OmniPod 5 User manual

Omnipod®5 Automated Insulin Delivery System
Quick Start Guide

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INDICATIONS FOR USE
The Omnipod®5 ACE Pump (Pod)
is intended for the subcutaneous
delivery of insulin, at set and
variable rates, for the management
of diabetes mellitus in persons
requiring insulin. The Omnipod
5 ACE Pump is able to reliably
and securely communicate with
compatible, digitally connected
devices, including automated
insulin dosing software, to receive,
execute, and confirm commands
from these devices. The Omnipod
5 ACE Pump is intended for single
patient, home use and requires
a prescription.
SmartAdjust™ technology is
intended for use with compatible
integrated continuous glucose
monitors (iCGM) and alternate
controller enabled (ACE) pumps to
automatically increase, decrease,
and pause delivery of insulin based
on current and predicted glucose
values. SmartAdjust technology
is intended for the management
of type 1 diabetes mellitus in
persons 2 years of age and older.
SmartAdjust technology is intended
for single patient use and requires
a prescription.
The Omnipod 5 SmartBolus
Calculator is software intended
for the management of diabetes
in persons aged 2 and older
requiring rapid-acting U-100
insulin. The Omnipod 5 SmartBolus
Calculator calculates a suggested
bolus dose based on user-entered
carbohydrates, most recent sensor
glucose reading (or blood glucose
reading if using fingerstick), rate
of change of the sensor glucose (if
applicable), insulin on board (IOB),
and programmable correction
factor, insulin to carbohydrate
ratio, and target glucose value. The
Omnipod 5 SmartBolus Calculator
is intended for single patient, home
use and requires a prescription.
CONTRAINDICATIONS
The Omnipod 5 System is NOT
recommended for people who:
• Are unable to monitor glucose
as recommended by their
healthcare provider
• Are unable to maintain contact
with their healthcare provider
• Are unable to use the Omnipod 5
System according to instructions
• Are taking hydroxyurea as it
could lead to falsely elevated
CGM readings and result in the
over-delivery of insulin that can
lead to severe hypoglycemia
• Do NOT have adequate hearing
and/or vision to allow recognition
of all functions of the Omnipod 5
System, including alerts, alarms,
and reminders
Device components including
the Pod, CGM transmitter, and
CGM sensor must be removed
before Magnetic Resonance
Imaging (MRI), Computed
Tomography (CT) scan, or
diathermy treatment. In addition,
the Controller and smartphone
should be placed outside of the
procedure room. Exposure to
MRI, CT, or diathermy treatment
can damage the components.
COMPATIBLE INSULINS
The Omnipod 5 Automated
Insulin Delivery System is
compatible with the following
U-100 insulins: NovoLog®,
Humalog®, and Admelog®.

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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.
2. Receive Training
Learning how to use your Omnipod 5 System the correct way is
important for safe and eective use. Dierent training methods to
learn how to use your system are available based on your and your
healthcare provider’s preferences.
3. Freedom Is Yours!
You’ll then be ready to enjoy the benets and exibility of your new
Omnipod 5 System.
If you have questions please contact Customer Care at
1-800-591-3455 for support 24 hours a day, 7 days a week.
WELCOME TO OMNIPOD®5
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Contents
Section 1: Omnipod 5 System Overview ............................ 6
Section 2: Set Up Your Omnipod 5 App ..............................8
Section 3: Set Up a New Pod ......................................10
Prepare...............................................................10
Fill the Pod ............................................................11
Apply the Pod .........................................................12
Section 4: Connect the Pod and CGM ...............................14
Section 5: Omnipod 5 System Modes ...............................15
System Modes, System States ...........................................15
Switch to Automated Mode..............................................19
Section 6: Get to Know the App....................................20
Omnipod 5 App Home Screen ...........................................20
Glucose Trends and Indicators, View CGM Graph ...........................21
Section 7: Key Insulin Delivery Actions .............................22
Deliver a Bolus ........................................................22
Start the Activity Feature ................................................24
Cancel the Activity Feature ..............................................25
Pause Insulin Delivery ..................................................27
Editing a Basal Program.................................................28
Additional Basal Programs ..............................................29
Set a Temporary Basal Rate .............................................30
Temp Basal Preset .....................................................31
Section 8: Clinical Evidence for Omnipod 5 ..........................32
Section 9: Settings and Technical Specifications .....................42
Section 10: Staying Safe while Using the Omnipod 5 System ..........55
Warnings .............................................................55
Precautions ...........................................................61
Emergency Kit .........................................................67
To access the complete Omnipod 5 System User Guide
At any time while using Omnipod 5, you can access or request the
Omnipod 5 User Guide.
1. Download or print a digital copy:
• Scan this QR code with your smartphone
• Visit omnipod.com/guides
2. Request to receive a free printed copy:
• Online request form at omnipod.com/guides
• Call in to request: 800-591-3455

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6
Omnipod 5 System Overview
The Omnipod 5 App
• on provided Controller or a compatible smartphone
• sends commands to the Pod
• displays glucose and insulin information from the Pod
• used to issue meal and correction boluses
The Pod
• delivers insulin to your body
• receives commands from the Omnipod 5 App
• receives CGM values from Dexcom G6 Transmitter
• sends CGM values to the Omnipod 5 App
• automatically adjusts insulin delivery in Automated Mode
The Dexcom G6 Transmitter
• sends CGM values to the Pod and to the Dexcom G6 app
• does not communicate directly with the Omnipod 5 App
• 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.

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Omnipod 5 App screens are for educational purposes only. Consult your healthcare
professional before using these features and for personalized recommendations.
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88
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. For a list of compatible
smartphones, go to omnipod.com/compatibility.
Initial pump therapy settings, provided by your healthcare provider, are
needed to set up your Omnipod 5 App.
Set Up Your Omnipod 5 App
The Omnipod 5 App will guide you through setup. Make
sure to read each screen and carefully enter information.
An Omnipod ID is needed for setup. You will be
prompted to sign in or be directed to create a new ID.
Setup is complete after entering your personalized
initial pump therapy settings (provided by your
healthcare provider).
If using the
provided
Controller as
your Controller:
• Hold down the
Power button
to turn it on
If using your compatible
personal smartphone:
• Download the Omnipod 5 App
on Google Play
• Ensure Bluetooth®is turned
ON on your compatible
smartphone
• In order to use Omnipod 5 App
on a compatible smartphone,
you must rst log into the
Omnipod 5 App on the
provided controller
OR
Dexcom G6 not included
You can set up & start your Dexcom G6 before or after setting up
your Omnipod 5 App. Please consult the Dexcom G6 User Guide for
more information.

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Omnipod 5 App screens are for educational purposes only. Consult your healthcare
professional before using these features and for personalized recommendations.
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Set Up a New Pod
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• After rst time
setup, tap SET
UP NEW POD
• From the POD
INFO tab on the
Home screen, tap
SET UP NEW POD
OR
Prepare
Gather the following supplies:
• Omnipod 5 Controller or smartphone
• Unopened Omnipod 5 Pod
• Alcohol prep swabs
• A vial of room temperature rapid-acting U-100 insulin approved
for use with Omnipod 5
Wash your hands with soap and water
Clean the top of the insulin vial with an alcohol prep swab
On the Omnipod 5 App, locate the Pod activation screen