Micromedical VisualEyes 505 Instructions Manual

Instructions for Use - US

Micromedical

VisualEyesTM 505

by Interacoustics

D-0115288 – C – 2018/02

Copyright © by Interacoustics. All rights reserved. Information in this document is subject to change
without notice. Companies, names, and data used in example herein are fictitious unless otherwise
noted. No part of this document may be reproduced or transmitted in any form or by any means,
electronic or mechanical, for any purpose, without express written permission of Interacoustics A/S or
its licensees.

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

1 INTRODUCTION ........................................................................................................................... 1

About this manual ............................................................................................................... 1

Intended use ....................................................................................................................... 1

Product description ............................................................................................................. 1

1.3.1 System configurations .............................................................................................. 1

1.3.2 Minimum requirements to PC ................................................................................... 2

1.3.3 ncluded and optional parts ....................................................................................... 2

Warnings and precautions .................................................................................................. 4

2 UNPACKING AND INSPECTION ................................................................................................. 7

Unpacking and inspection ................................................................................................... 7

Reporting imperfections ...................................................................................................... 7

Marking ............................................................................................................................... 8

3 SETUP AND INSTALLATION ...................................................................................................... 9

Introduction to VisualEyes™ VF 505 software suite ........................................................... 9

Installation of OtoAccess™ database ................................................................................. 9

Installation of VisualEyes™ 505 software ........................................................................... 9

Uninstall software ................................................................................................................ 9

Hardware setup ................................................................................................................. 10

3.5.1 Laptop / PC ............................................................................................................. 10

3.5.2 The VisualEyes™ 505 video fenzel goggles .......................................................... 10

3.5.3 Side mount camera goggles ................................................................................... 10

3.5.4 Top mount camera goggles .................................................................................... 11

3.5.5 Front mount camera goggles .................................................................................. 11

3.5.6 Foot Pedal .............................................................................................................. 11

3.5.7 VisualEyes™ remote control .................................................................................. 12

3.5.8 External room camera ............................................................................................ 12

Connection layout ............................................................................................................. 13

4 PATIENT ENTRY ........................................................................................................................15

Entering patient information .............................................................................................. 15

Licensing ........................................................................................................................... 16

Micromedical VisualEyes™ main screen .......................................................................... 17

4.4 Room recording................................................................................................................. 17

4.5 Patient preparation ............................................................................................................ 17

4.6 Testing the Patient ............................................................................................................ 18

4.6.1 Starting the test ....................................................................................................... 18

4.6.2 Pausing the test ...................................................................................................... 18

4.6.3 Ending the test ........................................................................................................ 18

4.6.4 Additional Functions ............................................................................................... 18

4.7 Session Review and Write Report .................................................................................... 18

4.8 Additional information ....................................................................................................... 18

5 CARE AND MAINTENANCE ......................................................................................................19

General maintenance procedures..................................................................................... 19

How to clean the VisualEyes™ system ............................................................................ 19

Warranty and Service ....................................................................................................... 20

5.3.1 PRODUCT LIFE ..................................................................................................... 20

5.3.2 PRODUCT SERVICE ............................................................................................. 20

5.3.3 PRODUCTS RETURNED FOR REPAIR ............................................................... 21

5.3.4 WARRANTY DETERMINATION ............................................................................ 21

5.3.5 EXTENDED WARRANTY....................................................................................... 21

5.3.6 SERVICE CONTRACT ........................................................................................... 21

5.3.7 NON-WARRANTY FACTORY REPAIRS ............................................................... 21

6 GENERAL TECHNICAL SPECIFICATIONS ..............................................................................23

PC Hardware and Software .............................................................................................. 23

Operation and storage specifications ............................................................................... 23

Standards .......................................................................................................................... 23

Component specifications ................................................................................................. 23

Electromagnetic compatibility (EMC) ................................................................................ 25

6.5.1 Electromagnetic compatibility (EMC) for top-mounted goggles ............................. 25

6.5.2 Electromagnetic compatibility (EMC) for side mounted goggles ............................ 27

VisualEyes™ 505 Instructions for Use – US Page 1

1 Introduction

About this manual

This manual is valid for the VisualEyes™ 505 Software version 2.1. 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

Distribution and service:

Micromedical Technologies Inc.

10 Kemp Drive
Chatham, IL 62629
USA
Tel.: [phone]
Web: www.micromedical.com

Intended use

The VisualEyes™ 505 is a Video Frenzel system which provides information to assist in the evaluation,

diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of a goggle
mounted with cameras. These images are displayed and stored in the software.
This information then can be used by a trained medical professional to assist in diagnosing vestibular
disorders. The target population for VisualEyes™ 505 is 5 years of age+.

The 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.

Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed
medical practitioner

NOTICE

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 consists of a goggle with one or two camers that are connected to a computer and
dedicated software. Additional parts may also be included as specified in section 1.3.3.

1.3.1 System configurations

The VisualEyes™ 505 is available in 2 different configurations:

1. VisualEyes™ 505 monocular: One camera, eye images are displayed and stored for later replay.
Option for external situation recording.

2. VisualEyes™ 505 binocular: Two cameras, eye images are displayed and stored for later replay.
Option for external situation recording.

VisualEyes™ 505 Instructions for Use – US Page 2

1.3.2 Minimum requirements to PC

Laptop PC: One 34 mm PCExpressCard slot available (for side mount FireWire® camera goggles only).
Desktop PC: One PCIExpress card available. (for side mount FireWire® camera goggles only).
Intel i5 processor 2.5 GHz or better.
Minimum 4 GB RAM or more.
Hard drive with min. 250GB space.
Minimum display of 1366X768 (Higher resolution recommended).

Operating Systems supported:

Windows®7 32-bit or 64-bit.
Windows® 8.1 64-bit.
Windows® 10 64-bit.

1.3.3 Included and optional parts

As standard, VisualEyes™ 505 system is delivered with the following:

USB camera systems

FireWire® camera systems

Included parts

Remote Control or Foot pedal
Instructions for Use

VisualEyes™ 505 installation media
OtoAccess™ Database media
VisualEyes™ 505 Quick Start Guide

Optional parts
based on goggle
type

2D-VOGfw goggle w. side
mounted cameras

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 camera

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 camera

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

2D-VOGfw goggle w. side mounted
cameras

FireWire® camera module (two modules
in binocular configuration)
Disposable goggle foam pads – Box of
24 pcs
PCExpressCard Stabilization kit (laptop
configuration)
PCExpressCard (for laptop
configuration)
PCI ExpressCard (for tower PC
configuration)
4-port USB hub

VisualEyes™ 505 Instructions for Use – US Page 3

BG4.0KUSB goggle w. top
mounted cameras

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
cameras

Goggles USB binocular
Two 15’ USB cables A to Mini B
7-port USB 3.0 hub w. external
power supply

Table 1. VisualEyes™ 505 included and optional parts

VisualEyes™ 505 Instructions for Use – US Page 4

Warnings and precautions

WARNING indicates a hazardous situation which, if not avoided, could result

in death or serious injury.

CAUTION, used with the safety alert symbol, indicates a hazardous situation
which, if not avoided, could result in minor or moderate injury.

NOTICE

NOTICE is used to address practices not related to personal injury.

1. 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.

2. The system must not be used in presence of explosive or flammable gases.

3. The goggle should not be worn by patients with strong defective vision and abnormal rare blink.
Please consult a specialist in such circumstances before using the mask on these types of patients.

4. The system must be switched off before cleaning.

5. Do not use any additional multiple socket-outlet or extension cord.

6. No modification of this equipment is allowed without Interacoustics authorization.

7. 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.

8. For maximum electrical safety, turn off the power from a mains powered instrument when it is left
unused.

9. 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.

10. Do not use the equipment if it is showing visible damage.

1. Use this device only as described in this manual.

2. The system must be serviced at least once a year. The service must verify system functionality.

3. Do not use the equipment if the equipment is broken. Have the equipment serviced.

4. Only personnel with proper training (skilled personnel) should operate the system.

5. Proper use of this device depends on careful reading of this manual and all additional instructions
and labels.

6. Let the system obtain room temperature before turning it on. Extra time for obtaining room.
temperature may be needed to avoid condensation if the system has been moved from a very cold
location to a warmer one.

7. The patients or test persons should not wear any optical utilities such as glasses or contact lenses.

8. The patients or test persons should not wear make up around the eyes.

VisualEyes™ 505 Instructions for Use – US Page 5

9. It is recommended that parts which are in direct contact with the patient (e.g. disposable goggle
foam pads) should only be used with one patient, and should therefore be discarded after each
session.

10. Be sure to use only stimulation movements that are acceptable to the patient.

NOTICE

1. To prevent system faults take appropriate precautions to avoid PC viruses and similar.

2. Clean the camera lens and the infrared coated mirrors of the goggle regularly to avoid shadows on
the displayed images.

3. Do not drop and avoid other undue impacts to this device. If the instrument is dropped or otherwise
damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if any
damage is suspected.

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.

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 therefore has to be collected separately. Such products will be marked
with the crossed-out wheeled bin shown below. The cooperation of the user is
important in order 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.

VisualEyes™ 505 Instructions for Use – US Page 6

VisualEyes™ 505 Instructions for Use - US Page 7

2 Unpacking and inspection

Unpacking and inspection

Check box and contents for damage

When the instrument is received, please check the shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty, please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.

Keep carton for future shipment

VisualEyes™ 505 comes in its own shipping carton, which is specially designed. Please keep this carton. It
will be needed if the instrument has to be returned for service. If service is required, please contact your
local distributor.

Reporting imperfections

Inspect before connection

Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and missing parts.

Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument together with
the invoice, serial number, and a detailed report of the problem. In the back of this manual, you will find a
‘Return Report’ where you can describe the problem.

Products returned for repair
If the manufacturer requests that you return the product for evaluation or repair, pack the product well,
preferably in the original shipping container with a Return Material Authorization (RMA) number provided by
the manufacturer. Systems with optional rotational chairs will be serviced on-site by the local distributor.