Page 1
CONTINUOUS GLUCOSE
MONITORING SYSTEM
USER’S GUIDE
LBL-012206 Rev 04 MT22434
Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
1.858.200.0200
1.877.339.2664
www.dexcom.com
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Dexcom G4 PLATINUM Professional System User’s Guide | 1
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.
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2 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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 ....................................... 13
1.2 Introduction ........................................... 14
1.3 Sensor Overview....................................... 15
1.4 Transmitter Overview ................................... 16
1.5 Receiver Overview ..................................... 17
1.6 Receiver Shield Overview................................ 20
CHAPTER 2: INDICATIONS FOR USE AND SAFETY
STATEMENT ................................. 23
2.1 INDICATIONS FOR USE ................................ 25
2.2 IMPORTANT USER INFORMATION ....................... 25
2.3 CONTRAINDICATIONS ................................. 26
2.4 WARNINGS ..........................................26
2.5 PRECAUTIONS .......................................29
2.6 CAUTION ............................................ 33
CHAPTER 3: RISKS AND BENEFITS 35
3.1 Risks ..............................................37
3.2Benets ............................................38
CHAPTER 4: CHARGING THE RECEIVER AND THE
RECEIVER MAIN MENU 41
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
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Dexcom G4 PLATINUM Professional System User’s Guide | 3
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 .......................................66
6.2 Removing the Sensor from its Packaging ................... 67
6.3 Choosing an Insertion Site ............................... 68
6.4 Placing the Sensor ..................................... 69
6.5 Sensor Insertion ....................................... 70
6.6 Transmitter Attachment.................................. 72
6.7 Starting a Sensor Session ...............................73
6.8 Sensor Startup Period................................... 75
6.9 Taping the Sensor Pod .................................. 76
6.10 Temporary Receiver Shutdown ..........................77
6.11 The Dexcom G4 PLATINUM Professional System and Water .. 78
CHAPTER 7: CALIBRATING THE DEXCOM G4
PLATINUM PROFESSIONAL SYSTEM 79
7.1 Calibration Overview.................................... 81
7.2 How to Calibrate .......................................83
7.3 Startup Calibration ..................................... 87
7.4 12-Hour Calibration Update ..............................88
7.5 Other Reasons You May Need to Calibrate ..................89
CHAPTER 8: VIEWING SENSOR GLUCOSE READINGS
AND TRENDS IN REAL-TIME MODE 91
8.1 Sensor Glucose Readings in Real-Time Mode ...............94
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4 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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 AlertProles ........................................ 118
9.3.1 AlertProleOptions .............................. 119
9.3.2 AlertProleDetails ............................... 120
CHAPTER 10: EVENTS, DEXCOM STUDIO™ SOFTWARE
AND BLINDED MODE 125
1 0 .1 Eve nt s ............................................. 127
10.1.1 Selecting an Event ............................... 127
10.1.2 Setting the Date and Time for an Event .............. 128
10.1.3 Carbohydrates . .................................129
10.1.4 Insulin ........................................130
10.1.5 Exercise ....................................... 131
10.1.6 Health ........................................ 132
10.2 Dexcom STUDIO Software and Blinded Mode . ............ 133
10. 2.1 Activating the Blinded Mode/Clinical Feature .......... 134
10.2.2 Blinding the Receiver............................. 136
10.2.3 Downloading the Receiver......................... 137
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Dexcom G4 PLATINUM Professional System User’s Guide | 5
10.2.4 Resetting the Receiver for Multiple Patient Use ........ 137
CHAPTER 11: ENDING A SENSOR SESSION 139
11.1 Automatic Sensor Shut-Off in Both Real-Time and Blinded
Modes . . . . . ........................................ 141
11.2 Removing a Sensor . ................................. 143
11.3 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 ..... 149
12.2 Removing the Receiver Shield . ......................... 149
12.3 Cleaning and Disinfection of the Transmitter . . . . . . . . . . . . . . . 152
12.4 Using the Receiver Shield . ............................ 158
12.5 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160
12.6 Storage ............................................ 161
12.7 Product Disposal .................................... 162
CHAPTER 13: TROUBLESHOOTING...............163
13.1 Sensor Insertion Troubleshooting........................ 165
13.2 Calibration Troubleshooting ............................ 166
13.2.1 Types Of Calibration Prompts..................... 167
13.2.2 What To Do For Calibration Prompts ............... 168
13.3 Calibration Error Troubleshooting........................ 168
13.4 System Glucose Error................................. 169
13.5 Sensor Inaccuracies in Real-Time Mode ................. 170
13.6 Sensor Shut-Off Troubleshooting........................ 172
13.6.1 Early Sensor Shut-Off – Sensor Failure............. 173
13.6.2 Manual Sensor Shut-Off – “Stop Sensor” ........... 173
13.7 Battery and Charger Troubleshooting .................... 175
13.8 Receiver and Transmitter Communication Troubleshooting ... 175
13.8.1 System Recovery Check ........................ 175
13.8.2 Receiver Error Code ............................ 176
13.8.3 Low Transmitter Battery ......................... 176
13.8.4 Transmitter Failed Error Code .................... 177
13.9 Out of Range/No Antenna ............................. 177
13.10 Alerts Are Not Working ............................... 179
1
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6 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
CHAPTER 14: TECHNICAL INFORMATION 181
14.1 Device Performance Characteristics .....................183
14.2 ProductSpecications ................................ 202
14.3 FCC Requirements ................................... 215
CHAPTER 15: USER ASSISTANCE 217
CHAPTER 16: WARRANTY 221
CHAPTER 17: TRAVEL INFORMATION 231
CHAPTER 18: APPENDIX 235
Appendix I, Receiver Alerts, Alarm and Prompts ................237
Appendix II, Index ........................................ 251
Appendix III, Symbols Used in Labeling ....................... 256
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Dexcom G4 PLATINUM Professional System User’s Guide | 7
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
BG Testing
This is when you take a blood glucose value on the meter
using a blood sample from an area on the body other than
the ngertip. 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)
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8 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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 xed
low alarm every 5 seconds until the sensor glucose value rises
above 55 mg/dL or you conrm it. This prole 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)
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Dexcom G4 PLATINUM Professional System User’s Guide | 9
GLOSSARY (continued from page before)
Proles 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 rst alert is not conrmed.
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
uid.
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)
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10 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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.
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Dexcom G4 PLATINUM Professional System User’s Guide | 11
1
chapter one
DEXCOM G4 PLATINUM PROFESSIONAL
CONTINUOUS GLUCOSE MONITORING
(CGM) SYSTEM DESCRIPTION
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1
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Dexcom G4 PLATINUM Professional System User’s Guide | 13
CHAPTER 1: DEXCOM G4® PLATINUM
PROFESSIONAL CONTINUOUS GLUCOSE
MONITORING (CGM) SYSTEM DESCRIPTION
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 Sensor
Dexcom G4® PLATINUM
Receiver
Dexcom G4 PLATINUM
Transmitter
Dexcom G4 PLATINUM
Professional Receiver Shield
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14 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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
1
Sensors and receiver shields are sold separately. Commercially
distributed blood glucose (BG) meter required for use.
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Dexcom G4 PLATINUM Professional System User’s Guide | 15
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
plasticandanadhesivepatch.Thesensorwireisthinandexible,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.
SeeChapter14forProductSpecications.
Plunger
Applicator barrel
(contains small introducer
needle and sensor)
Transmitter latch
Safety lock
Collar
Sensor pod
Release tab
Adhesive patch
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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.
SeeChapter14forProductSpecications.
Transmitter
Transmitter Low Battery screen
1
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Dexcom G4 PLATINUM Professional System User’s Guide | 17
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.
Donotspilluidsonthereceiverordropthereceiverintouids.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.
Receiver shield
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18 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
Real-Time Receiver Mode:
1
EXAMPLE: 3-Hour Trend Graph Screen
Status area
High glucose
alert setting
Low glucose
alert setting
Antenna
Battery
Most recent 5-minute
sensor glucose reading
Glucose
target
range
Plot of most
recent sensor
glucose
readings
Current time
Trend arrow
Trend graph hours
Glucose
values
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.
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Dexcom G4 PLATINUM Professional System User’s Guide | 19
Blinded Receiver Mode:
Therearevereceiverbuttonstomoveyouthroughthescreens.
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.
SeeSection14forProductSpecications.
Status area
Antenna
Battery
Current time
Trend graph hours
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.
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20 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
1
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.
UP button
DOWN
button
SELECT
button
RIGHT
button
LEFT
button
SpeakerDisplay screen USB port cover
USB port
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Dexcom G4 PLATINUM Professional System User’s Guide | 21
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.
Receiver shield pack
Triangle sealAcoustic spacer
Square seals Receiver shield
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PAGE INTENTIONALLY LEFT BLANK
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Dexcom G4 PLATINUM Professional System User’s Guide | 23
2
chapter two
INDICATIONS FOR USE AND
SAFETY STATEMENT
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2
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Dexcom G4 PLATINUM Professional System User’s Guide | 25
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
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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,
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
withdiathermytreatment.Themagneticeldsandheat
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.
MR
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Dexcom G4 PLATINUM Professional System User’s Guide | 27
• 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
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28 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System
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
havesymptomsofinfectionorinammation—redness,
swellingorpain—attheinsertionsite.Ifyouexperiencea
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.
• Sensor 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
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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
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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.
• Avoid 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
signicantrate,typicallymorethan2mg/dLperminute.
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
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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
signicantriseorfallofbloodglucosemayaffectaccuracy
of sensor glucose readings.
• The system accuracy may be affected when your glucose
ischangingatasignicantrate(e.g.,2-3mg/dL/minor
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
takenfromangerstickbloodglucosevalueandmaynot
represent the timeliest blood glucose value. Use a blood
glucosevaluetakenonlyfromangerstickforcalibration.
Alternative site blood glucose values might affect sensor
performance, and you might miss a low or high blood
glucose value.
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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
ofce.Donotchargethereceiverifyoucannotsealit.
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
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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.
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3
chapter three
RISKS AND BENEFITS
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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
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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
causesomeanxiety,butitisnotasignicantmedicalrisk.
3.2 BENEFITS
Real-timeCGMprovidesbenetsbeyondtheinformation
you get from a blood glucose meter. It provides glucose
readingseveryveminutesforuptosevendaystohelpyou
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
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Dexcom G4 PLATINUM Professional System User’s Guide | 39
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
alsoprovidebenetbyalertingyouwhenyourglucoseis
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
Thesebenets
can be seen especially with using real-time CGM at least 6
days per week
2
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
BlindedCGMalsoprovidesbenettoboththepatientand
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
canbeidentiedandchangestotheirdiabetesmanagement
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.
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3
1
Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L.
Improvement in glycemic excursions with a transcutaneous, real-time
continuous glucose sensor: a randomized controlled trial. Diabetes
Care. 2006; 29:44-50.
2
JDRF CGM Study Group. Continuous Glucose Monitoring and
Intensive Treatment of Type 1 Diabetes. NEJM 2008;359:1464-76.
3
Battelino. Effect of continuous glucose monitoring of hypoglycemia in
type 1 diabetes. Diabetes Care 2011; 34(4): 795-800.
4
The Diabetes Control and Complications Research Group. The effect
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
Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy
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.
6
JDRFCGMStudyGroup.SustainedBenetofContinuousGlucose
MonitoringonA1c,GlucoseProles,andHypoglycemiainAdultsWith
Type 1 Diabetes, Diabetes Care 2009; 32: 2047-2049.
7
JDRF CGM Study Group. Quality-of-Life Measures in Children and
Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177.
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Dexcom G4 PLATINUM Professional System User’s Guide | 41
4
chapter four
CHARGING THE RECEIVER AND
THE RECEIVER MAIN MENU
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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.
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.
Low battery prompt
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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.
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. Plug the included USB cable into the AC power adapter.
3. Plug the AC power adapter into an AC power outlet.
4. Make sure the USB door is open so
you can reach the port easily. If it is
closed,pressdownrmlywithathumb
when sliding open the USB port cover.
4
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.
USB port cover
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Dexcom G4 PLATINUM Professional System User’s Guide | 45
5. Plug 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.
7. After a few seconds the trend graph will show with the battery
charging symbol ( ) in the upper left corner.
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.
Battery charging screen
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
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4
2. Plug the included USB cable into the computer.
3. Plug the other end of the USB cable into the receiver.
4. The battery charging screen shows on the
receiver.
5. After a few seconds, the trend graph screen will show the battery
charging symbol in the upper left corner.
4.1.3 KNOWING THE RECEIVER IS CHARGED
Asthebatterycharges,thebatterychargingsymbolllsin.Whenthe
battery is fully charged, the battery charging symbol is completely
shaded.
After the receiver is fully charged:
Start
Fully Charged
Batterychargingsymbolllsinasbatterycharges
Battery charging screen
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
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Dexcom G4 PLATINUM Professional System User’s Guide | 47
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. Place 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.
5.Pressrmlyonthesquaresealtomakesureitissealedsecurely.
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:
Square seal on receiver shield
USB door open
PRECAUTION
If all 3 square seals have been used before the end
of the session, return the receiver to the healthcare
professionalofce.Donotchargethereceiverif
you cannot seal it. Unsealed receivers could spread
contamination.
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Receiver Main Menu Options
Menu Purpose
User’s
Guide
Reference
Trend
Graph
To show the trend graphs.
• The 3-hour trend graph is the default screen whenever
you turn on the receiver.
Chapter 8
Start
Sensor
To start a new sensor session.
• This 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
Proles
Proles 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
Shutdown
To temporarily turn off all communication between the
transmitter and receiver during a sensor session. You will
not get sensor glucose readings, and it will not extend the
life of the sensor.
Chapter 6
Stop
Sensor
To end a sensor session early.
• This 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
See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a
list of screens that may show on the receiver.
4
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5
chapter ve
DEXCOM G4 PLATINUM PROFESSIONAL
SYSTEM INITIAL SETUP
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CHAPTER 5: DEXCOM G4 PLATINUM
PROFESSIONAL SYSTEM INITIAL SETUP
ThischapterhelpsyouwhenyourstsetuptheContinuousGlucose
Monitoring system. Read this chapter before you start.
5.1 SETTING UP THE RECEIVER AND PAIRING
WITH THE TRANSMITTER
TheSetupWizardguidesyouthroughsetupthersttimeyouturnon
the receiver. These set up tasks are only needed to be done when a
newreceiverisusedforthersttime.
1. Remove the transmitter from its packaging. Wait 10 minutes for the
transmitter to turn on before setting up the receiver.
2. Make 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. Set 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) Press the RIGHT or SELECT button
to move to the next section.
(3) Press the SELECTbuttontoconrm
time and date.
b. Enter the transmitter ID.
Time/Date setting screen
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5
(1) Press the UP or DOWN button to
enter the transmitter ID.
(2) Press the RIGHT or SELECT
button to move to the next space.
(3) Press the SELECT button after
you enter the last number or letter
toconrmthetransmitterID.
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. Set 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.
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.
Transmitter ID setting screen
High Alert setting screenLow Alert setting screen
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Dexcom G4 PLATINUM Professional System User’s Guide | 53
(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 SELECTbuttontoconrmthealertlevel.
• 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
SetupWizardonlyworksthersttimeyouturnonthereceiver,butyou
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. Press the SELECT button to turn on the receiver. The 3-hour trend
WARNING
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.
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5
graph shows.
2. Press 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:
5.2.2 SETTING THE RECEIVER TIME AND DATE
1. From the Settings menu, press the UP or
DOWN button to scroll to “Time/Date,” and
press the SELECT button.
2. Press the RIGHT button to highlight each
value in the date and time.
3. Press the UP or DOWN button to make any
changes.
4. Press the RIGHT button to move to the
next value.
The date format is YYYY/MM/DD.
5. Press the SELECT button after choosing
Settings menu
Main Menu,
Settings highlighted
Settings menu,
Time/Date highlighted
Time/Date setting screen,
year highlighted
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Dexcom G4 PLATINUM Professional System User’s Guide | 55
“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
IfyoucannotndthetransmitterID,pleasecontactDexcomTechnical
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.
2.Startwiththerstnumberorletter(donotenter“SN”):
Settings menu,
Transmitter ID highlighted
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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.
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
symbolasagraphicalag;itdoesnottellyouwhetherthetransmitter
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. From the Settings menu, press the UP or
DOWN button to scroll to “Device Info.”
2. Press 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
Transmitter ID setting screen,
rstdigithighlighted
Settings menu,
Device Info highlighted
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Dexcom G4 PLATINUM Professional System User’s Guide | 57
• Transmitter ID
• Serial Number
• Part Number
• Part Revision
• Software Number
• Software Revision
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.
Device Info screen
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.
Themagneticeldsandheatcoulddamagethedevice
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
Press the SELECT, LEFT or RIGHT button to see the trend graph.
This antenna symbol shows that the transmitter and receiver are
communicating.
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.
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.
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
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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
professionalofce.Donotchargethereceiverif
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.
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
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The Dexcom G4 PLATINUM Receiver is protected by a receiver shield
when used with multiple patients.
Receiver shield pack
Triangle sealAcoustic spacer
Square seals Receiver shield
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.
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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. Wash hands and put on sterile gloves.
Peel acoustic spacer from paper
backing and secure on upper speaker
edge.
2. Note location of USB opening on
receiver shield. Stretch receiver shield
over receiver.
Acoustic spacer in upper
right of receiver
Stretch receiver shield
over receiver
Opening back of receiver
USB opening
lined up with
USB port
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5
3. Peel triangle seal from paper backing
and secure seal over opening on back
of receiver.
4. Peel 1 square seal from paper backing
and secure seal over USB door on side
of receiver. Save additional USB seals
for recharging.
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.
Square seal over USB port
USB door open
Triangle seal over
shield opening
USB opening
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6
chapter six
INSERTING A SENSOR AND
STARTING A SENSOR SESSION
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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
ifyouhavesymptomsofinfectionorinammation—
redness,swellingorpain—attheinsertionsite.Ifyou
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.
Therewasnosignicantmigrationorheatingofthewire
and imaging artifacts were limited to the area around the
wire.
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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.
6
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Review the sensor applicator picture before using a new sensor.
6.2 REMOVING THE SENSOR FROM ITS
PACKAGING
• 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.
PRECAUTION
Do not use the sensor if its sterile package has been
damaged or opened. Using an unsterile sensor might
cause infection.
Plunger
Applicator barrel
(contains small introducer
needle and sensor)
Transmitter latch
Safety lock
Collar
Sensor pod
Release tab
Adhesive patch
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6.3 CHOOSING AN INSERTION SITE
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
usuallyat,“pinchable,”andfreefromwhererubbingcanoccur,suchas
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.
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.
• Avoid 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.
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6.4 PLACING THE SENSOR
1. Clean 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. Remove 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.
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.
Step 2. Remove the
adhesive backing
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6
3. Place the sensor horizontally, NOT
vertically, on the skin.
4.Moveyourngersaroundtheadhesive
patch to secure the tape to the skin.
5. Hold the applicator, and pull the safety lock straight out away from the
applicator, in the direction of the arrows in the picture.
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.Placethengersofonehandattheedgeofthewhiteadhesive(atthe
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.
Step 3 and 4. Adhere
the sensor on the skin
Step 5. Remove the safety lock
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2.Whilestillpinching,usetheotherhandtoplacetwongersabove 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,makingsureitisushagainsttheapplicatorbarrel.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.
4. Keep pinching up on the skin with one
hand. With the other hand, place two
ngersunder 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.
5. Squeeze 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.
“2 CLICKS”
Steps 1-3. Push down the plunger - insert the needle and sensor
“ 2 CLICKS”
Step 4. Pull back the
collar - retract the needle
Step 5. Release the
applicator barrel
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6
• 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. Ensure 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. Place the transmitter in the sensor pod
(withtheatsidedown,andthenarrower
side away from the transmitter latch).
3. Snap in the transmitter:
a. With one hand, you may want to pinch up on the skin at the front
edge of the white adhesive.
b.Placeonengeronthetransmittertokeepitinplace.
Install transmitter in
sensor pod
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c. With the other hand, pull the
transmitter latch up and forward,
over the transmitter, to snap
it into place. The transmitter
shouldlieatinthesensorpod.
• Make sure you hear 2 clicks
when you snap the transmitter
in place. If it is not fully
snappedin,thismayleadtoapoorconnectionandletuidsto
get under the transmitter. This can lead to inaccurate sensor
glucose readings or missed sensor glucose readings as shown as
.
d. Release the pinch on the adhesive edge at this time.
e.Makesurethetransmitterissecurebyslidingthengersunder
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. Hold 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.
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. Press the SELECT button to turn on the receiver.
Side view of transmitter in
sensor pod
Transmitter latch
Transmitter installed
Twist transmitter latch
up or down
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6
2. From 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
the menu screen, you can continue the
current session or stop the session (refer
to Chapter 13, Section 13.6, Sensor Shut-off Troubleshooting).
4. Press the SELECTbuttontoconrmthe
start of a new sensor session. The Start
Sensor “thinking” screen lets you know the
sensor 2-hour startup has begun.
5. The 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.
Main Menu,
Start Sensor highlighted
Start Sensor
“thinking“ screen
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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
completetherstcalibrations.SeeChapter7,Section7.3,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 in the upper
right corner.
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
Countdown symbol appears
in upper right of trend graph
in real-time mode
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 llsin
overtimetoshowthatyouaregettingclosertotherstcalibrationtime.
You will not get sensor glucose readings, high/low glucose alerts and
alarm during the countdown.
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
[0-24]
minutes
[24-48]
minutes
[72-96]
minutes
Ready for
calibration
[48-72]
minutes
Start
Countdownsymbolllsinduringsensorstartup
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Dexcom G4 PLATINUM Professional System User’s Guide | 77
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.
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. From the main menu, scroll to highlight
“Shutdown.” Press the SELECT button.
2.Conrmthatyouwanttoshutdownthe
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.
The right way to use
tape for extra support
Main Menu,
Shutdown highlighted
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
specic 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.
Keepthereceiverdry.Donotspilluidsonitordropitintouids.The
receivershielddoesnotaddprotectionfromuidsthatmaydamage
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
stillworking.YoucandothisusingtheTryItoptionintheprolesmenu.
SeeChapter9,Section9.3,AlertProles.
6
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7
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.
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.
Ontherstdayofthesensorsession,youmustenter2bloodglucose
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
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.
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7
prompted to enter additional blood glucose values as needed.
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
thanthosetakenfromangerstickbloodglucosevalue
and may not represent the timeliest blood glucose value.
Useabloodglucosevaluetakenonlyfromangerstick
for calibration. Alternative site blood glucose values
might affect sensor performance, and you might miss a
low or high blood glucose value.
Example Minimum Calibration Schedule During
Seven-Day Sensor Session
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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.Forsafetyreasons,ifthebloodglucoseislow,rsttreatthelow
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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7
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:
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.
PRECAUTION
Do not calibrate if your blood glucose is changing at a
signicantrate,typicallymorethan2mg/dLperminute.
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.
Calibratingduringsignicantriseorfallofbloodglucose
may affect accuracy of sensor glucose readings.
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1. Wash 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. Take a blood glucose measurement using the meter.
• Carefully 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. Use 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. Press the SELECT button to choose this
option. You will see a screen with a blood
drop and a number in mg/dL units.
a. At 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
sensor glucose reading. Do not use the
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.
Main Menu,
Enter BG highlighted
Enter BG screen,
default is 120 mg/dL
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7
7. Conrm that the blood glucose value
you entered is correct. Entering
incorrect values may affect the sensor
accuracy.
a. Press the SELECT button if the blood
glucose value displayed is correct.
b. If the blood glucose value shown is
incorrect, press the RIGHT button
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. The Enter BG “thinking” screen lets you know
the blood glucose value is being used for
calibration.
9. For 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.
Enter BG screen,
OKhighlightedtoconrm
Enter BG
“thinking” screen
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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
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 conrm that it is properly recording
sensor glucose readings every 5 minutes
by showing “- - -” in the status area of the
receiver screen.
1.Thereceiverwillalertyoubasedonthealertprolesettingchosen.
When you see this screen, press the SELECT button to clear it.
Startup calibration prompt
“- - -” in status area
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a. The startup calibration symbol will stay at the top of the trend graph
until you calibrate.
b. The 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. Take 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
Calibratethesystematleastevery12hoursaftertherstcalibration
(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.
7
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. When you see this screen, press the
SELECT button to clear it.
a. The calibration needed symbol will stay
at the top of the trend graph until you
calibrate.
b. The system will silently prompt you every
15 minutes until you enter the blood glucose values.
2. Take 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.
These screens show calibration errors (see Chapter 13, Section 13.3,
Calibration Error Troubleshooting).
Calibration prompt
Calibration prompt
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7
Wait 15 minutes
calibration error screen
Wait 1 hour
calibration error screen
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8
chapter eight
VIEWING SENSOR GLUCOSE READINGS
AND TRENDS IN REAL-TIME MODE
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10
8
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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.
The blood glucose meter and sensor measure glucose from two
differenttypesofbodyuids:bloodandinterstitialuid.Therefore,
readings from the blood glucose meter and sensor may not match.
The greatest benet 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.
Ifyouhavetroublereadingthereceiverinbrightsunlight,ndashady
spot.
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.
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8
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:
EXAMPLE: 3-Hour Trend Graph Screen
Status area
High glucose
alert setting
Low glucose
alert setting
Antenna
Battery
Most recent 5-minute
sensor glucose reading
Glucose
target
range
Plot of most
recent sensor
glucose
readings
Current time
Trend arrow
Trend graph hours
Glucose
values
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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.
Thetrendgraphshowsaatlineordotsat400or40mg/dLwhenthe
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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8
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.
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.
Trend graph
reading HIGH
Trend graph
reading LOW
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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.
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)
Rate of change arrow
appears in upper right
of trend graph
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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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