The following describes general use of ELIOS device

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1 General use of the device The following describes general use of ELIOS device 1. Introduction of graphical user interface Presence indicator of SD card Charging indicator General Informations Screen title Back to the previous screen Buttons Language selection 2. Setting of test Important note: Make sure Memory SD card is inserted in the drive. Without SD card, you are unable to access to pages «Measure» and «USB». - From «Home page», click on «Measure». Page «Measure» is displayed. - To find an existing patient, click on «Search». List of patients appears, buttons «Prev.» and «Next» allow you to navigate in the list. Select wanted patient. - To create a new patient, click on «New»: Fill in the fields: «Name», «First name» and «Date of birth» by clicking on each item. According to the information field, alphabetic or numeric keyboard appears on screen. To complete the entry, click «OK». When all fields you want are filled, click on «Save». - The page that appears remember you information about your patient. Two buttons are available from this page: «Diagnosis» which allows a new measure. Select type of diagnosis you want and refer to the form of achievement of this test. «Consultation» which gives access to the list of test made on this patient. Select in the list the test you want to access to the curve.

2 3. Measures analysis tools Devices integrate a range of powerful tools allows you to analyse directly (without any computer) collected data. 3.1 DDPOAE, DPMC and DPgram - When viewing a graph, click on one point. - A table of data analysis is displayed. According to the kind of test, contents of table varies. - Toolbox offers two way to analyze data from one point. Spectral analysis by FFT: Touch «Freq» button. - Area of useful spectral energy is characterized by the vertical white line. - Slider allows you to adjust the maximum frequency of analysis. Temporal analysis: Touch «Temp» button. - Slider allows you to adjust the display window. General use of the device 3.2 ABR, VEMP et ECochG - When viewing a curve, you can place markers to verify the latencies of waves. In using the arrow in the header bar, you can access to display menu of latency tables. - A button lets you adjust the size of the display window. 4. Setting general parameters From «Home page», menu «Config» provides access to general settings of the device. 4.1 Setting date and time - Click on «Date» then set the date and time using + and buttons. 4.2 Setting touch screen - Click on «LCD», three settings are available from this menu: Brightness: Slide the cursor to adjust brightness. Rotation: This button allows a 180 rotation of the display. Calibration: If touch screen responds poorly, or is not accurate, click on calibration and follow procedure that appears on the screen. 4.3 Button «System» allows to view information about your device Version of the device (firmware), serial number (S/N), battery level and free space on the SD card. The «Reset» button can restore factory default settings in case of mishandling. 4.4 The button «About» can display details about company 4.5 Set up parameters of DDPOAE and DP-gram tests Menu «Config DP» is used to define power and frequency ratio between F1 and F2 signals used for distortion products. It also allows you to choose the distortion product to be studied. 4.6 Set up parameters of ABR, VEMP and ECochG Menu «Config Click» allows to set power levels of «click» signals. You can adjust threshold hearing value of a click «dbhl» and the power difference between click signal and contralateral masking.

3 1. Setup This form describe measurement of Phase Shift of Distortion Product of Otoacoustic Emissions with ELIOS device DDPOAE Equipment: - ELIOS unit. - ECHO-OAE probe. - 1 OAE «EarTip» (ER10D-Txx). Patient preparation: - By using an otoscope, make sure that the ear canal is not obstructed by earwax. - Choice of ear tip is the most important point for the measure quality, it should not be pressed against a side of ear canal. Ear tip must be hermetically sealed to prevent acoustic leaks and isolate to surrounding noise. - Connect the device and equip the patient according to the ear to test. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of DDPOAE measure. Parameters details: - «Power» (70 db by default) : Defines sound intensity from 50 to 75 db. - «Stim number» (40 by default) : Defines number of burst sent into the ear, an average of 40 or more provides quality measure.

4 - «Frequency (Hz)» (1200 by default): Sets frequency of stimulation signal F2. It s recommended to set 1200 Hz. - «Left» «Right»: Select ear to test. DDPOAE 3. Method - Once device settings made, touch «Start» button to access to the measurement screen. - A new DDPOAE measure opens. Click again on «Start» to launch it. Progress bar Rejection indicator Phase curve Last made point Min/Max signals Patient position Rejection level selection - You can select the position of the patient. There is a representative color for each position: Red «vertical», Green «horizontal», Blue «Inclined», Yellow «other». - Progress bar informs you about the status of a point. - When progress bar ends: system displays a point on the graph. - A point is composed about 2 information: Index given above: is the phase shift value in degree. Index indicated in white below: is the ratio between the effective signal and the average noise in db (S/N). To validate a point, this value must be greater than 3dB. - The rejection indicator light notifies you when the rejection threshold is reached. If 40 successive rejections are detected, the current point is rejected and the «Rejection» information appears on the screen. Note: You can suspend acquisition at any time using the «Pause» button. It is possible to resume current measurement at any time. - Once your achievement point is good (minimum of 4 points per position), click on «Stop» button. - You then have the choice of saving the data by clicking on «Save» or deleting it by exiting from the window using the back cross. - You can place markers (A and B) on the curve to quantify the phase shift between two points. - The acquired and recorded data can be viewed in the «Consultation» menu of the patient.

5 1. Setup The following describe measurement of the Cochlear Microphonic Potential Phase Shift with ELIOS device DPMC Equipment: - ELIOS unit. - ECHO-DIF unit. - Acoustic Stimulator. - Electrophysiology cable. - 2 electroacoustics tubes. - 2 surface electrodes F golden ear tips (ER3-26A or ER3-26B). Patient preparation: - Clean the surface of the skin where the electrodes will be attached with abrasive gel. This decreases the impedance of the skin. - Connect the device and equip the patient like on this picture. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of DPMC measure. Parameters details: - «Power» (80 db by default) : Defines sound intensity from 50 to 90dB. - «Stim number» (100 by default) : Defines number of burst sent into the ear, an average of 40 or more provides quality measure.

6 DPMC - «Frequency» (1000 by default): set stimulation signal frequency between 800Hz and 1200Hz. It s recommended to set 1000Hz with variance of ±50Hz depending on the surrounding disturbing electromagnetic frequencies - «Left» «Right»: Select ear to test. - «Rejection»: define the average muscular activity level of the patient at rest. Click on «Rejection» to open the configuration window for this parameter. It can be adjusted manually by sliding the cursor or automatically by clicking on «Auto». The higher the rejection percentage is low, more rejection is strict. - «Impedance»: Informs about the quality of electrodes placement. Impedance values must be as small and well balanced as possible to guarantee measurement quality (under than 5kΩ). If it s not the case, wipe the patient s forehead again and reattach new electrodes. Rejection Configuration 3. Measurement process - Once device settings made, touch «Start» button to access to the measurement screen. - A new DPMC measure opens. Click again on «Start» to launch it. Progress bar Rejection indicator Phase curve Min/Max signals Patient position Rejection level selection - You can select the position of the patient. There is a representative color for each position: Red «vertical», Green «horizontal», Blue «Inclined», Yellow «other». - Progress bar informs you about the status of a point. - When progress bar ends: system displays a point on the graph. - A point is composed about 2 information : Index given above : is the phase shift value in degree. Index indicated in white below: is the ratio between the effective signal and the average noise in db (S/N). To validate a point, this value must be greater than 3dB. - The rejection indicator light notifies you when the rejection threshold is reached. If 40 successive rejections are detected, the current point is rejected and the «Rejection» information appears on the screen. Note: You can suspend acquisition at any time using the «Pause» button. It is possible to resume current measurement at any time. - Once your achievement point is good (minimum of 4 points per position), click on «Stop» button. - You then have the choice of saving the data by clicking on «Save» or deleting it by exiting from the window using the back cross. - You can place markers (A and B) on the curve to quantify the phase shift between two points. - The acquired and recorded data can be viewed in the «Consultation» menu of the patient.

7 1. Setup DP-gram The following describe measurement of the Otoacosutic Emissions by Distortion Products with ELIOS device Equipment: - ELIOS unit. - ECHO-OAE probe. - 1 OAE «EarTip» (ER10D-Txx). Patient preparation: - By using an otoscope, make sure that the ear canal is not obstructed by earwax. - Choice of ear tip is the most important point for the measure quality, it should not be pressed against a side of ear canal. Ear tip must be hermetically sealed to prevent acoustic leaks and isolate to surrounding noise. - Connect the device and equip the patient according to the ear to test. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of DP-gram measure. Parameters details: - «Power» (70 db by default) : Defines sound intensity from 50 to 75 db. - «Stim number» (10 by default) : Defines necessary average to acquire a point. Advised at least 10. Validation of a point is automatic and depends on two parameters: the ambient noise and the signal measured. This variable defines the number of stimulation averaged before testing the validation of the point.

8 DP-gram - «Frequency»: Sets frequency of stimulation signal F2. It s recommended to test several intensities. These frequencies are tested from the highest to the lowest. - «Left» «Right»: Select ear to test. 3. Method - Once device settings made, touch «Start» button to access to the measurement screen. - A new DP-gram measure opens. Click again on «Start» to launch it. Progress bar Rejection indicator Frequency (Hz) Signal level (db SPL) Measure in progress Next measure Noise level - Progress bar informs you about the status of a point. All «Stim number» acquisition, the system calculates the ratio between useful signal and noise. If this ratio is sufficiently important to exploit the curve, it stops the current frequency and displays a point on the graph. - The white number is the ratio between the effective signal and the average noise in db (S/N). - The rejection indicator light notifies you when the rejection threshold is reached. If 40 successive rejections are detected, the current point is rejected and the «Rejection» information appears on the screen. - The measure stops automatically when all the frequencies selected during the configuration measure have been tested. - You then have the choice of saving the data by clicking on «Save» or deleting it by exiting from the window using the back cross. - The acquired and recorded data can be viewed in the «Consultation» menu of the patient.

9 1. Setup The following describe measurement of the Auditory Brainstem Response with ELIOS device ABR Equipment: - ELIOS unit. - ECHO-DIF unit. - Acoustic simulator. - Electrophysiology cable. - 2 electrophysiology clips. - 4 surface electrodes F foam ear tips (ER3-14A or ER3-14B). Patient preparation: - Clean the surface of the skin where the electrodes will be attached with abrasive gel. This decreases the impedance of the skin. - Connect the device and equip the patient like on this picture. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of ABR measure. Parameters details: - «Stim number» (1000 by default) : Defines numbers of clicks sent into the ear. An average between 500 & 1000 provides quality measure. - «Click / Second» (17 by default) : Defines rate of clicks.

10 - «Tube»: Select it if you used the electroacoustics tubes (red and blue) between the receiver and the foam eartip. - «Left» «Right»: Select ear(s) to test. - «Set Power»: Selection of power that will be tested successively (from highest to lowest), it is also possible to specify a number of repetitions by intensity. - «Rejection»: define the average muscular activity level of the patient at rest. Click on «Rejection» to open the configuration window for this parameter. It can be adjusted manually by sliding the cursor or automatically by clicking on «Auto». The higher the rejection percentage is low, more rejection is strict. - «Impedance»: Informs about the quality of electrodes placement. Impedance values must be as small and well balanced as possible to guarantee measurement quality (under than 5kΩ). If it s not the case, wipe the patient s forehead again and reattach new electrodes. ABR Power selection Rejection Configuration 3. Method - Click on «Start» to launch the measure. - A screen opens, it permits to select the ear in which you want to start the exam. - The steps measurement follows : Reminder of the ear and value of impedances measured Current measure Previous measure Marker selector Left / Right measurement Indication of diagnosed ear First measure Succession of measures End of the measurement Rejection level selection Ear Change (if left and right have been selected) Select ears to be displayed Change graph scale Scroll through measures 1 st measure / Succession of measures: The measurements proceed from the highest intensity to the lowest. On the bottom of the screen displays the current measurement, on the upper part, the previous measure. Change of ear: If both ears were selected in the ABR screen menu, the device indicates when to change stimulation. We must then verify that the measured impedances are always lower than 5kΩ. End of measurement: Once the measurement is completed, the acquired data are displayed with left / right differentiation. It is then possible to check all the powers tested and place markers I-II-III-IV- V to check the latencies. - The button «Save» saves the measure.

11 1. Setup The following describe measurement of Electrocochleography with ELIOS device ECochG Equipment: - ELIOS unit. - ECHO-DIF unit. - Acoustic simulator. - Electrophysiology cable. - 2 electroacoustics tubes. - 2 surface electrodes F golden ear tips (ER3-26A or ER3-26B). Patient preparation: - Clean the surface of the skin where the electrodes will be attached with abrasive gel. This decreases the impedance of the skin. - Connect the device and equip the patient like on this picture. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of ECochG measure. Parameters details: - «Power» (85 db by default) : Defines sound intensity. - «Stim number» (1000 by default) : Defines the number of clicks sent into the ear. An average between 500 & 1000 provides quality measure.

12 ECochG - «Click / Second» (17 by default) : Sets the rate of clicks. - «Left» «Right»: Select the ear(s) to test. - «Rejection» : define the average muscular activity level of the patient at rest. Click on «Rejection» to open the configuration window for this parameter. It can be adjusted manually by sliding the cursor or automatically by clicking on «Auto». The higher the rejection percentage is low, more rejection is strict. - «Impedance»: Informs about the quality of electrodes placement. Impedance values must be as small and well balanced as possible to guarantee measurement quality (under than 5kΩ). If it s not the case, wipe the patient s forehead again and reattach new electrodes. Rejection Configuration 3. Method - Once device settings made, touch «Start» button to access to the measurement screen. - A new «ECochG» measure opens. Click on «Start» again to launch it. Rejection indicator Graph area Number of click done Rejection level selection - The system traces in real-time the graph, so you can follow the evolution of the curve. - Clicks already done by polarity are indicated by«nb Click». - You can stop the measurement at any time with «Stop» button. Otherwise, the measurement stops automatically when the specified number of clicks setting is reached. - You will then have the choice between saving measure or raise a new acquisition. This allows you to superpose several curves on one graph, and thus to see the repeatability of the waves. - The acquired and recorded data can be viewed in the «Consultation» menu of the patient.

13 Audiometry The following describe Pure Tone Audiometry protocol with ELIOS device 1. Setup Equipment: - ELIOS unit. - Audiometry stimulator (insert / HDA280 Headset/ HDA200 Headset/ Radioear B71). Patient preparation: - Connect the device and fit out the patient as above. 2. Types of measures Refer to the «General use of the device» guide, to access to the setting menu of Audiometry. Four types of measures are available - «Patient Mode»: Fully automatic mode. Patient is the operator. - «Doctor mode»: semi-automatic mode. Device runs the protocol, but the physician must validate the patient s responses. - «Doctor mode - Manual» : the physician runs its own protocol himself (choice of frequency and power) and decides whether the patient s responses. - «Weber mode» : this mode is used to test the lateralization of the hearing by a weber test.

14 Audiometry 3. Method Test in automatic mode Parameters - «Left» «Right»: Select the ear to be tested. - «Frequency selection»: Select frequencies to be tested. - «Masking»: Allows to set power of contralateral masking. - «Insert / HDA200 / HDA280 / Radioear B71»: Select type of stimulator to be used. Conduct of measurement in Patient Mode - When the patient is ready and equipped, click on «Start» and give him the device. - Device starts its protocol test. - Patient must click on «OK» as soon he hears a sound. - When all frequencies have been tested, the device automatically displays the curve results. - The button «Save» saves the measurement. Conduct of measurement in Doctor Mode - When the patient is ready and equipped, click on «Start». - Device starts its protocol test. - In the upper left corner, an indicator shows the status of the stimulation. - For each intensity, you must indicate if the patient hears or not. You can to restart the stimulation by clicking «Restart». - When all frequencies have been tested, the device automatically displays the curve results. - The button «Save» saves the measurement. Test in manual mode Parameters - «Intensity (Hz)»: Select intensity to be tested. - «Fréquency (Hz)» : Select frequency to be tested. - «Masking»: Allows to set power of contralateral masking. Conduct of measurement in manual Mode - Equip the patient and select the type of stimulator used, «Insert / HDA200 / HDA280 / Radioear B71». - Select the ear to be tested by clicking on the image of one of the ears. - Each time you click on «Stim» the device generates the sound relating to the set parameters. - «Yes» and «No» allow indicate if the patient has heard the sound or not. - You can always check the graph of the current measurement by clicking on «Graph». The button «Save» saves the measure, the button «Measure» is used to go back to the window stimulation. Conduct of Weber test - Equip the patient with the stimulator «Radioear B71». - Each time you click on «Stim» the device generates the sound relating to the set parameters. - «Left», «L./R.» and «Right» allow to indicate allow indicate which ear the patient heard the sound. You can always check the graph of the current measurement by clicking on «Graph». The button «Save» saves the measure, the button «Measure» is used to go back to the window stimulation.

15 1. Setup VEMP The following describe measurement protocol of Vestibular Evoked Myogenic Potential (VEMP) with ELIOS device Equipment: - ELIOS unit. - ECHO-DIF unit. - Acoustic simulator. - Electrophysiology cable. - 2 electrophysiologys clips. - 4 surface electrodes F foam ear tips (ER3-14A or ER3-14B). Patient preparation: - Clean the surface of the skin where the electrodes will be attached with abrasive gel. This decreases the impedance of the skin. - Connect the device and equip the patient like on this picture. - The patient must contract the Sternocleidomastoid muscle SCM (eg. in raising his head and turning on the opposite side to stimulation). 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of VEMP. Parameters details: - «Stim numbers» (100 by default): Defines the number of clicks sent into the ear. An average between 80 & 200 provides a quality measure. - «Click / Second» (5 by default): Defines the rate of clicks.

16 - «Tube»: Select it if you used the electroacoustics tubes (red and blue) between the receiver and the foam eartip. - «Left» «Right»: Select the ear(s) to test. - «Set Power»: Selection of power that will be tested successively (from highest to lowest), it is also possible to specify a number of repetitions by intensity. - «Rejection»: define the average muscular activity level of the patient at rest. Click on «Rejection» to open the configuration window for this parameter. It can be adjusted manually by sliding the cursor or automatically by clicking on «Auto». The higher the rejection percentage is low, more rejection is strict. - «Impedance»: Informs about the quality of electrodes placement. Impedance values must be as small and well balanced as possible to guarantee measurement quality (under than 5kΩ). If it s not the case, wipe the patient s forehead again and reattach new electrodes. VEMP Power selection Rejection configuration 3. Method - Click on «Start» to launch the measure. - A screen opens, it permits to select the ear in which you want to start the exam. - The steps measurement follows: Reminder of the ear and value of impedances measured Current measure Previous measure Marker selector Left / Right measurement Indication of diagnosed ear First measure Succession of measures End of the measurement Rejection level selection Ear Change (if left and right have been selected) Select ears to be displayed Change graph scale Scroll through measures 1 st measure / Succession of measures: The measurements proceed from the highest intensity to the lowest. On the bottom of the screen displays the current measurement, on the upper part, the previous measure. Change of ear: If both ears were selected in the VEMP screen menu, the device indicates when to change stimulation. We must then verify that the measured impedances are always lower than 5kΩ. End of measurement: Once the measurement is completed, the acquired data are displayed with differentiation left / right. It is then possible to check all the powers tested and place markers P13-N23- P30-N34-P44 to check the latencies. - The button «Save» saves the measure.

17 1. Setup TEOAE The following describe measurement protocol of Transient Evoked Otoacoustic Emission (TEOAE) with ELIOS device Equipment: - ELIOS unit. - ECHO-OAE probe. - 1 OAE «EarTip» (ER10D-Txx). Patient preparation: - By using an otoscope, make sure that the ear canal is not obstructed by earwax. - Choice of ear tip is the most important point for the measure quality, it should not be pressed against a side of ear canal. Ear tip must be hermetically sealed to prevent acoustic leaks and isolate to surrounding noise. - Connect the device and equip the patient according to the ear to test. 2. Setting up measurement parameters Refer to the «General use of the device» guide, to access to the setting menu of TEOAE measure. Parameters details : - «Power» (84 db by default) : Defines the sound intensity from 40 to 95 db. - «Number of stim» (500 by default) : Defines the number of clicks sent to the ear, an average of 500 and provides a measure of quality. - «Left» «Right» : Select the ear to be tested.

18 TEOAE 3. Method - Once the device settings made, touch the button «Start» to access the measurement window. - A new TEOAE test appears. Click on «Start» to run the test. Rejection indicator Response curve of buffer A Simulus curve Response curve of buffer B Graph area Number of click done - The system traces the real time graph, so you can follow the progress of the curve. - The number of clicks already done by buffer is indicated by «Click Nb». - You can stop the measure at any time by «Stop» button. Otherwise, the measurement stops automatically when the specified number of clicks during configuration is reached. - Once the acquisition is completed, three modes of viewing results are available: Temp : Displays time graph of data acquired. The display can be separated into two, to see whether the curve of the stimulation. The red curve represents the buffer A, the blue curve the buffer B. Freq : Displays frequency graphs of data acquired. The display can be separated into two, to see whether the curve of the stimulation. The blue curve represents the average of the measured signal, the blue curve represents the noise. Table: Displays a table containing the signal/noise ratio and the rate of repeatability between the two buffers depending on the frequency. Simulus curve Signal (db SPL) Noise (db SPL) Signal/noise ratio for each frequency Measure informations Response curve Displaying stimulation graphs Repeatability between buffers for each frequency - You then have the choice of saving the data by clicking on «Save» or deleting it by exiting from the window using the back cross. - The acquired and recorded data can be viewed in the «Consultation» menu of the patient.

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