D-0126440-A – 2020/08
VisualEyes™ 515/525 Instructions for Use - US Page 2
The VisualEyes™ system is to be used by trained personnel only, such as audiologists, ENT surgeons,
physicians, hearing healthcare professionals or personnel with a similar level of education. The device should
not be used without the necessary knowledge and training to understand its use and how results should be
interpreted.
1.3 Contraindications
VNG testing may be contraindicated in patients who exhibit the following: blindness, broken nose or other
face/head trauma, recent eye surgery and lazy eye.
ENG testing is not recommended for patients with a cardiac pacemaker or any other electric/magnetic implanted
devices as the electrical equipment may interfere the device’s function.
Patients with strong defective vision, ptosis or abnormal blinks should be tested with caution as these conditions
can lead to artefacts. Patients with severe back/neck problems may be excluded for positional tests. Any other
relevant clinical history or medication of an individual patient should be considered before starting a test. A
medical specialist should be consulted for further information or guidance on clinical conditions that require
additional attention before starting the test.
1.4 Product description
The VisualEyes™ system is a sophisticated VNG analysis software platform that is available in two different
versions: VisualEyes™ 515 and VisualEyes™ 525.
The VisualEyes™ system can be configured with different hardware components/accessories
(laptop/desktop PC, goggles, Orion Reclining/Comprehensive/Auto Traverse chair and etc.) based on the
operator’s needs to perform various tests as per the intended use (refer to section 1.4.2) for default and optional
components of the product and 3.4 to learn more about individual hardware components).
The VisualEyes™ system extends support to existing users and is compatible with previous versions of
components/accessories (e.g: Nydiag 200 reclining chair, System 2000 chair
[Reclining/Comprehensive/Auto
Traverse]) based on their license upgrade.
VisualEyes™ 515 does not utilize an external stimulus, thereby limiting the system to nystagmus and caloric
testing. VisualEyes™ 525 utilizes an external stimulus for oculomotor testing and can be combined with
accessories to perform additional test procedures. The available tests in the VisualEyes™ system are outlined
in the following table. Please refer to Table 1.4-1 for details.
NOTICE The VisualEyes™ system can be provided with different test batteries and managed by user licenses.
The user gets a license key for their hardware and configuration. This will enable the software to recognize the
test battery assigned for the specific license. Refer to section 12.6 of ‘Additional Information’ for more detail.
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