natus Madsen Astera 2 User manual

MADSEN Astera²
User Guide
Doc. No.7-50-1350-EN/12
Part No.7-50-13500-EN

Copyright notice
© 2013,2020Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the OtometricsIcon, Aurical, Madsen, HI-PRO 2, Oto-
scan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries.
Version release date
2020-06-15 (217208)
Technical support
Please contact your supplier.
MADSEN Astera²
2

Table of Contents
1 Device description 4
2 Intended use 4
3 Unpacking 5
4 Installation 5
5 Powering the device 11
6 Connecting MADSEN Astera² to Otosuite 12
7 On-screen controls 12
8 PC keyboard controls 13
9 Toolbar icons in the Audiometry Module 13
10 The Sunshine Panel 15
11 Proper transducer placement 17
12 Performing tone audiometry 19
13 Performing speech audiometry 20
14 Service, cleaning and calibration 23
15 Other references 24
16 Technical specifications 25
17 Definition of symbols 39
18 Warning notes 39
19 Manufacturer 42
MADSEN Astera² 3

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.
With MADSEN Astera² you can perform all standard audiometric tests, tone and speech audiometry and special tests.
• You can operate MADSEN Astera² from the PC’s keyboard/mouse, or from the MADSEN Astera² Audiometer Control
Panel (ACP) with the Otosuite Audiometry Software Module acting as the display.
• From the Otosuite Audiometry Software Module, which is NOAH compatible, you can monitor test results, create
User Tests, store and export data, and print reports.
Test intensities and frequencies as well as the current test settings and other information are shown on the PC mon-
itor.
2 Intended use
MADSEN Astera² and the Audiometry module
Users: audiologists, ENTs and other health care professionals in testing the hearing of their patients.
Use: diagnostic and clinical audiometric testing.
The MADSEN Astera² Audiometer Control Panel (ACP)
The ACP is intended as a supplementary user interface connected to MADSEN Astera².
2.1 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses pre-
cautionary statements as follows:
Warning •Indicates that there is a risk of death or serious injury to the user or patient.
Caution •Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note •Indicates that you should take special notice.
4 MADSEN Astera²
1 Device description

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

2. Lift off the cable cover.
Connect accessories
See Connecting accessories to MADSEN Astera² ►9.
Connect the ACP
If you are using the ACP:
See Connecting the ACP to MADSEN Astera² ►7and 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.
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)
6 MADSEN Astera²
4 Installation

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

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

Direct connection to PC using single USB cable
Caution •Make sure that the total length of the USB cable used for connecting the ACP to the PC does not exceed 3
meters (10 feet).
1. Unfold the feet of the ACP.
2. Place the ACP in front of the PC monitor.
3. Plug one end of the USB cable into the USB socket located in the ACP rear panel and the other end of the
cable into a USB socket on the PC.
Connection to PC using externally powered USB hub
Caution •If the PC, the externally powered USB hub and the ACP are connected, make sure that you switch on power
to the hub before or right when you switch on the PC. This is to ensure that the USB connection between the PC and
the hub is established correctly. This connection is established when the PC is switched on.
Caution •If you are using an externally powered hub, no individual USB cable must exceed 3 meters (10 feet).
Power up sequence with externally powered USB hub
1. Connect the externally powered USB hub to the mains socket and switch it on.
2. Plug the single USB cable from the externally powered USB hub directly into a USB socket on the PC.
3. Connect the USB cable from the externally powered USB hub to the USB socket located in the ACP rear
panel.
4.3 Connecting accessories to MADSEN Astera²
Caution •Install Otosuite on the PC before you connect to MADSEN Astera² from the PC.
The following applies only when used with the specified power supply, XP Power, type PCM80PS24:
The installation must be carried out in accordance with IEC 60601-1-1, UL 60601-1 and CAN/CSA-C22.2 NO
601.1-90. The supplementary provisions on the reliability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (2nd) and/or IEC 60601-1-1.
except for the PC, and equipment connected to the line in and the line out sockets of MADSEN Astera².
MADSEN Astera² 9
4 Installation

The following applies only when used with the specified power supply, External power supply, Delta Elec-
tronics Inc., type MDS-090AAS24:
The installation must be carried out in accordance with Medical Electrical Systems clause 16 in IEC 60601-1
(3rd), AAMI ES60601-1 and CSA C22.2 NO. 60601-1-08-CAN/CSA. The supplementary provisions on the reli-
ability of electro-medical systems.
It is a general rule for all electrical equipment used in the proximity of the client that:
• The connected equipment must comply with IEC 60601-1 (3rd).
except for the PC, and equipment connected to the line in and the line out sockets of MADSEN Astera².
See also Connector warning notes ►40 and General warning notes ►40.
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.
All four cables for connecting accessories are joined in a bundle and color-coded for easy connection:
• Yellow: Operator desktop microphone
• Green: Operator monitor headset, headphones
• Pink: Operator monitor headset, boom microphone
• Gray: Operator monitor speaker
A. Patient Responders
B. Insert earphones
C. Headphones - air conduction
D. High-frequency headphones - air conduction
E. Bone oscillator
F. Operator monitor headset - headphones
G. Operator monitor headset - boom microphone
H. Operator monitor speaker
I. Operator desktop microphone
J. Talkback microphone
K. Assistant monitor headset
L. Sound field speakers (power output)
M. External power supply
N. PC/USB connection
O. Line-in
P. Sound field speakers (line output)
Note •Blue corresponds to Left and red corresponds to Right.
Warning •Use only the power supply provided by Otometrics.
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4 Installation