OmniPod 5 - AUTOMATED MODE; 21 About Automated Mode; 22 Switching Between Manual Mode and Automated Mode; 23 Activity Feature

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AUTOMATED MODE

About Automated Mode

Switching Between Manual Mode

and Automated Mode

Activity Feature

Automated Mode Alarms

Omnipod 5 System Clinical

Studies

Main Page

Table of Contents3
- Section 1: before You Begin9
Chapter 1 Introduction11
- The Omnipod 5 System Features12
- Welcome to Your Omnipod® 5 System12
- About this User Guide14
- Indications for Use14
- Compatible Insulins15
- Contraindications15
- General Warnings15
- General Precautions19
- Potential Risks20
- Important User Information21
- Emergency Kit22
- Section 2: Omnipod 5 Pump Features23
- Omnipod 5 Pump Important Safety Information25
Chapter 2 System Terminology and Navigation33
- Terminology34
- Tapping and Swiping37
- Touchscreen Basics37
- Using the Touchscreen and Entering Information37
- Entering Numbers and Text38
- Screen Time-Out and Brightness38
- Using a Keypad38
- Using a Number Pad38
- Add and Delete Buttons39
- Selecting, Adding and Deleting Items39
- Toggles39
- Using a Scroll Wheel39
- Navigation Buttons and Navigation Shorthand40
- Options Button40
- User Guide Navigation Shorthand40
Chapter 3 Omnipod 5 System Overview41
- Omnipod 5 App and Dexcom Communication42
- Omnipod 5 App43
- The Omnipod 5 Controller43
- Lock Screen and Security44
- Lock Your Controller44
- Omnipod 5 App Security on Your Controller44
- Unlock Your Controller44
- Forgotten Your PIN45
- Status Bar46
- Home Screen47
- DASHBOARD Tab48
- Without a Paired Transmitter48
- With a Paired Transmitter49
- INSULIN Tab50
- Manual Mode50
- Activity Feature51
- Automated Mode51
- Temp Basal51
- POD INFO Tab52
- POD INFO Banners53
- Between Boluses54
- Bolus Button54
- Bolus Information and Button54
- Bolus Information if There Is no Pod Communication54
- During a Bolus54
- Estimated and Unconfirmed Bolus Amounts54
- Home Screen Main Menu55
- About Screen56
- Alarms56
- Notifications and Messages56
- Omnipod 5 Notifications56
- Manual and Automated Mode Overview57
Chapter 4 Setting up Your Omnipod 5 Application61
- Omnipod 5 Intro Kit Contents62
- Preparing for Your Training62
- Setting up Your Account62
- General Settings on the Insulet-Provided Controller63
- Items Needed for Your Training63
- Turning on and Signing in to Your Controller64
- Setting up Training65
- Personalise Your Controller66
- Setting the PIN on Your Controller66
- Setting up Your Controller66
- Enabling Notifications and Sound on Your Controller67
- Basal Settings68
- Set Maximum Basal Rate68
- Create a Basal Programme69
- Define the Segments69
- Name the Basal Programme69
- Review the Basal Programme70
- Temporary Basal Configuration71
- Bolus Settings72
- Define the Segments72
- Target Glucose and Correct above Values72
- Define the Segments73
- Insulin to Carb (IC) Ratio73
- Correction Factor74
- Define the Segments74
- Duration of Insulin Action75
- Extended Bolus76
- Maximum Bolus76
- Your App Set-Up Is Complete76
- Saving Your Settings for Reference77
Chapter 5 Activating and Changing Your Pod79
- Beginning the Pod Activation Process80
- Fill the Syringe with Insulin82
- Setting up a New Pod82
- Filling, Activating, Applying and Starting the Pod83
- Activate the Pod84
- Fill the Pod with Insulin84
- Guidelines for Pod Site Selection86
- Prepare the Pod Site86
- Pod Site Examples87
- Pod Site Map (Optional)87
- Prepare the Infusion Site88
- Apply the Pod89
- Remove the Pod's Tab89
- Begin Insulin Delivery90
- Checking Your Infusion Site91
- Confirm Pod Is Securely Attached91
- Switching to Automated Mode92
- Deactivating an Active Pod93
- Avoiding Infusion Site Infections94
- More Information about Pod Use94
- Additional Information95
Chapter 6 Basal Programmes97
- About Basal Programmes98
- Reviewing All Basal Programmes98
- Creating New Basal Programmes99
- Editing a Basal Programme99
- Deleting a Basal Programme100
- Switching to a Different Basal Programme100
- Basal Insulin Delivery101
- Manual Mode Basal Programmes101
Chapter 7 Temporary Basal Rates and Presets103
- About Temporary Basal Rates104
- Starting a Temp Basal105
- Cancelling a Temp Basal or Temp Basal Preset107
- Creating a New Temp Basal Preset107
- Editing a Temp Basal Preset108
- Deleting a Temp Basal Preset109
- Temporary Basal Rates Delivery109
- Temp Basal Settings: Units Per Hour (U/Hr) or Percentage (%)110
- Temp Basal Limitations111
- Temp Basal Presets112
Chapter 8: Blood Glucose Readings113
- About Blood Glucose Readings114
- Entering Your Blood Glucose Reading115
- High and Low Blood Glucose Readings116
- How Blood Glucose Readings Are Displayed117
Chapter 9 Pausing and Starting Insulin Delivery119
- Pause Insulin Delivery120
- Pausing Insulin Delivery120
- Methods to Temporarily Pause Insulin Delivery in Manual Mode121
- Start Insulin Delivery after the Pause Period Ends122
- Start Insulin Delivery before the Pause Period Ends122
- Starting Insulin Delivery122
Chapter 10: Changing Settings123
- Flight Mode124
- General Settings124
- Network Connectivity124
- Lock Screen125
- Lock Screen Background125
- Lock Screen Message125
- Screen Display125
- Screen Time-Out125
- Device Time Zone126
- Pin126
- Time Change126
- Insulin Delivery Time Zone127
- Language128
- Reminder Settings128
- Reset128
- Low Pod Insulin129
- Pod Expiry129
- Confidence Reminders130
- Programme Reminders130
- Basal and Temp Basal Settings131
- Maximum Basal Rate131
- Temp Basal131
Chapter 11 Browsing Your History and Records133
- Default Chapter134
- Chapter 12: Managing Software Updates147
  - Insulet-Provided Controller148
Chapter 13 Alarms, Action and Reminder Notifications151
- Types of Alarms and Notifications153
- Alarms and Notifications Screen154
- Sounds and Vibrations155
- Informational Sounds and Vibrations156
- Programme Reminders156
- Basal Programme Changes157
- Cancelling Temp Basals and Boluses157
- Responding to Alarms158
- Diagnostics159
- Blockage Detected160
- Hazard Alarm List160
- Omnipod 5 App Error161
- Omnipod 5 Memory Corruption162
- Pod Error163
- Pod Expired164
- Pod out of Insulin165
- Pod Shutdown166
- System Error167
- Advisory Alarm List168
- Low Pod Insulin168
- Pod Expired169
- Pod Shutdown170
- Start Insulin171
- Urgent Low Glucose172
- Action Item Notification List173
- App Use Blocked173
- Connect to a Wireless Network174
- Daylight Saving Time Change175
- Omnipod 5 Error176
- Update Omnipod 5 - App no Longer Supported177
- Update Omnipod 5 - Software Update178
- Update179
- Update Time Zone180
- Controller Alarm181
- Silencing Unresolved Alarms181
- Responding to Reminder Notifications182
- Reminder Notifications List183
Chapter 14 Taking Care of Your Controller and Pod185
- Avoid Extreme Temperatures186
- Pod and Insulin Storage186
- Pod and Insulin Storage and Care186
- Pods and the Environment186
- Cleaning Your Pod187
- Controller Storage and Care187
- Water and Your Pod187
- Avoid Extreme Temperatures188
- Electrical Interference188
- Long-Term Storage of Your Controller188
- Water and Your Controller188
- Your Controller and the Environment188
- Cleaning Your Controller189
- If You Drop the Controller189
- USB Cable189
- Controller Battery Care190
- Safe Use of the Controller Battery190
- Charging the Controller Battery191
Chapter 15 Living with Diabetes193
- Infusion-Site Checks194
- Being Aware of Your Glucose195
- Keep Supplies Accessible196
- Travelling and Holidays196
- Airport Security197
- Airports and Flying197
- Plan for Changing Time Zones197
- Avoiding Lows, Highs and Diabetic Ketoacidosis198
- Flying and Flight Mode198
- General Precautions198
- Hypoglycaemia (Low Glucose)199
- Symptoms of Hypoglycaemia (Low Glucose)199
- To Avoid Hypoglycaemia (Low Glucose)200
- To Treat Hypoglycaemia (Low Glucose)201
- Hyperglycaemia (High Glucose)202
- Symptoms of Hyperglycaemia (High Glucose)202
- To Avoid Hyperglycaemia (High Glucose)202
- To Treat Hyperglycaemia (High Glucose)204
- Diabetic Ketoacidosis (DKA)205
- Symptoms of DKA205
- To Avoid DKA205
- To Treat DKA205
- Exercising, Playing Sports or Working Hard206
- Handling Special Situations206
- Sick Days206
- Surgery or Hospitalisation207
- X-Rays, Mris and CT Scans207
- Section 3: Smartbolus Calculator209
- Smartbolus Calculator Important Safety Information211
Chapter 16 Delivering a Bolus213
- Delivering a Manual Bolus214
- Delivering Immediate and Extended Boluses215
- Extended Bolus Progress216
- Immediate Bolus Progress216
- Tracking the Progress of a Bolus216
- Cancel a Bolus217
- Cancelling a Bolus in Progress217
- Deliver a New Bolus before an Extended Bolus Has Ended217
- Check BG after Bolus218
- Enable or Disable a Single Missed Bolus Reminder218
- Enable or Disable All Missed Bolus Reminders218
- Missed Bolus218
- Reminder Settings218
- Add a New Missed Bolus Reminder219
- Delete a Missed Bolus Reminder219
- Edit a Missed Bolus Reminder219
Chapter 17 Delivering a Bolus with the Smartbolus Calculator221
- About Correction Boluses and Meal Boluses222
- About the Smartbolus Calculator222
- About Using a Sensor Glucose Value with Trend222
- Entering a Blood Glucose Reading or Using a224
- Entering Meal Information224
- Manually Enter Your Blood Glucose Reading224
- Sensor Glucose Value224
- Using a Sensor Glucose Value224
- Import and Use Sensor Glucose Value225
- Insulin on Board (IOB)226
- Adjustments to Your Calculation227
- Delivering an Immediate Bolus227
- Delivering an Extended Bolus228
- Bolus Settings230
- Impacts to Suggested Bolus Calculations230
- Extended Bolus232
- Maximum Bolus232
- Smartbolus Calculator Settings232
- Target Glucose and Correct above232
- Insulin to Carb Ratio (IC Ratio)233
- Minimum Glucose for Calculations233
- Correction Factor234
- Duration of Insulin Action234
- Reverse Correction234
Chapter 18 Understanding Smartbolus Calculator Calculations235
- Controlling the Bolus Amount236
- Extended Boluses236
- Maximum Bolus236
- Smartbolus Calculator Boluses236
- The Smartbolus Calculator236
- Factors Used in the Smartbolus Calculator Calculations237
- When the Smartbolus Calculator Does Not Work237
- Correct above Threshold238
- Duration of Insulin Action238
- Insulin on Board238
- Minimum Glucose for Calculations238
- Sensor Glucose Trend238
- Target Glucose238
- Reverse Correction239
- Boundaries of the Smartbolus Calculator Suggestions241
- Considerations about Smartbolus Calculator Recommendations242
- Bolus IOB Depletion243
- Insulin on Board (IOB)243
- Smartbolus Calculator Equations245
- Smartbolus Calculator Rules246
- Overview of the Bolus Calculations Screen247
- Smartbolus Calculator Examples248
- Section 4: Using a Sensor with Omnipod251
- Sensor Important Safety Information253
Chapter 19 About the Dexcom G6255
- Dexcom G6 Overview256
- Adult Placement Examples257
- Dexcom G6 Sensor Placement257
- Paediatric Placement Examples258
- Using the Dexcom G6 with Omnipod 5258
- High and Low Sensor Glucose Values259
- Sensor Glucose Values259
- Urgent Low Glucose259
- Sensor Glucose Trend Arrows260
- Communication Messages261
Chapter 20 Connecting Dexcom G6 to the Pod263
- Default Chapter264
- Chapter 21: About Automated Mode271
Chapter 22 Switching between Manual Mode and Automated Mode281
- Default Chapter282
- Chapter 23: Activity Feature285
- Chapter 24: Automated Mode Alarms289
  - Advisory Alarm List290
Chapter 25 Omnipod 5 Clinical Studies293
- Studies in Children, Adolescents and Adults with294
- Type 1 Diabetes294
- Demographics295
- Change in A1C Analysed by Baseline A1C299
- Glycaemic Results by Baseline Treatment300
- Body Mass Index Results301
- Insulin Requirements301
- Adverse Events302
- Omnipod 5 System Use302
- Glycaemic Results at Target Glucose Settings in the Pivotal Study303
- Studies in very Young Children with Type 1 Diabetes308
- Demographics309
- Glycaemic Results310
- Change in A1C Analysed by Baseline A1C312
- Glycaemic Results by Baseline Treatment312
- Body Mass Index Results313
- Insulin Requirements313
- Omnipod 5 System Use313
- Adverse Events314
- Glycaemic Results at Target Glucose Settings315
- Section 6: Additional Information317
Chapter 26 Frequently Asked Questions and Troubleshooting319
- Omnipod 5 Pump Faqs320
- Pod Issues320
- Finding out How Much Insulin was Delivered321
- Controller Issues322
- Omnipod 5 App Issues322
- Smartbolus Calculator Faqs324
- Sensor Faqs325
- High Glucose Issues327
- Low Glucose Issues329
- Automated Mode Faqs330
- Error When Sending Insulin Instructions to the Pod331
- Pod Communication Issues - "Try Again331
- Error When Activating a Pod332
- Error When Cancelling a Bolus332
- Error When Deactivating a Pod332
- About Keeping Your Omnipod 5 Controller Nearby333
- Device Complaints333
- Boot Mode334
- How to Leave "Boot Mode334
- How to Put Your Controller into "Boot Mode334

OmniPod 5 - AUTOMATED MODE; 21 About Automated Mode; 22 Switching Between Manual Mode and Automated Mode; 23 Activity Feature

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