OmniPod 5 - About Keeping Your Omnipod 5 Controller Nearby; Device Complaints

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Frequently Asked Questions and Troubleshooting 2626 Frequently Asked Questions and Troubleshooting
equal to your Duration of Insulin Action setting. If you tap the Bolus button while
the SmartBolus Calculator is disabled, the Omnipod 5 App displays a message
that says “SmartBolus Calculator temporarily disabled”. You can deliver a manual
bolus when the SmartBolus Calculator is disabled.
26.6. About Keeping Your Omnipod 5 Controller Nearby
You will use your Controller to activate a new Pod every 2–3 days. Aer you
activate a Pod, you will start receiving insulin based on your active Basal
Programme in Manual Mode, whether or not your Controller is nearby. You will
need to access the App, however, to resolve any alerts or alarms that may originate
from your Pod, to deliver a bolus, or check the status of your System and glucose.
Aer you enter the Transmitter serial number (SN) into the Omnipod 5 App and
use the Dexcom G6 app on your smartphone to activate your Sensor, you can
switch from Manual Mode to Automated Mode. In Automated Mode, the Pod
will directly receive sensor glucose values wirelessly and automate insulin delivery
depending on your needs.
e system is designed to continue delivering insulin in the absence of your
Controller, so you will not be alerted that the Pod and display device are out of
range of one another if you choose to leave your Controller behind.
Although your Omnipod 5 System does not require the Controller to be nearby
to continue your insulin delivery in Manual Mode or Automated Mode, the
Controller provides you with important information about recent insulin delivery,
alerts and alarms that come from your Pod, and allows you to deliver a bolus.
Caution: AVOID leaving your Controller in a place that would prevent you
from hearing alarms and notications from your Omnipod 5 App. Delivery
of insulin in Manual Mode or Automated Mode continues as programmed if
you move away from your Controller.
26.7. Device Complaints
If, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorised representative,
and to your national authority.
Contact details for the manufacturer can be found inside the front cover of this
document (see “Contacts and Important Information” on page i). e contacts
of national competent authorities (Vigilance Contact Points) and further
information can be found on the following European Commission webpage:
https://ec.europa.eu/health/md_sector/contact_en