OmniPod 5 User manual

Omnipod®5 Automated Insulin Delivery System
Quick Start Guide

22
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®.

3
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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7

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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.
2
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.
2
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

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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.
2
Fill the Pod
Prepare the ll syringe
• Remove the fill needle and syringe from the Pod’s tray.
Keep the Pod in its tray during setup. Twist the needle
clockwise onto the top of the syringe for a secure fit.
Do not use any other type of needle or filling device
besides the syringe provided with each Pod.
• Remove the protective needle cap by carefully pulling
it straight off the needle.
Fill the syringe
• Gently pull back on the
plunger to draw air into the
syringe equal to the amount of
insulin you will use. You must
fill the syringe with at least 85
units of insulin (MIN fill line).
Insert the needle into the vial
and push the plunger in to
inject the air.
• With the syringe still in the vial,
turn the vial and syringe upside
down. Slowly pull the plunger to withdraw the insulin.
Tap or flick the filled syringe to remove any bubbles.
Fill the Pod
• Remove the needle from the
vial and insert it straight down
into the fill port. An arrow on
the white paper backing points
to the fill port. Slowly push the
plunger down to completely fill
the Pod.
• The Pod will beep twice to
indicate the Omnipod 5 Pod
is ready to proceed.
SET UP A NEW POD (continued)
MIN
ll
line

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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.
Activate the Omnipod 5 Pod
• With the Pod still in its tray, place it next to
and touching the controller to ensure proper
communication. Tap NEXT on the controller.
The system will perform a series of safety
checks and automatically primes the Pod.
Pod Placement
Adults and Children
SET UP A NEW POD (continued)
CGM Placement
The Pod and CGM should be worn in line of sight, which means worn on the
same side of the body in a way that the two devices can “see” one another
without your body blocking their communication.

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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.
Apply the Pod
Your Pod is now ready for application and insertion.
• Carefully follow the on-screen instructions. For more
information, please refer to “Activating and Changing
Your Pod” in your Omnipod 5 System User Guide.
• Check the infusion site after insertion to ensure that
the cannula was properly inserted.
Guidelines for Pod Site Selection
• Place at least 3 inches (7.62 cm) from your CGM sensor site, as indicated in
your Dexcom G6 System User Guide.
• Place within line of sight of the CGM sensor for the best connectivity.
Note: Line of sight means that the Pod and CGM are worn on the same
side of the body in a way that the two devices can “see” one another
without your body blocking their communication.
• 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.
• Avoid sites where belts, waistbands, or tight clothing may rub against or
dislodge the Pod.
• Avoid sites where the Pod will be affected by folds of skin.
• Avoid placing the Pod over a mole, tattoo, or scar, where insulin
absorption may be reduced.
• Avoid areas of the skin with an active infection.

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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.14
Connect the Pod and CGM
Locate your Dexcom G6 Transmitter Serial Number (SN)
from back of transmitter OR from transmitter box
Step 1: Locate CGM Transmitter Entry Screen
Step 2: Enter & Save New CGM Transmitter SN
OR
From first time setup
after Pod activation
• Tap rst box to
enter transmitter SN
• Tap SAVE
From Home screen
• Tap Menu button
• Tap Settings
• Tap CGM Transmitter
• Tap ENTER NEW

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System Modes
The Omnipod 5 System has two operating modes:
Automated Mode and Manual Mode
Automated Mode
• Adjusts every 5 minutes
• Adapts by updating your total daily
insulin with every Pod change
Manual Mode
• Uses your Basal Program
System States
Automated Mode: Limited
• Pod is not receiving CGM values
• System constantly compares
Automated Adaptive Basal Rate
and Manual Basal Program and
uses whichever is lower
No Pod Communication
• Pod status is unknown
• Bring Controller or
smartphone closer to Pod
Omnipod 5 System Modes

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Manual Mode Automated Mode
How it works
Basal Insulin
Delivery
Insulin is delivered
according to the active
Basal Program
Insulin is delivered and adjusted
automatically based on CGM
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
Basal Program and uses
whichever is lower.
Bolus Insulin
Delivery
Insulin is delivered using
the SmartBolus Calculator
or entered manually
Insulin is delivered using the
SmartBolus Calculator or
entered manually
Connected
CGM
Not required. If connected,
CGM values displayed,
stored in history, and
available for use in
SmartBolus Calculator.
Required. CGM values used
for automated insulin delivery,
displayed, stored in history,
and available for use in
SmartBolus Calculator.

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Manual Mode Automated Mode
What you can do
Basal Programs Edit, create new, activate
Basal Programs. Does not
impact Automated Mode.
Edit Target Glucose to
impact automated insulin
delivery. Cannot modify
Basal Programs in
Automated Mode.
Basal Insulin
Delivery
Start and cancel Temp
Basal rate, create Temp
Basal Presets
Start and cancel the
Activity feature
Bolus Calculator
Settings
Edit Bolus Settings Edit Bolus Settings
Bolus Insulin
Delivery
Deliver and cancel Immediate
and Extended Boluses
Deliver and cancel
Immediate Boluses
Pod Changes Activate and
Deactivate Pods
Deactivate Pods
When a Pod is deactivated, the
System switches to Manual
Mode. After you activate a new
Pod, you’ll be prompted to
switch to Automated Mode.
CGM
Transmitter
View and modify CGM
transmitter serial number
View CGM transmitter
serial number
Pause and
Start Insulin
Manually pause insulin
for a specied duration
of up to 2 hours. Manually
Start insulin.
System automatically
pauses automated insulin
delivery based on CGM
value/prediction. Switch to
Manual Mode to manually
pause insulin delivery.
History Details Review History Details Review History Details.
Auto Events tab shows
microbolus deliveries from
Automated Mode.
BG Entry Enter blood glucose readings
to save in History Details
Enter blood glucose readings
to save in History Details
How you will
be notied
Refer to Sections 2 & 5 of the Omnipod 5 System User Guide for
a detailed list of alarms and notications
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.
For your first Pod, since the System doesn’t have any history yet, your total daily insulin and
inital Adaptive Basal Rate are estimated from the Basal Program you entered during setup.
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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.
Switch to Automated Mode
• Tap the Menu
button on the
Home screen
1
• Tap Switch Mode
2
• Tap SWITCH
• An active Pod
and a saved
CGM transmitter
SN within the
Omnipod 5 App
are required
3
4
• Conrm that the mode
switched. Automated
should be indicated
at the top right of
the screen.
Note: Before switching to
Automated Mode, an active temp
basal, extended bolus, or insulin
pause must first be canceled.

8Get to Know the App
Omnipod 5 App Home Screen
Omnipod 5 App screens are for educational purposes only. Consult your healthcare
professional before using these features and for personalized recommendations.20
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Menu
Button
CGM Glucose
Value and
Trend Arrow
Current
System Mode
Tab Views:
• DASHBOARD
• INSULIN
• POD INFO
Alarms and
Notications
Insulin on
Board (IOB)
Last Bolus
Bolus
Button
CGM Graph