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2 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE
MONITORING SYSTEM
table of contents
GLOSSARY ..................................... 6
CHAPTER 1: DEXCOM G4 PLATINUM 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 Share Overview........................................ 18
CHAPTER 2: INDICATIONS FOR USE AND SAFETY
STATEMENT ....................................19
2.1 INDICATIONS FOR USE ................................ 21
2.2 IMPORTANT USER INFORMATION ....................... 21
2.3 CONTRAINDICATIONS .................................22
2.4 WARNINGS ..........................................22
2.5 PRECAUTIONS ....................................... 24
2.6 CAUTION ............................................ 27
CHAPTER 3: RISKS AND BENEFITS 29
3.1 Risks ............................................... 31
3.2 Benets ..............................................32
CHAPTER 4: CHARGING YOUR RECEIVER AND THE
RECEIVER MAIN MENU 35
4.1 Charging Your Receiver Battery ........................... 37
4.1.1 Charging Your Receiver Battery from an AC Power Outlet . 38
4.1.2 Charging Your Receiver Battery from a Windows
®
Compatible Computer.............................. 39
4.1.3 Knowing Your Receiver is Charged . . . . . . . . . . . . . . . . . . . 40
4.2 Receiver Menu Options .................................40
- USER’S GUIDE 1
- GLOSSARY 8
- GLUCOSE MONITORING (CGM) 13
- SYSTEM DESCRIPTION 13
- CHAPTER 1: DEXCOM G4 15
- PLATINUM 15
- 1.1 SYSTEM CONTENTS: 15
- 1.2 INTRODUCTION 16
- 1.3 SENSOR OVERVIEW 17
- 1.4 TRANSMITTER OVERVIEW 18
- 1.5 RECEIVER OVERVIEW 19
- 1.6 SHARE OVERVIEW 20
- INDICATIONS FOR USE AND 21
- SAFETY STATEMENT 21
- 2.1 INDICATIONS FOR USE 23
- 2.3 CONTRAINDICATIONS 24
- 2.4 WARNINGS 24
- 2.5 PRECAUTIONS 26
- 2.6 CAUTION 29
- RISKS AND BENEFITS 31
- 3.1 RISKS 33
- 3.2 BENEFITS 34
- 1, 2 , 3 35
- CHARGING YOUR RECEIVER 37
- AND THE RECEIVER MAIN MENU 37
- THE RECEIVER MAIN MENU 39
- FROM AN AC POWER OUTLET 40
- 4.2 RECEIVER MENU OPTIONS 42
- SYSTEM SETUP 47
- WITH YOUR TRANSMITTER 47
- 5.2 THE SETTINGS MENU 49
- AND DATE 49
- RECEIVER 51
- COMMUNICATION 52
- CONTRAINDICATION 53
- INSERTING A SENSOR AND 55
- STARTING A SENSOR SESSION 55
- 6.1 BEFORE YOU START 58
- PACKAGING 59
- 6.4 PLACING THE SENSOR 61
- 6.5 SENSOR INSERTION 62
- “ 2 CLICKS” 63
- 6.6 TRANSMITTER ATTACHMENT 64
- 6.8 SENSOR STARTUP PERIOD 67
- 6.9 TAPING THE SENSOR POD 68
- CALIBRATING YOUR DEXCOM 71
- G4 PLATINUM SYSTEM 71
- PLATINUM SYSTEM 73
- 7.1 CALIBRATION OVERVIEW 73
- 7.2 HOW TO CALIBRATE 75
- 7.3 STARTUP CALIBRATION 79
- CALIBRATE 80
- SENSOR GLUCOSE READINGS 83
- AND TRENDS 83
- 8.1 SENSOR GLUCOSE READINGS 86
- Which Trend Graph Do You See? 88
- 8.2 RATE OF CHANGE ARROWS 89
- No arrow 90
- ALERTS, ALARM & PROFILES 93
- 9.1 SETTING YOUR ALERTS 95
- 9.1.2.1 HIGH GLUCOSE ALERT 98
- 9.1.2.2 LOW GLUCOSE ALERT 98
- 9.1.2.3 LOW GLUCOSE ALARM 99
- 9.2 ADVANCED ALERTS 102
- HIGH AND LOW GLUCOSE ALERTS 103
- 9.3 ALERT PROFILES 107
- 9.3.1 ALERT PROFILE OPTIONS 108
- 9.3.2 ALERT PROFILE DETAILS 109
- PAGE INTENTIONALLY LEFT BLANK 112
- 10.1.1 SELECTING AN EVENT 115
- CHAPTER 10: EVENTS 115
- 10.1 EVENTS 115
- 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
- ENDING A SENSOR SESSION 123
- PRECAUTION 125
- 11.2 REMOVING A SENSOR 126
- 11.3 TRANSMITTER REMOVAL 128
- TAKING CARE OF YOUR 129
- DEXCOM G4 PLATINUM SYSTEM 129
- 12.1 MAINTENANCE 131
- 12.2 STORAGE 131
- 12.3 PRODUCT DISPOSAL 132
- TROUBLESHOOTING 133
- CHAPTER 13: TROUBLESHOOTING 135
- 13.3 CALIBRATION ERROR 138
- 13.4 SYSTEM GLUCOSE ERROR 139
- 13.5 SENSOR INACCURACIES 140
- 13.7 SHARE PAIRING ERROR 144
- 13.8 BATTERY AND CHARGER 145
- COMMUNICATION TROUBLESHOOTING 146
- 13.9.1 SYSTEM RECOVERY CHECK 146
- 13.9.2 RECEIVER ERROR CODE 146
- 13.9.4 TRANSMITTER FAILED 147
- (continued from page before) 148
- 13.11 ALERTS ARE NOT WORKING 149
- TECHNICAL INFORMATION 151
- 14.1 DEVICE PERFORMANCE 153
- CHARACTERISTICS 153
- Agreement Relative to YSI 157
- Values (Original Study) 160
- Values (Software 505 Study) 161
- Accuracy Relative to YSI 161
- Low and High Glucose Alerts 164
- The High Glucose Alert 166
- Calibration Stability 168
- Sensor Stability 170
- Precision of System Readings 171
- Sensor Life 171
- Over 7-Days 172
- Number of Readings Provided 172
- Glucose Ranges 174
- Adverse Events 177
- 14.2 PRODUCT SPECIFICATIONS 178
- Electromagnetic Immunity 180
- Electromagnetic Emissions 187
- 14.3 FCC REQUIREMENTS 190
- USER ASSISTANCE 193
- CHAPTER 15: USER ASSISTANCE 195
- TECHNICAL SUPPORT 195
- SALES SUPPORT 195
- WARRANTY 197
- CHAPTER 16: WARRANTY 199
- TRAVEL INFORMATION 205
- APPENDIX 209
- CHAPTER 18: APPENDIX 211
- APPENDIX II, INDEX 224
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