Professional Documents
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Videonystagmography System
USER´S MANUAL
V.16.04.07 ENGLISH
For more information, accessories, and replacement parts, contact
ECLERIS S.R.L.
FRANCISCO N. LAPRIDA 4955 - VILLA MARTELLI
(B1603ABK) BUENOS AIRES - ARGENTINA
E-Mail:
info@ecleris.com
www.ecleris.com
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INDEX
INDEX ........................................................................................................... 2
INTRODUCTION ............................................................................................ 6
GRAPHIC SYMBOLS AND LABELS.....................................................................7
INTENDED USE ................................................................................................8
OPERATING PRINCIPLE ...................................................................................9
WARNINGS ................................................................................................. 10
SAFETY INSTRUCTIONS .................................................................................10
Electrical....................................................................................................10
Environmental...........................................................................................11
During use .................................................................................................11
Malfunction...............................................................................................12
VNG PLUS DESCRIPTION ............................................................................. 13
FRONT PANEL............................................................................................14
REAR PANNEL............................................................................................14
JUNCTION BOX ..........................................................................................15
MASK.........................................................................................................15
PATIENT CONSIDARTIONS........................................................................... 16
USES INSTRUCTIONS ................................................................................... 17
RUNNING THE PROGRAM .............................................................................17
NEW PATIENT ...............................................................................................18
NEW SESSION ...............................................................................................18
START TESTS .................................................................................................18
DIZZINESS HANDICAP INVENTORY ................................................................21
ASSISTANT VNG PLUS ...................................................................................22
POSITION...................................................................................................22
GOGGLES...................................................................................................23
EYE SELECTION..............................................................................................24
CALIBRATION ................................................................................................25
DATA ADQUISITIONS ....................................................................................27
Registers ...................................................................................................27
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Warnings...................................................................................................28
Demonstration ..........................................................................................29
Performing the test ...................................................................................30
Using the Footswitch ................................................................................30
Spontaneous Nystagmus ..........................................................................30
Gaze ..........................................................................................................30
Saccades ...................................................................................................31
Smooth Pursuit..........................................................................................31
Optokinetic (OKN) .....................................................................................31
Active head rotation (AHR) .......................................................................31
Video head impulse test (vHIT) .................................................................32
Supine .......................................................................................................32
Calorics......................................................................................................33
ANALYSIS GENERAL.......................................................................................34
Playback Record........................................................................................34
Spontaneous .............................................................................................36
Gaze ..........................................................................................................37
Saccades ...................................................................................................37
Smooth pursuit..........................................................................................37
Optokinetic (OKN) .....................................................................................37
Active head rotation (AHR) .......................................................................38
Video head impulse test (VHIT).................................................................38
Supine .......................................................................................................38
Dix Hallpike ...............................................................................................39
Calorics......................................................................................................39
EDIT NYSTAGMUS .........................................................................................42
SOFTWARE SETUP.........................................................................................44
LISTS ..........................................................................................................45
MANAGEMENT DATA BASE ......................................................................45
PROTOCOL ................................................................................................46
VIEW DEMO ..............................................................................................49
ADVANCED ................................................................................................50
Warnings...................................................................................................50
Visual stimulator .......................................................................................51
Print Report...............................................................................................52
Time Plot ...................................................................................................53
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Acquisitions ...............................................................................................54
Beat Count ................................................................................................55
Pupils.........................................................................................................56
Hardware ..................................................................................................56
SUPPORT.......................................................................................................57
TECHNICAL SUPPORT TYPE .......................................................................57
TECHNICAL SUPPORT NOT AVAILABLE......................................................58
INSTALATION .............................................................................................. 59
SYSTEM REQUIREMENTS ..............................................................................59
SOFTWARE INSTALLATION ...........................................................................60
CHECKING DRIVERS INSTALLATION ..............................................................63
HARDWARE INSTALLATION ..........................................................................64
WIRELESS FOOTSWITCH INSTALLATION .......................................................65
WORKSTATION LAYOUT ...............................................................................66
MAINTENANCE ........................................................................................... 67
FUSE CHANGE ...............................................................................................67
CLEANING ................................................................................................... 69
TROUBLESHOOTING ................................................................................... 70
ACCESSORIES AND SPARE PARTS ................................................................ 71
ACCESSORIES ................................................................................................71
SPARE PARTS ................................................................................................71
TECHNICAL SERVICE .................................................................................... 72
WARRANTY................................................................................................. 73
TECHNICAL SPECIFICATIONS ....................................................................... 74
MODELS DESCRIPTION................................................................................ 75
DISPOSAL .................................................................................................... 77
RIGHTS........................................................................................................ 78
MANUFACTURER DATA .............................................................................. 79
APPENDIX ................................................................................................... 80
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TEST CLASIFICATIONS ...................................................................................80
ABNORMALITY THRESHOLD .........................................................................81
FREYSS DIAGRAM .........................................................................................84
DIZZINESS HANDICAP INVENTORY QUIZ .......................................................86
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INTRODUCTION
The content of the manual describes the procedures recommended to install and use the VNG
Plus. It has all the necessary information regarding the appropriate care and handling of the
equipment.
Please carefully read the precautions with the symbol , to make sure the device is used in
the best conditions and safely.
Should you have any doubt about the content of this manual or the operation or safety of the
equipment, please contact your local distributor or the closest ECLERIS office.
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GRAPHIC SYMBOLS AND LABELS
Recognize the following symbols indicate information or security to prevent damage or personal
injury
Caution!
Hazardous situation that can cause property damage or injury
Type BF
Manufacturer Identification
Up Ground protection
Environmental conditions of
Transportation Equipotential
Fragile
I On
Off
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INTENDED USE
VNG Plus is scheduled to assess, diagnose and document vestibular system disorders.
The eye movements (Nystagmus) are recorded by cameras mounted on the mask. These images
are processed, and stored for later review. This information is used by a professional trained in
diagnosing diseases of the central and peripheral vestibular system.
Use of this device is reserved for otolaryngologists, neurologists, specializing in balance disorders
or other trained medical personnel.
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OPERATING PRINCIPLE
The VNG goggles hold the 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 mirrors simultaneously direct IR illumination toward the
pupil and reflects an image of the eye back to the video camera. The mirror reflects short wave
infrared (~700-800 nm) and passes visible wavelengths.
The VNG goggles can function in both free field of view and light occluding mode. The front
cover plate of the mask is magnetically fixed and can easily be removed.
Before using the VNG goggles please consider the following:
The goggles and cameras contain sensitive electronic and optical devices. Do not expose the
goggles or cameras to mechanical shock.
VNG goggles are not to be used around explosive gases
VNG Plus has two different kinds of sensors to monitor test conditions:
Ultrasound sensor to get 3D static patient position relative to visual stimulator: It is
consisting o n ultrasound r e c e p t o r positioned o n to visual stimulator a n d an
ultrasound emitter, located on goggles. System measures the patient head position
relative to the center of visual stimulator.
Accelerometers to get tilt o f p a t i e n t head: Three Axis Low-g micr o
m a c h i n e d Accelerometer is used as tilt sensor (measuring gravidity vector projection
at each axis and convert it in angles).
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WARNINGS
ECLERIS assumes no responsibility for damage that may occur if the equipment is not used
according to instructions and observing the criteria listed below
Check the security of the operation and condition of the device before each use
Check that the product is fit for use and operation, as well as accessories and keep it
in good working condition.
Protecting patients, third party, other operators, assistants and themselves from
danger.
Only authorized Personal by Ecleris may repair this equipment.
SAFETY INSTRUCTIONS
Electrical
• The VNG Plus is manufactured a c c o r d i n g to IEC60601-1. It is classified as a
Class I type BF device. To avoid the risk of electric shock, be connected to a mains
power supply with protective earth
• Be sure to connect the computer to the specified voltage (100-230V, 50/60 Hz)
• Do not use the computer during electrical storms.
• Before lighting check that the power cord is not damaged. In which case you should
replace it immediately.
• All non-medical equipment connected to VNG Plus, you must meet electrical safety
standards IEC or ISO apply to that device.
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Environmental
• Do not install the equipment near any heat sources such as stoves.
• Put the machine on firm, horizontal surfaces.
• Do not block the vents. This vent should be located so that there is good air circulation.
• Avoid subjecting the device to sudden temperature changes to conditions of extreme
temperatures and relative humidity, direct sunlight and dust. Observe the following
conditions:
Operation Transport
Temperature 10°C-40°C 10°C-45°C
Relative Humidity 30-75% 10-95%
Air pressure 700-1060 hPa 500-1060 hPa
During use
• Evaluate whether the patient is suitable for nystagmography testing (See:
Consideration of the patient)
• Avoid using the system in the presence of explosive or flammable materials.
• Always ensure that all staff is familiar with using the system controls and you know
the right steps to turn it off instantly when needed.
• Only physicians, otolaryngologists, neurologists, balance disorder specialist physicians
trained or are authorized to operate the system.
• Do not submerge any part of the system liquid.
• Only original accessories and must be specified wires and used.
• Turn off the switch before connect / disconnect accessories.
• Always place the device so that it can be seen easily from the PC and comfortably
reach,
• The equipment may be affected and experience interference portable and mobile RF
Communications equipment.
• The glasses and cameras containing sensitive electronic and optical devices. Do not
expose the camera to goggles or mechanical shock
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Malfunction
In case of malfunction:
• Immediately stop using the device.
• Try to identify or eliminate the cause by Solving Problems described herein (See
Section Troubleshooting).
• If you cannot identify or eliminate the cause by this document, turn off the device and
call Customer Service Centre or your local Ecleris distributed (see section Data
manufacturer).
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VNG plus DESCRIPTION
Before installing the equipment is important that you read the entire manual. If you h a v e
questions about the operation or installation of the equipment, contact your local supplier.
Not require specialized personnel or experienced for installing the VNG Plus.
The VNG Plus includes the following components and elements needed for installation.
Note: the components and / or accessories may differ depending on version and model
• Main Unit
• Mascara (with shutter)
• Sensor (gyroscope, accelerometer and ultrasound transmitter)
• Bar with receptors Ultrasound
• Power cord
• Pen Drive Installation
• User Manual
OPTIONAL ACCESSORIES
• Wireless Switch
• Stimulating visual: visual stimulation monitors (VGA)
• OPK Laser stimulator
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FRONT PANEL
REAR PANNEL
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JUNCTION BOX
1. Right camera
2. Left Camera
3. Sensor
4. Data
MASK
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PATIENT CONSIDARTIONS
Vision: Patients must have adequate vision to follow targets for the oculomotor portion.
Physical status: If the patient has back or neck injuries, consideration should be given for some
positional testing (head hanging) and the Dix-Hallpike maneuver to avoid further complications.
To screen f o r vertebrobasilar insufficiency, the clinician may want to assess the patient prior to
head hanging or Dix-Hallpike maneuvers. This may include having the patient engage i n mental
tasking (e.g., counting, reciting multiplication tables) while gradually tilting the head back and
then holding. Change in cognitive status or reports of lightheadedness may be significant. This
screening method is especially important for older patients.
Status of the outer and middle ear: This should be evaluated prior to caloric assessment.
Presence of drainage in the outer ear canal precludes the use of water irrigation; it may also
affect air caloric stimulation because moisture will change the calibrated temperature, thus
limiting interpretation. Pressure equalization tubes or perforation of the tympanic membrane
precludes the use of water calorics. If unilateral, large perforations limit interpretation of air
calorics. Large perforations can increase stimulation with cool air above calibrated expectation
and can exhibit a cooling effect for warm air because moisture of the middle ear mucosa is
evaporated. Excessive cerumen must be removed prior to any vestibular stimulation. Middle ear
fluid affects stimulation of the vestibular system with air and water.
Medications: Many medications can affect test results. With physician approval, patients should
discontinue all m e d i c a t i o n s , unless contraindicated, for 2 4 -72 hours prior t o testing. Any
medications taken should be clearly noted on the test results. Alcohol ingestion can affect ENG
test results for 72 hours post-ingestion; results are unpredictable because alcohol can be an
agonist or antagonist.
Patient preparation: Inform patients that VNG may cause dizziness, nausea, or both. Patients
should be advised to limit food intake prior to examination and arrange for transportation after
the examination, which usually takes 1-1.5 hours.
Request the patient:
Dress comfortably.
DO NOT wear contact lenses to the exam
DO NOT wear eye make-up
For many part s of the test, mental tasking is necessary to prevent central suppression of
responses. If the examiner does not speak the patient’s language or the patient is hearing-
impaired, an interpreter may be necessary to assist in giving instructions, explanations, and
mental tasking
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USES INSTRUCTIONS
Once the hardware and software have been installed, you can begin using your VNG Plus.
NOTE: Plus VNG performance may vary depending on version and model Hardware
The VNG Plus user interface is available in English and Spanish. Language selections by pressing
the icon
English Spanish
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NEW PATIENT
To Create Patient File: enter First name (required), last name (required) and #chart, date of birth
(DOB), gender: To add demographic information (Phone, address, etc) press “more” (optional).
NEW SESSION
The tests performed on a patient are stored in a single session. You can perform different
sessions for the same paciente.VNG plus allows you to define the test protocol, configuring each
test as its own characteristics. (SEE: Configure/Protocols)
Ing Plus software will guide you through the protocol selected automatically, allowing you to
interrupt or skip scheduled tests or processes.
To create a session you must complete the following field:
1) Session: Identify the session with a name. If you want create it an automatic ID press
button.
2) Complete the data Clinic, Doctor, Technical (optional)
3) Select a protocol from the drop down menu (See: Create Protocol)
The button opens the database to set the dropdown menu associated with each parameter
START TESTS
Upon completion of patient data and the session can begin the study from the Start Session
button. VNG Plus will instruct and help step by step in a simple and safe way to perform
scheduled tests
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OTHER FUNCTIONS
Analysis window.
Use this option to publish your reports privately or publicly. See: Create a
publication
Export a Test
TOOLBAR:
Shut down: Close VNG Plus.
Setup: Setup hardware and software.
Support: User-friendly assistance for individuals having technical problems
with VNG Plus. The technical support team, is able to troubleshoot most
problems that a user experiences. Technical support may be provided,
through email, or with remote interface.
Start session: Starts the selected test protocol
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CUSTOM PROTOCOL
Shows sequence of the test to follow. The list includes patient preparation, calibration and test.
All will be included in the protocol you selected. (See: Software Setup Protocol).
You can deactivate some items uncheck them. These changes will not be saved
View detail Test allows look more data Test (Frequency, direction, Time, etc)
Toolbar bottom
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DIZZINESS HANDICAP INVENTORY
The dizziness handicap inventory (DHI) is an optional 25-item questionnaire, which was designed
to measure the self-perceived disability or handicap caused by symptoms of dizziness or
imbalance. The individual questions are designed to address the impact of the symptoms on the
physical, emotional, and functional aspects of daily activities, and there are three possible
answers, "yes," "sometimes," and "no," to each question. The maximum total score (indicating
maximum handicap) is 100. There are seven questions that comprise the physical subscale
(maximum score of 28) and nine questions each on the functional and emotional subscale
(maximum scores of 36). For ease of comparison the subscale scores are converted to percentage
scores. (See appendix Dizziness Handicap Inventory)
Press the answer button or press the keys Y (yes), S (Sometime) or N (No).
You can answer the questionnaire in automatic mode, which happens after
answering the question or you can do it manually with the next / previous
Arrows
For easy of comparison the subscale (emotional, functional, physical) scores are converted to
percentage scores
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Toolbar bottom
POSITION
Since the patients distance to the screen is a key part of the geometry to produce the visual
stimulation in degrees (+/- 20º 30º), it should only be changed on purpose. But do not worries
about to return the chair to its original position in case it have been moved, VNG Plus is
controlling it all the time (See: Alarms).
VNG Plus supports s c r e e n (monitor) of different geometries, which must be configured from the
Configure / Advanced / Stimulator
Toolbar bottom:
Home: Return to Home window
Back: Return to previous window
Go to: Select another Window
Next: Forward to next window
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GOGGLES
The Video Goggles shall be put in such a way that it fits the patient’s face the best possible.
Both elastic strips shall be firmly fixed t o the patient’s head. To center the image on eye
displayed move the mirrors slowly but don’t touch it.
Nystagmus assessment depends on the quality of the images. Center the image of the eye in the
respective box. If necessary use the fine adjustment of the cameras and/or move the mirrors from
the top screws to align the image so that the pupil is perfectly centered. The right frame displays
the left eye and the left frame displays the right eyes.
Place the junction box on the arm of the patient as a bracelet, so comfortable and
avoid getting wires tangle and twist.
Toolbar bottom:
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EYE SELECTION
It especially relevant for the settings in the Test, to define which eye's record to analyzing. VNG
Plus analyzes only one eye record at a time. The selected eye to analyze default is Left but this
may change at any time.
NOTE: If after carrying out the analysis of a session, you change the eye to analyze. You will lose
the previous analysis
Toolbar bottom:
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CALIBRATION
This is not a true calibration to determine the amplitude of the eye movements in degrees b u t
more an allowance for a correction factor due to the individual anatomical differences of the
orbit of the eye.
These corrections are especially important in the evidence that eye movements are compared to
a target stimulus from a known position (speed). In other test calibration is not essential.
However, i f the mask has been repositioned or removed since the initial calibration was carried
out the procedure must be repeated.
Checkpoint is it a quickly to the calibration state verification. It is only used after the calibration
process.
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When the calibration process has ended, the patient will look a dot red (led emitter) inside the
goggles. This is a checkpoint to use to verify if the mask has been moved. Otherwise, you need
to recalibrate
Toolbar bottom
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DATA ADQUISITIONS
Registers
Display on real time eyes position (or velocity) graphically, and superimposed to the target line
plotted as comparison criteria.
The eye position [º] (or speed [º/sec]) is plotted against time, whose description is the following:
• Horizontal position [º] vs. Time [sec.] In a Cartesian x-t graph. [Green]
• Vertical position [º] vs. Time [sec.] On a Cartesian graph y-t. [Blue]
• Position the stimulus pattern. [Red]
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Warnings
Alarms can be configured with different degrees of stringency (See: Configure / Advanced /
Warnings).
b) Head angles
c) Head tilt:
Warnings Colors
During recording
OK
Out of range
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Demonstration
For each test is available an audio-visual support with a video showing how to conduct the test,
and instructions for the user or patient. It also offers recommendations and a list of artifacts that
could influence the results. This support can be configured so that it is always available before a
test or access it at the discretion of the user and need. (See: Setup/Advanced/Demos and
Setup/Advanced/Acquisitions)
Toolbar:
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Performing the test
On the window there are the test warnings and also the eyes video display. When the subject is
ready, press Start button to record the test.
By clicking the Register button data recording starts automatically.
Tests have a configurable time limit, and they will stop automatically. However, you can stop a
test manually at any time pressing Stop button.
Note: If you run the test, this will be overwritten. To repeat the same test, without losing data
you must start a new session.
The pedal can be used only to record and stop capturing a test, do not respond to other events
Spontaneous Nystagmus
Spontaneous Nystagmus denotes movement of the eyes without a cognitive, visual or vestibular
stimulus. The tests are conducted with vision occluded, and with the eyes on primary position.
Vestibular Nystagmus is typically inhibited by visual fixation (see Setup: Spontaneous)
Warnings:
• Patient position
• Head Movements
• Head angles
Gaze
For gaze testing, the patient is instructed to look straight ahead and then to fixate on a target to
the right, left, up, and down.
Warnings:
• Patient position
• Head Movements
• Head angles
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Saccades
For saccadic testing, one may place dots on the Monitor at specified distances from each other
and then instruct the patient to look back and forth between the dots, keeping the head fixed.
Warnings:
• Patient position
• Head Movements
• Head angles
Smooth Pursuit
The patient follows a sinusoidal moving target with his or her eyes only.
Warnings:
• Patient position
• Head Movements
• Head angles
Optokinetic (OKN)
For O p t o k i n e t i c testing, the patient tracks multiple stimuli. Stimuli a r e moved a t a
rate programmed in each direction. (Clockwise and counterclockwise)
Warnings:
• Patient position
• Head Movements
• Head angles
Warnings
• Patient position
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Video head impulse test (vHIT)
This test records the movements of the eyes and head. The clinician’s hands must be well away
from the goggles and the goggle-strap to minimize the chance of any artifact camera movement.
The patient should keep staring at target point on the screen , and the clinician gives the
patient brief, abrupt, horizontal head rotations through a small angle (about 10-20 degrees)
unpredictably turning to the left or right on each trial.
In a full test usually around 20 impulses are delivered randomly in each direction. In a full test
Usually around 20 impulses are delivered randomly in each direction and it may take 4 or 5
minutes to do that.
This test plots the eyes velocity and head velocity.
Warnings
• Patient position
Supine
The examiner places the patient in each position and evaluates for a minimum of 20-30 seconds.
Mental tasking is used to keep the patient from suppressing Nystagmus. Visual suppression
must also be avoided by the use of infrared goggles. Some standard positions used include the
following:
Warnings
• Patient position
Dix Hallpike
Dix-Hallpike is performed o ver a stretcher that allows lying down and sitting the patient quickly.
The Dix-Hallpike maneuver i s performed by turning a patient’s head to the right or left and then
briskly assisting him or her to a supine position with the head hanging to the right or left.
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The patient is left in this position for a brief period while eye movements are observed. Finally,
the patient is returned to a sitting position.
The testing is conducted whit fixation suppression (goggles covered).
This test records the patient position and plots the eyes movements
Calorics
The patient is placed in a reclining position with his or her head at a 30° angle. This position
orients the lateral semicircular canals in the most vertical plane.
Protocol for caloric stimulation, alternating binaural bithermal caloric stimulation includes the following
conditions:
Left ear warm (LW)
Right ear warm (RW)
Left ear cool (LC)
Right ear cool (RC)
During each stimulation, the cool or warm stimulus is delivered for a preset time that is
determined by the type of stimulus and normative data. The countdown timer shows the warm
or cold stimulation time and recovery times.
The testing is conducted whit fixation suppression (goggles occludes)
Important: It should explore the ears (outer and middle) before proceeding with the caloric test
(See Patient Considerations: Status of the outer and middle ear)
FIXATION SUPPRESSION
After each caloric stimulus, the patient is instructed to fixate on a light Red (inside the goggles).
Fixation should normally eliminate or greatly reduce the induced Nystagmus.
Warnings:
• Head Movements
• Head position = 30º
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ANALYSIS GENERAL
The test will be opened and test data will be displayed in the analysis window. The analysis can
be recorded immediately after the test or after performing the scheduled Test Battery
The tests of the same type with multiple sub-tests are shown in one window. The test name
displayed should be selected from the drop down menu.
Records (horizontal / vertical) and the video are captured, along with alarm status.
Excellent
Regular
Poor
Playback Record
Pressing the Play button you can review the video, and alarm registers simultaneously
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Use the following tools for:
Create print windows: cropping a records area to print. (See: Create print window)
Edit Nystagmus manually. When reviewing an editable test, you can click on edit Icon to
open the Edit mode and display the Edit toolbar. The Edit icon appears example from
Caloric test (See Edit Nystagmus)
Graphical analysis: Graphs that display the measuring process over time. Those graphs
that show analyzed data (e.g., Peak velocity, latency and Accuracy in the saccades test).
The abnormal threshold is the dotted gray area (See: APENDIX Abnormality threshold)
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When is appropriate, the Test data is displayed in numeric and/or graphical form on the user
interface.
The software d i s p l a y s all test information in a single display screen. This allows the user to
simultaneously view the data collection along the analysis displays. In each measurement
diagram, you can maximize and minimize the display of the measured data by using the
zoom option
Toolbar bottom:
Spontaneous
Spontaneous Nystagmus: This may indicate either central or peripheral pathology. The
presence of Nystagmus can be evaluated with fixation (center, r i g h t , and left, down and upon)
o without fixation.
Nystagmus Count
SPV (º/sec) is average slow phase velocity
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Gaze
These Nystagmus tests document and measure the inability of the eyes to maintain a static
position. Nystagmus and slow phase velocity are evaluated for each position
Nystagmus Count
SPV (º/sec) is average slow phase velocity
Saccades
Saccadic test results are influenced by patient cooperation and visual acuity. Velocity, latency,
and accuracy should all be taken into consideration when interpreting saccades.
Velocity (º/sec) is approximately proportional to saccadic amplitude for sizes 5º and 20º.
After amplitude reaches 20º, saccadic velocity undergoes a soft saturation with respect
to further increase in amplitude. Velocity= asymptote (1-e Amplitude/15) the usual upper
limit for saccadic velocity is about 750º/sec and the lower limit is set at 350º/sec
Latency (mess) is calculated from difference in time between target displacement and
the onset of the first saccade toward the new target position
Accuracy (%) keeping in mind that the goal of a saccadic eye movement i s to fixate
visually both quickly and accurately on a new object. The eye movement should be
equal in amplitude to the distance between the former object of interest and the new
target.
Smooth pursuit
The smooth pursuit system is responsible for following targets within the visual field. Care should
be taken in interpreting smooth pursuit test results in geriatric and pediatric patients. Tracking is
also affected by attention and patient cooperation. Gain, Phase, and THD should all be taken
into consideration when interpreting smooth pursuit.
Gain refers to the ratio of the eye velocity (non saccadic) to the target velocity.
Phase refers to delay between the target and the tracking wave forms
THD: Total harmonic distortion. It is refer a global measurement to tracking test in
frequency and amplitude. If the peak is around the target frequency, the tracking was
good
Optokinetic (OKN)
For Optokinetic testing, the patient tracks multiple stimuli. Gain and Asymmetry should all be
taken into consideration when interpreting OKN
Gain refers to the ratio of the eye velocity to the target velocity.
Asymmetry refers to gain significantly worse in one direction than another
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Active head rotation (AHR)
The vestibular autorotation test provides a measure of vestibular function during active head
rotation. As such, it is a test of canal function during natural active movement, a common
situation for patients. This test is performed recor din g the eyes and head movement. The
gain, phase and THD of the vestibular ocular reflex are analyzed.
Gain refers to the ratio of the eye velocity to the head velocity.
Phase refers to delay between the head and the eyes movement wave forms,
normalized to the period, and multiplied by 360º
THD: Total harmonic distortion. It is refer a global measurement to tracking test in
frequency and amplitude. If the peak is around the target frequency, tracking was good
Results:
Avg. Gain Leftward/Rightward. The average gain of all Leftward/ Rightward shakes.
SD Leftward/Rightward. The standard deviations Leftward/ Rightward shakes.
Symmetry: refers to gain significantly worse in one direction than another.
Avg. Gain: The average gain of all shakes.
Test Compliance: refers to a measure of performance of the test.
Supine
These are VNG test to diagnose BPPV and other vestibular complaints. Parameters are calculated
for horizontal channel all positions
Nystagmus Count
Latency (sec) i s calculated from the difference in time between head displacement and
the onset the first Nystagmus
SPV (º/sec) is average slow phase velocity
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Dix Hallpike
These are very important as part of the standard V N G to diagnose BPPV and other vestibular
complaints. Parameters are calculated for horizontal channel both side (Dix-Hallpike Right and
Dix-Hallpike Left)
Nystagmus Count
Latency (sec) i s calculated from the difference in time between head displacement and
the onset the first Nystagmus
SPV (º/sec) is average slow phase velocity
Calorics
The caloric tests evaluate the viability of the peripheral end organs by stimulating them with
warm and cool water or air. The resulting dizziness and Nystagmus is taken as an index of
the viability of the organ. The culmination phase area is automatically defined (the best 30
sec). Nystagmus that lie outside the area, does not contribute to the analysis.
Time /SPV: show the slow-phase velocity evolution of the tests performed. To be able to
appreciate the test symmetry, i t is possible to generate an interpolating line that
automatically fits.
Fray’s graph: show the frequency (Hz) and slow-phase velocity (º/s) as well as absolute
and directional preponderance data, right and left Nystagmus beats,
symmetry, frequency and slow phase velocity for each ear. (See: APENDIX Frays Graph)
Parameters: show the absolute and directional preponderance data, right and left
Nystagmus beats, symmetry, frequency and slow phase velocity for each ear.
The report manages the printing functions of VNG Plus. Prints different configurations and
analysis of records obtained as well as use a wide variety of printers
Records and analysis on each test will be displayed in the preview. At the bottom show the
current page / Total pages Number. Use arrows to move between pages.
You can select a tests to print by pressing Selection Tests and Options Test of the same trials
Pressed Options (See also: Configure / Advanced / Print)
Pressing analysis, a form with the tests summary is open, which you can select any Test to review
it again.
Print Mode: With these controls you can select whether sending the report directly to a printer,
or save it to a pdf. File
PDF printer
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Logo: Insert a picture (.bmp/jpg) on to the report header
Toolbar
Page: Print current page.
All: Print all pages.
Back: quit the report window
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EDIT NYSTAGMUS
The nystagmus analysis constitutes a major part VNG Plus s y s t e m . The algorithm
accuracy depends on several factors:
The software searches for Nystagmus beats on the eye movement trace and perform automatics
detection. The software also calculates other important recording parameters ( slow phase
velocity, Nystagmus frequency, etc).
Even so VNG Plus offers a function, to allows you to overrule (partial or total) the automatic
analysis performed by the software algorithm. With the possibility of adding or deleting
Nystagmus marks you should optimize the results of the analysis by exerting your professional
training and experience.
To enter editing mode, click the edit mode button, the Edit Toolbar will appear. In this mode,
graph displayed the Horizontal Channel alone.
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Automatic Edition
Modify the algorithm´s sensibility, moving the slider control to vary the criteria used to determine
to the Nystagmus existence. Then press re- analysis button
Manual Edition:
To include a new Nystagmus press the Add button and
then
It is marked on the plot the slow phase slope added, an arrow indicating the Nystagmus, and is
shown in the graph properties. The slow phase and fast phase detected, and the criteria used to
determine the Nystagmus existence
To delete a Nystagmus, press the Delete
button
1. Click over to Nystagmus to remove it.
Toolbar
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SOFTWARE SETUP
The following section describe all of these options and parameters configurable by user
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LISTS
Edit the list to be available in patient records: Doctor, Administrators and Clinics.
Here you can add or remove items
To delete the selected patient session (highlighted in blue), pressures Delete icon
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PROTOCOL
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Details: Show the test description: Time, frequency, direction, etc
The protocol Tree is similar to the one in Windows Explorer and can consist of up to two levels.
First Level: Displays screen/Test
Second level: Displays description (paradigm, Velocity frequency, Etc) for performed tests
All tests are saved. The test disabled (unchecked) don't be included on the protocol
sequence and should use the GO TO function, to open this window.
Edit: Allow modify protocols add/ Remove/Move test and/or calibration process;
except the protocols predefined. The edits made to the protocol, can be saved as
a new protocol and keep the original protocol unchanged. For this select the Save
As option.
Move Up
Move Down
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Delete
Enable/Disabler
Nystagmus: Spontaneous
Visual Stimulation: Gaze, OKN, Saccades, Smooth pursuit
Posture: Dix-Hallpike, Supine
Caloric
At: AHR, vHIT
Questionnaire: DHI, DHI military
Assistances: Position, Angles, Goggles
Configuration: Eyes selection, Test selection, Calibration
Save the protocol and will be available to select in the patient session
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Delete: Deletes the selected protocol list
VIEW DEMO
You can see a Test instructions, recommendation and artifact (most probable
mistakes), and video test demonstration for each test (ex: Dix Hallpike v i d e o
demonstration is shown on figure). If you want to see it, before start the test
recording, you must activate Test instruction on the Advanced / Acquisitions tab
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ADVANCED
Toolbar
Back: return previous window
Default: Reset all parameters
Save and Exit: Store all new parameters a n d coming back to previous window
Warnings
Select the warning control: Soft /Normal/ Hard
Depending on the selected warnings level will be more or less stringent (demanding) perform a
test
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Visual stimulator
VGA:
OPK laser:
Set the amplitude in degrees to stimulate the patient, thus the location of the system is
determined
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Print Report
Check / uncheck the items you want to print. You may change these options on report print
settings by sessions
Opciones para las Pruebas: Estos ítem se aplican para todas las pruebas seleccionadas.
Spontaneous
Gaze
Saccades
Smooth pursuit
OKN
Dix-Hallpike
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Supine
Calorics
AHR
VHIT
DHI: dizziness Handicap inventory score
Medical release
CPT: Current Procedural Terminology codes are numbers assigned to every
task and service a medical practitioner may provide to a patient on USA. They
are then used to determine the amount of reimbursement that a practitioner will
receive. They e n s u r e uniformity. The codes are developed, maintained and
copyrighted by the AMA (American Medical Association.)
Time Plot
Time plot displays the history of eye position data. The time axis is always horizontal and
directed to the right.
Here you can choose the Time window (time axis) to be displayed or printed.
The offset- time area relative to the whole area allocated for the chart is defined here and the
scrollbar may be used to change the chart view. Not so in the printing, will only print the defined
time window.
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Part of the record does not appear at the viewing, so you must use the scroll bar to scroll the
entire layout. While printing, are printed only the first 25 sec of recording or window marked to
printing (See: Print the Bookmarks)
Acquisitions
Test Instruction: Before start the test, is opening a windows, to show how to administer the test.
There are also recommendations and descriptions of the most common mistakes to affect the
recording and a video demo too (See Demo)
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Audio Instructions: Enables the user-mode audio reading
Wireless Footswitch: Turn on the wireless pedal. (See installing the wireless footswitch)
VGA ON:
Overwrite Camera: Lets you use the system with a single camera (Right / Left)
Render: Enables support for rendering of video depending on the version of Windows ® (XP, 7,
8)
(VRM 0 Video Render/ V R M 9 Video Render/ Window 8 video render: Hardware setting only for
Ecleris technical staff.
Beat Count
Provides the ability to adjust the sensitivity of the detection algorithm (See: Edit Nystagmus)
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Pupils
Users rarely access this configuration tab. This requires technical information that is specific to
your installation. Request Support before changing any parameter, as it may affect the operation
of VNG Plus.
Hardware
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SUPPORT
To request technical assistance, click on Support button in home window.
Remote Support, access the following screen.
Include your inquiry or problem description in the field below. If this is a support request, please
include a full description of the problem, including the error message.
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After that technical support receive the application to Remote Access and until in fact is
established or canceled the connection you will see the following screen.
If is pressed the Cancel button, technical support will not able to establish the remote
connection.
It is seen that Technical support will establish the connection after 4 hour from the answer date.
If it is desired wait, only you must close the message and wait the attention. If you do not want
to wait, after close the message it is possible cancel the technical support application.
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INSTALATION
SYSTEM REQUIREMENTS
• Hardware:
• Software:
Operative System
Windows 7 (32 & 64 bit)
Windows 8 (32 & 64 bit)
System SDKs
DirectX
Windows Media distribution version
Windows Media encoder distribution version
Microsoft Framework 3.5
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SOFTWARE INSTALLATION
With the device disconnected plug in ECLERIS installation Pen drive in a free USB port.
If it does not executes automatically after a few seconds. You must be run installation manually,
executing USB Drive\Setup.exe
By default, the installation folder is
c:\Program F i l e s \Ecleris\VNG Plus
Select the installation language and press
Next to start installation process.
It is recommended t o follow the options that appear by default, by pressing Next button in each
of the screens, unless indicated otherwise.
Once the files are copied, the installation program w ill automatically begin drivers’ installation.
Remember that the VNG Plus must remain disconnected from the PC.
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You might be asked to restart your PC, you must choose in all cases “No, Restart
later", until installation is finished completely.
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If at this point is consulted on restarting the computer answer: No, Restart later.
The software and drivers installation has finished.
It is advised, before to beginning the drivers load, reading carefully Section Hardware
Installation.
When connecting the VNG Plus to the USB port automatically begin the drivers loading. At the
end, on the Windows® taskbar, yo u will see a legend confirming the correct installation of the
device.
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In some cases the operating system tries to loading first driver emulation (CDC RS-232 Emulation
Demo) a n d could appear an error message. Ignore it, and then check the correct driver
installation. See: Checking correct installation of the drivers in Windows7
You can check the correct driver installation from the Device Manager. It´s accessed over:
Start/Control Panel/ System and Maintenance/ Device Manager
1. USB 2862 Device means the VNG plus Video device was installed.
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2. Communications Port means the VNG plus Data device was installed.
HARDWARE INSTALLATION
Do not use the front ports of desktop PCs since normally they are not correctly
assembled. This can cause communication errors.
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WIRELESS FOOTSWITCH INSTALLATION
1-Connect the USB receiver d e v i c e located footswitch inside, onto USB port available on
your computer.
2- Put on one AA battery in the battery compartment located on the footswitch inside. Check the
battery position, according to schematic description (+ -)
3-Computer will automatically search and installs drivers necessary to the new device.
WORKSTATION LAYOUT
To generate v i s u a l stimulation VNG Plus two provides the stimulus image as a digital
signal.
The stimulus image should be displayed by a flat panel TV (LCD, LED or Plasma) or projected by
System with VGA input. The Monitor (or projection screen) should be centered i n front patient´s
eyes to achieve proper stimulus on the screen.
To select proper visual stimulator (LCD, TV, etc) tacking account device dimensions see Software
Setup: Advanced / Tab Screen and fill device data to validate device.
Visual stimulator is used in following tests:
• Gaze
• Smooth Pursuit (Tracking)
• Saccade
• Optokinetic test
• AHR
• VHIT
• Calibration
Component Placement:
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MAINTENANCE
- Cleaning.
- Electrical connections inspection.
At the user’s request, the manufacturer will provide circuit schemes, component list, technical
descriptions and other documents related to those parts of the equipment that can be repaired
by duly qualified technical personnel.
All revision or maintenance works, repairs or modifications shall be written down on the
Maintenance Card of this manual, indicating the work performed, date, name and signature of
the responsible person that performed it
FUSE CHANGE
To avoid loss of time due to unavailability of the equipment, it is recommended to have a spare
fuse (T1AL250V).
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MAINTENANCE CARD
This card shall only be completed by authorized personnel from the company, responsible for the
maintenance, repair and modification of the device.
We recommend keeping it updated f o r a faster and more efficient service.
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CLEANING
CONSOLE
The cabinet should be cleaning with a soft dry cloth. If the surfaces are very dirty, use a soft cloth
slightly wet with alcohol or isopropanol.
GOGGLES
Camera lenses and IR coated mirrors must be checked regularly for stains and dust, and should
be cleaned with lens cleaning wipes.
Goggle frame should be cleaned with a sterile cleaning tissue containing 70% ethanol, 2%
glycerol or isopropanol
Goggle straps can be machine washed at 40°C using normal washing detergents. Do not tumble
dry. Please note that the elastic qualities may deteriorate after more than 10 washing cycles,
after which the straps should be replaced.
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TROUBLESHOOTING
The device does The power supply cable is broken or Change the power supply cable
not turn on. cut
The plug is in bad conditions Change the plug
The fuse is broken or burnt. Change the fuse
The Device is not The drivers are not correctly Check drivers installation/Install
installed drivers
detected, or there
are faults in the You must connect it to a USB
capture or VNGPlus is not connected to a USB onboard port (mother). Wired
assistance display port on board ports do not guarantee the proper
functioning of VNG Plus.
the cameras are not properly Check for proper connection of
There aren't image connected to junction Box the (right / left) cameras
of (the) eye (s) and
The junction box is unplugged Connect the junction box correctly
test cannot be
recorded. The software installed is single Contact Technical Service to
channel (eye). activate both Channels
Missing to install drivers. Install the wireless switch drivers.
The wireless Plug USB receiver (It is inside the
USB wireless receiver is unplugged.
switch is not switch) to a USB port of the PC.
detected or not
working Function wireless switch is not Select the wireless switch into
activated. Setup/ Advanced / Acquisition
Please contact our support team if you were not able to locate the source of error with
our advices mentioned above.
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ACCESSORIES AND SPARE
PARTS
ACCESSORIES
Position and movement Sensor
U-Sound bar
VGA Monitor
OPK laser
Switch wireless
SPARE PARTS
Camera Left
Camera Right
Position and movement Sensor
Power supply
Mask Cushion
Google straps
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TECHNICAL SERVICE
VNG Plus m u s t be repaired and/or maintained exclusively in th o se facilities a u t h o r i z e d by
ECLERIS S.R.L. It recommends using the following procedures f o r a quicker repair service and
replacement of guarantee products.
1) Contact the technical department of your local distributor or the nearest ECLERIS S.R.L.
office.
2) Give detailed information of the problem.
3) If the problem cannot be solved by troubleshooting, the product must be sent for its repair
or replacement.
• Owner’s name.
• Owner’s address.
• Contact name and phone number.
• Product’s serial number.
• Problem’s description.
Send the VNG Plus for repair or replacement. It must be sent in its original packaging to avoid
damages during transportation. ECLERIS S.R.L. shall not be liable for those damages or defects
that may occur during transportation, caused by deficient packaging.
The following label is located on the main unit of the device. Physicians and all the personnel
should be familiar with the position and meaning of the label.
This label contains technical data and the serial number of the device. Please specify all of them
Whenever you issue an order for spare parts, accessories or send any question.
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WARRANTY
ECLERIS S.R.L. states that VNG Plus has complied with the required Quality Control verification
and has no manufacturing defects, thus it guarantees the appropriate functioning under
adequate use in agreement with the indications stated in this manual. The warranty period is
one (1) year as from the date of purchase.
ECLERIS S . R . L . is not liable for any damage caused to/by VNG Plus d u e to incorrect use,
negligence, incorrect cleaning or storage. Any repairs made by personnel not authorized by ECLERIS
S.R.L. will void the warranty. The described warranty is exclusively valid for the original buyer
The following parts are excluded from the warranty:
• Parts and components manufactured by third parties.
• Cables and plugs.
• Damages resulting from connections to inadequate power supplies.
Disregarding the warranty situation, all shipment from and to the authorized technical services of
ECLERIS S.R.L. is the sole responsibility of the customer.
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TECHNICAL SPECIFICATIONS
DEVICE CLASS I
TYPE OF CURRENT ~
FREQUENCIES 50 - 60 Hz
FUSE T1AL250V
SERVICE CONDITIONS 10 - 40 ºC
30 - 75 % Relative humidity
700 - 1060 hPa.
WEIGHT 4 Kg
DIMENSIONS 26.5 x 10 x 27 cm
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MODELS DESCRIPTION
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DISPOSAL
At the end of the lifetime of the product, it and all its components should be treated as
electronic waste.
Do not dispose of the device, as well nor any of its accessories together with household waste.
Check local regulations for proper disposal. It is the responsibility of the user of
the device delivers a designated collection point for recycling of electrical and
electronic equipment or contact the manufacturer or the manufacturer's
authorized representative to proceed with disposal in a safe and
environmentally friendly manner
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RIGHTS
All rights arising from the manual herein, especially its reproduction, publishing and translation
are reserved. No part of this manual shall be reproduced by any means (photocopy, microfilm or
other methods) without the previous written authorization by ECLERIS; likewise, no part shall be
reproduced, multiplied or published through electronic data processing.
The information contained in this manual can be modified or enlarged without previous
notification, without it representing any liability for ECLERIS.
Select the Crop Area tool in the Tools panel (circle or rectangle) and draw a crop area around
the figure
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MANUFACTURER DATA
ECLERIS S.R.L.
Av. Francisco Laprida 4955
(B1603ABK) Villa Martelli, Buenos Aires, República Argentina
Tel/Fax +5411 4838 3200
Web: www.ecleris.com
E-Mail: info@ecleris.com
ECLERIS USA
12335 World Trade Drive, Suite 8
San Diego, CA 92128
Tel: 858 613 8775
EU Authorized Representative:
MEDES Ltd. UK
5 Beaumont Gate, Shenley Hill, Radlett, Herts WD7 7AR, England
Tel: +423-663-169205
Tel/Fax: +44-192-385-9810
e-mail: medes@arazygroup.com
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APPENDIX
TEST CLASIFICATIONS
The table summarizes the Tests, together their most important setting parameters.
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ABNORMALITY THRESHOLD
These comments are generalities. Exceptions may occur
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Latency: reaction time in Age 90 and above: 300 msec Internuclear
msec. Velocity: ophthalmoplegia ( Brain
Age 50 and under: <240 stem)
Accuracy: deg/sec
undershoots/overshoots Age 60- 69: < 230º/sec Age
70-79: <220 º/sec Age 80-89:
< 210 º/sec
Age 90 and above: <200 º/sec
Accuracy:<55%
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While Videonystagmography is the most widely used clinical laboratory test to
assess vestibular function, remember that normal VNG test results do not
necessarily mean that a patient has typical vestibular function. VNG
abnormalities can be useful in the diagnosis and localization of site of lesion;
however, many abnormalities are no localizing; therefore, t h e clinical history
And otology examination of the patient is vital in formulating a diagnosis and treatment plan
for a patient presenting with dizziness or vertigo.
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FREYSS DIAGRAM
It was designed to perform the bilateral bi-thermal caloric test. Freyss butterfly or diagram shows
the Nystagmus intensity together with the results of absolute symmetry and preponderance.
In its most traditional form, Freyss butterfly represents the number of nystagmic flaps observed in
a 30-second period. It also requires the stimulus corresponding to Hallpike rules: irrigate 125cc
of water at 30 and 44° C during 30 seconds. The patient shall be in horizontal position with the
head at 30 degrees.
In these conditions, it is possible to use the results of the normative data published by G. Freyss
giving the symmetry normative limits (<15%) and a directional preponderance (12%). It is also
possible to evaluate a hypo-sensitivity condition (<30 saccades) or hyper-sensitivity (>122
saccades) of a single ear, if you add up the saccades induced by both ears with hot and cold
stimulus.
In general, the graph is centered in a point, the ordinate axis represents t he Nystagmus intensity
and the abscissa axis is graduated in percentage. There
are two limits: x = + 100 and x = - 100. Rightwards
Nystagmus flaps are positive while the leftwards ones
are negative. The results obtained from the right ear
are represented in line X = - 100 and the left ear ones in
line x = +100. Both points corresponding to the
intensity measure of a bilateral isotherm (cold or hot)
are thus connected defining a straight line and the
equation may be represented as y = a x + b whose slope
is positive for cold tests and negative for hot tests.
Once the four tests are completed, then the intersection
Point p ro j ec tion s in X a n d Y o f both straight
l ine s
Represent the following two
results:
In the vertical projection, the lateral symmetry value or channel paresis (X) is represented in
percentage. If the Nystagmus direction for each of the four tests is as expected, then you may
use the traditional Jongkee’s formula:
In the horizontal projection, the absolute preponderance (Y) is calculated using the following
formula
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The hyper or hyposensitivity condition for each ear is assumed from segment l e n g t h covered by
the butterfly wing in the axis: x = - 100 for the right side and x = + 100 for the left side.
FREYSS DIAGRAM FOR SLOW PHASE SPEEDS
The diagonal intersection coordinates represent the unilateral weakness calculated using
Jongkee’s formula. The absolute directional preponderance is not shown as a percentage but as
an absolute value, in degrees per second.
This format offers d i f f e r e n t advantages as the ability to compare the preponderance speed
against the speed of any Nystagmus that may be present. The relative directional preponderance
is also shown in % since this format is more familiar.
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DIZZINESS HANDICAP INVENTORY QUIZ
Yes Some…. No
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P11. Do quick movements of your head increase your dizziness?
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Does your dizziness interfere with your job or household
F24.
responsibilities?
Score:
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NOTES
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