natus Madsen A450 Reference Manual
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natus Madsen A450 Reference Manual

Pc-controlled audiometer
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Madsen A450
Reference Manual
Doc. No.7-50-1840-EN/05
Part No.7-50-18400-EN

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  • Page 1 Madsen A450 Reference Manual Doc. No.7-50-1840-EN/05 Part No.7-50-18400-EN...
  • Page 2 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 2021-06-10 (221278) Technical service and support Please contact your supplier.

  • Page 3: Table Of Contents

    2.9.6 Scoring phonemes using integrated Otosuite speech material 2.9.7 Scoring phonemes using external sound source 2.9.8 Saving source levels for speech material 2.9.9 Speech editing options - tabular view 2.9.10 Storing SNR for Speech testing 2.9.11 Speech feature boxes Madsen A450...
  • Page 4 Requirements to the location 6.1.1 Requirements to noise in the test environment Unpacking Storing Views of Madsen A450 Madsen A450 connection panel Assembling Madsen A450 Desktop or wall-mount installation Connecting accessories and PC to Madsen A450 Powering Madsen A450 Madsen A450...
  • Page 5 Maintenance Cleaning Calibration 10 Troubleshooting 10.1 Powering 10.2 Software/device communication 11 Standards and Safety 11.1 Madsen A450 11.2 Warnings, cautions, and notes 11.2.1 Connector warnings 11.2.2 General warnings 11.2.3 General cautions 11.2.4 General notes 11.3 The Otosuite Audiometry Module 12 Technical specifications 12.1 Accessories...

  • Page 6: Introduction

    Insert phones • Bone conductor • Sound field loudspeakers. The speakers can use either the power amplifier built into Madsen A450 or an external power amplifier. The Otosuite Audiometry Module Otosuite Otosuite is a software tool that integrates a suite of hearing tests and hearing instrument fit- ting functionality with result review and reporting capabilities into a single powerful PC application.

  • Page 7: Noah

    About this manual This is your guide to installing, calibrating and using Madsen A450 and to using the Otosuite Audiometry Module. It also introduces you to the key features of the device and the software, as well as to working scenarios for performing tests and viewing and printing test results.

  • Page 8: Typographical Conventions

    ► Training It is recommended that you read this manual and try out test scenarios before you start operating Madsen A450 so that you are familiar with both the device and the software program before testing a patient. Typographical conventions...

  • Page 9: Intended Use

    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.

  • Page 10: Navigating In The Otosuite Audiometry Module

    D. Control panel The control panel ► Work area The Tone test screen ► The Speech test screen ► Feature boxes Tone feature boxes ► Speech feature boxes ► G. Masking level indicator, stimulus marker The audiogram ► Madsen A450...

  • Page 11: Toolbar Icons And Menus

    Click to select the perspective of the patient's ears as presented on  > entation the screen for graph and table views. You can also select the location of the stimulus control. View Manual entry  > Click to create an audiogram manually. Madsen A450...

  • Page 12: File Menu

    Click to select the perspective of the patient's ears as presented on the screen for graph and table views. Enable or disable the Masking Assistant. Masking Assistant The Masking Assistant causes an unmasked threshold to flash repeatedly if masking is recommended. ► • The Masking Assistant Madsen A450...
  • Page 13 Click to enable or disable the display of the audiogram legend. The legend contains the most commonly used symbols for the audiogram. It is not configurable. The graph shows up to 20000 Hz. Madsen A450 presents stimulus up Standard / All / High to 12500 Hz.

  • Page 14: Measurement Menu

    Note Allow • Be aware that background noise must not be present if stimulation is checked. Scoring and Playing ► Selecting word or phoneme scoring Madsen A450...

  • Page 15: Tools Menu

    Pure Tone Hearing Thresholds, Audiologists’ Desk Reference - Vol 1, James W. Hall III, H. Gustav Mueller III, Singular Publishing Group 1997 Munro K.J., Agnew N. A comparison of inter-aural attenuation with the Ety- . and motic ER-3A insert earphone and the Telephonics TDH-39 supra-aural earphone. Br J Audiol 1999; 33: 259-262 Madsen A450...
  • Page 16 ... > Assistant Min IA is frequency specific These are the Min IA tables for TDH-39 and Natus Inserts used in the Masking Assistant 1 Katz, J., Lezynski, J. (2002). Clinical Masking. In J. Katz, ed., Handbook of Clinical Audiology , Williams and Wilkins, Bal- N.

  • Page 17: The Control Panel

    Munro & Agnew, BJA (1999) 4000 Munro & Agnew, BJA (1999) 6000 Munro & Agnew, BJA (1999) 8000 Munro & Agnew, BJA (1999) The control panel Control Panel Click the icon in the toolbar to activate the Control Panel. Madsen A450...
  • Page 18 Click to enable or disable selections of your choice. Tone testing Test ear selection Right • Both • • Left Transducer selection • Air conduction Phones (standard headphones) Insert • Air conduction (earphones) • Bone conduction Bone (bone conductor) Madsen A450...
  • Page 19 Pulsed • Test type selection • (audiogram threshold curve) • (Speech Recognition Threshold) • (Word Recognition Score) • (Most Comfortable Loudness level) • (Uncomfortable Loudness level) Speech testing Test ear selection Right • Both • Left • Madsen A450...
  • Page 20 Monitor and Level dialog. Test Selector Test Selector Click to open the dialog. The Control Panel right-click menu Right-click on the buttons in the control panel to view the right-click menu. Click to enable or disable selections of your choice. Madsen A450...
  • Page 21 • • (Speech Detection Threshold) (Speech Material) • (Speech Recognition Threshold) (Speech Material) • (Word Recognition Score) (Speech Material) • (Signal to Noise Ratio) (Speech Material) Masking Transducer Insert • Selection • Phone Bone • (Speech Material) • Madsen A450...

  • Page 22: The Stimulus Bar

    The green triple wave symbol above the level indicates that the stimulus is currently being presented. Stimulus bar color Indicates the routing for each channel: • Blue = left ear • Red = right ear • Blue/Red = binaural • Gray = unspecified Madsen A450...

  • Page 23: Test Controls

    Audiometry General On-screen controls Silence Mode • To enable silence mode, select  >  >  >  >  >  > • To change the level and frequency by more than one click at a time, use the mouse scroll wheel. Madsen A450...

  • Page 24: The Tone Stimulus Bar

    You can display speech score and word count either as “% Correct” or as “% Incorrect”. To set your pref- Tools Options Speech Misc. Score Presentation erence, select  >  >  >  > % Correct is the default setting. Madsen A450...

  • Page 25: The Tone Test Screen

    With a description of audiogram elements, how to view single or dual graphs, and how to view the intensity levels used for masking. • Tone feature boxes ► With a description of result boxes for special tests, utilities such as a timer and an overlays selector, and instructions for how to view/hide the feature boxes. Madsen A450...

  • Page 26: The Audiogram

    Intensity is shown to the left of the audiogram in dB HL. • Octave frequencies are shown below the audiogram in Hz. • Interoctave frequencies are shown above the audiogram in Hz. Viewing the audiogram You can choose between: Madsen A450...
  • Page 27 Below the audiogram, the intensity levels used for masking can be displayed. It is an option to display the masking Tools Options Tone View Misc. Masking Levels levels. Select  >  >  >  >  > • In combined view, the non-test ear masking levels are shown below the graph. Madsen A450...

  • Page 28: Curves And Symbols Selection

    Vertical Offset You can superimpose symbols on the audiogram where two different points share the same value (i.e. air and bone threshold). In order to see both superimposed symbols, you can define an offset direction for each individual symbol. Madsen A450...

  • Page 29: Compare Audiograms

    2.7.5 Tone feature boxes Tone You can access a number of Tone view options directly from the main screen. Tools Options Tone The view options can be turned on/off. To do so, select  >  > Madsen A450...
  • Page 30 These overlays assist in the counseling process. Tools Options Audiometry Tone Overlay Selection Box. • Select  >  >  >  > The overlay options are: Pictures Displays pictures representing common environmental sounds at their approximate dB level (e.g. bird, plane). Madsen A450...

  • Page 31: Tone Editing Options

    Deletes a selected data curve. Insert “No Response” • Inserts a “no response” symbol (default: symbol with arrow down- ward) on the audiogram. You can also access the “no response” symbol by holding down the "S" key on the keyboard. Madsen A450...

  • Page 32: Work-Flow Related Features

    (and level) when you store a point in the audiogram. To do so, select  >  >  > Measurement Auto Freq./Level Shift  > Note Masking is always switched off when the frequency is changed automatically. • You can set up the definitions for each of the test types THR/MCL and UCL individually: Madsen A450...

  • Page 33: Stimulus Duration

    If you use an external masking signal (non-audiometer masking noise) for speech masking, you can choose to store the presentation level of the non-stimulus channel as a masking level. Tools Options Speech Measurement Use Non-Stimulus Channel as Masking To do so, set  >  >  >  > Madsen A450...

  • Page 34: The Speech Test Screen

    2 Navigating in the Otosuite Audiometry module The Speech test screen Madsen A450 is intended for use with predefined speech pro- tocols that are loaded automatically when you select a user test. You can have a full overview and instantly select measurement type, ear, transducer, stimulus type, routing, and speech material.

  • Page 35: Creating And Editing The Speech Test Table

    The control contains four different columns as listed and described below. These columns present various controls, which you can com- bine to define how to run the test. To set up word or phoneme scoring, Madsen A450...
  • Page 36 Defines the total number of phonemes in the word. The default is 3 phonemes intended for monosyllabic words. The corresponding number of buttons is enabled in the Speech Player Panel , and on the Numerical pad of the PC keyboard. Madsen A450...
  • Page 37 The percentage is calculated based on the total number of words you have defined in advance - Tools  > Options  > Audiometry  > Speech  > Scoring and Playing  > Number of items to play back Phoneme/Sentence scoring Does not apply to phoneme scoring. Madsen A450...
  • Page 38 Does not apply to external sound source speech material. Phoneme/Sentence scoring When the number of correct phonemes has been scored for a word, the next word is presen- ted. External speech material: Does not apply to external sound source speech material. Madsen A450...

  • Page 39: Selecting Speech Stimulus

    Continuous Playback , the scoring is set automatically. External speech material: Does not apply to external sound source speech material. 2.9.3 Selecting speech stimulus Note • Only use speech material supplied by Natus. Madsen A450...
  • Page 40 – For binaural speech, select the same stimulus as in the primary stimulus channel (Mic, or recorded source). File/track/list selection 3. You can find the speech material files in the drop-down list. Madsen A450...

  • Page 41: Scoring Words Using Integrated Otosuite Speech Material

    2 Navigating in the Otosuite Audiometry module Speech list files (provided by Natus) When you use integrated Otosuite Speech Material, you can choose between speech lists in the File/track/list selection drop-down list. File Control Panel • Select in the . The installed Otosuite speech material will now be listed in the upper drop-...
  • Page 42 When you mouse over an item in the speech list, a Play button appears to the left of Play the item. Click the button to present the item to the patient. The word currently playing is indicated by a musical note and highlighted in blue in the list. Madsen A450...

  • Page 43: Scoring Words Using External Sound Source

    Speech material selection (disabled when Line In is selected) G. File/track/list selection (disabled when Line In is selected) Setting up for Scoring and Playing ► To set up for scoring and playing, see Selecting word or phoneme scoring Madsen A450...

  • Page 44: Scoring Phonemes Using Integrated Otosuite Speech Material

    This can be configured specifically for each item in the integrated Speech material. Please contact your sup- plier for further information. Setting up for Scoring and Playing ► To set up for scoring and playing, see Selecting word or phoneme scoring Madsen A450...
  • Page 45 Using word lists with monitored live voice testing Mic. When you have loaded an integrated Otosuite Speech Material, you can use the word list to read from using stimulus, for live voice testing. Store the phoneme score results The Speech test screen ► Madsen A450...

  • Page 46: Scoring Phonemes Using External Sound Source

    Tools  > Options Audiometry Speech View Score Presentation  >  >  >  > • Click on the relevant phoneme score counter button to record the response of the client. Store the phoneme score results The Speech test screen ► Madsen A450...

  • Page 47: Saving Source Levels For Speech Material

    The next time you play any file from this folder, it will be calibrated to the level set in the "0.speech- level" file. 2.9.9 Speech editing options - tabular view When you right-click any of the rows in tabular view, the fol- lowing options appear: Madsen A450...
  • Page 48 (BC), and the calculated Articulation Index (AI) for that ear. The PTA and AI are automatically calculated from the tone audiogram. Tools Options Audiometry General Misc. • To configure pure tone average (PTA) calculation, select  >  >  >  >  > Frequency AC/BC Madsen A450...

  • Page 49: Storing Snr For Speech Testing

     >  > eral  > Misc.  > PTA Frequency AC/BC • The AI is calculated according to the “Count-the-dot” method. Stenger Displays the results of a speech Stenger test (optional). • Scoring options are positive (+) or negative (-). Madsen A450...

  • Page 50: Safety When Using Live Speech

    Dosimeter SPL Peak Level Max time A dosimeter is built into Madsen A450. If you are using live speech, it will < 79.9 be working in the background as a safety precaution. The system monitors the sound level versus duration of exposure (1) .

  • Page 51: Special Tests

    The patient is instructed to report any jumps in loudness detected while listening to the sustained tone for a period of about two minutes. 2.10.2.1 Navigating in SISI The Control Panel Channel Continuous On When checked, the stimulus will be continuously on and will turn off when you press the stim- ulus button. Madsen A450...
  • Page 52 This determines the dB step size for the intensity of the stimulus when presenting the tone automatically using the play button. Options are 1 dB, 2 dB, and 5 dB. Natus recommends using a step size of 1 dB for testing.
  • Page 53 The score box tracks the number of 1 dB intensity changes presented and the number of 1 dB intensity changes the patient heard. The percentage is a ratio of the number of intensity changes heard compared to the number of intensity changes presented. Madsen A450...

  • Page 54: The Test Process - Sisi

    10 times out of the 20 1 dB increments, the sensitivity index is 50%. Before starting the test Before starting the test, present five 5 dB increments to give the patient a noticeably intense increment to respond to. Madsen A450...

  • Page 55: Ablb (Alternate Binaural Loudness Balance)

    ABLB dB Step This determines the dB step size for the intensity of the ABLB test stimulus. Options are 1 dB, 2 dB, and 5 dB. Natus recommends using a step size of 1 dB for testing. ABLB Stimulus Bar A.
  • Page 56 Controlling intensity and frequency, and storing data • Arrow up increases the intensity. Arrow down • decreases the intensity. Arrow left • decreases the stimulus frequency. • Arrow right increases the stimulus frequency. Store • Stores the data point. Madsen A450...
  • Page 57 Delete selected measurement • Deletes the data for the frequency that is currently displayed. Delete all at x (e.g. 1000) Hz • Deletes the data for that particular column when the frequency is currently set differently from that column. Madsen A450...

  • Page 58: The Test Process

    Test controls (keyboard, mouse) 2.11.1 PC keyboard controls You can open an overview of PC keyboard shortcuts from the Otosuite Manuals file. Otosuite Manuals was installed on your PC when you installed Otosuite. You can Otosuite Manuals Start open from the Windows menu. Madsen A450...

  • Page 59: Preparing For Testing

    Preparing for testing It is important to prepare properly before making measurements with Madsen A450 and the Otosuite software. It is time- saving for both you and the client if the environment, the client, the test device, and the software are ready for the test.

  • Page 60: Listening Check

    Launch Otosuite and the Audiometry module on the PC (see the Otosuite User Guide). • Make sure Madsen A450 is switched on. • Make sure the connection between the Audiometry module and Madsen A450 is enabled. ► Configuring the Audiometry Module Listening check Perform listening checks routinely to make sure that the equipment is functioning properly.

  • Page 61: Preparing The Client

    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. If the foam eartip is a little too large, consider cutting it down to make it a little smaller. Madsen A450...
  • Page 62 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. Madsen A450...

  • Page 63: Examples Of Audiometric Testing

    Talk to the patient occasionally. Encourage the patient to concentrate on the task. This will keep your patient from getting bored or becoming an unreliable responder. 14. Switch to the other ear and tell the patient to listen for the sounds in that ear. Madsen A450...

  • Page 64: Assessing Pure Tone Or Speech Most Comfortable Loudness Level (Mcl)

    1. Properly place the earphones. – Begin the test with the air conduction transducer. 2. Instruct the patient that you are trying to find the level at which the sound is uncomfortably loud. It should be tol- erable and not painful. Madsen A450...

  • Page 65: Assessing Speech Reception Threshold (Srt) Using The Hughson/Westlake Procedure

    9. Switch to the other ear and tell the patient to listen for the words in that ear. 10. Repeat steps to 7. 11. The SRT will be ± 8 dB of the PTA for each ear if the data are reliable. 5.1.5 Assessing word recognition score 1. Properly place the earphones. Madsen A450...

  • Page 66: Special Tests

    5. Make sure that the tone decay box and the timer box have appeared in the display. 6. Start the test at 5 dB above the patient's threshold for that frequency in that ear. 7. As soon as the subject responds, start the timer. You will be presenting a tone for at least one minute. Madsen A450...

  • Page 67: Performing A Pure Tone Stenger

    You must suspect that the patient is malingering. 2. Properly place the earphones. Begin the test with the air conduction transducer. 3. Instruct the patient to repeat the word back to the examiner even if the word is very soft. Madsen A450...

  • Page 68: Performing Weber

    4. Strike the tuning fork against the knee or the elbow, not the table, otherwise the vibrations will be excessive and cause the patient discomfort. 5. Hold the fork for 2-3 seconds and then place it on the patient's mastoid. Madsen A450...

  • Page 69: Performing Alternate Binaural Loudness Balancing (Ablb) Test

    Press the button on the responder immediately each time you hear a change." SISI SISI 4. Choose the tab or select in the Test Selector. – Make sure that the control panel of the Otosuite software is set to the correct transducer and desired routing. Madsen A450...

  • Page 70: Testing With Sound Files

    Reset Score Counter False • Does not change the score even if Reset is clicked. 5.3.2 Playing sound files with word lists Prepare playing Int. CD Int. File Sound Source 1. Use either Madsen A450...
  • Page 71 Reset Score Counter False • We actually reset the score in some cases even if Reset Score Counter False . This is in situations where we go from Stimulus CH1 Stimulus CH2 Mic. using a word list to e.g.  =   =  Madsen A450...

  • Page 72: Unpacking And Installing

    6 Unpacking and installing Unpacking and installing This section applies to Madsen A450 as well as to the various accessories available. If the accessories are not part of your configuration, disregard the instructions relating to the accessories. To install and get started with Madsen A450 and the Otosuite Audiometry module, follow the sequence below: •...

  • Page 73: Unpacking

    Storing If you need to store Madsen A450 before you put it into operation, follow the guidelines below: • Store Madsen A450 and accessories in the boxes provided to protect the equipment from damage.

  • Page 74: Madsen A450 Connection Panel

    6 Unpacking and installing Madsen A450 connection panel Install Otosuite on the PC before you connect Madsen A450 to the PC. 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: •...
  • Page 75 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.

  • Page 76: Assembling Madsen A450

    When you connect other electrical equipment to Madsen A450, remember that equipment that does • not comply with the same safety standards as Madsen A450 can lead to a general reduction in the system's safety level. J. Operator monitor headset - headphones •...
  • Page 77 6 Unpacking and installing For Otosuite installation instructions, see the Otosuite Installation Guide, on the Otosuite installation medium. Warning To connect Madsen A450 to the PC, use the supplied USB cable. The cable length must not • exceed 3 m (approx. 10 feet).

  • Page 78: Connecting Accessories And Pc To Madsen A450

    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.

  • Page 79: Configuring The Audiometry Module

    Preferences Enable BSA (United King- • Click to enable storing Tone audiometry according to the recommendations of the dom only) British Society of Audiology. Use Masking Threshold • If the BSA masking threshold is needed, click to enable. Madsen A450...
  • Page 80 7 Configuring the Audiometry Module Preferences SRT Designation • You can define how SRT data is stored in NOAH by selecting the appropriate type of speech material designation. This enables proper viewing in NOAH AUD. Madsen A450...

  • Page 81: Communicating With The Device

     > About Device Reconnecting to the device If communication with Madsen A450 is interrupted, a message appears stating that there is no longer connection to the device. The system will automatically try to reconnect. • If automatic reconnection fails, try disconnecting and reconnecting the USB cable.

  • Page 82: Maintenance And Calibration

    Service and repair It is recommended that you keep the packing material in which Madsen A450 was delivered. If you need to send it in for service, the original packing material will ensure protection against damage during transport, etc.

  • Page 83: Calibration

    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.

  • Page 84: Troubleshooting

    A problem occurred in the 1. Try to disconnect and reconnect the USB was lost. USB cable communication. cable. 2. If this does not work, power off and then power on the device. 3. Contact technical support if the problem per- sists. Madsen A450...

  • Page 85: Standards And Safety

    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. Madsen A450 ► Warnings, cautions, and notes ►...
  • Page 86 5.3.9 (ISO ation to be supplied – Part pressure for transport and 7000-2621) storage. 1: General requirements. ISO 15223 Atmospheric pressure limitation ISO 7000 Atmospheric Pressure limitation Madsen A450...
  • Page 87 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. Madsen A450...
  • Page 88 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. Madsen A450...

  • Page 89: Warnings, Cautions, And Notes

    Republic of China 11.2 Warnings, cautions, and notes 11.2.1 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. Madsen A450...

  • Page 90: General Warnings

    11 Standards and Safety Fig. 1 Sockets with direct connections to patient transducers - Madsen A450 connection panel Isolated connectors • All connectors within the red frame are isolated from patient transducers. Note The safety standards listed in Standards and Safety ►...

  • Page 91: General Cautions

    To avoid the risk of electric shock, this equipment must only be connected to a mains supply with pro- tective ground. 11.2.3 General cautions Caution Do not re-use single use accessories such as eartips. • Caution • Keep the Madsen A450 away from sources of heat. Madsen A450...

  • Page 92: General Notes

    Do not use the device for purposes other than the applications defined in the intended use. Caution Madsen A450 requires regular maintenance to continue operating as intended. This includes visual • inspection, cleaning, and calibration. If the equipment shows signs of damage or material degradation, do not use the device and contact your supplier.

  • Page 93: Technical Specifications

    12 Technical specifications Technical specifications Type identification Madsen A450 is type 1081 from Natus Medical Denmark ApS. Channels Two separate and identical channels. Frequency range Insert earphones: Standard frequencies: 125 - 8000 Hz TDH39 earphones: Standard frequencies: 125 - 8000 Hz Standard frequencies: 250 - 4000 Hz Standard frequencies: 125 - 8000 Hz...
  • Page 94 250 to 4000 Hz: ±4 dB The reference conditions for the specification of frequency response and sound pressure level depend on the type of audi- ometer. Madsen A450 can be calibrated as either a “corrected” (Type AE) or “uncorrected” (Type A) speech audiometer: Madsen A450...
  • Page 95 1 or 5 dB step resolution over the entire range. HL Range The maximum output levels from Madsen A450 depend on the actual sensitivity of the individual transducers, and they will be slightly different for each device. However, the minimum requirements from IEC and ANSI standards are fulfilled for all devices per the IEC and ANSI standards listed in this Technical Specifications section.
  • Page 96 6000 8000 Distortion of signals occurs for higher stimulus levels. Madsen A450 complies with IEC and ANSI standards with respect to maximum distortion. The following specification from IEC 60645-1:2017 applies: Specification of allowable distortion levels for airborne sound (test level and distortion)
  • Page 97 - For children and below normal skull size HB7 shall be applied (HB7 provides a greater force required to accommodate smaller skull size) For audiometric testing outside of noise attenuating test rooms, Natus recommends using earphones which feature passive noise reduction. For the applicable earphone models, the attenuation is specified in the following table.
  • Page 98 Normal: The signal is presented when the Stimulus Presentation button is activated. Continuous ON: The signal is interrupted when the Stimulus Presentation button is activated. Pulse: The signal is pulsed. Pulse duration: 200 ms on and 200 ms off configurable Madsen A450...
  • Page 99 Additionally, Madsen A450 includes a feature which allows the operator to select the maximum output level from a bone conductor. Using this feature, the maximum output may be set lower than the physically available output level (installation option).
  • Page 100 (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 A450 has been stored in a cold environment. • Disposal Madsen A450 can be disposed of as normal electronic waste, according to WEEE and local regulations. Madsen A450...

  • Page 101: Accessories

    < 60 VA Mains cables 7-08-017 POWER CABLE, SJ, US HOSP. PLUG Essential performance Madsen A450 has no essential performance. Standards Audiometer: IEC 60645-1:2017, Type 2 Class A, ANSI S3.6:2004 Type 2A Patient Safety: IEC 60601-1:2005/A1:2012 Class II Type B (Ed. 3.1), UL 60601-1: CAN/CSA C22.2 No.
  • Page 102 2066 Speech Material CD, BE Speech Material 8-49-94500 2066 Speech Material CD, CH 2066 Speech Material DVD, FR - Lafon et Speech Material 8-49-95300 Fournier Speech Material 8-49-91800 1066 Speech Material with Mono-Syllable, ES Speech Material 22600171 Mainzer Sprachtest Nr 4 Madsen A450...
  • Page 103 Speech Material 22600928 International Matrix Test Arabic Speech Material 22600901-UP Oldenburger Messprogramm Speech Material 22600902-UP Oldenburger Satztest Speech Material 22600903-UP Oldenburger Kinder Satztest Speech Material 22600904-UP Oldenburger Kinder Reimtest Speech Material 22600905-UP Gottinger Satztest Speech Material 22600906-UP Kateforiale Lautheitstest Madsen A450...

  • Page 104: Notes On Emc (Electromagnetic Compatibility)

    Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems Madsen A450 is intended for use in the electromagnetic environment specified below. The user of Madsen A450 should ensure that it is used in such an envir- onment.
  • Page 105 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems within Professional Healthcare use environment Madsen A450 is intended for use in the electromagnetic environment specified below. The user of Madsen A450 should ensure that it is used in such an envir- onment.
  • Page 106 Guidance and manufacturer's declaration - electromagnetic emissions for all equipment and systems Madsen A450 is intended for use in the electromagnetic environment specified below. The user of Madsen A450 should ensure that it is used in such an envir- onment.
  • Page 107 Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting Madsen A450 is intended for use in the electromagnetic environment specified below. The user of Madsen A450 should ensure that it is used in such an envir- onment.
  • Page 108 : 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. Madsen A450...

  • Page 109: Manufacturer

    13 Manufacturer Manufacturer Natus Medical Denmark ApS Hoerskaetten 9, 2630 Taastrup Denmark +45 45 75 55 55 www.natus.com 13.1 Responsibility of the manufacturer The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only •...
  • Page 110 13 Manufacturer Madsen A450...

  • Page 111: Index

    CD/tape connections Cleaning range specifications Client inspecting the ear preparing for testing Icons Combined audiogram combined view, Audiogram Mod- enabling/disabling Configuration Wizard split view, Audiogram Connections Module bone oscillator Insert earphone CD/tape connections Counseling and Simulations head- phones Madsen A450...
  • Page 112 Menu bar Rinne OTOsuite feature box;Feature box Microphones Rinne operator boom microphone con- nection talk-back microphone Safety connection Warning notes Monitoring Screens OTOsuite main window Navigating in Audiometry Speech Tone, Audiogram Module Select orientation On-screen controls toolbar Silence Mode Madsen A450...
  • Page 113 Talk-back microphone connection combined audiogram Talk forward frequency range selecting Masking Assistant Technical specifications Overlays Test devices View menu (Aud) connecting audiogram legend information about combined audiogram views frequency range Test devices (Audiometry) masking assistant firmware update Overlays Madsen A450...
  • Page 114 Index Views of the device Warning notes Weber feature box;Feature box Weber Madsen A450...

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