26
OmniPod
®
Customer Care Program
70 Wynford Drive, P .O . Box 383,
North York, ON M3C 2S7
© 2015 Insulet Corporation . All rights reserved . OmniPod
®
is a registered trademark of Insulet
Corporation . FreeStyle
®
is a registered trademark of Abbott Diabetes Care Inc . PDM imagery
is for illustrative purposes only . PDM screens may vary based on model or user settings .
Model: CAT45E
MyOmniPod.ca
15569-AW CA EN R4 5/15
Safety Information
Before deciding on the OmniPod
®
Insulin Management System, patients must discuss with their
healthcare practitioner the benefits and potential risks of the OmniPod
®
Insulin Management System,
as well as the responsibilities that come with insulin pump therapy.
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 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 a day
• Unable to maintain contact with their healthcare provider
• Unable to use the OmniPod
®
Insulin Management System according to instructions
Do not use the integrated FreeStyle
®
Blood Glucose Monitoring System for:
• Testing on newborns
• Testing arterial blood
• Diagnosing of or screening for diabetes mellitus
Warnings
The OmniPod
®
System is designed to use rapid-acting U-100 insulin. Refer to the insulin labelling and
follow your healthcare provider’s directions for how often to replace the Pod. Not recommended for
individuals with hearing loss; always verify ability to hear Pod/PDM alerts and alarms. The Pod and
PDM may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan
(or any similar test or procedure), remove your Pod and put it and the PDM outside the treatment
area. Monitor your blood glucose with the guidance of your healthcare provider. Undetected
hyperglycemia or hypoglycemia can result without proper monitoring. 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.
Refer to User Guide for complete information
1
*
Based on an interview with Insulet in the United States. May not be representative of the Canadian population.
Reference:
1
OmniPod
®
Insulin Management System User Guide. Insulet Corporation, 2013.
To report an adverse event, medical device incident or product complaint for OmniPod
®
Insulin
Management System please call 1-855-763-4636.