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OmniPod 5 Quick Start Manual
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OmniPod 5 Quick Start Manual

Automated insulin delivery system
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Omnipod
5 Automated Insulin Delivery System
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Quick Start Guide

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Summary of Contents for OmniPod 5

  • Page 1 Omnipod 5 Automated Insulin Delivery System ® Quick Start Guide...
  • Page 2 • Are unable to maintain contact from these devices. The Omnipod with their healthcare provider 5 ACE Pump is intended for single • Are unable to use the Omnipod 5 patient, home use and requires System according to instructions a prescription.
  • Page 3 WELCOME TO OMNIPOD® 5 New Omnipod 5 User Receiving training and understanding the User Guide are needed BEFORE using your new Omnipod 5 System. Follow these steps to get started: 1. Get Started Visit: omnipod.com/setup to create your account, link your data management accounts, and learn about training options.

  • Page 5: Table Of Contents

    Section 1: Omnipod 5 System Overview ......6 Section 2: Set Up Your Omnipod 5 App ......8 Section 3: Set Up a New Pod .

  • Page 6: Section 1: Omnipod 5 System Overview

    • cannot communicate with a Dexcom G6 receiver while paired with a Pod For CGM-specific information, refer to your Dexcom G6 CGM System User Guide. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 8: Section 2: Set Up Your Omnipod 5 App

    Omnipod 5 App Setup Before you set up your Omnipod 5 System, choose whether you want to use the Omnipod 5 App on the provided Controller or a compatible personal smartphone. Connectivity to cellular data or Wi-Fi is important when using the Omnipod 5 System. With either device, make sure to connect to your home or work Wi-Fi network.

  • Page 10: Section 3: Set Up A New Pod

    • From the POD setup, tap SET INFO tab on the UP NEW POD Home screen, tap SET UP NEW POD Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 11: Fill The Pod

    Pod. • The Pod will beep twice to indicate the Omnipod 5 Pod is ready to proceed. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.
  • Page 12 “see” one another without your body blocking their communication. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 13: Apply The Pod

    • Ideal sites have a layer of fatty tissue. • Ideal sites offer easy access and viewing. • The site should be at least 1 inch (2.5 cm) away from the previous site to avoid skin irritation. • The site should be at least 2 inches (5 cm) away from your navel.

  • Page 14: Section 4: Connect The Pod And Cgm

    Enter & Save New CGM Transmitter SN • Tap ENTER NEW • Tap first box to • Tap SAVE enter transmitter SN Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 15: Section 5: Omnipod 5 System Modes

    Omnipod 5 System Modes System Modes The Omnipod 5 System has two operating modes: Automated Mode and Manual Mode Automated Mode Manual Mode • Adjusts every 5 minutes • Uses your Basal Program • Adapts by updating your total daily...
  • Page 16 Manual Mode Automated Mode How it works Basal Insulin Insulin is delivered Insulin is delivered and adjusted according to the active automatically based on CGM Delivery Basal Program values and 60-minute prediction. When CGM values are not available for adjustments, in Automated: Limited, the System constantly compares Automated Adaptive Basal Rate and Manual...
  • Page 17 Note: In Automated Mode, your Adaptive Basal Rate will be updated with every Pod change. Adaptive Basal Rate is a continuous baseline that the System can adjust up or down every 5 minutes in response to your CGM values.

  • Page 19: Switch To Automated Mode

    • Confirm that the mode switched. Automated should be indicated at the top right of the screen. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 20: Section 6: Get To Know The App

    • DASHBOARD • INSULIN • POD INFO CGM Glucose Value and Trend Arrow Last Bolus CGM Graph Bolus Button Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 21: Glucose Trends And Indicators, View Cgm Graph

    • Tap VIEW on CGM Graph • CGM Graph Legend Note: CGM Graph differs slightly in appearance depending on Mode Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 22: Section 7: Key Insulin Delivery Actions

    • Home screen will are correct display progress of bolus delivery • Tap START to begin bolus insulin delivery Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.
  • Page 23 Note: Always bolus for meals as directed by your healthcare provider. In Automated Mode, bolus doses still require your programming and delivery. Failure to deliver a bolus for meals could lead to hyperglycemia.

  • Page 24: Start The Activity Feature

    Note: The Activity feature is available only in Automated Mode The Activity feature of the Omnipod 5 System can be enabled for times when there may be a decrease in insulin needs, like exercise. It will set the Automated Mode Target Glucose to 150 mg/dL and reduce insulin delivery.

  • Page 25: Cancel The Activity Feature

    You can cancel the Activity feature at any time. Upon cancellation or expiration of the defined time period, full automated basal delivery starts on its own, and the Omnipod 5 System returns to using the user-defined Target Glucose. • Tap CANCEL on •...

  • Page 27: Pause Insulin Delivery

    Insulin delivery does not automatically start at the end of the paused period. You must tap START INSULIN to start insulin delivery. Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 28: Editing A Basal Program

    • Tap to edit program name, choose program tag, or tap NEXT to edit basal time segments and rates Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 29: Additional Basal Programs

    Basal Program • Tap NEXT and define the basal segments one at a time Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 30: Set A Temporary Basal Rate

    • Tap CONFIRM • Tap START • Review selections are correct and tap START Omnipod 5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

  • Page 31: Temp Basal Preset

    Temp Basal Preset Temp Basal Presets can be created if there is a temp basal that you use often. • Navigate to the Temp Basal Presets screen by tapping Menu>Temp Basal Presets. From here, you can create a new Temp Basal Preset or edit existing Temp Basal Presets.

  • Page 32: Section 8: Clinical Evidence For Omnipod 5

    3-month Omnipod 5 System treatment phase. Adolescents, adults, and children experienced improvements in overall A1C and time in range after 3 months of Omnipod 5 System use. This was achieved with a reduction of time >180 mg/dL in adolescents, adults, and children as well as a reduction in median time <70 mg/dL in adolescents...
  • Page 33 Time in range < 70mg/dL and < 54mg/dL is reported as medians with interquartile ranges in brackets(Q1,Q3). The median is the middle number in an ascending list of numbers and the interquartile range represents the middle 50% of values. *Change between standard therapy phase and Omnipod 5 System phase was statistically significant...
  • Page 34 Avg % ≥250mg/dL 16.3% 5.4% -10.9%* 10.6% 4.8% -5.7%* (std dev) (15.0%) (5.1%) (12.7%) (7.0%) Avg % ≥300mg/dL 6.7% -4.8%* 4.2% 1.5% -2.7%* (std dev) (9.1%) (2.5%) (8.0%) (3.1%) *Change between standard therapy phase and Omnipod 5 System phase was statistically significant...
  • Page 35 3-month Omnipod 5 System treatment phase. Adolescents, adults, and children experienced a reduction in A1C after 3 months of Omnipod 5 System use regardless of baseline A1C < 8% or ≥ 8% category. Subgroup Analysis of Change in Average A1C(%) by Baseline A1C(%) Baseline A1C <8% (n=105)
  • Page 36 A study was conducted on 25 participants with type 1 diabetes aged 6-70 years to assess the Omnipod 5 CGM-informed SmartBolus Calculator. During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard SmartBolus Calculator).
  • Page 37 Omnipod 5 Clinical Study in Very Young Children The goal of this study was to assess the safety and effectiveness of the Omnipod 5 System in children with type 1 diabetes aged 2 to 5.9 years. This single-arm, multicenter, prospective study enrolled 80 children.
  • Page 38 Time in range < 70mg/dL and < 54mg/dL is reported as medians with interquartile ranges in brackets(Q1, Q3). The median is the middle number in an ascending list of numbers and the interquartile range represents the middle 50% of values. *Change between standard therapy phase and Omnipod 5 System phase was statistically significant...
  • Page 39 38.4% 16.9% -21.5%* (std dev) (20.1%) (10.3%) Avg % ≥250mg/dL 13.0% 3.9% -9.1%* (std dev) (13.2%) (3.9%) Avg % ≥300mg/dL 4.3% 1.2% -3.1%* (std dev) (6.7%) (1.6%) *Change between standard therapy phase and Omnipod 5 System phase was statistically significant...
  • Page 40 3-month Omnipod 5 System treatment phase analyzed by baseline A1C%. Participants experienced a reduction in A1C after 3 months of Omnipod 5 System use regardless of baseline A1C < 8% or ≥ 8% category.
  • Page 41 During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard SmartBolus Calculator). In Phase 2, participants used the Omnipod 5 system in Manual Mode with a connected CGM (CGM-informed SmartBolus Calculator) for 7 days.

  • Page 42: Section 9: Settings And Technical Specifications

    Insulin Delivery Software) Quality of Service The Omnipod 5 System includes two wireless transmission pathways. Insulet defines the quality of service of the Omnipod 5 System for each of the two pathways: Omnipod 5 App to Pod wireless communication definition...
  • Page 43 For additional information on communication errors in the Omnipod 5 System, see Chapter 21. To maintain quality of service when other devices operating in the 2.4 GHz band are around, the Omnipod 5 System uses the coexistence features provided by Bluetooth wireless technology.
  • Page 44 • The SmartBolus Calculator refreshes values every 5 minutes. If you do not start your bolus within 5 minutes of entering the SmartBolus Calculator, the Omnipod 5 System will need to clear the screen so that it has the latest IOB and CGM information. When changing time zones, always check your IC Ratio and Correction Factor settings for the new time to ensure it still meets your body’s true insulin needs.
  • Page 45 Setting exceed the Maximum Bolus Setting you entered (0.05 -30 U). For example, if you rarely deliver more than 5 U boluses, and you set the Maximum Bolus Setting at 5 U, the system will prevent you from delivering anything greater than this amount.
  • Page 46 Bolus size: 0.05-30 U in 0.05 U increments Delivery performance characterization To assess bolus delivery accuracy, 12 Pods were tested by delivering a minimum, intermediate, and maximum bolus amount (0.05, 5.00, and 30.0 Units). The following table summarizes the typical bolus performance observed for the requested minimum, intermediate, and maximum size bolus for all pumps tested.
  • Page 47 504/5987 1192/5987 582/5987 121/5987 0/5987 percent of (8.4%) (19.9%) (9.7%) (2%) (0%) boluses within range Amount of Insulin Delivery for an Intermediate (5.00 U) Bolus Request Amount (Units) <1.25 1.25-3.75 3.75-4.50 4.50-4.75 4.75-5.25 (% of settings) (<25%) (25-75%) (75-90%) (90-95%)
  • Page 48 Amount of Insulin Delivery for a Maximum (30.0 U) Bolus Request Amount (Units) <7.5 7.5-22.5 22.5-27.0 27.0-28.5 28.5-31.5 (% of settings) (<25%) (25-75%) (75-90%) (90-95%) (95-105%) Number and 0/72 0/72 0/72 0/72 72/72 percent of boluses (0%) (0%) (0%) (0%)
  • Page 49 [min, max] [28.85, 31.39] [177.49, 181.15] Note: A measurement at the 12-hour period with a 30.0 U/hr basal rate is not applicable to the Omnipod 5 System as the reservoir will empty at approximately 6 ²/ ³ hours at this rate.
  • Page 50 If the Omnipod 5 System detects a blockage, it sounds a hazard alarm and prompts you to deactivate and change your Pod. A blockage hazard alarm sounds when an average of 3 units to 5 units of missed insulin occurs. The following table depicts blockage detection for three different situations when using U-100 insulin.
  • Page 52 Omnipod 5 System Label Symbols The following symbols appear on the Omnipod 5 System or its packaging: Symbol Meaning Symbol Meaning Single-use only MR unsafe Consult Do not use if package accompanying is damaged documents Sterilized using Type BF applied part...
  • Page 53 Meaning Protects persons against access to hazardous parts with fingers and protects against Prescription only solid foreign object ingress of diameter 12.5 mm or greater; avoid liquid Do not dispose with household RoHS compliant waste Marking of Representative in the...

  • Page 55: Section 10: Staying Safe While Using The Omnipod 5 System

    Staying Safe while Using the Omnipod 5 System General Warnings Warning: DO NOT use the Omnipod 5 System if you are unable or unwilling to Warning: Read all the instructions use it as instructed by this User Guide provided in this User Guide before using and your healthcare provider.
  • Page 56 DO NOT use the Omnipod 5 Humalog, and Admelog are compatible System in high atmospheric pressure with the Omnipod 5 System for use up to environments (above 1060 hPA), which 72 hours (3 days). Follow your healthcare can be found in a hyperbaric chamber.
  • Page 57 Glucose Warnings Warning: ALWAYS treat “LOW” or “HIGH” sensor glucose values and “LOW” or Warning: ALWAYS follow your healthcare “HIGH” blood glucose readings according provider’s guidance on appropriate to your healthcare provider’s glucose monitoring to avoid recommendations. These values can hyperglycemia and hypoglycemia.
  • Page 58 App fails to beep during a diagnostic test, hypoglycemia or hyperglycemia. call Customer Care immediately. Continuing to use the Omnipod 5 System Warning: NEVER use a Pod if, while you in these situations may put your health are filling the Pod, you feel significant...
  • Page 59 Omnipod 5 App if: * You have not installed a required update to the Omnipod 5 App * An update for the Omnipod 5 App is not yet available to fix a known issue * Your smartphone device is no longer compatible with use of the Omnipod 5 App...
  • Page 60 Transmitter serial numbers could result should also NOT be used in people who in over-delivery or under-delivery of require less than 5 units of insulin per insulin, which can lead to hypoglycemia day as the safety of the technology has and hyperglycemia.
  • Page 61 Caution: NEVER use a blow and Dexcom G6 CGM). DO NOT attempt dryer or hot air to dry the Controller to use the Omnipod 5 System with or Pod. Extreme heat can damage unauthorized devices. Attempting to use the electronics. the Omnipod 5 System with...
  • Page 62 Caution: DO NOT navigate away from the Caution: DO NOT make changes or Omnipod 5 App while you are in the modifications to any component of the process of making changes to your insulin Omnipod 5 System that have not been delivery settings. If you leave the App authorized by Insulet Corporation.
  • Page 63 Caution: DO NOT reset the Omnipod 5 Caution: DO NOT expose your Controller App or clear the app data before to extreme temperatures while in checking with your healthcare provider. storage or during use. Extreme heat or This will erase all of your settings,...

  • Page 64: Precautions

    Controller for less than 1 second App while you have an active Pod, and or you may accidentally turn the power DO NOT clear the Omnipod 5 App data. If off. If the Controller displays a message you do, your Pod will remain active, but asking if you would like to “Power Off”,...
  • Page 65 Enabling these settings may Caution: ALWAYS apply the Pod as cause issues with the Omnipod 5 App directed. If you are applying a Pod in a and prevent normal app operation. place that does not have a lot of fatty...
  • Page 66 Silent, Vibrate or any other setting that prevents you from Alarm Precautions hearing alarms and notifications from your Omnipod 5 App, such as Digital Caution: ALWAYS respond to Pod Wellbeing for Android tools that limit Expired, Low Pod Insulin, and Pod Shut- sounds and notifications.

  • Page 67: Emergency Kit

    • Glucagon kit and written instructions for administering glucagon dosage if you are unconscious Always follow Omnipod 5 System instructions. Failure to do so could result in under-delivery or over-delivery of insulin which can lead to hypoglycemia and hyperglycemia.
  • Page 68 All such decisions and treatment should be discussed with a healthcare provider who is familiar with your individual needs. © 2022 Insulet Corporation. Insulet, Omnipod, the Omnipod logo, and SmartAdjust are trademarks or registered trademarks of Insulet Corporation. All rights reserved. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license.
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