Interacoustics Eclipse User manual

Instructions for Use - US
Eclipse
Science made smarter
D-0120578-C – 2019/11

TABLE OF CONTENTS
1Introduction..................................................................................................................................... 1
1.1 About this manual...................................................................................................................... 1
1.2 Indications for use ..................................................................................................................... 2
1.2.1 Intended operator.........................................................................................................................2
1.2.2 Patient population ........................................................................................................................2
1.2.3 Contraindications .........................................................................................................................2
1.3 Product description.................................................................................................................... 3
1.4 Warnings ................................................................................................................................... 4
2Unpacking and installation............................................................................................................ 7
2.1 Unpacking and inspection ......................................................................................................... 7
2.2 Markings.................................................................................................................................... 8
2.3Hardware 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
2.4 Software installation ................................................................................................................ 12
2.4.1 To know before you start installation..........................................................................................12
2.4.2 Minimum PC requirements.........................................................................................................12
2.4.3 What you will need:....................................................................................................................13
2.4.4 Software installation...................................................................................................................13
2.4.5 Driver installation........................................................................................................................13
2.4.6 Restoring factory default settings in the software.......................................................................14
2.4.7 Installing a language pack..........................................................................................................14
2.5 Reader station......................................................................................................................... 15
2.6 License .................................................................................................................................... 15
2.6.1 Eclipse serial number.................................................................................................................15
2.6.2 DSP serial number & license key...............................................................................................15
2.7 Starting up from OtoAccess® Database ................................................................................. 16
2.7.1 Module setup in OtoAccess® Database.....................................................................................16
2.8 Starting up from Noah (ASSR or IA OAE suite only) .............................................................. 17
3Operating instructions EP15/EP25 ............................................................................................. 19
3.1 The record tab ......................................................................................................................... 20
3.1.1 Main menu items........................................................................................................................20
3.1.2 Electronic help ...........................................................................................................................21
3.1.3 Viewing historic sessions ...........................................................................................................21
3.1.4 Protocol selection.......................................................................................................................21
3.1.5 Temporary setup........................................................................................................................21
3.1.6 Rearrange curves.......................................................................................................................21
3.1.7 Group waveforms.......................................................................................................................21
3.1.8 Reporting ...................................................................................................................................21
3.1.9 Printing.......................................................................................................................................22
3.1.10 Display A-B curves.....................................................................................................................22
3.1.11 Display contra curve...................................................................................................................22
3.1.12 Talk forward ...............................................................................................................................22
3.1.13 Single curve display ...................................................................................................................22
3.1.14 Split screen display ....................................................................................................................23
3.1.15 Save & New ...............................................................................................................................24

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.........................................................................................................................................26
3.1.25 Next intensity .............................................................................................................................26
3.1.26 Fmp & residual noise graph .......................................................................................................26
3.1.27 Extending the number of sweeps/averages ...............................................................................26
3.1.28 Raw EEG ...................................................................................................................................27
3.1.29 Advanced EEG ..........................................................................................................................27
3.1.30 Hide stimulus artefact.................................................................................................................28
3.1.31 Display gain ...............................................................................................................................29
3.1.32 Recording window......................................................................................................................29
3.1.33 Selecting a waveform.................................................................................................................29
3.1.34 Moving an individual curve.........................................................................................................29
3.1.35 Display differential curves ..........................................................................................................29
3.1.36 Adding a note to the waveform ..................................................................................................30
3.1.37 Monitoring rejection....................................................................................................................31
3.1.38 Placing waveform markers.........................................................................................................31
3.1.39 Deleting waveform markers .......................................................................................................31
3.1.40 Suggest waveform markers .......................................................................................................32
3.1.41 Normative latency data ..............................................................................................................32
3.1.42 Deleting individual curves ..........................................................................................................32
3.1.43 Enlarge/diminish individual curves .............................................................................................33
3.1.44 Hiding individual curves .............................................................................................................33
3.1.45 Fixate individual curves /comparing to a historic session...........................................................33
3.1.46 Merging curves (creating a summed curve)...............................................................................33
3.1.47 Adding curves ............................................................................................................................34
3.1.48 Differential Ipsi minus contra (Ipsi-Contra) curve .......................................................................34
3.1.49 Differential A minus B (A-B (N)) curve........................................................................................35
3.1.50 Changing display filtering...........................................................................................................35
3.1.51 Recorded curve conditions.........................................................................................................35
3.1.52 Adding comments to a curve......................................................................................................36
3.1.53 Using the cursor.........................................................................................................................36
3.1.54 Signal to noise ratio calculation (3:1) .........................................................................................36
3.1.55 CR, RA & INC waveform markers..............................................................................................37
3.2 The latency tab........................................................................................................................ 38
3.2.1 Latency values ...........................................................................................................................38
3.2.2 Interlatency values .....................................................................................................................38
3.2.3 Latency graph ............................................................................................................................39
3.2.4 Disabling desktop composition (EPx5 software only).................................................................39
3.2.5 Display of the peak to trough markers (SN10 marker) (EPx5 software only) .............................40
3.3 Windows®7, 8 & 10 fails to launch Help ................................................................................. 41
3.4 PC shortcuts............................................................................................................................ 42
3.5 Patient preparation prior to testing.......................................................................................... 43
3.5.1 Impedance check.......................................................................................................................43
3.5.2 Transducers ...............................................................................................................................43
3.6 Making an ABR threshold recording ....................................................................................... 44
3.6.1 Electrode montage.....................................................................................................................44
3.6.2 ABR threshold stimuli.................................................................................................................44
3.6.3 Editing of ABR threshold recordings ..........................................................................................45
3.6.4 Interpretation and use of ABR threshold results.........................................................................45
3.7 Making a neuro latency recording........................................................................................... 46
3.7.1 Electrode montage.....................................................................................................................46
3.7.2 Editing of neuro latency recordings............................................................................................46
3.8 Making an eABR recording ..................................................................................................... 48

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
3.9 Making an ECochG recording................................................................................................. 50
3.9.1 ECochG electrode montages .....................................................................................................50
TipTrode...................................................................................................................................................50
TMtrode 50
3.9.2 Editing an ECochG recording.....................................................................................................51
3.10 Making an CM recording ......................................................................................................... 52
Patient preparation...................................................................................................................................52
3.10.1 CM electrode montage...............................................................................................................52
3.10.2 Stimuli for CM recordings...........................................................................................................52
3.10.3 Example of a CM recording........................................................................................................52
3.10.4 Interpretation of the CM result....................................................................................................52
3.11 Making a AMLR recording....................................................................................................... 53
3.11.1 Example of electrode montage AMLR........................................................................................53
3.11.2 Available AMLR stimuli ..............................................................................................................53
3.11.3 Example of AMLR recording ......................................................................................................54
3.12 Making a ALR recording / cortical ERA................................................................................... 55
3.12.1 Example of electrode montage for an ALR threshold recording.................................................55
3.12.2 Stimuli ........................................................................................................................................55
3.12.3 Interpretation of the ALR result ..................................................................................................56
3.12.4 Electrophysiological threshold estimation and infant hearing instrument fitting..........................56
3.13 Making a P300/MMN recording............................................................................................... 57
3.13.1 Example of electrode montage for P300/MMN ..........................................................................57
3.13.2 Available P300/MMN stimuli ......................................................................................................57
3.13.3 Summary of parameters for P300 and MMN..............................................................................58
3.14 System performance / loop back (LBK15) testing................................................................... 59
4Operating instructions VEMP...................................................................................................... 61
4.1 Preamplifier setup ................................................................................................................... 62
4.2 VEMP monitor ......................................................................................................................... 62
4.3 VEMP waveform markers ....................................................................................................... 62
4.4 Calculating the VEMP asymmetry ratio (VEMP partner) ........................................................ 63
4.5 VEMP scaling .......................................................................................................................... 63
4.6 Making a cVEMP recording..................................................................................................... 64
4.6.1 Electrode montage for cVEMP...................................................................................................64
4.6.2 Stimuli for cVEMP ......................................................................................................................64
4.6.3 Default collection parameters.....................................................................................................65
4.6.4 Procedure ..................................................................................................................................65
4.6.5 Edit cVEMP results ....................................................................................................................65
4.6.6 Example of cVEMP result ..........................................................................................................66
4.7 Making a oVEMP recording .................................................................................................... 67
4.7.1 Electrode montage for oVEMP...................................................................................................67
4.7.2 Stimuli for oVEMP......................................................................................................................67
4.7.3 Default collection parameters.....................................................................................................67
4.7.4 Procedure ..................................................................................................................................68
4.7.5 Edit oVEMP results ....................................................................................................................68
4.7.6 Example of oVEMP result ..........................................................................................................68
5Research module.......................................................................................................................... 69
5.1.1 Logging of each sweep for a later ”replay”.................................................................................69
5.1.2 Exporting the averaged curve &/or full session..........................................................................70
5.1.3 Exporting the session (all curves) ..............................................................................................71
5.1.4 Exporting waveform when offline ...............................................................................................71

5.1.5 Importing WAV files for stimuli ...................................................................................................71
6Operating instructions IA OAE suite .......................................................................................... 75
6.1 Handling and selection of ear tips ........................................................................................... 76
6.2 Daily system checks for OAE devices..................................................................................... 77
6.2.1 Probe integrity test .....................................................................................................................77
6.2.2 Real-Ear Check.........................................................................................................................78
7The IA OAE suite .......................................................................................................................... 79
7.1 PC power configuration........................................................................................................... 79
7.2 Compatible devices ................................................................................................................. 79
7.2.1 Starting from OtoAccess® Database .........................................................................................79
7.2.2 Starting from Noah 4..................................................................................................................79
7.2.3 Simulation mode ........................................................................................................................79
7.2.4 Crash report...............................................................................................................................80
7.3 Using the menu ....................................................................................................................... 81
7.4 Using the DPOAE module....................................................................................................... 82
7.4.1 Preparing for the test..................................................................................................................82
7.4.2 Elements in the DPOAE module ................................................................................................84
7.5 Using the TEOAE module ....................................................................................................... 90
7.5.1 Preparing for the test..................................................................................................................90
7.5.2 Element in the TEOAE module ..................................................................................................92
7.6 Using the Print Wizard ............................................................................................................ 98
8Operating instructions ASSR.................................................................................................... 101
8.1 Using the ASSR module ....................................................................................................... 101
8.2 Preparations prior to the ASSR test ...................................................................................... 102
8.3 Preparations prior to testing .................................................................................................. 102
8.3.1 Preparation of the Skin.............................................................................................................102
8.3.2 Placement of electrodes...........................................................................................................102
8.3.3 Impedance check.....................................................................................................................102
8.4 Mounting electrodes .............................................................................................................. 104
8.5 Impedance check .................................................................................................................. 104
8.6 System performance / loop back (LBK15) testing................................................................. 104
8.7 The ASSR tab ....................................................................................................................... 105
8.7.1 Main menu items......................................................................................................................105
8.7.2 Protocol selection.....................................................................................................................105
8.7.3 Temporary setup......................................................................................................................106
8.7.4 Reporting .................................................................................................................................106
8.7.5 Printing.....................................................................................................................................106
8.7.6 Save & exit...............................................................................................................................106
8.7.7 Viewing historic sessions .........................................................................................................106
8.7.8 Stimulus window ......................................................................................................................106
8.7.9 Total session status window ....................................................................................................107
8.7.10 Stimulus rate ............................................................................................................................107
8.8 Making an ASSR recording................................................................................................... 108
8.8.1 Start & stop ..............................................................................................................................108
8.8.2 Pause.......................................................................................................................................108
8.8.3 Raw EEG graphs .....................................................................................................................108
8.8.4 Test frequency graph ...............................................................................................................108
8.8.5 ASSR table ..............................................................................................................................109
8.8.6 Extending the test time.............................................................................................................110
8.8.7 Adjusting the stimulus intensity................................................................................................110

8.8.8 Stopping a test frequency/intensity ..........................................................................................111
8.8.9 ASSR masking calculator.........................................................................................................111
8.9 The audiogram tab ................................................................................................................ 113
8.9.1 Estimated audiogram symbols .................................................................................................113
8.9.2 Audiometric symbols in NOAH or OtoAccess® Database........................................................114
8.9.3 Estimated audiogram ...............................................................................................................115
8.9.4 AC and BC in the same audiogram..........................................................................................116
8.9.5 No response.............................................................................................................................117
8.9.6 Selected correction factor ........................................................................................................117
8.9.7 PC shortcuts ............................................................................................................................117
9Maintenance................................................................................................................................ 119
9.1 General maintenance procedures......................................................................................... 119
9.2 How to clean Interacoustics products ................................................................................... 120
9.3 Cleaning the OAE probe tip .................................................................................................. 120
9.4 Concerning repair.................................................................................................................. 122
9.5 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 ........................................................................................... 129
10.4 Technical specifications DPOAE........................................................................................... 130
10.5 Technical specifications ASSR ............................................................................................. 131
10.6 Electromagnetic compatibility (EMC) .................................................................................... 132
10.7 Eclipse software module overview ........................................................................................ 136
10.7.1 EP15/EP25/VEMP modules.....................................................................................................136
10.7.2 EP15/EP25/VEMP module stimulus maximum intensity..........................................................137
10.7.3 TEOAE module ........................................................................................................................138
10.7.4 DPOAE module........................................................................................................................138
10.7.5 ASSR module ..........................................................................................................................138

D-0120578-C – 2019/11
Eclipse – Instructions for Use - US Page 1
1Introduction
1.1 About this manual
This manual is valid from software version EP15/25 v4.6, IA OAE suite 1.1, VEMP v4.6 and ASSR v 1.2.8.
The product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
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.

D-0120578-C – 2019/11
Eclipse – Instructions for Use - US Page 2
1.2 Indications for use
EP15 & EP25
The Eclipse EP15 and EP25 are intended for use in the electrophysiological evaluation, documentation and
diagnosis of ear disorders in humans. EP15/EP25 is a 2-channel evoked potential system that allows for
recording waveforms that can be used for screening and diagnostic applications.
The EP15 allows for the recording of ABRs (Auditory Brainstem Responses) while the EP25 allows for
recording ABRs, middle and late latency potentials. The target population for EP15 and EP25 includes all
ages.
cVEMP & oVEMP
The Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic
potential testing to assist in the assessment of vestibular function. The target population for Eclipse VEMP
includes children from 8 years and up.
The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific
facts underlying the procedure.
TEOAE
The Eclipse TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders
using Transient Evoked Otoacoustic Emissions. The target population for Eclipse TEOAE includes all ages.
DPOAE
The Eclipse DPOAE system is intended for use in the audiologic evaluation and documentation of ear
disorders using Distortion Product Otoacoustic Emissions. The target population for the Eclipse DPOAE
includes all ages.
ASSR
The Eclipse ASSR (Auditory Steady-State Response) is intended for use in the recording and analysis of
human physiological data for the diagnosis of auditory and hearing-related functions. The target population
for 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.
1.2.2 Patient population
The patient target population includes all ages for all modules, with the exception of VEMP testing, which is
from the age of 8 years and up.
1.2.3 Contraindications
Contraindications to place the stimuli transducer in/on 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. Testing should not be performed on patients with such symptoms without a medical doctor’s
approval.
Testing VEMP, patients with neck, muscular and cervical injury problems should not perform the VEMP
test. Furthermore patient with conductive hearing loss, patients whose sternocleidomastoid muscle is too
difficult to locate. For oVEMP testing, total blindness and patients with exenteration (removal of the eye and
extraocular muscles) should not be tested.