® 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. FCC ID: 2ADINN5004L Controller FCC ID: RBV-029 Pod Reference #: PDM-USA-H001-MG PT-000369-AW Rev.
Omnipod® 5 Automated Insulin Delivery System User Guide Contacts and Important Information Customer Care 1-800-591-3455 (24 hours/7 days) From Outside the US: 1-978-600-7850 Customer Care Fax: 877-467-8538 Address: Insulet Corporation 100 Nagog Park, Acton MA 01720 Emergency Services: Dial 911 (USA only; not available in all communities) Website: omnipod.
© 2022 Insulet Corporation. Insulet, Omnipod, the Omnipod logo, and SmartAdjust are trademarks or registered trademarks of Insulet Corporation. All rights reserved. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. Dexcom and Dexcom G6 are registered trademarks of Dexcom, Inc. and used with permission. All other trademarks are the property of their respective owners.
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 5.3. 5.4. 5.5. 5.6. 5.7. 5.8. Fill the Syringe with Insulin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Filling, Activating, Applying, and Starting the Pod . . . . . . . . . . . . . . . . . . . 84 Checking Your Infusion Site. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Switching to Automated Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Deactivating an Active Pod. . . . .
Contents 11.4. History Summary Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 11.5. Calculations for History Summaries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 11.6. History Details Section. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 Chapter 12: Managing Software Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 12.1.
Contents 17.1. 17.2. 17.3. 17.4. 17.5. 17.6. 17.7. 17.8. About the SmartBolus Calculator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240 Entering Meal Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .242 Entering a Blood Glucose Reading or Using a CGM Value. . . . . . . . 242 Insulin On Board (IOB) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244 Adjustments to Your Calculation. . . . . . . . . . .
Contents Chapter 23: Activity Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 301 23.1. About the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 302 23.2. Starting the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303 23.3. Canceling the Activity Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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BEFORE YOU BEGIN 1 Introduction
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CHAPTER 1 Introduction Contents 1.1. Welcome to Your Omnipod® 5 System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 The Omnipod 5 System Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Omnipod 5 SmartBolus Calculator Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Omnipod 5 SmartAdjust™ Technology Features. . . . . . . . . . . . .
1 Introduction 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 and the Omnipod® 5 App on an Insulet-provided Controller or installed on a compatible smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to your personal needs.
Introduction 1 Omnipod 5 SmartBolus Calculator Features • SmartBolus Calculator: If you are planning to eat or if your glucose is high, the SmartBolus Calculator can suggest a bolus amount of insulin based on your individual settings, entered values, and CGM value and trend when available. The SmartBolus Calculator allows for the immediate delivery of the bolus insulin in both Automated and Manual Mode. In Manual Mode, the SmartBolus Calculator also allows for an extended bolus.
1 Introduction 1.2. About This User Guide The purpose of this User Guide is to assist you with the features and functions of the Omnipod 5 System. It provides step-by-step instructions on how to properly operate the System, as well as important warnings and cautions to ensure your safety during use. Note: 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.
Introduction 1 SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust technology is intended for the management of type 1 diabetes mellitus in persons 6 years of age and older. SmartAdjust technology is intended for single patient use and requires a prescription.
1 Introduction 1.5. General Warnings Warning: Read all the instructions provided in this User Guide before using the Omnipod 5 System. Monitor your glucose with the guidance of your healthcare provider. Undetected hyperglycemia or hypoglycemia can result without proper monitoring. Warning: DO NOT start to use your system or change your settings without adequate training and guidance from your healthcare provider.
Introduction 1 Humalog, and Admelog are compatible with the Omnipod 5 System for use up to 72 hours (3 days). Follow your healthcare provider’s directions for how often to replace the Pod. Warning: AVOID administering insulin, such as by injection or inhalation, while wearing an active Pod as this could result in hypoglycemia. The Omnipod 5 System cannot track insulin that is administered outside of the system.
1 Introduction medical attention. If left untreated, these situations can quickly lead to diabetic ketoacidosis (DKA), shock, coma, or death. Warning: NEVER drive yourself to the emergency room if you need emergency medical care. Ask a friend or family member to take you to the emergency room or call an ambulance. Warning: ALWAYS be aware of your current CGM value, trust how your body feels, and do not ignore symptoms of high and low glucose.
Introduction 1 Warning: SmartAdjust technology should NOT be used by anyone under the age of 6 years old. SmartAdjust technology should also NOT be used in people who require less than 6 units of insulin per day as the safety of the technology has not been evaluated in this population. Warning: DO NOT use the Omnipod 5 System at low atmospheric pressure (below 700hPA).
1 Introduction 5 System with unauthorized devices could interrupt your insulin delivery and put your health and safety at risk. Caution: Connect ONLY to trusted Wi-Fi networks with your Controller or smartphone. AVOID connecting to public Wi-Fi networks, such as those found in airports, coffee shops, etc, as these networks are not secure and could result in exposing your Controller or phone to malware. DO NOT connect to public Wi-Fi networks during first-time setup of your Omnipod 5 System.
Introduction 1 those typically found on amusement park rides or flight take-off and landing, can affect insulin delivery, leading to possible hypoglycemia or injury. If needed, follow your healthcare provider's treatment instructions. 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 can lead to hypoglycemia or hyperglycemia. • Wearing a Pod might cause infection.
1 Introduction Emergency Kit Warning: ALWAYS keep an emergency kit with you to quickly respond to any diabetes emergency or in the case that your Omnipod 5 System stops working. Always carry supplies to perform a Pod change should you need to replace your Pod at any time. Warning: NEVER drive yourself to the emergency room if you need emergency medical care. Ask a friend or family member to take you to the emergency room or call an ambulance. Prepare an emergency kit to keep with you at all times.
OMNIPOD 5 PUMP FEATURES Omnipod 5 Pump Important Safety Information 2 System Terminology and Navigation 3 Omnipod 5 System Overview 4 Setting Up Your Omnipod 5 Application 5 Activating and Changing Your Pod 6 Basal Programs 7 Temporary Basal Rates and Presets 8 Blood Glucose Readings 9 Pausing and Starting Insulin Delivery 10 Changing Settings 11 Browsing Your History and Records 12 Managing Software Updates 13 Alarms, Action and Reminder Notifications 14 Taking Care of Your Controller and Pod 15 Living wit
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Omnipod 5 Pump Important Safety Information Pump Warnings Omnipod 5 System Settings and Training Warning: DO NOT start to use your system or change your settings without adequate training and guidance from your healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or underdelivery of insulin, which could lead to hypoglycemia or hyperglycemia.
Important Safety Information smartphone should be placed outside of the procedure room. Exposure to X-ray, MRI, or CT, treatment can damage these components. Check with your healthcare provider on Pod removal guidelines. Warning: DO NOT expose any Omnipod 5 System products or supplies to extreme temperatures as this results in them not functioning properly. Store all Omnipod 5 System products and supplies, including unopened Pods, in a cool, dry place.
Important Safety Information Omnipod 5 App fails to beep during a diagnostic test, call Customer Care immediately. Continuing to use the Omnipod 5 System in these situations may put your health and safety at risk. Warning: DO NOT expose a Pod to direct sunlight for long periods of time. Remove your Pod prior to using hot tubs, whirlpools, or saunas. These conditions could expose the Pod to extreme temperatures and may also affect the insulin inside the Pod which could lead to hyperglycemia.
Important Safety Information replacement is needed, ALWAYS consult with your healthcare provider to get instructions on using other backup insulin delivery methods, like insulin injections. Make sure to check your glucose frequently. result in under-delivery of insulin which can lead to hyperglycemia.
Important Safety Information you cannot check your glucose, waiting to treat symptoms could lead to severe hypoglycemia, which can lead to seizure, loss of consciousness, or death. Warning: ALWAYS promptly treat hyperglycemia (high glucose) according to your healthcare provider's recommendations. Symptoms of hyperglycemia include fatigue, thirst, excess urination, or blurry vision. If left untreated, hyperglycemia could lead to diabetic ketoacidosis (DKA), or death.
Important Safety Information your healthcare provider if you are unsure about how to set up the new device. If you are wearing a Pod and need to switch devices, you will need to deactivate your Pod and activate a new one, since the Pod cannot communicate with two devices at one time. If possible, wait to switch between devices until a scheduled Pod change.
Important Safety Information single use only and should only be used with the Omnipod 5 System. Failure to follow the instructions above may result in damage to your Pod. Caution: NEVER reuse the Pod or fill syringe or try to use a fill syringe that did not come with your Pod. Always dispose of the used Pod and fill syringe according to local disposal guidelines. Only use a new Pod with included fill syringe with each Pod change.
Important Safety Information becomes critically low, the Controller turns itself off, and you will not receive a low battery hazard alarm. Without the use of the Controller, you will not be able to make changes to your insulin delivery, which could result in the over-delivery or under-delivery of insulin that can lead to hypoglycemia or hyperglycemia. Caution: DO NOT expose your Controller battery to high heat [> 86ºF (> 30ºC) during storage and > 104ºF (>40ºC) during use].
Important Safety Information can be interrupted and may not be completed. "26.5. Pod Communication Issues – "Try Again"" on page 337. Caution: DO NOT delete the Omnipod 5 App while you have an active Pod, and DO NOT clear the Omnipod 5 App data. If you do, your Pod will remain active, but you will not be able to control your Pod even if you re-install or re-open the App. You must remove the Pod in order to stop receiving insulin.
Important Safety Information Android tools that limit sounds and notifications. If you do not hear alarms and notifications from your Controller or smartphone, you might not make the changes you need to make to your insulin therapy in a timely manner. Your Pod will still sound, and you will be able see the Alarm or Notification displayed on the Omnipod 5 App. See "13.3. Sounds and Vibrations" on page 157 to learn how to manage sounds and vibrations.
CHAPTER 2 System Terminology and Navigation Contents 2.1. Terminology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 2.2. Using the Touchscreen and Entering Information. . . . . . . . . . . . . . . . . . 31 Touchscreen Basics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Tapping and swiping. . . . . . . . . . .
2 System Terminology and Navigation 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 SmartAdjust™ technology to aim your glucose to your target. This amount changes over time based on your insulin delivery history.
System Terminology and Navigation 2 CGM (Continuous Glucose System to track glucose throughout the day and Monitor) night, supplied by a third-party medical device manufacturer. CGM sensor Component of a CGM that is inserted under the skin to measure glucose in interstitial fluid. CGM transmitter Component of a CGM that sends CGM values to the Pod. CGM value Glucose measured by a CGM. CGM values include trend, which indicates whether your glucose is going up, down, or remaining steady.
2 System Terminology and Navigation Hypoglycemia Low glucose. A lower-than-normal level of glucose in the blood; generally below 70 mg/dL. Hypoglycemia unawareness A condition in which a person does not feel or recognize the symptoms of hypoglycemia. Infusion site The place on the body where a Pod's cannula is inserted to deliver insulin. Insulin on board (IOB) Insulin that is still active (available to lower glucose) in the body.
System Terminology and Navigation Target Glucose Units 2 The user-customizable glucose target used by both SmartAdjust technology and the Omnipod 5 SmartBolus Calculator to calculate how much insulin you need based on both your manually entered blood glucose readings and the CGM values from your Dexcom G6. Target Glucose can be set from 110–150 mg/dL in 10 mg/dL increments. How insulin is measured. 2.2.
2 System Terminology and Navigation Entering Numbers and Text Tapping in an editable field can bring up a keypad or number pad.
System Terminology and Navigation 2 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. 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 Navigation Buttons and Navigation Shorthand Options button The Options button ( ) appears on the right side of certain lists. Tapping the Options button 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 button ( ) > Pod > CHANGE POD tells you to: 34 1. Tap the Menu button ( ) in the upper left of the Home screen.
CHAPTER 3 Omnipod 5 System Overview Contents 3.1. Omnipod 5 App and Dexcom Communication. . . . . . . . . . . . . . . . . . . . . 36 3.2. Omnipod 5 App. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 The Omnipod 5 Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 3.3. Lock Screen and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 Omnipod 5 System Overview Action Item notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Reminder notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Status. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Omnipod 5 System Overview 3 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. Caution: AVOID leaving your Controller or smartphone in a place that would prevent you from hearing alarms and notifications from your Omnipod 5 App.
3 Omnipod 5 System Overview 3.3. Lock Screen and Security Warning: ALWAYS identify the Omnipod 5 App as yours before using it. Using someone else's Omnipod 5 App can result in incorrect insulin delivery for both of you. Warning: ALWAYS keep your smartphone or Controller safe and within your control to ensure others cannot make changes to your insulin therapy.
Omnipod 5 System Overview 3 Caution: ONLY press the Power button on the Controller for less than 1 second or you may accidentally turn the power off. If the Controller displays a message asking if you would like to "Power Off", tap outside the message to cancel the message. If you accidentally power off your Controller, you can miss important notifications and alarms from the Omnipod 5 App.
3 Omnipod 5 System Overview 3.4. Status Bar At the top of the screen is a status bar that shows icons for both the Omnipod 5 App and your Controller or smartphone.
Omnipod 5 System Overview 3 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 button Current System Mode Tab Views Tab View Display; information will vary based on the selected Tab View.
