Interacoustics VisualEyes 505 User manual

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Instructions for Use - EN
VisualEyes™
Micromedical
by Interacoustics
Science made smarter
D-0134090-A - 2022/11

Copyright © Interacoustics⅍: All rights reserved. Information in this document is proprietary to
Interacoustics⅍. The information in this document is subject to change without notice. No part of this
document may be reproduced or transmitted in any form or by any means without a prior written
permission of Interacoustics⅍.
FireWire® is a registered trademark of Apple Inc., registered in the United States and other countries.
Windows® is a registered trademark of the Microsoft Corporation, registered in the United States and
other countries.

Table of contents
Introduction .................................................................................................................................... 1
About this manual ..................................................................................................................... 1
Intended use ............................................................................................................................. 1
Contraindications ...................................................................................................................... 2
Product description ................................................................................................................... 2
1.4.1 Standard configurations without rotary chairs ................................................................... 2
1.4.2 Standard configurations with rotary chairs ........................................................................ 5
1.4.3 Included and optional parts................................................................................................ 7
1.4.4 Additional parts based on VNG goggle type...................................................................... 8
1.4.5 Additional parts based on rotary chairs ............................................................................. 8
1.4.6 Additional parts based on add-on modules ....................................................................... 9
Warnings and precautions ...................................................................................................... 10
Safety features and complaints handling................................................................................ 13
1.6.1 Complaints/safety reporting: ............................................................................................ 13
1.6.2 Safety features of the product.......................................................................................... 13
1.6.2.1 All types of rotational chairs ......................................................................................... 13
1.6.2.2 Orion and System 2000 reclining chairs ...................................................................... 13
1.6.2.3 Orion Auto-Traverse/Comprehensive chairs................................................................ 13
1.6.2.4 Nydiag 200 reclining chair............................................................................................ 13
Unpacking and installation ......................................................................................................... 14
Unpacking and inspection....................................................................................................... 14
Markings and symbols ............................................................................................................ 15
To know before you start the installation ................................................................................ 17
PC setup ................................................................................................................................. 17
2.4.1 Power settings ................................................................................................................. 17
2.4.2 PCI Expresscard.............................................................................................................. 18
2.4.3 USB connection ............................................................................................................... 18
Software installation................................................................................................................ 18
2.5.1 Demo patients.................................................................................................................. 20
2.5.2 Uninstalling VisualEyes™................................................................................................ 21
Hardware components and installation................................................................................... 21
2.6.1 VNG and vHIT goggles.................................................................................................... 22
2.6.1.1 Side mount goggles ..................................................................................................... 22
2.6.1.2 Top mount goggles ...................................................................................................... 24
2.6.1.3 Front mount goggles .................................................................................................... 24
2.6.1.4 EyeSeeCam goggle ..................................................................................................... 25
2.6.2 External room camera ..................................................................................................... 26
2.6.3 Foot switch and RF remote control.................................................................................. 27
2.6.4 Caloric irrigators (optional)............................................................................................... 28
2.6.5 Digital Light Bar (optional) ............................................................................................... 29
2.6.6 VORTEQ™ 2nd eneration IMU (optional) ....................................................................... 30
2.6.6.1 Optotype Tests ............................................................................................................. 31
2.6.7 Rotary chairs (optional).................................................................................................... 32
2.6.7.1 Reclining rotary chair ................................................................................................... 33
2.6.7.2 Auto-Traverse & Comprehensive rotary chairs............................................................ 35
2.6.7.3 Auto-Traverse & Comprehensive rotary chairs optional add-ons ................................ 38
2.6.7.4 Rotary chair calibration & validation............................................................................. 39
2.6.7.5 Additional steps for Auto-Traverse and Comprehensive chairs................................... 41
2.6.8 DataLink (optional)........................................................................................................... 44
2.6.8.1 Installing DataLink in combination with Orion Reclining, System 2000 Reclining, or
System 2000 Comprehensive .................................................................................................... 44
2.6.9 TRV Chair (optional) ........................................................................................................ 46
Installation of DAQ hardware drivers for rotary chairs and DataLink...................................... 46
Hardware registration and licensing........................................................................................ 47
Display configuration............................................................................................................... 50

2.9.1 TV considerations ............................................................................................................ 50
2.9.2 Windows display settings................................................................................................. 50
2.9.3 VisualEyes™ software settings ....................................................................................... 51
2.9.3.1 Stimuli........................................................................................................................... 51
2.9.3.2 Hardware delay ............................................................................................................ 52
2.9.3.3 DVA stimulus................................................................................................................ 55
Language settings ............................................................................................................... 56
Data and video storage ....................................................................................................... 57
2.11.1 Session data .................................................................................................................... 57
2.11.2 Video recordings.............................................................................................................. 57
2.11.3 Session reports................................................................................................................ 58
Operating instructions................................................................................................................. 60
System startup ........................................................................................................................ 60
Main screen............................................................................................................................. 61
System default settings........................................................................................................... 63
Protocol management............................................................................................................. 64
3.4.1 Default protocols delivered with VisualEyes™ systems.................................................. 65
3.4.2 Customized protocols ...................................................................................................... 66
Patient preparation.................................................................................................................. 67
3.5.1 Seat the patient in the reclining rotary chair .................................................................... 68
3.5.2 Seat the patient in the Auto-Traverse/Comprehensive chair........................................... 69
3.5.2.1 Seat the infant patient in the Auto-Traverse/Comprehensive chair ............................. 69
3.5.3 Electrode placement and impedance test for ENG evaluation........................................ 69
3.5.4 Placing the goggles on the patient................................................................................... 70
Eye image adjustment ............................................................................................................ 70
3.6.1 Eye image centering: ....................................................................................................... 70
3.6.2 Focus adjustment ............................................................................................................ 71
3.6.3 Eye tools menu ................................................................................................................ 71
Calibration ............................................................................................................................... 72
3.7.1 Standard calibration......................................................................................................... 73
3.7.2 Torsion calibration ........................................................................................................... 75
3.7.3 EyeSeeCam calibration ................................................................................................... 76
3.7.4 ENG calibration and impedance test ............................................................................... 77
The test screen ....................................................................................................................... 79
Performing the tests ................................................................................................................ 81
3.9.1 VisualEyes™ 505, VisualEyes™ 515 and VisualEyes™ 525 ......................................... 81
3.9.1.1 Video Frenzel ............................................................................................................... 81
3.9.1.2 Spontaneous Nystagmus ............................................................................................. 81
3.9.1.3 Dix Hallpike .................................................................................................................. 81
3.9.1.4 Positional...................................................................................................................... 82
3.9.1.5 Caloric test ................................................................................................................... 82
3.9.1.6 Oculomotor tests .......................................................................................................... 83
3.9.1.7 Ocular counter roll........................................................................................................ 84
3.9.1.8 Rotary chair tests ......................................................................................................... 84
3.9.2 VORTEQ™ assessment.................................................................................................. 85
3.9.2.1 Dynamic Visual Acuity.................................................................................................. 85
3.9.2.2 Lateral Head Roll ......................................................................................................... 85
3.9.2.3 Dix Hallpike Advanced ................................................................................................. 86
3.9.2.4 Gaze Stabilization ........................................................................................................ 86
3.9.3 VORTEQ™ diagnostic..................................................................................................... 86
3.9.3.1 Active Head Rotation ................................................................................................... 86
3.9.3.2 vHIT VORTEQTM .......................................................................................................... 86
3.9.4 EyeSeeCam vHIT ............................................................................................................ 87
3.9.4.1 Lateral VHIT ................................................................................................................. 87
3.9.4.2 Left Anterior Right Posterior (LARP) / Right Anterior Left Posterior (RALP) vHIT....... 87
3.9.4.3 Performing the test....................................................................................................... 88
Test review screen .............................................................................................................. 92
3.10.1 Editing tools ..................................................................................................................... 93
Review previous sessions ................................................................................................... 93

3.11.1 Session review................................................................................................................. 94
Review patient videos ......................................................................................................... 95
Research module ................................................................................................................ 97
3.13.1 Nystagmus parameters.................................................................................................... 97
3.13.2 Data export ...................................................................................................................... 97
System shutdown ................................................................................................................ 98
Care and maintenance ................................................................................................................. 99
How to clean the VisualEyes™ system .................................................................................. 99
Warranty and service .............................................................................................................. 99
Rotational chair error messages ........................................................................................... 100
Cameras disconnecting ........................................................................................................ 102
General technical specifications .............................................................................................. 103
Minimum computer requirements ......................................................................................... 103
Standards.............................................................................................................................. 103
Goggles................................................................................................................................. 104
Accessories........................................................................................................................... 108
TRV Chair ............................................................................................................................. 110
Rotary chairs ......................................................................................................................... 111
Orion Auto-Traverse/Comprehensive accessories ............................................................... 113
Caloric irrigators .................................................................................................................... 113
Electromagnetic compatibility (EMC) .................................................................................... 114
Return procedure ....................................................................................................................... 119

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VisualEyes™ - Instructions for Use - EN Page 1
Introduction
About this manual
This manual is valid for VisualEyes™ 505, VisualEyes™ 515, VisualEyes™ 525, Orion Reclining, Orion
Comprehensive (+ Basic), Orion Auto-Traverse (+ Basic), and VisualEyes™ EyeSeeCam with software
version 3.1 These products are manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
E-mail: [e-mail]
Web: http://www.interacoustics.com/
Definitions:
VisualEyes™ 505, VisualEyes™ 515, VisualEyes™ 525, and VisualEyes™ EyeSeeCam will be referred to
as ‘VisualEyes™ system’ throughout this document. Wherever ‘operator’ is mentioned in this document, this
refers to the clinician, technician or qualified personnel who operates the system. Rotational chair refers to
all kinds of rotational chairs until a specific type is specified. Also, in the context of a rotational chair,
Reclining, Auto-Traverse and Comprehensive are abbreviated as R, AT and C, respectively. The term
‘VORTEQ™ IMU’ refers to 2nd or latest generation of VORTEQ™ IMU.
Instructions for Use/Additional Information:
‘Instructions for Use’ contain all the information required to operate this system in a safe and effective
manner but the ’Additional Information’ guide is also available to the interested reader. The operator can
find the Instructions for use and Additional information in the help menu in the software. The operator can
also refer to these manuals on the manufacturer’s official website.
Intended use
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.
Videonystagmography (VNG):
The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis, and
documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with
cameras. These images are measured, recorded, displayed and stored in the software. This information can
then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target
population for videonystagmography is five years of age and above.
Electronystagmography (ENG):
The VisualEyes™ system also provides information to assist in the electronystagmographic evaluation,
diagnosis and documentation of vestibular disorders. ENG testing evaluates nystagmus using electrodes.
The eye movement analysis can be viewed, recorded, and archived using this software. The target
population for ENG testing includes all age groups.
Video head impulse testing (vHIT):
VisualEyes™ EyeSeeCam provides objective measures of eye velocity in response to head-velocity stimuli,
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.

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VisualEyes™ - Instructions for Use - EN Page 2
VisualEyes™ EyeSeeCam is intended for patients from 5 years of age and above. The patient must be
physically sound as the procedures include some physical stimulation/movement. The patient must be able
the see the target without the use of spectacles.
Contraindications
VNG and vHIT 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 in patients with a cardiac pacemaker or any other electric/magnetic
implanted devices, as the electrical equipment may interfere with the device’s function.
Patients with strong defective vision, ptosis or abnormal blinks should be tested with caution as these
conditions can lead to artifacts. Patients with severe back/neck problems may be excluded for positional and
vHIT 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.
Product description
The VisualEyes™ system is a sophisticated software platform used for VNG, ENG, and vHIT testing.
1.4.1 Standard configurations without rotary chairs
The VisualEyes™ system is available in a number of different configurations with and without rotary chairs.
The standard configurations without rotary chairs are VisualEyes™ 505, VisualEyes™ 515, VisualEyes™
525, and VisualEyes™ EyeSeeCam. Refer to Table 1.4-1 for an overview of the included tests with each of
the systems.
•VisualEyes™ 505
VisualEyes™ 505 is a Video Frenzel system including video recording as well as spontaneous
nystagmus detection providing objective slow phase velocity data.
•VisualEyes™ 515
VisualEyes™ 515 is a VNG system for evaluating spontaneous nystagmus, positional testing, and
caloric testing. The system can also be combined with an Orion Reclining rotary chair for rotary chair
testing.
•VisualEyes™ 525
VisualEyes™ 525 is the full range VNG system including all tests from the VisualEyes™ 505 and
VisualEyes™ 515 systems, with the addition of an advanced oculomotor test battery and ocular
counter roll testing with torsional tracking. The system can also be combined with an Orion
Reclining, Orion Comprehensive, or Orion Auto-Traverse rotary chair for rotary chair testing.
•VisualEyes™ EyeSeeCam
VisualEyes™ EyeSeeCam is a vHIT system for quick and objective measurements of the
vestibulo-ocular reflex (VOR) through lateral, RALP, LARP, and SHIMP testing. Furthermore, the
system includes a protocol for spontaneous nystagmus providing objective slow phase velocity data.
VisualEyes™ EyeSeeCam can be combined with any of the other VisualEyes™ systems, combining
VNG and vHIT testing into the same software platform.

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VisualEyes™ - Instructions for Use - EN Page 3
On top of the standard modules, different optional add-on modules can be added to some of the
configurations:
•VORTEQ™ Assessment (VisualEyes™ 505 / VisualEyes™ 515 / VisualEyes™ 525)
VORTEQ™Assessment is an add-on module including the VORTEQ™ 2nd Generation IMU and
headband for head position and velocity tracking.
The module adds the following measurements on top of the extisting test battery:
oBPPV Module
Advanced Dix Hallpike
Lateral Head Roll
oDynamic Visual Acuity
oGaze Stabilization Test
•VORTEQ™ Diagnostic (VisualEyes™ 525)
VORTEQ™Diagnostic is an add-on module including the VORTEQ™ 2nd Generation IMU for head
position and velocity tracking.
The module adds the following measurements on top of the extisting test battery:
ovHIT VORTEQ™
oActive Head Rotation
•Research Module
The Research Module is an add-on module allowing for easy export of raw data along with
adjustment of nystagmus detection parameters.
•External Sync.
This is an add-on option allowing communication through OtoAccess® API.
•EOG Accessory kit for VNG (VisualEyes™ 515 / VisualEyes™ 525)
The EOG Accessory kit for VNG is an add-on module including the DataLink used for ENG testing.

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VisualEyes™ - Instructions for Use - EN Page 4
Table 1.4-1 License Overview (without Rotary Chairs):
VisualEyes™
505
VisualEyes™
515
VisualEyes™
525
VisualEyes™
EyeSeeCam
Video Frenzel
X
X
Spontaneous Nystagmus
X
X
X
X
Gaze
X
Dix Hallpike
X
X
Positional
X
X
Bithermal Caloric*
X
X
Optokinetic
X
Smooth Pursuit
X
Saccade
X
Ocular Counter Roll w. torsional tracking
X
Saccadometry
X
EyeSeeCam vHIT
X
ADD-ON: VORTEQ™Assessment**
- Dynamic Visual Acuity
- Dix Hallpike Advanced
- Lateral Head Roll
- Gaze Stabilization Test
XXX
ADD-ON: VORTEQ™Diagnostic**
- Active Head Rotation
- vHIT VORTEQ™
X
ADD-ON: Research Module
X
X
X
X
ADD-ON: EOG Accessory kit for VNG
X
X
ADD-ON: Static SVV module
X
X
X
ADD-ON: External Sync
X
X
X
X
* Requires separate caloric irrigator
** Only compatible with top mount or side mount goggles

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VisualEyes™ - Instructions for Use - EN Page 5
1.4.2 Standard configurations with rotary chairs
Rotary chairs can be combined with VisualEyes™ 515 and VisualEyes™ 525, as described below. The
Orion Comprehensive and the Orion Auto-Traverse can also be configured as Orion Comprehensive Basic
and Orion Auto-Traverse Basic. These include only the tests that can be performed inside the chair
enclosure. Refer to Table 1.4-2 for an overview of the included tests with each of the systems.
•Orion Reclining
Orion Reclining is a rotary chair that can be reclined for caloric and positioning testing.
•Orion Comprehensive
Orion Comprehensive is a rotary chair inside a chair enclosure, containing a built-in laser and an
optokinetic drum for visual stimuli.
•Orion Auto-Traverse
Orion Auto-Traverse is a rotary chair inside a chair enclosure, containing a built-in laser and an
optokinetic drum for visual stimuli. The chair has off-axis lateral movement capability used for
dynamic subjective visual vertical testing.
•Other Rotary chairs
VisualEyes™ 3rd generation also supports the rotary chairs below:
oSystem 2000 Reclining
oSystem 2000 Comprehensive
oSystem 2000 Auto-Traverse
oNydiag 200

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VisualEyes™ - Instructions for Use - EN Page 6
Table 1.4-2: License Overview (with Rotary Chairs):
Orion R +
VE515
Orion R
+ VE525
Orion C
Basic
Orion AT
Basic
Orion C
+
VE525
Orion AT
+ VE525
Video Frenzel
X
X
X
Spontaneous Nystagmus
X
X
X
X
X
X
Gaze
X
X
X
X
X
Dix Hallpike
X
X
X
X
Positional
X
X
X
X
Bithermal Caloric*
X
X
X
X
Optokinetic
X
X
X
X
X
Smooth Pursuit
X
X
X
X
X
Saccade
X
X
X
X
X
Ocular Counter Roll
X
X
X
Saccadometry
X
X
X
Step Velocity
X
X
X
X
X
X
Sinusoidal Harmonic Acceleration (SHA)
X
X
X
X
X
X
VOR Suppression
X
X
X
X
X
X
Visual VOR
X
X
X
X
X
X
Static SVV
X
X
X
X
Dynamic SVV
X
X
ADD-ON: VORTEQ™Assessment**
- Dynamic Visual Acuity
- Dix Hallpike Advanced
- Lateral Head Roll
- Gaze tabilization Test
X
X X X
ADD-ON: VORTEQ™Diagnostic**
- Active Head Rotation
- vHIT VORTEQ™
X X X
ADD-ON: Research Module
X
X
X
X
X
X
ADD-ON: Static SVV module
X
X
ADD-ON: External Sync
X
X
X
X
X
X
ADD-ON: EOG Accessory kit for VNG
X
X
X
X
ADD-ON: EOG Accessory kit for Orion
C/AT
X X X X
ADD-ON: Child Option Accessory kit for
Orion C/AT
X X X X
* Requires separate caloric irrigator
** Only compatible with top mount or side mount goggles

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VisualEyes™ - Instructions for Use - EN Page 7
1.4.3 Included and optional parts
VisualEyes™
505
VisualEyes™
515
VisualEyes™
525
VisualEyes™
EyeSeeCam
Orion AT/C
Basic
Included major parts:
•VNG goggle of
choice
•VisualEyes™
software
•Remote control / foot
switch
•Full HD room
camera
•Cleaning cloth
•Introduction guides
•Certificates and
reports: e.g. test
result report, license
certificate, certificate
of conformity, and if
applicable, safety
test report.
Included major parts:
•VNG goggle of
choice
•VisualEyes™
software
•Remote control /
foot switch
•Full HD room
camera
•Cleaning cloth
•Introduction guides
•Certificates and
reports: e.g. test
result report,
license certificate,
certificate of
conformity, and if
applicable, safety
test report.
Included major
parts:
•VNG goggle of
choice
•VisualEyes™
software
•Remote control /
foot switch
•Full HD room
camera
•Cleaning cloth
•Introduction
guides
•Certificates and
reports: e.g. test
result report,
license
certificate,
certificate of
conformity, and if
applicable, safety
test report.
Included major
parts:
•EyeSeeCam
vHIT goggle and
camera
•VisualEyes™
software
•Full HD room
camera
•Cleaning cloth
•Introduction
guides
•Certificates and
reports: e.g. test
result report,
license
certificate,
certificate of
conformity, and if
applicable, safety
test report.
Included major
parts:
•Orion Auto-
Traverse or
Comprehensive
chair
•Top mount
goggle
•VisualEyes™
software
•Remote control /
foot switch
•Full HD room
camera
•Cleaning cloth
•Introduction
guides
•Certificates and
reports: e.g. test
result report,
license
certificate,
certificate of
conformity, and if
applicable,
safety test report
Optional parts:
•Pediatric goggle
•TRV Chair
•VORTEQ™
Assessment
•Research Module
•Static SVV Module
•External Sync.
Optional parts:
•Pediatric goggle
•TRV Chair
•VORTEQ™
Assessment
•Research Module
•Static SVV Module
•EOG Accessory kit
for VNG
•Orion Reclining
•AquaStim
•AirFx
•External Sync.
Optional parts:
•Pediatric goggle
•TRV Chair
•VORTEQ™
Assessment
•VORTEQ™
Diagnostic
•Research Module
•
EOG Accessory
kit for VNG
•Orion Reclining
•Orion
Comprehensive
•Orion Auto-
Traverse
•AquaStim
•AirFx
•Digital Lightbar
•Static SVV
module
•External Sync.
Optional Parts:
•Research Module
•External Sync.
Optional Parts:
•Research
Module
•Appropriate
optional parts for
the chosen chair
(1.4.4)

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VisualEyes™ - Instructions for Use - EN Page 8
1.4.4 Additional parts based on VNG goggle type
Side Mount USB
(2D-VOGFW)
Side Mount
FireWire
(2D-VOGFW)
Top Mount
(BG4.0USB /
BG4.0KUSB)
Front Mount
(
USBM2.1A /
USBM2.1P)
Included major parts:
•USB 2.0 camera module
(two modules in binocular
configuration)
•Disposable goggle foam
pads – box of 24 pcs and
foam insert case
•1.5 mm hexagon
screwdriver for camera
retaining screws
•7-port USB 3.0 hub w.
external power supply
Included major parts:
•FireWire® camera module
(two modules in binocular
configuration)
•Disposable goggle foam
pads – box of 24 pcs and
foam insert case
•1.5 mm hexagon
screwdriver for camera
retaining screws
•4-port USB 3.0 hub w.
external power supply
•PCI ExpressCard (for
desktop PC configuration)
Included major parts:
•Binocular USB goggles
•7-port USB 3.0 hub w.
external power supply
Included major parts:
•Adult (USBM2.1A) /
Pediatric (USBM2.1P)
mask for monocular USB
camera
•7-port USB 3.0 hub w.
external power supply
1.4.5 Additional parts based on rotary chairs
Orion Reclining
Orion Comprehensive /
Orion Auto-Traverse
Included major parts:
•Orion Reclining rotary chair
•USB cable
•Emergency stop button with Ethernet connector
•Power cord
•Tools and accessories for assembly
•Isolation transformer
Included major parts:
•Orion Comprehensive / Auto-Traverse rotary chair
•Optokinetic drum
•X-Y laser assembly
•Booth and accessories
•USB cable
•Emergency stop button with Ethernet connector
•Power cord
•Booth observation camera
•Intercom
•Remote control for SVV line
•Tools and accessories for assembly
•
Isolation transformer
Optional parts: Optional Parts:
•EOG accessory kit for Orion C/AT
•Child option accessory kit for Orion C/AT

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VisualEyes™ - Instructions for Use - EN Page 9
1.4.6 Additional parts based on add-on modules
VORTEQ™
Diagnostic
VORTEQ™
Assessment
Research
Module
Static SVV
Module
Compatible
with:
•VisualEyes™
525 (top mount /
side mount
goggles)
•VisualEyes™ 505
(top mount / side
mount goggles)
•VisualEyes™ 515
(top mount / side
mount goggles)
•VisualEyes™ 525
(top mount / side
mount goggles)
•VisualEyes™ 505
•VisualEyes™ 515
•VisualEyes™ 525
•VisualEyes™
EyeSeeCam
•Orion Auto-
Traverse Basic
•Orion
Comprehensive
Basic
•VisualEyes™ 505
•VisualEyes™ 515
•VisualEyes™ 525
Included
features/tests:
•Active Head
Rotation
•vHIT VORTEQ™
•Dynamic Visual
Acuity
•Dix Hallpike
Advanced
•Lateral Head Roll
•Gaze Stablization
Test
•Adjustment of
nystagmus
parameters
•Data export
•Static SVV
Included
major parts:
•VORTEQ™ 2nd
gen sensor
•Bluetooth dongle
•USB cable (for
charging or
wired
connection)
•Goggle mounts
for side mount
and top mount
goggles
•VORTEQ™ 2nd
gen sensor
•Bluetooth dongle
•USB cable (for
charging / wired
connection)
•Goggle mounts
for side mount
and top mount
goggles
•Headband for
Dynamic Visual
Acuity
•License only
•Remote control for
SVV line
EOG accessory kit
for VNG
EOG accessory kit
for Orion C/AT
Child option
accessory kit for
Orion C/AT
Compatible
with:
•VisualEyes™ 515
•VisualEyes™ 525
•VisualEyes™ 525 + Orion
C/AT
•Orion Comprehensive Basic
•Orion Auto-Traverse Basic
•VisualEyes™ 525 + Orion
C/AT
•Orion Comprehensive Basic
•Orion Auto-Traverse Basic
Compatible
features/tests
(If system is
licensed for the
tests):
•3-channel ENG testing
compatible with below tests:
oSpontaneous
Nystagmus
oGaze
oSmooth Pursuit
oSaccade
oOptokinetic
oPositional
oDix Hallpike
oBithermal Caloric
oSaccadometry
•3-channel ENG testing
compatible with below tests:
oSpontaneous
Nystagmus
oGaze
oSmooth Pursuit
oSaccade
oOptokinetic
oStep Velocity
oSinusoidal
Harmonic
Acceleration
•Rotary chair testing for
children down to 1 year of
age

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Included major
parts:
•Datalink
•7x electrode cables (3
channels)
•Snap electrodes
•Electrode skin preparation
accessory
•ENG built into the back of the
Orion C/AT rotary chairs
•7x electrode cables (3
channels)
•Snap electrodes
•Electrode skin preparation
accessory
•Pediatric front mount goggle
(USBM2.1P)
•Child seat
•Pediatric observation camera
Warnings and precautions
The general warnings, precautions and points to be noticed for the VisualEyes™ system are discussed in
this section with appropriate symbols. Some of the specific warnings are discussed under respective
sections to get the maximum attention from the user.
Throughout this manual the following meaning of warnings, cautions and notices are used:
WARNING identifies conditions or practices that may present danger to the patient
and/or user.
CAUTION label identifies conditions or practices that could result in damage to the
equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
General warnings and precautions
WARNING indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
1. Federal law restricts this device to sale by or on the order of a physician.
2. Do not disassemble or modify the product as this may impact on the safety and/or performance of
the device. Always refer to qualified/authorized personnel for product service. No modification (if
necessary) should be done to this equipment/its component without authorization from
Interacoustics.
3. This equipment is intended to be connected to other equipment thus forming a Medical Electrical
System. External equipment intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g. IEC 62368-1 for IT equipment and
the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the safety requirements stated in the general standard IEC
60601-1, edition 3.1, clause 16. Any equipment not complying with the leakage current requirements
in IEC 60601-1 shall be kept outside the patient environment, i.e. at least 1.5 m from the patient or
shall be supplied via a separation transformer to reduce the leakage currents. Any person who
connects external equipment to a signal input, signal output or other connectors has formed a
Medical Electrical System and is therefore responsible for the system to comply with the
requirements. If in doubt, contact a qualified medical technician or your local representative.

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4. A separation device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular, such a
separation device is required when a network connection is made. The requirements for separation
devices are defined in IEC 60601-1, edition 3, clause 16.
5. The system must not be used in the presence of explosive or flammable gases.
6. The system must be switched off before cleaning.
7. Do not use any additional multiple-socket outlet or extension cord.
8. For irrigators, to avoid the risk of electric shock, this equipment must only be connected to a supply
main with protective earth.
9. The manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel designated by the
manufacturer to repair those parts of this system.
10. For maximum electrical safety, turn off the power to the equipment when it is left unused.
11. The equipment is not protected against harmful ingress of water or other liquids. If any spillage
occurs, check the equipment carefully before use or contact the manufacturer for service.
12. Do not use the equipment before service, if it shows a visible or suspected damage.
13. Grade 2 laser stimulus is used in the Orion Auto
Traverse / Orion Comprehensive chairs and the
System 2000 Auto Traverse / System 2000
Comprehensive chairs against the booth enclosure.
Both operator and patient should avoid looking into
the laser beam. There are no user-serviceable
components in the laser box assembly.
14. Do not service any part of the equipment while in use with a patient.
CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not
avoided, could result in damage to the equipment.
1. Before using the system, it is mandatory to read the user manual, labels and other additional
information. The system should be used as described in the user manual only.
2. The system should only be operated by qualified technicians with appropriate training.
3. The system must be serviced at least once a year. The service must include a safety test.
4. Handle the device components carefully to avoid system damage.
5. Allow the system to obtain room temperature before using the equipment. Any components that
have been stored previously should be brought to room temperature before usage.
6. It is important to ensure that the rotational chair center is situated at least 1 meter (39 inches) from
the center axis to any adjacent object to accommodate its reclined position.
NOTICE NOTICE is used to address practices not related to personal injury or damage to the equipment.
1. A CLASS 1 laser stimulus is used in the EyeSeeCam goggles. A
CLASS 1 laser is safe under all conditions of normal use. This means
the maximum permissible exposure (MPE) for this beam is not
exceeded when viewed with the naked eye or with the aid of typical
magnifying optics.
2. No other PC programs should be running or minimized while testing the patient with the software.
This can interfere with the VisualEyes™ system’s software.
3. To prevent system faults, take appropriate precautions to avoid PC viruses and similar.
4. Although the equipment fulfils the relevant EMC requirements, precautions should be taken to avoid
unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used
adjacent to other equipment, it must be observed that no mutual disturbance appears.

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Within the European Union it is illegal to dispose electric and electronic waste as unsorted
municipal waste. Electric and electronic waste may contain hazardous substances and must
therefore be collected separately. Such products will be marked with the crossed-out wheeled
bin. The cooperation of the user is important to ensure a high level of reuse and recycling of
electric and electronic waste. Failing to recycle such waste products in an appropriate way
may endanger the environment and consequently the health of human beings. Users from countries not
belonging to the European Union are entitled to follow the applicable local rules related to electric or
electronic waste management.

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Safety features and complaints handling
1.6.1 Complaints/safety reporting:
Please contact your local distributor in case of any incident related to product defects (hardware
defects or software bugs) or adverse events (which does not necessarily have a causal
association to the product). It is recommended for a user to report all the known facts about the
incident. Upon receipt of any serious incident with serious health impact for the patient or user
(serious adverse events), Interacoustics shall ensure that the regulatory authority in patient’s
home country is informed according to the vigilance requirements. Interacoustics shall handle all the product
complaints and adverse events as per the internal procedure.
1.6.2 Safety features of the product
The VisualEyes™ system provides various safety features to ensure patient safety and various error
messages as check points for the better performance of tests especially with all rotational chair options.
Refer to section 4.3 for details on the error messages. Other safety features are described below.
1.6.2.1 All types of rotational chairs
All types of rotational chairs (Orion Reclining/Auto Traverse/Comprehensive, System 2000 Reclining/Auto
Traverse/Comprehensive and Nydiag 200) have an emergency stop button which resides at the operator’s
station and the operator can manually override the system to stop the chair, laser, and optokinetic drum by
pressing the button. Rotating the emergency stop button will release the devices and the system is ready for
operation. The operator can restart the test from the software.
Rotational chair has seat belt to secure the patient from falling during the tests. Rotational chair tests do not
respond to the RF remote as an additional patient safety measure. Refer to Additional information guide for
more details.
1.6.2.2 Orion and System 2000 reclining chairs
The VisualEyes™ system does not allow a rotational chair to spin at the reclining position and the operator
immediately gets an alert message from the software.
1.6.2.3 Orion Auto-Traverse/Comprehensive chairs
The Orion Auto-Traverse/Comprehensive chairs come with a booth enclosure. The booth enclosure is wired
to ensure that the booth door is closed before testing. If the door is open, the test will not start. If you open
the door during testing, the test will be stopped, and the operator gets an alert message.
Note: the chair, laser and drum are disabled for any test when the booth is open.
The patient-controlled stop button is secured on the right side of the head support of the Orion
Auto-Traverse/Comprehensive chairs. The patient can press the stop button during testing. Pressing the
button during a test will stop the chair, laser and optokinetic drum.
The chair has a built-in watchdog timer that checks if the software and chair are communicating. If there is no
communication, the watchdog timer will stop the chair, laser and optokinetic drum. Following, the operator
must exit the test or go to the home screen and restarting the test will reset the watchdog timer (refer to
section 4.3 to know more). If the fault repeats, the operator must address the issue before proceeding with
the test.
1.6.2.4 Nydiag 200 reclining chair
The patient-controlled stop button is located underneath the right armrest. Pressing the button during a test
will stop the chair.

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Unpacking and installation
Unpacking and inspection
Check shipping box
As soon as you receive the instrument, please check the shipping box for any sign of rough handling or
damage. If the box is damaged, keep the shipping material as it may be required for inspection by the carrier
regarding any potential insurance claim.
Keep carton
The VisualEyes™ system comes with shipping cartons, which are specifically designed for the components.
It is recommended to keep the cartons for future shipments in case of any need for return or service.
Inspect instrument before connection
Inspect the product for potential damage before connecting it. Examine the cabinet and accessories for
scratches and missing parts.
Report any concerns immediately
Report any missing part or any mechanical or electrical malfunction immediately to your local distributor
together with the invoice, serial number, and a detailed report of the problem. In the back of this manual you
will find a “Return Report” where you can describe the problem.
Please use “Return Report”
Please realize that if the service engineer does not know what problem to look for he may not find it, so using
the Return Report will be of great help to us and is your best guarantee that the correction of the problem will
be to your satisfaction.
Storage
If you need to store the VisualEyes™ system for a period, please ensure it is stored under the appropriate
conditions as described for the different components in the Technical Specifications section 5: General
technical specifications.

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Markings and symbols
The following markings and symbols can be found on the instrument, accessories or packaging:
Symbol
Explanation
Type BF applied parts
Type B applied parts
Follow instructions for use
WEEE (EU-directive).
This symbol indicates that when the end-user wishes to discard this product,
it must be sent to separate collection facilities for recovery and recycling.
Failing to do so may endanger the environment.
0123
The CE-mark in combination with MD symbol indicates that Interacoustics
A/S meets the requirements of the Medical Device Regulation (EU)
2017/745. Approval of the quality system is made by TÜV – identification no.
0123.
Medical device
Manufacturer
Date of Manufacture
Indicates a component is intended for one use, or for use on a single patient
during a single procedure. Cross contamination risk
Reference number
Do-not-push symbol used with components that could easily tip over, such
as the Digital Light Bar
Chinese RoHS compliance standard where the product contains less than
the maximum concentration value of lead, mercury, cadmium, hexavalent
chromium, polybrominated biphenyls and polybrominated diphenyl ethers
CLASS 1 LASER PRODUCT. A CLASS 1 laser is safe under all conditions
of normal use. This means the maximum permissible exposure (MPE)
cannot be exceeded when viewing a laser with the naked eye or with the aid
of typical magnifying optics