Important Device Notes

Device Warranty:

All devices in the CONCEPTT trial are under warranty as per the contract between the purchaser, CMICR and the supplier, Medtronic.  If a device becomes defective at your site during the warranty period, the device will be serviced or replaced by Medtronic.  Please ensure that any foreseeable device issues are processed before the warranty expires. Contact Medtronic directly (see instructions on Chapter 8 of the Manual of Procedures) for all device replacements and exchanges. Please notify the CONCEPTT Coordinating Centre of device replacements and repairs.

Expiration of the Device and Enlite Sensors:

Before the use of the Enlite sensor, please ensure that it has not expired. The Enlite sensor has an expiration date but if it is returned to Medtronic prior to that date, it can be replaced.  If you require this service, please make your request to the CONCEPTT Coordinating Centre and we would happy to arrange the replacement for you.

When communicating with Medtronic please ensure the following:

  1. The subject or site should notify the operator that they are enrolled in the CONCEPTT trial.
  2. Provide the operator with their Subject ID number.
  3. The subject should not inform the operator of their name or address.
  4. The sites should complete the Device Accountability Logs to track the device exchange (old and new serial number, dates, etc.)
  5. Prior to sending any device back to Medtronic for replacement, it must be downloaded to the subject’s CareLink Personal site.

Thank you for your hard work!

The CONCEPTT Team

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