Users Manual Part 1
7
Introduction 11 Introduction
SmartAdjust™ technology is intended for use with compatible integrated
continuous glucose monitors (iCGM) and alternate controller enabled (ACE)
pumps to automatically increase, decrease, and pause delivery of insulin based
on current and predicted glucose values. SmartAdjust technology is intended
for the management of type 1 diabetes mellitus in persons 6 years of age and
older. SmartAdjust technology is intended for single patient use and requires a
prescription.
e Omnipod 5 SmartBolus Calculator is soware intended for the
management of diabetes in persons aged 6 and older requiring rapid-acting
U-100 insulin. e Omnipod 5 SmartBolus Calculator calculates a suggested
bolus dose based on user-entered carbohydrates, most recent sensor glucose
value (or blood glucose reading if using ngerstick), rate of change of the sensor
glucose (if applicable), insulin on board (IOB), and programmable correction
factor, insulin to carbohydrate ratio, and target glucose value. e Omnipod 5
SmartBolus Calculator is intended for single patient, home use and requires a
prescription.
Contraindications
e 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
• 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.
1.4. Compatible Insulins
e Omnipod 5 ACE Pump (Pod) is compatible with the following U-100
insulins: NovoLog®, Humalog®, and Admelog®.
SmartAdjust technology is compatible with the following U-100 insulins:
NovoLog®, Humalog®, and Admelog®
e Omnipod 5 SmartBolus Calculator is compatible with the following U-100
insulins: NovoLog®, Humalog®, and Admelog®