Ecleris VNG Plus User manual

VNG Plus
Videonystagmography System
USER´S MANUAL
V.18.11.18ENGLISH

For more information, accessories, and replacement parts, contact.
ECLERIS S.R.L
.
FRANCISCO N. LAPRIDA 4955. ILLA MARTELLI
(B1603ABK) BUENOS AIRES. ARGENTINA
Tel/Fax: [phone]
Web: www.ecleris.com
E-Mail: [e-mail]

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 ..................................................................................... 1
CUSTOM PROTOCOL ........................................................................... 19
DIZZINESS HANDICAP INVENTORY ....................................................... 20
ASSISTANT VNG PLUS ......................................................................... 22
POSITION ............................................................................................................ 22
GOGGLES ............................................................................................................ 23
EYE SELECTION ................................................................................... 24

2
CALIBRATION ..................................................................................... 25
STANDARD .......................................................................................................... 25
HEAD CALIBRATION ............................................................................................ 26
Active calibratio : AHR ....................................................................................... 27
Passive Calibratio : VHIT .................................................................................... 27
DATA ADQUISITIONS .......................................................................... 29
Registers ............................................................................................................. 29
War i gs ............................................................................................................. 30
Demo stratio .................................................................................................... 31
Performi g the test ............................................................................................ 32
Usi g the Footswitch .......................................................................................... 32
Spo ta eous Nystagmus .................................................................................... 32
Gaze .................................................................................................................... 33
Saccades ............................................................................................................. 33
Smooth Pursuit ................................................................................................... 33
Optoki etic (OKN)............................................................................................... 33
Active head rotatio (AHR) ................................................................................. 33
Video head impulse test (vHIT) .......................................................................... 34
Supi e ................................................................................................................. 34
Dix Hallpike ......................................................................................................... 35
Calorics ............................................................................................................... 35
ANALYSIS GENERAL ............................................................................ 3
Spo ta eous Nystagmus .................................................................................... 39
Gaze .................................................................................................................... 39
Saccades ............................................................................................................. 39
Smooth pursuit ................................................................................................... 40
Optoki etic (OKN)............................................................................................... 40
Active head rotatio (AHR) ................................................................................. 40
Video head impulse test (VHIT) .......................................................................... 41
Passive calibratio of the head (VHIT) ................................................................ 41
Supi e ................................................................................................................. 42
Dix Hallpike ......................................................................................................... 42
Calorics ............................................................................................................... 42
REPORT .............................................................................................. 44
EDIT ANALYSIS .................................................................................... 45
Nystagmus beat .................................................................................................. 45
Cefalic impulse cou t (VHIT) .............................................................................. 47

3
EXPORT TESTS .................................................................................... 48
SOFTWARE SETUP ............................................................................... 52
LISTS .................................................................................................................... 53
MANAGEMENT DATA BASE ................................................................................ 53
PROTOCOL .......................................................................................................... 54
DEMOS ................................................................................................................ 57
ADVANCED .......................................................................................................... 57
War i gs ............................................................................................................. 58
Visual stimulator ................................................................................................. 58
Pri t Report ........................................................................................................ 60
Grafical scale ....................................................................................................... 61
Acquisitio s ........................................................................................................ 62
A alysis ............................................................................................................... 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 ................................................................. 3
ASSEMBLY OF THE RECEIVER BAR ........................................................................... 73
CONECTIONS ....................................................................................................... 74
WORKSTATION LAYOUT ...................................................................... 6
LAYOUT ............................................................................................................... 76
CARE AND MANTEINANCE ............................................................. 77
CLEANING ...........................................................................................
CONSOLE............................................................................................................. 77
RECEIVER BAR ..................................................................................................... 77

4
GOGGLES ............................................................................................................ 77
CHANGE THE CUSHION OF GOGGLES ................................................... 8
FUSES CHANGE ................................................................................... 8
DISPOSE ............................................................................................. 8
MAINTENANCE AND REPAIRS .............................................................. 9
REPAYMENT AND TRANSPORTATION .................................................. 9
TROUBLESHOTINGS ....................................................................... 80
TECHNICALSPECIFICATIONS ........................................................... 82
APENDIX ....................................................................................... 8
ABNORMALITY THRESHOLD ................................................................ 84
Freyss Diagram ................................................................................... 8
DizzinessHandicapInventory ............................................................... 89
ELECTROMAGNECTIC COMPATIBILITY ................................................. 92

5
SECURITY WARNINGS
Before using NG 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 (100-230 ,
50-60 Hz)
• All non-medical equipment that connects to the NG 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.

6
• 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 NGPLUS 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
NGPLUS

7
• If you notice changes in performance or performance, stop using it and
contact ECLERIS technical support.

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
Recognize the following symbols indicate information or security to prevent damage
ernant current
ct against water
Temperature limit for
transport and storage
Atmospheric Pressure
for transport and
Relative Humidity
limit
for transport and

9
GENERAL INFORMATION
INTENDED USES
NG Plus is a ideonistagmógrafo 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 NG plus has a basic unit for peripheral vestibular exploration, and accessories
that constitute an expanded system that allows to evaluate the OR and the central
vestibular system through oculomotor stimulation.
INTENDED USER
NG Plus has been designed to be used by health professionals with experience in
the technique.
OPERATING PRINCIPE
The NG 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 NG 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
NG 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.

10
 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 an mi le 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.

11
Me ications: 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 NG test results for 72 hours post-ingestion; results are
unpredictable because alcohol can be an agonist or antagonist.
Patient preparation: Inform patients that NG 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.

12
DESCRIPTION
The NG 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

13
REAR PANEL
1. Power supply cable connection / Fuse holder
2. Ultrasoundsensors(Bar)
3. GA (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

14
GOGGLES
A. Sensor (position /movements)
B. Right Camera
B. Left Camera

15
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 NG
Plus.
NOTE: NG 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 /
NG Plus.
The NG Plus user interface is available in English and Spanish. Language
selections by pressing the icon

16
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).

17
NEW SESSION
The tests performed on a patient are stored in a single session. You can perform
different sessions for the same patient. NG 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. NG 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

18
Session Resume: Open a test table to Access the test recorded
Importtest
Export test (See: Export test)
TOOLBAR:
 Shut down: Close NG Plus.
 Setup: Setup hardware and software.
 Support: User-friendly assistance for individuals having technical problems
with NG 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