otometrics madsen itera ii User manual

MADSENIteraII
Reference Manual
Doc. No.7-50-0860-EN/26
Part No.7-50-08600-EN

Copyright notice
© 2010,2019Natus MedicalDenmark ApS. All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL, MADSEN, Otoscan,
ICS and HORTMANN are registered trademarks of Natus MedicalDenmark ApS in the U.S.A. and/or other countries.
Version release date
2019-06-11 (214086)
Technical support
Please contact your supplier.
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Table of Contents
1 Introduction to MADSEN Itera II 7
1.1 The Audiometry Module 7
1.2 Intended use 8
1.3 About this manual 8
1.3.1 Safety 9
1.4 Typographical conventions 9
1.4.1 Navigation in this manual 9
2 Getting started with MADSEN Itera II and the OTOsuite Audiometry Module 11
2.1 Unpacking 11
2.2 Getting started 11
2.3 Customizing your setup 12
3 Overview of MADSEN Itera II 13
3.1 Display 13
3.2 Front panel controls 15
3.2.1 Front panel layout 15
3.2.2 Test column 16
3.2.3 Transducer column 17
3.2.4 Signal column 18
3.2.5 Input - MIC, CD, REVERSE 18
3.2.6 Signal indicators 19
3.2.7 Extended range 19
3.2.8 Change Ear (L <--> R) 20
3.2.9 Setup 20
3.2.10 Talk back 20
3.2.11 Masking 20
3.2.12 dB steps 21
3.2.13 Microphone 21
3.2.14 Talk over 22
3.2.15 Response indicator 22
3.2.16 Start/Pause/Stop 22
3.2.17 Store/toggle threshold status 23
3.2.18 Stimulus/masking intensity knobs 23
3.2.19 Stimulus/speech count buttons 24
3.2.20 Frequency 25
3.2.21 Erase 25
3.2.22 Xmit 26
3.3 Socket connections - rear panel 26
3.4 Side panel 28
4 Navigating in the OTOsuiteAudiometry Module 29
4.1 Audiometry Module features 29
4.2 The Audiometry Module menu system and toolbar 29
4.2.1 File menu 30
4.2.2 Edit menu 30
4.2.3 View menu 31
4.2.4 Tools menu 32
4.3 The Patient Responder indicator 32
4.4 The Masking Assistant 33
4.5 The Audiometry Module Control Panel 35
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4.5.1 The Control Panel 36
4.6 The stimulus bar 37
4.6.1 The Tone stimulus bar 38
4.6.2 The Speech stimulus bar 38
4.7 The Tone test screen 39
4.7.1 The work area in the Tone screen 39
4.7.2 The audiogram 40
4.7.3 Curves and symbols selection 42
4.7.3.1 Selecting a symbol or curve 42
4.7.3.2 Creating new symbols 43
4.7.4 Compare audiograms 43
4.7.5 The Legend box 44
4.7.6 Tone view options 44
4.8 Work-flow related features 46
4.8.1 Selecting orientation 46
4.8.2 Ear shift frequency and level setting 46
4.9 The Speech test screen 46
4.9.1 The work area in the Speech screen 47
4.9.2 Speech feature boxes 47
4.9.3 Terms and abbreviations used in Speech testing 47
4.10 Speech testing - tabular view 48
4.11 Speech testing - graph view 49
5 Preparing for testing 53
5.1 Preparing the test environment 53
5.2 Preparing the test equipment 53
5.2.1 Connecting the cables of the test equipment 54
5.2.2 The patient responder 54
5.2.3 Preparing for air conduction testing 55
5.2.4 Preparing for bone conduction testing 55
5.2.5 Preparing for testing with masking 56
5.3 Listening check 56
5.4 Preparing the client 56
5.4.1 Hygienic precautions 57
5.4.2 Inspecting the client’s ear(s) 57
5.5 Preparing the Audiometry Module for testing 57
5.6 Proper transducer placement 58
6 Tone testing 61
6.1 Air Conduction threshold test 61
6.1.1 Testing 61
6.1.2 Sound Field testing 62
6.2 Bone Conduction threshold test 62
6.2.1 Testing 63
6.3 Testing with masking 64
6.3.1 When is masking required? 64
6.3.2 Air conduction with masking - suggested procedure 66
6.3.3 Bone conduction with masking - suggested procedure 66
6.4 Storing thresholds 67
7 Speech testing 69
7.1 Monaural Speech testing 69
7.1.1 Selecting input 69
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7.1.2 Selecting masking for speech testing 70
7.1.3 The counter function in speech testing 71
7.1.4 Interrupting the speech signal 71
7.2 Binaural Speech testing 71
7.2.1 One-channel or two-channel Speech testing 72
7.2.2 Adjusting input sensitivity 72
7.3 Special Speech routing 72
7.3.1 Mixing input signals for two-channel monaural Speech 72
7.3.2 Speech in Noise 73
7.3.3 Binaural Speech with masking 73
7.3.4 Masking level for binaural Speech 73
8 Special tests 75
8.1 MCL tone testing 75
8.2 UCL tone testing 75
8.3 SISI (Short Increment Sensitivity Index) 75
8.3.1 Masking during SISI 76
8.3.2 Using STORE in the SISI test 77
8.4 ABLB (Alternate Binaural Loudness Balance) 77
8.4.1 Using STORE in the ABLB (Fowler) test 77
8.5 STENGER Test 78
8.6 Hearing Instrument Simulation (HIS) 79
8.6.1 The HIS procedure 79
8.6.2 Viewing thresholds and filters 81
8.6.3 Manually adjusting the HIS filters 82
8.7 Overview of monaural/binaural test signals and themaskingside 84
9 Managing Data and Results 85
9.1 Transferring test results from the audiometer to the PC 85
9.2 Storing data 85
9.3 Printing results 85
10 Setup of parameters 87
10.1 What does SETUP do? 87
10.2 How to use SETUP 87
10.2.1 Permanent changes in the setup 87
10.2.2 Return to default settings 87
10.2.3 Temporary changes in the setup 88
10.3 SETUP items 89
11 Configuring the Audiometry Module 101
12 Communicating with the device 102
12.1 Reconnecting to the device 102
12.2 Updating device firmware 102
13 Maintenance and calibration 103
13.1 Service and repair 103
13.1.1 Fuses 103
13.2 Cleaning 103
13.3 Calibration 104
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14 Unpacking and installing 105
14.1 Unpacking 105
14.2 Installation 105
14.2.1 Powering 106
14.2.2 Connecting to a PC 106
14.2.3 Air conduction 106
14.2.4 Bone conduction 107
14.2.5 External microphone 107
14.2.6 Free Field 107
15 Maximum non-destructive voltage 109
App. 0.1 Input and output sockets 109
App. 0.2 RS232 interface sockets 109
16 Maximum output levels 111
16.1 Tone 111
16.2 NBN 111
17 Abbreviations 113
18 Standards and safety 115
18.1 Symbols used 115
18.2 Warning notes 115
18.3 The OTOsuite Audiometry Module 117
18.4 Manufacturer 117
18.4.1 Responsibility of the manufacturer 117
19 Technical specifications 119
19.1 MADSEN Itera II 119
19.2 Accessories 123
19.3 Notes on EMC (Electromagnetic Compatibility) 124
Index 127
6 Otometrics - MADSEN Itera II

1 Introduction to MADSEN Itera II
MADSEN Itera II is an audiometer for testing a person's hearing.
With MADSEN Itera II you can perform all standard audiometric tests, tone and speech
audiometry and special tests.
Depending on the configuration, various special tests such as SISI, Stenger, ABLB (Fowler),
and HIS are available.
• MADSEN Itera II can be used in connection with the OTOsuite Audiometry Module software for online monitoring
of test results, data export and storage, printing, and NOAH compatibility.
• MADSEN Itera II can be used as a portable instrument or as a desktop unit (fixed installation).
Operation
The front panel buttons have indicator lights, which clearly show the device's current settings.
Sound level, frequency and other information are shown clearly on the device display.
Speech input signals can be taken from a CD player, tape recorder and internal or external microphones. The masking sig-
nal for speech audiometry can be presented together with the speech signal for the ear being examined - "Speech in
Noise".
Output options
There are three output options:
• standard headphones (AC),
• bone conductors (BC)
• special output (SF), which can be connected for instance to a free-field loudspeaker or insert phone (see available out-
put in SETUP items ►89).
MADSEN Itera II can be calibrated for several types of headphones simultaneously.
Transferring data to and from a pc
The test results are stored in the device - even when it is switched off. The results can be transferred to a PC and displayed
in OTOsuite (see Managing Data and Results ►85).
You can download new firmware to MADSEN Itera II, and if this involves no change to the transducers, MADSEN Itera II
does not need to be recalibrated.
1.1 The Audiometry Module
OTOsuite
OTOsuite is a software tool that integrates a suite of audiological tests with result review
and reporting capabilities into a single powerful PC application.
The OTOsuite Audiometry Module is designed to operate with MADSEN Itera II 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 Otometrics
audiometer.
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As the module is part of OTOsuite, audiograms can be used directly in other OTOsuite modules such as the PMM and
Immittance modules for an optimized workflow independent of NOAH, and for combined reporting.
The OTOsuite Audiometry Module supports
• basic tone audiometry and
• speech testing
• a range of special tests.
Masking AssistantTM
The special Masking AssistantTM feature will notify you of thresholds that you might consider checking again with masking
applied. You may use this feature not only during testing but also to pinpoint possible masking issues with previously recor-
ded audiograms. The applied masking rules match the general recommendations in the audiometry literature.
Over the rim testing
Testing with the audiometer connected to a PC allows you to use the audiometer primarily as a handy control panel while
you follow the actual stimulus settings and test progress on your standard PC display. The large stimulus and patient
response graphics at the top of the display gives you a clear overview while keeping your focus on the patient.
1.2 Intended use
MADSEN Itera II and the Audiometry module
Users: audiologists, ENTs and other health care professionals in testing the hearing of their patients.
Use: diagnostic and clinical audiometric testing.
1.3 About this manual
This is your guide to installing, calibrating and using MADSEN Itera II 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.
We strongly recommend that you read this manual carefully before using MADSEN Itera II 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.
Training
It is recommended that you read this manual and the OTOsuite Platform User Manual, and make yourself familiar with
MADSEN Itera II before you begin testing a patient.
Terminology
The correct term for the person being tested/evaluated/serviced may depend on the setting in which the system is being
used. For this manual the term “Patient” was chosen, but when you use MADSEN Itera II with OTOsuite, you can configure
OTOsuite to use another term.
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1 Introduction to MADSEN Itera II

1.3.1 Safety
This User Manual contains information and warnings which must be followed to ensure the safe performance of MADSEN
Itera II and the OTOsuite Audiometry Module.
Warning •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 ►115.
•Standards and safety ►115 gives you an overview of device labelling and standards.
•Warning notes ►115 contains relevant warning notes.
1.4 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.
1.4.1 Navigation in this manual
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...
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1 Introduction to MADSEN Itera II

1 Introduction to MADSEN Itera II
10 Otometrics - MADSEN Itera II

2 Getting started with MADSEN Itera II and the
OTOsuite Audiometry Module
2.1 Unpacking
1. Inspect the package and its contents for possible visual damage.
2. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is
incomplete, contact your supplier.
2.2 Getting started
Training
We recommend that you read this manual and make yourself familiar with the MADSEN Itera II, and how it operates with
the OTOsuite Audiometry Module.
Safety
For safety information, see
•Standards and safety ►115
Installation
• To install the new system, see Unpacking and installing ►105
• If you are using OTOsuite, install OTOsuite from the OTOsuite Installation disk. See the OTOsuiteInstallation Manual.
Connecting to MADSEN Itera II
Socket connections - rear panel ►26 shows the location of the sockets for the various accessories required.
• To connect the accessories, see Installation ►105:
– Connect the Patient Response Switch.
– Connect headphones/insert phones.
– If bone conduction is required, connect the bone conductor.
– Connect external and Free Field microphones if required.
Configuring the OTOsuite Audiometry Module
• See see Configuring the Audiometry Module ►101.
Preparing for testing
Before you receive the client and start the session of testing and explaining test results, your time is well spent preparing
for the session.
• Test preparations are described in Preparing for testing ►53
• Customization of the test equipment is described in Customizing your setup ►12
Descriptions and testing
In order for you to feel well prepared and confident before you receive clients for testing using the Audiometry Module,
see the test screen descriptions. They provide you with examples on how to view the test results.
• The basic OTOsuite functions are described in the OTOsuiteUser Guide.
• The test screens are described in Navigating in the OTOsuiteAudiometry Module ►29.
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Printing
• See the OTOsuiteUser Guide.
2.3 Customizing your setup
With IteraII you can quickly and easily customize your test sequences for maximum efficiency.
Changing the setup
Make the changes you want in the setup of IteraII and save these changes in the specific test setup.
Example
1. Set dB STEP to 1 dB (press button 1in the dBSTEP column).
2. Press SETUP twice to enter setup mode.
3. Turn the Left dB LEVEL knob until SAVE TEST SETUP is shown on the display.
4. Press STORE.
5. Turn IteraII off and then on again. It now remembers your preferred settings.
Shortcuts
A number of functions in IteraII can be activated by a shortcut so that you just have to press and hold the appropriate but-
ton and turn the knob.
For a full list of shortcuts, see Temporary changes in the setup ►88.
Example
1. Press the SPEECH button to select Speech mode.
2. Press MIC to select microphone.
3. Press and hold MIC while you turn the Right level knob. You will then adjust the sensitivity of this microphone.
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2 Getting started with MADSEN Itera II and the OTOsuite Audiometry Module

3 Overview of MADSEN Itera II
A. Rear panel connections
The rear panel contains the sockets for connecting various accessories
and the socket for power connection. See Socket connections - rear
panel ►26.
B. On/Off switch
The side panel contains the On/Off switch. See Side panel ►28.
C. Display
Settings and the test as it progresses are shown on the display. See Dis-
play ►13.
D. Front panel controls
MADSEN Itera II is operated from the front panel. See Front panel con-
trols ►15.
3.1 Display
A. Test signal indicator
B. Audiogram symbols
C. Stored threshold
D. Ear indicator
E. Function key markers
During start-up the display briefly shows information regarding the device type and version, followed by the test screen last
used.
The abbreviations used on the display are explained in Abbreviations ►113.
Top line
• During Tone testing the upper line in the display shows the intensity numerically in dBHL for the left and right ear.
• During Speech testing and HIS the upper line is transformed into one or two VU meters.
Ear selection
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The ear being tested is indicated with Lor Rin the display. The display side for Land Rcan be changed in the settings. See
SETUP items ►89.
Frequency
The selected test frequency for tone testing is shown at the center.
Masking
If masking for the contralateral ear is enabled, this is shown on the opposite side.
Symbols used
Left ear
Response/No response
Right ear
Response/No response
Air, unmasked
Air, masked
Bone, mastoid, unmasked
Bone, mastoid, masked
Sound field, unmasked (binaural - applies to both
ears)
Sound field, masked
UCL (UnComfortable Loudness level)
MCL (Most Comfortable Loudness level)
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3 Overview of MADSEN Itera II

Other symbols
Stored results on this frequency
3.2 Front panel controls
You can access all basic functions directly by using the buttons and knobs on the front panel.
The button light indicators
Each button has its own function. Some buttons have a light to indicate whether the function is currently active or not.
• Press the button to activate.
• Press the button again to deactivate.
3.2.1 Front panel layout
The MADSEN Itera II buttons and controls are grouped according to their function and how frequently they are used.
The buttons and knobs most frequently used are placed directly below the display.
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3 Overview of MADSEN Itera II

A. Test column ►16
B. Transducer column ►17
C. Signal column ►18
D. Input - MIC, CD, REVERSE ►
18
E. Signal indicators ►19
F. Extended range ►19
Change Ear (L <--> R) ►20
G. Setup ►20
Talk back ►20
H. Masking ►20
I. dB steps ►21
J. Display ►13
K. Microphone ►21
L. Talk over ►22
M. Response indicator ►22
N. Start/Pause/Stop ►22
O. Store/toggle threshold status ►
23
P. Stimulus/masking intensity knobs ►
23
Q. Stimulus/speech count buttons ►
24
R. Frequency ►25
S. Erase ►25
T. Xmit ►26
Beep
If you try to use a button which is not enabled, you will hear two short beeps.
MADSEN Itera II also beeps when the SISI test is completed.
3.2.2 Test column
Press to select the test:
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3 Overview of MADSEN Itera II

•TONE
Selects the Tone Threshold test.
•SPEECH
Selects the Speech test.
• SPECIAL
Press to see the optional test types. Press the desired function key to select.
On versions of IteraII supplied with more than three special tests, press SPECIAL again while its LED is
flashing. This will display the names of more Special tests.
The most recently used special test always appears in the first row the next time you select SPECIAL.
For a description of the special tests, see
–MCL tone testing ►75
–UCL tone testing ►75
–SISI (Short Increment Sensitivity Index) ►75
–ABLB (Alternate Binaural Loudness Balance) ►77
–STENGER Test ►78
–Hearing Instrument Simulation (HIS) ►79
Current test settings
When you switch to a new test, the current setting of the test that you are leaving will be saved and re-established when
you return to the test.
3.2.3 Transducer column
Press to select the output transducer:
•AC
Selects the Air Conductor
•BC
Selects the Bone Conductor
•SF
Selects the Special Transducer
The identity of the transducer selected under SETUP is displayed as long as you press the button.
If a headphone/transducer is not selected under SETUP,SETUP items ►89,SETUP items ►89 and SETUP
items ►89, the relevant transducer cannot be selected.
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3 Overview of MADSEN Itera II

3.2.4 Signal column
WARBLE
Presentation of warble tone stimulus (WRB).
Warble shortcut functions
Warble frequency To change the warble frequency, press and hold WARBLE, while you turn the
left LEVEL selector.
Warble modulation To change warble modulation width, press and hold WARBLE, while you turn
the Right level selector.
PULSE
The test signal is presented with a Pulse/Pause ratio of 50%.
Pulse shortcut functions
Pulse frequency To change the pulse frequency, turn the Right level selector while you
press and hold PULSE.
IMPULSE
The test signal is presented within a preset period of time.
Impulse shortcut functions
Test signal duration To change the duration of the test signal, turn the Right level selector
while you press and hold IMPULSE.
3.2.5 Input - MIC, CD, REVERSE
MIC.
Press MIC. to select the signal from external or internal microphone input. The internal microphone is loc-
ated below the display. External microphones are for instance the goose neck microphone, or, if you are
using a monitor headset, the boom microphone.
CD.
Press CD to select the signal from external CD/TAPE input.
MIC/CD shortcut functions
Input signal sens-
itivity, MIC/CD
You can adjust the input signal sensitivity by holding down the MIC or CD button
and turning the LEVEL selector that is closest to the test signal side.
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3 Overview of MADSEN Itera II

REVERSE
Press REVERSE to toggle the function of the Interrupter between:
•REVERSE (lamp lit)
If REVERSE is on (the test signal is activated continuously), the test signal is interrupted when you press INT.
•Normal
The test signal is applied when you press INT.
Note •The presentation only applies to the test signal. The masking signal is normally always ON. You can change
the masking interrupter's function under SETUP,SETUP items ►89.
The permitted signal source depends on the TEST selected, see Display ►13.
Speech and HIS
• Press REVERSE to toggle the signal.
3.2.6 Signal indicators
Output
The indicators are located on either side of the display. They light up when the selected test signal is presen-
ted in the corresponding ear.
3.2.7 Extended range
Enables presentation of stimuli above the safety limit (approx. 100dB). The safety limit is set to 20dB below
the maximum dBHL for a given transducer and frequency.
The exception is at 125Hz, where the limit is 30dB below the maximum dBHL.
Extended Range has three modes (to select, see SETUP,SETUP items ►89):
•Auto
All levels at all frequencies are always accessible, but the Extended Range button is lit when a level above the safety
limit is reached.
•Manual
You must manually press the Extended Range button to test above the safety limit.
•Timeout
Selection of the time interval that passes between the device standing untouched and the EXTended (sound intensity)
RANGE is deactivated.
EXT. RANGE is automatically disabled when:
• the intensity falls below the limit selected under SETUP,SETUP items ►89,
• the duration set for Ext. Range Timeout is exceeded and the device has been inactive (SETUP,SETUP items ►89),
• you select a new test, or
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3 Overview of MADSEN Itera II

• you change FREQUENCY, see Frequency ►25.
3.2.8 Change Ear (L <--> R)
• Press this button to switch between testing the left and right ear.
Speech test
• Press twice (L+R) during the speech test to send the test signal to both ears, giving "Binaural Speech".
• Use L<-->R to mix the signals in speech testing.
• Use L<-->R to control setup masking in one ear in binaural speech testing.
3.2.9 Setup
Changing the setup temporarily
To change the setup temporarily, use the Shortcut function (Temporary changes in the setup ►88). These changes will
not be saved when you switch off the device.
Changing the setup permanently
To change the setup permanently, press the SETUP button to access the various parameters. See Permanent changes in
the setup ►87.
1. Press SETUP twice to change default settings, see Setup of parameters ►87. This serves to prevent
accidental changes in the setup.
– SISI
Press SETUP to enable the number of small increments to be changed using the right LEVEL
selector.
– Fowler (ABLB)
Press SETUP to enable changing the frequency of the alternating tone using the right LEVEL
selector.
3.2.10 Talk back
The patient's speech is always fed back to the operator's monitor headphone.
You can remove the signal
• by lowering the Talk Back volume (SETUP,SETUP items ►89), or
• by setting the switch on the Talk Back microphone to OFF.
You can choose to have the test signal and/or the masking signal switched ON or OFF in the monitor headphone (SETUP,
SETUP items ►89).
Talk back shortcut functions
Setup - volume To adjust the volume, press and hold TALK BACK while turning the right LEVEL selector.
3.2.11 Masking
• By default, you always adjust the stimulus signal level on the LeftLevel knob, regardless of whether you are testing
the right or left ear.
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3 Overview of MADSEN Itera II