natus Madsen A450 User manual

Madsen A450
Reference Manual
Doc. No.7-50-1840-EN/05
Part No.7-50-18400-EN

Copyright notice
© 2017,2021Natus MedicalDenmark ApS. All rights reserved. ® Natus, the NatusIcon, Aurical, Madsen, HI-PRO 2, Otoscan, ICS
and HORTMANN are registered trademarks of Natus MedicalDenmark ApS in the U.S.A. and/or other countries.
Version release date
2021-06-10 (221278)
Technical service and support
Please contact your supplier.
Madsen A450
2

Table of Contents
1 Introduction 6
1.1 The Otosuite Audiometry Module 6
1.1.1 Noah 7
1.2 About this manual 7
1.3 Typographical conventions 8
1.3.1 Navigation 8
1.3.2 Intended use 9
2 Navigating in the Otosuite Audiometry module 10
2.1 The Audiometry module main window 10
2.2 Toolbar icons and menus 11
2.2.1 File menu 12
2.2.2 Edit menu 12
2.2.3 View menu 12
2.2.4 Measurement menu 14
2.2.5 Tools menu 15
2.3 The Patient Responder indicator 15
2.4 The Masking Assistant 15
2.5 The control panel 17
2.6 The stimulus bar 22
2.6.1 Test controls 23
2.6.2 The Tone stimulus bar 24
2.6.3 The Speech stimulus bar 24
2.7 The Tone test screen 25
2.7.1 The work area in the Tone screen 25
2.7.2 The audiogram 26
2.7.3 Curves and symbols selection 28
2.7.3.1 Selecting a symbol or curve 28
2.7.4 Compare audiograms 29
2.7.5 Tone feature boxes 29
2.7.6 Tone editing options 31
2.8 Work-flow related features 32
2.8.1 Selecting orientation 32
2.8.2 Automatic frequency/level shift when storing 32
2.8.3 Stimulus duration 33
2.8.4 Ear shift frequency and level setting 33
2.8.5 Saving non-stimulus channel as masking 33
2.9 The Speech test screen 34
2.9.1 Creating and editing the speech test table 35
2.9.2 Selecting word or phoneme scoring 35
2.9.3 Selecting speech stimulus 39
2.9.4 Scoring words using integrated Otosuite speech material 41
2.9.5 Scoring words using external sound source 43
2.9.6 Scoring phonemes using integrated Otosuite speech material 44
2.9.7 Scoring phonemes using external sound source 46
2.9.8 Saving source levels for speech material 47
2.9.9 Speech editing options - tabular view 47
2.9.10 Storing SNR for Speech testing 49
2.9.11 Speech feature boxes 49
Madsen A450 3

2.9.12 Safety when using live speech 50
2.9.13 Terms and abbreviations used in Speech testing 50
2.10 Special tests 51
2.10.1 Available special tests 51
2.10.2 SISI (Short Increment Sensitivity Index) 51
2.10.2.1 Navigating in SISI 51
2.10.2.2 The test process - SISI 54
2.10.3 ABLB (Alternate Binaural Loudness Balance) 55
2.10.3.1 Navigating in ABLB 55
2.10.3.2 The test process 58
2.11 Test controls (keyboard, mouse) 58
2.11.1 PC keyboard controls 58
3 Preparing for testing 59
3.1 Preparing the test environment 59
3.2 Preparing the test equipment 59
3.3 Listening check 60
4 Preparing the client 61
4.1 Inspecting the client’s ear(s) 61
4.2 Proper transducer placement 61
5 Examples of audiometric testing 63
5.1 Testing the older child or adult patient 63
5.1.1 Assessing pure tone threshold using the Hughson/Westlake procedure 63
5.1.2 Assessing pure tone or speech most comfortable loudness level (MCL) 64
5.1.3 Assessing pure tone or speech uncomfortable loudness level (UCL) 64
5.1.4 Assessing speech reception threshold (SRT) using the Hughson/Westlake procedure 65
5.1.5 Assessing word recognition score 65
5.2 Special Tests 66
5.2.1 Performing Tone Decay using the Modified Carhart Method 66
5.2.2 Performing a pure tone Stenger 67
5.2.3 Performing speech Stenger 67
5.2.4 Performing Weber 68
5.2.5 Performing Rinne 68
5.2.6 Performing Alternate Binaural Loudness Balancing (ABLB) test 69
5.2.7 Performing Short Increment Sensitivity Index (SISI) test 69
5.3 Testing with sound files 70
5.3.1 Playing sound files without word lists 70
5.3.2 Playing sound files with word lists 70
6 Unpacking and installing 72
6.1 Requirements to the location 72
6.1.1 Requirements to noise in the test environment 72
6.2 Unpacking 73
6.3 Storing 73
6.4 Views of Madsen A450 73
6.5 Madsen A450 connection panel 74
6.6 Assembling Madsen A450 76
6.7 Desktop or wall-mount installation 76
6.8 Connecting accessories and PC to Madsen A450 78
6.9 Powering Madsen A450 78
4 Madsen A450

7 Configuring the Audiometry Module 79
8 Communicating with the device 81
8.1 Reconnecting to the device 81
8.2 Updating device firmware 81
9 Maintenance and calibration 82
9.1 Service and repair 82
9.1.1 Fuses 82
9.2 Maintenance 82
9.3 Cleaning 82
9.4 Calibration 83
10 Troubleshooting 84
10.1 Powering 84
10.2 Software/device communication 84
11 Standards and Safety 85
11.1 Madsen A450 85
11.2 Warnings, cautions, and notes 89
11.2.1 Connector warnings 89
11.2.2 General warnings 90
11.2.3 General cautions 91
11.2.4 General notes 92
11.3 The Otosuite Audiometry Module 92
12 Technical specifications 93
12.1 Accessories 101
12.2 Notes on EMC (Electromagnetic Compatibility) 104
13 Manufacturer 109
13.1 Responsibility of the manufacturer 109
Index 111
Madsen A450 5

1 Introduction
Madsen A450 Madsen A450 is a PC-controlled audiometer for testing a person's hear-
ing.The audiometer is operated from the Otosuite Audiometry Module PC
software.
With Madsen A450 you can perform standard audiometric tests, tone and
speech audiometry and special tests.
Madsen A450 can be placed on the desk top or mounted on the wall.
Operating Madsen A450
• You operate Madsen A450 from the PC’s keyboard and mouse with the Otosuite Audiometry Software Module acting
as the display showing the intensity, frequency as well as current settings and other information on the PC screen.
• From the Otosuite audiometry software, which is NOAH compatible, you can monitor test results, store and export
data, and print reports.
• Speech input signals can be taken from audio files on the PC hard drive, CD/DVDdrive, external line-in devices such as
a CD player, or live-voice from a microphone.
Outputs
Madsen A450 supports the following types of output:
• Headphones
• Insert phones
• Bone conductor
• Sound field loudspeakers. The speakers can use either the power amplifier built into Madsen A450 or an external
power amplifier.
1.1 The Otosuite Audiometry Module
Otosuite
Otosuite is a software tool that integrates a suite of hearing tests and hearing instrument fit-
ting functionality with result review and reporting capabilities into a single powerful PC
application.
Otosuite integrates closely with Natus audiometers by offering real time presentation of test results and full test control
directly from a PC with a comprehensive user interface and Noah compatibility.
The Otosuite Audiometry Module is designed to operate with Madsen A450 as the test device.
The Otosuite Audiometry Module
The Otosuite Audiometry Module provides you with comprehensive control and overview of the current stimulus and
masking choices both numerically and graphically in the displayed audiogram when you test with a connected Natus audi-
ometer.
6 Madsen A450
1 Introduction

As the module is part of Otosuite, audiograms can be used directly in other Otosuite modules such as the PMM and Immit-
tance modules for an optimized workflow independent of NOAH, and for combined reporting.
The Audiometry Module provides you with a wide range of features:
Testing
• Testing, using the Audiometry Module as a handy control panel while you follow stimulus settings and test progress on
your PC display
• Tone testing
• Speech testing
• Special tests
• Controlling play-back of speech test material
• Creating complete User Tests for specific audiometric tasks, including selecting specific speech lists, viewing pref-
erences, activating operator monitoring peripherals, etc.
• Entering tester details and test date entry for manually entered audiograms
• Entering special test and tuning fork test results
Viewing and printing
• Viewing and printing test results
• Viewing the progression of a range of tests online
• Viewing historic audiometry results from NOAH or XML format
• Viewing online audiometry results during testing
• Viewing masking level indicator in audiogram
• Viewing audiogram overlays
1.1.1 Noah
Otosuite integrates with:
• Noah systems
• Noah for ENT
• Noah-compatible Office Management systems.
The Noah System is a HIMSA product for managing clients, launching hearing test applications and fitting software, and stor-
ing audiological test results. Otosuite stores test results using Noah.
Note •Whenever reference in this manual is made to Noah, this reference should also apply to Noah-compatible sys-
tems.
1.2 About this manual
This is your guide to installing, calibrating and using Madsen A450 and to using the Otosuite Audiometry Module. It also
introduces you to the key features of the device and the software, as well as to working scenarios for performing tests and
viewing and printing test results.
Madsen A450 7
1 Introduction

We strongly recommend that you read this manual carefully before using Madsen A450 and the Audiometry Module for
the first time.
Note •If you are using the Audiometry Module with NOAH, we recommend that you are familiar with the screens and
functions provided in NOAH.
Installation and assembly
Unpacking ►73 and Assembling Madsen A450 ►76 contain a full description of unpacking instructions and how to
assemble the device. For instructions on installing the software, see the Otosuite Installation Guide.
Safety
This manual contains information and warnings which must be followed to ensure the safe performance of Madsen A450.
Note •Local government rules and regulations, if applicable, should be followed at all times.
Safety information is stated where it is relevant, and general safety aspects are described in Standards and Safety ►85.
Training
It is recommended that you read this manual and try out test scenarios before you start operating Madsen A450 so that
you are familiar with both the device and the software program before testing a patient.
1.3 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses pre-
cautionary statements as follows:
Warning •Indicates that there is a risk of death or serious injury to the user or patient.
Caution •Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note •Indicates that you should take special notice.
1.3.1 Navigation
Menus, icons and functions to select are shown in bold type, as for instance in:
• Click the Set Options icon on the toolbar or select Tools> Options...
8 Madsen A450
1 Introduction

1.3.2 Intended use
Madsen A450 with the Audiometry module
Users: audiologists, ENTs, hearing instrument dispensers and other health care professionals in testing the hearing of their
patients.
Use: diagnostic and clinical audiometric testing.
Intended Patient Population
The intended patient population is patients in all age groups, who are able to respond to the stimuli.
User Environment
• Professional healthcare facility environment
• The system is intended for use in a quiet environment within normal office temperature/humidity/pressure ranges
and lighting conditions
Clinical Benefit
Madsen A450 is used to conduct diagnostic and clinical audiometric testing, thereby providing a means to determine the
presence, type and degree of hearing loss, assist in the diagnosis of otologic disorders, and provide input for hearing aid
programming.
Madsen A450 9
1 Introduction

2 Navigating in the Otosuite Audiometry module
The general functions for navigating in the main window are described in the Otosuite manual.
You will find descriptions of the Audiometry test screens in:
•The Tone test screen ►25
•The Speech test screen ►34
Special tests are described in:
•Special tests ►51
2.1 The Audiometry module main window
The basic Otosuite functions are described in the OtosuiteUser Guide.
Audiometry elements
A. Menu bar See the OtosuiteUser Guide.
B. Audiometry toolbar Toolbar icons and menus ►11
C. Stimulus bar The stimulus bar ►22
D. Control panel The control panel ►17
E. Work area The Tone test screen ►25,The Speech test screen ►34
F. Feature boxes Tone feature boxes ►29,Speech feature boxes ►49
G. Masking level indicator, stimulus marker The audiogram ►26
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2 Navigating in the Otosuite Audiometry module

2.2 Toolbar icons and menus
General icons - see the Otosuite manual
Audiometry icons and menu selections
The icons and menu selections that are unique to Audiometry functionality depend on the test functions included in Oto-
suite and/or whether a test device is connected.
Audiometry icons
Tone audiometry Speech audiometry
Toolbar selections
Menu item Icon Description
View> Combined
Audiogram
Click to toggle between viewing both ears in a single audiogram (com-
bined audiogram) or both a left and a right audiogram on your screen.
Combined View
• Click to view both ears in a single audiogram.
Split View
• Click to view separate audiograms for each ear.
Scoring and Playing Click to open the Scoring and Playing dialog.
Menu selections
Menu item Icon Description
View> Select Ori-
entation
Click to select the perspective of the patient's ears as presented on
the screen for graph and table views.
You can also select the location of the stimulus control.
View> Manual entry Click to create an audiogram manually.
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2.2.1 File menu
Menu item Icon Description
New Audiogram Select new audiogram. You will be prompted to save or cancel current data.
2.2.2 Edit menu
Menu item Icon Shortcut Description
Audiometric prop-
erties...
Ctrl+U Click to enter Tester name, Test Date, and air conduction transducer
for a manually entered audiogram.
Note •The air conduction transducer is stored when you have
selected it in the transducer section of the Control Panel (or
with device controls, if applicable) and data points are entered
on the audiogram.
2.2.3 View menu
Menu item (Tone) Icon Description
Select Orientation Click to select the perspective of the patient's ears as presented on
the screen for graph and table views.
Masking Assistant Enable or disable the Masking Assistant.
The Masking Assistant causes an unmasked threshold to flash
repeatedly if masking is recommended.
• See The Masking Assistant ►15.
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Menu item (Tone) Icon Description
Overlays Enables or disables the overlays. Overlays display
• pictures
• severity
• speech banana,
• speech letters,
• unusable area
on the audiogram.
Overlays can also be displayed by selecting them from the overlays
box below or next to the audiogram.
To view/hide the overlays box, select Tools> Options> General.
See Tone feature boxes ►29.
Combined Audiogram Combined View
• Click to view both ears in a single audiogram.
Split View
• Click to view separate audiograms for each ear.
Click to toggle between viewing both ears in a single audiogram (com-
bined audiogram) or both a left and a right audiogram on your screen.
Audiogram Legend Click to enable or disable the display of the audiogram legend. The
legend contains the most commonly used symbols for the audiogram.
It is not configurable.
Standard / All / High
frequencies
The graph shows up to 20000 Hz. Madsen A450 presents stimulus up
to 12500 Hz.
• Click to choose between viewing:
Standard Frequencies
Displays the audiogram from 125 Hz to 8000 Hz.
All Frequencies
Displays the audiogram from 125 Hz to 20000 Hz.
High Frequencies
Displays the audiogram from 8000 Hz to 20000 Hz.
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2.2.4 Measurement menu
Menu item Icon Description
Monitoring Enables or disables the monitor speaker for monitoring stimuli presented
to the patient from the Stimulus or Masking channel.
Talk Forward Enables communicating with the patient in the sound booth. This will dis-
play the Talk Forward dialog box, where you can control the talk forward
microphone sensitivity and the output level in dB HL to the patient.
When enabled, the monitor speaker will be disabled.
When the Allow stimulation checkbox is checked, you can present stimuli
while leaving Talk Forward on. This is useful when you wish to present
stimuli and verbally reinforce the patient quickly, as for instance during
pediatric testing.
Note •Be aware that background noise must not be present if Allow
stimulation is checked.
Scoring and Playing See Selecting word or phoneme scoring ►35.
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2 Navigating in the Otosuite Audiometry module

2.2.5 Tools menu
Menu item Description
Curves and Symbols Click to select the Curves and Symbols dialog box.
This dialog box and its related function are specific to configuring the curves and symbols to
be displayed on the audiogram or speech graph during testing.
See Curves and symbols selection ►28.
Severity Overlay Click to select the Severity Overlay dialog box.
Double click to change the headline or the boundaries for a severity band. The severity
bands share boundaries so it is only possible to enter the lower boundary for each band
except for the upper band.
Live Video Otoscopy Click to launch a live video otoscopy window.
2.3 The Patient Responder indicator
When the patient presses the Patient Responder this is shown on the Stimulus bar, and a sound signal from the PC is heard
through the Monitor Speaker or Operator Headset. The sound signal is optional (Tools> Options> Audiometry>
General> Measurement, Misc> Audible patient response).
Single Responder setup
•Green
Indicates that the patient is pressing the Patient
Responder.
2.4 The Masking Assistant
If the Masking Assistant is enabled, it will at all times check for frequencies that may require testing with
masking. This also applies to saved audiograms imported from NOAH or XML as long as a supported transducer
was stored with the data.
The Masking Assistant is a tool provided to help you with an indication that there may be frequencies where testing with
masking1is recommended.
• The audiogram symbol will flash at the specific frequencies where contralateral masking may be recommended2.
1(Katz, J., Lezynski, J. (2002). Clinical Masking. In J. Katz, ed., Handbook of Clinical Audiology, Williams and Wilkins, Bal-
timore.)
2Based on criteria described in Clinical Masking, Essentials of Audiology, Stanley A. Gelfand, Thieme 1997, and Meas-
urement of Pure Tone Hearing Thresholds, Audiologists’ Desk Reference - Vol 1, James W. Hall III, H. Gustav Mueller
III, Singular Publishing Group 1997. and Munro K.J., Agnew N. A comparison of inter-aural attenuation with the Ety-
motic ER-3A insert earphone and the Telephonics TDH-39 supra-aural earphone. Br J Audiol 1999; 33: 259-262.
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2 Navigating in the Otosuite Audiometry module

• The masking criteria are configurable so that you can
set them up to match your local recommendations for
masking. You can for instance choose either frequency
specific criteria, which increases the efficacy of your
work, or the traditional "one-level-fits-all" criteria.
Select the Tools> Configuration Wizard> Audi-
ometry -Configure... > Masking Assistant to set up
the masking criteria.
All masking signals are calibrated in effective masking.
How does the Masking Assistant work?
Terminology
AC AC test ear
ACc AC contra
BC BC
BCc BC contra
Min IA Minimum inter-aural attenuation.
When is masking required?
Masking is recommended when the following conditions are met:
AC AC > ACc + Min IA or AC > BCc + Min IA
BC BC < AC - x* dB
Only stored thresholds measured without masking are checked. Levels which did not evoke a response are excluded from
the check. This means that as soon as a masked threshold has been stored, the flashing stops for that frequency.
* denotes configurable Air/Bone gap criterion (Tools> Configuration Wizard> Audiometry -Configure...> Masking
Assistant).
Min IA is frequency specific
These are the Min IA tables for TDH-39 and Natus Inserts used in the Masking Assistant 1.
1Katz, J., Lezynski, J. (2002). Clinical Masking. In J. Katz, ed., Handbook of Clinical Audiology, Williams and Wilkins, Bal-
timore. Munro, K.J., Agnew, N. A comparison of inter-aural attenuation with the Etymotic ER-3A insert earphone and
the Telephonics TDH-39 supra-aural earphone. Br J Audiol 1999; 33: 259-262. Hall, JW., MUELLER, HG. (1997). The audi-
ologists’ desk reference, Volume I., Singular Publishing Group, San Diego.
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Min IA (supraaural phone: TDH-39), frequency specific
Hz dB
125 35 Katz & Lezynski, (2002)
250 48 Munro & Agnew, BJA (1999)
500 44 Munro & Agnew, BJA (1999)
750 40 N/A - fulfill traditional approach
1000 48 Munro & Agnew, BJA (1999)
1500 40 N/A - fulfill traditional approach
2000 44 Munro & Agnew, BJA (1999)
3000 56 Hall J.W. III & Mueller G.H. III / Munro & Agnew, BJA (1999)
4000 50 Katz J / Munro & Agnew, BJA (1999)
6000 44 Hall J.W. III & Mueller G.H. III / Munro & Agnew, BJA (1999)
8000 42 Katz J / Munro & Agnew, BJA (1999)
Min IA insert phone
Hz dB
125 60 N/A - traditional value
250 72 Munro & Agnew, BJA (1999)
500 64 Munro & Agnew, BJA (1999)
750 60 N/A - traditional value
1000 58 Munro & Agnew, BJA (1999)
1500 60 N/A - traditional value
2000 56 Munro & Agnew, BJA (1999)
3000 58 Munro & Agnew, BJA (1999)
4000 72 Munro & Agnew, BJA (1999)
6000 54 Munro & Agnew, BJA (1999)
8000 62 Munro & Agnew, BJA (1999)
2.5 The control panel
Click the Control Panel icon in the toolbar to activate the Control Panel.
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2 Navigating in the Otosuite Audiometry module

Control panels
Tone testing Speech testing
In the control panel you can quickly select test ear, trans-
ducer, masking, and test type.
Click on the buttons to toggle the selection or right-click on a
button to select a combination of functions.
Your selections are shown in the Stimulus bar and as symbols
in the audiogram.
You can control the monitor level, activate the Talk Forward
dialog, and use the Test Selector to quick select the relevant
user test.
• Right-click on the buttons in the control panel to view
the right-click menu. Click to enable or disable selections
of your choice.
• Right-click on the blue masking link area in the control
panel to view the Masking Options right-click menu.
Click to enable or disable selections of your choice.
Tone testing
Test ear selection
•Right
•Both
•Left
Transducer selection
• Air conduction Phones (standard headphones)
• Air conduction Insert (earphones)
• Bone conduction Bone (bone conductor)
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Transducer selection
•SF Unaided (Sound Field speaker, unaided)
•SF Aided 1 and SF Aided 2 (Sound field speaker - Aided 1 and 2)
Stimulus type selection
•Tone
•Warble
•FRESH noise
•Pulsed
Test type selection
•AUD (audiogram threshold curve)
•SRT (Speech Recognition Threshold)
•WRS (Word Recognition Score)
•MCL (Most Comfortable Loudness level)
•UCL (Uncomfortable Loudness level)
Speech testing
Test ear selection
•Right
•Both
•Left
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2 Navigating in the Otosuite Audiometry module

Transducer selection
• Air conduction Phones (standard headphones)
• Air conduction Insert (earphones)
• Bone conduction Bone (bone conductor)
•SF Unaided (Sound Field speaker, unaided)
•SF Aided 1 and SF Aided 2 (Sound field speaker - Aided 1 and 2)
Stimulus type selection
• Microphone for presenting live speech stimulus
• Recorded stimulus
Talk Forward
Click to open the Talk Forward dialog.
Enables communicating with the patient in the sound booth. This will display the Talk Forward dialog
box, where you can control the talk forward microphone sensitivity and the output level in dB HL to
the patient.
Monitor and Level
Click to open the Monitor and Level dialog.
Test Selector
Click to open the Test Selector dialog.
The Control Panel right-click menu
Right-click on the buttons in the control panel to view the right-click menu. Click to enable or disable selections of your
choice.
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