User's Manual

ix
Introduction
■ Before You Get Started
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
Do not use the integrated FreeStyle® Blood Glucose Monitoring
System for:
• Testing on newborns
• Testing arterial blood
• Diagnosing diabetes
US Federal law restricts this device to sale by or on
the order of a physician.
This User Guide is intended for use only with the
PDM2. To learn which version of the PDM you have,
turn it over. On the battery door label, you will see
“PDM2” if this is the correct User Guide. If you do not
see “PDM2,” please call Customer Support immedi-
ately to receive the correct User Guide: 800-591-3455.
When calling from outside the United States: 781-
457-5098.
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.