GSi AUDERA PRO User manual

EP/OAE
VERSATILE
CLINICAL
AUDERA PRO
USER MANUAL

Title: Audera Pro User Manual
Manufacturer
Grason-Stadler, Inc.
10395 West 70th Street
Eden Prairie, MN 55344
USA
Copyright © 2020 Grason-Stadler. All rights reserved . No part of this publication
may
be reproduced or transmitted in any form or by any means without the prior
written permission of
Grason-Stadler . The information in this publication is
proprietary to Grason-Stadler.
This product incorporates software developed by others and redistributed according to
license agreements. Copyright notices and licenses for these external libraries are
provided in a supplementary document that is included with the other software
applications distributed with this product.
Compliance
The CE 0123 mark identifies compliance with the Medical Device Directive
93/42/EEC. Grason-Stadler is an ISO 13485 certified corporation.
European Authority Representative
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
0123
Caution: US Federal law restricts this device to sale by or on the order of a physician or licensed
hearing care professional.

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TABLE OF CONTENTS
Table of Contents ....................................................................................................................... 1
Preface....................................................................................................................................... 10
Manual Conventions ............................................................................................................ 10
Regulatory Symbols.............................................................................................................. 11
Device Symbols ..................................................................................................................... 13
Warnings and Cautions............................................................................................................ 14
Important Safety Instructions ............................................................................................. 14
Safety Precautions................................................................................................................ 14
Explosion ............................................................................................................................... 17
Environmental Factors ......................................................................................................... 17
Electromagnetic Compatibility (EMC) Considerations...................................................... 17
Ambient Noise....................................................................................................................... 18
Maximum Ambient Noise ................................................................................................ 18
Transducer Sound Attenuation ....................................................................................... 19
Introduction .............................................................................................................................. 20
Indications for Use................................................................................................................ 20
Contraindications ................................................................................................................. 20
Modalities .............................................................................................................................. 22
Evoked Potentials (EP) ...................................................................................................... 22
Vestibular-Evoked Myogenic Potentials (VEMP) ............................................................ 22
Auditory Steady-State Response (ASSR) ......................................................................... 22
Distortion Products Otoacoustic Emissions (DPOAE) ................................................... 23
Transient Evoked Otoacoustic Emissions (TEOAE)........................................................ 23
Unpacking the system.............................................................................................................. 24
Standard Components ......................................................................................................... 24
Included with EP/ASSR Option......................................................................................... 24
Included with OAE Option................................................................................................ 25
Applied Parts ..................................................................................................................... 25
Optional Components.......................................................................................................... 25
Getting Started.......................................................................................................................... 26
Components.......................................................................................................................... 26

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Base Unit............................................................................................................................ 26
Base Unit Stand................................................................................................................. 26
Transducers ....................................................................................................................... 26
System Assembly .................................................................................................................. 26
Placement of the Audera Pro base unit ......................................................................... 26
System Setup Diagram ..................................................................................................... 27
Connect the Cables........................................................................................................... 28
Base Unit Rear Panel............................................................................................................ 28
Connections....................................................................................................................... 28
Software Installation ............................................................................................................ 29
Minimum PC Requirements............................................................................................. 29
Supported Operating Systems ........................................................................................ 29
Installation ......................................................................................................................... 29
Recommendations............................................................................................................ 30
Upgrading the software ................................................................................................... 30
Uninstalling the software ................................................................................................. 30
Operating Audera Pro .......................................................................................................... 31
Launching Audera Pro Software ..................................................................................... 31
Opening Window ...................................................................................................................... 32
Menu Options ....................................................................................................................... 33
Opening Window Toolbar.................................................................................................... 34
Connection Status............................................................................................................. 35
Password ............................................................................................................................... 35
Testing.................................................................................................................................... 35
Hardware Setup.................................................................................................................... 36
Hardware ........................................................................................................................... 36
Registration........................................................................................................................ 37
Password............................................................................................................................ 37
Restore ............................................................................................................................... 37
Normative Data..................................................................................................................... 38
Menu Options.................................................................................................................... 38
Operators .............................................................................................................................. 39
System Log ............................................................................................................................ 40

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Patient Information Management.......................................................................................... 42
New Patient ........................................................................................................................... 42
Patient Information Function Buttons............................................................................ 43
Open Patient ......................................................................................................................... 44
Edit Patient ............................................................................................................................ 46
Backup Patient Data ............................................................................................................. 47
Evoked Potentials (EP).............................................................................................................. 48
Title Bar.................................................................................................................................. 48
EP Main Menu ....................................................................................................................... 49
Patient ................................................................................................................................ 49
Protocol.............................................................................................................................. 49
Stimulus ............................................................................................................................. 50
Amplifier............................................................................................................................. 50
Recordings ......................................................................................................................... 51
Averaging ........................................................................................................................... 52
Process ............................................................................................................................... 52
Display................................................................................................................................ 53
Report................................................................................................................................. 55
Print .................................................................................................................................... 56
Help .................................................................................................................................... 56
Information Bar..................................................................................................................... 57
Toolbar................................................................................................................................... 58
EP waveform area................................................................................................................. 60
Page Selection Control ......................................................................................................... 60
Side Toolbar .......................................................................................................................... 60
EEG Panel............................................................................................................................... 61
Collection Toolbar................................................................................................................. 62
Window and Sample Rate ................................................................................................ 64
Automated Protocol Dialog ................................................................................................. 65
Stimulus Dialog ..................................................................................................................... 67
Calibration Table ............................................................................................................... 71
SPL to HL Conversion Table ............................................................................................. 72
File Calibration Table ........................................................................................................ 73

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Stimulus Display Dialog.................................................................................................... 74
P300/MMN Setup Dialog...................................................................................................... 75
Amplifier Settings Dialog...................................................................................................... 76
External Trigger..................................................................................................................... 79
Remote Impedance Display Box ......................................................................................... 80
Data Analysis ......................................................................................................................... 82
Data Files Dialog ................................................................................................................... 82
Data Pages ......................................................................................................................... 83
Display Options ................................................................................................................. 84
Cursors ............................................................................................................................... 87
Waveforms ............................................................................................................................ 88
Labeling Peaks................................................................................................................... 89
Default Labels.................................................................................................................... 90
SP/AP Ratio ........................................................................................................................ 91
MMN Area.......................................................................................................................... 92
Waveform Options............................................................................................................ 93
Record Info ........................................................................................................................ 96
Post-Acquisition Processing ................................................................................................ 97
Calculating Bayesian Weighted average......................................................................... 97
Adding and Subtracting waveforms ............................................................................... 97
Comparing recordings...................................................................................................... 97
Inverting a waveform........................................................................................................ 98
Filtering .............................................................................................................................. 98
Cross-correlation............................................................................................................... 99
Split Active Recording ....................................................................................................... 99
Latency Intensity Graph ................................................................................................... 99
Reports.................................................................................................................................100
Adding Information.........................................................................................................101
Printing Options ..............................................................................................................101
Report Header and adding a Logo to the Report........................................................101
Keyboard Shortcuts............................................................................................................102
Typical EP Evaluation Workflow ........................................................................................103
Vemp Analysis Module...........................................................................................................104

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Open Records......................................................................................................................104
VEMP Analysis Window ......................................................................................................105
VEMP Analysis Menu ..........................................................................................................106
File.....................................................................................................................................106
Process .............................................................................................................................106
Settings.............................................................................................................................106
Help ..................................................................................................................................107
VEMP Analysis Toolbar .......................................................................................................108
VEMP Culling Mode View ...................................................................................................108
VEMP Calculation Mode View............................................................................................110
Auditory Steady-State Response (ASSR) ..............................................................................112
Title Bar................................................................................................................................112
ASSR Main Menu.................................................................................................................113
Patient ..............................................................................................................................113
Protocol............................................................................................................................113
Stimulus ...........................................................................................................................114
Recordings .......................................................................................................................115
Process .............................................................................................................................115
Display..............................................................................................................................115
Report...............................................................................................................................116
Print ..................................................................................................................................117
Help ..................................................................................................................................118
Information Bar...................................................................................................................118
Toolbar.................................................................................................................................119
ASSR waveform area ..........................................................................................................121
Page Selection Control .......................................................................................................121
Side Toolbar ........................................................................................................................121
EEG Panel.............................................................................................................................122
Stimulus Information Panel...............................................................................................123
Amplifier Settings Dialog....................................................................................................124
Collection Toolbar...............................................................................................................127
Automated Protocol Dialog ...............................................................................................128
Signal to Noise Ratio and Noise Graphs ..........................................................................129

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Keyboard Shortcuts............................................................................................................129
Data Analysis .......................................................................................................................130
Data Files Dialog .................................................................................................................130
Analyze Active Wave...........................................................................................................131
Polar Plot..........................................................................................................................131
Spectral Graph.................................................................................................................132
Data Table........................................................................................................................132
Record Selection and Option Buttons ..........................................................................133
ASSR Response Audiogram ...............................................................................................134
HL Correction Table............................................................................................................136
Distortion Products Otoacoustic Emissions (DPOAE)......................................................... 138
Title Bar................................................................................................................................138
DPOAE Main Menu .............................................................................................................139
Patient ..............................................................................................................................139
System..............................................................................................................................139
Print ..................................................................................................................................139
Help ..................................................................................................................................139
Toolbar.................................................................................................................................140
Data Collection....................................................................................................................141
Test Parameters ..............................................................................................................142
Passing Criteria Dialog....................................................................................................148
Normative Data Dialog ...................................................................................................150
Data Collection Screens..................................................................................................152
Data Analysis .......................................................................................................................158
Data Analysis Menu ........................................................................................................158
Data Analysis Toolbar.....................................................................................................158
Load Data Files ................................................................................................................159
Display Options ...............................................................................................................160
Print ..................................................................................................................................162
DP I/O ...................................................................................................................................163
Collection Settings ..........................................................................................................163
DP I/O Levels Dialog........................................................................................................164
Data Collection ................................................................................................................164

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Data Analysis ...................................................................................................................165
Transient Evoked Otoacoustic Emissions (TEOAE) ............................................................. 167
Title Bar................................................................................................................................167
TEOAE Main Menu ..............................................................................................................168
Patient ..............................................................................................................................168
Protocol............................................................................................................................168
Stimulus ...........................................................................................................................169
Recordings .......................................................................................................................169
Report...............................................................................................................................169
Print ..................................................................................................................................171
Help ..................................................................................................................................171
Information Bar...................................................................................................................172
Toolbar.................................................................................................................................172
TE waveform area...............................................................................................................174
Page Selection Control .......................................................................................................174
Side Toolbar ........................................................................................................................174
Meatal Response Panel......................................................................................................175
Collection Toolbar...............................................................................................................175
Data Collection....................................................................................................................176
Passing Criteria ...................................................................................................................177
Data Analysis .......................................................................................................................178
Data Files Dialog .................................................................................................................178
Data Pages .......................................................................................................................178
Display Options ...............................................................................................................179
Waveform Options..........................................................................................................182
Reports.................................................................................................................................184
Adding Information.........................................................................................................184
Printing Options ..............................................................................................................184
Cleaning and Maintenance....................................................................................................186
Cleaning ...............................................................................................................................186
OAE Probe Tube Replacement ......................................................................................186
Attaching Eartips .............................................................................................................188
Changing Insert Earphone sound tubes....................................................................... 188

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Maintenance........................................................................................................................189
Operational Checks.........................................................................................................189
Calibration and Safety checks .......................................................................................189
Cybersecurity ..........................................................................................................................190
Troubleshooting .....................................................................................................................193
Error Messages ...................................................................................................................193
USB Connection Not Found…. Continue without Hardware? ....................................193
Access Violation at address xxxxx ……..........................................................................193
Probe Fit Error: Probe Occluded ...................................................................................194
Probe Fit or Gain Problem .............................................................................................194
Incorrect Operating System Setting..............................................................................195
Corrupted or missing License file ................................................................................. 195
USB not Responding.......................................................................................................195
Loopback Test Cable ..........................................................................................................196
Setup ................................................................................................................................196
Loopback Test .................................................................................................................196
Loopback Test Analysis ..................................................................................................197
OAE Probe Check Cavity.................................................................................................198
Supplies and Accessories ......................................................................................................199
OAE Probe Ear Tips – Single Use – Sanibel ADI Silicone .................................................200
Appendix A – Default Settings...............................................................................................202
Default EP Settings .............................................................................................................202
VEMP Settings......................................................................................................................203
Default ASSR Settings .........................................................................................................204
Default DPOAE Settings .....................................................................................................205
Default TEOAE Settings ......................................................................................................206
File Naming..........................................................................................................................207
Recording Naming Convention .....................................................................................207
Appendix B – Technical Data.................................................................................................208
Appendix C – Transducer Reference Equivalent Threshold Levels and Maximum Output
Level .........................................................................................................................................212
Transducer Reference Equivalent Threshold Levels Table ............................................ 213
Transducer Reference Equivalent Threshold Levels Table Notes.................................214