Interacoustics Eclipse Instructions For Use Manual
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Interacoustics Eclipse Instructions For Use Manual

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Summary of Contents for Interacoustics Eclipse

  • Page 1 Science made smarter Instructions for Use - US Eclipse...

  • Page 3: Table Of Contents

    Unpacking and inspection ......................7 Markings ............................ 8 Hardware installation ......................... 9 2.3.1 Grounding the patient bed ......................10 2.3.2 Eclipse back panel ........................11 2.3.3 Eclipse front panel........................11 2.3.4 Preamplifier buttons ........................12 Software installation ........................ 12 2.4.1 To know before you start installation ..................
  • Page 4 3.1.16 Save & Exit ..........................24 3.1.17 Stimulus rate selection ....................... 24 3.1.18 Frequency selection ........................24 3.1.19 Stimulus window ........................24 3.1.20 Manual stimulation window ......................25 3.1.21 Status window ..........................25 3.1.22 Waveform reproducibility ......................25 3.1.23 Start / Stop ..........................25 3.1.24 Pause ............................
  • Page 5 3.8.1 Two suggested eABR electrode montages ................48 3.8.2 Editing an eABR recording ......................48 3.8.3 Electrical threshold estimation for cochlear implant fitting ............49 Making an ECochG recording ....................50 3.9.1 ECochG electrode montages ..................... 50 TipTrode ..............................50 TMtrode 50 3.9.2 Editing an ECochG recording .....................
  • Page 6 5.1.5 Importing WAV files for stimuli ....................71 Operating instructions IA OAE suite ..................75 Handling and selection of ear tips ................... 76 Daily system checks for OAE devices..................77 6.2.1 Probe integrity test ........................77 6.2.2 Real-Ear Check ......................... 78 The IA OAE suite ..........................
  • Page 7 Cleaning the OAE probe tip ....................120 Concerning repair ........................122 Warranty ..........................122 10 Technical specifications ......................125 10.1 Technical specifications - Eclipse hardware ................. 125 10.2 Technical specifications EP15/EP25/VEMP ................. 126 10.2.1 peSPL to nHL correction values ....................128 10.3 Technical specifications TEOAE ...................

  • Page 9: Introduction

    Web: www.interacoustics.com It is the purpose of this manual to provide users of Interacoustics EP15, EP25, VEMP, TEOAE, DPOAE and ASSR modules with the information required to carry out safe and reliable measurements. Some of the software modules described may not be included in your license. Please contact your local distributor if you want to upgrade your license to include other modules.

  • Page 10: Indications For Use

    Eclipse ASSR includes all ages. 1.2.1 Intended operator General for Eclipse System and all modules, is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

  • Page 11: Product Description

    Product description The Eclipse is a multifunctional screening and/or diagnostic device that interfaces with integrated audiologic software modules on a PC. Depending on the installed software modules and licenses, it can perform the following via OtoAccess® Database: Early, middle and late latency evoked potential testing (EP15/25) •...

  • Page 12: Warnings

    4. Do not use any additional multiple socket-outlet or extension cord. For safe setup please refer to section 2.3 5. No modification of this equipment is allowed without the authorization of Interacoustics. Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information.
  • Page 13 6. Do not switch the power on/off for the Eclipse device while a patient is connected. 7. The specifications for the device are valid if the device is operated within the environmental limits.
  • Page 14 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 6...

  • Page 15: Unpacking And Installation

    Storage If you need to store the instrument for a period, please ensure that it is stored under the conditions specified in the section for technical specifications. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 7...

  • Page 16: Markings

    Off (Power: disconnection from the mains). Equipotentiality is used to ground metal parts, e.g. the frame underneath a patient bed. This will reduce the noise pick up by patient. Use the Equipotentiality cable which is included in the Eclipse shipment. Keep dry D-0120578-C – 2019/11 Eclipse –...

  • Page 17: Hardware Installation

    NOTE. The instrument label is located on the backside of the Eclipse Hardware. Hardware installation When connecting the Eclipse to the mains supply and to a computer, the following warnings must be observed: 1. All contact between the conductive parts of electrodes or their connectors, including the neutral electrode and other conductive parts including earth must be avoided.

  • Page 18: Grounding The Patient Bed

    2.3.1 Grounding the patient bed The ground plug on the back of the Eclipse can be used to further reduce noise in the test environment during evoked potential testing. 1. Unscrew the Ground outlet bolt from the back of the Eclipse.

  • Page 19: Eclipse Back Panel

    E.g. eABR (cochlear implant) testing etc. Talk Forward Connector for talk forward microphone Plug for the OAE probe. Note the OAE probe is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Patient Resp. Plug for patient response button Bone...

  • Page 20: Preamplifier Buttons

    2.4.2 Minimum PC requirements The Eclipse is a medical device requiring to be used with a PC that meets certain minimum specifications. • Core i3 CPU or better (Intel recommended) • 8 GB RAM or more •...

  • Page 21: What You Will Need

    Install the OtoAccess® Database program from the enclosed CD. The Eclipse module software runs within the OtoAccess® Database (and/or Noah 4 in the case of the Eclipse ASSR software or IA OAE Suite software). Ensure that the database is installed prior to the Eclipse software installation. Follow the manufacturer’s installation instructions provided to install the relevant database.

  • Page 22: Restoring Factory Default Settings In The Software

    English to a different language. Insert the installation USB and follow the on-screen steps to install the Eclipse module software. If the installation procedure does not start automatically, click “Start”, then go to “My Computer” and double click the USB drive to view the contents of the installation USB.

  • Page 23: Reader Station

    License Each Eclipse software module and in some cases, tests within a module, are licensed. If you would like to add additional modules or tests to your system, please contact your distributor and inform them of the Eclipse serial number, the DSP serial number and your current license key for this instrument.

  • Page 24: Starting Up From Otoaccess® Database

    Starting up from OtoAccess® Database Ensure that the Eclipse is switched on and connected before opening the software module. If the hardware is not detected the selected Eclipse module can still be opened, but the test cannot start until the hardware is detected.

  • Page 25: Starting Up From Noah (Assr Or Ia Oae Suite Only)

    OK button. 4. Double click on the ASSR or IA OAE module. For further instructions about working with the Noah database, please see the operation manual for Noah. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 17...
  • Page 26 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 18...

  • Page 27: Operating Instructions Ep15/Ep25

    NOTICE 1. The Eclipse system consists of a 2-channel input board which allows the user to create measurements for both ears without switching the electrodes. 2. In the case of tense patient muscles, particularly in the region of the neck, nape and shoulders, the quality of the recordings may be poor or completely rejected.

  • Page 28: The Record Tab

    1. Select Help Topics for a comprehensive list of help topics from the operation manual. 2. Select About... to access information about the software version number, DSP1, DSP2, Hardware version and the Firmware version. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 20...

  • Page 29: Electronic Help

    Waveforms must have identical parameters to be grouped together. 3.1.8 Reporting The Report icon opens the report editor for selecting a pre-written report template, or for editing or writing a new report for the selected session. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 21...

  • Page 30: Printing

    Click on the icon a second time to view all recorded curves in single screen view. In Single Curve Mode, latency ranges may also be displayed for the selected curve if selected in the setup. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 22...

  • Page 31: Split Screen Display

    3.1.14 Split screen display The Split Screen function will display Right and Left waveforms on separate sides of the screen. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 23...

  • Page 32: Save & New

    – Stimulus level, Stimulus type, Masking on or off, Test ear, Transducer, Stimulus rate, Stimulus polarity, the High Pass Filter setting and the Low Pass Filter setting. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 24...

  • Page 33: Manual Stimulation Window

    3.1.23 Start / Stop The Start and Stop button are used for starting and stopping the measurement. The Start button changes into a Stop button when a recording is started. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 25...

  • Page 34: Pause

    13, 187-197. 3.1.27 Extending the number of sweeps/averages Click on the arrow next to the Fmp & Residual Noise Graph to extend the number of sweeps during testing. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 26...

  • Page 35: Raw Eeg

    The hide stimulus artefact shows a flat line, and e.g. large artefact can be hidden. 10. Center the EEG on the 0uV baseline. 11. Show normal EEG display. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 27...

  • Page 36: Hide Stimulus Artefact

    5. E.g. helpful in eABR recordings, making an easier overview with the large artifact hidden, see below picture. Right click and choose “Hide stimulus artifact” to disable the feature again if needed. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 28...

  • Page 37: Display Gain

    Click on the waveform’s handle to drag the curve up and down. 3.1.35 Display differential curves Right click on the selected waveform handle to display the A minus B (A-B) or Ipsi minus Contra (Ipsi-Contra) differential waveforms. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 29...

  • Page 38: Adding A Note To The Waveform

    Completed waveforms can be edited while another measurement is in progress or after the entire test has finished. Functions available on both the Record Tab and the Edit Tab, have been described in the previous section. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 30...

  • Page 39: Monitoring Rejection

    The SN10 (Wave V trough marker) must be placed for calculation of the waveform’s signal to noise ratio displayed in the Recorded Curve Conditions table. 3.1.39 Deleting waveform markers Delete waveform markers by right clicking on the selected waveform and following the delete options. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 31...

  • Page 40: Suggest Waveform Markers

    Gender and age data are taken from the database to provide the selection of the corresponding normative latency data. 3.1.42 Deleting individual curves Right click on the curve’s handle to Delete the curve. This will permanently delete the curve!! D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 32...

  • Page 41: Enlarge/Diminish Individual Curves

    Right click on the second curve and select Create sum curve (merge). The merged/summed curve can be split back into its two original curves by right clicking on the handle and selecting Undo Sum Curve. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 33...

  • Page 42: Adding Curves

    New Fmp and Residual noise values are calculated for the added curve, however the Fmp and Residual noise curves will not be available. 3.1.48 Differential Ipsi minus contra (Ipsi-Contra) curve Right click on the curve’s handle to show the differential Ipsi minus Contra curve. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 34...

  • Page 43: Differential A Minus B (A-B (N)) Curve

    13. Ratio – the signal to noise ratio. The SN10 (wave V trough marker) must be placed on the curve for the ratio to be calculated. LS). 14. Stim. – the test stimulus type (e.g., click, tone burst, CE-Chirp ® 15. Comments field – a curve comment. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 35...

  • Page 44: Adding Comments To A Curve

    V trough marker) on the selected curve. The Ratio is the amplitude of Wave V peak to SN10 trough. The noise is automatically calculated based on the residual noise value. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 36...

  • Page 45: Cr, Ra & Inc Waveform Markers

    Read more about the use of these markers in the document entitled “Auditory Brainstem Response testing in babies - Guidance v2.1 March 2013” on the following website: http://abrpeerreview.co.uk/resources.html D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 37...

  • Page 46: The Latency Tab

    The following section describes the elements of the Latency Tab. 3.2.1 Latency values Select Latency to display the latencies of all marked waveforms for left and right ears. 3.2.2 Interlatency values D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 38...

  • Page 47: Latency Graph

    1. Go to Control Panel 2. Select Performance information and tools 3. Select Adjust visual effects 4. Uncheck the Enable desktop composition box 5. Press OK to save changes. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 39...

  • Page 48: Display Of The Peak To Trough Markers (Sn10 Marker) (Epx5 Software Only)

    From the General setup tab, change the Level measure method to “Peak to trough” Press OK to save The Tr buttons will now appear in the Edit tab for manual positioning of the various trough /SN10 markers. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 40...

  • Page 49: Windows ® 7, 8 & 10 Fails To Launch Help

    In some cases, the Windows® 7, 8 & 10 version you are running may not be compatible to run online Help within the software. If the Help functions do not work, you will need to download and install KB917607 (WinHlp32.exe) from the Microsoft homepage. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 41...

  • Page 50: Pc Shortcuts

    Waveform marker 2 under edit tab Key 3 Waveform marker 3 under edit tab Key 4 Waveform marker 4 under edit tab Key 5 Waveform marker 5 under edit tab D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 42...

  • Page 51: Patient Preparation Prior To Testing

    Therefore, the waveform latencies on the test screen are the true latencies comparable across the transducers. Further information about test preparation can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 52: Making An Abr Threshold Recording

    NB CE-Chirp LS 500Hz, 1kHz, 2kHz and 4kHz • ® ® Tone bursts 250Hz – 4kHz • Click • • Custom WAV file (when Research Module license is enabled) D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 44...

  • Page 53: Editing Of Abr Threshold Recordings

    Left are correction values, these Frequency-specific ABR correction factors are used with the DSL prescriptive formula for air conduction thresholds. The same corrections are applied in the Genie fitting software, when selecting ‘Tone-burst ABR’. Further information about threshold determination with ABR can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse –...

  • Page 54: Making A Neuro Latency Recording

    Changes in response latency between right and left side are recorded and compared. The Eclipse also offers slow and fast rate markers and performs the calculation between the inter-peak Wave V latencies (between Left and Right) as well as the inter-peak latency shift change from slow to fast rate.
  • Page 55 Please refer to the Neuro Latency functions described under Record and Edit tabs later in this instruction for use manual and the quick guide Neuro Latency Testing with Eclipse in the Additional Information. Further information about Neuro Latency recordings can be obtained from Eclipse Additional Information Manual.

  • Page 56: Making An Eabr Recording

    Right eABR recordings from an adult wearing a a CI from Advanced Bionics. Cochlear Freedom CI. Use the function hide stimulus artifact for easier evaluation without the large CI artifact! D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 48...

  • Page 57: Electrical Threshold Estimation For Cochlear Implant Fitting

    …. It is suggested to use the function waveform note, to add the CI current level used for each waveform. Further information about eABR recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 58: Making An Ecochg Recording

    (-) Reference electrode is placed on non-test (mastoid/earlobe) • Common electrode is placed on the forehead • Switch the reference and active electrodes when changing test ear • D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 50...

  • Page 59: Editing An Ecochg Recording

    3.9.2 Editing an ECochG recording Example of Marked Points for Amplitude Ratio Example of Marked Points for Area Ratio Further information about ECochG recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 60: Making An Cm Recording

    Wave 1 is absent in alternating polarity when stimulating with high levels of ABR. In addition the latency of the CM duration is longer than expected. Further information about CM recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse –...

  • Page 61: Making A Amlr Recording

    For neuro diagnosis a moderate stimuli Intensity below 70dB nHL is appropriate. For estimation of threshold response amplitude follows the stimuli level as for traditional ABR threshold testing. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 53...

  • Page 62: Example Of Amlr Recording

    Please refer to the AMLR Threshold functions described under Record and Edit tabs later in this instruction for use manual. Further information about AMLR recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 63: Making A Alr Recording / Cortical Era

    Typically the ALR threshold recording is started at 60dB nHL and decision is made to increase or lower the stimulus intensity. Available ALR threshold stimuli are: • Tone bursts 250Hz – 4kHz • Click • Custom WAV file (when Research Module license is enabled) D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 55...

  • Page 64: Interpretation Of The Alr Result

    10 dB. Establishing the 6 threshold estimates (3 frequencies, 2 ears) took on average 20.6 minutes.” Further information about ALR recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 65: Making A P300/Mmn Recording

    NB CE-Chirp and NB CE-Chirp LS 500 Hz, 1 kHz, 2 kHz and 4 kHz • ® ® Custom WAV file (when Research Module license is enabled) • D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 57...

  • Page 66: Summary Of Parameters For P300 And Mmn

    Response 2-3x larger than Response 2-3 times larger than amplitude in prestimulus interval amplitude in prestimulus interval Further information about the P300 & MMN recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 67: System Performance / Loop Back (Lbk15) Testing

    System performance / loop back (LBK15) testing The Loop Back (LBK15) box allows for an easy check of the impedance measuring system, the stimulus quality and data acquisition. Further information about LBK 15 procedure can be obtained from Eclipse Additional Information Manual.
  • Page 68 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 60...

  • Page 69: Operating Instructions Vemp

    NOTICE 1. The Eclipse system consists of a 2-channel input board which allows the user to create measurements for both ears without switching the electrodes. 2. The digital filters of the EP system will attenuate unwanted signals/frequencies to a certain extent.

  • Page 70: Preamplifier Setup

    Absolute latency and amplitude data are displayed in the corresponding ms and µV fields after waveforms have been marked. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 62...

  • Page 71: Calculating The Vemp Asymmetry Ratio (Vemp Partner)

    EMG size recorded from each pre-stimulus period. Select EMG scaling by right clicking on the curve. All curves will now be scaled and an indication on the test screen will indicate scaling is enabled. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 63...

  • Page 72: Making A Cvemp Recording

    Typically, a 500Hz tone burst is used for cVEMP testing as it provides the largest response amplitude. Other stimuli available for testing include: Tone bursts 250Hz – 4kHz • Click • Custom WAV file (when Research Module license is enabled). • D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 64...

  • Page 73: Default Collection Parameters

    Use the Edit sheet to mark the peaks. To select the VEMP partner, double click the waveform handle, then right click the waveform handle of the opposite ear and select Set VEMP Partner. These will be used in the calculation of the Asymmetry Ratio calculation. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 65...

  • Page 74: Example Of Cvemp Result

    4.6.6 Example of cVEMP result Example of a cVEMP recording in a patient with a lowered VEMP threshold. Further information about the cVEMP procedure and recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US...

  • Page 75: Making A Ovemp Recording

    Electrode impedance less than 5 kohms, with interelectrode impedance less than 3 kOhm. Recording epoch 100ms with a 10ms prestimulus recording period and a 90ms post stimulus recording period. Approximately 150 sweeps per waveform shall be collected. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 67...

  • Page 76: Procedure

    Set VEMP Partner. These will be used in the calculation of the Asymmetry Ratio calculation. 4.7.6 Example of oVEMP result Further information about the oVEMP procedure and recordings can be obtained from Eclipse Additional Information Manual. D-0120578-C – 2019/11 Eclipse –...

  • Page 77: Research Module

    Now all sweep and data for this session has been logged and saved to the “C:\EP Log” folder. All raw data are hardware filtered. Open the C:\EP Log folder and start using the data under Matlab/Excel etc. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 69...

  • Page 78: Exporting The Averaged Curve &/Or Full Session

    To export a specific curve of interest, right click at the intensity handle and select to export this averaged waveform. Now this waveform can be found under the Export waveform folder, open for further analysis under Matlab/Excel etc. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 70...

  • Page 79: Exporting The Session (All Curves)

    Click Menu-File and Export session to export the full session of the averaged data seen on screen. 5.1.4 Exporting waveform when offline The recorded data is available for export when the eclipse is not connected, but only if the recordings are made on an Eclipse with license for the research module function, 5.1.5 Importing WAV files for stimuli...
  • Page 80 Stimuli can also be saved and presented to use only SPL format 4. Make sure to do this operation for any transducer and both Right and Left side! D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 72...
  • Page 81 6. You can create your protocol using the new stimuli and run e.g. an LBK test to see the stimuli being recorded. Please see more information on the research license in the additional information manual D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 73...
  • Page 82 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 74...

  • Page 83: Operating Instructions Ia Oae Suite

    9. Clean the probe tip regularly to ensure wax or other debris stuck in the probe tip does not affect the measurement. 10. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when high intensity stimuli are used. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 75...

  • Page 84: Handling And Selection Of Ear Tips

    Calm and stable positioning while testing is preferred for optimal accuracy. 2. The Eclipse should be operated in a quiet environment, so that measurements are not influenced by outside acoustic noises. This may be determined by an appropriately skilled person trained in acoustics.

  • Page 85: Daily System Checks For Oae Devices

    If the probe is functioning correctly, none of the frequency bands (TEOAE) or points (DPOAE) should have a checkmark, i.e., no artifacts/OAEs should be detected above the noise floor. System distortion present No system distortion D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 77...

  • Page 86: Real-Ear Check

    If results from the real-ear test do not match the expected result after checking items 1 to 5 above, the probe should not be used to test on patients. Contact your local service technician for assistance. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 78...

  • Page 87: The Ia Oae Suite

    Eclipse is only operated from the Eclipse Suite. However once saved to the database, the IA OAE Suite can be used to open and display the recordings.

  • Page 88: Crash Report

    Crash Report window will appear on the test screen (as shown below). The crash report provides information to Interacoustics about the error message and extra information can be added by the user outlining what they were doing before the crash occurred to assist in fixing the problem.

  • Page 89: Using The Menu

    Hardware version Firmware version Copyright Interacoustics Further, you can reach the Interacoustics website from this window by clicking on the link to www.interacoustics.com By pressing the License button, you are able to change the license keys of the device. The license keys for the device are specific for each serial number and define which modules, tests, protocol settings and other functionalities are available.

  • Page 90: Using The Dpoae Module

    Prepare the equipment 1. Turn on Eclipse by connection the USB to the PC. 2. Open the OtoAccess® Database or Noah database and enter new patient details.
  • Page 91 The DP points are line connected with the ear side color, to give an overall impression of the DPOAE levels. The grey area is the background noise in the DP test. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 83...

  • Page 92: Elements In The Dpoae Module

    OtoAccess® Database (or to a commonly used XML file when running in standalone mode) and exits the OAE software. Toggle Ear changes from right to left ear and vice versa in all modules. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 84...
  • Page 93 -30 and +30 dB SPL above which recordings are considered to be too noisy. The VU meter indicates the current noise level and becomes amber in color when exceeding the set level. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 85...
  • Page 94 The probe check graph provides a visual display of the probe fit in the patient’s ear before and after testing. During testing, the probe check is not running and the graph will not display a curve. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 86...
  • Page 95 In the general setup it can be chosen whether or not this type of indication is shown. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 87...
  • Page 96 Press Stop to stop testing. DPOAE norm data allows you to change which DP norm data is shown in the DP-Gram. Right clicking on the DP-I/O graph provides the following options: D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 88...
  • Page 97 Press Stop when the additional points are sufficiently tested. Next measurement point interrupts the automatic test procedure and forces the Eclipse to start testing at the next intensity immediately. This function is available when max test point has been selected in the protocol.

  • Page 98: Using The Teoae Module

    Prepare the equipment 1. Turn on Eclipse by connection the USB to the PC. 2. Open the OtoAccess® Database or Noah database and enter new patient details.
  • Page 99 The TE bars having no checkmark did not meet the TE criterion and can be either below the noise or absent. The grey area is the ambient background noise in the TE test. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 91...

  • Page 100: Element In The Teoae Module

    Toggle Ear changes from right to left ear and vice versa in all modules. List of Defined Protocols allows for selecting a test protocol for the current test session (refer to the Additional Information document for more details about protocols). D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 92...
  • Page 101 The hardware indication picture indicates whether the Lyra or Eclipse hardware is connected. Simulation mode is indicated when operating the software in simulation mode (user chosen). D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 93...
  • Page 102 After testing, a correlation value will be displayed giving an indication as to how well the probe stayed in the ear during testing. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 94...
  • Page 103 The area outside the recording window is grayed out. The recording window start and stop time can be changed prior to starting a test by moving the arrows on the graph with the mouse, D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 95...
  • Page 104 Press Stop to stop testing. Press Skip if you want to continue testing without the frequency for which this message appeared. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 96...
  • Page 105 Test time, Stimulus levels, SNR, Min DP level, DP tolerance, Reliability, Number of points required for a pass, Mandatory points required for a pass. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 97...

  • Page 106: Using The Print Wizard

    4. Templates added to My favorites are marked with a star. Adding templates to My favorites allows quick viewing of your most commonly used templates. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 98...
  • Page 107 Right clicking on a specific template provides a drop down menu offering an alternative method for performing the options as described above: More detailed information about the Print Wizard can be found in the Eclipse Additional Information document. D-0120578-C – 2019/11 Eclipse –...
  • Page 108 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 100...

  • Page 109: Operating Instructions Assr

    NOTICE 1. The Eclipse system consists of a 2-channel input board which allows the user to create measurements for both ears without switching the electrodes. 2. In the case of tense patient muscles, particularly in the region of the neck, nape and shoulders, the quality of the recordings may be poor or completely rejected.

  • Page 110: Preparations Prior To The Assr Test

    If the impedance of one or more electrodes is too high, you may want to wait for a minute or two, as the gel on the electrode has a tendency to improve its impedance with the skin over the first couple of minutes. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 102...
  • Page 111 This causes the Right electrode to show an impedance reading slightly higher than it actually is, if the Ground electrode has high impedance. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 103...

  • Page 112: Mounting Electrodes

    The LBK15 unit is not valid for performing a functional check of the ASSR due to the nature of the ASSR algorithm. For functional testing (detection of false passes), a patient must be connected with electrodes, in the absence of a stimulus (disconnected transducer). D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 104...

  • Page 113: The Assr Tab

    1. Select Guides and instructions to launch a PDF version of the operation manual. You will also find the ASSR masking calculator by Dr. Lightfoot in the folder. 2. Select About Interacoustics ASSR... to access information about the software version number, the DSP version, the Hardware version and the Firmware version.

  • Page 114: Temporary Setup

    Select a historic session from the session list. Alternatively, use the PgUp and PgDn keys on the keyboard to toggle through historic sessions. 8.7.8 Stimulus window The Stimulus window displays the frequencies for testing and the stimulus intensities running and/or waiting. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 106...

  • Page 115: Total Session Status Window

    Select the appropriate stimulus rate (40Hz or 90Hz) for testing. To change during testing (when the patient state changes), all test frequencies must have finished or be manually stopped. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 107...

  • Page 116: Making An Assr Recording

    5. The curve handle indicates the testing intensity and stimulus rate. An asterisk (*) in front of the stimulus level indicates a 40Hz stimulus rate was used. Select a detection curve by clicking on the handle. The selected curve handle will be presented in bold. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 108...

  • Page 117: Assr Table

    The efficiency of the method used for determining the residual noise level is described in the following article: Elberling, C., & Don, M. (1984). Quality estimation of average auditory brainstem responses. Scand Audiol, 13, 187-197. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 109...

  • Page 118: Extending The Test Time

    Right click within the desired Test Frequency Graph to change the Stimulus Intensity for the selected frequency. Only intensities within the grey area can be selected. This safeguards against stimulating at intensity levels greater than a 20dB difference between the test frequencies. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 110...

  • Page 119: Stopping A Test Frequency/Intensity

    ! Disclaimer – Interacoustics has produced this utility to aid testers but can accept no responsibility for errors or inappropriate use. This ASSR masking calculator is not a part of the Eclipse device and user should use his own judgement when performing tests on patients, and the user must carry clinical responsibility for any decision made.
  • Page 120 Pediatric Audiology (3rd Ed). The Interacoustics ASSR masking noise calculator is the first of its kind and sets new standards for masking ASSR. It was presented by Dr. Lightfoot at the XXVI IERASG symposium, Sydney, Australia 30th June – 4th July 2019.

  • Page 121: The Audiogram Tab

    These are the estimated thresholds to be used directly for hearing aid fitting. No response Transducer symbol used and arrow without a line between symbols. These symbols are not corrected, but instead shows the D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 113...

  • Page 122: Audiometric Symbols In Noah Or Otoaccess® Database

    The audiometric symbols are all displayed in the estimated audiogram. The audiometric symbols are saved and displayed in either Noah or OtoAccess® Database Example: no response using headphones. Minimum: Noah 4.x Database dependent. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 114...

  • Page 123: Estimated Audiogram

    The estimated audiogram is generated during recording based on the ASSRs detected. The grey ‘A’ markings connected with grey lines indicate the ASSR nHL level detected. The connected audiogram symbols indicate the corrected estimated audiogram in dB eHL. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 115...

  • Page 124: Ac And Bc In The Same Audiogram

    The ASSR can now show both AC and BC in the same audiogram. Example: insert phones (unmasked) and BC (masked). All AC and BC symbols are saved and displayed in both Noah and OtoAccess® Database. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 116...

  • Page 125: No Response

    Alt + X Save & Exit Page down Toggle backwards through historic sessions Page up Toggle forwards through historic sessions Home Return to Current session Jump to Oldest historic session D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 117...
  • Page 126 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 118...

  • Page 127: Maintenance

    10. Great care should be exercised during the handling of earphones and other transducers, as mechanical shock may cause change to the calibration. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 119...

  • Page 128: How To Clean Interacoustics Products

    In this case, the probe should be cleaned after every measurement. Thorough wiping of the Eclipse should also be considered. 2. Never wash or dry the probe tips with a temperature above 70º Celsius/ 158º Fahrenheit.
  • Page 129 7. Place the probe tip back onto the probe. Make sure that the holes fit into the corresponding cavities. 8. Screw the probe cap back onto the probe. Finger force will tighten the screw sufficiently. Never use tools to affix the probe cap! D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 121...

  • Page 130: Concerning Repair

    It is important that the customer (agent) fills out the RETURN REPORT every time a problem arises. This should also be done every time an instrument is returned to Interacoustics. (This of course also applies in the unlikely worst case scenario of death or serious injury to a patient or user).
  • Page 131 INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 123...
  • Page 132 D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 124...

  • Page 133: Technical Specifications

    10.1 Technical specifications - Eclipse hardware Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123. Standards:...

  • Page 134: Technical Specifications Ep15/Ep25/Vemp

    10.2 Technical specifications EP15/EP25/VEMP Medical CE-mark: The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no. 0123. Standards: Test Signal: IEC 60645-3, 2007 IEC 60645-7, 2009.
  • Page 135 Lost data due to crash of Windows® will in almost all cases be available upon re-establishing Windows® operation. Note ! The transducer is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Replacing the transducer will require new calibration of the transducer connected to the Eclipse.

  • Page 136: Pespl To Nhl Correction Values

    31.5 26.5 51.0 31.5 26.5 51.0 Only tone burst correction values change for ALR & MMN testing. For Click and CE-Chirps ® LS, the same correction is applied. D-0120578-C – 2019/11 Eclipse – Instructions for Use - US Page 128...

  • Page 137: Technical Specifications Teoae

    Cable: Length: 2980 mm cable Note ! The OAE probe is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Replacing the OAE transducer will require new calibration of the transducer connected to the Eclipse. TEOAE Calibration: Probe stimuli are calibrated in peSPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4.

  • Page 138: Technical Specifications Dpoae

    Cable: Length: 2980 mm cable Note ! The OAE probe is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Replacing the OAE transducer will require new calibration of the transducer connected to the Eclipse. DPOAE Calibration: Probe stimuli L1 and L2 are calibrated individually in SPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4.

  • Page 139: Technical Specifications Assr

    Test protocols included for children and adult Noah: Noah 4 compatible Note ! The transducer is dedicated to one Eclipse only! Calibration is stored on the Eclipse. Replacing the transducer will require new calibration of the transducer connected to the Eclipse.

  • Page 140: Electromagnetic Compatibility (Emc)

    10.6 Electromagnetic compatibility (EMC) CAUTION This instrument is suitable in hospital environments except for near 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 with other equipment should be avoided because it •...
  • Page 141 The Eclipse has been tested for EMC emissions and immunity as a standalone instrument. Do not use the Eclipse adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
  • Page 142 Note: UT is the A.C. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration — electromagnetic immunity The Eclipse is intended for use in the electromagnetic environment specified below. The customer or the user of the Eclipse should assure that it is used in such an environment,...
  • Page 143 To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use only the following accessories: ITEM MANUFACTURER MODEL EPA Preamplifier Interacoustics EPA3 Cable Collector Interacoustics EPA4 Cable Collector Interacoustics LBK 15 Loop Back Box...

  • Page 144: Eclipse Software Module Overview

    10.7 Eclipse software module overview 10.7.1 EP15/EP25/VEMP modules Test types/functionality: EP15 EP25 VEMP Click stimulus Broadband CE-Chirp® LS stimulus Optional Optional Narrow Band CE-Chirp® LS stimuli Optional Optional (0.5, 1, 2, 4 kHz) Tone Burst stimuli (0.25 – 8kHz) Recording window...

  • Page 145: Ep15/Ep25/Vemp Module Stimulus Maximum Intensity

    10.7.2 EP15/EP25/VEMP module stimulus maximum intensity From software 4.5 the stimulus maximal is increased for all transducers. Insert earphones and headphone can now go even louder. To get the increased intensity maximal for bone conductor. Firstly, get the B81 BC, secondly ensure that the correct bone vibrator is chosen in the calibration setup, to allow more output for the bone vibrator.

  • Page 146: Teoae Module

    10.7.3 TEOAE module Test types/functionality: TEOAE Module Stimulus level 30 – 90 dB SPL Non-linear click stimulus Frequency range 500-5500Hz Test time 5 seconds to 30 minutes FFT display Pass/refer bands SNR value display OAE level display Automated screening (pass/refer) algorithm (protocol) User definable pass/refer algorithm (protocol) 10.7.4 DPOAE module Test types/functionality:...
  • Page 147 Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.

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