® Omnipod 5 Automated Insulin Delivery System User Guide Insulet Corporation 100 Nagog Park Acton, MA 01720 1-800-591-3455 | 1-978-600-7850 omnipod.com Pod shown without the necessary adhesive. User Guide Omnipod 5 Automated Insulin Delivery System ® FCC ID: #TBD Controller # TBD FCC ID: #TBD Pod © 2020 Insulet Corporation. Omnipod and the Omnipod logo are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.
Omnipod® 5 Automated Insulin Delivery System User Guide Contacts and Important Information Customer Care 1-800-591-3455 — 24 hours/7 days 1-978-600-7850 when calling from outside the United States of America Customer Care Fax: 877-467-8538 Website: omnipod.
© 2021 Insulet Corporation. Insulet, Omnipod, the Omnipod logo, are trademarks or registered trademarks of Insulet Corporation. All rights reserved. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. All other trademarks are the property of their respective owners. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation.
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. . . . . . . . . . . . . . . . . . . . . . .
Contents 6.1. 6.2. 6.3. 6.4. 6.5. Reviewing All Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Creating New Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Editing or Renaming a Basal Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79 Deleting a Basal Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Switching to a Different Basal Program. . . . .
Contents Chapter 13: About the Dexcom G6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127 13.1. CGM Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 13.2. CGM Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 13.3. Using the Dexcom G6 with Omnipod 5. . . . . . . . . . . . . . . . . . . . . . . . . 130 13.4. CGM Values. . . . . . . . . . . . . . . . . . .
Contents Section 7: Notifications and Troubleshooting 185 Chapter 20: Alarms, Action and Reminder Notifications . . . . . . . . . . . . . . . 187 20.1. Notifications and Alarms Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 20.2. Types of Alarms and Notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 20.3. Priority and Predictability of Alarms and Notifications . . . . . . . . . 191 20.4. Sounds and Vibrations . . . . . . . . . . . . .
Contents Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287 Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311 Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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BEFORE YOU BEGIN 1 Introduction 2 System Terminology and Navigation 3 Omnipod 5 System Overview Effective Date: 22DEC2020, PCO-000267
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Before You Begin Chapter 1: Introduction Contents 1.1. Welcome to your Omnipod® 5 System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.2. About this User Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.3. Indications for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for use. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 Introduction Before You Begin 1.1. Welcome to your Omnipod® 5 System The Omnipod® 5 System is the first wearable, on-body, tubeless automated insulin delivery system. The Omnipod 5 System consists of a tubeless insulin Pod, the Omnipod® 5 app, and the Dexcom G6® Continuous Glucose Monitoring System. The Omnipod 5 System continuously adapts and automatically delivers insulin to your personal needs.
Introduction 1 Before You Begin exercise. When HypoProtect is activated, the system gives less basal insulin and aims for a Target Blood Glucose of 150 mg/dL. • Bolus Calculator: If your glucose level is high or if you are planning to eat, the Bolus Calculator can suggest a bolus amount of insulin based on your individual settings, entered values, and CGM trend when available. The Bolus Calculator allows for the immediate delivery of the bolus insulin in both Automated and Manual Mode.
1 Introduction Before You Begin 1.2. About this User Guide Caution: This User Guide is intended for use only with the Insulet-provided controller with the Omnipod 5 app, model PDM-USA-H001-MG, or the Omnipod 5 app on a compatible smartphone. To learn which version of the Insulet-provided controller you have, turn it over. If you see "PDM-USA-H001MG" on the back of the controller, this is the correct User Guide. If you do not see it, call Customer Care.
The Omnipod 5 Application and Omnipod 5 Algorithm are indicated for use with NovoLog, Humalog, Admelog, and Apidra U-100 insulin. The Omnipod 5 Bolus Calculator is a decision-support software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin.
1 Introduction Before You Begin 1.4. General Warnings and Safety Information Warning: The Omnipod 5 System is designed to use rapid-acting U100 insulin. The following U-100 rapid-acting insulin analogs have been tested and found to be safe for use in the Pod: NovoLog® (insulin aspart), Humalog® (insulin lispro), Admelog® (insulin lispro), and Apidra® (insulin glulisine). NovoLog, Humalog, and Admelog are compatible with the Omnipod 5 System for use up to 72 hours (3 days).
Introduction 1 Before You Begin Warning: If you are having symptoms that are not consistent with your blood glucose test results and you have followed all instructions described in this User Guide, contact your healthcare provider. Warning: The Omnipod 5 System should NOT be used at low atmospheric pressure (below 700 hPA). You could encounter such low atmospheric pressures at high elevations, such as when mountain climbing or living at elevations above 10,000 feet (3,000 meters).
1 Introduction Before You Begin Potential risks • The Omnipod 5 System uses CGM values and trends to calculate insulin delivery. If the CGM values are inaccurate, the System could deliver an inaccurate dose of insulin which could result in hypoglycemia or hyperglycemia. • Wearing a Pod might cause infection. Be aware of signs of infection including: bleeding, pain, and skin irritation including redness. See your healthcare provider if irritation occurs.
• Phone numbers for your healthcare provider and/or physician in case of an emergency • Glucagon kit and written instructions for administering glucagon dosage if you are unconscious (see "24.4. Avoiding Lows, Highs, and Diabetic Ketoacidosis" on page 276) Before You Begin Introduction 1 Tip: Ask your healthcare provider to help you develop plans for handling emergency situations, including what to do if you cannot reach your healthcare provider.
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Before You Begin Chapter 2: System Terminology and Navigation Contents 2.1. Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2.2. Using the Touchscreen and Entering Information. . . . . . . . . . . . . . . . . . 16 Touchscreen basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Tapping and swiping. . . . .
2 System Terminology and Navigation Before You Begin 2.1. Terminology Term Description Activation The process of waking up a Pod and setting up exclusive communication with the Omnipod 5 app that woke it up. Insulin delivery, in units per hour, that is calculated by Omnipod 5 to keep your blood glucose within your desired range. This amount changes over time based on your history, CGM value, and trend.
CGM transmitter Component of a CGM that sends CGM values to the Pod. CGM value Glucose level measured by a CGM. CGMs send the current glucose value with a "trend arrow" which indicates whether your glucose values are going up, down, or remaining steady. Connecting In Omnipod 5, "connecting" refers to setting up wireless communication between system components. Omnipod 5 uses Bluetooth® wireless technology to communicate with your Pod.
2 System Terminology and Navigation Before You Begin Ketoacidosis (Diabetic ketoacidosis, or DKA) Ketones Manual bolus Manual Mode Microbolus Omnipod 5 algorithm Omnipod 5 application (app) Units Diabetic ketoacidosis (DKA) is a serious condition in which extremely high blood glucose levels and a severe lack of insulin cause the body to break down fat for energy. The breakdown of fat releases ketones into the blood and urine.
System Terminology and Navigation 2 Before You Begin Touchscreen basics The Omnipod 5 app displays messages and options for you on its touchscreen. Tapping and swiping The basic instructions for interacting with the touchscreen are explained here. Tap Touch the screen, then lift your finger up. Swipe Touch a starting point and move your finger up, down, left, or right. Note: Scrolling and swiping are related actions.
2 System Terminology and Navigation Before You Begin Entering numbers and text Tapping in an editable field can bring up a keypad or number pad.
Using a scroll wheel Tapping an editable field can bring up a scroll wheel. Place your finger on the scroll wheel. Swipe up or down to select your desired value. The faster you move your finger, the faster the wheel will scroll. Before You Begin System Terminology and Navigation 2 When your desired selection is shown in the center of the wheel, select the value by tapping it or by tapping outside the scroll wheel. Using a slider Use sliders to select a value from a scale.
2 System Terminology and Navigation Before You Begin Navigation icons and navigation shorthand Options icon The Options icon ( ) appears on the right side of certain lists. Tapping the Options icon brings up a list of options relevant to the item on that row. User Guide navigation shorthand The User Guide uses the ">" symbol to indicate navigating from one screen to another. For example: • Menu icon ( ) > Pod > CHANGE POD tells you to: 1. Tap the Menu icon ( ) in the upper left of the Home screen. 2.
Before You Begin Chapter 3: Omnipod 5 System Overview Contents 3.1. Omnipod 5 App and Dexcom Communication. . . . . . . . . . . . . . . . . . . . . 22 3.2. Omnipod 5 App. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 The Omnipod 5 controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 3.3. Status Bar. . . . . . . . . . . . . . . . . . . . . . .
3 Omnipod 5 System Overview Before You Begin Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Action Item notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Reminder notifications. . . . . . . . . . . . . . . .
Omnipod 5 System Overview 3 Before You Begin 3.2. Omnipod 5 App You use the Omnipod 5 app to control and monitor the Pod's operations using Bluetooth® wireless technology. You can use the provided controller or a compatible smartphone with the Omnipod 5 app. Note: The Omnipod 5 app does not need to be near the Pod for the system to deliver your basal program in Manual Mode or to deliver automated basal in Automated Mode.
3 Omnipod 5 System Overview Before You Begin 3.3.
Omnipod 5 System Overview 3 Before You Begin 3.4. Controller Lock Screen and Security After you set up your provided controller, the Lock and PIN screens appear whenever you wake up your controller. The Lock and PIN screens help confirm that you are using the correct controller.
3 Omnipod 5 System Overview Before You Begin Once you begin using your controller, do not turn the power off. The controller can sound an alarm only when powered on and with sound enabled. The Pod will alarm regardless of the state of the controller. Forgot your PIN? If you have problems with your PIN, call Customer Care. For contact information, see the Customer Care card at the front of this User Guide.
Omnipod 5 System Overview 3 Before You Begin 3.5. Home Screen This section introduces you to what you may see on the Omnipod 5 app Home screen. Different information will display depending on which system mode is activated. Alarms and Notifications Status bar Menu icon Current System Mode Tab Views Tab View Display; information will vary based on the selected Tab View.
3 Omnipod 5 System Overview Before You Begin DASHBOARD tab The DASHBOARD tab displays the following information. Note: The DASHBOARD tab shows different content if a CGM transmitter is paired to the Omnipod 5 app. Without paired CGM transmitter • INSULIN ON BOARD (IOB): value displays when IOB is available. • INSULIN ON BOARD (IOB): displays as dashes when IOB is unavailable or there is no Pod communication. Tap MORE INFORMATION for possible reasons.
Omnipod 5 System Overview 3 • INSULIN ON BOARD (IOB) • CGM value (with trend arrow): when a CGM value is available. See "13.5. CGM Trend Arrows" on page 131. • CGM value (without arrow): when transmitter supplies a CGM value but is unable to report CGM trend. • HIGH: when CGM value received from your CGM transmitter is greater than 400. See "13.4. CGM Values" on page 130. • LOW: when CGM value received from your CGM transmitter is less than 40. See "13.4. CGM Values" on page 130.
3 Omnipod 5 System Overview Before You Begin INSULIN tab The INSULIN tab label changes to PROTECT when HypoProtect™ is running in Automated Mode or to TEMP ON when a temp basal is running in Manual Mode. Manual Mode By default, in Manual Mode, the INSULIN tab shows the name and graph of the user-defined Basal Program. A label below the Basal Program's name indicates whether the listed Basal Program is: • In Progress—This program is running on the active Pod.
Omnipod 5 System Overview 3 Before You Begin Temp basal If a temp basal is running, the INSULIN tab label changes to TEMP ON and is highlighted in green. It displays the temp basal graph and allows you to cancel the temp basal. See"7.1. About Temporary Basal Rates" on page 82. Automated Mode In Automated Mode, the INSULIN tab shows AUTOMATED MODE: ACTIVE and displays LAST BOLUS and CGM INFO. For more information on using Automated Mode, see"Section 5: Automated Mode" on page 133.
3 Omnipod 5 System Overview Before You Begin POD INFO tab The POD INFO tab shows whether there is an active Pod, and, if so, how much insulin is left in the Pod and when the Pod will expire. If the Omnipod 5 app cannot communicate with an active Pod, the POD INFO tab says "No Pod Communication." Tap MORE INFORMATION for details. Note: When there is no communication, the Pod continues delivering insulin according to the instructions it was given.
Omnipod 5 System Overview 3 Before You Begin POD INFO Banners When your Pod will expire soon, a yellow CHANGE POD SOON banner appears on the POD INFO tab. The yellow banner appears 12 hours before Pod expiration or at the time of your Pod expiration reminder, whichever is earlier. At six hours before Pod expiration, a red CHANGE POD banner appears on the POD INFO tab. When less than 5 units of insulin remain in the Pod, a red LOW POD INSULIN banner appears on the POD INFO tab.
3 Omnipod 5 System Overview Before You Begin Bolus information and button The lower left section of the Home screen displays bolus information. The Bolus icon is at the bottom. Between boluses When a bolus is not being delivered, the section is labeled LAST BOLUS and shows the amount and time of the most recent bolus.
3.6. Home Screen Main Menu The Main Menu on the Home screen lets you access most of the Omnipod 5 app's functions. To access the Main Menu: • Tap the Menu icon ( ) in the upper left corner of the Home screen. Before You Begin Omnipod 5 System Overview 3 or • Place your finger on the far left side of the Omnipod 5 app, and swipe right across the screen. Swipe left to hide the Menu. Tap an option on the Menu to bring up the related screen. Tip: The Menu extends beyond the bottom of the screen.
3 Omnipod 5 System Overview Before You Begin About screen The About screen displays details about your Omnipod 5 System, such as the Omnipod 5 application version number, the Customer Care phone number, the controller serial number, the Pod version number, the time of the most recent Omnipod 5 app-Pod communication, and other controller and legal information. 3.7. Notifications and Messages The Omnipod 5 app can deliver Omnipod 5 notifications and confirmation messages.
Action Item notifications Action item notifications (see page 205) are tasks that should be responded to as soon as possible. Action item notifications are related to changes you may have made to your Omnipod 5 app that could affect safe use of the system. For example, a Turn on Bluetooth action item means your Bluetooth has been shut off and your app is no longer communicating with your Pod.
3 Omnipod 5 System Overview Before You Begin 3.8. Manual and Automated Mode Overview Available tasks in each mode The following table defines the tasks that can be performed in Manual Mode and Automated Mode. Note: A ✓ in the field indicates the task can be performed in the specified mode. A blank field indicates the task cannot be performed in the specified mode.
Omnipod 5 System Overview 3 Before You Begin Identifying system modes The mode indicator shows Omnipod 5 System's current operating mode. Graphic Description Displays when there is no Pod communication or no active Pod. Displays when the Omnipod 5 System is in Automated Mode and the Pod is providing automated insulin delivery. Displays when the Omnipod 5 System is in Automated Mode: Limited state. The most common reason is that the Pod is not receiving CGM values.
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STARTING OMNIPOD 5 4 Setting Up Your Omnipod 5 Application 5 Activating and Changing Your Pod Effective Date: 22DEC2020, PCO-000267
