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Automated insulin delivery system
Hide thumbs Also See for Omnipod 5:
- User manual (391 pages) ,
- Quick start manual (92 pages) ,
- Resource manual (31 pages)
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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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Chapters
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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.
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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 .
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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...
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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 •...
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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.
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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.
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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. - Page 49 This page intentionally left blank. Effective Date: 22DEC2020, PCO-000267...
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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...
