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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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