Users Manual Part 1

Introduction 1
8
1 Introduction
1.5. General Warnings
Warning: Read all the instructions provided in this User Guide before using the
Omnipod 5 System. Monitor your glucose with the guidance of your healthcare
provider. Undetected hyperglycemia or hypoglycemia can result without proper
monitoring.
Warning: DO NOT start to use your system or change your settings without
adequate training and guidance from your healthcare provider. Initiating and
adjusting settings incorrectly can result in over-delivery or under-delivery of
insulin, which could lead to hypoglycemia or hyperglycemia. Settings that impact
insulin delivery mainly include: Pod Shut-O, basal rate(s), Max Basal Rate, Max
Bolus, Correction Factor(s), Insulin to Carb (IC) Ratio(s), Minimum Glucose for
Calculations, Target Glucose and Correct Above, and Duration of Insulin Action.
Warning: DO NOT rely upon this User Guide in any way in connection with
your personal healthcare, related decisions, and treatment. 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. All such
decisions and treatment should be discussed with a qualied healthcare provider
who is familiar with your individual needs.
Warning: DO NOT use the Omnipod 5 System if you are unable or unwilling to
use it as instructed by this User Guide and your healthcare provider. Failure to use
this system as intended could result in over-delivery or under-delivery of insulin
which can lead to hypoglycemia or hyperglycemia.
Warning: ALWAYS keep an emergency kit with you to quickly respond to any
diabetes emergency or in the case that your Omnipod 5 System stops working.
Always carry supplies to perform a Pod change should you need to replace your
Pod at any time.
Warning: ALWAYS dispose of the Pod according to local waste disposal
guidelines. e Pod is considered biohazardous aer use and can potentially
transmit infectious diseases.
Warning: DO NOT use SmartAdjust technology in pregnant women, critically
ill patients, and those on dialysis. e safety of SmartAdjust technology has not
been evaluated in these populations. Consult with your healthcare provider if any
of these conditions apply to you before using SmartAdjust technology.
Warning: DO NOT use the Omnipod 5 System if you do not have adequate
vision and/or hearing to recognize all functions of the Omnipod 5 System
including alerts, alarms, and reminders according to instructions.
Warning: ONLY use rapid-acting U-100 NovoLog® (insulin aspart), Humalog®
(insulin lispro), and Admelog® (insulin lispro) insulin in the Omnipod 5 System
as they have been tested and found to be safe for use with this system. NovoLog,