Device Dossier

M.scio Reader Unit Set - Patient monitor, pressure, intracranial

Device Dossier for M.scio Reader Unit Set - Patient monitor, pressure, intracranial (Patient monitor, pressure, intracranial, Class III, sponsor B…

Intended purpose

It displays & reads telemetrically and non-invasively data measured by the device. The measured data is stored on the SD card allowing them to be evaluated later.

Functional description

Reader Unit is designed to determine the pressure within the cerebrospinal fluid (CSF). The measurement data determined by the device implant are read out telemetrically and thus non-invasively shown on the display of the Reader Unit Set. The measurement data is stored on an SD card for retrospective analysis by the user.

TGA Public Summary