User's Guide
Introduction
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Introduction
Indications and Contraindications
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Indications for use
e 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.
Additionally, the Omnipod DASH™ System is interoperable with a compatible
blood glucose meter to receive and display blood glucose measurements.
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: e Omnipod DASH™ 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), Fiasp® (insulin aspart), Humalog® (insulin lispro), Admelog®
(insulin lispro), and Apidra® (insulin glulisine). NovoLog, 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 dierent insulin with
the Omnipod DASH™ 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. Fiasp has a faster initial
absorption than other rapid-acting U-100 insulins; always consult with your
healthcare provider and refer to the insulin labeling 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 hyperglycemia or hypoglycemia can
result without proper monitoring.