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Ecleris VNG Plus User Manual

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

Table of Contents

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Ecleris VNG Plus Specifications

General IconGeneral
CategoryMedical Equipment
TypeVideonystagmography (VNG)
ApplicationVestibular and Balance Assessment
ComponentsGoggles with camera, Calibration unit, Control unit with software
Eye TrackingInfrared video cameras for high-resolution eye movement recording
Software FeaturesReal-time analysis, Reporting
CompatibilityWindows-based PC
CalibrationAutomated calibration procedure
Tests SupportedSpontaneous nystagmus, gaze, saccades, pursuit, optokinetic, positional, caloric
Data ExportPDF, CSV

Summary

Security Warnings

Warning and Caution Conventions

Defines symbols used for warnings, cautions, and notes in the manual.

General Safety Warnings

Outlines safety precautions for electrical shock, fire, ventilation, and approved accessories.

Symbols and Conventions

Explanation of Manual Symbols

Explains various symbols used in the manual for information and safety.

General Information

Intended Uses of VNG Plus

Describes the purpose of VNG Plus in registering and analyzing involuntary eye movements.

Intended User Profile

Specifies that VNG Plus is for health professionals experienced in the technique.

Operating Principle

Explains how the VNG goggles use infrared light and mirrors to capture eye images.

Patient Considerations

Vision Requirements

States patients need adequate vision to follow targets for oculomotor tests.

Physical Status Assessment

Addresses patient's physical condition, especially neck/back injuries, for positional tests.

Ear Condition Evaluation

Details the importance of examining the outer and middle ear before caloric tests.

Medication and Alcohol Impact

Explains how medications and alcohol can affect VNG test results.

Patient Preparation Guidelines

Advises patients on preparation, including comfort, food intake, and transport.

Product Description

Core Components and Elements

Lists essential parts like MainUnit, Goggles, Powercord, and User's Manual.

Optional Accessories

Details optional items such as sensors, T Bar, cushion mask, and footswitch.

Front Panel Components

Data Connector Port

Identifies the port for data connection on the front panel.

Power ON/OFF Switch

Describes the main power switch on the front panel.

Rear Panel Components

Rear Panel Ports Overview

Lists rear panel connections including AC INPUT, ULTRASOUND, VGA, USB, and Equipotential terminal.

Junction Box Components

Junction Box Connections

Details connections for cameras and sensors to the junction box.

Goggles Description

Goggles Components and Identification

Identifies the sensor and cameras (Right/Left) on the goggles.

Instructions for Use

User Authorization Requirement

States that only authorized physicians can operate the system.

Initial Software and Hardware Setup

Guides users on starting the VNG Plus after installation.

Running the VNG Plus Program

Explains how to launch the VNG Plus software from the desktop or start menu.

Accessing Help Resources

Describes how to activate audio and video help for tests.

Creating a New Patient File

Details the process of entering patient name, chart number, DOB, and demographic data.

Creating a New Test Session

Guides on identifying a session, entering clinic data, and selecting a protocol.

Starting and Opening Test Sessions

Covers starting new tests and opening existing files or sessions.

Other Software Functions

Mentions accessing print reports as an additional function.

Session and Test Management

Explains resuming sessions, importing, and exporting tests.

Toolbar Functions Overview

Describes the purpose of toolbar buttons like Shut down, Setup, Support, and Start session.

Custom Protocol Configuration

Protocol Test Sequence

Details how to define the sequence of tests within a custom protocol.

Viewing Test Details

Explains how to view specific parameters for each test in a protocol.

Protocol Navigation Toolbar

Describes the function of Home, Back, Go To, and Next buttons in protocol screens.

Dizziness Handicap Inventory (DHI)

DHI Questionnaire Overview

Explains the DHI as a 25-item questionnaire measuring self-perceived disability from dizziness.

Answering the DHI Questionnaire

Guides on how to answer questions using buttons or keyboard input.

DHI Toolbar Navigation

Outlines the function of Home, Back, and Go To buttons for the DHI screen.

Assistant VNG Plus - Patient Positioning

Optimizing Patient-Screen Distance

Explains the importance of patient distance for visual stimulation geometry.

Screen Geometry Configuration

Notes that VNG Plus supports various screen geometries requiring configuration.

Assistant VNG Plus Toolbar

Describes the function of Home, Back, Go To, and Next buttons in the assistant interface.

Goggles Usage and Placement

Proper Goggle Fitting and Fixation

Instructs on fitting the goggles securely to the patient's head for optimal performance.

Image Quality and Pupil Centering

Emphasizes centering the pupil for nystagmus assessment and image quality.

Junction Box Placement for Comfort

Suggests placing the junction box on the patient's arm to avoid wire tangles.

Goggles Toolbar Navigation

Explains the function of Home, Back, Go To, and Next buttons on the goggles screen.

Eye Selection for Analysis

Defining Eye Record for Analysis

Explains the need to select which eye's record to analyze, as only one can be processed at a time.

Note on Analysis Data Loss

Warns that changing the eye for analysis after a session will lose previous analysis.

Eye Selection Toolbar

Describes the function of Home, Back, Go To, and Next buttons for eye selection.

Calibration Procedures

Standard Calibration Purpose and Method

Explains standard calibration as an allowance for correction factor, not amplitude.

Tests Requiring Calibration

Lists tests for which calibration is recommended, including Gaze, Saccades, OKN, etc.

Head Movement Calibration Requirement

Notes that VHIT and AHR tests require specific head movement calibration.

Performing Standard Calibration

Guides the user to have the patient fixate on target points during calibration.

Head Calibration

Calibration Checkpoint Verification

Explains the checkpoint as a quick verification after initial calibration.

Visual Status Indicators

Describes color indicators (green, yellow, red) for pupil detection status.

Calibration Toolbar Navigation

Details the function of Home, Back, Go To, and Next buttons during calibration.

Head Calibration Instructions

Guides the patient to look at the target and describes progress bar status.

Head Calibration Toolbar

Outlines the function of Home, Back, Go To, and Next buttons for head calibration.

Active Calibration for AHR

Active Calibration Procedure

Explains patient-driven head movements synchronized with a metronome for AHR calibration.

Passive Calibration for VHIT

Passive Calibration Procedure

Describes examiner-guided passive head movements for VHIT calibration.

Data Acquisition and Registers

Real-time Data Display (Registers)

Explains how eye position/velocity is graphically displayed against time.

Saccades Data Visualization

Illustrates the display of saccadic test data, including eye position and stimulus.

Data Acquisition Warnings and Colors

Describes warnings for subject position, head angles, and head tilt during data acquisition.

Test Demonstrations (Demos)

Accessing Test Instructions and Videos

Guides on accessing test instructions, recommendations, and video demonstrations.

Demo Toolbar Navigation

Mentions the Back button for navigating the demo screen.

Performing Tests

Starting and Stopping Tests

Details how to start recording a test and the options for stopping it.

Using the Footswitch

Explains the utility of the foot switch for hands-free operation during tests.

Spontaneous Nystagmus Test Procedure

Describes performing spontaneous nystagmus tests with vision occluded.

Gaze Test Procedure and Warnings

Details how to perform gaze testing and associated warnings.

Saccades Test Procedure and Warnings

Explains performing saccades tests and associated warnings.

Smooth Pursuit Test Procedure and Warnings

Guides on performing smooth pursuit tests and associated warnings.

Optokinetic (OKN) Test Procedure and Warnings

Describes performing OKN tests and associated warnings.

Active Head Rotation (AHR) Test Procedure

Explains performing AHR tests and the need for a loudspeaker.

Video Head Impulse Test (vHIT) Procedure

Details performing vHIT tests and associated warnings.

Supine Position Test Procedure

Guides on performing supine position tests and associated warnings.

Dix Hallpike Maneuver

Dix Hallpike Procedure

Describes the Dix Hallpike maneuver involving head turning and supine positioning.

Fixation Suppression in Dix Hallpike

Explains the use of fixation suppression (covered goggles) during testing.

Caloric Test

Patient Positioning for Caloric Test

Details reclining patient position with head at a 30° angle for caloric stimulation.

Caloric Stimulation Protocols

Lists standard caloric stimulation protocols (LW, RW, LC, RC).

Pre-Caloric Ear Examination

Emphasizes the importance of examining ears before performing caloric tests.

Fixation Suppression during Calorics

Instructs patients to fixate on a red light to reduce induced nystagmus.

General Analysis Procedures

Analysis Window Overview

Describes the display of test data within the analysis window.

Selecting Tests for Analysis

Explains how to choose specific tests or sub-tests from a dropdown menu.

Alarm Status Interpretation

Details how to interpret alarm status indicators (Excellent, Good, Poor).

Playback Record Functionality

Explains how to review video and alarm registers simultaneously.

Utilizing Analysis Tools

Describes tools like Zoom, Mark, Edit, and Graphical Analysis for data review.

Software Display and Navigation

Covers viewing all test information and using zoom options for detailed data.

Spontaneous Nystagmus Analysis

Interpretation of Spontaneous Nystagmus

Explains spontaneous nystagmus may indicate central or peripheral pathology.

Measured Parameters for Spontaneous Nystagmus

Lists parameters like Nystagmus Count and SPV for analysis.

Gaze Analysis

Measuring Eye Stability in Gaze Tests

Details how gaze tests document inability to maintain static eye position.

Measured Parameters for Gaze Analysis

Lists parameters like Nystagmus Count and SPV for gaze analysis.

Saccades Analysis

Factors Affecting Saccade Test Results

Notes that patient cooperation and visual acuity influence saccade test results.

Measured Parameters for Saccades Analysis

Details parameters like Velocity, Latency, and Accuracy for saccades.

Smooth Pursuit Analysis

Smooth Pursuit Tracking Mechanisms

Explains the system's role in tracking targets and factors affecting results.

Interpreting Smooth Pursuit Results

Mentions Gain, Phase, and THD as key factors for interpretation.

Optokinetic (OKN) Analysis

Optokinetic Stimuli Tracking

Describes how patients track multiple stimuli at programmed rates.

Interpreting OKN Results

Highlights Gain and Asymmetry for OKN interpretation.

Active Head Rotation (AHR) Analysis

AHR Test for Vestibular Function

Explains AHR tests vestibular function during active head rotation.

Measured Parameters for AHR

Lists Gain, Phase, and THD of the vestibular ocular reflex.

Video Head Impulse Test (vHIT) Analysis

vHIT for Semicircular Canal Deficit Assessment

States vHIT is useful for assessing semicircular canal deficits.

vHIT Parameters and Results

Details parameters like Velocity, Gain, and Acceleration for vHIT analysis.

Passive Head Calibration (vHIT) Analysis

Graphical Representation of Passive Calibration

Notes passive calibration results are shown graphically.

Passive Calibration Parameters

Lists parameters like speed and gain for passive head calibration.

Supine Position Analysis

Supine Test for Vestibular Complaints

Explains supine tests diagnose BPPV and other vestibular complaints.

Calculated Parameters for Supine Test

Lists parameters calculated for horizontal channel in supine positions.

Dix Hallpike Analysis

Dix Hallpike for Vestibular Complaint Diagnosis

Highlights Dix Hallpike's importance in diagnosing BPPV and vestibular complaints.

Calculated Parameters for Dix Hallpike

Lists parameters calculated for horizontal channel on both sides.

Caloric Test Analysis

Evaluating Peripheral End Organ Viability

Explains caloric tests evaluate peripheral end organ viability via stimulation.

Caloric Test Analysis Parameters

Details parameters like preponderance, beats, and velocity for caloric analysis.

Fixation Index Calculation Method

Provides the formula for calculating the Fixation Index (FI).

Report Generation

Report Management and Printing Functions

Describes managing report printing and configurations for various printers.

Previewing Test Records and Analysis

Explains how to preview records and analysis before printing.

Print Mode Options

Details options for printing directly to a printer or saving as a PDF.

Print Toolbar Functions

Outlines functions like printing current page, all pages, and returning to the report window.

Edit Analysis - Nystagmus Beat

Nystagmus Analysis Components

Lists key factors influencing nystagmus analysis accuracy.

Factors Affecting Algorithm Accuracy

Identifies image quality, eye detection, patient cooperation, and calibration as factors.

Software-Assisted Nystagmus Detection

Explains how the software detects nystagmus beats and calculates parameters.

Manual and Automatic Nystagmus Editing

Describes overriding automatic analysis by adding or deleting nystagmus marks.

Cefalic Impulse Count (vHIT) Analysis

vHIT Impulse Analysis Method

Explains analysis by separating rightward and leftward impulses.

Automatic Editing Options for vHIT

Guides on adjusting sensitivity for automatic discarding of impulses.

Manual Editing Options for vHIT

Details how to manually discard impulses based on characteristics.

Exporting Test Data

Accessing and Selecting Tests for Export

Describes accessing the test summary and selecting tests for export to external media.

Publishing Tests via ENDODIGIWEB

Explains publishing tests (data, report, videos) on the Endodigiweb.com website.

ENDODIGIWEB Registration Process

Guides users on registering to create an ENDODIGIWEB account.

Selecting ENDODIGIWEB Publication Access

Details options for Public or Private access to published content.

Adding Publication Details and Invitations

Covers adding titles, abstracts, and inviting contacts to view publications.

ENDODIGI Contacts Management

Managing Contacts and Importing Address Books

Describes adding new contacts or importing from address books.

Uploading Publication to ENDODIGIWEB

Confirms publication readiness after upload and provides upload success message.

Software Setup Options

Lists Configuration Management

Explains editing lists for patient records, doctors, administrators, and clinics.

Database Management Features

Covers sorting, searching, and filtering stored sessions and patient data.

Protocol Configuration and Management

Guides on creating, adapting, and managing custom test protocols.

Database Management Sorting and Searching

Details sorting by date/alphabetical order and using search tools for patients/sessions.

Protocol Tree Structure and Editing

Explains the protocol tree structure and how to modify existing protocols.

Creating New Protocols

Guides on creating new protocols and selecting tests by type/subtype.

Test Demonstrations (Demos)

Accessing Test Instructions and Videos

Guides on accessing test instructions, recommendations, and video demonstrations.

Demo Toolbar Navigation

Mentions the Back button for navigating the demo screen.

Advanced Configuration Settings

Overview of Advanced Setup Options

Introduces advanced settings grouped by characteristics for system configuration.

Advanced Setup Toolbar Navigation

Describes toolbar buttons like Back, Default, and Save & Exit.

Warning Level Configuration

Explains selecting warning control levels (Soft, Normal, Hard).

Visual Stimulator Setup

Details setting up the visual stimulator for correct stimulation patterns.

Monitor Dimensional Characteristics Input

Guides on inputting monitor dimensions for accurate stimulation.

Print Report Settings

Selecting Items for Printing

Describes checking/unchecking items for printing and changing report settings.

Test-Specific Print Options

Explains options like Auto Adjust, Graphics, Records, and Print Width.

Graphical Scale Configuration for Printing

Details setting the Time window for displaying or printing time plots.

Acquisition Settings

Time Offset and Scrollbar Usage

Explains defining time offset and using scrollbars for chart views.

Acquisition Sequence and Test Control

Guides on performing tests in user-defined sequences and controlling acquisition.

Detailed Acquisition Settings

Lists various acquisition settings such as Alert Message, Test Instructions, and Render options.

Analysis Sensitivity Adjustment

Adjusting Detection Algorithm Sensitivity

Explains how to adjust detection algorithm sensitivity for specific tests.

Pupil Configuration

Pupil Configuration Tab Access

Notes that pupil configuration requires technical support.

Pupil Detection Parameters

Lists detection parameters for pupil analysis.

Reprocessing Test Data

Modifying Eye Detection Area for Analysis

Describes modifying the eye detection area to improve analysis results.

Hardware Support for Reprocessing

States that reprocessing is exclusively for technical support use.

Technical Support Options

Requesting Technical Assistance

Guides on accessing the support screen via the Support button.

Technical Support Types

Differentiates between Email Support and Remote Support.

Remote Connection Status

Shows the screen displayed while waiting for a remote connection.

Technical Support Offline Status

Displays the message when remote support is unavailable.

Software and Hardware Installation

Software Installation Prerequisite

Emphasizes correct software installation before hardware installation.

System Requirements Overview

Lists hardware (processor, memory, etc.) and software (OS, SDKs) requirements.

Software Installation Process

Details steps for installing the VNG Plus software using the pen drive.

Installation Language Selection

Guides on selecting the installation language.

Default Installation Options

Recommends following default options during the installation screens.

Driver Installation Process

Explains the automatic driver installation after file copying.

Driver Installation Confirmation

Describes the confirmation message upon successful driver installation.

Automatic Drivers Installation

Explains the automatic loading of USB Video Device and Data drivers.

Checking Driver Installation (Windows 7)

Guides on verifying driver installation using Device Manager.

Hardware Installation Guide

Unpacking and Receiver Bar Assembly

Details unpacking the device and warnings for receiver bar assembly.

Receiver Bar Assembly Procedure

Provides step-by-step instructions for assembling the receiver bar.

System Connections

Mask, Junction Box, and Camera Connections

Guides on connecting the position sensor, cameras, and junction box.

Monitor, PC, and Power Connections

Details connecting the monitor, PC, and power supply.

Finalizing Installation and Verification

Instructs on powering on the device and verifying software installation.

Workstation Setup and Layout

Visual Stimulation Generation and Display

Explains visual stimulation via digital images on a monitor.

Stimulator Usage in Specific Tests

Lists tests where the visual stimulator is used (Gaze, Smooth Pursuit, etc.).

Workstation Layout Guidelines

Provides guidelines for eye height and ultrasonic sensor placement relative to the monitor.

Care and Maintenance Procedures

General Cleaning Precautions and Methods

Outlines precautions for cleaning the equipment to avoid damage.

Console and Receiver Bar Cleaning

Provides specific instructions for cleaning the console and receiver bar.

Goggles Cleaning and Maintenance

Details cleaning camera lenses, mirrors, frames, and mask straps.

Changing Goggle Cushions

Guides on replacing the goggle cushion pad.

Fuse Replacement Procedure

Details the steps for opening the fuse compartment and replacing fuses.

Component Disposal Guidelines

Advises on disposing of removed parts according to regulations.

Maintenance and Repairs

Authorized Maintenance and Repair Personnel

States that only qualified ECLERIS personnel should perform maintenance.

Repayment and Transportation Guidelines

Cautions about using original packaging for transport and environmental conditions.

Troubleshooting Common Problems

Device Power and Connection Issues

Addresses problems like the device not turning on or not being detected.

Image Recording and Display Problems

Solves issues related to image recording or display faults.

Wireless Switch Detection Issues

Troubleshoots problems with wireless switch detection or functionality.

Technical Specifications

Goggles and Console Specifications

Lists weight and dimensions for goggles and console.

Power and Electrical Safety Specifications

Details power input, consumption, fuse type, and electrical protection class.

Environmental and Storage Conditions

Specifies service, storage, and transport conditions.

Regulatory Standards Compliance

Lists compliance with IEC60601 standards for medical electrical equipment.

System and Test Capabilities

Outlines system input, sampling, tracking range, and test capabilities.

Video Camera and Visual Stimulus Specifications

Details specifications for video cameras and visual stimulus signals.

Appendix: Abnormality Thresholds

Spontaneous Nystagmus Abnormality Thresholds

Defines abnormality thresholds for spontaneous nystagmus and bilateral gaze.

Smooth Pursuit Abnormality Thresholds

Lists abnormality thresholds for smooth pursuit gain, phase, and asymmetry.

Saccade Abnormality Thresholds

Defines abnormality thresholds for saccade velocity, latency, and accuracy.

Optokinetic Nystagmus Abnormality Thresholds

Lists abnormality thresholds for OKN gain and symmetry.

Dix-Hallpike Abnormality Thresholds

Defines abnormality thresholds for Dix-Hallpike test results.

Caloric Test Abnormality Thresholds

Lists abnormality thresholds for caloric tests, including unilateral weakness and fixation index.

Freyss Diagram for Caloric Tests

Freyss Diagram Purpose and Design

Explains the Freyss diagram for showing nystagmus intensity, symmetry, and preponderance.

Interpreting the Freyss Diagram

Guides on interpreting the diagram's axes, lines, and intersection points.

Freyss Diagram Calculations

Details formulas for calculating lateral symmetry and absolute preponderance.

Dizziness Handicap Inventory Questionnaire

DHI Questionnaire Structure and Scoring

Presents the DHI questionnaire structure and scoring system.

Electromagnetic Compatibility (Emissions)

Guidance on Electromagnetic Emissions

Provides manufacturer's declaration on electromagnetic emissions.

RF Emissions CISPR 11 (Group 1)

Details RF emissions for internal functioning, unlikely to cause interference.

RF Emissions CISPR 11 (Class A)

Specifies suitability for use in establishments other than domestic premises.

Harmonic Emissions IEC61000-3-2

States compliance with harmonic emissions standards.

Flickers IEC61000-3-3 Compliance

Confirms compliance with flicker standards.

Electromagnetic Compatibility (Immunity)

Guidance on Electromagnetic Immunity

Provides manufacturer's declaration on electromagnetic immunity.

Electrostatic Discharge (ESD) Immunity

Details immunity levels for electrostatic discharge.

Transients / Rapid Electric Bursts Immunity

Specifies immunity levels for transients and rapid electric bursts.

Surge Voltage Immunity

Details immunity levels for surge voltages.

Voltage Drops, Interruptions, and Variations Immunity

Lists immunity requirements for voltage fluctuations.

Power Frequency and Magnetic Field Immunity

Specifies immunity levels for power frequency and magnetic fields.

RF Conducted Immunity (IEC 61000-4-6)

Details immunity levels for conducted RF interference.

RF Radiated Immunity (IEC 61000-4-3)

Specifies immunity levels for radiated RF interference.

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