Device Dossier
Sleep assessment device
Device Dossier for Sleep assessment device (Sleep assessment device, Class IIa, sponsor Compumedics). ARTG record, intended purpose, GMDN category —…
- GMDN category: Sleep assessment device
Intended purpose
The Grael System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various sleep disorders or neurological disorders. The Grael System is designed for use in a hospital or other clinical environment. The Grael System is only to be used under the direction of a physician. The Grael System is suitable for conducting either PSG or EEG studies, and is comprised of hardware and software which, depending on the model type, provides up to 60 separate parameters for recording, review and analysis.