INSULET OMNIPOD 5 USER MANUAL Pdf Download (2024)

INSULET OMNIPOD 5 USER MANUAL Pdf Download (1)
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Automated insulin delivery system

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  • 1 Welcome to Your Omnipod® 5 System
  • 2 General Warnings and Safety Information
  • 3 Omnipod 5 App and Dexcom Communication
  • 4 Manual and Automated Mode Overview
  • 5 Chapter 5: Activating and Changing Your Pod
  • 6 Section 2: Starting Omnipod
  • Download this manual

User Guide

Omnipod

5 Automated Insulin Delivery System

®

Effective Date: 22DEC2020, PCO-000267

Table ofContents

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INSULET OMNIPOD 5 USER MANUAL Pdf Download (2)

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Summary of Contents for Insulet Omnipod 5

  • Page 1 User Guide Omnipod 5 Automated Insulin Delivery System ® Effective Date: 22DEC2020, PCO-000267...
  • Page 2 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: omnipod.com Address: Insulet Corporation 100 Nagog Park, Acton MA 01720 Emergency Services: Dial 911 (USA only; not available in all communities) Controller Model PDM-USA-H001-MG...
  • Page 3 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. All other trademarks are the property of their respective owners. The use of third party trademarks does not constitute an endorsem*nt or imply a relationship or other affiliation.
  • Page 4: Table Of Contents

    Chapter 3: Omnipod 5 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 3.1. Omnipod 5 App and Dexcom Communication ....22 3.2.
  • Page 5 Contents 6.1. Reviewing All Basal Programs ........78 6.2.
  • Page 6 19.1. Insulet-provided Controller ........182...
  • Page 7 21.11. Omnipod5 App Issues .........236 21.12. About Uninstalling the Omnipod 5 App ..... . .238 Section 8: Additional Information Chapter 22: Taking Care of Your Controller and Pod .
  • Page 8 Contents Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287 Index .
  • Page 9 This page intentionally left blank. viii Effective Date: 22DEC2020, PCO-000267...
  • Page 10: Section 1: Before You Begin

    BEFORE YOU BEGIN Introduction System Terminology and Navigation Omnipod 5 System Overview Effective Date: 22DEC2020, PCO-000267...
  • Page 11 This page intentionally left blank. Effective Date: 22DEC2020, PCO-000267...
  • Page 12: Chapter 1: Introduction

    Chapter 1: Introduction Contents 1.1. Welcome to your Omnipod® 5 System ......4 1.2.
  • Page 13: Welcome To Your Omnipod® 5 System

    3 days and can be filled with up to 200 units of U-100 rapid- acting insulin (minimum 85 units). No tubing: There is no tubing connecting the Pod to the Omnipod 5 app. • You can wear the Pod under your clothes and carry the Omnipod 5 app separately.
  • Page 14 MY FOODS list or the BROWSE list to transfer the number of carbs in a meal to the Bolus Calculator. Keeping Track of CGM and Insulin The Omnipod 5 System records up •...
  • Page 15: About This User Guide

    This User Guide is intended for use only with the Insulet-provided controller with the Omnipod 5 app, model PDM-USA-H001-MG, or the Omnipod 5 app on a compatible smartphone. To learn which version of the Insulet-provided controller you have, turn it over. If you see "PDM-USA-H001- MG"...
  • Page 16: Contraindications

    Calculator with sensor glucose may reduce the risk of hypoglycemia compared to blood glucose readings alone. The Omnipod 5 Insulin Delivery Device (the Pod) is intended to be used with a compatible Controller for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
  • Page 17: General Warnings And Safety Information

    Omnipod 5 System for use up to 72 hours (3 days). Apidra is compatible with the Omnipod 5 System for use up to 48 hours (2 days). Before using a different insulin with the Omnipod 5 System, check the insulin drug label and consult your healthcare provider.
  • Page 18: Potential Benefits

    Inadequate training could put your health and safety at risk. Caution: Do not navigate away from the Omnipod 5 app while you are in the process of making changes to your insulin delivery programs. A phone call or other distraction may cause you to miss an important alarm or update, putting you at risk of developing hypoglycemia or hyperglycemia.
  • Page 19: Potential Risks

    Several new, sealed Omnipod 5 Pods • A vial of rapid-acting U-100 insulin (see "1.4. General Warnings and Safety Information" on page 8 for insulins cleared for use in the Omnipod 5 Pod) • Syringes or pens for injecting insulin •...
  • Page 20 Introduction 1 • Phone numbers for your healthcare provider and/or physician in case of an emergency • Glucagon kit and written instructions for administering glucagon dosage if you are unconscious (see "24.4. Avoiding Lows, Highs, and Diabetic Ketoacidosis" on page 276) Tip: Ask your healthcare provider to help you develop plans for handling emergency situations, including what to do if you cannot reach your healthcare provider.
  • Page 21 This page intentionally left blank. Effective Date: 22DEC2020, PCO-000267...
  • Page 22: Chapter 2: System Terminology And Navigation

    Chapter 2: System Terminology and Navigation Contents 2.1. Terminology ............14 2.2.
  • Page 23: Terminology

    Adaptive basal rate Insulin delivery, in units per hour, that is calculated by Omnipod 5 to keep your blood glucose within your desired range. This amount changes over time based on your history, CGM value, and trend.
  • Page 24 Pod. Deactivate Preferred method for shutting down the Pod. Deactivation turns off insulin delivery in the Pod and allows the Omnipod 5 app to activate a new Pod. Device In Omnipod 5, “device” refers to the smartphone or Omnipod 5 controller used to control the Omnipod 5 app.
  • Page 25: Using The Touchscreen And Entering Information

    Omnipod 5 app and how this User Guide describes moving between Omnipod 5 app screens. Note: If you are using your smartphone with your Omnipod 5 app, images in this section may differ from your smartphone. Effective Date: 22DEC2020, PCO-000267...
  • Page 26: Touchscreen Basics

    System Terminology and Navigation 2 Touchscreen basics The Omnipod 5 app displays messages and options for you on its touchscreen. Tapping and swiping The basic instructions for interacting with the touchscreen are explained here. Touch the screen, then lift your finger up.
  • Page 27: Using A Keypad

    2 System Terminology and Navigation Entering numbers and text Tapping in an editable field can bring up a keypad or number pad. Using a keypad Change between upper Delete most and lower case recent entry Open a different keyboard Close keypad Close keypad after entering text No function...
  • Page 28: Using A Scroll Wheel

    System Terminology and Navigation 2 Using a scroll wheel Tapping an editable field can bring up a scroll wheel. Place your finger on the scroll wheel. Swipe up or down to select your desired value. The faster you move your finger, the faster the wheel will scroll.
  • Page 29: Navigation Icons And Navigation Shorthand

    2 System Terminology and Navigation Navigation icons and navigation shorthand Options icon The Options icon ( ) appears on the right side of certain lists. Tapping the Options icon brings up a list of options relevant to the item on that row. User Guide navigation shorthand The User Guide uses the ">"...
  • Page 30: Chapter 3: Omnipod 5 System Overview

    Contents 3.1. Omnipod 5 App and Dexcom Communication .....22 3.2. Omnipod 5 App ........... .23 The Omnipod 5 controller .
  • Page 31: Omnipod 5 App And Dexcom Communication

    Omnipod 5 app. • Your Dexcom G6 transmitter sends sensor glucose values to the Pod and Dexcom G6 app. The Omnipod 5 app does not communicate directly with the Dexcom G6 app. For CGM specific information, refer to your CGM User Guide.
  • Page 32: Omnipod 5 App

    Bluetooth® wireless technology. You can use the provided controller or a compatible smartphone with the Omnipod 5 app. Note: The Omnipod 5 app does not need to be near the Pod for the system to deliver your basal program in Manual Mode or to deliver automated basal in Automated Mode.
  • Page 33: Status Bar

    3 Omnipod 5 System Overview 3.3. Status Bar At the top of the screen is a status bar that shows you the following and other information described in the table (when enabled or applicable): • Omnipod 5 Status icon •...
  • Page 34: Controller Lock Screen And Security

    The amount of insulin on board • Any alarm or notification messages Warning: Always identify the Omnipod 5 app as yours before using it. Using someone else's Omnipod 5 app can result in incorrect insulin delivery for both of you. Warning: Always keep your Omnipod 5 app safe and within your control to ensure others cannot make changes to your insulin therapy.
  • Page 35: Forgot Your Pin

    Caution: Do not turn off the Omnipod 5 security setting within the Omnipod 5 app. If Omnipod 5 security is off, someone could potentially use your Omnipod 5 app to change your insulin therapy without your permission. Effective Date: 22DEC2020, PCO-000267...
  • Page 36: Home Screen

    Omnipod 5 System Overview 3 3.5. Home Screen This section introduces you to what you may see on the Omnipod 5 app Home screen. Different information will display depending on which system mode is activated. Alarms and Notifications Status bar...
  • Page 37: 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.
  • Page 38: With Paired Cgm Transmitter

    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 "13.5. CGM Trend Arrows" on page 131. • CGM value (without arrow): when transmitter supplies a CGM value but is unable to report CGM trend.
  • Page 39: Insulin Tab

    3 Omnipod 5 System Overview INSULIN tab The INSULIN tab label changes to PROTECT when HypoProtect™ is running 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 user-defined Basal Program.
  • Page 40: Temp Basal

    Omnipod 5 System Overview 3 Temp basal If a temp basal is running, the INSULIN tab label changes to TEMP ON and is highlighted in green. It displays the temp basal graph and allows you to cancel the temp basal. See"7.1. About Temporary Basal Rates"...
  • Page 41: Pod Info Tab

    Note: When there is no communication, the Pod continues delivering insulin according to the instructions it was given. Tip: Bringing the Omnipod 5 app and the active Pod within 5 feet of one another may quickly restore their communication. If there is no active Pod, the POD INFO tab says "No Active Pod." To set up a new Pod, see "Chapter 5: Activating and Changing Your Pod"...
  • Page 42: Pod Info Banners

    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.
  • Page 43: Bolus Information And Button

    Duration of Insulin Action setting Bolus information if there is no Pod communication If the Pod is out of range of the Omnipod 5 app and cannot confirm the recent bolus amount, an estimated bolus amount is shown. Once the Pod is in range again and the bolus delivery is confirmed, the confirmed bolus amount is shown.
  • Page 44: Home Screen Main Menu

    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 icon ( ) in the upper left corner of the Home screen.
  • Page 45: Notifications And Messages

    Alarms require your immediate attention (see page 187). 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 ( ) are accompanied by a continuous vibration or tone and interrupt anything else the Omnipod 5 app is doing except another hazard alarm.
  • Page 46: Action Item Notifications

    Action item notifications are related to changes you may have made to your Omnipod 5 app that could affect safe use of the system. For example, a Turn on Bluetooth action item means your Bluetooth has been shut off and your app is no longer communicating with your Pod.
  • Page 47: Manual And Automated Mode Overview

    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. Note: A ✓ in the field indicates the task can be performed in the specified mode.
  • Page 48: Identifying System Modes

    Omnipod 5 System Overview 3 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.
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  • Page 50: Section 2: Starting Omnipod

    STARTING OMNIPOD 5 Setting Up Your Omnipod 5 Application Activating and Changing Your Pod Effective Date: 22DEC2020, PCO-000267...
INSULET OMNIPOD 5 USER MANUAL Pdf Download (2024)

FAQs

Has Omnipod 5 killed anyone? ›

Omnipod malfunction results in death

Overdoses of insulin can lead to harm or even death, as seen in the tragic fatal negligence case of a 5-year-old boy in 2019 who was given ten times the amount of insulin by a junior doctor in Rotherham. Another case relating to an Omnipod device was the death of Paul McNairney.

What is the minimum amount of insulin for the Omnipod 5? ›

The Pod can hold up to 200 units of insulin; it requires a minimum of 85 units of insulin to begin operation. Simply fill the Pod with the amount of insulin you will need while wearing it, up to 200 units. Where on my body can I wear the Pod?

Can you start Omnipod 5 without training? ›

Training is essential and must be completed before using the Omnipod 5 System.

Does Omnipod 5 automatically correct high blood sugar? ›

Automated Insulin Delivery (AID) systems automatically adjust insulin delivery to help manage glucose levels, reduce hypoglycemia, and increase time in range. For optimal glucose results, it is necessary to assess your initial Omnipod 5 settings with your healthcare provider.

Is Omnipod 5 being discontinued? ›

To continue bringing our users the latest in Omnipod technology, we have made the decision to discontinue the Omnipod Insulin Management System (also known as Omnipod Eros, Omnipod UST400, or Omnipod “Classic”) in the United States as of December 31, 2023.

Can Omnipod 5 go through mri? ›

The Omnipod 5 Automated Insulin Delivery System is compatible with the following U-100 insulins: NovoLog®, Humalog®, and Admelog®. Device components including the Pod, Sensor, and Transmitter must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment.

What is the average A1c on Omnipod 5? ›

Study in 240 people with T1D aged 6 - 70 years involving 2 weeks standard diabetes therapy followed by 3 months Omnipod 5 use in Automated Mode. Average A1c in adults/adolescents and children, standard therapy vs. Omnipod 5 = 7.16% vs 6.78%; 7.67% vs 6.99%.

Can you wear Omnipod 5 longer than 3 days? ›

NovoLog, Humalog, and Admelog are compatible with the Omnipod 5 System for use up to 72 hours (3 days). Follow your healthcare provider's directions for how often to replace the Pod.

Can I use Omnipod 5 without Dexcom? ›

The Dexcom G6 and Dexcom G7 receivers are not compatible with the Omnipod 5 System. Can the Omnipod 5 System be used without a CGM? The Omnipod® 5 System can be used with or without a continuous glucose monitor, but to benefit from automated insulin delivery, it must be paired with a compatible CGM.

How do you fly with Omnipod 5? ›

Flying with diabetes devices

The Bluetooth® setting remains enabled in the Omnipod PDM/Controller's aeroplane mode so you can communicate with your Pod. Your glucose sensor will still work if your phone is in aeroplane mode, and you can use it during the flight - just remember to keep your Bluetooth® on.

How to get free Omnipod 5? ›

Eligibility criteria: Subject to program limitations and terms and conditions, the Omnipod 5 10-day Free Trial Program (the “Program”) is open to patients who have a valid Omnipod 5 and Dexcom G6 prescription and who have commercial or private insurance, including plans available through state and federal healthcare ...

Does Omnipod 5 work without Wi-Fi? ›

The Omnipod 5 App sends and receives information from the Pod using Bluetooth wireless technology and therefore cellular connectivity does not impact insulin delivery.

Why does my blood sugar go up even after taking insulin? ›

Possible causes include:

Inadequate insulin dose. Rebound from a low blood glucose. Delayed stomach (gastric) emptying. Taking too little insulin because of fear of low blood sugars.

How many units of insulin can you put in Omnipod 5? ›

The Omnipod 5 Pods are equipped with SmartAdjust™ technology that can receive sensor glucose values and use those values to automate insulin delivery. The Pod is wearable, lightweight, holds up to 200 units of insulin, and is waterproof**.

How to tell how much insulin is left in an omnipod? ›

To establish communication to the Pod without delivering a command, simply swipe or tap the “Pod Info” tab on the Omnipod DASH® PDM Home screen. This allows information such as how much insulin is left in the Pod to be updated on the Omnipod DASH® PDM.

Is Omnipod 5 safe? ›

The Omnipod 5 System uses CGM values and trends to calculate insulin delivery. If the CGM values are inaccurate, the System could deliver an inaccurate dose of insulin which can lead to hypoglycemia or hyperglycemia. Wearing a Pod might cause infection.

Is there a recall on Omnipod 5? ›

Insulet's recall — a correction, not a product removal — affects software versions 1.1-1.2. 3 for the Omnipod 5 automated insulin delivery system. It distributed the software between April 20, 2023, and Dec. 20, 2023.

What is the failure rate of the Omnipod? ›

Approx. 76 of the pods have worked normally, resulting in a 28% failure rate (29/105 total pods to date).

What is the Omnipod class action lawsuit? ›

In this Action, Lead Plaintiffs allege that Defendants made materially false and misleading statements to investors touting the quality of the OmniPod Eros, the successful launch of the product, customers' broad acceptance of the product, and the high rate of new patient starts during the Settlement Class Period.

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