Indications And Contraindications; General Warnings - Insulet Omnipod Dash User Manual

Introduction

Indications and Contraindications

Indications for use
The Omnipod DASH™ Insulin Management System is intended for subcutaneous
delivery of insulin at set and variable rates for the management of diabetes mellitus
in persons requiring insulin.
Contraindications
Insulin pump therapy is NOT recommended for people who are:
• Unable to monitor blood glucose levels as recommended by their healthcare
provider
• Unable to maintain contact with their healthcare provider
• Unable to use the Omnipod DASH™ System according to instructions

General Warnings

Warnings:
Rapid-acting U-100 insulin: The Omnipod DASH™ System is designed
to use rapid-acting U-100 insulin. The following U-100 rapid-acting
insulin analogues have been tested and found to be safe for use in the Pod:
NovoRapid® (insulin aspart), Fiasp® (insulin aspart), Humalog® (insulin
lispro), Admelog® (insulin lispro) and Apidra® (insulin glulisine). NovoRapid,
Fiasp, Humalog and Admelog are compatible with the Omnipod DASH™
System for use up to 72 hours (3 days). Apidra is compatible with the
Omnipod DASH™ System for use up to 48 hours (2 days). Before using
a different insulin with the Omnipod DASH™ System, check the insulin
medication label and consult your healthcare provider. Refer to the insulin
labelling and follow your healthcare provider' s directions for how often to
replace the Pod. Fiasp has a faster initial absorption than other rapid-acting
U-100 insulins; always consult with your healthcare provider and refer to the
insulin labelling prior to use.
Read all the instructions provided in this User Guide before using the
Omnipod DASH™ System. Monitor your blood glucose with the guidance of
your healthcare provider. Undetected hyperglycaemia or hypoglycaemia can
result without proper monitoring.
Not recommended for individuals with hearing loss. Always verify your
ability to hear Pod/PDM alarms and notifications.
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Effective Date: 27SEP2019, ECO-000240