Dexcom G4 Platinum User manual

Dexcom G4 PLATINUM User’s Guide |1
USER’S GUIDE
DEXCOM G4®PLATINUM
(PEDIATRIC) CONTINUOUS
GLUCOSE MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS
Dexcom®Website: www.dexcom.com
Your Transmitter ID:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
© 2013 Dexcom, Inc. All rights reserved.
Dexcom, Dexcom G4, Dexcom G4 PLATINUM, 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 Continuous Glucose Monitoring System
DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS
GLUCOSE MONITORING SYSTEM
table of contents
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
CHAPTER 1: DEXCOM G4 PLATINUM (PEDIATRIC)
CONTINUOUS GLUCOSE MONITORING (CGM)
SYSTEM DESCRIPTION 9
1.1 System Contents ..................................... 11
1.2 Introduction .........................................12
1.3 Sensor Overview .....................................13
1.4 Transmitter Overview ..................................14
1.5 Receiver Overview....................................15
CHAPTER 2: INDICATIONS FOR USE AND SAFETY
STATEMENT ................................17
2.1 INDICATIONS FOR USE ...............................19
2.2 IMPORTANT USER INFORMATION ......................19
2.3 CONTRAINDICATIONS................................20
2.4 WARNINGS .........................................20
2.5 PRECAUTIONS ......................................23
2.6 CAUTION...........................................26
CHAPTER 3: RISKS AND BENEFITS 27
3.1 Risks ..............................................29
  ............................................30
CHAPTER 4: CHARGING YOUR RECEIVER AND THE
RECEIVER MAIN MENU 33
4.1 Charging Your Receiver Battery..........................35
4.1.1 Charging Your Receiver Battery from an AC Power Outlet 36
4.1.2 Charging Your Receiver Battery from a Windows Compatible
Computer ......................................37
4.1.3 Knowing Your Receiver is Charged ..................38
4.2 Receiver Menu Options ................................38
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Dexcom G4 PLATINUM User’s Guide |3
CHAPTER 5: DEXCOM G4 PLATINUM (PEDIATRIC)
SYSTEM SETUP 41
5.1 Setting Up the Receiver and Pairing with Your Transmitter .....43
5.2 The Settings Menu....................................45
5.2.1 Getting to the Settings Menu .......................45
5.2.2 Setting Your Receiver Time and Date . . . . . . . . . . . . . . . . 45
5.2.3 Entering Your Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . 46
5.3 Checking Information About Your Dexcom G4 PLATINUM
(Pediatric) System ....................................47
5.4 Transmitter and Receiver Communication..................48
CHAPTER 6: INSERTING A SENSOR AND STARTING A
SENSOR SESSION 51
6.1 Before You Start......................................54
6.2 Removing the Sensor from its Packaging ..................55
6.3 Choosing an Insertion Site..............................56
6.4 Placing the Sensor....................................58
6.5 Sensor Insertion......................................60
6.6 Transmitter Attachment ................................61
6.7 Starting a Sensor Session ..............................63
6.8 Sensor Startup Period .................................65
6.9 Taping the Sensor Pod.................................66
6.10 Temporary Receiver Shutdown .........................66
6.11 The Dexcom G4 PLATINUM (Pediatric) System and Water....67
CHAPTER 7: CALIBRATING YOUR DEXCOM G4
PLATINUM (PEDIATRIC) SYSTEM 69
7.1 Calibration Overview ..................................71
7.2 How to Calibrate .....................................73
7.3 Startup Calibration ....................................77
7.4 12-Hour Calibration Update .............................77
7.5 Other Reasons You May Need to Calibrate .................78
CHAPTER 8: SENSOR GLUCOSE READINGS AND
TRENDS 81
8.1 Sensor Glucose Readings ..............................84
8.2 Rate of Change Arrows ................................87
8.3 Glucose Status Area Symbols ...........................89
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4 |Dexcom G4 PLATINUM Continuous Glucose Monitoring System
CHAPTER 9: ALERTS, ALARM & PROFILES 93
9.1 Setting Your Alerts .................................... 95
9.1.1 Default Alert/Alarm Settings ........................ 95
9.1.2 Glucose Alerts and Alarm .......................... 98
9.1.2.1 High Glucose Alert......................... 99
9.1.2.2 Low Glucose Alert ......................... 99
9.1.2.3 Low Glucose Alarm ....................... 100
9.1.3 Getting to the Alerts Menu ........................ 101
9.1.4 High and Low Glucose Alerts ...................... 101
9.2 Advanced Alerts ..................................... 103
9.2.1 Setting a Snooze Time for Your High and Low Glucose
Alerts ........................................ 103
9.2.2 Rise and Fall Glucose Rate Alerts . . . . . . . . . . . . . . . . . . 104
9.2.3 Setting the Out of Range Alert . . . . . . . . . . . . . . . . . . . . . 106
 ........................................ 108
   ............................. 109
  .............................. 110
CHAPTER 10: EVENTS AND DEXCOM STUDIO™
SOFTWARE 113
10.1 Events .......................................... 115
10.1.1 Selecting an Event ............................. 115
10.1.2 Setting the Date and Time for an Event ............. 116
10.1.3 Carbohydrates ................................. 117
10.1.4 Insulin . ...................................... 118
10.1.5 Exercise . .................................... 119
10.1.6 Health . ...................................... 120
10.2 Dexcom STUDIO Software . .......................... 121
CHAPTER 11: ENDING A SENSOR SESSION 123
11.1 Automatic Sensor Shut-Off . .......................... 125
11.2 Removing a Sensor . ................................ 127
11.3 Transmitter Removal . ............................... 128
CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4
PLATINUM (PEDIATRIC) SYSTEM 129
12.1 Maintenance . ..................................... 131
12.2 Storage . ......................................... 131
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Dexcom G4 PLATINUM User’s Guide |5
1
12.3 Product Disposal . ..................................132
CHAPTER 13: TROUBLESHOOTING 133
13.1 Sensor Insertion Troubleshooting ......................135
13.2 Calibration Troubleshooting...........................136
13.2.1 Types Of Calibration Prompts ...................137
13.2.2 What To Do For Calibration Prompts..............138
13.3 Calibration Error Troubleshooting ......................138
13.4 System Glucose Error ...............................139
13.5 Sensor Inaccuracies ................................140
13.6 Sensor Shut-Off Troubleshooting ......................142
13.6.1 Early Sensor Shut-Off - Sensor Failure ............142
13.6.2 Manual Sensor Shut-Off - “Stop Sensor”...........143
13.7 Battery and Charger Troubleshooting . . . . . . . . . . . . . . . . . . . 144
13.8 Receiver and Transmitter Communication Troubleshooting . . 145
13.8.1 System Recovery Check .......................145
13.8.2 Receiver Error Code ..........................146
13.8.3 Low Transmitter Battery........................146
13.8.4 Transmitter Failed Error Code ...................146
13.9 Out of Range/No Antenna ............................147
13.10 Alerts Are Not Working ..............................148
CHAPTER 14: TECHNICAL INFORMATION 149
14.1 Device Performance Characteristics ....................151
 ...............................172
14.3 FCC Requirements .................................183
CHAPTER 15: USER ASSISTANCE 185
CHAPTER 16: WARRANTY 189
CHAPTER 17: TRAVEL INFORMATION 197
CHAPTER 18: APPENDIX 201
Appendix I: Receiver Alerts, Alarm and Prompt . . . . . . . . . . . . . . . . 203
Appendix II: Index.......................................212
Appendix III: Symbols Used in Labeling......................217
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6 |Dexcom G4 PLATINUM Continuous Glucose Monitoring System
GLOSSARY
Alternative Site
BG Testing
This is when you take a blood glucose value on your meter
using a blood sample from an area on your body other than


Applicator A disposable piece that comes attached to the sensor pod and


BG Meter 

BG Value 

Calibration When you enter blood glucose values from a blood glucose

receiver to show continuous sensor glucose readings and trend

CGM 
Commercially
Available

Default A setting that is selected automatically, unless you choose

Dexcom G4
PLATINUM
(Pediatric)
System

Glucose Data
Gaps

glucose reading to let you know that the receiver cannot

Glucose
Trends

graph shows where your glucose levels have been during the
time shown on the screen and where your glucose levels are

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Dexcom G4 PLATINUM User’s Guide |7
GLOSSARY (continued from page before)
Hypoglycemia 

professional to determine the appropriate hypoglycemic setting

Hyperglycemia 

professional to determine the appropriate hyperglycemic setting

HypoRepeat 
alarm every 5 seconds until your sensor glucose value rises


Mg/dL 

Obstruction Something that blocks the path between the transmitter and



tested whether items blocking the transmitter or receiver could

 
Range 
two devices within 20 feet of each other without obstruction to

Re-alert 
Receiver The small device that collects your glucose information from the


Rise and Fall
(Rate of
Change) Alerts
Alerts based on how fast and how much your glucose levels

(continued on next page)
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8 |Dexcom G4 PLATINUM Continuous Glucose Monitoring System
RF Radio-frequency transmission used to send glucose information

Safety Lock The safety lock keeps the needle inside the applicator before

transmitter out of the sensor pod after your sensor session

Sensor 

under your skin, and the wire measures glucose levels in your

Sensor Pod The small plastic base of the sensor attached to your skin that

Snoozing 

Startup Period The 2-hour period after you tell the receiver you inserted a new


System
Reading


Transmitter 
into the sensor pod and wirelessly sends glucose information to

Transmitter ID A series of numbers and/or letters that you enter into your

Transmitter
Latch
The small, disposable piece that snaps the transmitter into the

Trend (Rate
of Change)
Arrows
Arrows on trend graphs that show how fast your glucose levels


GLOSSARY (continued from page before)
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Dexcom G4 PLATINUM User’s Guide |9
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DEXCOM G4 PLATINUM (PEDIATRIC)
CONTINUOUS GLUCOSE MONITORING (CGM)
SYSTEM DESCRIPTION
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10 |Dexcom G4 PLATINUM Continuous Glucose Monitoring System
1
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