OmniPod 5 Manual

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Omnipod®5 Automated Insulin Delivery System Technical User Guide
Contacts and Important Information
Customer Care - 24 hours/7 days
Website: omnipod.com
Address: Insulet Corporation, 100 Nagog Park, Acton MA 01720
Controller Model: PDM-M001-G-XX
Serial Number:
Controller FCC ID: 2ADINN5004L
Controller FCC ID: 2ADINN5004LR1
Pod FCC ID: RBV-029
Pod FCC ID: RBV-029C
Omnipod® 5 Automated Insulin Delivery System
Start Date:
Name
Street Address
City County Post Code
Phone
Email
Healthcare Provider
Name
Street Address
City County Post Code
Phone
Policy Number
Health Insurance
Name
Street Address
City County Post Code
Phone
Email
Omnipod® Trainer
Name
Street Address
City County Post Code
Phone
Email
Pharmacy

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© 2022 Insulet Corporation. Insulet, Omnipod and the Omnipod logo are
trademarks or registered trademarks of Insulet Corporation in the United States
and other various jurisdictions. All rights reserved.
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-
party trademarks does not constitute an endorsement or imply a relationship or
other aliation.
Patent information at www.insulet.com/patents.
PT-001298-AW REV 001 12/22

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Contents
Section 1: Before You Begin 1
Chapter 1: Introduction ..................................................3
1.1. Welcome to Your Omnipod® 5 System ................................4
1.2. About This User Guide .................................................6
1.3. Indications For Use .....................................................6
1.4. Compatible Insulins ....................................................7
1.5. General Warnings ......................................................7
1.6. General Precautions..................................................11
Section 2: Omnipod 5 Pump Features 15
Omnipod 5 Pump Important Safety Information .......................17
Chapter 2: SystemTerminology and Navigation ........................25
2.1. Terminology ..........................................................26
2.2. Using the Touchscreen and Entering Information...................29
Chapter 3: Omnipod 5 System Overview................................33
3.1. Omnipod 5 App and Dexcom Communication .....................34
3.2. Omnipod5 App ......................................................35
3.3. Lock Screen and Security ............................................36
3.4. Status Bar .............................................................38
3.5. Home Screen .........................................................39
3.6. Home Screen Main Menu............................................47
3.7. Notications and Messages..........................................48
3.8. Manual and Automated Mode Overview ...........................49
Chapter 4: Setting Up Your Omnipod 5 Application .....................53
4.1. Setting Up Your Account .............................................54
4.2. Preparing for Your Training...........................................54
4.3. General Settings on the Insulet-provided Controller ................55
4.4. Basal Settings.........................................................60
4.5. Bolus Settings ........................................................64
4.6. Your App Set-up is Complete ........................................68
4.7. Saving Your Settings for Reference ..................................69
Chapter 5: Activating and Changing Your Pod ..........................71
5.1. Beginning the Pod Activation Process ...............................72
5.2. Setting Up a New Pod................................................74
5.3. Fill the Syringe with Insulin...........................................74
5.4. Filling, Activating, Applying and Starting the Pod ...................75

Contents
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Contents
5.5. Checking Your Infusion Site ..........................................83
5.6. Switching to Automated Mode......................................84
5.7. Deactivating an Active Pod ..........................................85
5.8. More Information about Pod Use....................................86
Chapter 6: Basal Programmes...........................................89
6.1. About Basal Programmes ............................................90
6.2. Reviewing All Basal Programmes ....................................90
6.3. Creating New Basal Programmes....................................91
6.4. Editing a Basal Programme ..........................................91
6.5. Deleting a Basal Programme.........................................92
6.6. Switching to a Dierent Basal Programme ..........................92
6.7. Basal Insulin Delivery.................................................93
Chapter 7: Temporary Basal Rates and Presets ..........................95
7.1. About Temporary Basal Rates........................................96
7.2. Starting a Temp Basal ................................................97
7.3. Cancelling a Temp Basal or Temp Basal Preset.......................99
7.4. Creating a New Temp Basal Preset...................................99
7.5. Editing a Temp Basal Preset .........................................100
7.6. Deleting a Temp Basal Preset .......................................101
7.7. Temporary Basal Rates Delivery.....................................101
Chapter 8: Blood Glucose Readings ................................... 105
8.1. About Blood Glucose Readings.....................................106
8.2. Entering Your Blood Glucose Reading ..............................107
8.3. High and Low Blood Glucose Readings ............................108
Chapter 9: Pausing and Starting Insulin Delivery...................... 111
9.1. Pausing Insulin Delivery.............................................112
9.2. Methods to Temporarily Pause Insulin Delivery in Manual Mode..113
9.3. Starting Insulin Delivery.............................................114
Chapter 10: Changing Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
10.1. General Settings ...................................................116
10.2. Reminder Settings .................................................120
10.3. Basal and Temp Basal Settings.....................................123
Chapter 11: Browsing Your History and Records ...................... 125
11.1. About Your Recent History and Past Records .....................126
11.2. Viewing the Sensor Graph .........................................126
11.3. Sensor Graph States ...............................................127
11.4. History Information Overview.....................................129
11.5. Calculations for History Summaries ...............................132
11.6. History Details Section.............................................133

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ContentsContents
Chapter 12: Managing Software Updates ............................. 139
12.1. Insulet-provided Controller .......................................140
Chapter 13: Alarms, Action and Reminder Notications .............. 143
13.1. Types of Alarms and Notications .................................145
13.2. Alarms and Notications Screen ..................................146
13.3. Sounds and Vibrations ............................................147
13.4. Informational Sounds and Vibrations .............................148
13.5. Responding to Alarms .............................................150
13.6. Hazard Alarm List ..................................................152
13.7. Advisory Alarm List ................................................160
13.8. Action Item Notication List .......................................165
13.9. Silencing Unresolved Alarms ......................................173
13.10. Responding to Reminder Notications ..........................174
13.11. Reminder Notications List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175
Chapter 14: Taking Care ofYour Controller and Pod ................... 177
14.1. Pod and Insulin Storage and Care .................................178
14.2. Controller Storage and Care .......................................179
14.3. Controller Battery Care.............................................182
Chapter 15: Living with Diabetes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
15.1. Infusion-Site Checks ...............................................186
15.2. Being Aware of Your Glucose ......................................187
15.3. Travelling and Holidays ............................................188
15.4. Avoiding Lows, Highs and Diabetic Ketoacidosis .................190
15.5. Handling Special Situations .......................................198
Section 3: SmartBolus Calculator 201
SmartBolus Calculator Important Safety Information................. 203
Chapter 16: Delivering a Bolus ........................................ 205
16.1. Delivering a Manual Bolus .........................................206
16.2. Delivering Immediate and Extended Boluses.....................207
16.3. Tracking the Progress of a Bolus ...................................208
16.4. Cancelling a Bolus in Progress .....................................209
16.5. Reminder Settings .................................................210
Chapter 17: Delivering a Bolus with the SmartBolus Calculator ....... 213
17.1. About the SmartBolus Calculator .................................214
17.2. Entering Meal Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216
17.3. Entering a Blood Glucose Reading or Using a
Sensor Glucose Value ..............................................216
17.4. Insulin On Board (IOB) .............................................218

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Contents
17.5. Adjustments toYour Calculation ..................................219
17.6. Delivering an Immediate Bolus....................................219
17.7. Delivering an Extended Bolus .....................................220
17.8. Bolus Settings ......................................................222
Chapter 18: Understanding SmartBolus Calculator Calculations...... 227
18.1. The SmartBolus Calculator.........................................228
18.2. SmartBolus Calculator Examples ..................................240
Section 4: Using a Sensor with Omnipod 5 243
Sensor Important Safety Information................................. 245
Chapter 19: About the Dexcom G6 .................................... 247
19.1. Dexcom G6 Overview .............................................248
19.2. Dexcom G6 Sensor Placement ....................................249
19.3. Using the DexcomG6 with Omnipod 5 ...........................250
19.4. Sensor Glucose Values .............................................251
19.5. Sensor Glucose Trend Arrows......................................252
19.6. Communication Messages ........................................253
Chapter 20: Connecting Dexcom G6 to the Pod ....................... 255
20.1. About Connecting DexcomG6 to the Pod........................256
20.2. Connecting the DexcomG6 during Initial Pod Set-up............256
20.3. Connecting the DexcomG6 Transmitter ..........................257
20.4. Disconnecting the Transmitter from the Pod .....................258
Section 5: Automated Mode 259
Automated Mode Important Safety Information ..................... 261
Chapter 21: About Automated Mode ................................. 263
21.1. About Automated Mode ..........................................264
21.2. About the DexcomG6 in Automated Mode ......................267
21.3. Bolus Settings and the Importance of a Bolus ....................268
21.4. Pod Adaptivity .....................................................268
21.5. About Automated Mode: Limited.................................269
21.6. Automated Delivery Restriction ...................................271
Chapter 22: Switching Between Manual Mode and Automated Mode 273
22.1. Switching from Manual Mode to Automated Mode..............274
22.2. Switching from Automated Mode to Manual Mode..............276
Chapter 23: Activity Feature .......................................... 277
23.1. About the Activity Feature.........................................278
23.2. Starting the Activity Feature .......................................279

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ContentsContents
23.3. Cancelling the Activity Feature ....................................279
Chapter 24: Automated Mode Alarms ................................ 281
24.1. Advisory Alarm List ................................................282
Chapter 25: Omnipod 5 Clinical Studies............................... 285
25.1. Studies in Children, Adolescents and Adults with
Type 1 Diabetes ...................................................286
25.2. Studies in Very Young Children with Type 1 Diabetes ............300
Section 6: Additional Information 309
Chapter 26: Troubleshooting ......................................... 311
26.1. Omnipod 5 Pump FAQs ...........................................312
26.2. SmartBolus Calculator FAQs .......................................316
26.3. Sensor FAQs........................................................317
26.4. Automated Mode FAQs............................................322
26.5. Pod Communication Issues –“Try Again”. . . . . . . . . . . . . . . . . . . . . . . . . .323
26.6. About Keeping Your Omnipod 5 Controller Nearby ..............325
26.7. Device Complaints.................................................325
26.8. Boot Mode .........................................................326
Appendix ............................................................. 327
Index ................................................................. 351
My Settings ........................................................... 356

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BEFORE YOU BEGIN
1 Introduction

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