Madsen Astera2

Madsen® Astera²
User Guide
Doc. No.7-50-1350-EN/15
Part No.7-50-13500-EN
Copyright notice
© 2013, 2022 Natus Medical Denmark ApS. All rights reserved. ® Natus, the Natus Icon, Otometrics, the Otometrics 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
2022-10-03 (229075)
Technical service and support
Please contact your supplier.
2 Madsen® Astera²
Table of Contents
1 Device description 4
2 Intended use 4
3 Unpacking 5
4 Installation 5
5 Powering the device 12
6 Connecting Madsen® Astera² to Otosuite 12
7 On-screen controls 13
8 PC keyboard controls 13
9 Toolbar icons in the Audiometry Module 13
10 The Sunshine Panel 15
11 Proper transducer placement 18
12 Performing tone audiometry 20
13 Performing speech audiometry 21
14 Maintenance 24
15 Other references 26
16 Technical specifications 26
17 Definition of symbols 51
18 Warnings, Cautions, and Notes 56
19 Manufacturer 61
Madsen® Astera² 3
1 Device description
1 Device description
Madsen® Astera² is a PC-controlled audiometer for testing a person's hearing.The audiometer is operated from the Oto-
suite Audiometry Module PC software.
Use Madsen® Astera² to perform 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.
Intended Patient Population

The intended patient population is patients in all age groups, who are able to respond to the stimuli.
Clinical Benefit
Madsen® Astera²is 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.
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.
4 Madsen® Astera²
3 Unpacking
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.
To obtain a free printed copy of the user documentation, contact Natus Medical Denmark ApS (www.natus.com).
3 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, 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 during transport.
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 Calibration Certificate to make sure that the transducers (headphones and bone conductor) are the correct
ones, and that they comply with the ordered calibration standards.
4 Installation
Install Otosuite on the PC before you connect Madsen® Astera² to the PC.
For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium.
To mount Madsen® Astera² on the wall or under the desktop, see the Madsen® Astera² Reference Manual.
Warning • 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 the cables.
Madsen® Astera² 5
4 Installation
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.
Connect accessories
See Connecting accessories to Madsen® Astera² ► 10.
Connect the ACP

If you are using the ACP:
See Connecting the ACP to Madsen® Astera² ► 7 and Connecting the ACP to the PC ► 8.
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.
6 Madsen® Astera²
4 Installation
Connecting Madsen® Astera² to Otosuite

• Run the Otosuite Configuration Wizard to connect to and set up communication with Madsen® Astera²: Select Tools >
Configuration Wizard (Tools > Configuration Wizard)
4.1 Connecting the ACP to Madsen® Astera²
Note • Install Otosuite on the PC before you connect Madsen® Astera² to the PC.
1. Remove the cable cover from

Madsen® Astera².
2. Connect the ACP to the Mad-
sen® 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.
Warning • 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.
Madsen® Astera² 7
4 Installation
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.
Note • Install Otosuite on the PC before you connect the ACP to the PC.
Warning • To connect the ACP to the PC, use the supplied USB cable. The cable length must not exceed 3 m
(approx. 10 feet).
Note • 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 :
• ANSI/AAMI ES60601-1 (2005/(R)2012 + A1:2012,C1:2009/(R)2012 + A2:2010/(R)2012) (Medical Elec-
trical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)
• CAN/CSA-C22.2 No. 60601-1:2014 (Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance) - Edition 3 - Revision Date 2014/03
• ES60601-1:2005/(R)2012 and A1:2012
• Medical Electrical Systems clause 16 in IEC 60601-1 (3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-
1:2014
Warning • Any equipment connected with the device or used in the proximity of the patient must
comply with IEC 60601-1-2 and IEC 60601-1.
8 Madsen® Astera²
4 Installation
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, UL 60601-1. The supplementary pro-
visions on the reliability of electro-medical systems.
comply with IEC 60601-1 and IEC 60601-1-2.
Any PC connected to the ACP must comply with the requirements of UL/IEC 62368-1, "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
Warning • 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.
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.
Warning • 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.
Madsen® Astera² 9
4 Installation
4.3 Connecting accessories to Madsen® Astera²
Caution • Install Otosuite on the PC before you connect Madsen® Astera² to 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, UL 60601-1. The supplementary pro-
visions on the reliability of electro-medical systems.
comply with IEC 60601-1 and IEC 60601-1-2.
except for the PC, and equipment connected to the line in and the line out sockets of 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 :
• ANSI/AAMI ES60601-1 (2005/(R)2012 + A1:2012,C1:2009/(R)2012 + A2:2010/(R)2012) (Medical Elec-
trical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)
• CAN/CSA-C22.2 No. 60601-1:2014 (Medical electrical equipment – Part 1: General requirements for
basic safety and essential performance) - Edition 3 - Revision Date 2014/03
• ES60601-1:2005/(R)2012 and A1:2012
• Medical Electrical Systems clause 16 in IEC 60601-1 (3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-
1:2014
comply with IEC 60601-1-2 and IEC 60601-1.
• Except for the PC, and equipment connected to the line in and the line out sockets of Madsen® Astera².
See also Connector warnings ► 56 and General warnings ► 57.

For a detailed description of the connection panel, see the Madsen® Astera² Reference Manual.
Connection panel - Madsen® Astera²

The connections are located at the back of Madsen® Astera².
10 Madsen® Astera²
4 Installation
A. Patient Responders I. Operator desktop microphone

B. Insert earphones J. Talkback microphone
C. Headphones - air conduction K. Assistant monitor headset
D. High frequency headphones - air conduction L. Sound field speakers (power output)
E. Bone conductor M. External power supply
F. Operator monitor headset - headphones N. PC/USB connection
G. Operator monitor headset - boom microphone O. Line-in
H. Operator monitor speaker P. Sound field speakers (line output)
Note • Blue corresponds to Left and red corresponds to Right.
Note • Use only the power supply provided by Natus.
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
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
Madsen® Astera² 11
5 Powering the device
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 provided by Natus.
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, press the ON/OFF button on the front of Madsen® Astera².
Note • To switch off the mains supply, 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 Mad-
sen® 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 con-
nect Madsen® Astera² as follows:
1. Switch on the device.
2. Launch Otosuite.
3. In the Otosuite toolbar, click Control Panel (Control Panel).
4. In the Control Panel, click Connect (Connect).
7 On-screen controls
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 (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
(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 (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.
9 Toolbar icons in the Audiometry Module
Audiometry icons
Tone audiometry
Speech audiometry
Menu item Icon Description
Combined Audiogram Click to toggle between viewing both ears in a single audiogram (com-
(Combined Audiogram) bined audiogram) or both a left and a right audiogram on your screen.
Combined View (Combined View)
• Click to view both ears in a single audiogram.
Split View (Split View)
• Click to view separate audiograms for each ear.
Masking Assistant Enable or disable the Masking Assistant.

(Masking Assistant) The Masking Assistant causes an unmasked threshold to flash
repeatedly if masking is recommended.
Standard Frequencies The graph shows up to 20000 Hz. Madsen® Astera² presents stimulus
(Standard up to 12500 Hz.
Frequencies)/All Fre- • Click to choose between viewing:
quencies (All Fre- Standard Frequencies (Standard Frequencies)
quencies)/ High Displays the audiogram from 125 Hz to 8000 Hz.
Frequencies (High Fre-
quencies)
All Frequencies (All Frequencies)
Displays the audiogram from 125 Hz to 20000 Hz.
High Frequencies (High Frequencies)

Displays the audiogram from 8000 Hz to 20000 Hz.
New Audiogram (New Select new audiogram. You will be prompted to save or cancel current
Audiogram) data.
10 The Sunshine Panel
Menu item Icon Description
Frequency Resolution The options for frequency resolutions are 1/6, 1/12, 1/24 and 1/48
(Frequency Resolution) octave as well as 1 Hz. Select the different tone stimulus resolutions
from the toolbar or from Tools > Options > Audiometry > General
(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 (Mon- Enables or disables the monitor speaker for monitoring stimuli presen-
itoring) ted to the patient from the Stimulus (Stimulus) or Masking (Masking)
channel.
Desktop/Headset Toggle microphone types (Toggle microphone types)

Microphone Click to toggle between the operator headset boom microphones and
(Desktop/Headset desktop microphone used to communicate with the patient and/or the
Microphone) assistant. The one displayed is the one currently active.
Enable Talk to Assist- Click to enable or disable talking to another party (usually a second
ant (Enable Talk to tester) in the booth.
Assistant)
Talk Forward (Talk For- Enables communicating with the patient in the sound booth. This will
ward) display the Talk Forward (Talk Forward) dialog box, where you can con-
trol the talk forward 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
(Select Orientation) screen for graph and table views.
You can also select the location of the stimulus control.
Sunshine Panel (Sun- When you have enabled the Control Panel icon on the toolbar, you can
shine Panel) choose between using the Classic Control Panel and the Sunshine
Panel.
Live Video Otoscopy Click to launch a Live Video Otoscopy.

Click the Control Panel (Control Panel) icon in the toolbar to activate the Control Panel.
Click the Sunshine Panel (Sunshine Panel) icon in the toolbar to select or deselect the Sunshine Panel in
either Tone (Tone) or Speech (Speech) testing.
Tone testing Speech testing

Use the Sunshine Panel to quickly select the main settings for testing.
In the Sunshine Panel you can quickly select test ear, transducer, masking,
and test type.
You can control the monitor level, activate the Talk Forward (Talk For-
ward) dialog, and select the Test Selector (Test Selector) for quickly
selecting the relevant user test.
Your selections are shown in the Stimulus (Stimulus) bar and as symbols
in the audiogram.
See also
• Performing tone audiometry ► 20
• Performing speech audiometry ► 21.
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 (Add/Remove buttons) you can cus-
tomize the setup.
1. Enable/disable the button(s) you wish to display.
2. Click to disable the selection Use Single Button (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:

(Stimulus Ear Selec- • Right (Right)
tion)
• Binaural (Binaural)
• Left (Left)
Transducer Selection Click to select the transducer used for the test ear:
(Transducer Selection) • Insert (Insert) (earphones)
• Phone (Phone) (standard headphones)
• High Frequency (High Frequency) (headphones)
• Bone (Bone) (conductor)
• SF Unaided (SF Unaided) (Sound Field speaker, unaided)
• SF Aided 1 (SF Aided 1) and SF Aided 2 (SF Aided 2) (Sound field speaker -
Aided 1 and 2
• Multispeaker (Multispeaker)
Masking Transducer Click to select the transducer used for the masked ear:
Selection (Masking • Insert (Insert) (earphones)
Transducer Selection)
• Phone (Phone) (standard headphones)
• High Frequency (High Frequency) (headphones)
• Bone (Bone) (conductor)
• SF (SF) (Sound Field speaker)
• SF Aided 1 (SF Aided 1) and SF Aided 2 (SF Aided 2) (Sound field speaker -
Aided 1 and 2)
Masking Options Mask Click to enable or disable masking.

(Masking Options) (Mask)
Stimulus Selection Click to select stimulus type.

(Stimulus Selection) • Tone (Tone testing)
• Warble (Tone testing)
• FRESH noise (Tone testing)
• Pre-recorded stimulus (Speech)
• Microphone to present live speech stimulus (Speech)
11 Proper transducer placement
Function Icon Description
Curve Selection (Curve Click to select the curve type:

Selection) • THR (THR) (Threshold level) (Tone)
• MCL (MCL) (Most Comfortable Loudness level)
• UCL (UCL) (Uncomfortable Loudness level)
• SDT (SDT) (Speech Detection Threshold) (Speech)
• SRT (SRT) (Speech Recognition Threshold) (Speech)
• WRS/SRS (WRS/SRS) (Word Recognition Score/Sentence Recognition
Score) (Speech)
Talk Forward (Talk For- The Talk Forward (Talk Forward) dialog is described in the Madsen® Aster-
ward) a²Reference Manual.
Monitor/Level (Mon- • Monitor (Monitor)

itor/Level) Click to enable monitoring of the stimulus channel.
• Level (Level)
Adjust the slider to set the preferred monitoring level for the respective
audiometer channels.
Test Selector (Test The Test Selector (Test Selector) dialog is described in the OtosuiteUser
Selector) Guide.

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
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 sound 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 Conductor
Note • For unmasked bone thresholds, you can store binaural data:
If there is a difference of 10 dB or greater between the bone conduction threshold and the air conduction threshold of
the same ear, masking is needed. The Masking Assistant can assist you in determining which thresholds need to be
masked.
If the SRT of the test ear and the bone conduction PTA of the nontest ear differ by 45 dB or more, masking is needed.
Mastoid placement
1. Move any hair covering the mastoid out of the way and place the flat round part of the bone conductor securely on
the boniest portion of the mastoid without any part of the transducer touching the external ear.
2. Make sure the bone conductor 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 conductor headband over the
patient's temple on the opposite side of the head so that the headband of the earphones and bone conductor fit on
the patient's head.
Forehead placement
1. For frontal bone placement, place the flat round part of the bone conductor securely on the middle of the forehead
about an inch (2.5 cm) below the hairline.
2. Make sure the bone conductor is tight on the forehead but still comfortable.
12 Performing tone audiometry
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
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 (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 (Talk Forward) button. You can talk to the patient to adjust the patient com-
munication levels when Talk Forward (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 (or on keypad).
5. Select the stimulus level with the Up/Down arrow buttons (or on keypad).
6. Present the tone stimulus with the Present (Present) button or the space bar on the keypad.
13 Performing speech audiometry
7. Use the Store (Store) button (the S key on the keypad) to store the data point and proceed to the next frequency.
8. Repeat steps 4 to 7 until all the measurements you need have been completed. If needed, did you test:
– Both ears
– Air conduction
– Bone conduction
– Masking (Mask (Mask) button or M on the keypad
– Audiogram threshold, MCL (MCL) and UCL (UCL)
9. Save the audiogram.
Note • If you are using white noise instead of the recommended narrow band noise in pure tone masking, see Mad-
sen® Astera² ► 26

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 (Speech) screen in the Otosuite Audiometry module.
2. If needed, click the Scoring and Playing (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 (Talk Forward) button. You can talk to the patient to adjust the patient com-
munication levels when Talk Forward (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 (or on keypad).
6. Select speech input signals.
You can choose from either microphone input or recorded input source. Combining recorded Source A (Source A) and
Source B (Source B) as Input (Input) sources in the Test Options (Test Options) section of the Control Panel (Control
Panel) will replace the audiometer speech masking with a recorded input.
7. Select your speech input from the right-click menu in the control panel.
– Int. CD (Int. CD) (CD material in CD/DVD drive)
– () (integrated Otosuite Speech Material or regular sound files)
– Line In (Line In) (analog input from external sound players, e.g. CD, MD, MP3 or cassette recorders connected to
the audiometer via the Line In (Line In) input).'
Note • If an external playback device is used to generate speech stimuli via the line input, take to ensure that the
player has a flat frequency response in the range 125 Hz to 6300 Hz. The maximum allowable deviation from the
average response level is +/-1 dB; the average response level should be measured over the range 250 Hz to 4000
Hz.
The headset microphone should be turned to a position just below the operator’s mouth.
If an external playback device is used to generate speech stimuli via the line input of Madsen® Astera², only a
high quality CD player or similar device should be used; tape recordings may not provide a sufficient signal to
noise ratio. Preferably, the external device should deliver its output via a fixed-level line out connector. The input
gain on Madsen® Astera² should be adjusted to obtain a 0 dBVU reading when the calibration signal is played by
the external device.
8. You can find speech material files in the File/track/list selection (File/track/list selection) drop-down list.
Note • You should only use speech materials with a stated relationship between the level of the speech signal and
the calibration signal.
Speech materials delivered on CD or other media are normally accompanied by a description of this relationship.
You should follow the instructions supplied with the speech materials, using the VU-meter in Otosuite for adjust-
ment of input gain
If you are using built-in speech materials supplied with Otosuite, the speech levels have been adjusted according
to the original speech material instructions.
Note • Speech signals are calibrated in dB HL.
If you are using an integrated word list, the word list is shown on the screen.
9. Present the word lists with the Play (Play) button.
10. Use the Correct (Correct) (+) and Incorrect (Incorrect) (-) buttons or click directly on the
key word to score.
11. Store the current data as the result, either by clicking Store (Store) in the highlighted
field, or by pressing (S (S)) on the keyboard.
12. Repeat until all the measurements you need have been completed.
Dosimeter
A dosimeter is built into Madsen® Astera². If you are using live speech, it will be working in the background as a safety pre-
caution. The system monitors the sound level versus duration of exposure(1).
14 Maintenance
If the patient is exposed to excessive levels of noise during the session, the system will interrupt the signal and display a
warning.
(1)Noise Exposure: Explanation of OSHA and NIOSH Safe. Exposure Limits and the Importance of Noise Dosimetry by Pat-
ricia A. Niquette, AuD, Etymotic Research Inc.
14 Maintenance
Madsen® Astera² requires regular maintenance to continue operating as designed. This includes visual inspection, clean-
ing, and calibration. If the equipment shows signs of damage or material degradation, do not use the device and contact
your supplier.
Warning • Do not disassemble Madsen® Astera². Contact your supplier. Parts inside Madsen® Astera² must only
be checked or serviced by authorized personnel.
14.1 Service
Warning • For the sake of safety and in order not to void the warranty, service and repair of electro-medical
equipment should be carried out only by the equipment manufacturer or by service personnel at authorized work-
shops. In case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a
defective device.
14.2 Cleaning
There are no specific requirements to sterilization or disinfection of the device.
Caution • Device and accessories shall be cleaned between every patient use
The device
• Remove dust using a soft brush.
• Use a soft, slightly damp cloth with a small amount of mild detergent.
Warning • Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can
damage the instrument and it may result in a risk of electrical shock to the user or patient.
Accessories
• Headphones and bone conductors
14 Maintenance
Use a non-alcohol based wipe (e.g. Audiowipe) to clean the headphones and bone conductor between patients.
• Eartips for Insert Earphones
The eartips are single use and should be disposed of after use.
• Bone conductor (BC-2)
Clean the bone conductor(BC-2) between patients with a disinfectant wipe for hearing systems, earmolds, or spec-
tacles (e.g. Cedis disinfectant wipes).
Disposal
There are no special requirements for the disposal of eartips, i.e. they can be discarded according to local regulations.
14.3 Calibration
Annual calibration
The audiometer, headphones, bone conductors, and sound field speakers must be calibrated once a year by your author-
ized service department.
Remote calibration
You can order a transducer and get the calibration data installed via remote support. The calibration data is included in
your shipment on a USB memory stick (or supplied by technical support during the installation).
To import calibration data:
1. Connect the new transducer to your audiometer.
2. Connect the audiometer to your Otosuite PC.
3. Insert the USB memory stick in an empty slot on your PC.
4. Call your Natus technical support team. They will use the application TeamViewer to ensure correct remote install-
ation of the new calibration data on your system.
TeamViewer is located at Help (Help) > Remote support (Remote support).
The technician installs the calibration data via the menu function Tools (Tools) > Audiometer service (Audiometer ser-
vice). The data is password protected.
5. When the installation has ended, hold the new transducer within hearing distance and cautiously perform a listening
check.
The purpose of the check is to ascertain that the transducer is functioning correctly (without wrong or excessive sound
levels), not to verify the exact calibration.
Caution • Note that calibration has been performed only on the transducers supplied. If you wish to use any other
transducer for testing with the device, please contact your local distributor first.
14.4 Conformity to loudspeakers or other components

Usage of loudspeakers and other transducers not provided with the audiometer, requires calibration of the system for con-
formity to meet applicable audiometer standards.
Please consult your local distributor.
15 Other references
15 Other references
Note • For more information, see the online Help in Otosuite, which contains detailed reference information about
Madsen® Astera² and the Otosuite modules.
Note • For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium.
For Troubleshooting information, refer to the Madsen® Astera² Reference Manual.
16 Technical specifications
16.1 Madsen® Astera²
Type identification
Madsen® Astera² is type 1066 from Natus Medical Denmark ApS.
Channels
Two separate and identical channels
Frequency range
TDH39 earphones: Standard frequencies: 125 Hz - 12500 Hz

High frequency headphones: Standard frequencies: 125 Hz - 20000 Hz
Insert headphones: Standard frequencies: 125 Hz - 8000 Hz
BC: Standard frequencies: 250 Hz - 8000 Hz
SF: Standard frequencies: 125 Hz - 20000 Hz
Tone accuracy: > 0.03%
FRESH noise stimulus: Available in entire frequency range within the transducer specified range.(For
SF 125 Hz - 12500 Hz). Accuracy 0.3%
Narrow Band Noise masking: Available in entire frequency range
Frequency resolution: 1/48, 1/24, 1/12, and 1/6 oct, 1 Hz step
Stimulus types
• Tone
• Warble
• Pulsed tone
• Pulsed warble
• FRESH noise Frequency-specific hearing assessment noise.
Consists of noise bands, with frequency-specific filter width.
The FRESH noise is filtered to obtain very steep slopes outside the passband.
• Pulsed FRESH noise
Masking types
• Narrow Band Noise

– AC and BC Correlated
– SF Non-correlatedA
• Speech Weighted Noise

• White Noise (Wide band noise)

A. A maximum of 3 non-correlated simultaneous masking signals.
White noise for Pure Tone masking

Conversion between displayed “effective masking level” and sound pressure level.
The level of white noise used for masking of pure tones is indicated in dB of “effective masking level” in Otosuite. This
means that the sound pressure level of the power contained in a third-octave band around the presented pure tone fre-
quency will equal the attenuator setting, plus the RETSPL at the pure tone frequency, plus the noise correction factor
from ISO 389-4:1994, Table 1.
The following tables can be used to calculate the actual sound pressure level of the white noise signal for a given atten-
uator setting (Table 1), or to select the attenuator setting required to obtain a specific level in dB SPL (Table 2).
Note: As the sound pressure level of the white noise signal will be quite high even for moderate attenuator settings, a
warning sign will be displayed in Otosuite for levels above 100 dB HL.
Table 1 - Offset from Effective Masking Level to Sound Pressure Level
Frequency (Hz) 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 9000 10000 11200 12500
Offset (dB) N/A* 53 37 32 31 29 30 29 27 31 27 26 26 25 25
This table indicates the number (“Offset”) to be added to the displayed masking level in order to calculate the sound pres-
sure level in dB SPL.
* White masking noise is not available at 125 Hz
Table 2 - Attenuator settings required to obtain a white noise level of 80 dB SPL
Frequency (Hz) 125 250 500 750 1000 1500 2000 3000 4000 6000 8000 9000 10000 11200 12500
Attenuator setting to N/A* 27 43 48 49 51 50 51 53 49 53 54 54 55 55

obtain 80 dB SPL
This table indicates the attenuator settings required to obtain a sound pressure level of 80 dB SPL at indicated frequencies.
Stimulus modulation
FM (Warble): Adjustable modulation rate and depth

• Modulation rate: 1Hz -20 Hz (default: 5 Hz).
• Modulation depth: 1-25% of center frequency (default: 5%).
SISI: 5, 2, 1 dB increments
Accuracy of sound level
Entire level range (AC): 125 Hz to 5000 Hz: ±3 dB

5000 Hz to 20000 Hz: ±5 dB
Entire level range (BC): 250 Hz to 5000 Hz: ±4 dB
5000 Hz to 8000 Hz: ±5 dB
Level resolution
1, 2, or 5 dB step resolution over the entire range
HL Range
Maximum output will be limited by the transducer.

AC: -10 dB HL to 120 dB HL (500 Hz to 4000 Hz; supra-aural earphones)
AC HF: -10 dB HL to 110 dB HL (500 Hz to 4,000 Hz; circumaural earphones)1, 2
BC: -10 dB HL to 80 dB HL (1500 Hz to 3000 Hz; mastoid placement)

SF: 103 dB HL (Note: with external amplifier)
1 Due to the frequency response of the Sennheiser HDA300 headphones, the system does not fulfill the maximum output
level above 6 kHz for Type 1 audiometers regarding IEC 60645-1:2017 and ANSI/ASA S3.6-2018. Note: This is only the case
with this specific headphones.
2 The output of DD450 High Frequency Headphones is as follows:
1) IEC 60645-1 / ANSI 3.6 Type 1: 125 Hz to 8 kHz, minimum HL Range 107 dB HL at 4 kHz;
2) EN 60645-1 / ANSI 3.6 Type 1 EHF: 8 kHz to 16 kHz, minimum HL Range 55 dB at 16 kHz; otherwise as stated in IEC
60645-1 / ANSI 3.6 Table 2 for Type 1 circumaural earphones.
All Audiometry Headphones
Headphone Madsen Astera2

HB-7 Air, Supra-aural Type 1 Class B
HB-8 Air, Supra-aural - -

ME70 Air, Supra-aural + noise isolation Type 1 Class B
Inserts Air, Inserts Type 1 Class B
HDA 300 Air, Circumaural Type 1 Class B
DD450 Air, Circumaural Type 1 Class B
B71 Bone vibrator (Mastoid/Forehead) Type 1 Class B
BC-1 Bone vibrator (Mastoid/Forehead) Type 1 Class B
bc-2 Bone vibrator (Mastoid/Forehead) Type 1 Class B
Pure Tone HL for Madsen Astera 2

Typical Pure Tone HL for Madsen Astera 2 – Standard Range
Frequency 125 250 500 750 1000 1500 2000 3000 4000 6000 8000
HB-7 85 105 120 120 120 120 120 120 120 118 107
ME70 85 105 120 120 120 120 120 120 120 118 107
HDA 300 70 90 110 110 110 110 110 110 110 100 81
DD450 70 90 110 110 110 110 110 110 107 100 90
B71 - 51 75 77 80 80 80 80 78 58 45
BC-1 - 51 75 77 80 80 80 80 78 58 45
BC-2 - 51 75 77 80 80 80 80 78 58 45
Typical Pure Tone HL for Madsen Astera 2 – Above Standard Range
Frequency 9000 10000 11200 12500 14000 16000 18000 20000

HB-7 70 70 70 70 - - - -
ME70 70 70 70 70 - - - -
HDA 300 68 81 81 70 64 44 18 -5
DD450 90 90 80 70 70 55 30 5
Reference Equivalent Threshold Levels

The maximum hearing level settings provided at each test frequency including limitations in use due to harmonic dis-
tortion are defined in the tables below.
ANSI Calibration
Calibration table according to ANSI S3.6-2018
TDH39 HDA200, Bone Bone NBN
TDH 39 HDA300 Insert Insert Spkr Spkr Spkr Spkr. Spkr.
Frequency IEC DD450 Mastoid Forehead Offset
303/9A1 31813 3 HA24 7114 0°5 45°5 90°5 135°8 180°8 6
3181 3182 3
125 45.0 45.0 30.5 26.213 - - 26.0 28.0 24.0 23.5 23.0 23.2 23.4 4.0
160 37.512 38.5 26.012 24.0 - - 22.0 24.5 20.0 19.0 18.5 19.1 19.0 4.0
200 31.512 32.5 22.012 22.1 - - 18.0 21.5 16.5 15.5 15.0 15.4 16.7 4.0
250 25.5 27.0 18.0 20.113 67.0 79.0 14.0 17.5 13.0 12.0 11.0 11.7 13.5 4.0
315 20.012 22.0 15.512 16.3 64.0 76.5 12.0 15.5 10.5 9.0 8.0 8.9 9.8 4.0
400 15.012 17.0 13.512 12.3 61.0 74.5 9.0 13.0 8.0 5.5 4.5 5.6 8.7 4.5
500 11.5 13.5 11.0 8.613 58.0 72.0 5.5 9.5 6.0 3.0 1.5 2.9 6.6 5.0
630 8.512 10.5 8.012 6.6 52.5 66.0 4.0 7.5 4.5 1.0 -0.5 0.9 4.8 5.5
750 8.0 9.0 6.0 5.113 48.5 61.5 2.0 6.0 4.0 0.5 -1.0 0.2 3.9 6.0
800 7.012 8.5 6.012 4.6 47.0 59.0 1.5 5.5 4.0 0.5 -1.0 -0.1 3.6 6.0
1000 7.0 7.5 5.5 2.713 42.5 51.0 0.0 5.5 4.0 0.0 -1.5 -1.0 2.2 6.5
1250 6.512 7.5 6.012 3.0 39.0 49.0 2.0 8.5 3.5 -0.5 -2.5 -2.4 1.2 7.0
1500 6.5 7.5 5.5 3.213 36.2 47.5 2.0 9.5 2.0 -1.0 -2.5 -2.1 1.1 7.0
1600 7.012 8.0 5.512 2.6 35.5 46.5 2.0 9.5 2.0 -1.5 -2.5 -2.0 0.7 7.0
2000 9.0 9.0 4.5 0.513 31.0 42.5 3.0 11.5 0.5 -2.5 -1.5 0.1 2.1 7.0
2500 9.512 10.5 3.012 -0.7 29.5 14.5 5.0 13.5 -2.0 -5.5 -4.0 -0.1 0.6 7.0
3000 1.0 11.5 2.5 -1.613 30.0 42.5 3.5 13.0 -4.0 -9.0 -6.5 -2.2 -1.5 6.5
3150 10.012 11.5 2.512 -1.6 31.0 42.5 4.0 13.0 -4.5 -9.5 -6.5 -1.7 -1.2 6.5
4000 9.5 12.0 9.5 0.113 35.5 43.5 5.5 15.0 -4.5 -8.5 -4.0 0.7 0.5 6.0
5000 13.012 11.0 14.0 11.313 40.0 51.0 5.0 18.5 -1.0 -7.0 -5.0 2.8 3.5 6.0
6000 15.5 16..0 17.0 20.913 40.0 51.0 2.0 16.0 4.5 -3.0 -5.0 2.8 9.6 6.0
6300 15.012 21.0 17.512 21.3 40.0 50.0 2.0 16.0 6.0 -1.5 -4.0 2.7 10.8 5.5
8000 13.0 15.5 17.5 23.113 40.0 50.0 0.0 15.5 13.5 8.0 5.5 9.7 17.3 5.5
9000 13.010 15.5 18.5 27.113 - - - - 15.5 10.5 8.5 12.2 19.9 5.511
10000 13.010 15.5 22.0 18.513 - - - - 15.5 11.0 9.5 11.5 19.5 5.511
11200 13.010 15.5 23.0 22.913 - - - - 14.0 10.0 7.0 10.7 19.1 5.511
12500 13.010 15.5 28.0 27.013 - - - - 13.0 11.5 5.0 10.0 18.7 5.511
- - - - - - - - - - - - - - -
Speech 19.5 20.0 19.0 15.214 55.0 63.5 12.5 18.0 16.5 12.5 11.0 12.0 15.0 -
Speech
19.5 20.0 19.0 15.214 55.0 63.5 12.5 18.0 16.5 12.5 11.0 12.0 15.0 -
noise7
Notes:
1. From ANSI S3.6: 2018 Table 5.
5. From ANSI S3.6: 2004, Table 9 (monaural listening in sound field).
6. From ANSI S3.6: 2018 Table 4, average of correction values for one-third / one-half octave BW.
7. ANSI S3.6 2018: Section 7.4.1: SPL values of speech noise to obtain 0dB effective masking.
8. Derived by Otometrics.
9. Copy of 8kHz value.

12. Copy from IEC60645.
13. From Sennheiser, HDA 300 Instruction Manual, Intermediate frequencies are logarithmically interpolated.
14. ANSI S3.6: 2018, Section 6.2.12, (Tone 1 kHz = 2.7 dB + 12.5 dB)
IEC Calibration
Calibration table according to IEC60645
Bone
TDH 39 ME- TDH39/ME- HDA200, HDA300 Insert Insert Spkr Spkr Spkr NBN
Frequency Mastoid
70 3031 70/PD-95 31811 DD450 3182 31812 3 IEC126 4 IEC7114 0°5 45°9 90°9 Offset6
125 45.0 45.0 30.5 26.212 - 26.0 28.0 22.0 23.5 23.0 4.0
250 25.5 27.0 18.0 20.112 67.0 14.0 17.5 11.0 12.0 11.0 4.0
500 11.5 13.5 11.0 8.612 58.0 5.5 9.5 4.0 3.0 1.5 5.0
750 8.0 9.0 6.0 5.112 48.5 2.0 6.0 2.0 0.5 -1.0 6.0
1000 7.0 7.5 5.5 2.712 42.5 0.0 5.5 2.0 0.0 -1.5 6.5
1500 6.5 7.5 5.5 3.212 36.2 2.0 9.5 0.5 -1.0 -2.5 7.0
2000 9.0 9.0 4.5 0.512 31.0 3.0 11.5 -1.5 -2.5 -1.5 7.0
3000 1.0 11.5 2.5 -1.612 30.0 3.5 13.0 -6.0 -9.0 -6.5 6.5
4000 9.5 12.0 9.5 0.112 35.5 5.5 15.0 -6.5 -8.5 -4.0 6.0
6000 15.5 16..0 17.0 20.912 40.0 2.0 16.0 2.5 -3.0 -5.0 6.0
8000 13.0 15.5 17.5 23.112 40.0 0.0 15.5 11.5 8.0 5.5 5.5
9000 13.010 15.5 18.5 27.112 - - - 13.5 10.5 8.5 5.5
10000 13.010 15.5 22.0 18.512 - - - 13.5 11.0 9.5 5.5
11200 13.010 15.5 23.0 22.912 - - - 12.0 10.0 7.0 5.5
12500 13.010 15.5 28.0 27.012 - - - 11.0 11.5 5.0 5.511
- - - - - - - - - - - -
20.0 20.0 20.0
Speech 208 20.0 19.09 20.013 55.08 12.59 18.09 13 13 13 -
Speech 20.0 20.0 20.0

20 20.0 19.0 20.013 55.0 12.5 18.0 13 13 13 -
noise
Notes:
1. ISO-389-1:1998, Table 1
2. ISO389-8:2004 and ISO/TR389-5:1998, Table 1
3. ISO 389-3:1994, Table 1
4. ISO389-2:1994, Table 1
5. ISO389-7:1996, Table 1 (free-field, frontal incidence)
6. ISO389-4:1994, Table 1
7. Derived by Otometrics.
8. IEC60645-2, Section 9: SPL produced when ref signal causes 0dBVU.
9. From ANSI S3.6.

10. Copied from 8kHz.
11. From ISO 389-1:1998, Table 2
12. From Sennheiser, HDA 300 Instruction Manual, Intermediate frequencies are logarithmically interpolated. 13. IEC
60645-2:1997, section 9
White noise for speech masking
Power adjusted to obtain effective masking in the frequency range 125-1000 Hz. RETSPL for white masking noise equals
speech RETSPL plus 11.4dB.
White noise for tone masking
Power adjusted to obtain effective masking in a third octave around tone frequency. RETSPL varies with frequency.
Standard reference sound pressure level for speech
The audiometer provides speech material with reference sound pressure level capabilities of 12.5 dB above the 1000 Hz at
standard RETSPL.
The audiometer can calibrate the signal to bring the indicator of the monitoring meter to its zero reference point and the
hearing level control is set for 0 HL.
The audiometer can provide the sound pressure level produced by the earphone equal to the standard reference equi-
valent sound pressure level for the speech recognition threshold
Refer to the "Saving source levels for speech material" in the Madsen® Astera² Reference Manual to learn how to adjust
the level.
Total harmonic distortion
Air < 2.5 %

Bone < 5 %
Selectable transducers
AC, AC HF: TDH39, High frequency headphones, and Insert Earphones

BC: Bone conductor (Mastoid / Forehead)
SF: • Passive sound field speaker, using the built-in amplifier in Madsen®
Astera², or
• Sound field speaker with built-in amplifier or external amplifier, with both
types using the line output from Madsen® Astera².
Transducer options depend on how Madsen® Astera² is ordered and calibrated.
Sound attenuation values for earphones
Frequency Attenuation
TDH39 with EAR 3A HDA300 DD450

MX41/AR cushion
(Hz) (dB) (dB) (dB) (dB)
Sound attenuation values for earphones
63 - - 12.5 -
125 3 33 12.5 15
160 4 34 - 15
200 5 35 - 16
250 5 36 12.7 16
315 5 37 - 18
400 6 37 - 20
500 7 38 9.4 23
630 9 37 - 25
750 - - - -
800 11 37 - 27
1000 15 37 12.8 29
1250 18 35 - 30
1500 - - - -
1600 21 34 - 31
2000 26 33 15.1 32
2500 28 35 - 37
3000 - - - -
3150 31 37 - 41
4000 32 40 28.8 46
5000 29 41 - 45
6000 - - - -
6300 26 42 - 45
8000 24 43 26.2 44
Outputs
AC: 3 x 2 mono jacks, 1/4 "

BC: 2 x mono jacks, 1/4 "
SF power output: 5 x terminals,
5 x 40 W peak, 8Ω load
SF line output: 3 x mini XLR 6 pin
5 x +6 dBu, balanced
External inputs
CD/Analog line in: 0.2 to 2.0 Vrms, 10 kΩ 2 x RCA phone

Talk Back microphone: • Electret microphone
• Input voltage: 0.002 to 0.02 Vrms
• Input resistance: 2.21 kΩ.
• 3.5 mm jack
Inputs/Outputs
Nominal Imped-
Inputs - Madsen Astera2 Voltage range Sensitivities* Connectors
ance
A. Patient Responders 20 kW 3.3 V N/A 2 x mono jacks, 1/4 "
G. Operator monitor headset - boom 0.002 to 0.02 Adjustable in Oto-
2.21 kW 3.5 mm jack
microphone Vrms suite
0.002 to 0.02 Adjustable in Oto-
I. Operator desktop microphone 2.21 kW 3.5 mm jack
Vrms suite
0.002 to 0.02 Adjustable in Oto-
J. Talkback microphone 2.21 kW 3.5 mm jack
Vrms suite
DC Power Jack 2mm
M. External power supply N/A 24 V N/A
RAPC722X
Adjustable in Oto-
O. Line-in >10 kW 0.2 to 2.0 Vrms 2 x RCA phone
suite
Load imped- Available

Outputs - Madsen Astera2 Connectors
ance voltage
Option depend-
B. Insert earphones Calibrated output 2 x mono jacks, 1/4 "
ent
Option depend-
C. Headphones - air conduction Calibrated output 2 x mono jacks, 1/4 "
ent
D. High-frequency headphones - air Option depend-
Calibrated output 2 x mono jacks, 1/4 "
conduction ent
Option depend-
E. Bone oscillator Calibrated output 2 x mono jacks, 1/4 "
ent
F. Operator monitor headset - head- Adjustable in Oto-
40 mW 16Ω 3.5 mm jack
phones suite
Adjustable in Oto- 3.5 mm jack, Connected between tip and ring,
H. Operator monitor speaker 1.5W 8Ω
suite sleeve floating
Adjustable on
K. Assistant monitor headset 40 mW 16Ω 3.5 mm jack
headset
L. Sound field speakers (power out- 40 W peak, 8Ω
Calibrated output 5 x terminals
put) load
P. Sound field speakers (line output) <600 W +6 dBu, balanced 3 x mini XLR 6 pin
PC Communication - Madsen Astera2 Connectors

N. PC/USB connection USB Type-B
For additional detail refer to Reference Manual Technical Specifications
Stimulus presentation
Normal: The signal is presented when the Stimulate button is pressed.

Continuous ON: The signal is interrupted when the Stimulate button is pressed.
Pulse: The signal is pulsed.
Pulse duration: 225 ms on and 225 ms off (default).
Operator accessories
Operator monitor speaker • 1.5W 8Ω , connected between tip and ring, sleeve floating
• 3.5 mm jack
Operator monitor headset - headphones • 40 mW 16Ω
• 3.5 mm jack
Operator monitor headset - boom micro- • Electret microphone
phone • Input voltage: 0.002 to 0.02 Vrms,
• 3.5 mm jack
Operator desktop microphone • Electret microphone
• Input voltage: 0.002 to 0.02 Vrms,
• 3.5 mm jack
Assistant monitor headset • 40 mW 16Ω
• 3.5 mm jack
Static force of transducer headbands
TDH 39: 4.5 N ±0.5 N

Bone vibrator: 5.4 N ±0.5 N
High frequency headphones: 10 N ±0.5 N
USB interface
Connector Type: USB Type B (Astera2), USB Type A (PC)

Interface: USB 1.1 (compatible with USB 2.0, USB 3.0, USB 3.1 and USB 3.2 per
www.USB.org)
Transport and storage
Temperature: -30°C to +60°C (-22°F to 140°F)

Air humidity: 10% to 90%, non-condensing
Air pressure: 50 kPa to 106 kPa
Operating environment
Mode of operation: Continuous

Temperature: +15°C to +35°C (59°F to 95°F)
Air pressure: 70 kPa to 106 kPa
Note • Recalibrate device if used in low air pressure.
(Operation in temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage.)
Warm-up time
< 5 min.
Note • Should be extended if Madsen® Astera² has been stored in a cold environment.
Disposal
Madsen® Astera² can be disposed of as normal electronic waste, according to WEEE and local regulations.
Dimensions
Approx. 325 x 255 x 60 mm (12.8 x 10 x 2.4 inches)
Weight
Approx. 1.3 kg (2.85 lb)
Power supply
External power supply, types:

Delta Electronics, Inc. Output: 24 V DC, 3.75 A
MDS-090AAS24 Input: 100-240 V AC, 50-60 Hz, 1.5 A - 0.75 A
Patient Safety when used with the specified power supply, Delta Electronics,
Inc., type MDS-090AAS24:
• Complies with ES60601-1:2005/(R)2012 and A1:2012
• CAN/CSA C22.2 NO 60601-1-14:2014
• IEC 60601-1:2005/A1:2012
• ES60601-1:2005/(R)2012 and A1:2012
• EMC: IEC 60601-1-2:2014
• IEC 60601-1 Class I, Type B
XP Power Output: 24 V DC, 3.33 A max
PCM80PS24 Input: 100-240 V AC, 47-63 Hz, 1.1 A - 0.45 A
Patient Safety when used with the specified power supply, XP Power, type
PCM80PS24:
• Complies with IEC 60601-1, Class 1, Type B; UL 60601-1.
Power consumption
< 90 VA
Essential performance
Madsen® Astera² has no essential performance.
Standards
Audiometer: EN 60645-1:2017 Type 1, Class B, IEC 60645-1:2017, and ANSI S3.6:2018

Patient Safety: Patient Safety when used with the specified power supply, Delta Electronics,
Inc., type MDS-090AAS24:
• Complies with ES60601-1:2005/(R)2012 and A1:2012
• CAN/CSA C22.2 NO 60601-1-14:2014
• IEC 60601-1:2005/A1:2012/A2:2020
• ES60601-1:2005/(R)2012 and A1:2012
Patient Safety when used with the specified power supply, XP Power, type
PCM80PS24:
• Complies with IEC 60601-1, Class 1, Type B; UL 60601-1.
EMC: IEC 60601-1-2:2007 and EN 60601-1-2:2007
IEC 60601-1-2:2014/A1:2020 and EN 60601-1-2:2015/A1:2021
16.2 Unwanted sound from a Bone Vibrator and Bone Conductor

Natus Bone Conductors and Bone Vibrators are considered equivalent to the clinical studies performed by Tom Frank et al.
under Acoustic Radiation from Bone Vibrators, Tom Frank and Alice Holmes. Ear and Hearing copyright 1981 by The Wil-
liams & Wilkins Co. Vol.2, No. 2.
In their studies, the thresholds were obtained with a Radioear B-70A, and B-71 vibrators when the subject's ear canal was
un-occluded and occluded.
The highest level of acoustic radiation corresponded to the third resonance of the vibrator which occurred at approx-
imately 5000 Hz for the B-70A and 3700 Hz for the B-71. Results of both studies indicate that the B-70A and B-71 at tested
frequencies produced minimal acoustic radiation.
Bell et al. estimated the influence of acoustic radiation by measuring the difference between un-occluded and occluded
BC thresholds at 4000 Hz on 10 normal-hearing subjects. The mean threshold difference due to acoustic radiation was less
than 3 dB.
Table 1 - Natus Bone Conductors (BC) / Vibrators
B-71 BC-1 BC1 BC-2

Standard frequencies
8522252 8-75-50000 1-25-01200 041545
Astera2 250 Hz - 8000 Hz Yes Yes N/A Yes
Table 2 - Difference of occluded to un-occluded on 10 subjects at 4000Hz
Subject 1 2 3 4 5 6 7 8 9 10 Mean
B-70A (dB) -4.0 1.0 -2.5 -3.0 -2.5 1.5 11.5 -1.5 3.0 -8.0 -0.5
B-71 (dB) 9.0 -0.5 1.5 -4.5 13.0 -1.0 -9.0 9.0 0.5 -11.5 0.7
16.3 Frequency Response Speech Signal

For a constant voltage in the frequency range from 250 Hz to 4000 Hz, the sound pressure level for headset shall not differ
by more than +/- 4 dB (ANSI +/- 3 dB) from the average sound pressure level. Below 250 Hz the acceptance limit is +4/-11
dB (ANSI +0/- 10 dB). Above 4 kHz the acceptance limit is +4/-6 dB (ANSI +/- 5 dB).
16.4 Frequency response of Bone Vibrators and Bone Conductors

The tolerances of the bone conductors are specified in the following charts:
The BC-2 frequency response is equivalent to BC-1
16.5 Békésy Subject’s response time for automated test procedures

The Subject’s response time for Békésy automated test procedures is 400 msec. The response time is at a rate change of
2,5 dB/s.
16.6 The ballistic characteristics of the monitoring meter

The audiometer provides a monitoring meter (VU Meter) that displays the level of the live-voice testing and speech mater-
ial. The VU Meter has the following characteristics:
• Scale from -20dB to +3dB
• Response time to reach 99% of 0dB reference point = 350 ±10 ms
• Recovery time on signal removal = max 1.5%
• Response time between 250 Hz and 8000 Hz similar to response time at 1000 Hz ±0.5 dB
Refer to the Reference Manual description of ‘The Speech stimulus bar’.
16.7 Advanced Control Panel

Outputs
Monitor headphone 3.5 mm jack (32 Ω.)

Boom microphone 3.5 mm jack
Desktop microphone 3.5 mm jack
Inputs
Monitor headphone 3.5 mm jack (32 Ω.)

Boom microphone 3.5 mm jack
Desktop microphone 3.5 mm jack
Built-in monitor speaker 3.5 mm jack (8 Ω.)
Operator interface
• 76 buttons (61 with built-in LEDs)

2 rotary knobs (32 steps in each rotation)
USB interface
Type: USB device port

Compliant: USB 2.0
Transport and storage
Temperature: -30°C to +60°C (-22°F to 140°F)

Air pressure 50 kPa to 106 kPa
Operating environment
Mode of operation: Continuous

Temperature: +15°C to +30°C (59°F to 95°F)
Air pressure 70 kPa to 106 kPa
(Operation in temperatures exceeding -20°C (-4°F) or +60°C (140°F) may cause permanent damage.)
Warm-up time
< 1 minute
Disposal
Madsen® Astera² ACP can be disposed of as normal electronic waste, according to WEEE and local regulations.
Dimensions
Approx. 410 x 290 x 36 mm (16.1 x 11.4 x 1.4 inches)
Weight
Approx. 2.1 kg (4.6 lb)
Power supply
No external power supply. Supplied by the USB (5 V).
Note • If you are using a USB hub, use a powered USB hub.
Power consumption
Normal operation: < 360 mA 5 V
Suspend mode: < 500 µA 5 V
Standards
Patient Safety: Complies with IEC 60601-1 Edition 3.2, Class 1, Type B; UL 60601-1;
CAN/CSA-C22.2 NO 60101.1-14.
EMC: IEC 60601-1-2:2014/A1:2020, IEC 60601-1-2:2007, EN 60601-1-
2:2015/A1:2020, and EN 60601-1-2:2007
16.8 Accessories
Standard accessories and optional accessories may vary from country to country - please consult your local distributor.
Madsen® Astera²
Group/Family Part number Accessory Details
Control Panel (ACP) 8-69-40800 1066, ACP ASTERA 2
Control Panel (ACP) 8-69-40802 1066 ACP upgrade w/ wrist support
Bone Conductor 1-25-01200 BC-1-HEADBAND-MON/SW
Bone Conductor 041545 BC-2 Bone Conductor with Headband
Bone Conductor 041863 BC-2 Headband
Bone Conductor 041547 BC-2 Cable with lock pins
Headset ME70 (12 kHz) matched TDH39 phones
Headphones 8-75-260
(jack)
Headset HB-7 (12 kHz) matched TDH39 phones
Headphones 8-75-780
(jack)
Headphones 8-75-790 HB-8 (12 kHz) Headband Jack
High frequency head-
8-75-82600 Headset HDA 300
phones
High frequency head- DD450 High Frequency Headset 2x6.3mm
RadioEar 8520324
phones straight jack
Bone Conductor 8522252 B71 Bone Conductor w/ headband and cable
Bone Conductor 8-75-50000 1099, BC-1 BONE W-HEADBAND
Patient responder 8-31-200 Patient Responder (Grey)

Patient responder 8-31-190 Patient Responder (Red)
Patient responder 8-31-19002 Patient Responder (Blue)
Insert Earphone - Eartip 80A4820900 Eartip, Earlink 3A, standard(bag of 50 pcs)
Insert Earphone - Eartip 80A4821000 Eartip, Earlink 3B, small(bag of 50 pcs)
Insert Earphone - Eartip 80A4821100 Eartip, Earlink 3C, jumbo(bag of 24 pcs)
Insert Earphone 8-75-81200 INSERT PHONE,10OHM,JACK,STEREO
Software 8-49-75800 1052 Otosuite DVD
Software 8-49-88000 1066 OTOsuite - QUASAR
Software 8-49-90600 1052 AB/OTOsuite Aud Control Panel
Microphone 8-72-26610 1066 Microphone w/ table stand (jack)
Miscellaneous 1-12-56200 1066 Cable cover
Miscellaneous 1-10-64700 1066 Wrist Support for the ACP
Miscellaneous 8-61-97300 1066 Wall mounting Kit
Miscellaneous 8-75-81702 TO/TB Sound Tube
Miscellaneous 8-36-02316 VDS-3000 SYS WIRELESSHD VRA-IR
Miscellaneous 8-36-02318 XM-5000 SYS, IR OPTION
Miscellaneous 8-36-02319 XM-5000 SYS,RE OPTION
Miscellaneous 49321077 Speaker Stand
Headset/Speaker 8-75-69003 1066, MONITOR HEADSET
Headset/Speaker 2-18-04200 Headset Monitoring
Headset/Speaker 8-02-450 FF LOUDSPEAKER SET,C 115
Power Supply 5-01-11300 Power Supply
Power Supply 5-01-10100 Power Supply, 24VDC, 80W
Cables 8-71-79100 Cable USB (3m)
Cables 8-71-79200 Cable USB (2m)
Cables 7-08-017 Power cord, US (UL approved)
Cables 8-71-86400 Power cord, CN
Cables 8-71-240 Power cord (Schuko)
Cables 7-08-027 Power cord, CH
Cables 8-71-290 Power cord, DK
Cables 8-71-80200 Power cord, UK
Cables 8-71-82700 Power cord, AUS
Cables 8-71-90600 Power cord, Class 1. for Brazil
Cables 8-71-86900 1066 Cable Multi (Mini jack, Male/Female)
Cables 8-71-86800 1066 Cable Multi (Mini jack, Male/Male)
Cables 8-71-87700 1066 Cable for Operator Headset (Mini Jack)
Cables 8-71-92100 1066 Cable for 5 Speaker - RCA line out
Cables 8-71-92200 1066 Cable for 2 Speaker - RCA line out
Cables 8-71-92300 1066 Cable for 5 Speaker - XLR line out

Cables 8-71-92400 1066 Cable for 2 Speaker - XLR line out
16.9 Notes on EMC (Electromagnetic Compatibility)

• Madsen® Astera² is part of a medical electrical system and is thus subject to special safety precautions. For this reason,
the installation and operating instructions provided in this document should be followed closely.
• Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the func-
tioning of Madsen® Astera².
IEC 60601-1-2:2014/A1:2020 and EN 60601-1-2:2015/A1:2021
Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems
Madsen® Astera² is intended for use in the electromagnetic environment specified below. The user of Madsen® Astera² should ensure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 Madsen® Astera² uses RF energy only for its internal function. Therefore, its RF emissions are very
CISPR11 low and are not likely to cause any interference in nearby electronic equipment.
RF emissions Class A Madsen® Astera² is suitable for use in hospital and clinic environments.
CISPR11
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
Harmonic emissions IEC Complies
B is normally required) this equipment might not offer adequate protection to radio-frequency
61000-3-2
communication services. The user might need to take mitigation measures, such as relocating or
Voltage fluctuations/flicker Complies re-orienting the equipment.
emissions IEC 61000-3-3
Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems
environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment - guidance

test level
Electrostatic discharge (ESD) +/- 8 kV contact +/- 8 kV contact Floors should be wood, concrete or ceramic tile. If floors
IEC 61000-4-2 +/- 2 kV, +/- 4 kV, +/- 2 kV, +/- 4 kV, are covered with synthetic material, the relative humid-
+/- 8 kV, +/- 15 kV air +/- 8 kV, +/- 15 kV air ity should be at least 30 %.
Electrical fast transient/burst +/- 2 kV for power supply lines +/- 2 kV for power supply lines Mains power quality should be that of a typical com-
IEC 61000-4-4 +/- 1 kV for input/output lines +/- 1 kV for input/output lines mercial or hospital environment.
Surge +/- 1 kV line(s) to line(s) +/- 1 kV line(s) to line(s) Mains power quality should be that of a typical com-
IEC 61000-4-5 +/- 2 kV line(s) to earth +/- 2 kV line(s) to earth mercial or hospital environment.
+/- 2 kV DC input line(s) to earth +/- 2 kV DC input line(s) to earth
+/- 1 kV DC input line(s) to line(s) +/- 1 kV DC input line(s) to line(s)
+/- 2 kV I/O line(s) to earth +/- 2 kV I/O line(s) to earth
Voltage dips, short inter- 0 % U ; 0.5 cycle 0 % U ; 0.5 cycle Mains power quality should be that of a typical com-
ruptions and voltage vari-
T T
At 0°, 45°, 90°, 135°, 180°, 225°, 270° At 0°, 45°, 90°, 135°, 180°, 225°, 270° mercial or hospital environment. If the user of the Mad-
ations on power supply input and 315° and 315° sen® Astera² requires continued operation during power
lines 0 % U ; 1 cycle 0 % U ; 1 cycle mains interruptions, it is recommended that the Mad-
IEC 61000-4-11 and
T and
T sen® Astera² be powered from an uninterruptible power
70 % U ; 25/30 cycles 70 % U ; 25/30 cycles supply or a battery.
T
Single phase: at 0°
T
Single phase: at 0°
Voltage interruptions on 0 % U ; 250/300 cycles 0 % U ; 250/300 cycles

power supply input lines
T T
IEC 61000-4-11
Power frequency 30 A/m No relevant ports that could be Power frequency magnetic fields should be at levels char-
(50/60 Hz) magnetic field affected acteristic of a typical location in a typical commercial or
IEC 61000-4-8 hospital environment.
U
T is the AC mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment
environment.

test level
Conducted RF 3 V rms 3 V rms

IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz
6 V rms 6 V rms
ISM Bands ISM Bands
Radiated RF 3 V/m 3 V/m

IEC 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz
Proximity fields from RF wireless com- 27 V/m 27 V/m Separation distance between any electronic
munications 385 MHz 385 MHz parts of Madsen® Astera² and any RF wireless
IEC 61000-4-3 communication equipment must be more
28 V/m 28 V/m
than 30 cm (11.8 inches).
450 MHz 450 MHz
9 V/m 9 V/m
710 MHz, 745 MHz, 780 MHz 710 MHz, 745 MHz, 780 MHz
28 V/m 28 V/m
28 V/m 28 V/m
28 V/m 28 V/m
2450 MHz 2450 MHz
9 V/m 9 V/m
Proximity magnetic fields 65A/m 65 A/m

IEC 61000-4-39 134.2 kHz 134.2 kHz
7.5 A/m 7.5 A/m
13.56 kHz 13.56 kHz
Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and
people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which Madsen® Astera² is used exceeds the applicable RF
compliance level above, the Madsen® Astera² should be observed to verify normal operation. If abnormal performance is observed, additional measures
might be necessary, such as reorienting or relocating Madsen® Astera².
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and Madsen® Astera²
The Madsen® Astera² is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
Madsen® Astera² can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip-
ment (transmitters) and the Madsen® Astera² as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of Separation distance according to frequency of transmitter

transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 d = 1.2 d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equa-
tion applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
people.
IEC 60601-1-2:2007 and EN 60601-1-2:2007
Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 Madsen® Astera² uses RF energy only for its internal function. Therefore, its RF emissions are very
CISPR11 low and are not likely to cause any interference in nearby electronic equipment.
RF emissions Class A Madsen® Astera² is suitable for use in all environments, including domestic environments and
CISPR11 those directly connected to the public low-voltage power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions IEC Complies Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
61000-3-2 and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-frequency
Voltage fluctuations/flicker Complies communication services. The user might need to take mitigation measures, such as relocating or
emissions IEC 61000-3-3 re-orienting the equipment.
Guidance and manufacturer's declaration - electromagnetic immunity for all equipment and systems
environment.

test level
Electrostatic discharge (ESD) +/- 6 kV contact +/- 6 kV contact Floors should be wood, concrete or ceramic tile. If floors are
IEC 61000-4-2 +/- 8 kV air +/- 8 kV air covered with synthetic material, the relative humidity should
be at least 30 %.
Electrical fast transient/burst +/- 2 kV for power supply lines +/- 2 kV for power supply lines Mains power quality should be that of a typical commercial or
IEC 61000-4-4 +/- 1 kV for input/output lines +/- 1 kV for input/output lines hospital environment.
Surge +/- 1 kV line(s) to line(s) +/- 1 kV line(s) to line(s) Mains power quality should be that of a typical commercial or
IEC 61000-4-5 +/- 2 kV line(s) to earth +/- 2 kV line(s) to earth hospital environment.
Voltage dips, short inter- <5 % U Mains power quality should be that of a typical commercial or
ruptions and voltage vari-
T (>95 % dip in UT)
for 0.5 cycle
<5 % U
T (>95 % dip in UT)
for 0.5 cycle hospital environment. If the user of the Madsen® Astera²
ations on power supply input 40 % U (60 % dip in U ) for 40 % U (60 % dip in U ) for requires continued operation during power mains inter-
lines 5 cycles
T T 5 cycles
T T ruptions, it is recommended that the Madsen® Astera² be
IEC 61000-4-11 70 % U (30 % dip in U ) for 70 % U (30 % dip in U ) for powered from an uninterruptible power supply or a battery.
25 cycles
T T 25 cycles
T T
<5 % U
for 5 s
T (>95 % dip in UT) <5 % U
for 5 s
T (>95 % dip in UT)
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at levels char-
(50/60 Hz) magnetic field acteristic of a typical location in a typical commercial or hos-
IEC 61000-4-8 pital environment.
U
T is the AC mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting
environment.

test level
Conducted RF 3 V rms 3 V rms Portable and mobile RF communications equip-

IEC 61000-4-6 150 kHz to 80 MHz 150 kHz to 80 MHz ment should be used no closer to any part of Mad-
sen® Astera², including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance:
d = 1.2
d = 1.2 for 80 MHz to 800 MHz
d = 2.3 for 80 MHz to 2.5 GHz,
where P is the maximum output power rating of the

Radiated RF 3 V/m 3 V/m
transmitter in watts (W) according to the trans-
IEC 61000-4-3 80 MHz to 2.5 GHz 80 MHz to 2.5 GHz
mitter manufacturer and d is the recommended sep-
aration distance in metres (m).
Field strengths from fixed RF transmitters, as determ-
ined by an electromagnetic site survey, a should be
less than the compliance level in each frequency
range. b
Interference may occur in the vicinity of equipment
marked with this symbol:
people.
a. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283
MHz; and 40.66 MHz to 40,70 MHz.
b. The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which Madsen® Astera² is used exceeds the applicable RF
compliance level above, the Madsen® Astera² should be observed to verify normal operation. If abnormal performance is observed, additional measures
might be necessary, such as reorienting or relocating Madsen® Astera².
d. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended separation distances between portable and mobile RF communications equipment and Madsen® Astera²
The Madsen® Astera² is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the
Madsen® Astera² can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equip-
ment (transmitters) and the Madsen® Astera² as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of Separation distance according to frequency of transmitter

transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.2 d = 1.2 d = 2.3
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equa-
tion applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
people.
17 Definition of symbols
Symbol Standards Standard Title of Symbol Symbol Title as Explanation
Reference per Referenced
Standard
EU Medical REGULATION (EU) 2017/745 CE marking (43) ‘CE marking of con-

Device Regu- OF THE EUROPEAN formity’ or ‘CE marking’
lations PARLIAMENT AND OF THE means a marking by which
2017/745 COUNCIL of 5 April 2017 on a manufacturer indicates
medical devices, amending Dir- that a device is in con-
ective 2001/83/ EC, Regu- formity with the applic-
lation (EC) No 178/2002 and able requirements set out
Regulation (EC) No 1223/2009 in this Regulation and
and repealing Council Dir- other applicable Union
ectives 90/385/ EEC and harmonisation legislation
93/42/EEC providing for its affixing
ISO 15223- Medical devices — Symbols to Manufacturer Indicates the medical

1:2016 Refer- be used with medical device device manufacturer.
ence no. labels, labelling and inform-
5.1.1 (ISO ation to be supplied.
7000-3082)
ISO 15223- Medical devices — Symbols to Date of man- Indicates the date when
1:2016 Refer- be used with medical device ufacture the medical device was
ence no. labels, labelling and inform- manufactured.
5.1.3. (ISO ation to be supplied – Part 1:
7000-2497) General requirements.
ISO 15223- Medical devices — Symbols to Use-by date Indicates the date after
1:2016 Refer- be used with medical device which the medical device
ence no. labels, labeling, and inform- is not to be used.
5.1.4. (ISO ation to be supplied – Part 1:
ISO 15223-1 Medical devices — Symbols to Batch or Lot code Indicates the man-
Reference be used with medical device ufacturer's batch code so
no. 5.1.5 labels, labelling and inform- that the batch or lot can
ation to be supplied. be identified.
ISO 15223-1 Medical devices — Symbols to Catalogue number Indicates the man-
Reference be used with medical device ufacturer’s catalogue num-
no. 5.1.6 labels, labelling and inform- ber so that the medical
ation to be supplied. device can be identified.
ISO 15223- Medical devices — Symbols to Serial number Indicates the man-
1:2016 Refer- be used with medical device ufacturer's serial number
ence no. labels, labeling, and inform- so that a specific medical
5.1.7. (ISO ation to be supplied – Part 1: device can be identified
ISO 15223- Medical devices — Symbols to Fragile, handle Indicates a medical device
1:2016 Refer- be used with medical device with care that can be broken or
ence no. labels, labeling, and inform- damaged if not handled
5.3.1. (ISO ation to be supplied – Part 1: carefully
ISO 15223- Medical devices — Symbols to Keep dry Indicates a medical device
1:2016 be used with medical device Keep away from that needs protection
Reference labels, labeling, and inform- rain from moisture
no. 5.3.4. ation to be supplied – Part 1: ISO 15223 Keep dry
(ISO 7000- General requirements.
ISO 7000 Keep away from
0626) rain
ISO 15223-1 Medical devices —Symbols to Temperature lim- Indicates the temperature
Reference be used with medical device itations limits to which the med-
no. 5.3.7(ISO labels, labelling and inform- ical device can be safely
7000-0632) ation to be supplied. exposed
ISO 15223- Medical devices —Symbols to Humidity lim- Indicates the range of
1:2016 Refer- be used with medical device itations (storage) humidity to
ence no. labels, labelling and inform- which the medical device
5.3.8. (ISO ation to be supplied. can be safely exposed.
7000-2620)
ISO 15223- Medical devices — Symbols to Atmospheric pres- To indicate the accept-
1:2016 Refer- be used with medical device sure limitation able upper and lower lim-
ence no. labels, labeling, and inform- its of atmospheric
5.3.9 (ISO ation to be supplied – Part pressure for transport and
7000-2621) 1: General requirements. storage.
ISO 15223 Atmospheric
pressure limitation
ISO 7000 Atmospheric
Pressure limitation
ISO 15223- Medical devices —Symbols to Do not use if pack- Indicates a medical device
1:2016 Refer- be used with medical device age is damaged that should not be used if
ence no. labels, labelling and inform- the package has been dam-
5.2.8. (ISO ation to be supplied. aged or opened and that
7000-2606) the user should consult
the instructions for use for
additional information
ISO 15223- Medical devices — Symbols to Do not re-use Indicates a medical device
1:2016 be used with medical device that is intended for one
Reference labels, labeling, and inform- single use only
no. 5.4.2. ation to be supplied – Part 1: NOTE: Synonyms for “Do
(ISO 7000- General requirements. not reuse” are “single
1051) use” and “use only once”.
ISO 15223- Medical devices — Symbols to Consult instruc- Indicates the need for the
1:2016 Refer- be used with medical device tions for use Oper- user to consult the instruc-
ence no. labels, labelling and inform- ator's manual; tions for use
5.4.3. (ISO ation to be supplied. operating instruc-
7000-1641) tions
ISO 15223-1, Medical devices — Symbols to Caution: Read all Indicates the need for the
Clause 5.4.4 be used with medical device warnings and pre- user to consult the instruc-
ISO 60601-1 labels, labelling and inform- cautions in instructions for use for important
Table D.1 ation to be supplied. tions for use cautionary information
symbol 10 Medical electrical equipment such as warnings and pre-
— Part 1: General require- cautions that cannot, for a
ments for basic safety and variety of reasons, be
essential performance. presented on the medical
device itself.
IEC 60601-1, Medical electrical equipment General warning Indicates the need for the
Table D.2 — Part 1: General require- sign user to consult the instruc-
symbol 2 ments for basic safety and tions for use for important
essential performance. cautionary information
such as warnings and pre-
cautions that cannot, for a
variety of reasons, be
presented on the medical
device itself.
ISO 15223- Medical devices —Symbols to Not made with Indicates a medical device
1:2016 Refer- be used with medical device Natural Rubber that is not made with dry
ence no. labels, labelling and inform- Latex natural rubber or natural
5.4.5. (ISO ation to be supplied. rubber latex as a material
7000, symbol of construction within the
2025) medical device or the
packaging of a medical
device
IEC 60601-1, Medical electrical equipment Type B Applied To identify a type B

Reference — Part 1: General require- Part applied part complying
no. Table ments. for basic safety and with, IEC 60601-1.
D.1, Symbol essential performance Classification of protection
19 (ICE against electrical shock.
60417-5480)
IEC 60601-1, Medical electrical equipment Type BF Applied To identify a type BF

Reference — Part 1: General require- Part applied part complying
no. Table ments. for basic safety and with, IEC 60601-1.
D.2, Symbol essential performance
20 (ICE
60417-5333)
EC 60601-1, Medical electrical equipment Follow instructions Refer to instruction

Reference — Part 1: General require- for use manual/ Booklet.
no. Table ments for basic safety and NOTE on ME EQUIPMENT
D.2, Safety essential performance. "Follow instructions for
sign 10 (ISO use”
7010-M002)
ISO 7000 Graphical symbols for use on This way up N/A

Reference equipment - registered sym-
no. 0623 bols
Directive Waste Electrical and Elec- Disposal at end of Indicates that electrical
2012/19/EU tronic Equipment (WEEE) operating life and electronic waste
instructions equipment waste should
not be discarded together
with unseparated waste
but must be collected sep-
arately.
- - An indication of The product is a medical

Medical device device.
21 CFR Part Labeling-Prescription devices. Prescription only Indicates the product is

801.109(b)(1) authorized for sale by or
on the order of a licensed
healthcare practitioner.
UL Listing N/A N/A Nationally Recognized

Testing Laboratories
(NRTL) certifications
INMETRO in InMetro and UL marking of MEDICAL - Gen- INMETRO in conjunction

conjunction conformity eral Medical with the Mark of the
with UL for Equipment as to National Institute of Met-
Latin Amer- electrical shock, rology, Standardization
ica fire and mech- and Industrial Quality in
anical hazards only Brazil
in accordance
with:
ANSI/AAMI
ES60601-1:2005/
(R)2012
IEC 60601-1-6
CAN/CSA-C22.2
No. 60601-1:14
CAN/CSA-C22.2
No. 60601-1-6
China RoHS 2 N/A N/A Restriction of 6 hazardous

Marking substances for electronic
and electrical products
sold in the People’s
Republic of China
Disposal Instructions
Natus is committed to meeting the requirements of the European Union WEEE (Waste Electrical and Electronic Equip-
ment) Directive 2012/19/EU. These regulations state that electrical and electronic waste must be separately collected for
the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus
may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made.
Please contact us for details on the collection and recovery systems available to you in your region at www.natus.com.
Electrical and electronic equipment (EEE) contains materials, components and substances that may be hazardous and
present a risk to human health and the environment when WEEE is not handled correctly. Therefore, end users also have a
role to play in ensuring that WEEE is reused and recycled safely. Users of electrical and electronic equipment must not dis-
card WEEE together with other wastes. Users must use the municipal collection schemes or the producer/importers take-
back obligation or licensed waste carriers to reduce adverse environmental impacts in connection with disposal of waste
electrical and electronic equipment and to increase opportunities for reuse, recycling and recovery of waste electrical and
electronic equipment.
Equipment marked with the crossed-out wheeled bin is electrical and electronic equipment. The crossed-out wheeled bin
symbol indicates that waste electrical and electronic equipment should not be discarded together with unseparated waste
but must be collected separately.
18 Warnings, Cautions, and Notes

This manual contains information, which must be followed to ensure the safe performance of the devices and software
covered by this manual. Local government rules and regulations, if applicable, should also be followed at all times.
Standards and safety-related issues relating to the Madsen® Astera² Audiometer Control Panel (ACP) are comprised by the
Madsen® Astera² symbols, standards and this safety information.
Note • Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to
the competent authority of the country or the EU Member State in which the user and/or patient is established.
See Definition of symbols ► 51, Connector warnings ► 56 and General warnings ► 57.
18.1 Connector warnings
Warning • Never mix connections between the Direct Connectors & Isolated Connectors
Direct connectors
• All connectors within the red frame are connected directly to patient transducers.
Fig. 1 Sockets with direct connections to patient transducers - Madsen® Astera² connection panel
Isolated connectors
• All connectors within the red frame are isolated from patient transducers.
Note • The safety standards listed in Technical specifications ► 26 do not apply to the isolated connectors used in
the Madsen® Astera² audiometer.
Fig. 2 Connectors isolated from patient transducers - Madsen® Astera² connection panel
18.2 General warnings
Warning • Do not store or operate the device at temperatures and humidity exceeding those stated in the Tech-
nical Specifications.
Warning • Do not use the instrument in the presence of flammable agents (gases) or in an oxygen-rich envir-
onment.
Warning • To avoid the risk of electric shock, this equipment must only be connected to a mains supply with pro-
tective ground.
Warning • The device and any device to be connected which has its own power supply should be turned off before
any connections are established. To disconnect the device from the mains supply, pull the mains plug out of the
wall mains outlet. Do not position the unit so that it is difficult to pull the mains plug out of the wall mains.
Warning • The device should not be stacked with other equipment or placed in a poorly ventilated space as this
may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure the oper-
ation of the device is not affected.
Warning • Unwanted noise may occur if the device is exposed to a strong radio field. Such noise may interfere
with the performance of the device. Many types of electrical devices, e.g. mobile telephones, may generate radio
fields. We recommend that the use of such devices in the vicinity of Madsen® Astera² be restricted.
Warning • The instrument is not used in the vicinity of devices sensitive to electromagnetic fields.
Warning • If an electro-medical device is connected to a multiple-socket power outlet, this can result in a reduced
level of safety.
Warning • When assembling an electro-medical system, the person carrying out the assembly must take into
account that other connected equipment which does not comply with the same safety requirements as this product
(e.g. PC and/or printer) may lead to a reduction in the overall safety level of the system. The equipment must comply
with IEC 62368-1:2020.
Warning • Provided power supply shall be used to isolate Medical Equipment from mains power supply.
Warning • The following applies only when used with the specified power supply, XP Power, type PCM80PS24:
When selecting accessories connected to the device, the following points must be considered:
• Use of connected equipment in a patient environment.
• Proof that connected equipment has been tested in accordance with IEC 60601-1.
Warning • The following applies only when used with the specified power supply, External power supply, Delta
Electronics Inc., type MDS-090AAS24:
When selecting accessories connected to the device, the following points must be considered:Use of connected equip-
ment in a patient environment.Proof that connected equipment has been tested in accordance with IEC 60601-1,
AAMI ES60601-1 and CAN/CSA-C22.2 NO. 60601-1-14:2014, ES60601-1:2005/(R)2012 and A1:2012.
Warning • Do not touch the output DC plug of the power supply or connectors of the device or connected devices
and the patient at the same time.
Warning • To comply with Medical Electrical Systems in IEC 60601-1 computer and printer must be placed at
least 1.5 meters/5 ft away from the patient, so that the patient cannot reach the computer or printer.
Warning • Do not touch the patient at the same time you touch the output DC plug of the power supply or con-
nectors of the device or connected devices.
Warning • Accidental damage and incorrect handling can have a negative effect on the functionality of the
device. Contact your supplier for advice.
Warning • Keep the unit away from liquids. Do not allow moisture inside the unit. Moisture inside the unit can
damage the instrument and it may result in a risk of electrical shock to the user or patient.
Warning • This class of equipment is allowed in professional healthcare establishments when used under the jur-
isdiction of a health care professional.
Warning • Madsen® Astera² is suitable for use in hospital and clinic environments.
Warning • Do not touch non-medical parts, such as the laptop/computer or printer and the patient at the same
time.
Warning • Any PC connected to the ACP (Audiometer Control Panel) must comply with the requirements of IEC
62368-1:2020.
Warning • For wall mounting of Madsen Astera2, screws specifically suited for the type of wall, must be used.
Warning • Avoid ElectroStatic Discharge (ESD) when installing the system.
Warning • Install the unit in an environment that minimizes the amount of static electricity. For example, anti-
static carpeting is recommended.”
18.3 General cautions
Caution • Madsen® Astera² is intended for diagnostic and clinical use by audiologists, ENTs, and other trained
health care professionals in testing the hearing of their patients.
Caution • For the sake of safety and in order not to void the warranty, service and repair of electro-medical equip-
ment should be carried out only by the equipment manufacturer or by service personnel at authorized workshops. In
case of any defects, make a detailed description of the defect(s) and contact your supplier. Do not use a defective
device.
Caution • No parts may be eaten, burnt, or in any way used for purposes other than the applications defined in
the Intended Use section of this manual.
Caution • Annual calibration must be performed on accessories containing transducers. Furthermore, it is recom-
mended that calibration be performed if the equipment has suffered any potential damage.
Caution • Note that calibration has been performed only on the transducers supplied. If you wish to use any other
transducer for testing with the device, please contact your local distributor first.
Caution • Disposable accessories, such as eartips, should not be reused and must be replaced between patients to
prevent cross-infection.
Caution • Changes or modifications not expressly approved by the manufacturer could void the user's authority to
operate the equipment.
Caution • The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and
performance of equipment serviced or repaired by other parties. Following repair, a qualified electronics engineer
should verify the safety of all equipment.
Caution • Madsen® Astera² and Otosuite must always be installed in accordance with the instructions in the Mad-
sen® Astera² Reference Manual and User Guide and the Otosuite Reference Manual and User Guide
18.4 General notes
Note • Use only the specified power supply.
Note • Unwanted background noise must not be present during audiometry tests.
Note • For automatic level shift, the sound level will not exceed 80 dB HL for safety reasons.
Note • To hide patient's confidential data from measurement reports, see the Otosuite User Guide
Note • For safety reasons and due to effects on EMC, accessories connected to the equipment's outlet fittings must be
identical to the type supplied with the system.
19 Manufacturer
19 Manufacturer
Natus Medical Denmark ApS
Hoerskaetten 9, 2630 Taastrup
Denmark
+45 45 75 55 55
www.natus.com
Distribuidor Autorizado no Brasil

Medstar Importação e Exportação Eireli
R. Valencio Soares Rodrigues, 89 – Sala 01
Vargem Grande Paulista – SP – Brasil CEP: 06.730 – 000
CNPJ: 03.580.620/0001-35
19.1 Responsibility of the manufacturer

The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only
if:
• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment man-
ufacturer or personnel authorized by the manufacturer.
• The electrical installation to which the equipment is connected complies with the requirements specified in the Tech-
nical Specifications section of this manual.
• The equipment is used in accordance with the instructions for use.
The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of
equipment serviced or repaired by other parties.
19 Manufacturer

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5 Powering the device 12

6 Connecting Madsen® Astera² to Otosuite 12

9 Toolbar icons in the Audiometry Module 13

10 The Sunshine Panel 15

11 Proper transducer placement 18

12 Performing tone audiometry 20

13 Performing speech audiometry 21

18 Warnings, Cautions, and Notes 56

Intended Patient Population

2.1 Typographical conventions

Note • Indicates that you should take special notice.

Remove the cable cover

2. Lift off the cable cover.

Connect the ACP

Secure cables to Madsen® Astera²

Remount the cable cover

Connecting Madsen® Astera² to Otosuite

4.1 Connecting the ACP to Madsen® Astera²

1. Remove the cable cover from

The connections are located at

Operator desktop microphone

Operator monitor headset with boom microphone

Speaker, built into the ACP

4.2 Connecting the ACP to the PC

Direct connection to PC using single USB cable

1. Unfold the feet of the ACP.

Connection to PC using externally powered USB hub

Power up sequence with externally powered USB hub

4.3 Connecting accessories to Madsen® Astera²

See also Connector warnings ► 56 and General warnings ► 57.

Connection panel - Madsen® Astera²

A. Patient Responders I. Operator desktop microphone

Note • Blue corresponds to Left and red corresponds to Right.

Note • Use only the power supply provided by Natus.

Connection panel - ACP

A. PC/USB connection • USB cable

B. Connections from Madsen® Astera² • Speaker built into the ACP

C. Connections to accessories • Operator desktop microphone

5 Powering the device

Switching on Madsen® Astera²

Use only the power supply provided by Natus.

Press the ON/OFF button on the front of Madsen® Astera².

Switching off Madsen® Astera²

6 Connecting Madsen® Astera² to Otosuite

9 Toolbar icons in the Audiometry Module

Menu item Icon Description

Masking Assistant Enable or disable the Masking Assistant.

High Frequencies (High Frequencies)

Menu item Icon Description

Desktop/Headset Toggle microphone types (Toggle microphone types)

Live Video Otoscopy Click to launch a Live Video Otoscopy.

10 The Sunshine Panel

Tone testing Speech testing

Customizing the Sunshine Panel

Using the Sunshine panel

Function Icon Description

Stimulus Ear Selection Click to select test ear:

Masking Options Mask Click to enable or disable masking.

Stimulus Selection Click to select stimulus type.