otometrics MADSEN Astera2 User manual

MADSEN Astera²
User Guide
Doc. No. 7-50-1350-EN/04
Part No. 7-50-13500-EN

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Copyright© 2015, GNOtometricsA/S
Published in Denmark by GNOtometricsA/S, Denmark
All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of
publication. GNOtometricsA/S reserves the right to make changes at any time without notice.
Registered trademarks and Trademarks
MADSENIteraII,MADSENOTOflex 100, OTOsuite,AURICALFreeFit, AURICAL VisibleSpeech, MADSEN Astera², MADSENXeta, ICS
Chartr 200 VNG/ENG, ICSChartr EP, OTOcam300,MADSENAccuScreen, MADSENAccuLink,ICSAirCal, AURICALAud, AURICALHIT,
ICSImpulse, OTObase and MADSEN Capella² are either registered trademarks or trademarks of GNOtometricsA/S.
Versionrelease date
2015-09-30 (117479)
Technicalsupport
Please contact your supplier.
2 Otometrics - MADSEN Astera²

Table of Contents
1 Device description 4
2 Intended use 4
3 Unpacking 5
4 Installation 5
5 Powering the device 11
6 Connecting MADSEN Astera² to OTOsuite 11
7 On-screen controls 12
8 PC keyboard controls 12
9 Toolbar icons in the Audiometry Module 12
10 The Sunshine Panel 14
11 Proper transducer placement 17
12 Performing tone audiometry 18
13 Performing speech audiometry 20
14 Service, cleaning and calibration 21
15 Other references 22
16 Technical Specifications 23
17 Definition of symbols 33
18 Warning notes 34
19 Manufacturer 37
Otometrics - MADSEN Astera² 3

1 Device description
MADSEN Astera² is a PC-controlled audiometer for testing a person'shearing. The audiometer is operated from the OTO-
suite Audiometry Module PC software.
With MADSEN Astera² you can perform all standard audiometric tests, tone and speech audiometry and special tests.
• You can operate MADSEN Astera² from the PC’s keyboard/mouse, or from the MADSEN Astera² Audiometer Control
Panel (ACP) with the OTOsuite Audiometry Software Module acting as the display.
• From the OTOsuite Audiometry Software Module, which is NOAH compatible, you can monitor test results, create
User Tests, store and export data, and print reports.
Test intensities and frequencies as well as the current test settings and other information are shown on the PC mon-
itor.
2 Intended use
MADSEN Astera² 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.
The MADSEN Astera² Audiometer Control Panel (ACP)
The ACP is intended as a supplementary user interface connected to MADSEN Astera².
2.1 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.
4 Otometrics - MADSEN Astera²
1 Device description

3 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the packing material in which they were
delivered. If you need to send the device in for service, the original packing material will protect against damage dur-
ing transport, etc.
2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is
incomplete, contact your local distributor.
4. Check the Test Report (Calibration Certificate), make sure that the transducers (headphones and bone oscillator) are
the correct ones, and that they comply with the ordered calibration standards.
4 Installation
Install OTOsuite on the PC before you connect to MADSEN Astera² from the PC.
For instructions on installing OTOsuite, see the OTOsuiteInstallation Guide, which you can find on the OTOsuite install-
ation medium (disk or memory stick).
To mount MADSEN Astera² on the wall or under the desktop, see the MADSEN Astera² Reference Manual.
Caution•To connect MADSEN Astera² to the PC, use the supplied USB cable. The cable length must not
exceed 3 m (approx. 10 feet).
MADSEN Astera² is fully assembled on delivery, and you simply have to connect cables.
Remove the cable cover
1. To remove the cable cover from MADSEN Astera² press the releases
on both sides of the cable cover, swing the cover up into vertical
position and lift it off MADSEN Astera².
2. Lift off the cable cover.
Otometrics - MADSEN Astera² 5
3 Unpacking

Connect accessories
See Connecting accessories to MADSEN Astera² ►9.
Connect the ACP
If you are using the ACP:
See Connecting the ACP to MADSEN Astera² ►6and Connecting the ACP to the PC ►7.
Secure cables to MADSEN Astera²
1. Secure the cables to the back of MADSEN Astera² with the rubber
bands provided.
Remount the cable cover
1. Remount the cable cover by inserting the blue tags of the cable cover
into the grooves of MADSEN Astera² and swinging the cover into place
until you hear a click.
Connecting to OTOsuite
• Run the OTOsuite Configuration Wizard to connect to and set up communication with MADSEN Astera²: Select Tools>
Configuration Wizard...
4.1 Connecting the ACP to MADSEN Astera²
Caution•Install OTOsuite on the PC before you connect to MADSEN Astera² from the PC.
6 Otometrics - MADSEN Astera²
4 Installation

1. Remove the cable cover from
MADSEN Astera².
2. Connect the ACP to the
MADSEN Astera² connection
panel.
The connections are located at
the back of the ACP in the
"From Main Unit" group.
All four cables for connecting the ACP to MADSEN Astera² are joined in a bundle and color-coded for easy connection.
Caution•Make sure that each jack, as depicted on each end of the cable, connects with the specific sockets on the
ACP and MADSEN Astera².
Operator desktop microphone
• Connect the yellow cable in the cable bundle from the Operator desktop microphone
socket in the MADSEN Astera² rear panel to the Operator desktop microphone socket
in the ACP.
Operator monitor headset with boom microphone
• Connect the green cable in the cable bundle from the Operator monitor headset - head-
phones socket in the MADSEN Astera² rear panel to the Operator monitor headset -
headphones socket in the ACP.
• Connect the pink cable in the cable bundle from the Operator monitor headset - boom
microphone socket in the MADSEN Astera² rear panel to the Operator monitor headset
- boom microphone socket in the ACP.
Speaker, built into the ACP
• Connect the gray cable in the cable bundle from the Operator monitor speaker socket
in the MADSEN Astera² rear panel to the Operator monitor speaker socket in the ACP.
3. When you have connected the accessories, slide the cable cover onto MADSEN Astera² and click it into place.
4.2 Connecting the ACP to the PC
The ACP is powered from the PC through a USB connection.
Caution•Install OTOsuite on the PC before you connect the ACP to the PC.
Otometrics - MADSEN Astera² 7
4 Installation

Caution•To connect the ACP to the PC, use the supplied USB cable. The cable length must not exceed 3
m (approx. 10 feet).
Caution•Do not connect the ACP to the PC using a bus powered hub (USB hub without external power supply). It can-
not provide sufficient power to the ACP. The Power on LED on the ACP will flash to indicate an error. Use instead a
USB hub with external power supply.
The following applies only when used with the specified power supply, External power supply, Delta Elec-
tronics Inc., type MDS-090AAS24:
The installation must be carried out in accordance with Medical Electrical Systems clause 16 in IEC 60601-1
(3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-1-08-CAN/CSA. The supplementary provisions on the reli-
ability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (3rd).
The following applies only when used with the specified power supply, XP Power, type PCM80PS24:
The installation must be carried out in accordance with IEC 60601-1-1, UL 60601-1 and CAN/CSA-C22.2 NO
601.1-90. The supplementary provisions on the reliability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (2nd) and/or IEC 60601-1-1.
Any PC connected to the ACP must comply with the requirements of UL/IEC 60950, "Safety of information
technology equipment, including electrical business equipment".
Only the supplied cable must be used for the connection.
Direct connection to PC using single USB cable
Caution•Make sure that the total length of the USB cable used for connecting the ACP to the PC does not exceed 3
meters (10 feet).
1. Unfold the feet of the ACP.
2. Place the ACP in front of the PC monitor.
3. Plug one end of the USB cable into the USB socket located in the ACP rear panel and the other end of the
cable into a USB socket on the PC.
8 Otometrics - MADSEN Astera²
4 Installation

Connection to PC using externally powered USB hub
Caution•If the PC, the externally powered USB hub and the ACP are connected, make sure that you switch on power
to the hub before or right when you switch on the PC. This is to ensure that the USB connection between the PC and
the hub is established correctly. This connection is established when the PC is switched on.
Caution•If you are using an externally powered hub, no individual USB cable must exceed 3 meters (10 feet).
Power up sequence with externally powered USB hub
1. Connect the externally powered USB hub to the mains socket and switch it on.
2. Plug the single USB cable from the externally powered USB hub directly into a USB socket on the PC.
3. Connect the USB cable from the externally powered USB hub to the USB socket located in the ACP rear
panel.
4.3 Connecting accessories to MADSEN Astera²
Caution•Install OTOsuite on the PC before you connect to MADSEN Astera² from the PC.
The following applies only when used with the specified power supply, XP Power, type PCM80PS24:
The installation must be carried out in accordance with IEC 60601-1-1, UL 60601-1 and CAN/CSA-C22.2 NO
601.1-90. The supplementary provisions on the reliability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (2nd) and/or IEC 60601-1-1.
except for the PC, and equipment connected to the line in and the line out socketsof MADSEN Astera².
The following applies only when used with the specified power supply, External power supply, Delta Elec-
tronics Inc., type MDS-090AAS24:
The installation must be carried out in accordance with Medical Electrical Systems clause 16 in IEC 60601-1
(3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-1-08-CAN/CSA. The supplementary provisions on the reli-
ability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (3rd).
except for the PC, and equipment connected to the line in and the line out socketsof MADSEN Astera².
See also Connector warning notes ►34 and General warning notes ►35.
For a detailed description of the connection panel, see the MADSEN Astera²Reference Manual.
Otometrics - MADSEN Astera² 9
4 Installation

Connection panel - MADSEN Astera²
The connections are located at the back of MADSEN Astera².
All four cables for connecting accessories are joined in a bundle and color-coded for easy connection:
• Yellow: Operator desktop microphone
• Green: Operator monitor headset, headphones
• Pink: Operator monitor headset, boom microphone
• Gray: Operator monitor speaker
A. Patient Responders
B. Insert earphones
C. Headphones - air conduction
D. High-frequency headphones - air conduction
E. Bone oscillator
F. Operator monitor headset - headphones
G. Operator monitor headset - boom microphone
H. Operator monitor speaker
I. Operator desktop microphone
J. Talkback microphone
K. Assistant monitor headset
L. Sound field speakers (power output)
M. External power supply
N. PC/USB connection
O. Line-in
P. Sound field speakers (line output)
Note •Blue corresponds to Left and red corresponds to Right.
Warning•Use only the power supply provided by Otometrics.
Caution•When you connect other electrical equipment to MADSEN Astera², remember that equipment that does not
comply with the same safety standards as MADSEN Astera² can lead to a general reduction in the system's safety
level.
Connection panel - ACP
10 Otometrics - MADSEN Astera²
4 Installation

A. PC/USB connection • USB cable
B. Connections from MADSEN Astera² • Speaker built into the ACP
• Operator monitor headset with boom microphone
• Operator desktop microphone
C. Connections to accessories • Operator desktop microphone
• Operator monitor headset with boom microphone
5 Powering the device
MADSEN Astera² is powered through an external power supply connected directly to the mains outlet.
Switching on MADSEN Astera²
Use only the power supply specified in Technical Specifications in the MADSEN Astera²Reference Manual.
1. Connect the mains plug of the external power supply directly to an AC mains outlet with a three-wire
protective ground.
2. Switch on the mains supply.
3. The On/Off indicator on MADSEN Astera² lights green.
Press the ON/OFF button on the front of MADSEN Astera².
Switching off MADSEN Astera²
1. To switch off MADSEN Astera², disconnect the power supply from the mains outlet.
6 Connecting MADSEN Astera² to OTOsuite
When you use MADSEN Astera² for the first time, run the Configuration Wizard to set up the connection between
MADSEN Astera² and OTOsuite. After you have configured OTOsuite for the first time, if MADSEN Astera² is turned on
when you open the Control Panel in OTOsuite, then MADSEN Astera² will connect to OTOsuite automatically. Otherwise,
you can connect MADSEN Astera² as follows:
1. Switch on the device.
Otometrics - MADSEN Astera² 11
5 Powering the device

2. Launch OTOsuite.
3. In the OTOsuite toolbar, click Control Panel.
4. In the Control Panel, click Connect.
7 On-screen controls
Test controls provide a means of operating the audiometer if you use the mouse and on-screen options to perform tests.
• To enable test controls, select Tools>Options>Audiometry>General>On-screen controls >Show>On.
Silence Mode
Silence Mode allows you to control tone levels and presentation by hovering the mouse cursor over the respective on-
screen controls. This is particularly useful when the operator of the audiometer and the person being tested are in the
same room.
• To enable silence mode, select Tools >Options >Audiometry >General >On-screen controls >Silence Mode >On.
• To change the level and frequency by more than one click at a time, use the mouse scroll wheel.
8 PC keyboard controls
You can open a separate PDF-file to have a proper view of the keyboard short-
cuts.
After you install OTOsuite, you can find OTOsuite manuals and related doc-
umentation on your PC. In the Start menu, open OTOsuite Manuals, which
contains an overview with links to all manuals.
Note •The actual position of the keys may depend on your keyboard
type.
9 Toolbar icons in the Audiometry Module
The icons available in the toolbar depend on the test function that you have selected.
12 Otometrics - MADSEN Astera²
7 On-screen controls

Audiometry icons
Tone audiometry
Speech audiometry
Menu item Icon Description
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.
Masking Assistant Enable or disable the Masking Assistant.
The Masking Assistant causes an unmasked threshold to flash
repeatedly if masking is recommended.
Standard
Frequencies/All Fre-
quencies/High Fre-
quencies
The graph shows up to 20,000 Hz. MADSEN Astera² presents stimulus
up to 12,500 Hz.
• Click to choose between viewing:
Standard Frequencies
Displays the audiogram from 125 to 8000 Hz.
All Frequencies
Displays the audiogram from 125 to 20,000 Hz.
High Frequencies
Displays the audiogram from 8000 to 20,000 Hz.
New Audiogram Select new audiogram. You will be prompted to save or cancel current
data.
Otometrics - MADSEN Astera² 13
9 Toolbar icons in the Audiometry Module

Menu item Icon Description
Frequency Resolution The options for frequency resolutions are 1/6, 1/12, 1/24 and 1/48
octave as well as 1 Hz. Select the different tone stimulus resolutions
from the toolbar or from Tools >Options >Audiometry >General.
You can store up to 24 points for each audiometry curve. You will be
prompted if you try to store more than the maximum number of
points.
Monitoring Enables or disables the monitor speaker for monitoring stimuli presen-
ted to the patient from the Stimulus or Masking channel.
Desktop/Headset
Microphone
Toggle microphone types
Click to toggle between the operator headset boom microphones and
desktop microphone used to communicate with the patient and/or the
assistant. The one displayed is the one currently active.
Enable Talk to Assist-
ant
Click to enable or disable talking to another party (usually a second
tester) in the booth.
Talk Forward Enables communicating with the patient in the sound booth. This will
display the Talk Forward dialog box, where you can control the talk for-
ward microphone sensitivity and the output level (in dB HL) to the
patient.
Select Orientation 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.
Sunshine Panel When you have enabled the Control Panel icon on the toolbar, you can
choose between using the Classic Control Panel and the Sunshine
Panel.
10 The Sunshine Panel
Click the Control Panel icon in the toolbar to activate the Control Panel.
Click the Sunshine Panel icon in the toolbar to select or deselect the Sunshine Panel in either Tone or
Speech testing.
14 Otometrics - MADSEN Astera²
10 The Sunshine Panel

Tone Speech
Use the Sunshine Panel to quickly select the main settings for testing.
In the Sunshine Panel you can quickly select test ear, transducer, mask-
ing, and test type.
You can control the monitor level, activate the Talk Forward dialog, and
select the Test Selector for quickly selecting the relevant user test.
Your selections are shown in the Stimulus bar and as symbols in the audi-
ogram.
See also
•Performing tone audiometry ►18
•Performing speech audiometry ►20.
Customizing the Sunshine Panel
You can customize the Sunshine Panel to display one or several buttons for some of the functions. For instance you can dis-
play one or more of the curve selection buttons on the panel.
When the right-click menu for a button includes the selection Add / remove buttons you can customize the setup.
1. Enable/disable the button(s) you wish to display.
2. Click to disable the selection Use Single Button. The enabled buttons are displayed immediately in the panel.
Using the Sunshine panel
• Click on the buttons to toggle the selection
or
• Right-click on a button to select a combination of functions.
Function Icon Description
Stimulus Ear Selection Click to select test ear:
•Right
•Binaural
•Left
Otometrics - MADSEN Astera² 15
10 The Sunshine Panel

Function Icon Description
Transducer Selection Click to select the transducer used for the test ear:
•Insert (earphones)
•Phone (standard headphones)
•High Frequency (headphones)
•Bone (oscillator)
•SF Unaided (Sound Field speaker, unaided)
•SF Aided 1 and SF Aided 2 (Sound field speaker - Aided 1 and 2
•Multispeaker
Masking Transducer
Selection
Click to select the transducer used for the masked ear:
•Insert (earphones)
•Phone (standard headphones)
•High Frequency (headphones)
•Bone (oscillator)
•SF (Sound Field speaker)
•SF Aided 1 and SF Aided 2 (Sound field speaker - Aided 1 and 2)
Masking Options Mask Click to enable or disable masking.
Stimulus Selection Click to select stimulus type.
• Tone (Tone testing)
• Warble (Tone testing)
• FRESH noise (Tone testing)
• Pre-recorded stimulus (Speech)
• Microphone to present live speech stimulus (Speech)
Curve Selection Click to select the curve type:
•THR (Threshold level) (Tone)
•MCL (Most Comfortable Loudness level)
•UCL (Uncomfortable Loudness level)
•SDT (Speech Detection Threshold) (Speech)
•SRT (Speech Recognition Threshold) (Speech)
•WRS/SRS (Word Recognition Score/Sentence Recognition Score) (Speech)
Talk Forward The Talk Forward dialog is described in the MADSEN Astera² Reference
Manual.
16 Otometrics - MADSEN Astera²
10 The Sunshine Panel

Function Icon Description
Monitor/Level •Monitor
Click to enable monitoring of the stimulus channel.
•Level
Adjust the slider to set the preferred monitoring level for the respective
audiometer channels.
Test Selector The Test Selector dialog is described in the OTOsuite User Guide.
11 Proper transducer placement
Headphones
1. Loosen the headband and place both the left and right side of the headphones simultaneously.
Note •If the headphones are not placed properly, there is risk of causing the ear canal to collapse which will result in
elevated thresholds.
2. Aim the center of the headphones towards the patient's ear canals and gently place them against the ears.
3. Tighten the headband while holding the headphones in place with your thumbs.
4. Examine the placement of the headphones to make sure they are level, and properly positioned.
Insert Earphones
Young children tolerate insert earphones better than headphones.
1. Select the largest foam eartip that will fit into the patient's ear.
If the eartip is too small the sound will leak out and the dB level will not be accurate at the eardrum.
Insert earphones have greater attenuation between ears especially at the low frequencies; this reduces the need for
masking.
2. It is best to clip the insert earphone transducers behind the child or on the back of their clothing and then fit the
foam eartip into the child's ears.
Bone Oscillator
Note •For unmasked bone thresholds, you can store binaural data by selecting Binaural bone in the routing section
of the control panel.
Otometrics - MADSEN Astera² 17
11 Proper transducer placement

Mastoid placement
1. Move any hair covering the mastoid out of the way and place the flat round part of the bone oscillator securely on the
boniest portion of the mastoid without any part of the transducer touching the external ear.
2. Make sure the bone oscillator is tight on the mastoid but still comfortable.
3. If you are going to perform masking with earphones, position the other end of the bone oscillator headband over the
patient's temple on the opposite side of the head so that the headband of the earphones and bone oscillator fit on
the patient's head.
Frontal bone placement
1. For frontal bone placement, place the flat round part of the bone oscillator securely on the middle of the forehead
about an inch (2.5 cm) below the hairline.
2. Make sure the bone oscillator is tight on the forehead but still comfortable.
12 Performing tone audiometry
Sunshine Panel
A. Ear selection
B. Stimulus transducer
C. Masking, transducer and On/Off
D. Stimulus type
E. Test type
F. Talk Forward dialog
G. Monitor/Level
H. Test Selector
18 Otometrics - MADSEN Astera²
12 Performing tone audiometry

Classic Control Panel
A. Control Panel
B. Test Options panel
C. Monitor/Level panel
Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the on-
screen controls located at the top of the screen or in the Control Panel to the left.
For detailed examples of audiometric testing, see the MADSEN Astera² Reference Manual.
1. Select the Tone screen in the OTOsuite Audiometry module.
2. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the
patient, you can use the Talk Forward button. You can talk to the patient to adjust the patient communication levels
when Talk Forward is active.
3. In the Control Panel, select test conditions for ear, transducer, unmasked/masked, and test type.
4. Select the test frequency with the Right/Left arrow buttons.
5. Select the stimulus level with the Up/Down arrow buttons.
6. Present the tone with the Stimulus Presentation button.
7. Use the Store button to store the data point and proceed to the next frequency.
8. Repeat steps 4 to 8 until all the measurements you need have been completed. If needed, did you test:
– Both ears
– Air conduction
– Bone conduction
– Masking
– Threshold, MCL and UCL
9. Save the audiogram.
Otometrics - MADSEN Astera² 19
12 Performing tone audiometry

13 Performing speech audiometry
Sunshine Panel
A. Ear selection
B. Stimulus transducer
C. Masking, transducer and On/Off
D. Stimulus type
E. Test type
F. Talk Forward dialog
G. Monitor/Level
H. Test Selector
Classic Control Panel
A. Control Panel
B. Test Options panel
C. Monitor/Level panel
Whenever the test buttons and other functions are used, you can use the corresponding keys on the keyboard, or the on-
screen controls located at the top of the screen or in the Control Panel to the left.
For detailed examples of audiometric testing, see the MADSEN Astera² Reference Manual.
1. Select the Speech screen in the OTOsuite Audiometry module.
2. If needed, click the Scoring and Playing icon to set up word or phoneme scoring.
3. Prepare the patient. If you wish to instruct the patient after you have placed the transducers on the head of the
patient, you can use the Talk Forward button. You can talk to the patient to adjust the patient communication levels
when Talk Forward is active.
4. In the Control Panel, select test conditions for ear, transducer, unmasked/masked, and test type.
5. Select the stimulus level with the Up/Down arrow buttons.
20 Otometrics - MADSEN Astera²
13 Performing speech audiometry