Intended Use - Medical Use

Following information is part of the intended use according to DIN EN ISO 14971 , 5.2.

Part of the Body / Type of Tissue Interacted With

Head / intact skin only

User Profile

The system is to be used by trained personnel only such as audiologists, ENT surgeons, neurologists, hearing healthcare professionals or personnel with a similar level of education.

Use Environment

Operating Principle

The device is worn like a goggle and fastened with a headband. Infrared light is emitted by the goggle and reflected by the eyeball. The reflected image of the eyeball is deflected by an infrared mirror through an infrared filter through a lens to the camera. One or two cameras can be installed for recording the image of one or both eyes. The system identifies the position of the pupil in the image and tracks the pupil position over time.

The system records determines the spatial position of the head relative to an adjustable origin. The head position is tracked over time.

The system continuously calculates the speed of head motion in one of three selectable spatial dimensions. When a adjustable speed threshold is detected, the system records pupil- and head positions for 1 second. Both head and eye positions are used to calculate the speed of the eye- and head-motion during the recording. The speed of eye and head motion are presented to the examiner for comparison. A quantitative comparison of eye and head speeds are provided for convenience at specific points in time and interval.