Audera Pro

VERSATILE
CLINICAL
EP/OAE
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.
GSI Audera Pro User Manual
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
D-0129360 Rev A Page 1 of 231

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
D-0129360 Rev A Page 2 of 231

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
D-0129360 Rev A Page 3 of 231

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
D-0129360 Rev A Page 4 of 231

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
D-0129360 Rev A Page 5 of 231

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
D-0129360 Rev A Page 6 of 231

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
D-0129360 Rev A Page 7 of 231

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
D-0129360 Rev A Page 8 of 231

Maximum Output Levels.................................................................................................... 215

DD45s Headphones ........................................................................................................ 215
IP30 Insert Phones .......................................................................................................... 216
B81 Bone Vibrator ........................................................................................................... 217
SP90 A Free Field Speaker .............................................................................................. 218
Appendix D – Specification of Input/output Connections ................................................. 219
Mains Cable ......................................................................................................................... 219
Patient Electrode Cable ...................................................................................................... 219
Headphones/Inserts (2 connectors, R, L) ......................................................................... 219
Bone Oscillator .................................................................................................................... 219
OAE Probe............................................................................................................................ 219
Speakers (R, L) ..................................................................................................................... 221
USB ....................................................................................................................................... 221
digital I/O ............................................................................................................................. 221
Appendix E - Warranty and Repair ....................................................................................... 222
Warranty .............................................................................................................................. 222
Repair ................................................................................................................................... 222
Appendix F – Recycling and Disposal ................................................................................... 224
Appendix G – Electromagnetic Compatibility (EMC) ........................................................... 225
Cautions regarding EMC .................................................................................................... 225
Guidance and manufacturer’s declaration Electromagnetic emissions ....................... 226
Recommended separation distances between portable and mobile RF
communications equipment ............................................................................................. 227
Guidance and Manufacturer’s Declaration Electromagnetic Immunity ....................... 228
D-0129360 Rev A Page 9 of 231

PREFACE
This user manual provides information about the GSI Audera Pro. This manual is
intended for technically qualified personnel.
Please note: This User Manual is not intended as a training manual. The reader should
consult standard audiology texts for the theory and application of the tests provided by
this instrument.
This operating manual contains information pertinent to the use of the Audera Pro
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!
MANUAL CONVENTIONS
Throughout this manual, the following meaning of warnings, cautions and notices are
used.
WARNING
The WARNING symbol identifies conditions or practices that may present
danger to the patient and/or user.
CAUTION
The CAUTION Symbol identifies conditions or practices that could result in
damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
D-0129360 Rev A Page 10 of 231

REGULATORY SYMBOLS
Symbol Description
Conforms to European Medical Device

Directive 93/42/EEC.
Indicates that the device is a Medical Device
Symbol for "SERIAL NUMBER."
GSI Part Number.
Return to Authorized Representative, Special

disposal required.
Medical Equipment Classified by Intertek

Testing Services NA Inc. with respect to
electric shock, fire, and mechanical hazards
only, in accordance with UL 60601-1.
Classified under the Medical Device Directive
(93/42/EEC) as a Class IIa device.
Symbol for “European Representative.”
Symbol for “Manufacturer.”
Symbol for “Date of Manufacture.”
On/Off
Keep Dry
D-0129360 Rev A Page 11 of 231

Symbol Description
This side up.
Electrostatic sensitive devices, or to identify a

device or connector that has not been tested
for immunity to electrostatic discharge.
Consult the operating instructions/directions

for use. A copy of the operating manual is
available on this website: www.grason-
stadler.com
A printed copy of the operating instructions
can be ordered from Grason-Stadler for
shipment within 7 days; or you can contact
your local representative.
Consult the operating instructions/directions

for use. A copy of the operating manual is
available on this website: www.grason-
stadler.com
A printed copy of the operating instructions
can be ordered from Grason-Stadler for
shipment within 7 days; or you can contact
your local representative.
Class II medical equipment
D-0129360 Rev A Page 12 of 231

DEVICE SYMBOLS
The following symbols appear on the instrument.
Definition: Type BF applied part – IEC 60601-1 uses the term applied part
to refer to the part of the medical device which comes into physical contact
with the patient for the device to carry out its intended function. Type BF is
used for devices that have conductive contact with the patient or having
medium or long-term contact with the patient. The GSI Audera Pro is Type BF according
to the international standard IEC 60601-1. The type BF applied parts are the electrodes,
headphones, insert earphones, bone oscillator, and the probe ear tips.
Symbol Description
Follow Instructions for Use.
Connection for the headphones or insert

earphones. The red markings around the connector
indicate the right and the blue marking indicate the
left connector.
Connection for the bone conductor transducer.
Connection for the sound field speakers. The red

markings around the connector indicate the right
and the blue marking indicate the left connector.
Connection for the patient electrode cable.
D-0129360 Rev A Page 13 of 231

WARNINGS AND CAUTIONS
IMPORTANT SAFETY INSTRUCTIONS

The following safety precautions must be observed always. General safety
precautions must be followed when operating electrical equipment. Failure
to observe these precautions could result in damage to the equipment and
injury to the operator or patient.
The instrument must only be used by hearing health care professional qualified to
perform evoked potential and otoacoustic tests such as an audiologist, otolaryngologist,
researcher or a technician under the direct supervision by the specialist. Users should
use their professional skills when interpreting the results and this should be done in
conjunction with other testing as deemed appropriate given their professional skills.
Incorrect use could lead to wrong results. It is intended for transient use as a screening
and diagnostic tool. However, no surgical or medical procedure should be undertaken
solely based on results obtained from the instrument.
The employer should instruct each employee in the recognition and avoidance of
unsafe conditions and the regulations applicable to his or her work environment to
control or eliminate any hazards or other exposure to illness or injury. It is understood
that safety rules within individual organizations vary. If a conflict exists between the
material contained in this manual and the rules of the organization using this
instrument, the more stringent rules should take precedence.
SAFETY PRECAUTIONS
This product and its components will perform reliably only when operated
and maintained in accordance with the instructions contained in this
manual, accompanying labels, and/or inserts. A defective product should
not be used. Make sure all connections to external accessories are snug
and secured properly. Parts which may be broken or missing or are visibly worn,
distorted, or contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from GSI.
This instrument is suitable in hospital environments except for near active high
frequency (HF) surgical equipment and radio frequency (RF) shielded rooms of systems
for magnetic resonance imaging, where the intensity of electromagnetic disturbance is
high. The instrument is not suitable for a residential environment.
In case of emergency, disconnect the instrument from the supply mains by pulling the
plug out of the power socket.
Before the first use of the instrument each day, or if suspect or inconsistent results are
apparent, the checks specified in the Performing Daily Checks section should be carried
out. If the system is not functioning properly, do not operate it until all necessary
D-0129360 Rev A Page 14 of 231

repairs are made and the unit is tested and calibrated for proper functioning in
accordance with Grason-Stadler published specifications.
No parts of the equipment can be serviced or maintained while in use with the patient.
Never insert the probe into a patient’s ear canal without a suitable ear tip fitted to the
probe.
Use only the recommended disposable ear tips. These are for single use only - that is,
each ear tip is intended to be used once only for a single ear for a single patient. Do not
reuse ear tips as this will pose the risk of ear-to-ear or patient-to-patient cross infection.
Latex is not used anywhere in the manufacturing process. The base material for the ear
tips is made from silicone rubber.
The device is not intended to be used in environments exposed to fluid spills. No

means is specified for fluid protection (not IP classed). Do not use the device in the
presence of fluid that can contact any of the electronic components or wiring. Should
the user suspect fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician. Do not
immerse the unit in any fluids. See the Routine Maintenance Section of this manual for
the proper cleaning procedure for the instrument and its accessories and the function
of single-use parts.
Do not drop or otherwise impact this instrument. If the instrument is dropped or

damaged, return it to the manufacturer for repair and/or calibration. Do not use the
instrument if any damage is suspected.
Do not attempt to open, modify, or service the instrument. Return the instrument to
the manufacturer or distributor for all repair and servicing requirements. Opening the
instrument will void the warranty.
This equipment is intended to be connected to other equipment thus forming a Medical

Electrical System. External equipment intended for connection to signal input, signal
output or other connectors shall comply with the relevant product standard e.g. IEC
60950-1 for IT equipment and the IEC 60601-series for medical electrical equipment. In
addition, all such combinations shall comply with the safety requirements stated the
general standard IEC 60601-1, edition 3, clause 16. Any equipment not complying with
the leakage current requirements in IEC 60601-1 shall be kept outside the patient
environment i.e. at least 1.5 m from the patient support or shall be supplied via a
separation (isolation) transformer to reduce the leakage currents.
Any person who connects external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is therefore responsible for the
system to comply with the requirements. If in doubt, contact qualified medical
technician or your local representative. As the instrument is connected to a PC (IT
equipment forming a system) ensure not to touch the patient while operating the PC.
D-0129360 Rev A Page 15 of 231

Since the instrument is connected to a PC, assembly and modifications shall be

evaluated by qualified medical technician according to safety regulations in IEC 60601.
A Separation Device (isolation device) is needed to isolate the equipment located

outside the patient environment from the equipment located inside the patient
environment. Such a Separation Device is required when a network connection is made.
The requirement for the Separation Device is defined in clause 16.5 of IEC 60601-1.
In case a Multiple Socket Outlet is used to supply the system, a Medical Electrical System
has been created, even if there is no signal connection to other equipment. This might
lead to an increase of leakage currents and protective earth impedances. Therefore, a
Multiple Socket Outlet should always be used with a Separation transformer as
described in clause 16.9 of IEC 60601-1.
NOTE: The total protective earth impedance, from each equipment in a system,
should be maximum 0.2 ohm measured to the earth pin in the mains plug of the
Multiple Socket Outlet.
To avoid the risk of electric shock, this equipment must only be connected to mains
supply with protective earth. Ensure that the earth connection at the mains electrical
power outlet is properly grounded. Do not use extension cords for the instrument or
Isolation Transformer. Extension cords can cause ground integrity and impedance
problems. In addition to electrical safety considerations, poorly earthed mains power
outlets could cause inaccurate test results due to the introduction of electrical
interference from the mains. Only use power cords with insulation rated for the
voltages and currents being carried and provided/approved by GSI. The third conductor
in the power supply cord is only a functional earth. The power supply in the device
provides protection against short-circuit, overload and over voltage. The device will not
operate outside the specified voltage rating.
D-0129360 Rev A Page 16 of 231

EXPLOSION
This system is not explosion proof.
Do NOT use in the presence of flammable gaseous mixtures. Users should

consider the possibility of explosions or fire when using this device near
flammable anesthetic gases.
Do NOT use the system in a highly oxygen-enriched environment, such as a hyperbaric

chamber, oxygen tent, etc.
ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the
instrument be operated within an ambient temperature range of 15 °C /
59 °F to 35 °C / 95 °F and in relative humidity between 30 % and 90 % (non-
condensing).
Transport the instrument in temperatures between -20 °C / -4 °F to +50 °C / +122 °F and

store the instrument in temperatures between 0 °C / 32 °F to 50 °C / 122 °F.
ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS

Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information in the Appendix.
Although the instrument fulfills the relevant EMC requirements, precautions should be
taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones
etc. This appendix provides guidance on the electromagnetic environment in which to
operate the instrument.
Portable and mobile radio frequency (RF) communications equipment can affect
medical electrical equipment. Use of this instrument adjacent to or stacked with other
equipment should be avoided because it could result in improper operation. If such use
is necessary, this instrument and the other equipment should be observed to verify that
they are operating normally.
D-0129360 Rev A Page 17 of 231

AMBIENT NOISE
The GSI Audera Pro is intended to be used in a hospital, clinic, or other healthcare
facility with a suitable quiet testing environment. Excessive noise in the test
environment, such as that produced by conversation, office equipment, or printers,
reduces test validity because it tends to mask the test signals. This is especially true at
the lower frequencies where earphone cushions provide less effective attenuation. A
room that attenuates sound may be required if ambient noise at the patient’s ears
reaches levels enough to cause apparent hearing loss at the lower frequencies.
Maximum Ambient Noise

The following table shows the maximum background levels (dB SPL, 1/3 octave band)
that can be present inside the room while a valid hearing test is being conducted.
These values apply for hearing threshold measurements to 0 dB HL.
Test Tone 125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Freq. (Hz)
Ears 29.0 17.5 14.5 16.5 21.5 21.5 23.0 28.5 29.5 33.0 38.5
covered
Ears not 23.0 13.5 9.5 7.5 9.0 5.5 3.5 3.5 4.0 9.0 5.5
covered
A room providing sound isolation from ambient noise is highly recommended so that
hearing threshold values may be obtained. If a separate examination (sound) room is
used, it is considered sufficiently quiet for the purposes of these tests if a group of
otologically “normal” listeners with their ears occluded is unable to detect any ambient
noise during the test period. See ANSI S3.1 (R2003) Criteria for Permissible Ambient
Noise during Audiometric Testing for maximum allowable outside octave band noise
levels with three prefabricated sound room types.
D-0129360 Rev A Page 18 of 231

Transducer Sound Attenuation
Sound Attenuation for Earphones per ISO 4869-1

Attenuation
Frequency (Hz) DD45s with IP30 insert
MX41/AR or PH51 earphones (dB)
Cushion (dB)
125 3 33
160 4 34
200 5 35
250 5 36
315 5 37
400 6 37
500 7 38
630 9 37
750
800 11 37
1000 15 37
1250 18 35
1500
1600 21 34
2000 26 33
2500 28 35
3000
3150 31 37
4000 32 40
5000 29 41
6000
6300 26 42
8000 24 43
D-0129360 Rev A Page 19 of 231

INTRODUCTION
Thank you for purchasing the GSI Audera Pro™ system. GSI Audera Pro can perform all
standard auditory evoked potential tests and, depending on the configuration, auditory
steady state responses and otoacoustic emissions tests.
INDICATIONS FOR USE

The GSI Audera Pro is intended to be used for the stimulation, recording and
measurement of auditory evoked potentials, vestibular evoked myogenic potentials,
auditory steady state responses and otoacoustic emissions. The device is indicated for
use in the evaluation, identification, documentation and diagnosis of auditory and
vestibular disorders. The device is intended to be used on patients of any age.
The GSI Audera Pro is intended to be used by qualified medical personnel such as an
audiologist, physician, hearing healthcare professional, or trained technician. The GSI
Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a
suitable quiet testing environment.
The anatomical sites of contact for auditory evoked potential (AEP) testing are the
patient’s ear canal (with the contact object being a sound delivery eartip or headphone,
or an ear probe and personal eartip) and the patient’s scalp and possibly other body
sites (with the contact object being a bone transducer or electrodes that are capable of
measuring bio-potentials). The anatomical sites of contact for vestibular evoked
myogenic potential (VEMP) testing are the patient’s ear canal (with the contact object
being a sound delivery eartip or headphone, or an ear probe and eartip) and the
patient’s head and neck and possibly other body sites (with the contact object being a
bone transducer or electrodes that are capable of measuring bio-potentials). The
anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the
patient’s ear canal (with the contact object being an ear probe and eartip).
CONTRAINDICATIONS
EP, ASSR, and OAE testing requires insertion of insert earphones or an OAE probe tip
into the ear canal. Ear canal examination with an illuminated otoscope is an essential
prerequisite to successful testing. Testing should not be performed on patients with
conditions listed below without a medical doctor’s approval.
• Impacted cerumen
• Recent stapedectomy or another middle ear surgery
• Discharging or draining ear
• Acute external auditory canal trauma
• Discomfort (e.g. severe otitis externa)
• Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may
contraindicate testing when high intensity stimuli are used
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In VEMP testing, a loud stimulus (90-95dB nHL) is often required to elicit the desired
response. VEMP testing contraindications1 include:
• Presence of tinnitus, hyperacusis or other sensitivity to loud sounds

• Conductive hearing loss caused by middle ear effusion, perforated eardrum or
otosclerosis which may decrease the intensity of the stimulus such that the
response is significantly reduced or absent
Recording cVEMP requires the patient to turn their head to the right and left of center to
a minimum of a 45-degree angle such as to contract the sternocleidomastoid (SCM)
muscle and therefore the contraindications include (in addition to the above mentioned
for VEMP testing):
• Cervical spine, neck issues or pain that prohibit head turn

• Cervical spine, neck issues or pain that prohibit the patient from performing and
maintaining the contraction the SCM muscle for the duration of the test
Recording oVEMP requires the patient to gaze upward and therefore the
contraindications include (in addition to the above mentioned for VEMP testing):
• absence or damage to the eyes or eye musculature

• inability to gaze upward for the duration of the test
If there is any doubt, then a medical opinion should be sought prior to testing. In all
cases the test should be terminated if any signs of discomfort are displayed.
1
References: Rosengren SM, Welgampola, MS and Colebatch JG. “Vestibular evoked
myogenic potentials: past present and future.”, Clinical Neurophysiology (2010) 121:
636-651; British Society of Audiology, Information document “Performing Cervical
Vestibular Evoked Myogenic Potential Measurements (2012)”; Audiology Online
“.Vestibular Evoked Myogenic Potentials (VEMP): How Do I Get Started?”; E.S.
Papathanasiou et al, “International guidelines for the clinical application of cervical
vestibular evoked myogenic potentials: An expert consensus report”. Clinical
Neurophysiology 125 (2014) 658–666
D-0129360 Rev A Page 21 of 231

MODALITIES
The Audera Pro system may be purchased with optional modality licenses allowing you
to perform different tests.
Evoked Potentials (EP)

An evoked potential is an electric response from the nervous system following the
presentation of a stimulus. This is a distinct response that is embedded in the
spontaneous EEG activity that can be measured and recorded. Signal averaging is a
technique used to isolate the EP response. It is assumed that the EP response is
synchronous with the onset of a stimulus; therefore, it will emerge in a predictable
shape within a specific timeframe of the stimulus and the random EEG background
signal will “cancel” out – leaving the desired EP response.
Auditory evoked potentials (AEP) may be used to evaluate the integrity of the auditory
system and are used to make inferences about hearing. AEPs encompass a series of
neurologic events that travel along the entire length of the auditory pathway – from the
cochlea to the auditory cortex. There have been many AEPs identified within the first
500 milliseconds post-stimulus onset. To identify the neural integrity of the auditory
system, it is necessary to consider the size and latency of the response and utilize
averaging and stimulus parameters to elicit and isolate the AEP of interest.
Vestibular-Evoked Myogenic Potentials (VEMP)

Short-latency potentials evoked through activation of vestibular receptors using sound
or vibration are referred to as vestibular-evoked myogenic potentials (VEMP). VEMPs
are generated by modulated electromyographic signals and recorded with surface
electrodes. A VEMP recorded from the sternocleidomastoid muscle is commonly
referred to as the cervical vestibular-evoked myogenic potentials (cVEMP). A VEMP
recorded from the inferior oblique muscle has been termed the ocular vestibular-
evoked myogenic potentials (oVEMP). These potentials appear to originate from the
otolith organs and thus complement existing methods of vestibular assessment, which
are mainly based upon canal function. VEMPs are used clinically to assess the function
of the saccule, utricle, and the inferior and superior portions of the vestibular nerve.
Auditory Steady-State Response (ASSR)

The auditory steady-state response is an auditory evoked potential elicited in response
to an on-going, modulated tone stimulus. The response itself is an evoked neural
potential that is phase-locked to the modulation envelope of a complex stimulus. That
is, the neural response closely follows the time course of the modulation and when
elicited with modulated tones, can be used to predict hearing sensitivity in patients of all
ages. The response can be detected objectively at intensity levels close to behavioral
threshold.
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Distortion Products Otoacoustic Emissions (DPOAE)

Otoacoustic emissions are low level audio-frequency sounds that are produced by the
cochlea as part of the normal-hearing process. Distortion product otoacoustic
emissions are acoustic signals that can be detected in the ear canal of a person with
normal outer hair cell function, by stimulation of the auditory system with a pair of pure
tones at frequencies (f1 and f2). The resulting emission of interest is the distortion
product tone at the frequency 2f1-f2.
The instrument generates a series of test tones, directs them into the ear canal, and
then measures the level of the DPOAE tone generated by the cochlea. By using
different test frequencies, the device provides an estimate of outer hair cell function
over a wide range of frequencies.
Transient Evoked Otoacoustic Emissions (TEOAE)

Transient evoked otoacoustic emissions are acoustic signals that can be detected in the
ear canal of a person with normal outer hair cell function, by stimulation of the auditory
system with a series of wideband clicks.
The instrument generates a series of clicks, directs them into the ear canal, and then
analyzes the spectrum of the returning signal, separating the noise and emission. By
using band pass filters, the device provides an estimate of outer hair cell function over a
wide range of frequencies.
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UNPACKING THE SYSTEM

 It is recommended that you unpack your Audera Pro carefully making sure that
all components are removed from the packing materials.
 Verify that all components are included as shown on the packing slip included
with your shipment.
 If any component is missing, contact your distributor immediately to report the

shortage.
 If any component appears to be damaged in shipment, contact your distributor

immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
 Please check that all accessories listed below have been received in good
condition.
Notify the carrier immediately if any mechanical damage is noted. This will ensure that
a proper claim is made. Save all packing material so the claim adjuster can inspect it as
well. Notify your dealer or GSI when the adjuster has completed the inspection.
Save all the original packing material and the shipping container so the instrument
can be properly packed if it needs to be returned for service or calibration.
STANDARD COMPONENTS
All standard components are part of the medical device and suitable for operation in a
patient environment. No special handling or treatment is required prior to use.
• Audera Pro Base Unit and power cord

• Audera Pro Stand
• USB Cable (with ferrites)
• USB Software Bundle
• USB License and Calibration files
Included with EP/ASSR Option

• IP30 Insert Earphones
• DD45s headphones
• B81 Bone transducer
• Patient Electrode Cable (4-snap lead connection)
• Patient Electrode Cable (5-electrode lead DIN connection)
• EP Starter Kit, includes:
• Nu Prep Gel
• Ten20 Electrode Paste
• Electrode Linker (jumper cable)
• Reusable Disc Electrodes, 5 PC
• Neurology Surface Electrodes
D-0129360 Rev A Page 24 of 231

• ETB Standard Electrode Kit (Reusable Snap Electrode Leads, 5 Each)

• Gauze 2x2
• Micropore Tape (12 pk)
• Remote Impedance Display Box
• GSI Audera Pro Loopback Test Cable
• GSI Audera Pro Digital I/O Cable
Included with OAE Option

• OAE Probe
• Ear Tip Starter Kit
• OAE Probe Checker Cavity (Infant Ear Simulator)
Applied Parts
The applied parts are the headphones, insert earphones, bone oscillator, probe ear
tips, and the electrodes.
Operation near a shortwave or microwave therapy equipment may

produce instability in the Applied Parts. Avoid accidental contact between
connected but unapplied Applied Parts and other conductive parts
including those connected to protective earth.
OPTIONAL COMPONENTS
• Audera Pro Laptop Computer Kit
• SP90A Amplified sound field speakers
• Audera Pro Vemp Biofeedback Monitor Kit
• 120V Isolation Transformer kit
• 230V Isolation Transformer kit
• HP Office Jet Printer (6230 or equivalent)
• ECochG starter kit, includes:
• Cable for TM ECochG electrode
• TM Electrode for ECochG 10pcs
• Electrode gel
Connect only items that have been specified as part of the system or
specified as being compatible with Audera Pro system.
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GETTING STARTED
Contact your GSI representative with any questions you may have regarding the setup
and installation of the system.
COMPONENTS
Base Unit
Base Unit Stand
Transducers
The supplied transducers depend on the ordered system configuration.
SYSTEM ASSEMBLY
Placement of the Audera Pro base unit
The Audera Pro unit may be placed horizontally on a flat surface such as a desktop, set
vertically in the provided stand or wall mounted.
With a horizontal placement you may place a notebook computer on top of the base
unit. For vertical placement, the included stand is required. The base unit only fits
properly in the stand one way with the power supply on the base unit to the back of the
stand. To wall mount the base unit, remove the rubber feet from the bottom of the
unit. The removal of the rubber feet exposes the keyhole cut outs that may be used for
wall mounting.
The keyhole cut outs are 27 mm apart for horizontal placement

and 16 mm apart for vertical placement (center to center).
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System Setup Diagram
The Electrodes referenced in the diagram include the patient electrode cable connected
to the Audera Pro and the electrodes connected to the patient. The transducers include
the IP30 Insert Earphones, DD45s headphones, B81 Bone transducer and the OAE
probe. The specific transducer will depend on the test being performed and the options
purchased with the system.
The Audera Pro base unit is intended to be connected to other equipment

(PC) thus forming a Medical Electrical System. When connecting the system
please note the safety precautions mentioned in the Warnings and
Precautions section of this manual. You are responsible for the system
compliance with the requirements of IEC 60950-1 for IT equipment. If connecting the
device to any other electrical equipment besides the PC, such as the amplified speakers
or electrical devices connected to the Digital I/O cable, a separation (isolation)
transformer should be used.
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Connect the Cables

Switch off the system power before connecting or disconnecting any
system component(s) or accessories. Do not switch on any system power
until all cables have been properly connected and verified.
1. Connect the transducers to the base unit as indicated on the rear panel label
(red denotes right and blue for left)
2. Connect the patient electrode cable to base unit (EP systems)
3. Connect USB cable from base unit to PC (only use the provided USB cable)
4. Connect the power cable from base unit to the mains outlet
NOTE: The system ships with two patient electrode cables for systems that include
EP. Only one cable is attached to the unit. One cable has four snap connectors and
must be used with snap electrodes without leads attached. The four-lead snap cable
uses the same active (non-inverting) electrode for both channels. The five-lead
patient electrode cable is used with electrodes with leads that terminate in DIN
connectors. The five-lead patient electrode cable has a separate active (non-inverting)
electrode for each channel.
BASE UNIT REAR PANEL

Connections
Digital I/O Headphones or Sound Field
Power Cable
Cable Insert Earphones Speakers
On/Off Switch
OAE Probe Bone Patient

Cable Conductor Electrode Cable
USB Cable
D-0129360 Rev A Page 28 of 231

SOFTWARE INSTALLATION
Before installing the software confirm that the computer meets the minimum
requirements.
Minimum PC Requirements
• CPU: 2.0 GHz, Intel dual or quad core processor or better
• RAM: 4 GB (or minimum required by OS)
• Storage: 64 GB or larger
• USB Ports: 1 minimum
• Display: 10” or larger recommended
• Resolution: 1920 x 1080 minimum
• Touch screen or mouse/trackball
Supported Operating Systems

• Microsoft Windows® 10 Pro (64 bit)
Installation
To install this application, the user must either be an Administrator or know the
Administrator password.
1. Insert the GSI Audera Pro USB Software Bundle into an available USB port. If
auto-run is disabled, browse the USB drive and double click on the GSISetup.exe
file.
2. The Setup Dialog will be displayed.
3. Select the “Start” button to install
the software.
4. Follow any on-screen instructions
to complete the installation.
5. Once the installation is complete,
eject the Software Bundle USB.
6. Insert the GSI License and
Calibration Files USB.
7. Click on the
AuderaProLicense_Calib file. If you
are prompted to overwrite a file,
select ‘Yes’.
8. Remove the USB and store in a
safe location.
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Recommendations
The following recommendations will aid in the secure collection and storage of patient
data. Please contact a local administrator for help and guidance.
• Disable the “suspend USB” power option to ensure proper communication

between instrument and PC.
• Create backup of patients’ data regularly
• Store backup of data in a safe manner.
• To avoid data from being misused, if stolen, the data must be encrypted.
• Ensure that an appropriate virus & spyware software is installed, updated,
and effective.
• All users should have a unique login to the PC.
Upgrading the software

The procedure for an upgrade is the same as the initial installation of the software as
described above. However, there may be some differences and you should follow any
instructions provided with the upgrade media. Only apply the Audera Pro program
software updates and patches provided by GSI.
Uninstalling the software

1. Open the Windows Start Menu
2. Select Grason-Stadler
3. Select GSI Audera Pro Uninstall
When the prompt is presented to enter the password, enter the original system
password ‘gsi’.
D-0129360 Rev A Page 30 of 231

OPERATING AUDERA PRO

Before turning on power to the system ensure all cables are connected to
the instrument. Power on the instrument before connecting the electrodes
to the patient. Do NOT power on/off the instrument with the patient
connected. Do not touch the PC and patient simultaneously. The device
has an indicator light (top, right, front) that, when lit (green), indicates that the power is
on.
Launching Audera Pro Software

Double-click the shortcut icon on the desktop to open the GSI Audera
Pro application. It is also possible to open this application from
Start>Programs>Grason-Stadler>GSI Audera Pro>GSI Audera Pro.
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OPENING WINDOW
The opening window of the Audera Pro application has a menu and toolbar displayed at
the top of the window and the patient, system number and connection status displayed
at the bottom of the window.
Menu Toolbar
Selected Patient
System serial number

(board number)
USB Connection Status
The Opening Window Menu allows the user to select or add a new patient, configure the
system and facility information, set the operator login requirements, add operators,
review system logs, display a copy of the manual and display the software version
information.
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MENU OPTIONS
Patient
• New -displays the Patient Information dialog where new patient information
may be entered.
• Open – displays the Patient Selection dialog where a list of patients is presented,
a patient may be selected, and their data loaded.
• Edit - displays the Patient Information dialog where the current patient
information may be edited.
• Quit Audera Pro – presents a confirmation dialog and if confirmed exits the
program and returns to the operating system.
Settings
• Configuration – displays the Hardware Setup window. In order to enter the

Hardware Setup, you must enter the system password (default password is ‘gsi’).
• Normative Data – displays a password entry screen, then displays the
Normative data dialog where you may enter the peak latency information for the
latency/intensity graphs used with ABR.
• Other Application – provides a submenu with an additional program that may
be added to the opening window.
o VEMP – opens the VEMP analysis module
Operator
• Current – displays the operator that is currently logged in (if any).

• Login/Logout – displays the login dialog if a login is required.
• Require Operator Login – displays a password entry screen to allow changing
the setting. A check next to the menu item indicates that a login is required.
• Add/Remove Operator - displays a password entry screen, then the add
operator dialog to add/edit individual operators.
Database
• Review System Log – displays a system log dialog with the audit log of events.
The user can filter the data, print and export the events.
Help
• Manual – displays the program manual (this document) in a new window.

• About – displays the versions of the software and Grason-Stadler information.
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The Opening Window Toolbar allows the user to add a new patient, search and select a
patient or edit the patient information, launch program modules and login/logout.
OPENING WINDOW TOOLBAR
Icon Description
Add Patient - displays the patient information screen where the

patient information may be added
Open/Search Patient – displays the patient listing dialog and

allows the user to search and select a patient
Edit Patient – displays the patient information screen where the

patient information may be edited
EP – launches the EP program module
ASSR – launches the ASSR program module
DPOAE – launches the DPOAE program module
TEOAE – launches the TEOAE program module
VEMP – launches the VEMP analysis program module
Login – only displayed if an operator login is required and no

operator has logged in
Logout – only displayed if an operator login is required and an

operator is logged in
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Connection Status
The connection status icon indicates if the USB connection between the device and the
computer is established.
The checkmark indicates a good connection between the device and the
computer. New data may be collected, and previous patient data may be
reviewed.
The exclamation point indicates a good connection between the device and
the computer, but the device is not the device matching the license on the
computer. The information along the bottom left shows the device serial
number (expected board serial number) and (found board serial number).
The X indicates that there is no USB connection between the device and the
computer. You may still review previously collected data, but no new data
can be collected until a USB connection is established with the device.
PASSWORD
Some administrative items in the program require a password. The default password is
‘gsi’. To change the password, go to the Settings menu, Configuration. You will be
prompted for the password. When the Hardware Setup dialog is displayed, select the
Password menu item in the Hardware Setup and you will be prompted for the new
password.
TESTING
Each test modality has an icon on the toolbar. Select the icon for the test you wish to
perform. When the Test icon is selected, a message dialog is displayed as the program
loads and the system initializes. If the connection to the base unit via the USB cable is
not established, a warning message dialog is displayed with the option to continue (or
not). You may continue without the connection; however, the program will not be able
to collect new data, but you will be able to analyze existing data. A new test modality
window will open. Only one test modality window may be opened at a time. When you
exit from the test modality program, you are returned to the opening screen.
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HARDWARE SETUP
The Hardware Setup dialog provides a menu at the top.
• Hardware – displays the information on the system.

• Registration – displays the facility information used in the reports.
• Password – allows you to change the administrative password
• Restore – provides options to
o Restore Factory Hardware settings
o Restore Factory Calibration Values
Hardware
Most of the information on the system hardware screen is read only (Serial Number,
Channels, DSP, USB). The OS Bit will be set automatically based on the operating
system of the connected PC. The Line Freq. has a dropdown with selections of 50 Hz or
60 Hz and should match the frequency of the main power. The Response box is used to
enable/disable the Remote Impedance Display box option. The No Hardware checkbox
allows usage of the software when no hardware is connected – this will not check and
give the dialogs about not connected to a system via the USB cable. The Language
dropdown offers the selection of language used for the program menus and screens.
D-0129360 Rev A Page 36 of 231

Registration
The Registration screen provides fields for the facility information that is printed on the
report header. The Save button will store the information and the Print Registration
button sends the information to the default printer.
Password
The Password menu item displays the sub menu
with the Select Password option. The Select
Password displays a dialog where you enter the new
password. Enter the new password and press the
OK button. This dialog is presented twice to confirm
the new password.
A reminder dialog is displayed to indicate that you must Save the change. Use the Save
button on the hardware screen to store the new password.
Restore
The Restore menu provides a submenu where you may select to restore the hardware
settings and the calibration tables that were delivered with the system.
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NORMATIVE DATA
After entry of the administrative password, the Normative Data option displays the
Latency-Intensity table dialog. This dialog is used to define the shaded areas that are
displayed on the Latency-Intensity Graph in the EP module. Multiple sets of normative
data may be defined. The dialog has a menu at the top. There are 3 peaks (I, III, V) that
allow for a Start and End latency value to be entered. Each row has the stimulus level to
the left (dB HL). On the right, the option for the age range for the data set is selected.
Menu Options
File
• Current – displays the name of the currently loaded Latency-Intensity data file.
• Mode – displays either Standard or Special to indicate the type of Latency-
Intensity data file. The Standard data file has multiple tables that correspond to
the age options. The Standard data file is used to set the default normative data
set used in the EP module. The Special data file contain a single table and these
file types are loaded directly from the Latency-Intensity Graph window in the EP
module.
• Load Norms – this option presents a file open dialog where you select the file to
review/edit.
• Save Norms - this option stores the current data in the table to the current file.
D-0129360 Rev A Page 38 of 231

• Save Norms as - this option presents a file save dialog where you can name and
save the current data set.
• Save Norms as Defaults – stores the current Standard file as the default
normative data for the Latency-Intensity graph in the EP module.
• Erase Norms File – deletes the current norms file.
• Quit – closes the dialog.
Data
• Clear All Ages – clears the data from all the start and stop fields for all the tables
in the file.
• Clear Current Age – clears the data from all the start and stop fields for all the
peaks for the currently selected age.
• Clear Peak I Current Age – clears the data from all the start and stop fields for
Peak I for all the currently selected age.
• Clear Peak III Current Age – clears the data from all the start and stop fields for
Peak III for all the currently selected age.
• Clear Peak V Current Age - clears the data from all the start and stop fields for
Peak V for all the currently selected age.
OPERATORS
The Operator menu has the options for determining if users are required to log into the
program, logging in and out of the program, and adding new users. To add a new user,
select the Add/Remove Operator item from the Operator menu. The Password dialog is
displayed and after entry of the administrative password, the Operator Sign In dialog is
presented.
Enter the name, password, ID and Level for the new user. The Level field has options
from 0 to 5 with 0 being the most restrictive and 5 being administrator.
• Level 0: Data acquisition Only, Settings Menu and Backup Data is not available.
• Level 1: Data Acquisition and limited Back-up. Some settings may not be
available.
• Level 2 - 4: Same privileges as Level 1.
• Level 5: Administrator. Data acquisition, Data backup and Modify all settings
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Select the Add/Update User button to add the user. To delete a user, select the name of
the user from the drop down in the name field, then select the Delete User button. The
Exit button closes the dialog and returns to the Opening window.
SYSTEM LOG
The system log provides an audit trail for the activities performed on the system. When
the Review System Log is selected a new dialog is displayed showing the system activity.
The activity is shown as a table with the columns indicating the item detail and the rows
indicating the individual event. The Operator field will contain data only if a user has
logged in. The individual events will be one of the following:
• ACC – data access

• DMGDEL – delete patient
• ENTER – open a program module
• EPNORMS – access the normative data table
• EXIT – exit the program module
• HWSET – access the hardware setup dialog
• LOGIN – user sign into the program
• TEST – test a patient
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Below the data table are buttons to allow the printing and export to a text file of the
displayed activity log. The OK button closes the dialog. The list of log files is shown with
the system ID and date in the center bottom of the window and the Update button
loads the selected file. The left bottom of the dialog has the checkbox options for
sorting the data.
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PATIENT INFORMATION MANAGEMENT

The patient information should be entered prior to collecting data. The Opening
Window and each of the test modality modules allow the entry of patient information
and the search and selection of a patient from previous sessions. The patient entry and
search dialogs are the same across all the test modules. The patient information may
be accessed from the Patient menu or the Patient buttons on the Toolbar.
Patient Menu Patient Buttons on the Toolbar
NEW PATIENT
To create a new patient, the New menu item from the Patient menu or the
New Patient button from the toolbar is selected. When the New option is
selected, the Patient Information dialog is displayed. The Patient Information
dialog is where the patient demographics may be entered or edited. The Patient
Information dialog has four fields in the section at the top. A tabbed section for
additional information is in the center and function buttons are on the right side of the
dialog.
The Identifier, First Name and Last Name are required fields. The Identifier is
automatically generated using the system number and a date code. The Identifier field
is not editable. The First and Last Name fields cannot be left blank. A small icon to the
right of the field indicates that the information is required and missing. The Status
dropdown menu allows assignment of the patient status as completed or pending.
There are five tabs; Personal, Age, Contact, Medical and Summary that provide fields for
additional information. The information in the tabbed sections is not required, however
the birth date and gestation age may be needed if you use the latency-intensity
normative data graphs.
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Required information
indicator
Required
information
Function
Buttons
Tabs for optional

information
Patient Information Function Buttons
Saves the data and closes the dialog

Closes the dialog and does not save any changes
Clears the fields for entry of new patient information

Opens the patient selection dialog
Prints the patient information

Presents the Font dialog where a font selection can be made
for printing
Deletes the patient data. A confirmation dialog is presented.
The deleted patient cannot be recovered.
Opens the backup data dialog
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OPEN PATIENT
The Open patient option from the Patient menu or the Open patient toolbar
button displays a dialog with the list of patients that have been entered into
the system. Options within the dialog allow you to sort the list and to select a
patient. The highlighted row indicates the currently selected patient.
Along the top of the window are options to hide the patient names, display
demonstration data, choose the patient status and refresh the list.
When checked the patient name is

displayed in the list. When unchecked
the patient name is replaced by ‘HIDDEN’
for both the first and last name.
The program provides a demonstration
data file that may be used for training.
When this option is checked, the patient
list is replaced with the demonstration
patient name.
Displays the list of patients based on the
assigned status. The ‘All’ status displays
D-0129360 Rev A Page 44 of 231

all patients regardless of status

assignment.
Updates the display of the patient list.
Also, along the top of the window are the column header buttons: First Name, Last
Name, Patient ID and System Identifier.
These buttons allow the patient list to be sorted on the column field. The underlined
letter in the column name allows the keyboard to be used to sort the column. The sort
order is indicated by an arrow pointing up or down to indicate the sort order. To
reverse the sort order, select the column header button a second time.
The patient list occupies the center portion of the window and a scroll bar on the right
side may be used to scroll the patient list. The arrow keys may also be used to move up
and down in the patient list. The highlighted row indicates the selected patient and
additional information on the patient is shown on the right-hand side below the list.
Below the patient list on the left side is an indication of the directory where the patient
information is stored with an option to select a different directory location.
A confirmation dialog is presented before changing the directory to confirm that you
wish to change the location. Changing the location does not move any existing data and
it is your responsibility to keep track of the location before and after changing the data
directory. Below the directory information, is an option to search for a specific text
string in the patient list.
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Enter the search string then select either the Search Down or Search Up button to
perform the search. If the search string is found within the four search columns, the
record will be highlighted and become the current selected patient.
At the bottom of the Patient list dialog are four function buttons and a check box.
Closes the Patient List and opens the Patient

Information dialog with the information from
the currently selected patient.
Closes the Patient List. No patient is selected
but the previously loaded patient, if any,
remains as the active patient.
Closes the Patient List and opens the Patient
Information dialog with the information cleared
and ready for the entry of new patient
information.
Sends the patient information (not collected
data) for the highlighted patient to the default
printer.
Instead of printing a single patient, the list
above and including the highlighted row may
be printed when the check box is selected.
EDIT PATIENT
The Edit patient option from the Patient menu or the Edit patient toolbar
button displays the Patient Information dialog with the information from the
currently selected patient. If no patient is currently selected, it opens the
dialog without any information filled in, like a new patient. The Patient Information
dialog is the same for both New patient and Edit patient. After any edits select the Ok
button to save your edits.
D-0129360 Rev A Page 46 of 231

BACKUP PATIENT DATA

To back up your patient data, select the Backup button from the Patient Information
dialog. The Backup dialog initially populates the backup table with the current patient.
If New patient was selected to display the Patient Information dialog, the table will be
blank.
The Show All button on the right side may be used to display all the patients. The top of
the dialog displays the options for selecting the patients for backup. There are fields for
selecting a date range and checkboxes to select all or all that have not been backed up.
You may also click on an individual patient to select
The bottom of the dialog has buttons to select the directories for the data, perform the
backup and options to delete data.
D-0129360 Rev A Page 47 of 231

EVOKED POTENTIALS (EP)

When the EP icon is selected, the system displays the initialization dialog while
the EP module loads and then the main EP screen is presented. The EP screen
layout has a title bar at the top, the main menu under the title bar,
information bar below the main menu, and the top Toolbar in the upper part of the
screen. The middle of the screen contains the EP waveform area, the page selection
control and side toolbar. If the data acquisition page is selected, an EEG panel is
displayed and there is a collection toolbar at the bottom of the page.
Menu
Information Bar
EP Data Collection Screen
Toolbar
Page Selection
EP Waveform Area
EEG Panel
Side Toolbar
Collection Toolbar
TITLE BAR
The Title Bar at the top of the window contains the name of the program, software
version number, system serial number, and hardware identification number.
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EP MAIN MENU
The EP Main Menu allows access to most of the functions of the program.
Each of the Main menu selections have sub-menus:
Patient
• New – Opens the Patient Information dialog with the information cleared and
ready for the entry of new patient information.
• Open – Displays the Patient Selection dialog.
• Edit – Opens the Patient Information dialog with the information from the
currently selected patient.
• Clear Data on New Patient – Removes the EP data from the display when a new
patient is selected or entered.
• Quit EP – Closes the EP program
Protocol
• Settings – Indicates the current settings file and when selected displays the file
open dialog where you can choose a new settings file. The settings file contains
the information for the modality, stimulus and amplifier settings.
• Modality – The modality menu item has a sub menu with the test options
available. When a specific test item is selected you are prompted to load the
default settings for the test. The default settings include the stimulus, amplifier
and labels settings. The Auditory – eABR – Cochlear Implant (External Trigger)
tests require the digital I/O cable for the external trigger from the cochlear
implant stimulation device.
o Auditory
 ECochG
 ABR
 MLR
 LLR
 SN10
o Auditory – P300/MMN
 P300
 MMN
o Auditory – eABR – Cochlear Implant (External Trigger)
 ECochG
 ABR
 MLR
 LLR
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• Continuous Acquisition – When selected, data collection continues with the

same parameters after each average is complete. The data collection will need
to be stopped manually from the control bar when in this mode.
• Set SNR Estimation Region – The Signal to Noise Estimation Region menu item
contains a sub menu where you can specify the start and stop times for the
calculation. This option is password protected.
o Select SNR Calculation Region
o Select SNR Calculation Region from Cursor
o Update SNR Calculation Region for Active Recording
o Update SNR Calculation Region for All Recording on Page
• Residual Noise Auto Stop Level – This option allows you to specify a residual
noise level that, when reached, will automatically stop the data collection. To
turn off this feature, select the option and enter 0 as the value.
• Setup Automated Protocol – Opens the Protocol Setup dialog where you may
create a sequence of data acquisition test sets.
• Execute Automated Protocol – Opens the Protocol Selection dialog to select
the automated protocol. After the automated protocol is selected, data
acquisition is automatically started and stops after completion of the steps in the
protocol.
Stimulus
• Stimulus – Opens the Stimulus generation dialog where you may define the
auditory stimulus, type, presentation and transducer.
• Masking – Opens the Stimulus generation dialog where you may define the
masking level.
• Level Step Size – The Level Step Size displays a sub menu where you may select
the dB increase/decrease used on the control panel when collecting data. The
Other option will prompt for a number to be entered. Only whole numbers up to
20 may be entered. Any numbers above 20 will be treated as 20.
o 10
o 5
o 2
o 1
o Other
Amplifier
• Amplifier Settings – Opens the Amplifier Settings dialog. The Amplifier Settings
dialog provides control for the gain, artifact reject levels and filters for each of
the amplifier channels.
• Amplifier Blanking Time – The Amplifier Blanking Time is used with the
Auditory eABR test modalities. If the Auditory eABR is the selected test modality,
and you select the option, then a dialog is presented where you enter the
amplifier blanking time. The amplifier blanking time is the time in the recording
where the gain is reduced to prevent the amplifier from over saturating as can
D-0129360 Rev A Page 50 of 231

occur from the electrical stimulus. You should make sure that the blanking time
is less than the beginning of the response.
• Digital Filter – Option to turn on/off the digital filter that is used with the
incoming collection data. The Digital Filter settings are used to define the digital
filter and since the filtering is performed on the acquisition data it cannot be
undone.
• Digital Filter Settings – The digital filter settings displays the current digital filter
settings and a sub menu where you may define the high and low pass filter
settings. These filter settings are applied to the collection data when the Digital
Filter option is enabled.
o Select High Pass
o Select Low Pass
Recordings
• Path – Displays the location where the data is stored.
• Load Recordings – Opens the Data Files dialog where you may select the
records from the current patient to load to the display for analysis.
• Load Recording from Protocol Results – Opens the Protocol Data Files dialog
where you may select the specific protocol and load recordings collected with
that protocol.
• Save Active Recording – Saves the currently selected recording.
• Save All Recordings – Saves the all the recordings on all pages.
• Save Active Recording As – Allows the currently selected record to be saved as
a different modality type or to a specific file name. Files names use a specific file
naming format that should be followed if the data is to be available to the
program.
o Specific File Name
o ECochG File
o ABR File
o MLR File
o LLR File
o P300/MMN
o cABR File
• Save as ASCII – Allows the data to be saved in a tab delimited text file. The
active waveform or all the data on the page may be saved based on the sub
menu selection.
o Active
o All on Page
• Auto Comment – Opens the comment dialog where you may enter a comment.
This comment is appended to each new test record that is collected until it is
changed, or the program restarted.
D-0129360 Rev A Page 51 of 231

Averaging
• Block Averaging – Displays the block size and opens a submenu where you may
select the number of sweeps that are used in the block average. Block averaging
divides the data into sets or blocks of data with an average preformed for each
block. This method of averaging is not available for all test modalities and is
used for the computation of the weighted average.
o Off
o 2 Sweeps
o 10 Sweeps
o 20 Sweeps
o 50 Sweeps
o 100 Sweeps
• Calculate Bayesian Weighted Average – Calculates the weighted average for
the active waveform. The recording must have been collected using block
averaging for the weighted average to be calculated. Bayesian weighting uses
the average of the individual blocks compared to the overall average to assign a
weight to each block and then computes the overall average based on the
assigned weights.
• Calculate Bayesian Weighted Average All on Page – Calculates the weighted
average for all the waveforms on the page. The recordings must have been
collected using block averaging for the weighted average to be calculated.
Process
• Addition/Subtraction Mode – Displays the mode used for adding and
subtracting waveforms and opens a sub menu where you may select the mode.
The Sweep Weighted mode takes into consideration the number of sweeps
contained in each recording and adds or subtracts the waveforms
proportionally. The uV Weighted mode performs a direct add or subtract
between the waveforms treating the waveform as a single sweep.
o Sweep Weighted
o uV Weighted
• Add Selected Recordings (+ key) – Adds the selected recordings and displays a
new calculated recording, using the chosen add/subtract mode option. To select
multiple recordings, hold down the [Ctrl] key while selecting the recordings. The
new recording must be saved manually.
• Subtract Two Selected Recordings (- key) – Subtracts the selected recordings
and displays a new calculated recording, using the chosen add/subtract mode
option. To select multiple recordings, hold down the [Ctrl] key while selecting the
recordings. The new recording must be saved manually.
• Compare Two Selected Recordings – Enables the comparison between right
and left ears. The comparison displays the difference in amplitude and latency
for the selected waves. The selected waveforms must have been recorded with
similar parameters. The comparison information is displayed in a pop-up dialog
D-0129360 Rev A Page 52 of 231

or on the waveform information panel. The comparison data made be added to

the page for reporting.
• Invert Active Recording – Flips the active recording upside-down.
• Filter – Displays the Filter sub menu. On the sub menu the current filter type is
displayed, and you may select the option to choose a new filter type. Filter types
include smoothing, bandpass and notch filters. The other sub menu items allow
you to filter the active waveform or all waveforms on the page.
o Filter Type
o Active Recording
o All on Page
• Duplicate Active to New Recording – Creates a copy of the selected waveform
to a new recording. The new recording must be saved manually.
• Cross Correlate – Performs a cross correlation calculation for the selected
waveforms. The cursors must be active and used to define the comparison time
start and end. The calculation is displayed in a pop-up dialog.
o Two Selected Recordings
o Within Active Recording
o Active Recording with All on Page
• Split Active Recording – Separates the two internal recording buffers for the
active waveform into two separate waveforms.
Display
• Acquisition Auto-Arrange by – Displays the sort order of the waveforms for the
data acquisition and opens a sub menu where you can choose the order. When
an option is selected the program updates the display as each recording is
completed. To remove the automatic sort order, select None from the sub
menu.
o Intensity
o Acquisition Order
o Stimulation Rate
o None
• Automatically Adjust Size – Sets the vertical spacing between waveforms based
on the number of waveforms acquired on the page. This option is a toggle and is
On by default.
• Arrange by Intensity – Arranges the waveforms on the page by the stimulus
level. The highest level is placed at the top. If you are on a split screen layout or
your data contains both right and left ears, the left and right ear waveforms will
be placed on separate sides.
• Arrange by Intensity (Overlapping Channels) – Arranges the waveforms on
the page by the stimulus level. The highest level is placed at the top. If you are
on a full screen layout, the left and right ear waveforms will be overlapped.
• Arrange by Acquisition Order – Arranges the waveforms on the page by the
time the data was collected. The earliest acquired waveform is placed at the top
D-0129360 Rev A Page 53 of 231

and the latest at the bottom. If you are on a split screen layout or your data
contains both right and left ears, the left and right ear waveforms will be placed
on separate sides.
• Arrange by Stimulation Rate – Arranges the waveforms on the page by the
stimulus rate used for the data collection. The faster stimulus rate for the
acquired waveform is placed at the top and the slowest rate at the bottom. If
you are on a split screen layout or your data contains both right and left ears, the
left and right ear waveforms will be placed on separate sides.
• Display Recording Label – Opens a sub menu that allows you to display
additional information about the recording. The information is placed below the
waveform under the waveform handle and stimulus level information. The
stimulus information indicates the AC/BC for air/bone conduction and the
stimulus type and ear abbreviation. The Rate information displays the rate in
stimuli per second.
o Stimulus Information
o Rate Information
• Display Text next to Peak Label – When you have marked a point on the
waveform, you have an option to display the latency and amplitude information
next to the peak label. The menu option opens a sub menu that allows you to
choose which data to display or remove the peak text labels.
o Apply to Acquired Data
o Apply to All Data
o Apply to All Data on Page
o Apply to Selected Data
o Remove from All Data
o Remove from All Data on Page
o Remove from Selected Data
• Display Baseline – places a horizontal line (at 0 uV) through each waveform.
The checkmark indicates the status (On/Off). This option is a toggle and is Off by
default.
• Display Cursors – Displays/hides 2 vertical cursors at the beginning of the time
plot. The cursor handle at the bottom of the cursor is used to select and move
the cursor. The checkmark indicates the status (On/Off). This option is a toggle
and is Off by default.
• Display Zero-Time Position – Displays a vertical line to indicate time 0 on the
axis. The checkmark indicates the status (On/Off). This option is a toggle and is
Off by default.
• Display Latency-Intensity Graph – Displays the Latency-Intensity graph dialog.
The marked peaks on the current page are plotted on the graph. The graph and
the table of values is presented in the dialog. Options to copy the graph to the
analysis page, print and save the graph are available in the dialog.
D-0129360 Rev A Page 54 of 231

Report
• Load Report – Opens the Load Report File dialog where you may select a saved
report. If you currently have data displayed, a warning message is displayed that
requires confirmation that the data will be replaced by the report data.
• Save Report – Opens the Save Report File dialog where you may save the
waveforms and other elements and their positions on the page as a report.
• Add – The Add option presents a sub menu with selections to add elements to
the report page. Some elements are static meaning that data does not change
even if the waveforms on the page change while others are dynamic where the
data automatically changes when the recordings change (such as marking
peaks). The static elements may be edited manually as needed. The dynamically
elements should not be edited manually as the edits will not be maintained
when the data is updated. The Text and Label elements both open the text
editor dialog. The Label element is only for a single line, any additional lines are
ignored. The add Image option allows the inclusion of graphic elements such as
audiograms from the ASSR module or DP-grams from the DPOAE module or
other bitmap images.
o Text
o Text – Demographic Information (Static)
o Text – Active Recording Information (Dynamic)
o Text – Active Recording Information (Static)
o Table (Dynamic)
o Table (Static)
o Label
o Image (Press {+} to increase OR {-} to decrease image size)
• Clear – Opens a sub menu with options to remove report elements from the
selected item, all items on the page or all items on all pages. The Clear &
Permanently Delete option presents a warning dialog to confirm that you wish to
permanently remove the item. Permanently removing items cannot be undone.
o Selected
o Page
o All Pages
o Clear & Permanently Delete Active Recording from Disk
• Page Labels – Open a sub menu with options for the labeling of the data display
pages. When a page is selected two dialogs are presented where you may enter
the new label and description for the page. The labels that appear on the side
menu are limited to 4 characters and are entered in the Page Button first dialog.
The description which appears as a tool tip and on the report is entered in the
Page Print second dialog. The Load Page Labels option allows you to use a
previously saved set of page labels. The Save Page Labels option saves the
current page labels to a file and the Save Page Labels as Default saves the
current labels and uses them when the program is started.
o Page Acq
D-0129360 Rev A Page 55 of 231

o Page 1
o Page 2
o Page 3
o Page 4
o Page 5
o Page 6
o Page 7
o Page 8
o Page 9
o Load Page Labels
o Save Page Labels
o Save Page Labels as Default
Print
• Deidentify Printouts – The option displays/removes the identifying patient
demographic information from the report print out. The checkmark indicates
the status (On/Off). This option is a toggle and is Off by default.
• Print Page – Sends the current page to the printer.
• Print Page PDF Preview – Displays the report page in a preview window using
the PDF viewer.
• Print All Pages – Sends the all pages to the printer.
• Print All Pages PDF Preview – Displays the all the report pages in a preview
window using the PDF viewer.
• Line Thickness – Opens a sub menu where the thickness for the printout of the
waveforms may be selected.
o 1 ------ (Thin)
o 2
o 3
o 4
o 5 ====(Thick)
• Black and White – Prints the report in black and white instead of color. If you
are using a black and white printer this option should be selected as some colors
do not render well on a black and white printer.
• Automatic Tables – Display a waveform information table automatically at the
bottom of the page when selected. The checkmark indicates the status (On/Off).
This option is a toggle.
• Multi-Page Format – Allows the report page data to extend beyond a single
page. If the option is not selected, the program will fit the data to a single page
(per test type) which may cause some data to be truncated to fit. The checkmark
indicates the status (On/Off). This option is a toggle.
• Printer Setup – Opens the Windows Printer setup dialog.
Help
• Manual – Displays the user manual in a new window.
D-0129360 Rev A Page 56 of 231

• About – Displays the program version information in a pop-up dialog.
INFORMATION BAR
The Information bar shows general information about the patient and the currently
selected waveform and is located below the Main Menu. The Information bar displays
the following:
• Patient Identifier
• Recording name
• Peak-to-peak amplitude (PP)
• Signal-to-noise ratio (SNR)
• Residual noise (RN)
• Cursor amplitude position
• Cursor time position
D-0129360 Rev A Page 57 of 231

TOOLBAR
Below the Information bar, there is a Toolbar with icons that are equivalent to the most
used menu items.
Icon Description
Add Patient – displays the patient information screen where the

Search Patient – displays the patient listing dialog and allows the
user to search and select a patient

Load EP File – displays the list of EP files and allows the user to
sort and select an EP file
Save EP File – saves the currently selected EP file
Load EP Report File – displays the Open dialog with the list of EP
report files and allows the user to select an EP report file
Save EP Report File – displays the Save As dialog and allows the
user to save the current pages as an EP report file
Mark Peak Labels – when a label is selected, allows the user to

mark the peak of a waveform with the label by clicking above the
peak with the mouse
Show/Hide Cursors – toggles the display of the two cursors, the

cursors are displayed on the left side of the waveform and may
be moved by selecting the handle and dragging to the desired
position
Arrange by Intensity – displays the waveforms sorted by stimulus

level from higher to low, overlapping the waveforms of the same
level
D-0129360 Rev A Page 58 of 231

Arrange by Acquisition Order – displays the waveforms sorted by

the time the data was collected from oldest to most recent
Arrange by Rate – displays the waveforms sorted by stimulus

rate from higher to low
Latency-Intensity Graph – opens a new window and displays the

marked peaks in a Latency-Intensity graph
Filter Active – filters the selected waveform using the current

filter type
Full/Split Page – toggles the record display area between full

page and split page
Add Text – opens a new dialog where the user can enter new
comments or load comments from a file
Print Page – displays a drop-down menu where the user can

select to print the current page or all pages
PDF Print Page – displays a drop-down menu where the user can
select to print the current page as a PDF file preview or all pages
as a PDF file
Clear Selected – erases the currently selected waveform
Clear Page – erases all the waveforms on the current page
Clear All Pages – erases all the waveforms on the all the pages
Open Manual – opens a new window with the program manual

(this document) displayed
D-0129360 Rev A Page 59 of 231

EP WAVEFORM AREA
The white area at the left and center of the screen contains all recordings collected or
loaded. There is a time scale at the bottom of this area and at the top left, a vertical
scale marker. There are ten recording display pages that correspond to report pages
and accessible from the Page Selection Control.
PAGE SELECTION CONTROL

The Page Selection Control has buttons corresponding to the acquisition page
and 9 other report pages. Only one page may be viewed at a time. The Acq
page is where the data that is currently being collected is displayed. Data may
be loaded on any page. The scroll bar allows movement up and down on the
page.
SIDE TOOLBAR
The Side Toolbar is located to the right of the EP waveform area. It has buttons
for setting page display parameters, increase/decrease the waveform display, check
impedance, display the amplifier dialog and to show/hide the recording information.
Icon Description
Page Settings – displays a pop-up menu with the display

parameters for the waveform scaling and time base
Increase Size – increases the size of the waveforms displayed on

the page
Decrease Size – decreases the size of the waveforms displayed

on the page
Check Impedance – displays the impedance values of the

electrodes under the EEG panel. The Remote Impedance box
may also be used to initiate an impedance test.
EEG and Amplifier Settings – displays the Amplifier Settings and

EEG dialog allowing the user to change the settings
Display/Hide Recording Information – toggles the recoding

information panel which displays the information on the
currently selected waveform
D-0129360 Rev A Page 60 of 231

EEG PANEL
Artifact Area
EEG
Artifact Level Adjustment
Channel Selector
The EEG Panel is displayed when the Acquisition (Acq) page is displayed. The incoming
EEG is displayed and an indication of where the EEG is checked for artifact is shown in
red. The artifact reject level may be adjusted using the Open-Close scroll bar. Opening
the bar will allow larger EEG into the average and Closing the bar will reject EEG with a
lower amplitude. The percentage of the total amplifier gain is displayed under the scroll
bar. The channel that is being displayed is indicated on the button in lower right and if
the button is clicked you may choose which EEG channel to display.
Below the EEG panel is a section for the display of impedance values. When the Check
Impedance Before Testing box is checked, an impedance test is performed when the
data acquisition button is pressed. The results are displayed with a timestamp when
the test was performed.
D-0129360 Rev A Page 61 of 231

COLLECTION TOOLBAR
The Collection toolbar contains frequently used data collection controls. The Collection
Toolbar is only displayed while on the Acquisition page (Acq.).
Icon Description
Starts the data collection using the current parameters
Replaces the Acquire button after data collection has started.

When selected during collection, the recording is paused. The
user may continue acquiring or stop acquiring.
Allows you to add averages to the current recording after

acquisition has completed. In order to continue a recording,
you must increase the number of sweeps but keep all other
parameters the same. A new recording will be created with the
additional sweeps. The original will remain unchanged.
Replaces the Continue button during collection. Selecting will

discard sweeps (zero the average) and restart data collection.
Indicates the current auditory stimulus level. A Right Click

increases the level by the step size defined in the stimulus
menu. A Left Click decreases the level and a Double Click
presents a dialog where the user may enter a value. As the
level is increased, the color of the text will change from white to
yellow to red as a warning for high stimulus levels.
Replaces the Intensity button when the auditory modality is

P300. When the button is selected a P300/MMN Setup Dialog is
presented.
Indicates the transducer ear to be stimulated. Right or Left

Click toggles through the options of Right, Left or Both.
Indicates the current stimulus to be used with the collection. A

Left Click displays the Auditory Stimulus Dialog.
D-0129360 Rev A Page 62 of 231

Indicates the polarity of the stimulus. Right or Left Click toggles

through the options of Rarefaction, Condensation or
Alternating.
Indicates the current auditory stimulus rate. A Right Click

increases the level by 10/s. A Left Click decreases the level by
10/s and a Double Click presents a dialog where the user may
enter a value.
Indicates the current number of sweeps to be collected. A Right

Click increases the number by 2 times. A Left Click decreases
the number by half and a Double Click presents a dialog where
the user may enter a value.
Indicates the post-stimulus recording time. A Right Click

doubles the window by 2 times. A Left Click decreases the
window by half and a Double Click presents a dialog where the
user may enter a value (see below on window and sample rate).
Opens a dialog where the user may select a settings file and
loads the parameters to the program.
Opens a dialog where the user may save the current settings in
the program to a settings file
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Window and Sample Rate

Choosing the Modality test type from the Protocol menu automatically sets the
window size. When you Double Click on the Window button in the Collection Toolbar
you are prompted to Enter Sampling Period in Intervals of 25 uS. This value defines the
time distance between samples in the recorded response. Each recording has 1024
data points, half of those are part of the pre-stimulus recording region and the other
half of those are part of the post-stimulus recording region (the Window). The table
shows this relationship between Sampling Periods and Windows.
Sample Period Post Stimulus Window

uSec ms
25 12.8
50 25.6
100 51.2
200 102.4
300 153.6
400 204.8
500 256.0
600 307.2
700 358.4
800 409.6
900 460.8
1000 512.0
When the Window is changed, the

horizontal scale at the bottom of the
page will be modified
automatically. If the Window is
changed after there are recordings on the page, the recordings will either get trimmed if
the time is reduced or shrunk if the window is extended. Changing the time setting
after acquisition will not modify a recording or it’s resolution, only the region displayed.
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AUTOMATED PROTOCOL DIALOG

The Automated Protocol dialog allows you to specify a series of steps that may be used
to automatically collect your data. The Item defines each step (set of parameters) in the
sequence. Items are consecutively numbered. The Count determines the number of
times the Item is run. The dialog is divided into sections that define the parameters for
each step.
New items are added to the protocol with the Insert Item button. The Delete Item
button deletes the item. Move between items using the Next and Previous buttons.
The Count determines the number of times the step is run. Enter a number in the
Count to run the step multiple times. Entering a number will activate the settings
selections.
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The Count may also be defined to perform a specific action as determined by the radio
buttons below the count field. The Repeat option runs the protocol two times (the
same as entering 2 for the count). The Stop option tells the sequence to end. The Link
option allows you to connect to another protocol – a dialog is presented where you
chose the protocol to link. The Move Data is used in conjunction with the dropdown
menu items in the “Move Acq. Page Data to” section to indicate which page to move the
data to and the order that the data is presented on the page. The checkbox for Save
Report will automatically save the collected data to a report. The parameters for the
Item are defined in the Stimulus, Acquisition and Amplifier sections. The parameters
are initially assigned the Default value. Leaving the parameter as Default means that
the protocol will use the values that are currently set in the Collection toolbar when the
protocol is executed.
Selecting the checkbox for the parameter allows you to change the setting. In many of
the fields the checkbox acts as a toggle between the options for the field. For example,
clicking the Ear checkbox the first-time changes from Default to Both, a second click
changes to Right, a third click changes to Left and a fourth click changes back to Default.
Some fields will pop up a dialog to enter the value such as Intensity, Rate, Sweeps and
Sample. The Stimulus and Masking fields display the Stimulus dialog when checked.
The Protocol File Options section provides the file control buttons.
The Load button displays a file open dialog where you may choose an existing protocol.
The Save button and the Save As button popup a dialog where you can name and save
the protocol. The Delete File deletes the currently loaded protocol file after a
confirmation. The Clear All resets the parameters of the currently loaded protocol after
a confirmation. The OK button closes the dialog.
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STIMULUS DIALOG
The Stimulus dialog is displayed when the Stimulus\Stimulus is selected from the menu
or the Stimulus button is clicked from the Collection Toolbar. The Stimulus dialog
presents the user with the options for defining an auditory stimulus. The top of the
dialog defines the stimulus type which includes Click, Tone Burst and File.
The Click stimulus is defined in microseconds and is specified in the Duration field. The
duration should be specified in increments of 25 uSec and defaults to 100 uSec. The
Cycles option for Duration is not applicable for a click stimulus.
The Tone Burst stimulus duration parameter that may be defined in uSec or cycles. An
additional field is provided for defining the tone burst frequency.
D-0129360 Rev A Page 67 of 231

The File stimulus type presents a dialog where you may select a stimulus file (*.STM).
The stimulus may be a file previously saved using this Stimulus dialog or may have been
provided with the installation.
The Tone Burst option also allows the specification of the envelope of the tone burst.
Envelopes shape the rise and fall of the stimulus. If you need to specify a Tone Burst
stimulus that includes the rise, plateau and fall parameters you need to select either the
Trapezoidal or Extended Cosine envelope. The total duration is specified in the
Duration field and the rise/fall specified in the Envelope Rise/Fall field. The plateau
would be the difference between the total duration and the rise plus fall. For example,
if you wish to specify a 2-1-2 (rise-plateau-fall) cycle tone burst, you would select the
cycle option in Duration and enter 5 (2+1+2) in the field. You would then choose the
appropriate envelope and enter 2 in the Rise/Fall field.
The Rectangle, Cosign Sqr. (Hann), Blackman, Gaussian envelopes do not have a user
specified field for the rise/fall parameter. These envelopes have a 0 plateau and the rise
and fall are each equal to half of the specified duration. The Gaussian envelope is
specified in cycles for duration and should be in increments of 0.5 to ensure a smooth
transition.
The Stimulator section allows you to choose the transducer that will be used for the
stimulation.
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NOTE: The Audera Pro supports both headphones and insert earphones. These
transducers plug into the same connectors on the back of the device and it is
important to make sure that the correct transducer is connected and matches the
one selected for the stimulation.
The Stimulus Presentation option allows you to specify if the stimulus always remains
on or is only presented during the collection of data.
Masking noise may be provided to the contralateral ear. The masking signal is white
noise. To enable masking, check the Contralateral check box.
The Masking Level may be specified in two different ways. The Specific level provides
the masking at the fixed level specified in the dB SPL field regardless of the stimulus
level. The Tracking level delivers the masking noise at a level relative to the stimulus
level. When the Tracking level is selected, the dB SPL field represents the offset relative
to the stimulus. For example, -20 would indicate that the masking would be presented
at 20 dB less than the stimulus and as the level of the stimulus changes so would the
masking. Any masking level above 100 dB SPL will display a warning message and
require confirmation to proceed.
The Mode option allows you to specify the reference level that is used for the stimulus.
The HL option applies the correction values from Sound Pressure Level to Hearing Level
that are defined in the SPL to HL Table. The Total Calibration section displays the
correction values that are applied to the stimulus.
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The File Calibration, Calibration Table and SPL to HL Table buttons display the values
used in the overall total calibration.
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Calibration Table
The Calibration Table button is available for the Click and Tone Burst stimulus. A
password is required to enter the Calibration Table. The table shows the calibration
values for each stimulator. The Calibration Table dialog shows the correction,
maximum and minimum sound output values, as well as the stimulus delay time for use
with the insert earphones.
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SPL to HL Conversion Table

The SPL to HL button will be available for the Click and Tone Burst stimulus types. A
password is required to enter the SPL to HL Table.
The values correspond to HL conversion.
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File Calibration Table

The File Calibration button in the Stimulus dialog is available for the File type stimulus.
This window shows the current file calibration, maximum, and minimum. Stimulus files
may have been calibrated directly or they might be calibrated as an offset to a pure
tone frequency. The top left of the dialog window shows the values for the stimulus
files that have been directly calibrated. Stimulus files using offset calibration will show
their offset at the bottom left of the window.
NOTE: Although values can be modified from all the Calibration and SPL to HL Table
windows, it is recommended that values are only modified by GSI authorized
personnel that are qualified to perform a system calibration.
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The bottom of the Stimulus Dialog section provides the file control buttons.
The OK button closes the dialog and applies the current settings. The Cancel button
closes the dialog and discards any changes that were made. The Load button displays a
file open dialog where you may choose an existing stimulus. The Load is the same as
selecting the File Stimulus Type. The Save button presents a dialog where you can
name and save the stimulus with the current settings. The Display button presents the
Stimulus Display dialog.
Stimulus Display Dialog

The Stimulus Display presents a time and frequency graph of the stimulus.
The << and >> buttons are used to show the stimulus whose time base extends beyond
the X axis of the graph. The Print button allows you to send a screen dump of the dialog
to the printer. The OK button closes the Stimulus display dialog.
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P300/MMN SETUP DIALOG

The P300 or MMN (Mismatched Negativity) test type is selected with the
Protocol\Modality menu item. When the P300 or MMN Modality is selected the
Stimulus Level button is replaced by the Setup P300 button on the Collection Toolbar.
When the Setup P300 button is selected from the Collection Toolbar, the P300/MMN
Setup Dialog is displayed.
The P300 test is usually performed using the oddball paradigm, in which low-probability
target items are mixed with high-probability non-target (or “standard”) items. The
standard stimulus is specified in buffer 0 and the buffer is activated by selecting the
checkbox. The intensity, stimulus and ear are specified in the Buffer 0 row. The %
Present is automatically calculated for Buffer 0 based on the other active buffers %
Present values. Each of the other buffers (target stimulus) are activated by checking the
Active box and have a specified level and file for the stimulus. The % Present
determines the probability of that target stimulus being delivered. The total number of
sweeps for the target is specified in the Collection Tollbar Sweeps item. The Default
setting for Stimulation Ear indicates that the Ear set in the Collection Toolbar will be the
stimulus ear.
The Acquisition Channels checkboxes determines which acquisition channels are

collected. The data for the standard stimulus is presented in A0 for Channel A and B0
for Channel B, the target recording displayed in A1 and B1. The Load button displays
the open dialog where you may choose a P300 settings files. The Save button allows
you to save the current settings in a P300 settings file. The OK button closes the dialog.
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AMPLIFIER SETTINGS DIALOG

The Amplifier Settings dialog is displayed when on the Amplifier menu you
click Amplifier Settings or when the Amplifier icon is selected from the Side
Toolbar.
The incoming EEG is displayed in the top left (blue line) with the artifact rejection area
shown in pink. The X axis (time) is determined by the total window size of the
acquisition window from the Collection Toolbar. The total time on the horizontal axis is
shown below the EEG and artifact area (25.6 ms in the dialog above). The Y axis
(amplitude) is determined by the gain setting of the amplifier. The total amplitude on
the vertical axis is shown in the area above the vertical bar Y axis (100 uV in the dialog
above). The green area on the amplitude axis bar indicate the area of acceptable EEG.
This acceptable EEG value would be less than the rejection value shown in the lower
right channel area, labeled Rejection (31.00 uV in the dialog above).
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Both the time and amplitude for artifact rejection may be adjusted. The
amplitude is adjusted using the scroll bar to the right of the EEG amplitude
axis. You can control the level indicator in the scroll bar directly with the
mouse or use the Open and Close buttons on the top and bottom of the
scroll bar to move incrementally. The selected artifact reject level is
displayed as a percentage to the right of the scroll bar. The time region
for the artifact rejection is displayed below the EEG time axis. The arrows
on the left-side control the start region and the arrows on the right side
control the ending region. The current artifact reject time region is indicated between
the arrows.
The display scroll bar under the artifact level scroll bar allows adjustment of the EEG
amplitude display size. The level is shown as a percent and only impacts the display of
the EEG – it has not impact on the parameters of the gain or reject level.
The Audera Pro has two amplifier channels and when performing a 2-channel data
collection you may choose which channel to display using the radio buttons in the top
right channel selection area. The channel selection area also indicates the channel color
for the recording. Selection of a channel displays the incoming EEG and the amplifier
settings for that channel. The Check Impedance button displays a pop-up dialog
showing the impedance values for each channel.
The amplifier channel settings for the selected channel are displayed in the lower right
side of the dialog. Any changes to the setting are not implemented until after the OK
button is pressed to close the dialog. If data is being acquired, the settings do not take
effect until a new acquisition is started.
The Gain determines the amplification of the incoming EEG from the patient electrodes.
The Gain dropdown menu provides a list of options. The High and Low pass fields are
settings for the filters that are applied to the incoming EEG. The dropdown menus
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provide a list of options for the filters. The High Pass filters out frequencies below the
selected value and the Low Pass filters out frequencies above the selected value. The
Line Filter check box determines if a power line notch filter is used.
The Audera Pro system designates the 2 amplifiers as Channel A and Channel B. The
Designation field determines the behavior of the channel with Right, Left, On and Off as
available options. The selection is made for both channel A and channel B. When the
designation is ‘On’ for a channel it is always collected. When the channel designation is
‘Off’ it is never collected. When the channel designation is ‘Right’ or ‘Left’ the channel is
collected based on the stimulus. A message is displayed to the user if there are no
channels designated to collect and the user presses the acquire button. Based on the
channel designation in the program a single channel or both channels may be recorded.
The channel(s) recorded are based on the channel designation and the stimulus ear.
Channel A Channel B
Stimulus Right Left Both Right Left Both
Channel Designation
Right √ √ √ √
Left √ √ √ √
On √ √ √ √ √ √
Off
The Audera Pro is supplied with 2 patient electrode cable options: 1) Snap Electrode 4-
Lead Patient cable and 2) Reusable Disc Electrode 5-Lead Patient cable. The polarities
are as follows:
• The Red electrode is the inverting electrode (-) for the right channel (A).
• The Blue electrode is the inverting electrode (-) for the left channel (B).
• The Black electrode is the ground electrode.
• The White electrode is the non-inverting electrode (+). In the 4-Snap Lead cable,
the electrode is a joint (right and left) non-inverting electrode. In the 5 Electrode
Lead cable, this socket is the non-inverting electrode for the right channel (A).
• The Grey electrode is the non-inverting electrode (+) for the left channel (B); this
electrode lead socket is only available in the 5-Electrode Lead cable.
The Electrode Montage fields are text fields that are stored with the recording. These
may be used to indicate the electrode position but do not have any impact on the
recording.
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EXTERNAL TRIGGER
The Audera Pro can trigger an external device using a trigger out pulse that is delivered
to ring of the 3.5 mm jack on the Digital I/O cable. The trigger pulse is a 3-volt square
wave delivered at the rate of the stimulus.
The BNC connector on the Digital I/O cable is used as a trigger in from an external
device. The Auditory – eABR – Cochlear Implant (External Trigger) modalities use the
BNC connector. In this mode the program waits for a TTL trigger pulse from the
external device to initiate a sweep.
Digital I/O
cable
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REMOTE IMPEDANCE DISPLAY BOX

The Remote Impedance Display box may be used to initiate an impedance test and
display the results of the impedance test as a colored LED. This is useful when the PC
and the patient are not in the same area. The box has two connectors that attach to the
mating connectors on the Digital I/O cable. Attach the Digital I/O cable to the back of
the Audera Pro. Connect the 3.5 mm jack and plug of the Digital I/O cable to the
corresponding 3.5 mm connectors on the Remote Impedance Display box. In order to
use the Remote Impedance Display box, you must enable the device in the
configuration. From the Opening Window, Select the Settings menu item and the
Configuration sub-menu item. And enter the administrative password when prompted
On the Hardware tab, select the Enable option of the Response Box section. Save the
change and restart the program.
NOTE: Make sure that if the Remote Impedance Display box is not connected to the
Audera Pro, the setting for the Response Box is set to Disable. If the Response Box is
set to Enable and no Remote Impedance Display box is connected, the system will
continuously run the impedance test when not acquiring data.
The Remote Impedance Display box has 5 LEDs at the top that correspond to the
electrode positions of the patient cable.
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Impedance
LED
Impedance
Test button
Battery
Status
The Remote Impedance Display box requires 3 AAA batteries (included) to operate.
There is a battery status LED in the lower left corner. The LED will light green when the
power is on and the battery level is good. The battery status LED will change to red
when the batteries need to be changed. The batteries should last for about 1900 tests.
The Impedance test button in the lower right is used to turn on the device and initiate
an impedance test. When the impedance test is initiated, the Audera Pro tests the
impedance of each electrode and sends the results back to the box which displays a
red, yellow or green LED that corresponds to the impedance level.
LED color Impedance Value

Green < 5 k Ohms
Yellow 5 - 10 k Ohms
Red > 10 k Ohms
The device will shut off automatically after approximately 4 minutes.
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DATA ANALYSIS
The center white area of the program window contains all recordings acquired or
loaded.
To load previously collected data, on the Recordings menu, click Load

Recordings or select the Load Recordings icon from the toolbar. The Data
Files dialog is presented where you select the recordings to load for analysis.
The recordings are loaded onto the current page.
DATA FILES DIALOG
The top of the dialog has options where you may choose the recording types to display
and how to sort the display. There is a Selection text box that shows the information
from the first recording if no record has been selected or the highlighted selection row.
To select a recording, click on the row in the listing. Selecting a record will highlight the
row. To select multiple recordings, hold the Shift key while clicking on the first and last
recording of the group of records you wish to load. You may also select multiple
recording by holding the Ctrl key and selecting the recordings from the list.
The bottom of the dialog provides options to arrange the data after it is loaded and to
Save or Print the list of records. Click OK to load the highlighted records to the active
page and close the dialog. Click Cancel to close the dialog without loading any
recordings.
You may also load recordings from the Recordings menu, Load Recordings from
Protocol Results for data that has been collected by executing an automated protocol.
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Data Pages
Recordings are displayed on the Acq page as the data is being collected and saved
automatically when the acquisition completes. In addition to the Acq page, there are 9
additional pages for the display and analysis of data. On each page there is a time scale
at the bottom and a vertical scale marker in the top left. There are ten waveform
display areas or pages and each page that contains test data is printed as a report page
when a report is printed. Each page is accessible from the Page Selection control. The
Page button on the control can be shaded a different color depending on the status of
the page. The current active page will be shaded the darkest and indicated at the top of
the control, pages that have data on them will be darker than those without data.
Current page
Page has data Current Page

shading scroll bar
Empty page
shading
Current page
shading
Pages may be renamed by selecting Report menu and clicking on Page Labels, then
choosing the page to modify. There are two labels that may be defined, the 4-character
button label and the tool tip label that appears when hovering over the button and
printed on the report. The page labels may be saved, loaded, or saved as the default
labels from the Page Labels sub menu.
To select a page, click on Page button in the control. The numeric character keys (at the
top of the keyboard), 0-9 may also be used to select the active page. The keyboard
shortcut keys function even if the pages have been renamed.
Data pages may be displayed as a full page or split page using the Toolbar
Full/Split Page icon which toggles between the two displays.
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The arrangement of waveforms and presentation on a page are controlled by several

icons on the Toolbar, options from the Display menu, and the Display icon on the Side
Toolbar. Individual waveforms may be moved manually as well.
Display Options
Display Menu
The Display menu options are described in the EP Main Menu section.
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Toolbar icons
The Toolbar has options that impact the display of waveforms and are described in the
Toolbar section.
Side Toolbar Display icon

The Display icon on the Side Toolbar provides a pop-up menu with options
for controlling the page layout and waveform display. The options are page
specific and the current page is indicated at the top of the menu. Depending
on the Page Mode (Full vs Split) different options are presented.
• Scale – defines the size of the waveforms on the page, the vertical axis. The sub-
menu provides the options. Normalized adjusts the size of
the waveforms based on the minimum and maximum
values within the window or specified scaling start and stop
time (determined by Scaling option). Each waveform is
scaled independently from the others with Normalized while
Normalized Page scales all the waveforms based on the
largest individual waveform to the same scale. The scale
may also be defined at a specific microvolt value selected
from the choices provided (1.0, 0.9, 0.8, 0.7) or user defined by selecting Other.
Other will prompt for the microvolt value.
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• Scaling – determines the time window that is used for the determining the
normalized scale. The Display Window uses the entire plot
shown (between plot start and end). Special enables the
Scaling Start and Scaling End menu items where you define
the time that is used for the normalized scaling.
• Scaling Start – defines the beginning of the waveform that will be considered in
the normalization calculation. This is only enabled when the Scaling is set to
Special and Normalization is used for Scale.
• Scaling End – defines the end of the waveform that will be considered in the
normalization calculation. This is only enabled when the Scaling is set to Special
and Normalization is used for Scale.
• Page Mode – determines if the display shows a single page of data or is split into
two columns or pages. In the Full Page mode, the waveforms
occupy the entire window in a single column. In the Split Page
mode, waveforms are displayed in two columns, recordings from
the left ears are placed on the left side and right ear waveforms placed on the
right side.
• Move Mode – determines how waveforms can be placed and moved on the
page. In Fixed mode, the recordings snap to predetermined vertical
positions. The number of available positions varies based on the Plot
Size setting In Free mode, waveforms may be placed at any position
vertically. In both modes the waveforms snap to the left side to match the time
scale.
• Plot Size – determines the vertical space an individual waveform can occupy and
thus the size of waveforms and the space between them.
The options are expressed as a percentage of the screen.
The plot size can be selected from the options is provided,
or the user may define a specific percentage with Other.
Other will prompt for the percentage value. Larger values
may result in the waveforms overlapping each other. At 100
% Full Screen the recordings will be overlapped and take up
the entire screen.
• Plot Start Time – determines the start of the time window x-axis (horizontal) at
the bottom of the screen of the waveform display. A prompt is presented where
you enter the start time (ms). This option is only enabled in Full Page mode.
• Plot End Time – determines the end of the time window, x-axis (horizontal) at
you enter the end time (ms). This option is only enabled in Full Page mode.
• Plot Time: Right = Left – this option is only displayed in Split Page mode. When
checked it indicates that the right and left columns of the split page use the same
plot start and end time (window). When unchecked, you may define the right
and left columns plot times independently.
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• Right or Left – Plot Start Time – determines the start of the time window, x-axis
(horizontal) at the bottom of the screen of the right or left column waveform
display. A prompt is presented where you enter the start time (ms). This option
is only enabled in Split Page.
• Right or Left – Plot End Time – determines the end of the time window, x-axis
display. A prompt is presented where you enter the end time (ms). This option
• Grid – displays vertical lines on the waveform display area. This item is a toggle
to turn on/off the grid.
• Apply above to – transfers the settings from the Display menu to other pages.
This item displays a sub-menu of pages when you can apply the settings from
the current display options to all pages or any specific page.
• Clear data on this page – removes the displayed data from the current page.
No data is deleted from the patient.
• Send all data on this page to – moves the data from the current page to a new
page specified by the page selected in the sub-menu of pages.
• Close – exits the pop-up menu.
Cursors
Two cursors are available to display measurements and differences. To turn
on the cursors click the Cursor icon on the Toolbar or Display menu, Display
Cursors. When active, the cursor handles can be found at the bottom left of
the recording area, just above the time scale. Two lines at the top of the page next to
the cursor display the latency and amplitude information (top line) and difference
between the two cursors including a frequency calculation (in parenthesis) of the time
difference.
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WAVEFORMS
Data collected from stimulation in the right ear are, by default, displayed as red
waveforms, the left ear as blue and both ears as black. The waveform display color for
an individual waveform is configurable.
Data analysis is performed on the active waveform. The active waveform may be
selected by clicking on a waveform. The active waveform is displayed in green. Each
waveform has a handle at the beginning of the graphic. This handle filled in to indicate
that the waveform is selected and may be used to move waveforms or to select multiple
waveforms for processing.
Waveform
handle
To move a waveform, select the waveform and drag (hold left mouse key down) with the
mouse to the desired location. The waveform will snap to the left side of the axis
automatically when the left mouse button is released. You may move a waveform to a
different page by dragging the waveform and releasing over the page number button
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on the Page control. To select multiple waveforms, hold the Ctrl key and click on the
waveforms you want to select.
Labeling Peaks
The current labels that are used to mark the peaks of a waveform are displayed as
buttons on the Toolbar. The set of labels is determined by the auditory modality
currently active (Protocol, Modality) when the data was collected and saved. You may
mark the peaks with labels using the Toolbar or from the Waveform Options menu.
To mark a peak, select the waveform making it the active waveform. Using the Toolbar,
click the label button that you wish to use. Then click above or below the peak on the
active waveform where you want the label placed. Using the Waveform Option menu,
right click above the peak on the active waveform where you want the label placed.
From the pop-up menu select Mark Peak and then the label you wish to use.
A marked point consists of three parts. The label and two peak indicators. The label is
the text above the peak and the peak indicators are displayed as a down arrow and
triangle. The top mark is used for the latency measurement. The bottom mark is used
to calculate the amplitude of the peak based on the difference between the top and
bottom marks.
Label
Peak Mark - top
Peak Mark - bottom
When the peak is initially marked, the peak indicators are placed at the same point on
the waveform. When a mark is active, the arrow and triangle will be colored red. When
a mark is not active you can click on mark to make the label active. To move the mark,
you can left click and hold the marker and drag to the appropriate location or you may
use the keyboard (see table).
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Peak Marker Movements using the Keyboard
Keyboard Marker Top Marker Bottom Marker

Movement
Move marker to left Alt +
(earlier)
Move marker to left Shift + Alt + Shift +
(earlier) large steps
Move marker to right Alt +
(later)
Move marker to right Shift + Alt + Shift +
(later) large steps
Marked points are automatically saved to the waveform. A table of labels for the
marked waveforms is displayed and printed on the bottom half of the page. The table
will include the marked points latency and amplitude and calculations that are defined
for the specific test modality such as interlatencies.
Default Labels
Each modality comes with a default set of labels. Some modalities also have built-in
interlatency comparisons, amplitude ratios and area under the curve measurements.
Protocol Modality Labels Calculations

ECochG SP, AP, Base, I, III, V SP/AP ratio
ABR I, II, III, IV, V, VI Interlatencies, Amplitude
Ratio
MLR V, Po, Na, Pa, Nb, Pb
LLR P1, N1, P2, N2, P3, N3
P300 P1, N1, P2, N2, P3, N3
MMN P1, N1, P2, N2, P3, MMN MMN Area
In addition to the default labels, custom labels may be created with the Mark Other
Peak in the Waveform Options.
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SP/AP Ratio
The ECochG modality test type has an option to calculate the SP/AP ratio. To calculate
the SP/AP ratio the Base (baseline), SP and AP points need to be marked. The bottom
marker of the Base is moved to the other side of the AP and placed at the same
amplitude as the top Base marker giving a 0 baseline amplitude. Then move the
bottom marks for both the SP and AP to the same location as the bottom Base marker.
The area for the SP and AP will be filled in with colors for the SP and AP area and the
calculations displayed next to the AP label.
Bottom marker for

Base, SP and AP
NOTE: The SP/AP ratio and the area calculations may be turned On or Off. If the
calculation is not displayed, turn it On by right clicking on the waveform which
displays the Waveform Options menu and choose Mark Other Peak.
Activate/Deactivate the area calculations by checking/unchecking the check box next
to the ECochG labels. The status of this check box is saved with settings files.
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MMN Area
The Mismatched Negativity (MMN) data collection and resultant waveforms will be, as
with P300, one recording buffer per stimulus used. Commonly, there is one standard
(buffer 0) and one deviant stimulus (buffer 1).
The measurement of significance may be difficult to assess visually and for this reason,
the area of the difference wave between the waveforms of the standard and the deviant
responses is calculated. The difference wave is obtained by subtracting the standard
waveform from the deviant waveform. To calculate the MMN area, mark the MMN with
the top and bottom markers. The bottom marker of the MMN recording will define the
zone for which the Area of the curve is calculated. The part of the curve used for the
calculation will be shown in yellow. Make sure the top and bottom markers for the MMN
label are within the same half cycle or the calculation cannot be completed.
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Waveform Options
Right click and the options for the current waveform are presented as a pop-up menu.
Note that the location on the time axis of where the mouse is clicked determines where
the peaks are marked.
• File Name – indicates the file name of the active recording. When the mouse is
placed over the name, a sub-menu is displayed with the stimulus, amplifier and
recording information.
• Peak Latency – displays a sub-menu with the marked peaks latency, amplitude,
interlatency and ratio information.
• Mark Peak – displays a submenu with the list of marker labels available for the
active recording. The label is placed on the waveform at the time position where
the mouse was when the menu was opened.
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• Mark Other Peak – Displays a new dialog with the list of defined labels in the
program. The User Defined Labels text box is an option available to define a
custom label. The user defined labels may be added to the drop-down list and
the list saved with the buttons next to the text box.
If a marked peak is active when the dialog is presented, you can remove the label from
the waveform with the Remove button. If you select a label button or create a new label,
the label is placed on the waveform at the time position where the mouse location was
when the menu was opened with the Mark Peak button.
• Remove Peak – removes the label for a marked peak or all marked peaks. The
Specific Peak option will remove the peak closest to the mouse
location on the active waveform when the menu was
displayed. The All Peaks option removes all the marked peaks
on the active waveform.
Plot Type – displays a sub-menu of options for the waveform data. Average is the
normal waveform with the results from the collection, an
average of the collected responses. Split Sweep shows two
overlapping averages from the two internal buffers of the
recording (even and odd sweeps). Plus-Minus shows the
difference between the two internal buffers of the recording.
Spectral performs a frequency analysis of the waveform and displays the waveform in
the frequency domain. The waveform is split into two curves, one for the response, and
one for the noise.
• Show Labels – provides the option to display or hide the labels on the marked
peaks of the active waveform. On displays the labels, Off hides the
labels (the waveform remains marked).
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• Show Text – displays a sub-menu that defines how the text information for the
marked points is displayed. Next to Label shows the amplitude
and latency information to the right of each peak label. Side
shows the stimulus amplifier, recording and peak label
information to the side of the waveform. Below shows the
stimulus amplifier, recording and peak label information under
the waveform. OFF hides all information except for the peak labels.
• Print Parameters – determines if the stimulus, amplifier, recording and peak
label information are printed for the active waveform. On prints the
parameters in the table when the page is printed. Off hides the
parameters for the waveform when the page is printed.
• Scaling – defines the scaling for the active waveform. The Display Window/Page
Region uses the entire plot shown (between plot
start and end). Post Stimulus Region uses the
time after the stimulus presentation Special
enables the Scaling Start and Scaling End menu
items where you define the time that is used for the normalized scaling.
• Scaling Start – defines the beginning of the active waveform that will be
considered in the normalization calculation. This is only enabled when the
Scaling is set to Special and Normalization is used for Scale for the page.
• Scaling End – defines the end of the active waveform that will be considered in
Special and Normalization is used for Scale for the page.
• Color – displays a color dialog where you may choose the color for the active
waveform.
• Send to Page – moves the data from the active waveform to a new page
specified by the page selected in the sub-menu of pages
• Clear – removes the active waveform from the page. The data is not deleted.
• Clear All Selected - - removes all the selected waveforms from the page. The
data is not deleted.
• Clear & Permanently Delete Active Recording from Disk – removes the active
waveform from the page and the data is deleted. A confirmation is required to
delete the data. Once deleted the data cannot be recovered
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Record Info
The Record Info icon on the Side toolbar toggles a panel to the left of the Side
toolbar. The name of the file corresponding to the active record is displayed
at the top of the panel. The multiple tabs organize the information for the
active waveform. Most of the information is read-only except for the Display tab.
General – shows information about the recording and

the patient. The tab includes the date and time when
the active recording was collected, patient’s age and
corrected age (adjusted for gestation weeks for
newborns) at the time of the recording, and any auto
comment entered for the recording.
Stimulus – displays the stimulation information used to

collect the waveform including: Ear, Intensity, Mode,
Rate, Stimulus, and Masking levels.
Recording – displays the recording information

including: Sampling rate, number of Sweeps, number of
Artifacts, Amplifier gain, low pass and high pass Filters,
Line Filter status, and Digital Filter status.
Peaks – displays the labels, latency, amplitude inter-

peak measurements and ratios for the marked peaks
on the active recording.
Resp. (Response) – displays calculated information

about the response including the Calculation Region,
SNR, and Residual Noise.
Display – presents options to change the way the

waveform is shown. It includes checkboxes to
show/hide peak labels and the printed parameters
table for the active waveform. Plot type options to show
the response as Average, Split-sweep (showing both
internal average buffers individually), Plus-Minus
(subtraction of the internal averages), or spectral
(frequency domain). Show text options to display the
recording information directly on the page placing the text next to the labels, to the side
of the waveform, or under the waveform.
Comp. (Comparison) – displays automatically-generated comparison information

between two waveforms. The comparison information is only be generated when the
recordings have been acquired using the same settings. The Add to Page button copies
the comparison to a new text field on the page.
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Select Recording – displays a drop-down menu that contains a list of all the recordings
on the page. You may select a different waveform from the list which then becomes the
new active recording and updates all the fields.
POST-ACQUISITION PROCESSING
After data has been collected, you may perform filtering, calculations, and comparisons.
With most processing, the original data will be preserved in the original recorded file
and the processed data copied to a new waveform. This processed data is not
automatically saved. Any data that has been modified is displayed and
indicated as a NEW file in the Information Bar. To save the NEW data, make
the waveform active and select the Save waveform icon from the toolbar or Recordings,
Save Active Recording from the menu.
Calculating Bayesian Weighted average

Bayesian weighting uses the average of the individual blocks compared to the overall
average to assign a weight to each block and then computes the overall average based
on the assigned weights (based on the variance and residual noise measurement). The
recording must have been collected using block averaging for the weighted average to
be calculated. Averaging menu, Calculate Bayesian Weighted Average calculates the
weighted average for the active waveform. Averaging menu, Calculate Bayesian
Weighted Average All on Page calculates the weighted average for all the waveforms
on the page. The new recording must be saved manually.
Adding and Subtracting waveforms

Two or more waveforms may be added up to create a new grand average waveform.
Two waveforms may be subtracted. There are two methods of addition and subtraction
Sweep Weighted and uV Weighted. The Sweep Weighted mode takes into consideration
the number of sweeps contained in each recording and adds or subtracts the
waveforms proportionally. Adding two recordings with 500 sweeps each would be the
equivalent of just acquiring one with 1000 sweeps. The uV Weighted mode performs a
direct add or subtract between the waveforms treating each waveform as a single
sweep. Select the calculation method by clicking the Process menu,
Addition/Subtraction Mode then choose the method from the menu.
To select the multiple recordings for the calculation, hold down the [Ctrl] key while
selecting the recordings. To calculate, Process menu, then Add Selected Recordings (+
key) or Subtract Two Selected Recordings (- key) displays a new calculated recording,
using the chosen add/subtract mode option. The new recording must be saved
manually.
Comparing recordings
Comparing recordings may be used to compare left and right sides. The differences in
latencies and amplitudes will be calculated. To compare waveforms, the recordings you
want to compare must have been collected using the exact same parameters or the
D-0129360 Rev A Page 97 of 231

comparison will not work. Mark all necessary labels on the recordings being compared
and select both waveforms by holding the [Ctrl] key and clicking on them, or their
handles. Click on the Process menu, Compare Selected. A pop-up window will show
the results of the comparison with an option to place the results the page. The Record
Info panel will also display the comparison in the Comp tab and may be added to the
page directly from there.
Inverting a waveform
Inverting a waveform changes the polarity and flips the active recording upside-down.
Click on the Process menu, then Invert Active Recording.
Filtering
To filter a waveform, select Process, Filter from the menu. Digital filtering options
include a Smoothing filter (FIR, finite impulse response), a Band Pass and Notch spectral
filters. The Smoothing filter slider bar controls the amount (number of points) of
smoothing.
For the Band Pass and Notch Filters, you specify the low and high frequency values.
The Band Pass filter keeps frequencies from the low pass value to the high pass value,
frequencies falling above the low pass or below the high pass will be filtered out. The
D-0129360 Rev A Page 98 of 231

Notch option filters out the frequencies in between the selected low pass and the high
pass filters, leaving intact those that fall outside the range. Once the desired filter is set
up, you can filter the active wave using the Filter icon from the Toolbar. The Process
menu, Filter Active Recording and All on Page options provide filtering for
the active waveform or all the waveforms on the page. To keep the filtered
version, save the recording manually, or save as part of a report.
Cross-correlation
Cross-correlation is a measure of the similarity between two waveforms or areas of
waveforms. The area of comparison needs to be defined using the cursors, and the
cross-correlation value will be calculated for the portions of the recordings falling within
this area. The resulting value is between 0 and 1 where 1 is perfect correlation. The
larger the difference between the two areas on the waveforms, the lower the value.
Move the cursors to the start and end points of your cross-correlation region of the
waveform. To correlate two waveforms, select the two waveforms by holding the [Ctrl]
key and clicking on them, or their handles. Click on the Process menu, then Cross-
Correlate. A sub-menu is presented, click
Two Selected Recordings. A pop-up window
will show the results of the comparison. The
Record Info panel will also display the
correlation in the Comp tab where the calculation may be added to the page. Since each
waveform consists of two buffers (even and odd stimuli) you can also compare the two
buffers that make up a single active waveform. The Within Active Recording option
performs this calculation. To compare the active waveform to all the recordings on the
page, click Active Recording with All on Page. The results are displayed in a pop-up
Notepad file window with the cross-correlation values showing the active waveform
compared to all the ones currently in the page.
Split Active Recording

Each acquired waveform consists of two buffers (even and odd stimuli) and the Split
Active Recording option allows you to duplicate both buffers as two new waveforms.
The Split Active Recording is different from the Waveform option of Plot Type: Split
buffer in that two new buffers are created by the Split Active Recording and can be
treated like any other waveform. The waveform display option of Plot Type Split Buffer
shows both buffers as overlapped waveforms, but each buffer is not a new waveform.
The new recordings created by the Split Active Recording must be saved manually.
Latency Intensity Graph

If you have marked peaks on an ABR recording, you can view a latency-
intensity graph and table of the marked points. Click on the Display menu,
Display Latency-Intensity Graph or select the Latency-Intensity Graph icon
from the Toolbar.
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A pop-up dialog displays the marked peaks in a Latency vs. Intensity graph and an
accompanying data table. The marked data on the page will be shown as a red or blue
line across the graph. Normative data will be displayed as a gray shaded area of the
graph. Specific data may be shown/hidden using the channel and stimulation side
controls at the top right of the dialog.
The Print Graph and Print Table buttons send the respective data to the default printer.
The Save Table button saves the table data as a text file and you are prompted to
provide the file name and location. To include the graph and/or the table in your
reports along with the waveforms, send the data to the page using the Copy Image to
Page and Copy Table to Page buttons. The default normative data is shown when the
dialog is displayed, it is also possible to load a custom normative data set. To use a
previously created special normative data file, click on the Norms button, and select the
file. To Close the dialog, press the OK button.
REPORTS
Each of the display pages is printed as a page in the report. In addition to the
waveforms, reports include any additional information that has been added to
the pages, such as comments or Latency-Intensity graphs. In addition to data
collected with the EP module, data from any of the other modules (ASSR,
DPOAE and TEOAE) may also be included. Reports may be saved and loaded
from the Toolbar icons and the Report menu, Load Report and Save Report.
D-0129360 Rev A Page 100 of 231

Adding Information
The Report menu has an option to Add information.
Some elements are static meaning that data does not change even if the waveforms on
the page change while others are dynamic where the data automatically changes when
the recordings change (such as marking peaks). The static elements may be edited
manually as needed. The dynamically elements should not be edited manually as the
edits will not be maintained when the data is updated. The Text and Label elements
both open the text editor dialog. The text editor dialog has options for loading and
saving text templates. The Label element is only for a single line, any additional lines are
audiograms from the ASSR module or DP-grams from the DPOAE module or other
bitmap images.
Printing Options
Printing may be initiated from the Print menu or the Print icons from the
Toolbar. The report may be printed to any printer attached to the computer
or saved as a PDF file. The print options allow you to print a single page or all
pages as a report. For the Print All Pages, only the display pages that contain
information are printed, no blank report pages are printed. The Print menu presents a
sub-menu which includes options to remove the patient information, configure the line
thickness and print in black and white.
Report Header and adding a Logo to the Report

By default, the header of the report uses the information that is found in the
Registration information. This information is modified in the Opening Screen, Settings
Menu Configuration, Hardware Setup dialog.
In place of the registration information, you may substitute a graphic file. This file must
be named LogoBitMap.bmp. This file must reside in the C:\GSIAuderPro folder on the
PC. The file should be approximately 650 x 210 pixels and will be resized automatically
to fit in the header space.
D-0129360 Rev A Page 101 of 231

KEYBOARD SHORTCUTS
Some options in the program may be controlled via the keyboard. The table below lists
the keys that are active in the EP modality.
Key Function
Esc or Space Pause or Stop a recording
Space Pause or Stop a recording
A Displays the Acquisition page
0-9 Displays the corresponding page (0=acquisition page)
P Displays the Set Page menu
S Selects the next recording on the page
↑ Moves the selected waveform up on the page
↓ Moves the selected waveform down on the page
+ Adds the currently selected recordings (to a new waveform)
- Subtracts two selected recordings (to a new waveform)
← Move top marker to left (earlier)
← + Shift Move top marker to left (earlier) large steps
← + Alt Move bottom marker to left (earlier)
← + Alt + Shift Move bottom marker to left (earlier) large steps
→ Move top marker to right (later)
→ + Shift Move top marker to right (later) large steps
→ + Alt Move bottom marker to right (later)
→ + Alt + Shift Move bottom marker to right (later) large steps
D-0129360 Rev A Page 102 of 231

TYPICAL EP EVALUATION WORKFLOW

Before performing any evaluation, check the system for cleanliness and for worn or
damaged transducers or cables. Check that there is no damage to the mains cable and
no mechanical load to the cable or other connectors that might cause damage. Make
sure all connections to transducers and patient cable required for the test are snug and
secured properly.
1. Turn on the computer and the Audera Pro base unit.

2. Launch the Audera Pro program.
3. Create a new patient file or load an existing patient file.
4. Select the EP test modality from the Opening window.
5. Choose the test type from the Protocol\Modality menu option or Load a saved
settings file.
6. Confirm the stimulus and amplifier settings.
7. Explain the procedure to the patient, scrub the skin at the electrode sites
appropriate for the test being performed and place the electrodes on the
patient. Position the desired transducers for the test on the patient.
8. Check the electrode impedance by selecting the icon from the side toolbar or
check the box under the EEG panel that checks impedance before testing.
9. Begin the collection of data by selecting the Acquire button from the Collection
toolbar. Alternatively, you can select an automated protocol from the Protocol
menu which will start collection using the parameters defined in the automated
protocol.
10. Continue collection modifying the stimulus and other parameters as needed
until all required data has been obtained.
11. Once data collection is complete, remove the transducers and electrodes from
the patient. Make sure any single-use items used on the patient are disposed of
properly.
12. Arrange the collected data on the pages as needed for analysis. Review the data
and mark points and comments as appropriate for analysis and reporting.
13. Save the data as a report and print or save as a PDF file if needed.
14. Turn off the system.
15. Clean the device and accessories.
D-0129360 Rev A Page 103 of 231

VEMP ANALYSIS MODULE

The VEMP analysis module provides analysis of VEMP data collected with the
EP module. This module allows you to select VEMP data, calculate the
Amplitude Asymmetry ratio and save the data to be viewed and reported
from the EP module. To analyze VEMP data, a patient with VEMP data should be
selected from the Opening window toolbar prior to launching the module. To launch
the VEMP analysis module, select the VEMP analysis icon from the Opening window
toolbar.
OPEN RECORDS
When the VEMP analysis module opens, a list of the records is displayed with the last
recording for each ear checked by default. If you select the VEMP analysis icon from the
Opening window and no patient has been selected or the patient does not have any
tests, the module displays a blank Open Records dialog. If the Open Records dialog is
blank, you should exit the module and select an appropriate patient with VEMP
recordings.
Select one record from each ear for analysis. Once the data has been selected, press
the OK button and the window for the VEMP analysis module is presented.
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VEMP ANALYSIS WINDOW

The VEMP analysis window consists of the title bar at the top, a menu bar, a toolbar and
the data display area. The records selected at the Open Records dialog are loaded and
the display depends on Mode set in the Process menu option and parameters saved in
the Settings option from the menu.
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VEMP ANALYSIS MENU
Each of the selections on the menu contain sub menu items:
File
• Open Records– displays the Open Records dialog where a list of records for the
patient is presented. The records patient may be selected, and their data
loaded.
• Save Record – saves the VEMP analysis records so that they may be loaded as
waveforms and a Report in the EP module.
• Exit – presents a confirmation dialog if the data has not been saved and if
confirmed exits the program and returns to the Opening Window in the Audera
Pro software.
Process
• Mode – displays a sub-menu to choose the display of the VEMP data.
o Culling – displays the Culling view.
o Calculation – displays the Calculation view.
• Invert Waves - Inverts all the waveforms displayed in the current mode. If the
current mode is calculation, the positive and negative peaks will be recalculated.
Settings
The Settings menu options are saved so that the last used settings will remain the next
time the module is loaded.
• Display Language – displays a sub-menu of the available languages for the

VEMP analysis module. When the language selection is changed, you will be
prompted to restart the application for the changes to take effect.
• EMG Rectification Calculation Window – displays a dialog where you define
the pre-stimulus start and end time used to determine the EMG activity
measurement. This EMG activity measurement is used for the waveform
rectification.
• Rectification Type – displays a sub-menu with the choices for the type of
rectification.
o Full wave – takes the absolute value of all points along a waveform.
o RMS – (Root Mean Square) takes the square root of the arithmetic mean
of the squares of the values.
• Sweep Culling Criteria Highlight – determines the criteria used to highlight the
waveforms that will be included/excluded in the grand average calculation.
o None – no criteria employed to highlight and include/exclude the sweeps
used in the average - all the waveforms are included.
o Wave Exclusion > 1 SD – excludes waveforms whose EMG activity is
greater than or less than 1 standard deviation from the mean.
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o Wave Exclusion > 1.5 SD - excludes waveforms whose EMG activity is

greater than or less than 1.5 standard deviations from the mean.
o Wave Exclusion > 2 SD - excludes waveforms whose EMG activity is
greater than or less than 2 standard deviations from the mean.
• Sweep Culling – displays a sub-menu of options for how the sweep culling is
performed. Only one option may be selected.
o Automatic – automatically generates the average based on the sweep
culling criteria.
o Manual – disables the automatic culling of the sweeps - individual sweeps
are included/excluded from the Culling view.
• Display Asymmetry Ratio - displays a sub-menu of options for which amplitude
ratio is displayed in the Calculation view. Only one option may be selected.
o Rectified – computes the asymmetry ratio from the rectified waveforms.
o Not Rectified - computes the asymmetry ratio from the unrectified
waveforms.
• Display Average - displays a sub-menu of options for which waveform average
is displayed in the Calculation view. One or both options may be selected.
o Not Rectified –displays the average of the unrectified waveform.
o Rectified - displays the average of the rectified waveform.
• Set to Defaults - returns all the settings in the Setting menus to their default
values.
 EMG Rectification Calculation Window: Start -60 ms, End -20 ms
 Rectification Type: RMS
 Sweep Culling Criteria Highlight: None
 Sweep Culling: Manual
 Display Asymmetry Ratio: Not Rectified
 Display Average: Not Rectified
Help
• Manual – opens the user manual in the default PDF viewer.
• Email Logs – compiles the log files and attaches to an email using the default
email client. Log files may be requested for troubleshooting any problems
encountered with the software.
• Export Logs - compiles the log files and launches a save file dialog to save the
log files.
• About – displays the about dialog showing the program version information.
D-0129360 Rev A Page 107 of 231

VEMP ANALYSIS TOOLBAR
Icon Description
Open Records - displays the patient Open Records dialog where

the VEMP records may be selected. This option is only available
when in the Culling mode.
Save Record – saves the VEMP averages and a report file from
the Calculation mode display. This data can then be opened in
the EP module. This option is only available when in the
Calculation mode and both right and left data is present.
Culling Mode– displays all the VEMP sweeps available in the

VEMP record. Multiple waveforms are only available when the
data is collected in block mode in the EP module.
Calculation Mode – displays the average calculation for the

selected VEMP sweeps as specified in the Settings. Displays the
amplitude Asymmetry Ratio for the calculated waveform as
specified in the Settings.
VEMP CULLING MODE VIEW

Culling allows the choice of which sweeps of the VEMP data are included in the average
VEMP waveform. In order to use culling, you should collect your VEMP data using a
block averaging protocol in the EP module. The ‘cVEMP wBlock Av’ settings file provided
in the EP module can be used to obtain the block VEMP data. The size of the block and
the total number of blocks determine the number of sweeps that are displayed for
culling. For the same total number of sweeps, the smaller the block size the more
sweeps available for culling but the overall test may take slightly longer as each set of
blocks is saved to the disk in the EP module. If the data is not saved in blocks, only the
final average is saved and there is no data to cull.
The culling may be performed automatically or manually. The module provides an

option to select data based on the EMG activity before the stimulus. This automatic
selection is based on the standard deviation of the amplitude of the sweep. You may
also select the sweeps to include/exclude manually.
D-0129360 Rev A Page 108 of 231

The Culling view displays the title bar, menu and toolbar at the top. In the data display
area, each sweep is shown with a scroll bar on the right to allow you to scroll through
the individual waveforms. The selection checkbox and amplitude axis for the sweep is
displayed to the left of each sweep. Check/uncheck to include/exclude the individual
sweep in the overall VEMP average. Sweeps that are included are colored red or blue
and the sweeps not included are shown in grey. The EMG activity used for the
calculation is located between the two vertical lines. The calculated average EMG
amplitude for that section of the data is based on the rectification type (Full wave or
RMS) and displayed above the sweep. The bottom of the Culling view displays the x axis
(ms) and a tool bar with the right and left ear icons. Select the ear icon to display the
data from the individual ears, red for right ear and blue for left ear.
D-0129360 Rev A Page 109 of 231

VEMP CALCULATION MODE VIEW

The Calculation view displays the averaged VEMP waveform from each ear and the
asymmetry ratio calculation. The display of the rectified or unrectified VEMP average
and asymmetry ratio is determined by the selections in the Settings menu.
The Calculation view displays the title bar, menu and toolbar at the top. In the data
display area, the VEMP average waveforms for each ear are presented. The asymmetry
ratio is shown at the top of the data area. The P1 and N1 peaks are automatically
labeled. Change the marked point by selecting the label with the left mouse button and
drag the label to the desired point. The latency and amplitude data for the marked
points is shown in the upper right section above the waveform. The Calculation view is
the view of the data that is saved when you press the Save button. When the data is
saved, the right and left VEMP waveforms and a new report record is created that
includes the waveforms and asymmetry ratio. The waveforms and report may be
loaded and displayed in the EP module.
Note: The asymmetry ratio and average VEMP waveforms are selected
independently via the Settings menu. You can select an unrectified waveform
and a rectified asymmetry ratio or vice versa. Make sure you select the data
appropriate for your report.
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D-0129360 Rev A Page 111 of 231

AUDITORY STEADY-STATE RESPONSE (ASSR)

When the ASSR icon is selected, the system displays the initialization dialog
while the ASSR module loads and then the main ASSR screen is presented.
The ASSR screen layout has a title bar at the top, the main menu under the
title bar, information bar below the main menu, and the top Toolbar in the upper part
of the screen. The middle of the screen contains the ASSR waveform area, the stimulus
information, the page selection control and side toolbar. If the data acquisition page is
selected, an EEG panel is displayed and there is a collection toolbar at the bottom of the
page. Menu Information Bar
Toolbar
ASSR Data Collection Screen
Stimulus Information
ASSR Waveform Area

Page Selection
EEG Panel
Collection Toolbar
Side Toolbar
TITLE BAR
D-0129360 Rev A Page 112 of 231

ASSR MAIN MENU

The ASSR Main Menu allows access to most of the functions of the program.
Each of the Main menu selections have sub-menus.
Patient
• Clear Data on New Patient – Removes the ASSR data from the display when a
new patient is selected or entered when this option is checked
• Quit ASSR – Closes the ASSR program
Protocol
• Settings – Indicates the current settings file.
• Load Settings – Displays the file open dialog where you can choose a new
settings file. The settings file contains the information for the stimulus and
amplifier settings.
• Save Settings – Displays the file open dialog where you name and save a
settings file. The settings file contains the information for the stimulus and
amplifier settings. These files are loaded with the Load Settings option.
• Save as Default – Saves the current settings as the DEFAULT.SSS file which are
the settings that are loaded when the program is started.
• Input Channel – Displays the current configuration for the channels that will be
collected and displays a submenu of choices. The default is to collect data from
both channels. Other choices provide options to collect a single channel based
on the amplifier channel designation and the ear being stimulated or a specific
channel.
o Dual Channel A & B (Based on Ear Tested)
o Dual Channel A & B (Always)
o Single Channel A
o Single Channel B
• Auto-Stop All Response – This option when selected, will stop data acquisition
when a response has been detected for all frequencies in the stimulus.
• Auto-Stop Level – When selected, data collection will stop when the total noise
reaches the selected level. The default recommended level is shown on the sub-
menu with the available options. At least four blocks of sweeps must be
collected before the Auto-Stop Level is evaluated.
o OFF
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o 0.50 uV
o 0.60
o 0.70 (Recommended Level)
o 0.08
o 0.90
o 1.00
o 1.25
o 1.50
o 1.75
o 2.00
o Other
• Intensity Sweep – Begins a data collect using the active stimuli starting at 80 dB
SPL and decreases the level in 10 dB steps. The submenu gives a choice of
o Right Ear
o Left Ear
o Both Ears
• Setup Automated Protocol – Opens the Protocol Setup dialog where you may
create a sequence of data acquisition test sets.
• Execute Automated Protocol – Opens the Protocol Selection dialog to select
the automated protocol. After the automated protocol is selected, data
acquisition is automatically started.
Stimulus
• Device – Indicates the currently selected transducer and displays a sub-menu of
available transducers that may be selected for the stimulus delivery.
o Headphones
o IP30 Insert phones
o Probe
o Sound Field
o Bone Vibrator
• Intensity – Displays the current level for the stimulus. When clicked a pop dialog
is presented where you may input the level to be used for stimulation. At high
stimulus levels you are asked to confirm and prompted to enter the system
password.
• Maximum Sweeps – Displays the current maximum number of sweeps for the
acquisition. When clicked a pop dialog is presented where you may input the
D-0129360 Rev A Page 114 of 231

maximum number of sweeps to be used in waveform average. When the

collection reaches the maximum, it will stop automatically.
• Sweep Block Size – Displays the current number of sweeps in a block for the
acquisition. A block of sweeps creates an internal average that is added to the
overall waveform average. The waveform is redrawn every time a block is
added. When selected, displays a submenu of choices.
o 20 Sweeps (Recommended)
o 40 Sweeps
o 60 Sweeps
o 80 Sweeps
o 100 Sweeps
• Masking – Displays the current masking status for the acquisition. White noise
is used as the masking signal and is presented to the ear opposite the stimulus.
When selected, displays a submenu of choices. The Specific Level and Following
options present a dialog where the value is entered. The Specific Level outputs
the white noise at the specified level that is entered, while the Following level will
change by the entered offset relative to the stimulus level as the stimulus level
changes.
o Specific Level
o Following
o OFF
• Right Stimulus – Presents an open dialog to load a stimulus file that will be used
for the stimulus presented to the right ear.
• Left Stimulus – Presents an open dialog to load a stimulus file that will be used
for the stimulus presented to the left ear.
Recordings
Process
• Analyze Active – Displays the ASSR analysis dialog showing the polar plot,
frequency analysis and data table for the current ASSR waveform.
• Generate ASSR Response Audiogram – Displays the ASSR Response Audiogram
dialog with the audiogram based on the waveforms on the current page.
Display
• Arrange by Intensity – Arranges the waveforms on the page by the stimulus
level. The highest level is placed at the top. If you are on a split screen layout or
your data contains both right and left ears, the left and right ear waveforms will
be placed on separate sides.
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• Arrange by Acquisition Order – Arranges the waveforms on the page by the

time the data was collected. The earliest acquired waveform is placed at the top
and the latest at the bottom. If you are on a split screen layout or your data
contains both right and left ears, the left and right ear waveforms will be placed
on separate sides.
• SNR History – When checked, displays the SNR and Noise graphs for the data
being acquired. When unchecked the graphs are not shown.
• Stimulus Information – When checked, displays the Stimulus Information panel
showing the frequencies being presented in the stimulus. When unchecked the
panel is not shown.
Report
editor dialog. The text editor dialog has options for loading and saving text
templates. The Label element is only for a single line, any additional lines are
ignored. The Label element is only for a single line, any additional lines are
o Text
o Table (Dynamic)
o Table (Static)
o Label
o Selected
D-0129360 Rev A Page 116 of 231

o Page
o All Pages
o Page Acq
o Page 1
o Page 2
o Page 3
o Page 4
o Page 5
o Page 6
o Page 7
o Page 8
o Page 9
o Load Page Labels
o Save Page Labels
Print
the PDF viewer.
• Automatic Tables – Displays a waveform information table automatically at the
D-0129360 Rev A Page 117 of 231

page. If the option is not selected the program will fit the data to a single page
which may cause some data to be truncated to fit. The checkmark indicates the
status (On/Off). This option is a toggle.
Help
INFORMATION BAR
selected waveform. It is located below the Main Menu. The Information bar displays
the following:
• Recording name
• Peak-to-peak amplitude (PP)
• Signal-to-noise ratio (SNR)
• Residual noise (RN)
D-0129360 Rev A Page 118 of 231

TOOLBAR
used menu items.
Icon Description


Load ASSR File – displays the list of ASSR files and allows the user
to sort and select an ASSR file
Save ASSR File – saves the currently selected ASSR file
Load Report File – displays the Open dialog with the list of EP
report files and allows the user to select an EP report file
Save Report File – displays the Save As dialog and allows the user
to save the current pages as an EP report file
Arrange by Intensity – displays the waveforms sorted by stimulus

level from higher to low, overlapping the waveforms of the same
level
Arrange by Acquisition Order – displays the waveforms sorted by

the time the data was collected from oldest to most recent

page and split page
D-0129360 Rev A Page 119 of 231

Add Text – opens a new dialog where the user can enter new
comments or load comments from a file

as a PDF file

D-0129360 Rev A Page 120 of 231

ASSR WAVEFORM AREA


page.
SIDE TOOLBAR
The Side Toolbar is located to the right of the ASSR waveform area. It has buttons for
setting page display parameters, increase/decrease the waveform display, check
impedance, display the amplifier dialog and to show/hide the recording information.
Icon Description


the page

on the page
Check Impedance – displays the impedance dialog window with

the impedance values of the electrodes
EEG and Amplifier Settings – displays the amplifier and EEG

dialog allowing the user to change the settings
D-0129360 Rev A Page 121 of 231

Analyze Active– displays the analysis window of the active

recording which has the phase and frequency information on the
waveform
Generate ASSR Response Audiogram – displays the audiogram of

the waveforms on the current page
EEG PANEL
Artifact Area
EEG
Channel Selector
The EEG Panel is displayed when the Acquisition (Acq) page is displayed. The incoming
EEG is displayed and an indication of where the EEG is checked for artifact is shown in
red. The artifact reject level may be adjusted using the Open-Close scroll bar. Opening
the bar will allow larger EEG into the average and Closing the bar will reject EEG with a
lower amplitude. The percentage of the total amplifier gain is displayed under the scroll
bar. The channel that is being displayed is indicated on the button in lower right and if
the button is clicked you may choose which EEG channel to display.
Below the EEG panel is a section for the display of impedance values. When the Check
Impedance Before Testing box is checked, an impedance test is performed when the
data acquisition button is pressed. The results are displayed with a timestamp when
the test was performed.
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STIMULUS INFORMATION PANEL
Stimulus
Information
Stimulus Ear
and Level
Frequency
Button to activate Selection
Frequency Selection
The Stimulus Information Panel is displayed when the Acquisition (Acq) page is
displayed. This panel displays the current information on the stimulus being used for
collection. The stimulus ear and level are informational and are changed from the
Collection Toolbar. The frequencies of the stimulus (with the modulation frequency in
parenthesis) are displayed in the stimulus information area (green indicates a
response). The user may change the stimulus frequency by selecting the frequencies in
the lower section and pressing the Activate Stimuli Selection button. The Display setting
‘Stimulus Information’ in the Main menu determines if the panel is displayed.
D-0129360 Rev A Page 123 of 231

AMPLIFIER SETTINGS DIALOG

The Amplifier Settings dialog is displayed when on the Amplifier menu you
click Amplifier Settings or when the Amplifier icon is selected from the Side
Toolbar.
The incoming EEG is displayed in the top left (blue line) with the artifact rejection area
shown in pink. The X axis (time) is determined by the total window size of the
acquisition window from the Collection Toolbar. The total time on the horizontal axis is
shown below the EEG and artifact area (1024.0 ms in the dialog above). The Y axis
(amplitude) is determined by the gain setting of the amplifier (100k for ASSR). The total
amplitude on the vertical axis is shown in the area above the vertical bar Y axis (100 uV
in the dialog above). The green area on the amplitude axis bar indicate the area of
acceptable EEG. This acceptable EEG value would be less than the rejection value
shown in the lower right channel area, labeled Rejection (31.00 uV in the dialog above).
D-0129360 Rev A Page 124 of 231

Both the time and amplitude for artifact rejection may be adjusted. The
amplitude is adjusted using the scroll bar to the right of the EEG amplitude
axis. You can control the level indicator in the scroll bar directly with the
mouse or use the Open and Close buttons on the top and bottom of the
scroll bar to move incrementally. The selected artifact reject level is
displayed as a percentage to the right of the scroll bar. The time region
for the artifact rejection is displayed below the EEG time axis. The arrows
on the left-side control the start region and the arrows on the right side
control the ending region. The current artifact reject time region is indicated between
the arrows.
The display scroll bar under the artifact level scroll bar allows adjustment of the EEG
amplitude display size. The level is shown as a percent and only impacts the display of
the EEG – it has not impact on the parameters of the gain or reject level.
The Audera Pro has two amplifier channels and when performing a 2 channel data
collection you may choose which channel to display using the radio buttons in the top
right channel selection area. The channel selection area also indicates the channel color
for the recording. Selection of a channel displays the incoming EEG and the amplifier
settings for that channel. The Check Impedance button displays a pop-up dialog
showing the impedance values for each channel.
The amplifier channel settings for the selected channel are displayed in the lower right
side of the dialog. Any changes to the setting are not implemented until after the OK
button is pressed to close the dialog. If data is being acquired, the settings do not take
effect until a new acquisition is started.
The Gain setting is read only and determines the amplification of the incoming EEG
from the patient electrodes. The High and Low pass fields are read only and are
settings for the filters that are applied to the incoming EEG. The Line Filter check box
determines if a power line notch filter is used.
D-0129360 Rev A Page 125 of 231

The Audera Pro system designates the 2 amplifiers as Channel A and Channel B. The
Designation field determines the behavior of the channel with Right, Left, On and Off as
available options. The selection is made for both channel A and channel B. When the
designation is ‘On’ for a channel it is always collected. When the channel designation is
‘Off’ it is never collected. When the channel designation is ‘Right’ or ‘Left’ the channel is
collected based on the stimulus. A message is displayed to the user if there are no
channels designated to collect and the user presses the acquire button. Based on the
channel designation in the program a single channel or both channels may be recorded.
The channel(s) recorded are based on the channel designation and the stimulus ear.
Channel A Channel B
Stimulus Right Left Both Right Left Both
Channel Designation
Right √ √ √ √
Left √ √ √ √
On √ √ √ √ √ √
Off
The Audera Pro is supplied with 2 patient electrode cable options: 1) Snap Electrode 4-
Lead Patient cable and 2) Reusable Disc Electrode 5-Lead Patient cable. The polarities
are as follows:
• The Red electrode is the inverting electrode (-) for the right channel (A).
• The Blue electrode is the inverting electrode (-) for the left channel (B).
• The Black electrode is the ground electrode.
• The White electrode is the non-inverting electrode (+). In the 4-Snap Lead cable,
the electrode is a joint (right and left) non-inverting electrode. In the 5 Electrode
Lead cable, this socket is the non-inverting electrode for the right channel (A).
• The Grey electrode is the non-inverting electrode (+) for the left channel (B); this
electrode lead socket is only available in the 5-Electrode Lead cable.
The Electrode Montage fields are text fields that are stored with the recording. These
may be used to indicate the electrode position but do not have any impact on the
recording.
D-0129360 Rev A Page 126 of 231

COLLECTION TOOLBAR
Icon Description
Starts the data collection stimulating the right ear
Starts the data collection stimulating both the right and left
ears
Starts the data collection stimulating the left ear
Checking the box increases the number of sweeps by 20
Indicates the current auditory stimulus level. A Right Click

increases the level by the step size defined in the stimulus
menu. A Left Click decreases the level.
Opens a dialog where the user may select a settings file and
loads the parameters to the program
The Stop Recording button appears when data is being

collected. A confirmation dialog is presented to confirm that
you wish to stop the data collection.
D-0129360 Rev A Page 127 of 231

AUTOMATED PROTOCOL DIALOG

The Automated Protocol dialog allows you to specify a series of steps that may be used
to automatically collect your data. The Protocol Item defines each step (set of
parameters) in the sequence. Items are consecutively numbered. The Count is used to
activate an item and determines the number of times the item is run. The Maximum
Sweeps determines the total collected sweeps that are used in the averaged waveform.
The dialog has separate sections that define the parameters for each ear. The On
checkbox determines if the stimulus is delivered to the ear. The field under the ear
label is where the value for the stimulus level is entered. The field next to the stimulus
level is the stimulus file name. The Browse button allows you to select the file. The
Previous button inserts the stimulus file from the previous step.
The Count field may also be defined to perform a specific action as determined by the
radio buttons below the Right Ear fields. The Continue option proceeds to the next step
or count. The Stop option tells the sequence to end. The Repeat option runs the
protocol two times (the same as entering 2 for the count). The Link option allows you to
connect to another protocol – a dialog is presented where you chose the protocol to
link.
The Protocol File Options section at the bottom left provides the file control buttons.
The Load button displays a file open dialog where you may choose to open an existing
protocol. The Save button displays popup a dialog where you can name and save the
protocol. The Clear resets the parameters of the currently loaded protocol. The OK
button closes the dialog.
NOTE: If the last step (Item) in the protocol is set to Continue, the step continues, and
you will need to manually stop the collection and protocol. Set the last item in the
protocol to Stop to automatically stop after the last step.
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SIGNAL TO NOISE RATIO AND NOISE GRAPHS

The SNR and Noise Plot graphs display the overall signal to noise ratio and the overall
noise for the currently collecting waveform. Each channel is plotted individually with a
red point/line for the right ear and a blue point/line for the left ear. The Display menu,
SNR History option acts as a toggle to display or hide the graphs.
The graphs are updated with each block of sweeps. The slider controls to the right of
each graph allow you to scroll to values not displayed in the window.
KEYBOARD SHORTCUTS
Some options in the program may be controlled via the keyboard. The table below lists
the keys that are active in the EP modality.
Key Function
Esc or Space Pause or Stop a recording
Space Pause or Stop a recording
A Displays the Audiogram dialog
V Displays the Analysis dialog
1-9 Display the page number
D-0129360 Rev A Page 129 of 231

DATA ANALYSIS
loaded.

Recording or select the Load Recordings icon from the toolbar. The Data Files
dialog is presented where you select the recordings to load for analysis. The
recordings are loaded onto the current page.
DATA FILES DIALOG
recordings.
D-0129360 Rev A Page 130 of 231

ANALYZE ACTIVE WAVE

The Analyze Active Wave displays the ASSR response data in a dialog with a
polar plot, spectral graph, and an optional data table. The patient, stimulus
and recording information is displayed in the top left of the dialog. There are
checkbox controls that determine the display of the data table and the frequency axis of
the spectral graph. The controls at the bottom of the dialog allow for the selection of
the waveform for analysis and options to copy and print the data.
Polar Plot Spectral Graph
Data
Record Selector
Polar Plot
The polar plot displays the phase relationship between the stimulus and the response.
The response to each stimulus is plotted as a vector where the length of the vector
indicates the strength of the response. Vectors from the right ear are displayed with a
red line and the left ear with a blue line. The voltage level is indicated by concentric
D-0129360 Rev A Page 131 of 231

circles in the plot with the voltage value displayed in each circle in the top right
quadrant of the plot. At the end of each vector line is a circle and a label to indicate the
stimulus frequency of the vector. The circle at the end of the vector line indicates the
standard deviation of the phase for each block is considered. Larger circles represent
larger standard deviation and less certainty of a response. Smaller circles indicate
smaller deviation and more certainty that the response is present. The label at the end
of the vector showing the stimulus frequency is color coded to indicate if a response
was detected. A green label indicates that a response was detected, and a black label
indicates that no response was detected.
When the Phase Criteria checkbox is checked the standard deviation of the
phase vector is considered when determining if a response is present. When checked,
the phase standard deviation must be less than 80 degrees to be considered a
response.
Spectral Graph
The spectral graph converts the response waveform to the frequency domain by using a
Fast Fourier Transform (FFT), displaying the amplitude on the Y axis and frequency on
the X axis. Each X axis point (bin) represents 0.9765 Hz. The response to the stimulus
should occur at the modulation frequency of the stimulus. The red lines represent the
expected location for the response from the right ear and the blue lines the response
from the left ear. Yellow lines are the sum of the A and B buffers which indicates
repeatable energy. The grey lines are the subtraction of the A and B buffers which
represents the noise energy.
The Harmonic Components checkbox toggles the display to expand

the X axis of the FFT graph to include higher frequency components. Additional
response calculation criteria are also enabled. When checked, the total response
energy will include the energy of the fundamental and next 3 harmonic components.
Data Table
The data table is displayed when the Show Table check box is checked. The
data from the response is displayed in a tabular format. The right and left ears are
presented as separate tables. The top of the table indicates the ear, the number of
frequencies in the stimulus, the stimulus level and stimulus file. There is a header row
with each column measurement label, followed by a row for each frequency tested.
• Freq. (Hz) – Displays the component number, the frequency and the modulation
rate.
• Resp – Displays a YES or NO to indicate if a response was present. For a
response to be considered probable, the SNR value must exceed 6.13. If the
Phase Criteria checkbox is checked, the phase standard deviation is also
considered and must be less than 80 degrees.
D-0129360 Rev A Page 132 of 231

• Signal (uV) – Displays the amplitude of the response at the frequency bin
corresponding to the component modulation rate. The standard deviation is
shown in parenthesis.
• SNR (dB) – Displays the signal-to-noise ratio between the response, and the
noise in the response bin.
• Phase (°) – Displays the angle of the vector in the Polar Plot. The standard
deviation of the phase is shown in parenthesis.
• Noise (uV) – Displays the amplitude of the noise at the response bin. The
corresponding standard deviation is shown in parenthesis.
• Phase (°) – Displays the angle of the noise at the response bin. The standard
deviation of the noise phase is shown in parenthesis.
• SideBins (uV) – Displays the averaged amplitude of the bins on either side of the
response bin. The standard deviation of this amplitude is shown in parenthesis.
• SNR (dB) – Displays the signal-to-noise ratio of the response amplitude versus
the amplitude of the noise in the side bins. Following the SNR is a p value
indicating the probability of a response, the lower the number, the more
certainty that a response is present.
The Show FFT Values checkbox when checked allows you to display the
data from the frequency transformation (FFT) of the response. The data is presented at
the end of the data table and includes the frequency bin, signal amplitude, and the
noise amplitude of each bin starting at 0 Hz and ending at 156 Hz.
Record Selection and Option Buttons

At the bottom of the dialog is the record selector and option buttons.
The Record Selector is a drop-down menu that includes a list of all the waveforms on the
current page. Selecting a different record from the list will update the graphic plots and
table.
The Copy to Clip Board button copies the data table to the Windows clipboard where you
can paste the data into another program.
The Copy Image button creates a graphic of the analysis window and automatically
places it on the report page.
The Print button sends the analysis window display to the default printer.
The OK button closes the Analysis Dialog.
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ASSR RESPONSE AUDIOGRAM

The ASSR Response Audiogram button displays the Response Audiogram
dialog. The response audiogram is generated from the ASSR response
waveforms on the current page. The patient information is displayed in the
top left. Separate audiograms for the right and let ears occupy the middle of the dialog.
Display options and a table of the data in the audiogram is presented at the bottom of
the dialog.
The Plot Individual Trials checkbox acts as a toggle and shows/hides

the individual tests combinations found in the waveforms. The responses appear as
filled color circles at their respective points on the audiogram and the no responses
appear as black open circles. When unchecked, only the audiogram is displayed based
on the lowest level detected for each frequency.
The Responses Only checkbox acts as a toggle and shows only the
responses of the individual of all trials found in the waveforms when checked. When
unchecked the non-response trials appear as unfilled circles on the audiogram.
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The HL Correction section has an

option for converting the
audiogram to HL scales. The
General Table (HLcg) option coverts
the response values by adding an
offset. This scale on the audiogram
shows values in HLcg, to indicate correction-general. The Edit Values button prompts for
a password and then displays the conversion table where you can set up the SPL to HL
offsets. The Load button provides an Open dialog where you may select a saved
correction table. The Save As button prompts for a password and then provides a dialog
where you may save the current table as a new HL correction file.
The Copy Audiogram to Report Page button places the current view of the audiogram on
the report page. This option also saves an image of the audiogram inside the patient’s
folder (so the image can be added to a page in ABR or TEOAE module.)
The Print button sends the audiogram to the default printer.
The OK button closes the audiogram dialog.
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HL CORRECTION TABLE
Selecting the Edit Values button in the ASSR Response Audiogram dialog, displays the
HL Correction Table dialog. The dialog is password protected. The SPL-to-HL table
contains the values to be used for the correction from SPL to HL. The selected
transducer is indicated with the selected radio button under Stimulator. The table
displays the values for the selected transducer. Changing the transducer changes the
values as each transducer may have its own set of correction values.
The Clipboard button copies the table data to the Windows clipboard where you can
paste the information into another program.
The Print button sends the table for the currently selected stimulator to the printer.
The Print All button sends all tables for all available stimulators to the printer.
The OK button closes the dialog and save any changes made.
D-0129360 Rev A Page 136 of 231

D-0129360 Rev A Page 137 of 231

DISTORTION PRODUCTS OTOACOUSTIC EMISSIONS (DPOAE)

When the DP icon is selected, the system displays the initialization dialog while
the DP module loads and then the main DP screen is presented. The DP
screen layout has a title bar at the top, the main menu under the title bar, and
the Toolbar and overall result box in the upper part of the screen. The middle of the
screen contains the DP data area, the stimulus and response spectra, the DP point
information and the stimulus level. An Informational Status bar is found along the
bottom of the screen.
Menu
DP Collection Screen Result Box
Toolbar
DP data point
Information
DP Spectra
DPGram
Stimulus
Level
Information Bar
TITLE BAR
D-0129360 Rev A Page 138 of 231

DPOAE MAIN MENU

The DPOAE Main Menu allows access to most of the functions of the program. In
addition to using the mouse to access the items in the menu, the Alt or F10 key may be
used for menu activation for navigation using the keyboard.
Patient
• Cleanup on New Patient – Removes the data from the display when a new
patient is selected or entered when this option is checked
• Return to Main Screen – Closes the DPOAE program
System
• Passing Criteria – Displays the Passing Criteria dialog.
• Normative Data – Displays the Normative Data dialog.
• Check Probe Fit – When checked, automatically checks the probe fit when
acquisition starts.
Print
• Print Data – Displays the DPGram Print dialog where you may choose the data
that will be printed and then print the data.
• Printer Setup – Displays the Printer Setup Dialog.
Help
D-0129360 Rev A Page 139 of 231

TOOLBAR
Below the Menu, there is a Toolbar with icons that are equivalent to the most used
menu items.
Icon Description


Starts the data collection stimulating the Left ear
Settings – displays a pop-up dialog with the parameters used for

the data collection
Page Settings – displays a pop-up dialog with the display

parameters for the axis and other DPGram options
Frequency Spectrum – displays a pop-up dialog with the

frequency spectrum data
Data Table – displays a pop-up dialog with the data displayed in a

tabular format
Load DP I/O data file – displays a pop-up dialog with where the
user may select the DP I/O data file to display. Only shown in the
DP I/O mode.
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Print DP Gram – displays a pop-up dialog with where the user

may select the print options and setup the printer
DP I/O – DP Input/Output data collection and analysis. The

program collects responses to a single frequency pair at different
stimulus levels.
Data Analysis Screen – displays the DP data analysis screen.
DP Collection – displays the DP collection screen

DATA COLLECTION
Data collection is initiated with the selection of the Right or Left ear
icon from the toolbar. The program has default settings included
with the system. To verify the settings or to change settings prior
to collection select the Parameters icon. Prior to collecting data, a
probe check is preformed if the System, Check Probe Fit item is selected. If the probe
fit is selected, the criteria for passing the probe fit is based on the average noise floor in
a frequency range.
Probe Fit Criteria

Frequency Band Average Noise Floor
100 – 1000 Hz 20 dB SPL
1000 – 2000 Hz 10 dB SPL
2000 – 4000 Hz 5 dB SPL
4000 – 8000 Hz 0 dB SPL
If the probe check fails, a warning message is displayed, and collection does not begin.
After the probe fit (if selected), the program measures the background noise followed
by an in-ear level correction. During the in-ear correction the program cycles through
each frequency pair presenting the stimuli and recording the level to adjust the levels as
needed. Vertical line pairs are shown on the screen while the in-ear correction is being
performed and removed once data acquisition begins. An error message may be
presented if the correction values are too large and recommend checking the probe fit.
D-0129360 Rev A Page 141 of 231

You may continue even with this error, but you should be aware of the actual stimulus
levels to make sure that they are not far from the entered L1 and L2.
Once the in-ear adjustment is performed, the data is collected in blocks of sweeps as set
in the parameters. Depending on the parameter settings, blocks may be repeated if
there is noise or artifacts in the block. Acquisition continues until all sweeps have been
collected or the stopping criteria is met.
Once data collection has started the Right and Left ear buttons on the toolbar
are replaced with a Pause icon. The keyboard key Esc may also be used to
Pause/Stop a recording. A confirmation dialog is presented showing you the
current frequency being tested and the number of sweeps and you are asked to
confirm that you wish to Abort or Ignore. Abort stops the data collection and Ignore
continues from where you paused the collection. If you choose to Abort, then another
confirmation dialog is presented that asks if you want to save the data that has been
collected.
Test Parameters
The parameters control the data collection options, stimulus settings, criteria
for stopping the test and indicating a passing result. When the Test
Parameters icon is clicked, the Parameters dialog is presented. It is organized
by tabs at the top of the dialog and option buttons on the right side. The top left of the
dialog contains two radio buttons that determine the mode of operation. The Use
Frequency is the normal mode of operation where the program calculates the
frequencies for the DP stimulus if you specify the parameters for the start and stop.
The Use Sequence is a scripted mode where the number of sweeps, F1 and F2
frequencies, and L1 and L2 stimulus levels are entered manually.
D-0129360 Rev A Page 142 of 231

The right side of the dialog contains the option buttons. The OK
button closes the dialog. If changes have been made, a
confirmation dialog is presented to allow you to save the changes.
The Cancel button closes the dialog and ignores any changes that
have been made. The Load button presents a new dialog listing any
saved DP protocols. You may select a new protocol from the list.
The Save button present a new dialog where you may name and
save the parameters. The Save as Defaults button saves the
parameters as the default protocol (Default.PRO) that is loaded
when the program is started. The Print button sends the parameter
settings to the printer.
D-0129360 Rev A Page 143 of 231

General Tab
• Sweeps – Determines the total number of sweeps collected for each frequency
pair.
• Block Size – Determines the subset of collected responses averaged together
and plotted during the acquisition. The program collects the sweeps in blocks of
data, cycling the frequency pairs until the full number of sweeps is reached or
other pass/stop criteria are met.
• Level 1 (dB SPL) – Output level for the F1 frequency of the frequency pair used
as a stimulus.
• Level 2 (dB SPL) – Output level for the F2 frequency of the frequency pair used
as a stimulus.
• Artifact (dB) – Microphone level maximum to be considered an artifact and not
included in the response.
• Retry – Number of times a block is re-collected if has been rejected due to
artifact.
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Frequency Tab
• Start Freq – Determines the first frequency to use for the DP response. The
program automatically calculates the F1 and F2 used for the stimulus pair.
• End Freq – Determines the last frequency to use for the DP response.
• Freqs/oct – Determines the number of DP results plotted per octave between
the Start and End frequencies.
• F2/F1 – Defines the ratio between F2 and F1 frequencies.
• Presentation – Determines if the stimulus presentation of the frequency pairs
starts from the high frequencies, or from the low frequencies.
• Test at ONE frequency only – Switches the mode to acquire using a single
frequency pair. When this option is checked, The Edit F1 and F2 checkbox
appears
o Edit F1 and F2 – this option automatically adjusts the F1 and F2
frequencies based on the current frequency in the list of frequency pairs.
• Next Freq – The Up and Down buttons cycle through the calculated frequency
pairs, showing the calculated data in the panel above the buttons.
D-0129360 Rev A Page 145 of 231

Advanced Tab
• Max Level (dB SPL) – Determines the maximum stimulation level that can be
selected. It also defines the upper limit of the level correction.
• Max Ear Corr (dB SPL) – Determines the maximum allowed stimulus level
correction applied to each stimulus frequency. The correction is determined at
the start of each acquisition.
• Ear Correction – Defines if the ear correction is used. The checkbox toggles the
ear correction ON and OFF. This correction is based on the human ear canal
volume.
D-0129360 Rev A Page 146 of 231

Stopping Tab
• On pass at that freq – Determines if the program stops collecting blocks of data
for a frequency pair that meets the single point passing criteria. The checkbox
acts as a toggle to turn on/off the frequency stop criteria.
• On overall pass – Determines if the collected data meets the current overall
passing criteria and then stops the acquisition. The checkbox acts as a toggle to
turn on/off the stopping when the overall pass criteria are met.
• On no chance to pass – When checked, if it is not possible for the current
recording to meet the passing criteria, it will stop the recording process.
Passing Criteria & Norms
The Select Passing Criteria button opens the Passing Criteria dialog where you may enter
the parameters used to determine a Pass result which are also used in the stopping
criteria. The Select Normative Data button opens the Normative Data dialog where you
select a normative data file or enter and edit the normative data for the DPGram.
D-0129360 Rev A Page 147 of 231

Passing Criteria Dialog

The Passing Criteria dialog provides options to determine when a specific frequency
passes as well as the criteria for passing the overall response. These values may be
modified to fit specific diagnostic or screening protocols.
The OK button closes the window and a confirmation dialog asks to save the criteria to
the current file. The Cancel button closes the window, disregarding any modifications to
the criteria. The Load button presents a dialog where you may select a previously saved
passing criteria file. The Save button presents a dialog where you may name and save
the passing criteria as a file. The Print button sends the current passing criteria to the
printer.
Criteria at a given frequency applies to each frequency independently. The Overall

criteria applies to all data points as a group. The checkbox on the left of each item turns
on/off the individua criteria parameter. The text box to the right of the item determines
the value that is used for the parameter.
Criteria at a given frequency

• DP – Ns = SNR (dB SPL) – Defines the Signal-to-Noise ratio. This is the required
difference between the signal and the noise level at the DP frequency.
• DP – Ns (in units of Std Dev) – Defines, in the number of standard deviations,
that are used to add to the mean amplitude of the side bins, to determine the
value for which the amplitude of the DP must be greater than for a response to
D-0129360 Rev A Page 148 of 231

be considered a pass. For example, if the mean noise is 5 dB SPL and the std is
3, and you have set the number of standard deviations to 2 in the text box, then
a DP must be greater than 5+(3x2) = 11 dB SPL to be considered a response
• DP Value – Defines the amplitude of the DP response. To be considered a
response the value for the test frequency must be at or above the value entered.
• Overall
• Percent passed from all freqs – Defines, as a percentage of the total
frequencies in the protocol, how many frequencies must meet the individual
criteria for the recording to be considered an overall passing response.
• Percent passed in every octave – Defines, as a percentage of the frequencies in
the octave, how many frequencies must pass at each octave for the entire
recording to be considered an overall passing response.
• Percent passed in freq range – Defines how many points must pass in the
defined, frequency range for the entire recording to be considered an overall
passing response. Up to three user defined frequency ranges may be specified.
D-0129360 Rev A Page 149 of 231

Normative Data Dialog

The Normative Data dialog defines the values for the shading used in the DPGram to
represent the normal range of values for the DP amplitude and noise. The dialog has a
data table in the middle with the value used for the shading. The text boxes on the left
side are used to indicate the collection parameters. The bottom of the dialog displays
the DPGram based on the values in the table. The option buttons on the bottom left
provide choices to add and remove columns from the data table and to define the axes
of the DPGram.
• Comment – User defined text to describe the data set.

• Freq Ratio – Frequency ratio used for acquisition of the normative data.
• Ears – Defines the number of ears used to obtain the normative data set.
• L1 (dB SPL) – The level of the lower (F1) frequency used during the collection of
the normative data set.
• L2 – The level of the higher (F2) frequency used during the acquisition of the
normative data set.
• Ear (L/R) – Defines if the normative data set applies to the left and/or right ears.
• Sex (M/F) – Defines if the data set applies to males and/or females.
D-0129360 Rev A Page 150 of 231

Normative Data Table

Values for the normative data set may be entered directly into the table. Each column
represents one data point and each row labeled (on the left) for the value that should
be entered.
• F1 – The F1 frequency for the normative data point.

• F2 – The F2 frequency for the normative data point.
• DP – Average DP amplitude for the normative data point.
• DP SD – One standard deviation of the DP average amplitude.
• NF – The average noise floor amplitude.
• NF SD – One standard deviation of the noise floor average amplitude.
• Impaired – The DP amplitude for the impaired boundary.
• Normal – The DP amplitude for the normal boundary.
The Impaired and Normal entries may be used to define a boundary when the values
for the DP, DP-SD, ND and NF-SD are set to 0. The region would then be defined as the
uncertainty region, the responses above normal and responses below abnormal.
If any entries are detected as an error, the error button appears on the bottom
left of the data table. Click on the button and a dialog is presented that indicates
the error.
Option buttons
The Add Col button adds a new column to the data table where you may enter the
values. The Remove button removes the current column in the table. The Options
button present a pop-up menu where you may define the Frequency axis and the dB
axis on the DPGram.
The OK button closes the window and if there are any changes to the data, a
confirmation dialog asks to save the normative data to the current file. The Cancel
button closes the window, disregarding any modifications to the data. The Load button
presents a dialog where you may select a previously saved normative data file. The Save
button presents a dialog where you may name and save the normative data as a file.
The Print button sends the current normative data to the printer.
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Data Collection Screens

During the acquisition of data, each section of the screen is updated as the data is
acquired. The DPGram, Spectrum graph, Stimulus Level graph, DP data point
information panel and the Results panel are synchronized with the data point being
collected or selected by the user.
DPGram
The DPGram is a graph of DPOAE amplitude as a function of frequency. The number of
data points displayed on the DPGram is based on the test parameters for the start and
stop frequency and the number of points per octave. The stopping criteria may also
impact the number of data points displayed. The current data point has the filled in
symbol, blue square for the left ear and a red triangle for the right ear. The other data
presented on the graph are based on the options selected from the Display Settings
dialog. The specific information for the current data point is presented in the Spectrum
graph, Level graph, and the data point panel.
The Display Settings option on the toolbar displays a pop-up dialog with the
display parameters for the axis and other DPGram options (described in the
Data Analysis section)
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Spectrum Graph
The Spectrum graph displays a subset of the overall response spectra, showing the
details of the current data point DP response amplitude and the associated frequencies
adjacent to the response frequency (side bins). The DP response is shown in the center
as a red line with a triangle for the right ear, or a blue line
with a square for the left ear. All other vertical lines next to
DP Response
the DP response represent the side bins.
The average noise floor is calculated from the 5 side bins on

each side of the DP frequency (ignoring the two side bins
closest to the DP frequency). The average noise is displayed
as the bar to the left of the spectra lines. The darker color
indicates the average noise and the lighter shade above it
indicates one standard deviation.
Standard Deviation
Average Noise
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Spectrum Dialog
In addition to the Spectrum graph for the current data point, a spectrum of
the current activity detected by the microphone is available during collection
by selecting the Spectrum icon from the toolbar. In this dialog you may view
data in both the frequency domain as well as the time domain.
At the top of the window is a menu bar.
• View
o 2F1-F2 – Displays the 2F1-F2 distortion product for the point
o 2F2-F1 – Displays the 2F2-F1 distortion product for the point
o Toolbar – Displays a toolbar at the top of the dialog with buttons to move
to the previous and next points and close the dialog.
o Time Domain – Displays the time domain graph
o Prev – Moves to the previous DP point
o Next – Moves to the next DP point
o Close – Closes the dialog and returns to the collection screen
A left click on the frequency or time graph provides a cursor and marks the specific
position. The values at the cross hairs are displayed at the top of the graph. Click-
dragging on the graph will show the information at the position of the cross hairs at the
end of the drag, and the difference between the start and end positions. For the cursor
information two values are displayed. The frequency graph displays the frequency (in
kHz) and the amplitude (in dB SPL). The time graph displays the time (in ms) and
amplitude (in volts).
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A right-click on the graph will bring up the context menu. This menu has options for the
display of the data graphs.
• Grid – Displays horizontal and vertical lines axis

lines on the graph. This item toggles between
ON/OFF with each click.
• Type – Displays the graph as a line or bar graph.
This item toggles between Line and Bar with each
click.
• Demean – Adjusts the graph by removing the DC
component of the frequency graph. This item
toggles between ON/OFF with each click.
• Auto Scale – Adjust the scale (Y axis) based on the
best fit of the data. This item toggles between ON/OFF with each click.
• Set Range – Displays two pop-up dialogs where the lower and upper boundaries
for the scale (Y axis) are entered.
• View – Zooms in on the current location of the cursor.
• Print – Prints the Spectra dialog.
• Graph Color – Displays a color picker dialog where you may select the color of
the graph data.
• Axis Color – Displays a color picker dialog where you may select the color of the
axis of the graph.
D-0129360 Rev A Page 155 of 231

Stimulus Level Graph

The Stimulus Level graph displays the stimulus output
levels during the collection as recorded by the
microphone in the probe. Ideally, the actual levels (A1
and A2) should be equal to the levels specified in the
parameters window (L1 and L2). A discrepancy
between the values can occur when the needed level
correction exceeds the maximum allowed correction.
Small differences of 1 or 2 dBs, would not invalidate

the results. Large differences between parameter
levels and actual levels indicate a possible sound
output problem, such as a blocked sound tubes in the
probe or bad probe placement.
Data Point Information Panel

The DP Data Point information panel
displays the numeric data for the specific
data point.
• Freq – Two stimulation frequencies,

F1. F2.
• Sqrt(F1*F2) – Geometric mean of the
stimulation frequencies.
• 2F1-F2 – Distortion product frequency for the response that is being measured
• Level – Two stimulus levels (L1, L2) of the two tones.
• DP – Response DP amplitude,
• Ns – Average noise
• SNR – Signal-to-noise ratio. The SNR is colored green when all the passing
criteria for the point are met, and red when they are not.
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Data Table
The Data Table toolbar option displays a pop-up dialog showing the
information displayed in the DPGram in a tabular format. This table is
available in both data collection and analysis. The dialog has a menu bar and
the top with options for viewing and printing the data table.
• View
o Toolbar – displays a toolbar with the Close button
o Status Bar – displays a status bar for program messages
• Print
o Short Table – prints the information as shown in the data table
o Long Table – prints the information in the data table plus additional data
from the acquisition. The additional information includes the initial noise
at the DP frequency before averaging, noise standard deviation, applied
in-ear correction and the side bands adjacent to the DP response
frequency.
Below the menu bar the information on the ear tested, the number of frequencies and
the filename of the data is displayed. The table has two header rows followed by a row
of data for each frequency tested.
• F1 – First stimulus components F1 of the stimulus frequency pair.

• F2 – Second stimulus component F2 of the stimulus frequency pair.
• Fdp – Expected DP response frequency.
• Sweeps – Total number of sweeps collected for the stimulus frequency pair.
• L1 – Stimulus level for the first frequency (F1).
• L2 – Stimulus level for the second frequency (F2).
• A1 – Actual stimulus levels detected by the probe microphone for F1
• A2 – Actual stimulus levels detected by the probe microphone for F2
• DP – Amplitude of the DP response (Fdp).
• Ns – Average noise level.
• SNR – Signal-to-noise ratio at the DP response frequency.
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DATA ANALYSIS
The Data Analysis option on the toolbar replaces the Data Collection screen
with the Data Analysis screen. The Data Analysis screen has a menu at the
top and a toolbar under the menu.
Data Analysis Menu

The Patient, System, Print and Help menu items are the same in both the data
collection screen and the data analysis screen.
The Report menu is only available in data analysis. The files that are save may be
imported into other program modules (as an image) or external programs.
• Report
o Copy Display Image to File – Saves the right and left DPGrams to a
graphics (*.bmp) file. The filename is generated automatically.
o Copy Right DPGram Image to File – Saves the right DPGram to a
graphics (*.bmp) file. The filename is generated automatically.
o Copy Left DPGram Image to File – Saves the left DPGram to a graphics
(*.bmp) file. The filename is generated automatically.
Data Analysis Toolbar

The Add Patient, Search Patient and Edit Patient options are
the same for both the collection and analysis screens.
D-0129360 Rev A Page 158 of 231

The DP Collection icon on the toolbar returns to the DP data collection screen.
The IO Collection icon on the toolbar returns to the IO data collection screen.
Load Data Files

Once the patient has been selected, you load DP recordings using
the Right or Left ear icon on the toolbar. The File open dialog
displays the list of recordings that match the ear selected. From the
list, you may select a single recording or multiple recordings (using
the Shift and/or Ctrl keys to select). Even though multiple recording may be selected, a
single recording is displayed. To choose the recording to display, or to remove
recordings, use the dropdown button below the toolbar.
The button is labeled with the ear and filename currently being displayed. Selecting the
button presents a dropdown menu. Options for removing the current record or all
records are followed by the list of loaded recordings. Click on any loaded record to
display on the DPGram. Display options can show the other records as lines on the
DPGram.
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Display Options
The Display Options button on the toolbar displays the Display Options dialog
where you may configure the settings for the DPGram.
The Display Options dialog has the display parameters on the left side and option
buttons on the right.
• Std Deviations – Dropdown menu provides the options for the standard
deviation of the average noise. You may select none, 1 or 2 standard deviations.
The standard deviation data is displayed as a lighter shade above the noise in
the DPGram.
• Internal Noise – A checkbox that toggles the display of the internal noise of the
system.
• Frequency Axis – Dropdown menu displays the options for the frequency axis
(X) on the DPGram. The selections are F1, F1, Sqrt(F1*F2) and (F1+F2)/2. The first
frequency of the stimulus pair, the second frequency of the stimulus pair, the
geometric mean and the arithmetic mean.
• dB Axis High – A text box where you enter the maximum value of the dB SPL
axis (Y).
• Low – A text box where you enter the minimum value of the dB SPL axis (Y).
• History Traces – A checkbox that toggles the display of all traces that are
currently loaded (or acquired if in the collection screen). The historical traces are
shown as dotted lines on the DPGram.
• Normative Data – A checkbox that toggles the display of the normative data file.
D-0129360 Rev A Page 160 of 231

• Display Ear – Dropdown menu with options on which ear(s) to display. When a
single ear is displayed, the Spectrum graph and Stimulus Level graph are show
(like in the collection screen).
dB Axis High
Historical DP
Response
Normative
DP Response
dB Axis Low
Noise Standard Deviation
Noise
Frequency Axis
Option Buttons
The OK button applies the changes and closes the dialog. The Cancel button discards
any changes made and closes the dialog. The Apply button updates the DPGram with
the selected settings and keeps the Display Options dialog open.
D-0129360 Rev A Page 161 of 231

Print
The Print options are available from the toolbar Print button or the Print
menu, Print Data item. The Print option displays the Print DPGram dialog.
The dialog has checkboxes for the selection of the items to print on the left
and option buttons on the right.
In order to print at least one ear must be selected and have data available.
• Right Ear – Print the DPGram for the right ear, when checked.
• Left ear – Print the DPGram for the left ear, when checked.
• Two per row – Prints the DPGrams for each ear on the same line side by side, if
there is more than one DPGram selected. If this item is not checked, each
DPGram prints on a separate page.
• History Files – Includes all currently loaded recordings when checked. If not
checked, only the currently displayed recording is printed.
• Data Table – Prints the data table along with the DPGram when checked.
• Passing Status – Prints of the result passing status when checked.
Option Buttons
The Print button: sends the print job to the printer using the selected printing options
and closes the dialog. The Cancel button closes the dialog (nothing sent to the printer).
The Setup button opens the Windows printer setup dialog.
D-0129360 Rev A Page 162 of 231

DP I/O
The DP I/O icon on the toolbar changes to the Input- Output mode of
operation. This mode of operation collects data from a single pair of stimulus
frequencies at multiple stimulus levels. The DP Gram graph is modified for
this mode by changing the X axis to reflect the stimulus level in place of the stimulus
frequency as only a single stimulus frequency is collected. The Load DP I/O files icon is
added to the toolbar and a new dropdown menu is displayed on the Setting icon on the
toolbar.
Collection Settings
The Settings icon on the toolbar displays a dropdown menu where you may
define the starting and stopping stimulus levels and the steps size for the
stimulus levels.
The Total Points displays the number of data points that will be collected. The number
of data points collected depends on the general DP settings and not just the stimulus
level and step size of the DP IO settings. The Other Parameters option displays the Test
Parameters dialog. In the Test Parameters dialog, the Frequency tab indicates the
number of data points (panel on the right side) based on the Start Frequency, End
Frequency and the Frequencies/octave. If the number of steps based on the stimulus
levels exceeds the number of data points (from the Test Parameters), not all steps will
be acquired. To increase the number of data points collected, either extend the end
testing frequency, or increase the number of frequencies per octave in the Frequency
tab. A maximum of 41 data points may be collected.
The frequency pair that is used for the data collection is also determined on the
Frequency tab in the Test Parameters dialog. Check the box labeled “Test at ONE
frequency only”. The frequency pair displayed in the panel on the right side of the tab is
the frequency pair that will be used for the data acquisition. You can change the
frequency pair using the up and down arrows to cycle through the list until you have the
desired stimulus pair.
The Start, End and Step for L1 and L2 display the current settings for the stimulus levels
and step size for the frequency pair. Selecting any of the menu items pops up a dialog
where you may set the levels and step size.
D-0129360 Rev A Page 163 of 231

DP I/O Levels Dialog
Setting the Step size to a negative value presents the stimulus levels from high to low.
Setting the Step size to a positive value starts at the low level (End) and increases the
levels to the Start value. The end level should match the step size and number of steps
desired. The number of steps and the levels for each step is indicated on the panel to
the right of the entered values. You can see each step using the Up and Down arrow
buttons.
Option buttons
The OK button closes the window and using the settings for the data collection. The
Cancel button closes the window, disregarding any modifications to the data. The Help
button displays the program manual in a new window. The Load button presents a
dialog where you may select a previously saved I/O parameter data file. The Save
button presents a dialog where you may name and save the I/O parameter data as a
file. The Print button sends the current I/O parameter data to the printer.
Data Collection
Data collection is initiated with the selection of the Right or
Left ear icon from the toolbar. The data collection process
and screen are like that previous described for the DPOAE.
The only difference is that the DPGram has a different X axis
showing the level of the stimulus pair instead of the
frequency of the stimulus pair.
D-0129360 Rev A Page 164 of 231

Data Analysis
The Data Analysis for the DP I/O mode takes place on the same screen as the data
collection.
The Load DP I/O icon on the toolbar presents a dialog where you select
previously recorded data. The options available in data analysis are the same
as those described for the DPOAE.
The Display and Print icons on the toolbar provide the options to configure the DPGram
and print a report. These are the same as described for the DPOAE.
D-0129360 Rev A Page 165 of 231

D-0129360 Rev A Page 166 of 231

TRANSIENT EVOKED OTOACOUSTIC EMISSIONS (TEOAE)

When the TE icon is selected, the system displays the initialization dialog while
the TE module loads and then the main TE screen is presented. The TE screen
layout has a title bar at the top, information bar below the main menu, and
the top Toolbar in the upper part of the screen. The middle of the screen contains the
TE waveform area, the page selection control and side toolbar. If the data acquisition
page is selected, a meatal response panel is displayed along with an artifact level
control and there is a collection toolbar at the bottom of the page.
Menu
Information Bar
Toolbar
TEOAE Collection Screen
Page Selection
TE Waveform Area
Side Toolbar Meatal Response

and Artifact Level
control
Collection Toolbar
TITLE BAR
D-0129360 Rev A Page 167 of 231

TEOAE MAIN MENU

The TEOAE Main Menu allows access to most of the functions of the program.
Patient
• Clear Data on New Patient ON – Removes the data from the display when a
new patient is selected or entered when this option is checked
• Quit TEOAE – Closes the TEOAE program
Protocol
• Load Settings – Opens the File Open dialog where you may select a settings file
• Save Settings – Opens the File Save dialog where you may save the current
settings to a file.
• Save as Defaults…- Save the current settings as the default settings file. This is
the file that is loaded when the program is started.
• Modality
o Transient (Non-Linear) – Sets the data collection to use the stimulus
sequence presentation in non-linear mode. Three stimuli are followed by
a fourth stimulus that is the opposite polarity and 3 times the amplitude
as the previous three. This protocol modality should be used when
stimulus levels are above 65 dB SPL.
o Transient (Linear) – Sets the data collection to use the stimulus
sequence presentation in linear mode. All the stimuli are the same. This
protocol modality should be used when stimulus levels are below 65 dB
SPL.
o Spontaneous – Sets the data collection to use the spontaneous mode of
data collection. In this mode there should be no stimulus to elicit a
response, so you should set the stimulus to a lower level (<60 dB SPL) for
synchronized spontaneous emissions or 0 for asynchronous.
• Passing Criteria – Opens the Passing Criteria dialog where you may specify what
is required for the overall results to be displayed as Pass/Refer. A password is
required to open the dialog.
D-0129360 Rev A Page 168 of 231

Stimulus
• Intensity – Display the current stimulus level (dB SPL). When clicked, pops up an
input dialog where you may enter the level.
• InEar Correction – Displays the current setting and when selected, provides a
sub menu where you may choose the maximum level allowed for any in-ear
stimulus correction. The correction may be set to off or a maximum in-ear
correction of 20 dB.
o OFF
o 5 dB
o 10 dB
o 15 dB
o 20 dB
• Rate – Display the current stimulus rate. When clicked, pops up an input dialog
where you may enter the rate.
• Sweeps – Displays the current number of sweeps that will be collected. When
clicked, pops up an input dialog where you may enter the number of sweeps.
• Stimulus Presentation – Displays the current status of how the stimulus is
presented. When selected, a sub-meu is presented where you may choose to
present the stimulus only when you are collecting data or continuously.
o Only While Acquiring
o Continuously
• Probe Check Enabled – Displays the current status of the Probe Check. When
the item is checked, the probe fit is checked prior to stating the data collection.
• Meatal Saturation Check – Displays the current status of the Meatal Saturation
Check. When the item is checked, a warning is presented when any meatal
saturations is detected. If saturation is detected, the system does not analyze
the data.
Recordings
Report
D-0129360 Rev A Page 169 of 231

editor dialog. The Label element is only for a single line, any additional lines are
o Text
o Table (Dynamic)
o Table (Static)
o Label
o Selected
o Page
o All Pages
o Page Acq
o Page 1
o Page 2
o Page 3
o Page 4
o Page 5
o Page 6
o Page 7
o Page 8
D-0129360 Rev A Page 170 of 231

o Page 9
o Load Page Labels
o Save Page Labels
Print
the PDF viewer.
• Automatic Tables – Display a waveform information table automatically at the
page. If the options are not selected the program will fit the data to a single page
which may cause some data to be truncated in order to fit. The checkmark
indicates the status (On/Off). This option is a toggle.
Help
D-0129360 Rev A Page 171 of 231

INFORMATION BAR
selected waveform and is located below the Main Menu.
The Information bar displays the following:
• Recording name
• Peak amplitude (dB SPL for the Time Domain Response)
• Signal-to-noise ratio
• Residual noise
TOOLBAR
commonly used menu items.
Icon Description


Load TE File – displays the list of TE files and allows the user to
sort and select an TE file
Save TE File – saves the currently selected TE file
D-0129360 Rev A Page 172 of 231

Load Report File – displays the Open dialog with the list of report
files and allows the user to select a report file
Save Report File – displays the Save As dialog and allows the user
to save the current pages as a report file

page and split page

as a PDF file

D-0129360 Rev A Page 173 of 231

TE WAVEFORM AREA

page.
SIDE TOOLBAR
The Side Toolbar is located to the right of the EP waveform area. It has buttons for
setting page display parameters, increase/decrease the waveform display, and check
the probe fit.
Icon Description


the page

on the page
Check Probe Fit – displays the probe fit values under the Meatal
Response panel
D-0129360 Rev A Page 174 of 231

MEATAL RESPONSE PANEL
Meatal Response
The Meatal Response Panel is displayed when the Acquisition (Acq) page is displayed.
The first 6 milliseconds of the incoming response are displayed, and a frequency
spectrum of the meatal response is displayed. The artifact reject level may be adjusted
using the Open-Close scroll bar. Opening the bar will allow larger microphone data into
the average and Closing the bar will reject the incoming microphone data with a lower
amplitude. The percentage of the total amplifier gain is displayed under the scroll bar.
COLLECTION TOOLBAR
Icon Description
Starts the data collection stimulating the left ear
Indicates the current auditory stimulus level. This is

informational only. The stimulus intensity is changed via the
Stimulus option in the Main Menu
D-0129360 Rev A Page 175 of 231

The Stop Recording button appears when data is being

collected. A confirmation dialog is presented to determine if
you want to save the collection data.
DATA COLLECTION
Data collection is initiated with the selection of the Right or Left
ear icon from the Collection toolbar. The program has default
settings included with the system. To verify the settings or to
change settings prior to collection, select the Protocol or
Stimulus menu and adjust the parameters. Once data
collection is initiated, a probe check is performed if this option is enabled in the
Stimulus menu. The results of the probe check are displayed under the meatal
response panel on the right side of the screen. Once data collection begins, the TE
waveform area of the screen will be updated as data is acquired. The sweeps and
artifact count are displayed in the top left of the TE waveform area. During acquisition,
the right/left ear buttons are replaced with the Stop Recording button on the collection
toolbar. The Esc key or the Spacebar key on the computer keyboard may also be used to
pause or stop the recording.
Time waveform
Response Frequency graph

Meatal Response
Response Information
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Time Waveform Average – Displays the average recording from the microphone in the
time domain. The stimulus level, ear and channel are displayed at the beginning of
waveform below the waveform handle. The time scale is indicated at the bottom of the
screen area.
Response Frequency Graph – Displays the frequency representation of the response

(FFT of the time domain data). The frequency (kHz) is displayed on the horizontal (X)
axis and the amplitude (dB SPL) on the vertical axis (Y) to the right of the graph. The
response is shown in the yellow color and the noise in the dark green.
Meatal Response – Displays the microphone data for the first 6 milliseconds of the
recording.
Response Information Table – Displays the numerical information of the response.
• Total amplitude of the response (dB SPL)

• Total noise of the response (dB SPL)
• Test Modality, Stimulus level and rate
• Total number of sweeps/artifacts, amplifier gain
• Frequency Band, cross correlation, amplitude, SNR, RESP if a response is
detected, blank if not detected. The first band (1000 Hz) has the overall response
cross correlation
• Overall diagnostic result
PASSING CRITERIA
The Protocol menu, sub-menu item Passing Criteria, displays a dialog where you may
enter the requirements for the response to be considered a Pass. The dialog is
password protected. For each frequency band you may enter the required minimum
cross correlation and the minimum signal to noise ratio. The number of passing
frequency bands may also be specified to provide the criteria for the overall response
pass.
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DATA ANALYSIS
loaded.

Recording or select the Load Recordings icon from the toolbar. The Data Files
dialog is presented where you select the recordings to load for analysis. The
recordings are loaded onto the current page.
DATA FILES DIALOG
recordings.
Data Pages
Recordings are displayed on the Acq page as the data is being collected and saved
automatically when the acquisition completes. In addition to the Acq page, there are 9
additional pages for the display and analysis of data. On each page there is a time scale
D-0129360 Rev A Page 178 of 231

at the bottom and a vertical scale marker in the top left. There are ten waveform
display areas or pages and the pages on the display are printed as report pages when a
report is printed. Each page is accessible from the Page Selection control. The Page
button on the control can be shaded a different color depending on the status of the
page. The current active page will be shaded the darkest and indicated at the top of the
control, pages that have data on them will be darker than those without data.
Current page
Page has data Current Page

shading scroll bar
Empty page
shading
Current page
shading
Pages may be renamed by selecting Report menu and clicking on Page Labels, then
choosing the page to modify. There are two labels that may be defined, the 4-character
button label and the tool tip label that appears when hovering over the button and
printed on the report. The page labels may be saved, loaded or saved as the default
labels from the Page Labels sub menu.
To select a page, click on Page button in the control. The numeric character keys (at the
top of the keyboard), 0-9 may also be used to select the active page. The keyboard
shortcut keys function even if the pages have been renamed.
Data pages may be displayed as a full page or split page using the Toolbar
Full/Split Page icon which toggles between the two displays.
Display Options
Side Toolbar Display icon
The Display icon on the Side Toolbar provides a pop-up menu with options
for controlling the page layout and waveform display. The options are page
specific and the current page is indicated at the top of the menu. Depending
on the Page Mode (Full vs Split) different options are presented.
D-0129360 Rev A Page 179 of 231

• Scale – defines the size of the waveforms on the page, the vertical axis. The sub-
menu provides the options. Normalized adjusts the size of
the waveforms based on the minimum and maximum
values within the window or specified scaling start and stop
time (determined by Scaling option). Each waveform is
scaled independently from the others with Normalized while
Normalized Page scales all the waveforms based on the
largest individual waveform to the same scale. The scale
may also be defined at a specific microvolt value selected
from the choices provided (1.0, 0.9, 0.8, 0.7) or user defined by selecting Other.
Other will prompt for the microvolt value.
• Scaling – determines the time window that is used for the determining the
normalized scale. The Display Window uses the entire plot
shown (between plot start and end). Special enables the
Scaling Start and Scaling End menu items where you define
the time that is used for the normalized scaling.
• Scaling Start – defines the beginning of the waveform that will be considered in
Special and Normalization is used for Scale.
• Scaling End – defines the end of the waveform that will be considered in the
normalization calculation. This is only enabled when the Scaling is set to Special
and Normalization is used for Scale.
D-0129360 Rev A Page 180 of 231

• Page Mode – determines if the display shows a single page of data or is split into
two columns or pages. In the Full Page mode, the waveforms
occupy the entire window in a single column. In the Split Page
mode, waveforms are displayed in two columns, recordings from
the left ears are placed on the left side and right ear waveforms placed on the
right side.
• Move Mode – determines how waveforms can be placed and moved on the
page. In Fixed mode, the recordings snap to predetermined vertical
positions. The number of available positions varies based on the Plot
Size setting In Free mode, waveforms may be placed at any position
vertically. In both modes the waveforms snap to the left side to match the time
scale.
• Plot Size – determines the vertical space an individual waveform can occupy and
thus the size of waveforms and the space between them.
The options are expressed as a percentage of the screen.
The plot size can be selected from the options is provided,
or the user may define a specific percentage with Other.
Other will prompt for the percentage value. Larger values
may result in the waveforms overlapping each other. At 100
% Full Screen the recordings will be overlapped and take up
the entire screen.
• Plot Start Time – determines the start of the time window x-axis (horizontal) at
you enter the start time (ms). This option is only enabled in Full Page mode.
• Plot End Time – determines the start of the time window, x-axis (horizontal) at
you enter the end time (ms). This option is only enabled in Full Page mode.
• Plot Time: Right = Left – this option is only displayed in Split Page mode. When
checked it indicates that the right and left columns of the split page use the same
plot start and end time (window). When unchecked, you may define the right
and left columns plot times independently.
• Right or Left – Plot Start Time – determines the start of the time window, x-axis
display. A prompt is presented where you enter the start time (ms). This option
• Right or Left – Plot End Time – determines the end of the time window, x-axis
display. A prompt is presented where you enter the end time (ms). This option
• Grid – displays vertical lines on the waveform display area. This item is a toggle
to turn on/off the grid.
D-0129360 Rev A Page 181 of 231

• Apply above to – transfers the settings from the Display menu to other pages.
This item displays a sub-menu of pages when you can apply the settings from
the current display options to all pages or any specific page.
• Clear data on this page – removes the displayed data from the current page.
No data is deleted from the patient.
• Send all data on this page to – moves the data from the current page to a new
page specified by the page selected in the sub-menu of pages.
Waveform Options
Right click and the options for the current waveform are presented as a pop-up menu.
Note that the location on the time axis of where the mouse is clicked determines where
the peaks are marked.
• File Name – indicates the file name of the active recording. When the mouse is
placed over the name, a sub-menu is displayed with the stimulus, amplifier and
recording information.
Plot Type – displays a sub-menu of options for the waveform data. Average is the
normal waveform with the results from the collection, an
average of the collected responses. Split Sweep shows two
overlapping averages from the two internal buffers of the
recording (even and odd sweeps). Plus-Minus shows the
difference between the two internal buffers of the recording.
Spectral performs a frequency analysis of the waveform and displays the waveform in
the frequency domain. The waveform is split into two curves, one for the response, and
one for the noise.
D-0129360 Rev A Page 182 of 231

• Print Parameters – determines if the stimulus, amplifier, recording and peak

label information are printed for the active waveform. On prints the
parameters in the table when the page is printed. Off hides the
parameters for the waveform when the page is printed.
• Scaling – defines the scaling for the active waveform. The Display Window/Page
Region uses the entire plot shown (between plot
start and end). Post Stimulus Region uses the
time after the stimulus presentation Special
enables the Scaling Start and Scaling End menu
items where you define the time that is used for the normalized scaling.
• Scaling Start – defines the beginning of the active waveform that will be
considered in the normalization calculation. This is only enabled when the
Scaling is set to Special and Normalization is used for Scale for the page.
• Scaling End – defines the end of the active waveform that will be considered in
Special and Normalization is used for Scale for the page.
• Color – displays a color dialog where you may choose the color for the active
waveform.
• Send to Page – moves the data from the active waveform to a new page
specified by the page selected in the sub-menu of pages
• Clear – removes the active waveform from the page. The data is not deleted.
• Clear All Selected - - removes all the selected waveforms from the page. The
data is not deleted.
• Clear & Permanently Delete Active Recording from Disk – removes the active
waveform from the page and the data is deleted. A confirmation is required to
delete the data. Once deleted the data cannot be recovered
D-0129360 Rev A Page 183 of 231

REPORTS
Each of the display pages is printed as a page in the report. In addition to the
waveforms, reports include any additional information that has been added to
the pages, such as comments or Latency-Intensity graphs. In addition to data
collected with the EP module, data from any of the other modules (ASSR,
DPOAE and TEOAE) may also be included. Reports may be saved and loaded
from the Toolbar icons and the Report menu, Load Report and Save Report.
Adding Information
The Report menu has an option to Add information.
Some elements are static meaning that data does not change even if the waveforms on
the page change while others are dynamic where the data automatically changes when
the recordings change (such as marking peaks). The static elements may be edited
manually as needed. The dynamically elements should not be edited manually as the
edits will not be maintained when the data is updated. The Text and Label elements
both open the text editor dialog. The text editor dialog has options for loading and
saving text templates. The Label element is only for a single line, any additional lines
are ignored. The Label element is only for a single line, any additional lines are ignored.
The add Image option allows the inclusion of graphic elements such as audiograms
from the ASSR module or DP-grams from the DPOAE module or other bitmap images.
Printing Options
Printing may be initiated from the Print menu or the Print icons from
the Toolbar. The report may be printed to any printer attached to the
computer or saved as a PDF file. The print options allow you to print a
single page or all pages as a report. For the Print All Pages, only the display pages that
contain information are printed, no blank report pages are printed. The Print menu
presents a sub-menu which includes options to remove the patient information and
print in black and white.
D-0129360 Rev A Page 184 of 231

D-0129360 Rev A Page 185 of 231

CLEANING AND MAINTENANCE
CLEANING
This instrument is not designated as a ‘sterile’ device. Non-disposable parts of the
system, including the patient electrode cable, electrodes and electrode lead wires,
headphone cushions, bone vibrator, and insert phone tubes which are in direct contact
with the patient need to be disinfected between patients. This includes physically
wiping down the equipment which contacts the patient using a disinfectant approved by
your facility. Use of a non-alcohol-based disinfectant is recommended. Non-alcohol-
based products contain the active ingredient referred to as quaternary ammonia
compound or a hydrogen peroxide-based cleaner may be used. The quaternary
ammonia compound and hydrogen peroxide are specifically designed to disinfect
rubber, plastic, silicone and acrylic products which are commonly used in hearing
evaluation instruments. Individual manufacturer’s instruction should be followed for
use of this disinfecting agent to provide an appropriate level of disinfection. Remove
disposable eartips or electrodes prior to disinfection.
Do not immerse the instrument or transducers in fluids or allow any fluid to enter the
device or transducers. Do not attempt to sterilize the instrument or any of its
accessories. Do not use alcohol-based disinfectants.
To avoid person-to-person cross contamination of communicable diseases,

all disposable items such as eartips and disposable electrodes are intended
for single-patient use only and need to be discarded after the testing.
These items cannot be cleaned.
If the surface of the instrument or parts of it is contaminated, it can be cleaned using a

soft cloth moistened with a mild solution of water and detergent or similar. Always
switch off the device, disconnect the mains power adapter and be careful that no fluid
enters the inside of the instrument or accessories.
Recommendations for cleaning and disinfection of the Audera Pro presented in this
document are not intended to replace or contradict policies in effect or procedures
required for infection control at the facility.
OAE Probe Tube Replacement

Probe tubes are disposable and should be replaced when they become clogged.
Replacement probe tubes are included with the instrument. Do not attempt to clean
the probe tube. A probe replacement tool is provided with the system. Follow the
instructions provided with the tool. To replace the tubes without using the probe tool
follow the instructions below.
To replace the probe tube, use the eartip to grasp the probe tube (the clear plastic tube)
and twist slightly while pulling the probe tube straight out of the probe head.
D-0129360 Rev A Page 186 of 231

Dispose of the used probe tube immediately to avoid confusing used tubes and new
tubes. Take a new probe tube from the package and insert the tube into the probe
head until it is fully seated.
A properly inserted probe tube will snap securely into place when it is fully seated in the
probe head.
Do not attempt to clean the probe tubes as this may cause damage to the
probe.
D-0129360 Rev A Page 187 of 231

Attaching Eartips
The Audera Pro instrument comes with a box of disposable, single use eartips that fit a
variety of ear canal sizes. The Audera Pro probe must have a probe tube applied and an
eartip attached before inserting it into an ear canal. The determination of the
appropriate eartip size should be made by persons with proper training and experience.
The eartip must seal the ear canal. The best test results are obtained when the eartip is
inserted deeply into the ear canal instead of flush with the ear canal opening. Caution
must be taken, however, to ensure that the eartip does not extend too deeply into the
ear canal. Use only the eartips approved for use with the instrument. The eartips are
disposable and must be replaced after each patient.
After selecting an eartip, push it onto the probe

tube until it is flush against the base of the probe
tube. Twisting the eartip slightly while pushing it
onto the probe tube is recommended. Be sure
the eartip is fully seated on the probe.
There should be no gaps between the eartip and

the collar of the probe head.
To remove the eartip, grasp the eartip gently at

the base and twist it while pulling it straight off the
end of the probe tube.
If the probe tube becomes dirty or clogged, it must be replaced. See the section Probe
Tube Replacement for further information.
NOTE: Grasping the base of the eartip will prevent the probe tube from being
inadvertently pulled out of the probe head along with the eartip.
Changing Insert Earphone sound tubes

Follow the instructions provided in the sound tube package.
D-0129360 Rev A Page 188 of 231

MAINTENANCE
This instrument requires no regular maintenance beyond routine cleaning and annual
calibration. No special measures need to be applied during preventative maintenance.
We do recommend that the transducers be checked regularly for worn or damaged
transducers or cables. Check that there is no damage to the mains cable and no
mechanical load to the cable or other connectors that might cause damage. Make sure
all connections to external accessories are snug and secured properly. Parts which may
be broken or missing or are visibly worn, distorted or contaminated should be replaced
immediately with clean, genuine replacement parts manufactured by or available from
GSI. The device and accessories are not user repairable. Repairs must be performed by
a qualified service representative only.
It is recommended to turn off the power from the mains when the system is not being
used.
Operational Checks
It is recommended that the user of the instrument should perform a subjective
instrument check of the acoustic stimulus and biologic measurements at least once per
week. The Loopback Test Cable may be used to perform a test of system integrity for
EP/ASSR systems. The Infant Ear Simulator may be used to perform a test of system
integrity for OAE systems.
Calibration and Safety checks

To guarantee that the Audera Pro works properly, the instrument should be checked
and calibrated at least once per year. Have an authorized service technician perform
electrical safety checks on the unit to maintain continued compliance to IEC and UL
60601-1.
The service and calibration must be performed by an authorized service center. If these
checks are not done, EU Medical Device Directive (MDD) and other regulations may be
violated, and warranties may be void.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.
D-0129360 Rev A Page 189 of 231

CYBERSECURITY
The Audera Pro system requires a computer running Windows 10 Pro and the computer
may have Wi-Fi or Ethernet connections that could allow access to the Internet. It is
your responsibility to protect your system and patient data from theft, unwanted,
and potentially harmful, files or programs by following cybersecurity best
practices. You should employ a unified platform for preventative protection, post-
breach detection, automated investigation, and response. Windows 10 Pro provides
many mitigations that you can use in response to these cybersecurity threats. You
should contact you IT department for your facility’s cybersecurity policy and measures.
For specific details on implementing the suggested measures below, on your computer,
contact your IT department or system administrator. Here are some tips to keep your
system and your data secure.
• Access Control - Identify and Protect. Limit Access to Trusted Users Only.
Limit access to devices through the authentication of users (e.g. user ID and
password). Employ Windows 10 user access controls and require a log in to the
system and set account permissions. Computers that are running Windows 10
can control the use of system and network resources through the interrelated
mechanisms of authentication and authorization. Use appropriate
authentication (e.g. multi-factor authentication to permit privileged device access
to system administrators, service technicians, maintenance personnel. As a
security best practice, use your local (non-Administrator) account to sign in and
then use Run as administrator to accomplish tasks that require a higher level of
rights than a standard user account. Do not use the Administrator account to
sign into your computer unless it is entirely necessary. You can use security
policies to configure how User Account Control works in your organization. They
can be configured locally by using the Local Security Policy snap-in (secpol.msc)
or configured for the domain, OU, or specific groups by Group Policy.
• Passwords. Create and use strong passwords, making them difficult for
attackers to guess. Strengthen password protection by avoiding “hardcoded”
password or common words (i.e. passwords which are the same for each device,
difficult to change, and vulnerable to public disclosure) and limit public access to
passwords used for privileged device access. Enable the Windows Password must
meet complexity requirements using the Windows Group Policy Editor.
• Disable Wi-Fi and Ethernet ports. If your system does not need to connect to
the facility network, disable Wi-Fi and the Ethernet ports. If you need to connect
to your facility network, consider disabling access to the Internet. Windows 10
Device Manager allows you to disable these connections.
• Disable unused USB ports. The Audera Pro needs only one USB port to
connect to the hardware device. If your computer contains more than one USB,
consider disabling the unused ports. Windows 10 Device Manager allows you to
disable the USB ports.
D-0129360 Rev A Page 190 of 231

• Disable external media AutoRun and AutoPlay features. If you do not disable
the USB port entirely, disable AutoRun and AutoPlay features to prevents
external media infected with malicious code from automatically running on your
computer. For more security, you can restrict removable storage with the
Windows 10 Group Policy editor.
• Encrypt your local disks. Use disk encryption software. If you do not have any
encryption software, Windows 10 comes with BitLocker. In Windows 10 Pro
Control Panel: Control Panel\All Control Panel Items\BitLocker Drive Encryption
turn on BitLocker. Enable BitLocker and use the strongest encryption option
available, 256-bit or higher for the cipher strength.
• Install or enable a firewall. Firewalls can prevent some types of infection by
blocking malicious traffic before it enters your computer. The Windows 10
operating systems includes a firewall and you should enable it. The Settings,
Windows Security, Firewall and network protection provide access to these
features.
• Install and maintain antivirus software. Antivirus software recognizes
malware and protects your computer against it. Installing antivirus software
from a reputable vendor is an important step in preventing and detecting
infections. Always visit vendor sites directly rather than clicking on
advertisements or email links. Because attackers are continually creating new
viruses and other forms of malicious code, it is important to keep your antivirus
software up to date. Windows 10 provides Windows Defender Antivirus. This is
available from Settings, Update & Security, Windows Security, Virus & threat
protection. Other vendors also offer anti-virus software that is compatible with
Windows 10 and the Audera Pro. These vendors include Symantec, Trend Micro,
McAfee, and AVG. Set up your selected program to automatically update if it
does not do so upon installation.
• Use anti-spyware tools. Spyware is a common virus source, but you can
minimize infections by using a program that identifies and removes spyware.
Most antivirus software includes an anti-spyware option; ensure you enable it.
• Keep software updated. Install software patches on your computer so attackers
do not take advantage of known vulnerabilities. Consider enabling automatic
updates, when available. The Windows 10 automatic update feature may be
accessed through the Settings, Update and Security, Windows Update.
• Ensure Trusted Content. Restrict software or firmware updates to
authenticated code. Use only materials supplied by GSI for your Audera Pro
software updates. GSI software is supplied in USB packaging – do not use any
USB software where tampering is evident. Use systematic procedures for
authorized users to download version-identifiable software from the
manufacturer.
• Intrusion Detection/Prevention. Consider deploying a hardware or software
Intrusion Detection and Prevention system for your system. Intrusion detection
and prevention are two broad terms describing application security practices
D-0129360 Rev A Page 191 of 231

used to mitigate attacks and block new threats. Microsoft Defender ATP protects
endpoints from cyber threats; detects advanced attacks and data breaches,
automates security incidents and improves security posture.
• Use caution with links and attachments. Take appropriate precautions when
using email and web browsers to reduce the risk of an infection. Be wary of
unsolicited email attachments and use caution when clicking on email links, even
if they seem to come from people you know.
• Block pop-up advertisements. Pop-up blockers disable windows that could
potentially contain malicious code. Most browsers have a free feature that can
be enabled to block pop-up advertisements.
• Use an account with limited permissions. When navigating the web, it’s a good
security practice to use an account with limited permissions. If you do become
infected, restricted permissions keep the malicious code from spreading and
escalating to an administrative account.
• Back up data. Regularly back up your data to the cloud or to an external hard
drive. In the event of an infection, your information will not be lost.
• Monitor accounts. Look for any unauthorized use of, or unusual activity on,
your accounts. If you identify unauthorized or unusual activity, contact your
account provider immediately.
• Avoid using public Wi-Fi. Unsecured public Wi-Fi may allow an attacker to
intercept your device’s network traffic and gain access to your patient
information.
• Detect, Respond, Recover. Watch for on-screen warnings of possible virus
infections. Respond by scanning for and removing possible virus infections.
Recover from possible virus infections by having up to date backups of your
system computer.
At GSI we are committed to providing you with validated software updates and patches
as needed throughout the lifecycle of the medical device to continue to assure its
continued safety and effectiveness. Only apply the Audera Pro program software
updates and patches provided by GSI.
D-0129360 Rev A Page 192 of 231

TROUBLESHOOTING
ERROR MESSAGES
USB Connection Not Found…. Continue without Hardware?
This message is displayed when the program is started and cannot communicate with
the device. Confirm that the device has power and that the connection to the computer
with the USB cable is secure. The device should be powered on before starting the
program. Try closing the program, power cycle on the device and then restart the
program. You can continue without the connection and the program will not be able to
collect new data, but you will be able to analyze existing data.
Access Violation at address xxxxx ……
This error indicates that there has been a disruption of the connection with the PC. The
driver on the PC has become unstable. This may be a result of excessive noise on the
power line. You may require a power line filter. You will need to reboot the computer
and restart the device.
D-0129360 Rev A Page 193 of 231

Probe Fit Error: Probe Occluded
This error may appear in the DPOAE or TEOAE module. The error indicates that the
microphone is not receiving sound as it should. This may be due to blockage in the
probe tube or the probe tip is against the ear canal. Remove the probe and check for
any debris in the probe tip and if necessary, replace the probe tip. Re-position the
probe in the ear making sure not to press against the ear canal.
Probe Fit or Gain Problem
This error may appear in the TEOAE module. The error indicates that the microphone is
not receiving sound as it should. This may be due to blockage in the probe tube or the
probe tip is against the ear canal. It may also mean there is not a good seal in the ear
canal. Remove the probe and check for any debris in the probe tip and if necessary,
replace the probe tip. Re-position the probe in the ear making sure not to press against
the ear canal and confirm a good seal.
D-0129360 Rev A Page 194 of 231

Incorrect Operating System Setting
This error indicates that the setting in the system file for the number of operating
system bits does not match the operating system that the program is running on. The
program automatically corrects the system file and this message should not reappear.
Corrupted or missing License file
This error indicates that the system license file GSIWIN.SYS that is required in the
C:\GSIAuderaPro directory is either missing or corrupted. Try copying the license file
from the USB delivered with the system to correct the problem.
USB not Responding
This error indicates that the USB connection between the PC and the device has been
severed. This may be a result of the USB being suspended or computer sleeping.
Disable the “suspend USB” power option to ensure proper communication between
instrument and PC. You will need to end and restart the program.
D-0129360 Rev A Page 195 of 231

LOOPBACK TEST CABLE

The Loopback Test Cable is provided with the EP/ASSR systems to confirm the integrity
of the system and for use in troubleshooting. The Loopback Test Cable connects the
output of the stimulus (1000 Hz tone) to the input of the amplifier and ensures that the
whole system is working properly. The test verifies the level of the sound output, input
to the amplifier, amplification, filters and data communication of the system.
Setup
1. Disconnect the headphone or insert earphone transducer jacks from the back of
the instrument.
2. Disconnect the EP patient cable from the back of the instrument.
3. Connect the red plug of the Loopback Test Cable to the right (red) headphone
jack on the back of the device.
4. Connect the blue plug of the Loopback Test Cable to the left (blue) headphone
jack on the back of the device.
5. Connect the grey plug of the Loopback Test cable to the Electrode input jack on
the back of the device.
Loopback Test
1. Start the EP program.
2. Create or Load a patient (System Test).
3. Select the Right Ear from the Collection Toolbar.
4. From the Main Menu options, select Protocol, then Execute Automated Protocol.
5. Select the LOOPBACK.PSE2 file from the Open dialog. This will begin the data
collection and as data is acquired, the waveforms are displayed on the screen.
The automated protocol collects data at 90, 80, 70, 60 and 50 dB.
6. Select the Left Ear from the Collection Toolbar.
7. From the Main Menu options, select Protocol, then Execute Automated Protocol.
D-0129360 Rev A Page 196 of 231

8. Select the LOOPBACK.PSE2 file from the Open dialog. This will begin the data
collection for the left ear.
Once data collection has completed analyze the waveforms.
Loopback Test Analysis

The resulting waveforms should be clean sine waves. Using the two cursors measure
the peak to peak voltage at the different stimulus levels. As an alternative to the
placement of the cursors, you can scroll down on the page and observe the PP
amplitude in the page data table. The measured voltage should be within the voltage
shown in the table.
Stimulus Level Peak to peak

voltage
90 dB 90-110 uV
80 dB 27-33 uV
70 dB 9-11 uV
60 dB 2.5-3.5 uV
50 dB 0.8-1.2 uV
If there are no waveforms, check that the

Loopback Test Cables is connected and
plugged in securely. If the values are outside
the range indicated in the table, contact your
GSI representative to troubleshoot further.
D-0129360 Rev A Page 197 of 231

OAE Probe Check Cavity

The OAE Probe Check Cavity accessory may be used to perform a quality check of the
Audera Pro system that has the OAE option. This can be done on a regular basis or may
be performed if you suspect a problem with the Audera Pro hardware or OAE probe.
The OAE Probe Check Cavity is a cavity specifically designed to mimic the acoustic
absorbance properties of a real infant ear including the ear canal and middle ear. Other
methods to assess probe performance use a hard-walled cavity. A hard-walled cavity
does not reflect the properties of an ear. Testing this way can produce false responses
due to the resonance characteristics of the hard-walled cavity, making it difficult to
assess how accurately the probe will perform in a real ear. Using the OAE Probe Check
Cavity, it is possible to perform an OAE probe quality check in a realistic test cavity.
1. Attach a clean disposable eartip of the smallest size to your OAE probe.
2. Insert the probe with eartip into the OAE Probe Check Cavity.
3. Launch the DPOAE or TEOAE program.
4. Create or Load a patient (System Test).
DPOAE
5. Click the Set Acquisition Parameters icon from the toolbar.

6. From the Parameter dialog, press the Load button.
7. Select the LOOPBACK.PRO file from the protocol list.
8. Select the OK button to close the protocol select dialog.
9. Select the OK button to close the Parameter dialog.
10. Select the Right or Left ear icon from the toolbar to begin the test.
TEOAE
5. From the Main Menu options, select Protocol, then Load Settings.
6. Select the LOOPBACK.TOS file from the Open dialog.
7. Select the Right or Left ear icon from the Collection toolbar to begin the test.
The overall test result should be REFER. If the probe check fails or the result is a PASS,
contact your GSI representative to troubleshoot further.
D-0129360 Rev A Page 198 of 231

SUPPLIES AND ACCESSORIES

To order consumables, additional accessories and to replace detachable parts that have
been damaged, please contact GSI or your GSI distributor for current prices and delivery
charges.
Part Number Description
8104159 OAE Probe tubes (100)
8500090 Standard Insert Foam Tips 3A Medium Yellow 50pcs
8500110 Pediatric insert foam tips 3B small beige 50 pcs
8106226 E-A-R-Link 3A 100pcs
8106227 E-A-R-Link 3B 100pcs
8500100 Jumbo insert foam tips 3C large yellow 24pcs
8517636 Disc Electrode 6 mm, Silver Cup, reusable, (5)
8107145 Casted electrodes gold 10 mm, 5 pcs
8011343 TIP TRODE connection cable, 2 pcs, 500mm
8500440 Gold Tip Trode, 10 mm, Bag of 20pcs
8500370 Gold TTE25 Tip Trode 20pcs
8500140 Tube nipples for Eartone 3A
8513131 Probe tube Removal Tool
8107616 Probe Cable Clip
8013209 ECochG starter kit
8500650 Cable for TM ECochG electrode
8011489 TM Electrode for ECochG 10pcs
8049550 TM ECochG Electrode (single)
8516845 EP Starter Kit
8500320 Nu Prep Gel, 4 oz Tube, 3 Each
8500070 Ten20 Electrode Paste, 8 oz jar
8107872 Electrode Linker (jumper cable)
8011345 Reusable Disc Electrodes, 5 PC
8500060 Neurology Surface Electrodes
D-0129360 Rev A Page 199 of 231

8011346 ETB Standard Electrode Kit
8500040 Gauze 2x2
8500760 Micropore Tape (12 pk)
8521483 Remote Impedance Display Box
8517075 B81 Bone Conductor Headset, 2.9m cable
8517069 IP30 Insert Earphone 10 Ohm, set
8517039 DD45s 10 Ohm P3045 headset 2.9m cable
8516972 4-Snap Lead Patient Cable
8516973 5-Electrode Lead Patient Cable
8525205 GSI Audera Pro Loopback Test Cable
8516968 GSI Audera Pro Digital I/O Cable
8517341 OAE Probe
8100590 ABR tube & ADI ear tip adaptor
8103765 Ear Tip Starter Kit
8505466 Infant Ear Simulator
8518077 Audera Pro Stand
8506056 Audera Pro Laptop Computer Kit
8100465 120V Isolation Transformer Kit
8100464 230V Isolation Transformer Kit
8505336 SP90A Amplified Speaker Kit
8109043 HP Office Jet Printer (6230 or equivalent)
8522836 Audera Pro Vemp Biofeedback Monitor Kit
8519279 USB 2.0 Gold Cable, A (Male)/B (Male) – 6 ft
OAE PROBE EAR TIPS – SINGLE USE – SANIBEL ADI SILICONE

Part Number Part Number
Description
100/bag 25/bag
8012964 8012963 3-5 mm flanged
8012966 8012965 4-7 mm flanged
D-0129360 Rev A Page 200 of 231

8012968 8012967 5-8 mm flanged
8013002 8013001 7 mm mushroom style
D-0129360 Rev A Page 201 of 231

APPENDIX A – DEFAULT SETTINGS
DEFAULT EP SETTINGS
The Audera Pro software comes pre-loaded with a set of default acquisition settings for
an ABR. These default values are loaded every time the software opens. If you wish to
create a new default settings file to load at start-up, select the modality, then change
the change the Stimulus, EEG and Amplifier settings to match your requirements. The
Save Settings button on the Collection Toolbar saves the current parameters including
the Modality, Stimulus and Amplifier settings. When you select the Save Settings
button, the software automatically assigns the name ‘GSIAuderaAEPDefault.SET’ in the
file name field. This is the name Audera Pro uses for default parameters. Changing the
name will result in saving a settings file that can be loaded; however, it will not
automatically load on start-up.
Modality Auditory (A-ABR)

Amplifier
Gain 100 k
High Pass Filter 100 Hz
Low Pass Filter 3000 Hz
Line Filter Off
Designation Right
Electrode Montage A1, Cz, A2
Artifact Rejection Region 1.0 – 10.0 ms
Artifact Rejection Level 31.00 uV (31%)
Stimulus
Transducer Insert earphones (IP30)
Type Click (100 uSec)
Level 60 dB HL
Phase Rarefaction
Rate 19.1/sec
Presentation Only while acquiring
Masking Off
Recording
Window 12.8 ms
Sweeps 1024
Block Averaging Off
D-0129360 Rev A Page 202 of 231

VEMP SETTINGS
Modality cVEMP oVEMP
Stimulus
Transducer Insert Earphones Insert Earphones
Stimulus 500Hz Blackman 500Hz Blackman
Intensity 95 dB nHL 95 dB nHL
Polarity Rarefaction Rarefaction
Rate 5.1 5.1
Amplifier
Number of Channels 2 2
Gain 5k 100k
High Pass Filter 10 Hz 10 Hz
Low Pass Filter 1 kHz 1 kHz
Recording
Window 102.4 ms 102.4 ms
Sweeps 200 200
D-0129360 Rev A Page 203 of 231

DEFAULT ASSR SETTINGS

an ASSR. These default values are loaded every time the software opens. If you wish to
create a new default settings file to load at start-up, change the change the Stimulus,
EEG and Amplifier settings to match your requirements. The Save as Default option on
the Protocol Menu saves the current parameters including the Stimulus and Amplifier
settings. When you select the Save as Default menu item, the software automatically
assigns the name ‘Default.SSS’.
Amplifier
Gain 100 k (fixed)
High Pass Filter 30 Hz (fixed)
Low Pass Filter 300 Hz (fixed)
Line Filter Off
Designation On
Electrode Montage A1, Cz, A2
Artifact Rejection Region 41.0 – 399.0 ms
Artifact Rejection Level 31.00 uV (31%)
Stimulus
Transducer Insert earphones (IP30)
Type Multiple Stimuli (500, 1k, 2k, 4k Hz)
Level 80 dB SPL
Masking Off
Recording
Window 1024.0 ms (fixed)
Sweeps 400
Block size 20
Auto Stop Level 0.70 uV
D-0129360 Rev A Page 204 of 231

DEFAULT DPOAE SETTINGS

an DPOAE. These default values are loaded every time the software opens. If you wish
to create a new default settings file to load at start-up, change the change the settings
to match your requirements. The Save as Default button on the Parameters dialog
saves the current parameters. When you select the Save as Default button the software
automatically assigns the name ‘Default.PRO’.
General Parameters
Sweeps 16
Block Size 8
Level 1 (dB SPL) 65
Level 2 (dB SPL) 55
Artifact (dB) 10
Retry 5
Frequency
Start 1500 Hz
End 6000 Hz
Frequencies/Octave 2.5
Frequency Ratio 1.22
Presentation High to Low
Advanced
Max Level (dB SPL) 65
Max Ear Correction (dB SPL) 15
Ear Correction On
Stopping
On Pass at Frequency Off
On overall Pass Off
On no chance to Pass Off
D-0129360 Rev A Page 205 of 231

DEFAULT TEOAE SETTINGS

an TEOAE. These default values are loaded every time the software opens. If you wish
to create a new default settings file to load at start-up, change the change the settings
to match your requirements. The Save as Default option on the Protocol Menu saves
the current parameters. When you select the Save as Default item the software
automatically assigns the name ‘Default.TOS’.
General Parameters
Modality Transient (non-linear)
Sweeps 1024
Rate 19.3/sec
Level (dB SPL) 80
In Ear Correction Off
Stimulus Presentation Only while acquiring
Probe Check Enabled On
Meatal Saturation Check On
D-0129360 Rev A Page 206 of 231

FILE NAMING
File names are automatically assigned when data is acquired and saved. The Main
menu also offers the option to save a file where you provide the filename (Recordings-
>Save Active Recording As-> Specific File Name). Although any name could be used, we
recommend following the program’s naming convention so that the program can
properly recognize the data type and perform any required automatic calculations.
Recording Naming Convention

File names are stored in the following format: ‘FLSMdBC.nn’. Where:
• FL: Patient first and last initials.

• S: Side of stimulation. R for right, L for left, B for both.
• M: Modality. E for ECochG, A for ABR, M for MLR, L for LLR, P for P300, D for
ASSR, O for TEOAE, D for DPOAE
• dB: Intensity value. This indicates the sound level that was used
• C: Hardware acquisition channel.
• nn: Recording Number. Incremental number when more than one recording
share the same settings as specified in the rest of the file name.
D-0129360 Rev A Page 207 of 231

APPENDIX B – TECHNICAL DATA

The Audera Pro is an active, diagnostic medical product. The device is classified as a
class IIa device according to the EU medical directive 93/42/EEC and a class II device
according to the US FDA.
Standards Compliance
Safety and Electromagnetic IEC 60601-1: 2012, Type B and BF applied parts
compatibility (EMC) IEC 60601-1-2: 2015
IEC 60601-2-40: 2016
Calibration and Test Signal ISO 389-2: 1994

ISO 389-6: 2007
IEC 60645-3: 2007
OAE IEC 60645-6: 2009, Type 1
EP (ABR) IEC 60645-7: 2009, Type 1
Protection from Fluids IPX0 – Ordinary equipment
General Specifications
ENVIRONMENTAL
Transport and Transport package shall be kept away from rain

Handling and in dry conditions
Operation: + 15° C to + 35° C (+ 59° F to + 95° F)

Temperature Transport: - 20° C to + 50° C (- 4° F to + 122° F)
Storage: 0° C to + 50° C (+32° F to + 122° F)
Operation: Maximum relative humidity 90 %,

Humidity non-condensing, at 40° C
Transport and Storage: Maximum relative
humidity 93 %, non-condensing
Ambient air pressure 98 kPa – 104 kPa
Altitude Maximum altitude: 3000 m (9843 feet) above sea

level
Location Indoor use, quiet environment
Mode of Operation Continuous
Degree of Mobility Portable equipment
D-0129360 Rev A Page 208 of 231

Vibration and Shock Not Applicable
Warm up Time None at room/operating temperature
Expected Lifetime 5 years
POWER
Power Supply (internal) Input Voltage: 100 – 240 VAC, 350-150 mA

Input Frequency: 50-60 Hz
No load power consumption: < 0.15 W

Maximum output power: 30 W
Maximum output voltage 15 VDC
Maximum output current: 2000 mA
Internal Fuse Time lag fuse rated to 2A, 250 V
PHYSICAL
Dimensions 30.48 x 38.1 x 7.62 cm (L x W x H) 12 x 15 x 3 in
Weight 2 kg (4.4 lbs.)
MODALITIES
Evoked Potentials ECOG, ABR, MLR, LLR, SN10, P300, MMN, VEMP,
ASSR
Otoacoustic Emissions DPOAE, TEOAE, SPOAE
EP AMPLIFIER
Channels 2
Gain 5000 – 200,000 (adjustable)
0.1 Hz – 300 Hz (adjustable)

High Pass Filters
(-6 dB/Oct., -24dB/Oct. for 70 Hz)
30 Hz – 5000 Hz (adjustable)
Low Pass Filters
(-6 dB/Oct., -24dB/Oct. for 500 Hz)
Sample Rate 200 – 40,000 Hz (adjustable)
A/D 16-bit
Common Mode Rejection ≥ 110 dB @ 1 kHz, 50/60 Hz
Input Impedance > 10 M Ohm
Noise Level ≤ 0.27 uV RMS
Artifact Rejections Adjustable level (0-100%) and any region within

the analysis time window
Line Frequency Filter 50 or 60 Hz, -12 dB/Octave
D-0129360 Rev A Page 209 of 231

Recording Window -2.5 sec to 2.5 sec (maximum)
Data points per waveform 1024
Digital Filter Finite Impulse Response (FIR), band pass and

notch
Electrode Impedance Measuring frequency: 1000 Hz

Range: 1-25k Ohm
EP STIMULUS
Types Click, CE-Chirp®, Tones, CE-Chirp Octave Bands,

Speech stimuli, User file
Click Duration 100 uSec default (adjustable)
CE-Chirp Frequency spectra; 200 - 10,000 Hz
CE-Chirp Octave Bands 500, 1000, 2000, 4000 Hz
Tone Parameters Frequency: 125 to 12,000 Hz

Rise/Fall/Plateau: adjustable in uSec or cycles
Duration: Up to 500 ms (adjustable)
Tone Window Types Rectangular, Hann, Blackman, and Gaussian,

Trapezoidal, Extended Cosine
Rate 0.1 to 100 /second
Polarity Rarefaction, Condensation, Alternating
Masking Type: White Noise,

Frequency response: Flat to 20 kHz (transducer
limits determine roll off)
Maximum output: 125 dB SPL
Specific level, or relative to stimulus
D/A 16 bit
Level Accuracy ±1 dB
Attenuation Range 150 dB
Frequency Accuracy ±1%
Total Harmonic Distortion < 1% (DD45s)

< 3% (IP30)
< 2% (B81)
< .1% (SP90A)
D-0129360 Rev A Page 210 of 231

OAE
Sample Rate 40k Hz
A/D 16 bit
Frequency Accuracy ±1% from selected
Frequency Analysis (FFT) Points DPOAE: 4096

TEOAE, 1024
Frequency Resolution DPOAE: 9.8 Hz

TEOAE: 39.1 Hz
Acquisition Time DPOAE: 102.24 ms

TEOAE: 25.56 ms
TEOAE Stimulus: 75 uS click

Presentation: Linear or non-linear train
Level: 80 dB SPL (user defined 40-83 dB SPL)
Stimulus Rate: 1-50/s (user defined)
Stimulus Frequency Range: 250-5000 Hz
Analysis Frequencies: 1000-4000 Hz
DPOAE Stimulus: 2 Pure Tones (500-12000 Hz user

defined start, end and F2/F1 ratio)
Levels: 65/55 (user defined L1, L2, 0-80 dB SPL)
Steps per Octave: 1-10 (user defined)
TRANSDUCERS
RadioEar IP30 Insert Earphones Frequency Range: 125 Hz – 8000 Hz

Output Level: -10 to 132 dB SPL
RadioEar DD45s Headphones Frequency Range: 125 Hz – 8000 Hz

RadioEar B81 Bone Conductor Frequency Range: 250 Hz – 8000 Hz

GSI OAE Probe Frequency Range: 300 Hz – 12000 Hz

Output Level: 40 to 83 dB SPL
RadioEar SP90A Speaker Frequency Range: 100 Hz – 8000 Hz

D-0129360 Rev A Page 211 of 231

APPENDIX C – TRANSDUCER REFERENCE EQUIVALENT THRESHOLD

LEVELS AND MAXIMUM OUTPUT LEVEL
The Audera Pro is supplied from the factory calibrated for the transducers that were
purchased with it. The exception is the speakers, as those must be calibrated in the
environment where they will be used. The calibration data supplied from the factory is
only valid for GSI supplied transducers and cannot be applied to non-GSI supplied
transducers.
It is recommended that calibration of the instrument and transducers be performed

annually by authorized GSI Representatives using appropriate calibration
instrumentation. If periodic checks are also desired, the tables in this section provide
the SPL values per frequency for each transducer. If the measured values are not within
± 5 dB at 125, 6,000, and 8,000 Hz in the earphones, the GSI Audera Pro should be
scheduled for immediate maintenance.
The maximum levels listed are achievable only if ANSI, ISO or GSI reference threshold
levels and not customized calibration values, are used. At no time will the hearing level
limit exceed 120 dB HL.
D-0129360 Rev A Page 212 of 231

TRANSDUCER REFERENCE EQUIVALENT THRESHOLD LEVELS TABLE
Transducer DD45s IP30 B81 SP90A

Impedance 10 Ω 10 Ω 10 Ω 0°
Coupler 318-1 711 Mastoid 1 m
RETSPL RETSPL RETFL RETSPL
Pure Tone
125 Hz 45 28 22
250 Hz 27 17.5 67 11.5
500 Hz 13.5 9.5 58 4.5
750 Hz 9 6 48.5 2.5
1000 Hz 7.5 5.5 42.5 2.5
1500 Hz 7.5 9.5 36.5 2.5
2000 Hz 9 11.5 31 -1.5
3000 Hz 11.5 13 30 -6
4000 Hz 12 15 35.5 -5.5
6000 Hz 16 16 40 4.5
8000 Hz 15.5 15.5 40 12.5
Short Duration Tone (2-1-2)
250 Hz 32 28 74.5 16
500 Hz 23 23.5 69.5 16
750 Hz 20.5 22.5 62.5 16.5
1000 Hz 18.5 21.5 56 16
1500 Hz 21.5 25 51 16.5
2000 Hz 25 28.5 47.5 15
3000 Hz 25.5 30.5 45.5 9.8
4000 Hz 27.5 32.5 52 11
6000 Hz 36 36.5 60 26
8000 Hz 41 41 65.5 38
Click 31 35.5 51.5 20

CE-Chirp 31 35.5 51.5 20
CE-Chirp
Octave Band
500 Hz 26 26 75 21.5
1000 Hz 21.5 18.5 61 21
2000 Hz 27 22 50 17.5
4000 Hz 30 25 55 14
D-0129360 Rev A Page 213 of 231

TRANSDUCER REFERENCE EQUIVALENT THRESHOLD LEVELS TABLE NOTES

DD45s Artificial ear uses IEC60318-1 coupler and RETSPL comes from ANSI S3.6 2010
and ISO 389-1 1998. Force 4.5N ±0.5N.
IP30 Ear simulator uses ANSI S3.25- IEC60318-4 coupler and RETSPL comes from ANSI
S3.6 2010 and ISO 389-2 1994
B81 uses ANSI S3.13 or IEC60318-6 2007 mechanical coupler and RETFL come from ANSI
S3.6 2010 and ISO 389-3 1994. Force 5.4N ±0.5N.
Loudspeaker RETSPL values for monaural listening in sound field, 0° Incidence from
ANSI S3.6 2010.
The Short Duration Tone Bursts were calibrated per ISO 389-6 and IEC 60645-3 using a 2
cycle rise/fall time and 1 cycle plateau.
The Audera Pro bone transducer uses the Mastoid placement RETFL.
D-0129360 Rev A Page 214 of 231

MAXIMUM OUTPUT LEVELS

DD45s Headphones
The DD45s Supra Aural Headphones were measured on a 318 – 1 artificial ear.
Maximum distortion allowed is 2.5 % THD as specified in IEC 60645 – 1.
Frequency (Hz) peRETSPL (dB) Maximum SPL (dB) Maximum HL (dB)
Click 32 132 100

CE-Chirp 32 132 100
125 28 130 102
250 28 135 107
500 25 135 110
750 24 135 111
1000 23 134 111
1500 21 133 112
2000 26 134 108
3000 24 142 118
4000 29 136 107
6000 22 133 111
8000 20 128 108
D-0129360 Rev A Page 215 of 231

IP30 Insert Phones

The IP30 Insert Phones were measured on an IEC 711 artificial ear with ear mold
substitute adapter. Maximum distortion allowed is 2.5 % THD as specified in IEC60645 –
1.
Maximum HL
Frequency (Hz) peRETSPL (dB) Maximum SPL (dB)
(dB)
Click 36 133 97
CE-Chirp 36 133 97
125 28 124 96
250 28 123 95
500 24 123 99
750 21 122 101
1000 22 129 107
1500 26 126 100
2000 29 118 89
3000 30 126 96
4000 33 132 99
6000 33 103 70
8000 33 102 69
D-0129360 Rev A Page 216 of 231

B81 Bone Vibrator

The B81 Bone Vibrator was measured on a Bruel & Kjaer 4930 artificial mastoid.
Maximum distortion allowed is 5.5 % THD as specified in IEC60645 – 1.
Maximum SPL
Frequency (Hz) peRETSPL (dB) Maximum HL (dB)
(dB)
Click 52 122 70
CE-Chirp 52 122 70
250 75 105 30
500 70 127 57
750 61 122 61
1000 56 123 67
1500 52 126 74
2000 48 119 71
3000 46 112 66
4000 52 119 67
6000 56 101 45
8000 56 92 36
D-0129360 Rev A Page 217 of 231

SP90 A Free Field Speaker

The SP90A Free Field Speakers were measured with a free field microphone placed on
axis with the speaker at one meter. Maximum allowed distortion is 10 %. The
measurements were made in a sound room approximately 2 meters on a side.
Maximum levels will be influenced by size of room and microphone placement.
Frequency (Hz) RETSPL (dB) Maximum SPL (dB) Maximum HL (dB)
Click 20 100 80
CE-Chirp 20 100 80
250 11 89 78
500 4 102 98
750 2 102 100
1000 2 102 100
1500 2 102 100
2000 -1 102 103
3000 -6 102 108
4000 -5 93 98
6000 4 104 100
8000 13 113 100
D-0129360 Rev A Page 218 of 231

APPENDIX D – SPECIFICATION OF INPUT/OUTPUT CONNECTIONS
MAINS CABLE
Pin Description
1 Live
2 Neutral
3 Earth
PATIENT ELECTRODE CABLE

Pin Description
1 CHA +
2 CHA -
3 CHB -
4 CHB +
5 Shield
6 ISO GND
Input impedance > 10M Ohm, Max input 24.8 Vrms
HEADPHONES/INSERTS (2 CONNECTORS, R, L)
Pin Description
1 Ground
2 Signal (7Vrms at 10 Ohm; 60-20,000Hz -3dB)
BONE OSCILLATOR
Pin Description
1 Ground
2 Signal (7Vrms at 10 Ohm; 60-10,000Hz -3dB)
OAE PROBE
D-0129360 Rev A Page 219 of 231

Pin Description
1 REC 1 +
2 REC 1Shield
3 REC 1 -
4 REC 2 +
HDMI Type A
5 REC 2 Shield
6 REC 2 -
7 MIC Power +
8 MIC Shield
9 MIC Out
10 Mic Power -
11 Not Used
12 Not Used
13 Not UsedC
14 Battery
15 SCL/UIOP
16 SDA/SCIO
17 I2C/UIO GND
18 Probe +3.3 V
19 Power GND
D-0129360 Rev A Page 220 of 231

SPEAKERS (R, L)
Pin Description
1 Ground
2 Signal (Max output 7 Vrms at 10 Ohm)
USB
Pin Description
1 + 5 V DC
2 Data
3 Data
4 GND
DIGITAL I/O
Pin Description
1 OUT 1
2 OUT 2
3 IN 1
4 IN 2
5 Trigger IN (TTL)
6 GND
Input impedance 165k Ohm, output impedance 725 Ohm. Maximum voltage In/Out +3.3
V. Maximum input current 20uA, max output current 4 mA.
D-0129360 Rev A Page 221 of 231

APPENDIX E - WARRANTY AND REPAIR
WARRANTY
We, Grason-Stadler, warrant that this product is free from defects in material and
workmanship and, when properly installed and used, will perform in accordance with
applicable specifications. This warranty is extended to the original purchaser of the
instrument by GSI through the distributor from whom it was purchased and covers
defects in material and workmanship for a period of one year from date of delivery of
the instrument to the original purchaser. If within one year after original shipment, it is
found not to meet this standard; it will be repaired, or at our option, replaced at no
charge except for transportation costs, when returned to an authorized Grason-Stadler
facility. If field service is requested, there will be no charge for labor or material;
however, there will be a charge for travel expense at the service center’s current rate.
NOTE: Opening the instrument case or changes to the product not approved in
writing by Grason-Stadler shall void this warranty. Grason-Stadler shall not be
responsible for any indirect, special, or consequential damages, even if notice has
been given in advance of the possibility of such damages. The transducers may go
out of calibration due to rough handling or impact (dropping). The lifetime of
probe, probe seals and ear tips is dependent upon conditions of use. These parts
are only guaranteed against faulty materials or manufacture.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,

INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
REPAIR
We advise you against attempting to rectify any faults by yourself or commissioning
non-experts to do so. Equipment is not user repairable. Repairs must be performed by
an authorized service representative only. The only parts that can be repaired/replaced
by users are: OAE-probe or tip, electrodes, and insert earphone tubes.
No modifications of the equipment are allowed by anyone other than a

qualified GSI representative. Modification of the equipment could be
hazardous. If this equipment is modified, appropriate inspection and
testing must be conducted to ensure continued safe use of the equipment.
To ensure that your instrument works properly, the GSI Audera Pro should be checked
and calibrated at least once per year. This check must be carried out by your dealer or
authorized GSI service facility.
D-0129360 Rev A Page 222 of 231

When returning the instrument for repairs or calibration it is essential to send the
acoustic transducers with the device. Send the device to an authorized service center
only. Please include a detailed description of faults. To prevent damage in transit,
please use the original packing if possible when returning the instrument.
Grason-Stadler will provide circuit diagrams, component part lists, descriptions,

calibration instructions, or other information to assist service personnel in parts repair.
This information is found in the Service Manual which may be ordered from GSI or the
GSI distributor.
D-0129360 Rev A Page 223 of 231

APPENDIX F – RECYCLING AND DISPOSAL

Many local laws and regulations require special procedures to recycle or
dispose of electrical equipment and related waste including batteries, printed
circuit boards, electronic components, wiring and other elements of electronic
devices. Follow all local laws and regulations for the proper disposal of
batteries and any other parts of this system.
Below is the contact address for proper return or disposal of electronic wastes relating
to Grason-Stadler products in Europe and other localities. The contact information for
the WEEE in Europe:
Grason-Stadler
c/o DGS Diagnostics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
D-0129360 Rev A Page 224 of 231

APPENDIX G – ELECTROMAGNETIC COMPATIBILITY (EMC)

Portable and mobile RF communications equipment can affect the Audera Pro. Install
and operate the system according to the EMC information presented in this chapter.
The Audera Pro has been tested for EMC emissions and immunity as a stand-alone
device. Do not use the system adjacent to or stacked with other electronic equipment.
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, except for
servicing parts sold by GSI as replacement parts for internal components, may result in
increased EMISSIONS or decreased IMMUNITY of the device.
Anyone connecting additional equipment is responsible for making sure the system
complies with the IEC 60601-1-2 standard.
CAUTIONS REGARDING EMC

This instrument is suitable in hospital environments except for near active
HF surgical equipment and RF shielded rooms of systems for magnetic
resonance imaging, where the intensity of electromagnetic disturbance is
high.
Use of this instrument adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this instrument
and the other equipment should be observed to verify that they are operating normally.
Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Audera Pro, including cables specified by the manufacturer. Otherwise, degradation
of the performance of this equipment could result.
ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:
This instrument does not have an ESSENTIAL PERFORMANCE.
Absence or loss of ESSENTIAL PERFORMANCE cannot lead to any unacceptable

immediate risk. Final diagnosis shall always be based on clinical knowledge.
The Audera Pro is intended for use in the electromagnetic environment specified below.
The customer or the user of the Instrument should assure that it is used in such an
environment.
D-0129360 Rev A Page 225 of 231

GUIDANCE AND MANUFACTURER’S DECLARATION

ELECTROMAGNETIC EMISSIONS
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The system uses RF energy only for its internal
CISPR 11 function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions Class A The Audera Pro is suitable for use in all

CISPR 11 commercial, industrial, and business
environments. The Audera Pro is not suitable
Harmonic emissions Not Applicable
for use in a home environment.
IEC 61000-3-2
Voltage fluctuations Not applicable

/flicker emissions
IEC 61000-3-3
D-0129360 Rev A Page 226 of 231

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPMENT
The Audera Pro is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the user of the system can
help prevent electromagnetic interferences by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the
system as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum output Separation distance according to frequency of transmitter

power of transmitter [W] [m]
150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5

d = 1.17√𝑷𝑷 MHz GHz
d = 1.17√𝑷𝑷 d = 2.23√𝑷𝑷
0.01 0.12 0.12 0.22
0.1 0.37 0.37 0.74
1 1.17 1.17 2.23
10 3.70 3.70 7.05
100 11.70 11.70 23.30
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHZ, the higher frequency range applies.
Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
D-0129360 Rev A Page 227 of 231

GUIDANCE AND MANUFACTURER’S DECLARATION

ELECTROMAGNETIC IMMUNITY
Immunity Test IEC 60601 Test level Compliance Electromagnetic
Environment-Guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood,

Discharge (ESD) concrete, or ceramic tile. If
±2 kV, ±4 kV, ±8 kV, ±2 kV, ±4 kV, ±8 kV,
floors are covered with
IEC 61000-4-2 ±15 kV air ±15 kV air
synthetic material, the
relative humidity should
be greater than 30%.
Electrical fast ±2 kV for power Not applicable Mains power quality

transient/burst supply lines should be that of a typical
±1 kV for
IEC61000-4-4 ±1 kV for commercial or residential
input/output lines
input/output lines environment.
Surge ±1 kV differential Not applicable Mains power quality

IEC 61000-4-5 mode should be that of a typical
±2 kV common mode commercial or residential
environment.
Voltage dips, short < 5% UT Not applicable Mains power quality

interruptions, and (>95% dip in UT) for should be that of a typical
voltage variations 0.5 cycle commercial or residential
on power supply environment. If the user of
40% UT
lines the system requires
(60% dip in UT) for 5
continued operation
IEC 61000-4-11 cycles
during power mains
70% UT interruptions, it is
(30% dip in UT) for 25 recommended that the
cycles system be powered from
an uninterruptable power
<5% UT
supply or its battery.
(>95% dip in UT) for 5
sec
Power frequency 3 A/m 3 A/m Power frequency magnetic

(50/60 Hz) fields should be at levels
IEC 61000-4-8 characteristic of a typical
location in a typical
commercial or residential
environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
D-0129360 Rev A Page 228 of 231

Immunity test IEC / EN 60601 Compliance level Electromagnetic

test level environment – guidance
Portable and mobile RF

communications
equipment should be used
no closer to any parts of
the system, including
cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the
transmitter.
Recommended separation
distance
Conducted RF 3 Vrms 3 Vrms 𝑑𝑑 = 1.2√𝑃𝑃
IEC / EN 61000-4-6 150 kHz to 80 MHz 𝑑𝑑 = 1.2√𝑃𝑃 80 MHz to 800
MHz
𝑑𝑑 = 2.3√𝑃𝑃 800 MHz to 2,5

Radiated RF 3 V/m
GHz
IEC / EN 61000-4-3 80 MHz to 2,5 GHz 3 V/m
Where P is the maximum
output power rating of the
transmitter in watts (W)
according to the
transmitter manufacturer
and d is the recommended
separation distance in
meters (m).
Field strengths from fixed

RF transmitters, as deter-
mined by an
electromagnetic site
survey, (a) should be less
than the compliance level
in each frequency range (b)
Interference may occur

near equipment marked
with the following symbol:
D-0129360 Rev A Page 229 of 231

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
(a)
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the system is used exceeds the applicable RF compliance
level above, the system should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the system.
(b)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
NOTICE: There are no deviations from the collateral standard and allowances uses
NOTICE: All necessary instruction for maintaining compliance regarding EMC can be
found in the general maintenance section in this instruction. No further steps required.
D-0129360 Rev A Page 230 of 231

Use of accessories, transducers, and cables other than those specified or provided by
the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation. 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 Item #
Patient Electrode Cable Grason-Stadler 8516972, 8516973
IP30 Insert Earphone RadioEar 8517069
DD45s Headphones RadioEar 8517039
B81 Bone Vibrator RadioEar 8517075
SP90A RadioEar 8505336
OAE Probe Grason-Stadler 8517021
Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the

cable types and cable lengths are as specified below:
Description Length Screened/Unscreened
Patient Electrode Cable 2.9 m Screened
IP30 Insert Earphone 2.9 m Unscreened
OAE Probe 2.9 m Screened
DD45s Headphones 2.9 m Unscreened
Power Supply Cable 2.5 m Unscreened
Electrode Cable 1m Unscreened
USB Cable (with ferrites) 2m Screened
NOTICE: The use of the accessories, transducers, and cables with medical
equipment/system other than this equipment may result in increased emissions or
decreased immunity of the medical equipment/system.
D-0129360 Rev A Page 231 of 231

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VERSATILE

Copyright © 2020 Grason-Stadler. All rights reserved. No part of this publication

This product incorporates software developed by others and redistributed according to

European Authority Representative

D-0129360 Rev A Page 1 of 231

Base Unit ............................................................................................................................ 26

D-0129360 Rev A Page 2 of 231

Patient Information Management .......................................................................................... 42

D-0129360 Rev A Page 3 of 231

Stimulus Display Dialog .................................................................................................... 74

D-0129360 Rev A Page 4 of 231

Open Records ...................................................................................................................... 104

D-0129360 Rev A Page 5 of 231

Keyboard Shortcuts ............................................................................................................ 129

D-0129360 Rev A Page 6 of 231

Data Analysis ................................................................................................................... 165

D-0129360 Rev A Page 7 of 231

D-0129360 Rev A Page 8 of 231

Maximum Output Levels.................................................................................................... 215

D-0129360 Rev A Page 9 of 231

READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM!

D-0129360 Rev A Page 10 of 231

Conforms to European Medical Device

Indicates that the device is a Medical Device

Symbol for "SERIAL NUMBER."

GSI Part Number.

Return to Authorized Representative, Special

Medical Equipment Classified by Intertek

Symbol for “European Representative.”

Symbol for “Manufacturer.”

Symbol for “Date of Manufacture.”

D-0129360 Rev A Page 11 of 231

This side up.

Electrostatic sensitive devices, or to identify a

Consult the operating instructions/directions

Consult the operating instructions/directions

Class II medical equipment

D-0129360 Rev A Page 12 of 231

Follow Instructions for Use.

Connection for the headphones or insert

Connection for the bone conductor transducer.

Connection for the sound field speakers. The red

Connection for the patient electrode cable.

D-0129360 Rev A Page 13 of 231

WARNINGS AND CAUTIONS

IMPORTANT SAFETY INSTRUCTIONS

D-0129360 Rev A Page 14 of 231

The device is not intended to be used in environments exposed to fluid spills. No

Do not drop or otherwise impact this instrument. If the instrument is dropped or

This equipment is intended to be connected to other equipment thus forming a Medical

D-0129360 Rev A Page 15 of 231

Since the instrument is connected to a PC, assembly and modifications shall be

A Separation Device (isolation device) is needed to isolate the equipment located

D-0129360 Rev A Page 16 of 231

Do NOT use in the presence of flammable gaseous mixtures. Users should

Do NOT use the system in a highly oxygen-enriched environment, such as a hyperbaric

Transport the instrument in temperatures between -20 °C / -4 °F to +50 °C / +122 °F and

ELECTROMAGNETIC COMPATIBILITY (EMC) CONSIDERATIONS

D-0129360 Rev A Page 17 of 231