Intended Use - Medical Purpose

Following information is part of the intended use according to DIN EN ISO 13485 , Annex II, 1.1 c and DIN EN ISO 14971 , 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.