Insulet Omnipod 5 Firmware update

Resource Guide

Omnipod®5 Automated Insulin Delivery System

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Introduction |TABLE OF CONTENTS

Introduction

Choosing Your Omnipod® 5 Controller........................................................................................................... 4

Preparing to Start Omnipod 5 Automated Insulin Delivery System ............................................................. 5

Understanding Automated Insulin Delivery Systems.................................................................................... 6

Omnipod 5 System

Omnipod 5 Components ................................................................................................................................ 8

Communication............................................................................................................................................... 9

Starting Omnipod 5 System |System Instruction

Omnipod 5 Application Settings .................................................................................................................. 12

Change a Pod

Activate a New Pod................................................................................................................................... 14

Pod Site Preparation and Placement Options ......................................................................................... 20

Deactivate a Pod....................................................................................................................................... 22

Connect Dexcom G6® CGM........................................................................................................................... 23

System Modes .............................................................................................................................................. 24

Switching Modes........................................................................................................................................... 26

Everyday Use |Omnipod 5 System Instructions

Omnipod 5 App Home Screen...................................................................................................................... 28

Glucose Trends and CGM Graph .................................................................................................................. 29

Eating: Deliver a Bolus.................................................................................................................................. 30

Activity: Start the Activity Feature ............................................................................................................... 32

Troubleshooting

History....................................................................................................................................................... 34

 Notications,AlertsandAlarms .............................................................................................................. 35

System States........................................................................................................................................... 36

Additional Use |Omnipod 5 System Instructions

Settings: Edit Target Glucose & Bolus Settings ........................................................................................... 39

Extended Bolus............................................................................................................................................. 41

Manual Mode

Pause Insulin Delivery.............................................................................................................................. 42

Start Insulin Delivery................................................................................................................................ 43

Start a Temporary Basal Rate................................................................................................................... 44

Edit Manual Basal Program ...................................................................................................................... 45

Create Additional Basal Programs ........................................................................................................... 46

Create Temp Basal Presets ...................................................................................................................... 48

Understanding Diabetes Therapy

Carbohydrate Counting................................................................................................................................. 52

Hypoglycemia ............................................................................................................................................... 54

Hyperglycemia .............................................................................................................................................. 56

Sick Day Management .................................................................................................................................. 58

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 conrm 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 suspend delivery

of insulin based on current and predicted glucose values.

SmartAdjust technology is intended for the management of

type 1 diabetes mellitus in persons 6 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 6 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 ngerstick),

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.

For full indications and instructions for use

please consult the Omnipod 5 System User

Guide available online at www.omnipod.com.

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Introduction |PREPARING TO START OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

4Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Introduction |CHOOSING YOUR OMNIPOD 5 CONTROLLER

Welcome to your Omnipod®5 System

Before you begin using your Omnipod 5 Automated Insulin Delivery

System you will need to choose to use the provided Controller or a

compatible personal smartphone* for the Omnipod 5 App.

Settings and history are stored on the device (Omnipod 5 Controller

or smartphone) that you choose.

Caution: If you decide later to switch between the Controller and your

smartphone, you will need to start setup again on the new device. New

setup requires entry of all your personalized settings. Consult with your

healthcare provider if you are unsure about how to set up the new

device. If you are wearing a Pod and need to switch devices, you will

need to deactivate your Pod and activate a new one with the new

device since the Pod cannot communicate with two devices at one time.

During rst time setup of the Omnipod 5 App you will be directed to

a website to create your Insulet prole. At this time you will create an

Omnipod account, link your accounts, select training preferences and

engage in eLearning courses.

• If you already have an Omnipod account, use the same username

and password to sign into your controller.

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 based on your and your healthcare

provider’s preferences.

This resource guide includes instructions for some of the key functions you may perform with the

Omnipod 5 System.

Have questions at any time? We are here to help with our 24/7 Customer Care.

Customer Care: 1-800-591-3455

From Outside the US: 1-978-600-7850

omnipod.com

For more information about indications, contraindications, warnings, and full instructions please consult

your Omnipod 5 System User Guide available online at www.omnipod.com.

In an emergency, you should call your healthcare provider.

You should also keep the following supplies on hand at all times to quickly respond to any diabetes emergency:

If using a compatible

personal smartphone:

• Download the

Omnipod 5 App

on Google Play.

• Ensure Bluetooth®

is turned ON on your

compatible smartphone

so that the Omnipod 5

App and your Pod

can communicate.

• In order to use the

Omnipod 5 App on a

compatible smartphone,

you must rst log into

the Omnipod 5 App on

the provided Controller.

*For a list of compatible smartphones please visit omnipod.com/compatibility.

Connecting to cellular data or Wi-Fi is important when

using the Omnipod 5 System. Being connected will allow

you to be notied of important updates as well as allow

seamless auto uploading of your data to Insulet’s secure

cloud. With either device, be sure to only connect to a

trusted Wi-Fi network.

Supplies

• Several new, sealed Omnipod 5 Pods

• A vial of rapid-acting U-100 insulin

• Glucose tablets or another fast-acting source

of carbohydrates

• Continuous glucose monitor (CGM) and supplies

• Blood glucose meter and test strips

• Lancing device and lancets

• Alcohol prep swabs

• Syringes or pens for injecting insulin

• Instructions from your healthcare provider

about how much insulin to inject if delivery

from the Pod is interrupted

• Phone numbers for your healthcare provider

in case of emergency

• Ketone testing supplies

• Glucagon kit and written instructions for

administration if you are unconscious

Preparing to Start your Omnipod®5 System

Warning: DO NOT start to use your system or change your settings without adequate training and guidance from

your healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery,

which could lead to hypoglycemia or hyperglycemia.

Dexcom CGM sold separately. You can

set up and start your Dexcom G6 before

or after setting up your Omnipod 5 App.

You must use the Dexcom G6 App,

not the Dexcom G6 receiver with the

Omnipod 5 System

Please consult the Dexcom G6 User

Guide for more information.

6Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Introduction |UNDERSTANDING AUTOMATED INSULIN DELIVERY SYSTEMS

Understanding Basal, Bolus, and Automated

Insulin Delivery (AID) Systems

Insulin Pump Therapy

With or Without Automation

• Basal insulin covers background needsto

keep glucose levels in target between meals

and overnight

• Bolus insulin is an additional dose of insulin

needed for food (meal bolus) and/or high

glucose (correction bolus)

Automated Insulin Delivery Systems

• An insulin pump/Pod that communicates

with CGM and algorithm to automatically

adjust insulin delivery

• Must still bolus for meals and snacks

• Benets of AID systems1,2:

– Increase the amount of hours each day

spent in time in range (70-180 mg/dL)

– Less hypoglycemia (low glucose)

– Less hyperglycemia (high glucose)

– Improved quality of life

Omnipod®5

System

Insulin Delivered From Pod

1. Cinar A. Automated insulin delivery algorithms. Diabetes Spectrum. 2019;32(3);209-214.

2. American Diabetes Association. 7. Diabetes technology: Standards of Medical Care in Diabetes - 2021. Diabetes Care 2021; 44(Suppl. 1):S85-S99.

Bolus Insulin

Basal Insulin

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Omnipod 5 System |COMMUNICATION

8Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Omnipod 5 System |OMNIPOD 5 COMPONENTS

* Please go to omnipod.com/compatibility for a list of compatible smartphones

** IP28 Rating, up to 25 ft. for 60 minutes

Dexcom G6 Transmitter

Controller or smartphone

Omnipod 5 Pod

Omnipod®5 System

The Omnipod 5 App

• Can be used on a compatible smartphone* or

the provided Controller

• Used to control and monitor the Pod’s operations

• Although your Omnipod 5 System does

not require the Controller to be nearby to

continue your insulin delivery in Manual Mode

or Automated Mode, the Controller and/or

smartphone provide(s) you with important

information about recent insulin delivery,

alerts, and alarms that come from your Pod,

and allows you to use the SmartBolus

Calculator to deliver a bolus

The Omnipod 5 Pod

• Small lightweight, waterproof**,

Bluetooth-enabled Pod

• Enhanced with SmartAdjust™ technology

which continuously adjusts glucose

levels using a customized glucose target

• Provides up to 72 hours of continuous

insulin delivery

Dexcom G6® CGM

• Provides real-time glucose readings

every 5 minutes (up to 288 times per day)

• Consists of auto applicator, sensor,

transmitter, and Dexcom app

System Communication

Bluetooth®wireless technology allows communication between the components of the Omnipod®5 System.

Omnipod 5 App

• Activates/deactivates

Pod

• Sends and receives

insulin delivery info

• Receives CGM info

from Pod

• Displays alerts

and alarms

Dexcom App

• Starts/stops

sensor session

• Displays CGM

value and trends

• Display alerts

and alarms

• Troubleshooting

guidance

Omnipod 5 Pod

• Delivers insulin to your body

• Sends CGM values to

Omnipod 5 App

• SmartAdjust™ technology

in Pod automatically adjusts

insulin delivery based on CGM

Dexcom G6 CGM

• Transmitter sends

sensor values to

the Pod and

Dexcom G6 app

Pod receives CGM Values

• The Omnipod 5 App does not have to be near the Pod for basal insulin delivery in both Manual or

Automated Mode. It is recommended to keep the Omnipod 5 App nearby as it displays important

information such as alerts and alarms.

• The Omnipod 5 App does not communicate directly with the Dexcom app or the Dexcom transmitter.

Dexcom CGM sold separately.

Caution: You cannot use the

Dexcom G6 receiver with the

Omnipod 5 System because

the Omnipod 5 System is

compatible only with the G6

app on a smartphone.

Starting Omnipod®5

System Instructions

12 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |OMNIPOD 5 APPLICATION SETTINGS

Omnipod®5 App Setup

Depending on the device you have chosen, you may see dierent screens and settings as you begin to set up

the Omnipod 5 App. If you have chosen to use your smartphone the Omnipod 5 System relies on some of your

smartphone’s settings to function. If these settings are not correctly set, you will not be able to use the App until

the setting is correctly enabled or disabled. The Omnipod 5 App relies on some of your smartphone’s settings

to function. For recommended smartphone settings please consult your Omnipod 5 System user guide.

Your initial pump therapy settings are needed to set up your Omnipod 5 App. These settings are provided to

you by your healthcare provider.

Keep a copy of your current settings in case you have to set up the Omnipod 5 App again. If you use a smartphone,

you may wish to take screenshots or photos of your Omnipod 5 App settings to keep for future reference.

Warning: Always identify the Omnipod 5 System as yours before using it. Using someone else’s

Omnipod 5 System can result in incorrect insulin delivery for both of you.

Warning: Always keep your Omnipod 5 App secure and within your control to ensure others cannot

make changes to your insulin therapy which could lead to hypoglycemia or hyperglycemia. Do not

share your Controller PIN or smartphone screen lock security with anyone. Do not share

your Controller screen lock security with anyone.

Caution: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other

setting that prevents you from hearing alarms and notications. If you do not hear

alarms and notications from your Controller or smartphone, you might not make

the changes you need to make to your insulin therapy in a timely manner. Your

Pod will still sound, and you will be able to see the Alarm or Notication

displayed on the Omnipod 5 App. Refer to Section 13 in the Omnipod 5

User Guide to learn how to manage sounds and vibrations.

14 15

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations. Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |ACTIVATE A NEW POD Starting Omnipod 5 System |ACTIVATE A NEW POD

Activate an Omnipod 5 Pod

Before activating a Pod wash your hands with soap and water and gather the necessary supplies:

• An unopened Omnipod 5 Pod

– Conrm that you are using an Omnipod 5 Pod by looking for the Omnipod 5 logo on the label or on the Pod itself

• Vial of U-100, rapid acting insulin cleared for use in Omnipod 5 System, at room temperature

• Alcohol prep swabs

• Controller or smartphone with Omnipod 5 App

Omnipod®5 Pod

Needle Tab

Fill Port

Adhesive

Backing

BOTTOMTOP

Viewing

Window

Pink Slide

Insert

• After rst time setup,

tap SET UP NEW POD

• From the POD INFO

tab on the Home

screen, tap SET UP

NEW POD

Tip

Follow the screen

instructions by tapping

the area highlighted

by the “red circle”

If you are using the

Omnipod 5 App on

your smartphone,

location permission

and Location setting

must be on in order

to activate a Pod

Caution: DO NOT use a Pod if the sterile packaging

is open or damaged, the Pod has been dropped

after removal from the package, or the Pod is

expired as the Pod may not work properly and

increase your risk of infection.

Warning: NEVER use insulin that is expired

or cloudy in the Pod as it may be damaged.

Using damaged or expired insulin could cause

hyperglycemia and put your health at risk.

TOP

Omnipod®5

product name

on Pod

Starting Omnipod 5 System |ACTIVATE A NEW POD

• Remove the ll syringe

and needle. Keep the Pod

in its tray during set up.

• Use the alcohol prep swab

to clean the top of the

insulin vial

• Securely twist the ll needle

onto the ll syringe

• Pull outward to remove

the protective cap from

the needle

• Determine how much insulin

you will use over the next

72 hours

• Draw air into the ll syringe

equal to the amount of

insulin you want

• Insert needle into the vial

of insulin and inject air.

Injecting air makes it easier

to withdraw insulin from

the vial.

• With the syringe still in the

vial, turn the vial and syringe

upside down

• Pull down on the plunger to

withdraw insulin from the

vial and ll the syringe with

the amount of insulin you

want; ll at least to the

MIN ll line

• With the needle still in the

vial, tap or ick the syringe to

dislodge any air bubbles to

the top of the syringe. Then

push in the plunger to expel

any air bubbles out of the

syringe and into the vial.

• Remove the needle from

the vial

1. Fill the Pod

• Leave Pod in its

plastic tray

• Insert the needle

straight down into the

ll port as indicated

by the arrow, on the

underside of the Pod.

To ensure proper ll,

do not insert ll syringe

at an angle into the

ll port.

• Completely empty the

syringe into the Pod

• The Pod will beep

twice, indicating that

the Omnipod®5 Pod

is ready to proceed

• Return to the Omnipod

5 App. If the screen

times out, press the

Power button to wake

the controller. Place

the controller next

to the Pod so they

are touching.

• Tap NEXT

• The Omnipod 5 App

establishes a one-to-one

relationship with the Pod,

which will prevent it from

communicating with any

other Pod while this Pod

is active

• Listen for the tone from

the Omnipod 5 App

that indicates the Pod

is activated and ready

to be applied

Reminder

During activation and

priming, the Controller or

smartphone running the

Omnipod 5 App and Pod

should be next to each

other and touching

Note

Minimum ll is 85 units,

Maximum ll is 200 units

Warning: NEVER use a Pod if, while you are lling the Pod, you feel signicant resistance while pressing the plunger

down on the ll syringe. Do not try to force the insulin in to the Pod. Signicant resistance may indicate that the Pod

has a mechanical defect. Using this Pod can result in the under-delivery of insulin that could lead to hyperglycemia.

Warning: NEVER inject large bubbles or pockets of air when lling the Pod with

insulin. Air in the system takes up space where insulin should be and can aect

insulin delivery. Doing so could result in over-delivery or under-delivery of insulin,

which can lead to hypoglycemia or hyperglycemia.

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |ACTIVATE A NEW POD

18 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |ACTIVATE A NEW POD

• Place your thumb on the

bottom of the Pod and pull

the tab upward. The tab will

snap o.

• Using the pull tabs, carefully

remove white paper backing

from the adhesive. Be

careful not to remove the

adhesive pad itself. Do not

allow the adhesive to fold

back on itself.

• Apply the Pod to the

selected site

• Run your nger around

the adhesive to secure it

2. Apply the Pod 3. Start Insulin Delivery

• Clean the site where the Pod will be applied

• Be careful to avoid areas where the Pod will be

aected by folds of skin and clothing

• Refer to Omnipod 5 Site Preparation and Placement

section for sites your healthcare provider may

recommend and placement tips

• Tap START • Verify that the Pod is

securely attached to your

body, then tap YES. For best

technique refer to pinching

up in the Pod Preparation

and Placement section of

this Resource Guide.

• The Pod automatically

inserts the cannula

• After insertion the

cannula is lled with

insulin and ready to

begin insulin delivery

• Once the cannula has

inserted, verify proper

insertion by checking

that the pink window

slide insert is visible in

the faint window on

the top of the Pod

• Tap YES

• Your Pod is now active!

The Omnipod®5 System

will generate an automatic

reminder to check your

blood glucose 90 minutes

after each Pod change. If

there is a valid CGM value

at that time, the alert will

be dismissed.

Tip

When choosing sites:

Consider where your CGM is placed.

Allow 3 inches between CGM and Pod.

Place Pod and CGM within direct line of

sight for best communication. See images

for placement examples on page 21.

Warning: Check the infusion site

after insertion to ensure that the

cannula was properly inserted. An

improperly inserted cannula can

result in under-delivery of insulin

which could lead to hyperglycemia.

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |POD SITE PREPARATION AND PLACEMENT OPTIONS

20 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |POD SITE PREPARATION AND PLACEMENT OPTIONS

Caution: ALWAYS apply the Pod as directed. If you are applying a Pod in a place that does

not have a lot of fatty tissue, squeeze the skin around the Pod until after the cannula has

inserted. Blockages may result if you do not use this technique for lean areas.

Arm & Leg:

Position the Pod vertically or at a slight angle.

Back, Abdomen & Buttocks:

Position the Pod horizontally or at a slight angle.

Site Preparation

• Be cool and dry (not perspiring) for Pod change.

• Clean your skin well. Body oils, lotions and sunscreen can loosen the Pod’s adhesive. To improve adhesion, use

an alcohol swab to clean the area around your site—about the size of a tennis ball. Then let it air dry completely

before applying the Pod. Do not blow dry the skin.

Best Placement for CGM and Pod

Pod Positioning

Trouble With... Problem Solution

Oily skin Residue from soap, lotion, shampoo or

conditioner can prevent your Pod from

sticking securely.

Clean your site thoroughly with alcohol

before applying your Pod—and be sure to

let your skin air dry.

Damp skin Dampness gets in the way of adhesion. Towel o and allow your site to air dry

thoroughly; do not blow on it.

Body hair Body hair gets in-between your skin and

your Pod—and if there is a lot of it, can

keep the Pod from sticking securely.

Clip/shave the site with a razor to create

a smooth surface for Pod adhesion. To

prevent irritation, we recommend doing

this 24 hrs before putting on the Pod.

Omnipod®5 Site Preparation and Placement

Site Selection

• Because there is NO TUBING, you can wear the Pod comfortably most places you would give yourself a shot.

Please note the recommended Pod positioning for each body area.

• Be careful not to put it where it will be uncomfortable or dislodge when you sit or move around. For instance,

don’t place it near folds of skin or directly under your waistband.

• Change the site location each time you apply a new Pod. Improper site rotation may reduce insulin absorption.

• The new Pod site should be at least: 1 inch away from the previous site; 2 inches away from the navel; and

3 inches away from a CGM site. Also, never insert Pod over a mole or a scar.

• Remember to place the Pod and CGM within direct line of sight, meaning the two devices can “see” one another,

for best communication.

CHILD

FRONT BACK

abdomen

arm

thigh

buttocks

leg

BACKFRONT

arm

back

buttocks

leg

YOUTH/ADULT

abdomen

thigh

YOUTH/ADULT

CHILD

Pod

CGM

Pod

CGM

Pod

CGM

22 23

Starting Omnipod 5 System |DEACTIVATE A POD Starting Omnipod 5 System |CONNECT DEXCOM G6 CGM

• Tap VIEW POD DETAILS

• The Pod will take a

moment to deactivate

• Tap POD INFO • Tap CHANGE POD

• Tap DEACTIVATE POD

How to Change the Pod

You may need to change the Pod:

• When the Pod is low on insulin or empty,

or the Pod is nearing expiration or expired

• In response to an alarm

• If the Pod/cannula has become dislodged

• If you have glucose of 250 mg/dL or more

and ketones are present

• If you experience unexpected elevated glucose

• As directed by your healthcare provider

• If, during activation, the Pod fails to beep

Connect Your Dexcom G6 CGM

Locate your Dexcom G6 Transmitter Serial Number (SN) from the back of the transmitter OR from the transmitter

box. If you already have a sensor session started, you can also locate your SN in the Dexcom G6 app.

1. Locate CGM Transmitter Entry Screen

2. Enter & Save New CGM Transmitter SN

From rst time setup

after Pod activation:

• Tap CONNECT CGM

in First Time Setup

• Tap entry eld within rst

box to begin entering

transmitter SN

• Tap SAVE • Tap CONFIRM

From Home screen:

• Tap the Menu button

• Tap Settings and Tap

CGM Transmitter

After the Pod is deactivated, gently lift the

edges of the adhesive tab from the skin

and remove the entire Pod.

Tip: Remove Pod slowly to help avoid

possible skin irritation.

After you have deactivated and removed

the old Pod, follow the instructions on

how to Activate a Pod in this guide.

DO NOT apply a new Pod until you

have deactivated and removed the

old Pod.

24 25

Starting Omnipod 5 System |SYSTEM MODES Starting Omnipod 5 System |SYSTEM MODES

Omnipod 5 System Modes

The Omnipod 5 System has two operating modes: Automated Mode and Manual Mode

Automated Mode Manual Mode

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 prediction.

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.

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.

Once deactivated, the system switches

to Manual Mode.

Pod Activation occurs in Manual Mode

(after activation, prompt to switch to

Automated Mode displayed).

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.

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 for a detailed list of alarms and notications.

26 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Starting Omnipod 5 System |SWITCHING MODES

Everyday Use

Omnipod®5 System

Switch to Automated Mode

• Tap the Menu button • Tap Switch Mode • Tap SWITCH • Tap CONFIRM

Switch to Manual Mode

• Tap Switch Mode• Tap the Menu button • Tap SWITCH

Warning: ALWAYS be aware of your current CGM value, trust how your body feels, and do not ignore symptoms

of high and low glucose. Even though insulin delivery adjusts automatically in Automated Mode with the goal of

bringing your glucose level to your dened Target Glucose, severe hypoglycemia or hyperglycemia may still occur.

If your CGM values do not match your symptoms, ALWAYS check your blood glucose using a BG meter, consider

treatment and/or CGM sensor calibration if necessary. ALWAYS switch to Manual Mode if you feel you are receiving

inaccurate CGM values.

Trending steady

Rapidly falling

Slowly rising

28 29

Everyday Use |OMNIPOD 5 APP HOME SCREEN Everyday Use |GLUCOSE TRENDS AND CGM GRAPH

CGM Glucose

Value and

Trend Arrow

Current

System Mode

Tab Views:

• DASHBOARD

• INSULIN

• POD INFO

Alarms and

Notications

Menu Button

Insulin on

Board (IOB)

Last Bolus

Bolus Button

CGM Graph

Omnipod®5 App Home Screen Glucose Trends and Indicators

CGM Value Color Key:

The CGM value and trend arrow will change color depending on your Glucose Goal Range.*

CGM value within Glucose Goal Range (Manual Mode)

CGM value within Glucose Goal Range (Automated Mode)

CGM value below Glucose Goal Range (Automated & Manual Modes)

CGM value above Glucose Goal Range (Automated & Manual Modes)

Note: CGM Graph diers

slightly in appearance

depending on Mode

• Tap the symbol to see a Legend of symbols used in the CGM graph

View CGM Graph

• Tap VIEW under

CGM Graph

* Refer to Section 19 for CGM trend arrows

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Everyday Use |DELIVER A BOLUS

30 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Everyday Use |DELIVER A BOLUS

• Tap the Bolus button • Tap on the Carbs eld

to manually enter

grams of carbs

• Tap USE CGM to use

CGM value and trend*

• Tap CONFIRM • Tap START to begin

bolus insulin delivery

• Always look for the progress bar on

the Home screen to conrm bolus

delivery has started before navigating

away from the Omnipod 5 App

*Note: Tap Glucose eld to manually enter your blood glucose reading

Deliver a Bolus

The Omnipod 5 SmartBolus calculator suggests a bolus (an additional dose of insulin) to correct glucose that is

high (correction bolus) and/or to cover the carbohydrates in the meal or snack you may be eating (meal bolus).

Tip

When you tap USE CGM the SmartBolus calculator will

use BOTH CGM Value and Trend in the bolus calculation

The SmartBolus calculator tries to keep

glucose at target and adds more insulin

to the correction bolus

The SmartBolus calculator tries to keep

glucose at target and subtracts insulin

from the correction bolus

Tip

Follow the screen

instructions by tapping

the area highlighted

by the “red circle”

Note: Always bolus for meals

as directed by your healthcare

provider. In Automated Mode,

bolus doses still require your

programming and delivery. Failure

to deliver a bolus for meals could

lead to hyperglycemia.

32 33

Everyday Use |ACTIVITY Everyday Use |ACTIVITY

Start the Activity Feature

While in Automated Mode there may be times, like during or after exercise, activities like housework, or illness

when you would like less insulin automatically delivered. When the Activity feature is enabled, the SmartAdjust™

technology reduces insulin delivery and sets the Target Glucose to 150 mg/dL for the time you choose.

Cancel the Activity Feature

• Tap the Menu button

• Tap START • The Home screen will show

that the Activity feature

is enabled by displaying

ACTIVITY in green

• Tap Activity • Tap Duration eld

• Set Duration (1-24 hrs)

• Tap CONFIRM

• Tap CANCEL on the

ACTIVITY Tab

• Tap YES

Tip

Follow the screen

instructions by tapping

the area highlighted

by the “red circle”

Note

The Activity feature is available

only in Automated Mode

Warning: ALWAYS monitor for symptoms of hypoglycemia while the Activity feature is in progress. Hypoglycemia

can still occur when using the Activity feature. Follow your healthcare provider’s advice on hypoglycemia avoidance

and treatment. If untreated, hypoglycemia can lead to seizure, loss of consciousness, or death.

34 35

Troubleshooting |HISTORY Troubleshooting |NOTIFICATIONS, ALERTS AND ALARMS

• Tap the Menu button

• Summary section includes:

– Average CGM, CGM % in

range, above range and

below range

– Total Insulin (basal + bolus),

Basal Insulin, Bolus Insulin

and Total Carbs

• Swipe up on the

history screens to

see the details section

• Details section shows

individual records

listed by time of day

• Tap AUTO EVENTS

• Insulin amounts

delivered are shown

every 5 minutes while

in Automated Mode

• Tap History Detail

View History Details Notications, Alerts & Alarms

• If your device is asleep when you hear or feel a notication,

wake up your device to check if the notication is coming from the

Omnipod 5 App. The lock screen will show the reminder notication

icon and the message.

• Waking your device up and using the Omnipod 5 App does not

automatically acknowledge or silence notications. To acknowledge

notications, tap on the notications icon at the top of the screen.

• Read any messages with a blue notication icon ( ). Scroll down the

screen, if necessary, to see any additional notications with blue icons.

• Tap the back arrow ( ) in the top left corner to mark the notications

as acknowledged.

Hazard Alarms

High priority alarms that indicate a serious problem has occurred and you may need to remove your Pod.

Examples: Pod Expired, Pod Out of Insulin, Pod Shut-O, Blockage, Pod Error, System Error,

Omnipod®5 App Error, and Omnipod 5 Memory Corruption

Advisory Alarms

Lower priority alarms that indicate a situation exists that needs your attention.

Examples: Pod Expiration, Low Pod Insulin, Pod Shut-O, Start Insulin, Low Battery, Urgent Low

Glucose, Missing CGM Values, and Automated Delivery Restriction

Notications

Remind you of an action that you may want to perform. Some are generated automatically and others

have settings that you can control.

WARNING: ALWAYS respond to hazard alarms as soon as they occur. Pod hazard alarms

indicate that insulin delivery has stopped. Failure to respond to a hazard alarm could result

in the under-delivery of insulin which can lead to hyperglycemia.

CAUTION: AVOID setting your Controller or smartphone to Silent, Vibrate, or any other setting that

prevents you from hearing alarms and notications. If you do not hear alarms and notications

from your Controller or smartphone, you might not make the changes you need to make to your

insulin therapy in a timely manner. Your Pod will still sound, and you will be able to see the Alarm

or Notication displayed on the Omnipod 5 App. See Section “13.3 Sounds and Vibrations” in the

Omnipod 5 User Guide to learn how to manage sounds and vibrations.

Tip

Tapping on a specic row with a

bolus entry brings up additional

details about the bolus

36 Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Troubleshooting |SYSTEM STATES

Missing CGM Values in Omnipod 5

• If the Pod is not receiving updated CGM values, the system can no longer

fully adjust your automated insulin delivery. After 20 minutes not receiving

CGM values, ‘Limited’ will be displayed on the Home screen.

• When the System enters Limited state, SmartAdjust™ technology never gives

more than the Basal Program that would be active during Manual Mode.

• When CGM values are updated, full automated delivery resumes.

There are times when your Pod and CGM may lose connection.

Some common reasons for loss of communication are:

• Pod and CGM not being in direct line of sight

• Temporary loss of communication due to environmental interference

(for example, while swimming)

• Sensor warm up or required calibration

What should you do?

• Make sure that the Pod and CGM are in direct line of sight.

• Sometimes you can see ‘Limited” if the loss of communication is between the Pod and CGM. It is possible

that your Dexcom G6 app is still receiving CGM values. Open your Dexcom G6 app to check. Also look to

see if there are any CGM actions that you need to take to re-establish communication.

No Pod Communication

• If the Omnipod 5 App cannot communicate with an active Pod ‘No Pod

Communication” will be displayed

• Follow the on-screen instructions to resolve the issue.

At times there may be communication issues between the Omnipod 5 App

and your Pod. What should you do?

• Bring the device running the Omnipod 5 App and active Pod closer – within

5 feet of each other may restore communication

• Omnipod 5 App will oer you options to resolve the communication issue.

Leave any options to DISCARD or DEACTIVATE POD as last choice after trying

the other options.

Additional Use

Omnipod®5 System

Omnipod®5 App screens are for educational purposes only. Consult your healthcare professional before using these features and for personalized recommendations.

Additional Use |EDIT TARGET GLUCOSE

Change Your Target Glucose

There may be a time where you want to change your Target Glucose. Check with your healthcare provider before

changing your settings.