Insulet Omnipod 5, Care Manual

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SECTION 1 | CATEGORY
Important User Information
The Omnipod 5 Automated Insulin Delivery System is indicated for use
by individuals with Type 1 diabetes mellitus in persons 2 years of age and
older. The Omnipod 5 System is intended for single patient, home use
and requires a prescription. The Omnipod 5 System is compatible with
the following U-100 insulins: NovoLog
® , Humalog ® , and Admelog ® .
Refer to the Omnipod 5 Automated Insulin Delivery System User
Guide and www.omnipod.com/safety for complete safety information
including indications, contraindications, warnings, cautions, and instructions.
WARNING: DO NOT start to use the Omnipod 5 System or change settings
without adequate training and guidance from a healthcare provider. Initiating
and adjusting settings incorrectly can result in over-delivery or under-delivery
of insulin, which could lead to hypoglycemia or hyperglycemia.
Screen images shown in this guide are examples only and are not suggestions
for user settings. This guide is for informational purposes only. Be sure to
consult with your healthcare provider before making any treatment decisions.
The Omnipod 5 System is designed to work with the Dexcom G6 CGM.
The Dexcom G6 CGM System is sold separately. Use of the Dexcom app
on your personal smartphone is required. Be sure to review both the
Omnipod 5 System User Guide and Dexcom G6 User Guide before using
the system.
Potential Risks
• Inaccurate CGM values could cause the System could deliver an
inaccurate dose of insulin
• Wearing a Pod might cause infection
• Kinks or air bubbles in the cannula, or dislodging of the cannula can
affect insulin delivery
• Hardware defects, software glitches, and Pod failures can cause an
interruption in insulin delivery
These potential risks could lead to the over-delivery or under-delivery
of insulin which can result in hypoglycemia or hyperglycemia. For full
details on potential risks refer to the Omnipod 5 System User Guide.
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