GSi AUDERA PRO User manual

EP/OAE
VERSATILE
CLINICAL
AUDERA PRO
USER MANUAL

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

GSI Audera Pro User Manual
D-0129360 Rev A Page 1 of 231
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

GSI Audera Pro User Manual
D-0129360 Rev A Page 2 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 3 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 4 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 5 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 6 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 7 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 8 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 9 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 10 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.

GSI Audera Pro User Manual
D-0129360 Rev A Page 11 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 12 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 13 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.

GSI Audera Pro User Manual
D-0129360 Rev A Page 14 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

GSI Audera Pro User Manual
D-0129360 Rev A Page 15 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.

GSI Audera Pro User Manual
D-0129360 Rev A Page 16 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.

GSI Audera Pro User Manual
D-0129360 Rev A Page 17 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.

GSI Audera Pro User Manual
D-0129360 Rev A Page 18 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
Freq. (Hz)
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
Ears
covered
29.0
17.5
14.5
16.5
21.5
21.5
23.0
28.5
29.5
33.0
38.5
Ears not
covered
23.0 13.5 9.5 7.5 9.0 5.5 3.5 3.5 4.0 9.0 5.5
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.