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184 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
14
System Electromagnetic Immunity Specications
(continued from page before)
Immunity Test IEC 60601 Test
Level
Receiver
Compliance Level
Electromagnetic
Environment
Guidance
the transmitter
manufacturer
and d is the
recommended
separation distance
in meters (m).
Field strengths
from xed RF
transmitters, as
determined by an
electromagnetic
site survey
a
should
be less than
the compliance
level in each
frequency range
b
.
Interference may
occur in the vicinity
of equipment
marked with
following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reection
from structures, objects and people.
- 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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