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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

The product is used to present information on the performance of the balance system by providing objective measures of eye-velocity response to head-velocity stimulus, showing the VOR gain in the plane of rotation of the head.

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 5 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.