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trademarks or registered trademarks of Insulet Corporation in the United States

e Bluetooth® word mark and logos are registered trademarks owned by

Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under

licence.

All other trademarks are the property of their respective owners. e use of third-

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Patent information at www.insulet.com/patents.

PT-001298-AW REV 001 12/22

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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 - Page 2

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