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Agreement between the matched pair was estimated by evaluating the difference between the Guardian
RT reading and the blood glucose meter measurement. The difference between them was calculated as a
percentage of the blood glucose meter measurement (Mean Absolute Percent Difference). The bias was
also calculated, and it is defined as the overall difference between the Guardian RT glucose values and
the blood glucose meter values. The paired glucose measurements are summarized in the following table
Number of Paired Glucose Measurements 2599
Mean Absolute Percent Difference (± SD) 19.0 ± 19.7%
Bias -6.0 mg/dL (-0.3 mmol/L)
Appendix A148
- User Guide 1
- Guardian 2
- REAL-Time 2
- 6025254-019_c 3
- Contents 8
- Contentsviii 9
- Contents ix 10
- Contentsx 11
- Contents xi 12
- Contentsxii 13
- Contents xiii 14
- Contentsxiv 15
- Introduction 16
- Emergency kit 17
- Your system 17
- Accessories 18
- 1 Open the MAIN MENU 19
- 3 Select Alarm, press ACT 19
- Introduction4 19
- User safety 20
- Contraindications 21
- Safety Warnings 21
- Precautions 22
- Adverse reactions 22
- Compliance information 23
- Introduction 9 24
- Introduction10 25
- The basics 26
- Battery cap 27
- The monitor buttons 28
- The monitor screen 30
- Scroll bar 31
- Screen backlight 31
- BATT TEST 32
- MAIN MENU 33
- SENSOR MENU 33
- CAPTURE EVENT 33
- UTILITIES MENU 33
- The STATUS screen 34
- The basics20 35
- Entering your settings 36
- Month Day 37
- Selecting the language 38
- Setting your Alarm/Alert Type 39
- Turning on the sensor 40
- Selecting the BG units 40
- Turning on the Glucose Alerts 40
- Setting the Glucose Limits 41
- Entering your settings 27 42
- Setting the High Snooze 43
- Setting the Low Snooze 44
- Setting the Rate Alerts 45
- AUC calculation 46
- Entering your settings32 47
- Setting the Alarm Snooze 48
- Setting the Cal Reminder 48
- SN GT2XXXXXXM 49
- Reviewing your settings 50
- Using the Sensor Demo 51
- Basic steps 52
- Transmitter charger 52
- Charging the transmitter 53
- Inserting the sensor 54
- Starting the sensor 55
- Meter option 58
- Meter rules 59
- Add, delete, review meter IDs 59
- Meter option 45 60
- Meter option46 61
- Using your system 62
- Using your system48 63
- Using your system 49 64
- Capturing Events 65
- Using your system 51 66
- Before you begin 67
- Entering exercise information 68
- Entering Other markers 69
- The graphs 71
- 3 hour graph 72
- 6 hour graph 73
- 12 hour graph 74
- 24 hour graph 75
- The rapid change arrows 76
- Checking the sensor status 77
- Using your system 63 78
- Using your system64 79
- Using your system 65 80
- Viewing your current settings 81
- Using your system in water 82
- Using your system68 83
- Utilities 84
- Sensor glucose information 85
- Utilities 71 86
- The Alarm Clock 87
- Utilities 73 88
- The Block feature 89
- The Lock Keypad feature 90
- Running the Selftest 90
- User settings 91
- Restoring your settings 92
- Clearing your settings 93
- Utilities 79 94
- Utilities80 95
- Therapy management software 96
- Therapy management software82 97
- About alarms and alerts 98
- Sensor alerts 99
- LOST SENSOR 100
- LOW TRANSMTR 100
- CHARGE TRANSMTR 100
- CHANGE SENSOR 100
- SENSOR END 101
- CAL ERROR 101
- METER BG NOW 101
- METER BG BY 102
- LOW SG 102
- HIGH SG 102
- LOW PREDICTED 102
- HIGH PREDICTED 102
- FALL RATE 103
- RISE RATE 103
- SENSOR ERROR 103
- LOW BATTERY 103
- System alarms 105
- FAILED BATT TEST 106
- OFF NO POWER 106
- WEAK BATTERY 106
- Connecting the tester 109
- Disconnecting the tester 109
- Troubleshooting the monitor 110
- My screen looks distorted 112
- I dropped my monitor 112
- System maintenance 114
- Cleaning the system 115
- Cleaning the Sen-serter 116
- Watertight tester 116
- System maintenance102 117
- For single-patient use 118
- System maintenance104 119
- System maintenance 105 120
- For multiple-patient use 121
- System maintenance 107 122
- System maintenance108 123
- System maintenance 109 124
- Removing adhesive residue 125
- System specifications 126
- Sensor glucose graph timeout 127
- Daily totals 128
- Default screen 128
- Default settings 128
- ENTER BG meter values 134
- Meter ID entries 134
- Power supply 134
- System safety checks 134
- Quality of service 135
- Data security 135
- Monitor size 136
- Monitor weight 136
- TIME/DATE SET screen 136
- STATUS screen 136
- System specifications122 137
- System specifications 123 138
- System specifications124 139
- System specifications 125 140
- System specifications126 141
- System specifications 127 142
- System specifications128 143
- MiniLink specifications 144
- Warranty 145
- Icon table 146
- System specifications132 147
- Sensor accuracy 148
- Performance results in adults 149
- Sensor accuracy 135 150
- Appendix A136 151
- Meter BG (mg/dL) 152
- Sensor BG (mg/dL) 152
- Appendix A138 153
- Time of day 154
- The Low Glucose Alert 155
- The High Glucose Alert 155
- Function of Time 156
- Appendix A142 157
- Sensor accuracy 143 158
- Appendix A144 159
- Glucose Conc (mg/dL) 160
- Appendix A148 163
- Sensor accuracy 149 164
- Sensor accuracy 153 168
- Appendix A154 169
- Glossary 170
- Glossary156 171
- Glossary 157 172
- Glossary158 173
- Glossary 159 174
- Glossary160 175
- Numerics 176
- Index162 177
- Index 163 178
- Index164 179
- Index 165 180
- Index166 181
- Index 167 182
- Index168 183
- 6025254-018C_a 184
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