natus Madsen A450 User manual

Madsen A450
User Guide
Doc. No.7-50-1830-EN/06
Part No.7-50-18300-EN

Copyright notice
© 2017,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 A450
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Table of Contents
1 Device description 5
2 Intended use 5
3 Unpacking 6
4 Installation 6
5 Connecting accessories to Madsen A450 7
6 Powering the device 9
7 Connecting Madsen A450 to Otosuite 9
8 Control panels and on-screen controls 10
9 Toolbar icons in the Audiometry Module 15
10 PC keyboard controls 16
11 Proper transducer placement 16
12 Performing tone audiometry 17
13 Performing speech audiometry 18
14 Maintenance 20
15 Other references 22
16 Technical specifications 23
17 Definition of symbols 38
18 Warnings, Cautions, and Notes 44
19 Manufacturer 47
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User Guide
Madsen A450

Madsen A450
4

1 Device description
Madsen A450 Madsen A450 is a PC-controlled audiometer for testing a person's
hearing.The audiometer is operated from the Otosuite Audiometry Module
PC software.
With Madsen A450 you can perform standard audiometric tests, tone and
speech audiometry and special tests.
2 Intended use
Madsen A450 with the Audiometry module
Users: audiologists, ENTs, hearing instrument dispensers 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.
User Environment
• Professional healthcare facility environment
• The system is intended for use in a quiet environment within normal office temperature/humidity/pressure ranges
and lighting conditions
Clinical Benefit
Madsen A450 is 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:
Madsen A450 5
1 Device description

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.
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 A450 to the PC.
For Otosuite installation instructions, see the OtosuiteInstallation Guide, on the Otosuite installation medium.
Madsen A450 is fully assembled on delivery, and you simply have to connect the cables.
Warning •To connect Madsen A450 to the PC, use the supplied USB cable. The cable length must not
exceed 3 m (approx. 10 feet).
Desktop or wall-mount installation
You can place Madsen A450 on the desktop or mount it on the wall.
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3 Unpacking

Wall-mount installation
It is recommended that you connect the external power sup-
ply and the accessories before you mount Madsen A450 on
the wall.
1. Select two suitably sized screws that will pass through the
wall-mount holes on the back of the device:
Max. screw diameter 4.3 mm (0.15 in).
Max. screw head diameter: 9 mm (0.35 in).
2. The distance between the two wall-mount holes on the
back of the device is 24 cm (9.4 inches), measured from
the center of each hole.
3. Mark up the two holes on the wall and make sure that the
device will be placed horizontally.
4. Fix the two screws in the wall.
5. Hang Madsen A450 on the screws.
Madsen A450 cabling
A. External power supply cable
B. USB cable between Madsen A450 and the PC
5 Connecting accessories to Madsen A450
The installation must be carried out in accordance with IEC 60601-1 (Ed. 3.1), UL60601-1, and CAN/CSAC22.2
No. 60601-1-14:2014.
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 (Ed. 3.1) except for the PC.
See also General warnings ►45.
For a detailed description of the connection panel, see the Madsen A450Reference Manual.
Connection panel - Madsen A450
Connect the plugs to the sockets in the connection panel.
Madsen A450 7
5 Connecting accessories to Madsen A450

1. PC/USB connection
2. External power supply
3. Sound field speakers (power output)
4. Insert Earphones
5. Headphones - air conduction
6. Patient Responder
7. Speaker, Analog (line output)
8. Operator monitor headset - headphones
9. Operator monitor headset - boom microphone
10. Insert Earphones
11. Headphones - air conduction
12. Bone conductor
13. Line-in
14. Counseling and Simulations headphones
15. Talk-back microphone
Note •Blue corresponds to Left and red corresponds to Right.
Warning •Use only the power supply provided by Natus.
Note •When you connect other electrical equipment to Madsen A450, remember that equipment that does not com-
ply with the same safety standards as Madsen A450 can lead to a general reduction in the system's safety level.
Connecting an external speaker
External speakers can be connected to Madsen A450 via powered output terminals or line-out terminals. In both cases you
should contact your service department for installation and calibration. See also Calibration ►22.
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5 Connecting accessories to Madsen A450

6 Powering the device
Madsen A450 is powered through an external power supply connected directly to the mains outlet.
Warning •Madsen A450 is not provided with a mains switch.
To connect Madsen A450 to the mains supply, plug the mains plug into the wall mains outlet.
To disconnect Madsen A450 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.
1. Plug the external power supply into the Power socket in the con-
nection panel.
2. Plug the mains plug of the external power supply into an AC mains
outlet with a three-wire protective ground.
Switching on Madsen A450
Warning •Use only the power supply provided by Natus.
3. Switch on the mains supply.
4. The On/Off indicator on Madsen A450 lights green.
Switching off Madsen A450
1. To completely switch off Madsen A450, disconnect the power supply from the mains outlet.
7 Connecting Madsen A450 to Otosuite
To connect Otometrics Madsen A450 to the PC, you must install Otosuite on the PC. For instructions, refer to the Install-
ation ►6section of this manual.
Caution •Use only the USB cable supplied with Madsen A450.
Madsen A450 9
6 Powering the device

1. Switch on the device.
2. Launch Otosuite.
3. Connect the USB cable from the USB socket on the back of the device to a USB socket on the PC. The
Otosuite software automatically detects the device.
8 Control panels and on-screen controls
Control panels
Tone testing Speech testing
In the control panel you can quickly select test ear, trans-
ducer, masking, and test type.
Click on the buttons to toggle the selection or right-click on a
button to select a combination of functions.
Your selections are shown in the Stimulus bar and as symbols
in the audiogram.
You can control the monitor level, activate the Talk Forward
dialog, and use the Test Selector to quick select the relevant
user test.
• Right-click on the buttons in the control panel to view
the right-click menu. Click to enable or disable selections
of your choice.
• Right-click on the blue masking link area in the control
panel to view the Masking Options right-click menu.
Click to enable or disable selections of your choice.
Tone testing
Test ear selection
•Right
•Both
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8 Control panels and on-screen controls