Important Safety Information
The Omnipod® 5 Automated Insulin Delivery System is a single hormone insulin delivery system intended to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in persons aged 2 and older requiring insulin. The Omnipod 5 System is intended for single patient use. The Omnipod 5 System is indicated for use with NovoLog®/NovoRapid®, Humalog® /Liprolog ®, Trurapi®/Truvelog®/Insulin aspart Sanofi®, Kirsty®, and Admelog/Insulin lispro Sanofi U-100 insulin.
Refer to the Omnipod 5 Automated Insulin Delivery System User Guide for complete safety information including indications, contraindications, warnings, cautions, and instructions.
Warning: SmartAdjust technology should not be used by anyone under the age of 2 years old or by people who require less than 5 units of insulin per day as the safety of the technology has not been evaluated in this population.
Warning: DO NOT start to use the Omnipod 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.
The Omnipod 5 System is NOT recommended for people who are unable to monitor glucose as recommended by their healthcare provider, are unable to maintain contact with their healthcare provider, are unable to use the Omnipod 5 System according to instructions, are taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia, and do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod® 5 System, including alerts, alarms, and reminders. Device components including the Pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components.
Warning: DO NOT start to use the Omnipod 5 System or change settings without adequate training and guidance from a healthcare provider. Initiating and adjusting settings incorrectly can result in over-delivery or under-delivery of insulin, which could lead to hypoglycemia or hyperglycemia.
The Omnipod 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 and for the quantitative measurement of glucose in fresh whole capillary blood from the finger. The glucose measurements should not be used for the diagnosis or screening for diabetes. The Personal Diabetes Manager (PDM) glucose meter is intended for single-patient use and should not be shared. The Omnipod® System has been tested and found to be safe for use with the following U-100 insulin: NovoRapid®, Humalog®, Apidra® or Admelog® Refer to the Omnipod Insulin Management System User Guide at omnipod.ca for complete safety information including indications, contraindications, warnings, cautions, and instructions.
The Omnipod DASH® Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable rates to control blood glucose levels in persons with diabetes mellitus who require insulin. Additionally, the Omnipod DASH System permits manual entry of readings from blood glucose metres, enabling storage and display of blood glucose measurements. The Omnipod DASH System has been tested and found to be safe for use with the following: NovoRapid® (insulin aspart), Fiasp® (insulin aspart), Humalog® (insulin lispro), Admelog® (insulin lispro), and Apidra® (insulin glulisine). Refer to the Omnipod DASH Insulin Management System User Guide for complete safety information including indications, contraindications, warnings, cautions, and instructions.