natus Madsen Astera 2 User manual

Madsen® Astera²
User Guide
Doc. No.7-50-1350-EN/13
Part No.7-50-13500-EN

Copyright notice
© 2013,2021Natus MedicalDenmark ApS. All rights reserved. ® Natus, the NatusIcon, Aurical, Madsen, HI-PRO 2, Otoscan, ICS
and HORTMANN are registered trademarks of Natus MedicalDenmark ApS in the U.S.A. and/or other countries.
Version release date
2021-06-01 (221163)
Technical service and 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 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 25
16 Technical specifications 26
17 Definition of symbols 41
18 Warnings, Cautions, and Notes 46
19 Manufacturer 51
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 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.
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1 Device description

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
3 Unpacking

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 ►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.
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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.
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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 (4th Edition)and IEC 60601-1 (3rd).
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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.
Warning •Any equipment connected with the device or used in the proximity of the patient must
comply with IEC 60601-1 (Edition 2) and IEC 60601-1-2:2014.
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.
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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.
Warning •Any equipment connected with the device or used in the proximity of the patient must
comply with IEC 60601-1 (Edition 2) and IEC 60601-1-2:2014.
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
Warning •Any equipment connected with the device or used in the proximity of the patient must
comply with IEC60601-1-2 (4th Edition)and 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 warnings ►46 and General warnings ►47.
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.
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4 Installation