OmniPod UST400, User Manual, Page: 11 / 202

Introduction
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Introduction
Indications and Contraindications
Caution: This device is for prescription use only.
Indication
The Omnipod® Insulin Management System is intended for subcutaneous
(below the skin) delivery of insulin at set and variable rates for the management
of diabetes mellitus in persons requiring insulin and for the quantitative
measurement of glucose in fresh capillary whole blood ( in vitro ).
Abbott FreeStyle and FreeStyle Lite test strips are used with the built-in FreeStyle
meter for the quantitative measurement of blood glucose in fresh whole capillary
blood from the finger, upper arm and palm.
Abbott FreeStyle Control Solutions are used to verify that the meter and test strips
are working together properly and that the test is performed correctly.
Contraindications
Insulin pump therapy is NOT recommended for people who are:
• 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 built-in blood glucose meter for:
• Testing on newborns
• Testing arterial blood
• Diagnosing of or screening for diabetes mellitus
Note:
Unless stated otherwise, references to FreeStyle Blood Glucose Test Strips
or FreeStyle Test Strips include both FreeStyle and FreeStyle Lite Test Strips.