Ecleris VNG Plus User Manual

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VNG Plus
Videonystagmography System
USER´S MANUAL
V.18.11.18ENGLISH
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For more information, accessories, and replacement parts, contact.
ECLERIS S.R.L
. FRANCISCO N. LAPRIDA 4955.VILLA MARTELLI (B1603ABK) BUENOS AIRES. ARGENTINA Tel/Fax: +54 11 48383200 Web: www.ecleris.com E-Mail: info@ecleris.com
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INDEX
INDEX ............................................................................................. 1
SECURITY WARNINGS ...................................................................... 5
SIMBOLS ......................................................................................... 8
GENERAL INFORMATION ................................................................. 9
INTENDED USES .................................................................................... 9
INTENDED USER .................................................................................... 9
OPERATING PRINCIPE ........................................................................... 9
PATIENT CONSIDERATIONS ................................................................. 10
DESCRIPTION ................................................................................ 12
FRONT PANEL ..................................................................................... 12
REAR PANEL ....................................................................................... 13
JUNTION BOX ..................................................................................... 13
GOGGLES ............................................................................................ 14
INSTRUCTIONS FOR USE ................................................................ 15
RUNNING THE PROGRAM ................................................................... 15
HELP ................................................................................................... 16
NEW PATIENT ..................................................................................... 16
NEW SESSION ..................................................................................... 17
CUSTOM PROTOCOL ........................................................................... 19
DIZZINESS HANDICAP INVENTORY ....................................................... 20
ASSISTANT VNG PLUS ......................................................................... 22
POSITION ............................................................................................................ 22
GOGGLES ............................................................................................................ 23
EYE SELECTION ................................................................................... 24
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CALIBRATION ..................................................................................... 25
STANDARD .......................................................................................................... 25
HEAD CALIBRATION ............................................................................................ 26
Active calibration: AHR ....................................................................................... 27
Passive Calibration: VHIT .................................................................................... 27
DATA ADQUISITIONS .......................................................................... 29
Registers ............................................................................................................. 29
Warnings ............................................................................................................. 30
Demonstration .................................................................................................... 31
Performing the test ............................................................................................ 32
Using the Footswitch .......................................................................................... 32
Spontaneous Nystagmus .................................................................................... 32
Gaze .................................................................................................................... 33
Saccades ............................................................................................................. 33
Smooth Pursuit ................................................................................................... 33
Optokinetic (OKN)............................................................................................... 33
Active head rotation (AHR) ................................................................................. 33
Video head impulse test (vHIT) .......................................................................... 34
Supine ................................................................................................................. 34
Dix Hallpike ......................................................................................................... 35
Calorics ............................................................................................................... 35
ANALYSIS GENERAL ............................................................................ 37
Spontaneous Nystagmus .................................................................................... 39
Gaze .................................................................................................................... 39
Saccades ............................................................................................................. 39
Smooth pursuit ................................................................................................... 40
Optokinetic (OKN)............................................................................................... 40
Active head rotation (AHR) ................................................................................. 40
Video head impulse test (VHIT) .......................................................................... 41
Passive calibration of the head (VHIT) ................................................................ 41
Supine ................................................................................................................. 42
Dix Hallpike ......................................................................................................... 42
Calorics ............................................................................................................... 42
REPORT .............................................................................................. 44
EDIT ANALYSIS .................................................................................... 45
Nystagmus beat .................................................................................................. 45
Cefalic impulse count (VHIT) .............................................................................. 47
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EXPORT TESTS .................................................................................... 48
SOFTWARE SETUP ............................................................................... 52
LISTS .................................................................................................................... 53
MANAGEMENT DATA BASE ................................................................................ 53
PROTOCOL .......................................................................................................... 54
DEMOS ................................................................................................................ 57
ADVANCED .......................................................................................................... 57
Warnings ............................................................................................................. 58
Visual stimulator ................................................................................................. 58
Print Report ........................................................................................................ 60
Grafical scale ....................................................................................................... 61
Acquisitions ........................................................................................................ 62
Analysis ............................................................................................................... 63
Pupils .................................................................................................................. 64
Reprocess ........................................................................................................... 65
Hardware ............................................................................................................ 65
TECHNICAL SUPPORT .......................................................................... 66
TECHNICAL SUPPORT TYPE ................................................................................. 66
REMOTE CONNECTION ....................................................................................... 67
TECHNICAL SUPPORT OFF LINE .......................................................................... 67
INSTALLATION ............................................................................... 68
SYSTEM REQUIREMENTS ..................................................................... 68
SOFTWARE INSTALATION .................................................................... 68
AUTOMATIC DRIVERS INSTALLATION ................................................................. 71
CHECKING DRIVERS INSTALLATION (WINDOWS 7) ............................................ 72
HARDWARE INSTALLATION ................................................................. 73
ASSEMBLY OF THE RECEIVER BAR
........................................................................... 73
CONECTIONS ....................................................................................................... 74
WORKSTATION LAYOUT ...................................................................... 76
LAYOUT ............................................................................................................... 76
CARE AND MANTEINANCE ............................................................. 77
CLEANING ........................................................................................... 77
CONSOLE............................................................................................................. 77
RECEIVER BAR ..................................................................................................... 77
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GOGGLES ............................................................................................................ 77
CHANGE THE CUSHION OF GOGGLES ................................................... 78
FUSES CHANGE ................................................................................... 78
DISPOSE ............................................................................................. 78
MAINTENANCE AND REPAIRS .............................................................. 79
REPAYMENT AND TRANSPORTATION .................................................. 79
TROUBLESHOTINGS ....................................................................... 80
TECHNICALSPECIFICATIONS ........................................................... 82
APENDIX ....................................................................................... 84
ABNORMALITY THRESHOLD ................................................................ 84
Freyss Diagram ................................................................................... 87
DizzinessHandicapInventory ............................................................... 89
ELECTROMAGNECTIC COMPATIBILITY ................................................. 92
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SECURITY WARNINGS
Before using VNG plus with a patient, familiarize yourself with this user manual, especially with regard to the safety considerations indicated. This manual is only a reference; its purpose is not to replace its protocol for the safe use of videonystagmography
This manual uses the following conventions:
WARNING: Alerts the user of the possibility of injury or other serious adverse reactions associated with the use or misuse of the device
CAUTION: Alerta al usuario de la posibilidad de un problema conel dispositivo relacionado con su uso o mal uso, como unfuncionamiento incorrecto, un fallo o daños en el dispositivoo daños a otros bienes.
NOTE: Emphasize information of special importance.
WARNINGS
To avoid the risk of electric shock, it must be connected to an AC power supply with protective grounding.
To reduce the risk of fire, use the equipment in well-ventilated areas and / or in the presence of potentially explosive or flammable materials as environments rich in oxygen or the presence of flammable anesthetic gases.
The equipment may cause radio interference or may affect the operation of nearby equipment. It may be necessary to reorient or relocate it.
Connect it to a power supply network with the specified voltage (100-230V, 50-60 Hz)
All non-medical equipment that connects to the VNG Plus, must comply with electrical safety standards according to IEC or ISO of application to said device. Also, all configurations must comply with the requirements for medical electrical systems (See IEC 60601-1 Ed. 3.1) When connecting other equipment to medical electrical equipment, a medical system is being configured and, consequently, is responsible for ensuring that the system meet the requirements for medical electrical systems. Keep in mind that local laws may take precedence over the aforementioned requirements.
Do not install the equipment near heat sources, such as stoves.
Install the equipment on firm and horizontal surfaces.
To reduce the risk of the device heating up, do not obstruct the ventilation
grilles so that there is good air circulation.
Do not use cables, adapters or extenders that have not been approved by Ecleris.
To reduce the risk of electric shock, regularly inspect the AC power cord and check that it has not frayed or split.
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To reduce the risk of strangulation, dispose of the cables so that they do not get tangled
To avoid possible injury to the patient due to the use of the device, I evaluated if the patient is apt to perform nystagmographic tests (See: Consideration of the patient)
Only doctors of otolaryngologists, neurologists, balance disorders specialists or properly trained doctors are authorized to operate the system.
Turn off the switch before connecting / disconnecting accessories.
Always position the device so that you can see the PC screen properly and
reach it comfortably,
The mask contains sensitive electronic and optical devices. Do not subject it to mechanical shocks
Turn off the equipment and disconnect it from the AC mains before cleaning or repairing it.
Equipment modification is not allowed and may affect performance and performance. Maintenance must be carried out by qualified technical service personnel.
To avoid the risk of communication failures, connect the equipment to USB ports onboard.
CAUTIÓN:
Do not attempt to sterilize the mask or any other part of the equipment in an autoclave or other way.
To avoid possible damage to the equipment, use only the cleaning and disinfection products and procedures indicated in this manual.
To avoid damage, do not drip or spray liquids directly on any part of the equipment.
The VNGPLUS has been designed to work in certain environmental conditions. Respect the following conditions:
Operation Transport
Temperature 10°C-40°C -30°C-50°C
Relative Humidity 30-75% 10-95%
Pressure Atmospheric 700-1060 hPa 500-1060 hPa
Always transfer it in its original packaging
NOTE:
The images shown in this manual may not exactly match that of your VNGPLUS
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If you notice changes in performance or performance, stop using it and contact ECLERIS technical support.
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SIMBOLS
Recognize the following symbols indicate information or security to prevent damage
or personal injury
(Blue) See attached documents
Alt
ernant current
Manufacturer identification
Fuse
Manufactured date
On
Serial number
OFF
Order number
Prote
ct against water
Equipotential
Up side
RF interferencecan occur in the vicinity of equipment that has this symbol
Fragile
The product must be eliminated according to the directives RAEEs (waste electrical and electronic equipment)
Temperature limit for
transport and storage
Attention!
Atmospheric Pressure
limit
for transport and
storage
Part type BF
Relative Humidity
for transport and
storage
8
limit
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GENERAL INFORMATION
INTENDED USES
VNG Plus is a Videonistagmógrafo whose intended use is register, reproduce and analyze the involuntary eyes movements (Nystagmus).
The eyes movements (Nystagmus) are recorder through the cameras mounted on the mask. These images are processed, and stored, for later review.
This information is used by a trained professional to diagnose pathologies of the central and peripheral vestibular system such as otorrinolaryngologists, neurologists, balance disorders specialist or properly trained medical personnel.
The VNG plus has a basic unit for peripheral vestibular exploration, and accessories that constitute an expanded system that allows to evaluate the VOR and the central vestibular system through oculomotor stimulation.
INTENDED USER
VNG Plus has been designed to be used by health professionals with experience in the technique.
OPERATING PRINCIPE
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.
Patient-stimulus relative position and head angles record and tracking
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 on ultrasound receptor positioned on to visual stimulator and an ultrasound emitter, located on goggles. System measures the patient head position relative to the center of visual stimulator.
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Accelerometers to get tilt of patient head: Three Axis Low-g micro
machined Accelerometer is used as tilt sensor (measuring gravidity vector projection at each axis and convert it in angles).
These sensors are just intended to help trained doctor to positioning patient in right place and with right head angles for each type of test andkeepingarecordofthese parameters. Never are intended to use these sensor’s data into test analysis just to monitor test conditions. Depending of test type hostsoftware indicates to hardware witch sensor monitor, for example if an optokinetic test will be performed patient needs to use visual stimulator, so system active ultrasound sensors to monitor patient relative position respect stimulator to achieve desired stimulus.
PATIENT CONSIDERATIONS
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 for 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 in 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.
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Medications: Many medications can affect test results. With physician approval, patients should discontinue all medications, unless contraindicated, for 24-72 hours prior to testing. Any medications taken should be clearly noted on the test results. Alcohol ingestion can affect VNG 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 parts 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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DESCRIPTION
The VNG Plus includes the following components and elements needed for installation
MainUnit  Goggles (withshutter)  Powercord  Pen Drive Installation  User`s Manual
ACCESORIES (OPTIONAL)
Sensor (gyroscope, accelerometer and ultrasound transmitter)  T Bar withreceptorsUltrasound  Cushionmask  Wirelessfootswitch
It is recommended to identify and verify its existence prior to equipment installation.
WARNING: Las prestaciones del equipo pueden variar de acuerdo a los accesorios
FRONT PANEL
1. Dataconnector
2. ON/OFF
1
2
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REAR PANEL
1. Power supply cable connection / Fuse holder
2. Ultrasoundsensors(Bar)
3. VGA (Monitor screen)
4. USB Cable
5. Equipotential terminal
JUNTION BOX
1. Right Camera
2. Left Camera
3. Sensor (position, movements)
4. Data wire
1
2 3 4 5
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GOGGLES
A. Sensor (position /movements) B. Right Camera B. Left Camera
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INSTRUCTIONS FOR USE
In this section the process of implementation and use of equipment detailed.
Only physicians, otolaryngologists, neurologists, balance disorder specialist physicians trained or are authorized to operate the system
Once the hardware and software have been installed, you can begin using your VNG Plus.
NOTE: VNG Plus performance may vary depending on version and model hardwareinstalled
RUNNING THE PROGRAM
Run the program from the icon on your desktop PC, or from the Start / All Programs / VNG Plus.
The VNG Plus user interface is available in English and Spanish. Language selections by pressing the icon
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ENGLISH SPAIN
HELP
Activate audio help
Activate video help (Demonstrations)
NEW PATIENT
To Create Patient File: enter First name (required), last name (required) and #chart, date of birth (DOB), gender:
To enter demographic data (phone, address, etc.) and Anamnesis press the OTHERS button (optional).
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NEW SESSION
The tests performed on a patient are stored in a single session. You can perform different sessions for the same patient.VNG plus allows you to define the test protocol, configuring each test as its own characteristics. (See: Configure/Protocols).
The protocol set upped is a user interface that presents a sequence that leads the user through a series of well-defined step, it allowing you to interrupt or skip tests or scheduled 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
NOTE: Default protocols are set by the hardware installed
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
OPENING AN EXISTING FILE
Press Load button and select the patient on the list and open the File.
OPENING AN EXISTING SESSION For the patient press Load session button and select the session on the list
and open the File
OTHER FUNCTIONS
Report: See the print report
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Session Resume: Open a test table to Access the test recorded
Importtest
Export test (See: Export 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 technicalsupportteam, is able to troubleshoot most problems that a user experiences. Technical support may be provided, through email, or with remote interface (See: Technical support).
Start session: Startsthe selected test protocol
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CUSTOM PROTOCOL
Shows sequence of the test to follow. The list includes patientpreparation, 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
See the test description by clicking View Detail test description. A label is displayed that shows the parameters that define the test (Frequency, direction, Time, etc.)
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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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. (SeeappendixDizzinessHandicapInventory)
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
Toolbar bottom
Home: Return to the main window.  Back: Return to previous window.
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Go to: Select another Window.
Next: Forward to next window
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ASSISTANT VNG PLUS
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 screen (monitor) of different geometries, which must be configured from theConfigure / Advanced / Stimulator
Toolbarbottom:
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 to the patient’s head.
The correct placement of the goggles is of vital importance to perform the tests
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:
Home: Return to Home window  Back: Return to previous window  Go to: Select another Window  Next: Forward to next window
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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 changeat any time.
NOTE: If after carrying out the analysis of a session, you change the eye to analyze. Youwill lose thepreviousanalysis
Toolbarbottom:
Home: Return Home Windows  Back: ReturnpreviousWindows  Go to: Select another Window  Next: Forward Windows
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CALIBRATION
STANDARD
This is not a true calibration to determi
ne the amplitude of the eye movements in
degrees but 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
is not essential. However, if the mask has been repositioned or removed since the
initial calibration was carried out the procedure must be repeated. Calibration is recommended for the following tests:
Gaze
Saccades
OKN
Smooth pursuit
AHR*
vHIT*
Note: VHIT and AHR require a head movement’s calibration.
To set the calibration (See Configuration/ Protocol) o
n protocols setting are determine
what stimulus type you want to use for ca
libration (Center, right, left, down and up)
Request the patient tofixate upon points that are projected onto a monitor in a pre
defined pattern for about 5 second while the calibration proceeds. When it iscomplete
the next screen opens automatically.
25
test calibration
-
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Checkpoint is it a quickly to the calibration state verification. It is only used after the calibration process. This should only be used after it has been calibrated at least once. The patient should look at the red light (Led) that lights inside the goggles. Verification checks if the mask has been moved, in which case it is necessary to re­calibrate again.
In addition to the position and head movements assistance, in this window a frame is shown whose color (green: Good, yellow: regular, red: insufficient) indicates the state of detection of pupil according to the
count, lighting.
If the state is red, it is recommended to reduce the ambient lighting and / or to use the mask cover if possible. Iftheconditionpersists, contacttechnicalservice.
Toolbarbottom
Home: Return to main window  Back: Return to previous window  Go to: SelectanotherWindow  Next: Forward to next window
HEAD CALIBRATION
Toolbarbottom
Home: Return to main window  Back: Return to previous window
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Go to: Select another Window  Next: Forward to next window
Active calibration: AHR
The head movements in this calibration are active, where the patient moves his own head. The patient is instructed to keep their eyes on the target shown on the screen and to swing the head gently to the right and left (as if saying with the head "no-no") trying to follow the rhythm of the metronome When all warnings are valid the calibration starts automatically for about 20 seconds (See: Protocol Settings).
When you hear the metronome, you should start moving your head to the right and left alternately and the screen will show the graph of the position of the eye and head in time.
Passive Calibration: VHIT
The head movements in this calibration are passive. The examiner should perform head calibration by standing behind the patient and holding the head in the same way as during the cephalic impulse test of the lateral channels. When the alarms are valid the calibration will start automatically. Approximately for 20 seconds (configurable) the examiner should perform the sinusoidal oscillations in both directions following the
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metronome, similar way to AHR, while the patient should try to keep the eye on the objective shown on the screen
During the head calibration, are shown in the diagrams: the head speed and the eyes position on time
Once the calibration is finished, the information corresponding to the head calibration will automatically be generated. The data is displayed in a similar way to the VHIT test itself. (See: Data Acquisition: VHIT)
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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).
a) Relative subject position to the visual stimulator to achieve desired stimulus.
b) Head angles
c) Head tilt:
WarningsColors
Duringrecording
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 itat the discretion of the user and need. (See: Setup/Advanced/Demos and Setup/Advanced/Acquisitions)
Toolbar:
Back: Returnto back Window
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Performing the test
On the window there arethetest warnings and also the eyes video display. When thepatient is ready, press Start buttonto recordsthetest.
By clicking the Register button data recording starts automatically. All 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.
Using the Footswitch
The foot switch can be very useful when you need your hands free to care for the patient orto operate other devices; for example, in the Dix-Hallpike caloric irrigator oroperate.
The pedal can be used only to record and stop capturing atest, donot respond to other events
The following icon will be displayed when it is pressed.
See: Installing andConfiguring wireless pedal / advanced / Acquisition
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 Nystagmusistypically inhibited by visual fixation (see Setup: Spontaneous)
Warnings:
Patient position
Head Movements
Head angles
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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
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 yes only. Warnings:
Patient position
Head Movements
Head angles
Optokinetic (OKN)
For Optokinetic testing, the patient tracks multiple stimuli. Stimuli are moved at a rate programmed in each direction. (Clockwise and counterclockwise)
Warnings:
Patient position
Head Movements
Head angles
Active head rotation (AHR)
This test records the movements of the eyes and head. This requires the stereo loudspeaker. The patient must move the head to the right or left when hears a click in the respective ear
Warnings
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Patient position
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 20­30 seconds. Mental tasking is used to keep the patient from suppressing Nystagmus. Visual suppression must also be avoided by the use of infrared goggles. Somestandard positions usedincludethefollowing:
Supine Head 20-30º
1. Supine, head right 60º
2. Supine, head left 60º
3. Supine Head 20-30º (Primary position)
Warnings
Patient position
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Dix Hallpike
Dix-Hallpike is performed over a stretcher that allows lying down and sitting the patient quickly. The Dix-Hallpike maneuver is 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. 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.
Careful otoscopic examination allows the stimulus to be directed appropriately and at an equivalent depth in each ear canal.
Protocol for caloric stimulation, alternating binaural bithermal caloric stimulation includes the following conditions:
Leftearwarm (LW)
Righteararm (RW)
Leftearcool (LC)
Rightearcool (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 timershows 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)
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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.
StatusAnalysis of alarms [%]:
Excellent Good
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:
Increase or decrease the scale of plot.
Zoom out/Zoom in amplitude Scale
Zoom out/ Zoom in Time scale
Create print windows: cropping a records area to print. (See: Createprintwindow)
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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The software displays 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
Toolbarbottom:
Back: Returnpreviouswindow  Play: Replay the test performed (record, warnings and videos)
Spontaneous Nystagmus
Spontaneous Nystagmus: This may indicate either central or peripheral pathology. The presence of Nystagmus can be evaluated with fixation (center, right, and left, down and upon) o without fixation.
NystagmusCount SPV (º/sec) is average slow phase velocity
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
NystagmusCount  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 is to fixate visually both quickly and accurately on a new object. The eye
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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
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 recording 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 referring a global measurement to tracking test in frequency and amplitude. Ifthepeakis around the target frequency, tracking was good
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Video head impulse test (VHIT)
The video head impulse test is useful in the assessment of vestibular disorders. The test offers a clinical indicator of a semicircular canal deficit.
Velocity Leftward/Rightward: head velocity stimuli and eye velocity responses are
Superimposed and displayed.
Gain Leftward/Rightward vs. Peak head velocity (deg/s): refers to the ratio of the
eye velocity to the head velocity.
Acceleration Leftward/Rightward: The head acceleration and eyes acceleration during the head shake (leftward/Rightward.)
Stimulus Leftward/Rightward vs. the Peak Head velocity: refers to the maximum angular displacement applied during the head shake.
Results:
Gain Avg.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 thetest.
Discard left/ right: Impulse not included on the analysis
Passive calibration of the head (VHIT)
It is not a test in itself. But the results are shown in graphical form of the passive calibration of the head
Speed Left / Right: The head speed stimuli and the responses of the speed of the eye over time are superimposed.
Gain Left / Right vs. head speed peak (º / s): Refers to the ratio of the speed of the eye to the velocity of the head.
Results:
Gain avg. Left / right: The average gain to the left / to the right.
Symmetry: refers to the gain significantly worse in one direction than in
another.
Gain AVG: The average gain of all impulses.
Discarded left / right. Stimuli those were not included in any of the previous
calculations.
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Supine
These are VNG test to diagnose BPPV and other vestibular complaints. Parameters are calculatedfor horizontal channelall positions
Nystagmus Count
Latency (sec) is calculated from the difference in time between head
displacement and the onset the first Nystagmus
SPV (º/sec) is average slow phase velocity
Dix Hallpike
These are very important as part of the standard VNG to diagnose BPPV and other vestibular complaints. Parameters are calculated for horizontal channel both side (Dix-Hallpike Right and Dix-Hallpike Left)
NystagmusCount
Latency (sec) is 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. Tobeableto appreciate the test symmetry, it 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 anddirectional preponderance data, right and left Nystagmus beats, symmetry, frequency and slow phase velocity for each ear. (See: APENDIX Freyss Graph)
Parameters: show the absolute and directional preponderance data, right and left Nystagmus beats, symmetry, frequency and slow phase velocity for each ear.
Unilateralweakness=(RE44+RE
30)-(
LE44 +LE30)x100.
(RE44+
RE30+LE44+LE30)
ABSPrep
=(RE44*LE30-RE
30*LE44) (RE44+RE30+LE44+LEI30)
Dir
Preponderances
= (RE44+LE30)-(
LE44 +RE30)x100.
(RE44+RE30+LE44+LE30)
RightBeat=RE44+LE30
LeftBeat=RE30+LE44
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RightEar=RE44+RE30
LeftEar=LE44+LE30
Where SPV|
after_fix
represents the average slow-phase Nystagmus eye velocity that
occurs for 5 second after the eyes are fixated and SPV|
before_fix
represent the average slow-phase Nystagmus eyes velocity that occurs for 5 seconds before eyes are fixated on the light point
.
FI (Fixationindex) =SPV|
afterfix
SPV
|
b
efore_f
ix
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REPORT
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/Totalpages Number. Use arrows to move betweenpages.
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
Choose output printer in the drop down menu. When printing a document, all the printers installed in Windows are listed you can always select a different printe
r
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Logo: Insert a picture (.bmp/jpg) on to the report header
TOOLBAR
Page: Printcurrent page.  All: Printallpages.  Back: quitthereportwindow
EDIT ANALYSIS
Nystagmus beat
TheNystagmus analysis constitutes a major part VNG Plus system. Thealgorithmaccuracydependsonseveralfactors:
The image quality of the eye.  An accurate eye detection procedure (training during the mask setup)  The patient cooperation (blink, keeping eyes open, wearing no eye makeup,
etc.)
Thecalibrationprocess.
The software searches for Nystagmus beats on the eye movement trace and perform automatics detection. The software alsocalculates other important recording parameters (slow phase velocity, Nystagmus frequency, etc).
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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
.
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 analuzed button
(See also Setup/ Advanced/ Beat Count)
Manual Edition:
To include a new Nystagmus press the Add button and then
1. Click on the beat slow phase beginning
2. Drag the mouse to the end of slow phase (blue area)
3. Click on the end Nystagmus edited. 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
Click over to Nystagmus to moveit
Toolbar
Cancel: Nystagmus edition (or modification) will be disregarded  Ok: New edition will be saved.
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Cefalic impulse count (VHIT)
The analysis is done by separating impulses to Rightward and Leftward from the top pull-down menu.
For each impulse, the response of the eye in speed and acceleration (green) is plotted next to the cephalic impulse (red) and the relevant parameters of the same as gain, maximum speed of eye and head, duration, etc.
The averages of the impulse analysis are shown in graphical form and numerical data.
Automatic editing:
With the automatic discard option enabled. Increase (+) or decrease (-) the sensitivity by modifying the gain dispersion: | Gi-Gprom |, those impulses whose gain differs from the average of the specified value will be discarded. Then press the Re-Analyze
button, so that they are evaluated with pulses with the new sensitivity
Manual editing:
Those impulses that due to their characteristics (acceleration, speed) you want to ignore in the analysis, you can discard them manually.
1. Click on the right or left arrows to observe each impulse. The impulse is numbered in the counter
2. Activate the discarded option
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NOTE. The manual edition is reversible
EXPORT TESTS
In the home window you can access the test summary recorded and export it.
Select the test to be exported by clicking on it, and the check box of the selected test will be activated
Pressing the Export testbutton opens a dialog to export the selected test in some external medium (Pendrive, CD, etc.)
Pressing Publish Test, you can publish the test (data, report or videos on the website Endodigiweb.com in public or private).
ENDODIGIWEB gives you the possibility to upload and share your own cases or reports. The wizard will help you publish videos, images or reports. Use the Next, Back or Cancel buttons.
To ensure the ENDODIGIWeb service you need to be connected to the internet.
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First you need register Complete all the required fields to create an account.
Select the publication type you want to make
Public: anyone who visits EndodigiWeb. Private: only people that you invite by email
In both cases PUBLIC or PRIVATE, you must provide a title and a brief summary (optional)
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Make sure not to publish patient’s personal and confidential information
Invite your contacts to visit the publication. Adding contacts from your address book
Add: open a dialog to create a contact list to share your publications
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ENDODIGI CONTACTS
New: Add a new contact email
Import: This enables you to import your address book from mail clients to ENDODIGI.
Now your publication is ready to upload on the website!
If your publication was uploaded successfully, you'll see an “Upload succeeded " message.
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Please note if you attaching many files large, it may result in a long upload times
Visit the Endodigi website at http://www.endodigi.com to view your publication
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. Hereyou can addorremoveitems
MANAGEMENT DATA BASE
The database shows a list of stored sessions. You can sort in ascending / descending order by date or alphabetical items: Last Name, Name or Chart # (Medical Records), pressing the top of each column.
Use the search tools, pressing the Search button to locate a patient and / or sessions. Filters allow discrimination by Name, Last name, NHC and date. When the
Database is large it is recommended to use filters because it substantially reduces the searching time The searched matches the data will be displayed in the same list.
To delete the selected patient session (highlighted in blue), pressDelete icon
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PROTOCOL
Here you can create custom protocols and adapt it to your needs and experience in clinical practice. VNG Plus includes default protocols that fit the characteristics of hardware detected.
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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
To expand / collapse the description use +/­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. Any edited protocolcan be saved as a new protocol and keep the original protocol unchanged. ForthisselecttheSave As option.
Move up
Move down Delete
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Enabled/Desabled
New: To create a new protocol (test sequence),
Identify the protocol with a NAME. Identify the test with an (optional) personal name Select the test from the available options by type / subtype
Nystagmus: Spontaneous  Visual Stimulation: Gaze, OKN, Saccades, Smooth pursuit  Posture: Dix-Hallpike, Supine  Caloric: Cool; Warm  At: AHR, vHIT  Questionnaire: DHI, DHI military  Assistances: Position, Angles, Goggles  Configuration: Eyes selection, Test selection, Calibration( standard), Head
calibration: AHR(active) AND/OR VHIT( passive)
Save the protocol and will be available to select in the patient session
Delete:Deletes the selected protocol list
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DEMOS
You can see a Test instructions, recommendation and artifact (most probable mistakes), and video test demonstration for each test (ex: Dix Hallpike video 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
ADVANCED
Different variables grouped by their characteristics are presented to setting up;
Which are describedbelow:
Toolbar
Back: returnpreviouswindow  Default: Resetallparameters
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Save and Exit: Store all new parameters and 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
Visual stimulator
VGA:To produce stimulation patterns of correct size, position and angle velocity, the required information about the geometry of the screen setup in your laboratory. These values will have to be updated whenever the display screen geometry is changed
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Fill out the actual lengths in the fields that describe the Monitor dimensional characteristics
(
See also Technical Requirements and Setup/ Advanced /Acquisition).
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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
Options for Tests: These items are applied for all selected tests
Auto adjusts: Prints entire record based on the time recorded  Graphics: graphicalanalysis  Analytics Analysis: To print the measure data of a test Records: eye positionplot  Alarms: warning records  Eachonown page. Print Nystagmus mark: on to printout eyes position trace show Nystagmus
mark
Only printing window: To print one or more specific sections of the records
(See: Create record print windows)
Print width: Increase / decrease the thickness of the line of the records to be
printed.
High register: Increase / decrease the height of the records of each test
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Tests: Select the test to print
Spontaneous Gaze Saccades Smooth pursuit OKN Dix-Hallpike 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 ensure uniformity. The codes are developed, maintained and copyrighted by the AMA (American Medical Association.)
Grafical scale
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.
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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.
For example: Test recorded: 60 sec Time plot: 25 sec. 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)
If set to auto scale the layout adapts to the recorded times
Check time-plot scales when comparing different records
Acquisitions
Tests may be performed in any sequence defined by the user. Mark the Next step Acquisition desired by test.
When stop recording of the test data,
Stop: the test window
Next: the test next window will be open automatically. Result: the test analysis window will be open automatically
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Alert Message: Disable warning’s control messages 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)
Audio Instructions: Enables the user-mode audio reading Wireless Footswitch: Turn on the wireless pedal. (See installing the wireless
footswitch) On VGA: This activate the stimuli-screen when connects a VGA monitor. Overwrite
Camera: Lets you use the system with a single camera (Right / Left) WMI Hardware: Hardware setup for the technical support only.
Force connect: Communication Protocol Mask A: select mask type A (hardware)
Mask Nselect mask type N (hardware) Time out M: Timeout on connection Wait Filter: Filter video Render: Enables support for rendering of video depending on the version of Windows
® (XP, 7,
8)
(VRM 0 Video Render/ VRM 9 Video Render/ Window 8 video render:
Analysis
It offers the possibility to adjust the sensitivity of the detection algorithm for each particular test. (See also Edition of nystagmus)
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Pupils
The user rarely has to access this configuration tab. This requires technical information that is specific to its installation. Request technical support before modifying any parameter, since it could affect the operation of the VNG Plus
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Reprocess
It allows modifying the eye detection area in tests already registered to improve the analysis. The modifications are over the video itself and it does not affect the general mask parameters. You can modify the area from the default configuration drop-down menu or by reducing / enlarging the central area.
Hardware
Exclusively to use technical support
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TECHNICAL 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.
TECHNICAL SUPPORT TYPE
Email Support: the field required must be completed and is send the query. The technical support will receive an email with that data, after that it will answer through the configured email address.
Remote Support: This mode allow that technical support establish a remote connection to try solving the problem.
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It’s possible that technical support is not available at the moment of realize the query. If so, you be informed how time the service will be available,to decide wait.See: Technical support is not available.
REMOTE CONNECTION
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.
TECHNICAL SUPPORT OFF LINE
When the technical support request is not available to attend a Remote Connection, is shown the following message.
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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.
INSTALLATION
CAUTION: The software must be correctly installed before to install the hardware. Check hardware requirements
SYSTEM REQUIREMENTS
Hardware:
Processor Intel I5 2GHz Memory 6GB RAM Video card with 512MB of memory Hard Disk 500GB of free space USB Port 2.0 ONBOARD port (DO NOT USE WIRED PORT!)
Software SO
Windows® 7/8 (32 & 64 bit)
SDKs
DirectX Windows Media distribution version Windows Media encoder distribution version Microsoft Framework 3.5
SOFTWARE INSTALATION
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 Files\Ecleris\VNG Plus Select the installation language and press
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Next to start installation process.
It is recommended to 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 will automatically begin drivers’ installation. Remember that theVNG 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.
Press Install to continue
If consulted, keep the defaults and click Next.
If at this point is consulted on restarting the computer answer: No, Restart later.
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The software and drivers installation has finished.
It is recommended, before loading the drivers, to carefully read the hardware
installation section
If you experience problems during installation of theVideo drivers See:
Troubleshooting section
AUTOMATIC DRIVERS INSTALLATION
When the software and hardware (See hardware installation) are perfectly installed,
two drivers must be automatically loaded:
USB Video Device Driver  USB Data Driver
You must have administrator privileges or pa
ssword to elevate privileges,
every time Windows request you, in order to correctly install the device.
When connecting the VNG Plus to the USB port automatically begin the drivers
loading.
At the end, on the Windows® taskbar, you will see a legend confi
correct installation of the device el VNG Plus.
71
rming the
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In some cases the operating system tries to loading first driver emulation (CDC RS­232 Emulation Demo) and could appear an error message. Ignore it, and then check the correct driver installation. See: Checking correct installation of the drivers in Windows7
CHECKING DRIVERS INSTALLATION (WINDOWS 7)
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.
2. Communications Port means the VNG Plus Data device was installed.
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HARDWARE INSTALLATION
Unpack the device very carefully and place it on a flat and firm surface, before proceeding to connect the accessories
The software must be correctly installed before to install the hardware
ASSEMBLY OF THE RECEIVER BAR
WARNINGS:
Make sure you have a Phillips screwdriver for the screws before mounting. Confirm that the VESA mount of the monitor is suitable for installation (75mmx75mm
or 100mm x100mm)
Prepare at least four 8 mm diameter screws (not supplied). Be sure to use the screws and fasteners provided following the instructions described
below correctly. Do not attempt to install the "T" bar mounting bracket if the monitor is mounted to the
wall using a VESA wall mount. Be sure to tighten the screws, nuts in the corresponding position otherwise the bar
and / or the monitor could be damaged. The bar of ultrasound receivers should be placed on the monitor where the visual
stimuli are generated (See Requirements of the visual stimulus monitor) If you have any doubt, it is better to have a professional to assemble the bar (a
distributor or an authorized technician).
Procedure:
1) Fix part A to part B with 2 screws (M8), place washer and nut and adjust them smoothly (Figure 1)
2) Fix the bar on the part B by means of 2 screws (M8) place the washer and nut adjust them smoothly (Figure 1)
3) Present the entire system on the monitor and fit piece A to the monitor with 4 screws (not provided) (Figure 2)
4) If necessary, move the piece B upwards / downwards or move the bar backwards / forwards until it is on the edge of the monitor screen.
5) When the bar is properly placed. Tighten all screws well (Figure 3)
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Figure 1: Assembling Parts. Figure2: Mount over monitor
(a)(b) (c)
Figure 3: Correct installation. (b)
CONECTIONS
1. Put the position sensor into the center of the mask by pressing.
2. Connect the cameras (Right (1) / Left (2)) to the junction box.
3. Connect the position sensor to the central connector (3) of the junction box.
4. Connect the junction box to the data input in the console (Data source)
B
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5.
Connect the ultrasound bar to the connector on the rear pan
6.
Connect the visual stimulus monitor to the VGA on the back panel of the
console.
7. Connect the monitor to the power network
8.
Connect the console to a free USB port of the desktop or laptop PC
Do not use the front ports of desktop PCs, as th
ey are usually not properly
assembled. This can cause communication errors.
9.
Connect the Power Supply Cable to the Power connector located on the
back of the equipment (1)
10. Connect the Power Cable to the Network.
11. Turn on the device from the ON / OFF tab
to finish the automatic loading of
drivers
At the end of the installation, run the software from the desktop icon of
your PC, to verify that it has been installed perfectly. If an error occurs,
restart the PC. If the error persists consult troubleshootin
support
75
el of the console
g or service
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WORKSTATION LAYOUT
La estimulación visual VNGPlus es generada a través deimágenes (puntos/ bandas) digitales.La imagen del estímulo se muestra en un monitor (televisor LCD, LED, Plasma). El paciente debe estar centrado al monitor para lograr el estímulo adecuado en amplitud
VNG Plus admite dispositivos (TV, LCD, LED) de distintas configuraciones para generar la estimulación visual. (Ver Configuración/ Avanzados/Estimulador)
El estimulador visual se utiliza en las siguientes pruebas:
Gaze
Smoothpursuit
Saccades
Optokinetic(OKN)
Auto rotatory (AHR)
Impulse test (VHIT)
Calibration
LAYOUT
1. Eyes height should be level with center of monitor screen
2The Ultrasonic sensors are on the screen top
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CARE AND MANTEINANCE
WARNING: To reduce the risk of electric shock, turn off and disconnect the equipment from the power supply before cleaning or repairing it.
NOTE: It is the responsibility of the user to comply with the information provided in this section
The procedures detailed below must be performed by the operator. For other maintenance or repair, contact the technical service or an authorized maintenance representative.
CLEANING
CAUTION: Carry out the cleaning taking great care not to introduce water or humidity to the equipment or its parts
CONSOLE
CAUTION: Do not use harsh chemicals. Cleaning the exterior surface of the equipment should be done using a soft damp
cloth that does not drip. Rinse with a clean cloth moistened with water and let it dry thoroughly before reuse.
RECEIVER BAR
Use a soft cloth to remove dust. In case the dirt is abundant you can go over the outer surface with a slightly dampened cloth
GOGGLES
Camera lenses and coated mirrors should be cleaned regularly of marks and dust. These should be cleaned with lens cleaning wipes.
The frame of the glasses should be cleaned with a sterile disposable handkerchief with a cleaning solution of ethanol (or isopropyl) at 70%
CAUTION: It is recommended to clean the frame every time it is used with different patients.
Mask straps can be removed and machine washed at 40 ° C with normal washing detergents. Do not dry in a dryer. Note that the elastic qualities may deteriorate after more than 10 wash cycles, after which they must be replaced.
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CHANGE THE CUSHION OF GOGGLES
Peel off the pad and wipe the surface well with a soft cloth lightly moistened with alcohol.
Remove the protective paper from the new pad and press the self-adhesive side onto the mask. Do not stretch the pad.
FUSES CHANGE
Replace the fuses as detailed below:
1. Under the connector for the power cable is a small box where the fuses are housed
2. Open the fuse compartment. To do this, insert a flat head screwdriver into the notch and gently lift the fuse compartment with a slight downward and outward movement.
3. Fuses must be replaced if they appear black or burned.
4. Replace the fuses with a new T1AL250V.
5. Close the lid of the fuse box until you hear a "Click".
6. Connect the power cable to the computer. .
Note: It is convenient to have two spare fuses, in the event of requiring a replacement.
DISPOSE
Dispose of all parts removed from the device according to local, community and national regulations and then the protocols of the health institutions. Especially as regards the protection of the environment, especially when disposing of the electronic device or parts thereof (eg: fuses)
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MAINTENANCE AND REPAIRS
VNGPLUS must be repaired and / or maintained exclusively by qualified technical personnel authorized by ECLERIS and only those parts of the equipment that are designated by ECLERIS as repairable must be repaired. To perform any other procedure that is not detailed in this section, contact the Ecleris technical support.
REPAYMENT AND TRANSPORTATION
CAUTION: To avoid possible damage, always transfer it with the original packaging
NOTE: Ensure that the environmental conditions of transport are met.
ECLERIS will not be held responsible for any damage or defects caused during transportation that are linked to poor packaging.
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TROUBLESHOTINGS
The following table indicates the most frequent problems and their quick solutions. Please, in case of any inconvenience, consult this table.
PROBLEM CAUSE ACCIÓN
The device does not turn on.
It is no connected to the electrical network
Connect the power supply cable to the electrical network
The power supply cable is broken or cut
Change the power supply cable
The plug is in bad conditions
Changetheplug
The fuse is broken or burnt.
Changethe fuse
The Device is not detected, or there are faults in the capture or assistance display
The drivers are not correctly installed
Check drivers installation/Install drivers
VNGPlus is not connected to a USBport on board
You must connect it to a USB onboard port (mother). Wired ports do not guarantee the proper functioning of VNG Plus.
There aren't image of (the) eye (s) and test cannot be recorded.
The cameras are not properly connected to junction Box
Check for proper connection of the (right / left) cameras
The junction box is unplugged
Connect the junction box correctly
The software installed is Contact Technical Service
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single channel (eye). to activate both Channels
The wireless switch is not detected or not working
Missingtoinstall drivers. Install the wireless switch
drivers.
USB wireless receiver is unplugged.
Plug USB receiver (It is inside the switch) to a USB port of the PC.
Function wireless switch is not activated.
Select the wireless switch into
Setup/ Advanced / Acquisition
If you cannot solve the problem, contact your local ECLERIS office or distributor and request technical services.
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TECHNICALSPECIFICATIONS
Goggles:
Weight: 330gr (without occlusion)
375gr (with occlusion) 435gr (with position sensor)
Dimensions (LxHxW): 27x14x10 cm
Console:
Weight:4kg Dimensions:(LxHxW):26.05 x10 x 30 cm
Power
Voltage input: 100-240V, 50-60hz Consume: 40VA Fuse: 2x T1AL250V
Electrical security:
Class IEC60601-1: Electrical Protection: Class I, Type: BF PROTECTIVE LEVEL AGAINST WATER ENTRANCE: IPX0
NOT suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide
Functioning mode: Continue
Service conditions: 10°C-40°C 700-1060 hPa 30-75% (Relative humidity) Storage and transport Conditions:
-10°C-50°C 500-1060 hPa 10-95%(Relative humidity)
Estándares y Regulaciones:
IEC60601-1: Equipos médicos eléctricos: Requisitos generales para funcionamiento esencial y seguridad básica
IEC6061-1-2Equipos médicos eléctricos, Parte 1-2: Requisitos generales para funcionamiento esencial y seguridad básica, Norma colateral: Perturbaciones electromagnéticas
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System capabilities
Input: 1/ 2 Eyes. 2/ 4 channels (real time) Sampling: 60hz Tracked range: ±30 horizontal ± 20 vertical
Software Features: : Patient database. Test storage and Analysis of main parameters corresponding to each test. Lighting conditions to perform the test: complete darkness
Test
1. SpontaneousNystagmus
2. Calorics
3. Postural
4. Dix Hallpike
5. Gaze *1
6. Smooth pursuit *1
7. Saccades*1
8. Optokinetics*1 (OKN)
9. Autorotatory head*2 (AHR)
10. Head Impulse
*2
Horizontal (vHIT)
*1 Visualstimuly is required *2 Position sensor is required
Video cameras
Two cameras Output signal: monocrome NTSC (CCD IR sensitive) Sensor size: 1/4 '' Vertical Resolution: 540TVL Frame rate: 60 frames /s Illumination Led: Infrared wavelength: 940 nm Class: No risk according to IEC 62471 (EXEMPT GROUP)
Visual Stimuly
VGA Signal Patient distance: measured by ultrasound
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APENDIX
ABNORMALITY THRESHOLD
TEST
ABNORMALITY
SIGNIFICANCE
SPONTANEOUS Nystagmus: slow component, followed by fast component.
Bilateral gaze Nystagmus: eyes open and looking to right or left.
2 Beats (horizontal) in 5 sec. with average velocity of >6 deg/sec.
CNS: Nystagmus in all gaze directions or direction changing Nystagmus in same gaze direction. SPONTANEOUS NYSTAGMUS: CNS (brain stem)
PVS: direction-fixed, horizontal, or torsional Nystagmus. Inhibited by fixation, follows Alexander’s law.* rule out drugs, lack of alertness
SMOOTH PURSUIT/ Gain: eye velocity/target velocity
Phase: lag or lead of eye relative to target.
Asymmetry: right gain – left gain
Gain: Age 50 and under: <70%
or
>140% Age 60 – 69: <65% or > 145% Age 70 – 79 :
<60% or > 150% Age 80 – 89 :
Low gain in one direction: CNS lesion. Marked saccadic pursuit:(stair step tracking) CNS lesion
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SACCADE Velocity: peak eye
velocity Latency: reaction time in
msec.
Accuracy: undershoots/overshoots
Latency: Age 50 and under : >260
msec Age 60- 69: >270 msec
Age 70- 79: >280 msec Age 80– 89: >290msec
Age 90 and above: 300 msec
Velocity: Age 50 and under: <240
deg/sec 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%
Significant saccadic slowing, overshooting or undershooting: CNS lesion or ocular disorder Lower velocity of trailing eye:
Internuclear ophthalmoplegia (
Brain stem)
OPTOKINETIC NYSTAGMUS Gain: eye velocity/ target velocity.
Symmetry= SPV right/
Gain < 60% is abnormal. Symmetry > 30% difference is abnormal.
SPV < 6.0 is abnormal
Symmetrical low gain: impaired vision or likely CNS (parietal) lesion.
DIX-HALLPIKE >2 eats (horizontal) with
average velocity >6.0 deg/sec.
delay onset of Nystagmus paroxysmal Nystagmus associated with vertigo fatigable Nystagmus
Unilateral: Usually peripheral undermost ear. Bilateral: peripheral (both ears) or CNS
BPPV: both horizontal and vertical Nystagmus (with
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CALORIC TEST Directional
Preponderance: Nystagmus beats stronger one way than another.
Fixation Index: when Nystagmus is at its peak, the ratio of velocity with no fixation to velocity with fixation.
Unilateral weakness: of more than 25% is abnormal. Bilateral weakness: sum of velocities of all 4 irrigations
<20 º/sec Directional
preponderance: >25% difference.
Caloric weakness: is a function of the labyrinth or VIII cranial nerve (vestibular portion).
Unilateral: indicates disabled side.
Bilateral: peripheral organs,
Acute unilateral lesion or perhaps CNS (cerebellar). Directional preponderance: is not localizing.
Videonystagmography is the most commonly used clinical test to evaluate vestibular function, remember that the results of normal VNG tests do not necessarily mean that a patient has a typical vestibular function. The anomalies detected by VNG can be useful in the diagnosis and
localization of the site. Of the injury; however, many of the abnormalities are not localized; therefore, the clinical history and otological examination of the patient are of vital importance in the formulation of a diagnosis and treatment plan for a patient with dizziness
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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 the 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 projections in X and Y of both straight lines 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:
= RE44 + RE30) - (LE44 + LE30) x100 (RE44 - RE30 - LE44 + LE30)
In the horizontal projection, the absolute preponderance (Y) is calculated using the following formula
= (RE44 * LE30 - RE30 * LE44) (RE44 - RE30 - LE44 + LEI30) The hyper or hyposensitivity condition for each ear is assumed from segment length 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
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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 different 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. Diseñado para el examen calórico bitérmico bilateral, el diagrama llamado mariposa de Freyss, muestra la intensidad del nistagmo junto con los resultados de simetría y preponderancia absoluta.
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DizzinessHandicapInventory
YES Sometimes No
(4) (3) (2)
P1. Does looking up increase your problem?
E2. Because of your dizziness do you feel frustrated?
F3.
Because of your dizziness do you restrict your travel for business or recreation
P4.
Does walking down the aisle of a supermarket increase your dizziness?
F5.
Because of your dizziness do you have difficulty getting into or out bed?
F6.
Does your dizziness significantly restrict your participation in social activities, such as going out to dinner, going to the Movies, dancing, or going to parties?
F7
Because of your problem do you have difficulty reading?
P8.
Does performing more ambitious activities like sport, dancing, or household chores such as sweeping or putting dishes away increase your dizziness?
E9
Because of your problem are you leaving home without?Eaving someone accompany you?
E10.
Because of your dizziness have you been embarrassed in front of others?
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P11.
Do quick movements of your head increase your dizziness
F12. Because of your dizziness, do you avoid heights?
P13. .Does turning over in bed increases your dizziness?
E14.
Because of your dizziness is it difficult for you to do strenuous housework or yard work??
E15.
Because of your dizziness are you afraid people may think you are intoxicated
F16.
Because of your dizziness, is it difficult for you to go for a walk by yourself?
P17.
Does walking down a sidewalk increase your dizziness?
E18.
Because of your dizziness, is it difficult for you to concentrate?
F19.
Because of your dizziness is it difficult for you to walk around your house in thedark?
E20.
Because of your dizziness are you afraid to stay home alone?
E21.
Because of your dizziness do you feel handicapped?
E22.
Has your dizziness placed stress on your relationships with members of your family or friends?
E23. Because of your dizziness, are you depressed?
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F24.
Does your dizziness interfere with your job or household responsibilities?
P25. Does bending over increase your dizziness
Score: Functional =Emotional=Physical=..Total=.
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ELECTROMAGNECTIC COMPATIBILITY
Guidance and manufacturer's declaration -Electromagnetic emissions
The device is indicated for use in the electromagnetic environment specified below. The client or user of the equipment must ensure that it is used in said environment.
Emissions Test Accomplishments
Electromagnetic
environment-Guide
RF emissions CISPR 11 Group 1
Radio energy is used only for its internal functioning. Therefore, RF emissions are very low and are unlikely to cause any interference with nearby electronic equipment.
RF emissions CISPR 11 Class A
The device is suitable for use in establishments other than domestic premises and other than that directly connected to a low voltage power supply network that supplies buildings for domestic use.
Harmonic Emissions IEC61000­3-2
Class A
Flickers IEC61000-3-3 OK
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Guidance and manufacturer's declaration
- Electromagnetic immunity
The VNGPlus unit is intended for use in the electromagnetic environment specified below. The customer or user of the unit must ensure that it is used in this environment
Test Immunity
Test level IEC 60601
Level of compliance
Electromagnetic environment - guide
Electrostatic discharge (ESD) IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
The floors must be made of wood, concrete or ceramic tile. If the floors are covered with synthetic material, the relative humidity must be at least 30%.
Transients / rapid electric bursts IEC 61000-4-4
± 2 kV for power lines ± 1 kV for in / out lines
± 2 kV for power lines ± 1 kV for in / out lines
The power quality of the network should be that of a typical commercial or hospital environment
Surge voltage IEC 61000-4-5
± 1 kV Line to line ±2 kV Line to ground
line to ground ± 1 kV Line to line ±2 kV
The quality of the network's power should be that of a typical commercial or hospital environment.
Voltage drops, short interruptions and voltaje variations in power input lines
IEC 61000-4-11
< 5% UT (>95% drop in UT) for 0.5 cycles 40% UT (60% drop in UT) for 5 cycles 70% UT (30% drop in UT) For 25 cycles < 5% UT (>95% drop in UT) for 5 s
< 5% UT (>95% drop in UT) for 0,5 cycles 40% UT (60% drop in UT) For 5 cycles 70% UT (30% drop in UT) For 25 cycles < 5% UT (>95% drop in UT) for 5 s
The quality of the network's power should be that of a typical commercial or hospital environment. The quality of the network's power should be that of a typical commercial or hospital environment. If the user of the VNGPLU unit requires continuous operation during interruptions of the power supply, it is recommended that the VNGPlus unit be activated from an uninterrupted power supply or battery.
Power frequency (50/60 Hz) Magnetic field
3 A/m 3 A/m The industrial frequency
magnetic fields must be at characteristic levels of
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IEC 61000-4-8
a typical location in a typical commercial or hospital environment.
NOTE: UT is the voltage of the AC network before the application of the test level.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The VNGPlus unit is intended for use in the electromagnetic environment specified below. The client or user of the unit must ensure that it is used in this environment.
Prueba de inmunidad
Nivel de prueba IEC 60601
Level of compliance
Electromagnetic environment ­guide
RF conducida IEC 61000­4-6
RF radiada IEC 61000­4-3
3 V rms 150 kHz a 80 MHz
3 V/m 80 MHz a 2,5 GHz
3 V rms
3 V/m
Portable or mobile RF communications equipment should not be used closer to any part of the VNGPlus unit, including cables, than the recommended separation distance calculated from the equation applicable to the transmitter frequency. Recommended separation distance:
d = 1.2 √P d = 1.2 √P 80 MHz at 800 MHz d = 2.3 √P 800 MHz at 2.5 GHz where P is the maximum rated output power of the transmitter in watts (W) according to the manufacturer of the transmitter and d is the recommended separation distance in meters (m). The field strength of fixed RF transmitters, determined by an electromagnetic site survey, a must be less than the compliance level in each frequency range. b Interference may occur near the archived equipment with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a.- Field strengths from fixed RF transmitters, such as base equipment for radio (cellular / cordless) telephones and mobile field radios, Amateur Radio, AM and FM radio stations and TV stations can not be predicted theoretically with accuracy . To assess the electromagnetic environment due to fixed RF transmitters, an Electromagnetic site survey should be considered. If the field resistance measured at
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the location in which the VNGPLUS unit is used exceeds the applicable RF compliance level above, the VNGPlus unit must be examined to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as a reorientation or relocation of the VNGPlus unit. b.- In the frequency range from 150 kHz to 80 MHz, the field strengths must be less than 3 V / m.
ECLERIS S.R.L. FRANCISCO N. LAPRIDA 4955 - VILLA MARTELLI
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(B1603ABK) BUENOS AIRES - ARGENTINA Tel/Fax: +54 11 48383200 Web: www.ecleris.com
E-Mail: info@ecleris.com
All rights reserved. Reproduction or transmission in whole or in part, in any form or by any means, electronic, mechanical or otherwise, is prohibited without the prior written consent of the copyright owner
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