Interacoustics VisualEyes 515 User manual

Science made smarter
Instructions for Use - US
VisualEyes™
515/525
Micromedical
by Interacoustics
D-0126440-A – 2020/08

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
1INTRODUCTION ...........................................................................................................................1
1.1 About this manual ............................................................................................................... 1
1.2 Intended use ....................................................................................................................... 1
1.3 Contraindications ................................................................................................................ 2
1.4 Product description ............................................................................................................. 2
1.4.1 Minimum PC requirements ....................................................................................... 2
1.4.2 Included and optional parts ...................................................................................... 2
1.5 Warnings and precautions .................................................................................................. 5
1.6 Safety features and complaints handling............................................................................ 7
1.6.1 Complaints/safety reporting:..................................................................................... 7
1.6.2 Safety features of the product .................................................................................. 7
1.6.3 All types of rotational chairs...................................................................................... 7
1.6.4 Orion and System 2000 reclining chairs................................................................... 7
1.6.5 Orion Auto Traverse/Comprehensive chairs ............................................................ 7
1.6.6 Nydiag 200 reclining chair ........................................................................................ 7
2UNPACKING AND INSPECTION .................................................................................................2
2.1 Unpacking and inspection................................................................................................... 2
2.2 Marking ............................................................................................................................... 2
3SETUP AND INSTALLATION ......................................................................................................6
3.1 Introduction to the VisualEyes™ software .......................................................................... 6
3.2 Installation of the VisualEyes™ software............................................................................ 6
3.3 Installation of DAQ hardware driver for data acquisition components
................................ 6
3.3.1 Installing DAQ hardware driver for Orion Chair/System 2000 chair/
DataLink/VLink.......................................................................................................... 6
3.3.2 Installation of DAQ hardware driver for Nydiag 200 rotary chair.............................. 7
3.4 Hardware components........................................................................................................ 7
3.4.1 Laptop/desktop PC ................................................................................................... 7
3.4.2 Television/projector display/Digital Light Bar............................................................ 7
3.4.3 Side mounted camera goggles................................................................................. 8
3.4.4 Top mounted camera goggles.................................................................................. 8
3.4.5 Front mounted camera goggles................................................................................ 9
3.4.6 EyeSeeCam camera................................................................................................. 9
3.4.7 Pediatric observation camera ................................................................................. 10
3.4.8 Reclining rotary chair (optional) .............................................................................. 11
3.4.9 AT/C rotary chairs (optional)................................................................................... 11
3.4.10 Foot pedal (optional)............................................................................................... 12
3.4.11 VisualEyes™ remote control (optional) .................................................................. 12
3.4.12External room camera and observation camera .................................................... 13
3.4.13 VORTEQ™ IMU ..................................................................................................... 14
3.4.14 DataLink.................................................................................................................. 15
3.5 System configuration ........................................................................................................ 15
3.5.1 Systems configured without a rotational chair........................................................ 15
3.5.2 Systems configured with a rotational chair ............................................................. 16
3.5.3 Reclining chair setup .............................................................................................. 16
3.5.4 Auto Traverse and Comprehensive chair setup ..................................................... 17
4OPERATING INSTRUCTIONS ...................................................................................................20
4.1 System startup .................................................................................................................. 20
4.1.1 Turn on power sources ........................................................................................... 20
4.1.2 Turn on accessories ............................................................................................... 20
4.1.3 Turn on stimulus then computer ............................................................................. 20
4.2 Entering patient information .............................................................................................. 20

4.3 Starting the VisualEyes™ software................................................................................... 20
4.4 Room recording................................................................................................................. 20
4.5 Patient preparation............................................................................................................ 21
4.5.1 Seat the patient in the reclining chair (Orion/System 2000/Nydiag 200)................ 22
4.5.2 Seat the patient in the AT/C chairs (Orion/System 2000) ...................................... 22
4.5.3 Seat the infant patient in the AT/C chairs ............................................................... 23
4.5.4 Electrode placement and impedance test for ENG evaluation............................... 23
4.5.5 Placing the goggles on the patient ......................................................................... 24
4.5.6 Eye image adjustment ............................................................................................ 24
4.6 Calibration ......................................................................................................................... 24
4.7 Testing the patient ............................................................................................................ 25
4.7.1 Performing tests...................................................................................................... 25
4.7.2 Video Frenzel.......................................................................................................... 25
4.7.3 Spontaneous nystagmus ........................................................................................ 26
4.7.4 Dix-Hallpike / Advanced Dix-Hallpike ..................................................................... 26
4.7.5 Positional ................................................................................................................ 26
4.7.6 Oculomotor tests..................................................................................................... 27
4.7.7 Active Head Rotation .............................................................................................. 27
4.7.8 Dynamic Visual Acuity ............................................................................................ 27
4.7.9 Video Head Impulse Testing (vHIT for VORTEQTM and EyeSeeCam) .................. 28
4.7.10 Ocular Counter Roll ................................................................................................ 28
4.7.11 Caloric test.............................................................................................................. 28
4.7.12 Rotary chair tests.................................................................................................... 29
4.8 Rotational chair error messages ....................................................................................... 30
4.8.1 Rotary chair speed error (applicable for Orion and System 2000 rotational
chairs) ..................................................................................................................... 30
4.8.2 Patient safety error (applicable for all type of rotational chairs) ............................. 30
4.8.3 Emergency stop error (applicable for Orion and System 2000 rotational
chairs) ..................................................................................................................... 30
4.8.4 Chair servo error state error (applicable for Orion and System 2000
rotational chairs) ..................................................................................................... 30
4.8.5 Rotary chair reclined position error (applicable for Orion/System 2000
reclining chair)......................................................................................................... 31
4.8.6 Booth door open error (applicable for Orion AT/C chair)........................................ 31
4.8.7 Patient safety switch error (applicable for Orion AT/C chair) ................................. 31
4.8.8 Chair control board error (applicable for Orion AT/C chair).................................... 31
4.8.9 Watchdog timeout error (applicable for Orion AT/C chair) ..................................... 31
4.9 Cameras disconnecting .................................................................................................... 32
4.10 System shutdown.............................................................................................................. 32
4.10.1 Turn off computer ................................................................................................... 32
4.10.2 Turn off stimulus ..................................................................................................... 32
4.10.3 Turn off accessories ............................................................................................... 32
4.10.4 Turn off power sources ........................................................................................... 32
5CARE AND MAINTENANCE ......................................................................................................34
5.1 How to clean the VisualEyes™ system ............................................................................ 34
5.2 Warranty and service ........................................................................................................ 34
5.2.1 Product warranty..................................................................................................... 34
5.2.2 Concerning product repair / service........................................................................ 35
6GENERAL TECHNICAL SPECIFICATIONS ..............................................................................36
6.1 Computer specifications.................................................................................................... 36
6.2 Standards.......................................................................................................................... 36
6.3 Operation and storage specifications ............................................................................... 36
6.4 Component specifications................................................................................................. 37
6.5 Electromagnetic compatibility (EMC) ................................................................................ 39

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1Introduction
1.1 About this manual
This manual is valid for the VisualEyes™ 515 and VisualEyes™ 525 software version 3.0. These products are
manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: http://www.interacoustics.com/
Definitions:
VisualEyes™ 515 and VisualEyes™ 525 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 user manual refers to this document as ‘Instructions for use’. The term ‘VORTEQTM
IMU’ refers to 2nd or latest generation of VORTEQTM IMU. The term ‘VORTEQTM rate sensor’ refers to 1st
generation of VORTEQTM head rotational rate sensor which works with VLink.
Instructions for Use/Additional information:
‘Instructions for use’ contain all the information required to operate this system in a safe and effective manner
but ’Additional information’ guide is also available to the interested reader. The operator can find these
Instructions for use and Additional information under the help menu in the software. The operator can also refer
to these manuals on the manufacture’s official website.
1.2 Intended use
Videonystagmography (VNG):
The Orion rotary chair is an optional accessory for VisualEyes 525/ VisualEyes 515 eye movement recording
systems.
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.

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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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Table 1.4-1 Product description of VisualEyes™System
Test Availability
Additional Accessory
Requirement
ENG*
Calibration
515 / 525
None
Yes
Spontaneous nystagmus
515 / 525 None
Yes
Dix Hallpike
515 / 525
Exam Table / Reclining Chair
Yes
Positional
515 / 525 Exam Table / Reclining Chair
Yes
Caloric
515 / 525
Exam Table / Reclining Chair,
Caloric Irrigator
Yes
Gaze
525 None
Yes
Smooth Pursuit
525
None
Yes
Random Saccade
525 None
Yes
Saccadometry
525
None
Yes
Optokinetic
525 None
Yes
Sinusoidal Harmonic
Acceleration
515 / 525
Reclining / Comprehensive / Auto
Traverse Chair
Yes
Step Velocity
515 / 525
Reclining / Comprehensive / Auto
Traverse Chair
Yes
VOR Suppression
515 / 525
Reclining / Comprehensive / Auto
Traverse Chair
Yes
Visual VOR
515 / 525
Reclining / Comprehensive / Auto
Traverse Chair
Yes
Subjective Visual Vertical
(SVV)- Static
525
Comprehensive / Auto Traverse
Chair
No
Subjective Visual Vertical
(SVV)- Dynamic
525 Auto Traverse Chair
No
Video Frenzel
525
None
No
Ocular Counter Roll
525 None
No
VORTEQ
TM
AHR
525
VORTEQTM IMU / VORTEQTM
rate sensor with VLink No
vHIT for VORTEQ
TM
525
Dynamic Visual Acuity
(DVA) 515 / 525
Dix Hallpike Advanced
515 / 525 VORTEQTM IMU No
Lateral Head Roll
515 / 525
vHIT for EyeSeeCam
-Lateral
-LARP
-RALP
-SHIMP
515 / 525 EyeSeeCam camera with goggle
and built-in IMU. No
Note: The Orion AT/C chairs will not support caloric, Dix Hallpike/Dix Hallpike Advanced,
Positional, DVA or VORTEQTM vHIT testing inside the booth. However, these tests can be
performed on an external examination table/chair with the provided extended goggle cables.
* If the user has the ENG option, the tests marked as ‘Yes’ under ENG can be performed using
electrodes.

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1.4.1 Minimum PC requirements
The user must ensure that the chosen PC is complying to minimum PC requirements to be compatible to the
VisualEyes™ system. Please refer to section 6.1 for the recommended computer specifications.
NOTICE: As a part of data protection, ensure to be compliant with the following points
1. Use Microsoft supported operating systems
2. Ensure operating systems are security patched
3. Enable database encryption
4. Use individual user accounts and passwords
5. Secure psychical and network access to computers with local data storage
6. Use updated antivirus and firewall and anti-malware software
7. Implement appropriate backup policy
8. Implement appropriate log retention policy
1.4.2 Included and optional parts
The VisualEyes™ system is delivered with the following major items based on the system configuration. Please
refer to Table 1.4-2 for details.

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Table 1.4-2 Detailed Description of Included and Optional components of VisualEyes™
USB camera systems
FireWire®camera
systems
Included parts*
VisualEyes™ 515/525 installation media
OtoAccess® Database media
Handheld RF remote control and/or foot pedal
Certificates and reports: e.g: VNG test result report, license certificate, certificate
of conformity and if applicable safety test report.
Optional parts
based on goggle
type*
2D-VOGfw goggle w. side mounted
cameras1
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
USBM2.1A goggle w. front mounted camera1
Adult mask for USB monocular camera
Camera module with 15’ USB cable
7-port USB 3.0 hub w. external power supply
USBM2.1P goggle w. front mounted camera1
Pediatric mask for USB monocular camera
Camera module with 15’ USB cable A to Mini B
7-port USB 3.0 hub w. external power supply
BG4.0KUSB goggle w. top mounted
cameras1
Goggles USB Asian faceplate binocular
Two 15’ USB cables A to Mini B
7-port USB 3.0 hub w. external power supply
BG4.0USB goggle w. top mounted cameras1
Goggles USB binocular
Two 15’ USB cables A to Mini B
7-port USB 3.0 hub w. external power supply
2D-VOGfw goggle w. side
mounted cameras
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
PCI ExpressCard (for tower PC
configuration)
4-port USB hub
Optional parts
based on the chair
type*
Orion Reclining Chair1
Orion Rotary Chair
USB cable
Emergency stop button with Ethernet connector
Power cord
Tools and accessories for assembly
Orion Comprehensive/Auto Traverse Chair1
Orion Rotary Chair
OKN Drum
X-Y Laser assembly
Off-axis stepper motor
USB cable
Emergency stop button with Ethernet connector
Power cord
1Applied part according to IEC 60601-1

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USB camera systems
FireWire®camera
systems
Booth and accessories
Booth observation camera
Intercom
Remote control for SVV line
Tools and accessories for assembly
Pediatric option
- Child seat1
- USBM2.1P goggle w. front mounted camera
- Pole mounted patient observation camera
ENG on Chair option
- Electrode skin prep pads1
- Set of 7 leadwires (40”)
- Disposable electrodes
1
Optional parts
based on ENG
test*
DataLink
Preamplifier
EOG patient cable
Lead wires 24’
Electrodes1
USB cable
Accessory kit (Alcohol prep pads and etc.)
Optional parts
based on vHIT
module
vHIT camera with goggle/EyeSeeCam camera1with goggle
Built-in IMU
USB cable
Optional parts
based on Caloric
Irrigators*
Caloric Irrigators (Air Fx / Aqua Stim)
Please refer to the respective product user manual for the irrigator system
Note: The VisualEyes™ system also supports old systems such as VLink for VORTEQTM rate
sensor, System 2000 (reclining chair/Auto Traverse/comprehensive) chair or Nydiag 200 rotary
chair
*- the system may include other minor accessories like Digital Light Bar (DLB), custom cables,
adapters, logo badges, cable wrap, cable tie and cleaning cloth for goggles etc., may be included
in the package according to the choice of product configurations.

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1.5 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.
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.

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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.
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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1.6 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 4.8
for details on the error messages. Other safety features are described below.
1.6.3 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 OKN 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.
1.6.4 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.
1.6.5 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 remains 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 OKN 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 OKN drum. Following, the operator shall exit
the test or go to home screen and restarting the test will reset the watchdog timer (refer to section 4.8.9 to know
more). If the fault repeats, the operator shall address the issue before proceeding with the test.
1.6.6 Nydiag 200 reclining chair
The patient-controlled stop button is located underneath the right armrest. Pressing the button during a test will
cause the chair to stop.

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2Unpacking and inspection
2.1 Unpacking and inspection
Check shipping containers and contents for damage
When the VisualEyes™ system is received, please check the shipping box for rough handling and damage.
Ensure that you have received all the components on the shipping checklist. All the components should be
checked visually for scratches and missing parts before use. All the contents of the shipment have to be
checked for their mechanical and electrical functioning. If the equipment is found faulty, please contact your local
distributor immediately. Keep the shipping materials for the carrier’s inspection and insurance claim.
Keep carton for future shipment
The 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.
Reporting and returning procedure
Any missing part or malfunction should be reported immediately to the supplier/local distributor along with the
invoice, serial number and a detailed report of the issue. For any on-site service-related information, please contact
your local distributor. If the system / components are to be returned for service, please fill all the details related to
product issues in the ‘Return Report’, which is attached to this manual. It is very important that you describe all
the known facts about the issue in the return report, as this will help the engineer to understand and solve the
problem to your satisfaction. Your local distributor holds the responsibility for coordinating any service/return
procedure and related formalities.
2.2 Marking
The following markings (Table 2.2-1) can be found on the equipment:
Table 2.2-1 Label markings and Explanations for VisualEyesTM
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 indicates that Interacoustics A/S meets the requirements of
Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service,
Identification No. 0123, has approved the quality system

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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
This product contains a component (Orion
Comprehensive/Auto Traverse chair) of ‘Class
2 Laser beam’. Hence, do not look directly
into the laser beam
Keep dry
Transport and storage temperature range
Transport and storage humidity limitations

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ETL listing mark
Logo

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3Setup and installation
3.1 Introduction to the VisualEyes™ software
The VisualEyes™ software combines cutting-edge technology with touch-screen capability in a streamlined
software interface. The VisualEyes™ software is considered as the gold standard for testing the vestibular
system and oculomotor function, a process known as vestibular assessment. It involves the use
of infrared goggles or electrodes to record and analyze eye movements during visual stimulation, positional
changes and caloric stimulation. The VisualEyes™ software can be configured with a rotary chair to test
patients’ vestibular-ocular reflex (VOR). This software can also be configured with VORTEQTM IMU to test VOR,
vHIT AHR and DVA.
3.2 Installation of the VisualEyes™ software
If the computer is purchased from Interacoustics, all the software / databases / drives (e.g: OtoAccess®
Database, VisualEyes™, rotational chair drivers) are preinstalled. If the customer wants to install VisualEyes™
software in any other computer or in the event of re-installation, the following procedure is to be followed for
successful installation.
Ensure that the chosen computer is compliant with all minimum PC requirements (refer to section 6.1) and that
OtoAccess® Database is installed prior to the installation of the VisualEyes™ software. Consult the OtoAccess®
Database instructions for use to install the software on computers bought outside Interacoustics. To install the
VisualEyes™ software, run the Micromedical VisualEyes™ Installer.exe file from the VisualEyes™ installation
media.
3.3 Installation of DAQ hardware driver for data acquisition components
NOTICE Ensure that the DAQ hardware software is installed for data acquisition from the hardware
components such as rotational chairs, DataLink and VLink. Refer to the installation procedures below. After
installation, the operator can refer to ’Addtional Information’ for the settings to register these hardware
components in the ’Remember to register these components’ in the VisualEyes™ system.
3.3.1 Installing DAQ hardware driver for Orion Chair/System 2000 chair/DataLink/VLink
Open Windows® Explorer. Navigate to the following location:
C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles and run the program icalsetup.exe.
Click on Setup to begin installing InstaCal.
Choose to install InstaCal to the default location of C:\Program Files (x86)\Measurement Computing\DAQ\.
When asked which program features should be installed, choose the default option to install the Universal
Library Examples.
During installation, Windows Security may request permission to install the device software from Measurement
Computing. Check the box to always trust software from ‘Measurement Computing’, then choose Install. The
computer will need to be rebooted after the InstaCal setup is complete.
After the computer has been restarted, launch the InstaCal software. Before launching the Instacal software,
ensure that the USB cable from the chair is connected to the system and the Rotational Chair is powered on.
Give few seconds for all hardware to go through auto-discovery after connecting USB cable. You can find the
software at the below-mentioned locations.
In Windows® 7 / 8.1, click on Start > All Programs > Measurement Computing > InstaCal.
In Windows® 10, click on Start > All apps > Measurement Computing > InstaCal.

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3.3.2 Installation of DAQ hardware driver for Nydiag 200 rotary chair
Ensure that the CAN motor control cable from the Nydiag 200 chair is connected to the computer’s USB port.
Open Windows® Explorer. Navigate to the following location:
C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles and run the program
kvaser_drivers_setup.exe.
When asked which components should be installed, choose the default selections for installing the Drivers
(32/64-bit x86), Start Menu Shortcuts, and GUI tools.
When asked for the destination folder for installing the drivers, choose the default location of C:\Program
Files\Kvaser\Drivers.
During installation, Windows Security may request permission to install the device software from Kvaser AB.
Check the box to always trust software from ‘Kvaser AB’, then choose Install.
3.4 Hardware components
The VisualEyes™ system is composed of several hardware components to build the complete equipment setup.
Its software is designed to be compatible with both Interacoustics A/S and Micromedical Technologies Inc.
equipment.
3.4.1 Laptop/desktop PC
The customer can choose between a laptop or desktop PC from Interacoustics, which comes with pre-installed
software (Figure 3.4-1). Laptop systems are configured with an externally powered USB hub to connect
additional devices. Desktop PCs may be configured with a combination monitor stand to reduce desk space. The
software also supports any other system of customer choice if the system is compliant with all pre-requirements
to install the software.
Figure 3.4-1 Laptop/Desktop PC
3.4.2 Television/projector display/Digital Light Bar
The VisualEyes™ system can be configured with either a TV or a Projector or a DLB (Figure 3.4-2). The TV may
be mounted on the wall or placed on a table with the TV feet. Windows Desktop can be extended across both
displays. Digital Light Bar can be set up with desired height level by adjusting the tripod. Whenever the
TV/projector/DLB is changed, the operator should calibrate the stimulus before taking the system for routine use.
This helps the software to calculate the new hardware delay based on the patient’s gain delay and
accommodates for televisions and projectors. Refer to Section 8.2.4 of ‘Additional information’ for more detail
on calibration.