Insulet Omnipod 5 Actualización de firmware

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.

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