6 (144 hours)
3%
7 (168 hours)
89%
There were 6 Sensors that did not last at least 6 days or more than 144 hours.
Five (5) of those sensors became non-functional due to an Early Sensor
Shut-off, and 1 Sensor ended before 6 days because the subject bumped the
Sensor and it fell off.
G4-Global System User’s Guide | 141
11
Number of Readings Provided
Section
11.1
The
G4-Global Receiver
is capable of Receiver
providing a reading
to everyResults
5 minutes,
Placeholder
for G4-Global
PivotalupStudy
or up to 288 readings per day. For a variety of reasons, this does not always
happen. Sometimes sensors cannot provide readings after calibration and
readings are “skipped” (see Chapter 5). Table 11, below, estimates the number
of readings you can expect to receive from the G4-Global Receiver over the
entire 7-day period. For example, 87% of G4-Global Receiver devices provided
between 1,557 and 1,992 readings (or at least 76% of the expected number of
readings).
Table 11. Number of Readings Provided by Each Sensor Over 7-Days
% of Total Possible
Readings Provided
Total
Readings
Provided
% of G4-Global Receiver Devices
Providing that number of readings
0-25%
261
1%
26-50%
521-782
7%
51-75%
1005-1477
4%
76-100%
1557-1992
87%
Approximately 7% of readings were lost because the Transmitter and Receiver
were not communicating. Approximately 1% of the time the G4-Global Receiver
required additional calibration readings to start displaying glucose readings
again. Over 7 days of use, on average, subjects experienced 3 periods of time
where the Receiver could not display glucose readings and displayed “???”
instead. These periods lasted on average for 1 hour. A small percentage of
subjects (<10%) experienced a period of missing glucose readings (or “???”)
for more than 4 hours. However, per the Sensor Life data above, 89% of the
Sensors were able to “recover” from these periods of signal problems and begin
displaying continuous glucose readings again.
142 | Continuous Glucose Monitoring System
Time-Elapsed Plots
Section 11.1
Examples
of G4-Global
Receiver Continuous
Glucose
Monitoring
System
Placeholder
for G4-Global
Receiver
Pivotal
Study
Results
overlaid with the corresponding YSI readings over time are presented on the
next page. The horizontal axis represents time, with the matching
G4-Global Receiver and YSI readings plotted above the point in time when the
measurements were taken. The circles (•) on the graph represent the G4-Global
Receiver data. The “Y” represents the YSI reading.
There are three Figures presented. Figure 2 is an example of when the
G4-Global Receiver performed well, Figure 3 represents a period when the
G4-Global Receiver performed in an average manner, and Figure 4 represents
when the G4-Global Receiver performed poorly.
Figure 2. Example of “Good” G4-Global Receiver Performance
G4-Global System User’s Guide | 143
11
Figure 3. Example of “ Average”Section
G4-Global11.1
Receiver Performance
Placeholder for G4-Global Receiver Pivotal Study Results
Figure 4. Example of “Poor” G4-Global Receiver Performance
144 | Continuous Glucose Monitoring System
11.2 PRODUCT SPECIFICATIONS
Sensor
Glucose Range
40-400 mg/dL (2.2 – 22.2 mmol/L)
Sensor Life
Up to 7 days
Calibration
FDA-cleared blood glucose meter
Calibration Range
40-400 mg/dL (2.2 – 22.2 mmol/L)
Operational
Conditions
Humidity: Maximum 95 % Relative
Storage
Condition
Temperature: 2°-25° C (36°-77° F)
Moisture
Protection
IPX 5: water resistance to jetting water
Sterilization
Sterile by radiation
IPX 8: temporary submersion to a depth
of 8 feet (2.44 meters) for 24 hours
G4-Global System User’s Guide | 145
11
Transmitter
Dimensions
(including
Sensor Pod)
Length: 1.5 inches (3.8 cm)
Width: 0.9 inches (2.3 cm)
Thickness: 0.5 inches (1.3 cm)
Weight (including
Sensor Pod)
0.4 ounces (10 grams)
Communication
Range
20 ft (6m)
Frequency Range
2.425 - 2.477 GHz
Power Supply
Silver Oxide Batteries
Operational
Conditions
Temperature: 10°- 42° C (50°- 108° F)
Storage
Conditions
Temperature: 0°- 45° C (32°- 113° F)
Limited Warranty
6 months
Moisture
Protection
IPX 5: water resistance to jetting water
Protection Against
Electrical Shock
Type B Applied Part
Humidity: Maximum 95% Relative
IPX 8: temporary submersion to a depth of
8 feet (2.44 meters) for 24 hours
146 | Continuous Glucose Monitoring System
PARAMETER
PERFORMANCE CHARACTERISTICS
Frequency Allocation
2.4 GHz ISM Band
TX/RX Frequencies
2.424 999 877 GHz
2.449 993 677 GHz
2.474 737 539 GHz
2.477 236 919 GHz
Bandwidth
270.833 kHz
Maximum Output Power
1.25 mW EIRP
Modulation
Minimum Shift Key
Data Rate
49.987 Kbits/Sec
Total Packet
224 bits
Transmit Duty Cycle
4.48 ms every 5 minutes at each of the
four TX frequencies.
Data Detection Range
20 ft (6m)
Average Number of Collisions due to
Coexistence. 20 DexCom Transmitters
within 20 feet over a 24 hr period (288
transmissions each)
Total of 2 collisions, if collision occurs, no
glucose value is received
G4-Global System User’s Guide | 147
11
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The Transmitter is intended for use in the electromagnetic environment specified
below. The customer or the user of the Transmitter should assure that it is used
in such an environment
Immunity Test
IEC 60601 Test Level
Transmitter
Compliance
Level
Electromagnetic
Environment
Guidance
Electromagnetic
Environment
Guidance
Electrostatic
Discharge (ESD)
± 6 kV Contact
± 6 kV Contact
± 8 kV Air
± 8 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 %
Electrical Fast
Transient /burst
± 2 kV for power
supply lines
Not
Applicable-
IEC 61000-4-4
± 1 kV for input/output
lines
Battery
Operated
Surge
± 1 kV
differential mode
Not
Applicable-
± 2 kV
common mode
Battery
Operated
Voltage
Dips, Short
Interruptions
and Voltage
Variations on
Power Supply
Input Lines
< 5 % UT (>95 % dip
in UT) for 0.5 cycle
Not
Applicable-
40 % UT (60 % dip in
UT) for 5 cycles
Battery
Operated
IEC 61000-4-11
< 5% UT (>95% dip in
UT) for 5 sec
Power
Frequency
3 A/m
IEC 61000-4-2
IEC 61000-4-5
70 % UT (30 % dip in
UT) for 25 cycles
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
148 | Continuous Glucose Monitoring System
3 A/m
Power Frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment
Receiver
Reading Frequency
Every 5 minutes
Dimensions
Length: 4.5 inches (11.4 cm)
Width: 2.3 inches (5.8 cm)
Thickness: 0.85 inches (2.2
cm)
Weight
4.0 ounces (113.39 g)
Communication Range
20 ft (6m)
Memory Storage
30 days of user data,
7 days of tech support
Re-Chargeable Battery Use
3 to 5 days
Charging Time
3 hours wall outlet,
5 hours USB
Storage/Operating
Conditions
Temperature: 0°- 45° C
(32°- 113° F)
Humidity: 10-95 %
Relative
Operating Pressure
10.2 to 21.8 psi
Moisture Protection
None
Limited Warranty
1 year
G4-Global System User’s Guide | 149
11
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
The Receiver is intended for use in the electromagnetic environment specified
below. The customer or the user of the Receiver should assure that it is used in
such an environment.
Immunity Test
IEC 60601 Test
Level
Receiver
Compliance
Level
Electromagnetic
Environment Guidance
Electromagnetic
Environment
Guidance
Electrostatic
Discharge (ESD)
± 6 kV Contact
± 6 kV Contact
± 8 kV Air
± 8 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%
Electrical Fast
Transient /burst
± 2 kV for power
supply lines
± 2 kV for power
supply lines
IEC 61000-4-4
± 1 kV for input/
output lines
± 1 kV for input/
output lines
Surge
± 1 kV
differential mode
± 1 kV
differential mode
± 2 kV
common mode
± 2 kV
common mode
< 5 % UT
(>95 % dip in
UT) for 0.5 cycle
< 5 % UT
(>95 % dip in
UT) for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
< 5% UT
(>95% dip in UT)
for 5 sec
< 5% UT
(>95% dip in UT)
for 5 sec
IEC 61000-4-2
IEC 61000-4-5
Voltage
Dips, Short
Interruptions and
Voltage Variations
on Power Supply
Input Lines
IEC 61000-4-11
150 | Continuous Glucose Monitoring System
Main power quality
should be that of a typical
commercial or hospital
environment
Main power quality
should be that of a typical
commercial or hospital
environment
Main power quality
should be that of a typical
commercial or hospital
environment
Immunity Test
IEC 60601 Test
Level
Receiver
Compliance
Level
Electromagnetic
Environment Guidance
Power Frequency
3 A/m
3 A/m
Power Frequency
magnetic fields should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
Note: UT is the a.c. main voltage prior to application of the test level
Guidance and Manufacturer’s Declaration- Electromagnetic Immunity
The Receiver is intended for use in the electromagnetic environment specified
below. The customer or the user of the Receiver should assure that it is used in
such an environment.
Electromagnetic Environment Guidance
Portable and mobile RF communications equipment should be used no closer to any
part of the Receiver, including cables than the recommended separation distance
calculated from the equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d =1.2 P1/2
d = 1.2 P1/2
80 MHz to 800 MHz
d = 2.3 P1/2
800 MHz to 2.5 GHz
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people
G4-Global System User’s Guide | 151
11
Immunity Test
Conducted RF
IEC 61000- 4-6
Radiated
RF
IEC 61000-4-3
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
3 Vrms
150 k Hz to
80 MHz
3V
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).
3 V/m
80 MHz to
2.5 GHz
3 V/m
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site surveya
should be less than the compliance
level in each frequency rangeb.
Interference may occur in the vicinity
of equipment marked with
following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
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
measure field strength in the location in which the Receiver is used exceeds
the applicable RG compliance level above, the Receiver should be observed
to verify normal operation. If abnormal performance is observed, additional
measures may be necessary such as reorienting or relocating the Receiver.
b. Over the frequency range 150 KHz to 80 MHz, field strengths should be less
than 3 V/m.
152 | Continuous Glucose Monitoring System
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and 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 below, according to the
maximum output power of the communications equipment.
Rated maximum
Output Power of Transmitter (W)
0.01
0.1
10
100
Separation Distance
According to Frequency of Transmitter (m)
150 kHz to
80 MHz
d = 1.2 P1/2
80 MHz to
800 MHz
d = 1.2 P1/2
800 MHz to
2.5 GHz
d = 2.3 P1/2
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance in meters (m) 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
manufacture.
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
propagation is affected by absorption and reflection from structures,
objects and people.
Charging Cable*
AC Input
110-240 V, 50-60 Hz
Length
6.6 FT (2 M)
* There is a separate USB cable and USB power supply.
G4-Global System User’s Guide | 153
11
11.3 FCC REQUIREMENTS
The Transmitter covered by this User’s Guide has been certified under FCC ID:
PH29433
Although the Transmitter has been approved by the Federal Communications
Commission, there is no guarantee that it will not receive interference or that any
particular transmission from the Transmitter will be free from interference.
Compliance Statement (Part 15.19)
This device complies with Part 15 of the FCC Rules.
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.
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.
154 | Continuous Glucose Monitoring System
chapter
hapter twelve
APPENDIX
APPENDIX I, OTHER ALERTS
This table describes the Other Alerts, how to clear them and when you will be
re-alerted by the Receiver.
Screen
Alert Title
Description
Re-Alert
Clearing
Alerts
ReAlert
After
Clear
Low Battery
The Receiver
battery is
low. Charge
your Receiver
as soon as
possible when
you see the
Low Battery
Alert.
2 times
in the
next 10
minutes
Press any
Receiver
button
Every
60
minutes
Single
Blood Drop
Prompt
The Receiver
needs a
calibration
fingerstick
reading. Take
a fingerstick
reading and
enter it into the
Receiver.
None
Press any
Receiver
button
Every
15
minutes
Double
Blood Drop
Prompt
You must enter
two additional
fingerstick
readings
for Startup
Calibration.
Every 5
minutes
Press any
Receiver
button
Every
15
minutes
Additional
Blood Drop
Prompt
You must enter
one additional
fingerstick
reading
for Startup
Calibration.
Every 5
minutes
Press any
Receiver
button
Every
15
minutes
G4-Global System User’s Guide | 157
12
Screen
Alert Title
Description
Re-Alert
Clearing
Alerts
Re-Alert
After
Clear
Wait 15
minutes to
calibrate
The Sensor is
not calibrating
properly (see
Section 8.4,
“Error Code
Troubleshooting
for instructions
on what to do
is you see this
screen).
Every 5
minutes
Press any
Receiver
button
Every 15
minutes
until you
fix the
problem,
or your
glucose
level
changes
enough
to fix the
problem
itself
Your Sensor
session will
soon expire,
and you will
need to change
your Sensor
soon. There
will be no
sound when
the 6-hour and
2-hour screens
display. The
30-minute
screen will be
set to your
“Other Alert”
options.
None for
6-hour and
2-hour.
Press any
Receiver
button
None
The Sensor
session is
complete. You
should change
your Sensor at
this time.
2 times
in the
next 10
minutes
Press any
Receiver
button
None
Wait 1 Hour
to calibrate
Sensor
Expiration
Sensor
Expiration
158 | Continuous Glucose Monitoring System
2 times
in the
next 10
minutes
for
30-minute
Screen
Alert Title
Description
Re-Alert
Clearing
Alerts
ReAlert
After
Clear
Sensor
Failed
The Sensor
is not working
properly (see
Section 8.3,
“Sensor Failed
Troubleshooting”).
2 times
in the
next 10
minutes
Press any
Receiver
button
None
Receiver
Error
There is a
problem with
the Receiver.
Write down
the code on
the screen,
and contact
DexCom.
None. The
Receiver
will beep
and
vibrate for
5 seconds
and then
will be
silent.
Cannot
clear alert
None
System
Recovery
There was a
problem with
the Receiver,
but it was able
to fix itself.
Every 5
minutes
Press any
Receiver
button
None
Time Loss
The Receiver
backup battery
has drained,
and you will
need to reset
the Receiver
time and date.
The Time
Loss Alert
automatically
takes you to
the Time/Date
Setting screen.
None
Enter the
time and
date
None
G4-Global System User’s Guide | 159
12
APPENDIX II, RECEIVER SCREENS & PROMPTS
The following prompt screens may appear on the Receiver during use:
DOUBLE BLOOD DROP PROMPT: Appears about 1 hour after you
insert a new Sensor, and tells you that you need to take 2 fingerstick
readings on your meter and enter them for calibration.
DOUBLE BLOOD DROP PROMPT, (1 CHECKED): This tells you
that only 1 fingerstick reading has been successfully entered. You
need to take at least 1 more fingerstick reading on your meter and
enter it for calibration.
SINGLE BLOOD DROP PROMPT: This screen appears during
Calibration Update or Re-Calibration. This means it is time for you to
take a fingerstick reading on your meter and enter it into the Receiver.
Only enter fingerstick readings if the Single Blood Drop Symbol
or
your current glucose reading is displayed on the Trend Graph. Do not
enter any fingerstick readings if
or
appear in the upper
right corner of the Trend Graph.
RECEIVER LOW BATTERY NOTIFICATION: Your Receiver battery
is running low and needs to be recharged. Charge the battery as
soon as possible.
ENTER BG PROCESSING SCREEN: The meter reading that you
entered is being processed for calibration by the Receiver.
HIGH GLUCOSE ALERT: Your glucose reading is at or above the
High Glucose Alert level you set.
LOW GLUCOSE ALERT: Your glucose reading is at or below the
Low Glucose Alert level you set.
160 | Continuous Glucose Monitoring System
LOW GLUCOSE ALARM: Your System reading is at or below the
factory Low Glucose ALARM level (55 mg/dL). You cannot change
this ALARM level.
RISE ALERTS: Either the Rise Alert or Rapid Rise Alert may appear,
depending on the Rise Alert level you set.
Rise Alert: Your glucose levels are rising at 2 mg/dL per minute or
more.
OR
Rapid Rise Alert: Your glucose levels are rising fast at 3 mg/dL per
minute or more.
FALL ALERTS: Either the Fall Alert or the Rapid Fall Alert may
appear, depending on the Fall Rate Alert level you set.
Fall Alert: Your glucose levels are falling at 2 mg/dL per minute or
more.
OR
Rapid Fall Alert: Your glucose levels are falling fast at 3 mg/dL per
minute or more.
OUT OF RANGE ALERT: The Transmitter and Receiver are not
talking and you will not receive glucose readings.
SENSOR FAILED SCREEN: The Sensor is not working. You will
need to replace the Sensor at this time.
TIME/DATE LOSS ALERT: The Receiver backup battery is drained,
so you need to reset the Receiver time and date. The Time Loss Alert
will automatically take you to the Time/Date Setting Screen.
If you were in the middle of a Sensor Session, this Alert will end your
session. You must recharge the Receiver battery. Then, you must set
the correct date and time and start a new session.
G4-Global System User’s Guide | 161
12
OUT OF RANGE/NO ANTENNA: The Receiver and Transmitter
are not talking and your glucose readings have not been sent to the
Receiver in the last 5 minutes. If you see this screen (with no Antenna
in the upper left hand corner) you should make sure the
Symbol
Receiver and Transmitter are within 20 feet (6m) of each other. See
Chapter 8 for Troubleshooting.
UNKNOWN SENSOR GLUCOSE READINGS:
appears in the
upper right corner of the Trend Graph. The Sensor is sending glucose
readings that the Receiver does not understand.
15 MINUTE CALIBRATION ERROR: The Sensor cannot calibrate.
If you see this screen, enter at least 1 more fingerstick reading for
calibration after about 10-15 minutes. If no glucose readings appear
on the Receiver, the Sensor needs to be replaced.
1 HOUR CALIBRATION ERROR: The Sensor is not calibrating
correctly. If you see this screen, wait approximately 1 hour and
then enter at least 1 more fingerstick reading for calibration. If no
glucose readings appear up on the Receiver, the Sensor needs to be
replaced.
WAIT: The Single Hourglass Symbol
in the upper right hand
corner means the Receiver has detected a potential problem with the
Sensor signal. You should wait about 30 minutes for more prompts.
Do not enter any fingerstick readings for calibration when you see this
symbol.
ERROR CODE: The Receiver may not be working correctly. If you
see this code, write the code down for troubleshooting and use your
meter to check your blood glucose readings.
SYSTEM RECOVERY: The Receiver discovered an error that it was
able to fix itself. Press any Receiver button to clear this display. Your
Sensor session will continue.
6-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor
session will end in 6 hours.
162 | Continuous Glucose Monitoring System
2-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor
session will end in 2 hours.
30-MINUTE SENSOR EXPIRATION NOTIFICATION: Your Sensor
session will end in 30 minutes.
0-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor
session has ended. Once you clear the Alert, your Receiver will be
notified that the Sensor has been removed. You should clear this
notification by pressing any Receiver button, then remove your
Sensor at this time.
G4-Global System User’s Guide | 163
12
GLOSSARY
The following list of terms will help you while reading though this guide:
Alternative Site
Testing (BG)
This is when you obtain a glucose reading on your meter using
a blood sample from an area on your body other than your
fingertip. Do not use alternative site testing for entering blood
glucose readings into the G4-Global Receiver.
Applicator
A disposable component piece that comes attached to the
Sensor Pod, and inserts the Sensor Probe under the skin. There
is a needle inside the Applicator that you remove once you have
inserted the Sensor Probe.
BG meter
Blood Glucose meter. You can use any FDA-cleared meter
for obtaining fingerstick readings to enter into your G4-Global
Receiver.
BG reading
Blood Glucose reading. A fingerstick blood glucose reading
taken with your FDA-cleared blood glucose meter.
Calibration
This is when you enter fingerstick readings from a blood glucose
meter into the G4-Global Receiver. Calibrations are needed for
your G4-Global Receiver to display continuous glucose readings
and trend information. (Do not use alternative site testing for
calibration.)
Default
A setting that is selected automatically unless another option is
chosen.
FDA-cleared
System
The product has met the U.S. Food and Drug Administration’s
standards and may be sold legally in the United States.
G4-Global System
The Sensor, Transmitter, and Receiver.
G4-Global Reading
A glucose reading shown on your Receiver. This reading is
given in mg/dL units and is updated every 5 minutes.
Glucose Data Gaps
This can happen when the Receiver does not display a glucose
reading that is sent from the Transmitter. A symbol will appear
instead of a glucose reading to let you know that the Receiver
cannot display a reading.
Glucose Trends
Trends let you see the pattern of your glucose levels; you can
see where your glucose levels have been and where your
glucose levels are headed. The G4-Global Receiver displays
five glucose Trend Graphs: the 1-Hour, 3-Hour, 6-Hour, 12-Hour,
and 24-Hour Graphs. Each Trend Graph shows glucose trends
over the amount of time shown on the screen.
164 | Continuous Glucose Monitoring System
mg/dL
Milligrams per deciliter. The standard unit of measure for
glucose readings in the United States.
Range
The distance between the Receiver and Transmitter. Keep the 2
devices within 20 feet (6 meters) from each other to get glucose
information on your Receiver
Rise and Fall
(Rate of Change)
Alerts
Alerts based on how fast your glucose levels rise/fall, and by
how much.
Receiver
An MP3-like device, which collects your glucose information
from the Sensor/Transmitter. Your results are displayed on the
Receiver screen as a glucose reading (mg/dL) and as a trend.
RF
Radio-Frequency transmission used to send glucose information
from the Transmitter to the Receiver.
Safety Lock/
Transmitter Key
The Safety Lock keeps the needle inside the Applicator before
you are ready to insert the Sensor Probe. It also helps you snap
the Transmitter out of the Sensor Pod after your Sensor session
has ended.
Sensor
The G4-Global System component that is inserted under the
skin to continuously measure your glucose levels.
Sensor Pod
The small base of the Sensor attached to your belly that holds
the Transmitter in place. The Sensor Pod and Transmitter are all
that remain on your skin during each Sensor use.
Sensor Probe
The part of the Sensor that is inserted under your skin with the
Applicator. It measures the glucose levels in your surrounding
tissue fluid.
Startup Period
The 1-hour “startup” period after you tell the Receiver you have
inserted a new Sensor (glucose readings cannot be provided
during this time).
Transmitter
The G4-Global System component that snaps into the Sensor
Pod and wirelessly sends glucose information to your Receiver.
Transmitter ID
Transmitter ID Number that is entered into your Receiver to
enable it to talk to the Transmitter.
G4-Global System User’s Guide | 165
12
Transmitter Latch
The small disposable component that snaps the Transmitter
into the Sensor Pod. It is removed after the Transmitter is
snapped in.
Trend (Rate of
Change) Arrows
Arrows on Trend Graphs that indicate if and how fast your
glucose levels are changing. The are 7 different arrows that
show when your glucose speed and direction change.
SYMBOLS USED IN LABELING
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
G4-Global System. This table shows what each symbol means.
“Use By” Date
Lot Number
Caution
Part Number,
Catalog Number
Date of Manufacture
Lower Limit of
Temperature
Do Not Reuse
Two-sided
Temperature Limits
Serial Number
Upper Limit of
Temperature
Sterilized by Radiation
Keep Dry
Do Not Use if Package
is Damaged
Direct Current
166 | Continuous Glucose Monitoring System
Water resistant to jetting
water
Type B Applied Part
Temporary submersion to
a depth of 8 feet
(2.44 meters) for 24 hours
Follow Operating
Instructions
Manufacturer
Authorized Representative
in the European
community
Humidity Limitation
::
ADDITIONAL INFORMATION
Receiver INPUT: 5 VDC, 750 mA
Rated supply voltage range: 100-240 VAC (AC supply)
Phases and current: 0.3A (AC supply)
Rated frequency range: 50-60 Hz (AC supply)
G4-Global System User’s Guide | 167
index
ALARM, Low Glucose
65
Alerts
62
Glucose Alerts
29, 62
High
29, 63, 90
Low
29, 64, 90
Snooze
108
Not Working
118
Other Alerts
105
Setting
29, 63, 64, 90, 92, 103
Rise and Fall
65, 92, 103
(Rate of Change)
Setting Out of Range Alert
106
Alternative Site Testing (BG)
47
Antenna Symbol
42
Missing
69
Arrows, Trend
(Rate of Change)
61, 105
Battery, Receiver
31
Charging
31
Troubleshooting
117
Blood Glucose (BG) Meter 6, 7, 15, 47
Blood Glucose (BG) Reading 15, 47
Cable, Connection
31, 117
Calibration
15, 45
Calibration Update
51
How to Calibrate
48
Re-Calibration
52
(Blood Drop in Status Area)
Startup Calibration
50
Troubleshooting
112
Contact Information
168 | Continuous Glucose Monitoring System
DexCom Technical Support
DexCom Website
Contents,
G4-Global Receiver Continuous
Glucose Monitoring System Kit
DexCom Studio Software
103
Events, Diabetes
98
Carbohydrates
99
Exercise
101
Health
102
Insulin
100
Setting the Date and Time for an
Event
99
FDA-cleared meter
6, 18, 47
Glucose Data Gaps
Glucose Readings
High
Low
Missing
Glucose Trends
164
58
63
64
68
61
Maintenance, System
121
R
Radio-Frequency
Range
Receiver
Charging your
Overview
Screens, viewing
Settings
15
69
17
31
17
19
27
Safety Information
Caution
Contraindications
Indication for Use
Precautions
Safety Lock (Transmitter Key) 15, 79
Screens, Receiver
19
Prompts and Notifications 50, 52, 112
Trend Graphs
19, 58-60
Sensor
5, 33
Applicator
5, 38
Automatic Shut-Off
76
Early Shut-Off
77
Expiration Date
35
Failed
77, 115
Insertion
39
Insertion Site
37
Overview
15
Pod
15, 36, 38
Probe
15
Removing the Sensor from
Package
37
Sensor Failure
115
Starting a Session
43
Startup Period
44
Stop Sensor
(Manual Sensor Shut-Off)
77
Temporary Shut Down
71, 117
Troubleshooting
111, 115
Settings, Alerts
29, 87
Settings, Receiver
25, 81
Date and Time
27, 83
Transmitter ID
28, 84
Setup Wizard
25
Specifications, Product
145
Startup Period
44
Status Area
66, 114
Gray Zone
59
Symbols
Calibration Needed Glucose
Reading
48, 52, 67, 157
Glucose Reading
Error
Out of Range
67, 68
67, 69, 161
15 Minute Calibration
Error
53, 67, 157
1 Hour Calibration
Error
53, 67, 157
Troubleshooting
Storage, System
Symbols, Labeling
111
122
166
Tape
44, 111
Transmitter
Attaching to Sensor
40
ID Number
25, 28, 84
Setting
25, 28, 84
Latch
15, 36
Overview
16
Removal
79
Safety-Lock/Transmitter Key 15, 79
G4-Global System User’s Guide | 169
index
Water Resistance
44, 122, 167
170 | Continuous Glucose Monitoring System
DexCom, INC
6340 Sequence Drive,
San Diego, CA 92121 USA
+1.858.200.0200
www.DexCom.com
LBL-010797 Rev 01
MT21202
Stay Between the Lines®

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : Yes
XMP Toolkit                     : Adobe XMP Core 4.0-c321 44.398116, Tue Aug 04 2009 14:24:39
Create Date                     : 2010:09:30 13:20:41-07:00
Creator Tool                    : PScript5.dll Version 5.2.2
Modify Date                     : 2010:11:04 16:13:14-05:00
Metadata Date                   : 2010:11:04 16:13:14-05:00
Producer                        : Acrobat Distiller 9.3.2 (Windows)
Format                          : application/pdf
Title                           : LBL-010797 Rev01 Users Guide_ IUO.indd
Creator                         : jrichey
Document ID                     : uuid:cefff012-453f-468c-9b04-cbf57851d417
Instance ID                     : uuid:0e005291-db57-4c16-8b31-6624a22eb253
Page Count                      : 172
Author                          : jrichey

EXIF Metadata provided by EXIF.tools