Following information is part of the intended use according to /wiki/spaces/QA/pages/1800011780 , Annex II, 1.1 c and , /wiki/spaces/QA/pages/176685192 , 5.2.
Intended Medical Indication / Claim
The product is used to present information on the performance of the peripheral vestibular function by providing objective measures of eye-movement with or without stimulation of the balance organ in general as well as eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.
It enables the recording of eye movements in response to head movements without making a diagnostic statement about the user's state of health. The results are intended to serve as a tool for professionals to observe and analyze the functionality of the vestibular system.
Contraindication
Blindness
Broken nose or other face/head trauma
Problems with the cervical spine, e.g., neck trauma, acute cervical disc herniation
Recent eye surgery
Ptosis on measurement eye
Excessive eye blinks
Excessive eye make up
Contact with insured skin
Patient Population
The product is intended for patient from 6 years and up. The patient must be physically sound as the procedures include some physical stimulation/movement. Patient must be able the see the target without the use of spectacles.