Introduction; Before You Get Started; Indication; Contraindications - Insulet OmniPod User Manual

Introduction

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Before You Get Started

US Federal law restricts this device to sale by or on
the order of a physician.

Indication

The OmniPod Insulin Management System is intended for sub-
cutaneous (below the skin) delivery of insulin at set and variable
rates for the management of diabetes mellitus in persons requir-
ing insulin and for the quantitative measurement of glucose in
fresh whole capillary blood (in vitro).

Contraindications

Insulin pump therapy is NOT recommended for people who are
either:
• Unable to perform at least four (4) blood glucose tests per day
• Unable to maintain contact with their healthcare provider
• Unable to use the System according to instructions
Up/Down Controller
Do not use the integrated FreeStyle® Blood Glucose Monitoring
System for:
• Testing on newborns
• Testing arterial blood
• Diagnosing diabetes
If you are unable to use the 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
System properly.
Please read all the instructions provided in this User
Guide and practice the blood glucose testing proce-
dures before using the System. Monitor your blood
glucose with the guidance of your healthcare pro-
vider. Undetected hyperglycemia or hypoglycemia
can result without proper monitoring.
User Info/Support Blood Glucose Records
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