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Insulet Corporation 029D Omnipod 5 Pod

Insulet-Corporation-029D-Omnipod-5-Pod-PRODUCT

Product Specifications

  • Product Name: Omnipod 5 System
  • Mode: Manual Mode and Automated Mode
  • Display: Sensor Graph for glucose values
  • Indicator Colors: Blue for Manual Mode, Purple for Automated Mode (Limited state), Gray for Automated Mode (Limited state)
  • Supported Views: 3-hour, 6-hour, 12-hour, and 24-hour
  • Glucose Unit: mg/dL

Product Usage Instructions

  • Sensor Graph States
    • When using the Omnipod 5 System in Manual Mode, the mode indicator will be displayed in blue.
    • The sensor graph displays your most recent glucose values over different time periods (3, 6, 12, and 24 hours).
  • Current Status
    • Your current sensor glucose value, trend arrow, and current IOB are displayed.
  • Glucose Goal Range
    • The shaded area shows your Glucose Goal Range with Upper and Lower Limits set in Settings.
  • Target Glucose
    • The dashed green line represents the Target Glucose set in Settings. It may change when the Activity feature is enabled.
  • Event Area
    • The row below the graph indicates different events with color codes for various system states and actions taken.
  • View Selection
    • Use the buttons to select different time views: 3-, 6-, 12-, and 24-hours.
  • Vertical Axis and Time Scale
    • The vertical axis displays sensor glucose values in mg/dL, while the time scale shows hour and half-hour markings.
  • History Summary Section
    • The history section provides an overview of your past data including automated event details, glucose summary, and insulin/carb details.
  • Date Summary Section
    • Tap AUTO EVENTS to view automated event details.
  • Browsing History Records
    • Your history records are displayed starting with the newest records on top. Swipe to see expanded details of insulin and carb summaries.

FAQs

  • Q: How do I switch between Manual Mode and Automated Mode on the Omnipod 5 System?
    • A: To switch modes, go to the settings menu on the device and select the desired mode option.
  • Q: Can I customize my Glucose Goal Range and Target Glucose values?
    • A: Yes, you can customize these values in the Settings section of the Omnipod 5 System.

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Browsing Your History and Records 11

Sensor Graph States

When the Omnipod 5 System is in Manual Mode, the mode indicator is blue.

Insulet-Corporation-029D-Omnipod-5-Pod-FIG- (1)

1

6

2 7

3
4 8
5
The graph shows your most recent sensor glucose values over the last 3, 6, 12, and 24 hours .
Note: You can tap the ? symbol in the lower right hand corner to see a Legend of symbols used in the Sensor Graph .
1 . Current Status: Your current sensor glucose value and trend arrow display, along with the current IOB .
2 . Sensor Glucose Trend Line: Each dot on the graph represents a sensor glucose value . Plotted values are from 40­400 mg/dL .
3 . Glucose Goal Range: This shaded area shows your Glucose Goal Range . The yellow line shows the Upper Limit, and the red line shows the Lower Limit that you set in Settings .
4 . Target Glucose: Dashed green line shows the Target Glucose that you set in Settings . When the Activity feature is enabled, this value changes to 150 mg/dL .
5 . Event area: The row below the graph shows:
– Purple background for periods of time that Omnipod 5 was in Automated Mode
– Blank (white) background for the periods of time that Omnipod 5 was in Manual Mode, when there was no active Pod, or when there is no Pod communication
– Dark gray background when Omnipod 5 was delivering insulin in Automated Mode: Limited state

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11 Browsing Your History and Records
– A red line during the time that SmartAdjust technology paused insulin
– An orange line during time that the maximum amount of basal insulin was delivered by the Omnipod 5 System
– Bolus button at the time you started a bolus 6 . View Selection: Use the buttons to select 3-, 6-, 12-, and
24-hour views . 7 . Vertical axis: Displays sensor glucose values in mg/dL . 8 . Time scale: Displays hour and half-hour markings . When the Omnipod 5 System is in Automated Mode, the mode indicator is purple .Insulet-Corporation-029D-Omnipod-5-Pod-FIG- (2)
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Browsing Your History and Records 11
When the Omnipod 5 System is in Automated Mode: Limited state, the mode indicator is gray .Insulet-Corporation-029D-Omnipod-5-Pod-FIG- (3)

History Summary Section

History Information Overview
You can access the history summary and detail information, and a list of automated events from the History Detail screen . ¾ Navigate to: Menu button ( ) > History Detail .Insulet-Corporation-029D-Omnipod-5-Pod-FIG- (4)
Date Summary Section
-Tap AUTO EVENTS to see automated event details
Glucose Summary
Insulin and Carb summary Details section – Swipe to see expanded details
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11 Browsing Your History and Records

Today’s history records are displayed below the summary circles, beginning with the newest records on the top .
Note: Tap the “<” next to the date arrow to view an earlier day .The upper section of the History screens summarizes the records for the day .

Summary item

Description

Row 1 – Sensor Average Sensor Sensor in Range
Sensor Above
Sensor Below

Average of sensor glucose values for the day .
Percentage of sensor glucose values within your Glucose Goal Range .
Percentage of sensor glucose values above your Glucose Goal Range .
Percentage of sensor glucose values below your Glucose Goal Range .

Row 2 – Insulin & Carbs

Total Insulin

Total insulin (basal + bolus) delivered for the day .

Basal Insulin

Percentage of the total insulin that was delivered as basal along with the number of units of basal insulin delivered . Basal insulin includes delivery based on your Basal Program while in Manual Mode, and any automated deliveries received while in Automated Mode .

Bolus Insulin

Percentage of the total insulin that was delivered through bolus(es) along with the number of units of bolus insulin delivered .

Total Carbs

Sum of meal carbohydrates (in grams) that were used in bolus delivery calculations for the given day .

Note: Percentages may not add to 100 due to rounding .

For the summary of these calculations, see page 156 .

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Browsing Your History and Records
When insulin delivery is unconfirmed After delivering a bolus or basal dose of insulin, the Pod sends a confirmation to the Omnipod 5 App once completed . If a bolus, basal, or total insulin delivery has not been confirmed, the following icons will display:
Bolus Insulin amount for the day is displayed as dashes (- -) along with a gray exclamation point (!) if there are estimated bolus deliveries . The grayed-out value displayed can consist of both confirmed and scheduled amounts. Bolus Insulin amount for the day is displayed as dashes (- -) along with a yellow exclamation point (!) when the Pod has been discarded before it could confirm insulin delivery. Basal Insulin amounts for the day are displayed as dashes (- -) along with a gray exclamation point (!) when there are unconfirmed insulin deliveries, either bolus or basal. Basal Insulin amounts for the day are displayed as dashes (- -) along with a yellow exclamation point (!) when the Pod has been discarded, and there are lost insulin delivery records .
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11 Browsing Your History and Records

11.5 Calculations for History Summaries
This section lists the calculations for the summary data shown on the History screens .

Glucose Summaries
The calculations used for the glucose summaries include sensor glucose values (including HIGH and LOW values) and exclude manually-entered readings .

Item Calculation Row 1

Average Sensor

=

Sum of all sensor glucose values Total number of sensor glucose values

Note: Note: HIGH sensor glucose values are included as 401 and LOW sensor glucose values as 39 .

Sensor in Range

=

Qty of sensor glucose values within Glucose Goal Range Total number of sensor glucose values

x 100

Qty of sensor glucose values above

Sensor Above

=

Glucose Goal Range upper limit Total number of sensor glucose values

x 100

Qty of sensor glucose values below

Sensor Below

=

TotaGl nluucmosbeeGrooaflsReannsgoerlogwluecrolismeitvaluesx 100

Insulin Delivery Summaries
Bolus insulin calculations include: · SmartBolus Calculator boluses · Manual boluses · Any partial bolus amounts delivered from immediate or extended
boluses that were canceled that the Pod can confirm Basal insulin calculations include: · Basal adjustments from SmartAdjust technology
(Automated Mode) · Basal Programs (Manual Mode)

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· Any adjustments for temp basals, pause periods, or times without an active Pod
When your Omnipod 5 System has not received updates from the Pod about confirmed insulin delivery, the insulin delivery calculations are estimates based on the scheduled insulin delivery .

Summary item Calculation Row 2
Total Insulin = Sum of basal and bolus insulin delivered

Amount of basal insulin delivered in Manual Basal Insulin = Mode and all automated insulin deliveries in
Automated Mode

Bolus Insulin = Amount of bolus insulin delivered

Total Carbs

=

Total grams of carbs entered into the SmartBolus Calculator

11.6 History Details Section
Scroll on the History screens to see the details section . The details section of the History screen shows individual records listed by time of day .
Tap a row with a down arrow to display more details . Tap again to hide the details .
Glucose Details
The icon displayed with a blood glucose reading indicates whether the glucose was in range .

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11 Browsing Your History and Records

The blood glucose icons are:

Above Glucose Goal Range
Within Glucose Goal Range
Below Glucose Goal Range

BG entry

The Dexcom icon is:
The FreeStyle Libre 2 Plus Sensor icon is:
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 Sensor 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 . Navigate to: Menu button ( ) > Settings > Glucose Goal Range .
2 . Set the limits of the Glucose Goal Range:
a . Tap the Upper Limit field and enter the desired value.
b . Tap the Lower Limit field and enter the desired value.
3 . Tap SAVE .

Bolus Details
The icon displayed with a bolus entry indicates whether the SmartBolus Calculator was used:
· The insulin bottle icon ( ) indicates that the SmartBolus Calculator was used .
· The syringe icon ( ) indicates a manual bolus was delivered .

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Immediate and extended boluses The bolus amount listed next to the Bolus button is the total of an immediate bolus plus any extended portion of the bolus . If you cancel an immediate or extended bolus, the amount listed is the confirmed amount delivered before cancellation. Tapping a row with a bolus entry expands the record to show additional details about the bolus, including: · Whether the bolus was calculated by the SmartBolus Calculator or
it was a manual bolus . · The VIEW BOLUS CALCULATIONS button if the SmartBolus
Calculator was used . Tapping this button brings up a screen showing the calculation details and whether you made a manual adjustment to the calculated bolus .
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 278 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. Extended bolus events
A Bolus button and banner indicate an extended bolus event: · An Extended Bolus started banner marks the time when the
immediate bolus finishes and the extended bolus starts. In addition to the start time of the bolus, the banner lists the number of units extended and the duration of the extension . · An Extended Bolus completed banner marks the end of the extended bolus . · An Extended Bolus canceled banner marks the cancellation of an extended bolus and states the confirmed amount of the bolus that was delivered before cancellation .
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11 Browsing Your History and Records
When the Pod has not confirmed a bolus delivery After you confirm the amount of a bolus that you want to be delivered, a bolus instruction is sent to your Pod . When the Pod completes delivery, it sends a confirmation to the Omnipod 5 App that the bolus was delivered .
Before the Omnipod 5 App receives confirmation from the Pod that the bolus has been delivered, the Omnipod 5 App estimates the amount delivered . During this time, the History screens use a gray exclamation icon to indicate that the bolus is estimated .
In most cases, after the Controller or smartphone running the Omnipod 5 App and Pod are back in range, the Pod confirms the bolus delivery. However, in rare cases, the Pod is unable to confirm bolus delivery due to a communication error . If you tap the DISCARD POD option in this situation, the History screens use a yellow exclamation icon to mark the bolus as “unconfirmed.” If a Pod is discarded with an unconfirmed bolus, the basal and total insulin amounts for that day are also marked as unconfirmed with dashes and a yellow exclamation icon . The listed bolus amount includes the amount that was scheduled for delivery up until the Pod was discarded . 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 . Bolus events indicate whether carbs were manually entered or from Custom Foods .
Basal Rate Details
Activity feature In Automated Mode, an Activity icon and banner indicate the start, end, or cancellation of the Activity feature .
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Basal Programs A Basal Program icon and banner indicate the start of a Basal Program and the restart of a Basal Program at the end of a temp basal or insulin pause period .
Temp basals In Manual Mode, a temp basal icon and banner indicate the start, end, or cancellation of a temp basal .
If a temp basal was defined as a percentage (%) of the Basal Program in progress, the banner displays the percent increase or decrease as well as the duration. If a temp basal was defined as a flat basal rate (U/hr), the banner displays the temp basal rate and the duration . Tapping a Temp Basal started banner displays a graph of basal rates associated with each time segment . If a temp basal was canceled, the Temp Basal started banner contains the scheduled duration, and the Temp Basal canceled banner contains the actual duration . 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 . An Insulin Delivery Started icon and banner indicate the time insulin delivery was restarted .
Time Change Details
A Time zone changed banner appears if you change your insulin delivery time zone . After the time zone change has occurred, new history entries will reflect your new time zone. Note: History entries recorded before your time zone changed will show in your prior time zone .
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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 .
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CHAPTER 12

Managing Software Updates

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 . When an update is available, you will receive a notification prompting you to update. Note: You will not be able to navigate in the Omnipod 5 App during an Omnipod 5 update; however, your insulin therapy will not be impacted. The Pod continues delivering insulin and will re-establish connection with the Omnipod 5 App once the update is complete. Note: The Controller must be connected to a network to receive over-the-air updates. If you turn Airplane Mode ON, you may miss important updates. Note: All updates on the Controller that are considered optional require a Wi-Fi connection. Note: If you have an immediate bolus in progress, software updates will be delayed until the bolus is complete.
Caution: ALWAYS make sure your battery has adequate charge prior to installing a software update. 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.
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Managing Software Updates 12
Operating System (OS) Update
Operating System (OS) updates may be either “optional” or “required.” Required updates require you to perform the update immediately before you can use the Omnipod 5 App. Optional updates may be postponed to a later time. To download and install an OS update on the Controller: 1 . Ensure your Controller is currently charging or the battery is
charged to above 40%. Note: If your Controller is currently charging, the battery must be above 20%. 2. Tap Update Now. The Omnipod 5 Controller begins to update. Once the update is complete, you will see a confirmation screen. 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 . Ensure your Controller is currently charging or the battery is charged to above 40%. Note: If your Controller is currently charging, the battery must be above 20%. 2. Go to the Home screen. 3 . Tap the notification bell. 4 . Tap the update notification. 5 . Tap Update Now. Once the update is complete, a confirmation screen displays to inform you that the update was completed successfully.
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12 Managing Software Updates
Omnipod 5 App Update on the Controller
Omnipod 5 App updates may be either “optional” or “required.” Required updates require you to perform the update immediately before proceeding to use the Controller. Optional updates may be postponed to a later time. To download and install an Omnipod 5 App update on the Controller: 1 . Ensure your battery is charged to above 15%. 2. Select Update Now. After the update is complete, a confirmation screen displays to inform you that the update was completed successfully. 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 Omnipod 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 battery is charged to above 15%. 2. Go to the Home screen. 3 . Tap the notification bell. 4 . Tap the update notification. 5 . Tap Update Now. Once the update is complete, a confirmation screen displays to inform you that the update was completed successfully.
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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. The Pod continues delivering insulin and will re-establish connection with the Omnipod 5 App once the update is complete.
Caution: ALWAYS make sure your battery has adequate charge prior to installing a software update. 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.
Automatic Updates Enabled
If you have Automatic Updates enabled on your phone, the Omnipod 5 App updates will be downloaded and installed automatically through Google Play. If an automatic update occurs, the Omnipod 5 App informs you that an update was successfully completed when you open the app. For more information on how to enable automatic updates, see your smartphone’s user manual.
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Automatic Updates Disabled
To download and install an Omnipod 5 App update on your smartphone: 1 . Ensure your phone battery is charged to above 15%. 2. If prompted when using the app, select Update Now .
Or navigate to your list of apps in Google Play. Tap Update next to the Omnipod 5 App . After the update is complete and the Omnipod 5 App is reopened, a confirmation screen displays to inform you that the update was completed successfully. 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 Omnipod 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 . Once the update is complete and the Omnipod 5 App is reopened, a confirmation screen displays to inform you that the update was completed successfully.
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CHAPTER 13
Alarms, Action and Reminder Notifications

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.
Caution: DO NOT stop the Omnipod 5 App in a way that stops it from running in the background (called force stopping) on your smartphone. The Omnipod 5 App must be open or be running in the background in order to display and sound alarms on the smartphone. If the app is not running, you could miss important alarms and notifications on the smartphone. If you do not hear alarms and notifications from your smartphone, you might not make the changes you need to make to your therapy in a timely manner. Your Pod will continue to operate and sound alarms. In addition, if you stop the Omnipod 5 App while sending commands to the Pod, the command can be interrupted and may not be completed.
Caution: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other setting that prevents you from hearing alarms and notifications from your Omnipod 5 App. Avoid the use of tools that limit sounds and notifications, including but not limited to:
· Android: Digital Wellbeing, Private Space, Notification cooldown
· iPhone: Screen Time, Focus Mode, Hide App, Lock App
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.
Note: The Omnipod 5 App on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON.
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The Omnipod 5 System generates the following types of alarms and notifications: · Alarms:
– Hazard Alarms are high-priority alarms that indicate a serious problem has occurred, and you may need to remove your Pod. Hazard Alarms will repeat every15 minutes until acknowledged. The audible alarm on the Pod will continue until acknowledged in the Omnipod 5 App. See “13.5 Hazard Alarm List” on page 181 .
– In general, only one hazard alarm can occur at a time. In the unlikely even that a Pod and Omnipod 5 App hazard alarm occur simultaneously, the 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 “13.6 Advisory Alarm List” on page 189 .
· Notifications: – Action Item notifications are for technical System tasks that need your attention. See page 173 . – Reminder notifications remind you about a diabetes management action that you may want to perform. See “13 .10 Reminder Notifications List” on page 217 . – Communication error messages display when the Omnipod 5 App is unable to communicate with the Pod. See “27.5 Pod Communication Issues ­ “Try Again”” on page 458 .
For how to view the alarms and notifications history, see page 173 . For Dexcom G6 alarm information, see the Dexcom G6 CGM System Instructions for Use. For FreeStyle Libre 2 Plus Sensor alarm information, see “20.5. FreeStyle Libre 2 Plus Sensor Communication and Problem Messages” on page 283.
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Alarms and Notifications Screen
To review past alarms and notifications: 1 . Tap Menu button ( ) >
Notifications. Messages from today are displayed first, with newest at the top of the screen and oldest at the bottom of the screen. 2 . To display a specific date range, tap FILTER BY DATE . a . Tap the starting date on
the calendar. Note: Tap the “<” arrow to view an earlier month. b. Tap END at the top of the screen. c. Tap the ending date for the date range. d . Tap OK. 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 171 . 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.
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13.2 Sounds and Vibrations
The Omnipod 5 System uses sounds and vibrations to attract your attention to an alarm or notification.
Caution: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other setting that prevents you from hearing alarms and notifications from your Omnipod 5 App. Avoid the use of tools that limit sounds and notifications, including but not limited to: · Android: Digital Wellbeing, Private Space, Notification
cooldown · iPhone: Screen Time, Focus Mode, Hide App, Lock App 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.
Note: The Omnipod 5 System on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON. Tip: To test the sounds and vibrations, see “Check alarms” on page 180 .
Pod alarms The Pod sounds a tone when it detects a problem that can affect insulin delivery. · Pod Hazard Alarms are continuous tones broken up periodically by
a set of beeps. · Pod Advisory Alarms and notifications are intermittent beeps,
which periodically repeat until you acknowledge them.
Omnipod 5 App alarms Omnipod 5 App alarm sounds are dependent on your Controller or smartphone sound settings, for example, silent or vibrate setting. The Sound/vibrate button on your Controller The Sound/vibrate button, located on the upper right side of the Controller, controls whether all notifications use vibrations or sounds.
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Alarms, Action and Reminder Notifications 13
· 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. On the screen, you can also move the volume indicator to the left to decrease the volume and move it to the right to increase the volume
Smartphone Sounds and Vibrations
Caution: ALWAYS make sure you can hear alarms and notifications when paired to alternative audio devices (e.g. Bluetooth speaker, headphones). Navigate to your smartphone’s sound settings to ensure that all Omnipod 5 App notifications are enabled to produce a vibration and audible sound. See “4.5 General Settings on Your Smartphone” on page 75 for more information on how to adjust your smartphone sound and vibration settings. Note: When paired to an alternative Bluetooth device to project sound, such as headphones or speakers, alarms/alerts/notifications may sound on your smartphone or on the Bluetooth accessory. Each accessory is different. Test yours prior to use to ensure alarms/ alerts/notifications are audible. See “Check alarms” on page 180 .
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13.3 Informational Sounds and Vibrations

Caution: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other setting that prevents you from hearing alarms and notifications from your Omnipod 5 App. Avoid the use of tools that limit sounds and notifications, including but not limited to:
· Android: Digital Wellbeing, Private Space, Notification cooldown
· iPhone: Screen Time, Focus Mode, Hide App, Lock App
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.

Note: The Omnipod 5 System on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON.
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

Omnipod 5 App

Tones or vibrations let you know that your temp basals and boluses are working as expected. These reminders are ON by default. To turn them ON or OFF, see “Confidence Reminders” on page 147 .

Tone/vibration at the start of a temp basal, bolus, or extended bolus.

Pod
Beeps once at the end of a temp basal, bolus, or extended bolus.

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Alarms, Action and Reminder Notifications 13

Note: Confidence reminders and program reminders are turned on by default. These reminders cause the Omnipod 5 App or Pod to beep at the beginning and end of boluses and temp basals, and also once an hour during an extended bolus or temp basal. For more information, see “Confidence Reminders” on page 147 .

Program reminders

Cause
Beeps remind you that you have a temp basal or extended bolus running. These reminders are ON by default. To turn them ON or OFF, see page 147 .

Omnipod 5 App No tone/vibration

Pod
Beeps once every 60 minutes while a temp basal or extended bolus is running.

Basal Program changes

Cause
Tones or vibrations inform you of changes to your Basal Program . You cannot turn these OFF .

Omnipod 5 App
Tone/vibration when a Basal Program is activated, edited, paused, or started.

Pod
Beeps once every 15 minutes after the pause period has ended.

Canceling temp basals and boluses

Cause

Omnipod 5 App

Tone informs you

No tone/vibration

that the temp

basal or bolus has

been successfully

canceled. You cannot

turn these OFF .

Pod
Beeps once when you cancel a temp basal, bolus, or extended bolus.

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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 .

Omnipod 5 App
Tone/vibration when the Pod and Omnipod 5 App are successfully paired.
Sounds tone/ vibrates twice when the Pod is successfully deactivated.

Pod
Beeps twice when it has been filled with the minimum amount of insulin needed for activation (see page 100).
Beginning 10 minutes after the Pod is filled with insulin, beeps every five minutes until insulin delivery has started.

13.4 Responding to Alarms
Caution: AVOID leaving your Controller or smartphone in a place that would prevent you from hearing alarms and notifications from your Omnipod 5 App. Delivery of insulin in Manual Mode or Automated Mode continues as programmed if you move away from your Controller or smartphone.
Caution: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other setting that prevents you from hearing alarms and notifications from your Omnipod 5 App. Avoid the use of tools that limit sounds and notifications, including but not limited to:
· Android: Digital Wellbeing, Private Space, Notification cooldown
· iPhone: Screen Time, Focus Mode, Hide App, Lock App
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.
Note: The Omnipod 5 System on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure
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you always receive 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 180 .
Note: You can use your Omnipod 5 System even if you do not address an Advisory Alarm immediately. However, you must acknowledge a Hazard Alarm before you can use your Omnipod 5 System.
Tip: If you follow the Omnipod 5 App’s instructions and are still not able to silence a hazard alarm, see “13.8 Silencing Unresolved Alarms” on page 215 .
Note: If a temp basal or extended bolus is running when a Pod Hazard Alarm occurs, the Omnipod 5 App informs you that it was canceled.
Timing of Pod Alarms on the Omnipod 5 App If the Pod is sounding a HazardAlarm, the Pod sends a signal to your Omnipod 5 App.
· If the Controller or smartphone running the Omnipod 5 App is in range and awake within 25 seconds of the Pod’s initial alarm sound, your Omnipod 5 App also sounds an alarm and displays the alarm message.
· If the Controller or smartphone running the Omnipod 5 App is in range but asleep, there could be a delay of up to 6 minutes between when the Pod sounds the alarm and when your Omnipod 5 App sounds the alarm.
· If the Controller or smartphone running the Omnipod 5 App is out of range of the Pod, your Omnipod 5 App cannot receive any communication from the Pod. Therefore, if you hear a Pod alarm or notification, bring your Controller or smartphone in range of the Pod and wake up your Omnipod 5 App. Within 25 seconds, your Omnipod 5 App sounds the alarm and displays the alarm message.
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Diagnostics
Warning: DO NOT continue using an activated Pod that fails to beep during a diagnostic test. The Pod should be changed immediately. If the Omnipod 5 App fails to beep during a diagnostic test, contact Customer Care immediately. Continuing to use the Omnipod 5 System in these situations could put your health and safety at risk.
Check alarms Before you begin, switch to Manual Mode if currently using Automated Mode. See “23.2 Switching from Automated Mode to Manual Mode” on page 386 . 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 . If you have an active Pod, tap PAUSE INSULIN and tap YES . 3 . Tap CHECK ALARMS to initiate the alarm check. 4 . Listen and feel: The Controller or smartphone running the
Omnipod 5 App beeps and vibrates three times. If you are wearing a Pod, the Pod beeps several times and sounds the alarm tone for several seconds. 5. If the Pod did not beep, tap NO. Then either tap CHECK AGAIN to retry testing the alarms, or tap DONE and change your Pod. 6 . If the Omnipod 5 System alarms did not sound, tap NO. Then either tap CHECK AGAIN to retry testing the alarms or contact Customer Care. 7 . If the beeps and vibrations worked properly, tap YES. If you paused insulin to check the alarms, tap YES to start insulin delivery.
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13.5 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. Give that number to Customer Care if you call about that alarm.
Blockage Detected
Warning: ALWAYS monitor your glucose and follow your healthcare provider’s treatment guidelines when you stop receiving insulin due to a blockage (occlusion). Not taking action promptly could result in under-delivery of insulin which can lead to hyperglycemia or diabetic ketoacidosis (DKA).

Screen Alert Omnipod 5 App:
Lock Screen:

Description Why it occurs: A blockage (occlusion) was detected from the blocked cannula, a Pod malfunction, or from using old or inactive insulin, which has stopped insulin delivery. Pod sound: Continuous tone 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, DEACTIVATE POD NOW .
2 . Change your Pod.
3 . Check your blood glucose.

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Omnipod 5 App Error

Screen Alert Omnipod 5 App:
Lock Screen:

Description
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 . Tap OK to acknowledge or silence the alarm.
Note: Depending on the cause of this error, the Controller may restart after you tap OK. Whether or not that happens, continue with the following steps.
2 . Check your blood glucose.

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Omnipod 5 Memory Corruption

Screen Alert Omnipod 5 App:
Lock Screen:

Description 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.
3 . Check your blood glucose.

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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 Omnipod 5 App:
Lock Screen:

Description Why it occurs: The Pod detects an unexpected error and insulin delivery has stopped. Pod sound: Continuous tone 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, DEACTIVATE POD NOW .
2 . Change your Pod.
3 . Check your blood glucose.

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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 Omnipod 5 App:
Lock Screen:

Description Why it occurs: The Pod has reached the end of its operating life, and insulin delivery has stopped. Pod sound: Continuous tone 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, DEACTIVATE POD NOW .
2 . Change your Pod.
3 . Check your blood glucose.

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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 Omnipod 5 App:
Lock Screen:

Description Why it occurs: The Pod’s insulin reservoir is empty, and insulin delivery has stopped. Pod sound: Continuous tone 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, DEACTIVATE POD NOW .
2 . Change your Pod.
3 . Check your blood glucose.

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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 Omnipod 5 App:
Lock Screen:

Description 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. Pod sound: Continuous tone 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, DEACTIVATE POD NOW .
2 . Change your Pod.
3 . Check your blood glucose.
Note: To change the Pod ShutOff setting, see “Pod Shut-Off” on page 146 .

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System Error
Screen Alert Omnipod 5 App:
Lock Screen:

Description 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.
3 . Check your blood glucose.

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13.6 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.

Low Pod Insulin

Screen Alert Omnipod 5 App:
Lock Screen:

Description Why it occurs: The amount of insulin in the Pod is below the value specified in your settings. Pod sound:
· 8 beep tone pattern
· Tone pattern sounds once every 3 minutes for 60 minutes.
Controller/Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· Vibration and tone repeat every 15 minutes until acknowledged. .
What to do:
1 . Tap OK .
2 . Change your Pod.

Note: This escalates to the Pod Out of Insulin hazard alarm if ignored.
Note: To change this value, see “Low Pod Insulin” on page 146 .

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13 Alarms, Action and Reminder Notifications

Pod Expired
Screen Alert Omnipod 5 App:
Lock Screen:

Description 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:
1 . Tap OK .
2 . Change your Pod.

Note: After acknowledgment or if ignored, the alarm will repeat when there is 1 hour left of Pod life.
Note: This escalates to the Pod Expired hazard alarm if ignored.

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Pod Shut-Off
Screen Alert Omnipod 5 App:
Lock Screen:

Description 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.
Pod sound:
· 6 beep tone
· Once every minute for 15 minutes Controller/Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· Vibration and tone repeat every 15 minutes until acknowledged.
What to do: ¾ Tap NEXT to reset the Pod Shut-
Off timer.

Note: To enable or disable the Pod Shut-Off feature or to change the countdown period, see “Pod Shut-Off” on page 146 .

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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 Omnipod 5 App:
Lock Screen:

Description 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. Pod sound:
· 8 beep tone
· Tone sounds once every minute for 3 minutes.
· Repeats every 15 minutes until acknowledged.
Controller/Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· Vibration and tone repeat every 15 minutes until acknowledged
What to do:
Do one of the following:
· If you want to start insulin with the Basal Program, tap START INSULIN.
· If you want to keep insulin paused, tap REMIND ME IN 15 MIN.

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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 Omnipod 5 App:
Lock Screen:

Description Why it occurs: Your glucose is at or below 55 mg/dL, according to what your Sensor sent to the Omnipod 5 App . Pod sound:
· 4 beep tone
· Repeats every 5 minutes that sensor glucose value is urgently low.
Controller/Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· Vibration and tone repeat every 15 minutes until acknowledged.
What to do: ¾ Tap OK to acknowledge the alarm.

Note: This Advisory Alarm will only stop repeating after a glucose value of 56 mg/dL or greater is received. You may silence this Advisory Alarm for 30 minutes by acknowledging the on-screen message.
Note: After the initial Advisory Alarm is acknowledged, the Advisory Alarm will occur again if sensor glucose values are still below 55 mg/dL after 30 minutes.
Note: Use a blood glucose meter to confirm your blood glucose reading. Treat low glucose as needed.
Note: The Urgent Low Glucose Advisory Alarm has to do directly with your body’s current glucose, while other alarms have to do with the Pod or Omnipod 5 App state.
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13.7 Action Item Notification List
Action Item notifications are technical System tasks that need your attention.
App Use Blocked
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 method. Failure to deactivate your Pod and use another form of insulin delivery could result in over-delivery or under-delivery of insulin. This can lead to hypoglycemia or hyperglycemia.
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Screen Alert Omnipod 5 App:

Description
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. (This option only appears if you have an active Pod.)
2 . Check your Omnipod 5 App for available update notifications frequently. When you see a notification for an available App update, follow the instructions to install the update.

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Attention
Screen Alert Omnipod 5 App:

Description
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. The notification will display once per day until testing is complete. If you notice any unexpected effects on your screen or otherwise have concerns about the way your Omnipod 5 System is working, contact Customer Care.
For a list of compatible operating systems, go to https://www.omnipod.com/compatibility

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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.

Screen Alert Omnipod 5 App:

Description
Why it occurs: Your Omnipod 5 App has not connected to Insulet’s network for 7 or more days.

Pod sound: None
Controller/Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· No repetition What to do: ¾ Tap WI-FI SETTINGS when
prompted. Connect to a Wi-Fi network. Tip: When you are connected to a network, your Omnipod 5 App is notified about software updates when you need them.
Tip: If Wi-Fi is not available, move to an area with a better cellular signal.
Note: The SIM Card on your Omnipod 5 Controller enables data to be sent and received via the AT&T wireless network when your Controller is not connected to a Wi-Fi network. If you stop using the Omnipod 5 App over a cellular network on your Controller, Insulet may deactivate the SIM Card.
Note: Please note that the Controller is still functional using Wi-Fi. If you return to using the Omnipod 5 App on your Controller after a significant period of time, please contact Customer Care to request SIM card reactivation for full coverage via both cellular network and Wi-Fi. Upon request, the SIM card is reactivated.
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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.

Screen Alert Omnipod 5 App:

Description
Why it occurs: The Omnipod 5 App has detected that Daylight Saving Time has started or ended.
Pod sound: None
Controller/Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition
What to do: ¾ Tap UPDATE to update your insulin
delivery time.

Or:
¾ Tap NOT NOW to continue using your current insulin delivery time.
Note: Correct time is essential for correct insulin delivery and history records. If you tap NOT NOW, you can find this Action Item notification at Menu button ( ) > Notifications and every 24 hours you will be reminded to update.

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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. Doing so may put you at risk of unintentionally installing malware on your device. Malware, or “malicious software” from unknown third-parties, is designed to damage your device and/or read your private information. Unknown apps and unknown downloads are the most common method for spreading malware. Malware could prevent the Omnipod 5 System from functioning as intended, causing over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia. The Omnipod 5 App performs a check to ensure that your device is not rooted or jailbroken. If the Omnipod 5 App determines your device is, you will be blocked from Omnipod 5 App use. If you believe you may have an App installed from a third-party source, take steps to delete that App. If you believe you may have malware on your device, discontinue use of your Omnipod 5 System and use an alternate means of insulin delivery until you can resolve. Delete any apps installed from a third-party source, restore your phone to factory default settings, and contact Insulet Customer Care. Caution: DO NOT attempt to use the Omnipod 5 App on a smartphone device with unauthorized modifications. If you do, you will not be able to use the Omnipod 5 App.
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Screen Alert Omnipod 5 App:

Description
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 . Return your device to the unmodified configuration to continue using Omnipod 5.

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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 method. Failure to deactivate your Pod and use another form of insulin delivery could result in over-delivery or under-delivery of insulin. This can lead to hypoglycemia or hyperglycemia.
Note: If you get this message while using the Controller, contact Customer Care.

Screen Alert Omnipod 5 App:

Description
Why it occurs: Your smartphone is incompatible with the Omnipod 5 System, and an update will not fix the problem.
Pod sound: None
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. (This option only appears if you have an active Pod.)
2 . Find out if your smartphone is on the compatible device list here: https://www.omnipod.com/compatibility

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Not Enough Storage

Screen Alert Omnipod 5 App:

Description
Why it occurs: You do not have enough available storage for the Omnipod 5 App to run on your smartphone. Your smartphone must have enough storage space for the Omnipod 5 App 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 . Clear up storage by deleting files such as photos and videos, or by deleting other apps that you are not using.
Note: If you do not delete enough files, you will see this Action Item Notification again.

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Omnipod 5 Error
Screen Alert Omnipod 5 App:

Description 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.

OS 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 method. Failure to deactivate your Pod and use another form of insulin delivery can result in over-delivery or under-delivery of insulin. This can lead to hypoglycemia or hyperglycemia.

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Screen Alert Omnipod 5 App:

Description
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 you update the operating system of your smartphone. 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 . Update your smartphone to the latest operating system.
For a list of compatible operating systems, go to https://www.omnipod.com/compatibility

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Stop Optimizing Battery Usage

Screen Alert Omnipod 5 App:

Description
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. Your Pod continues to deliver insulin according to its program.
Pod sound: None
Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition What to do:

1 . Tap OK after reading the message.

2 . Tap ALLOW when prompted to stop battery optimization.
Note: You cannot navigate within the Omnipod 5 App until you tap ALLOW .

Note: You will not be able to use the Omnipod 5 App until you stop battery optimization for the Omnipod 5 App.

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Turn Bluetooth ON

Screen Alert Omnipod 5 App:

Description 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.

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Turn Do Not Disturb Access ON

Screen Alert Omnipod 5 App:

Description 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 . Press the back button to return.

Note: The Omnipod 5 App on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON.

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Turn Lock Screen Security ON

Screen Alert Omnipod 5 App:

Description 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.

Use of the Omnipod 5 App on your phone requires that you select a screen lock type and set security options on your phone to protect against unintended use and accidental therapy changes. This feature can be enabled from your phone’s Settings. From the Home screen, swipe up and tap Settings to access Settings.
If someone other than you uses or has regular access to your phone (e.g. your child, partner, roommate), they may unintentionally access the Omnipod 5 App, which could result in unintended changes to your therapy. Changes to your therapy could cause over-delivery or under-delivery of insulin, which can lead to hypoglycemia and hyperglycemia.
To prevent unintended access, the Omnipod 5 App will require you to enter your phone’s PIN (or other selected security method) each time you access the Omnipod 5 App.
Omnipod 5 Security cannot be turned off.

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Turn ON Automatic Date and Time

Screen Alert Omnipod 5 App:

Description
Why it occurs: You have turned OFF Automatic Date and Time in your smartphone settings. The Omnipod 5 App has many therapyrelated 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.
Pod sound: None
Smartphone sound and vibration:
· 3 second tone
· 3 second vibration
· No repetition
What to do:
1 . Tap OK.
You will be taken to the Android “Date and Time” screen.
2 . Tap Automatic date and time to turn it ON.
The toggle will turn blue if it is ON.

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Turn Notifications ON

Screen Alert Omnipod 5 App:

Description
Why it occurs: You have turned OFF any of the following:

Show notifications, Hazard & Advisory Alarms, or Action Item Notifications.

Omnipod 5 System notifications should be turned ON in your smartphone settings so that you get important information regarding your insulin therapy and alarms.
Pod sound: None
Controller/Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition What to do:

1 . Tap TURN ON when prompted.

You see the Android “App Notifications” screen.

2 . Tap Show notifications to turn Omnipod 5 App notifications ON.

Note: The Omnipod 5 App on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON.

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Update Omnipod 5 – App No Longer Supported
Caution: ALWAYS make sure your battery has adequate charge prior to installing a software update.

Screen Alert Omnipod 5 App:

Description
Why it occurs: The Omnipod 5 App version you are currently using is obsolete and no longer supported.
Pod sound: None
Controller/Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition What to do:

1 . Tap UPDATE NOW.

Your battery power must be above 15% before updating.

2 . If you do not have enough battery power, charge your battery before continuing.

You will see that the update is in progress.

3 . When you see the message that the update was successful, tap OK .
Note: If the update is critical (required), you will not have the option to dismiss the notification. If you tap NOT NOW, you can find this Action Item notification at Menu button ( ) > Notifications.

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Update Omnipod 5 – Software Update
Caution: ALWAYS make sure your battery has adequate charge prior to installing a software update.

Screen Alert Omnipod 5 App:

Description
Why it occurs: An Omnipod 5 App software update is available.
Pod sound: None
Controller/Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition What to do:

1 . Tap UPDATE NOW .

Your battery power must be above 15% before updating.

2 . If you do not have enough battery power, charge your battery before continuing.

3 . When you see the message that the update was successful, tap OK .
Note: If the update is critical (required), you will not have the option to dismiss the notification. If you tap NOT NOW, you can find this Action Item notification at Menu button ( ) > Notifications.

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Alarms, Action and Reminder Notifications 13

Update OS

Screen Alert Omnipod 5 App:

Description Why it occurs: An operating system update is available for your Controller .
Pod sound: None Controller sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition What to do:

1 . Tap UPDATE NOW

Your battery power must be above 40%, or be above 20% and charging, before updating.

2 . If you do not have enough battery power, charge your battery before continuing.

3 . When you see the message that the update was successful, tap OK .
Note: If the update is critical (required), you will not have the option to dismiss the notification. If you tap NOT NOW, you can find this Action Item notification at Menu button ( ) > Notifications.

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Update Time Zone
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.

Screen Alert

Description

Omnipod 5 App:

Why it occurs: Your Controller or smartphone time zone does not match the Omnipod 5 App insulin delivery time zone.

Pod sound: None

Controller/Smartphone sound and vibration:

· 3 second tone

· 3 second vibration

· No repetition

What to do:

1 . Tap UPDATE when prompted to update your insulin delivery time zone.

2 . If you are in Automated Mode, follow the on-screen instructions to switch to Manual Mode and pause insulin delivery.

3 . After the time zone is updated, you may start insulin delivery and return to Automated Mode.

Note: Correct time is essential for correct insulin delivery and history records. If you tap NOT NOW, you can find this Action Item notification at Menu button ( ) > Notifications and every 24 hours you will be reminded to update.

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Alarms, Action and Reminder Notifications 13

13.8 Silencing Unresolved Alarms
You can silence Pod or Omnipod 5 App alarms by acknowledging the alarm screen displayed on your Omnipod 5 App. If the alarm continues, follow the directions in this section.

Pod Alarm

Caution: Permanently silencing a Pod alarm requires the Pod to be removed from your body. Once removed and discarded, promptly activate a new Pod to avoid going too long without insulin, which could lead to hyperglycemia.

To permanently silence a Pod alarm:
1 . If the Pod is on your body, remove it.

Press down firmly

2 . Peel back a little bit of the adhesive pad from the bottom of the Pod at the square end (see figure).
3 . Locate the alarm shut-off port to the right of the gold circle. The alarm shut-off port can be felt with a fingernail or paper clip as soft plastic.

Alarm shut-off port
Gold circle Fill port

4 . Firmly press a paper clip or similar item straight down into the alarm shut-off port. You need to apply enough force to break a thin layer of plastic. If an alarm is sounding, the alarm will stop.

Controller Alarm
If a Controller alarm is not silenced when you acknowledge the alarm:
1 . Press and hold the Power button, then tap Power off .
2 . Press and hold the Power button to turn the Controller back on.
This action silences the Controller’s alarm. Your history records and personal settings are preserved. However, you may have to confirm the time zone.

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13 Alarms, Action and Reminder Notifications
13.9 Responding to Reminder Notifications
Reminder Notifications remind you about diabetes management actions you may want to perform.
Finding out about reminder notifications
To alert you to a notification, the Pod sounds a 3-beep tone, and the Omnipod 5 App either sounds a tone or vibrates (see “13.2 Sounds and Vibrations” on page 174). When you hear a sound or feel a vibration, check your Omnipod 5 App for a message.
Note: Program reminders, confidence reminders, and some informational signals do not have an accompanying message.
If your Omnipod 5 App is asleep when you hear or feel a notification, wake it up. The Lock screen shows the reminder notification icon ( ) and the notification message.
· If there are multiple messages, the most recent message is shown at the top of the list.
· If there are more messages than can be displayed on the Lock screen, a banner beneath the messages shows the number of additional messages.
Note: The Omnipod 5 App on your smartphone requires Do Not Disturb permission and Notifications to be turned ON to ensure you always receive important safety alarms. You cannot use the app until Do Not Disturb permission is provided and Notifications is turned ON.
If you are using your Omnipod 5 App when a notification is triggered, the notification message appears at the top of the screen. To remove the message from the screen:
· Do nothing. The message disappears after several seconds and is saved as a new message.
· Swipe up to remove the message immediately and save it as a new message.
· Swipe right to remove the message immediately and save it as an acknowledged message.
Acknowledging reminder notifications
Note: Waking up your Omnipod 5 App and using it does not automatically acknowledge or silence notifications.
All new notifications are included in the Notifications & Alarms count ( ) in the red circle over the notification bell in the upper right of the Home screen.
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Alarms, Action and Reminder Notifications 13
To acknowledge the notification: 1 . Wake up your Omnipod 5 App . 2 . Tap the notification bell icon ( ) to bring up the Notifications &
Alarms screen. 3 . Scroll down the screen, if necessary, to see any additional
notifications with blue icons ( ). 4 . Tap the back arrow ( ) in the upper left of the screen to mark
the notifications as acknowledged. Note: Putting the Omnipod 5 Controller to sleep by pressing the Power button does not mark the notifications as acknowledged. You must tap the back arrow ( ) to acknowledge the notification.

13.10 Reminder Notifications List
Reminder Notifications remind you about various diabetes management actions you may want to perform. Some are automatically generated and others have settings that you control (see “10.2 Reminder Settings” on page 145).
Tip: Use the Sound/vibrate button on the right side of the Controller to control whether the notification sounds a tone or vibrates (see “The Sound/vibrate button on your Controller” on page 174).
The reminder notifications are:
No Active Pod
Screen Displayed

Cause
Pod sound: Controller/ Smartphone sound and vibration: What to do

Reminds you to activate a new Pod to begin basal insulin delivery. None Repeats once, 15 minutes after initial notification unless acknowledged.
Unlock the Omnipod 5 App. Activate a new Pod.
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13 Alarms, Action and Reminder Notifications
Pod Expiration
Screen Displayed

Cause Pod sound:

Tells you how much time is left before the Pod expiration advisory alarm.
· 8 beep tone

· Tone issued once every minute for 3 minutes

Controller/ Smartphone sound and vibration:
What to do

· Repeats every 15 minutes until acknowledged
Repeats once, 15 minutes after initial notification unless acknowledged.
Acknowledge the message (see “Acknowledging reminder notifications” on page 216). Change your Pod.

Note: To change the timing of this notification, see “Pod Expiration” on page 146. Both the Pod and the Omnipod 5 App sound the notification.

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Chapter 14: Taking Care of Your Controller and Pod
CHAPTER 14
Taking Care of Your Controller and Pod

Taking Care of Your Controller and Pod

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 .
The Omnipod 5 Automated Insulin Delivery System has no user-serviceable parts . If you require assistance operating or maintaining the Omnipod 5 System, contact Customer Care .
14.1 Pod and Insulin Storage and Care
This section describes proper care of your Pod .
Pod and Insulin Storage
Extreme heat or cold can damage Pods and cause them to malfunction . It is especially important to store your insulin in a well-controlled environment . Inspect insulin before using it; never use insulin that looks cloudy or discolored . Insulin that is cloudy or discolored may be old, contaminated, or inactive . Check the insulin manufacturer’s instructions for use and the insulin’s expiration date .
Pods and the Environment
Avoid extreme temperatures
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 .
The Pod’s operating temperature has been tested and found to operate safely between 41°F and 104°F (between 5°C and 40°C) . Under normal circumstances, your body temperature keeps the Pod within a range of 73°F and 98 .6°F (23°C and 37°C) .
Caution: NEVER use a blow dryer or hot air to dry the Controller or Pod . Extreme heat can damage the electronics .
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Taking Care of Your Controller and Pod 14
If you remove your Pod to avoid exposing it to extreme temperatures, remember to check your glucose frequently . Note: Check with your healthcare provider for guidelines if you plan on not using a Pod for extended periods . Note: Check the labeling for your rapid-acting insulin, as maximum insulin exposure temperatures may vary between insulins . Water and your Pod
Warning: DO NOT expose your Pod to water at depths greater than 25 feet (7 .6 meters) or for longer than 60 minutes because damage to the Pod can occur . This could result in over-delivery or under-delivery of insulin, which can lead to hypoglycemia or hyperglycemia . The Pod is waterproof up to a depth of 25 feet (7 .6 meters) for up to 60 minutes (IP28) . After swimming or similar exposure to water, rinse off the Pod with clean water and gently dry it with a towel.
Cleaning Your Pod
Pods are waterproof . If you need to clean a Pod, gently wash it with a clean, damp cloth, or you can use mild soap and water . However, do not use strong detergents or solvents, as they can damage the Pod’s casing or irritate the infusion site .
Caution: Use caution while cleaning the Pod on your body . Hold the Pod securely so the cannula does not kink and the Pod does not detach from your skin .
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14 Taking Care of Your Controller and Pod
14.2 Controller Storage and Care
When you are not using your Controller, store it in a convenient, nearby location that is cool and dry .
Caution: ALWAYS keep your Controller safe and within your control to ensure others cannot make changes to your insulin therapy . Do not share your Controller screen lock security with anyone . Caution: DO NOT use any component of the Omnipod 5 System (smartphone, Controller, Pod) if you suspect damage after an unexpected event such as dropping or hitting on a hard surface . Using damaged components may put your health at risk as the system may not be working properly . If you are unsure if one or more of your components are damaged, stop using the system and contact Customer Care for support .
Long term storage of your Controller If you are not going to use your Controller for an extended period of time, allow your battery to reach approximately 50% to 60% charge . Then press and hold the Power button to turn the Controller OFF .
Your Controller and the Environment
Avoid extreme temperatures Extrem operating temperatures can affect the Controller battery and interfere with Omnipod 5 System operation . Avoid using the Controller in temperatures below 41°F (5°C) or above 104°F (40°C) .
Caution: DO NOT expose your Controller to extreme temperatures while in storage or during use . Extreme heat or cold can cause the Controller to malfunction . Extreme heat is defined as >86°F(30°C) during storage and >104°F(40°C) during use. Extreme cold is defined as <32°F(0°C) during storage and < 41°F(5°C) during use .
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Taking Care of Your Controller and Pod 14
Water and your Controller
Caution: DO NOT place the Controller in or near water because the Controller is not waterproof . Failure to do so may result in damage to the Controller .
If the Controller gets wet: 1 . Dry the outside of the Controller with a clean, lint-free cloth .
Caution: NEVER use a blow dryer or hot air to dry the Controller or Pod . Extreme heat can damage the electronics . 2 . After the Controller has thoroughly air-dried, turn ON the Controller to see if it is working . 3 . If the Controller is not working, contact Customer Care . Electrical interference The Controller and Pod are designed to withstand normal radio interference and electromagnetic fields, including airport security and cellular phones . However, as with all wireless communication technology, certain operating conditions can interrupt communication . For example, electric appliances such as microwave ovens and electric machinery located in manufacturing environments may cause interference . In most cases, interruptions are easy to resolve by moving to a new location (for more information, see “27 .5 Pod Communication Issues ­ “Try Again”” on page 458) . USB charging cable and adapter
Caution: Use ONLY the USB charging cable and adapter that you received in the box with your Controller . AVOID using alternative charging cables or other accessories, as they may damage the Controller or affect the way it charges in the future. If you must use a different cable, use only cables less than or equal to 4 feet (1 .2 meters) in length .
Note: You can use the Controller while it is charging .
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14 Taking Care of Your Controller and Pod
Cleaning Your Controller
Always keep your Controller USB port free of debris and liquids . Dirt, dust, and liquids can impair the functionality of your Controller or damage it . Use compressed air to clean any dust . Never blow in the port with your mouth .
Caution: DO NOT use solvents to clean your Controller . DO NOT immerse your Controller in water as it is not waterproof . The use of solvents or immersion in water could cause the Controller to malfunction .
To clean your Controller: 1 . Press the Power button briefly to put your Controller to sleep . 2 . Wipe the outer surface of the Controller with a damp, lint-free
cloth . If necessary, use a solution of a mild detergent mixed in warm water on the cloth . 3 . Dry the outer surface with a dry, lint-free cloth .
Caution: DO NOT allow debris or liquid to get into the USB port, speaker, sound/vibrate button, or Power button while cleaning the Controller . Failure to do so may result in damage to the Controller .
Every time you clean your Controller, examine the entire Controller for discoloration, cracks, or separations . Also, check for deteriorating performance, such as illegible messages, button malfunction, or repeated communication failures . If you notice any signs of deterioration, stop using the Controller . Contact Customer Care if you have questions .
If You Drop the Controller
Shock or a severe impact can damage your Controller . If you drop the Controller or if it is otherwise subjected to severe impact: 1 . Inspect the outside of the Controller for visible signs of damage . 2 . If the Controller has turned off, press and hold the Power
button to see whether the Controller turns on and the Lock screen appears .
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Taking Care of Your Controller and Pod 14
Caution: Do not use the Controller if it appears damaged or is not working as it should . Do not use the Controller if its screen is broken .
14.3 Controller Battery Care
The provided Controller uses a rechargeable lithium polymer battery . The battery cannot be removed from your Controller . If there is a problem with your battery or charging cable and adapter, contact Customer Care .
Safe Use of the Controller Battery
Caution: DO NOT expose your Controller battery to high heat [> 86ºF (> 30ºC) during storage and > 104ºF (>40ºC) during use]. Do not puncture, crush, or apply pressure to your battery . Failure to follow these instructions could result in an explosion, fire, electric shock, damage to the Controller or battery, or battery leakage .
To safely use the rechargeable battery: · Store and charge the Controller in a cool, dry place out of direct
sunlight to prolong battery life . Avoid leaving the Controller in a car where temperature extremes can permanently damage the battery · Your Controller may become warm after prolonged use or when exposed to high temperatures . If your Controller becomes hot to the touch, unplug the USB charging cable and adapter if it is plugged in, and avoid touching or holding the Controller . Place it in a cool location and allow it to cool down to room temperature · Do not expose the charging cable and adapter to liquids, including water, rain, or snow, as this can cause malfunction . If the battery or charging cable and adapter is exposed to liquid, allow it to dry · Do not place the Controller on or in heating devices, such as microwave ovens, stoves, or radiators . The battery may explode if overheated · Do not drop the Controller · Only use an Insulet approved charging cable and adapter to charge your Controller . Using unapproved charging cable and adapters
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14 Taking Care of Your Controller and Pod
can cause the battery to explode or damage the Controller and may void the warranty
· If the battery is damaged so that fluid leaks from the battery, do not allow the leaked fluid to make direct contact with your skin or eyes. If this happens, immediately flush your skin or eyes with clean water and consult a doctor
· Inspect your Controller battery charging cable and adapter before each use . If the adapter for the charging cable falls in water or is cracked, do not use it
Charging the Controller Battery
Caution: ALWAYS plug in and charge your Controller when you see the low battery message . If the battery charge 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 over-delivery or under-delivery of insulin that can lead to hypoglycemia or hyperglycemia .
Under normal use, the battery should hold its charge for more than one day .
An Omnipod 5 App message alerts you when the battery charge is low . The battery icon in the status bar tracks the remaining charge in the battery (see “3 .4 Status Bar” on page 51) .
Note: Check the charging port and the charging cable for any signs of dust or debris . Use compressed air to clean any dust . Never blow in the port with your mouth .
To charge your Controller:
1 . Assemble the charging cable by attaching its wall adapter .
Caution: Use ONLY the USB charging cable and adapter that you received in the box with your Controller . AVOID using alternative charging cables or other accessories, as they may damage the Controller or affect the way it charges in the future. If you must use a different cable, use only cables less than or equal to 4 feet (1 .2 meters) in length .
2 . Plug the charging cable and adapter into an outlet . Select an outlet that you can access easily and unplug the charging cable and adapter from easily when necessary .
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Taking Care of Your Controller and Pod 14
3 . Plug the other end of the cable into the USB port of the Controller .
4 . Charge the Controller until the battery level icon shows 100% charge .
5 . Disconnect the charging cable and adapter from the Controller and the wall outlet .
You can charge your battery many times, but all batteries have a limited lifespan . Contact Customer Care if you notice a significant deterioration in the duration of the Controller’s battery charge . Note: Charging times can vary depending on the surrounding temperature and the remaining battery level . Tip: Develop a routine to charge the Controller battery at the same time every day . Do not wait for the low battery message . Note: If the Controller battery is critically low and the Controller has turned OFF, your Pod continues to deliver Automated Mode insulin or Manual Mode basal insulin according to the Basal Program in progress or temp basal . If you do not charge your Controller battery, this insulin delivery continues until the Pod expires . Note: The history records stay in memory for 1 year even if the battery power is critically low .
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CHAPTER 15
Living with Diabetes

Living with Diabetes

15.1 Infusion Site Checks
Caution: ALWAYS check for signs of infection often . If an infusion site shows signs of infection: · Immediately remove the Pod and apply a new Pod at a different
infusion site . · Contact your healthcare provider . Treat the infection according
to instructions from your healthcare provider . If you see blood in your cannula, check your glucose more frequently to ensure insulin delivery has not been affected. If you experience unexpected high glucose, change your Pod . At least once a day, use the Pod’s viewing window to inspect the infusion site . Check the site for: · Leakage or scent of insulin, which may indicate the cannula has dislodged · Signs of infection, such as pain, swelling, redness, discharge, or heat Tip: Consider making infusion site checks a part of your daily routine, like showering or brushing your teeth .
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Living with Diabetes 15
15.2 Being Aware of Your Glucose
Warning: ALWAYS be aware of your current sensor glucose value, trust how your body feels, and do not ignore symptoms of high and low glucose . Even though insulin delivery adjusts automatically in Automated Mode with the goal of bringing your glucose level to your defined Target Glucose, severe hypoglycemia or hyperglycemia may still occur .
If your sensor glucose values do not match your symptoms, ALWAYS check your blood glucose using a BG meter, consider treatment and/or Sensor calibration (for Sensors requiring calibration, if necessary) . ALWAYS switch to Manual Mode if you feel you are receiving inaccurate sensor glucose values .
· Erroneously high sensor glucose values can cause excessive insulin delivery, leading to severe hypoglycemia, seizure, loss of consciousness or death .
· Erroneously low sensor glucose values can cause prolonged insulin suspension leading to hyperglycemia, DKA, or death .
If you are having symptoms that are not consistent with your blood glucose readings and you have followed all instructions described in this Technical User Guide, contact your healthcare provider .
When you routinely view your sensor glucose values and/or check your glucose, you can better identify when you need to make a treatment decision or troubleshoot an issue . If you are not wearing a Sensor, it is advisable to check your blood glucose at least 4­6 times per day (when you wake up, before each meal, and before going to bed) .
Check your glucose:
· Whenever you feel nauseated or sick
· Before driving a car
· Whenever your glucose has been running unusually high or low
· If you suspect that your glucose is high or low
· Before, during, and after exercise
· As directed by your healthcare provider
When using a Sensor, if your sensor glucose values are different than what you expect based on how you feel, then check your blood glucose using a BG meter to verify your sensor glucose value’s
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accuracy . For example, if you feel shaky and sweaty, which usually means your glucose is very low, but your sensor glucose value shows as in your acceptable range, you should confirm by checking with your BG meter . If your blood glucose readings are verified too low or too high, consider treatment . A sensor calibration may also be needed if you use a Dexcom Sensor; consult your compatible Dexcom CGM System Instructions for Use for more information .
15.3 Traveling and Vacations
It is important that you check your glucose more frequently while you are traveling . Changes in time zones, activity levels, and mealtimes can all affect your glucose. Proper preparation is important when traveling . The following sections will help you prepare for your travels .
Keep Supplies Accessible
On airplanes, trains, and buses, keep these items with you, rather than checking them: · Your Controller or your smartphone with the Omnipod 5 App · Extra Pods · An emergency kit · Vials of insulin (cargo area temperatures may affect insulin) · A signed letter from your healthcare provider explaining that you
need to carry insulin supplies and the Omnipod 5 System · Prescriptions for all medications · Medications and supplies with their original prescription label
Note: Generic medications may be easier to find than brand names outside your country . · Snacks and hypoglycemia treatment, in case food is not available · Bottled water (especially on planes) to prevent dehydration · The name and phone number of your physician and of a physician at your final destination
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Living with Diabetes 15
Note: For information about the recommended glucose sensing supplies to carry, see the Instructions for Use for your compatible glucose Sensor Note: Keep your emergency kit with you during trips or vacations (see “Emergency Kit” on page 17). As it may be difficult or impossible to get insulin or supplies in an unfamiliar place, take more supplies than you think you’ll need . Tip: When you travel outside the country or for long periods of time, be sure to take extra Pod supplies . Prior to departure, contact Customer Care to inquire about additional Omnipod 5 System supplies for your trip .
Plan for Changing Time Zones
If you’re planning a vacation or business trip to a different time zone, you may need to adjust Basal Programs that you would typically follow while in Manual Mode . For changes of just a few hours, basal rate adjustments are minor and easy to calculate . For longdistance travel, however, figuring out the correct Basal Program can be more challenging . Your healthcare provider can help with these adjustments .
Airports and Flying
Before traveling by plane, familiarize yourself with the airport’s security procedures and prepare your diabetes supplies for the security process and flight.
Airport security Prepare for your travel: · Airport security checks and screening procedures may change, so
review the airport website and the TSA website for travel updates before your trip . · Arrive at the airport 2­3 hours before your flight. · Have your insulin management supplies easily accessible to ensure that airport security checks run smoothly . The airport may offer the option of requesting a visual inspection of your medical supplies rather than putting them through the X-ray . You must request this before the screening process begins . Your medical supplies should be in a separate bag when you approach the security officer.
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To prevent contamination or damage to your supplies, you should be asked at the security checkpoint to display, handle, and repack your own supplies during the visual inspection process . Any medication and/or associated supplies that cannot be cleared visually must be submitted for X-ray screening .
If you are concerned about going through the walk-through metal detector, notify the security officer that you’re wearing an insulin pump. You should advise the security officer that the insulin pump cannot be removed because it is inserted with a catheter (tubing) under the skin .
Visit the TSA Contact Center if you have any further questions or concerns .
For information about passing glucose sensor equipment through airport X-ray machines, see the Instructions for Use for your compatible glucose Sensor .
Flying and airplane mode
Caution: ALWAYS check your glucose frequently during amusement park rides and flying or other situations where sudden changes or extremes of air pressure, altitude, or gravity may be occurring . Though the Omnipod 5 System is safe to use at atmospheric pressures typically found in airplane cabins during flight, the atmosphere pressure in an airplane cabin can change during flight, which may affect the Pod’s insulin delivery. Rapid changes in altitude and gravity, such as 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 .
The Omnipod 5 System sends and receives information from the Pod using Bluetooth wireless technology. Before flying, check your airline’s policy regarding the use of Personal Medical Electronic Devices that communicate using Bluetooth technology .
If the use of a Personal Medical Electronic Device using Bluetooth technology is allowed, set your Omnipod 5 App to airplane mode while on the airplane (see “Airplane mode” on page 140) . The Bluetooth setting remains enabled in the Controller’s Airplane Mode so you can communicate with your Pod .
Note: The Omnipod 5 System is safe to use at atmospheric pressures typically found in airplane cabins during flight. The Omnipod 5 System can be used at atmospheric pressures as low as 700 hPa, which is lower than the typical pressure in airplane cabins .
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Living with Diabetes 15
15.4 Avoiding Lows, Highs, and Diabetic Ketoacidosis
You can avoid most risks related to using the Omnipod 5 System by following the instructions in this Technical User Guide and by promptly treating symptoms of hypoglycemia (low glucose), hyperglycemia (high glucose), or diabetic ketoacidosis (DKA) according to your healthcare provider’s instructions . The easiest and most reliable way to avoid these conditions is to check your glucose often .
General Precautions
· Keep careful records and discuss changes and adjustments with your healthcare provider .
· Tell your healthcare provider if you have extreme high glucose or low glucose, or if high glucose or low glucose are occurring more often than usual .
· If you have technical problems with your Omnipod 5 System and cannot resolve them, contact Customer Care immediately .
Hypoglycemia (Low Glucose)
Warning: DO NOT wait to treat hypoglycemia (low glucose) or symptoms of hypoglycemia . Even if you cannot check your glucose, waiting to treat symptoms could lead to severe hypoglycemia, which can lead to seizure, loss of consciousness or death . Hypoglycemia can occur even when a Pod is working properly . Never ignore the signs of low glucose, no matter how mild . If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness . If you suspect that your glucose is low, check your glucose to confirm.
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Symptoms of hypoglycemia (low glucose)

Never ignore the following symptoms, as they could be signs of hypoglycemia:

· Shakiness

· Sudden hunger

· Fatigue

· Rapid heart rate

· Unexplained sweating

· Confusion

· Cold, clammy skin

· Tingling in the lips or tongue

· Weakness

· Anxiety

· Blurred vision or a headache

Tip: Hypoglycemia unawareness is a condition in which you do not realize when your glucose is low .
Tip: Make sure your glucose is at least 100 mg/dL before driving or working with dangerous machinery or equipment . Hypoglycemia may cause you to lose control of a car or dangerous equipment . Also, when you focus intently on a task, you may miss the symptoms of hypoglycemia .
Tip: Teach people you trust (like family members and close friends) how to administer glucagon dosage . You will need to rely on them to give it to you if you have severe hypoglycemia and become unconscious . Include a copy of the glucagon instructions in your emergency kit and periodically review the procedure with family and friends .

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To avoid hypoglycemia (low glucose)
· Work with your healthcare provider to establish individualized Target Glucose settings and guidelines .
· Keep a fast-acting carbohydrate with you at all times to respond quickly to low glucose . Examples of fast-acting carbs are glucose tablets, hard candies, or juice .
· Teach your friends, family members, and colleagues to recognize the signs of hypoglycemia so they can help if you develop hypoglycemia unawareness or a severe adverse reaction .
· Keep a glucagon kit with your emergency supplies . Teach friends and family members how to administer a glucagon dosage in case you have severe hypoglycemia and become unconscious .
Periodically check the expiration date of your glucagon kit to make sure it has not expired .
Note: Always carry medical identification (such as an emergency wallet card) and wear an emergency medical necklace or bracelet such as the Medic Alert tag .
Again, frequent glucose checks are the key to avoiding potential problems . Detecting low glucose early lets you treat it before it becomes a problem .
Check with your healthcare provider for guidance in avoiding low glucose .

Possible causes of hypoglycemia Incorrect Basal Program (Manual Mode)
Incorrect bolus timing or bolus too large

Suggested action
Confirm that the correct Basal Program is active. Consult your healthcare provider about adjusting your Basal Programs or using a temp basal . Take bolus with food .
Check blood glucose before giving a meal bolus . If necessary, adjust the bolus .
Check the bolus size and timing .
Do not overcorrect for post-meal glucose .
Check carb intake .
Consult your healthcare provider for guidance .

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Possible causes of hypoglycemia Incorrect Target Glucose level or incorrect Correction Factor or incorrect IC Ratio Prone to severe hypoglycemia or hypoglycemia unawareness Unplanned physical activity
Prolonged or intense exercise
Low carbohydrate intake prior to activity
Alcohol consumption

Suggested action
Consult your healthcare provider about refining these settings as needed.
Consult your healthcare provider about hypoglycemia unawareness and about raising Target Glucose .
Consult with your healthcare provider about using Temp Basal (Manual Mode) or the Activity feature (Automated Mode) . Adjust insulin delivery as instructed by your healthcare provider . Check glucose before, during, and after activity and treat as necessary . Note: Effects of exercise can last several hours–even a full day–after activity ends . Consult your healthcare provider about adjusting your Basal Programs or using a temp basal (Manual Mode) or the Activity feature (Automated Mode) to avoid hypoglycemia . Check glucose before activity . Consult your healthcare provider for guidance. Check glucose frequently, especially before going to bed . Consult your healthcare provider for guidance.

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To treat hypoglycemia (low glucose) Any time your glucose is low, treat it immediately according to your healthcare provider’s instructions . Your healthcare provider might recommend that you treat hypoglycemia with a different amount of carbs during Automated Mode compared to Manual Mode . Check your glucose every 15 minutes while you are treating to make sure you don’t overtreat the condition and cause glucose levels to rise too high . Contact your healthcare provider as needed for guidance .
Hyperglycemia (High Glucose)
Warning: ALWAYS monitor your glucose and follow your healthcare provider’s treatment guidelines when you stop receiving insulin due to a blockage (occlusion) . Not taking action promptly could result in under-delivery of insulin which can lead to hyperglycemia or diabetic ketoacidosis (DKA) (see” Blockage Detected” on page 181) . Pods use rapid-acting insulin, which has a shorter duration than long-acting insulin, so you have no long-acting insulin in your body when using the Omnipod 5 System . If a blockage (interruption of insulin delivery from the Pod, or occlusion) occurs, your glucose can rise rapidly . Tip: Hyperglycemia symptoms can be confusing . Always check your glucose before you treat for hyperglycemia .
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15 Living with Diabetes
Symptoms of hyperglycemia (high glucose) Never ignore the following symptoms, as they could be a sign of hyperglycemia: · Fatigue · Frequent urination, especially during the night · Unusual thirst or hunger · Unexplained weight loss · Blurred vision · Slow healing of cuts or sores To avoid hyperglycemia (high glucose) Check your glucose: · At least 4­6 times a day (when you wake up, before each meal, and
before going to bed); unless you are using a continuous glucose monitoring system · If you feel nauseated or sick · Before driving a car · Whenever your glucose has been running unusually high or low · If you suspect that your glucose is high or low · Before, during, and after exercise · As directed by your healthcare provider
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Possible causes of hyperglycemia Expired insulin or insulin exposed to extreme temperatures Infusion site in or near a scar or mole Infected infusion site
Dislodged cannula
Empty Pod
Incorrect Basal Program (Manual Mode)
Incorrect bolus timing or bolus too small
High-protein or high-fat meal
Less activity than usual

Suggested action
Deactivate and remove the used Pod . Apply a new Pod filled from a new vial of insulin.
Deactivate and remove the used Pod . Apply a new Pod in a different location. Deactivate and remove the used Pod . Apply a new Pod in a different location and consult your healthcare provider . Deactivate and remove the used Pod . Apply a new Pod in a different location. Note: Avoid sites near a waistband, belt, or other areas where friction may dislodge the cannula . Deactivate and remove the used Pod . Apply a new Pod in a different location. Confirm that the correct Basal Program is active. Consult your healthcare provider about adjusting your Basal Programs or using a temp basal . Check carb intake . Take bolus with or before eating food rather than after . Check glucose before giving meal bolus . If necessary, adjust bolus . Consult your healthcare provider for guidance . Calculate protein/fat intake and account for it in your bolus timing and bolus type . Consult your healthcare provider about using the extended bolus option . Consult your healthcare provider about adjusting your Basal Programs or using a temp basal (Manual Mode) .

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15 Living with Diabetes

Possible causes of hyperglycemia

Suggested action

Glucose greater than 250 mg/dL (with ketones present) before exercise
Infection or illness or medication change
Weight loss or gain or menstrual cycle or pregnancy
Blockage (occlusion)

Do not exercise when ketones are present . Note: Glucose increases with exercise when ketones are present . Consult your healthcare provider for guidance . See “Sick Days” on page 244 . Consult your healthcare provider about sick day guidelines and about medication changes .
Consult your healthcare provider for guidance .
Deactivate and remove the used Pod . Apply a new Pod in a different location.

To Treat Hyperglycemia (High Glucose)

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 .
Always check your glucose frequently while treating hyperglycemia . You don’t want to over-treat the condition and cause your glucose to drop too low .
1 . Check your glucose. The result will help you to find out how much insulin is needed to return your glucose to your glucose goal .
2 . If your glucose is 250 mg/dL or above, check for ketones . If ketones are present, follow your healthcare provider’s guidelines .
3 . If ketones are not present, take a correction bolus as prescribed by your healthcare provider .
4 . Check your glucose again after 2 hours .
5 . If glucose has not decreased, do both of the following:
– Take a second bolus by injection, using a sterile syringe . Ask your healthcare provider whether to inject the same amount of insulin as in step 3

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Living with Diabetes 15
– Replace the Pod. Use a new vial of insulin to fill the new Pod. Then contact your healthcare provider for guidance
Note: The Omnipod 5 System cannot track insulin that is administered outside of the system . Consult your healthcare provider about how long to wait after manually administering insulin before you start Automated Mode . 6 . If you feel nauseated at any point, check for ketones and contact your healthcare provider immediately .
Diabetic Ketoacidosis (DKA)
Warning: DO NOT wait to treat DKA . If left untreated, DKA can quickly lead to breathing difficulties, shock, coma, or death.
Pods use rapid-acting insulin, which has a shorter duration than long-acting insulin, so you have no long-acting insulin in your body when using the Omnipod 5 System . If insulin delivery from the Pod is interrupted (a blockage or occlusion), your glucose can rise rapidly and lead to diabetic ketoacidosis (DKA) . DKA is a serious– but preventable–emergency that can occur if high glucose is not resolved, in times of illness, or when there is not enough insulin working in your body . Symptoms of DKA · Nausea and vomiting · Abdominal pain · Dehydration · Fruity-smelling breath · Dry skin or tongue · Drowsiness · Rapid pulse · Labored breathing The symptoms of DKA are much like those of the flu. Before assuming you have the flu, check your glucose and check for ketones to rule out DKA .
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15 Living with Diabetes
To avoid DKA The easiest and most reliable way to avoid DKA is by checking your glucose at least 4­6 times a day . Routine checks allow you to identify and treat high glucose before DKA develops . To treat DKA · Once you have begun treatment for high glucose, check for
ketones . Check for ketones any time your glucose is 250 mg/dL or above . · If ketones are negative or trace, continue treating for high glucose . · If ketones are positive and you are feeling nauseated or ill, immediately contact your healthcare provider for guidance . · If ketones are positive but you are not feeling nauseated or ill, replace the Pod using a new vial of insulin . · Check your glucose again after 2 hours . If your glucose has not declined or if your ketone levels have risen or remain elevated, immediately contact your healthcare provider for guidance .
15.5 Handling Special Situations
Sick Days
Any physical or emotional stress can cause your glucose to rise, and illness is physical stress . Your healthcare provider can help you make a plan for sick days . The following are only general guidelines . When you are ill, check your glucose more often to avoid DKA . The symptoms of DKA are much like those of the flu. Before assuming you have the flu, check your glucose to rule out DKA (see “To Treat Hyperglycemia (High Glucose)” on page 242) . To handle sick days: · Treat the underlying illness to promote faster recovery . · Eat as normally as you can . Your body still needs carbohydrates
and insulin for energy . · Adjust bolus doses, if necessary, to match changes in meals
and snacks . · Always continue your basal insulin, even if you are unable to eat .
Contact your healthcare provider for suggested basal rate adjustments during sick days .
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Living with Diabetes 15
· Check your glucose every 2 hours and keep careful records of results .
· Check for ketones when your glucose is 250 mg/dL or higher, and/ or when you are feeling ill, as ketones can also be present when glucose is in range during illness .
· Follow your healthcare provider’s guidelines for taking additional insulin on sick days .
· Drink plenty of fluids to avoid dehydration. · Contact your healthcare provider if symptoms persist .
Exercising, Playing Sports, or Working Hard
Check your glucose before, during, and after exercising, playing sports, or doing unusually hard physical labor . The Pod’s adhesive keeps it securely in place for up to 3 days . However, if necessary, several products are available to enhance adhesion . Ask your healthcare provider about these products . Avoid getting body lotion, creams, or oils near the infusion site; these products may loosen the adhesive . For some contact sports, if the Pod is in a location where it is likely to be knocked off, consider removing the Pod and placing a new one in a more protected location . Make sure to check your glucose before removing the Pod and after applying a new one . Pods are designed for one-time use . Do not attempt to reapply a Pod that has been removed . If you will need to remove the Pod for more than one hour, ask your healthcare provider to recommend appropriate guidelines .
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15 Living with Diabetes
X-rays, MRIs, and CT Scans
Warning: Device components including the Pod, Dexcom G6 Sensor and Transmitter, Dexcom G7 Sensor, and FreeStyle Libre 2 Plus Sensor may be affected by strong radiation or magnetic fields. Device components must be removed (and the Pod and Sensor should be disposed of) before X-ray, Magnetic Resonance Imaging (MRI), or Computed Tomography (CT) scan (or any similar test or procedure) . In addition, the Controller and 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 . The Pod and Controller can tolerate common electromagnetic and electrostatic fields, including airport security and cellular phones.
Surgery or Hospitalization
For scheduled surgeries or hospitalization, you should tell the physician/surgeon or hospital staff about your Pod. It may be necessary to remove it for certain procedures or treatments . Remember to replace the basal insulin that was missed while the Pod was removed . Your healthcare provider can help you prepare for these situations .
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SMARTBOLUS CALCULATOR
SmartBolus Calculator Important Safety Information

16 Delivering a Bolus

17

Delivering a SmartBolus

Bolus with Calculator

the

18 SmartBolus Calculator Calculations

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SmartBolus Calculator Important Safety Information

SmartBolus Calculator Warnings
Warning: AVOID changing your SmartBolus Calculator settings before consulting with your healthcare provider . Incorrect changes could result in overdelivery or under-delivery of insulin, which can lead to hypoglycemia or hyperglycemia . Settings that impact bolus calculations mainly include: Max Bolus, Minimum Glucose for Calculations, Correct Above, Correction Factor(s), Insulin to Carb (IC) ratio(s), Duration of Insulin Action, and Target Glucose .
Warning: ALWAYS check your glucose frequently when you use the extended bolus function to avoid hypoglycemia or hyperglycemia .
Warning: AVOID entering a blood glucose reading that is older than 10 minutes . If you use a reading older than 10 minutes, the bolus calculator could calculate and recommend an incorrect dose, which could result in over-delivery or under-delivery of insulin . This can lead to hypoglycemia or hyperglycemia .

Warning: ALWAYS be aware of your current sensor glucose value, trust how your body feels, and do not ignore symptoms of high and low glucose . Even though insulin delivery adjusts automatically in Automated Mode with the goal of bringing your glucose level to your defined Target Glucose, severe hypoglycemia or hyperglycemia may still occur .
If your sensor glucose values do not match your symptoms, ALWAYS check your blood glucose using a BG meter, consider treatment and/ or Sensor calibration (for Sensors requiring calibration, if necessary) . ALWAYS switch to Manual Mode if you feel you are receiving inaccurate sensor glucose values .
· Erroneously high sensor glucose values can cause excessive insulin delivery, leading to severe hypoglycemia, seizure, loss of consciousness or death .
· Erroneously low sensor glucose values can cause prolonged insulin suspension leading to hyperglycemia, DKA, or death .

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Important Safety Information

· If you are having symptoms that are not consistent with your blood glucose readings and you have followed all instructions described in this Technical User Guide, contact your healthcare provider .
Warning: Do NOT use Omnipod 5 System with a Dexcom Sensor if you are taking hydroxyurea, a medication used in the treatment of diseases including cancer and sickle cell anemia . Your Dexcom sensor glucose values could be falsely elevated and could result in overdelivery of insulin which can lead to severe hypoglycemia .
Warning: DO NOT use the Omnipod 5 System with the FreeStyle Libre 2 Plus Sensor if you are taking more than 1000mg of ascorbic acid (Vitamin C) per day, a substance found in supplements like multivitamins or cold remedies such as Airborne® and Emergen-C® . Taking more than 1000mg of Vitamin C per day may falsely raise your sensor glucose values and result in over-delivery of insulin that could result in severe hypoglycemia .

SmartBolus Calculator Precautions
Caution: ALWAYS check your glucose prior to delivering a bolus so you are better informed on how much to take . Delivering a bolus without checking your glucose could result in the over-delivery or under-delivery of insulin, which can lead to hypoglycemia or hyperglycemia .
Caution: DO NOT navigate away from the Omnipod 5 App while you are in the process of making changes to your insulin delivery settings . If you leave the app before you are able to save the setting change and before the app is able to put the setting change into effect, the system will continue to use your last saved settings . As a result, you may continue with therapy settings that you did not intend . If you are unsure about whether your changes were saved, review your settings .
Caution: During the first 12 hours of use of a FreeStyle Libre 2 Plus Sensor, use a fingerstick reading from a BG meter before making treatment decisions. After the first 12 hours, you can tap “Use Sensor” to use the value and trend in the SmartBolus Calculator .

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CHAPTER 16
Delivering a Bolus

Delivering a Bolus

16.1 Delivering a Manual Bolus
In certain situations, you may decide to deliver a manual bolus . A manual bolus is a bolus that you have calculated without the help of the SmartBolus Calculator . You can use manual boluses when the SmartBolus Calculator is temporarily disabled or when you choose not to use the SmartBolus Calculator . Consult your healthcare provider for instructions about how to calculate a bolus . You can extend some or all of a manual bolus in Manual Mode . When delivering a manual bolus, the Omnipod 5 System does not adjust the bolus amount based on your glucose value, carbohydrates being consumed, or IOB as it does when the SmartBolus Calculator is used . Note: Any bolus delivered by you will be considered as IOB and may impact automated insulin delivery in Automated Mode . Current glucose values will continue to be considered in Automated Mode and may impact automated insulin delivery . A bolus cannot be greater than your Maximum Bolus setting . See “Note: The Extended Bolus feature can only be used in Manual Mode . All other therapy settings are used similarly in both Manual and Automated Modes .” on page 272 . To deliver a manual bolus: 1 . On the Home screen, tap the Bolus button ( ) . 2 . Tap the Total Bolus field and enter the bolus amount. 3 . Tap Done . 4 . To deliver the entire bolus immediately, tap CONFIRM . 5 . Review the bolus details on the Confirm Bolus screen. 6 . Tap START to begin the bolus . The bolus amount and bolus details are stored in your history records . The Home screen tracks the delivery of an immediate or extended bolus .
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Delivering a Bolus 16

16.2 Delivering Immediate and Extended Boluses
A bolus is an extra dose of insulin that is delivered in addition to the continuous basal rate of insulin delivery . Use boluses to cover the carbohydrates in a meal and/or bring down a high glucose .
You have the option of delivering the entire bolus at once . This is referred to as an “immediate bolus” or, simply, a “bolus .” In Manual Mode, you can also spread out the delivery of all or part of a meal bolus so that it is delivered steadily over a specified period of time. This is referred to as an “extended bolus .”

Insulin infusion (U)

5 .0 Bolus

4 .0

(immediate)

3 .0 Basal Program

2 .0

1 .0

0 Midnight

6 am Noon

Extended bolus
6 pm Midnight

You may want to extend a bolus if your meal contains high-fat or high-protein foods . These foods slow down digestion and therefore slow down the post-meal rise in your glucose .

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16 Delivering a Bolus
16.3 Tracking the Progress of a Bolus
During a bolus, the Home screen displays a progress bar . Immediate bolus progress During an immediate bolus, the Home screen displays a Delivering Bolus message along with a progress bar and details . An estimate of the IOB is displayed in the lower left of the screen . If IOB is unavailable, then the amount of the last completed bolus is displayed in the lower left of the screen . Note: You cannot navigate within the Omnipod 5 App during an immediate bolus . Note: Look for the progress bar to confirm the bolus delivery has started before navigating away from the Omnipod 5 App . To cancel a bolus, see “16 .4 Canceling a Bolus in Progress” on page 256 .
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Delivering a Bolus 16
Extended bolus progress During an extended bolus, the Home screen’s DASHBOARD tab displays a Delivering Extended Bolus message along with a progress bar and other details . An estimate of the IOB is displayed in the lower left of the screen . If IOB is unavailable, then the amount of the last completed bolus is displayed in the lower left of the screen . Note: You can still navigate within the Omnipod 5 App during an extended bolus but some functions will be unavailable until the bolus is complete. Unless you cancel the bolus, the Pod will finish delivering a bolus whether or not it is in range of the Controller or smartphone running your Omnipod 5 App . To cancel a bolus, see “16 .4 Canceling a Bolus in Progress” in the next section .
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16 Delivering a Bolus
16.4 Canceling a Bolus in Progress
When an immediate bolus is in progress, you must cancel it or allow it to finish before performing any other action. During an extended bolus, you can use your Omnipod 5 System normally, except that the Bolus button will be disabled (grayed out), preventing you from

Documents / Resources

Insulet Corporation 029D Omnipod 5 Pod [pdf] User Guide
029D, 29D, RBV-029D, RBV29D, RBV-29D, 029D Omnipod 5 Pod, 029D, Omnipod 5 Pod, 5 Pod, Pod

References

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