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Secure Balance™ Video ENG Vestibular Function Testing

The Secure Balance™ VNG Modules offer complete function analysis that is easy to administer and comfortable for the patient. The lightweight Goggle is recognized as one of the best video masks available today for reasons of patient comfort and versatility in fitting on a variety of patient populations. The Secure Balance™ Video ENG provides the solution to the limitations of previous measurement techniques.

Video images of the eyes are obtained without direct contact using high resolution cameras with infrared illumination. The eyes are visualized, enabling simultaneous subjective evaluation, while eye position is analyzed by digital image processing to obtain vertical and horizontal eye position.

The Challenge

Eye movement measurements play an essential part in patient diagnosis by providing the clinician with important qualitative and quantitative information. However, traditional electro-nystagmography (ENG) has the same problems inherent in most electrode-based systems, including biologic and external noise and signal drift. Electrodes consume additional time and expense and are generally an uncomfortable inconvenience for the patient. ENG does not allow the visual evaluation of eye movements.

VNG – The Solution

Video Nystagmography (VNG) provides the solution to the limitations of previous measurement techniques. Video images of the eyes are obtained without direct contact using high resolution cameras with infrared illumination. Setup is as fast and as easy as using Frenzel glasses. The eyes are visualized, enabling simultaneous subjective evaluation, while eye position is analyzed by digital image processing to obtain vertical and horizontal eye position. VNG can also demonstrate eye movement patterns for teaching purposes. Disease processes and their effects can be visualized by both patients and students while being described by the clinician.

The Advantages

Eye tracking algorithm registering the centre of the pupil.

  • Didactic documentation: visual tool for documenting transient disorders for teaching purposes Accurate: resolution 0.1°
  • Time saving: easy setup with visual control, no need to spend time attaching electrodes
  • Cost saving: no disposable materials
  • Easy to use: slip on mask and start! Analysis software within Microsoft Windows
  • Complete evaluation: standard analyses for all nystagmography tests
  • High quality printouts of all analyses and selected raw data
  • Database: full measurement data and analyses, GDT interface, intuitive search of patient details, supports all Interacoustics modules.
  • Objective: positional examinations can be recorded and documented without artifact problems
    Subjective evaluation during the whole examination.

The Combi Mask

The lightweight and comfortable combi mask offers the possibility of doing free-fi eld-of-view as well as light occluded testing.

The Combi Mask offers unparalleled patient comfort and diagnostic advantages. The unique design allows the examiner to observe the patient’s eye movements with a free-field view of both eyes while the software collects the data for objective analysis. A light occluding cover plate is easily added or removed during the examination. Because the mask is so lightweight it does not shift - even during positioning maneuvers. The Combi Mask provides an excellent fit on the majority of patients including those with smaller physical head dimensions (e.g. children).

Advantages of the Combi Mask

A footswitch to control the test allows the examiners to keep their hands free during testing.

  • Lightweight and comfortable
  • No need for darkened exam room
    Visual observation of both eyes
  • Easy adjustments for interpupillary distance and focus
  • Built-in fixation lights for visual suppression
  • Higher stability for recordings and
    maintaining calibration
  • Cover can easily be fitted and removed, particularly practical with the apprehensive patient.
  • Can be used in stand-alone Video Frenzel system

Test situation for Caloric Irrigation

Air Irrigator

Air Irrigator

Secure Balance™ Video Oculography

Performing an oculomotor test and examples of included
patterns for the visual stimulus system for oculomotor
testing and calibration.

The Secure Balance™ offers a complete vestibular analysis system that is easy to administer and comfortable for the patient. The Secure Balance™ provides all of the standard vestibular examinations plus the unique VisualLab for optimal presentation of optokinetic stimuli. In addition, the Secure Balance™ lightweight Combi Mask is recognized as one of the best video masks available today because of patient comfort and versatility in fitting on a variety of patient populations. The Secure Balance™ Windows based examination software and report generator make it easy to run through a test, analyze the data and quickly generate a professional report. Depending on requirements, the Secure Balance™ is available in a binocular or monocular confi guration. In addition to the tests included with the Secure Balance™ (see next page) the Secure Balance™ includes oculomotor tests such as:

  • Saccade
  • Optokinetic
  • Smooth Pursuit
  • Gaze

Secure Balance™ - VisualLab

VisualLab for Secure Balance™

The included stand alone VisualLab offers a unique selection of stimulus patterns unmatched by other systems. Choices in color patterns, scenery and image size make the VisualLab an obvious choice for the professional vestibular clinic.

Advantages of the VisualLab

  • Full visual field stimulation
  • Assorted stimulus patterns
  • Easy adaption to different test spaces
  • Able to import custom stimuli

Saccade Test Window

OptokineticTest Window

Secure Balance™ Alternate System

Secure Balance offers an alternate system that is available at a reduced price. This system offers many similarities but does not include the VisualLab for the specialized oculomotor testing. This Alternate system records the patient’s eye movements using the same mask and camera system as used with the Secure Balance System. The PC-based system then analyzes the video images. Tests can include:

  • Spontaneous nystagmus
  • Caloric
  • Multi-Condition

Advantages of the software

  • Create your own examination templates
  • Create independent, high quality reports for each template
  • View graphical data and corresponding eye positions
  • Fast statistical analysis
  • Normative value comparisons
  • Record comments during exam
  • Hands free operation with footswitch

Examination Templates and Test Views

The Examination Designer allows the creation of your own test protocol. Once the protocol is defined you can step through the examination by simply pressing a footswitch. It couldn’t be any easier! During the examination the test view provides you with graphical data and immediate »On Line Analysis« while simultaneously displaying the eye images for subjective control during the exam. The examiner can even type in comments while the test is in progress. These features greatly reduce the number of time consuming steps often involved in generating test data.

 

Printouts

The Secure Balance™ can produce clear and detailed color reports suitable for hardcopy storage. Reports collate patient details, traces, analysis and display diagrams in an easy-to-read-format.

The Database

The integrated extensive database provides a practically unlimited storage capability. The database works with both the Secure Balance™/Alternate Systems.

Stand Alone Unit

The Secure Balance™ / Alternate Systems are integrated into the Interacoustics Medical PC platform. This is designed for convenient transportation around a clinic and the amount of extraneous equipment required is kept to a minimum.

Additional Options

  • Reader station for remote data access
  • Setup to record rotary chair movement
  • Separate monitors for easier visualisation of the eye
Secure Balance™ Video ENG System
General Technical Specifications
Included Parts
• Combi Mask/Goggle
• One Camera module for Combi Mask for 2-Channel Recordings (Please specify if PAL or NTSC)
• Two Camera modules for Combi Mask and 4-channel software (Please specify if PAL or NTSC)
• Installation CD
• Tracking Interface Controller
• Footswitch
• Full-Field Projection System
• Flashcard memory
• Operation Manual

Standards:

EN60601-1 (General safety)
EN60601-1-1 (Safety of system)
EN60601-1-2 (EMC)

Medical CE-mark:
The Secure Balance™ Interacoustics A/S meets the requirements of the Annex VI of the Medical Device Directive 93/42/EEC. Approval is made by TÜV – Identification no. 0123.

System:

Stand alone system with Windows98 and XP®.

Examination Templates:

Several default examination templates included. As many examination templates as desired may be designed and added by examiner.
Database:
Included - storage only limited by hard drive size. Patient demographic data. Patient journal. Compliant with GDT standard for Root Data
Transfer definition “6301.” May additionally include data from Interacoustics’ ABR and TEOAE systems, Audiometers and Impedance audiometers. Easy back-up function.

Recording:
Binocular/4 channel, Monocular/2 channel.

Data Acquisition:

Method: Infra-red illuminated eye image captured by camera module (PAL or NTSC, please specify). Tracking: From cross hair movement. Dynamic Range: Approx. +/- 20°.
Data Analysis:
Continuous algorithm. Discreet algorithm: User defined velocity acceleration, amplitude, temporal and sensitivity thresholds.
Stimuli Available with VisualLab:
• Colors and targets entirely user defined.
• Optokinetic - horizontal and vertical stimulation available. User designed jpeg stimuli
can be imported. Also chessboard, stars and stripes available.
• Smooth pursuit-sinusoidal/linear, with or without acceleration.
• Saccade - horizontal/vertical.
• Gaze.
Reports:
One page holding statistical data for four tests. One page holding traces, display diagrams, statistical data for one test. Easy to use templates with default settings for audiology and oto-neurology clinics.

Normative Data:

Implemented in software.

Screen:

12’1” High Bright Wide Angle. Industrial TFT. May be disconnected from main unit.

Networks:

VNG may be connected to a network. Then testing may be monitored from any reader station. Subsequent editing, including nystagmus, analysis may be carried out from any networked PC.

Help:

On-line help through electronic operation manual.

VNG Attributes:

Includes VisualLab for specialized oculomotor Testing in Full-Field peripheral display.

Number of tests per session:

Unlimited.

Number of sessions per patient:

Unlimited.

Optional display monitors:

May be mirror imaged.

Dimensions:
(W x D x H) 36.6 x 25.5 x 38 cm / 14 x 10x 15 inches.
Weight: 17.9 kgs. / 40 lbs.
Technical Information
Channels Monocular/Binocular
Mask Mode Free-field-of-view/light included
Operating System Windows®
Scanning Rate 50Hz/60Hz
Occulomotor Stimuli Yes, VisualLab, Full-Field Studies
Programmed Test Protocols (Records both horizontal and vertical eye movement live on computer display) Tracking (variable speeds both vertical & horizontal stimulus), Gaze (variable speeds both vertical & horizontal stimulus), Saccade (variable speeds both vertical & horizontal stimulus), OPK (variable speeds both left and right stimulus direction), Torsion, Active Head Shake, Spontaneous, Hallpike (Left & right), lateral (left & right), Supine (left & right), head hanging (forward & back), and build your own protocol testing, Bithermal Calorics, and built-in fixation.
Normative Data Yes for all tests
Caloric Display Options Statistical Data, Butterfly, Freyss, Claussen, Scherer, Haid/Stoll
Reader Station Software Optional
Report Generator Integrated-build and design the report you like.
Kit Option, without system PC Yes
Patient Database Included - unlimited storage
Foot switch Yes
Dimensions (WxDxH) 36.5x25.5x38cm / 14x10x15inches
Mask Weight Binocular 580 gm
System Weight 21.9kg / 48lbs
Rotary Chair Extension Kit Optional
Medical CE mark / FDA Yes / Yes

Included Parts:

  • Combi Mask or Goggle
  • One Camera module for Combi Mask
  • Two Camera modules for Combi Mask and 2-channel software
  • Installation CD
  • Computer System with Tracking Interface Controller
  • Footswitch
  • Full-Field Projector (dimensions 2”X6”x6”: Weight 1.2lbs)
  • Null-modem cable
  • VisualLab Operation Disk
  • Flashcard Mobile Storage
  • Operational Manual