Following information is part of the intended use according to DIN EN ISO 13485:2016-08, Annex II, 1.1 c and , /wiki/spaces/QA/pages/176685192 , 5.2.
Intended Medical Indication
<Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by your software.>
Contraindication
<List exclusion criteria: Maybe patients with a certain diagnosis should not be using your device.>
Patient Population
<e.g. age groups (adults, children,adolescent, elderly), gender (male, female) or disease state>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.
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.
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
Excessive eye blinks
Excessive eye make up
Patient Population
The product is intended for patient from 5 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.