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142

15About Automated Mode

Automated insulin delivery

Automated insulin delivery changes as your CGM value and trend change. e

table below describes how CGM trend aects your automated insulin delivery in

Automated Mode:

Automated insulin delivery depends on your baseline

adaptive basal rate. is rate is based on your past insulin

usage and adapts with each Pod change.

e System works to keep CGM values at your specied

Target BG (110-150 mg/dL).

Your automated insulin deliveries increase when you are

predicted to be above your Target BG.

Your automated insulin deliveries decrease or pause if you

are predicted to be below your target BG.

e System always pauses insulin delivery when CGM

values are under 60 mg/dL.

e main information that informs Automated Mode insulin delivery is your

past insulin history or average total daily insulin, together with your Target BG.

If you are very insulin sensitive, the system knows to give you less insulin than

if you have higher insulin needs. While you are using Automated Mode, the

main adjustable setting aecting automated insulin delivery is Target BG. Bolus

Calculator settings can also be adjusted including Insulin to Carbohydrate ratio,

Correction Factor, Correct Above, Reverse Correction and Duration of Insulin

Action. ese all aect the bolus amounts you deliver during both Manual Mode

and Automated Mode. It is important to understand that changing your Basal

Programs, Max Basal, Correction Factor or Duration of Insulin Action setting will

not make a dierence for automated insulin delivery during Automated Mode.

Automated

Mode

Effective Date: 22DEC2020, PCO-000267

Summary of content (100 pages)

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5About Automated Mode Automated insulin delivery Automated insulin delivery changes as your CGM value and trend change. The table below describes how CGM trend affects your automated insulin delivery in Automated Mode: Automated insulin delivery depends on your baseline adaptive basal rate. This rate is based on your past insulin usage and adapts with each Pod change. The System works to keep CGM values at your specified Target BG (110-150 mg/dL).
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About Automated Mode15 15.2. About the Dexcom G6 in Automated Mode While in Automated Mode, the Omnipod 5 System relies on your CGM values to deliver the correct automated insulin delivery. CGM values and trends are also used by the Bolus Calculator. It is important that your Dexcom G6 is functioning properly. To ensure CGM accuracy, be aware of your CGM values. If you are experiencing symptoms that do not align with your CGM values, use a separate BG meter to test.
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15About Automated Mode available, for example, when using your first Pod or your first Pod after a pump break of more than a few weeks, the Pod uses your Basal Program as a base for calculations. All of your insulin delivery history is stored in your Omnipod 5 app and is available to your new Pod when you change your Pod. If you reset or replace the Omnipod 5 app, your adaptive basal rate will be based on your Basal Program until 48 hours of data from your new Pod is passed to the next Pod at Pod change.
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Chapter 16: HypoProtect™ Contents 16.1. About HypoProtect™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 16.2. Starting HypoProtect™. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Before you begin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Automated Mode 16.3. Canceling HypoProtect™ . . . . . .
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16HypoProtect™ 16.1. About HypoProtect™ Caution: Closely monitor your glucose levels while using HypoProtect™ to avoid possible hypoglycemia and/or hyperglycemia. While in Automated Mode, you cannot start a temp basal or manually pause insulin delivery. The Omnipod 5 System provides an option for modified automated insulin delivery through HypoProtect™. HypoProtect™ can be useful in times when you need less insulin, for example, when you are exercising.
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HypoProtect™16 16.2. Starting HypoProtect™ Before you begin ¾ Switch to Automated Mode, if currently using Manual Mode. See "14.1. Switching from Manual Mode to Automated Mode" on page 136. To start HypoProtect™: 1. Navigate to: Menu icon ( ) > HypoProtect™ 2. Tap the Duration field and select the HypoProtect™ duration. 3. Tap CONFIRM. 4. From the Confirmation screen, tap START. Automated Mode The INSULIN tab changes to a green PROTECT tab when HypoProtect™ is started. 16.3.
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SETTINGS, HISTORY, AND UPDATES 17 Changing Settings 18 Browsing Your History and Records 19 Managing Software Updates Effective Date: 22DEC2020, PCO-000267
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Chapter 17: Changing Settings Contents 17.1. General Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Network connectivity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 Airplane mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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17 Changing Settings 17.4. Glucose Goal Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 17.5. Basal and Temp Basal Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Maximum Basal Rate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Temp basal. . . . . . . . . . . . . . . . . . . . . . . . .
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Changing Settings 17 17.1. General Settings Some settings will differ between the Insulet-provided controller with the Omnipod 5 app and the Omnipod 5 app on your smartphone. If you are using the controller, settings allow you to change your network connectivity, screen display settings, lock screen settings, time zones, and also check alarms, and reset the controller.
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17 Changing Settings Screen brightness To adjust brightness of the screen on the controller: 1. Navigate to: Menu icon ( ) > Settings > PDM Device > Brightness. 2. Place your finger on the blue dot of the slider. Slide your finger to the right to increase the screen brightness. Slide your finger to the left to decrease the screen brightness. Tip: Lower screen brightness extends the battery charge.
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Changing Settings 17 Time zone The Omnipod 5 app automatically acquires and sets the time, date, and time zone every time it is turned ON. You can manually change the time zone. If you are traveling to a different time zone, see "Plan for changing time zones" on page 275. If you change the time zone, the change is noted on the Home and History screens. The Pod expiration time on the POD INFO tab is adjusted to reflect the new date and time.
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17 Changing Settings To verify that your Omnipod 5 app and Pod's alarms and vibration functions are working properly, you can test them as follows: 1. Navigate to: Menu icon ( ) > Settings > PDM Device > 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 Omnipod 5 app beeps and vibrates three times. Then, if you are wearing a Pod, the Pod beeps several times and sounds the alarm tone for several seconds. 5.
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Changing Settings 17 17.3. Reminder Settings Reminder notifications bring attention to various actions you may want to perform (see "20.12. Reminder Notifications List" on page 219 and "20.5. Understanding Regular Tones and Vibrations" on page 192). Note: If you have turned sound/vibration OFF on your controller or smartphone, the Omnipod 5 app will not beep/vibrate at the time of the reminder notification.
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Changing Settings provider prior to changing the Pod Shut-Off setting. This feature requires active participation on your part. To enable or disable Pod Shut-Off: 1. Navigate to: Menu icon ( ) > Settings > Reminders > Pod Shut-Off. 2. Tap the Pod Shut-Off toggle to enable or disable the Pod Shut-Off feature. 3. If Pod Shut-Off is enabled, tap the Inactivity Timer field and select the length of time for the countdown timer. This setting can range from 1 to 24 hours.
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Changing Settings 17 Enable or disable a single Missed Bolus reminder To turn an individual Missed Bolus reminder ON or OFF: 1. Navigate to: Menu icon ( ) > Settings > Reminders > Missed Bolus. 2. Tap the toggle next to an individual Missed Bolus reminder to turn it ON or OFF. Add a new Missed Bolus reminder To add a new Missed Bolus reminder: 1. Navigate to: Menu icon ( ) > Settings >Reminders > Missed Bolus. 2. Tap Add Reminder.
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17 Changing Settings Confidence reminders When confidence reminders are ON, you will hear a tone at the start and end of a bolus, extended bolus, or temp basal: • The Omnipod 5 app beeps at the start. • The Pod beeps at the end. Confidence reminders are especially useful when you are getting familiar with your Omnipod 5 app and Pod. To turn confidence reminders ON or OFF: 1. Navigate to: Menu icon ( ) > Settings > Reminders. 2.
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Changing Settings 17 Edit or turn ON or OFF an individual custom reminder If custom reminders are enabled, you can edit or turn ON or turn OFF an individual custom reminder: 1. Navigate to: Menu icon ( Reminders. ) > Settings > Reminders > Custom 2. Tap the name of a custom reminder. 3. Tap the toggle next to Custom Reminder to turn this custom reminder ON or OFF. 4. Make any desired changes to the frequency, day(s), time, name, and text. 5. Tap SAVE.
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17 Changing Settings 17.4. Glucose Goal Range The goal of using the Omnipod 5 System is to keep your glucose within your CGM/BG Goal Range. You define this range by setting the upper and lower limits. The CGM Graph and the Enter BG screen use the CGM/BG Goal Range to determine which glucose readings are within your goal and which are above or below your goal. Note: The Bolus Calculator does not use the CGM/BG Goal Range values to calculate a bolus. Your defined Target BG is used during bolus calculations.
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Changing Settings 17 Temp basal To turn ON or OFF the ability to set temp basals: 1. Navigate to: Menu icon ( ) > Settings > Basal & Temp Basal. 2. To enable or disable the ability to set temporary basal rates (temp basals), tap the toggle ON or OFF. 3. To change between using percent (%) or flat rate (U/hr) temp basals: a. Tap Temp Basal. b. Select the desired method for setting a temp basal: • Tap Percent (%) to modify the Basal Program in progress by a set percentage increase or decrease.
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17 Changing Settings 1. Navigate to: Menu icon ( ) > Settings > Bolus. 2. Tap the toggle next to Extended Bolus to turn ON or OFF the ability to extend a bolus. Bolus Calculator settings This section describes how to adjust the settings used by the Bolus Calculator to calculate meal and correction boluses. Tip: Write a list of all of the desired settings and segments to guide you through reentering the values for each segment.
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Changing Settings 17 Minimum BG for Calcs Your Minimum BG for Calcs is used to prevent you from delivering a bolus when your BG is too low. If your blood glucose reading is below your Minimum BG for Calcs, the Bolus Calculator is disabled and does not calculate a bolus. To edit this value: 1. Navigate to: Menu icon ( ) > Settings > Bolus > Min BG for Calcs. 2. Tap the Min BG for Calcs field and enter the desired value. 3. Tap SAVE.
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17 Changing Settings Correction Factor The Bolus Calculator uses your Correction Factor to calculate a correction bolus when your blood glucose value is above your Correct Above setting (see "23.4. The Bolus Calculator" on page 256). To edit this value: 1. Navigate to: Menu icon ( ) > Settings > Bolus > Correction Factor. 2. Tap NEXT. 3. To edit a segment, tap the row containing the segment you want to edit. a. Tap the End Time field to enter a new end time. b.
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Chapter 18: Browsing Your History and Records Contents 18.1. About Your Recent History and Past Records . . . . . . . . . . . . . . . . . . . . 168 18.2. Viewing the CGM Graph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168 18.3. CGM Graph States. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169 18.4. History Summary Section . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172 18.6.
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18Browsing Your History and Records 18.1. About Your Recent History and Past Records The Omnipod 5 app can store 90 days of history records. Once the memory is full, new records begin to replace the oldest records. You can browse, but not edit the information in your records.
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Browsing Your History and Records18 18.3. CGM Graph States The top section of the CGM Graph changes color based on your current system mode. When the Omnipod 5 System is in Manual Mode, the graph heading is light gray. 1. 2. 6. 3. 4. 7. 5. The graph shows your most recent CGM readings over the last 3 hours. Tip: Use your Dexcom G6 app to view CGM readings that are more than 3 hours old. 1. Current Status: Your current CGM value and trend arrow display, along with current IOB 2.
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18Browsing Your History and Records • An orange line during time that the maximum amount of basal insulin was delivered by the Omnipod 5 System • Bolus icon at the time you started a bolus 6. Vertical axis: Displays CGM values in mg/dL 7. Time scale: Displays hour and half-hour markings. When the Omnipod 5 System is in Automated Mode, the graph heading is purple. When the Omnipod 5 System is in Automated Mode: Limited state, the graph heading is dark gray.
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Browsing Your History and Records18 History information overview You can access history summary and detail information and a list of automated events from the History Detail screen. ¾ Navigate to: Menu icon ( ) > History Detail. Date Summary Section -Tap AUTO EVENTS to see automated event details CGM/BG Summary Insulin and Carb summary Details section - Swipe to see expanded details Today's history records are displayed below the summary circles, beginning with the newest records on the top.
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18Browsing Your History and Records 18.4. History Summary Section The upper section of the History screens summarize the records for the day. Summary item Description Row 1 - CGM Average CGM Average of CGM values for the day. CGM in Range Percentage of CGM values within your CGM/BG Goal Range. CGM Above Percentage of CGM values above your CGM/BG Goal Range. CGM Below Percentage of CGM values below your CGM/BG Goal Range.
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Browsing Your History and Records18 When insulin delivery is unconfirmed After receiving a command to deliver 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: Total Bolus Insulin amount for the day is displayed as dashes (- -) along with a gray exclamation point (!) if there are estimated bolus deliveries.
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18Browsing Your History and Records 18.5. 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 CGM values (including HIGH and LOW values) and exclude manually-entered readings. Item Calculation Row 1 Average = Sum of all CGM values CGM Total number of CGM values Note: HIGH CGM values are included as 401 and LOW CGM values as 39.
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Browsing Your History and Records18 Summary item Calculation Row 2 Total Insulin = Sum of basal and bolus insulin delivered Basal Insulin = Amount of basal insulin delivered in Manual 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 Bolus Calculator 18.6. History Details Section Swipe up on the history screens to see the details section.
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18Browsing Your History and Records Bolus details The icon displayed with a bolus entry indicates whether the Bolus Calculator was used: • The insulin bottle icon ( • The syringe icon ( ) indicates that the Bolus Calculator was used. ) indicates a manual bolus was delivered. Immediate and extended boluses The bolus amount listed next to the Bolus icon is the total of an immediate bolus plus any extended portion of the bolus.
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Browsing Your History and Records18 Extended bolus events A Bolus icon and banner indicate an extended bolus event: • An Extended Bolus started banner marks the time when the immediate bolus has finished and the extended bolus begins. 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.
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18Browsing Your History and Records Basal rate details HypoProtect™ In Automated Mode, a HypoProtect icon and banner indicate the start, end or cancellation of HypoProtect. 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.
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Browsing Your History and Records18 Time zone change details A Time zone changed banner appears if you change the time zone. Once the time zone change has occurred, the times shown in the History will update to reflect the new time zone. 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.
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Chapter 19: Managing Software Updates Contents 19.1. Insulet-provided Controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Operating System (OS) update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182 Omnipod 5 App update on the controller. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183 Settings History Updates 19.2. Omnipod 5 App on Smartphone .
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19Managing Software Updates 19.1. Insulet-provided Controller When connected to a network, the Omnipod 5 controller offers over-theair 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.
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Managing Software Updates19 To manually update the operating system of the controller: 1. Ensure your controller is currently charging or the battery is charged to above 40%. 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 will be displayed to inform you that the update was completed successfully. Omnipod 5 App update on the controller Omnipod 5 app updates may be either "optional" or "forced".
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19Managing Software Updates 19.2. Omnipod 5 App on Smartphone The Omnipod 5 app offers updates through the Google Play Store. You will be notified when an update is available for download. It is important to note that 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 will continue delivering insulin and will re-establish connection with the Omnipod 5 app once the update is complete.
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NOTIFICATIONS & TROUBLESHOOTING 20 Alarms, Action and Reminder Notifications 21 Troubleshooting Effective Date: 22DEC2020, PCO-000267
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Chapter 20: Alarms, Action and Reminder Notifications Contents 20.1. Notifications and Alarms Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189 20.2. Types of Alarms and Notifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 190 20.3. Priority and Predictability of Alarms and Notifications . . . . . . . . . . 191 20.4. Sounds and Vibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192 20.5.
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20Alarms, Action and Reminder Notifications Daylight Savings Time Change. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device Not Compatible. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Device Not Secure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Alarms, Action and Reminder Notifications20 20.1. Notifications and Alarms Screen To review past notifications and alarms: 1. Tap Menu icon ( ) > Notifications. Messages from today are displayed first, followed by messages from previous days with the most recent at the top and the oldest at the bottom. Swipe up to see additional messages. 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.
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20Alarms, Action and Reminder Notifications 20.2. Types of Alarms and Notifications Warning: If you need to return the controller for replacement, contact your healthcare provider for instructions about using injections to ensure appropriate insulin delivery. Warning: Do not turn off or prevent Omnipod 5 notifications from appearing on your phone. Without notifications enabled, you may miss alarms and important updates.
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Alarms, Action and Reminder Notifications20 20.3. Priority and Predictability of Alarms and Notifications Hazard alarms take priority over advisory alarms. In general, only one hazard alarm can occur at a time. In the unlikely event that a Pod and Omnipod 5 app hazard alarm occur simultaneously, the Omnipod 5 app hazard alarm is displayed first. Advisory alarms take priority over Action Item notifications, which take priority over reminder notifications.
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20Alarms, Action and Reminder Notifications 20.4. Sounds and Vibrations The Omnipod 5 System uses sounds and vibrations to attract your attention to an alarm or notification. Caution: The Omnipod 5 app does not override any of your phone's sound settings. If your phone is set to Do Not Disturb, Silent, or Vibrate, you may not hear alarms and notifications from the Omnipod 5 app. Tip: To test the sounds and vibrations, see "Check alarms" on page 155.
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Alarms, Action and Reminder Notifications20 Note: If your controller or smartphone has sound and vibration turned OFF, you will miss the Omnipod 5 app tones described below. Confidence reminders—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 160. Omnipod 5 app: Tone/vibration at the start of a temp basal, bolus, or extended bolus.
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20Alarms, Action and Reminder Notifications 20.6. Responding to Alarms Although you do not have to keep your Omnipod 5 or Dexcom G6 app close to remain in Automated Mode, both apps provide important information including recent insulin delivery, alerts, and alarms; so it is recommended that you keep these apps nearby. Tip: Keep your apps nearby so you can quickly review and respond to important alarms and notifications. To respond to a hazard alarm or advisory alarm: 1. Wake up your controller.
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Alarms, Action and Reminder Notifications20 Blockage Detected Cause Vibration/Tone What to do The Pod’s cannula is blocked, which has stopped insulin delivery. Receiving too little insulin may lead to hyperglycemia and DKA. The Pod sounds the alarm. The Omnipod 5 app also sounds the alarm, if enabled. 1. Tap OK, DEACTIVATE POD NOW. 2. Change your Pod. Troubleshooting 3. Check your blood glucose.
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20Alarms, Action and Reminder Notifications Omnipod 5 error Cause Vibration/Tone What to do An unexpected error is detected in the Omnipod 5 app. Note: If your Omnipod 5 app stopped and restarted on its own, you may have noticed the app flashing white for a few seconds before you saw this screen. The Omnipod 5 app sounds the alarm if enabled. 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.
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Alarms, Action and Reminder Notifications20 Omnipod 5 memory corruption Cause Vibration/Tone What to do An unexpected error is detected in the Omnipod 5 app. The Omnipod 5 app sounds the alarm, if enabled. 1. Tap OK to acknowledge or silence the alarm. You see a message asking you to remove your Pod and reset the Omnipod 5 app. 2. Call Customer Care immediately. 3. Check your blood glucose. Pod Error Vibration/Tone What to do The Pod detects an unexpected error. The Pod sounds the alarm.
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20Alarms, Action and Reminder Notifications Pod Expired Cause Vibration/Tone What to do The Pod has reached the end of its operating life and insulin delivery has stopped. The Pod sounds the alarm. The Omnipod 5 app also sounds the alarm, if enabled. 1. Tap OK, DEACTIVATE POD NOW. 2. Change your Pod. 3. Check your blood glucose. Note: If you do not deliver insulin soon, you could develop hyperglycemia.
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Alarms, Action and Reminder Notifications20 Pod Shut-Off Cause Vibration/Tone What to do The Pod has stopped delivering insulin because you did not respond to the Pod Shut-Off advisory alarm. The Pod sounds the alarm. The Omnipod 5 app also sounds the alarm, if enabled. 1. Tap OK, DEACTIVATE POD NOW. 2. Change your Pod. 3. Check your blood glucose. Note: To change the Pod Shut-Off setting, see "Pod Shut-Off" on page 157. Note: If you do not deliver insulin soon, you could develop hyperglycemia.
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20Alarms, Action and Reminder Notifications 20.8. Advisory Alarm List Advisory alarms inform you of a situation that needs your attention in the near future. Warning: Three advisory alarms (Pod Expiration, Low Pod Insulin, and Pod Shut-Off) become hazard alarms and result in a stoppage of insulin delivery if ignored. Be sure to respond to all advisory alarms when they occur. Automated Delivery Restriction Only occurs in Automated Mode. Cause What to do Insulin was either 1.
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Alarms, Action and Reminder Notifications20 While in Manual Mode, you can check your CGM graph to find out whether your insulin has been paused or has been at a maximum for a long time. Automated Mode: Limited state is the automated insulin delivery used when CGM values are not available. Insulin delivery is based on your settings and recent history. At this point, you are receiving a steady basal rate that will not vary until CGM readings are restored.
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20Alarms, Action and Reminder Notifications Low Pod Insulin Cause Vibration/Tone What to do The amount of insulin in the Pod is below the value specified in your settings. The Pod sounds the alarm. The Omnipod 5 app also sounds the alarm, if enabled. 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 157.
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Alarms, Action and Reminder Notifications20 Missing CGM Values Only occurs in Automated Mode. Cause The Pod has not received CGM values for more than one hour. The system will continue to operate in Automated Mode: Limited state until CGM values are received or until you switch to Manual Mode. The Omnipod 5 app sounds Vibration/Tone the alarm. ¾ Tap OK to acknowledge What to do the alert. For more information about Automated Mode: Limited state, see "15.5. About Automated Mode: Limited" on page 144.
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20Alarms, Action and Reminder Notifications Pod Shut-Off Cause The Pod Shut-Off setting is enabled and you have not used your Omnipod 5 app in the Pod Shut-Off period that you specified. The Pod will stop delivering insulin soon if you do not respond to this alarm. The Pod sounds the alarm. Vibration/Tone The Omnipod 5 app also sounds the alarm, if enabled. ¾ Tap OK to reset the Pod What to do Shut-Off timer.
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Alarms, Action and Reminder Notifications20 Urgent Low Glucose Cause Your glucose level is at or below 55 mg/dL according to what your CGM told the Omnipod 5 app. The Pod sounds the alarm. Vibration/Tone The Omnipod 5 app also sounds the alarm, periodically, if enabled, until acknowledged or a CGM value over 55 mg/dL is received. ¾ Tap OK to acknowledge What to do the alarm. Note: This alert will occur again if another CGM value of 55 mg/dL or lower is received after the initial alert was acknowledged.
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20Alarms, Action and Reminder Notifications 20.9. Action Item Notification List Action Item notifications are tasks that need your attention. App Use Blocked Cause What to do The installed version of the Omnipod 5 app is no longer supported for usage. 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 updated notifications frequently.
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Alarms, Action and Reminder Notifications20 Attention Cause What to do Your smartphone's operating system has not been completely tested for use with the Omnipod 5 System. 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 app is working, call Customer Care.
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20Alarms, Action and Reminder Notifications Daylight Savings Time Change Cause What to do The Omnipod 5 app has detected that daylight savings time has started or ended. ¾ Tap UPDATE to update your 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 icon ( ) > Notifications and in 24 hours you will be reminded to update.
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Alarms, Action and Reminder Notifications20 Device Not Secure Cause What to do Your lock screen security has been turned OFF. It is strongly recommended you set and keep a security method on your smartphone to protect against unintended use and accidental therapy changes. The Omnipod 5 app will require you to enter your smartphone security method, such as your PIN or fingerprint, each time you access the app. 1. Tap SET UP. 2. Enable your passcode or other security method.
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20Alarms, Action and Reminder Notifications OS Not Compatible Cause What to do The Omnipod 5 app cannot be used on the your device’s current operating system (OS)” 1. If you have an active Pod, tap DEACTIVATE POD. 2. Check your Omnipod 5 app frequently to see when Insulet has approved app use on the current OS your device is operating on. You will not get a notification from the Omnipod 5 app when this occurs. For a list of compatible operating systems, go to https://www.omnipod.com/ compatibility.
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Alarms, Action and Reminder Notifications20 Stop Optimizing Battery Usage Cause 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. Your smartphone battery must NOT be optimized 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. What to do 1.
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20Alarms, Action and Reminder Notifications Turn On Automatic Date and Time Cause What to do You have turned OFF Automatic Date and Time in your smartphone settings. The Omnipod 5 app has many therapy-related actions that depend on time. Automatic Date and Time is a setting on your smartphone that ensures the accuracy of your time. The Omnipod 5 app uses the setting to detect if you have traveled to a different time zone. 1. Tap OK. You will be taken to the Android "Date and Time" screen. 2.
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Alarms, Action and Reminder Notifications20 Turn Notifications ON Cause You have turned OFF any of the following: Show notifications, Hazard & Advisory Alarms, or Action Item Notifications What to do Omnipod 5 notifications should be turned ON in your smartphone settings so that you get important information regarding your insulin therapy and alarms. 1. Tap TURN ON when prompted. You see the Android "App Notifications" screen. 2. Tap Show notifications to turn Omnipod 5 app notifications ON.
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20Alarms, Action and Reminder Notifications Update Omnipod 5 - App No Longer Supported Cause What to do The Omnipod 5 version you are currently using is obsolete and no longer supported. 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.
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Alarms, Action and Reminder Notifications20 Update OS Cause What to do An operating system update is available for your controller. 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. Troubleshooting 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.
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20Alarms, Action and Reminder Notifications Update Time Zone Cause What to do Your controller or smartphone time zone does not match the Omnipod 5 app insulin delivery time zone. 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.
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Alarms, Action and Reminder Notifications20 20.10. Silencing Alarms You can usually silence Pod or Omnipod 5 app alarms by tapping a button on the alarm screen displayed on your Omnipod 5 app. If the alarm continues, or if you are discarding a Pod and want to prevent a future alarm, follow the directions in this section. Press down firmly. Pod alarm To permanently silence a Pod alarm: 1. If the Pod is on your body, remove it. 2.
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20Alarms, Action and Reminder Notifications 20.11. Responding to Reminder Notifications Reminder Notifications remind you about actions you may want to perform. Finding out about reminder notifications To alert you to a notification, the Pod sounds a tone and the Omnipod 5 app either sounds a tone or vibrates (see "20.4. Sounds and Vibrations" on page 192). When you hear a sound or feel a vibration, check your Omnipod 5 app for a message.
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Alarms, Action and Reminder Notifications20 4. Tap the back arrow ( ) in the upper left of the screen to mark the notifications as acknowledged. Note: Putting the Omnipod 5 app to sleep by pressing the Power button does not mark the notifications as acknowledged. You must tap the back arrow ( ) to acknowledge the notification. 20.12. Reminder Notifications List Reminder Notifications remind you about various actions you may want to perform.
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20Alarms, Action and Reminder Notifications No Active Pod Screen Displayed Cause Vibration/Tone What to do The Omnipod 5 app reminds you to activate a new Pod to begin basal insulin delivery. Every 15 minutes. Unlock the Omnipod 5 app. Activate a new Pod. Check BG After Pod Change Screen Displayed Cause Vibration/Tone What to do The Omnipod 5 app reminds you to check your blood glucose and the cannula infusion site 90 minutes after activating a new Pod. Every 5 minutes until acknowledged.
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Alarms, Action and Reminder Notifications20 Check BG After Bolus Screen Displayed Cause Vibration/Tone What to do The Omnipod 5 app reminds you to check your blood glucose after a bolus. Every 5 minutes until acknowledged. Acknowledge the message (see "Acknowledging reminder notifications" on page 218). Check your blood glucose. Note: To edit these reminders, see "Check BG after bolus" on page 158.
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Chapter 21: Troubleshooting .Contents 21.1. Pod Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 224 21.2. Controller or Smartphone Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225 21.3. Automated Mode Issues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 226 21.4. Finding Out How Much Insulin Was Delivered. . . . . . . . . . . . . . . . . . . 227 21.5. Viewing CGM Values. . . . .
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21Troubleshooting Introduction Omnipod 5 System users have frequently asked about the following topics, which are detailed next, with their main causes and recommended actions. 21.1. Pod Issues Issue Possible Cause During Pod activation, did not hear the 2 beep confirmation after filling the Pod with insulin The adhesive around the Pod keeps lifting from the skin Pod not filled with at Make sure the Pod is filled with least 85 units of insulin. at least 85 units of insulin.
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Troubleshooting21 21.2. Controller or Smartphone Issues Issue Possible Cause What to do Cannot run the Omnipod 5 app on a particular smartphone The Omnipod 5 app will work only on selected smartphones. Review the list of the latest compatible smartphones at https://omnipod.com/ compatibility. Screen turns black Screen Time-Out (times out) too setting needs soon adjustment. Try restarting the controller by holding down the Power button for 10 seconds.
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21Troubleshooting 21.3. Automated Mode Issues Issue Possible Cause What to do Activated a Pod and unable to switch to Automated Mode You can switch from Manual Mode to Automated Mode after you have activated a Pod and your CGM transmitter serial number is entered into the Omnipod 5 app. Interruption in communication between the CGM and the Pod. ¾ Go to: Menu icon ( ) > Settings > CGM Transmitter.
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Troubleshooting21 21.4. Finding Out How Much Insulin Was Delivered Issue What to do Where to see how much insulin is delivered while in Automated Mode The CGM graph will show you the latest CGM value received by the Pod and what mode of insulin delivery the system is in. (To see the graph, tap VIEW from the lower right part of the Home screen.) The graph will also show when your last boluses were delivered.
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21Troubleshooting 21.5. Viewing CGM Values Issue Possible Cause What to do Activated a Pod and can't see CGM values in the Omnipod 5 app Problem with the CGM. Check your Dexcom G6 app and if you don't see CGM values, then follow instructions there. CGM transmitter serial number is not entered into the Omnipod 5 app. 1. Go to: Menu icon ( ) > Settings > CGM Transmitter. You are using the Dexcom G6 receiver. 1. Use the Dexcom G6 app on your smartphone.
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Troubleshooting21 Issue Possible Cause What to do CGM values no longer show up in the Omnipod 5 app. Instead there are dashed lines. The Dexcom G6 app does not show a problem. The most likely reason for this to happen is an interruption in communication between the CGM and the Pod. To minimize the risk of interruption, make sure your CGM and Pod are worn on the same side of the body. Wireless communications do not travel well through the body.
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21Troubleshooting 21.6. Bolus Issues Issue Possible Cause What to do With carbs entered and CGM value available, the Bolus Calculator recommends no bolus or 0 insulin. You have already received a lot of insulin (your IOB will be high) and your CGM trend is falling. You can remove the CGM value so that the calculator only suggests a bolus amount for the carbs entered. Alternatively, you can decide on a different amount and enter this directly into the Total Bolus field at the bottom of the screen.
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Troubleshooting21 21.7. Review of High Glucose Examples Issue Possible Cause What to do After using the system for a couple of weeks CGM values are running high after breakfast. Insulin to carbohydrate ratio is the same. One of the benefits of automated insulin delivery is the greater ability to stay closer to your Target BG overnight. What this often means is that prior to breakfast, there is less insulin in your body compared to Manual Mode.
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21Troubleshooting Issue Possible Cause What to do After using the system in Automated Mode for a few weeks, CGM values have been running high. Your Target BG may need to be adjusted. In Automated Mode, Target BG is the main setting that you can control to adjust automated insulin delivery. Check your Target BG here: Other Bolus Calculator settings may need to be adjusted. Menu icon ( Bolus ) > Settings > The Target BG can be set between 110-150 mg/dL.
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Troubleshooting21 21.8. Review of Low Glucose Examples Issue Possible Cause CGM values are running low in the late evening; needing hypo treatment before going to bed. Your Target BG Check your Target BG here: may need to be Menu icon ( ) > Settings > Bolus adjusted for the period to avoid the low. Discuss with your healthcare provider what settings are best for you.
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21Troubleshooting 21.9. About Keeping Your Apps Nearby Once you activate a Pod, you will start receiving insulin indicated by your active Basal Program. Once you enter the CGM transmitter serial number into the Omnipod 5 app, you can switch from Manual Mode to Automated Mode. In Automated Mode, the Pod will directly receive CGM values wirelessly and automate insulin delivery depending on your needs.
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Troubleshooting21 • CHECK STATUS: Move to a new location, then select this option to recheck for confirmation that the instruction was carried out. • DEACTIVATE POD: This should not be your first choice. When you select this option, you can follow the instructions for replacing your Pod. If the Omnipod 5 app has not sent the Pod the instruction, the Omnipod 5 app tells you to move to a new location and tap TRY AGAIN to reattempt communication.
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21Troubleshooting • TRY AGAIN: Select this option to attempt to reestablish communication. Error When Deactivating a Pod If a communication error occurs during Pod deactivation, the following options become available: • DISCARD POD: Select this option if the "TRY AGAIN" option has not resolved the problem. This will tell your Omnipod 5 app to unpair from that Pod. The Omnipod 5 app instructs you to remove your Pod and tap CONTINUE.
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Troubleshooting21 of your settings to re-enter into your Omnipod 5 app. You will also need to activate a new Pod after resetting. Issue Possible Cause What to do Omnipod 5 app does not work on the smartphone Using a smartphone If you are not using a compatible that is not smartphone, you will not be able to use compatible. the Omnipod 5 app. To find out if your smartphone is compatible, go to: https://www.omnipod.com/compatibility.
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21Troubleshooting Issue Possible Cause What to do Opening the Omnipod 5 app restarts setup process You cleared app data for the Omnipod 5 app. This causes you to lose all your settings and insulin history. Note: If you clear data for the Omnipod 5 app, your current Pod will still be delivering insulin but you won't be able to manage it with your Omnipod 5 app. 1. Remove the current Pod in order to stop receiving insulin. 2.
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ADDITIONAL INFORMATION 22 Taking Care of Your Controller and Pod 23 Understanding Insulin Delivery and Calculations 24 Living with Diabetes Effective Date: 22DEC2020, PCO-000267
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Chapter 22: Taking Care of Your Controller and Pod Contents 22.1. Pod and Insulin Storage and Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242 Pod and insulin storage. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 242 Pods and the environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .