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EP/OAE

VERSATILE

CLINICAL

AUDERA PRO

USER MANUAL

Summary of Contents for AUDERA PRO

Page 1: ...EP OAE VERSATILE CLINICAL AUDERA PRO USER MANUAL...

Page 2: ...and redistributed according to license agreements Copyright notices and licenses for these external libraries are provided in a supplementary document that is included with the other software applica...

Page 3: ...Ambient Noise 18 Maximum Ambient Noise 18 Transducer Sound Attenuation 19 Introduction 20 Indications for Use 20 Contraindications 20 Modalities 22 Evoked Potentials EP 22 Vestibular Evoked Myogenic...

Page 4: ...e Installation 29 Minimum PC Requirements 29 Supported Operating Systems 29 Installation 29 Recommendations 30 Upgrading the software 30 Uninstalling the software 30 Operating Audera Pro 31 Launching...

Page 5: ...le Bar 48 EP Main Menu 49 Patient 49 Protocol 49 Stimulus 50 Amplifier 50 Recordings 51 Averaging 52 Process 52 Display 53 Report 55 Print 56 Help 56 Information Bar 57 Toolbar 58 EP waveform area 60...

Page 6: ...ult Labels 90 SP AP Ratio 91 MMN Area 92 Waveform Options 93 Record Info 96 Post Acquisition Processing 97 Calculating Bayesian Weighted average 97 Adding and Subtracting waveforms 97 Comparing record...

Page 7: ...Auditory Steady State Response ASSR 112 Title Bar 112 ASSR Main Menu 113 Patient 113 Protocol 113 Stimulus 114 Recordings 115 Process 115 Display 115 Report 116 Print 117 Help 118 Information Bar 118...

Page 8: ...on Table 136 Distortion Products Otoacoustic Emissions DPOAE 138 Title Bar 138 DPOAE Main Menu 139 Patient 139 System 139 Print 139 Help 139 Toolbar 140 Data Collection 141 Test Parameters 142 Passing...

Page 9: ...72 Toolbar 172 TE waveform area 174 Page Selection Control 174 Side Toolbar 174 Meatal Response Panel 175 Collection Toolbar 175 Data Collection 176 Passing Criteria 177 Data Analysis 178 Data Files D...

Page 10: ...195 Loopback Test Cable 196 Setup 196 Loopback Test 196 Loopback Test Analysis 197 OAE Probe Check Cavity 198 Supplies and Accessories 199 OAE Probe Ear Tips Single Use Sanibel ADI Silicone 200 Appen...

Page 11: ...connectors R L 219 Bone Oscillator 219 OAE Probe 219 Speakers R L 221 USB 221 digital I O 221 Appendix E Warranty and Repair 222 Warranty 222 Repair 222 Appendix F Recycling and Disposal 224 Appendix...

Page 12: ...ertinent to the use of the Audera Pro system including safety information as well as maintenance and cleaning recommendations READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM MANUAL CONVEN...

Page 13: ...GSI Part Number Return to Authorized Representative Special disposal required Medical Equipment Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical hazar...

Page 14: ...ailable on this website www grason stadler com A printed copy of the operating instructions can be ordered from Grason Stadler for shipment within 7 days or you can contact your local representative C...

Page 15: ...with the patient 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 prob...

Page 16: ...ury It is understood that safety rules within individual organizations vary If a conflict exists between the material contained in this manual and the rules of the organization using this instrument t...

Page 17: ...gle use parts Do not drop or otherwise impact this instrument If the instrument is dropped or damaged return it to the manufacturer for repair and or calibration Do not use the instrument if any damag...

Page 18: ...cribed in clause 16 9 of IEC 60601 1 NOTE The total protective earth impedance from each equipment in a system should be maximum 0 2 ohm measured to the earth pin in the mains plug of the Multiple Soc...

Page 19: ...rument in temperatures between 0 C 32 F to 50 C 122 F ELECTROMAGNETIC COMPATIBILITY EMC CONSIDERATIONS Medical electrical equipment needs special precautions regarding EMC and needs to be installed an...

Page 20: ...ls dB SPL 1 3 octave band that can be present inside the room while a valid hearing test is being conducted These values apply for hearing threshold measurements to 0 dB HL Test Tone Freq Hz 125 250 5...

Page 21: ...es per ISO 4869 1 Attenuation Frequency Hz DD45s with MX41 AR or PH51 Cushion dB IP30 insert earphones dB 125 3 33 160 4 34 200 5 35 250 5 36 315 5 37 400 6 37 500 7 38 630 9 37 750 800 11 37 1000 15...

Page 22: ...phone or an ear probe and personal eartip and the patient s scalp and possibly other body sites with the contact object being a bone transducer or electrodes that are capable of measuring bio potentia...

Page 23: ...rming and maintaining the contraction the SCM muscle for the duration of the test Recording oVEMP requires the patient to gaze upward and therefore the contraindications include in addition to the abo...

Page 24: ...parameters to elicit and isolate the AEP of interest Vestibular Evoked Myogenic Potentials VEMP Short latency potentials evoked through activation of vestibular receptors using sound or vibration are...

Page 25: ...s of test tones directs them into the ear canal and then measures the level of the DPOAE tone generated by the cochlea By using different test frequencies the device provides an estimate of outer hair...

Page 26: ...e Save all packing material so the claim adjuster can inspect it as well Notify your dealer or GSI when the adjuster has completed the inspection Save all the original packing material and the shippin...

Page 27: ...shortwave or microwave therapy equipment may produce instability in the Applied Parts Avoid accidental contact between connected but unapplied Applied Parts and other conductive parts including those...

Page 28: ...e 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 For vertical placement the included stand...

Page 29: ...and the options purchased with the system The Audera Pro base unit is intended to be connected to other equipment PC thus forming a Medical Electrical System When connecting the system please note the...

Page 30: ...le from base unit to the mains outlet NOTE The system ships with two patient electrode cables for systems that include EP Only one cable is attached to the unit One cable has four snap connectors and...

Page 31: ...stallation 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 ru...

Page 32: ...ncrypted Ensure that an appropriate virus spyware software is installed updated and effective All users should have a unique login to the PC Upgrading the software The procedure for an upgrade is the...

Page 33: ...t Do NOT power on off the instrument with the patient connected Do not touch the PC and patient simultaneously The device has an indicator light top right front that when lit green indicates that the...

Page 34: ...r and connection status displayed at the bottom of the window The Opening Window Menu allows the user to select or add a new patient configure the system and facility information set the operator logi...

Page 35: ...e data dialog where you may enter the peak latency information for the latency intensity graphs used with ABR Other Application provides a submenu with an additional program that may be added to the o...

Page 36: ...arch Patient displays the patient listing dialog and allows the user to search and select a patient Edit Patient displays the patient information screen where the patient information may be edited EP...

Page 37: ...the device PASSWORD 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 pa...

Page 38: ...ion on the system hardware screen is read only Serial Number Channels DSP USB The OS Bit will be set automatically based on the operating system of the connected PC The Line Freq has a dropdown with s...

Page 39: ...isplays the sub menu with the Select Password option The Select Password displays a dialog where you enter the new password Enter the new password and press the OK button This dialog is presented twic...

Page 40: ...he option for the age range for the data set is selected Menu Options File Current displays the name of the currently loaded Latency Intensity data file Mode displays either Standard or Special to ind...

Page 41: ...t and stop fields for Peak III for all the currently selected age Clear Peak V Current Age clears the data from all the start and stop fields for Peak V for all the currently selected age OPERATORS Th...

Page 42: ...on the system When the Review System Log is selected a new dialog is displayed showing the system activity The activity is shown as a table with the columns indicating the item detail and the rows ind...

Page 43: ...ting 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 Updat...

Page 44: ...Information dialog is where the patient demographics may be entered or edited The Patient Information dialog has four fields in the section at the top A tabbed section for additional information is i...

Page 45: ...entry of new patient information Opens the patient selection dialog Prints the patient information Presents the Font dialog where a font selection can be made for printing Deletes the patient data A...

Page 46: ...y selected patient Along the top of the window are options to hide the patient names display demonstration data choose the patient status and refresh the list When checked the patient name is displaye...

Page 47: ...ndow and a scroll bar on the right side may be used to scroll the patient list The arrow keys may also be used to move up and down in the patient list The highlighted row indicates the selected patien...

Page 48: ...Closes the Patient List and opens the Patient Information dialog with the information cleared and ready for the entry of new patient information Sends the patient information not collected data for th...

Page 49: ...tient Information dialog the table will be blank The Show All button on the right side may be used to display all the patients The top of the dialog displays the options for selecting the patients for...

Page 50: ...lbar in the upper part of the screen The middle of the screen contains the EP waveform area the page selection control and side toolbar If the data acquisition page is selected an EEG panel is display...

Page 51: ...EP program Protocol Settings Indicates the current settings file and when selected displays the file open dialog where you can choose a new settings file The settings file contains the information for...

Page 52: ...utomated protocol After the automated protocol is selected data acquisition is automatically started and stops after completion of the steps in the protocol Stimulus Stimulus Opens the Stimulus genera...

Page 53: ...the records from the current patient to load to the display for analysis Load Recording from Protocol Results Opens the Protocol Data Files dialog where you may select the specific protocol and load r...

Page 54: ...lculated Process Addition Subtraction Mode Displays the mode used for adding and subtracting waveforms and opens a sub menu where you may select the mode The Sweep Weighted mode takes into considerati...

Page 55: ...recording buffers for the active waveform into two separate waveforms Display Acquisition Auto Arrange by Displays the sort order of the waveforms for the data acquisition and opens a sub menu where y...

Page 56: ...oint on the waveform you have an option to display the latency and amplitude information next to the peak label The menu option opens a sub menu that allows you to choose which data to display or remo...

Page 57: ...or DP grams from the DPOAE module or other bitmap images o Text o Text Demographic Information Static o Text Active Recording Information Dynamic o Text Active Recording Information Static o Table Dy...

Page 58: ...viewer Line Thickness Opens a sub menu where the thickness for the printout of the waveforms may be selected o 1 Thin o 2 o 3 o 4 o 5 Thick Black and White Prints the report in black and white instead...

Page 59: ...N BAR 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 Identifi...

Page 60: ...file Save EP File saves the currently selected EP file Load EP Report File displays the Open dialog with the list of EP report files and allows the user to select an EP report file Save EP Report Fil...

Page 61: ...oggles the record display area between full page and split page 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 wher...

Page 62: ...The Side Toolbar is located to the right of the EP waveform area It has buttons for setting page display parameters increase decrease the waveform display check impedance display the amplifier dialog...

Page 63: ...l reject EEG with a lower amplitude The percentage of the total amplifier gain is displayed under the scroll bar The channel that is being displayed is indicated on the button in lower right and if th...

Page 64: ...th the additional sweeps The original will remain unchanged Replaces the Continue button during collection Selecting will discard sweeps zero the average and restart data collection Indicates the curr...

Page 65: ...er of sweeps to be collected A Right Click increases the number by 2 times A Left Click decreases the number by half and a Double Click presents a dialog where the user may enter a value Indicates the...

Page 66: ...er half of those are part of the post stimulus recording region the Window The table shows this relationship between Sampling Periods and Windows When the Window is changed the horizontal scale at the...

Page 67: ...cutively numbered The Count determines the number of times the Item is run The dialog is divided into sections that define the parameters for each step New items are added to the protocol with the Ins...

Page 68: ...s that the protocol will use the values that are currently set in the Collection toolbar when the protocol is executed Selecting the checkbox for the parameter allows you to change the setting In many...

Page 69: ...uditory stimulus The top of the dialog defines the stimulus type which includes Click Tone Burst and File The Click stimulus is defined in microseconds and is specified in the Duration field The durat...

Page 70: ...e rise fall specified in the Envelope Rise Fall field The plateau would be the difference between the total duration and the rise plus fall For example if you wish to specify a 2 1 2 rise plateau fall...

Page 71: ...c level provides the masking at the fixed level specified in the dB SPL field regardless of the stimulus level The Tracking level delivers the masking noise at a level relative to the stimulus level W...

Page 72: ...GSI Audera Pro User Manual D 0129360 Rev A Page 70 of 231 The File Calibration Calibration Table and SPL to HL Table buttons display the values used in the overall total calibration...

Page 73: ...ble 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 correc...

Page 74: ...0129360 Rev A Page 72 of 231 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 value...

Page 75: ...or they might be calibrated as an offset to a pure tone frequency The top left of the dialog window shows the values for the stimulus files that have been directly calibrated Stimulus files using offs...

Page 76: ...g stimulus The Load is the same as selecting the File Stimulus Type The Save button presents a dialog where you can name and save the stimulus with the current settings The Display button presents the...

Page 77: ...e Present is automatically calculated for Buffer 0 based on the other active buffers Present values Each of the other buffers target stimulus are activated by checking the Active box and have a specif...

Page 78: ...window size of the acquisition window from the Collection Toolbar The total time on the horizontal axis is shown below the EEG and artifact area 25 6 ms in the dialog above The Y axis amplitude is det...

Page 79: ...the display of the 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 ch...

Page 80: ...l or both channels may be recorded The channel s recorded are based on the channel designation and the stimulus ear Channel A Channel B Stimulus Right Left Both Right Left Both Channel Designation Rig...

Page 81: ...the Digital I O cable The trigger pulse is a 3 volt square wave delivered at the rate of the stimulus The BNC connector on the Digital I O cable is used as a trigger in from an external device The Aud...

Page 82: ...In order to use the Remote Impedance Display box you must enable the device in the configuration From the Opening Window Select the Settings menu item and the Configuration sub menu item And enter the...

Page 83: ...batteries should last for about 1900 tests 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...

Page 84: ...ding if no record has been selected or the highlighted selection row To select a recording click on the row in the listing Selecting a record will highlight the row To select multiple recordings hold...

Page 85: ...indicated at the top of the control pages that have data on them will be darker than those without data Pages may be renamed by selecting Report menu and clicking on Page Labels then choosing the page...

Page 86: ...d 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 Displa...

Page 87: ...options are presented 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 max...

Page 88: ...ons The number of available positions varies based on the Plot Size setting In Free mode waveforms may be placed at any position vertically In both modes the waveforms snap to the left side to match t...

Page 89: ...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 Clear data on this page removes the displ...

Page 90: ...e active waveform is displayed in green Each waveform has a handle at the beginning of the graphic This handle filled in to indicate that the waveform is selected and may be used to move waveforms or...

Page 91: ...the Waveform Option menu right click above the peak on the active waveform where you want the label placed From the pop up menu select Mark Peak and then the label you wish to use A marked point consi...

Page 92: ...age The table will include the marked points latency and amplitude and calculations that are defined for the specific test modality such as interlatencies Default Labels Each modality comes with a def...

Page 93: ...th the SP and AP to the same location as the bottom Base marker The area for the SP and AP will be filled in with colors for the SP and AP area and the calculations displayed next to the AP label NOTE...

Page 94: ...of the difference wave between the waveforms of the standard and the deviant responses is calculated The difference wave is obtained by subtracting the standard waveform from the deviant waveform To c...

Page 95: ...ame indicates the file name of the active recording When the mouse is placed over the name a sub menu is displayed with the stimulus amplifier and recording information Peak Latency displays a sub men...

Page 96: ...Specific Peak option will remove the peak closest to the mouse location on the active waveform when the menu was displayed The All Peaks option removes all the marked peaks on the active waveform Plo...

Page 97: ...l enables the Scaling Start and Scaling End menu items where you define the time that is used for the normalized scaling Scaling Start defines the beginning of the active waveform that will be conside...

Page 98: ...n low pass and high pass Filters Line Filter status and Digital Filter status Peaks displays the labels latency amplitude inter peak measurements and ratios for the marked peaks on the active recordin...

Page 99: ...tive waveform Averaging menu Calculate Bayesian Weighted Average All on Page calculates the weighted average for all the waveforms on the page The new recording must be saved manually Adding and Subtr...

Page 100: ...here Inverting a waveform Inverting a waveform changes the polarity and flips the active recording upside down Click on the Process menu then Invert Active Recording Filtering To filter a waveform sel...

Page 101: ...dow will show the results of the comparison The Record Info panel will also display the correlation in the Comp tab where the calculation may be added to the page Since each waveform consists of two b...

Page 102: ...nd or the table in your reports along with the waveforms send the data to the page using the Copy Image to Page and Copy Table to Page buttons The default normative data is shown when the dialog is di...

Page 103: ...ages Printing Options Printing may be initiated from the Print menu or the Print icons from the Toolbar The report may be printed to any printer attached to the computer or saved as a PDF file The pri...

Page 104: ...age menu S Selects the next recording on the page Moves the selected waveform up on the page Moves the selected waveform down on the page Adds the currently selected recordings to a new waveform Subtr...

Page 105: ...eing performed and place the electrodes on the patient Position the desired transducers for the test on the patient 8 Check the electrode impedance by selecting the icon from the side toolbar or check...

Page 106: ...s module select the VEMP analysis icon from the Opening window toolbar OPEN RECORDS When the VEMP analysis module opens a list of the records is displayed with the last recording for each ear checked...

Page 107: ...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...

Page 108: ...used settings will remain the next time the module is loaded Display Language displays a sub menu of the available languages for the VEMP analysis module When the language selection is changed you wil...

Page 109: ...ms o Not Rectified computes the asymmetry ratio from the unrectified waveforms Display Average displays a sub menu of options for which waveform average is displayed in the Calculation view One or bot...

Page 110: ...s VEMP CULLING MODE VIEW Culling allows the choice of which sweeps of the VEMP data are included in the average VEMP waveform In order to use culling you should collect your VEMP data using a block av...

Page 111: ...e the individual sweep in the overall VEMP average Sweeps that are included are colored red or blue and the sweeps not included are shown in grey The EMG activity used for the calculation is located b...

Page 112: ...beled Change the marked point by selecting the label with the left mouse button and drag the label to the desired point The latency and amplitude data for the marked points is shown in the upper right...

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Page 114: ...per part of the screen The middle of the screen contains the ASSR waveform area the stimulus information the page selection control and side toolbar If the data acquisition page is selected an EEG pan...

Page 115: ...gs file The settings file contains the information for the stimulus and amplifier settings These files are loaded with the Load Settings option Save as Default Saves the current settings as the DEFAUL...

Page 116: ...to select the automated protocol After the automated protocol is selected data acquisition is automatically started Stimulus Device Indicates the currently selected transducer and displays a sub menu...

Page 117: ...the stimulus level changes o Specific Level o Following o OFF Right Stimulus Presents an open dialog to load a stimulus file that will be used for the stimulus presented to the right ear Left Stimulus...

Page 118: ...e 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 markin...

Page 119: ...age 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 o Save Page Labels as Default Print Deidentify Printouts The option displays removes the iden...

Page 120: ...oggle Printer Setup Opens the Windows Printer setup dialog Help Manual Displays the user manual in a new window About Displays the program version information in a pop up dialog INFORMATION BAR The In...

Page 121: ...ays the list of ASSR files and allows the user to sort and select an ASSR file Save ASSR File saves the currently selected ASSR file Load Report File displays the Open dialog with the list of EP repor...

Page 122: ...t the current page or all pages PDF Print Page displays a drop down menu where the user can select to print the current page as a PDF file preview or all pages as a PDF file Clear Selected erases the...

Page 123: ...played Data may be loaded on any page The scroll bar allows movement up and down on the page SIDE TOOLBAR The Side Toolbar is located to the right of the ASSR waveform area It has buttons for setting...

Page 124: ...d using the Open Close scroll bar Opening the bar will allow larger EEG into the average and Closing the bar will reject EEG with a lower amplitude The percentage of the total amplifier gain is displa...

Page 125: ...from the Collection Toolbar The frequencies of the stimulus with the modulation frequency in parenthesis are displayed in the stimulus information area green indicates a response The user may change t...

Page 126: ...ize of the acquisition window from the Collection Toolbar The total time on the horizontal axis is shown below the EEG and artifact area 1024 0 ms in the dialog above The Y axis amplitude is determine...

Page 127: ...t 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 t...

Page 128: ...l A Channel B Stimulus Right Left Both Right Left Both Channel Designation Right Left On Off The Audera Pro is supplied with 2 patient electrode cable options 1 Snap Electrode 4 Lead Patient cable and...

Page 129: ...h the right and left ears Starts the data collection stimulating the left ear Checking the box increases the number of sweeps by 20 Indicates the current auditory stimulus level A Right Click increase...

Page 130: ...ts the stimulus file from the previous step The Count field may also be defined to perform a specific action as determined by the radio buttons below the Right Ear fields The Continue option proceeds...

Page 131: ...lay menu SNR History option acts as a toggle to display or hide the graphs a The graphs are updated with each block of sweeps The slider controls to the right of each graph allow you to scroll to valu...

Page 132: ...ay There is a Selection text box that shows the information from the first recording if no record has been selected or the highlighted selection row To select a recording click on the row in the listi...

Page 133: ...he frequency axis of the spectral graph The controls at the bottom of the dialog allow for the selection of the waveform for analysis and options to copy and print the data Polar Plot The polar plot d...

Page 134: ...ts 0 9765 Hz The response to the stimulus should occur at the modulation frequency of the stimulus The red lines represent the expected location for the response from the right ear and the blue lines...

Page 135: ...amplitude of the noise in the side bins Following the SNR is a p value indicating the probability of a response the lower the number the more certainty that a response is present The Show FFT Values c...

Page 136: ...m is presented at the bottom of the dialog The Plot Individual Trials checkbox acts as a toggle and shows hides the individual tests combinations found in the waveforms The responses appear as filled...

Page 137: ...can set up the SPL to HL offsets The Load button provides an Open dialog where you may select a saved correction table The Save As button prompts for a password and then provides a dialog where you m...

Page 138: ...selected radio button under Stimulator The table displays the values for the selected transducer Changing the transducer changes the values as each transducer may have its own set of correction value...

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Page 140: ...lbar and overall result box in the upper part of the screen The middle of the screen contains the DP data area the stimulus and response spectra the DP point information and the stimulus level An Info...

Page 141: ...Information dialog with the information from the currently selected patient Cleanup on New Patient Removes the data from the display when a new patient is selected or entered when this option is check...

Page 142: ...re the patient information may be edited Starts the data collection stimulating the right ear Starts the data collection stimulating the Left ear Settings displays a pop up dialog with the parameters...

Page 143: ...r to collecting data a probe check is preformed if the System Check Probe Fit item is selected If the probe fit is selected the criteria for passing the probe fit is based on the average noise floor i...

Page 144: ...ps and you are asked to confirm that you wish to Abort or Ignore Abort stops the data collection and Ignore continues from where you paused the collection If you choose to Abort then another confirmat...

Page 145: ...button closes the dialog and ignores any changes that have been made The Load button presents a new dialog listing any saved DP protocols You may select a new protocol from the list The Save button p...

Page 146: ...s in blocks of data cycling the frequency pairs until the full number of sweeps is reached or other pass stop criteria are met Level 1 dB SPL Output level for the F1 frequency of the frequency pair us...

Page 147: ...the ratio between F2 and F1 frequencies Presentation Determines if the stimulus presentation of the frequency pairs starts from the high frequencies or from the low frequencies Test at ONE frequency o...

Page 148: ...upper limit of the level correction Max Ear Corr dB SPL Determines the maximum allowed stimulus level correction applied to each stimulus frequency The correction is determined at the start of each a...

Page 149: ...tion The checkbox acts as a toggle to turn on off the stopping when the overall pass criteria are met On no chance to pass When checked if it is not possible for the current recording to meet the pass...

Page 150: ...where you may name and save the passing criteria as a file The Print button sends the current passing criteria to the printer Criteria at a given frequency applies to each frequency independently The...

Page 151: ...l Percent passed from all freqs Defines as a percentage of the total frequencies in the protocol how many frequencies must meet the individual criteria for the recording to be considered an overall pa...

Page 152: ...The option buttons on the bottom left provide choices to add and remove columns from the data table and to define the axes of the DPGram Comment User defined text to describe the data set Freq Ratio...

Page 153: ...en be defined as the uncertainty region the responses above normal and responses below abnormal If any entries are detected as an error the error button appears on the bottom left of the data table Cl...

Page 154: ...ed on the test parameters for the start and stop frequency and the number of points per octave The stopping criteria may also impact the number of data points displayed The current data point has the...

Page 155: ...line with a triangle for the right ear or a blue line with a square for the left ear All other vertical lines next to the DP response represent the side bins The average noise floor is calculated fro...

Page 156: ...dialog with buttons to move to the previous and next points and close the dialog o Time Domain Displays the time domain graph o Prev Moves to the previous DP point o Next Moves to the next DP point o...

Page 157: ...he graph by removing the DC component of the frequency graph This item toggles between ON OFF with each click Auto Scale Adjust the scale Y axis based on the best fit of the data This item toggles bet...

Page 158: ...results Large differences between parameter levels and actual levels indicate a possible sound output problem such as a blocked sound tubes in the probe or bad probe placement Data Point Information...

Page 159: ...before averaging noise standard deviation applied in ear correction and the side bands adjacent to the DP response frequency Below the menu bar the information on the ear tested the number of frequenc...

Page 160: ...ble in data analysis The files that are save may be imported into other program modules as an image or external programs Report o Copy Display Image to File Saves the right and left DPGrams to a graph...

Page 161: ...he list you may select a single recording or multiple recordings using the Shift and or Ctrl keys to select Even though multiple recording may be selected a single recording is displayed To choose the...

Page 162: ...e A checkbox that toggles the display of the internal noise of the system Frequency Axis Dropdown menu displays the options for the frequency axis X on the DPGram The selections are F1 F1 Sqrt F1 F2 a...

Page 163: ...are show like in the collection screen Option Buttons The OK button applies the changes and closes the dialog The Cancel button discards any changes made and closes the dialog The Apply button update...

Page 164: ...n checked Two per row Prints the DPGrams for each ear on the same line side by side if there is more than one DPGram selected If this item is not checked each DPGram prints on a separate page History...

Page 165: ...arameters dialog In the Test Parameters dialog the Frequency tab indicates the number of data points panel on the right side based on the Start Frequency End Frequency and the Frequencies octave If th...

Page 166: ...settings for the data collection The Cancel button closes the window disregarding any modifications to the data The Help button displays the program manual in a new window The Load button presents a...

Page 167: ...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 The...

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Page 169: ...dle of the screen contains the TE waveform area the page selection control and side toolbar If the data acquisition page is selected a meatal response panel is displayed along with an artifact level c...

Page 170: ...efault settings file This is the file that is loaded when the program is started Modality o Transient Non Linear Sets the data collection to use the stimulus sequence presentation in non linear mode T...

Page 171: ...rrent status of the Probe Check When the item is checked the probe fit is checked prior to stating the data collection Meatal Saturation Check Displays the current status of the Meatal Saturation Chec...

Page 172: ...menu with options to remove report elements from the selected item all items on the page or all items on all pages The Clear Permanently Delete option presents a warning dialog to confirm that you wi...

Page 173: ...iewer Black and White Prints the report in black and white instead of color If you are using a black and white printer this option should be selected as some colors do not render well on a black and w...

Page 174: ...on Cursor time position TOOLBAR Below the Information bar there is a Toolbar with icons that are equivalent to the most commonly used menu items Icon Description Add Patient displays the patient infor...

Page 175: ...a between full page and split page Print Page displays a drop down menu where the user can select to print the current page or all pages PDF Print Page displays a drop down menu where the user can sel...

Page 176: ...ay be viewed at a time The Acq page is where the data that is currently being collected is displayed Data may be loaded on any page The scroll bar allows movement up and down on the page SIDE TOOLBAR...

Page 177: ...losing the bar will reject the incoming microphone data with a lower amplitude The percentage of the total amplifier gain is displayed under the scroll bar COLLECTION TOOLBAR The Collection toolbar co...

Page 178: ...parameters Once data collection is initiated a probe check is performed if this option is enabled in the Stimulus menu The results of the probe check are displayed under the meatal response panel on t...

Page 179: ...6 milliseconds of the recording Response Information Table Displays the numerical information of the response Total amplitude of the response dB SPL Total noise of the response dB SPL Test Modality St...

Page 180: ...d selection row To select a recording click on the row in the listing Selecting a record will highlight the row To select multiple recordings hold the Shift key while clicking on the first and last re...

Page 181: ...el that appears when hovering over the button and printed on the report The page labels may be saved loaded or saved as the default labels from the Page Labels sub menu To select a page click on Page...

Page 182: ...hoices provided 1 0 0 9 0 8 0 7 or user defined by selecting Other Other will prompt for the microvolt value Scaling determines the time window that is used for the determining the normalized scale Th...

Page 183: ...cordings will be overlapped and take up the entire screen Plot Start Time determines the start of the time window x axis horizontal at the bottom of the screen of the waveform display A prompt is pres...

Page 184: ...up menu Note that the location on the time axis of where the mouse is clicked determines where the peaks are marked File Name indicates the file name of the active recording When the mouse is placed...

Page 185: ...ization calculation This is only enabled when the Scaling is set to Special and Normalization is used for Scale for the page Scaling End defines the end of the active waveform that will be considered...

Page 186: ...ly elements should not be edited manually as the edits will not be maintained when the data is updated The Text and Label elements both open the text editor dialog The text editor dialog has options f...

Page 187: ...GSI Audera Pro User Manual D 0129360 Rev A Page 185 of 231...

Page 188: ...cers Do not attempt to sterilize the instrument or any of its accessories Do not use alcohol based disinfectants To avoid person to person cross contamination of communicable diseases all disposable i...

Page 189: ...using 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 A properly inserted probe tube will snap securely into place when...

Page 190: ...approved for use with the instrument The eartips are disposable and must be replaced after each patient After selecting an eartip push it onto the probe tube until it is flush against the base of the...

Page 191: ...only It is recommended to turn off the power from the mains when the system is not being used Operational Checks It is recommended that the user of the instrument should perform a subjective instrume...

Page 192: ...privileged device access to system administrators service technicians maintenance personnel As a security best practice use your local non Administrator account to sign in and then use Run as administ...

Page 193: ...ly creating new viruses and other forms of malicious code it is important to keep your antivirus software up to date Windows 10 provides Windows Defender Antivirus This is available from Settings Upda...

Page 194: ...cted permissions keep the malicious code from spreading and escalating to an administrative account Back up data Regularly back up your data to the cloud or to an external hard drive In the event of a...

Page 195: ...d on before starting the program Try closing the program power cycle on the device and then restart the program You can continue without the connection and the program will not be able to collect new...

Page 196: ...the probe tip Re position the probe in the ear making sure not to press against the ear canal Probe Fit or Gain Problem This error may appear in the TEOAE module The error indicates that the micropho...

Page 197: ...g License file This error indicates that the system license file GSIWIN SYS that is required in the C GSIAuderaPro directory is either missing or corrupted Try copying the license file from the USB de...

Page 198: ...onnect the red plug of the Loopback Test Cable to the right red headphone jack on the back of the device 4 Connect the blue plug of the Loopback Test Cable to the left blue headphone jack on the back...

Page 199: ...different stimulus levels As an alternative to the placement of the cursors you can scroll down on the page and observe the PP amplitude in the page data table The measured voltage should be within th...

Page 200: ...he OAE Probe Check Cavity it is possible to perform an OAE probe quality check in a realistic test cavity 1 Attach a clean disposable eartip of the smallest size to your OAE probe 2 Insert the probe w...

Page 201: ...bo insert foam tips 3C large yellow 24pcs 8517636 Disc Electrode 6 mm Silver Cup reusable 5 8107145 Casted electrodes gold 10 mm 5 pcs 8011343 TIP TRODE connection cable 2 pcs 500mm 8500440 Gold Tip T...

Page 202: ...8 GSI Audera Pro Digital I O Cable 8517341 OAE Probe 8100590 ABR tube ADI ear tip adaptor 8103765 Ear Tip Starter Kit 8505466 Infant Ear Simulator 8518077 Audera Pro Stand 8506056 Audera Pro Laptop Co...

Page 203: ...13004 8013003 8 mm mushroom style 8012970 8012969 9 mm mushroom style 8012972 8012971 10 mm mushroom style 8012974 8012973 11 mm mushroom style 8012976 8012975 12 mm mushroom style 8012978 8012977 13...

Page 204: ...er settings When you select the Save Settings button the software automatically assigns the name GSIAuderaAEPDefault SET in the file name field This is the name Audera Pro uses for default parameters...

Page 205: ...ducer Insert Earphones Insert Earphones Stimulus 500Hz Blackman 500Hz Blackman Intensity 95 dB nHL 95 dB nHL Polarity Rarefaction Rarefaction Rate 5 1 5 1 Amplifier Number of Channels 2 2 Gain 5k 100k...

Page 206: ...option on the Protocol Menu saves the current parameters including the Stimulus and Amplifier settings When you select the Save as Default menu item the software automatically assigns the name Default...

Page 207: ...requirements The Save as Default button on the Parameters dialog saves the current parameters When you select the Save as Default button the software automatically assigns the name Default PRO Genera...

Page 208: ...lt settings file to load at start up change the change the settings to match your requirements The Save as Default option on the Protocol Menu saves the current parameters When you select the Save as...

Page 209: ...roperly recognize the data type and perform any required automatic calculations Recording Naming Convention File names are stored in the following format FLSMdBC nn Where FL Patient first and last ini...

Page 210: ...3 2007 OAE IEC 60645 6 2009 Type 1 EP ABR IEC 60645 7 2009 Type 1 Protection from Fluids IPX0 Ordinary equipment General Specifications ENVIRONMENTAL Transport and Handling Transport package shall be...

Page 211: ...48 x 38 1 x 7 62 cm L x W x H 12 x 15 x 3 in Weight 2 kg 4 4 lbs MODALITIES Evoked Potentials ECOG ABR MLR LLR SN10 P300 MMN VEMP ASSR Otoacoustic Emissions DPOAE TEOAE SPOAE EP AMPLIFIER Channels 2 G...

Page 212: ...000 Hz CE Chirp Octave Bands 500 1000 2000 4000 Hz Tone Parameters Frequency 125 to 12 000 Hz Rise Fall Plateau adjustable in uSec or cycles Duration Up to 500 ms adjustable Tone Window Types Rectang...

Page 213: ...250 5000 Hz Analysis Frequencies 1000 4000 Hz DPOAE Stimulus 2 Pure Tones 500 12000 Hz user defined start end and F2 F1 ratio Levels 65 55 user defined L1 L2 0 80 dB SPL Steps per Octave 1 10 user de...

Page 214: ...n GSI supplied transducers It is recommended that calibration of the instrument and transducers be performed annually by authorized GSI Representatives using appropriate calibration instrumentation If...

Page 215: ...7 5 9 5 36 5 2 5 2000 Hz 9 11 5 31 1 5 3000 Hz 11 5 13 30 6 4000 Hz 12 15 35 5 5 5 6000 Hz 16 16 40 4 5 8000 Hz 15 5 15 5 40 12 5 Short Duration Tone 2 1 2 250 Hz 32 28 74 5 16 500 Hz 23 23 5 69 5 16...

Page 216: ...4 coupler and RETSPL comes from ANSI S3 6 2010 and ISO 389 2 1994 B81 uses ANSI S3 13 or IEC60318 6 2007 mechanical coupler and RETFL come from ANSI S3 6 2010 and ISO 389 3 1994 Force 5 4N 0 5N Loudsp...

Page 217: ...318 1 artificial ear Maximum distortion allowed is 2 5 THD as specified in IEC 60645 1 Frequency Hz peRETSPL dB Maximum SPL dB Maximum HL dB Click 32 132 100 CE Chirp 32 132 100 125 28 130 102 250 28...

Page 218: ...h ear mold substitute adapter Maximum distortion allowed is 2 5 THD as specified in IEC60645 1 Frequency Hz peRETSPL dB Maximum SPL dB Maximum HL dB Click 36 133 97 CE Chirp 36 133 97 125 28 124 96 25...

Page 219: ...er 4930 artificial mastoid Maximum distortion allowed is 5 5 THD as specified in IEC60645 1 Frequency Hz peRETSPL dB Maximum SPL dB Maximum HL dB Click 52 122 70 CE Chirp 52 122 70 250 75 105 30 500 7...

Page 220: ...m allowed distortion is 10 The measurements were made in a sound room approximately 2 meters on a side Maximum levels will be influenced by size of room and microphone placement Frequency Hz RETSPL dB...

Page 221: ...ive 2 Neutral 3 Earth PATIENT ELECTRODE CABLE Pin Description 1 CHA 2 CHA 3 CHB 4 CHB 5 Shield 6 ISO GND Input impedance 10M Ohm Max input 24 8 Vrms HEADPHONES INSERTS 2 CONNECTORS R L Pin Description...

Page 222: ...231 Pin Description HDMI Type A 1 REC 1 2 REC 1Shield 3 REC 1 4 REC 2 5 REC 2 Shield 6 REC 2 7 MIC Power 8 MIC Shield 9 MIC Out 10 Mic Power 11 Not Used 12 Not Used 13 Not UsedC 14 Battery 15 SCL UIOP...

Page 223: ...2 Signal Max output 7 Vrms at 10 Ohm USB Pin Description 1 5 V DC 2 Data 3 Data 4 GND DIGITAL I O Pin Description 1 OUT 1 2 OUT 2 3 IN 1 4 IN 2 5 Trigger IN TTL 6 GND Input impedance 165k Ohm output i...

Page 224: ...pecial or consequential damages even if notice has been given in advance of the possibility of such damages The transducers may go out of calibration due to rough handling or impact dropping The lifet...

Page 225: ...r only Please include a detailed description of faults To prevent damage in transit please use the original packing if possible when returning the instrument Grason Stadler will provide circuit diagra...

Page 226: ...s electronic components wiring and other elements of electronic devices Follow all local laws and regulations for the proper disposal of batteries and any other parts of this system Below is the conta...

Page 227: ...r active HF surgical equipment and RF shielded rooms of systems for magnetic resonance imaging where the intensity of electromagnetic disturbance is high Use of this instrument adjacent to or stacked...

Page 228: ...only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The Audera Pro is suita...

Page 229: ...of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 22 0 1 0 37 0 37 0 74 1 1 17...

Page 230: ...4 5 1 kV differential mode 2 kV common mode Not applicable Mains power quality should be that of a typical commercial or residential environment Voltage dips short interruptions and voltage variations...

Page 231: ...he recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 1 2 1 2 80 MHz to 800 MHz 2 3 800 MHz to 2 5 GHz Where P...

Page 232: ...magnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable...

Page 233: ...Ear 8517069 DD45s Headphones RadioEar 8517039 B81 Bone Vibrator RadioEar 8517075 SP90A RadioEar 8505336 OAE Probe Grason Stadler 8517021 Conformance to the EMC requirements as specified in IEC 60601 1...

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Summary of Contents for AUDERA PRO

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