Interacoustics VisualEyes 505 User manual

Instructions for Use - US
VisualEyes™
505
Micromedical
by Interacoustics
D-0126472-A – 2020/08
Science made smarter

Copyright © Interacoustics A/S All rights reserved. Information in this document is proprietary to
Interacoustics A/S. 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 A/S.
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
About this manual ............................................................................................................... 1
Intended use ....................................................................................................................... 1
Contraindications ................................................................................................................ 1
Product description ............................................................................................................. 1
1.4.1 Minimum PC requirements ....................................................................................... 1
1.4.2 Included and optional parts ...................................................................................... 2
Warnings and precautions .................................................................................................. 4
Complaints handling ........................................................................................................... 6
2UNPACKING AND INSPECTION .................................................................................................8
Unpacking and inspection................................................................................................... 8
Marking ............................................................................................................................... 8
3SETUP AND INSTALLATION ....................................................................................................10
Introduction to the VisualEyes™ 505 software suite ........................................................ 10
Installation of OtoAccess® Database and VisualEyes™ 505 software............................ 10
3.2.1 OtoAccess® Database installation ......................................................................... 10
3.2.2 VisualEyes™ 505 software installation................................................................... 10
Hardware setup................................................................................................................. 11
3.3.1 Laptop / PC............................................................................................................. 11
3.3.2 Side mount camera goggles................................................................................... 11
3.3.3 Top mount camera goggles.................................................................................... 12
3.3.4 Front mount camera goggles.................................................................................. 12
3.3.5 EyeSeeCam camera............................................................................................... 12
3.3.6 VORTEQ™ IMU ..................................................................................................... 13
3.3.7 Foot Pedal .............................................................................................................. 14
3.3.8 VisualEyes™ remote control .................................................................................. 14
3.3.9 External room camera ............................................................................................ 15
System configurations....................................................................................................... 16
4OPERATING INSTRUCTIONS ...................................................................................................18
System Startup.................................................................................................................. 18
4.1.1 Turn on the power sources and accessories.......................................................... 18
Entering patient information .............................................................................................. 18
VisualEyes™505 Home screen ........................................................................................ 18
4.4 Room recording................................................................................................................. 18
4.5 Patient preparation............................................................................................................ 19
4.6 Testing the Patient ............................................................................................................ 19
4.6.1 Performing tests...................................................................................................... 19
4.6.2 Video Frenzel.......................................................................................................... 20
4.6.3 Spontaneous Nystagmus........................................................................................ 20
4.6.4 Dix-Hallpike / Advanced Dix-Hallpike (optional) ..................................................... 20
4.6.5 Dynamic Visual Acuity (optional) ............................................................................ 20
4.6.6 vHIT for EyeSeeCam (optional).............................................................................. 20
4.6.7 Additional functions................................................................................................. 20
4.7 Session Review and Write Report .................................................................................... 21
5CARE AND MAINTENANCE ......................................................................................................22
How to clean the VisualEyes™ system ............................................................................ 22
Warranty and Service ....................................................................................................... 22
5.2.1 Product warranty..................................................................................................... 22
5.2.2 Concerning product repair / service........................................................................ 23

6GENERAL TECHNICAL SPECIFICATIONS..............................................................................24
PC Hardware and Software .............................................................................................. 24
Standards.......................................................................................................................... 24
Operation and storage specifications ............................................................................... 24
Component specifications................................................................................................. 25
Electromagnetic compatibility (EMC)................................................................................ 27

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1Introduction
About this manual
This manual is valid for VisualEyes™ 505 software version 3.0. This product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
Definitions:
Wherever ‘operator’ is mentioned in this document, this refers to a clinician, technician or qualified personnel
who operates the system. The user manual refers to this document as ‘Instructions for use’.
Instructions for Use/Additional information:
‘Instructions for use’ contains all the information required to operate this system in a safe and effective
manner. ’Additional information’ is also available to the interested reader. The operator can find these
documents under the help menu in the software. The operator can also refer to these manuals on the
manufacture’s official website.
Intended use
VisualEyes™ 505 is a Video Frenzel system that provides information to assist in the evaluation, diagnosis and
documentation of vestibular disorders. This system evaluates nystagmus using a goggle mounted with cameras.
These images are 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 patient population for VisualEyes™ 505 is
five years of age and above.
VisualEyes™ 505 is to be used by trained personnel only, such as audiologists, physical therapists, ENT
surgeons, doctors, hearing healthcare professionals or personnel with a similar level of qualifications. The device
should not be used without the necessary knowledge and training to understand its use and how results should
be interpreted.
Contraindications
VisualEyes™ 505 testing may be contrainidicated in patients who exhibit the following: blindness, broken nose
or other face/head trauma, recent eye surgery and ptosis.
Product description
VisualEyes™ 505 is a piece of software that can be configured with a goggle with one or two cameras, which
are connected to a computer to perform the testing. Standard and optional tests are described below (Table
1.4-1).

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VisualEyes™ 505 is licensed, requiring a specific license key to be put into the software upon its initial launch to
make the test battery available. The VisualEyes™ licenses are not time limited, and the same license can be
installed on more than one computer, allowing one to move the cameras between two or more workstations.
Refer to ‘Additional information’ to learn more about licensing.
Table 1.4-1 Product description of VisualEyesTM 505
Test Availability Additional Accessory Requirement
Video Frenzel (Dix Hallpike,
HeadShake)
505 (Standard) None
Spontaneous nystagmus
505 (standard) None
Dynamic Visual Acuity (DVA) 505 (Optional)
VORTEQTM IMU / VORTEQTM VLink (Head
rotation rate sensor)
Dix Hallpike Advanced 505 (Optional) VORTEQ IMU
vHIT for EyeSeeCam
-Lateral
-LARP
-RALP
-SHIMP
505 (Optional) EyeSeeCam camera with goggle and built-in
IMU.
1.4.1 Minimum PC requirements
The operator has to ensure that the chosen PC complies with the minimum PC requirements to be able to run
VisualEyes™ 505. 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

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1.4.2 Included and optional parts
VisualEyes™ 505 is delivered with the following items based on the system configuration. Please refer to Table
1.4-2 for details.
Table 1.4-2 Detailed Description of Included and Optional components of VisualEyesTM 505
USB camera systems
FireWire® camera systems
Included
parts
VisualEyes™ 505 installation media
OtoAccess™ Database media
Remote Control or Foot pedal
Web camera
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
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
PCI ExpressCard (for tower PC
configuration)
4-port USB hub
Optional
parts based
on
EyeSeeCam
EyeSeeCam camera with goggle1
Built-in IMU
USB cable
1Applied part according to IEC 60601-1

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USB camera systems
FireWire® camera systems
Optional
parts based
on
VORTEQ
TM
BPPV module and/or VORTEQTM IMU / VORTEQTM VLink (Head rotation rate sensor)
Note:
*- the system may include other minor accessories like 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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Warnings and precautions
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.
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
must comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-
series for medical electrical equipment. In addition, all such combinations – Medical Electrical Systems –
must 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 must be
kept outside the patient environment i.e. at least 1.5m from the patient support or must be supplied via a
separation transformer to reduce the leakage currents. Any person who connects external equipment to
signal input, signal output or other connectors has formed a Medical Electrical System and is therefore
responsible for the system to comply with these requirements. If in doubt, contact a qualified medical
technician or your local representative. When the instrument is connected to a PC, or other similar items,
beware of not touching the PC and patient simultaneously.
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 requirement for the Separation Device is
defined in IEC 60601-1, edition 3, clause 16.
5. The system must not be used in 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. The manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair those parts of this
system that are designated by the manufacturer as repairable by authorized service personnel.

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9. For maximum electrical safety, turn off the power from a mains powered instrument when it is left
unused.
10. The instrument is not protected against harmful ingress of water or other liquids. If any spillage occurs
check the instrument carefully before use or return for service.
11. Do not use the equipment before service, if it shows a visible or suspected damage.
12. 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 minor or moderate injury.
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 verify system functionality.
4. Handle the device components carefully to avoid system damage.
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. Do not use the equipment
if the equipment is broken. Have the equipment serviced.
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 instrument 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.
5. Clean the camera lens and the infrared coated mirrors of the goggle regularly to avoid shadows on the
displayed images.
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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Complaints handling
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.

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2Unpacking and inspection
Unpacking and inspection
Check shipping containers and contents for damage
When you receive VisualEyes™ 505, 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.
Marking
The following markings (Table 2.2-1) can be found on the instrument:
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
Keep dry
Transport and storage temperature range
Transport and storage humidity limitations
ETL listing mark
Logo

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3Setup and installation
Introduction to the VisualEyes™ 505 software suite
VisualEyes™ 505 combines cutting-edge technology with touch-screen capability in a streamlined software
interface. VisualEyes™ 505 provides information to assist in the evaluation, diagnosis and
documentation of vestibular disorders. Eye movements are recorded by use of a goggle mounted with one or
two infrared video cameras. The eye images are displayed in real time in high resolution on a computer monitor.
External environments (room) are recorded by use of an integrated / external USB camera if desired. Patient
interviews are recorded separately for recording medical histories. This information can then be used by a
trained medical professional to assess vestibular disorders.
Installation of OtoAccess® Database and VisualEyes™ 505 software
If the computer is purchased from Interacoustics, all the software / databases / drives (e.g: OtoAccess®
Database, VisualEyes™ 505) are pre-installed. If the operator wants to install these in any other computer or in
the event of re-installation, the following procedures are to be followed for successful installation.
3.2.1 OtoAccess® Database installation
The VisualEyes™ 505 software is accesssed through OtoAccess® Database. OtoAccess® Database is used to
store patient information and data recordings.
If the operator wants to install OtoAccess® Database in any computer (not of interacoustics) or in the event of
re-installation, please read the instructions for use that are included with the OtoAccess® Database installation
media (CD or flash drive) or contact your distributor.
3.2.2 VisualEyes™ 505 software installation
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.
NOTICE OtoAccess® Database must be installed prior to installing VisualEyes™ 505.
Ensure that the chosen computer is compliant with all minimum PC requirements (refer to section 6.1). To install
the VisualEyes™ software, run the Micromedical VisualEyes™ Installer.exe file from the VisualEyes™
installation media.
NOTICE:As a part of data protection, ensure to be compliant to all 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

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Hardware setup
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.
3.3.1 Laptop / PC
The operator can choose between a laptop or desktop PC from Interacoustics, which comes with pre-installed
software (Figure 3.3-1). 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 operator choice if the system is compliant with all pre-requirements
to install the software.
Figure 3.3-1 Laptop/Desktop PC
3.3.2 Side mount camera goggles
The VisualEyes™ side mounted goggles (Figure 3.3-2) allow the recording of eye movements during various
test conditions, both with and without visual stimulation. The VisualEyes™ side mounted goggles use either
FireWire® or USB cameras to record eye images. The cameras use infrared light (IR), which is not visible to the
naked eye.
Figure 3.3-2 The FireWire® or USB cameras are fixed on the sides of the goggles (Left). Side mounted camera
goggles with replaceable foam pads (Right)
The side mounted goggles come with replaceable foam pads that are meant for single use as reuse
of foam pads can cause cross contamination. This should be changed after every single use by
pulling the used foam pad off of the hook and loop pads on the inside of the mask and then aligning a
new foam pad on top of the hook and loop.

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The front cover plate of the side mounted goggle is magnetically fixed and can easily be removed for visual
stimulation tests (i.e. oculomotor). The mask has an adjustable Velcro head strap that comfortably secures the
goggles to the patient. The side mounted camera goggles can be configured with one camera and cover for
monocular systems. In this configuration, the user would physically move the camera to the side of the goggles
to record the desired eye, and the cover would be placed on the other side to block out light in vision-denied
tests.
3.3.3 Top mount camera goggles
The top mount camera goggles (Figure 3.3-3) block out ambient light with the removable cover over the portal
for vision-denied testing. Side-lights on the goggle provide guidance/ illumination when placing the cover on the
goggles. On the left side of the goggles is a switch to start and stop tests. The goggles have an adjustable
Velcro head-strap that secures the goggles while still providing patient comfort.
Figure 3.3-3 Top mounted camera goggles
3.3.4 Front mount camera goggles
The front mount camera goggles (Figure 3.3-4) use a single USB camera pressed into the camera portal on the
front of the goggles mask. The camera can be pressed into either camera portal to record the desired eye. The
USB cable is secured in the cable clip above the portal. Each portal has a swivel cover plate to provide vision-
denied testing. The goggles have an adjustable head-strap that secures the goggles while still providing patient
comfort.
Figure 3.3-4 Front mount camera goggles
3.3.5 EyeSeeCam camera
The EyeSeeCam camera (Figure 3.3-5) acquires the eye position and head position data during video head
impulse tests (vHIT). Along with vHIT, VisualEyes™ can now use the EyeSeeCam goggle for standard VNG
tests where applicable. The camera can be mounted over either eye and a laser stimulus projects from the
goggles in the vHIT test if selected.

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Figure 3.3-5 EyeSeeCam camera and goggle with built-in IMU.
3.3.6 VORTEQ™ IMU
The VORTEQ™ IMU sensor (Figure 3.3-6) connects to the laptop or mid-tower computer either by USB cable or
wirelessly through Bluetooth with the accompanying Bluetooth receiver dongle. The VORTEQ™ IMU measures
head position in space, allowing the VisualEyes™ software to determine where the patient’s head is in space,
and is used in active VOR testing, dynamic visual acuity, head roll testing, advanced Dix-Hallpike and advanced
positional testing. This can be used with or without goggles depends on the test (Figure 3.3-7).
Figure 3.3-6 VORTEQ™ IMU
The inertial measurement unit (IMU) slides into the sensor mount on the top mounted or side mounted goggles.
The USB cable from the IMU should be routed along the left side of the goggles if not used wirelessly. Visual
acuity tests have the IMU placed on the DVA headband and route the USB cable along the right side of the
headband. Patients should wear eyeglasses or contact lenses for best visual acuity with the DVA headband.
To turn on the VORTEQ™ IMU, slide the power switch on top of the unit to the right. The On light will then flash
every four seconds. The Charging light will be lit when connected to USB. If using the IMU in Bluetooth mode,
the BLE Connected light will blink every four seconds when the computer has successfully connected to the
device.
Figure 3.3-7 IMU with Goggles / only with head band

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3.3.7 Foot Pedal
The foot pedal (Figure 3.3-8) allows you to begin the measurement testing by pressing the foot switch so you
have both hands free to look after the patient (e.g. Dix Hallpike). Connection with the PC is via a USB port.
Figure 3.3-8 VisualEyes™ Foot pedal
3.3.8 VisualEyes™ remote control
The remote control (Figure 3.3-9) provides a hand held option for controlling and performing tests within the
VisualEyes™ suite. The operator can operate the software using the remote control while remaining at the
patient’s side during testing. The remote control’s receiver connects to the PC via a USB port, while the remote
control connects to the receiver using 2.4 GHz rf transmission.
1. Top button:
•Centers eyes (top mount goggles only)
2. Right button:
Typically, this can perform any command in VisualEyes which is selected (indicated with white background).
Please find the below example for better explanation:
Before calibration, one can command to select ‘Calibration’ option which is shown
in white background.
After calibration, one can command to select ‘START’ option which is shown in
white background.
This way, the operator can perform below listed actions.
•Goes forward in the software
•Launches calibration
•Following calibration, button will start the test
•If the test is running, it stops the test
•If in playback mode, the button will advance to the next test in the
list
3. Left button:
•Stops the test
4. Bottom button:
•Turns on/off the fixation light during a test
Figure 3.3-9 VisualEyes™ Remote Control

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3.3.9 External room camera
The room camera (Figure 3.3-10) is an external device connected to the computer’s
USB port. It serves to record the external environment and patient testing process
from the beginning. The external room camera provides additional flexibility in
recording the testing procedure, though the laptop’s integrated observation camera
can be used with orienting the computer towards the patient.
Figure 3.3-10 USB room camera