Dexcom G4 Professional User manual

USER’S GUIDE
Dexcom G4
CONTINUOUS GLUCOSE
MONITORING SYSTEM

Dexcom G4
CONTINUOUS GLUCOSE
MONITORING SYSTEM

4 |Dexcom G4 Continuous Glucose Monitoring System
IMPORTANT CONTACTS AND NUMBERS
Dexcom Website: www.dexcom.com
Your Transmitter ID:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
Other Notes:
© 2013 Dexcom, Inc. All rights reserved.
Dexcom, Dexcom G4, Dexcom Studio, SEVEN, Stay Between the Lines and The
Glucose Sensor Company 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.

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SYSTEM CONTENTS:
Reorder only the Dexcom G4 System components listed below:
DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM
Dexcom G4 Sensor
Dexcom G4 Receiver
Dexcom G4 Transmitter
• sensor
• transmitter
• receiver
• receiver USB charging/download cable
• charger - MT21255
• adapter plugs - MT21561
• receiver case
• user’s guide
• quick start guide
• tutorial disc
•
Dexcom Studio software (optional
and available in select countries –
check with your local distributor)
HELPFUL HINT:
Sensors are sold separately. Commercially distributed blood glucose (BG)
meter required for use. Make sure to use the correct version of Dexcom
Studio with your system. The sensor works with the Dexcom G4 family
of products. The Dexcom G4 Sensor, Transmitter, and Receiver are not
compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver.
The Dexcom G4 Continuous Glucose Monitoring System is a
glucose-monitoring device indicated for detecting trends and
tracking patterns in persons (age 18 and older) with diabetes.

6 |Dexcom G4 Continuous Glucose Monitoring System
When you use the system, you will see continuous sensor glucose readings
updated every 5 minutes for up to 7 days. These readings will help you detect
trends and patterns in your glucose levels.
The system includes the sensor, the transmitter, and the receiver. The sensor
is a disposable unit that you insert under the skin of your abdomen (belly) to
continuously monitor your glucose levels for up to 7 days. The transmitter
is a reusable device that wirelessly sends your sensor-measured glucose
information to your receiver. The receiver is a hand-held device that receives
and displays your glucose information.
This user’s guide describes how to use your system.
Please review this user’s guide.
INTRODUCTION
HELPFUL HINT:
Dexcom has developed an interactive, self-guided training tutorial for
the Dexcom G4 CGM System based on well-established adult-learning
principles. Some people have found this to be an effective method of
product training. Please review the tutorial on the disc and discuss with
your healthcare professional if the Dexcom G4 training tutorial is an
appropriate training option for you.

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INDICATIONS FOR USE
The Dexcom G4 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 use by
patients at home and in healthcare facilities and requires a prescription (United
States).
The Dexcom G4 System is indicated for use as an adjunctive device to
complement, not replace, information obtained from standard home glucose
monitoring devices.
The Dexcom G4 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 System
results should be based on the trends and patterns seen with several sequential
readings over time.
IMPORTANT USER INFORMATION
Please review your product instructions before using your continuous glucose
monitoring system. 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 manage your diabetes. Your product instructions
contain important information on troubleshooting your system and on the
performance characteristics of the device.
CONTRAINDICATIONS
• The Dexcom G4 Sensor, Transmitter, and Receiver must be removed prior
to Magnetic Resonance Imaging (MRI), CT scan, or diathermy treatment.
The Dexcom G4 System has not been tested during MRI or CT scans or with
diathermy treatment, and it is unknown if there are safety or performance
issues.
• Taking acetaminophen (paracetamol) containing products (such as Tylenol)
while wearing the sensor may falsely raise your sensor glucose readings. The
level of inaccuracy depends on the amount of acetaminophen (paracetamol)
active in your body.

8 |Dexcom G4 Continuous Glucose Monitoring System
WARNINGS
• Do not use the Dexcom G4 CGM System until after you have been trained or
viewed the training materials included with your CGM system.
• The blood glucose value from your blood glucose meter should be used for
treatment decisions, such as how much insulin you should take. The Dexcom
G4 System does not replace a blood glucose meter. Blood glucose values may
differ from sensor glucose readings. The direction, rate of glucose change, and
trend graph on your Dexcom G4 System provide additional information to help
with your diabetes management decisions.
• Symptoms of high and low glucose should not be ignored. If your sensor
glucose readings do not t with your symptoms, you should measure your
blood glucose with a blood glucose meter.
• Your sensor glucose readings may be inaccurate if you calibrate less than
every 12 hours.
• 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 inammation—redness, swelling or
pain—at the insertion site. If you experience a broken sensor, please report this
to your local distributor.
• The Dexcom G4 System is not approved for use in children or adolescents,
pregnant women or persons on dialysis.
• Sensor placement is not approved for sites other than under the skin of the
belly (abdomen).
• If your transmitter or receiver case is damaged/cracked, do not use them, as
this could create an electrical safety hazard or malfunction.
PRECAUTIONS
• Before opening the sensor package, wash your hands with soap and water and
dry them to avoid contamination.
• Before inserting the sensor, always clean the skin at the sensor insertion
location with a topical antimicrobial solution, such as isopropyl alcohol. This
may help prevent infection. Do not apply the sensor until the cleaned area is
dry so that it will stick better.
• Change the site where you place your sensor with each insertion to allow your
skin to heal.

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• Avoid 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.
• Avoid injecting insulin or placing an insulin pump infusion set within 7.62 cm of
the sensor in case the insulin affects the sensor glucose readings.
•
The sensor is sterile in its unopened, undamaged package. Do not use any
sensor if its sterile package has been previously damaged or opened.
• To calibrate the system, you must 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 ago could result in inaccurate sensor
glucose readings.
•
The transmission range from the transmitter to the receiver is up to 6 meters
without obstruction. Wireless communication does not work well through water
so the range is much less if you are in a pool, bathtub, water bed, etc.
• Sensors should be stored at temperatures between 2° C - 25° C for the length
of the shelf life. You may store your sensors in the refrigerator if it is within this
temperature range. Sensors should not be stored in a freezer.
• Keep the USB port cover on the receiver closed whenever the USB cable is not
attached. The receiver may malfunction if water gets into the USB port.

10 |Dexcom G4 Continuous Glucose Monitoring System
DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM:
SYSTEM KIT CONTENTS 5
INTRODUCTION 6
INDICATIONS FOR USE 7
IMPORTANT USER INFORMATION 7
CHAPTER 1: THE DEXCOM G4 SYSTEM BASICS 13
1.1 Sensor Overview 15
1.2 Transmitter Overview 15
1.3 Receiver Overview 16
1.4 Charging Your Receiver Battery 18
1.4.1 Charging Your Receiver Battery from an AC Power Outlet 18
1.4.2 Charging Your Receiver Battery from a Windows Compatible
Computer. 20
1.4.3 Knowing Your Receiver is Charged 21
CHAPTER 2: DEXCOM G4 SYSTEM SETUP 23
2.1 The Setup Wizard 25
2.2 The Settings Menu 28
2.2.1 Getting to the Settings Menu 28
2.2.2 Setting Your Receiver Time and Date 28
2.2.3 Entering Your Transmitter ID 29
2.2.4 Setting Your Receiver Time Format 30
2.2.5 Selecting Your Receiver Language 30
2.3 Checking Information About Your Dexcom G4 System 31
2.4 Transmitter and Receiver Communication 32
CHAPTER 3: INSERTING A SENSOR AND STARTING A SENSOR
SESSION 33
3.1 Before You Start 35
3.2 Removing the Sensor From Its Packaging 37
3.3 Choosing an Insertion Site 37
3.4 Placing the Sensor 38
3.5 Sensor Insertion 39
3.6 Transmitter Attachment 40
3.7 Starting a Sensor Session 42
3.8 Sensor Startup Period 43
3.9 Taping the Sensor Pod 44
3.10 Temporary Receiver Shutdown 44
3.11 The Dexcom G4 System and Water 45
table of contents

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CHAPTER 4: CALIBRATING YOUR DEXCOM G4 SYSTEM 47
4.1 Calibration Overview 49
4.2 How to Calibrate 50
4.3 Startup Calibration 53
4.4 12 Hour Calibration Update 53
4.5 Other Reasons You May Need to Calibrate 54
CHAPTER 5: SENSOR GLUCOSE READINGS AND TRENDS 55
5.1 Sensor Glucose Readings 58
5.2 Rate of Change Arrows 60
5.3 Glucose Status Area Symbols 62
CHAPTER 6: ALERTS, ALARMS AND ALERT PROFILES 65
6.1 Setting Your Alerts 67
6.1.1 Default Alert/Alarm Settings 67
6.1.2 Glucose Alerts 69
6.1.3 High Glucose Alert 69
6.1.4 Low Glucose Alert 70
6.1.5 Low Glucose Alarm 71
6.1.6 Getting to the Alerts Menu 71
6.1.7 High and Low Glucose Alerts 72
6.2 Advanced Alerts 73
6.2.1 Setting a Snooze Time for Your High and Low Glucose Alerts 74
6.2.2 Rise and Fall Glucose Rate Alerts 75
6.2.3 Setting the Out of Range Alert 77
6.3 Alert Proles 78
6.3.1 Alert Prole Options 80
6.3.2 Alert Prole Details 81
CHAPTER 7: EVENTS 83
7.1 Event s 85
7.1.1 Selecting an Event 85
7.1.2 Setting the Date and Time for an Event 86
7.1.3 Carbohydrates 87
7.1.4 Insulin 88
7.1.5 Exercise 89
7.1.6 Health 90
7.2 Dexcom Studio Software 90

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CHAPTER 8: COMPLETING A SENSOR SESSION 91
8.1 Automatic Sensor Shut-off 94
8.2 Removing a Sensor 95
8.3 Transmitter Removal 95
CHAPTER 9: TROUBLESHOOTING 97
9.1 Sensor Insertion Troubleshooting 99
9.2 Calibration Troubleshooting 100
9.2.1 Types of Calibration Prompts 101
9.2.2 Status Area Symbols During Calibration Prompts 102
9.3 Calibration Error Troubleshooting 102
9.4 System Glucose Error 103
9.5 Sensor Inaccuracies 104
9.6 Sensor Shut-off Troubleshooting 105
9.6.1 Early Sensor Shut-off - Sensor Failure 106
9.6.2 Manual Sensor Shut-off - “Stop Sensor” 106
9.7 Battery and Charger Troubleshooting 108
9.8 Receiver and Transmitter Communication Troubleshooting 108
9.8.1 System Recovery Check 108
9.8.2 Receiver Error Code 108
9.8.3 Low Transmitter Battery 109
9.8.4 Transmitter Failed Error Code 109
9.9 Out of Range/No Antenna 109
9.10 Alerts Not Working 110
CHAPTER 10: TAKING CARE OF YOUR DEXCOM G4 SYSTEM 111
10.1 Maintenance 113
10.2 Storage 114
10.3 Cleaning and Disinfection 114
10.4 Product Disposal 116
CHAPTER 11: TECHNICAL INFORMATION 117
11.1 Product Specications 119
11.2 Device Performance Characteristics 129
11.3 FCC Requirements 138
CHAPTER 12: APPENDIX 139
Appendix I, Receiver Alerts, Alarm and Prompts 141
Glossary 148
Symbols Used in Labeling 150

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chapter one
THE DEXCOM G4 SYSTEM BASICS

14 |Dexcom G4 Continuous Glucose Monitoring System

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Plunger
Applicator barrel
(contains small
introducer needle
and sensor)
Transmitter Latch
Safety lock
Collar
Sensor pod
Release Tab
1.1 SENSOR OVERVIEW
The sensor is placed under the skin of your belly and continuously measures
your glucose levels.
The sensor and transmitter (once snapped in) remain on your belly for the entire
sensor session, up to 7 days.
1.2 TRANSMITTER OVERVIEW
The transmitter wirelessly sends your glucose information to the receiver. The
transmitter and sensor are water resistant when properly connected. Do not
throw away your transmitter. It is reusable.
The transmission range from the transmitter to the receiver is up to 6 meters
without obstruction. Wireless communication does not work well through
water so the range is much less if you are in a pool,
bathtub, water bed, etc.
The transmitter battery will last at least 6 months.
Once you see the transmitter low battery screen
shown on the right, replace the transmitter as soon
as possible. Your transmitter battery may drain as
quickly as one week after this alert appears.

16 |Dexcom G4 Continuous Glucose Monitoring System
1
1.3 RECEIVER OVERVIEW
The receiver is a small hand-held device that shows your sensor glucose
readings, direction and rate of change arrow and trend graph. The international
standard unit of measurement used for glucose testing systems (i.e., blood
glucose meters) is mmol/L (millimoles per liter). The transmission range from
the transmitter to the receiver is up to 6 meters.
Your receiver is rated IP22, which means that it offers some protection from rain
drops. Do not spill uids on the receiver or drop the receiver into uids. Keep
the micro USB port cover closed to help prevent uid and dust from getting
inside the receiver.
Wireless communication does not work well through water so the range is much
less if you are in a pool, bathtub, water bed, etc.
EXAMPLE: 3-Hour Trend Graph Screen
Trend Graph Hours
Trend Arrow
Current Time
Most recent 5-minute
sensor glucose reading
Glucose
Target Range
Low Glucose
Alert Setting
Plot of most
recent sensor
glucose reading
Antenna
Battery Status Area
High Glucose
Alert Setting Glucose
Values

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There are ve receiver buttons to move you through the display screens that
control setup and operation and allow you to change your receiver settings. The
screens display sensor glucose readings, trend graphs and trend arrows.
Your receiver and transmitter are wirelessly paired together to communicate
securely and only with each other.
You will need a commercially available blood glucose meter to use with your
system.
UP button
DOWN
button
SELECT button
RIGHT
button
LEFT
button

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1
1.4 CHARGING YOUR RECEIVER BATTERY
The receiver battery is rechargeable. The
rechargeable battery will typically last about 3 days
before you need to charge it with the charging cable
provided. Your battery life depends on how often you
interact with your receiver. The receiver will alert you
when the battery charge is low.
The receiver battery may be charged using one of the
following options:
• an AC power outlet
• a Windows-compatible computer (Microsoft Windows 7, Microsoft Windows
Vista SP2, Microsoft Windows XP SP2 or Microsoft Server 2008 SP2)
In order to use a PC cable to charge your receiver, you will need to install the
driver for this receiver. Please see the Dexcom Studio installation card for driver
installation instructions.
It takes about 3 hours to fully charge an empty battery with the wall charger, and
about 5 hours when the receiver is connected to a computer.
You can charge your receiver at any time and the battery does not need to be
drained in order to fully charge the battery.
1.4.1 CHARGING YOUR RECEIVER BATTERY FROM AN AC
POWER OUTLET
The AC power adapter comes with interchangeable plugs.
Install the appropriate plug for your wall outlet style by
sliding the plug down onto the adapter until it snaps into
place.
Low battery prompt
HELPFUL HI NT:
• When the receiver is used in a healthcare facility, charging must take
place away from the patient.

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To recharge your battery, follow the instructions below:
1. Plug the included USB cable into the AC power adapter.
2. Plug the AC power adapter into an AC power outlet.
3. Slide open the USB port cover on the side of the receiver to
access the port
4. Plug the micro USB end of the cable into the receiver USB
port.
Keep the USB port cover on the receiver closed whenever the USB cable is
not attached.
HELPFUL HI NT:
• Press down rmly with your thumb when sliding open the USB port cover.
To remove the plug from the AC power adapter place both
thumbs on the bottom of the plug and push up until the
plug pops out of the adapter.
5. The battery charging screen will appear on the
receiver.
6. After a few seconds the trend graph will reappear
with the battery charging symbol ( ) shown in
the upper left corner.

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1
1.4.2 CHARGING YOUR RECEIVER BATTERY FROM A
WINDOWS COMPATIBLE COMPUTER
The Dexcom Studio software must be installed to charge your receiver
from a computer.
1. Plug the included USB cable into your computer.
2. Plug other end of the USB cable into the receiver.
3. The battery charging screen will appear on the
receiver.
4. After a few seconds the trend graph will reappear
with the battery charging symbol shown in the
upper left corner.
HELPFUL HI NT:
• Charge only from a USB port on your 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.