OmniPod 5 - About this User Guide; Indications for Use

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-M001-G-XX. To learn which
version of the Insulet-provided Controller you have, turn it over. If you see “PDM-
M001-G-XX” on the back of the Controller, this is the correct User Guide. If you
do not see it, contact 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 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 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.
1.3. Indications For Use
Indications for use
e Omnipod 5 Automated Insulin Delivery System is a single-hormone
insulin delivery system intended to deliver U-100 insulin subcutaneously for the
management of type 1 diabetes in persons aged 2 and older requiring insulin.
e Omnipod 5 System is intended to operate as an automated insulin delivery
system when used with compatible Continuous Glucose Monitors (CGM).
When in Automated Mode, the Omnipod 5 System is designed to assist people
with type 1 diabetes in achieving glycaemic targets set by their healthcare
providers. It is intended to modulate (increase, decrease or suspend) insulin
delivery to operate within predened threshold values using current and
predicted sensor glucose values, to maintain blood glucose at variable target
glucose levels, thereby reducing glucose variability. is reduction in variability
is intended to lead to a reduction in the frequency, severity and duration of both
hyperglycaemia and hypoglycaemia.