Maico MA 41 Operating Instructions Manual
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Maico MA 41 Operating Instructions Manual

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MAICO Diagnostic GmbH
Operating Instructions MA 41
MAICO Diagnostic GmbH • Salzufer 13/14 • D-10587 Berlin • Tel.: +49 30 707146-50 • Fax: -99

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  • Page 1 MAICO Diagnostic GmbH Operating Instructions MA 41 MAICO Diagnostic GmbH • Salzufer 13/14 • D-10587 Berlin • Tel.: +49 30 707146-50 • Fax: -99...
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  • Page 3: Table Of Contents

    3.4 Rear Panel Connections ............... 5 4 Working with the MA 41 ............... 7 4.1 Using the Control Panel of the MA 41 ..........7 4.2 Functionality of Operating Elements ............ 9 4.3 The Display of the MA 41 ..............12 5 Measurement Methods of Audiometry ..........
  • Page 4 Operating Instructions MA 41 6 Quick Reference Guide ................. 29 6.1 General Setup ................... 29 6.1.1 Startup settings ................ 29 6.1.2 Transducer Selection ..............29 6.1.3 Signal Selection ................ 29 6.1.4 Masking ................... 29 6.2 Tone and Speech Audiometry ............29 6.2.1 How to Select Tone or Speech Audiometry Mode ......
  • Page 5 Operating Instructions MA 41 8100456_OI_MA41_EN_15a 8100456-8 04/15...

  • Page 6: Introduction

    CE-symbol according to Medical Directive 93/42/EEC. In designing the MA 41 we placed particular importance on making it a user- friendly device, meaning its operation is simple and easy to understand. All functions of the MA 41 are software controlled, allowing for easy upgrades of new features and functions in the future.

  • Page 7: Intended Use

    Results can also print directly via the USB printer or stored as a PDF file on the included SD memory card or USB flash drive. The MA 41 can be connected to the PC via USB to track the session and store results in NOAH or the MAICO Database.

  • Page 8: Getting Started

    3 Getting Started 3.1 Unpacking the Instrument Prior to shipping, the MA 41 was carefully packed and inspected. However, it is good practice to thoroughly inspect the outside of the shipping box for signs of damage. If any damage is noted, please notify the carrier immediately.

  • Page 9: Calibration Of The Device

    The use of non-calibrated audiometers can lead to incorrect results! 3.3 Where to setup The MA 41 should be operated in a quiet room, so that the audiometric examinations are not influenced by outside noises. Ambient sound pressure levels in an audiometric test room shall not exceed the values specified in the norm ISO 8253-1:2010 or ANSI S3.1-1999.

  • Page 10: Rear Panel Connections

    17 : Phone right channel 9 : Monitor phone output socket Place the MA 41 on a stable counter or table. Plug the power cord into the power socket on the rear panel. Connect all accessories with the appropriate sockets as shown above. Plug the power cord into a grounded outlet.
  • Page 11 Operating Instructions MA 41 detected the startup is stopped and a description of the error will be shown on the display. In this case please contact your local dealer for service. 8100456_OI_MA41_EN_15a 8100456-8 04/15...

  • Page 12: Working With The Ma 41

    The frequency can be adjusted with the Plus (4) and Minus (5) buttons on both sides of the instrument. The ergonomic design of the MA 41 makes it easy to control the dB level, signal presentation, and frequency adjustments with one hand.
  • Page 13 Operating Instructions MA 41 An extensive user menu for the customization of the MA 41 is available for advanced users (see chapter 7). 8100456_OI_MA41_EN_15a 8100456-8 04/15...

  • Page 14: Functionality Of Operating Elements

    The following table describes the main functions of each button for the tone and speech audiometry screens: Figure 3 - Control Panel MA 41 Level control: adjusts the hearing level for the left/right ear STIM bar: presents or interrupts the signal for the left/right ear...
  • Page 15 Operating Instructions MA 41 Tone: Select New, to delete all stored results and start a new session Speech: Reset the result percentage counter or Play wave file Channel STIM Mode button/TALK: to change from presenter to interrupter mode, or to talk to the patient by pressing and holding the...
  • Page 16 Operating Instructions MA 41 (17) Functional selector button Menu: to enter the user menu, where settings can be adjusted, results can be printed out or stored as PDF on SD memory card or USB flash drive or the patient list can be entered...

  • Page 17: The Display Of The Ma 41

    The display has an energy saving function; the backlight of the display is automatically dimed after approximately three minutes. Any action with the MA 41, such as pressing a button or rotating the dial, will immediately illuminate the backlight. 8100456_OI_MA41_EN_15a...

  • Page 18: Measurement Methods Of Audiometry

    For hygienic reasons it is important to disinfect the ear cushions on the headphone between patients (see chapter 8). 5.1 Tone Audiometry The MA 41 supports tone audiometric testing methods. The following testing methods can be started in the tone audiometry mode and the results can be saved to the instrument.

  • Page 19: Pure Tone Testing

    Operating Instructions MA 41 5.1.1 Pure Tone Testing During pure tone audiometry, the patient’s hearing threshold is measured. Typically the threshold search begins with air conduction testing in the ear with better hearing. While viewing the tone screen the following settings will be displayed.
  • Page 20 Operating Instructions MA 41 Use the frequency plus (4) or minus (5) keys to increase or decrease the frequency. Press the STIM button (the blue button touching the attenuator dials) to present or interrupt the tone. The status LED for the stimulus mode button (8) will illuminate when the tone is presented.
  • Page 21 Operating Instructions MA 41 5.1.1.1 Masking Masking is required if there is a notable threshold difference between the left and right ears. It is possible for sound to be transmitted to both ears via bone conduction while testing the poorer ear. This is called “crossover.”...

  • Page 22: Bone Conduction Testing

    Automatic Masking With the manual masking, as described before, the masking level should be adjusted every time you change the test signal level. The MA 41 has a tracking function for easy masking. Set the tone level and the masking level to a desired difference for effective masking.

  • Page 23: Sound Field Testing (Optional)

    Operating Instructions MA 41 Perform the test utilizing the same method as air conduction testing. If you are using bone conductor with contra lateral masking like the BKH 10, connect the contra phone to the left insert phone socket (14, Fig. 1). If masking is switched on, the masking noise will be routed to this output.

  • Page 24: Stenger

    Operating Instructions MA 41 5.1.5 Stenger The Stenger test is a test to confirm the presence of pseudohypacusis. During this test two tones of the same frequency will be presented simultaneously to both ears, and only the louder tone will be perceived. Select HL to perform the Stenger test and select both ears (9).

  • Page 25: Speech Audiometry

    5.2.1 Input Calibration The MA 41 must be calibrated to the particular speech test to ensure valid test levels. That means every time you change the speech test CD you must recalibrate the instrument.

  • Page 26: Performing Speech Testing

    Operating Instructions MA 41 5.2.2 Performing Speech Testing Use the functional button for Speech on the right side of the tone screen (16) to switch to speech testing. The speech test screen will open, and the unit will default to the right ear and the level will be set to the default value.

  • Page 27: Speech Audiometry With Microphone Or Cd Player

    Operating Instructions MA 41 5.2.3 Speech Audiometry with Microphone or CD player Connect the microphone or CD player to the corresponding input (10). Select the test ear (9) and MIC or CD as signal source by the functional button (11).

  • Page 28: Speech Audiometry With Wave Files

    Operating Instructions MA 41 5.2.4 Speech Audiometry with Wave Files If Wave is selected by the speech signal selector (11) a menu will pop-up with the available word lists, stored on the SD memory card. A word list can be selected by using the level controls to scroll through the list.

  • Page 29: Masking

    Operating Instructions MA 41 5.2.5 Masking Speech audiometry masking can be used in the same manner as described in chapter 5.1.1.1 for pure tone audiometry. Instead of narrowband noise, speech noise (SN) is applied when masking is turned on. Masking noise is activated in the non-test ear by pressing the functional button Masking On/Off (15).

  • Page 30: Monitoring

    Operating Instructions MA 41 5.3 Monitoring All signals presented to the patient can be monitored by the examiner via a monitoring headset or the internal speakers. For this purpose, press the Monitor button (6) and the monitor screen will appear.

  • Page 31: Documentation Of The Results

    Operating Instructions MA 41 5.5 Documentation of the Results All stored results can be directly printed via the USB printer. Make sure that a compatible printer is connected via the USB port (4) and the device is configured according to the connected printer settings; refer to menu settings in chapter 7.2.

  • Page 32: Patient Management

    Operating Instructions MA 41 5.6 Patient Management The patient management option allows the results of the audiological tests to be stored on the SD memory card. The results can be reloaded at a later time to be reviewed, edited, or printed. Patients can be stored by a number ID or by entering the name and birth date.
  • Page 33 Operating Instructions MA 41 Figure 13 – New Patient Enter the characters of the name by scrolling through the alphabet with the level controls and enter the selected character by using the Stimulus button (2). Jump to the next or previous field by using the Frequency Up (4) or Down (5) button.

  • Page 34: Quick Reference Guide

    Operating Instructions MA 41 6 Quick Reference Guide 6.1 General Setup 6.1.1 Startup settings • Air conduction • Pure tone on the right channel, left channel is switched off • 30 dBHL tone • Presenter mode 6.1.2 Transducer Selection Select the transducer to be used, headphones (Phones) or insert phones (Insert), by pressing the appropriate button (10).

  • Page 35: Tone Audiometry

    Operating Instructions MA 41 6.2.2 Tone Audiometry Frequency Selection Use one of the two sets of frequency keys (4) or (5) to select the frequency. The maximum and minimum frequency depends on the transducer you have selected. Warble Tone Press the Test Signal button (12) to activate the warble tone. The LED will highlight Warble.

  • Page 36: Speech Audiometry

    Operating Instructions MA 41 To store the actual settings press OK (19). 6.2.3 Speech Audiometry To select speech audiometry, select Speech (16) and the test SRT or WRS (13). Use the frequency up (4) and down (5) key to select a word in the word list.

  • Page 37: User Menu

    Operating Instructions MA 41 7 User Menu The User Menu enables the user to customize the device to meet their specific needs. Additionally, the menu allows the user to printout the results via USB printer, store the results as a PDF on an SD memory card or USB flash drive, and the ability to enter the patient list.
  • Page 38 Operating Instructions MA 41 highest and lowest frequency was reached Stop: Frequency control function stops at highest and lowest frequency Wrap: Jumps to the lowest/highest frequency when the highest/lowest frequency Standard Select/deselect Frequencies Default Level On/Off: Set default level Level...
  • Page 39 Operating Instructions MA 41 Controller Assign ear side fixed to the Signal Assignment left or right controller; - Same, left dial controls level of the left ear, right dial the level of the right - Interchanged, left and right dial controls the level...
  • Page 40 Operating Instructions MA 41 Change Frequency Moves to next test Store Properties After Store frequency after storing a threshold (on) or stays on same frequency after storing (off) Change Level After Change in level after Store storing a threshold (stay at...
  • Page 41 Operating Instructions MA 41 Number of Diagrams No audiogram, only the in Tone Test level and frequency, one combined audiogram or two separate audiograms for left and right Bone Lines On/Off, displays a dotted line, connecting the bone conduction results...

  • Page 42: Set Up Date And Time

    Operating Instructions MA 41 7.1 Set up Date and Time Select Date/Time in the user menu by scrolling down with the left or right level control (1) and select Set Date/Time by using the stimulus presenter bar. The following screen will appear: Figure 15 - Date and Time Settings Set the date format to International or US by the functional button (9).

  • Page 43: Set Printer Settings

    Operating Instructions MA 41 7.2 Set Printer Settings Select the printer by turning the left or right level control (1) down. The color mode is automatically adjusted. If the color mode is wrong adjust the color mode as well. Jump to the field paper format by pressing the stimulus presenter bar several times and select A4 or Letter format by using the level controls.

  • Page 44: Disinfection

    After receiving the key, store it as text file with the name Key.txt on your SD memory card, then insert the card to the SD card slot of your MA 41 and switch it on. The feature will be activated automatically and the functionality will be available.

  • Page 45: Connection To The Pc

    Install the included software on your PC. The driver for the device will be installed automatically. Connect the MA 41 by USB cable to the PC and turn on the device. The required driver will be installed. Please follow the installation procedure.
  • Page 46 Operating Instructions MA 41 Once the instrument is linked to the PC audiometry software, you are able to record the results while performing your audiological assessment. Make sure that the software is running and that a connection is built up before starting a new session.

  • Page 47: Technical Data

    Operating Instructions MA 41 12 Technical Data The MA 41 audiometer is an active, diagnostic medical product according to the class IIa of the EU medical directive 93/42/EEC. Standards: IEC60645-1 / EN 60645-1: Type 2 IEC60645-2: Type B ANSI S3.6-1996 / ANSI S3.6-2010:...
  • Page 48 Operating Instructions MA 41 Insert earphones Ear 3A: - 10 dB ... 120 dB Sound field speaker: - 10 dB ... 90 dB , for CD 220 Test Signal: Pure tone, Pulse tone, Warble tone Narrow Band Noise: 5/12 Octave...
  • Page 49 Operating Instructions MA 41 Supported printers: External Devices: HP (PCL 3 and PCL 5e) Epson (ESC/P2, LQ, Stylus Color) Canon (iP100, iP90, BubbleJet) USB keyboard Tone Presenter / Interrupter Stimulus Functions: Interlock (tone presentation of both channels simultaneously) Tracking (fixed level difference...
  • Page 50 Operating Instructions MA 41 Figure 19 – Connection Sockets of the MA 41 Connection sockets Specification Power switch on/off Power (100 ... 240 V~ 50/60 Hz) Network Ethernet USB out USB 2.0 USB in USB 2.0 Patient response switch RI= 500 ...
  • Page 51 Operating Instructions MA 41 Standard Accessories: Items Item Number MA 41 audiometer includes: 8013739 DD45 headphones 88010880 B71W bone conductor 8102514 Patient response switch 8011091 Power cable 8011237 Gooseneck microphone 8006479 SD memory card (2 GB) 8010775 Optional Accessories: Item...

  • Page 52: Warranty, Maintenance And After-Sales Service

    The MA 41 may be repaired and serviced only by your dealer or by an authorized service center. We urgently advise you against attempting to rectify any faults by yourself or commissioning non-experts to do so.

  • Page 53: Safety Regulations

    READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM. 14.1 Electrical Safety The MA 41 audiometer is constructed to comply with protection class I of the international standard IEC 601-1 (EN 60601-1). The instruments are not intended for operation in areas with an explosion hazard.

  • Page 54: Measuring Security

    Operating Instructions MA 41 14.2 Measuring Security To guarantee that the audiometer works properly, the instrument has to be checked and calibrated at least once a year. The service and calibration must be performed by an authorized service center. In accordance with the regulations of the EU Medical Directive, warranties may be void if these checks are not done.

  • Page 55: Appendix A: Checklist For Subjective Audiometer Testing

    Operating Instructions MA 41 Appendix A: Checklist for subjective audiometer testing - Clean the ear and head cushion! Instrument:........- Untangle all lines when necessary! - Are the headphone cushions in good condition? Manufacturer:…........ If not replace. - Are plugs and leads in good condition/ undamaged? - Are all controls working properly? Serial No.:.........

  • Page 56: Appendix B: Calibration Values And Maximum Levels

    Operating Instructions MA 41 Appendix B: Calibration values and maximum levels Headphone DD45 with Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN dB re 20µPa dB re 20µPa 47.5 51.5 27.0...
  • Page 57 Operating Instructions MA 41 Headphone Holmco 8103 with Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN dB re 20µPa dB re 20µPa 39.5 43.5 25.0 29.0 18.5 22.5 13.5 18.5 1000 12.0...
  • Page 58 50.5 83.0 88.0 18000* 105.0 110.0 20000* *Calibration values for 18 kHz and 20 kHz are not covered by the norm ISO389-5 and defined by MAICO Diagnostic GmbH Signal IEC60645-2 IEC Max Level ANSI S3.6 RETSPL ANSI Max Level RETSPL Speech 20.0...
  • Page 59 Operating Instructions MA 41 Insert phone Eartone 3A Reference equivalent threshold sound pressure level Frequency Hz Tone IEC NBN IEC 60318- Tone sound damping 60318-5 Max Level dB Max Level dB RETSPL dB re RETSPL dB re 20µPa 20µPa 26.0 30.0...
  • Page 60 55.00 35.00 55.00 Sound field (0 degree incidence) Reference equivalent threshold sound pressure level and maximum hearing levels For Canton CD 220 / Maico SBC speaker ISO 389 – 7 and ANSI S3.6-1996 Frequency Hz Tone RETSPL NBN RETSPL Max level Tone dB...
  • Page 61 Operating Instructions MA 41 Specifications are subject to change without notice. MAICO Diagnostic GmbH Salzufer 13/14 10587 Berlin Germany Phone: +49 30 70 71 46 50 Telefax: +49 30 70 71 46 99 E-mail: sales@maico.biz Internet: www.maico.biz 8100456_OI_MA41_EN_15a 8100456-8 04/15...

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