Interacoustics Virtual SVV User manual

Instructions for Use
Virtual SVV™
D-0116067 – A – 2017/09
EN
USA
DA
DE
ES
IT
FR
NO
SV

Copyright © February 1, 2017 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.

Table of Contents
1 INTRODUCTION .......................................................................................................................... 1
About this manual ...............................................................................................................1
Intended use........................................................................................................................1
Contraindications ................................................................................................................ 1
Product description .............................................................................................................2
Warnings and precautions ..................................................................................................2
2 UNPACKING AND INSPECTION................................................................................................ 3
Unpacking and inspection...................................................................................................3
Reporting imperfections ......................................................................................................3
Labeling...............................................................................................................................4
General warnings and precautions .....................................................................................5
3 SETUP AND INSTALLATION...................................................................................................... 7
The Virtual SVV™ system components..............................................................................7
3.1.1 Virtual reality goggle ................................................................................................. 7
3.1.2 Handheld remote ...................................................................................................... 7
3.1.3 Base station ..............................................................................................................8
3.1.4 Application software..................................................................................................8
Installation of OtoAccess™ database.................................................................................8
Installation of Virtual SVV™ software .................................................................................8
Installation of Virtual SVV™ drivers..................................................................................11
Configuring Virtual SVV™ in OtoAccess™.......................................................................11
Hardware setup.................................................................................................................12
3.6.1 Attaching the face cushion to the virtual reality goggle ..........................................12
3.6.2 Attaching the head strap.........................................................................................13
3.6.3 Handheld remote ....................................................................................................14
3.6.4 Preparing the base station......................................................................................15
3.6.5 Battery charging......................................................................................................16
4 OPERATIONAL INSTRUCTIONS.............................................................................................. 17
System startup ..................................................................................................................17
Entering patient information..............................................................................................17
Starting the Virtual SVV™ software..................................................................................18
Navigating the Virtual SVV™ user interface .....................................................................19
Virtual SVV™ settings.......................................................................................................20
Virtual SVV™ findings sheet.............................................................................................21
5 TEST PROCEDURES ................................................................................................................ 23
Test mode selection..........................................................................................................23
Patient preparation............................................................................................................23
5.2.1 Mounting the virtual reality goggle..........................................................................24
5.2.2 Securing the handheld remote................................................................................24
5.2.3 Connecting the device ............................................................................................24
5.2.4 Patient instructions..................................................................................................24
Starting measurements.....................................................................................................25
Testing with static tilt.........................................................................................................26
5.4.1 Configuration and operation ...................................................................................26
5.4.2 Viewing the sequence of measurement positions ..................................................27
5.4.3 Adjusting the patient ...............................................................................................27
5.4.4 Performing measurements .....................................................................................27
5.4.5 Angle of deviation ...................................................................................................28
5.4.6 Results diagram and measurement data table.......................................................28
5.4.7 Swapping measurement sequences.......................................................................29
5.4.8 Static tilt – step procedure ......................................................................................29
Testing with unilateral centrifugation.................................................................................29
Discarding data .................................................................................................................29

6 CARE AND MAINTENANCE ..................................................................................................... 31
General maintenance procedures.....................................................................................31
How to clean Interacoustics products ...............................................................................34
Concerning repair..............................................................................................................35
Warranty............................................................................................................................35
7 TROUBLESHOOTING ............................................................................................................... 37
Troubleshooting table........................................................................................................37
System function check ......................................................................................................38
8 GENERAL TECHNICAL SPECIFICATIONS............................................................................. 39
System requirements ........................................................................................................39
Virtual SVV™ hardware specifications .............................................................................40
Electromagnetic compatibility (EMC)................................................................................41
Safety regulations .............................................................................................................44

Virtual SVV™ Instructions for Use – EN Page 1
1Introduction
About this manual
This manual is valid for the Virtual SVV™ software version 2.0. These products are manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
Intended use
The Virtual SVV™ is intended for the measurement of subjective visual vertical. The system provides the
means for the estimation of the gravitational vertical by the examined patient. In otherwise total darkness the
patient is required to rotate, by remote control, a luminous line to be parallel to gravitational vertical. These
responses are measured, recorded, and displayed in the software. This information can be used by a
trained medical professional to assist in the clinical diagnosis of vestibular disorders. The target population
for the Virtual SVV™ is 8 years of age and over. The Virtual SVV™ system is to be used by trained
personnel only, such as physicians, audiologists, physical therapists, medical assistants, 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. The
operator must comply with the instructions in this manual.
The Virtual SVV™ system is intended for use in the clinic and medical practice. For example, it is suitable
for use:
•With the patient seated on a normal examination chair
•With the patient secured in a rotary chair or tilt device
•At the bedside
Contraindications
Virtual SVV™ testing may be contraindicated in patients who exhibit the following: blindness, broken nose or
other face/head trauma, or recent eye surgery.

Virtual SVV™ Instructions for Use – EN Page 2
Product description
The Virtual SVV™ system provides a method to assess the patient’s ability to adjust a line, in the absence of
any other visible cues, to be parallel with gravity. The sensory information required to perform this task is
provided predominantly by the vestibular system of the inner ear.
As standard Virtual SVV™ is delivered with the following
Figure 1-1 Virtual SVV™ Hardware Components
Warnings and precautions
Throughout this manual the following meaning of warnings, cautions and notices are used:
Included parts
1. Virtual Reality Goggle
2. Head Strap
3. Padded Face Cushions (24 units per package)
4. Handheld Remote
5. Base Station
6. Power Adaptor
7. Virtual SVV™ Software Installation Media
8. OtoAccess
TM
Database Media
Optional parts
1. USB Foot Pedal
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 of the equipment.
NOTICE NOTICE is used to address practices not related to personal injury or damage of the
equipment.

Virtual SVV™ Instructions for Use – EN Page 3
2Unpacking 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 shipping carton for future shipment
The Virtual SVV™ comes in its own shipping carton, which is specially designed for the Virtual SVV™.
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.
Please use "Return Report"
Please use the Return Report to help to us guarantee that the correction of the problem will be to your
satisfaction.
Storage
If you need to store the Virtual SVV™ for a period, please ensure it is stored under the conditions specified
in the section for technical specifications.

Virtual SVV™ Instructions for Use – EN Page 4
Labeling
The following labeling can be found on the instrument:
Symbol
Explanation
Type B applied parts.
Patient applied parts without electrical connection to the patient.
Refer to instruction manual.
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.
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.
Year of manufacture.
Manufacturer address.
Serial number.
European representative.
Do not re-use.
Parts like face cushions and similar are for single use only
Non-ionizing radiation.
This device radiates non-ionizing radiation and can possibly interfere with
other equipment in the vicinity.

Virtual SVV™ Instructions for Use – EN Page 5
General warnings and precautions
Intended purpose
1. The Virtual SVV™ system is intended to be used exclusively for medical purposes. It is not intended
for private or entertainment use.
2. The Virtual SVV™ system must only be operated according to the instructions described in this
manual. The measurement of the subjective visual vertical is intended for use in the clinical
diagnosis of vestibular disorders.
3. The operator is exclusively responsible if the equipment is used for any other purpose.
4. The equipment must only be operated by trained personnel. The operator is responsible for the
familiarization and training of the operating personnel.
Precautions during testing
1. The virtual reality goggle occludes all ambient light such that the patient’s visual perception is
strongly restricted during testing. Therefore, the virtual reality goggle should only be placed on the
patient when the patient is sitting.
2. Do not leave the patient unattended at any time during testing.
3. Terminate testing at any time if the patient suffers discomfort or requires assistance.
4. Do not leave the equipment unattended and do not use it without the presence of qualified
personnel.
Electrical safety
1. The equipment operates with electrical energy and requires that appropriate caution be taken to use
only the delivered power adaptor.
2. The operator and the patient should not touch the AC plug or the power adaptor with damp or wet
hands.
3. If you wish to unplug the power adaptor from the AC outlet, grip and pull the AC plug. Never pull on
the cable, as this could cause damage or breakage.
4. Take appropriate measures to avoid pinching or clampling the power cable in any way. Avoid any
contact with sourses of heat.
5. Contact with any live cables or components (e.g. due to damage to isolation layer) can lead to
electric shock and danger to life.
6. The base station should be set up so that the power cable is accessible and easy to disconnect from
the AC outlet.
7. Any AC extension cables that are used should be appropriately rated for the required power
consumption.
8. Do not use any extension cables with multiple socket outlets.
9. The voltage rating of the AC outlet employed for powering the equipment must match the specified
voltage on the label of the power adaptor. Incorrect voltage could damage the equipment.
10. The base station does not possess an ON/OFF switch. Before cleaning or disinfecting the power
adaptor must be disconnected from the AC outlet.
11. Never immerse any of the device in water or any other liquid.
12. Take measures to lie the AC power cable so that it does not represent a trip hazard.
13. Unplug the power adaptor from the AC when the batteries are fully loaded and the Virtual SVV™
device is not in use for a long period of time.

Virtual SVV™ Instructions for Use – EN Page 6
Battery safety
1. The Virtual SVV™ handheld remote contains two rechargeable AA NiMH batteries. Read the
instructions in Chaper 6 Exchanging Batteries carefully before opening the battery compartment
and exchanging the batteries.
2. Only the VARTA Ready-to-use – NiMN AA 1.2V 2600mAh battery type may be used.
3. During the battery charging process the housing of the handheld remote may become warm. This
has no influence on the operation of the system, or on the operator or patient.
Patient safety
1. The base station is equipped with a USB interface for connection to a PC port. Note that the USB
interface is not galvanically isolated.
2. “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 in 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 device to reduce the leakage currents.
3. 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.”
Additional precautions
1. Do not open the housing of the virtual reality goggle, the handheld remote or the base station. The
Virtual SVV™ devices may only be opened by authorized personnel.
2. Avoid equipment contact with hot or cold surfaces, chemicals, heavy dust or strong vibrations or
impacts. All Virtual SVV™ devices contain sensitivie electronic components that could be damaged.
3. The handheld remote draws current from the base station to charge the integrated battery and must
therefore not come into contact with dampness. If this should occur, the cable connected to the
virtual reality goggle must be disconnected and the handheld remote must be removed from the
base station immediately and be dried throroughly.
4. The base station draws current from the power adaptor and must therefore not come into contact
with dampness. If this should occur, the power adaptor must be disconnected immediately from the
AC outlet and the base station should be dried throroughly.
5. Always use the safety loop to secure the handheld remote to the patient’s wrist to avoid any damage
via dropping or impact.
6. No component of the equipment may be altered or modified without the express permission of the
manufacturer.
Contact the manufacturer in case of suspected system fault or defect.

Virtual SVV™ Instructions for Use – EN Page 7
3Setup and installation
The Virtual SVV™ system components
The Virtual SVV™ Device is comprised of four main components:
Virtual Reality Goggle Base Station
Handheld Remote Virtual SVV™ Application Software
3.1.1 Virtual reality goggle
The virtual reality goggle provides the patient with the display of the luminous line in otherwise full darkness.
It is designed to be lightweight and comfortable. It is wired to the handheld remote to enable the patient to
adjust the orientation of the line. Sensors are incorporated into the virtual reality goggle in order to measure
continuously head orientation relative to gravity. This data are then compared with the orientation of the
luminous line to achieve correct measurement. The medically approved foam padded face cushion facilitates
fitting to the individual facial structure and ensures that the patient is in full darkness for the examination.
The virtual reality goggle transfers all data via a wireless link to the base station, and in turn to the PC
application. The use of a wireless link provides maximum freedom of movement of the patient during the
examination.
3.1.2 Handheld remote
The handheld remote enables the patient to adjust the orientation of the projected luminous line to the
perceived visual vertical and to confirm the setting. The capacity of the integrated batteries provides for
normal usage over several hours. The batteries are charged automatically when the handheld remote is
inserted into the cradle on the Base Station.

Virtual SVV™ Instructions for Use – EN Page 8
3.1.3 Base station
The Base Station Incorporates the wireless transceiver for communication between the patient’s handheld
remote and the USB interface to the PC. This permits real-time transfer of the patient’s settings and the data
from the virtual reality goggle sensors to the application software.
3.1.4 Application software
The application provides the operator with control of the test routine and continuous monitoring of all
parameters (e.g. angle of head tilt, angle of luminous line). The graphic display elements indicate
continuously the movements of the luminous line as the patient adjusts it to the perceived visual vertical and
monitors the orientation of the virtual reality goggle. After confirmation by the patient, the set values are
stored and presented in the on-screen results chart. In this way the operator can track how well the patient is
performing with reference to the threshold range. The software also generates a test report sheet containing
all measurement data. This can be output to electronic or hardcopy media.
Installation of OtoAccess™ database
The Virtual SVV™ software is accessed through the Interacoustics OtoAccess™ database. The
Interacoustics OtoAccess™ database is used for storage of patient information and data recordings.
OtoAccess™ should be installed prior to installing the Virtual SVV™ software. Please refer to the
instructions for use included with the OtoAccess™ installation media (CD or Flash drive) or contact your
distributor.
Installation of Virtual SVV™ software
NOTICE
The OtoAccess™ database must be installed prior to installing Virtual SVV™ software.
To install the Virtual SVV™ application on a Windows PC initiate the Setup program in the correct directory on
the installation media delivered with the device. Note that either the 32 bit or the 64 bit version must be installed
according to which Windows operating system is installed on the host PC.
An installation setup assistant guides installation.
Figure 3-1 First step in Virtual SVV™ installation setup
A valid user license in the form of a license file is included with the purchase of a Virtual SVV™ device. The
name of the license file is generated as the combination of “device number.license”.

Virtual SVV™ Instructions for Use – EN Page 9
The setup requires the location of the valid license file. This is illustrated in the figure below.
Figure 3-2 Selection of directory path for license file
The license file is to be found in the directory /License on the Virtual SVV™ installation media. Press
“Browse” to select the path as shown in the dialogue box. The installation can only be completed after the
license file has been identified.
Note that a valid license permits installation of the Virtual SVV™ application on more than one PC.
Accept the terms in the license agreement to continue with installation.
Figure 3-3 Software license agreement

Virtual SVV™ Instructions for Use – EN Page 10
The following default directory path will be selected for the installation procedure.
Figure 3-4 Selecting directory path for Virtual SVV™ installation
Select “Next” to proceed with installation. Upon successful installation, the setup assistant may be closed by
selecting “Finish”.
Figure 3-5 Completing the setup assistant after successful installation

Virtual SVV™ Instructions for Use – EN Page 11
Installation of Virtual SVV™ drivers
Connect the base station of the Virtual SVV™ to a USB port on the PC or laptop. The installation procedure
identifies whether the necessary driver software is already installed on the PC. If this is not the case, these
are installed automatically. If the necessary drivers are not installed on the PC, a Windows error message
will appear and a corresponding warning in the Device Manager is indicated. In order to install the drivers
manually, select the file FTDI-Setup.exe from the directory /FTDI Driver on the delivered installation media.
Select “Extract” to perform driver setup. Successful completion is notified by the message shown in the
figure below.
Configuring Virtual SVV™ in OtoAccess™
In order to setup Virtual SVV™ as an instrument within OtoAccessTM, the database must be configured
appropriately. Open OtoAccessTM and select “File” and proceed to “Setup”. Select the “Instruments” tab.
Enter Virtual SVV™ in the “New Instrument Name” field. Select Virtual SVV™ in both the software and
hardware fields. Select “Create” to confirm Virtual SVV™ as a new instrument in OtoAccessTM. Select
“Apply Settings” to keep changes. Select “OK” to exit setup.
NOTICE
Please note that OtoAccessTM must be restarted before the new instrument will appear in the Select
Instrument field.

Virtual SVV™ Instructions for Use – EN Page 12
Hardware setup
The Virtual SVV™ system is composed of several components. Each component, its function and
installation is described below.
3.6.1 Attaching the face cushion to the virtual reality goggle
Step 1
Align the face cushion to the virtual reality goggle, with the side with black fabric towards the virtual reality
goggle. To facilitate this, fold the face cushion slightly, as shown in Figure 3-6. Center it against the virtual
reality goggle. The face cushion should be positioned so that the upper section of the cutaway is aligned with
the upper edge of the viewing aperture of the virtual reality goggle as illustrated below. Ensure that the face
cushion does not occlude the viewing aperture of the virtual reality goggle.
Figure 3-6 Aligning the face cushion to the virtual reality goggle
Step 2
The lower section of the face cushion is intended to fit snugly around the nose. This section should be
aligned with the lower edge of the viewing aperture as shown in Figure 3-7. When correctly aligned, the face
cushion can be pressed firmly to adhere to the virtual reality goggle.
Figure 3-7 Fastening the face cushion

Virtual SVV™ Instructions for Use – EN Page 13
Step 3
Press the face cushion to the virtual reality goggle, beginning in the center (see Figure 3.3) and working
towards the outer edges. Ensure that the entire interface between face cushion and virtual reality goggle is
bonded. This is necessary to occlude any light sources from the surroundings while the virtual reality goggle
is worn. The finished product is shown in Figure 3-8.
Figure 3-8 Correctly attached face cushion
3.6.2 Attaching the head strap
The head strap is fastened and adjusted using the hook-and-loop tape. Unfold both ends of the head strap
and proceed as follows:
Step 1
Take the shorter end of the head strap and slip it through the slot on the right of the virtual reality goggle (as
viewed in Figure 3-9). Ensure that the rougher side of the head strap is facing outwards. Continue to slip the
head strap through the left-hand side of the virtual reality goggle.
Figure 3-9 Attaching the head strap

Virtual SVV™ Instructions for Use – EN Page 14
Step 2
Fold the left-hand end of the head strap around the slot and fixate the Velcro hooks and loops. This end of the
head strap remains fastened throughout the examination.
The head strap can now be pulled through the right-hand slot from right to left. The head strap can be
adjusted in length to fit each patient’s head, and then secured with the Velcro pads. The complete virtual
reality goggle with face cushion and head strap is illustrated in Figure 3-10.
Figure 3-10 Complete virtual reality goggle with head strap
3.6.3 Handheld remote
Attach the black tape cable to the handheld remote at the top of the device as shown in Figure 3-11.
Figure 3-11 Plug connection on handheld remote
The control elements for the adjustment of the luminous line by the patient are incorporated into the
handheld remote.

Virtual SVV™ Instructions for Use – EN Page 15
Figure 3-12 Elements of the handheld remote
OK button for confirming completion of adjustment
Buttons for left / right rotation of the luminous line
LED indicating power ON (green)
LED indicating charge status (yellow)
Armband for securing handheld remote
3.6.4 Preparing the base station
Connect the AC power adaptor to the socket on the back of the base station so that it latches.
Figure 3-13 Connecting the AC power adaptor to the base station
Connect the AC power adaptor to a standard (110/230 VAC) outlet. Note the safety warnings in Chapter 2,
as well as the technical specifications.

Virtual SVV™ Instructions for Use – EN Page 16
NOTICE
Positioning the base station
To ensure a reliable wireless transmission it is important that a free line-of-sight is maintained between the
virtual reality goggle and base station. It is recommended that the base station is positioned in the vicinity of
the patient. To avoid electrical interference it should not be positioned close to the PC or monitor or any other
equipment likely to generate high frequency radiation.
The base station also functions as a charger for the handheld remote. For this purpose it should be positioned
so that the handheld remote can be inserted and held securely.
During charging in the base station the unit should be arranged so that the charge indicator LED can be
observed.
Access to the AC Power Adaptor must be ensured so that the AC Power cable can be pulled at any time.
Do not expose the device to direct sunlight or high heat supply.
3.6.5 Battery charging
During initial charging it is important that the handheld remote is kept continuously in the base station until
the yellow indicator LED extinguishes. Do not disconnect the base station from the AC power outlet during
this procedure.
Charging process
In order to charge the battery of the handheld remote insert it into the base station as shown in the figure
below. Charging is initiated automatically, and is indicated by the illuminated yellow LED on the handheld
remote. When charging is complete the indicator LED extinguishes.
Figure 3-14 Handheld remote in base station
During normal use the green ON LED blinks when the battery capacity has reached a critically low level after
4 hours of continuous use. When this occurs, the handheld remote must be inserted into the base station for
recharging. Depending on battery capacity, recharging can take up to 5 hours.
NOTICE
If it is necessary to replace the batteries, please read and follow the safety instructions in Chapter 6.