Device Dossier
Vision Monitor - Vision physiology/eye movement analysis system
Device Dossier for Vision Monitor - Vision physiology/eye movement analysis system (Vision physiology/eye movement analysis system, Class IIa, sponsor…
- GMDN category: Vision physiology/eye movement analysis system
Intended purpose
The Vision Monitor is intended to identify defects of the visual system for the purposes of screening, monitoring, and assisting in the diagnosis and management of ocular diseases and related neurological disorders. The Vision Monitor is not intended to be used as the sole diagnostic method for disease. It is relying on several techniques: - Psychophysical techniques use the voluntary answer from the patient to the presentation of visual stimulations These techniques include tests of the visual field (automated or manual perimetry), tests of visual acuity (acuity charts), contrast sensitivity, glare, dark adaptometry - Electrophysiological techniques use bioelectric signals originating from the retina, the optic nerve and visual cortex in response to visual stimulations These techniques include electroretinography (ERG) which records the electrical activity of the retina with a contact lens electrode and visual evoked potentials (VEP) with record the electrical activity of the visual cortex with skin electrodes placed on the scalp. - Eye movement techniques use video recordings of the image of the head (video-oculography) or electrophysiology recordings of the electro-oculographic signal to measure the movements of the eyes In addition, video-oculography can also record pupillary responses (changes in the diameter of the pupils). The Vision Monitor system includes several models that can be combined with different possibilities of visual function exams.