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Instructions for Use Instructions for Use Part 1 Instructions for Use – GB Manual de instrucciones – ES Bruksanvisning – SE Instructions d’utilisation – FR Οδηγίες Χρήσης - GR Gebrauchsanweisung – DE Istruzioni per l’uso – IT Instruções de utilização – PT VNG Stand Alone Unit VN415 / VO425 Valid from software version 7.07 8011826 Rev. 3 - 11/2013 Instructions for Use - GB VNG Stand Alone Unit VN415 / VO425 Valid from software version 7.00 VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 1 Intended Use The two Interacoustics VNG systems, VN415 and VO425, are primarily intended for use in the evaluation, documentation and diagnosis of vestibular disorders. This is of particular interest to Ear, Nose and Throat specialists, to Neurology specialists, Audiology specialists and other health care professions concerned with balance assessment. The VN415 is the basic unit for peripheral vestibular testing and the VO425 is the extended system for central testing using oculomotor stimuli. Precautions WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION, used with the safety alert symbol, indicates a hazardous situation which, if not avoided, could result in minor or moderate injury. NOTICE is used to address practices not related to personal injury. 1. It is recommended that parts which are in direct contact with the patient (e.g. disposable goggle foam pads) should only be used with one patient, and should therefore be discarded after each session. 2. Please note that the CE Marking is only legal if this Instruction is translated into the national language of the user no later than at the delivery to him, if the national legislation demands a text in the national language according to MDD article 4.4. 3. Please note that if connection is made to standard equipment like printers and network, special precautions must be taken in order to maintain medical safety. 4. Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears. If this apparatus is connected to one or more other devices with medical CE marking, to make up a system or pack, the CE marking is only valid also for the combination if the supplier has issued a declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the combination. Operation Instructions Preparations prior to the VNG Test To ensure reliable and valid test results from your VN415 / VO425 it is important that the patient is prepared for the test. Preparation of the patient No glasses or contact lenses should be worn during the examination. Eye makeup should also be removed, as this may disrupt the registration of the pupil. Finally, the patient should have received instructions to discontinue any form of non life sustaining medication prior to the examination. VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 2 Calibration To make an allowance for different depths of patient eye orbits a calibration procedure can be performed. This is initiated using the button. The setup of this procedure can be altered in the configuration screen. Calibration points can be presented to the patient via the VisualLab software or via dots on the wall. Placement of the mask The mask should be placed on the head. Tighten the headband around the head. Make sure that the pupil is visible and in the centre of the eye image. The Infra-red mirrors inside the cover have two possible positions. Make sure that they are adjusted to the most suitable position. Adjust the cameras with the vertical and horizontal adjustment knobs. The image must be brought into focus with the focus knob – always avoid unfocused, blurred images since this will disrupt eyetracking. Setting of the pupil identification threshold The software will automatically detect the optimum grey scale for pupil identification, but this may also be done manually. To adjust the threshold manually simply find the optimum position for the slider controlling the setting for the grey-scale. This is done by tweaking the and arrows on the sliders either side of the eye images. Short Instruction HELP The Operation Manual is a very important partner in getting to know your VNG unit. This is available in hard copy and Online in the Electronic operation manual: Select Help/Help in the main menu bar, and a comprehensive list of help topics makes up an operation manual including easy searching and cross referencing functions. Operating the OtoAccess™ database The first screen that will come up after the system has been turned on is the OtoAccess™ database screen. To add a new client to the database click the “New Client” button and after entering the required details such as name, person ID etc, save by To search for any client, click the “Search Client” button , write client details (e.g. Person ID) and use Enter. VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 3 To add a new examiner, open the File tab and click “Setup” in the pull-down menu. Open the “Examiners” panel and enter the relevant details for the new examiner. Left click on the “Save” button to store the examiner. New Test To enter test mode from the name database, double click the instrument symbol in the “Select Instrument” box . Open a new session from the Session Template by clicking , or simply click one of the test icons to prepare for immediate testing. Start the test with the button Then use the return key or the IR remote control to progress through the steps of each test. The IR remote control acts as a functional return key and can be used to start and stop testing, and for switching on the fixation light. Activating the fixation light To activate the fixation light inside the goggle the can be used. Automatic activation can be set in the Configuration dialogues. Manual Edit Mode To enter manual editing mode, click the “Toggle edit mode” button . In this mode graphs are displayed in single mode, and in a larger scale than in the normal mode. Video recording With the test in progress, click the ’Start Record’ button located on the left of the eye images. To change the default setting of a test into automatic video recording, this option must be activated in the test configuration dialogue under ‘Configure Test’. Start record Stop Record When ‘Record’ button has been activated it will flash until the test is stopped, or until you press the ‘Stop recording’ button. Recording will automatically stop when the test is stopped or finished. VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 4 To review a recorded test, activate the button in the toolbar. The screen will now change into playback mode and the cameras will be disconnected. Adding notes Notes about the Session or the individual test can be added by clicking on the button. Creating a Letter Select the ‘Letter Wizard. .’ from the ‘Session’ menu. Select the appropriate information from the presented fields. New selectable information can be added with the button. This can then be saved with button or deleted with button. Printing Select the “Print Session” button to receive printouts from the whole session. Select the “Print Test” button to receive printouts for a selected test. Save and Exit Select to save data and to exit session. Alternately select if you want to exit without saving data. …………………………………………………………………………………………………………………............................................. Various additional tools: Lock Chair Click the ‘Lock Chair’ button to lock the Interacoustics rotary chair in any horizontal position. This function is relevant for clinics using the Interacoustics rotary chair as an examination table for caloric irrigations and positional testing. To release the chair, click the ‘Lock Chair’ button again. Tree View Click , to access the tree view. This will display the Session and test order information on the left side of the screen. Session Template Designer To view and make changes to a Session Template choose ‘Session Template Designer’ under the Session menu. In this dialogue the properties of a Session can be changed. A new Session Template can be configured by pressing the button. Changes to the selected template can be saved with the button. The number of tests performed and their order can be changed in the tests to be performed list . Tests can be inserted by using the button. Tests can be deleted using the button. The order of tests performed can be changed by using the and buttons. The settings of a selected test can be changed in by using the button. VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 5 Automatic threshold detection The grey-scale threshold by which the pupil is identified is set automatically when the goggle is positioned on the client. This can be deactivated and then re-activated with the and buttons. Shifting between Eye Trackers To facilitate optimal eyetracking on as many patients as possible, two different eyetrackers are available for the user: Elliptical – searches for edges; those that combine into an elliptical shape are defined as the pupil. Will normally provide optimal tracking on patients wearing mascara Circular – searches for dark areas and locks onto the roundest object, identifying this as the pupil. To shift between the two eye trackers on the fly, click the symbol in the lower left corner of the eye image area and select the required eye tracker – Elliptical or Circular. 1. 2. Image Brightness Adjustment Sliders for image brightness adjustment VN415 / VO425 Instructions for Use - English Date: 2010-12-20 Page 6 Move the sliders to adjust the image brightness in enlaged eye view mode (opened by right- clicking the eye image).
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