TM OMNIPOD DASH USER GUIDE *Up to 72 hours of insulin delivery Insulet Corporation 100 Nagog Park Acton, MA 01720 1.800.591.3455 | 1.978.600.7850 www.myomnipod.com © 2018 - 2020 Insulet Corporation. Omnipod, the Omnipod logo, Podder, DASH, and the DASH logo, are trademarks or registered trademarks of Insulet Corporation. All rights reserved. Reference #: PDM-USA1-D001-MG-USA1 FCC ID: RBV-041 FCC ID: RBV-SAW 2797 18296-ENG-AW Rev.
Omnipod DASH™ Insulin Management System User Guide Contacts and Important Information Customer Care 1-800-591-3455 — 24 hours/7 days 1-978-600-7850 when calling from outside the United States of America Customer Care Fax: 877-467-8538 Website: myomnipod.
© 2018-2020 Insulet Corporation. Omnipod, the Omnipod logo, DASH, the DASH logo, and Podder are trademarks or registered trademarks of Insulet Corporation. All rights reserved. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. Contour is a registered trademark of Ascensia Diabetes Care. All other trademarks are the property of their respective owners.
Contents Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi About This User Guide. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi Indications and Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents General PDM Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Turning on and personalizing the PDM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Enter a PIN. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents 4 Entering Blood Glucose Readings. . . . . . . . . . . . . . . . . . . . . . . 51 About Blood Glucose Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Entering Your Blood Glucose Reading from a Paired BG Meter. . . . . . . . . . . . . . Entering Your Blood Glucose Reading Manually. . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents 8 Browsing Your PDM Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Notifications & Alarms Screens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Overview of the Insulin and BG History Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Date Selection. . . . . . . . . . . . . . . . . . . . . . . . .
Contents Reference 10 Alarms, Notifications, and Communication Errors. . . . . 121 Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121 Responding to Alarms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents Basal Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150 Temporary basal rates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Contents Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 Troubleshooting PDM Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 Summary of Settings and Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188 Pod Specifications. . . . . . . . . . . . .
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Introduction About This User Guide Caution: This User Guide is intended for use only with Personal Diabetes Manager (PDM) model PDM-USA1-D001-MG-USA1. To learn which version of the PDM you have, turn it over. If you see "PDM-USA1-D001-MG-USA1" on the back of the PDM, this is the correct User Guide. If you do not see it, call Customer Care. Note: Screen images shown in this User Guide are examples only and are not suggestions for user settings.
Introduction Indications and Contraindications Caution: Federal (US) law restricts this device to sale by or on the order of a physician. Indications for use The Omnipod DASH™ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Additionally, the Omnipod DASH™ System is interoperable with a compatible blood glucose meter to receive and display blood glucose measurements.
Introduction Warnings: Not recommended for individuals with hearing loss. Always verify your ability to hear Pod/PDM alarms and notifications. If you are unable to use the Omnipod DASH™ System according to instructions, you may be putting your health and safety at risk. Talk with your healthcare provider if you have questions or concerns about using the Omnipod DASH™ System properly. After use, parts of the device are considered biohazardous and can potentially transmit infectious diseases.
Introduction Your healthcare provider is a valuable resource. You will rely on him or her for critical information about your Omnipod DASH™ System, especially during the first few weeks and months. When you have questions about diabetes management after starting on the Omnipod DASH™ System, do not hesitate to talk with your healthcare provider.
Introduction Alarms and notifications For your safety, the Omnipod DASH™ System provides a range of alarms and notifications to tell you that your attention is needed or to warn you of hazardous situations. For a description of the PDM's alarms and notifications, see "Alarms, Notifications, and Communication Errors" on page 121. Note: Brief alarm and notification messages appear on the Lock screen. You must unlock the screen and enter your personal identification number (PIN) to see the full alarm messages.
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CHAPTER 1 Your Omnipod DASH™ Insulin Management System Welcome The Omnipod DASH™ Insulin Management System is a continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion (CSII) therapy. Features of the Omnipod DASH™ System include: No tubing: There is no tubing connecting the Pod to the Personal Diabetes Manager (PDM). You can wear the Pod under your clothes and carry the PDM separately. You can swim wearing the Pod and leave the PDM on dry land.
1 Omnipod DASH™ Insulin Management System The Pod and PDM The Omnipod DASH™ System is made up of two primary parts: The Pod, which delivers insulin to your body, and the Personal Diabetes Manager (PDM), which lets you control the Pod. The Pod The Pod is a lightweight device that you fill with insulin and wear directly on your body. The Pod receives insulin delivery instructions from the PDM. The Pod then delivers insulin into your body through a small, flexible tube called a cannula.
Omnipod DASH™ Insulin Management System 1 The Personal Diabetes Manager (PDM) The PDM is a handheld device that controls and monitors the Pod's operations using wireless technology.
1 Omnipod DASH™ Insulin Management System Navigating Screens and Entering Information This section explains how to use the touchscreen, how to enter numbers or text into the PDM, and how this User Guide describes moving between PDM screens. Touchscreen Basics The PDM displays messages and options for you on its touchscreen. You communicate with the PDM by tapping or swiping your finger on the touchscreen. Tapping and swiping The basic instructions for interacting with the touchscreen are explained here.
Omnipod DASH™ Insulin Management System 1 Entering Numbers and Text Tapping fields to enter data Fields allow you to specify values to be used by the PDM. Tapping an editable field (which is either framed by a box or underlined) opens a keypad, number pad or scroll wheel. Tap the letters or numbers or scroll the wheel to enter data for use in that field. Editable fields are underlined or framed by a box. Non-editable fields are not underlined or framed by a box.
1 Omnipod DASH™ Insulin Management System Using a number pad Tap a number to add it to the entry field. Tap the period (.) to add a decimal point. Tap the backspace icon ( ) to delete the most recent entry from the entry field. The comma (,), dash (-), and underscore (_) are not used. Tap the green checkmark ( ) to accept the entered number. You can also tap outside the number pad to accept the entered number. Using a scroll wheel Place your finger on the scroll wheel.
Omnipod DASH™ Insulin Management System 1 Checkboxes, radio buttons, and drop-down lists Checkboxes are squares. Tap a checkbox to check or uncheck it. You can check more than one checkbox in a list. Radio buttons are circles. Tap a radio button to select it. A dot appears inside the selected radio button. You can select only one radio button at a time. To deselect a radio button, tap the radio button next to a different option. Drop-down lists are indicated by a down or up arrow next to an item.
1 Omnipod DASH™ Insulin Management System Navigation shorthand The User Guide uses the ">" symbol to indicate navigating from one screen to another. For example, the following notation: • Menu icon ( ) > Pod > CHANGE POD tells you to: • 1. Tap the Menu icon ( 2. Tap Pod to open the Pod screen. 3. Tap CHANGE POD. Menu icon ( ) in the upper left of the Home screen. ) > History : Insulin & BG History tells you to: 1. Tap the Menu icon ( ) in the upper left of the Home screen. 2.
Omnipod DASH™ Insulin Management System 1 The Status Bar Most screens have a status bar that shows you: • The Pod status, including how much insulin is left in an active Pod • Whether a temp basal rate is running • Whether the PDM will vibrate for selected notifications • The Bluetooth® icon • If Wi-Fi is on, the strength of the Wi-Fi signal • The status of the PDM's battery • The current time Status bar icon definitions: More than 50 units in Pod Airplane mode on Between 50 and 26 units in
1 Omnipod DASH™ Insulin Management System For charging instructions, see"Charge the battery" on page 22. The PDM's Lock and PIN Screens After you set up your PDM, the Lock and PIN screens appear whenever you wake up your PDM. The Lock and PIN screens help confirm that you are using the correct PDM.
Omnipod DASH™ Insulin Management System 1 Lock your PDM To lock your PDM when you are finished using it: 1. Press the Power button briefly. This locks the PDM by putting it to sleep. 2. Store your PDM in a safe, accessible location. Caution: Only press the Power button briefly. If the PDM asks if you would like to "Power off," tap outside the message to cancel the instruction. Once you begin using your PDM, do not turn the power off. The PDM can sound an alarm only when powered on.
1 Omnipod DASH™ Insulin Management System The PDM's Home Screen The Home screen provides information about recent boluses, blood glucose values, the active basal rate, and the active Pod. It also provides access to the PDM functions, alarm information, and settings. The Home screen also has a Bolus button to give quick access to the bolus screen. Today's date Settings icon Status bar Menu icon Tab labels: The name of the visible tab is blue and underlined.
Omnipod DASH™ Insulin Management System 1 Dashboard tab The Dashboard tab is available if the Bolus Calculator is on and is usually not available if the Bolus Calculator is off. When the Bolus Calculator is on When the Bolus Calculator is on, the Dashboard tab displays: • IOB (insulin on board), when IOB is available. • IOB is Not Available, when the Bolus Calculator is disabled. Tap the icon for a list of reasons for the Bolus Calculator to be disabled.
1 Omnipod DASH™ Insulin Management System Basal tab / Temp Basal tab This tab is labeled Basal or Temp Basal, depending on whether a Basal Program or temp basal is active. Basal Program By default, the Basal tab shows the name and graph of the active Basal Program. A label below the Basal Program's name indicates whether the listed Basal Program is: • Active—This program is running on the active Pod. • Suspended—This program will resume when you resume insulin delivery.
Omnipod DASH™ Insulin Management System 1 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 PDM cannot communicate with an active Pod, the Pod Info tab says "No Pod Communication." Tap the icon for a list of reasons why the PDM may not be able to communicate with the Pod. Note: Even when there is no communication, the Pod continues delivering insulin according to the instructions it was given.
1 Omnipod DASH™ Insulin Management System 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 six hours before Pod expiration, a red Change Pod banner appears on the Pod Info tab. When less than five units of insulin remain in the Pod, a red Low Reservoir banner appears on the Pod Info tab.
Omnipod DASH™ Insulin Management System 1 Last bolus section The lower left side of the Home screen displays bolus information. 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.
1 Omnipod DASH™ Insulin Management System The Home Page's Menu The Menu on the Home page lets you access most of the PDM's functions. To display the Menu: • Tap the Menu icon ( ) in the upper left corner of the Home screen. • Place your finger on the far left of the PDM, 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. Swipe up or down to see all parts of the Menu.
Omnipod DASH™ Insulin Management System 1 Food library The Food Library option allows you to look up the carbohydrate content of various foods and to create food favorites (see "Using the Food Library" on page 66). History menu Tap the down arrow ( ∨ ) next to History to reveal the submenu: • Notifications & Alarms history (see page 89) • Insulin & BG History (see page 90) Tip: Tap the bell icon ( or ) at the top-right of many screens to open the Notifications & Alarms history screen.
1 Omnipod DASH™ Insulin Management System PDM Messages to You The PDM can deliver alarm messages, notifications, and confirmation messages. Alarms Hazard alarms and advisory alarms require your immediate attention (see "Alarms, Notifications, and Communication Errors" on page 121). If you ignore an alarm, you could develop hypoglycemia or hyperglycemia. Hazard alarms ( ) are accompanied by a continuous vibration or tone and interrupt anything else the PDM is doing except another hazard alarm.
CHAPTER 2 Initial PDM Setup This chapter guides you through setting up your first PDM or a replacement PDM. If you are setting up a replacement PDM, be sure to unpair any BG meters paired to your old PDM before setting up your new PDM (see "Pairing, unpairing, or renaming a BG meter" on page 114). Then go to "Charge the battery" on page 22. The Omnipod DASH™ PDM Kit Your initial shipment contains the Omnipod DASH™ PDM Kit and other items needed to begin using the Omnipod DASH™ Insulin Management System.
2 Initial PDM Setup Warnings: Do NOT use the Omnipod DASH™ System before you have been trained. Inadequate training could put your health and safety at risk. Follow your healthcare provider's instructions for initializing the PDM. Improper setup could put your health and safety at risk. Note: Keep an emergency kit with you at all times to quickly respond to a diabetes emergency (see "Prepare for Emergencies" on page 175).
Initial PDM Setup 2 • Instructions from your healthcare provider with PDM settings tailored to your needs. These settings include Basal Program, IC Ratio, Correction Factor, Target BG values, and Duration of Insulin Action. General PDM Settings Although PDM setup is easy, if you are a first-time user, your trainer must guide you through the setup process. You can adjust these settings later as needed. Tip: Use the pages at the end of this User Guide to write down all of your settings.
2 Initial PDM Setup b. Tap the box to add a checkmark. c. Tap CONTINUE. Note: If you are under 18, your parent or guardian must accept for you. 5. Tap BEGIN SETUP. 6. Tap letters on the keypad to enter a personalized screen message (see "Selecting, Adding, and Deleting Items" on page 6). Then tap the checkmark. Note: You must enter at least one character. Tip: Including a contact phone number in the message could help in recovering a misplaced PDM. 7. Tap CONTINUE.
Initial PDM Setup 2 2. On the number pad, tap each number of your PIN. Then tap the checkmark. 3. Enter the same four numbers again to confirm your PIN. Tap the checkmark. If the second PIN entry does not match the first, you must repeat the above steps. Set the time zone and time To set the current time zone and time: 1. Tap Select One to show the list of time zones. 2. Tap your time zone. You may need to swipe up or down to find your time zone. 3. Tap CONTINUE. 4.
2 Initial PDM Setup Set the date On the Set Current Date screen: 1. Tap MM/DD/YYYY to display a list of date formats. Tap the desired date format. 2. Set the Month, Day, and Year fields by scrolling their respective wheels one at a time. 3. Review the date and date format, then tap CONTINUE. 4. On the Confirm Time & Date screen, review the time zone, time, and date. If correct, tap CONTINUE.
Initial PDM Setup 2 You can adjust your Maximum Basal Rate later, if your needs change. Create a Basal Program The next step is to define a Basal Program. For a description of basal rates, basal segments, and Basal Programs, see "Basal Insulin Delivery" on page 149. Name and tag the Basal Program 1. Review the description of Basal Programs, then tap NEXT. 2. The default name for the Basal Program is Basal 1.
2 Initial PDM Setup Note: The two vertical blue lines on the graph near the top of the screen show the start and end time for the basal segment. The selected basal rate for the segment is shown between the two vertical lines. 3. Check the values of your start and end times and the basal rate. Then tap NEXT. Define additional segments If the Basal Program does not cover 24-hours, you must add additional segments: 1. Tap the End Time field and select the duration of the next segment. 2.
Initial PDM Setup 2 4. To add a new segment: a. Tap the row containing the start time of the new segment. b. Tap the End Time field, and enter the start time of the new segment as the end time of this segment. c. Change the basal rate, if necessary. d. Tap NEXT. e. Then define the end time and basal rate for any following segments, as needed. 5. To delete a segment: a. Note the end time of the segment you want to delete. b. Tap the segment that precedes the segment you want to delete. c.
2 Initial PDM Setup Blood Glucose Settings The blood glucose settings define what blood glucose readings are considered in range and allow you to pair to a CONTOUR® NEXT ONE BG meter. Upper and lower limits for BG Goal Range You can set the upper and lower limits of your BG Goal Range by using the number pad or the slider: 1. Review the description of blood glucose levels, then tap the arrow (>). 2. To define the lower limit, tap the Lower Limit field and type the number using the number pad.
Initial PDM Setup 2 Pair to a BG meter If desired, you can pair your PDM to a CONTOUR® NEXT ONE BG meter (BG meter). Once paired, blood glucose readings can be transmitted via Bluetooth® wireless technology from your BG meter to your PDM. Note: If you do not want to pair to a BG meter, tap SKIP. Then go to "Bolus Calculator Settings" on page 32 To pair a BG meter: 1. Turn off your BG meter, and place it within six feet of your PDM. 2. Turn on the blue light on your BG meter.
2 Initial PDM Setup 7. Optional: Rename your paired BG meter: a. Tap the Options icon ( ) next to the paired BG meter. Then tap Edit. b. Tap the Name field and use the keypad to enter a new name for your BG meter, then tap the checkmark. c. Tap SAVE. 8. Tap NEXT. Caution: After pairing, the PDM controls the date, time and BG goal/target range on your paired BG meter. To avoid mislabeling of history records, make all changes to date and time on your PDM, not on your BG meter.
Initial PDM Setup 2 Target BG and Correct Above values The Bolus Calculator aims to bring your blood glucose to the Target BG value if your current blood glucose level is above the Correct Above value. You can establish up to eight different blood glucose targets for different times of day. Define the segments Setting values for each segment follows the same pattern that you used to create your Basal Program: 1. Review the description of Target BG and Correct Above, then tap NEXT. 2.
2 Initial PDM Setup Minimum BG for Calcs If your blood glucose level is below the Minimum BG for Calcs that you specify, the Bolus Calculator is disabled (see "The Bolus Calculator" on page 156). 1. To enter your Minimum BG for Calcs, tap the Min BG for Calcs field and enter the number on the number pad. Tip: Alternatively, touch the blue circle and slide it to the desired number. 2. Tap NEXT.
Initial PDM Setup 2 Correction Factor Your Correction Factor defines how much one unit of insulin lowers your blood glucose level. The Bolus Calculator uses the Correction Factor to calculate the correction portion of a suggested bolus. You can create up to eight Correction Factor segments per day. 1. Review the description of Correction Factor, then tap NEXT. 2. Enter the end time. 3. Enter the Correction Factor in the 1 Unit of Insulin Decreases BG by field. 4. Tap NEXT. 5.
2 Initial PDM Setup 1. Tap the Duration of Insulin Action field and use the scroll wheel to specify your Duration of Insulin Action. 2. Tap NEXT. Other Bolus Settings The remaining bolus settings are used whether the Bolus Calculator is on or off. Maximum Bolus The PDM will not let you request a bolus above the Maximum Bolus setting. You will see a message if the Bolus Calculator calculates a bolus that is above this amount. 1. Tap the Max Bolus field and use the number pad to specify your Maximum Bolus.
CHAPTER 3 Changing Your Pod Beginning the Pod Change Process Changing your Pod consists of deactivating your current Pod and activating a new 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 and refer to the insulin labeling to determine if you should change your Pod more often.
3 Changing Your Pod First Time Activating a Pod Your Omnipod DASH™ System trainer will help you set up your first Pod. After completing the PDM setup flow, the Home screen displays "No Active Pod." 1. Tap SET UP NEW POD. 2. Go to "Preliminary Pod Change Steps" on page 40. Deactivate an Active Pod To deactivate and remove an active Pod: 1. Navigate to the Pod change screen: Home > Pod Info tab > VIEW POD DETAILS or Menu icon ( ) > Pod 2. Tap CHANGE POD, then tap DEACTIVATE POD.
Changing Your Pod 3 3. When the green banner tells you to remove your Pod, remove the deactivated Pod from your body: a. Gently lift the edges of the adhesive tape from your skin and remove the entire Pod. Tip: Remove the Pod slowly to help avoid possible skin irritation. b. Use soap and water to remove any adhesive that remains on the skin, or, if necessary, use an adhesive remover. c. Check the infusion site for signs of infection (see "Avoid Infusion Site Infections" on page 49). d.
3 Changing Your Pod Preliminary Pod Change Steps Warnings: NEVER use insulin that is cloudy; it may be old or inactive. Always follow the insulin manufacturer’s instructions for use. Failure to use rapid-acting U-100 insulin, or using insulin that has expired or is inactive, could put your health at risk. Do NOT apply or use a Pod if the sterile packaging is open or damaged, or if the Pod has been dropped after removal from the package, as this may increase the risk of infection.
Changing Your Pod 3 Fill the Syringe with Insulin The next step is to fill the syringe that came with the Pod (the "fill syringe") with insulin: 1. Use an alcohol prep swab to clean the top of the insulin vial. 2. Securely twist the fill needle onto the fill syringe. 3. Pull outward to remove the protective cap from the needle. Save the cap; you will need it later. Pull apart 4. Determine how much insulin you will put into the Pod.
3 Changing Your Pod 9. Remove the needle from the vial. Fill, Pair, and Apply the Pod Warning: Before filling a Pod, ensure that no other Pods are being activated within 5 feet (1.5 m) of your PDM. Caution: Be sure to insert the fill syringe into the fill port and not any other location on the Pod. Do not insert the fill syringe more than once into the fill port. Only use the fill syringe and needle that came with your Pod.
Changing Your Pod 3 Warnings: NEVER use a Pod if you feel resistance when you depress the plunger. This condition can result in interrupted insulin delivery. NEVER inject air into the fill port. Doing so may result in unintended or interrupted insulin delivery. 5. Remove the needle from the insulin fill port. The port is self-sealing; insulin will not leak after the needle is removed. 6. Place the protective cap back on the syringe needle and remove the needle from the fill syringe.
