User's Guide
8
1 Introduction
1.4. General Warnings and Safety Information
Warning: e Omnipod 5 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),
Humalog® (insulin lispro), Admelog® (insulin lispro), and Apidra® (insulin
glulisine). NovoLog, Humalog, and Admelog are compatible with the
Omnipod 5 System for use up to 72 hours (3 days). Apidra is compatible
with the Omnipod 5 System for use up to 48 hours (2 days). Before using a
dierent insulin with the Omnipod 5 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 oen to replace the Pod.
Warning: e Omnipod® 5 System relies on accurate, current CGM values
to determine your insulin needs. Always make sure you are using the CGM
per manufacturer's instructions and do not extend the sensor wear beyond
the recommended duration.
Warning: If you notice that your CGM value does not match your
symptoms, check your blood glucose using a BG meter, consider treatment
and/or CGM sensor calibration if necessary, and contact your healthcare
provider.
• Always make sure you are using the CGM per manufacturer’s
instructions and do not extend the sensor wear beyond the
recommended duration.
• Erroneously high CGM values can cause excessive insulin delivery,
leading to severe hypoglycemia, seizure, loss of consciousness and death.
• Erroneously low CGM values can cause prolonged insulin suspension
leading to hyperglycemia, DKA, and death.
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: Not recommended for individuals with hearing loss. Always
verify your ability to hear Pod/Omnipod 5 app alarms and notications.
Warning: If you are unable to use the Omnipod 5 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 5 System properly.
Warning: Aer use, parts of the device are considered biohazardous and can
potentially transmit infectious diseases.
Before You
Begin
Effective Date: 22DEC2020, PCO-000267