3 Omnipod 5 System Overview DASHBOARD Tab The DASHBOARD tab displays the following information. Note: The DASHBOARD tab shows different content if a CGM transmitter is paired to the Omnipod 5 App. Without paired CGM transmitter • INSULIN ON BOARD (IOB): value displays when IOB is available. • INSULIN ON BOARD (IOB): displays as dashes when IOB is unavailable or there is no Pod communication. Tap MORE INFORMATION for possible reasons.
Omnipod 5 System Overview 3 With paired CGM transmitter • INSULIN ON BOARD (IOB) • CGM value (with trend arrow): when a CGM value is available. See "19.5. CGM Trend Arrows" on page 278. • CGM value (without arrow): when transmitter supplies a CGM value but is unable to report CGM trend. • HIGH: when CGM value received from your CGM transmitter is greater than 400. See "19.4. CGM Values" on page 277. • LOW: when CGM value received from your CGM transmitter is less than 40. See "19.4.
Omnipod 5 System Overview INSULIN Tab The INSULIN tab label changes to ACTIVITY when the Activity feature is enabled in Automated Mode or to TEMP ON when a temp basal is running in Manual Mode. Manual Mode By default, in Manual Mode, the INSULIN tab shows the name and graph of the userdefined Basal Program. A label below the Basal Program's name indicates whether the listed Basal Program is: • In progress—This program is running on the active Pod.
Omnipod 5 System Overview 3 Temp basal When a temp basal is running, the INSULIN tab label changes to TEMP ON and is highlighted in light blue. It displays the temp basal graph and allows you to cancel the temp basal. See"7.1. About Temporary Basal Rates" on page 104. Automated Mode In Automated Mode, the INSULIN tab shows AUTOMATED MODE: ACTIVE and displays LAST BOLUS and CGM INFO. For more information on using Automated Mode, see"About Automated Mode" on page 289.
3 Omnipod 5 System Overview POD INFO Tab The POD INFO tab shows whether there is an active Pod, and, if so, how much insulin is left in the Pod and when the Pod will expire. If the Omnipod 5 App cannot communicate with an active Pod, the POD INFO tab shows "No Pod Communication." Tap MORE INFORMATION for details.
Omnipod 5 System Overview 3 POD INFO banners When your Pod will expire soon, a yellow CHANGE POD SOON banner appears on the POD INFO tab. The yellow banner appears 12 hours before Pod expiration or at the time of your Pod expiration reminder, whichever is earlier. At 6 hours before Pod expiration, a red CHANGE POD banner appears on the POD INFO tab. When less than 5 units of insulin remain in the Pod, a red LOW POD INSULIN banner appears on the POD INFO tab.
3 Omnipod 5 System Overview Bolus Information and Button The lower left section of the Home screen displays bolus information. The Bolus button is at the bottom. Between boluses When a bolus is not being delivered, the section is labeled LAST BOLUS and shows the amount and time of the most recent bolus. During a bolus When a bolus is being delivered , the last bolus information is replaced by an estimate of the insulin on board (IOB): • During an immediate bolus, the IOB estimate is updated every second.
Omnipod 5 System Overview 3 3.6. Home Screen Main Menu The Main Menu on the Home screen lets you access most of the Omnipod 5 App's functions. To access the Main Menu: • Tap the Menu button ( ) in the upper left corner of the Home screen. or • Place your finger on the far left side of the Omnipod 5 App and swipe right across the screen. Swipe left to hide the Menu. Tap an option on the Menu to bring up the related screen. Tip: The Menu extends beyond the bottom of the screen.
3 Omnipod 5 System Overview About screen The About screen displays details about your Omnipod 5 System, such as the Omnipod 5 App version number, the Customer Care contact information, the Controller serial number (if viewing on the Controller), the Pod version number, the time of the most recent Omnipod 5 App-Pod communication, and other Controller and legal information. 3.7.
Omnipod 5 System Overview 3 Alarms Alarms require your immediate attention (see page 160). If you ignore an alarm, you could develop hypoglycemia or hyperglycemia. When an alarm occurs, the Pod will beep and the Omnipod 5 App will beep or vibrate if sound/vibrate is on. Hazard alarms ( ) alert you to a problem with your insulin delivery, Pod, or Omnipod 5 App that requires immediate attention to resolve.
3 Omnipod 5 System Overview 3.8. Manual and Automated Mode Overview Available tasks in each mode The following table defines the tasks that can be performed in Manual Mode and Automated Mode. Manual Mode How it works Basal Insulin Delivery Bolus Insulin Delivery Connected CGM Insulin is delivered according Insulin is delivered and to the Active Basal Program. adjusted automatically based on CGM values and prediction.
Omnipod 5 System Overview Manual Mode 3 Automated Mode What you can do Pod Changes Activate and Deactivate Pods Deactivate Pods Once deactivated, the system switches to Manual Mode.
3 Omnipod 5 System Overview Identifying System modes The mode indicator shows Omnipod 5 System's current operating mode. Graphic Description Displays when there is no Pod communication or no active Pod. Displays when the Omnipod 5 System is in Automated Mode and the Pod is providing automated insulin delivery. Displays when the Omnipod 5 System is in Automated Mode: Limited state. The most common reason is that the Pod is not receiving CGM values.
CHAPTER 4 Setting Up Your Omnipod 5 Application Contents 4.1. Setting Up Your Account. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 4.2. Preparing for Your Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Omnipod 5 Intro Kit contents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Items needed for your training . . . . . . . . . . . . .
4 Setting Up Your Omnipod 5 Application Duration of Insulin Action. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Maximum Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 Extended Bolus. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Setting Up Your Omnipod 5 Application 4 • Omnipod 5 Controller and Pods • USB cable and charger • User Guide and Quick Start Guide After you unpack the shipment, use the "Contents" label on the side of the box to make sure you have everything. The Dexcom G6 CGM System and supplies must be obtained from Dexcom or an authorized distributor. Refer to the Dexcom G6 CGM System User Guide for instructions for use.
4 Setting Up Your Omnipod 5 Application Omnipod 5 App. You can find a list of compatible smartphones at omnipod.com/ compatibility. If you choose to use the Omnipod 5 App on your smartphone, you will need to sign into the Insulet-provided Controller first to confirm that your healthcare provider has prescribed the use of the Omnipod 5 System.
Setting Up Your Omnipod 5 Application 4 2. The Controller runs through a series of checks. If prompted, allow permissions and connect to Wi-Fi. See page 179 for more details. 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.
4 Setting Up Your Omnipod 5 Application Setting Up Training After signing into the Controller, you will be prompted to schedule or confirm training for the Omnipod 5 System. Training is critical to the safe and effective use of the Omnipod 5 System. ¾ Review the training options provided and tap the option that applies to you. After tapping the training option: • If you tap I will schedule training: ¾ You will be provided 3 options to schedule training. Once completed, tap OK.
Setting Up Your Omnipod 5 Application 4 Personalize your Controller Follow the steps below to personalize your Controller. 1. Enter a personalized screen message (at least two characters), tap Done, then tap CONTINUE. A screen appears showing several background images. 2. Swipe right or left to see more images. Tap on your preferred image, then tap CONTINUE. Note: When you wake up your Controller, you will see your personalized screen message and background image.
4 Setting Up Your Omnipod 5 Application 2. Read the message explaining the importance of enabling sound on your Omnipod 5 App. If you do not have sound enabled, you may miss important messages. ¾ Tap I UNDERSTAND. If you do silence your device, the Omnipod 5 App will still be able to sound for important alerts and alarms, such as Urgent Low glucose. Your Pod will not be silenced. 4.5.
Setting Up Your Omnipod 5 Application 4 Using the Omnipod 5 App on Your Smartphone If you use your smartphone, you will need to download the Omnipod 5 App from Google Play. 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.
4 Setting Up Your Omnipod 5 Application Follow the setting requirements below to ensure the Omnipod 5 System works as intended. To change your settings on an Android phone, find the Settings app, and then tap the gear icon( ) labeled Settings.
Setting Up Your Omnipod 5 Application 4 Signing in to the Omnipod 5 App on Your Smartphone 1. Review the terms and conditions, including End User License Agreement (EULA), warranty and Legal Notices as follows: a. Tap the HIPAA Privacy Notice, EULA, ToU, and Warranty link to read the Omnipod 5 System's legal notices and privacy policy. Then tap AGREE. A checkmark is added to the checkbox to indicate agreement. b. Tap CONTINUE. Note: If you are under 18, your parent or guardian must accept for you. 2.
4 Setting Up Your Omnipod 5 Application Setting Your Omnipod 5 App Security (on Your Smartphone) 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.
Setting Up Your Omnipod 5 Application 4 Enabling Notifications and Sound on Your Smartphone 1. Read the message explaining the importance of enabling Omnipod 5 App notifications. You cannot enter or use the App if you turn Notifications off. ¾ Tap I UNDERSTAND. 2. Read the message explaining the importance of enabling sound on your Omnipod 5 App. If you do not have sound enabled, you may miss important messages. ¾ Tap I UNDERSTAND.
4 Setting Up Your Omnipod 5 Application 4.6. Basal Settings Warning: DO NOT start to use your system or change your settings without adequate training and guidance from your healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.
Setting Up Your Omnipod 5 Application 4 Create a Basal Program The next step is to create a Basal Program. For a description of basal rates, basal segments, and Basal Programs, see "Basal Programs" on page 97. ¾ Tap NEXT on the Create Basal Program description screen to continue. Name and tag the Basal Program The default name for the Basal Program is Basal 1. 1. To change the name, tap the Program Name field and enter the new name, then tap Done.
4 Setting Up Your Omnipod 5 Application additional segments. Repeat steps 1-3 as needed until your final segment ends at midnight. Review the Basal Program The next screen summarizes the start and end times, and basal rate for each segment of the Basal Program. 1. Tap CONTINUE to review your Basal Program. 2. Check that the graph and the individual segment values are correct. The total daily amount of basal insulin to be delivered by this Basal Program is listed below the graph. 3.
Setting Up Your Omnipod 5 Application 4 c. Tap the End Time field and enter the end time of the segment you want to delete. This 'overwrites' the segment you want to delete. d. Tap NEXT. e. Set the end time and basal rate for any following segments, as needed. 7. When the Basal Program is correct, tap SAVE. Note: If the basal rate for a segment is 0 U/hr, the Omnipod 5 App displays a message calling this to your attention. Tap OK if the 0 U/hr rate is correct.
4 Setting Up Your Omnipod 5 Application 4.7. Bolus Settings Next, you will set Bolus Settings that will be used to calculate a bolus in the SmartBolus Calculator. You can adjust your bolus settings later, if your needs change (see "17.8. Bolus Settings" on page 248 for more information). 1. Tap the arrow (>) on the Bolus screen to move to the Target Glucose & Correct Above description screen. 2. Tap NEXT to move to the segment screen.
Setting Up Your Omnipod 5 Application 4 a. Tap the row containing the entry to be changed and enter the corrected value. b. Review and correct as needed any remaining segments. 8. When the segments and values are correct, tap SAVE. Insulin to Carb (IC) Ratio Your Insulin to Carbohydrate Ratio, or "IC Ratio," defines how many carbohydrates are covered by one unit of insulin. The SmartBolus Calculator uses the IC Ratio to calculate the meal portion of a suggested bolus.
4 Setting Up Your Omnipod 5 Application 6. Review your 24-hour IC Ratio segments. 7. To change any of the entries: a. Tap the row containing the entry to be changed and enter the corrected value. b. Review and correct as needed any remaining segments. 8. When the segments and values are correct, tap SAVE. Correction Factor Your Correction Factor defines how much one unit of insulin lowers your glucose. For example, if your Correction Factor is 50, one unit of insulin lowers your glucose by 50 mg/dL.
Setting Up Your Omnipod 5 Application 4 5. Review the segments for the full 24hour profile. 6. To change any of the entries: a. Tap the row containing the entry to be changed and enter the corrected value. b. Review and correct as needed any remaining segments. 7. When the segments and values are correct, tap SAVE. Duration of Insulin Action The Duration of Insulin Action is the length of time that insulin stays active in your body.
4 Setting Up Your Omnipod 5 Application Maximum Bolus The Omnipod 5 App will not let you request a bolus above the Maximum Bolus setting. You will see a message if the SmartBolus Calculator calculates a bolus that is above this amount. 1. Tap the Max Bolus field and enter your Maximum Bolus. Tap DONE to close the number pad. 2. Tap NEXT.
Setting Up Your Omnipod 5 Application 4 4.9. Saving Your Settings for Reference Caution: DO NOT reset the Omnipod 5 App or clear the app data before checking with your healthcare provider. This will erase all of your settings, Adaptive Basal Rate, and history, and require you to change your active Pod. Before resetting or clearing app data, make sure you have a current record of your settings and a new Pod with supplies to use when restarting the app.
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CHAPTER 5 Activating and Changing Your Pod Contents 5.1. Beginning the Pod Activation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 5.2. Setting Up a New Pod. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Turn on location access. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 5.3. Fill the Syringe with Insulin . . . . . . . . . . . . . . . . . .
5 Activating and Changing Your Pod 5.1. Beginning the Pod Activation Process Warning: DO NOT wear a Pod if you are sensitive to or have allergies to acrylic adhesives, or have fragile or easily damaged skin. Applying a Pod under these circumstances could put your health at risk. Warning: ALWAYS be prepared to inject insulin with an alternative method if insulin delivery from the Pod is interrupted.
Activating and Changing Your Pod 5 After initial Omnipod 5 App setup, you will activate your first Pod. Your Pod should be changed at least once every 48 to 72 hours (2 to 3 days) or after delivering 200 units of insulin. Consult with your healthcare provider to determine if you should change your Pod more often. Before activating a Pod, do the following: 1. Gather the necessary supplies: • A vial of rapid-acting U-100 insulin cleared for use in the Omnipod 5 System. See "1.4.
5 Activating and Changing Your Pod 5.2. Setting Up a New Pod 1. Navigate to: Menu button ( ) > Pod or Home > POD INFO 2. Tap SET UP NEW POD. Turn on location access If you are using the Omnipod 5 App on your smartphone, location permission must be allowed and location setting must be turned on to activate a Pod. If you deny the permission or turn off the setting, you will be prompted to turn it on to activate a Pod. • If your location setting is off, tap CONTINUE and turn on your location setting.
Activating and Changing Your Pod 5 5.3. Fill the Syringe with Insulin Warning: NEVER inject large bubbles or pockets of air when filling the Pod with insulin. Air in the system takes up space where insulin should be and can affect insulin delivery. Doing so could result in over-delivery or underdelivery of insulin, which can lead to hypoglycemia or hyperglycemia. The next step is to fill the syringe that came with the Pod (the "fill syringe") with insulin: 1.
5 Activating and Changing Your Pod 5.4. Filling, Activating, Applying, and Starting the Pod Warning: NEVER use a Pod if, while you are filling the Pod, you feel significant resistance while pressing the plunger down on the fill syringe. Do not try to force the insulin into the Pod. Significant resistance may indicate that the Pod has a mechanical defect. Using this Pod could result in underdelivery of insulin that can lead to hyperglycemia.
Activating and Changing Your Pod 5 Fill the Pod with Insulin To fill the Pod with insulin (screen step ) 1. Locate the arrow on the underside of the Pod. The arrow points to the insulin fill port. Tip: You can leave the Pod in its tray during filling and activating. 2. Insert the fill syringe straight down—not at an angle—into the fill port. 3. Depress the fill syringe plunger to transfer the insulin into the Pod. Listen for two beeps from the Pod during the filling process (screen step ): 4.
5 Activating and Changing Your Pod • If more than one, non-paired, filled Omnipod 5 Pod is in range, the Omnipod 5 App informs you of this and prevents you from completing activation. Move at least 20 feet (6 m) away from any other filled Omnipod 5 Pod and tap TRY AGAIN. • Only Omnipod 5 Pods are compatible with the Omnipod 5 System. If you try to use an older Pod that cannot communicate with the system, the Omnipod 5 App informs you of this and prevents you from completing activation.
Activating and Changing Your Pod 5 Prepare the Pod Site Caution: ALWAYS rotate insulin infusion sites to help prevent infusion site complications like scar tissue and infection. Rotating insulin infusion sites reduces the risk of scarring. Using a site with scar tissue can lead to problems with insulin absorption.
5 Activating and Changing Your Pod Pod site examples Pod site map (optional) The Pod site map is an optional feature that helps you track your current and recent Pod site locations. This option only appears if the Pod Sites setting is turned on (see "10.2. Reminder Settings" on page 128). 1. Tap RECORD POD SITE to bring up the Record Pod Site screen. 2. Tap the FRONT or BACK tab to select an area of your body for your Pod.
Activating and Changing Your Pod 5 4. Tap the DETAILS tab to add a detail about the placement of this Pod. For example, you could add a detail that says "Facing up" or "Facing down" to describe the Pod's orientation. a. To add a new detail, tap ADD NEW and type in the new detail. Tap ADD when done. The new detail is added to the list. b. Select a detail for the new Pod by tapping the circle next to that detail. You may only add one detail for each Pod. Tap again to deselect the detail.
5 Activating and Changing Your Pod Remove the Pod's Tab Warning: DO NOT apply a Pod if you see the cannula is extended beyond the adhesive backing after the tab on the Pod is removed. This cannula cannot be inserted resulting in under-delivery of insulin which could lead to hyperglycemia. Remove the Pod's tab (screen step ): 1. Turn the Pod so the tab is up and facing you. 2. Place your thumb on the bottom (flat edge) of the tab and pull the tab upwards. The tab snaps off. Throw the tab away.
Activating and Changing Your Pod 5 2. Orient the Pod so it is: • Horizontal or diagonal on your abdomen, hip, lower back, or buttocks. Up, down, or slight angle Horizontal or diagonal • Up and down or at a slight angle on your upper arm or thigh. Up, down, or slight angle • For optimal connectivity, Back the Pod should Front be placed at least 3 inches (7.62 cm) from and within line of sight to the CGM. The Bluetooth connection between the CGM and the Pod does not travel well through the body.
