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OmniPod 5 User Manual

OmniPod 5
366 pages
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i
Omnipod
Ā®
5 Automated Insulin Delivery System Technical User Guide
Contacts and Important Information
Customer Care - 24 hours/7 days
Website: omnipod.com
Address: Insulet Corporation, 100 Nagog Park, Acton MA 01720
Controller Model: PDM-M001-G-XX
Serial Number:
Controller FCC ID:
2ADINN5004L
Controller FCC ID: 2ADINN5004LR1
Pod FCC ID: RBV-029
Pod FCC ID: RBV-029C
OmnipodĀ® 5 Automated Insulin Delivery System
Start Date:
Name
Street Address
City County Post Code
Phone
Email
Healthcare Provider
Name
Street Address
City County Post Code
Phone
Policy Number
Health Insurance
Name
Street Address
City County Post Code
Phone
Email
OmnipodĀ® Trainer
Name
Street Address
City County Post Code
Phone
Email
Pharmacy

Table of Contents

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OmniPod 5 Specifications

General IconGeneral
Device TypeInsulin Pump
Insulin DeliveryContinuous subcutaneous insulin infusion (CSII)
ConnectivityBluetooth
ModelOmniPod 5
ManufacturerInsulet Corporation
Reservoir Capacity200 units
Water ResistanceIP28
ControllerSmartphone app or dedicated controller
Automated Insulin DeliveryYes
Insulin TypeU-100 insulin
Pod Wear TimeUp to 3 days
Control MethodSmartphone app
Age Indication2 years and older
Battery LifeUp to 72 hours (pod life)
BatteryBuilt-in
Compatible DevicesiOS and Android smartphones

Summary

Before You Begin

1 Introduction

An overview of the Omnipod 5 System and user guide.

Omnipod 5 Pump Features

2 System Terminology and Navigation

Defines key terms and explains navigation within the Omnipod 5 System interface.

3 Omnipod 5 System Overview

Provides a general overview of the Omnipod 5 System components and interface.

4 Setting Up Your Omnipod 5 Application

4.1. Setting Up Your Account

Guides users through creating an Omnipod account for therapy information.

4.2. Preparing for Your Training

Lists items needed and preparation steps for Omnipod 5 system training.

4.3. General Settings on the Insulet-provided Controller

Covers initial controller setup, personalization, and security settings.

4.4. Basal Settings

Details how to set up basal rates and create basal programs for insulin delivery.

4.5. Bolus Settings

Explains how to configure settings for calculating bolus doses, including carb ratios and correction factors.

4.7. Saving Your Settings for Reference

Advises on backing up important settings for future reference or system reset.

5 Activating and Changing Your Pod

5.1. Beginning the Pod Activation Process

Details the initial steps and safety precautions for activating a new Pod.

5.2. Setting Up a New Pod

Guides on initiating the process of setting up a new Pod.

5.3. Fill the Syringe with Insulin

Provides instructions on how to properly fill the syringe with insulin for the Pod.

5.4. Filling, Activating, Applying and Starting the Pod

Comprehensive guide to filling, activating, applying, and starting the Pod.

5.5. Checking Your Infusion Site

Explains how to inspect the infusion site for proper insertion and signs of infection.

5.6. Switching to Automated Mode

Details how to switch from Manual to Automated Mode for insulin delivery.

5.7. Deactivating an Active Pod

Instructs on the proper procedure for deactivating and removing an active Pod.

5.8. More Information about Pod Use

Offers additional information and tips for optimal Pod usage and care.

6 Basal Programmes

6.1. About Basal Programmes

Explains the concept of basal insulin and how Basal Programmes work in Manual Mode.

6.2. Reviewing All Basal Programmes

Guides users on how to view and check saved Basal Programmes.

6.3. Creating New Basal Programmes

Provides steps for creating custom Basal Programmes for different routines.

6.4. Editing a Basal Programme

Explains how to modify existing Basal Programmes, including renaming and adjusting segments.

6.5. Deleting a Basal Programme

Details the process for removing a Basal Programme that is no longer needed.

6.6. Switching to a Different Basal Programme

Describes how to activate a different saved Basal Programme.

6.7. Basal Insulin Delivery

Explains how basal insulin is delivered in Manual and Automated Modes.

7 Temporary Basal Rates and Presets

7.1. About Temporary Basal Rates

Explains the purpose and use of temporary basal rates (temp basals) in Manual Mode.

7.2. Starting a Temp Basal

Guides users on how to set up and start a temporary basal rate.

7.3. Cancelling a Temp Basal or Temp Basal Preset

Explains how to stop or cancel an active temporary basal rate or preset.

7.4. Creating a New Temp Basal Preset

Details how to create and save custom temporary basal rate presets for quick activation.

7.5. Editing a Temp Basal Preset

Describes how to modify existing temporary basal rate presets.

7.6. Deleting a Temp Basal Preset

Explains how to remove temporary basal rate presets that are no longer needed.

7.7. Temporary Basal Rates Delivery

Details how temporary basal rates are delivered and limitations.

8 Blood Glucose Readings

8.1. About Blood Glucose Readings

Explains how the system uses sensor glucose values and when to use a BG meter.

8.2. Entering Your Blood Glucose Reading

Provides step-by-step instructions for manually entering blood glucose readings.

8.3. High and Low Blood Glucose Readings

Explains how high and low glucose readings are displayed and indicated by the system.

9 Pausing and Starting Insulin Delivery

9.1. Pausing Insulin Delivery

Details how to pause insulin delivery for a specified duration.

9.2. Methods to Temporarily Pause Insulin Delivery in Manual Mode

Compares pausing insulin delivery with temp basal settings for temporary halts.

9.3. Starting Insulin Delivery

Explains how to restart insulin delivery after a pause period has ended.

10 Changing Settings

10.1. General Settings

Covers settings related to network connectivity, screen display, and lock screen.

10.2. Reminder Settings

Allows users to configure reminders for Pod expiry, low insulin, and other actions.

10.3. Basal and Temp Basal Settings

Details how to adjust Maximum Basal Rate and Temp Basal settings.

11 Browsing Your History and Records

11.1. About Your Recent History and Past Records

Explains the data storage capacity and how to browse records.

11.2. Viewing the Sensor Graph

Guides users on how to view sensor glucose data and trends on the graph.

11.3. Sensor Graph States

Explains the different states and colors used in the sensor graph display.

11.4. History Information Overview

Provides an overview of the history summary and detail screens.

11.5. Calculations for History Summaries

Details the calculations used for generating history summaries.

11.6. History Details Section

Explains how to view detailed records for glucose, bolus, and other events.

12 Managing Software Updates

12.1. Insulet-provided Controller

Covers over-the-air updates for the Controller's operating system and app.

13 Alarms, Action and Reminder Notifications

13.1. Types of Alarms and Notifications

Categorizes and explains different types of alarms and notifications generated by the system.

13.2. Alarms and Notifications Screen

Guides users on how to review past alarms and notifications.

13.3. Sounds and Vibrations

Explains how sounds and vibrations are used to attract attention to alarms and notifications.

13.4. Informational Sounds and Vibrations

Describes informational sounds and vibrations for normal system activity.

13.5. Responding to Alarms

Provides instructions on how to respond to hazard and advisory alarms.

13.6. Hazard Alarm List

Lists and describes critical hazard alarms requiring immediate attention.

13.7. Advisory Alarm List

Lists and describes advisory alarms that indicate situations needing attention.

13.8. Action Item Notification List

Details notifications related to technical system tasks requiring user action.

14 Taking Care of Your Controller and Pod

14.1. Pod and Insulin Storage and Care

Provides guidance on proper storage and care of Pods and insulin.

14.2. Controller Storage and Care

Offers advice on storing and caring for the Omnipod 5 Controller.

14.3. Controller Battery Care

Covers safe usage and charging procedures for the controller's rechargeable battery.

15 Living with Diabetes

15.1. Infusion-Site Checks

Explains how to check the infusion site for signs of infection or dislodgement.

15.2. Being Aware of Your Glucose

Advises users on monitoring glucose levels and recognizing symptoms of highs and lows.

15.3. Travelling and Holidays

Provides guidance on preparing for travel, including keeping supplies accessible and managing time zones.

15.4. Avoiding Lows, Highs and Diabetic Ketoacidosis

Details how to prevent and manage hypoglycemia, hyperglycemia, and DKA.

15.5. Handling Special Situations

Offers advice on managing diabetes during sick days, exercise, and medical procedures.

16 Delivering a Bolus

16.1. Delivering a Manual Bolus

Explains how to calculate and deliver a manual bolus without the SmartBolus Calculator.

16.2. Delivering Immediate and Extended Boluses

Differentiates between immediate and extended boluses and their use.

16.3. Tracking the Progress of a Bolus

Guides users on how to monitor the progress of an ongoing bolus.

16.4. Cancelling a Bolus in Progress

Details how to cancel a bolus that is currently being delivered.

16.5. Reminder Settings

Covers setting reminders for checking glucose after bolus and for missed boluses.

17 Delivering a Bolus with the SmartBolus Calculator

17.1. About the SmartBolus Calculator

Explains the function of the SmartBolus Calculator for meal and correction boluses.

17.2. Entering Meal Information

Guides users on how to input carbohydrate information for meal bolus calculations.

17.3. Entering a Blood Glucose Reading or Using a Sensor Glucose Value

Details how to input glucose readings or sensor data for bolus calculations.

17.4. Insulin On Board (IOB)

Explains the concept of Insulin On Board (IOB) and its role in bolus calculations.

17.5. Adjustments to Your Calculation

Describes how various factors can adjust suggested bolus calculations.

17.6. Delivering an Immediate Bolus

Guides on how to review and deliver an immediate bolus.

17.7. Delivering an Extended Bolus

Explains how to extend the delivery of a meal bolus over a period of time.

17.8. Bolus Settings

Details various settings that impact bolus calculations, like Max Bolus and IC Ratio.

18 Understanding SmartBolus Calculator Calculations

18.1. The SmartBolus Calculator

Explains how the SmartBolus Calculator works, its components, and limitations.

18.2. SmartBolus Calculator Examples

Provides examples of bolus calculations for various scenarios.

USING A SENSOR WITH OMNIPOD 5

Sensor Important Safety Information

Crucial safety warnings and precautions related to using a sensor with the system.

19 About the Dexcom G6

Provides an overview of the Dexcom G6 continuous glucose monitoring system.

20 Connecting Dexcom G6 to the Pod

Guides on how to connect the Dexcom G6 CGM system to the Omnipod 5.

19 About the Dexcom G6

19.1. Dexcom G6 Overview

Introduces the Dexcom G6 CGM system and its basic functions.

19.2. Dexcom G6 Sensor Placement

Illustrates recommended placement examples for the Dexcom G6 sensor.

19.3. Using the Dexcom G6 with Omnipod 5

Explains how to use the Dexcom G6 sensor with the Omnipod 5 System.

19.4. Sensor Glucose Values

Describes how sensor glucose values and trends are displayed and interpreted.

19.5. Sensor Glucose Trend Arrows

Explains the meaning of different sensor glucose trend arrows.

19.6. Communication Messages

Lists and explains various communication messages from the system.

20 Connecting Dexcom G6 to the Pod

20.1. About Connecting Dexcom G6 to the Pod

Explains the requirements and benefits of connecting the Dexcom G6 to the Pod.

20.2. Connecting the Dexcom G6 during Initial Pod Set-up

Guides on connecting the Dexcom G6 system during the initial Pod setup process.

20.3. Connecting the Dexcom G6 Transmitter

Details the steps for connecting the Dexcom G6 transmitter's serial number to the Omnipod 5 App.

20.4. Disconnecting the Transmitter from the Pod

Explains how to disconnect the Dexcom G6 transmitter from the Pod.

AUTOMATED MODE

21 About Automated Mode

Provides a comprehensive overview of the Automated Mode operation.

22 Switching Between Manual Mode and Automated Mode

Guides users on switching between Manual and Automated modes.

23 Activity Feature

Explains how to use the Activity feature to adjust insulin delivery during physical activity.

24 Automated Mode Alarms

Lists and describes alarms specific to the Automated Mode of operation.

25 Omnipod 5 System Clinical Studies

Presents information from clinical studies on the Omnipod 5 System's safety and effectiveness.

21 About Automated Mode

21.1. About Automated Mode

Explains how Automated Mode and SmartAdjust technology work to deliver insulin.

21.2. About the Dexcom G6 in Automated Mode

Details how the Dexcom G6 CGM integrates with Automated Mode for insulin delivery.

21.3. Bolus Settings and the Importance of a Bolus

Covers bolus settings and their significance in Automated Mode.

21.4. Pod Adaptivity

Explains how SmartAdjust technology adapts insulin delivery based on historical data.

21.5. About Automated Mode: Limited

Describes the Automated Mode: Limited state and its causes.

21.6. Automated Delivery Restriction

Explains the Automated Delivery Restriction alarm and what to do.

22 Switching Between Manual Mode and Automated Mode

22.1. Switching from Manual Mode to Automated Mode

Guides on transitioning from Manual Mode to Automated Mode operation.

22.2. Switching from Automated Mode to Manual Mode

Details the process for switching from Automated Mode back to Manual Mode.

23 Activity Feature

23.1. About the Activity Feature

Explains the Activity feature's purpose and how it modifies insulin delivery.

23.2. Starting the Activity Feature

Provides steps for enabling and configuring the Activity feature.

23.3. Cancelling the Activity Feature

Details how to cancel the Activity feature before its scheduled duration ends.

24 Automated Mode Alarms

24.1. Advisory Alarm List

Lists and explains advisory alarms specific to Automated Mode operation.

25 Omnipod 5 Clinical Studies

25.1. Studies in Children, Adolescents and Adults with Type 1 Diabetes

Presents results from a pivotal study involving young people with type 1 diabetes.

25.2. Studies in Very Young Children with Type 1 Diabetes

Details findings from a study conducted on very young children with type 1 diabetes.

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