OmniPod DASH System User manual

*Up to 72 hours of insulin delivery
USER
GUIDE
www.myomnipod.com
Insulet Corporation
100 Nagog Park
Acton, MA 01720
1.800.591.3455 | 1.978.600.7850
© 2018 - 2020 Insulet Corporation. Omnipod, the Omnipod logo, Podder, DASH, and the
DASH logo, are trademarks or registered trademarks of Insulet Corporation. All rights reserved.
Reference #: PDM-USA1-D001-MG-USA1
FCC ID: RBV-041
FCC ID: RBV-SAW
OMNIPOD DASHTM USER GUIDE
Podder’s handbook
TM
2
7
9
7
18296-ENG-AW Rev. 006 04/20

i
Omnipod DASH™ Insulin Management System User Guide
Contacts and Important Information
Customer Care
1-800-591-3455— 24 hours/7 days
1-978-600-7850 when calling from outside the United States of America
Customer Care Fax:[phone]
Website:myomnipod.com
Address: Insulet Corporation
100 Nagog Park, Acton MA 01720
Emergency Services: Dial 911 (USA only; not available in all communities)
PDM Model PDM-USA1-D001-MG-USA1
Serial Number __________________________________________________
Omnipod DASH™ Insulin Management System Start Date _______________
Healthcare Provider Omnipod® System Trainer
Name Name
Address Address
Phone Phone
Email Email
Health Insurance Pharmacy
Name Name
Address Address
Phone Phone
Policy Number Email

ii
© 2018-2020 Insulet Corporation. Omnipod, the Omnipod logo, DASH, the
DASH logo, and Podder are trademarks or registered trademarks of Insulet
Corporation. All rights reserved. e Bluetooth® word mark and logos are
registered trademarks owned by the Bluetooth SIG, Inc. and any use of such
marks by Insulet Corporation is under license. Contour is a registered trademark
of Ascensia Diabetes Care. 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. Patent information at
www.insulet.com/patents.
18296-ENG-AW Rev.006 04/20

Contents
iii
Introduction ................................................xi
About This User Guide .........................................................xi
Indications and Contraindications............................................xii
General Warnings .............................................................xii
Working with Your Healthcare Provider ..................................... xiii
Safety Features ...............................................................xiv
Getting Started
1 Your Omnipod DASH™ Insulin Management System .....1
Welcome .......................................................................1
The Pod and PDM ..............................................................2
Navigating Screens and Entering Information ................................4
Touchscreen Basics .........................................................4
Entering Numbers and Text ...............................................5
Navigation Icons and Navigation Shorthand ..............................7
The Status Bar ..................................................................9
The PDM's Lock and PIN Screens .............................................10
The PDM's Home Screen......................................................12
Dashboard tab.............................................................13
Basal tab / Temp Basal tab.................................................14
Pod Info tab................................................................15
Last BG section ............................................................16
Last bolus section .........................................................17
Bolus button...............................................................17
The Home Page's Menu ...................................................18
PDM Messages to You. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Alarms .....................................................................20
Notications ...............................................................20
Conrmation Messages ...................................................20
2 Initial PDM Setup........................................21
The Omnipod DASH™ PDM Kit ...............................................21
Preparing for Your Training....................................................21

Contents
iv
Contents
General PDM Settings.........................................................23
Turning on and personalizing the PDM...................................23
Enter a PIN .................................................................24
Set the time zone and time ...............................................25
Set the date................................................................26
Basal Insulin Settings..........................................................26
Maximum Basal Rate ......................................................26
Create a Basal Program....................................................27
Temp basal conguration .................................................29
Blood Glucose Settings .......................................................30
Upper and lower limits for BG Goal Range................................30
Pair to a BG meter .........................................................31
Bolus Calculator Settings......................................................32
Turn the Bolus Calculator on or o........................................32
Target BG and Correct Above values......................................33
Minimum BG for Calcs.....................................................34
Insulin to Carb Ratio .......................................................34
Correction Factor ..........................................................35
Reverse Correction ........................................................35
Duration of Insulin Action .................................................35
Other Bolus Settings ..........................................................36
Maximum Bolus ...........................................................36
Extended bolus setting....................................................36
PDM Setup Complete.........................................................36
User Guide
3 Changing Your Pod ......................................37
Beginning the Pod Change Process ..........................................37
First Time Activating a Pod ....................................................38
Deactivate an Active Pod .....................................................38
No Active Pod .................................................................39
Preliminary Pod Change Steps................................................40
Fill the Syringe with Insulin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41
Fill, Pair, and Apply the Pod ...................................................42
Fill the Pod with insulin....................................................42
Pair the PDM and Pod .....................................................43
Prepare the Pod site .......................................................44
Remove the Pod's blue cap ...............................................46
Apply the Pod .............................................................47
Begin insulin delivery......................................................47
Check the Infusion Site........................................................48
Avoid Infusion Site Infections .................................................49
More Information about Pod Use.............................................50

v
ContentsContents
4 Entering Blood Glucose Readings .......................51
About Blood Glucose Testing .................................................51
Entering Your Blood Glucose Reading from a Paired BG Meter ..............51
Entering Your Blood Glucose Reading Manually .............................53
TaggingYour Blood Glucose Reading ........................................54
How Blood Glucose Readings are Displayed .................................55
5 Delivering a Bolus of Insulin.............................57
Bolusing with the Bolus Calculator ...........................................57
Enter your meal information ..............................................57
Enter your blood glucose reading ........................................58
Delivering an immediate or extended bolus .............................59
Manually-calculated Bolus ....................................................62
Tracking the Progress of a Bolus ..............................................64
Altering a Bolus in Progress ...................................................65
Using the Food Library........................................................66
Add carbs to the Bolus Calculator.........................................67
Search for a food on the BROWSE list .....................................69
Create a list of favorite foods on the MY FOODS list ......................70
Removing foods from the MY FOODS list ................................73
6 Modifying Basal Insulin Delivery ........................75
Using Temporary Basal Rates .................................................75
Activate a temp basal .....................................................75
Activate a temp basal preset ..............................................77
Cancel a temp basal .......................................................77
Switching to a Dierent Basal Program.......................................78
Suspending and Resuming Insulin Delivery..................................79
7 Managing Programs and Presets........................81
Basal Programs ................................................................81
Create a new Basal Program ..............................................81
Review all Basal Programs.................................................82
Edit or rename a Basal Program ...........................................83
Delete a Basal Program....................................................85
Temp Basal Presets ............................................................85
Create a new temp basal preset...........................................85
Edit or rename a temp basal preset .......................................86
Delete a temp basal preset................................................87
Bolus Presets ..................................................................87
Create a new bolus preset.................................................87
Edit or rename a bolus preset .............................................88
Delete a bolus preset ......................................................88

Contents
vi
Contents
8 Browsing Your PDM Records ............................89
Notications & Alarms Screens ...............................................89
Overview of the Insulin and BG History Screens .............................90
Date Selection.................................................................91
Summary Section .............................................................92
Details Section ................................................................94
Blood glucose details......................................................95
Bolus details ...............................................................95
Carbs details ...............................................................97
Basal rate details...........................................................97
Pod details .................................................................98
Insulin suspended and resumed details ..................................98
Time change details .......................................................98
Date change details .......................................................98
9 Adjusting Settings ......................................99
PDM Device Settings..........................................................99
Network connectivity .....................................................99
Screen display ...........................................................101
Lock screen ..............................................................102
Date and time, and language ...........................................102
Diagnostics ..............................................................105
Software update (Wireless update) .....................................106
Pod Sites Setting ............................................................108
Reminder Settings ..........................................................109
Pod expiration ...........................................................109
Low reservoir level.......................................................109
Pod Auto-o.............................................................109
Check BG after Bolus reminders.........................................110
Missed bolus reminders .................................................110
Condence reminders ..................................................112
Program reminders......................................................112
Custom reminders.......................................................112
Blood Glucose Settings .....................................................114
BG Goal Range...........................................................114
Pairing, unpairing, or renaming a BG meter ............................114
Basal and Temp Basal Settings ..............................................116
Maximum Basal Rate ....................................................116
Temp basal ..............................................................116
Bolus Delivery Settings......................................................117
Maximum Bolus .........................................................117
Extended bolus..........................................................117
Bolus Calculator settings ................................................117

vii
ContentsContents
Reference
10 Alarms, Notications, and Communication Errors .... 121
Overview ....................................................................121
Responding to Alarms ......................................................122
Responding to Notications ................................................122
Priority and Predictability of Alarms and Notications .....................123
Sounds and Vibrations ......................................................124
Hazard Alarm List ...........................................................125
Advisory Alarm List..........................................................128
Notications List ............................................................129
Informational Signals List ...................................................131
Communication Errors......................................................132
Error when canceling a bolus ...........................................133
Error when sending insulin instructions to the Pod ....................133
Error when activating a Pod.............................................134
Error when deactivating a Pod ..........................................134
Silencing an Alarm ..........................................................135
Pod alarm................................................................135
PDM alarm...............................................................135
11 Taking Care of Your PDM and Pod .................... 137
Pod and Insulin Care ........................................................137
Pod and insulin storage .................................................137
Pods and the environment..............................................137
Cleaning your Pod.......................................................138
PDM Care....................................................................138
PDM storage.............................................................139
PDM and the environment..............................................139
Cleaning your PDM......................................................140
If you drop the PDM .....................................................141
PDM Battery Care ...........................................................141
Safe use of the PDM battery.............................................141
Charging the PDM battery ..............................................142
Inserting or replacing the PDM battery ................................143
12 Understanding PDM and Pod Function............... 145
PDM and Pod Interactions ..................................................145
Pod actions controlled by the PDM .....................................145
What the Pod can do between PDM instructions ......................148
Auto-o..................................................................148
PDM and Paired BG Meter Interaction......................................149

Contents
viii
Contents
Basal Insulin Delivery........................................................149
Basal Programs ..........................................................150
Temporary basal rates ...................................................151
Methods to temporarily stop insulin delivery...........................154
Immediate and Extended Boluses..........................................155
About Manually-Calculated Boluses........................................155
The Bolus Calculator ........................................................156
Bolus Calculator boluses ................................................156
When the Bolus Calculator does not work..............................157
Factors used in the Bolus Calculator's calculations .....................157
Insulin on board (IOB) ...................................................160
Bolus Calculator equations..............................................162
Bolus Calculator rules....................................................163
Overview of the Bolus Calculator CALCULATIONS screen ..............164
Bolus Calculator examples ..............................................166
Calculations for History Summaries ........................................171
Blood glucose summaries...............................................171
Insulin delivery summaries..............................................172
13 Living with Diabetes.................................. 173
Daily Activities...............................................................173
Infusion site checks......................................................173
Check your blood glucose frequently...................................174
Prepare for Emergencies ....................................................175
Traveling and Vacations .....................................................175
Keep supplies accessible ................................................176
Plan for changing time zones ...........................................176
Airports and ying.......................................................176
Avoid Lows, Highs, and DKA ................................................178
General precautions.....................................................178
Hypoglycemia (low blood glucose).....................................178
Hyperglycemia (high blood glucose) ...................................181
Diabetic ketoacidosis (DKA) .............................................184
Handling Special Situations.................................................185
Sick days .................................................................185
Exercising, playing sports, or working hard .............................186
X-rays, MRIs, and CT scans ...............................................186
Surgery or hospitalization ...............................................186

ix
ContentsContents
Appendix ................................................ 187
Troubleshooting PDM Startup..............................................187
Summary of Settings and Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188
Pod Specications...........................................................189
PDM Specications .........................................................191
Protection from Over-infusion or Under-infusion ..........................192
Omnipod DASH™ System Label Symbols ..................................193
Omnipod DASH™ System Notice Concerning Interference................194
Electromagnetic Compatibility .............................................194
Customer's Bill of Rights.....................................................197
Warranty.....................................................................199
HIPAA Privacy Notice........................................................202
Glossary ................................................. 207
Index..................................................... 213

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xi
Introduction
About This User Guide
Caution: is User Guide is intended for use only with Personal Diabetes
Manager (PDM) model PDM-USA1-D001-MG-USA1. To learn which version
of the PDM you have, turn it over. If you see "PDM-USA1-D001-MG-USA1"
on the back of the PDM, this is the correct User Guide. If you do not see it, call
Customer Care.
Note: Screen images shown in this User Guide are examples only and are not
suggestions for user settings. Always consult with your healthcare provider to
determine the appropriate settings for you.
Healthcare and treatment are complex subjects requiring the services of qualied
healthcare providers. is User Guide is informational only and not intended
as medical or healthcare 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 healthcare advice, recommendations, and/or services from a
qualied healthcare provider. is User Guide may not be relied upon in any way
in connection with your personal healthcare, related decisions, and treatment.
All such decisions and treatment should be discussed with a qualied healthcare
provider who is familiar with your individual needs.
is User Guide is periodically updated. Visit www.myomnipod.com to see the
most recent version and to nd other helpful information. To access the User
Guide in Spanish, see www.myomnipod.com.
For instructions about how to use the CONTOUR® NEXT ONE Blood Glucose
Monitoring System, see the CONTOUR® NEXT ONE Blood Glucose Monitoring
System User Guide.
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
xii
Introduction
Indications and Contraindications
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Indications for use
e Omnipod DASH™ Insulin Management System is intended for subcutaneous
delivery of insulin at set and variable rates for the management of diabetes mellitus
in persons requiring insulin.
Additionally, the Omnipod DASH™ System is interoperable with a compatible
blood glucose meter to receive and display blood glucose measurements.
Contraindications
Insulin pump therapy is NOT recommended for people who are:
• Unable to monitor blood glucose levels as recommended by their healthcare
provider
• Unable to maintain contact with their healthcare provider
• Unable to use the Omnipod DASH™ System according to instructions
General Warnings
Warnings:
Rapid-acting U-100 insulin: e Omnipod DASH™ System is designed to
use rapid-acting U-100 insulin. e following U-100 rapid-acting insulin
analogs have been tested and found to be safe for use in the Pod: NovoLog®
(insulin aspart), Fiasp® (insulin aspart), Humalog® (insulin lispro), Admelog®
(insulin lispro), and Apidra® (insulin glulisine). NovoLog, Fiasp, Humalog,
and Admelog are compatible with the Omnipod DASH™ System for use
up to 72 hours (3 days). Apidra is compatible with the Omnipod DASH™
System for use up to 48 hours (2 days). Before using a dierent insulin with
the Omnipod DASH™ System, check the insulin drug label and consult your
healthcare provider. Refer to the insulin labeling and follow your healthcare
provider’s directions for how oen to replace the Pod. Fiasp has a faster initial
absorption than other rapid-acting U-100 insulins; always consult with your
healthcare provider and refer to the insulin labeling prior to use.
Read all the instructions provided in this User Guide before using the
Omnipod DASH™ System. Monitor your blood glucose with the guidance of
your healthcare provider. Undetected hyperglycemia or hypoglycemia can
result without proper monitoring.

xiii
IntroductionIntroduction
Warnings:
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 Omnipod DASH™ 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
Omnipod DASH™ System properly.
Aer use, parts of the device are considered biohazardous and can potentially
transmit infectious diseases.
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, contact your healthcare provider.
e Omnipod DASH™ System should NOT be used at low atmospheric
pressure (below 700 hPA). You could encounter such low atmospheric
pressures at high elevations, such as when mountain climbing or living at
elevations above 10,000 feet (3,000 meters).
e Omnipod DASH™ System should NOT be used in oxygen rich
environments (greater than 25% oxygen) or at high atmospheric pressure
(above 1060 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.
Working with Your Healthcare Provider
Insulin 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 your child’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 to 15, then you need to deliver one unit of insulin to cover every 15 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 50, one unit of insulin
lowers your blood glucose by 50 mg/dL.
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 100 mg/dL.
Duration of Insulin Action: e length of time that insulin remains active and
available in your body aer a correction or meal bolus.

Introduction
xiv
Introduction
Your healthcare provider is a valuable resource. You will rely on him or her for
critical information about your Omnipod DASH™ System, especially during
the rst few weeks and months. When you have questions about diabetes
management aer starting on the Omnipod DASH™ System, do not hesitate to
talk with your healthcare provider.
For technical questions about your Omnipod DASH™ System setup or operation,
or to order Omnipod DASH™ System products and supplies, you can call
Customer Care 24 hours a day, 7 days a week. See the rst page of this User Guide
for your Customer Care contact information.
For technical questions about your CONTOUR® NEXT ONE Blood Glucose
Monitoring System setup or operation, or to order CONTOUR® NEXT ONE BG
meter products or supplies, see the CONTOUR® NEXT ONE instructions for use
for Customer Service contact information.
Your healthcare provider will give you all the tools and training you need to be
successful with the Omnipod DASH™ System. As you become actively involved
in your diabetes management, you can enjoy the exibility that is possible with the
Omnipod DASH™ System.
Being actively involved means to frequently monitor your blood glucose levels,
to learn how to operate your Omnipod DASH™ System, to practice proper
techniques, and to visit your healthcare provider regularly.
Safety Features
e Omnipod DASH™ System’s safety features include:
Automatic priming, safety checks, and insertion
When you activate a new Pod, the Omnipod DASH™ System automatically
primes and performs safety checks on the Pod, then inserts and primes the
cannula (a small, thin tube). ese safety checks take only a few seconds.
e Omnipod DASH™ System also performs safety checks on the Personal
Diabetes Manager (PDM) whenever the PDM is awake. If it detects any problems
in the PDM or the Pod—or in the communication between them—it informs you
with vibrations or beeps and on-screen messages.

xv
IntroductionIntroduction
Alarms and notications
For your safety, the Omnipod DASH™ System provides a range of alarms and
noti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 "Alarms,
Notications, and Communication Errors" on page 121.
Note: Brief alarm and notication messages appear on the Lock screen. You must
unlock the screen and enter your personal identication number (PIN) to see the
full alarm messages.
Note: Wake up your PDM periodically to conrm that there are no notication
or alarm messages that require a response.
Warning: Do NOT attempt to use the Omnipod DASH™ System before you
receive training. Inadequate training could put your health and safety at risk.
Software updates
Occasionally, an update may be provided for the PDM soware. e PDM
periodically checks for soware updates if Wi-Fi is on. For information about
checking for and installing soware updates, see "Soware update (Wireless
update)" on page 106.

xvi
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1
CHAPTER 1
Your Omnipod DASH™ Insulin
Management System
Welcome
e Omnipod DASH™ Insulin Management System is a continuous insulin
delivery system that provides all the proven benets of continuous subcutaneous
insulin infusion (CSII) therapy.
Features of the Omnipod DASH™ 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 25 feet (7.6 meters) for up to 60 minutes (IP28).
Bolus Calculator: If your blood glucose is high or if you are planning to eat,
the PDM's Bolus Calculator can suggest a bolus dose based on your individual
settings.
Glucose readings: Your PDM can pair to and record blood glucose readings
from the CONTOUR® NEXT ONE BG meter via Bluetooth® wireless technology.
While the CONTOUR NEXT ONE BG meter is the only BG meter compatible
for pairing to the PDM, you can also manually enter blood glucose readings from
any BG meter into the PDM.
Record keeping: e PDM displays up to 90 days of information, including basal
rates, bolus doses, carbohydrates, alarms, and blood glucose entries.
e Getting Started section of this book gives an overview of the basic operation
and setup of the Omnipod DASH™ System. e User Guide section gives step-by-
step instructions for using the Omnipod DASH™ System. e Reference section
explains how the Omnipod DASH™ System works.
Terms and conventions used in this User Guide
Screen Area of the PDM that displays menus, instructions, and messages.
Menu List of options on the screen.
Icon An image on the screen that indicates a menu option or that
provides information.
Button Physical buttons on the PDM, such as the Power button. Also, areas
of the screen that you can tap to perform an action.
Field e area of a screen where you enter information.

Omnipod DASH™ Insulin Management System 1
2
1Omnipod DASH™ Insulin Management System
The Pod and PDM
e Omnipod DASH™ System is made up of two primary parts: e Pod, which
delivers insulin to your body, and the Personal Diabetes Manager (PDM), which
lets you control the Pod.
e Pod
e Pod is a lightweight device that you ll with insulin and wear directly on your
body. e Pod receives insulin delivery instructions from the PDM. e Pod then
delivers insulin into your body through a small, exible tube called a cannula.
e Pod is applied to your skin with an adhesive, similar to an adhesive bandage.
e Pod that is used with the Omnipod DASH™ System has a blue needle cap.
Blue needle cap
Viewing window
Paper cover for
adhesive backing
Air vent
Fill port
Adhesive backing
Bottom
Top

3
Omnipod DASH™ Insulin Management System 11 Omnipod DASH™ Insulin Management System
e Personal Diabetes Manager (PDM)
e PDM is a handheld device that controls and monitors the Pod's operations
using wireless technology.
Not used
Not used
Back button
Touchscreen
Power button:
Used for
wake/sleep
and on/o
Sound/vibrate
button
Micro-B USB port:
Used for charging the battery and exporting data