1 Browsing Your History and Records Glucose Goal Range The goal of using the Omnipod 5 System is to keep your glucose within your Glucose Goal Range. You define this range by setting the upper and lower limits. The CGM Graph and the Enter BG screen use the Glucose Goal Range to determine which glucose readings are within your goal and which are above or below your goal. Note: The Glucose Goal Range does not impact insulin delivery. To set the upper and lower limit of your Glucose Goal Range: 1.
Browsing Your History and Records 11 You may need to scroll up or down to see all of the calculations. Tap CLOSE when done (see "18.1. The SmartBolus Calculator" on page 254 for details). • The amount originally scheduled for delivery if you canceled an immediate bolus. • For an extended bolus, the amount delivered now and extended, and the percentage (%) of the meal bolus delivered now and extended. • If a bolus is ongoing, unconfirmed, or lost, how much of the bolus has been confirmed.
11 Browsing Your History and Records Note: If you have an unconfirmed bolus, the SmartBolus Calculator is disabled for the duration of insulin action. Pod Details A Pod icon and banner mark the activation and deactivation (or discarding) of each Pod. Tapping a Pod banner displays the Pod's lot number and sequence number. Carbs Details A carbs icon ( ) is displayed next to carbohydrate entries used by the SmartBolus Calculator.
Browsing Your History and Records 11 Basal rate at midnight The first entry for each day is a banner displaying the status of the basal insulin delivery at midnight. If a Basal Program, temp basal, or use of the Activity feature was carried over from the day before, the banner indicates that this is a continued program. If insulin was paused at midnight, the banner states this. Insulin Paused and Started Details An Insulin Delivery Paused icon and banner indicate the time an insulin paused period began.
11 Browsing Your History and Records Automated Events (Auto Events) Tap AUTO EVENTS on the history screen to display the amount of insulin delivered at each 5-minute period while in Automated Mode. A system mode icon and banner show the time the system switched to Automated Mode or to Manual Mode.
CHAPTER 12 Managing Software Updates Contents 12.1. Insulet-provided Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Operating System (OS) Update. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Omnipod 5 App Update on the Controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 12.2. Omnipod 5 App on Smartphone . . . . . . . . . . . . . . . .
12 Managing Software Updates 12.1. Insulet-provided Controller When connected to a network, the Omnipod 5 Controller offers over-the-air updates when a software update is available. There are two types of updates for the Omnipod 5 Controller: OS (Operating System) updates and Omnipod 5 App updates. OS update refers to updating the operating system of the Controller. Omnipod 5 App update refers to updating the Omnipod 5 App on the Controller.
Managing Software Updates 12 If the update is not considered required, you may select Not Now to delay the update to a later time; however, it is recommended that you update the OS as soon as the update is available. If you choose to postpone an optional update, you can manually update at any time. After 72 hours have passed, you will receive a notification every 24 hours reminding you to update. To manually update the operating system of the Controller: 1.
12 Managing Software Updates 5. Tap Update Now. Once the update is complete, a confirmation screen displays to inform you that the update was completed successfully. 12.2. Omnipod 5 App on Smartphone The Omnipod 5 App offers updates through Google Play. You will be notified when an update is available for download. You will not be able to navigate in the Omnipod 5 App during an update; however, your insulin therapy will not be impacted.
Managing Software Updates 12 5 App as soon as the update is available. If you choose to postpone an optional update to a later time, you can manually update the Omnipod 5 App at any time. After 72 hours have passed, you will receive a notification every 24 hours reminding you to update your Omnipod 5 App. To manually update your Omnipod 5 App: 1. Ensure your phone battery is charged to above 15%. 2. Navigate to your list of apps in Google Play. 3. Tap Update next to the Omnipod 5 App.
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CHAPTER 13 Alarms, Action and Reminder Notifications Contents 13.1. Types of Alarms and Notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 13.2. Alarms and Notifications Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156 13.3. Sounds and Vibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 157 Pod alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms, Action and Reminder Notifications 13.8. Action Item Notification List. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 App Use Blocked. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176 Attention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms, Action and Reminder Notifications 13 13.1. Types of Alarms and Notifications Warning: ALWAYS contact Customer Care if your Omnipod 5 System Controller is damaged and not working properly. If a Controller replacement is needed, ALWAYS consult with your healthcare provider to get instructions on using other backup insulin delivery methods, like insulin injections. Be sure to check your glucose frequently.
13 Alarms, Action and Reminder Notifications hazard alarm that most recently occurred will be displayed first on the Omnipod 5 App. Any Pod hazard alarms will be sounded on the Pod. • • Advisory alarms are low-priority alarms that indicate that a situation exists that needs your attention. Advisory alarms will repeat every 15 minutes until acknowledged (see Alarm tables for additional details) and continue on the Pod until acknowledged in the Omnipod 5 App. See "13.7. Advisory Alarm List" on page 171.
Alarms, Action and Reminder Notifications 13 3. When finished, tap the back arrow to exit ( ). Unread notifications have colored icons described in "13.1. Types of Alarms and Notifications" on page 155. Note: When a notification has been displayed on this screen, and you have exited by tapping the back arrow ( ), the icon for those notifications will be gray the next time you view this screen. 13.3.
13 Alarms, Action and Reminder Notifications • To turn vibrations ON, press and hold the lower end of the Sound/vibrate button until the vibrate icon ( ) appears on the screen. • To turn sound ON, press the upper end of the Sound/vibrate button until the sound icon ( ) appears on the screen. • To increase or decrease the volume, press the upper or lower end of the Sound/vibrate button.
Alarms, Action and Reminder Notifications 13 The Pod and the Omnipod 5 App can provide informational sounds (tones, beeps) or vibrations to let you know that normal activity between the Pod and the Omnipod 5 App is occurring as expected. See the tables below for descriptions of informational sounds you will encounter during use. Confidence reminders Cause Tones or vibrations let you know that your temp basals and boluses are working as expected. These reminders are ON by default.
13 Alarms, Action and Reminder Notifications Canceling temp basals and boluses Cause Tone informs you that the temp basal or bolus has been successfully canceled. You cannot turn these OFF. Omnipod 5 App No tone/vibration Pod Beeps once when you cancel a temp basal, bolus, or extended bolus. Pod activation / Pod deactivation Cause Tones or vibrations occur at various times during the Pod activation process to indicate progress. You cannot turn these OFF.
Alarms, Action and Reminder Notifications 13 important safety alarms. You cannot use the App until Do Not Disturb permission is provided and Notifications is turned ON. To respond to a hazard alarm or advisory alarm: 1. Wake up your Controller or smartphone. The Lock screen shows an alarm message along with the hazard alarm ( ) icon or advisory alarm ( ) icon. 2. After unlocking your Omnipod 5 App, follow the on-screen instructions or see the individual alarm details starting on page 162.
13 Alarms, Action and Reminder Notifications Check alarms Before you begin, switch to Manual Mode if currently using Automated Mode. See "22.2. Switching from Automated Mode to Manual Mode" on page 300. Note: Your Controller or smartphone sound settings must be ON to hear a tone on the Omnipod 5 App. To verify that your Omnipod 5 App and Pod's alarms and vibration functions are working properly, test them as follows: 1. Navigate to: Menu button ( ) > Settings > General > Check Alarms. 2.
Alarms, Action and Reminder Notifications 13 13.6. Hazard Alarm List Warning: ALWAYS respond to Hazard Alarms as soon as they occur. Pod Hazard Alarms indicate that insulin delivery has stopped. Failure to respond to a Hazard Alarm could result in under-delivery of insulin which can lead to hyperglycemia. Hazard alarms make you aware of serious situations. Always respond to a hazard alarm immediately. Some alarm messages give you a unique number called a reference number.
13 Alarms, Action and Reminder Notifications Omnipod 5 App Error Screen Alert Description Omnipod 5 App: Why it occurs: An unexpected error is detected in the Omnipod 5 App. Note: If your Omnipod App stops and restarts on its own, you may notice the app flashing white before this screen appears. Pod sound: None Controller/Smartphone sound and vibration: • 30 second tone • 30 second vibration • Vibration and tone repeat every 15 minutes until acknowledged What to do: 1.
Alarms, Action and Reminder Notifications 13 Omnipod 5 Memory Corruption Screen Alert Description Omnipod 5 App: Why it occurs: An unexpected error is detected in the Omnipod 5 App. Pod sound: None Controller/Smartphone sound and vibration: • 30 second tone • 30 second vibration • Vibration and tone repeat every 15 minutes until acknowledged What to do: 1. Tap OK to acknowledge the alarm and reset the Omnipod 5 App. 2. Remove your Pod. Lock Screen: 3. Call Customer Care immediately. 4.
13 Alarms, Action and Reminder Notifications Pod Error Caution: ALWAYS activate a new Pod in a timely manner. Waiting too long between Pod changes could result in under-delivery of insulin which can lead to hyperglycemia. If another Pod is not available, use a different insulin delivery method. Screen Alert Description Omnipod 5 App: Why it occurs: The Pod detects an unexpected error and insulin delivery has stopped.
Alarms, Action and Reminder Notifications 13 Pod Expired Caution: ALWAYS activate a new Pod in a timely manner. Waiting too long between Pod changes could result in under-delivery of insulin which can lead to hyperglycemia. If another Pod is not available, use a different insulin delivery method. Screen Alert Description Omnipod 5 App: Why it occurs: The Pod has reached the end of its operating life, and insulin delivery has stopped.
13 Alarms, Action and Reminder Notifications Pod Out of Insulin Caution: ALWAYS activate a new Pod in a timely manner. Waiting too long between Pod changes could result in under-delivery of insulin which can lead to hyperglycemia. If another Pod is not available, use a different insulin delivery method. Screen Alert Description Omnipod 5 App: Why it occurs: The Pod’s insulin reservoir is empty, and insulin delivery has stopped.
Alarms, Action and Reminder Notifications 13 Pod Shut-Off Caution: ALWAYS activate a new Pod in a timely manner. Waiting too long between Pod changes could result in under-delivery of insulin which can lead to hyperglycemia. If another Pod is not available, use a different insulin delivery method. Screen Alert Description Omnipod 5 App: Why it occurs: The Pod has stopped delivering insulin because you have set a Pod Shut-Off time and you did not respond to the Pod Shut-Off advisory alarm.
13 Alarms, Action and Reminder Notifications System Error Screen Alert Description Omnipod 5 App: Why it occurs: An unexpected error is detected in the Pod or the Omnipod 5 App. Pod sound: None Controller/Smartphone sound and vibration: • 30 second tone • 30 second vibration • Vibration and tone repeat every 15 minutes until acknowledged What to do: 1. Tap OK to acknowledge the alarm. 2. Remove your Pod. Lock Screen: 170 3. Call Customer Care immediately. 4. Check your blood glucose.
Alarms, Action and Reminder Notifications 13 13.7. Advisory Alarm List Caution: ALWAYS respond to Pod Expired, Low Pod Insulin, and Pod Shut-Off Advisory Alarms when they occur. These alarms escalate to Hazard Alarms if no action is taken. When Hazard Alarms occur, insulin delivery stops. Advisory alarms inform you of a situation that needs your attention in the near future.
13 Alarms, Action and Reminder Notifications Pod Expired Screen Alert Description Omnipod 5 App: Why it occurs: Your Pod will stop delivering insulin soon. Pod sound: • 8 beep tone • Tone issued once every 60 minutes starting after 72 hours of Pod life • After 79 hours of Pod life, tone is issued once every 5 minutes Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • Vibration and tone repeat every 15 minutes until acknowledged What to do: Lock Screen: 1.
Alarms, Action and Reminder Notifications 13 Pod Shut-Off Screen Alert Description Omnipod 5 App: Why it occurs: You have reached the Pod Shut-Off time you set. The Pod will stop delivering soon if you do not respond to this alarm.
13 Alarms, Action and Reminder Notifications Start Insulin Caution: ALWAYS tap START INSULIN to start insulin delivery after a pause period has ended during Manual Mode use. Insulin delivery does not automatically start after a pause. If you do not start insulin delivery, you could develop hyperglycemia. Screen Alert Description Omnipod 5 App: Why it occurs: The time period that you specified to pause insulin has passed. If you do not start insulin delivery, you could develop hyperglycemia.
Alarms, Action and Reminder Notifications 13 Urgent Low Glucose Warning: ALWAYS promptly treat low glucose. Glucose at or below 55 mg/ dL indicates significant hypoglycemia (very low glucose). If left untreated, this could lead to seizure, loss of consciousness or death. Follow your healthcare provider's recommendations for treatment. Screen Alert Description Omnipod 5 App: Why it occurs: Your glucose is at or below 55 mg/dL, according to what your CGM sent to the Omnipod 5 App.
13 Alarms, Action and Reminder Notifications 13.8. Action Item Notification List Action Item notifications are tasks that need your attention.
Alarms, Action and Reminder Notifications 13 Screen Alert Description Omnipod 5 App: Why it occurs: The installed version of the Omnipod 5 App is no longer supported for use. You will not be able to use the App until an update becomes available. This message may appear whether you have an active Pod or not. Pod sound: None Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. If you have an active Pod, tap DEACTIVATE POD.
13 Alarms, Action and Reminder Notifications Attention Screen Alert Description Omnipod 5 App: Why it occurs: Your smartphone's operating system has not been completely tested for use with the Omnipod 5 System. Pod sound: None Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: ¾ Tap OK. You may continue using the Omnipod 5 App on your device, as essential functions should not be affected.
Alarms, Action and Reminder Notifications 13 Connect to a Wireless Network 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.
13 Alarms, Action and Reminder Notifications Daylight Saving Time Change Caution: ALWAYS be aware of possible changes to your time zone when traveling. If you do not update your time zone, your insulin therapy will be delivered based on your old time zone which may cause disruptions in your insulin delivery schedule and inaccurate history logs. Talk to your healthcare provider about how to manage your insulin delivery while traveling between time zones.
Alarms, Action and Reminder Notifications 13 Device Has Been Modified Caution: DO NOT install apps on your smartphone from untrusted sources. These apps may contain malware that may impact use of the Omnipod 5 App. Install apps only from trusted sources (i.e. Google Play). If you do not know what an App is, do not install it, regardless of the source. It is not advised to install any app from a source other than Google Play on your smartphone that is running the Omnipod 5 App.
13 Alarms, Action and Reminder Notifications Screen Alert Description Omnipod 5 App: Why it occurs: You have modified your device and it is not safe to use with the Omnipod 5 App. Pod sound: None Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. Remove your Pod if you have an active Pod 2.
Alarms, Action and Reminder Notifications 13 Device Not Compatible Warning: You will NOT be able to use the Omnipod 5 App if: • You have not installed a required update to the Omnipod 5 App • An update for the Omnipod 5 App is not yet available to fix a known issue • Your smartphone device is no longer compatible with use of the Omnipod 5 App • The operating system of your smartphone has not yet been tested for safety by Insulet Use the Insulet-provided Controller or a different insulin delivery me
13 Alarms, Action and Reminder Notifications Not Enough Storage Screen Alert Description Omnipod 5 App: Why it occurs: You do not have enough available storage for the Omnipod 5 App to run on your smartphone. Your smartphone musthaveenoughstoragespacefortheOmnipod5App to work and save important information about your insulin therapy. Pod sound: None Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. Tap STORAGE when prompted. 2.
Alarms, Action and Reminder Notifications 13 Omnipod 5 Error Screen Alert Description Omnipod 5 App: Why it occurs: Your Omnipod 5 App has encountered a problem. Pod sound: None Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. Tap RESTART to restart your device.
13 Alarms, Action and Reminder Notifications Screen Alert Description Omnipod 5 App: Why it occurs: The Omnipod 5 App cannot be used on your device’s current operating system (OS). You will not be able to use the app until an update becomes available. This message may appear whether you have an active Pod or not. Pod sound: None Controller/Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. If you have an active Pod, tap DEACTIVATE POD. 2.
Alarms, Action and Reminder Notifications 13 Stop Optimizing Battery Usage Screen Alert Description Omnipod 5 App: Why it occurs: Battery optimization is an Android setting that limits what apps can do in the background in order to save battery life. You have turned ON battery optimization for the Omnipod 5 App on your smartphone. Battery optimization must be turned OFF in order for your Omnipod 5 App to communicate with the Pod every 5 minutes.
13 Alarms, Action and Reminder Notifications Turn Bluetooth ON Screen Alert Description Omnipod 5 App: Why it occurs: Bluetooth is turned OFF on your smartphone. Your Omnipod 5 App and Pod communicate via Bluetooth so Bluetooth must be turned ON. Pod sound: None Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: ¾ Tap TURN ON when prompted.
Alarms, Action and Reminder Notifications 13 Turn Do Not Disturb Access ON Screen Alert Description Omnipod 5 App: Why it occurs: Do Not Disturb access for the Omnipod 5 has been turned off. Pod sound: None Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. Tap NEXT and you will be directed to the Android list of applications 2. Find the Omnipod 5 App 3. Turn on Do Not Disturb Permission for the Omnipod 5 App 4.
13 Alarms, Action and Reminder Notifications Turn Lock Screen Security ON Screen Alert Description Omnipod 5 App: Why it occurs: Your lock screen security has been turned OFF. Pod sound: None Smartphone sound and vibration: • 3 second tone • 3 second vibration • No repetition What to do: 1. Tap SET UP. 2. Enable your passcode or another security method.
Alarms, Action and Reminder Notifications 13 Turn On Automatic Date and Time Screen Alert Description Omnipod 5 App: Why it occurs: You have turned OFF Automatic Date and Time in your smartphone settings. The Omnipod 5 App has many therapy-related actions that depend on time. Automatic Date and Time is a setting on your smartphone that ensures the accuracy of your time. The Omnipod 5 App uses the setting to detect if you have traveled to a different time zone.
