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OmniPod 5 - Compatible Insulins; Contraindications; General Warnings

OmniPod 5
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7
Introduction 11 Introduction
e Omnipod 5 System can also operate in a Manual Mode that delivers insulin at
set or manually adjusted rates.
e Omnipod 5 System is intended for single-patient use. e Omnipod 5 System
is indicated for use with NovoLog®/NovoRapid®, Humalog® and Admelog® U-100
insulin.
Contraindications
e Omnipod 5 System is NOT recommended for people who:
are unable to monitor glucose as recommended by their healthcare provider
are unable to maintain contact with their healthcare provider
are unable to use the Omnipod 5 System according to instructions
are taking hydroxyurea, as it could lead to falsely elevated sensor glucose
values and result in over-delivery of insulin, which can lead to severe
hypoglycaemia
do NOT have adequate hearing and/or vision to allow recognition of all
functions of the Omnipod 5 System, including alerts, alarms and reminders
Device components including the Pod, Sensor and Transmitter must be removed
before Magnetic Resonance Imaging (MRI), a Computed Tomography (CT) scan
or diathermy treatment. In addition, the Controller should be placed outside of
the procedure room. Exposure to MRI, CT or diathermy treatment can damage
the components.
1.4. Compatible Insulins
e Omnipod 5 System is compatible with the following U-100 insulins:
NovoLog®/NovoRapid®, Humalog® and Admelog®.
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 hyperglycaemia or hypoglycaemia can develop 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 hypoglycaemia or hyperglycaemia. Settings that
impact insulin delivery mainly include: Pod Shutdown, basal rate(s), Max Basal

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