USER’S GUIDE CONTINUOUS GLUCOSE MONITORING SYSTEM

USER’S GUIDE CONTINUOUS GLUCOSE MONITORING SYSTEM
CONTINUOUS GLUCOSE
MONITORING SYSTEM
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
1.858.200.0200
1.877.339.2664
www.dexcom.com
LBL-012206 Rev 04 MT22434
USER’S GUIDE
USER’S GUIDE
DEXCOM G4® PLATINUM
PROFESSIONAL CONTINUOUS
GLUCOSE MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS
Dexcom® Website:
www.dexcom.com
The Transmitter ID:
The Receiver ID:
Dexcom Technical Support:
1.877.339.2664
© 2014 Dexcom, Inc. All rights reserved.
Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G4 PLATINUM
Professional, Dexcom STUDIO, and SEVEN are either registered
trademarks or trademarks of Dexcom, Inc. in the United States and/or
other countries. All other product or company names that may be
mentioned in this publication are tradenames, trademarks or registered
trademarks of their respective owners.
Dexcom G4 PLATINUM Professional System User’s Guide | 1
DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS
GLUCOSE MONITORING SYSTEM
table of contents
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CHAPTER 1: DEXCOM G4 PLATINUM PROFESSIONAL
CONTINUOUS GLUCOSE MONITORING (CGM)
SYSTEM DESCRIPTION
11
1.1 System Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 Sensor Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 Transmitter Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 Receiver Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 Receiver Shield Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13
14
15
16
17
20
CHAPTER 2: INDICATIONS FOR USE AND SAFETY
STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.1 INDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.2 IMPORTANT USER INFORMATION . . . . . . . . . . . . . . . . . . . . . . .
2.3CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.4WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.5PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.6CAUTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
25
25
26
26
29
33
CHAPTER 3: RISKS AND BENEFITS
35
CHAPTER 4: CHARGING THE RECEIVER AND THE
RECEIVER MAIN MENU
41
3.1Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
3.2 Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
4.1 Charging the Receiver Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.1.1 Charging the Receiver Battery from an AC Power Outlet . . . 44
4.1.2 Charging the Receiver Battery from a Windows Compatible Computer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
4.1.3 Knowing the Receiver is Charged . . . . . . . . . . . . . . . . . . . . . 46
4.2 Receiver Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
2 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 5: DEXCOM G4 PLATINUM PROFESSIONAL
SYSTEM INITIAL SETUP
49
5.1 Setting Up the Receiver and Pairing with the Transmitter . . . . . . . . 51
5.2 The Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.2.1 Getting to the Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.2.2 Setting the Receiver Time and Date . . . . . . . . . . . . . . . . . . . 54
5.2.3 Entering the Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.3 Checking Information About the Dexcom G4 PLATINUM
Professional System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.4 Transmitter and Receiver Communication . . . . . . . . . . . . . . . . . . . 57
5.5 Using the Receiver Shield and Preparing the Receiver for Multiple
Patient Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
CHAPTER 6: INSERTING A SENSOR AND STARTING A
SENSOR SESSION
63
6.1 Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.2 Removing the Sensor from its Packaging . . . . . . . . . . . . . . . . . . . .
6.3 Choosing an Insertion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.4 Placing the Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.5 Sensor Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.6 Transmitter Attachment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.7 Starting a Sensor Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.8 Sensor Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.9 Taping the Sensor Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.10 Temporary Receiver Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.11 The Dexcom G4 PLATINUM Professional System and Water . . .
66
67
68
69
70
72
73
75
76
77
78
CHAPTER 7: CALIBRATING THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM
79
7.1 Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.2 How to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.3 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.4 12-Hour Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.5 Other Reasons You May Need to Calibrate . . . . . . . . . . . . . . . . . .
81
83
87
88
89
CHAPTER 8: VIEWING SENSOR GLUCOSE READINGS
AND TRENDS IN REAL-TIME MODE
91
8.1 Sensor Glucose Readings in Real-Time Mode . . . . . . . . . . . . . . . . 94
Dexcom G4 PLATINUM Professional System User’s Guide | 3
8.2 Rate of Change Arrows in Real-Time Mode . . . . . . . . . . . . . . . . . . 97
8.3 Glucose Status Area Symbols in Both Real-Time and Blinded
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
CHAPTER 9: ALERTS, ALARM & PROFILES . . . . . . . 103
9.1 Setting the Alerts in Real-Time Mode . . . . . . . . . . . . . . . . . . . . . . 105
9.1.1 Default Alert/Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . 105
9.1.2 Glucose Alerts and Alarm in Real-Time Mode . . . . . . . . . . 108
9.1.2.1 High Glucose Alert in Real-Time Mode . . . . . . . . 108
9.1.2.2 Low Glucose Alert in Real-Time Mode . . . . . . . . . 109
9.1.2.3 Low Glucose Alarm in Real-Time Mode . . . . . . . . 109
9.1.3 Getting to the Alerts Menu for Both Real-Time and Blinded
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
9.1.4 Changing the High and Low Glucose Alerts . . . . . . . . . . . . 111
9.2 Advanced Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
9.2.1 Setting a Snooze Time for the High and Low Glucose Alerts
in Real-Time Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
9.2.2 Rise and Fall Glucose Rate Alerts in Real-Time Mode . . . . 115
9.2.3 Setting the Out of Range Alert for Both Real-Time and
Blinded Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
9.3 Alert Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
9.3.1 Alert Profile Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
9.3.2 Alert Profile Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
CHAPTER 10: EVENTS, DEXCOM STUDIO™ SOFTWARE
AND BLINDED MODE
125
10.1 Events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.1Selecting an Event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.2Setting the Date and Time for an Event . . . . . . . . . . . . . . .
10.1.3 Carbohydrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.4 Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.5 Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.1.6 Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2 Dexcom STUDIO Software and Blinded Mode . . . . . . . . . . . . . .
10.2.1 Activating the Blinded Mode/Clinical Feature . . . . . . . . . . .
10.2.2Blinding the Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10.2.3Downloading the Receiver . . . . . . . . . . . . . . . . . . . . . . . . .
4 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
127
127
128
129
130
131
132
133
134
136
137
1
10.2.4Resetting the Receiver for Multiple Patient Use . . . . . . . . . 137
CHAPTER 11: ENDING A SENSOR SESSION
11.1
11.2
11.3
139
Automatic Sensor Shut-Off in Both Real-Time and Blinded
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Removing a Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
Transmitter Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
CHAPTER 12: TAKING CARE OF THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM
147
12.1 Receiving the Transmitter and Receiver from Each User . . . . . .
12.2 Removing the Receiver Shield . . . . . . . . . . . . . . . . . . . . . . . . . .
12.3 Cleaning and Disinfection of the Transmitter . . . . . . . . . . . . . . .
12.4 Using the Receiver Shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.6Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
12.7 Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
149
149
152
158
160
161
162
CHAPTER 13: TROUBLESHOOTING . . . . . . . . . . . . . . 163
13.1 Sensor Insertion Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . .
13.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13.2.1 Types Of Calibration Prompts . . . . . . . . . . . . . . . . . . . . .
13.2.2 What To Do For Calibration Prompts . . . . . . . . . . . . . . . .
13.3 Calibration Error Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . .
13.4 System Glucose Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13.5 Sensor Inaccuracies in Real-Time Mode . . . . . . . . . . . . . . . . . .
13.6 Sensor Shut-Off Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . .
13.6.1 Early Sensor Shut-Off – Sensor Failure . . . . . . . . . . . . .
13.6.2 Manual Sensor Shut-Off – “Stop Sensor” . . . . . . . . . . . .
13.7 Battery and Charger Troubleshooting . . . . . . . . . . . . . . . . . . . . .
13.8 Receiver and Transmitter Communication Troubleshooting . . . .
13.8.1 System Recovery Check . . . . . . . . . . . . . . . . . . . . . . . . .
13.8.2 Receiver Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13.8.3 Low Transmitter Battery . . . . . . . . . . . . . . . . . . . . . . . . . .
13.8.4 Transmitter Failed Error Code . . . . . . . . . . . . . . . . . . . . .
13.9 Out of Range/No Antenna . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
13.10 Alerts Are Not Working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
165
166
167
168
168
169
170
172
173
173
175
175
175
176
176
177
177
179
Dexcom G4 PLATINUM Professional System User’s Guide | 5
CHAPTER 14: TECHNICAL INFORMATION
181
CHAPTER 15:
CHAPTER 16:
CHAPTER 17:
CHAPTER 18:
217
221
231
235
14.1 Device Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . 183
14.2 Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
14.3 FCC Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
USER ASSISTANCE
WARRANTY
TRAVEL INFORMATION
APPENDIX
Appendix I, Receiver Alerts, Alarm and Prompts . . . . . . . . . . . . . . . . . 237
Appendix II, Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
Appendix III, Symbols Used in Labeling . . . . . . . . . . . . . . . . . . . . . . . . 256
6 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
GLOSSARY
Acoustic
Spacer
Small, L-shaped plastic piece to be placed above the receiver
speaker to ensure the sound of alerts and alarms is audible.
Alternative Site This is when you take a blood glucose value on the meter
BG Testing
using a blood sample from an area on the body other than
the fingertip. Do not use alternative site testing to calibrate the
receiver.
Applicator
A disposable piece that comes attached to the sensor pod and
inserts the sensor under the skin. There is a needle inside the
applicator that you remove after you insert the sensor.
Blinded Mode
When the Dexcom G4 PLATINUM Receiver is set to hide
sensor glucose readings and glucose trend information. The
receiver records glucose information that can be downloaded
and reviewed later with the Dexcom STUDIO software.
BG Meter
Blood glucose meter. You can use any commercially available
meter for testing blood glucose.
BG Value
Blood glucose value. A blood glucose value taken with the
commercially available blood glucose meter.
Calibration
When you enter blood glucose values from a blood glucose
meter into the receiver. Calibrations are needed for the
receiver to show continuous sensor glucose readings and
trend information. (Do not use alternative site testing for
calibration).
CGM
Continuous Glucose Monitoring.
Commercially
Available
Product that may be sold in the United States.
Default
A setting that is selected automatically, unless you choose
another option.
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 7
GLOSSARY (continued from page before)
Dexcom G4
PLATINUM
Professional
System
The sensor, transmitter, and receiver.
Glucose Data
Gaps
Different symbols show on the trend graph instead of a sensor
glucose reading to let you know that the receiver cannot
provide a reading.
Glucose
Trends
Trends let you see the pattern of glucose levels. The trend
graph shows where glucose levels have been during the time
shown on the screen and where glucose levels are now.
Hypoglycemia
Low blood glucose. Same as “low.” The default low alert in the
receiver is set to 80 mg/dL. Consult a healthcare professional
to determine the appropriate hypoglycemic setting.
Hyperglycemia
High blood glucose. Same as “high.” The default high alert
in the receiver is set to 200 mg/dL. Consult a healthcare
professional to determine the appropriate hyperglycemic
setting.
HypoRepeat
Optional receiver alert setting that keeps repeating the fixed
low alarm every 5 seconds until the sensor glucose value rises
above 55 mg/dL or you confirm it. This profile can be helpful if
you want extra awareness for severe lows.
mg/dL
Milligrams per deciliter. The standard unit of measure for
sensor glucose readings in the United States.
Obstruction
Something that blocks the path between the transmitter and
receiver. There are many types of things that could come
between the transmitter and receiver, and Dexcom could not
test them all. “Without obstruction” means that we have not
tested whether items blocking the transmitter or receiver could
affect the transmission range.
(continued on next page)
8 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
GLOSSARY (continued from page before)
Profiles
Sound pattern and volume level settings for the alerts.
Range
The distance between the receiver and transmitter. Keep the
two devices within 20 feet of each other without obstruction to
get glucose information on the receiver.
Re-Alert
A re-alert happens after the first alert is not confirmed.
Receiver
The small device that collects glucose information from the
sensor/transmitter. The results show on the receiver screen as
a sensor glucose reading (mg/dL) and as a trend.
Receiver
Shield
Protective shield that is placed over the receiver when used by
multiple patients.
Rise and Fall
(Rate of
Change) Alerts
Alerts based on how fast and how much glucose levels rise/fall.
RF
Radio-frequency transmission used to send glucose
information from the transmitter to the receiver.
Safety Lock
The safety lock keeps the needle inside the applicator before
you are ready to insert the sensor. It also helps you snap the
transmitter out of the sensor pod after the sensor session ends.
Sensor
The Dexcom G4 PLATINUM Professional System part that
includes an applicator and wire. The applicator inserts the wire
under the skin, and the wire measures glucose levels in tissue
fluid.
Sensor Pod
The small plastic base of the sensor attached to the belly that
holds the transmitter in place.
Snoozing
The option to delay the alert for a set amount of time. A snooze
time can be set for high and low glucose re-alerts.
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 9
GLOSSARY (continued from page before)
Square Seal
Square-shaped tape that is used to seal the USB port of the
receiver. Three square seals are provided. Each seal is used
once and then discarded when the port is reopened.
Startup Period
The 2-hour period after you tell the receiver you inserted a new
sensor. Sensor glucose readings are not provided during this
time.
System
Reading
A sensor glucose reading shown on the receiver. This reading
is in mg/dL units and is updated every 5 minutes.
Transmitter
The Dexcom G4 PLATINUM Professional System part that
snaps into the sensor pod and wirelessly sends glucose
information to the receiver.
Transmitter ID
A series of numbers and/or letters that you enter into the
receiver to let it communicate with the transmitter.
Transmitter
Latch
The small, disposable piece 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 show how fast glucose levels are
changing. There are 7 different arrows that show when glucose
speed and direction change.
Triangle Seal
Triangle-shaped tape that is used to seal the back of the
receiver shield placed over the receiver.
10 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
1
chapter one
DEXCOM G4 PLATINUM PROFESSIONAL
CONTINUOUS GLUCOSE MONITORING
(CGM) SYSTEM DESCRIPTION
Dexcom G4 PLATINUM Professional System User’s Guide | 11
1
12 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 1: DEXCOM G4® PLATINUM
PROFESSIONAL CONTINUOUS GLUCOSE
MONITORING (CGM) SYSTEM DESCRIPTION
Dexcom G4® PLATINUM
Receiver
Dexcom G4 PLATINUM
Professional Receiver Shield
Dexcom G4 PLATINUM
Transmitter
Dexcom G4
PLATINUM Sensor
1.1 SYSTEM CONTENTS:
• sensor
• transmitter
• receiver
• receiver USB charging/download cable
• AC power adapter - MT21255
• user’s guide
• 2 quick start guides (real-time and blinded use)
• site training checklist
• receiver shield pack containing receiver shield, square seals, triangle
seal and acoustic spacer
• Dexcom STUDIO™ software CD bundle
Dexcom G4 PLATINUM Professional System User’s Guide | 13
1
Sensors and receiver shields are sold separately. Commercially
distributed blood glucose (BG) meter required for use.
PRECAUTION
The Dexcom G4 PLATINUM Sensor, Transmitter, and
Receiver are not compatible with the SEVEN®/SEVEN®
PLUS Transmitter and Receiver. Different generations
will not connect with each other and will not work. Also,
make sure to use the correct version of Dexcom STUDIO
with your system.
1.2 INTRODUCTION
The system can be used in two modes – real-time and blinded modes.
When you use the system in real-time mode, you will see continuous
sensor glucose readings updated every 5 minutes for up to 7 days.
These readings will help you and your patients notice trends and
patterns in their glucose levels. When the system is used in blinded
mode, the sensor glucose readings are not displayed to the patient but
are recorded every 5 minutes. They can be downloaded and reviewed
later using the Dexcom STUDIO software.
The Dexcom G4 PLATINUM Professional System includes the Dexcom
G4 PLATINUM Sensor, the Dexcom G4 PLATINUM Transmitter, and the
Dexcom G4 PLATINUM Receiver with a receiver shield. The sensor is a
disposable unit that you insert under the skin of the abdomen (belly) to
continuously monitor glucose levels for up to 7 days. The transmitter is a
reusable device that wirelessly sends the sensor’s glucose information
to the receiver. The receiver is a hand-held device that receives and
displays glucose information. When healthcare professionals use
one system for multiple patients, the transmitter must be cleaned and
disinfected and a new receiver shield must be applied between each
patient’s use. These disposable receiver shields are components of the
Dexcom G4 PLATINUM Professional CGM System that help reduce the
14 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
spread of contamination between multiple patient use.
Please read this user’s guide closely. It describes how to use the system
in detail.
1.3 SENSOR OVERVIEW
The sensor is the piece that comes in a sterile, sealed sensor pouch.
The sensor is made up of an applicator, a sensor pod, and a sensor
wire. You remove the applicator after insertion. The sensor pod stays on
the belly for the entire sensor session, up to 7 days. The pod is made of
plastic and an adhesive patch. The sensor wire is thin and flexible, and
inserts just under the skin of the belly. It is attached to the sensor pod,
and is made of silver and platinum metal with polymer membranes. You
discard the sensor at the end of the session.
See Chapter 14 for Product Specifications.
Plunger
Safety lock
Applicator barrel
(contains small introducer
needle and sensor)
Collar
Transmitter latch
Sensor pod
Release tab
Adhesive patch
Dexcom G4 PLATINUM Professional System User’s Guide | 15
1
1.4 TRANSMITTER OVERVIEW
The transmitter is the gray, plastic “chip” that snaps into the sensor
pod. The transmitter (including sensor pod) is about 1.5 inches long,
0.9 inches wide and 0.5 inches thick. Once snapped into the sensor
pod, the transmitter wirelessly sends the glucose information to the
receiver. The transmitter and sensor are water resistant when properly
connected. Do not throw away the transmitter. It is reusable. When
healthcare professionals use one transmitter for multiple patients, the
transmitter must be cleaned and disinfected between each patient’s use.
The transmission range from the transmitter to the receiver is up to 20
feet without obstruction. Wireless communication does not work well
through water, so the range is much less if you are in a pool, bathtub or
water bed.
The transmitter battery will last at least 6 months. Once you see the
transmitter low battery screen, replace the transmitter as soon as
possible. The transmitter battery may drain as quickly as one week after
this alert appears.
See Chapter 14 for Product Specifications.
Transmitter
Transmitter Low Battery screen
16 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
1.5 RECEIVER OVERVIEW
The receiver is the small hand-held device that looks like a cell phone.
It is about 4 inches long, 1.8 inches wide and 0.5 inches thick. When
used in real-time mode, it shows the sensor glucose readings, trend
graph, direction and rate of change arrow. When used in blinded mode,
it records, but does not display, sensor glucose readings throughout
the sensor session. Regardless of the mode used, the receiver alerts
the patient to any errors in the system, such as low battery. When
healthcare professionals use one receiver for multiple patients, the
receiver shield must be replaced between each patient’s use. The shield
is a thin, stretchy plastic that covers the receiver.
Receiver shield
Do not spill fluids on the receiver or drop the receiver into fluids. Keep
the micro USB port door open, and keep the square seal on the receiver
shield over the USB port.
NOTE: The receiver will store each patient’s data in its memory. For
multiple patient use, it is important that you erase the receiver data
memory after each patient use. This will ensure patient privacy with
subsequent users. See Chapter 10 for instructions on erasing patient
data from the receiver.
NOTE: In the Dexcom STUDIO software, select the “Prompt to reset
receiver after every download” option under the Options - Healthcare
Professional setting. This feature will remind the healthcare professional
to erase the receiver data after each use.
Dexcom G4 PLATINUM Professional System User’s Guide | 17
1
Real-Time Receiver Mode:
Battery
Most recent 5-minute
sensor glucose reading
Status area
Trend arrow
Antenna
Glucose
values
High glucose
alert setting
Plot of most
recent sensor
glucose
readings
Glucose
target
range
Low glucose
alert setting
Trend graph hours
Current time
EXAMPLE: 3-Hour Trend Graph Screen
When used in real-time mode, the trend graph screen on the
receiver shows the sensor glucose readings, trend graph, direction
and rate of change arrow.
18 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Blinded Receiver Mode:
Battery
Status area
Antenna
Trend graph hours
Current time
When used in blinded mode, no sensor glucose readings are
displayed to the patient, but the sensor readings are recorded
every 5 minutes and can be downloaded and reviewed later using
the Dexcom STUDIO software.
There are five receiver buttons to move you through the screens.
When in real-time mode, the trend graph screens show sensor glucose
readings, trend graphs and trend arrows. The receiver menu screens let
you change the receiver settings.
The receiver and transmitter wirelessly pair together to communicate
securely and only with each other.
You will need a commercially available blood glucose meter to use with
the system.
See Section 14 for Product Specifications.
Dexcom G4 PLATINUM Professional System User’s Guide | 19
1
Display screen
UP button
Speaker
USB port cover
RIGHT
button
LEFT
button
DOWN
button
SELECT
button
USB port
Receiver buttons:
• Press the UP and DOWN buttons to scroll through trend screens,
highlight menu items, or set values.
• Press the SELECT button to turn the receiver on or select the
highlighted option.
• Press the LEFT button to go back to the last item or screen.
• Press the RIGHT button to highlight the next item.
1.6 RECEIVER SHIELD OVERVIEW
The Dexcom G4 PLATINUM Professional System requires the use of
the receiver shield and its components to help protect the receiver from
contamination. The receiver shield pack includes the receiver shield, 3
square seals, 1 triangle seal and 1 acoustic spacer.
20 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Acoustic spacer
Triangle seal
Square seals
Receiver shield
Receiver shield pack
The receiver shield and components are disposable and must be
replaced with each individual patient’s use. The receiver shield and
seals are used to help protect the receiver from contamination. The
acoustic spacer is used to ensure the alert and alarm sounds are still
audible when the receiver shield is over the receiver.
Dexcom G4 PLATINUM Professional System User’s Guide | 21
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22 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
2
chapter two
INDICATIONS FOR USE AND
SAFETY STATEMENT
Dexcom G4 PLATINUM Professional System User’s Guide | 23
2
24 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 2: INDICATIONS FOR USE AND
SAFETY STATEMENT
2.1 INDICATIONS FOR USE
The Dexcom G4 PLATINUM Professional Continuous
Glucose Monitoring System is a glucose monitoring device
indicated for detecting trends and tracking patterns in
persons (age 18 and older) with diabetes. The system is
intended for multiple patient use and requires purchase by a
healthcare provider. The system is not intended for use in a
hospital setting.
The Dexcom G4 PLATINUM Professional System is
indicated for use as an adjunctive device to complement, not
replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 PLATINUM Professional 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
Dexcom G4 PLATINUM Professional System results should
be based on the trends and patterns seen with several
sequential readings over time.
2.2 IMPORTANT USER INFORMATION
Please review your product instructions before using
your continuous glucose monitoring system. Indications,
contraindications, warnings, precautions, cautions, and other
important user information can be found in your product
instructions. Discuss with your healthcare professional
how you should use your sensor trend information to help
Dexcom G4 PLATINUM Professional System User’s Guide | 25
2
manage your diabetes. Your product instructions contain
important information on troubleshooting your system and on
the performance characteristics of the device.
2.3 CONTRAINDICATIONS
• Remove the Dexcom G4 PLATINUM Sensor,
MR Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomography
(CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM Professional System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
• Taking medications with acetaminophen (such as Tylenol®)
while wearing the sensor may falsely raise your sensor
glucose readings. The level of inaccuracy depends on the
amount of acetaminophen active in your body and may be
different for each person.
2.4 WARNINGS
• Thoroughly review the training materials included with your
CGM system before using the Dexcom G4 PLATINUM
Professional CGM System. Incorrect use might lead to you
misunderstanding the information provided by your system,
or might affect system performance, and you might miss a
low or high blood glucose value.
26 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
• Do not use the Dexcom G4 PLATINUM Professional
System for treatment decisions, such as how much insulin
you should take. The Dexcom G4 PLATINUM Professional
System does not replace a blood glucose meter. Always
use the values from your blood glucose meter for treatment
decisions. Blood glucose values may differ from sensor
glucose readings. Using the sensor glucose readings for
treatment decisions could lead to low or high blood glucose
value.
• Do not ignore symptoms of high and low glucose. If your
sensor glucose readings do not match your symptoms,
measure your blood glucose with a blood glucose meter
even if your sensor is not reading in the high or low range,
so you do not miss a low or high blood glucose value.
• Calibrate at least once every 12 hours. Calibrating less
often than every 12 hours might cause sensor glucose
readings to be inaccurate, and you might miss a low or high
blood glucose value.
• Users need to adhere to Standard Precautions when
handling or using this device. All parts of the system
should be considered potentially infectious and are
capable of transmitting blood-borne pathogens
between patients and healthcare professionals.
For more information, refer to “Guideline for
Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings 2007,”
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
• The transmitter should be cleaned and disinfected after use
on each patient. This system may only be used for testing
multiple patients when Standard Precautions and the
Dexcom G4 PLATINUM Professional System User’s Guide | 27
2
manufacturer’s cleaning and disinfection procedures are
followed.
• Replace the receiver shield and acoustic spacer when
transferring the receiver to a new patient. Wear gloves
when handling the receiver. Handling the receiver
without a shield or with a damaged shield could lead to
contamination, which could cause infection.
• 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 at 1.877.339.2664 or 1.858.200.0200.
• The Dexcom G4 PLATINUM Professional System is not
approved for use in children or adolescents, pregnant
women or persons on dialysis.
• It is not known how different conditions or medications
common to the critically ill population may affect the
performance of the system. Therefore, the use of this
system in the critically ill population is not recommended.
•S
ensor placement and insertion is not approved for sites
other than the belly (abdomen).
• Do not expect alerts from the Dexcom G4 PLATINUM
Professional System until after the 2-hour startup. You
will NOT get any sensor glucose readings or alerts until
after the 2-hour startup ends AND you complete the
startup calibration. During this time you might miss severe
hypoglycemia (low blood glucose) or hyperglycemia (high
28 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
blood glucose) events.
• If your transmitter or receiver case is damaged/cracked, do
not use it. This could create an electrical safety hazard or
malfunction, which might cause electrical shocks.
• Store the sensor at temperatures between 36° F - 77° F
for the length of the sensor’s shelf life. You may store the
sensor in the refrigerator if it is within this temperature
range. The sensor should not be stored in a freezer. Storing
the sensor improperly might cause the sensor glucose
readings to be inaccurate, and you might miss a low or high
blood glucose value.
• Low/high glucose alerts and the 55 mg/dL low glucose
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and will
not alert you when the glucose is low or high. Check blood
glucose meter if there are any signs or symptoms of low or
high glucose.
2.5 PRECAUTIONS
• Before opening the sensor package, wash your hands with
soap and water, and let them dry. You may contaminate the
insertion site and suffer an infection if you have dirty hands
while inserting the sensor.
• Before inserting the sensor, clean the skin with a topical
antimicrobial solution, such as isopropyl alcohol, and allow
to dry. This may help prevent infection. Do not insert the
sensor until the cleaned area is dry so the sensor adhesive
will stick better.
• Change the site where you place the sensor with each
Dexcom G4 PLATINUM Professional System User’s Guide | 29
2
insertion, if the system is used multiple times. Using the
same site too often might not allow the skin to heal, and
might cause scarring or skin irritation.
• Avoid inserting the sensor in areas that are likely to be
bumped, pushed or compressed or areas of skin with
scarring, tattoos, or irritation as these are not ideal sites
to measure glucose. Insertion in those areas might affect
sensor performance, and you might miss a low or high
blood glucose value.
•A
void injecting insulin or placing an insulin pump infusion
set within 3 inches of the sensor. The insulin might affect
sensor performance, and you might miss a low or high
blood glucose value.
• Do not use the sensor if its sterile package has been
damaged or opened. Using an unsterile sensor might
cause infection.
• To calibrate the system, enter the exact blood glucose value
that your blood glucose meter displays within 5 minutes of a
carefully performed blood glucose measurement. Entering
incorrect blood glucose values or blood glucose values
from more than 5 minutes before entry might affect sensor
performance, and you might miss a low or high blood
glucose value.
• Do not calibrate if your blood glucose is changing at a
significant rate, typically more than 2 mg/dL per minute.
Do not calibrate when your receiver screen is showing the
rising single arrow or double arrow, which indicates that
your blood glucose is rising 2-3 mg/dL/min or more than
3 mg/dL/min. Also, do not calibrate when your receiver
30 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
screen is showing the falling single arrow or double arrow,
which indicates that your blood glucose is falling 2-3
mg/dL/min or more than 3 mg/dL/min. Calibrating during
significant rise or fall of blood glucose may affect accuracy
of sensor glucose readings.
• The system accuracy may be affected when your glucose
is changing at a significant rate (e.g., 2-3 mg/dL/min or
more than 3 mg/dL each minute), such as during exercise
or after a meal. Since the system will not display your
glucose rate of change in blinded mode, avoid calibrating
after a meal or exercise.
• The transmission range from the transmitter to the
receiver is up to 20 feet without obstruction. Wireless
communication does not work well through water so the
range is much less if you are in a pool, bathtub, or on a
water bed, etc. Types of obstruction differ and have not
been tested. If your transmitter and receiver are farther than
20 feet apart or are separated by an obstruction, they might
not communicate or the communication distance may be
shorter and you might miss a low or high blood glucose
value.
• Do not use alternative blood glucose site testing (blood
from your palm or forearm, etc.) for calibration. Alternative
site blood glucose values may be different than those
taken from a fingerstick blood glucose value and may not
represent the timeliest blood glucose value. Use a blood
glucose value taken only from a fingerstick for calibration.
Alternative site blood glucose values might affect sensor
performance, and you might miss a low or high blood
glucose value.
Dexcom G4 PLATINUM Professional System User’s Guide | 31
2
• Do not discard your transmitter. It is reusable. The same
transmitter is used for each session until you have reached
the end of the transmitter battery life. When healthcare
professionals use one transmitter for multiple patients, the
transmitter must be returned to the healthcare professional.
• The Dexcom G4 PLATINUM Sensor, Transmitter, and
Receiver are not compatible with the SEVEN/SEVEN
PLUS Transmitter and Receiver. Different generations will
not connect with each other and will not work. Also make
sure to use the correct version of Dexcom STUDIO with
your system.
•If all 3 square seals have been used before the end of the
session, return the receiver to the healthcare professional
office. Do not charge the receiver if you cannot seal it.
Unsealed receivers could spread contamination.
•Do not puncture the receiver shield for any reason.
Punctured shields could spread contamination.
•Return the receiver to the healthcare professional if the
acoustic spacer moves away from the upper right corner.
The entire receiver shield must be discarded and replaced.
The spacer allows the receiver speaker to work properly
when the shield is in place. If the spacer moves and the
receiver speaker volume is low, you might miss alerts or
alarms.
• Inspect the receiver shield, seals and spacer for tears or
other damage or defects before you place the components
on the receiver. Do not use any parts of the receiver shield
pack that are damaged or defective. If the receiver shield,
seals and spacer are torn, damaged or otherwise defective
32 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
after giving to the patient, the patient should return the
receiver to the healthcare professional for a replacement.
The damaged or defective receiver shield should not
be taken off by the patient. If a defect or malfunction is
suspected, the healthcare professional should retain the
shield and contact Dexcom® Technical Support. The shield
helps protect the user and healthcare professionals from
contamination and allows the receiver to function properly.
2.6 CAUTION
U.S. (Federal) law restricts the sale of the Dexcom G4
PLATINUM Professional System to sale by or on order of a
physician.
Dexcom G4 PLATINUM Professional System User’s Guide | 33
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34 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
3
chapter three
RISKS AND BENEFITS
Dexcom G4 PLATINUM Professional System User’s Guide | 35
3
36 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
1
CHAPTER 3: RISKS AND BENEFITS
3.1 RISKS
There are some known risks with using real-time or blinded
CGM.
You will not get sensor glucose alerts when the alert function
is turned off, your transmitter and receiver are out of range,
or when your receiver is not showing sensor glucose
readings. You might not notice alerts if you are unable to
hear them or feel the vibration. Sometimes your sensor
glucose reading may be slightly different than your blood
glucose meter. For example, your blood glucose meter may
show a blood glucose value of 78 mg/dL, but your sensor
glucose reading may show as 82 mg/dL. If your low alert is
set at 80 mg/dL, your system will not alert for a low glucose
at this time because 82 mg/dL is still above your low alert
setting. In most cases, the sensor glucose readings will
move in the right direction and will alert you of a high or low
shortly after. If you do not get an alert for any reason, and
you do not take frequent blood glucose measurements with
your blood glucose meter, you might not be aware of low or
high blood glucose levels. If this happens, and your blood
glucose levels are very high or low, there is a remote chance
you might need medical help. There is a risk of disease
transmission when the device is used on multiple patients.
When the CGM system is used in blinded mode, the sensor
glucose readings are not displayed, only recorded for
review when downloaded later by the Dexcom STUDIO
software. Using the system in blinded mode might cause
you to expect glucose alerts, but you will not receive high
Dexcom G4 PLATINUM Professional System User’s Guide | 37
3
or low glucose alerts in blinded mode since these alerts are
deactivated. Taking frequent blood glucose measurements is
necessary to be aware of low or high blood glucose levels.
Inserting the sensor and wearing the adhesive patch might
cause infection, bleeding, pain or skin irritations (redness,
swelling, bruising, itching, scarring or skin discoloration).
There is a low chance of this happening. In the clinical study
for the Dexcom G4 PLATINUM System (which used the
same sensor as the Dexcom G4 PLATINUM Professional
System), only slight redness and swelling occurred in a
few patients. If any of these events happen, you might feel
discomfort in the area the sensor is inserted.
There is a remote chance that a sensor fragment could
remain under your skin if the sensor breaks while you are
wearing it. This did not happen in the clinical study for the
Dexcom G4 PLATINUM System. If you think a sensor has
broken under your skin, contact your healthcare professional
and call Dexcom’s Technical Support. Sensor breakage may
cause some anxiety, but it is not a significant medical risk.
3.2 BENEFITS
Real-time CGM provides benefits beyond the information
you get from a blood glucose meter. It provides glucose
readings every five minutes for up to seven days to help you
detect trends and patterns in your glucose levels. This trend
information can help you see where your glucose is now
as well as where your glucose may be heading and how
fast you may be getting there. Understanding your glucose
trends and patterns may help you take action to help avoid
high or low glucose values by working with your healthcare
38 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
professional to adjust your diabetes management therapy or
techniques.
Alerts and the low alarm tell you when your glucose is
outside of your target glucose range and may help you avoid
low and high blood sugar. Rise and fall glucose alerts can
also provide benefit by alerting you when your glucose is
rapidly going down or up. This way you can be alerted to
this information before you are too high or too low and take
action to avoid it. Real-time CGM can help increase time in
your target glucose range without increasing your time in the
low or high glucose range.1
Real-time CGM can help improve diabetes control (lower
A1c values, reducing glycemic variability and time spent
in low and high blood glucose ranges)1, 2 , 3 which can help
reduce diabetes related complications.4, 5 These benefits
can be seen especially with using real-time CGM at least 6
days per week2 and can be sustained over time.6 In some
cases, patients perceived an increase in their quality of life
and peace of mind when using real-time CGM as well as
reporting a high satisfaction with CGM.7
Blinded CGM also provides benefit to both the patient and
healthcare professionals. Using blinded CGM allows for the
uninterrupted glucose patterns and trends of a patient’s daily
schedule be documented so glucose patterns and trends
can be identified and changes to their diabetes management
can be made to help avoid glucose excursions. Blinded
CGM can also allow for assessment of the true diurnal
glucose patterns as it relates to basal management
adjustment and lifestyle choices of diet and exercise.
Dexcom G4 PLATINUM Professional System User’s Guide | 39
3
1
arg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L.
G
Improvement in glycemic excursions with a transcutaneous, real-time
continuous glucose sensor: a randomized controlled trial. Diabetes
Care. 2006; 29:44-50.
2
J DRF CGM Study Group. Continuous Glucose Monitoring and
Intensive Treatment of Type 1 Diabetes. NEJM 2008;359:1464-76.
3
attelino. Effect of continuous glucose monitoring of hypoglycemia in
B
type 1 diabetes. Diabetes Care 2011; 34(4): 795-800.
4
he Diabetes Control and Complications Research Group. The effect
T
of intensive treatment of diabetes on the development and progression
of long-term complications of insulin-dependent diabetes mellitus. N
Eng J Med. 1993; 329:997-1036.
5
hkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy
O
prevents progression of diabetic microvascular complications in
Japanese patients with non-insulin dependent diabetes mellitus: a
randomized prospective 6-year study. Diabetes Res Clin Pract. 1995;
28:103-117.
JDRF CGM Study Group. Sustained Benefit of Continuous Glucose
Monitoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With
Type 1 Diabetes, Diabetes Care 2009; 32: 2047-2049.
6
7
J DRF CGM Study Group. Quality-of-Life Measures in Children and
Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177.
40 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
4
chapter four
CHARGING THE RECEIVER AND
THE RECEIVER MAIN MENU
Dexcom G4 PLATINUM Professional System User’s Guide | 41
4
42 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 4: CHARGING THE RECEIVER AND
THE RECEIVER MAIN MENU
4.1 CHARGING THE RECEIVER BATTERY
The receiver battery is rechargeable and will last about 3 days with
normal use before you need to charge it. The battery life depends on
how often you press the receiver buttons or get alerts. The receiver will
tell you when the battery charge is low.
Low battery prompt
Charge the receiver battery using one of these options:
• an AC power outlet
• a personal computer with Windows® operating system (to charge
the receiver from the PC, Dexcom STUDIO must be installed. For
system requirements and more information, see the Dexcom website
(www.dexcom.com) or the Dexcom STUDIO Software User’s Guide.)
Only use the Dexcom battery charger provided in the receiver kit. Do not
use any other battery charger.
Charge only from a USB port on the computer or the AC power
adapter. Do not use an external USB hub. An external USB hub
may not provide enough power to charge the receiver.
Fully charging an empty battery takes about 3 hours with the wall
charger and about 5 hours with a computer. The battery does not need
to be drained to charge fully.
You may use the receiver while it is charging with an AC power outlet or
PC.
Dexcom G4 PLATINUM Professional System User’s Guide | 43
4
Charge the receiver battery before each sensor insertion. Periodically
check the battery level to make sure it has enough charge.
If the battery drains, it will keep the time and date for 3 days without
being charged. After 3 days, the receiver will prompt you to reset the
time and date (see Chapter 5, Section 5.2, The Settings Menu).
When the receiver is used in a healthcare facility, charging must take
place away from the patient.
When the receiver is used for multiple patients, charging should take
place before the patient is given the system so only a recharge would be
necessary during the 7- day sensor session.
WARNING
It is not known how different conditions or medications
common to the critically ill population may affect the
performance of the system. Therefore, the use of this
system in the critically ill population is not recommended.
4.1.1 CHARGING THE RECEIVER BATTERY
FROM AN AC POWER OUTLET
To recharge the battery during the 7-day sensor session:
1. Carefully peel back the square seal that is over the USB port.
2. P
lug the included USB cable into the AC power adapter.
3. Plug the AC power adapter into an AC power outlet.
4. M
ake sure the USB door is open so
you can reach the port easily. If it is
closed, press down firmly with a thumb USB port cover
when sliding open the USB port cover.
44 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
5. P
lug the micro USB end of the cable into the receiver USB port.
Keep the USB port cover on the receiver open whenever the USB
cable is not attached. The receiver shield works with the port open
so you can access the USB port easily as needed.
6. The battery charging screen will show on
the receiver.
Battery charging screen
7. A
fter a few seconds the trend graph will show with the battery
charging symbol (
) in the upper left corner.
Battery charging symbol in
upper left corner of trend
graph in real-time mode
Battery charging symbol in
upper left corner of trend
graph in blinded mode
4.1.2 CHARGING THE RECEIVER BATTERY
FROM A WINDOWS COMPATIBLE COMPUTER
You must install the Dexcom STUDIO software to charge the
receiver from a computer. Please see the Dexcom STUDIO
Installation Card for driver installation instructions. This charging
option should be used by the healthcare professional only.
1. Carefully peel back the square seal that is over the USB port.
Dexcom G4 PLATINUM Professional System User’s Guide | 45
4
2. P
lug the included USB cable into the computer.
3. Plug the other end of the USB cable into the receiver.
4. T
he battery charging screen shows on the
receiver.
Battery charging screen
5. A
fter a few seconds, the trend graph screen will show the battery
charging symbol in the upper left corner.
Battery charging symbol in
upper left corner of trend
graph in real-time mode
Battery charging symbol in
upper left corner of trend
graph in blinded mode
4.1.3 KNOWING THE RECEIVER IS CHARGED
s the battery charges, the battery charging symbol fills in. When the
A
battery is fully charged, the battery charging symbol is completely
shaded.
Start
Fully Charged
Battery charging symbol fills in as battery charges
After the receiver is fully charged:
46 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
1. Disconnect the cable and power adapter.
2. Do not move the USB port cover; leave it open.
3. Carefully remove the square seal over the USB port.
4. P
lace a new square seal over
the receiver USB port by peeling
the seal from the tape backing
and placing the seal over the
USB port in a diagonal shape.
This reseals the port.
USB door open
Square seal on receiver shield
5. Press firmly on the square seal to make sure it is sealed securely.
PRECAUTION
If all 3 square seals have been used before the end
of the session, return the receiver to the healthcare
professional office. Do not charge the receiver if
you cannot seal it. Unsealed receivers could spread
contamination.
4.2 RECEIVER MENU OPTIONS
The receiver’s Main Menu lets you scroll through important menu
options. This table explains the purpose of each option. These menu
options can be seen in both real-time and blinded modes. More
information on Main Menu options can be found in the chapters listed:
Dexcom G4 PLATINUM Professional System User’s Guide | 47
4
Receiver Main Menu Options
Menu
Purpose
User’s
Guide
Reference
Trend
Graph
To show the trend graphs.
•T
he 3-hour trend graph is the default screen whenever
you turn on the receiver.
Chapter 8
Start
Sensor
To start a new sensor session.
•T
his option only shows if you have entered a transmitter
ID and you are not in the middle of a sensor session
Chapter 6
Enter BG
To enter blood glucose values for calibration.
Chapter 7
Profiles
Profiles allow you to customize the sound and volume of
alerts and alarm.
Chapter 9
Events
To enter personal information about meals, insulin,
exercise, and health status.
Chapter 10
Alerts,
High/Low
To change the settings for high and low alerts. High and
low alerts and alarm are not activated in blinded mode.
Chapter 9
Settings
To change the time, date and transmitter ID; to look up the
Dexcom G4 PLATINUM Professional System hardware
and software version numbers; to view transmitter battery
status, last calibration value and sensor insertion time.
Chapter 5
To temporarily turn off all communication between the
transmitter and receiver during a sensor session. You will
Shutdown not get sensor glucose readings, and it will not extend the
life of the sensor.
Chapter 6
To end a sensor session early.
•T
his option only shows when you are in the middle of a
sensor session. You will not get sensor glucose readings,
and you must dispose of the sensor if you stop the session.
Chapter 13
Stop
Sensor
See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a
list of screens that may show on the receiver.
48 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
5
chapter five
DEXCOM G4 PLATINUM PROFESSIONAL
SYSTEM INITIAL SETUP
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5
50 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 5: DEXCOM G4 PLATINUM
PROFESSIONAL SYSTEM INITIAL SETUP
This chapter helps you when you first set up the Continuous Glucose
Monitoring system. Read this chapter before you start.
5.1 SETTING UP THE RECEIVER AND PAIRING
WITH THE TRANSMITTER
The Setup Wizard guides you through setup the first time you turn on
the receiver. These set up tasks are only needed to be done when a
new receiver is used for the first time.
1. R
emove the transmitter from its packaging. Wait 10 minutes for the
transmitter to turn on before setting up the receiver.
2. M
ake sure the receiver is fully charged (see Chapter 4, Section 4.1,
Charging The Receiver Battery).
3. Press the SELECT button on the receiver to turn it on. The Setup
Wizard will guide you to enter the following setup information:
a. S
et the time and date. The date format is YYYY/MM/DD.
(1) Press the UP or DOWN button to
enter the current date and time.
(2) P
ress the RIGHT or SELECT button
to move to the next section.
(3) P
ress the SELECT button to confirm
time and date.
Time/Date setting screen
b. Enter the transmitter ID.
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5
(1) Press the UP or DOWN button to
enter the transmitter ID.
(2) P
ress the RIGHT or SELECT
button to move to the next space.
(3) P
ress the SELECT button after
you enter the last number or letter
to confirm the transmitter ID.
Transmitter ID setting screen
The transmitter ID is a unique code with 5 numbers and/or letters found
in the following locations:
• On the transmitter box label
• On the bottom of the transmitter
c. S
et the low and high glucose alert values appropriate for each
individual patient. The low and high glucose alerts are pre-set to 80
mg/dL and 200 mg/dL but can be changed.
Low Alert setting screen
High Alert setting screen
NOTE: Even though alerts and alarm for low or high glucose levels
are inactive in blinded mode, you must set the low and high alert
levels as part of the Setup Wizard process in order to proceed.
52 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
WARNING
ow/high glucose alerts and the 55 mg/dL low glucose
L
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and
will not alert you when the glucose is low or high. Check
blood glucose meter if there are any signs or symptoms
of low or high glucose.
(1) Press the UP or DOWN button to select the alert level. The low
alert can be changed in steps of 5 mg/dL, and the high alert can
be changed in steps of 10 mg/dL.
(2) Press the SELECT button to confirm the alert level.
• You can also change the alert levels in the Alerts menu.
• The unit of measurement (mg/dL) is not adjustable.
• If you need to change the time, date or transmitter ID after
you complete the Setup Wizard see Section 5.2, The Settings
Menu.
The Setup Wizard is now complete. To start using the Dexcom G4
PLATINUM Professional CGM System you must insert a sensor (see
Chapter 6, Inserting a Sensor and Starting a Sensor Session).
5.2 THE SETTINGS MENU
The Settings menu lets you change the time, date or transmitter ID. The
Setup Wizard only works the first time you turn on the receiver, but you
can always use the Settings menu to make changes to the transmitter
ID, time and date, etc.
5.2.1 GETTING TO THE SETTINGS MENU
1. P
ress the SELECT button to turn on the receiver. The 3-hour trend
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5
graph shows.
2. P
ress the SELECT button to see the Main Menu.
3. From the Main Menu, press the UP or DOWN button to scroll to
“Settings” and press the SELECT button. The Settings menu shows:
Main Menu,
Settings highlighted
Settings menu
5.2.2 SETTING THE RECEIVER TIME AND DATE
1. F
rom the Settings menu, press the UP or
DOWN button to scroll to “Time/Date,” and
press the SELECT button.
Settings menu,
Time/Date highlighted
2. P
ress the RIGHT button to highlight each
value in the date and time.
3. Press the UP or DOWN button to make any
changes.
4. P
ress the RIGHT button to move to the
next value.
The date format is YYYY/MM/DD.
5. P
ress the SELECT button after choosing
Time/Date setting screen,
year highlighted
54 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
“AM” or “PM.” You will return to the Settings menu.
You might need to reset the receiver’s time and date if the rechargeable
battery drains. If this happens, the receiver will alert you and
automatically take you to the Time/Date setting screen.
5.2.3 ENTERING THE TRANSMITTER ID
Any time you switch to a new transmitter and/or receiver you must enter
the transmitter ID into the receiver. The transmitter ID is a series of 5
numbers and/or letters that can be found in the following locations:
• On the transmitter box label
• On the bottom of the transmitter
If you cannot find the transmitter ID, please contact Dexcom Technical
Support (see Chapter 15, User Assistance).
You can only set the transmitter ID when you are not in a sensor
session. During a sensor session, “Transmitter ID” will not be an option
on the Settings menu.
To enter the transmitter ID follow these steps:
1. From the Settings menu, press the UP or
DOWN button to scroll to “Transmitter ID”
and press the SELECT button.
Settings menu,
Transmitter ID highlighted
2. Start with the first number or letter (do not enter “SN”):
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5
a. Press the UP or DOWN button to
show the correct number or letter.
b. Press the RIGHT or SELECT button
to move to the next value and repeat
step a.
c. Continue repeating steps a and b to
enter the whole transmitter ID.
Transmitter ID setting screen,
first digit highlighted
d. Press the SELECT button after you
enter the last number or letter. You will return to the Settings menu.
NOTE: The “Transmitter ID” menu option is marked with an antenna
symbol as a graphical flag; it does not tell you whether the transmitter
and receiver are communicating. The “Transmitter ID” menu option only
shows when you are not in a sensor session. See Section 5.4 for the
antenna symbol that shows whether the transmitter and receiver are
communicating.
5.3 CHECKING INFORMATION ABOUT THE
DEXCOM G4 PLATINUM PROFESSIONAL
SYSTEM
You can check the receiver for information about the CGM system at
any time.
1. F
rom the Settings menu, press the UP or
DOWN button to scroll to “Device Info.”
2. P
ress the SELECT button. Information
about the sensor session and system will
show.
3. Scroll down to see all of the Device Info:
• Insertion Time
• Last Calibration
• Transmitter Battery
Settings menu,
Device Info highlighted
56 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
• Transmitter ID
• Serial Number
• Part Number
• Part Revision
• Software Number
• Software Revision
Device Info screen
4. Press the LEFT button to return to the Settings menu.
When healthcare professionals use more than one system in their
practice, remember to check that the correct Transmitter ID is entered
into the receiver.
5.4 TRANSMITTER AND RECEIVER
COMMUNICATION
When you are in a sensor session, you can check that the receiver and
transmitter are communicating.
CONTRAINDICATION
Remove the Dexcom G4 PLATINUM Sensor,
Transmitter, and Receiver before Magnetic
Resonance Imaging (MRI), Computed
Tomography (CT) scan, or diathermy treatment. The
device is MR Unsafe. Do not bring any portion of the
device into the MR environment. The Dexcom G4
PLATINUM Professional System has not been tested
during MRI or CT scans or with diathermy treatment.
The magnetic fields and heat could damage the device
so that it might not display sensor glucose readings or
provide alerts, and you might miss a low or high blood
glucose value.
MR
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5
PRECAUTION
The transmission range from the transmitter to the
receiver is up to 20 feet without obstruction. Wireless
communication does not work well through water so the
range is much less if you are in a pool, bathtub, or on a
water bed, etc. Types of obstruction differ and have not
been tested. If your transmitter and receiver are farther
than 20 feet apart or are separated by an obstruction,
they might not communicate or the communication
distance may be shorter and you might miss a low or
high blood glucose value.
Press the SELECT, LEFT or RIGHT button to see the trend graph.
This antenna symbol
shows that the transmitter and receiver are
communicating.
Antenna symbol appears
in upper left of trend
graph in real-time mode
Antenna symbol appears
in upper left of trend
graph in blinded mode
This out of range symbol
shows the transmitter and receiver are not
communicating. See Chapter 13 for troubleshooting instructions if the
out of range symbol appears.
58 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Out of range symbol appears
in upper right of trend graph
in real-time mode
Out of range symbol appears
in upper right of trend graph
in blinded mode
5.5 USING THE RECEIVER SHIELD AND
PREPARING THE RECEIVER FOR MULTIPLE
PATIENT USE
PRECAUTIONS
• If all 3 square seals have been used before the end
of the session, return the receiver to the healthcare
professional office. Do not charge the receiver if
you cannot seal it. Unsealed receivers could spread
contamination.
• Do not puncture the receiver shield for any reason.
Punctured shields could spread contamination.
• Return the receiver to the healthcare professional if
the acoustic spacer moves away from the upper right
corner. The entire receiver shield must be discarded
and replaced. The spacer allows the receiver speaker
to work properly when the shield is in place. If the
spacer moves and the receiver speaker volume is low,
you might miss alerts or alarms.
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5
PRECAUTION
Inspect the receiver shield, seals and spacer for tears
or other damage or defects before you place the
components on the receiver. Do not use any parts of the
receiver shield pack that are damaged or defective. If the
receiver shield, seals and spacer are torn, damaged or
otherwise defective after giving to the patient, the patient
should return the receiver to the healthcare professional
for a replacement. The damaged or defective receiver
shield should not be taken off by the patient. If a defect
or malfunction is suspected, the healthcare professional
should retain the shield and contact Dexcom Technical
Support. The shield helps protect the user and
healthcare professionals from contamination and allows
the receiver to function properly.
The Dexcom G4 PLATINUM Receiver is protected by a receiver shield
when used with multiple patients.
Acoustic spacer
Triangle seal
Square seals
Receiver shield
Receiver shield pack
60 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
The receiver shield pack includes:
• Receiver shield
•1
triangle seal (tape to cover the slot in the back of the receiver
shield)
•3
square seals (tape to cover the USB port)
•1
acoustic spacer to ensure proper volume from the receiver
Before inserting the sensor and giving the receiver to the patient for their
7-day session, you need to place the acoustic spacer, receiver shield,
and seals:
1. W
ash hands and put on sterile gloves.
Peel acoustic spacer from paper
backing and secure on upper speaker
edge.
Acoustic spacer in upper
right of receiver
Opening back of receiver
2. N
ote location of USB opening on
receiver shield. Stretch receiver shield
over receiver.
USB opening
lined up with
USB port
Stretch receiver shield
over receiver
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5
3. Peel triangle seal from paper backing
and secure seal over opening on back
of receiver.
USB opening
Triangle seal over
shield opening
USB door open
4. P
eel 1 square seal from paper backing
and secure seal over USB door on side
of receiver. Save additional USB seals
for recharging.
Square seal over USB port
NOTE: The receiver shield is not waterproof.
Be sure to instruct the patient on how to properly recharge the receiver
as needed based on proper Standard Precautions when handling
or using this device. All parts of the system should be considered
potentially infectious and are capable of transmitting blood-borne
pathogens between patients and healthcare professionals. For more
information, refer to “Guideline for Isolation Precautions: Preventing
Transmission of Infectious Agents in Healthcare Settings 2007,”
http://www.cdc.gov/hicpac/2007ip/2007isolationprecautions.html.
If a patient returns a receiver because the shield or seals are torn,
damaged or defective, assume that the receiver has been contaminated
and discard the receiver, shield, seals and spacer. If a patient returns a
receiver because the spacer is torn, damaged or defective, discard the
shield, seal and spacer and replace with a new shield, seal and spacer.
62 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
6
chapter six
INSERTING A SENSOR AND
STARTING A SENSOR SESSION
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64 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 6: INSERTING A SENSOR AND
STARTING A SENSOR SESSION
You need a sensor, a transmitter, a receiver and a receiver shield to
use the Dexcom G4 PLATINUM Professional Continuous Glucose
Monitoring System. You also need a blood glucose meter and test strips
for calibration. The blood glucose meter and test strips are not provided
in the Dexcom G4 PLATINUM Professional System. The sensor
continuously measures and displays the sensor glucose readings for up
to 7 days when in real-time mode. The following sections will show you
how to insert the sensor and start a new continuous glucose monitoring
session both in real-time and blinded modes.
WARNING
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 at 1.877.339.2664 or
1.858.200.0200.
For patients undergoing an MRI with a retained wire
broken off from a Dexcom G4 PLATINUM Sensor,
in-vitro MRI testing did not detect any safety hazards.
There was no significant migration or heating of the wire
and imaging artifacts were limited to the area around the
wire.
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6
6.1 BEFORE YOU START
• Make sure the correct transmitter ID has been entered into the receiver
(see Chapter 5, Section 5.2, The Settings Menu). You do not need to
re-enter the transmitter ID each time you start a sensor session.
• Check the expiration date on the sensor package label. The format is
YYYY-MM-DD. Insert sensors on or before the end of the expiration
date calendar day.
• Follow the blood glucose meter’s manufacturer’s instructions to make
sure you are getting accurate blood glucose values for calibration.
• The healthcare professional must clean and disinfect the transmitter
before giving it to a new user (see Chapter 12, Section 12.3, Cleaning
and Disinfection of the Transmitter).
• Make sure the blood glucose meter and receiver date and time are
correct and match.
WARNING
Store the sensor at temperatures between 36° F - 77° F
for the length of the sensor’s shelf life. You may store the
sensor in the refrigerator if it is within this temperature
range. The sensor should not be stored in a freezer.
Storing the sensor improperly might cause the sensor
glucose readings to be inaccurate, and you might miss a
low or high blood glucose value.
66 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Review the sensor applicator picture before using a new sensor.
Plunger
Safety lock
Applicator barrel
(contains small introducer
needle and sensor)
Collar
Transmitter latch
Sensor pod
Release tab
Adhesive patch
6.2 REMOVING THE SENSOR FROM ITS
PACKAGING
PRECAUTION
Do not use the sensor if its sterile package has been
damaged or opened. Using an unsterile sensor might
cause infection.
• Wash hands thoroughly, and dry them.
• Carefully remove the sensor from its packaging. Look closely at the
sensor to make sure it is not damaged.
• The applicator is for single use and is disposable.
• The safety lock prevents you from releasing the needle accidentally
before you are ready.
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6.3 CHOOSING AN INSERTION SITE
PRECAUTIONS
• Avoid inserting the sensor in areas that are likely to be
bumped, pushed or compressed or areas of skin with
scarring, tattoos, or irritation as these are not ideal sites
to measure glucose. Insertion in those areas might
affect sensor performance, and you might miss a low or
high blood glucose value.
•A
void injecting insulin or placing an insulin pump
infusion set within 3 inches of the sensor. The insulin
might affect sensor performance, and you might miss a
low or high blood glucose value.
Choose a site on the belly to place the sensor. You can choose a site
above or below the belt line. The best areas to insert the sensor are
usually flat, “pinchable,” and free from where rubbing can occur, such as
along the waist band and seat belt strap.
• Choose an area at least 3 inches from the insulin pump infusion set or
injection site.
• If more than one sensor is used, 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
the adhesive patch sticks securely.
• Make sure there are no traces of lotions, perfumes or medications
on the area. Clean the skin with isopropyl alcohol to remove these
products from the skin.
68 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
6.4 PLACING THE SENSOR
WARNING
Do not use the Dexcom G4 PLATINUM Professional
System for treatment decisions, such as how much
insulin you should take. The Dexcom G4 PLATINUM
Professional System does not replace a blood glucose
meter. Always use the values from your blood glucose
meter for treatment decisions. Blood glucose values may
differ from sensor glucose readings. Using the sensor
glucose readings for treatment decisions could lead to
low or high blood glucose value.
1. C
lean the skin at the sensor placement site with an alcohol wipe.
Make sure the area is clean and completely dry before you insert the
sensor.
2. R
emove the adhesive backing from the
sensor pod one half at a time, using
the white tabs on the backing. Hold the
sensor by the applicator barrel, and try
not to touch the sticky adhesive patch.
Step 2. Remove the
adhesive backing
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3. Place the sensor horizontally, NOT
vertically, on the skin.
4. Move your fingers around the adhesive
patch to secure the tape to the skin.
Step 3 and 4. Adhere
the sensor on the skin
5. H
old the applicator, and pull the safety lock straight out away from the
applicator, in the direction of the arrows in the picture.
Step 5. Remove the safety lock
6. Save the safety lock to help you remove the transmitter at the end
of the sensor session. The safety lock can be used for transmitter
removal but is not required. When the glucose monitoring session
is over, follow the steps in Chapter 11, Section 11.3, Transmitter
Removal, with or without the safety lock.
6.5 SENSOR INSERTION
You are ready to insert the sensor after you place the applicator on the
belly and remove the safety lock. To insert the sensor follow these steps:
1. Place the fingers of one hand at the edge of the white adhesive (at the
opposite side of the sensor from the transmitter latch). You may pinch
up on the skin using this hand. Do not pinch up in the middle section
of the plastic base.
70 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
2. While still pinching, use the other hand to place two fingers above the
collar on the applicator barrel so they are resting above the collar.
3. Place a thumb on the white plunger. Push the plunger down
completely, making sure it is flush against the applicator barrel. You
should hear 2 clicks. This inserts the needle and sensor under the
skin.
When you are pushing down on the plunger, do not pull back on
the collar.
“2 CLICKS”
Steps 1-3. Push down the plunger - insert the needle and sensor
4. K
eep pinching up on the skin with one
hand. With the other hand, place two
fingers under the collar. Keep the thumb
lightly on top of the white plunger, and
pull the collar back towards the thumb
until you hear 2 clicks or cannot pull
back any more. This leaves the sensor
under the skin and removes the needle
from the body.
“ 2 CLICKS”
Step 4. Pull back the
collar - retract the needle
5. S
queeze the center of the ribbed
release tabs on the sides of the sensor
pod to remove the applicator barrel.
Only the sensor pod will be left on the
body.
Step 5. Release the
applicator barrel
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• Make sure the transmitter latch is down (against the body) before
squeezing the tabs to remove the applicator barrel.
• Squeeze the center of the ribbed part of the release tabs.
• While squeezing the tabs, rock the applicator barrel forward and out
away from the body.
If you have any problems with insertion, save the sensor and applicator
and contact Dexcom Technical Support (see Chapter 15, User
Assistance).
6.6 TRANSMITTER ATTACHMENT
You must snap the transmitter into the sensor pod after you insert the
sensor. Follow these steps to attach the transmitter.
1. E
nsure the transmitter is free of dust before placing the transmitter
in the sensor pod (see Chapter 12, Section 12.3, for cleaning
instructions).
Do not to touch the metal circles on the bottom of the transmitter with
the skin.
Do not to scratch the bottom of the transmitter as scratches may
compromise the waterproof seal.
2. P
lace the transmitter in the sensor pod
(with the flat side down, and the narrower
side away from the transmitter latch).
Install transmitter in
sensor pod
3. Snap in the transmitter:
a. W
ith one hand, you may want to pinch up on the skin at the front
edge of the white adhesive.
b. Place one finger on the transmitter to keep it in place.
72 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Transmitter latch
c. W
ith the other hand, pull the
transmitter latch up and forward, Transmitter installed
over the transmitter, to snap
it into place. The transmitter
should lie flat in the sensor pod.
Side view of transmitter in
• M
ake sure you hear 2 clicks
sensor pod
when you snap the transmitter
in place. If it is not fully
snapped in, this may lead to a poor connection and let fluids to
get under the transmitter. This can lead to inaccurate sensor
glucose readings or missed sensor glucose readings as shown as
.
d. R
elease the pinch on the adhesive edge at this time.
e. Make sure the transmitter is secure by sliding the fingers under
each long side of the sensor pod and pressing down on the
transmitter with the thumb of the same hand, like you are pinching
it.
4. H
old the sides of the sensor pod with one
hand. Remove the transmitter latch with the
other hand by quickly twisting off the latch away
from the body.
Twist transmitter latch
up or down
5. Do not remove the transmitter from the sensor pod while the
pod is attached to the skin.
6.7 STARTING A SENSOR SESSION
Follow the steps below to tell the receiver that you inserted a new
sensor.
1. P
ress the SELECT button to turn on the receiver.
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6
2. F
rom any trend graph, press the SELECT button to see the Main
Menu.
3. Press the DOWN button to highlight “Start
Sensor.”
• The “Start Sensor” menu option will
disappear from the Main Menu after you
select it. The option will only come back
after an active sensor session ends. If you
do not see the “Start Sensor” option on
Main Menu,
the menu screen, you can continue the
Start Sensor highlighted
current session or stop the session (refer
to Chapter 13, Section 13.6, Sensor Shut-off Troubleshooting).
4. P
ress the SELECT button to confirm the
start of a new sensor session. The Start
Sensor “thinking” screen lets you know the
sensor 2-hour startup has begun.
Start Sensor
“thinking“ screen
5. T
he receiver returns to the 3-hour trend graph.
6. Check the receiver 10 minutes after starting the sensor session to
make sure the receiver and transmitter are communicating. The
antenna symbol
should be in the upper left corner of trend graph.
If the out of range symbol
shows in the upper right corner of the
trend graph, see Chapter 13, Section 13.9, Out of Range/No Antenna.
74 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Antenna symbol should
appear in upper left of trend
graph in real-time mode
Antenna symbol should
appear in upper left of trend
graph in blinded mode
7. If in real-time mode, you will not get sensor glucose readings or
high/low glucose alerts until the 2-hour startup period ends and you
complete the first calibrations. See Chapter 7, Section 7.3, Startup
Calibration. If in blinded mode, you will not get sensor glucose
readings or high/low glucose alerts during the entire 7-day sensor
session.
6.8 SENSOR STARTUP PERIOD
The sensor needs a 2-hour startup period to adjust to being under the
skin.
The trend graph shows a 2-hour countdown symbol
right corner.
Countdown symbol appears
in upper right of trend graph
in real-time mode
in the upper
Counddown symbol appears
in upper right of trend graph
in blinded mode
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6
1. Press SELECT during the startup period to turn the on receiver
display and see this symbol.
In both real-time and blinded modes, the countdown symbol
fills in
over time to show that you are getting closer to the first calibration time.
You will not get sensor glucose readings, high/low glucose alerts and
alarm during the countdown.
Start
[0-24]
minutes
[24-48]
minutes
[48-72]
minutes
[72-96]
minutes
Ready for
calibration
Countdown symbol fills in during sensor startup
If you see the out of range symbol
at the top of the screen during the
2-hour startup, review the following troubleshooting tips:
• Make sure the receiver and transmitter are within 20 feet of each
other without obstruction. Check in 10 minutes to see if the antenna
symbol shows in the upper left corner of the receiver screen.
• If the receiver and transmitter are still not communicating, check the
device information screen to make sure the correct transmitter ID is
entered into the receiver (see Chapter 5, Section 5.2, The Settings
Menu).
• If the correct transmitter ID is in the receiver and the receiver and
transmitter are still not communicating, contact Dexcom Technical
Support (see Chapter 15, User Assistance).
At the end of the 2-hour startup period the receiver lets you know it
is time to calibrate the sensor. Chapter 7, Calibrating the Dexcom G4
PLATINUM Professional System, tells you how to calibrate the sensor.
6.9 TAPING THE SENSOR POD
The sensor pod should stay on the skin using its own adhesive. But, if
the patch is peeling up, you can use medical tape (such as Blenderm™,
Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support.
If you use tape, only tape over the white adhesive patch on all sides
76 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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 sensor.
The right way to use
tape for extra support
6.10 TEMPORARY RECEIVER SHUTDOWN
There may be times when you want to shut down the receiver
temporarily. Shutdown stops all communication between the transmitter
and receiver and turns the receiver off. You will not receive sensor
glucose readings or any alerts or alarm while the receiver is shut down,
but the current sensor session will continue. During the shutdown
period, no sensor glucose readings will be recorded or kept in memory.
Follow these steps to shut down the receiver:
1. F
rom the main menu, scroll to highlight
“Shutdown.” Press the SELECT button.
Main Menu,
Shutdown highlighted
2. Confirm that you want to shut down the
receiver.
a. If you want to shut down, press the LEFT
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.
Shutdown screen,
OK highlighted
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To turn the receiver back on and resume communication with the
transmitter, press and hold the SELECT button. It may take up to 20
seconds for the display to turn back on.
Remember that the alerts and low glucose alarm will not work
when the receiver is shut down nor will any sensor glucose
readings be recorded. All sensor glucose data will be lost.
Shutting down the receiver does not extend the sensor life beyond
7 days. The sensor session will stop 7 days after you started
the sensor session. Once you turn the receiver back on from
Shutdown mode, you will not need to calibrate or do anything
specific to resume.
6.11 THE DEXCOM G4 PLATINUM
PROFESSIONAL SYSTEM AND WATER
The sensor is water resistant when showering, bathing or swimming if
the transmitter is fully snapped in. The sensor has been tested to be
water resistant when submerged for up to 8 feet and up to 24 hours.
Keep the receiver dry. Do not spill fluids on it or drop it into fluids. The
receiver shield does not add protection from fluids that may damage
the receiver. Keep the micro USB port cover open throughout
the sensor session and keep the square seal over the USB port.
Wireless communication does not work well through water so the range
is much less if you are in a pool, bathtub or water bed.
If the receiver gets wet, make sure the speaker and vibrate mode are
still working. You can do this using the Try It option in the profiles menu.
See Chapter 9, Section 9.3, Alert Profiles.
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chapter seven
CALIBRATING THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM
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CHAPTER 7: CALIBRATING THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM
In both real-time and blinded modes, you must calibrate Dexcom G4
PLATINUM Professional System sensor glucose readings to the blood
glucose meter.
CONTRAINDICATION
Taking medications with acetaminophen (such as
Tylenol) while wearing the sensor may falsely raise
your sensor glucose readings. The level of inaccuracy
depends on the amount of acetaminophen active in your
body and may be different for each person.
7.1 CALIBRATION OVERVIEW
The receiver needs calibrations to display and record accurate
continuous sensor glucose readings and trend information. There are
important times when you must calibrate:
1. 2-hour startup: 2 hours after you insert the sensor
2. 12 hour update: every 12 hours after the 2-hour startup calibration
3. More information needed or other reasons
When calibrating, you must enter the blood glucose values into the
receiver by hand. You can use any commercially available blood glucose
meter. You must calibrate with accurate blood glucose meter values to
get accurate sensor glucose readings.
On the first day of the sensor session, you must enter 2 blood glucose
values into the receiver. You must enter at least 1 blood glucose value
calibration 12 hours after the startup calibration. You must enter 1 blood
glucose value every 12 hours throughout the 7-day sensor session. The
receiver will remind you when it needs these calibrations. You may be
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prompted to enter additional blood glucose values as needed.
Example Minimum Calibration Schedule During
Seven-Day Sensor Session
PRECAUTION
Do not use alternative blood glucose site testing
(blood from your palm or forearm, etc.) for calibration.
Alternative site blood glucose values may be different
than those taken from a fingerstick blood glucose value
and may not represent the timeliest blood glucose value.
Use a blood glucose value taken only from a fingerstick
for calibration. Alternative site blood glucose values
might affect sensor performance, and you might miss a
low or high blood glucose value.
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7.2 HOW TO CALIBRATE
You must enter the exact blood glucose value from the meter for each
calibration. Blood glucose values used for calibration must be between
40-400 mg/dL and must have been taken within the past 5 minutes.
• In real-time mode, make sure either a sensor glucose reading or a
calibration needed symbol
shows at the top of the trend graph in the
status area before calibrating. In blinded mode, make sure either “- - -”
or a calibration needed symbol
shows at the top of the trend graph
in the status area before calibrating.
• The sensor can be calibrated if the meter glucose is 40 mg/dL or
above. For safety reasons, if the blood glucose is low, first treat the low
blood sugar.
• Always make sure the antenna symbol
is in the upper left corner of
the trend graph before you enter blood glucose values for calibration.
• Always use the same meter to calibrate that you routinely use to
measure the blood glucose. Do not switch the meter in the middle of a
sensor session. Blood glucose meter and strip accuracy vary between
blood glucose meter brands.
• The accuracy of the blood glucose meter value used for calibration
may affect the accuracy of sensor glucose readings.
WARNING
Calibrate at least once every 12 hours. Calibrating less
often than every 12 hours might cause sensor glucose
readings to be inaccurate, and you might miss a low or
high blood glucose value.
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PRECAUTION
Do not calibrate if your blood glucose is changing at a
significant rate, typically more than 2 mg/dL per minute.
Do not calibrate when your receiver screen is showing
the rising single arrow or double arrow, which indicates
that your blood glucose is rising 2-3 mg/dL/min or more
than 3 mg/dL/min. Also, do not calibrate when your
receiver screen is showing the falling single arrow or
double arrow, which indicates that your blood glucose
is falling 2-3 mg/dL/min or more than 3 mg/dL/min.
Calibrating during significant rise or fall of blood glucose
may affect accuracy of sensor glucose readings.
PRECAUTION
To calibrate the system, enter the exact blood glucose
value that your blood glucose meter displays within
5 minutes of a carefully performed blood glucose
measurement. Entering incorrect blood glucose values or
blood glucose values from more than 5 minutes before
entry might affect sensor performance, and you might
miss a low or high blood glucose value.
Only use blood glucose values between 40-400 mg/dL for calibration. If
the blood glucose value you enter is outside of this range, the receiver
will not accept the value for calibration. You must wait until the blood
glucose is in this range to calibrate.
These steps show you how to enter the blood glucose values for
calibration in both real-time and blinded modes:
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1. W
ash and dry hands, make sure the glucose test strips are not
expired and have been stored properly, and make sure the meter is
properly coded (if required).
2. T
ake a blood glucose measurement using the meter.
•C
arefully apply the blood sample to the test strip following the meter
or test strip instructions.
3. From any trend graph, press the SELECT button to see the Main
Menu.
4. U
se the UP or DOWN button to scroll until
you highlight “Enter BG.”
• “ Enter BG” will be the second Main Menu
option when you are in the middle of a
sensor session.
5. P
ress the SELECT button to choose this
option. You will see a screen with a blood
drop and a number in mg/dL units.
Main Menu,
Enter BG highlighted
a. A
t all times in real-time and blinded modes,
when the receiver does not have a recent
sensor glucose reading the default is 120
mg/dL.
b. If there has been a sensor glucose reading
in the past 15 minutes in real-time mode,
the Enter BG screen shows the current
Enter BG screen,
sensor glucose reading. Do not use the
default is 120 mg/dL
current sensor glucose reading for
calibration. Use only blood glucose values from the meter.
6. Use the UP or DOWN button to scroll until you see the correct blood
glucose value, and then press the SELECT button.
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7. C
onfirm that the blood glucose value
you entered is correct. Entering
incorrect values may affect the sensor
accuracy. a. P
ress the SELECT button if the blood
glucose value displayed is correct.
b. If the blood glucose value shown is
Enter BG screen,
incorrect, press the RIGHT button
OK highlighted to confirm
to highlight “Cancel” then press the
SELECT button to return to the Enter BG screen. Repeat the steps
to enter the correct blood glucose value.
c. If you do not press the SELECT button, the receiver will “time out”
and no blood glucose value will be recorded for calibration.
8. T
he Enter BG “thinking” screen lets you know
the blood glucose value is being used for
calibration.
Enter BG
“thinking” screen
9. F
or 2-hour startup calibration, repeat these steps for the second
blood glucose value.
A sensor glucose reading appears on the receiver right away, and
sensor glucose readings are updated every 5 minutes.
If readings do not appear immediately, see Chapter 13, Section 13.2,
Calibration Troubleshooting.
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PRECAUTION
To calibrate the system, enter the exact blood glucose
value that your blood glucose meter displays within
5 minutes of a carefully performed blood glucose
measurement. Entering incorrect blood glucose values or
blood glucose values from more than 5 minutes before
entry might affect sensor performance, and you might
miss a low or high blood glucose value.
7.3 STARTUP CALIBRATION
Two hours after you start the sensor session
(see Chapter 6, Section 6.7, Starting a
Sensor Session) the receiver tells you
that you need to calibrate by showing the
startup calibration prompt. This means you
need to calibrate with 2 separate blood
glucose values from the meter. If used in
Startup calibration prompt
real-time mode, the receiver will not
show sensor glucose readings until
the receiver accepts the blood glucose
values for calibration. If used in blinded
mode, the receiver will not show sensor
glucose readings throughout the 7-day
sensor session. However, the receiver
will confirm that it is properly recording
sensor glucose readings every 5 minutes
“- - -” in status area
by showing “- - -” in the status area of the
receiver screen.
1. The receiver will alert you based on the alert profile setting chosen.
When you see this screen, press the SELECT button to clear it.
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a. T
he startup calibration symbol will stay at the top of the trend graph
until you calibrate.
b. T
he system will re-alert you every 15 minutes until you enter the
blood glucose values.
c. If you do not clear the prompt, the system will re-alert you every 5
minutes.
2. T
ake 2 separate blood glucose measurements with the blood glucose
meter, and enter the blood glucose values into the receiver (see
Chapter 7, Section 7.2, How to Calibrate).
7.4 12-HOUR CALIBRATION UPDATE
Calibrate the system at least every 12 hours after the first calibration
(2-hour startup calibration) to make sure the sensor glucose readings
remain accurate and close to the blood glucose meter values. You can
enter blood glucose values earlier than 12 hours if you want. If you have
not entered any blood glucose values in the past 12 hours, the receiver
will prompt you to enter a blood glucose value to update its calibration
by displaying the calibration prompt.
NOTE: The 12-hour calibration update will not audibly alert you to the
need to calibrate. A calibration prompt will silently appear on the receiver
screen to let you know it is time to calibrate.
WARNING
Calibrate at least once every 12 hours. Calibrating less
often than every 12 hours might cause sensor glucose
readings to be inaccurate, and you might miss a low or
high blood glucose value.
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The following steps show you how to enter this
calibration.
1. W
hen you see this screen, press the
SELECT button to clear it.
a. T
he calibration needed symbol will stay
at the top of the trend graph until you
calibrate.
Calibration prompt
b. T
he system will silently prompt you every
15 minutes until you enter the blood glucose values.
2. T
ake 1 blood glucose measurement with the meter, and enter the
blood glucose value into the receiver. If this screen reappears soon,
see Chapter 13, Section 13.2, Calibration Troubleshooting.
7.5 OTHER REASONS YOU MAY NEED TO
CALIBRATE
You may need to calibrate when the system did not accept the last
calibration or the blood glucose value is very different from the sensor
glucose reading.
When you see this calibration prompt it means
it is time to calibrate with a single blood glucose
value.
Take 1 blood glucose measurement with the
meter, and enter the blood glucose into the
receiver. If this screen reappears soon, see
Chapter 13, Section 13.2.1, Types of Calibration
Prompts.
Calibration prompt
These screens show calibration errors (see Chapter 13, Section 13.3,
Calibration Error Troubleshooting).
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Wait 15 minutes
calibration error screen
Wait 1 hour
calibration error screen
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chapter eight
VIEWING SENSOR GLUCOSE READINGS
AND TRENDS IN REAL-TIME MODE
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10
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CHAPTER 8: VIEWING SENSOR GLUCOSE
READINGS AND TRENDS IN REAL-TIME MODE
This chapter teaches you how to view the sensor glucose readings and
trend information. The trend graph provides additional information that
the blood glucose meter does not. It shows the current glucose value,
the direction it is changing and how fast it is changing. The trend graph
can also show you where the glucose has been over time.
NOTE: In blinded mode, sensor glucose readings will not be displayed
to the patient throughout the 7-day sensor session. The sensor glucose
readings and glucose patterns can be downloaded and reviewed later
with a healthcare professional using the Dexcom STUDIO software.
CONTRAINDICATION
Taking medications with acetaminophen (such as
Tylenol) while wearing the sensor may falsely raise
your sensor glucose readings. The level of inaccuracy
depends on the amount of acetaminophen active in your
body and may be different for each person.
The blood glucose meter and sensor measure glucose from two
different types of body fluids: blood and interstitial fluid. Therefore,
readings from the blood glucose meter and sensor may not match.
The greatest benefit you get from using the Dexcom G4 PLATINUM
Professional System used in real-time mode will come from the
trending information. It is important that you focus on the trends
and rate of change on the receiver, rather than the exact sensor
glucose reading.
If you have trouble reading the receiver in bright sunlight, find a shady
spot.
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WARNING
Do not use the Dexcom G4 PLATINUM Professional
System for treatment decisions, such as how much
insulin you should take. The Dexcom G4 PLATINUM
Professional System does not replace a blood glucose
meter. Always use the values from your blood glucose
meter for treatment decisions. Blood glucose values may
differ from sensor glucose readings. Using the sensor
glucose readings for treatment decisions could lead to
low or high blood glucose value.
8.1 SENSOR GLUCOSE READINGS IN
REAL-TIME MODE
Press the SELECT button to wake up the receiver screen and see the
home screen (the 3-hour trend graph). The 3-hour trend graph shows
the following:
Most recent 5-minute
Status area
sensor glucose reading
Battery
Trend arrow
Antenna
Glucose
values
High glucose
alert setting
Plot of most
recent sensor
glucose
readings
Glucose
target
range
Low glucose
alert setting
Trend graph hours
Current time
EXAMPLE: 3-Hour Trend Graph Screen
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• Each “dot” on the trend graph is a sensor glucose reading reported
every 5 minutes.
• The trend graph shows the current time.
• The status area shows needed calibration updates, calibration errors
and sensor glucose reading issues.
• The high alert setting shows as a yellow line across the trend graph.
• The low alert setting shows as a red line across the trend graph.
• The gray zone highlights the target glucose range, based on the high
and low glucose alert settings.
• The current sensor glucose reading is red if it is low and yellow if it is
high, based on the high and low glucose alert settings.
• If the low glucose alert is not set and the user’s glucose is 55 mg/dL or
lower, the glucose value is red.
• If the sensor glucose readings are in between the high and low glucose
alert settings, the glucose value is white.
• The dots on the trend graph change colors based on the high and low
alert settings.
You can view the past glucose information on the 1, 3, 6, 12, and 24
hour trend graphs by pressing the UP or DOWN button.
• The system only reports glucose information between 40-400 mg/dL.
The trend graph shows a flat line or dots at 400 or 40 mg/dL when the
glucose is outside this range. If the sensor glucose reading is less than
40 mg/dL the receiver will read “LOW”; if the sensor glucose reading is
greater than 400 mg/dL, the receiver will read “HIGH.”
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The sensor glucose reading is in
milligrams per deciliter (mg/dL) unit
Which Trend Graph Do You See?
(Scroll up from the 3-hour graph to reach the 1-hour graph)
1-Hour Trend Graph: The 1-hour trend graph
shows the current sensor glucose reading and the
last 1 hour of sensor glucose readings.
3-Hour Trend Graph: The 3-hour trend graph
shows the current sensor glucose reading and the
last 3 hours of sensor glucose readings.
(Scroll down from the 3-hour graph to reach the 6-hour graph)
6-Hour Trend Graph: The 6-hour trend graph
shows the current sensor glucose reading and the
last 6 hours of sensor glucose readings.
(continued on next page)
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Which Trend Graph Do You See? (continued from page
before)
(Scroll down from the 6-hour graph to reach the 12-hour graph)
12-Hour Trend Graph: The 12-hour trend graph
shows the current sensor glucose reading and the
last 12 hours of sensor glucose readings.
(Scroll down from the 12-hour graph to reach the 24-hour graph)
24-Hour Trend Graph: The 24-hour trend graph
shows the current sensor glucose reading and the
last 24 hours of sensor glucose readings.
The receiver displays “LOW” when the most recent sensor glucose
reading is less than 40 mg/dL and “HIGH” when the most recent sensor
glucose reading is greater than 400 mg/dL.
Trend graph
reading LOW
Trend graph
reading HIGH
8.2 RATE OF CHANGE ARROWS IN REAL-TIME
MODE
The rate of change arrows add detail about the direction and speed of
glucose change over the last 15-20 minutes.
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The trend arrows show to the right of the current
sensor glucose reading.
Do not overreact to the rate of change
arrows. Consider recent insulin dosing, activity,
food intake, the overall trend graph and the
blood glucose value before taking action.
If there are missed communications between
the sensor and receiver during the last 15-20
minutes, an arrow may not display.
Rate of change arrow
appears in upper right
of trend graph
This table shows the different trend arrows the receiver displays:
Trend Arrows
Constant: The glucose is steady (not increasing/decreasing more
than 1 mg/dL each minute). The glucose could increase or decrease
by up to 15 mg/dL in 15 minutes.
Slowly rising: The glucose is rising 1-2 mg/dL each minute. If it
continued rising at this rate, the glucose could increase up to 30
mg/dL in 15 minutes.
Rising: The glucose is rising 2-3 mg/dL each minute. If it continued
rising at this rate, the glucose could increase up to 45 mg/dL in 15
minutes.
Rapidly rising: The glucose is rising more than 3 mg/dL each minute.
If it continued rising at this rate, the glucose could increase more than
45 mg/dL in 15 minutes.
Slowly falling: The glucose is falling 1-2 mg/dL each minute. If it
continued falling at this rate, the glucose could decrease up to 30
mg/dL in 15 minutes.
(continued on next page)
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Trend Arrows (continued from page before)
Falling: The glucose is falling 2-3 mg/dL each minute. If it continued
falling at this rate, the glucose could decrease up to 45 mg/dL in 15
minutes.
Rapidly falling: The glucose is falling more than 3 mg/dL each
minute. If it continued falling at this rate, the glucose could decrease
more than 45 mg/dL in 15 minutes.
No arrow
No rate of change information: The receiver cannot calculate how
fast the glucose is rising or falling at this time.
Trend arrows show to the right of the sensor glucose reading.
They tell you more about the glucose’s speed and direction.
Trend arrows do not show when there are
glucose data gaps (see Chapter 13, Section
13.4, System Glucose Error). If the glucose
reading error symbol
, the wait symbol ,
the out of range symbol
, or the calibration
needed symbol
show at the top of the trend
graph, the trend arrows will not show.
If the trend arrow is missing, but you are
concerned that the blood glucose level may
be rising or falling, take a blood glucose
measurement test on the blood glucose meter.
Trend graph with
out of range symbol
in upper right and
glucose data gaps
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WARNING
Do not ignore symptoms of high and low glucose. If your
sensor glucose readings do not match your symptoms,
measure your blood glucose with a blood glucose meter
even if your sensor is not reading in the high or low
range, so you do not miss a low or high blood glucose
value.
8.3 GLUCOSE STATUS AREA SYMBOLS IN
BOTH REAL-TIME AND BLINDED MODES
The “status area” at the top of the trend graph may show any of the
status symbols below during the sensor session. You will not get sensor
glucose readings during the time a status symbol shows except during
the regular 12-hour calibration prompt or if the receiver is in blinded
mode. See Chapter 8, Section 8.1, Sensor Glucose Readings in
Real-Time Mode, for receiver display status area.
Status Symbols
This symbol means you need to enter a calibration. This prompt will
show when it is time for the 12-hour calibration update or any other time
Calibration an additional calibration is needed (see Chapter 7, Section 7.2, How to
Needed Calibrate).
Additional This symbol means you need to enter one more blood glucose value in
Startup
order to calibrate the system and start getting sensor glucose readings.
Calibration
Needed
(continued on next page)
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Status Symbols (continued from page before)
Glucose
Reading
Error
This symbol means the receiver does not understand the sensor signal
but is likely to recover. This symbol is related to the sensor only. You
should wait for more prompts and do not enter any blood glucose
values when you see this symbol (see Chapter 13, Section 13.4, System
Glucose Error, for more information).
Out of
Range
This symbol means the receiver and sensor/transmitter are not
communicating. Make sure the receiver and sensor/transmitter are
within 20 feet of each other without obstruction (see Chapter 1, Section
1.4, Transmitter Overview).
This symbol means the sensor cannot calibrate right now. If you see
this screen, enter at least one more calibration blood glucose value after
Wait 15
Minutes about 10-15 minutes. If the sensor still cannot calibrate after that, the
Calibration sensor needs to be removed and a new sensor needs to be inserted.
Error
This symbol means the sensor is not calibrating correctly. If you see
this screen, wait a minimum of one hour and then enter one more blood
Wait 1
glucose value. If no readings display on the receiver after this, the
Hour
Calibration sensor needs to be removed and a new sensor needs to be inserted.
Error
Wait
This symbol means the receiver has detected a potential significant
problem with the sensor signal and may result in a sensor failure. You
should wait about 30 minutes for more prompts. Do not enter any blood
glucose values when you see this symbol.
Status symbols show in the upper right of the trend graph.
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chapter nine
ALERTS, ALARM & PROFILES
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CHAPTER 9: ALERTS, ALARM & PROFILES
This chapter teaches you about the Dexcom G4 PLATINUM
Professional CGM System’s many alerts and alarm and how to set
them.
9.1 SETTING THE ALERTS IN REAL-TIME
MODE
WARNING
ow/high glucose alerts and the 55 mg/dL low glucose
L
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and
will not alert you when the glucose is low or high. Check
blood glucose meter if there are any signs or symptoms
of low or high glucose.
9.1.1 DEFAULT ALERT/ALARM SETTINGS
The following alerts and alarms are preset on the receiver.
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Default Alert/Alarm Settings in Real-Time Mode
What will I see
on the receiver
screen?
What does this
mean?
What
How will the
is the
receiver notify
default me?
setting?
Will the
receiver
re-notify
me?
On at
High Glucose
200
Alert
The most recent mg/dL
sensor glucose
reading is at or
above the high
alert setting.
Vibrates 2
times and then
vibrates/beeps
2 times every
5 minutes until
confirmed or the
glucose value
drops below the
alert level.
No, unless
you have
turned on
the high
alert snooze
feature.
On at
Low Glucose
80
Alert
The most recent mg/dL
sensor glucose
reading is at or
below the low
alert setting.
Vibrates 3
times and then
vibrates/beeps
3 times every
5 minutes until
confirmed or the
glucose value
goes above the
alert level.
No, unless
you have
turned on
the low alert
snooze
feature.
On
Low Glucose
Alarm
The most recent
sensor glucose
reading is at or
below 55 mg/dL
Vibrates 4
times and then
vibrates/beeps
4 times every
5 minutes until
confirmed or the
glucose value
goes above 55
mg/dL.
Yes, every
30 minutes
after each
confirmation
until the blood
glucose value
comes back
into range.
(continued on next page)
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Default Alert/Alarm Settings (continued from page before)
What will I see
on the receiver
screen?
What does this
mean?
What
is the
default
setting?
How will
the receiver
notify me?
Will the
receiver
re-notify
me?
Out of Range
Alert
The
sensor/transmitter
and receiver are
not communicating
to each other.
Off
The alert will
not notify you.
You must
change the
settings to
receive this
alert.
No
Rise/Fall Alert
Single Arrow
The glucose is
rising/falling at or
above a rate of
2 mg/dL/min (at
least 30 mg/dL in
15 minutes).
Off
The alert will
not notify you.
You must
change the
settings to
receive this
alert.
No
Rise/Fall Alert
Double Arrow
The glucose is
rising/falling at or
above a rate of
3 mg/dL/min (at
least 45 mg/dL in
15 minutes).
Off
The alert will
not notify you.
You must
change the
settings to
receive this
alert.
No
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This table describes the receiver alerts and alarm and explains how the
receiver will notify you in the default setting. The only alert in this table
that can be activated in blinded mode is the out of range alert.
The receiver may alert you at other times you need to take action, such
as low battery, failed sensor, etc. See Chapter 18, Appendix I, for a
detailed list of these other alerts.
9.1.2 GLUCOSE ALERTS AND ALARM IN
REAL-TIME MODE
The Dexcom G4 PLATINUM Professional System lets you create
personal settings for how you want the receiver to tell you what is going
on if the receiver is used in real-time mode. The low and high glucose
alerts tell you when the sensor glucose readings are outside the target
glucose range. Rise and fall (rate of change) alerts let you know when
the glucose levels are changing fast (see Chapter 9, Section 9.2,
Advanced Alerts). The Dexcom G4 PLATINUM Professional System also
has a 55 mg/dL low glucose alarm that cannot be changed or turned off.
This safety feature tells you the glucose level may be dangerously low.
You can set high and low glucose alerts to vibrate and beep. This feature
can help during sleeping, driving, exercising or during meetings.
When you have both the high and low alerts turned on, a gray zone on
the trend graph shows the target range.
9.1.2.1 HIGH GLUCOSE ALERT IN REAL-TIME
MODE
When the sensor glucose readings are at or
above the high alert level, this screen shows the
high glucose alert level. The receiver vibrates
and/or beeps depending on the profile setting
(see Chapter 9, Section 9.3, Alert Profiles). This
level shows as a yellow line on the trend graph.
The receiver continues to alert until you press
the SELECT button to clear the alert or until the
High glucose alert
set at 200 mg/dL
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sensor glucose readings drop below the high
glucose alert level. You can have the receiver
re-alert after clearing the alert (to change the
snooze settings see Chapter 9, Section 9.2,
Advanced Alerts).
High glucose alert setting
9.1.2.2 LOW GLUCOSE ALERT IN REAL-TIME
MODE
When the sensor glucose readings are at or
below the low alert level, this screen shows the
low glucose alert level. The receiver vibrates
and/or beeps depending on the profile setting.
This level shows as a red line on the trend
graph.
The receiver continues to alert until you press
the SELECT button to clear the alert or until
the sensor glucose readings rise above the
low glucose alert level. You can have the
receiver re-alert after clearing the alert (to
change the snooze settings see Chapter 9,
Section 9.2, Advanced Alerts).
Low glucose alert set
at 80 mg/dL
Low glucose alert setting
9.1.2.3 LOW GLUCOSE ALARM IN REAL-TIME
MODE
The Dexcom G4 PLATINUM Professional System also has a fixed low
alarm at 55 mg/dL. This is different than the low glucose alert. You
cannot change or turn off this alarm or its re-alarm settings.
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9
• The receiver displays the low glucose alarm
screen.
• Re-alarm: The receiver automatically alerts
again 30 minutes after you press the SELECT
button to clear it, if the sensor glucose readings
are still at or below 55 mg/dL.
• The receiver does not alert for reading below
55 mg/dL if you calibrated in the last 5 minutes.
Low glucose alarm
• The receiver alerts if the sensor glucose reading stays outside the
target range after five minutes.
9.1.3 GETTING TO THE ALERTS MENU FOR
BOTH REAL-TIME AND BLINDED MODES
1. P
ress the SELECT button to turn on the receiver. The 3-hour trend
graph shows.
Trend graph in
real-time mode
Trend graph in
blinded mode
2. Press the SELECT button to see the Main Menu.
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3. From the Main Menu, press the UP or DOWN
button to scroll to “Alerts,” and press the
SELECT button. The Alerts menu shows.
Main Menu,
Alerts highlighted
Alerts menu,
High Alert highlighted
9.1.4 CHANGING THE HIGH AND LOW
GLUCOSE ALERTS
WARNING
ow/high glucose alerts and the 55 mg/dL low glucose
L
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and
will not alert you when the glucose is low or high. Check
blood glucose meter if there are any signs or symptoms
of low or high glucose.
The steps for changing both the high alert and the low alert are the
same.
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NOTE: Changing the high and low glucose alert is not necessary in
blinded mode as the high/low glucose alerts are disabled.
The following steps show you how to change the high and low alert
settings.
1. F
rom the Alerts menu, press the UP or
DOWN button to select “High Alert” or “Low
Alert” and press the SELECT button.
Alerts menu,
High Alert highlighted
2. H
ighlight “On/Off,” and then press the
SELECT button to set this option. A check
mark shows next to the current setting.
High Alert menu,
On/Off highlighted,
On selected
High Alert menu,
On selected
3. Press the LEFT button to return to the last screen.
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4. P
ress the DOWN button to highlight “Level.”
The number that shows is the current high
glucose alert level.
High Alert menu,
Level highlighted
5. T
o change this number, press the SELECT
button, and then press the UP or DOWN
button to select the high glucose alert level.
•T
he high glucose alert value can be set
between 120 and 400 mg/dL in 10 mg/dL
steps.
•T
he low glucose alert value can be set
between 60 and 100 mg/dL in 5 mg/dL
steps.
High Alert setting screen,
200 mg/dL selected
6. Press the SELECT button to confirm the alert level.
7. Press the LEFT button to return to the Alerts menu when you finish.
9.2 ADVANCED ALERTS
Advanced alerts include the high and low snooze, rise and fall rate, and
out of range alerts. All advanced alerts follow the following steps.
NOTE: The only advanced alerts that can be activated in blinded mode
is the out of range alert.
1. P
ress the SELECT button to turn on the receiver.
2. P
ress the SELECT button to enter the Main Menu.
3. Press the UP or DOWN button to highlight “Alerts,” and press the
SELECT button.
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9
4. F
rom the Alerts menu, press the UP or
DOWN button to select “Advanced,” and
press the SELECT button.
Alerts menu,
Advanced highlighted
9.2.1 SETTING A SNOOZE TIME FOR THE HIGH
AND LOW GLUCOSE ALERTS IN REAL-TIME
MODE
The snooze feature lets you delay the high and low glucose re-alerts.
You have the option to set a snooze time for every 15 minutes for up to
5 hours.
1. P
ress the UP or DOWN button to highlight
“High Snooze” or “Low Snooze” and press
the SELECT button.
Advanced menu,
High Snooze highlighted
2. P
ress the UP or DOWN button to select
the amount of time (in 15 minute steps)
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.
High Alert setting screen,
15 minutes selected
3. Press the LEFT button to return to the Alerts menu when you finish.
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9.2.2 RISE AND FALL GLUCOSE RATE ALERTS
IN REAL-TIME MODE
Rate alerts tell you when the glucose levels are rising (rise alert) or
falling (fall alert) and by how much. You can choose for the receiver
to alert when the sensor glucose reading is rising or falling 2 mg/dL or
more per minute, or 3 mg/dL or more per minute.
If you set the fall rate to 2 mg/dL per minute
and the sensor glucose readings fall at this rate
or faster, the “FALLING single arrow” screen
shows, and the receiver vibrates or beeps in line
with the profile settings.
Fall alert
If you set the rise rate to 3 mg/dL per minute
and the sensor glucose readings rise at this rate
or faster, the “RISING double arrow” screen
shows, and the receiver vibrates or beeps in line
with the profile settings.
Rapid Rise alert
These steps show how to change the rise or fall rate alert settings.
1. P
ress the UP or DOWN button to choose
“Rise Rate” or “Fall Rate,” and press the
SELECT button.
Alerts menu,
Fall Rate highlighted
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9
2. H
ighlight “On/Off” and then press the
SELECT button.
Fall Rate menu,
On/Off highlighted
3. Press the UP or DOWN button to choose
“On” or “Off.” Then, press the SELECT
button to select “On” or “Off.”
Fall Rate menu,
On selected
4. P
ress the LEFT button to go back to the last
screen. Highlight “Level” and then press the
SELECT button.
Fall Rate menu,
Level highlighted
5. C
hoose “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.
Fall Rate menu,
2 mg/dL/min selected
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6. Press the LEFT button to return to the alerts menu when you finish.
9.2.3 SETTING THE OUT OF RANGE ALERT
FOR BOTH REAL TIME AND BLINDED MODES
The out of range alert lets you know when the transmitter and receiver
are not communicating with each other. Keep the transmitter and
receiver within 20 feet of each other without obstruction. When the
transmitter and receiver are too far apart, you will not get sensor glucose
readings.
The out of range symbol
in the upper
right corner of the trend graph and the Out of
Range alert screen show when the transmitter
and receiver are not communicating. The
amount of time out of range shows on the
Out of Range alert screen. It will continue to
re-alert until they are back in range.
Out of Range alert screen
1. P
ress the UP or DOWN button to choose
“Out of Range,” and press the SELECT
button.
Advanced menu,
Out of Range highlighted
2. P
ress the UP or DOWN button to choose
“On/Off.” Then, press the SELECT button to
select “On.” If you do not want to get out of
range alert press the SELECT button again
to choose “Off.”
Out of Range menu,
On/Off highlighted
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9
3. Press the UP or DOWN button to choose
“Time,” and press the SELECT button.
Out of Range menu,
Time highlighted
4. P
ress the UP or DOWN button to choose
the amount of time out of range after
which the receiver will alert (20-200
minutes). Press the SELECT button.
Out of Range setting screen,
20 minutes selected
5. P
ress the LEFT button to return to the Alerts menu when you finish.
9.3 ALERT PROFILES
The Dexcom G4 PLATINUM Professional
System lets you set profiles to choose the
way you want the alerts to act. This feature is
found under the Profiles option on the Main
Menu. You can set the profile to the sound
pattern and volume that fits the user’s needs.
The profile options are:
1. Vibrate
2. Soft
3. Normal
4. Attentive
5. HypoRepeat
Main Menu,
Profiles highlighted
NOTE: For each profile option, the first alert is vibration only.
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Regardless of which alert profile you choose, if you confirm the first
vibrate alert, you will not get a sound alert.
When you choose the profile setting this setting applies to all
alerts, alarm and prompts.
Within each profile setting, each alert has its own unique sound pattern,
tone and volume level. This lets you to easily identify each alert and
alarm and its meaning.
The fixed low alarm at 55 mg/dL cannot be turned off or adjusted. It is
disabled in blinded mode.
The soft, normal, attentive and HypoRepeat profiles have the following
alert sequence:
• The first alert is vibrate only.
• If the alert is not confirmed in five minutes, the system vibrates and
beeps.
• If the alert is not confirmed in five more minutes, the system vibrates
and beeps louder. This continues at the same volume every five
minutes until confirmed.
For the HypoRepeat profile in real-time mode only:
• If the alert is confirmed and the sensor glucose readings continue to
be at or below 55 mg/dL the system repeats the alert sequence in 30
minutes.
Press the SELECT button to confirm any alert.
9.3.1 ALERT PROFILE OPTIONS
Vibrate profile: when you want to silence the receiver and be
alerted by vibration. The only exception to this is the fixed
low alarm at 55 mg/dL in real-time mode, which alerts you
as a vibration first, followed by beeps 5 minutes later if not
confirmed.
(continued on next page)
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9
ALERT PROFILE OPTIONS (continued from page
before)
Soft profile: when you need the alert to be less noticeable.
This profile sets all the alerts and alarm to lower volume
beeps.
Normal profile: the default profile when you receive the
system. This profile sets all alerts and alarms to higher
volume beeps.
Attentive profile: when you need the alert to be the most
noticeable. This profile sets all the alerts and alarm to loud
and highly distinctive melodies.
“HypoRepeat” profile: very similar to the normal profile, but
it continuously repeats the fixed low alarm every 5 seconds
until the sensor glucose reading rises above 55 mg/dL or
is confirmed. This profile is only applicable if the receiver is
used in real-time mode and can be helpful if you want extra
alerts for severe low sensor glucose readings.
The “Try It” feature is found under the Profiles menu and lets you hear
an example of each alert and alarm.
9.3.2 ALERT PROFILE DETAILS
VIBRATE
SOFT
NORMAL
ATTENTIVE HYPOREPEAT
2 long
vibrates
+ 2 low
beeps
2 long
vibrates +
2 medium
beeps
2 long
vibrates +
ascending
melody
PROFILE
TYPE
High Alert 2 long
In Real-Time vibrates
Mode Only
2 long vibrates
+ 2 medium
beeps
(continued on next page)
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ALERT PROFILE DETAILS (continued from page
before)
VIBRATE
SOFT
NORMAL
ATTENTIVE HYPOREPEAT
PROFILE
TYPE
Low Alert
In
Real-Time
Mode Only
3 short
vibrates
3 short
vibrates
+ 3 low
beeps
3 short
vibrates +
3 medium
beeps
3 short
vibrates +
descending
melody
3 short vibrates
+ 3 medium
beeps
Rise Alert
In
Real-Time
Mode Only
2 long
vibrates
2 long
vibrates
+ 2 low
beeps
2 long
vibrates +
2 medium
beeps
2 long
vibrates
+ 1 short
ascending
melody
2 long vibrates
+ 2 medium
beeps
Fall Alert
In
Real-Time
Mode Only
3 short
vibrates
3 short
vibrates
+ 3 low
beep
3 short
vibrates +
3 medium
beeps
3 short
vibrates
+ 2 short
descending
melodies
3 short
vibrates + 3
medium beeps
1 long
vibrate +
3 short
repeating
melodies
1 long vibrate
+ 1 medium
beep
1 long
Out of
Range Alert vibrate
In Both
Real-Time
and Blinded
Modes
1 long
1 long
vibrate + 1 vibrate +
low beep
1 medium
beep
(continued on next page)
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9
ALERT PROFILE DETAILS (continued from page
before)
VIBRATE
SOFT
NORMAL
ATTENTIVE HYPOREPEAT
4 short
vibrates
+4
medium
tone
beeps
4 short
vibrates
+ 2 long
descending
melodies +
pause + 4
low beeps
4 short
vibrates + 4
low beeps +
pause + repeat
sequence
1 long
vibrate +
1 short
melody
1 long vibrate
+ 1 medium
beep
PROFILE
TYPE
Fixed Low
In
Real-Time
Mode only
4 short
vibrates
+4
medium
tone
beeps
4 short
vibrates +
4 medium
tone
beeps
All Other
Alerts
In Both
Real-Time
and Blinded
Modes
1 long
vibrate
1 long
1 long
vibrate + 1 vibrate +
low beep
1 medium
beep
Other alerts are calibration error, low battery, transmitter low battery,
transmitter failure, calibration required, sensor failure, system check,
30-minute replace sensor and replace sensor now.
These steps show you how to select the profile you want.
1. P
ress the SELECT button to turn on the receiver. The 3-hour trend
graph will show.
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Trend graph in
real-time mode
Trend graph in
blinded mode
2. P
ress the SELECT button to see the Main
Menu.
3. Press the UP or DOWN button to scroll to
“Profiles,” and press the SELECT button. The
Profiles menu will show
4. P
ress the UP or DOWN button to scroll to
the profile you want to set, and press the
SELECT button.
Main Menu,
Profiles highlighted
5. P
ress the LEFT button to return to the Main
Menu when you finish.
Profiles menu,
Vibrate highlighted
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PAGE INTENTIONALLY LEFT BLANK
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10
chapter ten
EVENTS, DEXCOM STUDIO SOFTWARE
AND BLINDED MODE
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10
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CHAPTER 10: EVENTS, DEXCOM STUDIO
SOFTWARE AND BLINDED MODE
The Events feature lets you record information that may help users
and healthcare professionals better understand glucose patterns and
trends. Event markers can be used in both real-time and blinded mode.
You can enter details about carbohydrates, insulin, exercise, and health
issues. You can view these events with the trends and patterns later with
a healthcare professional when the receiver is downloaded using the
Dexcom STUDIO software.
10.1 EVENTS
Event markers can be downloaded and viewed in the Dexcom STUDIO
software but cannot be viewed on the receiver.
10.1.1 SELECTING AN EVENT
1. P
ress the SELECT button to turn on the receiver. The 3-hour trend
graph will show.
Trend graph in
real-time mode
Trend graph in
blinded mode
2. P
ress the SELECT button to see the Main Menu.
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10
3. Press the UP or DOWN button to scroll to
“Events,” and press the SELECT button. The
Events menu will show.
Main Menu,
Events highlighted
4. P
ress the UP or DOWN button to choose the
event you want: “Carbs,” “Insulin,” “Exercise”
or “Health.” Press the SELECT button.
Events menu,
Carbs highlighted
10.1.2 SETTING THE DATE AND TIME FOR AN
EVENT
When you enter an event, you must check that the date and time for that
event are correct. The default is the current date and time stored in the
receiver. The date format is YYYY/MM/DD.
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 the receiver.
To change the date and time for an event:
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1. P
ress the RIGHT button to highlight each
value in the date and time.
2. P
ress the UP or DOWN button to make any
changes, and then press the RIGHT button to
move to the next value.
3. Press the SELECT button after choosing AM
or PM.
Carbs setting screen,
minutes highlighted
4. P
ress the SELECT button to confirm the
entry.
Carbs setting screen,
OK highlighted
10.1.3 CARBOHYDRATES
The Carbs event lets you enter the amount of carbohydrates you have
taken, up to 250 grams.
1. F
rom the events menu press the UP or
DOWN button to choose “Carbs,” and press
the SELECT button.
Events menu,
Carbs highlighted
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10
2. P
ress the UP or DOWN button to enter the
carb amount (0-250 grams), and press the
SELECT button.
• The number that shows on this screen is
the last number you entered or the default
amount of 50 grams.
Carbs setting screen,
50 grams selected
3. Check that the date and time for this entry are correct. Press the
SELECT button to confirm.
4. P
ress the LEFT or RIGHT button to choose
either “OK” to confirm or “Cancel” to discard
this entry, and then press the SELECT
button. You will return to the Events menu.
Carbs setting screen,
OK highlighted
10.1.4 INSULIN
The Insulin event lets you enter the amount of insulin you have taken,
up to 250 units. You can only enter an insulin amount, not the type of
insulin.
1. F
rom the Events menu press the UP or
DOWN button to choose “Insulin,” and press
the SELECT button.
Events menu,
Insulin highlighted
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2. P
ress the UP or DOWN button to enter the
insulin amount (0-250 units), and press the
SELECT button.
•T
he number that shows on this screen is
the last number you entered or the default
amount of 10 units.
Insulin setting screen,
10 units highlighted
3. Check that the date and time for this entry are correct. Press the
SELECT button to confirm.
4. P
ress the LEFT or RIGHT button to choose
either “OK” to confirm this entry or “Cancel”
to discard this entry, and then press the
SELECT button. You will return to the Events
menu.
Insulin setting screen,
OK highlighted
10.1.5 EXERCISE
The Exercise event lets you enter intensity (light, medium, or heavy) and
duration (up to 360 minutes).
1. F
rom the Events menu press the UP or
DOWN button to choose “Exercise,” and
press the SELECT button.
Events menu,
Exercise highlighted
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2. P
ress the UP or DOWN button to choose
the exercise intensity level, and press the
SELECT button.
Exercise Type menu,
Light highlighted
3. Press the UP or DOWN button to enter the
exercise duration (0-360 minutes), and press
the SELECT button.
• The number that shows on this screen is the
default amount of 30 minutes.
Exercise setting screen,
30 minutes selected
4. C
heck that the date and time for this entry are correct. Press the
SELECT button to confirm.
5. P
ress the LEFT or RIGHT button to choose
either “OK” to confirm this entry or “Cancel”
to discard this entry, and then press the
SELECT button. You will return to the
Events menu.
Exercise setting screen,
OK highlighted
10.1.6 HEALTH
The Health event lets you enter episodes of illness, stress, high
symptoms, low symptoms, cycle (menstrual) or alcohol consumption.
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1. From the Events menu press the UP or
DOWN button to choose “Health,” and press
the SELECT button.
Events menu,
Health highlighted
2. Press the UP or DOWN button to choose the
health event, and press the SELECT button.
Health menu,
Illness highlighted
3. Check that the date and time for this entry are correct. Press the
SELECT button to confirm.
4. Press the LEFT or RIGHT button to choose
either “OK” to confirm this entry or “Cancel”
to discard this entry, and then press the
SELECT button. You will return to the Events
menu.
Health setting screen,
OK highlighted
10.2 DEXCOM STUDIO SOFTWARE AND
BLINDED MODE
The Dexcom STUDIO software is optional. This software lets you view
trends, track patterns and create custom charts to display the glucose
trends.
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10
You can use data from downloads and save or print files for users and
healthcare professionals to review.
Dexcom STUDIO allows healthcare professionals to blind and unblind
receivers. Blinded receivers do not display sensor glucose readings,
trends or any glucose alerts or alarms. Blinded receivers record glucose
information that the healthcare professional can later download and
review using Dexcom STUDIO software.
Healthcare professionals must obtain an authorization code from
Dexcom to be able to access this feature. The act of blinding turns on
this feature, and unblinding returns the receiver to its normal functions.
To obtain a healthcare professional authorization code, please contact
Dexcom Technical Support.
For system requirements and more information, see the Dexcom
website (www.dexcom.com) or the Dexcom STUDIO Software User’s
Guide.
10.2.1 ACTIVATING THE BLINDED
MODE/CLINICAL FEATURE
WARNING
ow/high glucose alerts and the 55 mg/dL low glucose
L
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and
will not alert you when the glucose is low or high. Check
blood glucose meter if there are any signs or symptoms
of low or high glucose.
To activate clinical features, you need to install the Dexcom
STUDIO software from either the CD bundle in the Dexcom G4
PLATINUM Professional Receiver Kit or from the Dexcom website at
www.dexcom.com. For system requirements and more information,
134 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
see the Dexcom website (www.dexcom.com) or the Dexcom STUDIO
Software User’s Guide.
Once the Dexcom STUDIO software has been installed successfully,
follow the following instructions to activate the blinded mode/clinical
feature:
1. C
lick “Tools” on the tool bar
and select “Activate Clinical
Features” from the drop down
menu.
Activate Clinical Features highlighted
2. D
excom STUDIO software prompts you to contact Dexcom Technical
Support and provide them with the Activation Request Key that
appears in the Activate Clinical Features pop-up window. Contact
Dexcom Technical Support at 1.877.339.2664 or via e-mail at
[email protected] and provide them your name, your
practice name and the Activation Request Key Code. Once you
receive an Activation Code from Dexcom Technical Support, enter
it in the Activate Clinical Features window. Then click “OK.” Clinical
features activation is a one-time process, and you will not need to
repeat it.
Activate Clinical Features window
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10
The Tools drop down menu now
includes an option to Blind/Unblind
Attached Receiver, and Display
Blinded Data. These options
may be useful for healthcare
Blind Attached Receiver highlighted
professionals.
10.2.2 BLINDING THE RECEIVER
NOTE: This feature is for the healthcare professional use only and
not for the use of patients.
1. C
onnect a receiver to the USB port of a computer. This activates the
Blind/Unblind Attached Receiver option on the Tools drop down menu
if you have previously entered the proper Activation Code.
2. C
lick on the “Tools” option to either blind or unblind the attached
receiver.
3. The option that appears (Blind Attached Receiver or Unblind Attached
Receiver) depends on whether the connected receiver is currently
blinded or unblinded.
When connected the receiver
is currently unblinded
When connected the receiver
is currently blinded
4. C
hoose “Blind Attached Receiver” or “Unblind Attached Receiver”
from the drop down menu. You will be prompted to confirm your
selection before the receiver display is updated.
If you change the current blind/unblind setting, an updated group of
receiver settings will automatically be downloaded to the software.
Some of the downloaded settings may affect the charts/reports currently
being displayed in the software.
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NOTE: The choice of blinding/unblinding the receiver does not impact
the data that is downloaded from the receiver. It does impact whether
the data will be visible in charts/reports after downloading.
10.2.3 DOWNLOADING THE RECEIVER
You will need the USB to Micro USB cable
provided with the Dexcom G4 PLATINUM
Professional System to connect the receiver to
the PC.
USB to Micro USB cable
Before downloading the receiver, remove the receiver shield from the
receiver to help reduce the spread of contamination.
1. Slide open the USB port cover on the side of the receiver.
2. Plug the Micro USB end of the cable into the receiver USB port.
3. Connect the other end of the cable into any free USB port on the PC.
The software will first try to assign the new receiver download to an
existing patient record (using this same receiver). If it does not find
a match, the Edit Patient pop-up window will appear where you can
create a new patient record for this download. See the Dexcom STUDIO
Software User’s Guide, Section 5, Patient Management, for editing
patient record information.
10.2.4 RESETTING THE RECEIVER FOR
MULTIPLE PATIENT USE
A useful feature for healthcare professionals is to be able to reset
the receiver database. Resetting will erase all data from the receiver
database, and set the receiver time and date to the Internet time and
date. The transmitter ID and blind/unblind settings in the receiver will be
preserved. The receiver must be attached to the PC and the Dexcom
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10
STUDIO software must be open to reset the receiver.
Customize what happens each time you open/run the software. These
options are intended for healthcare professionals only.
You can also choose to automatically be prompted to reset after every
download by making this selection in the Options menu.
1. C
lick on “Health Care
Professionals” option and
this screen will drop down.
Health Care Professionals
2. C
lick on “Prompt to reset the receiver after every download.” – select
whether to be prompted to reset the receiver after every time you
download data.
Resetting will erase all data from the receiver database, set the receiver
time and date to the Internet time and date, and set the prior transmitter
ID and blind/unblind settings back into the receiver. This is the preferred
setting when you are using the Dexcom G4 PLATINUM Professional
System for multiple patient use.
For additional information on the Health Care Professional settings in
the Dexcom STUDIO software, see the Dexcom STUDIO Software
User’s Guide.
NOTE: The receiver will store each patient’s data in its memory. For
multiple patient use, it is important that you erase the receiver data
memory after each patient use. This will ensure patient privacy with
subsequent users.
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chapter eleven
ENDING A SENSOR SESSION
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11
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CHAPTER 11: ENDING A SENSOR SESSION
PRECAUTION
Do not discard your transmitter. It is reusable. The
same transmitter is used for each session until you
have reached the end of the transmitter battery life.
When healthcare professionals use one transmitter for
multiple patients, the transmitter must be returned to the
healthcare professional.
The sensor gives you sensor glucose readings for up to seven days
when used in real-time mode. The performance of a sensor has not
been tested beyond seven days.
Information for the end of a sensor session:
•D
o not remove the transmitter from the sensor pod while the pod is
attached to the skin.
•C
onsult the local waste management authorities for instructions
to dispose of blood contacting parts (sensor and applicator) if you
remove the sensor outside of the healthcare professional office.
• In some cases, the sensor session may end before you have
finished a full 7-day period. If this happens, see Chapter 13, Section
13.6, Sensor Shut-Off Troubleshooting.
• Glucose alerts and alarm do not work after the sensor session
ends in both real-time and blinded modes.
11.1 AUTOMATIC SENSOR SHUT-OFF IN BOTH
REAL-TIME AND BLINDED MODES
The receiver tells you how much time you have left until the sensor
session is complete. The Replace Sensor screen shows at 6 hours, 2
hours and 30 minutes before the 7-day sensor session ends.
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11
6-hour Replace Sensor
2-hour Replace Sensor
30-minute Replace Sensor
Replace Sensor
end of session
You can set these alerts with the profiles setting (see Chapter 9, Section
9.3.2, Alert Profile Details, “All Other Alerts”). After the 6-hour, 2-hour,
and 30-minute reminders, you continue to receive sensor glucose
readings. Press SELECT to clear these screens. You must remove the
sensor after the Replace Sensor Now screen (00:00:00) shows.
Sensor glucose readings do not show
on the receiver after the sensor session
ends. The trend graphs show that the
sensor session has ended with a red
stoplight symbol at the top.
You must remove the sensor based on the
instructions of your healthcare professional
(i.e., the healthcare professional will tell you
if you should remove the sensor yourself or
return to the healthcare professional’s office
to remove the sensor).
Trend graph with
red stoplight in upper right
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11.2 REMOVING A SENSOR
WARNING
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 at 1.877.339.2664 or
1.858.200.0200.
When you remove the sensor, make sure to pull out the sensor
pod while the transmitter is still attached.
1. G
ently peel up the sensor pod adhesive patch from the skin. This will
pull out the sensor.
Keep the transmitter
in the sensor pod
Peel up the sensor pod
adhesive patch
Completely remove
the adhesive patch
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11
11.3 TRANSMITTER REMOVAL
WARNING
The transmitter should be cleaned and disinfected after
use on each patient. This system may only be used for
testing multiple patients when Standard Precautions and
the manufacturer’s cleaning and disinfection procedures
are followed.
PRECAUTION
Do not discard your transmitter. It is reusable. The
same transmitter is used for each session until you
have reached the end of the transmitter battery life.
When healthcare professionals use one transmitter for
multiple patients, the transmitter must be returned to the
healthcare professional.
Do not remove the transmitter while the sensor pod is still
attached to the body.
After the sensor pod is off the body, you must remove the transmitter to
reuse it. Use either of these two transmitter removal methods:
Method 1
The safety lock that you removed from the applicator (see Chapter 6,
Section 6.4, Placing the Sensor), can be used as a tool to remove the
transmitter.
1. Place the sensor pod/transmitter on a flat surface.
2. Hold the rounded edge of the safety lock.
3. Make sure the jagged edge of the safety lock is facing down, with
the arrow pointing up, as shown:
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Safety lock
Transmitter
with safety lock
snapped in
Method 2
Use the fingers to spread out the tabs at the back of the sensor pod (end
closest to the sensor pod tab wings). The transmitter will “pop” out of the
sensor pod.
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PAGE INTENTIONALLY LEFT BLANK
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12
chapter twelve
TAKING CARE OF THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM
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CHAPTER 12: TAKING CARE OF THE DEXCOM
G4 PLATINUM PROFESSIONAL SYSTEM
12.1 RECEIVING THE TRANSMITTER AND
RECEIVER FROM EACH USER
Before touching the transmitter and receiver used by a patient, make
sure the healthcare professional wears personal protective equipment as
appropriate (gloves, protective goggles, lab coat, etc.).
12.2 REMOVING THE RECEIVER SHIELD
Remove the receiver shield after each patient’s use to help reduce the
spread of contamination to healthcare professionals and other patients.
You will need gloves, Dispatch® Hospital Cleaner Disinfectant Towels
with Bleach (any disinfectant wipes containing a bleach solution strength
of 6500 parts per million with the EPA registration number 56392-8 may
be used), and a clean table or other surface.
1. Wear gloves.
Step 1. Wear gloves
2. Wipe the shield with the disinfectant wipe to help reduce the
likelihood of transferring contaminants from the outside of the
shield to the surface of the receiver. Allow shield to dry on a clean
table or surface.
3. Remove and change gloves.
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12
4. Remove and discard the triangle seal
that is over the t-shaped slot in the back
of the receiver.
Step 4. Remove triangle seal
5. Hold one corner of the shield near the
top of the t-shaped slot. Stretch that
corner of the shield off the receiver.
Step 5. Stretch corner of
shield off the receiver
6. Hold the other corner of the shield near the top of the t-shaped slot.
Stretch that corner of the shield off the receiver.
7. Peel back the shield, being careful
not to touch the outside of the shield
or gloved hands to the surface of the
receiver.
Step 7. Peel back shield
8. Hold the edge of the shield that is still on the receiver, just above a
clean surface.
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9. S
queeze the receiver out of
the shield (like squeezing
toothpaste from a tube)
until the receiver is released
onto the clean surface. This
prevents the outside of the
shield from contacting the
surface of the receiver.
Step 9. Squeeze receiver out of shield
10. V
iew the shield closely under adequate lighting. Inspect the shield for
any signs of damage or deterioration.
a. If a defect or malfunction of the shield is suspected, the healthcare
professional should retain the shield and contact Dexcom
Technical Support.
b. If there is no evidence of defect or malfunction, discard the shield.
11. Remove and change gloves before handling the receiver.
12. V
iew the receiver closely under adequate lighting. Inspect the
receiver for any soil or signs of contamination to the receiver.
a. D
iscard the receiver if there is any indication of contamination,
such as dirt or spots of dried fluid.
b. C
onsider whether there has been incorrect shield application or
removal that potentially could lead to contamination.
c. If there is any doubt about contamination, assume it is
contaminated and discard the receiver.
Do not clean or disinfect the receiver once the shield is removed.
Cleaning and disinfection products could damage the receiver.
NOTE: When removing the shield, peel the receiver shield straight back.
While holding the receiver upside down over a clean table or surface,
squeeze the receiver out of the shield. Avoid manipulating the receiver
shield so that the shield exterior does not come into contact with the
receiver and gloves do not transfer material from outside the shield to
the receiver.
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12
12.3 CLEANING AND DISINFECTION OF THE
TRANSMITTER
Dexcom validated 52 cleaning and disinfection cycles. This represents
one cleaning and one disinfection cycle per week over twelve months of
use, which exceeds the expected transmitter battery life of six months
and meets the warranty time of the receiver.
Healthcare professionals must clean and disinfect the transmitter before
providing to each user. Clean the transmitter before disinfecting. Use
caution when handling products worn or handled by another person.
Wear personal protective equipment as appropriate (gloves, protective
goggles, lab coat, etc.).
Cleaning
Cleaning removes dirt from the surface of the transmitter. It does not
kill bacteria or viruses. The transmitter should be cleaned whenever
it is visibly dirty and between each use. In addition to the minimum
recommendations to clean between each use, the transmitter can
be cleaned whenever it is visibly dirty up to 26 times over the six
month use life. You will need Clorox Healthcare® Bleach Germicidal
Cleaner (formerly “Dispatch®”; any disinfectant product in a spray bottle
containing a bleach solution strength of 6500 parts per million with the
EPA registration number 56392-7 may be used), low-lint cloths or wipes,
a nylon bristled brush and water.
Clorox Healthcare Bleach Germicidal Cleaner
Low-lint wipes Nylon bristled brush
Water
Components to clean the transmitter
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Cleaning the Transmitter
1. Wear clean gloves and goggles.
Step 1. Wear gloves
and goggles
2. P
repare a soaking container by adding enough Clorox Healthcare
Bleach Germicidal Cleaner solution to submerge a transmitter.
3. P
lace the transmitter with the contact
(metal circles) side down on an
absorbent wipe or clean surface.
Step 3. Transmitter with contact
side down on absorbent wipe
4. H
old the Clorox Healthcare Bleach
Germicidal Cleaner spray bottle 6-8
inches from unit, and dispense two
sprays onto the top surface.
Step 4. Spray transmitter
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12
5. Flip the transmitter over to expose the
contacts (metal circles).
Step 5. Transmitter with contact
side up on absorbent wipe
6. Hold the Clorox Healthcare Bleach Germicidal Cleaner spray bottle
6-8 inches from unit, and dispense two sprays onto the side with the
contacts (metal circles).
7. Using a nylon brush, scrub the
transmitter on all sides for thirty
seconds.
Step 7. Scrub transmitter
using nylon brush
8. Place the transmitter in the Clorox
Healthcare Bleach Germicidal Cleaner
spray solution for one minute.
Step 8. Place transmitter
in solution
9. Remove the transmitter and rinse it under flowing tap water for ten
seconds.
10. Wipe the transmitter with a cloth until it is completely dry.
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Disinfection
Disinfection removes and destroys microorganisms and pathogens
from the transmitter’s surface. Disinfect the transmitter between each
user and whenever you suspect that blood or body fluid has come in
contact with the surface of the device. You will need Clorox Healthcare
Bleach Germicidal Cleaner (formerly, “Dispatch;” any disinfectant
product containing a bleach solution strength of 6500 parts per million
with the EPA registration number 56392-7 may be used), Dispatch
Hospital Cleaner Disinfectant Towels with Bleach (any disinfectant wipes
containing a bleach solution strength of 6500 parts per million with the
EPA registration number 56392-8 may be used), low-lint cloths or wipes,
and water (products needed are illustrated in the next image). Clean the
transmitter before disinfecting.
Clorox Healthcare
Bleach Germicidal
Cleaner
Dispatch Hospital Cleaner
Disinfectant Towels
with Bleach
Low-lint wipes
Water
Components to disinfect the transmitter
Disinfecting the Transmitter
1. Wear clean gloves and goggles.
Step 1. Wear gloves and goggles
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12
2. Prepare a soaking container by adding enough Clorox Healthcare
Bleach Germicidal Cleaner to submerge a transmitter.
3. Place the transmitter with the contact (metal circles) side down on an
absorbent wipe or clean surface.
4. Remove a pre-saturated Dispatch Hospital Cleaner Disinfectant Towel
with Bleach from its packaging.
5. Fold the Dispatch Hospital Cleaner Disinfectant Towel with Bleach into
a 2 x 2 inch square.
6. Wipe all surfaces of the transmitter by
passing over the transmitter surface
in one direction and then back in the
opposite direction (back and forth
means two passes).
Step 6. Wipe transmitter
back and forth
7. Turn over the Dispatch Hospital Cleaner Disinfectant Towel with
Bleach to use a clean side for a second back and forth wipe.
8. Refold the Dispatch Hospital Cleaner Disinfectant Towel with Bleach
to use a clean side for a third back and forth wipe.
9. Turn over the Dispatch Hospital Cleaner Disinfectant Towel with
Bleach to use a clean side for a fourth back and forth wipe.
10. Keep track to be sure you wiped four times back and forth for a total
of eight passes and that all transmitter surfaces are covered with
disinfectant.
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11. Place the transmitter on a clean
non-porous surface and allow the
disinfectant to contact it for one
minute.
Step 11. Place transmitter
on clean surface
12. P
lace the transmitter in the Clorox
Healthcare Bleach Germicidal
Cleaner spray solution for one minute.
Step 12. Place transmitter
in solution
13. R
emove the transmitter and rinse
it under flowing tap water for ten
seconds.
Step 13. Rinse transmitter
under flowing water
14. W
ipe the transmitter with a low lint, absorbent cloth until it is
completely dry.
After cleaning and disinfection, remove and discard gloves, and wash
hands thoroughly with soap and water.
Clorox Healthcare Bleach Germicidal Cleaner (EPA registration number
56392-7) and Dispatch Hospital Cleaner Disinfectant Towels with Bleach
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12
(EPA registration number 56392-8) may be purchased from medical
office supply providers. For current suppliers, see the Clorox® Company
at www.cloroxprofessional.com.
Stop using the transmitter and contact Dexcom Technical Support
if signs of deterioration are noted. Signs of deterioration include
corrosion or discoloration on the metal transmitter contacts, pitting of
the transmitter’s gray epoxy surface, reduced legibility of the text on the
bottom of the transmitter, or any other visual changes to the transmitter.
Repeated sensor failures (see Chapter 13, Section 13.6.1, Sensor Failed
screen) or glucose reading errors (
symbol, see Chapter 8, Section
8.3, Glucose Status Area Symbols in Both Real-Time and Blinded
Modes) that occur with multiple sensors could indicate deterioration of
the transmitter.
TECHNICAL SUPPORT
For Dexcom product questions and troubleshooting issues.
Dexcom Technical Support Phone Numbers:
1.877.339.2664 or 1.858.200.0200
(24 hours, 7 days a week)
Dexcom Technical Support E-mail:
[email protected]
Dexcom Technical Support Fax:
1.877.633.9266
References:
“FDA Public Health Notification: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010),
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
“CDC Clinical Reminder: Use of Fingerstick Devices on More than One
Person Poses Risk for Transmitting Bloodborne Pathogens” (2010),
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html.
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12.4 USING THE RECEIVER SHIELD
Healthcare professionals must apply a shield and its components to
the receiver before providing to each user. Use caution when handling
products worn or handled by another person. Wear personal protective
equipment as appropriate (gloves, protective goggles, lab coat, etc.).
Use only legally marketed Dexcom G4 PLATINUM Professional
Receiver Shields (manufactured by Seal Shield™ specifically for the use
of the Dexcom G4 PLATINUM Receiver).
The shield helps prevent microorganisms and pathogens from reaching
the receiver’s surface. Replacing the receiver shield between each use
helps reduce the spread of contamination between users and healthcare
practitioners.
The receiver volume may be reduced if the acoustic spacers are not in
place. If the acoustic spacer is not in place, the user should return the
receiver to the healthcare professional.
1. W
ash hands and put on sterile gloves.
Peel acoustic spacer from paper
backing and secure on upper speaker
edge.
Acoustic spacer in upper
right of receiver
Opening back of receiver
2. N
ote location of USB opening on
receiver shield. Stretch receiver shield
over receiver.
USB opening
lined up with
USB port
Stretch receiver shield
over receiver
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12
3. Peel triangle seal from paper backing
and secure seal over opening on back
of receiver.
USB opening
Triangle seal over
shield opening
USB door open
4. P
eel 1 square seal from paper backing
and secure seal over USB door on side
of receiver. Save additional USB seals
for recharging.
Square seal over USB port
NOTE: The receiver shield is not waterproof and does not protect the
receiver from water or liquids.
12.5 MAINTENANCE
Transmitter
• Keep the transmitter protected when not in use.
Receiver
• Do not spill fluid on the receiver or submerge the receiver in liquid.
• Keep the receiver protected.
• Charge the receiver when the battery gets low, optimally before each
new patient use.
Accessories
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• Insert cables only as directed. Do not force cables in place.
• Look at cables for signs of wear and tear.
•O
nly use Dexcom-supplied parts (including cables and chargers).
Use of non-Dexcom supplied parts may affect safety and
performance.
There is no repair service available for the Dexcom G4 PLATINUM
Professional CGM System. If you experience problems with the system
contact Dexcom Technical Support (see Chapter 15, User Assistance).
12.6 STORAGE
Sensor
•K
eep the sensor in its sterile packaging until you are ready to use it.
•D
o not insert sensors past the expiration date. The expiration date
format is YYYY-MM-DD. Insert sensors on or before the end of the
calendar day printed on the sensor package label.
•S
tore at temperatures between 36° F - 77° F. Storing outside this
temperature may result in reduced sensor response to glucose and
may cause inaccurate CGM readings. You may store the sensors in
the refrigerator if it is within this temperature range. Sensors should
not be stored in a freezer.
• Store
at humidity levels between 15% - 85% relative humidity.
Transmitter
• Keep the transmitter protected when not in use.
• Store at temperatures between 32° F - 113° F.
•S
tore at humidity levels between 10% - 95% relative humidity.
Receiver
• Keep the receiver protected when not in use.
• Fully charge the battery before storing for over 3 months.
• Store at temperatures between 32° F - 113° F.
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12
• Store at humidity levels between 10% - 95% relative humidity.
12.7 PRODUCT DISPOSAL
Consult the local waste management authorities for instructions to
dispose of devices containing electronic waste (transmitter and receiver)
and blood contacting parts (sensor and applicator).
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13
chapter thirteen
TROUBLESHOOTING
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13
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CHAPTER 13: TROUBLESHOOTING
This chapter provides helpful tips and instructions to fix issues you
may have while using the Dexcom G4 PLATINUM Professional CGM
System.
If any of the troubleshooting steps in this chapter do not fix the
issue, contact Dexcom Technical Support (see Chapter 15, User
Assistance).
13.1 SENSOR INSERTION TROUBLESHOOTING
Sensor insertion difficulties
• I am having trouble taking out the safety lock:
-M
ake sure to pull the safety lock straight out away from the body. Use
the arrows on the safety lock as a guide.
• I am not able to pull the collar up:
-M
ake sure the white plunger is completely pressed down before
pulling the collar up.
- Use force when pulling the collar up.
• I am not able to remove the applicator barrel from the sensor pod:
- Make sure the collar is pulled all
the way up. When pulling the collar
up you should hear 2 “clicks.” You
may need to use extra force to pull
the collar as close to the top of the
applicator as possible.
- Make sure the transmitter latch is
flat against the adhesive on the body
before squeezing the release tabs.
- Use force when squeezing the ribbed
release tabs on the sides of the sensor pod.
Release the
applicator barrel
- Lift the applicator in a curving movement away from the body.
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13
• I am not able to remove the transmitter latch:
- Hold the sensor pod with one hand and twist the transmitter latch
with the other hand to remove it.
- Do not try to snap it straight off.
Sensor pod is not sticking long enough
- Make sure the skin is clean, clear of any cream or lotion, and
completely dry before you insert the sensor.
- Shave the skin before you insert the sensor if hair is preventing the
sensor pod from sticking.
- You may use medical tape (such as Blenderm, Tegaderm, Smith
& Nephew IV3000, 3M tape) 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.
13.2 CALIBRATION TROUBLESHOOTING
Calibration prompts may show during the sensor session. Review the
following troubleshooting tips for calibration.
• Do not calibrate if the out of range symbol
area.
shows in the status
• Do not calibrate if the glucose reading error symbol
the status area.
shows in
• Do not calibrate if the blood glucose value is below 40 or above 400
mg/dL.
• Before you take a blood glucose value for calibration, wash hands,
make sure the glucose test strips have been stored properly and
are not expired and make sure that the meter is properly coded (if
required). Carefully apply the blood sample to the test strip following
the instructions that came with the meter or test strips.
• Make sure you have not taken any medications containing
acetaminophen (such as Tylenol).
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•S
ee Chapter 7, Calibrating the Dexcom G4 PLATINUM Professional
System, for further information.
13.2.1 TYPES OF CALIBRATION PROMPTS
This section describes the three calibration symbols. The next section
describes what to do when you see one of these symbols.
Startup calibration prompt
This prompt means the receiver’s 2-hour startup
period is complete. You need to enter two blood
glucose values to calibrate the system.
The receiver shows the 2-hour startup
calibration prompt screen every 15 minutes until
the receiver accepts the blood glucose values.
Startup calibration
prompt
Additional startup calibration prompt
This prompt means you need to enter one more
blood glucose value to calibrate the system.
The receiver shows the additional startup
calibration prompt screen every 15 minutes until
the receiver accepts the blood glucose value.
Additional startup
calibration prompt
Calibration prompt
This prompt means you need to enter one blood
glucose value. It shows when it is time for the
12-hour calibration update or any other time you
need to calibrate.
The receiver shows this prompt screen every
15 minutes until the receiver accepts the blood
glucose value.
Calibration prompt
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13.2.2 WHAT TO DO FOR CALIBRATION
PROMPTS
1. When you see a calibration prompt, press the SELECT button to clear
the prompt.
2. Check the status area at the top of the
screen.
a. If the startup calibration symbol
shows, take 2 more blood glucose values
and enter them into the receiver.
b. If the additional startup calibration symbol
shows, take 1 more blood glucose
value and enter it into the receiver.
Prompt in status area
c. If the calibration needed symbol
shows, take 1 more blood
glucose value and enter it into the receiver.
13.3 CALIBRATION ERROR
TROUBLESHOOTING
This screen means you recently entered
a calibration blood glucose value, and the
sensor is having trouble calibrating. If you
press the SELECT button to clear this screen,
this symbol
shows in the status area.
If you see this screen, wait 15 minutes and
then enter 1 more calibration blood glucose
Wait 15 minutes
value. Wait 15 more minutes. If this error
calibration error screen
screen still shows, enter 1 more blood glucose
value. Wait another 15 minutes. If this error screen still shows, the
sensor needs to be replaced.
This screen also means you recently entered a calibration blood glucose
value and the sensor is having trouble calibrating. If you press the
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SELECT button to clear the screen, this symbol
status area.
shows in the
If you see this screen, wait at least 1 hour and
then enter 1 more calibration blood glucose
value. Wait 15 minutes. If this error screen still
shows, enter 1 more blood glucose value. Wait
another 15 minutes. If this error screen still
shows, the sensor needs to be replaced.
Wait 1 hour
calibration error screen
13.4 SYSTEM GLUCOSE ERROR
The system may tell you that it cannot provide a sensor glucose reading.
When this happens you will see either the glucose reading error symbol
or the wait symbol
in the status area. These symbols mean
the receiver does not understand the sensor signal temporarily. These
symbols are related to the sensor only.
Wait for more prompts, and do not enter any blood glucose values
when you see these symbols. The system will not use a blood glucose
value for calibration when these symbols show (see Chapter 8, Section
8.3, Glucose Status Area Symbols in Both Real-Time and Blinded
Modes).
No glucose data (
in real-time mode
)
No glucose data (
in blinded mode
)
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13
No glucose data (
)
in real-time mode
No glucose data (
in blinded mode
)
Often, the system can correct the problem and continue providing or
recording sensor glucose readings. If it has been at least 3 hours since
the last sensor glucose reading, contact Technical Support (see Chapter
15, User Assistance).
If you see these system glucose error icons often, follow these
troubleshooting tips before inserting another sensor:
• Make sure the sensor is not expired.
• Make sure the sensor pod is not dislodged or peeling up.
• Make sure the transmitter is snapped in completely.
• Make sure nothing is rubbing the sensor pod (i.e. clothing, seat belts,
etc.).
• Make sure you selected a good insertion site (see Chapter 6, Section
6.3, Choosing an Insertion Site).
• Make sure the insertion site is clean and dry before sensor insertion.
13.5 SENSOR INACCURACIES IN REAL-TIME
MODE
Inaccuracies are usually related to the sensor only and not the receiver
or transmitter. The sensor glucose readings are meant to be used for
trending purposes only. The blood glucose meter and sensor measure
the glucose from two different types of body fluids: blood and interstitial
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fluid. Therefore, the readings from the blood glucose meter readings and
sensor may not match.
WARNING
Calibrate at least once every 12 hours. Calibrating less
often than every 12 hours might cause sensor glucose
readings to be inaccurate, and you might miss a low or
high blood glucose value.
PRECAUTION
To calibrate the system, enter the exact blood glucose
value that your blood glucose meter displays within
5 minutes of a carefully performed blood glucose
measurement. Entering incorrect blood glucose values or
blood glucose values from more than 5 minutes before
entry might affect sensor performance, and you might
miss a low or high blood glucose value.
If the difference between the sensor glucose reading and blood glucose
value is greater than 20% of the blood glucose value for sensor glucose
readings > 80 mg/dL or greater than 20 points for sensor glucose
readings < 80 mg/dL, wash hands and take another blood glucose
measurement. If the difference between this second blood glucose
measurement and the sensor is still greater than 20% for sensor glucose
readings > 80 mg/dL or greater than 20 points for sensor glucose
readings < 80 mg/dL, recalibrate the sensor using the second blood
glucose value. The sensor glucose reading will correct over the next 15
minutes. If you see differences between the sensor glucose readings
and blood glucose values outside of this acceptable range, follow the
troubleshooting tips below before inserting another sensor:
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13
• Make sure the sensor is not expired.
• Make sure you do not calibrate when the
or
are shown.
•D
o not use alternative blood glucose site testing (blood from the
palm or forearm, etc.) for calibration as alternative site readings may
be different than those from a blood glucose value. Use a blood
glucose value only from the fingers for calibration.
•U
se only blood glucose values between 40-400 mg/dL for
calibration. If one or more of the values is outside of this range, the
receiver will not calibrate.
•U
se the same meter you routinely use to measure the blood glucose
to calibrate. Do not switch the meter in the middle of a sensor
session. Blood glucose meter and strip accuracy vary between
blood glucose meter brands.
•B
efore taking a blood glucose measurement for calibration, wash
hands, make sure the glucose test strips have been stored properly
and are not expired and make sure that the meter is properly coded
(if required). Carefully apply the blood sample to the test strip
following the instructions provided with the meter or test strips.
•M
ake sure you are using the blood glucose meter following the
manufacturer’s instructions to get accurate blood glucose values for
calibration.
•M
ake sure you have not taken any medications containing
acetaminophen (such as Tylenol) to ensure you are getting accurate
blood glucose values for calibration.
13.6 SENSOR SHUT-OFF TROUBLESHOOTING
In some cases the sensor session may stop or need to be stopped
before the end of a full 7-day period. You must remove the sensor and
contact your healthcare professional.
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13.6.1 EARLY SENSOR SHUT-OFF – SENSOR
FAILURE
The receiver may detect issues with the sensor
where it cannot determine the sensor glucose
reading. The sensor session ends and the
receiver shows the “Sensor Failed” screen. If
you see this screen, it means the CGM session
has ended. Press the SELECT button to clear
this screen.
Sensor Failed screen
Contact your healthcare professional. You may
need to remove the sensor yourself or your healthcare professional
might help you remove it and insert a new sensor, if appropriate.
To help improve future sensor performance:
• Make sure the sensor is not expired.
• Make sure the transmitter is snapped in.
• Make sure the sensor pod is not dislodged or peeling up.
• Make sure nothing is rubbing the sensor pod (i.e. clothing, seat belts,
etc.).
• Make sure you have selected a good insertion site (see Chapter 6,
Section 6.3, Choosing an Insertion Site).
• Make sure the insertion site is clean and dry prior to sensor insertion.
13.6.2 MANUAL SENSOR SHUT-OFF – “STOP
SENSOR”
There may be times that the user or healthcare professional will want
to stop the sensor session before the end of the seven days. Some of
these times may include removing the sensor early due to:
• Calibration issues that cannot be resolved
•
symbol that does not resolve
• Sensor adhesion issues
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13
• Lifestyle needs
When you are in an active sensor session, you
will see the “Stop Sensor” option but not the
“Start Sensor” option on the Main Menu.
When you are not in an active sensor session,
you will see the “Start Sensor” option but not
the “Stop Sensor” option on the Main Menu.
Stop the sensor session if you remove the
sensor before the end of the full 7-day period.
Main Menu,
Stop Sensor highlighted
1. T
o end the sensor session, select “Stop Sensor” from the Main Menu.
2. P
ress the SELECT button with “OK”
highlighted to confirm.
Stop Sensor screen,
OK highlighted
3. The Stop Sensor “thinking” screen will
show to let you know the sensor session is
stopping.
Stop Sensor
“thinking” screen
4. O
nce the session has stopped, a red stoplight symbol (
in the upper right of the trend graph.
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) shows
Trend graph with red
stoplight in upper right
in real-time mode
Trend graph with red
stoplight in upper right
in blinded mode
13.7 BATTERY AND CHARGER
TROUBLESHOOTING
Only use the Dexcom cable and battery charger to charge the
receiver.
A full charge can take up to 5 hours and will last about 3 days,
depending on how often you turn on the receiver, use the alerts, and
enter events.
If the receiver does not show the battery charging symbol when plugged
into the charger, make sure that both ends of the USB cable are fully
inserted into the receiver port and wall charger or computer.
If the battery drains and is not charged for a few weeks it may not turn
on. If the receiver does not turn on, try to charge it (see Chapter 4,
Section 4.1, Charging the Receiver Battery). If the receiver does not
charge, contact Dexcom Technical Support and tell them that you are
using a receiver with a shield.
13.8 RECEIVER AND TRANSMITTER
COMMUNICATION TROUBLESHOOTING
13.8.1 SYSTEM RECOVERY CHECK
This screen means the system found an error that it was able to fix.
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13
Press the SELECT button to clear this display,
and continue the sensor session.
System Check screen
13.8.2 RECEIVER ERROR CODE
This screen shows an error code that means
the receiver may not be working properly. Write
down the error code and contact Dexcom
Technical Support (see Chapter 15, User
Assistance). Continue to check the blood
glucose value using the blood glucose meter.
No alert sound or vibration will warn you
that you are no longer getting sensor
glucose readings.
Receiver Error Code
screen
13.8.3 TRANSMITTER LOW BATTERY
This screen shows when the transmitter nears
the end of its battery life (see Chapter 1,
Section 1.4, Transmitter Overview). It will first
show when there is about 1 week of battery
life left. When the transmitter battery drains
low enough, the transmitter and receiver will
stop communicating. Replace the transmitter
Transmitter Low Battery
as soon as possible after you see this
screen
screen. Contact Dexcom Sales Support (see
Chapter 15, User Assistance) to order a new
transmitter.
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13.8.4 TRANSMITTER FAILED ERROR CODE
This screen means that the transmitter is not
working. If you get this alert during a sensor
session, the sensor session automatically
stops. Contact Dexcom Technical Support
(see Chapter 15, User Assistance). Continue to
check the blood glucose value using the blood
glucose meter.
Transmitter Failed
screen
13.9 OUT OF RANGE/NO ANTENNA
PRECAUTION
The transmission range from the transmitter to the
receiver is up to 20 feet without obstruction. Wireless
communication does not work well through water so the
range is much less if you are in a pool, bathtub, or on a
water bed, etc. Types of obstruction differ and have not
been tested. If your transmitter and receiver are farther
than 20 feet apart or are separated by an obstruction,
they might not communicate or the communication
distance may be shorter and you might miss a low or
high blood glucose value.
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13
This screen means the receiver and transmitter
are not communicating and you are not getting
sensor glucose readings.
• The receiver and transmitter only
communicate when you are in an active
sensor session.
• Each time you start a new sensor session,
wait 10 minutes for the receiver and
transmitter to start communicating.
Out of range symbol
appears in upper right
of trend graph
• You may sometimes experience loss of communication for 10
minutes at a time. This is normal.
• If you see the out of range symbol in the status area for more than
10 minutes, move the receiver and transmitter within 20 feet of each
other without obstruction. Wait 10 minutes and communication
should be restored.
• You must enter the transmitter ID correctly into the receiver to
receive sensor glucose readings (see Chapter 5, Section 5.2,
The Settings Menu). Make sure you have removed the sensor
and stopped the sensor session before checking or changing the
transmitter ID. “Transmitter ID” will not appear as an option on the
Settings menu during a sensor session.
• The out of range alert is an advanced feature
that can be turned on when appropriate.
If this advanced feature is turned on, it will
alert when the receiver and transmitter are
not communicating for a set amount of time
depending on the profile settings.
Out of Range
alert screen
If you are still having trouble getting system readings, contact Dexcom
Technical Support (see Chapter 15, User Assistance).
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13.10 ALERTS ARE NOT WORKING
WARNING
ow/high glucose alerts and the 55 mg/dL low glucose
L
alarm are all disabled when using the Dexcom G4
PLATINUM Professional System in blinded mode and
will not alert you when the glucose is low or high. Check
blood glucose meter if there are any signs or symptoms
of low or high glucose.
1. M
ake sure you have not turned off the sound and/or vibrations for the
alerts. Chapter 9, Section 9.1, Setting the Alerts in Real-Time Mode
explains how to change these alert options.
2. C
heck that you have turned on and set the level for the advanced
alerts (see Chapter 9, Section 9.2, Advanced Alerts).
3. Remember, the first alert is vibrate only. See Chapter 18, Appendix
I, Receiver Alerts, Alarm and Prompts sequence tables for how the
alerts, alarm and prompts work.
If the receiver gets wet, dropped, or the acoustic spacer moves,
make sure the speaker and vibrations still work. You can do this
with the Try It option in the profiles menu (see Chapter 9, Section
9.3.1, Alert Profile Options).
PRECAUTIONS
• Return the receiver to the healthcare professional if
the acoustic spacer moves away from the upper right
corner. The entire receiver shield must be discarded
and replaced. The spacer allows the receiver speaker
(continued on next page)
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13
PRECAUTIONS (continued from page before)
to work properly when the shield is in place. If the
spacer moves and the receiver speaker volume is low,
you might miss alerts or alarms.
• Inspect the receiver shield, seals and spacer for tears
or other damage or defects before you place the
components on the receiver. Do not use any parts of the
receiver shield pack that are damaged or defective. If the
receiver shield, seals and spacer are torn, damaged or
otherwise defective after giving to the patient, the patient
should return the receiver to the healthcare professional
for a replacement. The damaged or defective receiver
shield should not be taken off by the patient. If a defect
or malfunction is suspected, the healthcare professional
should retain the shield and contact Dexcom Technical
Support. The shield helps protect the user and
healthcare professionals from contamination and allows
the receiver to function properly.
If a patient returns a receiver because
the spacer is torn, damaged or defective,
discard the shield, seal and spacer and
replace with a new shield, seal and spacer.
Acoustic spacer in upper
right of receiver
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14
chapter fourteen
TECHNICAL INFORMATION
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14
182 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 14: TECHNICAL INFORMATION
14.1 DEVICE PERFORMANCE
CHARACTERISTICS
NOTE: We recommend that you review the information in this chapter to
understand how well the Dexcom G4 PLATINUM Professional System
performs. The Dexcom G4 PLATINUM Professional System is the same
as the Dexcom G4 PLATINUM System with the addition of the receiver
shield. Therefore, the Dexcom G4 PLATINUM System clinical study
is applicable to this system. The Dexcom G4 PLATINUM Professional
System uses a real-time algorithm and does not retrospectively process
sensor glucose data.
The Dexcom G4 PLATINUM System (the System) uses a glucose
sensor to continuously measure and monitor your glucose levels. The
sensor is “calibrated” using a commercially available blood glucose
meter; and once calibrated the System reports sensor glucose readings
up to every 5 minutes. The System was evaluated in a clinical study
in which System readings were compared to blood glucose values to
assess its performance and how well the System readings compare to a
laboratory test method that measures blood glucose values. Additionally,
patients performed self-monitoring blood glucose meter tests at home to
assess the System performance in real use environment.
Although the performance characteristics of the System are presented
in the following, there is no commonly accepted statistical approach for
capturing performance of continuous glucose monitors (CGMs), such as
the Dexcom G4 PLATINUM System.
Clinical Study Overview
The System performance was evaluated in a prospective clinical study;
72 participants were enrolled. All participants had Type 1 or Type 2
diabetes mellitus, and required insulin or oral medication to manage
their diabetes. About 83% of participants had Type 1 diabetes and about
17% of participants had Type 2 diabetes. The study included subjects
greater than 18 years of age.
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14
Participants used the System for seven days. Thirty-six participants
each wore 2 sensors. Sensors were calibrated approximately once
every 12 hours, using the self-monitoring blood glucose (SMBG)
meter values obtained from the LifeScan® OneTouch® Ultra® 2 meter.
Throughout the 7-day wear period, the sensor was calibrated with an
average of 2 fingersticks per day (approximately once every 12 hours).
All subjects were evaluated in a controlled clinic environment on Day
1, Day 4, and Day 7 of the 7-day wear period. While using the System
in the clinic, 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 System were reported every 5 minutes
and paired with YSI values in order to characterize how well the System
readings agreed with laboratory standard blood glucose results. The
remainder of the study took place at home, the System performance
was also paired with the comparative LifeScan OneTouch Ultra 2 meter
results, and that is referred to as the ‘SMBG’.
Agreement
Agreement between the System and blood glucose values is
characterized using paired System and YSI values. The System and
YSI results were compared by pairing the YSI blood glucose value to
a System glucose reading that occurred immediately after the YSI was
collected.
The agreement of the System to blood glucose value was assessed by
calculating the percentage of System readings that were within 15%,
20%, 30%, 40% and greater than 40% of the YSI values. For readings
less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference
in mg/dL (mmol/L) between the two glucose results was calculated.
For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent
difference (%) from the YSI values was calculated. The percentages
of total readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1
mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L)
or 40% or greater than 40 mg/dL (2.2 mmol/L) or 40% were then
calculated in Table 1-A and Table 1-B.
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The total number of data pairs considered in this analysis was 9152. Of
these, eighty-two percent (82%) of the System readings fall within ±20
mg/dL (1.1 mmol/L) of the YSI blood glucose values (≤ 80 mg/dL or 4.4 mmol/L) and within ±20% of YSI blood glucose values (> 80 mg/dL or
4.4 mmol/L).
Table 1-A. System Agreement to YSI within CGM
Glucose Ranges
CGM
Glucose
Range
mg/dL
(mmol/L)
Overall
40-60
(2.2-3.3)
61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
9152
71%
82%
92%
97%
Percent
Greater
than
40/40%
YSI
3%
512
67%
78%
88%
94%
6%
781
73%
85%
94%
98%
2%
3853
67%
78%
91%
97%
3%
2784
72%
84%
93%
96%
4%
775
82%
91%
97%
98%
2%
447
74%
84%
91%
95%
5%
Number
of paired
CGM-YSI
Percent Percent Percent
within
within
within
15/15% 20/20% 30/30%
YSI
YSI
YSI
Percent
within
40/40%
YSI
NOTE: CGM readings are within 40-400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Table 1-A is categorized within CGM glucose ranges. When you see
a CGM reading on your receiver, this table shows you how likely that
reading matches your blood glucose level (measured by YSI in the
study). For example, if your CGM reads 100 mg/dL (5.6 mmol/L), it is
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14
in the range of 81-180 mg/dL (4.5-10.0 mmol/L). You may expect your
CGM readings to be within 20% of YSI values 78% of the time.
Table 1-B. System Agreement to YSI within YSI Glucose
Ranges
YSI Glucose
Range
mg/dL
(mmol/L)
Overall
< 40
(2.2)
40-60
(2.2-3.3)
61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
> 400
(22.2)
9152
71%
82%
92%
97%
Percent
Greater
than
40/40%
YSI
3%
22
59%
73%
86%
100%
0%
461
75%
87%
94%
98%
2%
890
69%
81%
94%
98%
2%
3892
65%
76%
88%
95%
5%
2644
74%
85%
94%
97%
3%
869
79%
92%
99%
100%
0%
337
84%
91%
98%
100%
0%
37
81%
86%
100%
100%
0%
Number
of paired
CGM-YSI
Percent Percent Percent
within
within
within
15/15% 20/20% 30/30%
YSI
YSI
YSI
Percent
within
40/40%
YSI
NOTE: CGM readings are within 40-400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Table 1-B is categorized within YSI reference value ranges. When you
know your blood glucose level (measured by YSI in the study), this table
shows how likely your CGM reading matches with your blood glucose
186 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
level. For example if you feel normal and your blood glucose level is at
100 mg/dL (5.6 mmol/L), you can expect your CGM reading to be within
20% of YSI values, i.e. 80 to 120 mg/dL (4.5-6.7 mmol/L), 76% of the time.
During the clinical study, the reference YSI values outside of the
System measurable range were collected. Among these samples, on 22
occasions, when the actual blood glucose concentrations (as determined
by the YSI analyzer) were lower than 40 mg/dL (2.2 mmol/L), 73% of the
paired CGM glucose readings were within 20 mg/dL (1.1 mmol/L) of the
YSI values, and 86% of the paired CGM glucose readings were within
30 mg/dL (1.7 mmol/L) of the YSI values. On 37 occasions, when the
actual blood glucose concentration (as determined by the YSI analyzer)
were greater than 400 mg/dL (22.2 mmol/L), 86% of paired System
readings were within 20% of the YSI values, and 100% of the paired
CGM glucose readings were within 30% of the YSI values.
Agreement When CGM Reads “LOW” or “HIGH”
The System reports glucose concentrations between 40 and 400 mg/dL
(2.2-22.2 mmol/L). When the System determines the glucose level is
below 40 mg/dL (2.2 mmol/L), it displays “LOW” in the Receiver Status
Box. When the Dexcom G4 PLATINUM System determines that the
glucose level is above 400 mg/dL (22.2 mmol/L), it displays “HIGH”
in the Receiver Status Box. Because the System does not display
glucose values below 40 mg/dL (2.2 mmol/L) or above 400 mg/dL (22.2
mmol/L), the comparisons to the actual blood glucose concentrations
(as determined by the YSI analyzer) when CGM is classified as “LOW”
or “HIGH” are included separately in Table 2. The table includes the
numbers and the cumulative percentages when YSI values were less
than certain glucose levels (for ‘LOW’), and when YSI values were
greater than certain glucose levels (for ‘HIGH’).
For example, on 155 occasions, the System displayed “LOW”, 92% (141
out of 155) of YSI values were less than 80 mg/dL (4.4 mmol/L), and
only 79% (123 out of 155) of the YSI values were less than 70 mg/dL
(3.9 mmol/L); On 248 occasions, the System displayed “HIGH”, 99%
(246 out of 248) of the YSI values were greater than 240 mg/dL (13.3
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14
mmol/L), and 96% (238 out of 248) of the YSI values were greater than
280 mg/dL (15.6 mmol/L).
Table 2. Number and Percentage of YSI Values When
CGM Readings are ‘Low’ or ‘High’
YSI mg/dL (mmol/L)
CGM
Readings
‘LOW’
CGM-YSI
pairs
< 55
(3.1)
< 60
(3.3)
< 70
(3.9)
< 80
(4.4)
> 80
(4.4)
Total
n
66
18
39
19
13
155
Cumulative
Percent
42%
54%
79%
92%
8%
YSI mg/dL (mmol/L)
CGM
Readings
‘HIGH’
CGM-YSI
pairs
> 340
(18.9)
> 320
(17.8)
> 280
(15.6)
> 240
(13.3)
< 240
(13.3)
Total
n
189
31
18
8
2
248
Cumulative
Percent
76%
89%
96%
99%
1%
Concurrence of System and Laboratory Reference
The percentage of concurring CGM readings and YSI reference values
were included in Table 3. For example, when CGM readings are within
81 to 120 mg/dL (4.4-6.7 mmol/L), you can expect your blood glucose
levels are within 40 to 60 mg/dL (2.2-3.3 mmol/L) 2% of time; within
60 to 80 mg/dL (3.3-4.4 mmol/L) 17% of time; within 81 to 120 mg/dL
(4.4- 6.7 mmol/L) 66% of time; within 121 to 160 mg/dL (6.7 to 8.9
mmol/L) 13% of time; and within 161 to 180 mg/dL (8.9 to 10 mmol/L) 1%
of time.
Table 3 is categorized by each range of CGM glucose ranges. This table
describes for each range of CGM glucose readings, what percentage
of paired YSI values were in the same glucose range (shaded) or in
188 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
glucose ranges above and below the paired CGM readings.
Table 3. Concurrence of CGM Readings and YSI Values
CGM
mg/dL
(mmol/L)
YSI mg/dL (mmol/L)
Percent of matched pairs in each YSI glucose range
for each Sensor glucose range
40- 61< 40 60
80
(<2.2) (2.2- (3.43.3) 4.4)
81120
(4.56.7)
121160
(6.78.9)
161200
(8.911.1)
201- 251- 301250 300 350
(11.1- (13.9- (16.713.9) 16.7) 19.4)
351400 > 400
(19.4- (>22.2)
22.2)
Number
of
Paired
CGMYSI
< 40
(< 2.2)
6%
48% 37%
7%
1%
0%
0%
0%
0%
0%
0%
155
40-60
(2.2-3.3)
4%
49% 36%
11%
1%
0%
0%
0%
0%
0%
0%
512
61-80
(3.4-4.4)
0%
22% 51%
24%
1%
0%
0%
0%
0%
0%
0%
781
81-120
(4.5-6.7)
0%
2%
17%
66%
13%
1%
0%
0%
0%
0%
0%
1706
121-160
(6.7-8.9)
0%
0%
1%
25%
60%
13%
2%
0%
0%
0%
0%
1492
161-200
(8.9-11.1)
0%
0%
0%
2%
28%
53%
16%
2%
0%
0%
0%
1240
201- 250
(11.1- 13.9)
0%
0%
0%
0%
3%
21%
51%
21%
3%
1%
0%
1181
251- 300
(13.9- 16.7)
0%
0%
0%
0%
0%
4%
19%
49%
24%
3%
0%
1018
301- 350
(16.7- 19.4)
0%
0%
0%
0%
0%
0%
3%
28%
51%
16%
1%
775
351- 400
(19.4- 22.2)
0%
0%
0%
0%
0%
0%
3%
10%
43%
38%
7%
447
> 400
(> 22.2)
0%
0%
0%
0%
0%
0%
1%
6%
21%
57%
15%
248
Accuracy
Accuracy between matched pairs was also estimated by calculating the
percent difference between the System reading and the YSI value. For
example, if the YSI value is 100 mg/dL (5.6 mmol/L) and the System
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14
reading is 90 mg/dL (5.0 mmol/L), a 10% difference between the System
and the YSI is reported. The System and YSI values were compared by
pairing the System reading that fell immediately after the YSI value was
collected.
In the example above the System reading is less than the YSI value, so
the percent difference reading is negative. The mean percent difference
is the average of all positive and negative percent differences between
the two devices; it tells you if the System reads higher or lower on
average than the YSI at each glucose range.
Another estimate used to show the accuracy of the System is the
absolute percent difference. The absolute percent difference tells you
the percent difference or “distance” between the System and YSI values,
but does not tell you whether the System is reading, on average, higher
or lower than the YSI laboratory standard. The mean absolute percent
difference is the average “distance” (regardless if positive or negative)
between System readings and YSI values.
These accuracy measures in differences are based on 9152 paired
glucose results and summarized in the following Table 4-A and Table
4-B.
Overall, the System reads, on average, 2.9% different (Mean Percent
Difference) than the reference and 13.3% absolute different (Mean
Absolute Difference) than the reference values. The Median Percent
Difference shows that half of the time the System reads 1.7% or less
than the YSI blood glucose values and the Median Absolute Percent
Difference shows that half of the time the System reads about 9.8% or
less different than YSI blood glucose values.
190 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Table 4-A. System Difference to YSI within CGM
Glucose Ranges
CGM
Glucose
Ranges
mg/dL
(mmol/L)
Overall
*40-60
(2.2-3.3)
*61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
Mean
Percent
Difference
(%)
Median
Percent
Difference
(%)
Mean
Absolute
Percent
Difference
(%)
Median
Absolute
Percent
Difference
(%)
2.9
-10.0
(-0.6)
-2.4
(-0.1)
1.7
-8.2
(-5.2)
-0.4
(-0.0)
13.3
13.5
(0.8)
11.4
(0.6)
9.8
9.7
(0.5)
8.6
(0.5)
3853
4.8
3.0
13.8
9.8
2784
2.1
0.0
11.9
9.2
775
3.8
2.8
9.8
7.9
447
10.4
7.7
12.8
9.1
Number
of Paired
CGM-YSI
9152
512
781
* For CGM ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L)
are included instead of percent differences (%).
NOTE: CGM readings are within 40 to 400 mg/dL (2.2- 22.2 mmol/L),
inclusive.
Table 4-A is categorized within CGM glucose ranges. For example, on
average, CGM reads 10.0 mg/dL (0.6 mmol/L) lower than the reference
at CGM glucose levels of 40-60 mg/dL (2.2-3.3 mmol/L) and reads 2.4
mg/dL (0.1 mmol/L) lower than the reference at CGM glucose level of
61-80 mg/dL (Mean Difference, i.e. 3.4-4.4 mmol/L), 9.8% different than
the reference at CGM glucose values of 301-350 mg/dL (Mean Absolute
Percent Difference, i.e. 16.7-19.4 mmol/L), and 12.8% different than
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the reference at CGM reading within 351-400 mg/dL (Mean Absolute
Percent Difference, i.e. 19.4-22.2 mmol/L).
Table 4-B. System Difference to YSI within YSI Glucose
Ranges
YSI Glucose
Ranges
mg/dL
(mmol/L)
Overall
*< 40
(2.2)
*40-60
(2.2-3.3)
*61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
> 400
(22.2)
1.7
12.9
(0.7)
6.3
(0.4)
2.4
(0.1)
Mean
Absolute
Percent
Difference
(%)
13.3
14.4
(0.8)
11.0
(0.4)
12.2
(0.7)
Median
Absolute
Percent
Difference
(%)
9.8
12.9
(0.7)
8.8
(0.5)
10.2
(0.6)
3.8
3.0
14.0
10.1
2644
1.3
0.3
11.2
8.5
869
-1.7
-1.5
9.8
8.6
337
-5.8
-5.2
8.8
6.8
37
-11
-10
11.2
10.3
Mean
Percent
Difference
(%)
Median
Percent
Difference
(%)
2.9
14.4
(0.8)
7.3
(0.4)
3.6
( 0.2)
3892
Number
of paired
CGM-YSI
9152
22
461
890
* For YSI ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L)
are included instead of percent differences (%).
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Table 4-B is categorized within YSI glucose value ranges. For example,
192 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
on average, CGM reads 7.3 mg/dL (0.4 mmol/L) higher than the
reference at YSI glucose levels of 40-60 mg/dL (2.2-3.3 mmol/L) and
reads 3.6 mg/dL (0.2 mmol/L) higher than the reference at YSI glucose
level of 61-80 mg/dL (Mean Difference, i.e. 3.4-4.4 mmol/L), 9.8%
different than the reference at YSI glucose values of 301-350 mg/dL
(Mean Absolute Percent Difference, i.e. 16.7-19.4 mmol/L), and 8.8%
different than the reference at YSI glucose values of 351-400 mg/dL
(Mean Absolute Percent Difference, i.e. 19.4-22.2 mmol/L).
Low and High Glucose Alerts
The ability of the System to detect high and low glucose levels
(concentrations) is assessed by comparing System results to YSI results
at low and high blood glucose levels and determining if the alert may
have sounded. The System and YSI readings were compared by pairing
the System reading that occurred immediately after the YSI reading was
collected. There were 9555 paired System 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 Table 5.
Table 5. Hypoglycemic Alert Evaluation
Hypoglycemic
Alert Level
mg/dL (mmol/L)
55 (3.1)
60 (3.3)
70 (3.9)
80 (4.4)
90 (5.0)
True
Alert
Rate
50%
64%
79%
87%
90%
False
Alert
Rate
50%
36%
21%
13%
10%
Hypoglycemia
Detection Rate
Hypoglycemia Missed
Detection Rate
71%
75%
83%
86%
89%
29%
25%
17%
14%
11%
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Hypoglycemia Alert Rate
The Alert Rate shows how often the alert is right or wrong. The True
Alert Rate is the % of time the device alarmed when the blood glucose
level was at or below the alert setting within 15 minutes before or after
the device alarmed. The False Alert Rate is the % of time the device
alarmed when the blood glucose level was above the alert setting within
15 minutes before or after the device alarmed.
For example, if you set the Low Glucose Alert to 70 mg/dL (3.9 mmol/L)
and your alarm sounds, how often can you expect your blood sugar to
actually be low? If your alarm sounds, you can expect your blood sugar
to be below 70 mg/dL (3.9 mmol/L) approximately 79% of the time and
not be below 70 mg/dL (3.9 mmol/L) approximately 21% of the time
within the 15 minute period before or after your alarm sounds.
Hypoglycemia Detection Rate
The Detection Rate shows how often the device recognizes and alerts
you to an episode of hypoglycemia or how often it misses such an event.
The Hypoglycemia Detection Rate is the % of time the blood glucose
level was at or below the alert setting and device alarmed within 15
minutes before or after the blood glucose was at or below the alert
settings. The Hypoglycemia Missed Detection Rate is the % of time
the blood glucose was at or below the alert setting, but the device did
not alarm within 15 minutes before or after the blood glucose was at or
below the alert setting.
For example, if you set the Low Glucose alert to 70 mg/dL (3.9 mmol/L),
how often will your alarm alert you if your blood glucose goes below
70 mg/dL (3.9 mmol/L)? If your blood sugar goes below 70 mg/dL (3.9
mmol/L), you can expect your alarm to sound 83% of the time and not to
sound approximately 17% of time within the 15 minute period before or
after your blood sugar goes below 70 mg/dL(3.9 mmol/L).
The High Glucose Alert
Estimates of how well the adjustable High Glucose Alert performs are
presented in Table 6.
194 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Table 6. Hyperglycemic Alert Evaluation
Hyperglycemic
Alert Level mg/dL
(mmol/L)
True
Alert
Rate
False
Alert
Rate
Hyperglycemia
Detection Rate
Hyperglycemia
Missed Detection
Rate
120 (6.7)
95%
5%
98%
2%
140 (7.8)
94%
6%
97%
3%
180 (10.0)
92%
8%
97%
3%
200 (11.1)
92%
8%
97%
3%
220 (12.2)
91%
9%
95%
5%
240 (13.3)
91%
9%
94%
6%
300 (16.7)
82%
18%
86%
14%
Hyperglycemia Alert Rate
The Alert Rate shows how often the alert is right or wrong. The True
Alert Rate is the % of time the device alarmed when the blood glucose
level was at or above the alert setting within 15 minutes before or after
the device alarmed. The False Alert Rate is the % of time the device
alarmed when the blood glucose level was below the alert setting within
15 minutes before or after the device alarmed.
For example, if you set the High Glucose alert to 200 mg/dL (11.1
mmol/L) and your alarm sounds, how often can you expect your blood
sugar to actually be high? If your alarm sounds, you can expect your
blood sugar to be at or above 200 mg/dL (11.1 mmol/L) approximately
92% of the time and not be above 200 mg/dL (11.1 mmol/L)
approximately 8% of the time within the 15 minute period before or after
your alarm sounds.
Hyperglycemia Detection Rate
The Detection Rate shows how often the device recognizes and alerts
you to an episode of hyperglycemia or how often it misses such an
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event. The Hyperglycemia Detection Rate is the % of time the blood
glucose level was at or above the alert setting and the device alarmed
within 15 minutes before or after the blood glucose was at or above the
alert settings. The Hyperglycemia Missed Detection Rate is the % of
time the blood glucose was at or above the alert setting, but the device
did not alarm within 15 minutes before or after the blood glucose was at
or above the alert setting.
For example, if you set your High Glucose alert to 200 mg/dL (11.1
mmol/L), how often will your alarm alert you if your blood glucose goes
at or above 200 mg/dL (11.1 mmol/L)? If your blood sugar goes above
200 mg/dL (11.1 mmol/L), you can expect your alarm to sound 97% of
the time and not to sound approximately 3% of time within the 15 minute
period before or after your blood sugar goes above 200 mg/dL (11.1
mmol/L).
Calibration Stability
The System must be calibrated every 12 hours. To demonstrate
performance of the System over a 12-hour calibration period, sensors
were evaluated to verify that performance remains consistent over
the 12-hour calibration period. Systems were evaluated in 2-hour
increments after calibration. Performance was estimated at each 2-hour
interval and stratified by glucose concentrations by calculating the
percentage of System readings within 15 mg/dL (0.9 mmol/L) or 15%,
20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL
(2.2 mmol/L) or 40% and greater than 40 mg/dL (2.2 mmol/L) or 40% of
the YSI values in Table 7.
196 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Table 7. Percentage of System Readings within YSI
Values with Data Stratified in 2-Hour Increments after
Calibration
Time from
Calibration
Number
of paired
CGM-YSI
0-2 hours
2-4 hours
4-6 hours
6-8 hours
8-10 hours
10-12 hours
12-14 hours
1929
1516
1547
1520
1555
1068
17
Percent Percent Percent
within
within
within
15/15% 20/20% 30/30%
YSI
YSI
YSI
78%
88%
96%
69%
81%
91%
69%
79%
91%
68%
79%
92%
71%
82%
92%
65%
77%
91%
65%
76%
82%
Percent Percent
within
greater
40/40%
than
YSI
40/40% YSI
98%
2%
96%
4%
95%
5%
97%
3%
96%
4%
96%
4%
88%
12%
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Sensor Stability
Sensors can be worn for up to 7 days. To verify sensor performance
over time, 108 sensors were evaluated across the 7-day wear period.
Performance was estimated by calculating the percentage of System
readings within 15 mg/dL (0.9 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L)
or 20%, 30 mg/dL (1.7 mmol/L) or 30% , 40 mg/dL (2.2 mmol/L) or 40%
and greater than 40 mg/dL (2.2 mmol/L) or 40% of the YSI values at
the beginning (Day 1), middle (Day 4) and end (Day 7) of the System
lifecycle. The average and median of the absolute percent differences
are included in Table 8 showing consistent accuracy and sensor stability
over the 7-day life of the sensor.
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Table 8. Sensor Stability (Accuracy over Time)
Day of
Wear
Number
of paired
CGM-YSI
Mean
Absolute
Percent
Differences
(%)
Median
Absolute
Percent
Differences
(%)
Percent
within
15/15%
YSI
Percent
within
20/20%
YSI
Percent
within
30/30%
YSI
Percent
within
40/40%
YSI
Percent
greater
than
40/40%
YSI
Day 1
Day 4
Day 7
3023
3108
3021
16.7%
11.4%
11.9%
13.2%
8.2%
8.9%
59%
77%
76%
71%
87%
87%
86%
95%
95%
94%
98%
98%
6%
2%
2%
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Precision of System Readings
In the study, 36 participants wore two Systems. This was to look at how
similarly two Systems function on the same patient (sensor precision).
Precision was evaluated by comparing the glucose readings from the
two Systems worn on the same subject at the same time. Results
showed that System readings from the two sensors generally agreed
with each other within 9% (absolute percent difference) with a 7%
coefficient of variation.
Sensor Life
Sensors may be worn for up to 7 days (168 hours). To estimate how
long a sensor will work over 7 days, 108 sensors were evaluated to
determine how many days/hours of readings each sensor provided.
Ninety-four percent (94%) of the sensors lasted until Day 7 (145-168
hours). There were 6 (4%) sensors that ended early, four of which lasted
more than 3 days.
Number of Readings Provided
The System is capable of providing a reading up to every 5 minutes,
or up to 288 readings per day. For a variety of reasons, the System
may not display a glucose reading and readings are “skipped.” Table
9 estimates the number of readings you can expect to receive from
198 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
the System over the entire 7-day period after calibration. For example,
93.5% of Systems provided between 1,811 and 1,992 valid glucose
readings (or more than 76% of the expected number of readings).
Adjusted within each system wear-day, the System provided an average
of 97% of all expected glucose readings (288) as seen in Table 10.
Table 9. Number of Readings Provided by Each Sensor
Over 7-Days
% of Total Possible
Readings Provided
Total
Readings
Provided
(Min-Max)
% of Systems Providing
that Number of Readings
0-25%
167-491
1.9%
26-50%
719-914
3.7%
51-75%
1267-1267
0.9%
76-100%
1811-1992
93.5%
Table 10. System Readings Within Wear Days
Statistic Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
All Days
(N = 108)
Mean
Median
STD
98%
100%
3%
98%
100%
9%
98%
100%
8%
97%
100%
10%
99%
100%
3%
95%
100%
11%
97%
100%
8%
98%
100%
5%
Agreement and Accuracy Relative to SMBG
During the study, agreement between the System and blood glucose
values is also characterized using paired System and SMBG results.
The System and SMBG values were compared by pairing the
comparative SMBG value to a System glucose reading that occurred
immediately after the SMBG was collected. These results characterize
the performance patients expect during real-time use of the system in
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their daily diabetes management when comparing the system readings
to their home blood glucose meter results.
Table 11. System Agreement to SMBG Within CGM
Glucose Ranges
CGM
Glucose
Ranges
mg/dL
(mmol/L)
Overall
40-60
(2.2-3.3)
61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
7508
69%
81%
94%
98%
Percent
greater
than
40/40%
SMBG
2%
731
75%
84%
92%
96%
4%
968
78%
86%
95%
99%
1%
3141
65%
78%
93%
98%
2%
1960
68%
81%
94%
97%
3%
450
77%
88%
98%
99%
1%
258
75%
85%
95%
98%
2%
Number
of paired
CGM-SMBG
Percent Percent Percent
within
within
within
15/15% 20/20% 30/30%
SMBG
SMBG
SMBG
Percent
within
40/40%
SMBG
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Table 11 is categorized within CGM glucose ranges. For readings less
than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference in mg/dL
(mmol/L) between the two glucose results was calculated. For values
greater than 80 mg/dL (4.4 mmol/L) the absolute percent difference
(%) from the SMBG values was calculated. The percentages of total
readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L)
or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L) or 40%
200 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
or greater than 40 mg/dL (2.2 mmol/L) or 40% were then calculated.
For example, if the CGM reads 100 mg/dL, it is between 81-180 mg/dL
(4.5-10.0 mmol/L) range, you can expect the CGM readings to be within
20% of the SMBG values 78% time.
Table 12. System Difference to SMBG within CGM
Glucose Ranges
CGM Glucose
Ranges mg/dL
(mmol/L)
Overall
*40-60
(2.2-3.3)
*61-80
(3.4-4.4)
81-180
(4.5-10.0)
181-300
(10.1-16.7)
301-350
(16.7-19.4)
351-400
(19.4-22.2)
Mean
Median
Mean
Median
Number
Absolute Absolute
Percent
Percent
of Paired
Percent
Percent
Difference Difference
CGM-SMBG
Difference Difference
(%)
(%)
(%)
(%)
7508
-0.4
-1.4
14.0
11.0
-9.3
(-0.5)
-1.0
(-0.1)
-8.0
(-0.4)
1.0
(0.1)
11.7
(0.7)
10.7
(0.6)
8.0
(0.4)
8.0
(0.4)
3141
1.4
0.0
14.2
11.0
1960
-0.7
-2.8
13.0
10.3
450
-0.7
-2.6
10.5
8.6
258
5.0
3.0
11.9
8.6
731
968
* For CGM ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L)
are included instead of percent differences (%).
NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L),
inclusive.
Overall, the System reads, on average, 0.4% lower (Mean Percent
Difference) than SMBG values and 14.0% absolute different (Mean
Absolute Percent Difference) than the SMBG values. The Median
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14
Percent Difference shows that half of the time the System reads -1.4%
or less than the SMBG values and the Median Absolute Percent
Difference shows that half of the time the System reads about 11.0% or
less different than SMBG values (Table 12).
Adverse Events
No serious adverse events or device-related serious adverse events
occurred during the study. Mild skin irritation, such as erythema or
edema, occurred in low frequency around adhesive area. No infection,
bruising, or bleeding occurred at the sensor needle insertion area or the
adhesive area.
14.2 PRODUCT SPECIFICATIONS
Sensor Product Specifications
Glucose Range
40 - 400 mg/dL
Sensor Life
Up to 7 days
Calibration
Commercially available blood glucose meter
Calibration Range
40 - 400 mg/dL
Storage
Condition
Temperature: 36° F - 77° F
Humidity: 15% - 85% RH
Sterilization
Sterile by radiation
Transmitter Product Specifications
Part Number
9438-01
Dimensions
(including
sensor pod)
Length: 1.5 inches
Width: 0.9 inches
Thickness: 0.5 inches
Weight (including
sensor pod)
0.4 ounces
(continued on next page)
202 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Transmitter Product Specifications (continued from page
before)
Power Supply
Silver oxide batteries (not replaceable)
Operational
Conditions
Temperature: 50° F - 108° F
Storage Conditions
Temperature: 32° F - 113° F
Humidity: 10% - 95% RH
Operating Altitude
-500 to 12000 feet
Limited Warranty
6 months
Moisture Protection
IP28: temporary submersion
Protection Against
Electrical Shock
Type BF applied part
Humidity: 10% - 95% RH
Transmitter Performance Characteristics
Parameter
Performance Characteristic
TX/RX Frequencies
2.424 999 877 GHz
2.449 993 677 GHz
2.474 737 539 GHz
2.477 236 919 GHz
Bandwidth
334.7 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 feet
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The Dexcom G4 PLATINUM Professional Continuous Glucose
Monitoring System is safe for use on U.S. commercial airlines. The
Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels
that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory,
Circular #91-21, 1B, dated 8/25/06, any M-PED that meets this standard
in all modes may be used onboard the aircraft without any further
testing by the operator. This device can withstand exposure to common
electrostatic (ESD) and electromagnetic interference (EMI).
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The transmitter (P/N 9438-01) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
transmitter should ensure that it is used in such an environment.
Transmitter Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Test Transmitter
Level
Compliance
Level
Electromagnetic
Environment
Guidance
Electrostatic
Discharge
(ESD)
± 6 kV Contact
Floors should be
wood, concrete
or ceramic
tile. If floors
are covered
with synthetic
material, the
relative humidity
should be at least
30%.
± 8 kV Air
IEC 61000-4-2
Electrical Fast
Transient
/burst
± 2 kV for
power supply
lines
± 6 kV
Contact
± 8 kV Air
Not applicable
(continued on next page)
204 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Transmitter Electromagnetic Immunity Specifications
(continued from page before)
Immunity Test
IEC 60601 Test Transmitter
Level
Compliance
Level
IEC 61000-4-4
± 1 kV for
input/output
lines
Battery
operated
Surge
± 1 kV line(s) to
line(s)
Not applicable
IEC 61000-4-5
Voltage
Dips, Short
Interruptions
and Voltage
Variations on
Power Supply
Input Lines
IEC 61000-4-11
± 2 kV line(s) to
earth
Electromagnetic
Environment
Guidance
Battery
operated
< 5% UT
Not applicable
(> 95% dip in
Battery
UT) for 0.5 cycle operated
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
< 5% UT
(> 95% dip in
UT) for 5 sec
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 205
14
Transmitter Electromagnetic Immunity Specifications
(continued from page before)
Immunity Test
IEC 60601 Test Transmitter
Level
Compliance
Level
Electromagnetic
Environment
Guidance
Power
Frequency
3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of
a typical location
in a typical
commercial
or hospital
environment.
3 A/m
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Receiver Product Specifications
Part Number
MT20649
Reading Frequency
Every 5 minutes
Dimensions
Length: 4.0 inches
Width: 1.8 inches
Thickness: 0
.5 inches
Weight
2.4 ounces
Receiver Input
5V DC, 1A
Power Supply
MT21255
Communication Range
20 feet
Memory Storage
30 days of glucose data,
7 days of tech support data
Re-Chargeable Battery Use
3 days
(continued on next page)
206 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Product Specifications (continued from page
before)
Charging Time
3 hours wall outlet,
5 hours powered USB
Storage/Operating
Conditions
Temperature: 32° F - 113° F
Humidity: 10% - 95% RH
Operating Altitude
-500 to 12000 feet
Moisture Protection
IP22: vertically falling drops
Limited Warranty
1 year
Control Classification
Class II equipment
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The receiver (P/N MT20649) is intended for use in the electromagnetic
environment specified in the next table. The customer or the user of the
receiver should ensure that it is used in such an environment.
Receiver Electromagnetic Immunity Specifications
Immunity Test IEC 60601
Test Level
Receiver
Compliance
Level
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%.
IEC 61000-4-2
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 207
14
Receiver Electromagnetic Immunity Specifications
(continued from page before)
Immunity Test IEC 60601
Test Level
Receiver
Compliance
Level
Electromagnetic
Environment
Guidance
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
Not applicable
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
Surge
± 1 kV line(s)
to line(s)
± 1 kV line(s)
to line(s)
± 2 kV line(s)
to earth
Not applicable
< 5% UT
(> 95% dip in UT)
for 0.5 cycle
< 5% UT
(> 95% dip
in UT) for 0.5
cycle
IEC 61000-4-5
Voltage
Dips, Short
Interruptions
and Voltage
Variations on
Power Supply
Input Lines
Mains power
quality should be
that of a typical
commercial
or hospital
environment.
Mains power
quality should be
that of a typical
commercial
40% UT
or hospital
(60% dip in UT) 40% UT
for 5 cycles
(60% dip in UT) environment.
for 5 cycles
(continued on next page)
208 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Electromagnetic Immunity Specifications
(continued from page before)
Immunity Test
IEC 60601
Test Level
Receiver
Compliance
Level
IEC 61000-4-11
70% UT
(30% dip in UT)
for 25 cycles
70% UT
(30% dip in UT)
for 25 cycles
85% UT
(15% dip in UT)
for 5 sec
85% UT
(15% dip in UT)
for 5 sec
IEC 60601-1-11
Electromagnetic
Environment
Guidance
< 5% UT
< 5% UT
(> 95% dip in UT) (> 95% dip in UT)
for 5 sec
for 5 sec
Power
Frequency
(50/60 Hz)
Magnetic Field
IEC 61000-4-8
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.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration –
Electromagnetic Immunity
The Dexcom G4 PLATINUM Professional System is intended for use
in the electromagnetic environment specified in the next table. The
customer or the user of the Dexcom G4 PLATINUM Professional
System should ensure that it is used in such an environment.
Dexcom G4 PLATINUM Professional System User’s Guide | 209
14
System Electromagnetic Immunity Specifications
Immunity Test
IEC 60601 Receiver
Electromagnetic
Test Level Compliance Environment
Level
Guidance
Conducted RF
3 Vrms
3 Vrms
IEC 61000- 4-6
150 kHz to
(Receiver only) 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
10 V/m
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 √P 150 kHz to
80 MHz
d = 1.2 √P 80 MHz to
800 MHz
d = 2.3 √P 800 MHz to
2.5 GHz
(continued on next page)
210 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
System Electromagnetic Immunity Specifications
(continued from page before)
Immunity Test
IEC 60601 Receiver
Test Level Compliance
Level
Electromagnetic
Environment
Guidance
Where P is the
maximum output
power rating of the
transmitter in watts
(W) according to
the transmitter
manufacturer and d
is the recommended
separation distance in
meters (m).
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
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.
Dexcom G4 PLATINUM Professional System User’s Guide | 211
14
a. Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast, and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the
location in which the Dexcom G4 PLATINUM Professional System is
used exceeds the applicable RF compliance level above, the Dexcom
G4 PLATINUM Professional System should be observed to verify
normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the
Dexcom G4 PLATINUM Professional System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should
be less than 3 V/m.
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
The Dexcom G4 PLATINUM Professional System is intended for use
in the electromagnetic environment specified in the next table. The
customer or the user of the Dexcom G4 PLATINUM Professional
System should ensure that it is used in such an environment.
Electromagnetic Emissions Specifications
Emissions Test
Compliance
Electromagnetic Environment
Guidance
RF emissions
Group 1
The Dexcom G4 PLATINUM
Professional System uses
RF energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any interference
in nearby electronic equipment.
CISPR 11
(continued on next page)
212 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Electromagnetic Emissions Specifications (continued
from page before)
Emissions Test
Compliance
Electromagnetic Environment
Guidance
RF emissions
Class B
The Dexcom G4 PLATINUM
Professional System is suitable
for use in all establishments
other than domestic and those
directly connected to the public
low-voltage power supply
network that supplies buildings
used for domestic purposes.
CISPR 11
Harmonic
emissions
Not
applicable
IEC 61000-3-2
Not
Voltage
fluctuations/flicker applicable
emissions
IEC 61000-3-3
Recommended Separation Distances Between Portable
and Mobile RF Communications Equipment and the
Receiver
The receiver is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the
user of the receiver can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the receiver as
recommended below, according to the maximum output power of
the communications equipment. Portable and mobile RF equipment
include: baby monitors, Bluetooth wireless headsets, wireless routers,
microwave ovens, laptops with internal wi-fi adapters, GSM cell phones,
RFID scanners and hand-held security metal detector often used by
security screeners.
Dexcom G4 PLATINUM Professional System User’s Guide | 213
14
Minimum Recommended Distance Between Transmitter
and Receiver
Rated
maximum
Output Power
of Transmitter
(W)
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
0.01
0.1
1
10
100
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 (d) in feet can be estimated using the
equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according
to the transmitter 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.
USB Charging/Download Cable* Specifications
Dexcom P/N
MT20655
Input/Output
5V DC, 1A
Type
USB A to USB micro B
Length
3 feet
* The power supply/charger can be connected to the USB
charging/download cable for charging using an AC power outlet.
214 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Power Supply/Charger Specifications
Dexcom P/N
MT21255
Class
II
Input:
AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at
100Vac
DC Output:
5V DC, 1A (5.0 Watts)
14.3 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
Dexcom G4 PLATINUM Professional System User’s Guide | 215
14
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.
216 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
15
chapter fifteen
USER ASSISTANCE
Dexcom G4 PLATINUM Professional System User’s Guide | 217
15
218 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 15: USER ASSISTANCE
Dexcom Website:
www.dexcom.com
Dexcom Address:
6340 Sequence Drive
San Diego, CA 92121
TECHNICAL SUPPORT
For Dexcom product questions and troubleshooting issues8.
Dexcom Technical Support Phone Numbers:
1.877.339.2664 or 1.858.200.0200
(24 hours, 7 days a week)
Dexcom Technical Support E-mail:
[email protected]
Dexcom Technical Support Fax:
1.877.633.9266
8
Dexcom Technical Support does not offer medical advice.
Dexcom G4 PLATINUM Professional System User’s Guide | 219
15
SALES SUPPORT
For help with first-time orders, re-orders, tracking shipments, and
locating a Dexcom representative in your area. If, after using a
Dexcom G4 PLATINUM Professional System, your patients would
like to purchase a Dexcom CGM system for their personal use,
please have them contact Dexcom Sales Support or their local
Dexcom representative.
Dexcom Sales Support Phone Numbers:
1.877.339.2664 or 1.858.200.0200
Dexcom Sales Support E-mail:
[email protected]
Dexcom Sales Support Fax:
1.877.633.9266
220 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
16
chapter sixteen
WARRANTY
Dexcom G4 PLATINUM Professional System User’s Guide | 221
16
222 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 16: WARRANTY
Dexcom G4 PLATINUM Professional System Limited
Warranty
1. What is Covered and for How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to the
original purchaser that the Dexcom G4 PLATINUM Receiver
is free from defects in material and workmanship under
normal use (“Limited Warranty”) for the period commencing
upon the date of shipment and continuing for the following
specified period of time after that date (“Warranty Period”):
Dexcom G4 PLATINUM Receiver: 1 Year
NOTE: If you received this receiver as a replacement for an
in-warranty receiver, any remaining warranty on the original
receiver shall transfer to this replacement receiver, and this
warranty page shall be void.
2. What is Not Covered?
This Limited Warranty is conditioned upon proper use of
the product by the purchaser. This Limited Warranty does
not cover: (a) defects or damage resulting from accident,
misuse, abuse, neglect, unusual physical, electrical or
electromechanical stress, modification of any part of the
product, or cosmetic damage; (b) equipment that has the ID
number removed or made illegible; (c) all surfaces and other
externally exposed parts that are scratched or damaged
due to normal use; (d) malfunctions resulting from the use
of the product in conjunction with accessories, products or
ancillary or peripheral equipment not furnished or approved
by Dexcom; (e) defects or damage from improper testing,
Dexcom G4 PLATINUM Professional System User’s Guide | 223
16
operation, maintenance, installation or adjustment; (f)
installation, maintenance, and service of products; or (g)
equipment that has been disassembled; or (h) water damage
to the receiver (receiver is not water resistant, do not get the
receiver wet at any time).
3. What are Dexcom’s Obligations Under the Limited
Warranty?
During the Warranty Period, Dexcom will replace, at
Dexcom’s sole option, without charge to purchaser, any
defective Dexcom G4 PLATINUM Receiver. Purchaser
must return the product to an authorized Dexcom Customer
Support Department in an adequate container for shipping,
accompanied by purchaser’s sales receipt or comparable
substitute proof of sale showing the date of purchase, the ID
number of the product, and the seller’s name and address.
To obtain assistance on where to deliver the Dexcom G4
PLATINUM Receiver, call Dexcom Customer Support
Department at 1.877.339.2664 or 1.858.200.0200. Upon
receipt, Dexcom will promptly replace the defective product.
If Dexcom determines that any product is not covered by this
Limited Warranty, purchaser must pay all shipping charges
for the return of such product.
4. What are the Limits on Dexcom’s Warranty and
Liability Obligations?
THE LIMITED WARRANTY OF DEXCOM DESCRIBED
ABOVE IS EXCLUSIVE AND IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT OR BY OPERATION OF LAW, STATUTORY OR
OTHERWISE, AND DEXCOM EXPRESSLY EXCLUDES
224 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
AND DISCLAIMS ALL SUCH OTHER WARRANTIES,
INCLUDING WITHOUT LIMITATION, ANY WARRANTY
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO
THE EXTENT PROHIBITED BY APPLICABLE LAW,
DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL, OR INDIRECT
DAMAGES, HOWEVER CAUSED AND ON ANY THEORY
OF LIABILITY, ARISING IN ANY WAY OUT OF THE
SALE, USE, MISUSE OR INABILITY TO USE ANY
DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM.
THIS LIMITATION SHALL APPLY EVEN IF DEXCOM OR
ITS AGENT HAS BEEN ADVISED OF SUCH DAMAGES
AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL
PURPOSE OF THIS LIMITED REMEDY. THIS LIMITED
WARRANTY SHALL NOT EXTEND TO ANYONE OTHER
THAN THE ORIGINAL PURCHASER OF THIS PRODUCT
AND STATES PURCHASER’S EXCLUSIVE REMEDY.
IF ANY PORTION OF THIS LIMITED WARRANTY IS
ILLEGAL OR UNENFORCEABLE BY REASON OF ANY
LAW, SUCH PARTIAL ILLEGALITY OR ENFORCEABILITY
SHALL NOT AFFECT THE ENFORCEABILITY OF THE
REMAINDER OF THIS LIMITED WARRANTY WHICH
PURCHASER ACKNOWLEDGES IS AND WILL ALWAYS
BE CONSTRUED TO BE LIMITED BY ITS TERMS OR AS
LIMITED AS THE LAW PERMITS.
Dexcom G4 PLATINUM Transmitter Limited Warranty
1. What Is Covered And For How Long?
Dexcom, Inc. (“Dexcom”) provides a limited warranty to
Dexcom G4 PLATINUM Professional System User’s Guide | 225
16
the original purchaser that the Dexcom G4 PLATINUM
Transmitter is free from defects in material and workmanship
under normal use (“Limited Warranty”) for the period
commencing upon the date of shipment and continuing
for the following specified period of time after that date
(“Warranty Period”):
Dexcom G4 PLATINUM Transmitter: 6 Months
NOTE: If you received this transmitter as a replacement
for an in-warranty transmitter, any remaining warranty on
the original transmitter shall transfer to this replacement
transmitter, and this warranty page shall be void.
2. What Is Not Covered?
This Limited Warranty is conditioned upon proper use of
the product by the purchaser. This Limited Warranty does
not cover: (a) defects or damage resulting from accident,
misuse, abuse, neglect, unusual physical, electrical or
electromechanical stress, modification of any part of the
product, or cosmetic damage; (b) equipment that has
the ID number removed or made illegible; (c) all surfaces
and other externally exposed parts that are scratched or
damaged due to normal use; (d) malfunctions resulting
from the use of the product in conjunction with accessories,
product or ancillary or peripheral equipment not furnished or
approved by Dexcom; (e) defects or damage from improper
testing, operation, maintenance, installation or adjustment;
(f) installation, maintenance, and service of products; (g)
equipment that has been disassembled, or (h) water damage
to the transmitter beyond the specifications listed in the
226 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Dexcom G4 PLATINUM Professional CGM System User’s
Guide, a copy of which was included with the Dexcom G4
PLATINUM Professional CGM System and may be found at
www.dexcom.com.
3. What Are Dexcom’s Obligations Under The Limited
Warranty?
During the Warranty Period, Dexcom will replace, at
Dexcom’s sole option, without charge to purchaser, any
defective Dexcom G4 PLATINUM Transmitter. Purchaser
must return the product to an authorized Dexcom Customer
Support Department in an adequate container for shipping,
accompanied by purchaser’s sales receipt or comparable
substitute proof of sale showing the date of purchase, the ID
number of the product, and the seller’s name and address.
To obtain assistance on where to deliver the Dexcom G4
PLATINUM Transmitter, contact Dexcom Customer Support
Department at 1.877.339.2664 or 1.858.200.0200. Upon
receipt, Dexcom will promptly replace the defective product.
If Dexcom determines that any product is not covered by this
Limited Warranty, purchaser must pay all shipping charges
for the return of such product.
4. What Are The Limits on Dexcom’s Warranty And
Liability Obligations?
THE LIMITED WARRANTY OF DEXCOM DESCRIBED
ABOVE IS EXCLUSIVE AND IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN
FACT OR BY OPERATION OF LAW, STATUTORY OR
OTHERWISE, AND DEXCOM EXPRESSLY EXCLUDES
AND DISCLAIMS ALL SUCH OTHER WARRANTIES,
Dexcom G4 PLATINUM Professional System User’s Guide | 227
16
INCLUDING WITHOUT LIMITATION, ANY WARRANTY
OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO
THE EXTENT PROHIBITED BY APPLICABLE LAW,
DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL,
INCIDENTAL, CONSEQUENTIAL, OR INDIRECT
DAMAGES, HOWEVER CAUSED AND ON ANY THEORY
OF LIABILITY, ARISING IN ANY WAY OUT OF THE SALE,
USE, MISUSE OR INABILITY TO USE ANY DEXCOM
G4 PLATINUM PROFESSIONAL CGM SYSTEM. THIS
LIMITATION SHALL APPLY EVEN IF DEXCOM OR ITS
AGENT HAS BEEN ADVISED OF SUCH DAMAGES AND
NOTWITHSTANDING ANY FAILURE OF ESSENTIAL
PURPOSE OF THIS LIMITED REMEDY. THIS LIMITED
WARRANTY SHALL NOT EXTEND TO ANYONE OTHER
THAN THE ORIGINAL PURCHASER OF THIS PRODUCT
AND STATE PURCHASER’S EXCLUSIVE REMEDY.
IF ANY PORTION OF THIS LIMITED WARRANTY IS
ILLEGAL OR UNENFORCEABLE BY REASON OF ANY
LAW, SUCH PARTIAL ILLEGALITY OR ENFORCEABILITY
SHALL NOT AFFECT THE ENFORCEABILITY OF THE
REMAINDER OF THIS LIMITED WARRANTY WHICH
PURCHASER ACKNOWLEDGES IS AND WILL ALWAYS
BE CONSTRUED TO BE LIMITED BY ITS TERMS OR AS
LIMITED AS THE LAW PERMITS.
Dexcom Receiver Shield
LIMITED WARRANTY – SEAL SHIELD LIMITED
WARRANTY COVERS THE REPLACEMENT OF THE
SHIELD ONLY. SEAL SHIELD CANNOT BE HELD
RESPONSIBLE FOR DAMAGES TO THE DEXCOM G4
228 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
PLATINUM RECEIVER DUE TO MISUSE, AND IMPROPER
INSTALLATION, CARE OR MAINTENANCE OF THE
SHIELD. SEAL SHIELD’S LIMITED WARRANTY DOES
NOT, UNDER ANY CIRCUMSTANCES, COVER THE
DAMAGE, REPAIR, REPLACEMENT OR COST OF THE
DEXCOM G4 PLATINUM RECEIVER OR DATA INSIDE.
Dexcom G4 PLATINUM Professional System User’s Guide | 229
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230 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
17
chapter seventeen
TRAVEL INFORMATION
Dexcom G4 PLATINUM Professional System User’s Guide | 231
17
232 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 17: TRAVEL INFORMATION
It is safe for you to go through the metal detector or be “handwanded”
while wearing the Dexcom sensor and transmitter. If you’re concerned
or uncomfortable about going through the walk-through metal detector,
the Transportation Security Administration (TSA) states that you should
notify the Security Office that you’re wearing a continuous glucose
monitor and would like a full-body pat-down and a visual inspection of
your Dexcom sensor and transmitter instead. Advise the Security Office
that the sensor cannot be removed because it is inserted under the skin.
Instead of putting your Dexcom G4 PLATINUM Professional System
through the x-ray, request that the TSA officer perform a visual
inspection. This must be requested before the screening process
begins. Your Dexcom G4 PLATINUM Professional System components
that are not attached to your body (e.g., receiver, extra sensors) should
be ready in a separate bag when you approach the Security Officer. For
other medical supplies, such as medications, meters and strips, check
the manufacturer’s instructions or the TSA website.
You may keep the receiver on before take-off, while in flight and after
landing. The Dexcom G4 PLATINUM Professional Continuous Glucose
Monitoring System is safe for use on U.S. commercial airlines. The
Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels
that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory,
Circular #91-21, 1B, dated 8/25/06. Any M-PED that meets this standard
in all modes may be used onboard the aircraft without any further
testing by the operator. This device can withstand exposure to common
electrostatic (ESD) and electromagnetic interference (EMI).
Visit the TSA’s website if you have any questions or concerns.
www.tsa.gov
E-mail: [email protected]
Phone: Call 1.866.289.9673
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234 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
18
chapter eighteen
APPENDIX
Dexcom G4 PLATINUM Professional System User’s Guide | 235
18
236 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 18: APPENDIX
APPENDIX I, RECEIVER ALERTS, ALARM AND
PROMPTS
The following tables describe the alarm, alerts and prompts and how the
receiver notifies you in both real-time and blinded modes.
Prompt - Shows on screen only. Silent, no vibrate or beep.
Alert - Notifies with vibrate and beep depending on the profile settings.
Alarm - Low 55 - Notifies with vibrate and beep. Cannot be changed.
Disabled in blinded mode.
Receiver Alerts, Alarm and Prompts
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
Low
glucose
alarm
The most recent
sensor glucose
reading is at or
below 55 mg/dL.
Vibrates 4
times and then
vibrates/beeps
4 times every
5 minutes until
confirmed or the
glucose value
goes above 55
mg/dL.
Yes, every
30 minutes
after each
confirmation
until the
blood
glucose
value
comes back
into range.
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
(continued on next page)
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18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
High
glucose
alert
The most recent
sensor glucose
reading is at or
above the high
alert setting.
Vibrates 2 times
and then
vibrates/beeps
2 times every
5 minutes until
confirmed or
the glucose
value drops
below the alert
level.
No, unless
you have
turned on
the high
snooze
feature. See
Chapter 9,
Section 9.2,
Advanced
Alerts.
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
In real-time mode:
Low
glucose
alert
The most recent
sensor glucose
reading is at or
below the low
alert setting.
Vibrates 3
times and then
vibrates/beeps
3 times every
5 minutes until
confirmed or
the glucose
value goes
above the alert
level.
No, unless
you have
turned on
the low
snooze
feature. See
Chapter 9,
Section 9.2,
Advanced
Alerts.
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
(continued on next page)
238 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In both real-time
Low
and blinded modes: battery
alert
The receiver
battery is low.
Charge the
receiver as soon
as possible when
you see this alert.
Vibrates 1 time
at 20% battery
capacity left.
Yes, at 10%
battery
capacity
left.
In both real-time
Out of
and blinded modes: Range
alert
The transmitter
and receiver
are not
communicating
and you will not
receive sensor
glucose readings.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
until the receiver
and transmitter
are back in
range.
No, unless
you have
turned on
the out
of range
alert under
the Alerts,
Advanced
menu
option.
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 239
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
Glucose
reading
error
prompt
The sensor
is sending
sensor glucose
readings that the
receiver does not
understand. You
will not receive
sensor glucose
readings.
Symbol in status N/A
area only.
In blinded mode:
Glucose
reading
error
prompt
The sensor
Symbol in status N/A
is sending
area only.
sensor glucose
readings that the
receiver does
not understand.
You will not be
recording sensor
glucose readings.
(continued on next page)
240 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
Wait
prompt
Symbol in
The receiver has
detected a potential status area
only.
problem with the
sensor signal. You
should wait about
30 minutes for
more prompts. Do
not enter any blood
glucose values
during this time.
You will not receive
sensor glucose
readings.
N/A
In blinded mode:
Wait
prompt
The receiver has
Symbol in
detected a potential status area
problem with the
only.
sensor signal. You
should wait about
30 minutes for
more prompts. Do
not enter any blood
glucose values
during this time.
You will not receive
or record sensor
glucose readings.
N/A
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 241
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
In both real-time
Wait 15
and blinded modes: minutes
calibration
error alert
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
The sensor
cannot calibrate.
Wait 15 minutes
then enter 1 more
blood glucose
value. Wait 15
more minutes. If
error screen still
appears enter
1 more blood
glucose value.
Wait 15 minutes.
If no sensor
glucose readings
appear on the
receiver, the
sensor needs to
be replaced.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
until confirmed.
No
(continued on next page)
242 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
In both real-time
Wait 1
and blinded modes: hour
calibration
error alert
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
The sensor
cannot calibrate.
Wait a minimum
of 1 hour then
enter 1 more
blood glucose
value for
calibration. If no
sensor glucose
readings appear
on the receiver,
the sensor needs
to be replaced.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
until confirmed.
No
Prompt screen
only.
Yes,
every 15
minutes.
In both real-time
12 hour
The receiver
and blinded modes: calibration needs a blood
prompt
glucose value
entered to
calibrate.
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 243
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In both real-time
Calibration
and blinded modes: prompt
The receiver
needs a blood
glucose value
entered to
calibrate. Sensor
glucose readings
will not be
displayed at this
time.
Vibrates 1
time then
vibrates/beeps
every 5 minutes
until confirmed.
Yes,
every 15
minutes.
In both real-time
Startup
and blinded modes: calibration
prompt
The receiver
needs 2 blood
glucose values
entered to
calibrate.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
until confirmed.
Yes,
every 15
minutes.
In both real-time
Additional
and blinded modes: startup
calibration
prompt
The receiver
needs 1
additional blood
glucose value to
complete startup
calibration.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
until confirmed.
Yes,
every 15
minutes.
(continued on next page)
244 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In both real-time
Enter BG
and blinded modes: processing
screen
prompt
The receiver is
processing the
blood glucose
value you
entered.
Prompt screen
only.
N/A
In real-time mode:
Rise alert
The glucose
levels are rising
at 2 mg/dL per
minute or more.
Vibrates 2
times and then
vibrates/beeps
2 times every 5
minutes or until
confirmed (2
repeats max).
No
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 245
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
Rapid rise
alert
The glucose
levels are rising
fast at 3 mg/dL
per minute or
more.
Vibrates 2
times and then
vibrates/beeps
2 times every 5
minutes or until
confirmed (2
repeats max).
No
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
In real-time mode:
Fall alert
The glucose
levels are falling
at 2 mg/dL per
minute or more.
Vibrates 3
times and then
vibrates/beeps
3 times every 5
minutes or until
confirmed (2
repeats max).
No
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
(continued on next page)
246 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In real-time mode:
Rapid fall
alert
The glucose
levels are falling
fast at 3 mg/dL
per minute or
more.
Vibrates 3
times and then
vibrates/beeps
3 times every 5
minutes or until
confirmed (2
repeats max).
No
In blinded mode:
No display
Disabled
N/A
Disabled
Disabled
In both real-time
6-hour
and blinded modes: sensor
expiration
prompt
The sensor
session will end
in 6 hours.
Prompt screen
only.
N/A
In both real-time
2-hour
and blinded modes: sensor
expiration
alert
The sensor
session will end
in 2 hours.
Prompt screen
only.
No
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 247
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In both real-time
30-minute
and blinded modes: sensor
expiration
alert
The sensor
session will end
in 30 minutes.
Vibrates 1
No
time and then
vibrates/beeps
every 5 minutes
(2 repeats max).
In both real-time
End of
and blinded modes: session
sensor
expiration
alert
The sensor
session has
ended.
Vibrates 1
No
time and then
vibrates/beeps
every 5 minutes
(2 repeats max).
In both real-time
Sensor
and blinded modes: failed alert
The sensor is not
working properly.
Vibrates 1
time and then
vibrates/beeps
every 5 minutes
(2 repeats max).
Yes, 2
re-alerts
in the
next 10
minutes
for 30
minutes.
(continued on next page)
248 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
In both real-time
Receiver
and blinded modes: error code
alert
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
The receiver
is not working
properly. Record
the error code
and call Dexcom
Technical
Support.
Vibrates 1 time
(4 seconds) + 4
beeps.
No
In both real-time
System
There was a
and blinded modes: recovery
system error
check alert and the receiver
fixed it.
Vibrates 1
No
time and then
vibrates/beeps
every 5 minutes
until confirmed.
In both real-time
Set
and blinded modes: time/date
prompt
Vibrates 1 time.
Backup battery
has drained,
time/date need to
be reset.
No
(continued on next page)
Dexcom G4 PLATINUM Professional System User’s Guide | 249
18
Receiver Alerts, Alarm and Prompts (continued from page
before)
What will I see
on the receiver
screen?
Prompt,
alert or
alarm?
What does this
mean?
How will the
receiver notify
me?
(vibrate and/or
beep)
Will the
receiver
re-notify
me?
In both real-time
Transmitter Transmitter
and blinded modes: low battery battery is low.
alert
Replace the
transmitter as
soon as possible.
Vibrates 1
Yes, once
time and then
a day.
vibrates/beeps
every 5 minutes
(2 repeats max).
In both real-time
Transmitter The transmitter
and blinded modes: failed alert has failed.
Replace the
transmitter
immediately.
Vibrates 1
No
time and then
vibrates/beeps
every 5 minutes
(2 repeats max).
Important alerts that can be checked by the user in both real-time and
blinded modes:
• Out of range alert - You can test this alert by moving the receiver
more than 20 feet away for 30 minutes or more.
• 30-minute sensor expiration alert - You will see this alert in the
normal course of using a sensor for seven days.
• 0-hour sensor expiration alert - You will see this alert in the
normal course of using a sensor for seven days.
Other alerts and alarms cannot be safely checked by the user.
250 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
APPENDIX II, INDEX
A
Alarm, Low Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Glucose Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
Changing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Not Working . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179
Out of Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122
Rise and Fall (Rate of Change) . . . . . . . . . . . . . . . . . . . 115
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Alternative Site Testing (BG) . . . . . . . . . . . . . . . . . . . . . . . . 7
Antenna Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Missing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
Arrows, Trend (Rate of Change) . . . . . . . . . . . . . . . . . . . . . 97
B
Battery, Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Battery, Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Blood Glucose (BG) Meter . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Blood Glucose (BG) Value . . . . . . . . . . . . . . . . . . . . . . . . . . 7
C
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Dexcom G4 PLATINUM Professional System User’s Guide | 251
18
Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
How to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167
Re-Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Charging, Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175
Contact Information, Dexcom . . . . . . . . . . . . . . . . . . . . . . 219
Sales Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Website . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Contents, Dexcom G4 PLATINUM Professional CGM
System Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
D
Device Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Dexcom STUDIO Software . . . . . . . . . . . . . . . . . . . . . . . . 133
E
Events, Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
Carbohydrates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132
Insulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
G
Glucose Data Gaps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Glucose Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
M
Maintenance, System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
252 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
R
Radio-Frequency (RF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Charging the . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Pairing with Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Prompts and Notifications . . . . . . . . . . . . . . . . . . . . . . . 237
Trend Screen, Viewing . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Temporary Shut Down . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
S
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Caution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Important User Information . . . . . . . . . . . . . . . . . . . . . . . 25
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Applicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7, 15
Automatic Shut-Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141
Expiration Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Failed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
Insertion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Dexcom G4 PLATINUM Professional System User’s Guide | 253
18
Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 15
Removing from Package . . . . . . . . . . . . . . . . . . . . . . . . . 67
Sensor Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Starting a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Stop Sensor (Manual Sensor Shut-Off) . . . . . . . . . . . . 173
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 165
Wire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Settings, Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Settings, Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Device Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Setup Wizard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Specifications, Product . . . . . . . . . . . . . . . . . . . . . . . . . . . 202
Startup Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166
Storage, System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
Symbols, Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256
T
Tape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Transmitter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Attaching to Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
ID Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10, 73
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Pairing with Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
254 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Safety Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Removing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70, 165
Using . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
Trend Screen, Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
W
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 221
Water Resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Dexcom G4 PLATINUM Professional System User’s Guide | 255
18
APPENDIX III, 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 Dexcom G4 PLATINUM Professional CGM System.
Some of these symbols may not have meaning in your region, and
are listed for informational purposes only. This table shows what each
symbol means.
Symbols
“Use By” Date
Caution
SN
~
Lot Number
REF
Part Number,
Catalog Number
Date of Manufacture
Sterile by Radiation
Do Not Reuse
Two-sided
Temperature Limits
Serial Number
Temporary
submersion
Class II Equipment
Vertically falling drops
Alternating Current
Direct Current
Type BF Applied Part
Follow Operating
Instructions
(continued on next page)
256 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Symbols (continued from page before)
Manufacturer
EC REP
Two-Sided Humidity
Limitation
Non-Ionizing Radiation
European Union
WEEE Directive
2006-66-EC
Marking Certifies that
the Device Meets the
European Council
Directive 93/42/EEC
Electrical Equipment
Designed Primarily for
Indoor Use
Do Not Use if Package
is Damaged
SB
Input
Keep Dry
LATEX
Authorized
Representative in the
European Community
Ship By Date
Prescription Required
Not Made with Natural
Rubber Latex
MR
MR Unsafe
Dexcom G4 PLATINUM Professional System User’s Guide | 257
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258 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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