Interacoustics VisualEyes 515 Instructions For Use Manual

Brand: Interacoustics

Model: VisualEyes 515

Type: Instructions For Use Manual

Instructions for Use - US

Micromedical

VisualEyes™ 515

VisualEyes™ 525

by Interacoustics

D-0107857-B - 2018/02

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, Micromedical Technologies 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

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

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

1.3 Contraindications ................................................................................................................ 1

1.4 Product description ............................................................................................................. 2

1.4.1 Minimum requirements to PC ................................................................................... 2

1.4.2 Included and optional parts ...................................................................................... 3

1.5 Warnings and precautions .................................................................................................. 5

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

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

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

2.3 Marking ............................................................................................................................... 8

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

3.1 Introduction to VisualEyes™ software ................................................................................ 9

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

3.3 Installation of VisualEyes™ software .................................................................................. 9

3.4 Installation of rotary chair drivers ........................................................................................ 9

3.4.1 Installing drivers for NyDiag 200 rotary chair............................................................ 9

3.4.2 Installing drivers for System 2000 reclining chair ................................................... 10

3.4.1 Installing drivers for the Orion rotary chair.............................................................. 11

3.5 Uninstall software .............................................................................................................. 13

3.6 Hardware setup ................................................................................................................. 13

3.6.1 Laptop/desktop PC ................................................................................................. 13

3.6.2 Television/projector display .................................................................................... 13

3.6.3 Side mount camera goggles ................................................................................... 14

3.6.4 Top mount camera goggles ................................................................................... 15

3.6.5 Front mount camera goggles .................................................................................. 15

3.6.6 Reclining rotary chair (optional) .............................................................................. 16

3.6.7 The foot pedal (optional) ......................................................................................... 16

3.6.8 VisualEyes™ remote control (optional) .................................................................. 17

3.6.9 External room camera ............................................................................................ 17

3.7 Connection layout ............................................................................................................. 18

3.7.1 VisualEyes™ setup with mid-tower computer using top mount or side mount (USB

or FireWire®) cameras ............................................................................................ 18

3.7.2 VisualEyes™ setup with laptop computer using top mount or side mount (USB)

cameras .................................................................................................................. 18

3.7.3 Reclining rotary chair setup .................................................................................... 19

3.7.4 VisualEyes™ setup precautions ............................................................................. 20

4 OPERATING INSTRUCTIONS ...................................................................................................21

4.1 System startup .................................................................................................................. 21

4.2 Initializing the reclining rotary chair ................................................................................... 21

4.3 Entering patient information .............................................................................................. 21

4.4 Starting the VisualEyes™ software................................................................................... 22

4.5 Room recording................................................................................................................. 22

4.6 Patient preparation ............................................................................................................ 22

4.6.1 Seat the Patient in the Chair ................................................................................... 22

4.6.2 Placing the goggles on the patient ......................................................................... 23

4.6.3 Eye image adjustment ............................................................................................ 23

4.7 Calibration ......................................................................................................................... 24

4.8 Testing the patient ............................................................................................................ 25

4.8.1 Performing tests ...................................................................................................... 25

4.8.2 Spontaneous nystagmus ........................................................................................ 25

4.8.3 Dix-Hallpike ............................................................................................................. 25

4.8.4 Positional ................................................................................................................ 26

4.8.5 Oculomotor tests ..................................................................................................... 26

4.8.6 Caloric test .............................................................................................................. 26

4.8.7 Rotary chair tests .................................................................................................... 27

4.9 Rotary chair error messages ............................................................................................. 29

4.9.1 Rotary chair speed error ......................................................................................... 29

4.9.2 Patient safety error ................................................................................................. 29

4.9.3 Emergency stop error ............................................................................................. 29

4.9.4 Chair servo error state error ................................................................................... 29

4.9.5 Reclined chair error ................................................................................................ 30

4.10 Additional information ....................................................................................................... 30

5 CARE AND MAINTENANCE ......................................................................................................31

5.1 General maintenance procedures..................................................................................... 31

5.2 How to clean the VisualEyes™ system ............................................................................ 31

5.3 Warranty and Service ....................................................................................................... 32

5.3.1 Product Life ............................................................................................................. 32

5.3.2 Product Service ...................................................................................................... 32

5.3.3 Products returned for Repair .................................................................................. 33

5.3.4 Warranty Determination .......................................................................................... 33

5.3.5 Extended Warranty ................................................................................................. 33

5.3.6 Service Contract ..................................................................................................... 33

6 GENERAL TECHNICAL SPECIFICATIONS ..............................................................................35

6.1 Computer specifications .................................................................................................... 35

6.2 Standards .......................................................................................................................... 35

6.3 Operation and storage specifications ............................................................................... 35

6.4 Component specifications ................................................................................................. 35

6.5 Electromagnetic compatibility (EMC) ................................................................................ 37

6.5.1 Electromagnetic compatibility (EMC) for goggles with top-mounted

cameras .................................................................................................................. 37

6.5.2 Electromagnetic compatibility (EMC) for goggles with side-mounted

cameras .................................................................................................................. 39

VisualEyes™ 515/525 Instructions for Use – US Page 1

1 Introduction

1.1 About this manual

This manual is valid for the VisualEyes™ 515 and VisualEyes™ 525 Software version 2.1. These products

are manufactured by:

Interacoustics A/S

Audiometer Allé 1

5500 Middelfart

Denmark

Tel.: +45 6371 3555

Fax: +45 6371 3522

E-mail: info@interacoustics.com

Web: www.interacoustics.com

Distribution and service: Micromedical Technologies Inc.

10 Kemp Drive

Chatham, IL 62629

USA

Tel.: 1 (800) 334-4154

Web: www.micromedical.com

1.2 Intended use

The VisualEyes™ 515 and VisualEyes™ 525 system provides information to assist in the nystagmographic

evaluation, diagnosis and documentation of vestibular disorders. Nystagmus of the eye is recorded by use of

goggles mounted with cameras. These images are measured, recorded, 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™ 515 and VisualEyes™ 525 system is 5 years of

age+.

The VisualEyes™ 515 and VisualEyes™ 525 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

qualifications. The device should not be used without the necessary knowledge and training to understand its

use and how results should be interpreted.

VisualEyes™ 515 and VisualEyes™ 525 will be here forth referred to as ‘VisualEyes™ system’ throughout

the instructions for use document.

1.3 Contraindications

VisualEyes™ testing may be contraindicated in patients who exhibit the following: blindness, broken nose or

other face/head trauma, recent eye surgery, lazy eye, and ptosis.

More intensive rotary chair tests may be contraindicated in patients less than 5 years of age or greater than

110 years of age.

VisualEyes™ 515/525 Instructions for Use – US Page 2

1.4 Product description

The VisualEyes™ system is a sophisticated, videonystagmography (VNG) analysis software platform that is

available in two different versions: VisualEyes™ 515 and VisualEyes™ 525. Both systems consist of a

laptop/desktop PC, goggles (top mounted/ side mounted/ front mounted cameras) and other parts as

specified in section 1.4.2.

The products vary in their testing capabilities. Tests included in VisualEyes™ 515 are Spontaneous

Nystagmus, Dix-Hallpike, Positional and Calorics. VisualEyes™ 525 includes these tests with the addition of

the oculomotor tests (Gaze, Smooth Pursuit, Saccade and Optokinetic) and the Video Frenzel test for patient

screening and rehabilitation studies. VisualEyes™ can also be used with the rotary chairs, which includes

the tests above, with the addition of Sinusoidal Harmonic Acceleration, Step Test, VOR Suppression, Visual

VOR and Video Frenzel.

Tests

VisualEyes™

515

VisualEyes™

515 with

reclining chair

VisualEyes™

525

VisualEyes™

525

with reclining

chair

Calibration

Yes

Spontaneous

nystagmus

Yes

Gaze

Yes

Smooth Pursuit

Yes

Random Saccade

Yes

Optokinetic

Yes

Dix Hallpike

Yes

Positional

Yes

Bithermal Caloric

Yes

Sinusoidal

Harmonic

Acceleration

Yes

Step Test

Yes

VOR Suppression

Yes

Visual VOR

Yes

Video Frenzel

Yes

1.4.1 Minimum requirements to PC

Laptop PC: One 34mm PCExpressCard slot available (FireWire® systems only).

Desktop PC: One PCI Express card available (FireWire® systems only).

USB port required (expanded by USB hub)

Intel i5 processor 2.5 GHz or better, and not older than 2nd generation

Minimum 8 GB RAM or more.

Hard drive with min. 250GB space.

Minimum display of 1366X768 (Higher resolution recommended).

Touch monitor or laptop with touch screen is highly recommended though not required.

Operating Systems supported:

Windows® 7 32-bit and 64-bit.

Windows® 8.1 64-bit.

Windows® 10 64-bit.

VisualEyes™ 515/525 Instructions for Use – US Page 3

1.4.2 Included and optional parts

The VisualEyes™ system is delivered with the following items based on system configuration.

USB camera systems

FireWire® camera systems

Included parts

Hand held RF remote control and/or foot pedal

VisualEyes™ 515/525 installation media

OtoAccess™ Database media

Cleaning cloth for lens and goggle mirrors

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

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

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™ 515/525 Instructions for Use – US Page 4

Optional parts

based on

reclining chair

type

Using the Orion rotary chair

Orion rotary chair

USB cable

Emergency stop button with Ethernet

connector

Power cord

Using the System 2000 reclining

chair

System 2000 reclining chair

Chair controller

USB cable

Emergency stop button

Power cord

Using the Nydiag 200 rotary chair

Nydiag 200 rotary chair

Ethernet to USB chair cable

Emergency stop button with Ethernet

connector

FireWire® cable

Table 1. VisualEyes™ included and optional parts.

VisualEyes™ 515/525 Instructions for Use – US Page 5

1.5 Warnings and precautions

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

practitioner. The system components should not be modified without consulting the manufacturer.

General 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 damage to the equipment.

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

damage to the equipment.

1. 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 60950-1 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 the general standard IEC

60601-1, edition 3, 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 support

or shall 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 the requirements. If in

doubt, contact qualified medical technician or your local representative.

2. 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.

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

4. The goggles 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.

5. The system must be switched off before cleaning. Patients should not be in the rotary chair or

wearing the goggles while chair is being serviced.

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

7. No modification of this equipment is allowed without manufacturer authorization.

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.

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 contact the manufacturer for service.

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

VisualEyes™ 515/525 Instructions for Use – US Page 6

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

2. The system must be serviced at least once a year. The service must include a safety test.

3. Do not use the equipment if the equipment is damaged; 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. 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.

7. Patients cannot use corrective eyeglasses when tested though corrective contact lenses can be

worn to improve visual acuity.

8. Patients should not wear makeup around the eyes. Cosmetic tattoos or permanent makeup may

interfere with eye tracking and should be disclosed to the testing facility prior to patient testing.

9. Disposable foam pads used with the side mount camera goggles are single use and should be

replaced after testing the patient. Front mount camera goggles and top mount camera goggles

should be disinfected with approved cleansing wipes as described in the care and maintenance

section of this manual.

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

11. If the system uses a rotary chair, inform the patient that the test battery will include rotary tests.

Patients with a history of motion sickness should be informed and monitored during testing. If the

patient is feeling discomfort, the tester should stop the test within the software. If the test needs to

be stopped immediately, the Emergency Stop button should be pressed to stop the chair. The

Nydiag 200 rotary chair also has a patient controlled stop button underneath the right armrest for the

patient to use if the patient cannot tolerate the test.

12. If the system uses a rotary chair, the chair is not allowed to spin when it is reclined. The software

will alert the operator that the chair is reclined and will not allow the rotary chair test to be performed.

13. Goggles headband straps should be checked with each patient. If the headband strap does not

remain fastened, then the headband strap should be replaced. Replacement headband straps are

available from the manufacturer.

14. If the system uses a rotary chair, the chair center should be situated at least 1 meter (39 inches)

from the center axis to any adjacent object to accommodate the chair in a reclined state.

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 goggles regularly to avoid shadows on

the displayed images.

3. Do not drop the components and avoid other undue impacts to this device. If the system is

damaged, contact the manufacturer for repair. Do not use the system 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. 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™ 515/525 Instructions for Use – US Page 7

2 Unpacking and inspection

2.1 Unpacking and inspection

Check shipping containers and contents for damage

When the system 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 shipping containers for future shipment

Keep the shipping box and/or shipping crates if the instrument has to be returned for service. Contact your

local distributor for on-site service.

2.2 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.

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 rotary chairs will be serviced on-site by the local distributor.

VisualEyes™ 515/525 Instructions for Use – US Page 8

2.3 Marking

The following marking can be found on the instrument:

Symbol

Explanation

Type BF applied parts.

Type B applied parts.

Read and understand instructions for use before operating this device.

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 the manufacturer meets the requirements of

Annex II of the Medical Device Directive 93/42/EEC for the quality system.

Manufacturer.

Year of Manufacturer.

Do not re-use.

Parts like foam cushions and similar are for single use only.

Reference number used to denote the model of the equipment.

Table 2.3.1 Symbol legend.

VisualEyes™ 515/525 Instructions for Use – US Page 9

3 Setup and installation

3.1 Introduction to VisualEyes™ software

The VisualEyes™ software combines leading edge technology with touch screen capability in a new

streamline software interface. VisualEyes™ software is considered the standard for testing the vestibular

system and oculomotor functions, a process known as vestibular assessment. It involves the use

of infrared goggles 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).

3.2 Installation of OtoAccess™ database

The VisualEyes™ software is accessed through the Interacoustics OtoAccess™ database. The

Interacoustics OtoAccess™ database is used for storage of patient information and data recordings.

Your computer/ laptop will have OtoAccess™ and VisualEyes™ software pre-installed.

If you find that it is not already installed, or if a re-install is required please read the instructions for use

included with the OtoAccess™ installation media (CD or Flash drive) or contact your distributor.

3.3 Installation of VisualEyes™ software

NOTICE

The OtoAccess™ database must be installed prior to installing VisualEyes™ software.

The VisualEyes™ software will be pre-installed on the computer purchased from Interacoustics. In the event

that software must be re-installed, please follow these instructions.

1. Insert the VisualEyes™ Installation CD or flash drive into the computer.

2. If the installation procedure does not start automatically, click Start, then go to My Computer and

double click the DVD/CD-RW drive or Flash Drive to view the contents of the installation media.

3. Double click the Micromedical VisualEyes™ Installer file to initiate the installation.

4. The VisualEyes™ Setup Wizard will start.

5. Check the box to accept the terms and click Install.

6. After the installation completes, exit the installer.

7. Remove the installation media from the drive and store in a convenient place.

The VisualEyes™ installation will configure OtoAccess™ for VisualEyes™ testing. To use the VisualEyes™

software, select the Micromedical VisualEyes™ instrument from OtoAccess™.

3.4 Installation of rotary chair drivers

3.4.1 Installing drivers for Nydiag 200 rotary chair

Open Windows® Explorer. Navigate to the following location:

C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles

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.

Connect the CAN motor control cable from the blue reclining chair to the computer’s USB port.

VisualEyes™ 515/525 Instructions for Use – US Page 10

3.4.2 Installing drivers for System 2000 reclining chair

Open Windows® Explorer. Navigate to the following location:

C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles

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.

Verify the chair controller is connected to the rotary chair and PC and the FireWire cable from the chair is

connected to the PC. Windows will recognize the chair with the new drivers.

After the drivers have been installed, launch the InstaCal software.

In Windows® 7 / 8.1, click on Start > All Programs > Measurement Computing > InstaCal.

In Windows® 10, click on Start > All apps > Measurement Computing > InstaCal.

When the InstaCal software is launched, the software will detect the rotary chair as a PCI-DAS6025 device.

Click on the OK button to register the device in the program.

Figure 3.4.1 Detecting the System 2000 reclining chair in InstaCal

Right-click on the device in InstaCal after it is registered and choose Configure. Alternatively the Configure

button is also the fourth icon from the left. In the combo box choose 16 Referenced (to GND) Single Ended

for the No. of Channels field and choose OK. Exit InstaCal.

Figure 3.4.2 Configure the System 2000 reclining chair in InstaCal

VisualEyes™ 515/525 Instructions for Use – US Page 11

3.4.3 Installing drivers for the Orion rotary chair

Open Windows® Explorer. Navigate to the following location:

C:\Program Files (x86)\Interacoustics\Micromedical VisualEyes™\Driverfiles

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.

At this point connect the USB cable from the rotary chair to the computer. Windows will recognize the chair

with the new drivers.

After the drivers have been installed, launch the InstaCal software.

In Windows® 7 / 8.1, click on Start > All Programs > Measurement Computing > InstaCal.

In Windows® 10, click on Start > All apps > Measurement Computing > InstaCal.

When the InstaCal software is launched, the software will detect the rotary chair as a USB-231 device. Click

on the OK button to register the device in the program.

Figure 3.4.3 Detecting the Orion rotary chair in InstaCal

Right-click on the device in InstaCal after it is registered and choose Configure. Alternatively the Configure

button is also the fourth icon from the left. In the combo box choose 16 Referenced (to GND) Single Ended

for the No. of Channels field and choose OK. Exit InstaCal.

VisualEyes™ 515/525 Instructions for Use – US Page 12

Figure 3.4.4 Configure the Orion rotary chair in InstaCal

VisualEyes™ 515/525 Instructions for Use – US Page 13

3.5 Uninstall software

In Windows® 7 and 8.1, the VisualEyes™ software can be removed from Programs and Features.

1. Open Windows® Control Panel and then select Programs and Features. If the Category option is

used, then under Programs choose Uninstall a program.

2. Select the Micromedical VisualEyes™ entry. Click on Uninstall.

3. In the installer package, choose Uninstall. Once the program is uninstalled, close the installer and

Control Panel.

In Windows® 10, the VisualEyes™ software can be removed from Settings.

1. From the start menu choose Settings

2. Choose Apps. Choose System, then select Apps & features.

3. In the sort box, choose Sort by name.

4. Select the Micromedical VisualEyes™ program in the list, then click on Uninstall.

5. Confirm the process by clicking on the Uninstall button.

6. In the installer package, choose Uninstall. Once the program is uninstalled, close the installer and

Settings.

3.6 Hardware setup

The VisualEyes™ system is composed of several selected pieces of equipment. The software is designed to

be compatible with both Interacoustics a/s and Micromedical Technologies Inc. equipment.

Each piece of equipment, its function and installation is described below.

3.6.1 Laptop/desktop PC

The VisualEyes™ software comes preloaded on a dedicated laptop or desktop PC (Figure 3.6.1). If the

VisualEyes™ software will be installed on additional computers please follow the recommended minimum

PC requirements.

Figure 3.6.1 Laptop / desktop PC

3.6.2 Television/projector display

Figure 3.6.2 TV and projector display

VisualEyes™ system is to be configured with either a Projector or a TV (Figure 3.6.2).The TV may be

mounted on the wall or placed on a table with the TV feet. Windows Desktop is extended across both

displays.

VisualEyes™ 515/525 Instructions for Use – US Page 14

3.6.3 Side mount camera goggles

The VisualEyes™ goggles allow for recording of eye movements during various test conditions, both with

and without visual stimulation. The VisualEyes™ side mount goggles hold FireWire® or USB cameras that

are used to record the eye images. The cameras use infrared light (IR), which is not visible to the naked eye.

The IR illumination enables sessions to be performed in complete darkness.

The FireWire® or USB cameras are fixed on the sides of the goggles (Figure 3.6.3).

Figure 3.6.3 Side mount camera goggles

The goggles come with replaceable foam cushions (Figure 3.6.4) that are removed between patients by

pulling the used foam cushion off of the hook and loop pads on the inside of the mask and then aligning a

new foam cushion on top of the Velcro.

Figure 3.6.4 Replaceable foam cushions for side mount camera goggles

The front cover plate of the side mount 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. Side mount 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.

VisualEyes™ 515/525 Instructions for Use – US Page 15

3.6.4 Top mount camera goggles

The binocular video goggles (Figure 3.6.5) block out ambient light with the easy-to-place cover over the

portal for vision-denied testing. Side-lights on the goggles are programmed to flash to remind the operator

which ear to irrigate during the caloric test and are also used to provide illumination when placing the cover

on the goggles. On the left side of the goggles is a switch to start and stop tests. The binocular video

goggles have an adjustable Velcro head-strap that secures the goggles while still providing patient comfort.

Figure 3.6.5 Top mount camera goggles. Cover slips over front of goggles for vision-denied testing. The

switch on the left side of the goggles starts and stops the test

3.6.5 Front mount camera goggles

The front mount camera goggles use a single USB camera pressed into the camera portal on the front of the

goggles mask. The camera can be placed into either camera portal to record the desired eye. The 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. The front mount camera goggles are typically used for smaller and younger patients.

Figure 3.6.6 Front mount camera goggles. Left picture shows the standard goggles, and the right picture

shows the small face goggles

VisualEyes™ 515/525 Instructions for Use – US Page 16

3.6.6 Rotary chair (optional)

The reclining rotary chair provides sinusoidal harmonic acceleration (SHA) test and step test capability to the

VisualEyes™ system. The reclining rotary chair can also be used as the exam table for positional and

caloric testing. The backrest can be reclined to 30 degrees from horizontal for caloric irrigations. Positional

tests can be performed with the backrest reclined to 0 degrees horizontal. For Dix-Hallpike tests, the

headrest can be removed on the System 2000 and Orion chairs to allow the clinician to bring the head below

the frame. A head strap located on the back of the System 2000 and Orion chairs’ headrest secure the

patient’s head to the head rest during rotation tests.

Figure 3.6.7 Reclining rotary chair.

3.6.7 The foot pedal (optional)

The foot pedal (Figure 3.6.8) 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) or to operate other devices (e.g., caloric

irrigators). Connection with the PC is via a USB port.

Figure 3.6.8 VisualEyes™ foot pedal

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Interacoustics VisualEyes 515 Instructions For Use Manual

Brand: Interacoustics

Model: VisualEyes 515

Type: Instructions For Use Manual

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Interacoustics VisualEyes 515 Instructions For Use Manual

Interacoustics VisualEyes 515 Instructions For Use Manual

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