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.