OmniPod ENT450 User manual

INSULIN MANAGEMENT SYSTEM
www.myomnipod.com
*Up to 72 hours of insulin delivery
USER GUIDE ENT450
USER GUIDE
ENT450
Podder’s handbook
INSULIN MANAGEMENT SYSTEM
© 2012-2017 Insulet Corporation. Omnipod and the Omnipod logo are
trademarks or registered trademarks of Insulet Corporation in the United States
of America and other various jurisdictions. All rights reserved.
Patent information at www.insulet.com/patents.
Printed in USA.
PDM imagery is for illustrative purposes only.
PDM screens may vary based on model or user settings.
Model: ENT450
**IPX8 up to 25 feet for 60 minutes – PDM not waterproof
17845-5C-AW Rev A 10/17
Insulet Corporation
600 Technology Park Drive, Suite 200
Billerica, MA 01821 USA
Support/Supplies: 0800 011 6132 | [email protected]
Welcome, Podder !
™
™

i
Contacts and Important Information
Customer Care
From the UK: 0-800-011-6132
From Ireland: [phone]
24 hours/7 days
Website:www.myomnipod.com
Address: Insulet Corporation, 600 Technology Park Drive, Ste 200
Billerica, MA, 01821, USA
PDM Model: ENT450
Serial Number: __________________________________________________
Omnipod® Insulin Management System Start Date: _____________________
Healthcare Provider Nurse/Educator
Name Name
Address Address
Phone Phone
Email Email
Health Insurance Pharmacy
Name Name
Address Address
Phone Phone
Policy Number Email

ii
© 2012-2017 Insulet Corporation. Omnipod and the Omnipod logo are
trademarks or registered trademarks of Insulet Corporation in the United States
of America and other various jurisdictions. All rights reserved.
Patent information at www.insulet.com/patents.
FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in
various jurisdictions and used with permission.
All other trademarks are the property of their respective owners. e use of third
party trademarks does not constitute an endorsement or imply a relationship or
other aliation.
17845-5C-AW Rev A 09/17

Contents
iii
Introduction ...............................................................ix
About This User Guide ..........................................................ix
Indications and Contraindications ..............................................x
General Warnings and Cautions ................................................xi
Safe Use.........................................................................xii
Safety Features ................................................................ xiii
Getting Started
1 Your Omnipod® Insulin Management System .......................... 1
Welcome ........................................................................1
The Pod and PDM ...............................................................2
Screen Navigation...............................................................4
The Home/Power button.....................................................4
The Up/Down button.........................................................4
Soft keys and soft key labels ..................................................4
The Info button ...............................................................5
Screen brightness.............................................................5
Navigation shorthand ........................................................5
Data Entry .......................................................................6
Entering numbers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Entering text ..................................................................6
The Header Bar ..................................................................7
PDM battery level indicator...................................................7
More info indicator............................................................7
Insulin level indicator .........................................................7
Time and date.................................................................7
The PDM's Top-level Screens....................................................8
ID screen ......................................................................8
Home screen and More actions screen.......................................9
Status screen .................................................................10
IOB screen....................................................................11
2 Initial PDM Setup ......................................................13
PDM Setup .....................................................................13
Insert the batteries...........................................................14
Personalize your PDM........................................................14

Contents
iv
Contents
Basal and BG settings ........................................................15
Bolus Calculator settings.....................................................17
Adding time segments ......................................................19
Other bolus settings .........................................................20
Pod settings ..................................................................21
Activate Your First Pod..........................................................21
User Guide
3 Changing Your Pod ....................................................23
Begin the Pod Change Process.................................................23
Preliminary steps.............................................................23
Prepare the PDM and deactivate the old Pod...............................24
Fill the Syringe with Insulin.....................................................26
Fill and Activate a Pod ..........................................................27
Select the Pod Site..............................................................29
Prepare the Infusion Site .......................................................29
Apply the Pod ..................................................................30
Check the Infusion Site .........................................................32
Avoid Infusion Site Infections ..................................................33
More Information about Pod Use ..............................................34
4 Checking Your Blood Glucose..........................................35
About Blood Glucose Testing ..................................................35
Using the Built-in BG Meter ....................................................37
Insert a test strip into the PDM ..............................................37
Test your blood glucose or control solution.................................39
Control solution results ......................................................41
Blood glucose results ........................................................42
Using BG Meter ................................................................44
Tagging the Blood Glucose Results ............................................45
5 Delivering a Bolus of Insulin ...........................................47
Why Bolus? .....................................................................47
Bolusing with the Bolus Calculator.............................................47
Enter your BG and meal information ........................................47
Deliver the bolus .............................................................48
Manually-calculated Bolus .....................................................50
Altering an Ongoing Bolus.....................................................51
Cancel an immediate bolus..................................................52
Cancel an extended bolus ...................................................52
Replace an extended bolus..................................................53

v
ContentsContents
6 Modifying Basal Insulin Delivery ......................................55
Using Temporary Basal Rates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Activate a temp basal ........................................................55
Activate a temp basal preset.................................................57
Cancel a temp basal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .58
Use beeps to monitor temp basal progress .................................58
Switching to a Dierent Basal Program........................................58
Suspending and Resuming Basal Insulin Delivery.............................59
7 Adjusting Settings.....................................................61
General PDM Settings..........................................................61
Date and time................................................................61
Username and screen color. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .62
Storing brief notes ...........................................................62
Vibrate and sound options ..................................................62
Lock or unlock the PDM buttons ............................................63
Screen time-out..............................................................63
Backlight time-out ...........................................................63
Factory defaults settings.....................................................64
Basal and Temp Basal Settings .................................................64
Maximum Basal Rate ........................................................64
Basal Programs...............................................................65
Temp basal conguration ...................................................68
Temp basal presets ..........................................................68
Bolus Calculator Settings.......................................................70
Turn the Bolus Calculator on or o ..........................................70
Target BG and Correct Above value .........................................70
Minimum BG for Calcs .......................................................71
IC Ratio .......................................................................71
Correction Factor ............................................................72
Reverse Correction...........................................................72
Duration of insulin action....................................................72
Carb presets..................................................................73
Bolus Delivery Settings.........................................................75
Extended bolus conguration...............................................75
Maximum Bolus .............................................................75
Bolus increment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75
Bolus presets .................................................................76
Reminder and Notication Settings ...........................................77
BG reminders ................................................................77
Pod expiration ...............................................................77
Low reservoir level ...........................................................78
Pod Auto-o .................................................................78
Bolus reminders..............................................................78

Contents
vi
Contents
Program reminders ..........................................................80
Condence reminders .......................................................80
Custom reminders ...........................................................80
BG Readings Settings ..........................................................82
Upper limit and lower limit of the BG Goal Range ..........................82
BG tags .......................................................................82
Built-in BG meter sound .....................................................83
8 Browsing Your Records ................................................85
Overview of the Records Screens ..............................................85
The Records menu...........................................................85
Selecting list items or dates..................................................86
Meaning of icons used on record screens ...................................87
Insulin Delivery Records........................................................88
Combined basal and bolus summary .......................................88
Bolus history .................................................................88
Basal history..................................................................89
BG History Records .............................................................90
View BG records for one day.................................................90
View BG records for multiple days ...........................................91
Alarm History Records..........................................................92
Carbohydrate History Records .................................................92
Combined Listing of All History Data ..........................................93
My Info..........................................................................93
Reference
9 Alarms, Notications, and Other Messages ............................95
Overview .......................................................................95
Hazard Alarms ..................................................................96
Advisory Alarms ................................................................98
Notications ....................................................................99
Informational Beeps..........................................................101
Pod Communication Failures ................................................102
Failure to receive a Pod status .............................................102
Failure when activating or sending a command to a Pod ................103
Failure when canceling a bolus............................................104
Failure when deactivating a Pod ..........................................105
Errors in the Built-in BG Meter................................................106
Silencing an Alarm ...........................................................108
10 Taking Care of Your PDM and Pod ....................................109
Pod and Insulin Care .........................................................109
Pod and insulin storage....................................................109

vii
ContentsContents
Pods and the environment ................................................109
PDM Care .....................................................................110
PDM storage ...............................................................110
PDM and the environment ................................................111
Replacing the PDM's batteries.............................................112
PDM cleaning and disinfecting ............................................113
If you drop the PDM .......................................................115
11 Living with Diabetes..................................................117
Daily Activities ................................................................117
Infusion site checks ........................................................117
Check your blood glucose frequently .....................................118
Prepare for Emergencies .....................................................118
Traveling and Vacations ......................................................119
Plan for changing time zones..............................................119
Take enough supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
Airport issues...............................................................120
Keep supplies accessible...................................................121
Avoid Lows, Highs, and DKA .................................................121
General precautions .......................................................121
Hypoglycemia (low blood glucose) .......................................121
Hyperglycemia (high blood glucose)......................................126
Diabetic ketoacidosis (DKA) ...............................................129
Handling Special Situations ..................................................130
Sick days....................................................................130
Exercising, playing sports, or working hard ...............................131
X-rays, MRIs, and CT scans .................................................131
Surgery or hospitalization .................................................131
12 Understanding PDM and Pod Function ...............................133
PDM and Pod Interactions ...................................................133
Pod actions controlled by the PDM .......................................133
What the Pod can do between PDM instructions.........................136
PDM's self-checks ..........................................................137
Auto-o ....................................................................137
Basal Insulin Delivery .........................................................138
Basal Programs.............................................................138
Temporary basal rates .....................................................139
Methods to temporarily stop insulin delivery .............................142
Immediate and Extended Boluses .........................................143
Manually-calculated Boluses.................................................143
The Bolus Calculator..........................................................144
Bolus Calculator boluses...................................................144
When the Bolus Calculator does not work ................................145
Factors used in the Bolus Calculator's calculations ........................145

viii
Contents
Bolus Calculator equations ................................................148
Bolus Calculator examples.................................................150
Bolus Calculator rules ......................................................154
Appendix ................................................................155
Summary of Settings and Options...........................................155
Pod Specications............................................................156
PDM Specications...........................................................158
Built-in BG Meter Specications..............................................158
Protection from Over-infusion or Under-infusion ...........................159
System Accuracy according to International Standard
ISO 15197:2013 ............................................................160
PDM Icons ....................................................................161
Omnipod® System Label Symbols ...........................................162
Medical Device Directive .....................................................163
Omnipod® System Notice Concerning Interference.........................163
Warranty for the PDM and Pods .............................................168
WARRANTY FOR THE OMNIPOD® INSULIN MANAGEMENT SYSTEM
PERSONAL DIABETES MANAGER AND PODS
(United Kingdom and Ireland).............................................168
WARRANTY COVERAGE....................................................168
Glossary .................................................................173
Index.....................................................................177

ix
Introduction
About This User Guide
Caution: is User Guide is intended for use only with PDM model ENT450 To
learn which version of the PDM you have, turn it over. On the back of the PDM,
look for "ENT450." If you see it, this is the correct User Guide. If you do not see it,
please call Customer Care.
Note: Screen images shown in this User Guide are examples only and are not
suggestions for user settings. Consult with your healthcare provider to determine
the appropriate settings for you.
Health care and treatment are complex subjects requiring the services of qualied
health care providers. is user Guide is informational only and not intended
as medical or health care advice or recommendations to be used for diagnosis,
treatment or for any other individual needs. is user guide is not a substitute
for medical or health care advice, recommendations and/or services from a
qualied health care provider. is user guide may not be relied upon in any way
in connection with your personal health care, related decisions and treatment.
All such decisions and treatment should be discussed with a qualied health care
provider who is familiar with your individual needs.
is User Guide is periodically updated. Visit the Learning Center section of
www.myomnipod.com to see the most recent version and to nd other helpful
information.
Term Meaning
Warning Alerts you to the possibility of injury, death, or other serious adverse
reactions associated with the use or misuse of the device.
Caution Alerts you to the possibility of a problem with the device associated
with its use or misuse. Such problems include device malfunctions,
device failure, damage to the device or damage to other property.
Note Provides helpful information.
Tip Oers a suggestion for successful use of the device.

Introduction
x
Introduction
Indications and Contraindications
Caution: is device is for prescription use only.
Indication
e Omnipod® Insulin Management System is intended for subcutaneous
(below the skin) delivery of insulin at set and variable rates for the management
of diabetes mellitus in persons requiring insulin andfor the quantitative
measurement of glucose in fresh capillary whole blood (in vitro).
Abbott FreeStyle and FreeStyle Lite test strips are used with the built-in FreeStyle
meter for the quantitative measurement of blood glucose in fresh whole capillary
blood from the nger, upper arm and palm.
Abbott FreeStyle Control Solutions are used to verify that the meter and test strips
are working together properly and that the test is performed correctly.
Contraindications
Insulin pump therapy is NOT recommended for people who are:
• Unable to perform at least four (4) blood glucose tests per day
• Unable to maintain contact with their healthcare provider
• Unable to use the System according to instructions
Do not use the built-in blood glucose meter for:
• Testing on newborns
• Testing arterial blood
• Diagnosing of or screening for diabetes mellitus
Note: Unless stated otherwise, references to FreeStyle Blood Glucose Test Strips
or FreeStyle Test Strips include both FreeStyle and FreeStyle Lite Test Strips.

xi
IntroductionIntroduction
General Warnings and Cautions
Warnings:
Rapid-acting U-100 insulin: e Omnipod® System is designed to use
rapid-actingU-100 insulin. e following U-100 rapid-acting insulin
analogs have been tested and found to be safe for use in the Pod: NovoRapid®,
Humalog®, or Apidra®. NovoRapid®, Humalog, and Apidra are compatible
with the Omnipod® System for use up to 72 hours (3 days). Before using a
dierent insulin with the Omnipod® System, check the insulin drug label to
make sure it can be used with a pump. Refer to the insulin labeling and follow
your healthcare provider’s directions for how oen to replace the Pod.
Read all the instructions provided in this User Guide and practice the
blood glucose testing procedures before using the System. Monitor your
blood glucose with the guidance of your healthcare provider. Undetected
hyperglycemia or hypoglycemia can result without proper monitoring.
Warnings:
Personal health considerations
Not recommended for individuals with hearing loss. Always verify your
ability to hear Pod/PDM alarms and notications.
If you are unable to use the System according to instructions, you may be
putting your health and safety at risk. Talk with your healthcare provider if
you have questions or concerns about using the System properly.
Parts of the device are considered biohazardous and can potentially transmit
infectious diseases, even aer you have performed cleaning and disinfection.
e glucose meter and lancing device are for single-patient use. Do not share
the device with anyone including other family members. Do not use on
multiple patients.

Introduction
xii
Introduction
Warnings:
Environments to avoid
e Pod and PDM may be aected by strong radiation or magnetic elds.
Before having an X-ray, MRI, or CT scan (or any similar test or procedure),
remove your Pod and put it and the PDM outside the treatment area. Check
with your healthcare provider for Pod removal guidelines.
e Omnipod® System should NOT be used at low atmospheric pressure
(below 696 hPA). You could encounter such low atmospheric pressures at
high elevations, such as when mountain climbing or living at elevations above
3,000 meters (10,000 feet).
e Omnipod® System should NOT be used in oxygen rich environments
(greaterthan25% oxygen) or athigh atmosphericpressure (above1062 hPA),
both of which can be found in a hyperbaric chamber. Hyperbaric, or high
pressure chambers are sometimes used to promote healing of diabetic ulcers,
or to treat carbon monoxide poisoning, certain bone and tissue infections,
and decompression sickness.
Caution: is device is intended for self-testing by the user.
Caution: If you are having symptoms that are not consistent with your blood
glucose test results and you have followed all instructions described in this
User Guide, call your healthcare provider.
Safe Use
Pump therapy requires substantial caregiver involvement, especially with
children. Work with your healthcare provider to establish diabetes management
guidelines and settings that best t your, or yourchild’s, needs. ese may include:
Insulin-to-Carbohydrate (IC) Ratio: Number of grams of carbohydrate covered
by one unit of insulin. For example, if your Insulin-to-Carbohydrate Ratio is
1:15, then you need to deliver one unit of insulin to cover every een grams of
carbohydrate you eat.
Correction (or Sensitivity) Factor: How much one unit of insulin lowers your
blood glucose. For example, if your Correction Factor is 2.8, one unit of insulin
lowers your blood glucose by 2.8 mmol/L.
Target Blood Glucose (Target BG): e blood glucose level you want to achieve.
For example, you may want to keep your blood glucose close to 5.6 mmol/L.

xiii
IntroductionIntroduction
Duration of Insulin Action: e length of time that insulin remains active and
available in your body aer a correction or meal bolus.
Your healthcare provider is a valuable resource. You will rely on him or her for a lot
of critical information about your Omnipod® System, especially during the rst
few weeks and months. When you have questions about diabetes management
aer starting on the Omnipod® System, do not hesitate to talk with your
healthcare provider.
For technical questions about your Omnipod® System setup or operation, or to
order Omnipod® System products and supplies, you can call Customer Care 24
hours a day, 7 days a week. See the front page of this User Guide for your Customer
Care contact information.
Your healthcare provider will give you all the tools and training you need to be
successful with the Omnipod® System. However, in the end, your success depends
on YOU. You must become actively involved in your own diabetes management
to enjoy the control, freedom and exibility that is possible with the Omnipod®
System.
Being actively involved means:
• Frequently monitoring your blood glucose levels
• Learning how to operate your Omnipod® System and practicing proper
techniques
• Visiting your healthcare provider
Safety Features
e Omnipod® System’s built-in safety features include:
Automatic priming, safety checks, and insertion
Every time you activate a new Pod, the Omnipod® System automatically primes
and performs a safety check on the Pod, then inserts and primes the cannula.
ese safety checks take only a few seconds.
e Omnipod® System also performs safety checks on the PDM each time you
turn on your PDM. If it detects any problems in the PDM or the Pod—or in
the communication between them—it informs you with beeps and on-screen
messages.
Alarms and notications
For your safety,the Omnipod®Systemprovides arangeofalarmsandnotications
to tell you that your attention is needed or to warn you of hazardous situations. For
a description of the PDM's alarms and notications, see Chapter 9.

xiv
Introduction
Warning: You need to press Conrm on the ID screen before you can read
the alarm or notication message.
Note: Activate your PDM periodically to conrm that there are no notications
or alarms that require a response.
Warning: Do NOT attempt to use the Omnipod® System before you
receive training from your Omnipod® System Trainer or healthcare provider.
Inadequate training could put your health and safety at risk.

1
CHAPTER 1
Your Omnipod® Insulin
Management System
Welcome
e Omnipod® Insulin Management System is an innovative continuous insulin
delivery system that provides all the proven benets of continuous subcutaneous
insulin infusion (CSII) therapy. Features ofthe Omnipod® Insulin Management
System include:
No tubing: ere is no tubing connecting the Pod to the Personal Diabetes
manager (PDM). You can wear the Pod under your clothes and carry the PDM
separately. You can swim wearing the Pod and leave the PDM on dry land. e
Pod is waterproof to 7.6 meters (25 feet) for up to 60 minutes (IP28).
Bolus Calculator: If your blood glucose is high or if you plan to eat, the PDM's
Bolus Calculator can suggest a bolus dose based on your individual settings.
Built-in blood glucose meter: e PDM contains a built-in blood glucose meter.
You can also use a separate blood glucose meter and enter the results manually
into the PDM.
Record keeping: e data storage system in the PDM displays up to 90 days of
information. is includes blood glucose results, basal rates and bolus doses,
carbohydrates, and alarms.
e Getting Started section of this book explains the basic operation and setup of
the Omnipod® System. e User Guide section gives step-by-step instructions for
using the System. e Reference section explains the System in detail.
Terms and conventions
Bold text Buttons that you press, so keys, menus, and screens are in bold.
Screen Area of the PDM that displays menus, instructions, and messages.
Menu List of options. Options allow you to perform tasks.
Icon An image on the PDM screen that indicates a menu option or item
of information (see "PDM Icons" on page 161).
Button Physical button on the PDM, such as the Home/Power button.
So keys Row of three buttons directly beneath the screen. e so key's label
or function appears on the screen directly above the button.
Press Press and release a button or so key.
Hold Keep pressing a button until its function is complete.

Your Omnipod® Insulin Management System 1
2
1Your Omnipod® Insulin Management System
The Pod and PDM
e Omnipod® System is made up of two parts: e Pod, which delivers insulin
to your body, and the Personal Diabetes Manager (PDM), which allows you to
control the Pod.
e Pod: e Pod is a lightweight, self-adhesive device that you ll with insulin
and wear directly on your body. e Pod delivers insulin into your body through a
small exible tube called a cannula, based on instructions from the PDM.
e Pod is applied to your skin with an adhesive, similar to an adhesive bandage.
Pod needle cap
Viewing window
Paper cover for
adhesive backing
Housing vent
Fill port
Adhesive backing
BottomTop

3
Your Omnipod® Insulin Management System 11 Your Omnipod® Insulin Management System
e PDM: e PDM is a handheld device that:
• Wirelessly programs the Pod with your personalized insulin-delivery
instructions
• Wirelessly monitors the Pod's operation
• Includes a built-in blood glucose meter
Up/Down buttonTest strip port
Home/Power
button
Info
button
Soft key
Soft key label
Home
Screen
USB port
Header bar

Your Omnipod® Insulin Management System 1
4
1Your Omnipod® Insulin Management System
Screen Navigation
e PDM communicates with you by displaying images on its screen. You
communicate with the PDM by pressing buttons and so keys.
The Home/Power button
Press and hold the Home/Power button to turn the PDM on or o.
When the PDM is on, briey press this button to return to the Home
screen from any other screen.
The Up/Down button
e Up/Down button is used in the following ways:
• Press and release to increase or decrease a number. Holding the
button down changes the number more rapidly.
• Press and release to scroll through a list of available menu options.
Holding the button down scrolls faster.
• Some screens have text that continues below what is visible on
the screen. Use the Up/Down button to scroll down to view any
o-screen text.
Press the Up arrow (the upper part of the Up/Down button) to increase a number
or to move up on a screen. Press the Down arrow (the lower part of the Up/Down
button) to decrease a number or move down on a screen.
Soft keys and soft key labels
So key labels appear on the screen directly above the so key buttons. e so
key labels dier on dierent PDM screens. Press a so key to select an action or
to navigate between screens. For example, on the Home screen shown on the
previous page, the two so key labels are "Status" and "Select."
• Press the right-hand so key, directly below the "Select" so key label, to select
the highlighted "Bolus" menu item. e Bolus screenappears.
• Press the le-hand so key, beneath the word "Status," to bring up the Status
screen.
Tip: Pressing a so key that has no so key label above it prevents the PDM from
going to sleep but has no other action.

5
Your Omnipod® Insulin Management System 11 Your Omnipod® Insulin Management System
The Info button
Some screens have a "more info" icon in the header bar (see
page 7) or displayed to the right of an item in a list. When the "more
info" icon is present, press theInfo button to display a screen with
additional details.
Screen with icon Pressing the Info button displays
Home screen Username, other personalized entries (if any),
Insulet Corporation contact information, device
serial number
Status screen Insulin on board (IOB) details
Suggested bolus screen Bolus calculation details
History screen Details about a tagged event
Screen brightness
e Info button can also be used to make your PDM screen brighter or less bright.
Press and hold the Info button for two seconds to toggle the “bright mode" on or
o. To control the dimming of the screen, see "Backlight time-out" on page 63.
Navigation shorthand
e User Guide uses the ">" symbol to indicate navigating from one screen to
another. For example, the following notation:
Home > Settings > Presets > Carb presets
tells you to:
1. Turn on the PDM and conrm your ID, if necessary.
2. Press the Home/Power button.
3. Use the Up/Down button to highlight the Settings option, then press the so
key under Select to bring up the Settings menu.
4. Use the Up/Down button to highlight the Presets option, then press the so
key under Select to bring up the Presets menu.
5. Use theUp/Down buttonto highlighttheCarb presets option, thenpress the
so key under Select to bring up the Carb presets menu.