Device Dossier
Patient monitor, nerve
Device Dossier for Patient monitor, nerve (Patient monitor, nerve, Class IIa, sponsor GRZAN). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Patient monitor, nerve
Intended purpose
This Intraoperative Neurophysiological Monitoring?IONM?System is intended for use to monitor sensory and motor pathways, to record, monitor and stimulate/record biopotential signals including EEG(electroencephalogram), EMG(electromyogram) and evoked potential (visual, auditory, somatosensory, motor evoked potential) intraoperatively. Transcranial stimulation techniques for motor evoked potentials are used to assess for acute dysfunction in axonal conduction of the corticospinal tract.