Users Manual Part 1
Introduction 1
6
1 Introduction
1.2. About This User Guide
e purpose of this User Guide is to assist you with the features and functions of
the Omnipod 5 System. It provides step-by-step instructions on how to properly
operate the System, as well as important warnings and cautions to ensure your
safety during use.
Note: is User Guide is intended for use only with the Insulet-provided
Controller with the Omnipod 5 App, model PDM-USA-H001-MG, or the
Omnipod 5 App on a compatible smartphone. To learn which version of the
Insulet-provided Controller you have, turn it over. If you see "PDM-USA-H001-
MG" on the back of the Controller, this is the correct User Guide. If you do not see
it, call Customer Care. Using an incorrect User Guide can lead to improper use of
the Omnipod 5 System.
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 qualied
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
qualied 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 qualied healthcare
provider who is familiar with your individual needs.
1.3. Indications For Use
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Indications for use
e 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. e Omnipod 5 ACE Pump is able to reliably and
securely communicate with compatible, digitally connected devices, including
automated insulin dosing soware, to receive, execute, and conrm commands
from these devices. e Omnipod 5 ACE Pump is intended for single patient,
home use and requires a prescription.