Device Dossier
Cortex Strip Electrode - Electrode, cortical
Device Dossier for Cortex Strip Electrode - Electrode, cortical (Electrode, cortical, Class III, sponsor Neuroclast). ARTG record, intended purpose, GMDN…
- GMDN category: Electrode, cortical
Intended purpose
The Cortex Strip Electrode serves as disposable tool commonly used during neurosurgical operations. It serves as interface between biochemical (ionic) signal transmission of the brain and the electrical signal transmission of the monitoring device. To preserve the integrity of the central nervous system with a focus on the brain, the electrode is used to assist the neurosurgeon by periodically testing the integrity of certain brain areas, either by electrical recording of neural activities on the cortex or by direct stimulation. Cortex Strip Electrodes are indicated for use in the sterile area of the operating room during surgeries for patients of any age or gender that require direct cortical measurement of electrophysiological signals or direct cortical stimulation, and are intended for temporary intraoperative use only.
Functional description
inomed cortex electrodes are indicated for the intra-operative recording of electrical activity to support the measurement of epileptogenic foci and brain mapping during surgery. They are single-use items with stainless steel contacts moulded into a silicone rubber matrix in a fixed strip pattern, and wiring is maintained in a silicone tube, terminating in 1.5mm touchproof connectors with corresponding numbering used for identification after connection to a monitoring system.