Interacoustics VN415 User manual

Instructions for Use
Part 1
VNG Stand Alone Unit
VN415 / VO425
Valid from software version 7.07
8011826 Rev. 3 - 11/2013
Instructions for Use –GB
Manual de instrucciones –ES
Bruksanvisning –SE
Instructions d’utilisation – FR
Οδηγίες Χρήσης - GR
Gebrauchsanweisung –DE
Istruzioni per l’uso – IT
Instruções de utilização –PT

Instructions for Use - GB
VNG Stand Alone Unit
VN415 / VO425
Valid from software version 7.00

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 1
Intended Use
The two Interacoustics VNG systems, VN415 and VO425, are primarily intended for use in the
evaluation, documentation and diagnosis of vestibular disorders. This is of particular interest to Ear,
Nose and Throat specialists, to Neurology specialists, Audiology specialists and other health care
professions concerned with balance assessment. The VN415 is the basic unit for peripheral vestibular
testing and the VO425 is the extended system for central testing using oculomotor stimuli.
Precautions
1. 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.
2. Please note that the CE Marking is only legal if this Instruction is translated into the national
language of the user no later than at the delivery to him, if the national legislation demands a
text in the national language according to MDD article 4.4.
3. Please note that if connection is made to standard equipment like printers and network,
special precautions must be taken in order to maintain medical safety.
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.
If this apparatus is connected to one or more other devices with medical CE marking,
to make up a system or pack, the CE marking is only valid also for the combination if
the supplier has issued a declaration stating that the requirements in the Medical
Device Directive article 12 are fulfilled for the combination.
Operation Instructions
Preparations prior to the VNG Test
To ensure reliable and valid test results from your VN415 / VO425 it is important that the patient is
prepared for the test.
Preparation of the patient
No glasses or contact lenses should be worn during the examination. Eye makeup should also be
removed, as this may disrupt the registration of the pupil. Finally, the patient should have received
instructions to discontinue any form of non life sustaining medication prior to the examination.
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 is used to address practices not related to personal injury.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 2
Calibration
To make an allowance for different depths of patient eye orbits a calibration procedure can be
performed.
This is initiated using the button. The setup of this procedure can be altered in the configuration
screen. Calibration points can be presented to the patient via the VisualLab software or via dots on the
wall.
Placement of the mask
The mask should be placed on the head. Tighten the headband around the head.
Make sure that the pupil is visible and in the centre of the eye image. The Infra-red mirrors inside the
cover have two possible positions. Make sure that they are adjusted to the most suitable position.
Adjust the cameras with the vertical and horizontal adjustment knobs. The image must be brought
into focus with the focus knob –always avoid unfocused, blurred images since this will disrupt
eyetracking.
Setting of the pupil identification threshold
The software will automatically detect the optimum grey scale for pupil identification, but this may also
be done manually. To adjust the threshold manually simply find the optimum position for the slider
controlling the setting for the grey-scale.
This is done by tweaking the and arrows on the sliders either side of the eye images.
Short Instruction
HELP
The Operation Manual is a very important partner in getting to know your VNG unit.
This is available in hard copy and Online in the Electronic operation manual: Select Help/Help in
the main menu bar, and a comprehensive list of help topics makes up an operation manual
including easy searching and cross referencing functions.
Operating the OtoAccess™database
The first screen that will come up after the system has been turned on is the OtoAccess™
database screen.
To add a new client to the database click the “New Client” button and after entering the
required details such as name, person ID etc, save by
To search for any client, click the “Search Client” button , write client details (e.g. Person ID)
and use Enter.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 3
To add a new examiner, open the File tab and click “Setup” in the pull-down
menu. Open the “Examiners” panel and enter the relevant details for the new examiner. Left click
on the “Save” button to store the examiner.
New Test
To enter test mode from the name database, double click the instrument symbol in the “Select
Instrument” box .
Open a new session from the Session Template by clicking , or simply click one of the test
icons to prepare for immediate testing.
Start the test with the button
Then use the return key or the IR remote control to progress through the steps of each test. The IR
remote control acts as a functional return key and can be used to start and stop testing, and for
switching on the fixation light.
Activating the fixation light
To activate the fixation light inside the goggle the can be used. Automatic activation can be set
in the Configuration dialogues.
Manual Edit Mode
To enter manual editing mode, click the “Toggle edit mode” button . In this mode graphs are
displayed in single mode, and in a larger scale than in the normal mode.
Video recording
With the test in progress, click the ’Start Record’ button located on the left of the eye images.
To change the default setting of a test into automatic video recording, this option must be activated in
the test configuration dialogue under ‘Configure Test’.
When ‘Record’ button has been activated it will flash until the test is stopped, or until you press the
‘Stop recording’ button. Recording will automatically stop when the test is stopped or finished.
Start record
Stop Record

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 4
To review a recorded test, activate the button in the toolbar. The screen will now change into
playback mode and the cameras will be disconnected.
Adding notes
Notes about the Session or the individual test can be added by clicking on the button.
Creating a Letter
Select the ‘Letter Wizard. . .’ from the ‘Session’ menu. Select the appropriate information from the
presented fields. New selectable information can be added with the button. This can then be
saved with button or deleted with button.
Printing
Select the “Print Session” button to receive printouts from the whole session. Select the “Print
Test” button to receive printouts for a selected test.
Save and Exit
Select to save data and to exit session. Alternately select if you want to exit without
saving data.
………………………………………………………………………………………………………………….............................................
Various additional tools:
Lock Chair
Click the ‘Lock Chair’ button to lock the Interacoustics rotary chair in any horizontal position.
This function is relevant for clinics using the Interacoustics rotary chair as an examination table for
caloric irrigations and positional testing.
To release the chair, click the ‘Lock Chair’ button again.
Tree View
Click , to access the tree view. This will display the Session and test order information on the left
side of the screen.
Session Template Designer
To view and make changes to a Session Template choose ‘Session Template Designer’ under the
Session menu. In this dialogue the properties of a Session can be changed. A new Session
Template can be configured by pressing the button. Changes to the selected template can
be saved with the button. The number of tests performed and their order can be changed in
the tests to be performed list . Tests can be inserted by using the button.
Tests can be deleted using the button. The order of tests performed can be changed by
using the and buttons. The settings of a selected test can be changed in by using the
button.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 5
Automatic threshold detection
The grey-scale threshold by which the pupil is identified is set automatically when the goggle is
positioned on the client. This can be deactivated and then re-activated with the and buttons.
Shifting between Eye Trackers
To facilitate optimal eyetracking on as many patients as possible, two different
eyetrackers are available for the user:
Elliptical –searches for edges; those that combine into an elliptical shape are defined as the
pupil. Will normally provide optimal tracking on patients wearing mascara
Circular –searches for dark areas and locks onto the roundest object, identifying this as the
pupil.
To shift between the two eye trackers on the fly, click the symbol in the lower left
corner of the eye image area and select the required eye tracker –Elliptical or Circular.
Image Brightness Adjustment
Sliders for image brightness adjustmentSliders for image brightness adjustmentSliders for image brightness adjustmentSliders for image brightness adjustment
1.
.
2.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 6
Move the sliders to adjust the image brightness in enlaged eye view mode (opened by right-
clicking the eye image).
The eye tracker will have optimal working conditions on images with significant contrasts between
the pupil and the iris.
Change test configuration
When a test has been selected the configuration of the test can be changed using the button.
Alternately, the eye position graphs can be double clicked on. In the dialogue box that is displayed,
test/graphs/analysis/stimulation/calibration parameters can be changed.
Change nystagmus identification
The thresholds by which nystagmus analysis is determined and the sensitivity of slow phase detection
can be set in the configuration dialogue under analysis. If changes in these values are to be saved
the button can be used. If changes are not saved and to use the last saved changes
press the button.
Record different traces
To record different eye traces check the appropriate radio button in the test panel
section of the Configuration screen.
Changes to oculomotor stimuli (only with VO425)
Changes can be made to the Oculomotor stimuli characteristics in the stimulus leaf of the configure
screen.
Testing Oculomotor Stimuli (only with VO425)
Stimuli can be previewed without recording by using the button within the Configuration/Stimuli
screen.
Changes to geometry of test environment (only with VO425)
The geometry of the test environment can be changed to accommodate different test situations. To
change these settings new horizontal, vertical and distance from eye to display measurements must
be entered in the dialogue. An outline from which to measure the vertical and
horizontal projection sizes can be given with the button.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 7
Connection Layout
Plug the USB connected foot pedal (8)
into the USB port on the laptop.

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 8
To connect the VNG hardware to a desktop PC, the exact same procedure as for the laptop should be
followed.
In case the desktop PC does not feature an analog HD15 VGA port, or if only one DVI-I port is
available, a splitter cable with the following specifications should be inserted between PC and
monitor/projector:
DVI-I Male to 1 Ft. HD15 Female (VGA) / 6 Ft. DVI-D (Single Link) Male Analog and Digital Y Splitter
VNG
Workstation

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 9
O

Explanation to symbols which can be found on the instrument:
I
On (Power: connection to the mains)
Off (Power: disconnection from the mains)
Alternating current
Fuse
Ground
Dangerous voltage
!
See explanation in manual
Type BF equipment
Technical Specifications
The technical specifications provided here cover the general aspects of the instrument, while more
specific details can be found in the Operation Manual in English.
Standards
IEC 60601-1 (General Safety) Class lI, Type BF
IEC 60601-1-1 (Safety of Systems)
IEC 60601-1-2 (EMC)
The CE mark indicates that Interacoustics AS meets the requirements of Annex II of the Medical
Device Directive 93/42/EEC. Approval of the quality system is made by TÜV - Identification no. 0123.
Power Supply:
Input Volts:
100-240 V AC 50/60Hz 0.5A universal input switch mode.
Safety:
VDE750, EN60601-1, IEC601-1, UL544, CSA22.2
Software Features:
External patient database
Real time eye image analysis
Implemented norm data
Windows®XP operating system
Windows®7 (32 & 64 bit)
Windows®Vista Business Premium & Ultimate
Parts included
Interacoustics Combi Goggle w. FireWire®Camera Module(s)
USB connected Foot Switch
IEEE1394 PCExpressCard/34 with power supply
Operation Manual
VNG Quick Guide
CE Manual
VNG Software Installation CD
Disposable Goggle Foam Pads, Box of 24 units

VN415 / VO425 Instructions for Use - English
Date: 2010-12-20 Page 10
Concerning Repair
1. Interacoustics is only considered to be responsible for the validity of the CE marking, effects on
safety, reliability and performance of the equipment if:
assembly operations, extensions, readjustments, modifications or repairs are carried out
by authorized persons,
a 1 year service interval is maintained
the electrical installation of the relevant room complies with the appropriate requirements,
and
the equipment is used by authorized personnel in accordance with the documentation
supplied by Interacoustics.
2. Should a problem with the device arise, please contact your local distributor. The RETURN
REPORT must also be sent to Interacoustics, Drejervaenget 8, DK-5610 Assens in connection with
reporting of problems, incidents, etc.

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 12
General Information
The Rotary Chair is constructed to a maximum patient weight of 135 kilos
This instruction manual is a part of the instrument and should always be kept at hand.
It documents the state of development of the unit, valid at the time of printing, and contains all the
information required by the IEC 60601-1.
Exact adherence to the instruction manual is a prerequisite for the perfect and intended functioning of
the Interacoustics instrument.
Always be sure to disconnect the power supply before cleaning or disinfecting mains operated
instruments.
Interacoustics A/S only guarantees for the safety, reliability and function of the instrument, if:
installation, extensions, modifications and repair are exclusively carried out by personnel authorized by
Interacoustics A/S;
the room in which the equipment is installed complies with the country-specific regulation;
the installation site complies with the ambient conditions of the instrument;
the unit is used in accordance with the instruction manual after initiation in the operation;
The device is not approved for operation in potentially explosive
rooms or flammable atmospheres.
If fluid gets into the instrument, the instrument will have to be switched off at once. The fluid must
immediately be removed by Interacoustics service technicians and the instrument tested for technical
safety. Defective connectors and leads must immediately be replaced or repaired by a specialist or by
personnel authorized by Interacoustics A/S.
Precautions
Following the ANSI recommendations (American National Standards Institute) for safety notes,
specific passages of this instruction manual are clearly marked as safety notes.
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 is used to address practices not related to personal
injury

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 13
Operation Instructions
Examination Room Layout
The Rotary Chair may be installed using the following guidelines for room size and hardware
installation:

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 14
Hardware installation
The rotary chair must be secured to the floor with 4 screws
through the bottom rim of the base. Please use 12 mm dowels
and 8 x 120 mm screws.
The Patient is not allowed to sit on the calves-area of the chair when
this has been reclined into its horisontal position
Never connect the instrument to the power outlet before the side panels
and the top cover have been correctly refitted and secured.
Consult with the product specification plate on the unit for compliance between the unit’s own data and
those of the local power supply system (mains voltage and mains frequency) before connecting the
unit.
Connect only if all data agrees!
Inspect the mains connection cables for visible damage prior to establishing the connection. Damaged
cables or plugs must immediately be replaced by Interacoustics service technicians, an authorized
person or specialist.
Connection Panel
The backrest features a connection panel with purpose specific connections:
Input/output connection panel , back rest
FireWire® interface for
the camera(s) mounted in
the goggles
USB 1.1
interface
For future
use

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 15
Signal input/output connection panel, chair base
Software Installation
The VNG installation CD received with the VNG system holds the relevant software for the Kvaser
CanBus-to-USB adapter.
The Rotary Chair can be connected to any laptop or desktop PC with the following specifications:
Intel Core 2 Duo processor 1.8 GHz or better
Minimum 1 GB of RAM
Laptop PC: One 34 mm PCExpressCard slot available
Desktop PC: Texas Instruments chipset PCI FireWire® board with dual 6-pM ports
Three USB ports available
One VGA port available
Monitor resolution 1024 x 768 or better
WindowsXP™, Windows Vista® or Windows 7® Ultimate Operating system
Never connect these
sockets to a computer
LAN interface!
FireWire®
connection to PC
USB 1.1
connection to to
socket in back
rest
Socket for the
emergency stop
switch
CAN interface for
the motor controller
(CAN-bus-to-USB
converter)
Mains switch for the
rotary chair. Illuminated
when power is on
For future
use

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 15
The Sinusoidal Pendular Test, or Sinusoidal Harmonic Acceleration
(SHA)
In the Sinusoidal Pendular Rotary Chair Test the patient is positioned on a motor driven rotary chair
that rotates in a sinusoidal pattern from left to right.
Figure 1: SHA test windows
Setting up the SHA test
To set up the rotary chair stimulus for the SHA test, open the ‘Stimulus’ tab in the configuration dialog
box.
1. Select ‘Manual chair control’ if you want to control the chair manually.
2. Select ’Automatic chair control’ if you have a Nydiag 200 chair connected via USB and you
want VNG software to control the chair automatically.
3. Select the starting direction of the chair rotation.
4. Selected frequencies of sinusoidal harmonic acceleration testing will display in this field. The
stimulus parameters will be displayed, including velocity (°/s), frequency (Hz), cycles, test time
(s), and start direction.

Rotary Chair Instruction for Use - English
Date: 2011-09-27 Page 16
5. Click on ‘New’ to add another stimulus to the test. The new stimulus will get added directly
below the highlighted frequency. To make changes to the parameters of the new stimulus,
highlight it in the frequencies field and enter desired velocity, frequency, and cycles in the
appropriate fields.
The minimum frequency that can be selected is .01 Hz and the maximum frequency is 2 Hz.
When the desired frequency is selected, the software calculates the resulting acceleration.
When the acceleration exceeds 100°/sec2, the frequency will automatically be changed to the
maximum possible.
Alternatively, by reducing the selected velocity a higher frequency can be selected. The
maximum number of stimuli that can be added to one test is 10.
6. Click on ‘Update’ for any changes made to the stimulus to become active.
7. Click on ‘Remove’ to delete the highlighted stimulus from the list of stimuli.
8. If this box is checked the chair will move to its zero position before the test is started.
9. If this box is checked the chair will move to its zero position after the test is complete.
10. In this field enter the number (in degrees) at which the desired zero position is for the chair.
Starting the SHA test
1. To start the test click in the test toolbar. The following dialog box will appear.
2. Select the desired SHA or VOR Suppression frequency from the list of stimuli. Once a stimuli
is selected, the following dialog will display for a brief moment: