Page 1 VERSATILE CLINICAL EP/OAE AUDERA PRO USER MANUAL...
Page 2 Title: Audera Pro User Manual Manufacturer Grason-Stadler, Inc. 10395 West 70th Street Eden Prairie, MN 55344 Copyright © 2020 Grason-Stadler. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of Grason-Stadler.
Page 3: Table Of Contents
GSI Audera Pro User Manual ABLE OF ONTENTS Table of Contents ........................1 Preface ............................10 Manual Conventions ......................10 Regulatory Symbols ......................11 Device Symbols ........................13 Warnings and Cautions ......................14 Important Safety Instructions ..................... 14 Safety Precautions ........................ 14 Explosion ..........................
Page 4 Base Unit ..........................26 Base Unit Stand ......................... 26 Transducers ........................26 System Assembly ........................26 Placement of the Audera Pro base unit ................. 26 System Setup Diagram ..................... 27 Connect the Cables ......................28 Base Unit Rear Panel ......................28 Connections ........................
Page 5 GSI Audera Pro User Manual Patient Information Management ..................42 New Patient ........................... 42 Patient Information Function Buttons ................43 Open Patient ......................... 44 Edit Patient ..........................46 Backup Patient Data ......................47 Evoked Potentials (EP) ......................48 Title Bar ..........................48 EP Main Menu ........................
Page 6 GSI Audera Pro User Manual Stimulus Display Dialog ....................74 P300/MMN Setup Dialog ...................... 75 Amplifier Settings Dialog ...................... 76 External Trigger ........................79 Remote Impedance Display Box ..................80 Data Analysis ......................... 82 Data Files Dialog ........................82 Data Pages ......................... 83 Display Options .........................
Page 7 GSI Audera Pro User Manual Open Records ........................104 VEMP Analysis Window ...................... 105 VEMP Analysis Menu ......................106 File ............................. 106 Process ..........................106 Settings ..........................106 Help ..........................107 VEMP Analysis Toolbar ....................... 108 VEMP Culling Mode View ....................108 VEMP Calculation Mode View ....................
Page 8 GSI Audera Pro User Manual Keyboard Shortcuts ......................129 Data Analysis ........................130 Data Files Dialog ......................... 130 Analyze Active Wave ......................131 Polar Plot .......................... 131 Spectral Graph ......................... 132 Data Table ........................132 Record Selection and Option Buttons ................133 ASSR Response Audiogram ....................
Page 9 GSI Audera Pro User Manual Data Analysis ........................165 Transient Evoked Otoacoustic Emissions (TEOAE) ............. 167 Title Bar ..........................167 TEOAE Main Menu ......................168 Patient ..........................168 Protocol ..........................168 Stimulus ........................... 169 Recordings ........................169 Report ..........................169 Print ..........................
Page 10 GSI Audera Pro User Manual Maintenance ........................189 Operational Checks......................189 Calibration and Safety checks ..................189 Cybersecurity .......................... 190 Troubleshooting ........................193 Error Messages ........................193 USB Connection Not Found…. Continue without Hardware? ........193 Access Violation at address xxxxx …… ................193 Probe Fit Error: Probe Occluded ...................
Page 11 GSI Audera Pro User Manual Maximum Output Levels ....................215 DD45s Headphones ......................215 IP30 Insert Phones ......................216 B81 Bone Vibrator ......................217 SP90 A Free Field Speaker ....................218 Appendix D – Specification of Input/output Connections ..........219 Mains Cable .........................
Page 12: Preface
GSI Audera Pro User Manual REFACE This user manual provides information about the GSI Audera Pro. This manual is intended for technically qualified personnel. Please note: This User Manual is not intended as a training manual. The reader should consult standard audiology texts for the theory and application of the tests provided by this instrument.
Page 13: Regulatory Symbols
GSI Audera Pro User Manual EGULATORY YMBOLS Symbol Description Conforms to European Medical Device Directive 93/42/EEC. Indicates that the device is a Medical Device Symbol for "SERIAL NUMBER." GSI Part Number. Return to Authorized Representative, Special disposal required. Medical Equipment Classified by Intertek Testing Services NA Inc.
Page 14 GSI Audera Pro User Manual Symbol Description This side up. Electrostatic sensitive devices, or to identify a device or connector that has not been tested for immunity to electrostatic discharge. Consult the operating instructions/directions for use. A copy of the operating manual is available on this website: www.grason-...
Page 15: Device Symbols
The GSI Audera Pro is Type BF according to the international standard IEC 60601-1. The type BF applied parts are the electrodes, headphones, insert earphones, bone oscillator, and the probe ear tips.
Page 16: Warnings And Cautions
Parts which may be broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from GSI. This instrument is suitable in hospital environments except for near active high...
Page 17 GSI Audera Pro User Manual repairs are made and the unit is tested and calibrated for proper functioning in accordance with Grason-Stadler published specifications. No parts of the equipment can be serviced or maintained while in use with the patient.
Page 18 Only use power cords with insulation rated for the voltages and currents being carried and provided/approved by GSI. The third conductor in the power supply cord is only a functional earth. The power supply in the device provides protection against short-circuit, overload and over voltage.
Page 19: Explosion
GSI Audera Pro User Manual XPLOSION This system is not explosion proof. Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device near flammable anesthetic gases. Do NOT use the system in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc.
Page 20: Ambient Noise
MBIENT OISE The GSI Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment. Excessive noise in the test environment, such as that produced by conversation, office equipment, or printers, reduces test validity because it tends to mask the test signals.
Page 21: Transducer Sound Attenuation
GSI Audera Pro User Manual Transducer Sound Attenuation Sound Attenuation for Earphones per ISO 4869-1 Attenuation Frequency (Hz) DD45s with IP30 insert MX41/AR or PH51 earphones (dB) Cushion (dB) 1000 1250 1500 1600 2000 2500 3000 3150 4000 5000 6000...
Page 22: Introduction
The GSI Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The GSI Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment.
Page 23 GSI Audera Pro User Manual In VEMP testing, a loud stimulus (90-95dB nHL) is often required to elicit the desired response. VEMP testing contraindications include: • Presence of tinnitus, hyperacusis or other sensitivity to loud sounds Conductive hearing loss caused by middle ear effusion, perforated eardrum or •...
Page 24: Modalities
GSI Audera Pro User Manual ODALITIES The Audera Pro system may be purchased with optional modality licenses allowing you to perform different tests. Evoked Potentials (EP) An evoked potential is an electric response from the nervous system following the presentation of a stimulus. This is a distinct response that is embedded in the spontaneous EEG activity that can be measured and recorded.
Page 25: Distortion Products Otoacoustic Emissions (Dpoae)
GSI Audera Pro User Manual Distortion Products Otoacoustic Emissions (DPOAE) Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Distortion product otoacoustic emissions are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, by stimulation of the auditory system with a pair of pure tones at frequencies (f1 and f2).
Page 26: Unpacking The System
GSI Audera Pro User Manual NPACKING THE SYSTEM  It is recommended that you unpack your Audera Pro carefully making sure that all components are removed from the packing materials.  Verify that all components are included as shown on the packing slip included with your shipment.
Page 27: Included With Oae Option
Cable for TM ECochG electrode • TM Electrode for ECochG 10pcs • Electrode gel Connect only items that have been specified as part of the system or specified as being compatible with Audera Pro system. D-0129360 Rev A Page 25 of 231...
Page 28: Getting Started
SSEMBLY Placement of the Audera Pro base unit The Audera Pro unit may be placed horizontally on a flat surface such as a desktop, set vertically in the provided stand or wall mounted. With a horizontal placement you may place a notebook computer on top of the base unit.
Page 29: System Setup Diagram
System Setup Diagram The Electrodes referenced in the diagram include the patient electrode cable connected to the Audera Pro and the electrodes connected to the patient. The transducers include the IP30 Insert Earphones, DD45s headphones, B81 Bone transducer and the OAE probe.
Page 30: Connect The Cables
GSI Audera Pro User Manual Connect the Cables Switch off the system power before connecting or disconnecting any system component(s) or accessories. Do not switch on any system power until all cables have been properly connected and verified. 1. Connect the transducers to the base unit as indicated on the rear panel label (red denotes right and blue for left) 2.
Page 31: Software Installation
To install this application, the user must either be an Administrator or know the Administrator password. 1. Insert the GSI Audera Pro USB Software Bundle into an available USB port. If auto-run is disabled, browse the USB drive and double click on the GSISetup.exe file.
Page 32: Recommendations
The procedure for an upgrade is the same as the initial installation of the software as described above. However, there may be some differences and you should follow any instructions provided with the upgrade media. Only apply the Audera Pro program software updates and patches provided by GSI.
Page 33: Operating Audera Pro
(top, right, front) that, when lit (green), indicates that the power is Launching Audera Pro Software Double-click the shortcut icon on the desktop to open the GSI Audera Pro application. It is also possible to open this application from Start>Programs>Grason-Stadler>GSI Audera Pro>GSI Audera Pro.
Page 34: Opening Window
GSI Audera Pro User Manual PENING INDOW The opening window of the Audera Pro application has a menu and toolbar displayed at the top of the window and the patient, system number and connection status displayed at the bottom of the window.
Page 35: Menu Options
Edit - displays the Patient Information dialog where the current patient • information may be edited. Quit Audera Pro – presents a confirmation dialog and if confirmed exits the • program and returns to the operating system. Settings Configuration –...
Page 36: Opening Window Toolbar
GSI Audera Pro User Manual The Opening Window Toolbar allows the user to add a new patient, search and select a patient or edit the patient information, launch program modules and login/logout. PENING INDOW OOLBAR Icon Description Add Patient - displays the patient information screen where the patient information may be added Open/Search Patient –...
Page 37: Connection Status
Some administrative items in the program require a password. The default password is ‘gsi’. To change the password, go to the Settings menu, Configuration. You will be prompted for the password. When the Hardware Setup dialog is displayed, select the Password menu item in the Hardware Setup and you will be prompted for the new password.
Page 38: Hardware Setup
GSI Audera Pro User Manual ARDWARE ETUP The Hardware Setup dialog provides a menu at the top. Hardware – displays the information on the system. • Registration – displays the facility information used in the reports. • Password – allows you to change the administrative password •...
Page 39: Registration
GSI Audera Pro User Manual Registration The Registration screen provides fields for the facility information that is printed on the report header. The Save button will store the information and the Print Registration button sends the information to the default printer.
Page 40: Normative Data
GSI Audera Pro User Manual ORMATIVE After entry of the administrative password, the Normative Data option displays the Latency-Intensity table dialog. This dialog is used to define the shaded areas that are displayed on the Latency-Intensity Graph in the EP module. Multiple sets of normative data may be defined.
Page 41: Operators
GSI Audera Pro User Manual Save Norms as - this option presents a file save dialog where you can name and • save the current data set. Save Norms as Defaults – stores the current Standard file as the default •...
Page 42: System Log
GSI Audera Pro User Manual Select the Add/Update User button to add the user. To delete a user, select the name of the user from the drop down in the name field, then select the Delete User button. The Exit button closes the dialog and returns to the Opening window.
Page 43 GSI Audera Pro User Manual Below the data table are buttons to allow the printing and export to a text file of the displayed activity log. The OK button closes the dialog. The list of log files is shown with the system ID and date in the center bottom of the window and the Update button loads the selected file.
Page 44: Patient Information Management
GSI Audera Pro User Manual ATIENT NFORMATION ANAGEMENT The patient information should be entered prior to collecting data. The Opening Window and each of the test modality modules allow the entry of patient information and the search and selection of a patient from previous sessions. The patient entry and search dialogs are the same across all the test modules.
Page 45: Patient Information Function Buttons
GSI Audera Pro User Manual Required information indicator Required information Function Buttons Tabs for optional information Patient Information Function Buttons Saves the data and closes the dialog Closes the dialog and does not save any changes Clears the fields for entry of new patient information...
Page 46: Open Patient
GSI Audera Pro User Manual ATIENT The Open patient option from the Patient menu or the Open patient toolbar button displays a dialog with the list of patients that have been entered into the system. Options within the dialog allow you to sort the list and to select a patient.
Page 47 GSI Audera Pro User Manual all patients regardless of status assignment. Updates the display of the patient list. Also, along the top of the window are the column header buttons: First Name, Last Name, Patient ID and System Identifier. These buttons allow the patient list to be sorted on the column field.
Page 48: Edit Patient
GSI Audera Pro User Manual Enter the search string then select either the Search Down or Search Up button to perform the search. If the search string is found within the four search columns, the record will be highlighted and become the current selected patient.
Page 49: Backup Patient Data
GSI Audera Pro User Manual ACKUP ATIENT To back up your patient data, select the Backup button from the Patient Information dialog. The Backup dialog initially populates the backup table with the current patient. If New patient was selected to display the Patient Information dialog, the table will be blank.
Page 50: Evoked Potentials (Ep)
GSI Audera Pro User Manual (EP) VOKED OTENTIALS When the EP icon is selected, the system displays the initialization dialog while the EP module loads and then the main EP screen is presented. The EP screen layout has a title bar at the top, the main menu under the title bar, information bar below the main menu, and the top Toolbar in the upper part of the screen.
Page 51: Ep Main Menu
GSI Audera Pro User Manual EP M The EP Main Menu allows access to most of the functions of the program. Each of the Main menu selections have sub-menus: Patient New – Opens the Patient Information dialog with the information cleared and •...
Page 52: Stimulus
GSI Audera Pro User Manual Continuous Acquisition – When selected, data collection continues with the • same parameters after each average is complete. The data collection will need to be stopped manually from the control bar when in this mode.
Page 53: Recordings
GSI Audera Pro User Manual occur from the electrical stimulus. You should make sure that the blanking time is less than the beginning of the response. Digital Filter – Option to turn on/off the digital filter that is used with the •...
Page 54: Averaging
GSI Audera Pro User Manual Averaging Block Averaging – Displays the block size and opens a submenu where you may • select the number of sweeps that are used in the block average. Block averaging divides the data into sets or blocks of data with an average preformed for each block.
Page 55: Display
GSI Audera Pro User Manual or on the waveform information panel. The comparison data made be added to the page for reporting. Invert Active Recording – Flips the active recording upside-down. • Filter – Displays the Filter sub menu. On the sub menu the current filter type is •...
Page 56 GSI Audera Pro User Manual and the latest at the bottom. If you are on a split screen layout or your data contains both right and left ears, the left and right ear waveforms will be placed on separate sides.
Page 57: Report
GSI Audera Pro User Manual Report Load Report – Opens the Load Report File dialog where you may select a saved • report. If you currently have data displayed, a warning message is displayed that requires confirmation that the data will be replaced by the report data.
Page 58: Print
GSI Audera Pro User Manual o Page 1 o Page 2 o Page 3 o Page 4 o Page 5 o Page 6 o Page 7 o Page 8 o Page 9 o Load Page Labels o Save Page Labels...
Page 59: Information Bar
GSI Audera Pro User Manual About – Displays the program version information in a pop-up dialog. • NFORMATION The Information bar shows general information about the patient and the currently selected waveform and is located below the Main Menu. The Information bar displays...
Page 60: Toolbar
GSI Audera Pro User Manual OOLBAR Below the Information bar, there is a Toolbar with icons that are equivalent to the most used menu items. Icon Description Add Patient – displays the patient information screen where the patient information may be added Search Patient –...
Page 61 GSI Audera Pro User Manual Arrange by Acquisition Order – displays the waveforms sorted by the time the data was collected from oldest to most recent Arrange by Rate – displays the waveforms sorted by stimulus rate from higher to low Latency-Intensity Graph –...
Page 62: Ep Waveform Area
GSI Audera Pro User Manual WAVEFORM AREA The white area at the left and center of the screen contains all recordings collected or loaded. There is a time scale at the bottom of this area and at the top left, a vertical scale marker.
Page 63: Eeg Panel
GSI Audera Pro User Manual EEG P ANEL Artifact Area Artifact Level Adjustment Channel Selector The EEG Panel is displayed when the Acquisition (Acq) page is displayed. The incoming EEG is displayed and an indication of where the EEG is checked for artifact is shown in red.
Page 64: Collection Toolbar
GSI Audera Pro User Manual OLLECTION OOLBAR The Collection toolbar contains frequently used data collection controls. The Collection Toolbar is only displayed while on the Acquisition page (Acq.). Icon Description Starts the data collection using the current parameters Replaces the Acquire button after data collection has started.
Page 65 GSI Audera Pro User Manual Indicates the polarity of the stimulus. Right or Left Click toggles through the options of Rarefaction, Condensation or Alternating. Indicates the current auditory stimulus rate. A Right Click increases the level by 10/s. A Left Click decreases the level by 10/s and a Double Click presents a dialog where the user may enter a value.
Page 66: Window And Sample Rate
GSI Audera Pro User Manual Window and Sample Rate Choosing the Modality test type from the Protocol menu automatically sets the window size. When you Double Click on the Window button in the Collection Toolbar you are prompted to Enter Sampling Period in Intervals of 25 uS. This value defines the time distance between samples in the recorded response.
Page 67: Automated Protocol Dialog
GSI Audera Pro User Manual UTOMATED ROTOCOL IALOG The Automated Protocol dialog allows you to specify a series of steps that may be used to automatically collect your data. The Item defines each step (set of parameters) in the sequence. Items are consecutively numbered. The Count determines the number of times the Item is run.
Page 68 GSI Audera Pro User Manual The Count may also be defined to perform a specific action as determined by the radio buttons below the count field. The Repeat option runs the protocol two times (the same as entering 2 for the count). The Stop option tells the sequence to end. The Link option allows you to connect to another protocol –...
Page 69: Stimulus Dialog
GSI Audera Pro User Manual TIMULUS IALOG The Stimulus dialog is displayed when the Stimulus\Stimulus is selected from the menu or the Stimulus button is clicked from the Collection Toolbar. The Stimulus dialog presents the user with the options for defining an auditory stimulus. The top of the dialog defines the stimulus type which includes Click, Tone Burst and File.
Page 70 GSI Audera Pro User Manual The File stimulus type presents a dialog where you may select a stimulus file (*.STM). The stimulus may be a file previously saved using this Stimulus dialog or may have been provided with the installation.
Page 71 GSI Audera Pro User Manual NOTE: The Audera Pro supports both headphones and insert earphones. These transducers plug into the same connectors on the back of the device and it is important to make sure that the correct transducer is connected and matches the one selected for the stimulation.
Page 72 GSI Audera Pro User Manual The File Calibration, Calibration Table and SPL to HL Table buttons display the values used in the overall total calibration. D-0129360 Rev A Page 70 of 231...
Page 73: Calibration Table
GSI Audera Pro User Manual Calibration Table The Calibration Table button is available for the Click and Tone Burst stimulus. A password is required to enter the Calibration Table. The table shows the calibration values for each stimulator. The Calibration Table dialog shows the correction, maximum and minimum sound output values, as well as the stimulus delay time for use with the insert earphones.
Page 74: Spl To Hl Conversion Table
GSI Audera Pro User Manual SPL to HL Conversion Table The SPL to HL button will be available for the Click and Tone Burst stimulus types. A password is required to enter the SPL to HL Table. The values correspond to HL conversion.
Page 75: File Calibration Table
NOTE: Although values can be modified from all the Calibration and SPL to HL Table windows, it is recommended that values are only modified by GSI authorized personnel that are qualified to perform a system calibration.
Page 76: Stimulus Display Dialog
GSI Audera Pro User Manual The bottom of the Stimulus Dialog section provides the file control buttons. The OK button closes the dialog and applies the current settings. The Cancel button closes the dialog and discards any changes that were made. The Load button displays a file open dialog where you may choose an existing stimulus.
Page 77: P300/Mmn Setup Dialog
GSI Audera Pro User Manual P300/MMN S ETUP IALOG The P300 or MMN (Mismatched Negativity) test type is selected with the Protocol\Modality menu item. When the P300 or MMN Modality is selected the Stimulus Level button is replaced by the Setup P300 button on the Collection Toolbar.
Page 78: Amplifier Settings Dialog
GSI Audera Pro User Manual MPLIFIER ETTINGS IALOG The Amplifier Settings dialog is displayed when on the Amplifier menu you click Amplifier Settings or when the Amplifier icon is selected from the Side Toolbar. The incoming EEG is displayed in the top left (blue line) with the artifact rejection area shown in pink.
Page 79 EEG – it has not impact on the parameters of the gain or reject level. The Audera Pro has two amplifier channels and when performing a 2-channel data collection you may choose which channel to display using the radio buttons in the top right channel selection area.
Page 80 Line Filter check box determines if a power line notch filter is used. The Audera Pro system designates the 2 amplifiers as Channel A and Channel B. The Designation field determines the behavior of the channel with Right, Left, On and Off as available options.
Page 81: External Trigger
XTERNAL RIGGER The Audera Pro can trigger an external device using a trigger out pulse that is delivered to ring of the 3.5 mm jack on the Digital I/O cable. The trigger pulse is a 3-volt square wave delivered at the rate of the stimulus.
Page 82: Remote Impedance Display Box
Digital I/O cable. Attach the Digital I/O cable to the back of the Audera Pro. Connect the 3.5 mm jack and plug of the Digital I/O cable to the corresponding 3.5 mm connectors on the Remote Impedance Display box. In order to use the Remote Impedance Display box, you must enable the device in the configuration.
Page 83 The Impedance test button in the lower right is used to turn on the device and initiate an impedance test. When the impedance test is initiated, the Audera Pro tests the impedance of each electrode and sends the results back to the box which displays a red, yellow or green LED that corresponds to the impedance level.
Page 84: Data Analysis
GSI Audera Pro User Manual NALYSIS The center white area of the program window contains all recordings acquired or loaded. To load previously collected data, on the Recordings menu, click Load Recordings or select the Load Recordings icon from the toolbar. The Data Files dialog is presented where you select the recordings to load for analysis.
Page 85: Data Pages
GSI Audera Pro User Manual Data Pages Recordings are displayed on the Acq page as the data is being collected and saved automatically when the acquisition completes. In addition to the Acq page, there are 9 additional pages for the display and analysis of data. On each page there is a time scale at the bottom and a vertical scale marker in the top left.
Page 86: Display Options
GSI Audera Pro User Manual The arrangement of waveforms and presentation on a page are controlled by several icons on the Toolbar, options from the Display menu, and the Display icon on the Side Toolbar. Individual waveforms may be moved manually as well.
Page 87 GSI Audera Pro User Manual Toolbar icons The Toolbar has options that impact the display of waveforms and are described in the Toolbar section. Side Toolbar Display icon The Display icon on the Side Toolbar provides a pop-up menu with options for controlling the page layout and waveform display.
Page 88 GSI Audera Pro User Manual Scaling – determines the time window that is used for the determining the • normalized scale. The Display Window uses the entire plot shown (between plot start and end). Special enables the Scaling Start and Scaling End menu items where you define the time that is used for the normalized scaling.
Page 89: Cursors
GSI Audera Pro User Manual Right or Left – Plot Start Time – determines the start of the time window, x-axis • (horizontal) at the bottom of the screen of the right or left column waveform display. A prompt is presented where you enter the start time (ms). This option is only enabled in Split Page.
Page 90: Waveforms
GSI Audera Pro User Manual AVEFORMS Data collected from stimulation in the right ear are, by default, displayed as red waveforms, the left ear as blue and both ears as black. The waveform display color for an individual waveform is configurable.
Page 91: Labeling Peaks
GSI Audera Pro User Manual on the Page control. To select multiple waveforms, hold the Ctrl key and click on the waveforms you want to select. Labeling Peaks The current labels that are used to mark the peaks of a waveform are displayed as buttons on the Toolbar.
Page 92: Default Labels
GSI Audera Pro User Manual Peak Marker Movements using the Keyboard Top Marker Bottom Marker Keyboard Marker Movement Move marker to left Alt + (earlier) Move marker to left Shift + Alt + Shift + (earlier) large steps Move marker to right...
Page 93: Sp/Ap Ratio
GSI Audera Pro User Manual SP/AP Ratio The ECochG modality test type has an option to calculate the SP/AP ratio. To calculate the SP/AP ratio the Base (baseline), SP and AP points need to be marked. The bottom marker of the Base is moved to the other side of the AP and placed at the same amplitude as the top Base marker giving a 0 baseline amplitude.
Page 94: Mmn Area
GSI Audera Pro User Manual MMN Area The Mismatched Negativity (MMN) data collection and resultant waveforms will be, as with P300, one recording buffer per stimulus used. Commonly, there is one standard (buffer 0) and one deviant stimulus (buffer 1).
Page 95: Waveform Options
GSI Audera Pro User Manual Waveform Options Right click and the options for the current waveform are presented as a pop-up menu. Note that the location on the time axis of where the mouse is clicked determines where the peaks are marked.
Page 96 GSI Audera Pro User Manual Mark Other Peak – Displays a new dialog with the list of defined labels in the • program. The User Defined Labels text box is an option available to define a custom label. The user defined labels may be added to the drop-down list and the list saved with the buttons next to the text box.
Page 97 GSI Audera Pro User Manual Show Text – displays a sub-menu that defines how the text information for the • marked points is displayed. Next to Label shows the amplitude and latency information to the right of each peak label. Side shows the stimulus amplifier, recording and peak label information to the side of the waveform.
Page 98: Record Info
GSI Audera Pro User Manual Record Info The Record Info icon on the Side toolbar toggles a panel to the left of the Side toolbar. The name of the file corresponding to the active record is displayed at the top of the panel. The multiple tabs organize the information for the active waveform.
Page 99: Post-Acquisition Processing
GSI Audera Pro User Manual Select Recording – displays a drop-down menu that contains a list of all the recordings on the page. You may select a different waveform from the list which then becomes the new active recording and updates all the fields.
Page 100: Inverting A Waveform
GSI Audera Pro User Manual comparison will not work. Mark all necessary labels on the recordings being compared and select both waveforms by holding the [Ctrl] key and clicking on them, or their handles. Click on the Process menu, Compare Selected. A pop-up window will show the results of the comparison with an option to place the results the page.
Page 101: Cross-Correlation
GSI Audera Pro User Manual Notch option filters out the frequencies in between the selected low pass and the high pass filters, leaving intact those that fall outside the range. Once the desired filter is set up, you can filter the active wave using the Filter icon from the Toolbar. The Process menu, Filter Active Recording and All on Page options provide filtering for the active waveform or all the waveforms on the page.
Page 102: Reports
GSI Audera Pro User Manual A pop-up dialog displays the marked peaks in a Latency vs. Intensity graph and an accompanying data table. The marked data on the page will be shown as a red or blue line across the graph. Normative data will be displayed as a gray shaded area of the graph.
Page 103: Adding Information
GSI Audera Pro User Manual Adding Information The Report menu has an option to Add information. Some elements are static meaning that data does not change even if the waveforms on the page change while others are dynamic where the data automatically changes when the recordings change (such as marking peaks).
Page 104: Keyboard Shortcuts
GSI Audera Pro User Manual EYBOARD HORTCUTS Some options in the program may be controlled via the keyboard. The table below lists the keys that are active in the EP modality. Function Esc or Space Pause or Stop a recording...
Page 105: Typical Ep Evaluation Workflow
1. Turn on the computer and the Audera Pro base unit. 2. Launch the Audera Pro program. 3. Create a new patient file or load an existing patient file.
Page 106: Vemp Analysis Module
GSI Audera Pro User Manual NALYSIS ODULE The VEMP analysis module provides analysis of VEMP data collected with the EP module. This module allows you to select VEMP data, calculate the Amplitude Asymmetry ratio and save the data to be viewed and reported from the EP module.
Page 107: Vemp Analysis Window
GSI Audera Pro User Manual VEMP A NALYSIS INDOW The VEMP analysis window consists of the title bar at the top, a menu bar, a toolbar and the data display area. The records selected at the Open Records dialog are loaded and the display depends on Mode set in the Process menu option and parameters saved in the Settings option from the menu.
Page 108: Vemp Analysis Menu
GSI Audera Pro User Manual VEMP A NALYSIS Each of the selections on the menu contain sub menu items: File Open Records– displays the Open Records dialog where a list of records for the • patient is presented. The records patient may be selected, and their data loaded.
Page 109: Help
GSI Audera Pro User Manual o Wave Exclusion > 1.5 SD - excludes waveforms whose EMG activity is greater than or less than 1.5 standard deviations from the mean. o Wave Exclusion > 2 SD - excludes waveforms whose EMG activity is greater than or less than 2 standard deviations from the mean.
Page 110: Vemp Analysis Toolbar
GSI Audera Pro User Manual VEMP A NALYSIS OOLBAR Icon Description Open Records - displays the patient Open Records dialog where the VEMP records may be selected. This option is only available when in the Culling mode. Save Record – saves the VEMP averages and a report file from the Calculation mode display.
Page 111 GSI Audera Pro User Manual The Culling view displays the title bar, menu and toolbar at the top. In the data display area, each sweep is shown with a scroll bar on the right to allow you to scroll through the individual waveforms.
Page 112: Vemp Calculation Mode View
GSI Audera Pro User Manual VEMP C ALCULATION The Calculation view displays the averaged VEMP waveform from each ear and the asymmetry ratio calculation. The display of the rectified or unrectified VEMP average and asymmetry ratio is determined by the selections in the Settings menu.
Page 113 GSI Audera Pro User Manual D-0129360 Rev A Page 111 of 231...
Page 114: Auditory Steady-State Response (Assr)
GSI Audera Pro User Manual (ASSR) UDITORY TEADY TATE ESPONSE When the ASSR icon is selected, the system displays the initialization dialog while the ASSR module loads and then the main ASSR screen is presented. The ASSR screen layout has a title bar at the top, the main menu under the title bar, information bar below the main menu, and the top Toolbar in the upper part of the screen.
Page 115: Assr Main Menu
GSI Audera Pro User Manual ASSR M The ASSR Main Menu allows access to most of the functions of the program. Each of the Main menu selections have sub-menus. Patient New – Opens the Patient Information dialog with the information cleared and •...
Page 116: Stimulus
GSI Audera Pro User Manual o 0.50 uV o 0.60 o 0.70 (Recommended Level) o 0.08 o 0.90 o 1.00 o 1.25 o 1.50 o 1.75 o 2.00 o Other Intensity Sweep – Begins a data collect using the active stimuli starting at 80 dB •...
Page 117: Recordings
GSI Audera Pro User Manual maximum number of sweeps to be used in waveform average. When the collection reaches the maximum, it will stop automatically. Sweep Block Size – Displays the current number of sweeps in a block for the •...
Page 118: Report
GSI Audera Pro User Manual Arrange by Acquisition Order – Arranges the waveforms on the page by the • time the data was collected. The earliest acquired waveform is placed at the top and the latest at the bottom. If you are on a split screen layout or your data contains both right and left ears, the left and right ear waveforms will be placed on separate sides.
Page 119: Print
GSI Audera Pro User Manual o Page o All Pages o Clear & Permanently Delete Active Recording from Disk Page Labels – Open a sub menu with options for the labeling of the data display • pages. When a page is selected two dialogs are presented where you may enter the new label and description for the page.
Page 120: Help
GSI Audera Pro User Manual Multi-Page Format – Allows the report page data to extend beyond a single • page. If the option is not selected the program will fit the data to a single page which may cause some data to be truncated to fit. The checkmark indicates the status (On/Off).
Page 121: Toolbar
GSI Audera Pro User Manual OOLBAR Below the Information bar, there is a Toolbar with icons that are equivalent to the most used menu items. Icon Description Add Patient – displays the patient information screen where the patient information may be added Search Patient –...
Page 122 GSI Audera Pro User Manual Add Text – opens a new dialog where the user can enter new comments or load comments from a file Print Page – displays a drop-down menu where the user can select to print the current page or all pages PDF Print Page –...
Page 123: Assr Waveform Area
GSI Audera Pro User Manual ASSR WAVEFORM AREA The white area at the left and center of the screen contains all recordings collected or loaded. There is a time scale at the bottom of this area and at the top left, a vertical scale marker.
Page 124: Eeg Panel
GSI Audera Pro User Manual Analyze Active– displays the analysis window of the active recording which has the phase and frequency information on the waveform Generate ASSR Response Audiogram – displays the audiogram of the waveforms on the current page...
Page 125: Stimulus Information Panel
GSI Audera Pro User Manual TIMULUS NFORMATION ANEL Stimulus Information Stimulus Ear and Level Frequency Selection Button to activate Frequency Selection The Stimulus Information Panel is displayed when the Acquisition (Acq) page is displayed. This panel displays the current information on the stimulus being used for collection.
Page 126: Amplifier Settings Dialog
GSI Audera Pro User Manual MPLIFIER ETTINGS IALOG The Amplifier Settings dialog is displayed when on the Amplifier menu you click Amplifier Settings or when the Amplifier icon is selected from the Side Toolbar. The incoming EEG is displayed in the top left (blue line) with the artifact rejection area shown in pink.
Page 127 EEG – it has not impact on the parameters of the gain or reject level. The Audera Pro has two amplifier channels and when performing a 2 channel data collection you may choose which channel to display using the radio buttons in the top right channel selection area.
Page 128 GSI Audera Pro User Manual The Audera Pro system designates the 2 amplifiers as Channel A and Channel B. The Designation field determines the behavior of the channel with Right, Left, On and Off as available options. The selection is made for both channel A and channel B. When the designation is ‘On’...
Page 129: Collection Toolbar
GSI Audera Pro User Manual OLLECTION OOLBAR The Collection toolbar contains frequently used data collection controls. The Collection Toolbar is only displayed while on the Acquisition page (Acq.). Icon Description Starts the data collection stimulating the right ear Starts the data collection stimulating both the right and left...
Page 130: Automated Protocol Dialog
GSI Audera Pro User Manual UTOMATED ROTOCOL IALOG The Automated Protocol dialog allows you to specify a series of steps that may be used to automatically collect your data. The Protocol Item defines each step (set of parameters) in the sequence. Items are consecutively numbered. The Count is used to activate an item and determines the number of times the item is run.
Page 131: Signal To Noise Ratio And Noise Graphs
GSI Audera Pro User Manual IGNAL TO OISE ATIO AND OISE RAPHS The SNR and Noise Plot graphs display the overall signal to noise ratio and the overall noise for the currently collecting waveform. Each channel is plotted individually with a red point/line for the right ear and a blue point/line for the left ear.
Page 132: Data Analysis
GSI Audera Pro User Manual NALYSIS The center white area of the program window contains all recordings acquired or loaded. To load previously collected data, on the Recordings menu, click Load Recording or select the Load Recordings icon from the toolbar. The Data Files dialog is presented where you select the recordings to load for analysis.
Page 133: Analyze Active Wave
GSI Audera Pro User Manual NALYZE CTIVE The Analyze Active Wave displays the ASSR response data in a dialog with a polar plot, spectral graph, and an optional data table. The patient, stimulus and recording information is displayed in the top left of the dialog. There are checkbox controls that determine the display of the data table and the frequency axis of the spectral graph.
Page 134: Spectral Graph
GSI Audera Pro User Manual circles in the plot with the voltage value displayed in each circle in the top right quadrant of the plot. At the end of each vector line is a circle and a label to indicate the stimulus frequency of the vector.
Page 135: Record Selection And Option Buttons
GSI Audera Pro User Manual Signal (uV) – Displays the amplitude of the response at the frequency bin • corresponding to the component modulation rate. The standard deviation is shown in parenthesis. SNR (dB) – Displays the signal-to-noise ratio between the response, and the •...
Page 136: Assr Response Audiogram
GSI Audera Pro User Manual ASSR R ESPONSE UDIOGRAM The ASSR Response Audiogram button displays the Response Audiogram dialog. The response audiogram is generated from the ASSR response waveforms on the current page. The patient information is displayed in the top left.
Page 137 GSI Audera Pro User Manual The HL Correction section has an option for converting the audiogram to HL scales. The General Table (HLcg) option coverts the response values by adding an offset. This scale on the audiogram shows values in HLcg, to indicate correction-general. The Edit Values button prompts for a password and then displays the conversion table where you can set up the SPL to HL offsets.
Page 138: Hl Correction Table
GSI Audera Pro User Manual HL C ORRECTION ABLE Selecting the Edit Values button in the ASSR Response Audiogram dialog, displays the HL Correction Table dialog. The dialog is password protected. The SPL-to-HL table contains the values to be used for the correction from SPL to HL. The selected transducer is indicated with the selected radio button under Stimulator.
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Page 140: Distortion Products Otoacoustic Emissions (Dpoae)
GSI Audera Pro User Manual (DPOAE) ISTORTION RODUCTS TOACOUSTIC MISSIONS When the DP icon is selected, the system displays the initialization dialog while the DP module loads and then the main DP screen is presented. The DP screen layout has a title bar at the top, the main menu under the title bar, and the Toolbar and overall result box in the upper part of the screen.
Page 141: Dpoae Main Menu
GSI Audera Pro User Manual DPOAE M The DPOAE Main Menu allows access to most of the functions of the program. In addition to using the mouse to access the items in the menu, the Alt or F10 key may be used for menu activation for navigation using the keyboard.
Page 142: Toolbar
GSI Audera Pro User Manual OOLBAR Below the Menu, there is a Toolbar with icons that are equivalent to the most used menu items. Icon Description Add Patient – displays the patient information screen where the patient information may be added Search Patient –...
Page 143: Data Collection
GSI Audera Pro User Manual Print DP Gram – displays a pop-up dialog with where the user may select the print options and setup the printer DP I/O – DP Input/Output data collection and analysis. The program collects responses to a single frequency pair at different stimulus levels.
Page 144: Test Parameters
GSI Audera Pro User Manual You may continue even with this error, but you should be aware of the actual stimulus levels to make sure that they are not far from the entered L1 and L2. Once the in-ear adjustment is performed, the data is collected in blocks of sweeps as set in the parameters.
Page 145 GSI Audera Pro User Manual The right side of the dialog contains the option buttons. The OK button closes the dialog. If changes have been made, a confirmation dialog is presented to allow you to save the changes. The Cancel button closes the dialog and ignores any changes that have been made.
Page 146 GSI Audera Pro User Manual General Tab Sweeps – Determines the total number of sweeps collected for each frequency • pair. Block Size – Determines the subset of collected responses averaged together • and plotted during the acquisition. The program collects the sweeps in blocks of data, cycling the frequency pairs until the full number of sweeps is reached or other pass/stop criteria are met.
Page 147 GSI Audera Pro User Manual Frequency Tab Start Freq – Determines the first frequency to use for the DP response. The • program automatically calculates the F1 and F2 used for the stimulus pair. End Freq – Determines the last frequency to use for the DP response.
Page 148 GSI Audera Pro User Manual Advanced Tab Max Level (dB SPL) – Determines the maximum stimulation level that can be • selected. It also defines the upper limit of the level correction. Max Ear Corr (dB SPL) – Determines the maximum allowed stimulus level •...
Page 149 GSI Audera Pro User Manual Stopping Tab On pass at that freq – Determines if the program stops collecting blocks of data • for a frequency pair that meets the single point passing criteria. The checkbox acts as a toggle to turn on/off the frequency stop criteria.
Page 150: Passing Criteria Dialog
GSI Audera Pro User Manual Passing Criteria Dialog The Passing Criteria dialog provides options to determine when a specific frequency passes as well as the criteria for passing the overall response. These values may be modified to fit specific diagnostic or screening protocols.
Page 151 GSI Audera Pro User Manual be considered a pass. For example, if the mean noise is 5 dB SPL and the std is 3, and you have set the number of standard deviations to 2 in the text box, then a DP must be greater than 5+(3x2) = 11 dB SPL to be considered a response DP Value –...
Page 152: Normative Data Dialog
GSI Audera Pro User Manual Normative Data Dialog The Normative Data dialog defines the values for the shading used in the DPGram to represent the normal range of values for the DP amplitude and noise. The dialog has a data table in the middle with the value used for the shading. The text boxes on the left side are used to indicate the collection parameters.
Page 153 GSI Audera Pro User Manual Normative Data Table Values for the normative data set may be entered directly into the table. Each column represents one data point and each row labeled (on the left) for the value that should be entered.
Page 154: Data Collection Screens
GSI Audera Pro User Manual Data Collection Screens During the acquisition of data, each section of the screen is updated as the data is acquired. The DPGram, Spectrum graph, Stimulus Level graph, DP data point information panel and the Results panel are synchronized with the data point being collected or selected by the user.
Page 155 GSI Audera Pro User Manual Spectrum Graph The Spectrum graph displays a subset of the overall response spectra, showing the details of the current data point DP response amplitude and the associated frequencies adjacent to the response frequency (side bins). The DP response is shown in the center as a red line with a triangle for the right ear, or a blue line with a square for the left ear.
Page 156 GSI Audera Pro User Manual Spectrum Dialog In addition to the Spectrum graph for the current data point, a spectrum of the current activity detected by the microphone is available during collection by selecting the Spectrum icon from the toolbar. In this dialog you may view data in both the frequency domain as well as the time domain.
Page 157 GSI Audera Pro User Manual A right-click on the graph will bring up the context menu. This menu has options for the display of the data graphs. Grid – Displays horizontal and vertical lines axis • lines on the graph. This item toggles between ON/OFF with each click.
Page 158 GSI Audera Pro User Manual Stimulus Level Graph The Stimulus Level graph displays the stimulus output levels during the collection as recorded by the microphone in the probe. Ideally, the actual levels (A1 and A2) should be equal to the levels specified in the parameters window (L1 and L2).
Page 159 GSI Audera Pro User Manual Data Table The Data Table toolbar option displays a pop-up dialog showing the information displayed in the DPGram in a tabular format. This table is available in both data collection and analysis. The dialog has a menu bar and the top with options for viewing and printing the data table.
Page 160: Data Analysis
GSI Audera Pro User Manual NALYSIS The Data Analysis option on the toolbar replaces the Data Collection screen with the Data Analysis screen. The Data Analysis screen has a menu at the top and a toolbar under the menu. Data Analysis Menu The Patient, System, Print and Help menu items are the same in both the data collection screen and the data analysis screen.
Page 161: Load Data Files
GSI Audera Pro User Manual The DP Collection icon on the toolbar returns to the DP data collection screen. The IO Collection icon on the toolbar returns to the IO data collection screen. Load Data Files Once the patient has been selected, you load DP recordings using the Right or Left ear icon on the toolbar.
Page 162: Display Options
GSI Audera Pro User Manual Display Options The Display Options button on the toolbar displays the Display Options dialog where you may configure the settings for the DPGram. The Display Options dialog has the display parameters on the left side and option buttons on the right.
Page 163 GSI Audera Pro User Manual Display Ear – Dropdown menu with options on which ear(s) to display. When a • single ear is displayed, the Spectrum graph and Stimulus Level graph are show (like in the collection screen). dB Axis High...
Page 164: Print
GSI Audera Pro User Manual Print The Print options are available from the toolbar Print button or the Print menu, Print Data item. The Print option displays the Print DPGram dialog. The dialog has checkboxes for the selection of the items to print on the left and option buttons on the right.
Page 165: Dp I/O
GSI Audera Pro User Manual DP I/O The DP I/O icon on the toolbar changes to the Input- Output mode of operation. This mode of operation collects data from a single pair of stimulus frequencies at multiple stimulus levels. The DP Gram graph is modified for this mode by changing the X axis to reflect the stimulus level in place of the stimulus frequency as only a single stimulus frequency is collected.
Page 166: Dp I/O Levels Dialog
GSI Audera Pro User Manual DP I/O Levels Dialog Setting the Step size to a negative value presents the stimulus levels from high to low. Setting the Step size to a positive value starts at the low level (End) and increases the levels to the Start value.
Page 167: Data Analysis
GSI Audera Pro User Manual Data Analysis The Data Analysis for the DP I/O mode takes place on the same screen as the data collection. The Load DP I/O icon on the toolbar presents a dialog where you select previously recorded data. The options available in data analysis are the same as those described for the DPOAE.
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Page 169: Transient Evoked Otoacoustic Emissions (Teoae)
GSI Audera Pro User Manual (TEOAE) RANSIENT VOKED TOACOUSTIC MISSIONS When the TE icon is selected, the system displays the initialization dialog while the TE module loads and then the main TE screen is presented. The TE screen layout has a title bar at the top, information bar below the main menu, and the top Toolbar in the upper part of the screen.
Page 170: Teoae Main Menu
GSI Audera Pro User Manual TEOAE M The TEOAE Main Menu allows access to most of the functions of the program. Each of the Main menu selections have sub-menus: Patient New – Opens the Patient Information dialog with the information cleared and •...
Page 171: Stimulus
GSI Audera Pro User Manual Stimulus Intensity – Display the current stimulus level (dB SPL). When clicked, pops up an • input dialog where you may enter the level. InEar Correction – Displays the current setting and when selected, provides a •...
Page 172 GSI Audera Pro User Manual even if the waveforms on the page change while others are dynamic where the data automatically changes when the recordings change (such as marking peaks). The static elements may be edited manually as needed. The dynamically elements should not be edited manually as the edits will not be maintained when the data is updated.
Page 173: Print
GSI Audera Pro User Manual o Page 9 o Load Page Labels o Save Page Labels o Save Page Labels as Default Print Deidentify Printouts – The option displays/removes the identifying patient • demographic information from the report print out. The checkmark indicates the status (On/Off).
Page 174: Information Bar
GSI Audera Pro User Manual NFORMATION The Information bar shows general information about the patient and the currently selected waveform and is located below the Main Menu. The Information bar displays the following: Patient Identifier • Recording name • •...
Page 175 GSI Audera Pro User Manual Load Report File – displays the Open dialog with the list of report files and allows the user to select a report file Save Report File – displays the Save As dialog and allows the user to save the current pages as a report file Full/Split Page –...
Page 176: Te Waveform Area
GSI Audera Pro User Manual WAVEFORM AREA The white area at the left and center of the screen contains all recordings collected or loaded. There is a time scale at the bottom of this area and at the top left, a vertical scale marker.
Page 177: Meatal Response Panel
GSI Audera Pro User Manual EATAL ESPONSE ANEL Artifact Level Adjustment Meatal Response The Meatal Response Panel is displayed when the Acquisition (Acq) page is displayed. The first 6 milliseconds of the incoming response are displayed, and a frequency spectrum of the meatal response is displayed. The artifact reject level may be adjusted using the Open-Close scroll bar.
Page 178: Data Collection
GSI Audera Pro User Manual The Stop Recording button appears when data is being collected. A confirmation dialog is presented to determine if you want to save the collection data. OLLECTION Data collection is initiated with the selection of the Right or Left ear icon from the Collection toolbar.
Page 179: Passing Criteria
GSI Audera Pro User Manual Time Waveform Average – Displays the average recording from the microphone in the time domain. The stimulus level, ear and channel are displayed at the beginning of waveform below the waveform handle. The time scale is indicated at the bottom of the screen area.
Page 180: Data Analysis
GSI Audera Pro User Manual NALYSIS The center white area of the program window contains all recordings acquired or loaded. To load previously collected data, on the Recordings menu, click Load Recording or select the Load Recordings icon from the toolbar. The Data Files dialog is presented where you select the recordings to load for analysis.
Page 181: Display Options
GSI Audera Pro User Manual at the bottom and a vertical scale marker in the top left. There are ten waveform display areas or pages and the pages on the display are printed as report pages when a report is printed. Each page is accessible from the Page Selection control. The Page button on the control can be shaded a different color depending on the status of the page.
Page 182 GSI Audera Pro User Manual Scale – defines the size of the waveforms on the page, the vertical axis. The sub- • menu provides the options. Normalized adjusts the size of the waveforms based on the minimum and maximum values within the window or specified scaling start and stop time (determined by Scaling option).
Page 183 GSI Audera Pro User Manual Page Mode – determines if the display shows a single page of data or is split into • two columns or pages. In the Full Page mode, the waveforms occupy the entire window in a single column. In the Split Page...
Page 184: Waveform Options
GSI Audera Pro User Manual Apply above to – transfers the settings from the Display menu to other pages. • This item displays a sub-menu of pages when you can apply the settings from the current display options to all pages or any specific page.
Page 185 GSI Audera Pro User Manual Print Parameters – determines if the stimulus, amplifier, recording and peak • label information are printed for the active waveform. On prints the parameters in the table when the page is printed. Off hides the parameters for the waveform when the page is printed.
Page 186: Reports
GSI Audera Pro User Manual EPORTS Each of the display pages is printed as a page in the report. In addition to the waveforms, reports include any additional information that has been added to the pages, such as comments or Latency-Intensity graphs. In addition to data collected with the EP module, data from any of the other modules (ASSR, DPOAE and TEOAE) may also be included.
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Page 188: Cleaning And Maintenance
Recommendations for cleaning and disinfection of the Audera Pro presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility.
Page 189 GSI Audera Pro User Manual Dispose of the used probe tube immediately to avoid confusing used tubes and new tubes. Take a new probe tube from the package and insert the tube into the probe head until it is fully seated.
Page 190: Attaching Eartips
The Audera Pro instrument comes with a box of disposable, single use eartips that fit a variety of ear canal sizes. The Audera Pro probe must have a probe tube applied and an eartip attached before inserting it into an ear canal. The determination of the appropriate eartip size should be made by persons with proper training and experience.
Page 191: Maintenance
GSI. The device and accessories are not user repairable. Repairs must be performed by a qualified service representative only.
Page 192: Cybersecurity
GSI Audera Pro User Manual YBERSECURITY The Audera Pro system requires a computer running Windows 10 Pro and the computer may have Wi-Fi or Ethernet connections that could allow access to the Internet. It is your responsibility to protect your system and patient data from theft, unwanted, and potentially harmful, files or programs by following cybersecurity best practices.
Page 193 • authenticated code. Use only materials supplied by GSI for your Audera Pro software updates. GSI software is supplied in USB packaging – do not use any USB software where tampering is evident. Use systematic procedures for authorized users to download version-identifiable software from the manufacturer.
Page 194 Recover from possible virus infections by having up to date backups of your system computer. At GSI we are committed to providing you with validated software updates and patches as needed throughout the lifecycle of the medical device to continue to assure its continued safety and effectiveness.
Page 195: Troubleshooting
GSI Audera Pro User Manual ROUBLESHOOTING RROR ESSAGES USB Connection Not Found…. Continue without Hardware? This message is displayed when the program is started and cannot communicate with the device. Confirm that the device has power and that the connection to the computer with the USB cable is secure.
Page 196: Probe Fit Error: Probe Occluded
GSI Audera Pro User Manual Probe Fit Error: Probe Occluded This error may appear in the DPOAE or TEOAE module. The error indicates that the microphone is not receiving sound as it should. This may be due to blockage in the probe tube or the probe tip is against the ear canal.
Page 197: Incorrect Operating System Setting
GSI Audera Pro User Manual Incorrect Operating System Setting This error indicates that the setting in the system file for the number of operating system bits does not match the operating system that the program is running on. The program automatically corrects the system file and this message should not reappear.
Page 198: Loopback Test Cable
GSI Audera Pro User Manual OOPBACK ABLE The Loopback Test Cable is provided with the EP/ASSR systems to confirm the integrity of the system and for use in troubleshooting. The Loopback Test Cable connects the output of the stimulus (1000 Hz tone) to the input of the amplifier and ensures that the whole system is working properly.
Page 199: Loopback Test Analysis
GSI Audera Pro User Manual 8. Select the LOOPBACK.PSE2 file from the Open dialog. This will begin the data collection for the left ear. Once data collection has completed analyze the waveforms. Loopback Test Analysis The resulting waveforms should be clean sine waves. Using the two cursors measure the peak to peak voltage at the different stimulus levels.
Page 200: Oae Probe Check Cavity
The OAE Probe Check Cavity accessory may be used to perform a quality check of the Audera Pro system that has the OAE option. This can be done on a regular basis or may be performed if you suspect a problem with the Audera Pro hardware or OAE probe.
Page 201: Supplies And Accessories
GSI Audera Pro User Manual UPPLIES AND CCESSORIES To order consumables, additional accessories and to replace detachable parts that have been damaged, please contact GSI or your GSI distributor for current prices and delivery charges. Part Number Description 8104159 OAE Probe tubes (100)
Page 202: Oae Probe Ear Tips - Single Use - Sanibel Adi Silicone
DD45s 10 Ohm P3045 headset 2.9m cable 8516972 4-Snap Lead Patient Cable 8516973 5-Electrode Lead Patient Cable 8525205 GSI Audera Pro Loopback Test Cable 8516968 GSI Audera Pro Digital I/O Cable 8517341 OAE Probe 8100590 ABR tube & ADI ear tip adaptor...
Page 203 GSI Audera Pro User Manual 5-8 mm flanged 8012968 8012967 8013002 8013001 7 mm mushroom style 8013004 8013003 8 mm mushroom style 8012970 8012969 9 mm mushroom style 8012972 8012971 10 mm mushroom style 8012974 8012973 11 mm mushroom style...
Page 204: Appendixa - Default Settings
‘GSIAuderaAEPDefault.SET’ in the file name field. This is the name Audera Pro uses for default parameters. Changing the name will result in saving a settings file that can be loaded; however, it will not automatically load on start-up.
Page 205: Vemp Settings
GSI Audera Pro User Manual VEMP S ETTINGS Modality cVEMP oVEMP Stimulus Transducer Insert Earphones Insert Earphones Stimulus 500Hz Blackman 500Hz Blackman Intensity 95 dB nHL 95 dB nHL Polarity Rarefaction Rarefaction Rate Amplifier Number of Channels Gain 100k High Pass Filter...
Page 206: Default Assr Settings
EFAULT ETTINGS The Audera Pro software comes pre-loaded with a set of default acquisition settings for an ASSR. These default values are loaded every time the software opens. If you wish to create a new default settings file to load at start-up, change the change the Stimulus, EEG and Amplifier settings to match your requirements.
Page 207: Default Dpoae Settings
EFAULT ETTINGS The Audera Pro software comes pre-loaded with a set of default acquisition settings for an DPOAE. These default values are loaded every time the software opens. If you wish to create a new default settings file to load at start-up, change the change the settings to match your requirements.
Page 208: Default Teoae Settings
EFAULT ETTINGS The Audera Pro software comes pre-loaded with a set of default acquisition settings for an TEOAE. These default values are loaded every time the software opens. If you wish to create a new default settings file to load at start-up, change the change the settings to match your requirements.
Page 209: File Naming
GSI Audera Pro User Manual AMING File names are automatically assigned when data is acquired and saved. The Main menu also offers the option to save a file where you provide the filename (Recordings- >Save Active Recording As-> Specific File Name). Although any name could be used, we recommend following the program’s naming convention so that the program can...
Page 210: Appendix B - Technical Data
B – T PPENDIX ECHNICAL The Audera Pro is an active, diagnostic medical product. The device is classified as a class IIa device according to the EU medical directive 93/42/EEC and a class II device according to the US FDA.
Page 211 GSI Audera Pro User Manual Vibration and Shock Not Applicable Warm up Time None at room/operating temperature Expected Lifetime 5 years POWER Power Supply (internal) Input Voltage: 100 – 240 VAC, 350-150 mA Input Frequency: 50-60 Hz No load power consumption: < 0.15 W...
Page 212 GSI Audera Pro User Manual Recording Window -2.5 sec to 2.5 sec (maximum) Data points per waveform 1024 Digital Filter Finite Impulse Response (FIR), band pass and notch Electrode Impedance Measuring frequency: 1000 Hz Range: 1-25k Ohm EP STIMULUS Types Click, CE-Chirp®, Tones, CE-Chirp Octave Bands,...
Page 213 GSI Audera Pro User Manual Sample Rate 40k Hz 16 bit Frequency Accuracy ±1% from selected Frequency Analysis (FFT) Points DPOAE: 4096 TEOAE, 1024 Frequency Resolution DPOAE: 9.8 Hz TEOAE: 39.1 Hz Acquisition Time DPOAE: 102.24 ms TEOAE: 25.56 ms...
Page 214: Level
If periodic checks are also desired, the tables in this section provide the SPL values per frequency for each transducer. If the measured values are not within ± 5 dB at 125, 6,000, and 8,000 Hz in the earphones, the GSI Audera Pro should be scheduled for immediate maintenance.
Page 215: Transducer Reference Equivalent Threshold Levels Table
GSI Audera Pro User Manual RANSDUCER EFERENCE QUIVALENT HRESHOLD EVELS ABLE Transducer DD45s IP30 SP90A Impedance 10 Ω 10 Ω 10 Ω 0° Coupler 318-1 Mastoid 1 m RETSPL RETSPL RETFL RETSPL Pure Tone 125 Hz 250 Hz 17.5 11.5 500 Hz 13.5...
Page 216: Transducer Reference Equivalent Threshold Levels Table Notes
The Short Duration Tone Bursts were calibrated per ISO 389-6 and IEC 60645-3 using a 2 cycle rise/fall time and 1 cycle plateau. The Audera Pro bone transducer uses the Mastoid placement RETFL. D-0129360 Rev A Page 214 of 231...
Page 217: Maximum Output Levels
GSI Audera Pro User Manual AXIMUM UTPUT EVELS DD45s Headphones The DD45s Supra Aural Headphones were measured on a 318 – 1 artificial ear. Maximum distortion allowed is 2.5 % THD as specified in IEC 60645 – 1. Frequency (Hz)
Page 218: Ip30 Insert Phones
GSI Audera Pro User Manual IP30 Insert Phones The IP30 Insert Phones were measured on an IEC 711 artificial ear with ear mold substitute adapter. Maximum distortion allowed is 2.5 % THD as specified in IEC60645 – Maximum HL Maximum SPL (dB)
Page 219: B81 Bone Vibrator
GSI Audera Pro User Manual B81 Bone Vibrator The B81 Bone Vibrator was measured on a Bruel & Kjaer 4930 artificial mastoid. Maximum distortion allowed is 5.5 % THD as specified in IEC60645 – 1. Maximum SPL Maximum HL (dB)
Page 220: Sp90 A Free Field Speaker
GSI Audera Pro User Manual SP90 A Free Field Speaker The SP90A Free Field Speakers were measured with a free field microphone placed on axis with the speaker at one meter. Maximum allowed distortion is 10 %. The measurements were made in a sound room approximately 2 meters on a side.
Page 221: Appendix D - Specification Of Input/Output Connections
GSI Audera Pro User Manual D – S PPENDIX PECIFICATION OF NPUT OUTPUT ONNECTIONS AINS ABLE Description Live Neutral Earth ATIENT LECTRODE ABLE Description CHA + CHA - CHB - CHB + Shield ISO GND Input impedance > 10M Ohm, Max input 24.8 Vrms...
Page 222 GSI Audera Pro User Manual Description REC 1 + REC 1Shield REC 1 - REC 2 + HDMI Type A REC 2 Shield REC 2 - MIC Power + MIC Shield MIC Out Mic Power - Not Used Not Used...
Page 223: Speakers (R, L)
GSI Audera Pro User Manual (R, L) PEAKERS Description Ground Signal (Max output 7 Vrms at 10 Ohm) Description + 5 V DC Data Data DIGITAL Description OUT 1 OUT 2 IN 1 IN 2 Trigger IN (TTL) Input impedance 165k Ohm, output impedance 725 Ohm. Maximum voltage In/Out +3.3 V.
Page 224: Appendixe - Warranty And Repair
To ensure that your instrument works properly, the GSI Audera Pro should be checked and calibrated at least once per year. This check must be carried out by your dealer or authorized GSI service facility.
Page 225 Grason-Stadler will provide circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist service personnel in parts repair. This information is found in the Service Manual which may be ordered from GSI or the GSI distributor. D-0129360 Rev A...
Page 226: Appendixf - Recycling And Disposal
GSI Audera Pro User Manual F – R PPENDIX ECYCLING AND ISPOSAL Many local laws and regulations require special procedures to recycle or dispose of electrical equipment and related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices.
Page 227: Appendixg - Electromagnetic Compatibility (Emc)
EMC information presented in this chapter. The Audera Pro has been tested for EMC emissions and immunity as a stand-alone device. Do not use the system adjacent to or stacked with other electronic equipment.
Page 228: Guidance And Manufacturer's Declaration Electromagnetic Emissions
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class A The Audera Pro is suitable for use in all CISPR 11 commercial, industrial, and business environments. The Audera Pro is not suitable Harmonic emissions Not Applicable for use in a home environment.
Page 229: Recommended Separation Distances Between Portable And Mobile Rf
ECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE COMMUNICATIONS EQUIPMENT The Audera Pro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the system can help prevent electromagnetic interferences by maintaining a minimum distance...
Page 230: Guidance And Manufacturer's Declaration Electromagnetic Immunity
GSI Audera Pro User Manual ’ UIDANCE AND ANUFACTURER ECLARATION LECTROMAGNETIC MMUNITY Immunity Test IEC 60601 Test level Compliance Electromagnetic Environment-Guidance Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, Discharge (ESD) concrete, or ceramic tile. If ±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV,...
Page 231 GSI Audera Pro User Manual Immunity test IEC / EN 60601 Compliance level Electromagnetic test level environment – guidance Portable and mobile RF communications equipment should be used no closer to any parts of the system, including cables, than the...
Page 232 GSI Audera Pro User Manual 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.
Page 233 GSI Audera Pro User Manual Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories.

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