Table Of Contents - Dexcom G5 User Manual

Table of Contents

Table Of Contents3
Part 1: Getting Started5
Glossary7
Introduction11
Chapter 1 - Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (Cgm) System Journey11
Self-Paced Resources12
Tutorials12
Written Mobile Resources13
How To Use Your User Guide15
Your Dexcom Account15
Important User Information17
Chapter 2 - Indications For Use And Safety Statement17
Safety Statements18
Overview Of Safety Statements20
Indications For Use20
Contraindications21
Mri/Ct/Diathermy21
Medications21
Sensor Fractures21
Do Not Use Damaged Goods22
Choking22
Avoid Strangulation22
Who Should Not Use22
Calibrate On Schedule23
Placement23
Prior To Initial Calibration: Data/Alarm/Alert23
Sensor Storage24
Smart Device Settings24
To Receive Alarm Or Alerts24
Precautions25
Missed An Alarm Or Alert?25
Sensor Package25
Clean And Dry Before Using25
Treatment Decisions26
Expiration Date26
Sensor Placement26
Use Correct Transmitter, Receiver, And Sensor26
Communication Range27
Setting Alarm/Alert Notifications27
Is It On?27
Test Receiver28
No Alternative Site Testing – Fingerstick Only28
When Not To Calibrate28
Don't Share Your Transmitter29
Airport Scanners29
Not Receiving Alarm/Alerts31
Chapter 3 - Risks And Benefits31
Using Cgm For Treatment Decisions32
Sensor Glucose Reading Different From Your Expectations Or Symptoms32
Benefits33
Sensor Insertion Risks33
Knowing Your Trends33
Making Treatment Decisions Based On Your Cgm33
Helping Your Diabetes Management34
The Basics37
Product Overview39
Safety Statement39
Part 2: Let's G539
Chapter 4 - What's The Dexcom G5 Mobile39
Precaution40
Components Compatible With Each Other Within The Dexcomg5 Mobile System41
Cgm41
Options To View Your Trends41
The Dexcom G5 Mobile41
Tracking Real-Time Cgm Data42
View Glucose Levels42
Trend Arrows42
Alarm/Alerts43
Viewing Your Glucose Values43
On Treatment Decisions43
What's New To The Dexcom G5 Mobile43
System Information44
System Components44
Package44
Overview Of System Components45
Sensor Overview46
Applicator And Sensor Pod47
Transmitter Overview48
Receiver48
Receiver Overview49
Smart Device Overview51
Chapter 5 - Set Up Your Display Devices53
Why Different Monitoring Methods?54
Dexcom G5 Mobile App54
Suggested Device Settings54
Dexcom G5 Mobile App Installation55
Initial Dexcom G5 Mobile App Setup55
Initial App Setup56
Introductory Screens56
Setting Up Your App Alarm/Alerts And Basic Settings58
Connecting/Pairing Transmitter With App61
Initial Setup Of The Receiver67
Setup Wizard Prompts67
Date/Time69
Transmitter70
Setting Low Alert71
Setting High Alert71
Chapter 6 - Starting A Sensor Session: Inserting Sensor, Attaching Transmitter, And Starting Your Session73
Prepping For Sensor Insertion76
Included In Your Dexcom G5 Mobile Packages76
Sensor Applicator77
Inside Sensor Box77
Dexcom G5 Mobile Sensor Applicator And Pod View77
Applicator Components78
Transmitter Box79
Choosing Your Insertion Site79
Optional Site Preparation81
Inserting Your Sensor81
Attaching Sensor Pod82
Inserting Sensor Wire83
Removing Applicator And Collar84
Attaching Your Transmitter85
Loose Sensor Pod88
Starting Your Sensor Session88
Dexcom App: Starting A Session89
Receiver: Starting A Session91
Receiver Bluetooth Tips93
No Communication Between Transmitter And Receiver94
Sensor Session Warmup94
Chapter 7 - Calibration97
Calibration Overview100
How Do I Calibrate?100
How Often Do I Calibrate?101
When To Calibrate101
Initial Calibration: Sensor Startup Completed102
Update Calibration102
Sensor Session Startup Calibration Prompts103
First Calibration104
Second Calibration105
Update Calibration Prompts106
Update Calibration Notifications106
Calibration Sound/Vibration Prompts107
Preparing For Calibration107
Nine Steps To Successful Calibration107
Ready? Set? Calibrate108
Initial Calibrate With Your Dexcom G5 Mobile App109
Initial Calibration With Your Receiver112
Calibration Errors116
Chapter 8 - Ending Your Sensor Session And Transmitter Session119
Ending Your Sensor Session121
End Seven-Day Sensor Session Prompts122
End Of Sensor Session Sound/Vibration Prompts126
Ending Your Sensor Session Early127
Prompts To End Sensor Session Early128
App: Ending A Sensor Session Early130
Receiver: Ending A Sensor Session Early132
Temporarily Shutting Down Receiver133
Receiver: Temporary Shutdown134
Preventing Sensor Failures135
Removing Sensor Pod135
Removing Transmitter From Sensor Pod135
Remove Sensor Pod And Transmitter135
End Of Transmitter Battery137
Transmitter Battery Messages138
Transmitter Sound/Vibration Prompts140
Pair New Transmitter141
Pairing New Transmitter With App141
Pairing New Transmitter With Receiver148
Getting The Most Out Of The G5 Mobile153
Part 3: Next Steps - Getting The Most153
Introduction To Home Screens155
Chapter 9 - Home Screen, Rate Of Change Arrows, And Errors155
Home Screen Overview157
App Home Screen158
App Task Bar159
App Glucose Information160
App: Optional Views166
App: Smart Watches166
Receiver Home Screen167
Status Bar167
Receiver Status Bar168
Receiver Task Bar169
Receiver Glucose Information170
Glucose Information: Review171
Rate Of Change Arrows172
Error Messages174
Signal Loss174
Bluetooth Off175
No Readings175
Sensor Error176
Calibration Error: Calibrate Now176
Calibration Error: Calibrate Later177
What Is An Event?179
Chapter 10 - Daily Events Affect Your Glucose Trends And Patterns179
Event Categories180
Events Menu181
Carbs181
Insulin182
Exercise183
Health184
Event Time185
Health Events Menu186
Health Main Menu187
Entering Events: Smart Device188
Entering Events: Dexcom G5 Mobile App188
Enter Carbs Event189
Enter Stress Event191
Entering Events: Receiver194
Viewing Events198
Event Markers: App198
Chapter 11 - Sensor Glucose Alarm And Alerts201
What Is An Alarm?204
What Are Alerts?204
Alarm And Alerts204
Alarm/Alert Prompts205
Default Alerts205
Low/High Glucose Alerts205
Rise Rate/Fall Rate Alerts, Signal Loss Alert205
Alarm And Alerts Screens206
Urgent Low Glucose Alarm207
Rise Rate/Fall Rate Alerts210
Signal Loss Alert212
App: Alert Sound And Vibration213
Low/High Glucose Alarm214
Always Sound216
Receiver: Alert Sound And Vibration217
Confirming Alarm/Alerts221
App: Confirming Alarm/Alerts222
Receiver: Confirming Alarm/Alerts222
Receiver: Test Speaker And Vibrations223
Chapter 12 - On The Go With G5: Customizing Your Alarm And Alerts227
Changing App Alarm And Alerts228
Alerts Menu228
Customizing Alerts: App228
Customizing Alerts231
App: Alert Schedule239
App: Setting Up Your Alert Schedule239
App: Changing Scheduled Alert Settings243
App Status Icons: Alert Schedule244
Changing Receiver Alarm And Alerts244
Sounds245
Alarm/Alert Sounds246
Customizing Alert Sounds: Receiver247
Alerts Menu - Low And High248
Rise And Fall Rates249
Steps To Customize Receiver Alarm/Alerts249
Customizing Alerts: Receiver250
Change Low Alert Level251
Turn On Repeat251
Chapter 13 - Using The Dexcom G5 Mobile System For Treatment Decisions255
Treatment Decisions: The Basics256
How Do You Know You're Ready?256
Creating Personal Guidelines257
Make A List257
What Not To Do258
Use Your BG Meter When...258
Not Sure If Your Dexcom G5 Mobile Is Correct258
Your Symptoms Don't Match258
When In Doubt259
Just Took Acetaminophen259
Use A Smart Watch259
No Arrows Or Readings259
Watch And Wait260
Treatment Decisions: Beyond The Basics260
Alarm/Alerts Table261
Sensor Readings And Arrows262
Sensor Glucose Readings And Trend Arrows264
Using Your Trend Arrows264
You Decide!267
Scenario 1: What Would You Do?267
Scenario 2: What Would You Do?268
General Guidelines270
Everything Else G5273
Part 4: Everything Else G5275
Chapter 14 - Warranty: The Fine Print275
Receiver Warranty Information275
Transmitter Warranty Information278
Dexcom's Obligations Under The Limited Warranty279
Dexcom G5 Mobile System User Guide280
Chapter 15 - How To Take Care Of Your Dexcom G5 Mobile281
Basic Maintenance283
Sensor Maintenance283
Transmitter Maintenance284
Receiver Maintenance284
Charging Receiver's Battery Maintenance284
Accessories288
Sensor: Storage288
Transmitter Storage288
Checking App And Receiver Information289
Receiver Storage289
Check Cgm System Settings: App289
Check Cgm System Settings: Receiver290
System Disposal290
Chapter 16 - On The Go With Dexcom G5 Mobile: Getting Through Security293
Walk-Through Metal Detectors294
Going Through Security294
X-Ray Machines295
Body Scanners295
In The Plane295
Technical Information295
Chapter 17 - Need Help? You're Not Alone297
Dexcom Technical Support Team297
Dexcom Patient Care Team298
Dexcom Sales Support Team299
Corporate300
Device Performance Characteristics301
Clinical Study Overview301
Chapter 18 - Technical Information301
Overview Of Adult Studies302
Overview Of Pediatric Studies302
System Agreement To Ysi Within Cgm Glucose Ranges (Adult)304
System Agreement To Ysi Within Cgm Glucose Ranges (Pediatric)305
Agreement Relative To Ysi305
Number and Percentage of YSI Values When CGM Readings Are "LOW" or "HIGH" (Adult)307
Number and Percentage of YSI Values When CGM Readings Are "LOW" or "HIGH" (Pediatric)308
Agreement When CGM Reads "LOW" or "HIGH"308
Concurrence Of Cgm Readings And Ysi Values (Original Adult Study)310
Concurrence Of Cgm Readings And Ysi Values (Software 505 Adult Study)311
Concurrence Of Cgm Readings And Ysi Values (Original Pediatric Study)312
Concurrence Of Cgm Readings And Ysi Values (Software 505 Pediatric Study)313
Concurrence Of System And Laboratory Reference313
System Difference To Ysi Within Cgm Glucose Ranges (Adult)314
System Difference To Ysi Within Cgm Glucose Ranges (Pediatric)315
Accuracy Relative To Ysi315
Hypoglycemia Alert And Detection Rate Evaluation In Reference To Ysi 15 Minutes Before And After (Adult)317
Hypoglycemia Alert And Detection Rate Evaluation In Reference To Ysi 15 Minutes Before And After (Pediatric, Ages 6-17 Years)318
Hypoglycemia Alert And Detection Rate Evaluation In Reference To Smbg 30 Minutes Before And After (Pediatric, Ages 2-5 Years)319
Low And High Glucose Alerts319
The Low Glucose Alert319
Hypoglycemia Alert Rate320
Hypoglycemia Detection Rate320
Hyperglycemia Alert And Detection Rate Evaluation In Reference To Ysi 15 Minutes Before And After (Adult)321
Hyperglycemia Alert And Detection Rate Evaluation In Reference To Ysi 15 Minutes Before And After (Pediatric, Ages 6-17 Years)322
Hyperglycemia Alert And Detection Rate Evaluation In Reference To Smbg 30 Minutes Before And After (Pediatric, Ages 2-5 Years)323
The High Glucose Alert323
Hyperglycemia Alert Rate324
Hyperglycemia Detection Rate324
Percentage Of System Readings Within Ysi Values With Data Stratified In 2-Hour Increments After Calibration (Adult)325
Percentage Of System Readings Within Ysi Values With Data Stratified In 2-Hour Increments After Calibration (Pediatric)326
Calibration Stability326
Sensor Stability Relative To Ysi (Accuracy Over Time) - (Adult)327
Sensor Stability Relative To Ysi (Accuracy Over Time) - (Pediatric, Ages 6-17 Years)328
Sensor Stability Relative To Smbg (Accuracy Over Time) - (Pediatric, Ages 2-17 Years)329
Sensor Stability329
Precision Of System Readings330
Sensor Life330
Number Of Readings Provided By Each Sensor Over 7 Days (Adult)331
Number Of Readings Provided By Each Sensor Over 7 Days (Pediatric)332
System Readings Within Wear Days (Adult)333
System Readings Within Wear Days (Pediatric)334
Number Of Readings Provided334
System Agreement To Smbg Within Cgm Glucose Ranges (Adult)335
System Agreement To Smbg Within Cgm Glucose Ranges (Pediatric)336
System Difference To Smbg Within Cgm Glucose Ranges (Adult)337
System Difference To Smbg Within Cgm Glucose Ranges (Pediatric)338
Agreement And Accuracy Relative To Smbg338
Adverse Events339
Product Specifications339
Sensor Product Specifications339
Transmitter Product Specifications340
Transmitter Performance Characteristics340
Transmitter Electromagnetic Immunity Specifications341
Receiver Product Specifications341
Receiver Electromagnetic Immunity Specifications343
System Electromagnetic Immunity Specifications344
Electromagnetic Emissions Specifications345
Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Receiver345
Usb Charging/Download Cable Specifications346
Power Supply/Charger Specifications346
Immunity To Electro-Magnetic Events Statement (Iec 60601-1-2)347
Fcc Requirements347
Chapter 19 - Troubleshooting349
No Alarm/Alerts351
Troubleshooting351
Sensor Glucose Readings352
Applicator Troubleshooting356
Hardware Error358
Calibration Error362
Transmitter Error364
Chapter 20 - Symbols On Package Labels367
Dexcom Share371
Part 5: Sharing Is Caring371
Learning About Dexcom Share - Glossary373
Chapter 21 - Dexcom Share373
Dexcom Share Overview377
Conditions Affecting Use Of Dexcom Share379
Risks And Benefits Of Dexcom Share379
Intended Use Of Dexcom Share381
Precautions On Dexcom Share382
Setting Up Dexcom Share384
Dexcom Share Description384
Installing The Dexcom G5 Mobile App385
Activating Your Share Feature386
Inviting Followers389
Using Dexcom Share394
Dexcom Share Status394
Dexcom Share Status Icons395
Troubleshooting Sharing Status Issues396
Share Status Troubleshooting Tips397
Follower List398
Icon/Status398
Editing/Removing Followers399
Stop Sharing399
Dexcom Follow App Description400
Receiving Dexcom Follow Invitation Email400
Glucose Alarm/Alerts400
Sharer Status Changes That Notify The Follower401
The Follower Dashboard401
Follower Information With Trend Graph402
Dexcom Share Troubleshooting403
Sharing Checklist404
Part 6: Index Index407