User's Guide
6
1 Introduction
1.2. About this User Guide
Caution: 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.
e purpose of this User Guide is to provide direction 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: 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 Application and Omnipod 5 Algorithm are 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 to achieve the
user-selected target glucose.
e Omnipod 5 Application and Omnipod 5 Algorithm are intended for the
management of type 1 diabetes mellitus in persons 6 years of age and greater.
e Omnipod 5 Application and Omnipod 5 Algorithm are intended for single-
patient use and requires a prescription.
Before You
Begin
Effective Date: 22DEC2020, PCO-000267