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G6 Pro User Guide

152Appendix H: Labeling Symbols

Keep Away from Heat

Keep Dry

Manufacturer

MR

MR Unsafe

PN

Part Number

Prescription Required

SN

Serial Number

STERILE R

Sterile by Radiation

Temperature Limitation

Type BF Applied Part

Use By Date

Table of Contents

Default Chapter5
- Table of Contents5
Chapter 1: Welcome7
- Introduction: Welcome to G6 Pro7
- Resources7
  - Product Instruction8
  - In-Box Materials8
- Your Dexcom Account9
- Indications for Use11
Chapter 2: Safety Statements11
- Contraindication12
- Warnings13
- Precautions17
- Caution20
  - Risks and Benefits21
  - Sensor Insertion Risks21
Chapter 3: Risks and Benefits21
- Not Getting Alarm/Alerts22
- Benefits23
Chapter 4: Overview27
- Introduction27
- G6 Pro Components27
- Unblinded CGM Patient Display Device28
- G6 Pro Reader29
- How They Work Together30
- Unblinded/Blinded31
- Dexcom CLARITY33
- Getting Your Patient Started33
- Preparing for Patient’s Visit35
Chapter 5: Getting Started with G6 Pro35
- Introduction35
- Sensor Insertion37
  - Choose Sensor Site37
  - Attach Transmitter41
- Next Steps for Your Patient44
- Setting up System47
Chapter 6: Unblinded - Using the G6 Pro47
- Home Screen Overview50
- Home Screen Navigation56
- Glucose Alarm and Alerts57
Chapter 7: Alarm, Alerts, and Sounds57
- What Your Patient Sees What It Means59
- Signal Loss60
Chapter 8: Events61
- Introduction61
- Events Overview61
- Types of Events62
- Enter Long-Acting Insulin62
- Other Events63
- Edit or Delete an Event65
- Delete Event66
- App: View Events67
- When to Use Meter and the G6 Pro69
Chapter 9: Treatment Decisions69
- When to Use Meter Only70
- When to Watch and Wait71
- Using the Trend Arrows72
- Practice Making Treatment Decisions72
Chapter 10: Blinded/Unblinded End of Sensor Session75
- Introduction75
- Unblinded - End Your75
  - Notification Example76
  - Sensor Session over77
- Patient Materials78
Appendices81
Appendix A: Faqs and Troubleshooting83
- Alarm/Alerts and G6 Pro Readings84
  - Alarm/Alerts Sound While Display Device Is Muted/Silenced84
  - Cannot Hear Alarm/Alerts84
- Error Messages85
- Sensor or Applicator Issues92
- Accuracy98
  - G6 Pro Readings Do Not Match Symptoms98
  - Can't Download App99
Appendix B: Glossary100
Appendix C: Technical Support103
- Applicator/Sensor Care105
- Transmitter Care105
Appendix D: Maintenance of105
- G6 Pro System105
Appendix F: Warranty111
Appendix G: Technical113
- Technical Information115
- Device Performance Characteristics115
- Clinical Study Overview115
- Accuracy Tables117
- Agreement When CGM Reads “LOW” or “HIGH”123
- Distribution of YSI Values When CGM Readings Are “LOW” or "HIGH"124
- Concurrence of the Unit and Laboratory Reference124
- Trend Accuracy129
- Hypoglycemia and Hyperglycemia Alerts130
- Low and High Glucose Alerts130
- Hypoglycemic Detection Rate131
- Hyperglycemic Alert Rate134
- Hyperglycemia Detection Rate134
- Sensor Stability137
- Sensor Life138
- Sensor Survival Rate by Wear Day139
- Kaplan Meier Curve of Sensor Life140
- Number of Readings Provided143
- Precision of System Readings144
- Precision by Wear Location144
- Study 2 Overview145
- Accuracy (Study 2 - Automatic Applicator)145
- Patient Comfort (Study 2 - Automatic Applicator)146
- Adverse Events147
- Product Specifications148
- Electromagnetic Immunity and Emissions Declaration and Guidance150
- Electromagnetic Emissions Specifications152
Appendix H: Label Symbols153
Appendix I: Alerts and Notifications155
- Today View161
Appendix J: Extend Your App161
- Quick Glance163
- Smart Watches164
- Apple Watch Setup164
- Android Wear Setup165
- Siri (Apple)166
- Health Apps167
- Index169

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