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

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Instructions for Use - US
Eclipse
D-0104783-C 05/2015

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  • Page 1 Instructions for Use - US Eclipse D-0104783-C 05/2015...

  • Page 3: Table Of Contents

    Reporting Imperfections ......................7 Markings ............................ 8 Hardware installation ......................... 9 2.4.1 Grounding the patient bed ......................10 2.4.2 Eclipse Back Panel ........................11 2.4.3 Eclipse Front Panel ........................11 2.4.4 Preamplifier Buttons ........................12 Software installation ........................ 12 2.5.1 To know before you Start Installation ..................
  • Page 4 3.1.18 Frequency Selection ........................24 3.1.19 Stimulus Window........................24 3.1.20 Manual Stimulation Window ....................... 24 3.1.21 Status Window ........................... 24 3.1.22 Waveform Reproducibility ......................24 3.1.23 Start / Stop ..........................25 3.1.24 Pause ............................25 3.1.25 Next Intensity ..........................25 3.1.26 Fmp &...
  • Page 5 3.9.3 Electrical Threshold Estimation for cochlear implant Fitting ............45 3.10 Making an ECochG recording ....................46 3.10.1 EcochG Electrode Montages ..................... 46 TipTrode ..............................46 3.10.2 Editing an ECochG recording ..................... 47 3.11 Making an CM recording ......................48 Patient preparation ...........................
  • Page 6 Operating Instructions DPOAE20 ....................67 Using the DPOAE20 module ....................67 OAE Probe Tips ........................67 Mounting & Dismounting the Probe Tip .................. 68 5.3.1 Mounting the Probe Tip ......................68 5.3.2 Dismounting the Neonatal Probe Tip ..................68 Handling and selection of ear tips ................... 69 The DPOAE20 Test Screen ....................
  • Page 7 Cleaning the OAE Probe Tip ....................90 Concerning Repair ........................91 Warranty ..........................92 Technical Specifications ......................93 Technical Specifications - Eclipse Hardware ................93 Technical Specifications EP15/EP25 ..................94 7.5.1 peSPL to nHL Correction Values ....................96 Technical Specifications TEOAE25 ..................97 Technical Specifications DPOAE20 ..................

  • Page 9: Introduction

    Eclipse Instructions for Use - US Page 1 1 Introduction 1.1 About this Manual This manual is valid for the Eclipse EP15/25 v4.4, DPOAE20 v1.03.1, TEOAE25 v3.04.2, and ASSR v 1.2.4. The product is manufactured by: Interacoustics A/S Audiometer Allé 1...

  • Page 10: Intended Use

    The target population for Eclipse ASSR includes all ages. The Eclipse System 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

    Eclipse Instructions for Use - US Page 3 1.3 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™: •...

  • Page 12: Warnings

    Please disconnect the Eclipse device when defibrillators are used. 7. If the Eclipse is connected to one or more other devices with medical CE marking, to make up a system or pack, the CE marking is valid for the combination only if the supplier has issued a declaration stating that the requirements in the Medical Device Directive article 12 are fulfilled for the combination.
  • Page 13 IEC/ES 60601-1. 12. When the instrument is connected to a PC and/or other electrical items, do not touch the Eclipse or other connected electrical items, and the patient simultaneously.
  • Page 14 Eclipse Instructions for Use - US Page 6 12. Single use items such as ear tips and electrodes should not be reused. Reuse of such items can lead to the spread of infection from patient to patient. 1. The LBK15 unit is not valid for performing a functional check of ASSR due to the nature of ASSR algorithms.

  • Page 15: Unpacking And Installation

    Keep carton for future shipment The Eclipse comes in its own shipping carton, which is specially designed for the Eclipse. Please keep this carton. It will be needed if the instrument has to be returned for service.

  • Page 16: Markings

    Parts like ear-tips and similar are for single use only. On (Power: connection to the mains). Equipotentiality Off (Power: disconnection from the mains). This label is located on the backside of the Eclipse Hardware. The label to the left shows manufacturer and address. Eclipse serial number is SN802872...

  • Page 17: Hardware Installation

    1. The Eclipse contains a built-in, medically approved safety transformer and must, in all cases, be connected to a wall outlet with a proper ground. 2. The Eclipse should not be connected to an external safety transformer as this is not required and may cause excess noise in the recordings.

  • Page 18: Grounding The Patient Bed

    Please consult with a medical device safety specialist if in doubt. 2.4.1 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.

  • Page 19: Eclipse Back Panel

    Eclipse Instructions for Use - US Page 11 2.4.2 Eclipse Back Panel Position: Symbol: Function: Power Turns power on/off Mains 50-60 Hz Plug for mains cable Aux Out For future use Preamp. Plug for Preamplifier Pat. Resp. Plug for patient response button...

  • Page 20: Preamplifier Buttons

    2.5.2 Minimum PC Requirements The Eclipse is a medical device requiring to be used with a PC that meets certain minimum specifications. • 2 GHz Dual Core CPU or better (Intel recommended) • 4 GB RAM or better.

  • Page 21: What You Will Need

    Install the OtoAccess™ program from the enclosed CD. The Eclipse module software runs within the OtoAccess (and/or Noah 4 in the case of the Eclipse ASSR module). 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 CD 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 DVD/CD-RW drive to view the contents of the installation CD.
  • Page 23 Eclipse Instructions for Use - US Page 15 EP15 EP25 ASSR DPOAE20 TEOAE25 German German German German German French French French French French Spanish Spanish Spanish Spanish Spanish Italian Italian Italian Italian Italian Russian Russian Russian Russian Russian Polish Polish...

  • Page 24: Reader Station

    2.7 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 25: Starting Up From Otoaccess

    2.8 Starting up from OtoAccess 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 26: Starting Up From Noah (Assr Only)

    Eclipse Instructions for Use - US Page 18 For further instructions about working with the database, please see the operation manual for OtoAccess™. 2.9 Starting up from NOAH (ASSR only) 1. Open NOAH 2. Select the patient you want to work with by highlighting it orange 3.

  • Page 27: Operating Instructions Ep15/Ep25

    5. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when high intensity stimuli are used. 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.

  • Page 28: The Record Tab

    Eclipse Instructions for Use - US Page 20 3.1 The Record Tab The following section describes the elements of the Record Tab. Some functions will also be available in the Edit Tab. 3.1.1 Main Menu Items File provides access to System setup, Print all pages, Print preview, Print setup and Exit.

  • Page 29: Electronic Help

    Eclipse Instructions for Use - US Page 21 3.1.2 Electronic Help Click on the Electronic Help icon and then point/click on an item you require more information for. If context sensitive help is available, a window will open to provide the relevant information.

  • Page 30: Printing

    Eclipse Instructions for Use - US Page 22 3.1.9 Printing The Print icon prints the report for the selected session. The number of printed pages may vary according to selection in the Printer layout setup. 3.1.10 Display A-B Curves The A-B Curve icon displays the A and B curves for the selected waveform.

  • Page 31: Split Screen Display

    Eclipse Instructions for Use - US Page 23 3.1.14 Split Screen Display The Split Screen function will display Right and Left waveforms on separate sides of the screen. 3.1.15 Save & New The Save & New icon saves the current test session and allows a new session to be started without closing down the software.

  • Page 32: Frequency Selection

    Eclipse Instructions for Use - US Page 24 3.1.18 Frequency Selection Select a different stimulus frequency from the dropdown menu. 3.1.19 Stimulus Window The Stimulus window displays the stimulus parameters for the curve currently being recorded – 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.

  • Page 33: Start / Stop

    Eclipse Instructions for Use - US Page 25 The waveform reproducibility calculation time frame can be adjusted (position/time frame) in the protocol setup or by simply dragging the bold black line at each end or by grabbing it with the mouse and sliding it back and forth along the time scale.

  • Page 34: Extending The Number Of Sweeps/Averages

    Eclipse Instructions for Use - US Page 26 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.

  • Page 35: Display Gain

    Eclipse Instructions for Use - US Page 27 3.1.30 Display Gain Change the Display Gain of all curves using the arrow buttons to the left of the recording area. Alternatively, use the up and down arrow keys on the keyboard.

  • Page 36: Monitoring Rejection

    Eclipse Instructions for Use - US Page 28 3.2.1 Monitoring Rejection Continue to monitor the rejection situation by observing the small oval light at the bottom of the screen. Green indicates no rejection, while red indicates rejection. 3.2.2 Placing Waveform Markers The marker buttons will display the relevant markers for the test type selected.

  • Page 37: Deleting Waveform Markers

    Eclipse Instructions for Use - US Page 29 The corresponding ms and µV values will be displayed in the boxes next to the Waveform Markers. Interlatency values will also be calculated after the required markers have been placed. 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.

  • Page 38: Deleting Individual Curves

    Eclipse Instructions for Use - US Page 30 3.2.6 Deleting individual curves Right click on the curve’s handle to Delete the curve. This will permanently delete the curve!! 3.2.7 Enlarge/Diminish Individual Curves Change the Display Gain for a single curve by right clicking on the selected curve’s handle and selecting the Enlarge or Diminish option.

  • Page 39: Merging Curves (Creating A Summed Curve)

    Eclipse Instructions for Use - US Page 31 3.2.10 Merging Curves (Creating a Summed Curve) Curves of the same intensity, stimulus type and ear can be merged to create a sum curve based on the total average of the individual sweeps of the two selected curves.

  • Page 40: Differential A Minus B (A-B (N)) Curve

    Eclipse Instructions for Use - US Page 32 Right click on the curve’s handle to show the differential Ipsi minus Contra curve. 3.2.13 Differential A minus B (A-B (N)) Curve Right click on the curve’s handle to show the differential A minus B curve.

  • Page 41: Adding Comments To A Curve

    Eclipse Instructions for Use - US Page 33 6. Headset – the transducer used for recording. 7. Wave repro. – the waveform reproducibility percentage. 8. Residual noise – the residual noise level in nV. 9. Polarity – the polarity of the stimulus used for testing.

  • Page 42: Cr, Ra & Inc Waveform Markers

    Eclipse Instructions for Use - US Page 34 3.2.19 CR, RA & INC Waveform Markers The CR, RA and INC waveform markers were established in the United Kingdom and can be used to categorize waveforms. CR = Clear Response RA = Response Absent INC = Inconclusive Read more about the use of these markers in the document entitled “Auditory Brainstem Response...

  • Page 43: The Latency Tab

    Eclipse Instructions for Use - US Page 35 3.3 The Latency Tab The following section describes the elements of the Latency Tab. 3.3.1 Latency Values Select Latency to display the latencies of all marked waveforms for left and right ears.

  • Page 44: Latency Graph

    Eclipse Instructions for Use - US Page 36 3.3.3 Latency Graph A graphical presentation of the marked waveform’s latencies is provided. This allows for an easy interpretation of latency change relative to the change in stimulus intensity. The grey shaded area indicates the normative range and will be displayed providing normative latency data has been added in the System Setup.

  • Page 45: Display Of The Peak To Trough Markers (Sn10 Marker) (Epx5 Software Only)

    Eclipse Instructions for Use - US Page 37 3.3.5 Display of the Peak to Trough Markers (SN10 marker) (EPx5 software only) By default, the amplitude of waveforms is calculated from peak to baseline. To enable the trough markers in the edit tab, so as to calculate waveform amplitude from peak to trough, follow these instructions.

  • Page 46: Pc Shortcuts

    Eclipse Instructions for Use - US Page 38 3.5 PC Shortcuts Many of the functions carried out by dragging and clicking with the mouse can be accessed also from the keyboard. Shortcut Description Ctrl +F7 Enter temporary setup Launch Help Topics...

  • Page 47: Patient Preparation Prior To Testing

    The insert phone and headphone delay has been compensated for within the software, so time 0ms on the time scale equals the acoustic presentation. 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.

  • Page 48: Making An Abr Threshold Recording

    Eclipse Instructions for Use - US Page 40 3.7 Making an ABR Threshold recording ABR Threshold recording are used to determine the threshold of individuals that cannot participate in a traditional behavioural audiometry. Prior to testing make sure the patient is relaxed. You can monitor this by watching the EEG Window on the top right of the recording window.

  • Page 49: Editing Of Abr Threshold Recordings

    Eclipse Instructions for Use - US Page 41 3.7.3 Editing of ABR threshold recordings ® LS A typical ABR threshold recording is using NB CE-chirp or Tone Burst for threshold evaluation Above is an example of a threshold recording using 2kHz Tone Burst. Note the large PAM response from the right side caused by the loud stimulus of 80dBnHL.

  • Page 50: Making A Neuro Latency Recording

    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. 3.8 Making a Neuro Latency recording Neuro testing is traditionally used to help to determine the auditory pathway functions, related to acoustic neuromas and other nervous system abnormalities.
  • Page 51 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 52: Making An Eabr Recording

    Eclipse Instructions for Use - US Page 44 3.9 Making an eABR recording An eABR (electrical ABR) threshold testing is traditionally used to help determine the degree of cochlear tuning in pediatric or difficult to test populations. 3.9.1 Two suggested eABR Electrode Montages YELLOW Contralateral (non-implant) earlobe or mastoid.

  • Page 53: Electrical Threshold Estimation For Cochlear Implant Fitting

    Instead interpolation is used across the recorded electrode bands. Below is an example of the estimated eABR tuning for a Cochlear Freedom. CL\ electrode Band …. Recorded eABR threshold Interpolation value …. Further information about eABR recordings can be obtained from Eclipse Additional Information Manual.

  • Page 54: Making An Ecochg Recording

    Eclipse Instructions for Use - US Page 46 3.10 Making an ECochG recording An ECochG (Electrocochleography) is a measure of the response of the cochlear (summating potential (SP), action potential (AP), and cochlear microphonic (CM)). ECochG is used in for multiple purposes i.e. in the diagnosis of Meniere’s disease, Perilymph Fistula, and sudden deafness.

  • Page 55: Editing An Ecochg Recording

    Eclipse Instructions for Use - US Page 47 3.10.2 Editing an ECochG recording Example of Marked Points for Area Ratio Example of Marked Points for Amplitude Ratio Further information about ECochG recordings can be obtained from Eclipse Additional Information Manual.

  • Page 56: 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.

  • Page 57: Making A Amlr Recording

    Eclipse Instructions for Use - US Page 49 3.12 Making a AMLR recording AMLR can be used to help determine the degree of hearing loss in adult populations. But the most common neurological use of the AMLR are for the assessment of the functional integrity of the auditory pathway above the level of the brainstem in cases with suspected lesions and for the assessment of nonorganic hearing loss.

  • Page 58: Example Of Amlr Recording

    AMLR may this way be used to assess the efficacy of cochlear implant in activating the auditory pathway 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.

  • Page 59: Making A Alr Recording / Cortical Era

    Eclipse Instructions for Use - US Page 51 3.13 Making a ALR recording / Cortical ERA ALR/ACR threshold testing is traditionally used to help determine the degree of hearing loss in adult populations. Compared to traditional ABR octave wide stimuli, the stimuli of ALR/ACR are much more frequency specific due to the longer tonal and is much closer to the behavioral audiometric pure tone stimuli.

  • Page 60: Interpretation Of The Alr Result

    Note occasionally very poor response > 20dB error *Reference www.corticalera.uk , At Liverpool it has been indicated that the mean ACR and PTA difference is 6.5 dB. Further information about ALR recordings can be obtained from Eclipse Additional Information Manual.

  • Page 61: Making A P300/Mmn Recording

    Eclipse Instructions for Use - US Page 53 3.14 Making a P300/MMN recording P300 and MMN (mismatch negativity) can be used for evaluation of the auditory function. The MMN test is particular related to the brain ability to discriminate between speech sounds.

  • Page 62: Summary Of Parameters For P300 And Mmn

    Determined by Replicable components Replicable components presence 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.

  • Page 63: System Performance / Loop Back (Lbk15) Testing

    3.15 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 64 Eclipse Instructions for Use - US Page 56...

  • Page 65: Operating Instructions Teoae25

    Eclipse Instructions for Use - US Page 57 4 Operating Instructions TEOAE25 4.1 Using the TEOAE25 module 1. Contraindications to placing a probe in a patient’s ear include a discharging ear, acute external auditory canal trauma, discomfort (e.g, severe otitis externa) or occlusion of the external auditory canal.

  • Page 66: Mounting & Dismounting The Probe Tip

    Eclipse Instructions for Use - US Page 58 4.3 Mounting & Dismounting the Probe Tip 1. The neonatal probe tip is fragile and may break if not handled carefully when being attached or detached from the probe. 2. It is important to use the probe tip tool to dismount the neonatal probe tip.

  • Page 67: Handling And Selection Of Ear Tips

    Eclipse Instructions for Use - US Page 59 4.4 Handling and selection of ear tips Always use the dedicated ear tips from Sanibel for OAE measurements. Use of an incorrect ear tip could invalidate the OAE measurement. Neonatal probe ear tips: Blue 4mm, Red 4.5mm & Green 5mm, must only be used together with the dedicated purple neonatal probe tip.

  • Page 68: The Teoae25 Test Screen

    Eclipse Instructions for Use - US Page 60 4.5 The TEOAE25 Test Screen The following section describes the elements of the test screen. 4.5.1 Main Menu Items File provides access to the System setup, Print..., Print preview, Print setup and Exit.

  • Page 69: Electronic Help

    Eclipse Instructions for Use - US Page 61 4.5.2 Electronic Help Click on the Electronic Help icon and then point/click on an item you require more information for. If context sensitive help is available, a window will open to provide the relevant information.

  • Page 70: Save & Exit

    Eclipse Instructions for Use - US Page 62 4.5.9 Save & Exit The Save & Exit icon saves the current test session and closes down the software. If no data was recorded, a session will not be saved. When editing a historic session, the session date remains unchanged in the database as this always refers to the date of the recording.

  • Page 71: Making A Teoae Recording

    Eclipse Instructions for Use - US Page 63 4.6 Making a TEOAE recording 4.6.1 Probe Check Click on the Probe Check button to run the probe check before testing. Click again to stop the probe check. 4.6.2 Start, Stop & Pause Press Start to start testing.

  • Page 72: Teoae Response Graph

    Eclipse Instructions for Use - US Page 64 The Stimulus Graph will also give an indication of probe status (e.g., leaking, blocked) during testing as the click curve will move away from the original stimulus indication (grey curve) obtained during the probe check.

  • Page 73: Response Waveform Graph

    Eclipse Instructions for Use - US Page 65 4.6.7 Response Waveform Graph The response waveform along with the recording window and response reproducibility range are shown in the Response Waveform Graph. The white area of the graph indicates the recording window start and stop time. The area outside the recording window is greyed out.
  • Page 74 Eclipse Instructions for Use - US Page 66...

  • Page 75: Operating Instructions Dpoae20

    Eclipse Instructions for Use - US Page 67 5 Operating Instructions DPOAE20 5.1 Using the DPOAE20 module 1. Contraindications to placing a probe in a patient’s ear include a discharging ear, acute external auditory canal trauma, discomfort (e.g, severe otitis externa) or occlusion of the external auditory canal.

  • Page 76: Mounting & Dismounting The Probe Tip

    Eclipse Instructions for Use - US Page 68 5.3 Mounting & Dismounting the Probe Tip 1. The neonatal probe tip is fragile and may break if not handle carefully when being attached or detached from the probe. 2. It is important to use the probe tip tool to dismount the neonatal probe tip.

  • Page 77: Handling And Selection Of Ear Tips

    Eclipse Instructions for Use - US Page 69 5.4 Handling and selection of ear tips Always use the dedicated ear tips from Sanibel for OAE measurements. Use of an incorrect ear tip could invalidate the OAE measurement. Neonatal probe ear tips: Blue 4mm, Red 4.5mm & Green 5mm, must only be used together with the dedicated purple neonatal probe tip.

  • Page 78: The Dpoae20 Test Screen

    Eclipse Instructions for Use - US Page 70 5.5 The DPOAE20 Test Screen The following section describes the elements of the test screen. 5.5.1 Main Menu Items File provides access to the System setup, Print..., Print preview, Print setup and Exit.

  • Page 79: Electronic Help

    Eclipse Instructions for Use - US Page 71 5.5.2 Electronic Help Click on the Electronic Help icon and then point/click on an item you require more information for. If context sensitive help is available, a window will open to provide the relevant information.

  • Page 80: Save & New

    Eclipse Instructions for Use - US Page 72 When editing a historic session, the session date remains unchanged in the database as this always refers to the date of the recording. To exit without saving, click on the red ‘X’ in the upper right hand corner of the screen.

  • Page 81: Rejection Level Db Spl

    Eclipse Instructions for Use - US Page 73 5.5.13 Rejection Level dB SPL The Rejection Level slider allows setting the rejection level limit between -30 and +30 dB SPL. Sweeps recorded above the set rejection level are considered to be too noisy and are rejected.

  • Page 82: Making A Dpoae Recording

    Eclipse Instructions for Use - US Page 74 5.6 Making a DPOAE recording 5.6.1 Probe Check Click on the Start Probe Check button to begin the probe check. Click again to stop the probe check. 5.6.2 Start, Stop, Pause & Next Press Start to start testing.

  • Page 83: Dpoae Graph

    Eclipse Instructions for Use - US Page 75 5.6.5 DPOAE Graph The DPOAE Graph displays either a DP-Gram or DP I/O graph, depending on the test protocol. A checkmark a test point indicates that the individual measurement has met its specified criteria.

  • Page 84: Graph

    Eclipse Instructions for Use - US Page 76 The DP-Response Graph displays two sound stimuli and the position of the DPOAE at 2f for the selected point in the DPOAE Graph. Use the arrow keys on the right-hand side of the graph to increase or decrease the range of frequencies displayed in the graph.

  • Page 85: Operating Instructions Assr

    5. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when high intensity stimuli are used. 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.

  • Page 86: Preparations Prior To The Assr Test

    Eclipse Instructions for Use - US Page 78 6.2 Preparations prior to the ASSR Test For obtaining reliable and valid test results it is most important that the patient is well prepared for the test. 6.3 Preparations prior to Testing 6.3.1 Preparation of the Skin...

  • Page 87: Mounting Electrodes

    Eclipse Instructions for Use - US Page 79 Note: The Ground electrode impedance is not very critical for obtaining good results. You may have an easier job, if you place the ground electrode above the nose (below the vertex electrode), as this place is much easier to rub down with the skin abrasive gel –...

  • Page 88: The Assr Tab

    Help provides access Help topics and About... 1. Select Operation Manual to launch a PDF version of the operation manual. 2. Select About Interacoustics ASSR... to access information about the software version number, the DSP version, the Hardware version and the Firmware version.

  • Page 89: Temporary Setup

    Eclipse Instructions for Use - US Page 81 6.6.3 Temporary Setup The Temporary Setup icon allows temporary changes to be made the selected protocol. Changes will only apply to the current test session. Modified protocols will display an asterisk (*) next to the protocol name.

  • Page 90: Total Session Status Window

    Eclipse Instructions for Use - US Page 82 6.6.9 Total Session Status Window The Total Session Status window indicates the Elapsed Test Time and the Transducer used. 6.6.10 Stimulus Rate 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.

  • Page 91: Test Frequency Graph

    Eclipse Instructions for Use - US Page 83 6.7.4 Test Frequency Graph The graph shows an indication of the ongoing or completed results for the specified stimuli. 1. The grey area behind the detection curves indicates the residual noise level for the selected curve.

  • Page 92: Extending The Test Time

    Eclipse Instructions for Use - US Page 84 The ASSR table displays the detection curve information in a table format. Each tested frequency and intensity is shown along with the detection percentage (response probability) and residual noise level in nV.

  • Page 93: Stopping A Test Frequency/Intensity

    Eclipse Instructions for Use - US Page 85 6.7.8 Stopping a Test Frequency/Intensity Right click within the desired Test Frequency Graph to Stop the Current Ongoing Intensity Immediately.

  • Page 94: The Audiogram Tab

    Eclipse Instructions for Use - US Page 86 6.8 The Audiogram Tab The following section describes the elements of the Audiogram Tab. The Audiogram Tab is where the resulting estimated audiogram is displayed and correction factors can be modified. 6.8.1 Estimated Audiogram...

  • Page 95: Selected Correction Factor

    Eclipse Instructions for Use - US Page 87 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.

  • Page 96: Pc Shortcuts

    Eclipse Instructions for Use - US Page 88 6.9 PC Shortcuts Shortcut Description Operation Manual Start / Stop test Pause / Resume test Report Print session Ctrl + F7 Temporary Setup Ctrl + P Print session Alt + X Save & Exit...

  • Page 97: Maintenance

    Eclipse Instructions for Use - US Page 89 7 Maintenance 7.1 General Maintenance Procedures The performance and safety of the instrument is maintained if the following recommendations for care and maintenance are observed: 1. To maintain electrical safety during the lifetime of the instrument, a safety check must be made regularly according to IEC 60601-1, Class 1, Type BF if used for ABR measurements and IEC60601- 1, Class 1, Type B if used for OAE measurements.

  • Page 98: Cleaning The Oae Probe Tip

    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 99: Concerning Repair

    7.4 Concerning Repair Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if: 1. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised persons;...

  • Page 100: Warranty

    7.5 Warranty INTERACOUSTICS warrants that: • The Eclipse is free from defects in material and workmanship under normal use and service for a period of 12 months from the date of delivery by Interacoustics to the first purchaser. • Accessories are free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by Interacoustics to the first purchaser.

  • Page 101: Technical Specifications

    Technical Specifications 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.

  • Page 102: Technical Specifications Ep15/Ep25

    Page 94 8.2 Technical Specifications EP15/EP25 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 103 Eclipse Instructions for Use - US Page 95 A/D Resolution: 16 bit. Sampling frequency 30 kHz Artifact Reject System: Standard voltage based system Rejection levels: Manual 0.2 - 640 µV input wuth 0.1uV steps. Anti aliasing filter: Analog 5kHz, 24 dB / octave Dots per Trace: 450 displayed.

  • Page 104: Pespl To Nhl Correction Values

    Eclipse Instructions for Use - US Page 96 7.5.1 peSPL to nHL Correction Values Toneburst Toneburst ECochG/ABR15/ABR30/AMLR/Neuro ALR/MMN dB 25-50-25 ms 0 dB 2-2-2 cycle linear envelope Insert phone Headphone Bone Insert phone Headphone Bone 74.5 17.5 23.5 69.5 13.5 48.5...

  • Page 105: Technical Specifications Teoae25

    , the same correction is applied. 8.3 Technical Specifications TEOAE25 Medical CE-mark: The Medical CE mark indicates that Interacoustics AS meets the requirements of Annex II of the Medical Device Directive 93/42EEC. Approval of the quality system is made by TÜV – identification no 0123.

  • Page 106: Technical Specifications Dpoae20

    Page 98 8.4 Technical Specifications DPOAE20 Medical CE-mark: The Medical CE mark indicates that Interacoustics AS 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.

  • Page 107: Technical Specifications Assr

    Page 99 8.5 Technical Specifications ASSR 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 108: Electromagnetic Compatibility (Emc)

    If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device.
  • Page 109 Eclipse Instructions for Use - US Page 101 (>95% dip in UT) for 5 sec Power frequency (50/60 Hz) 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical IEC 61000-4-8 location in a typical commercial or residential environment.
  • Page 110 Eclipse Instructions for Use - US Page 102 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 CIR55...

  • Page 111: Eclipse Software Module Overview

    Eclipse Instructions for Use - US Page 103 8.8 Eclipse Software Module Overview 8.8.1 EP15/EP25 Modules Test types/functionality: EP15 EP25 Stimulus level 0 – 100 dB nHL 0 – 100 dB nHL Click stimulus Broadband CE-Chirp® LS stimulus Optional Narrow Band CE-Chirp® LS stimuli Optional (0.5, 1, 2, 4 kHz)

  • Page 112: Dpoae20 Module

    Eclipse Instructions for Use - US Page 104 8.8.3 DPOAE20 Module Test types/functionality: DPOAE Module Stimulus level 30 - 75 dB SPL (70 dB for freq. above 6kHz) Stimulus range 500 – 8000 Hz Test time Min 2 sec – unlimited...
  • Page 113 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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