Maico MA 42 Operation Manual
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Maico MA 42 Operation Manual

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  • Page 1 Operation Manual MA 42...

  • Page 3: Table Of Contents

    Where to Setup ................ 10 Rear Panel Connections ............11 Working with the MA 42 ............. 12 Using the Control Panel of the MA 42 ........12 Functionality of Operating Elements .......... 13 The Display of the MA 42 ............16 Measurement Methods of Audiometry ........
  • Page 4 Operation Manual MA 42 6.1.7.1 Preparation of the SISI Test ........... 24 6.1.7.2 Training of the Patient ............24 6.1.7.3 Performing the SISI Test ............25 6.1.8 The Threshold Decay (Carhart) Test ........26 6.1.9 ABLB ..................27 6.1.10 MLB ..................28 6.1.11...
  • Page 5 Operation Manual MA 42 Set Printer Settings ..............51 Cleaning and Disinfection Recommendations ......52 Connection to the PC ..............54 Technical Data ................55 Classification ................55 Technical Data ................. 55 Pin Assignment ................ 59 Warranty, Maintenance and After-Sales Service ....60 Safety Regulations ..............
  • Page 6 All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO. The information in this publication is proprietary to MAICO. Compliance MAICO Diagnostics is an ISO 13485 certified corporation.

  • Page 7: Introduction

    The user manual should make it as easy as possible for you to become familiar with the functions of the MA 42. If you have problems or have ideas for further improvements, please get in touch with us.

  • Page 8: Description

    Results can be printed directly by a USB connected printer or stored as a PDF file on the included SD memory card or USB flash drive. The MA 42 can be connected to the PC via USB to track the session and store the results in NOAH or the MAICO Database.

  • Page 9: For Your Safety

    3. For your Safety How to read this Operation Manual This operating manual contains information pertinent to the use of the MAICO MA 42 system including safety information as well as maintenance and cleaning recommendations. READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM! Use this device only as described in this manual.

  • Page 10: Regulatory Symbols

    Operation Manual MA 42 Regulatory Symbols IEC Pub. Description Symbol 980 & 60601-1 Serial Number 980 & 60601-1 Date of Manufacture 980 & 60601-1 Manufacturer Caution, Consult Accompanying 980 & 60601-1 Documents Return Authorized 980 & 60601-1 Representative, Special Disposal Required 980 &...

  • Page 11: General Precautions

    60950 for IT equipment. This is to avoid electrical shock to the user or patient. This complete system consisting of the MAICO device, computer and isolation transformer, is suitable for use in the patient environment. Equipment not complying with EN 60601 shall be kept outside the patient environment, as defined in the standard (at least 1.5...
  • Page 12 To avoid the risk of electric shock, this equipment must WARNING only be connected to the medical power supply originally delivered by MAICO. Using another power supply can also lead to electrical damage on the instrument. In case of emergency, disconnect the instrument from...

  • Page 13: Device Control

    Operation Manual MA 42 12 Warranty, Maintenance and After-Sales Service on page 61. The use of non-calibrated devices can lead to incorrect test results and is not advisable. CAUTION US federal law restricts this device to sale by or on the...

  • Page 14: Getting Started

    4. Getting Started Unpacking the Instrument The MA 42 was carefully inspected and packed for shipping. However, it is a 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 15: Calibration Of The Device

    The use of non-calibrated audiometers can lead to incorrect measurements! Where to Setup The MA 42 should be operated in a quiet room, so that the audiometric examinations are not influenced by outside noises. Ambient sound pressure levels in an audiometry test room shall not exceed the values specified in the norm ISO 8253-1: 2010 or ANSI S3.1:1999.

  • Page 16: Rear Panel Connections

    17: Phone right channel 9: Mon (monitor phone output) socket Place the MA 42 on a stable counter or table. Plug the power cord into the power socket on the rear panel. Connect all accessories with the adequate sockets as shown above. Plug the power cord into a grounded outlet.

  • Page 17: Working With The Ma 42

    Figure 2 - Control Buttons The ergonomic design of the MA 42 makes it easy to control the dB level, signal presentation, and frequency with one hand. The Stimulus presenter buttons (2) are the large blue button next to the dial. Store buttons (3) are located beside the left and right level control dials (1) and labeled with an ‘S.’...

  • Page 18: Functionality Of Operating Elements

    The following table describes the main functions of each button for the tone and speech audiometry screen: Figure 3 - Control Panel MA 42 Level control: adjusts the signal level for the left/right ear. Stim button: presents or interrupts the signal for the left/right ear.
  • Page 19 Operation Manual MA 42 Functional selector button: function changes based on testing screen (i.e. Tone or Speech). Tone: new, to delete all stored results and start a new session. Speech: reset the result percentage counter or play Wave file. Channel Stim button/Talk: to change from presenter to interrupter...
  • Page 20 Operation Manual MA 42 (16) Transducer selector button: to choose between Phones, Insert, Bone and Speaker (only calibrated receivers are available for selection). (17) Functional selector button: to select left, right, or swap. (18) Functional selector button: to switch from the tone screen to the speech screen and back.

  • Page 21: The Display Of The Ma 42

    The display has an energy saver function. The backlight of the display is automatically dimmed after approximately three minutes. Any action with the MA 42, such as pressing a button or rotating the dial, switches the backlight immediately on again.

  • Page 22: Measurement Methods Of Audiometry

    (see Chapter 8) after testing. Tone Audiometry The MA 42 supports the main tone audiometric testing methods. The following testing methods can be started out of the tone audiometry mode and the results will be documented in the instrument.

  • Page 23: Pure Tone Testing

    Operation Manual MA 42 6.1.1 Pure Tone Testing In the pure tone audiometry, the hearing threshold of the patient is measured in comparison with the normal hearing threshold. The examination starts with air conduction on the ear with better hearing.

  • Page 24: Masking

    Operation Manual MA 42 to present or interrupt the tone. The status LED above the Stim button will flash when the tone is presented. Follow your preferred procedure for the evaluation of the hearing threshold. Note: A warning prompt appears on the display in the event that the hearing level exceeds 100 dB .
  • Page 25 Operation Manual MA 42 For bone conduction measurements the interaural attenuation is 0 to 15 dB. Bone conduction crossover is therefore possible even with a slight difference in hearing loss between ears. To ensure that the patient will not experience crossover, mask the opposite ear.

  • Page 26: High Tone Audiometry (Optional)

    Automatic Masking With the manual masking, as described above, the masking level should be adjusted every time you change the test signal level. The MA 42 has a tracking function for easy masking. Set the tone level and the masking level to a desired difference for effective masking.

  • Page 27: Sound Field Testing (Optional)

    Operation Manual MA 42 Perform the test the same way as for air conduction. For hygienic reasons it is important to clean the bone oscillator (see chapter 6.1.4 Sound Field Testing (optional) Set the transducer selector (10) or (16) to Speaker. Perform the test the same way as for air conduction.

  • Page 28: Most Comfortable Loudness (Mcl)

    The continuous test tone is increased by 1 dB for a period of 0.2 seconds every 4.8 seconds. Whenever the increment is heard the patient has to press the response switch. The MA 42 calculates the percentage of detected increments. The SISI test information and the test score are shown on the LCD display.

  • Page 29: Preparation Of The Sisi Test

    Operation Manual MA 42 6.1.7.1 Preparation of the SISI Test To start the test select SISI with the functional selector button (13), choose OT Tests and SISI Test. Figure 6 - Start Screen SISI Test Select the test frequency with the frequency keys (4), (5). For the test you should choose the frequency where the maximum bone conduction hearing loss is measured as described in chapter 5.1.3.

  • Page 30: Performing The Sisi Test

    Operation Manual MA 42 When the patient has understood the procedure of the test press the “Inc” button (11) to select the increment level for the test (i.e. 1, 2, 3, 4, or 5 dB increments). Once selected the increment level will be displayed at the top of the screen below the frequency.

  • Page 31: The Threshold Decay (Carhart) Test

    Operation Manual MA 42 6.1.8 The Threshold Decay (Carhart) Test This examination is conducted as a fatigue test in cases of sensitivity loss. To start the test select Decay with the functional selector button (13), choose OT Tests. When the screen advances, select Decay Test. Make sure that the correct transducer is selected in advance as you cannot change transducers in this screen.

  • Page 32: Ablb

    Operation Manual MA 42 6.1.9 ABLB The ABLB (Alternate Binaural Loudness Balance) test is a recruitment test. Alternating tones between the two ears with headphones are used. The intensity of the tone in the better hearing ear is varied until the loudness of the tone is judged by the patient to be equivalent to a tone at a constant intensity in the normal ear.

  • Page 33: Mlb

    Operation Manual MA 42 6.1.10 The MLB (Monaural Level Balance) test is used to detect perceived loudness differences between two frequencies in the same ear. A tone with two alternating frequencies is presented to the same ear. The level of the frequency with normal hearing threshold is adjusted until it matches the loudness of the other frequency.

  • Page 34: Stenger

    Operation Manual MA 42 6.1.11 Stenger The Stenger test is used 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 setup the audiometer to presetn a tone in both ears (9,11, 15,17).

  • Page 35: Speech Audiometry

    6.2.1 Input Calibration The MA 42 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 36: Performing Speech Testing

    Operation Manual MA 42 Note: When multiple individuals use the device, input calibration will be required when switching to a new user. The device does store that last input calibration for ease of use. Store the calibration and leave the calibration mode with the Exit button on the left side of the display.

  • Page 37: Speech Audiometry With Microphone Or Cd Player

    Connect the microphone or CD player to corresponding input on the rear side of your MA 42. Set the signal of the test channel to microphone or CD by the functional selector button (11), (15). Make sure that the input signal is calibrated correctly, as described above.

  • Page 38: Speech Audiometry With Wave Files

    Operation Manual MA 42 6.2.4 Speech Audiometry with Wave Files If Wave is selected by the speech signal selector (11) or (15), a menu will pop- up with available word lists which are stored on the SD memory card (see Figure 12).

  • Page 39: Masking

    Operation Manual MA 42 button Play (7) is pressed, the selected word is presented. Increase or decrease the level when the patient has a correct or incorrect response until the SRT is estimated and store the result by pressing the Store (3) button.

  • Page 40: Master Hearing Aid (Mha)

    , was developed to provide a quick estimate of signal-to-noise ratio (SNR) loss. This test is incorporated into the MA 42, with selection made in the speech testing screen under the Wave file lists (11) or (15). The complete QuickSIN Speech-in-Noise Test manual, version 1.3 is provided in Appendix B.

  • Page 41: Monitoring

    Operation Manual MA 42 Monitoring All signals presented to the patient can be monitored by the examiner via a monitoring headset or the speakers integrated in the device. For this purpose, press the monitor button (6) and the monitor screen will appear. The monitor level of the left and right channel can be adjusted with the corresponding level control dial (1).
  • Page 42 Operation Manual MA 42 results of the measurement. An SD memory card needs to be inserted in the SD card slot (20) or a USB flash drive connected to the USB socket (4) on the rear side of the device.

  • Page 43: Patient Management

    Operation Manual MA 42 Patient Management The Patient Management enables storing the results of the audiological tests on the SD memory card. The results can be loaded later to be reviewed, edited or printed. The patients can be stored by numbers or by entering name and birthdate.
  • Page 44 Operation Manual MA 42 Figure 17 - New Patient Enter the characters of the name by scrolling through the alphabet by the level controls (1) and enter the selected character by the Stim button (2). Jump to the next or previous field with the frequency up (4) or down (5) button.
  • Page 45 Operation Manual MA 42 Each time you enter the patient list this PIN must be entered by selecting the digit by the level dial and entering it by pressing the STIM bar (2). Moving forward, the PIN will be required to enter the patient list. To deactivate the PIN, select Login Off after following the same steps as listed above.

  • Page 46: Quick Reference Guide

    Operation Manual MA 42 7. Quick Reference Guide General Setup 7.1.1 Startup Settings Air conduction on both channels Pure tone on both channels 30 dB on right channel, 0 dB on left channel Presenter mode 7.1.2 Transducer Selection Select the transducer to be used, headphones (Phones) or insert phones (Insert), by pressing the appropriate button.

  • Page 47: Tone Audiometry

    Operation Manual MA 42 Use the MODE button (18) to switch between tone and speech mode. 7.2.2 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 receiver you have selected.

  • Page 48: Speech Audiometry

    Operation Manual MA 42 STIM Mode Selection Press Stim button (8) key to switch between continuous presentation and presentation by pressing the Stim button (2). When in continuous presentation mode the STIM buttons (2) functions as interrupters. The light above the Stim button is On if continuous presentation is selected.

  • Page 49: Documentation Of The Results

    Operation Manual MA 42 Speech Calibration To calibrate the MIC or CD speech input, select the input with the Signal selector key (11) or (15). Press the Monitor button (6), the monitor setting screen appears, press now the Incal button (19) on the right side of the display and the calibration screen appears.

  • Page 50: User Menu

    Operation Manual MA 42 8. 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 51 Operation Manual MA 42 These menu items are available (bold reflects default setting): Frequency Settings Frequency Default frequency Set (On/Off): Set default frequency if side, transducer or signal type has changed Frequency roll Back: Frequency control jumps to 1000 Hz if the...
  • Page 52 Operation Manual MA 42 Swap Ears, the left and right ear is interchanged, the signals of the channels remain Swap signals, only the signals are interchanged and the ears remain Display of the left and Same, left dial controls level...
  • Page 53 Operation Manual MA 42 Change level after Change in level after store storing a threshold (Stay at the same test level (0 dB) or decrease by 10, 20, or 30 Which transducers Headphones (on) or Inserts Default Transducer shall be used as default...
  • Page 54 Operation Manual MA 42 Bone Lines On/Off, displays a dotted line, connecting the bone conduction results Bone Symbol Setting Int. Symbols/US Symbols/ UK Symbols Export User Settings to SD- Import/Export User Card/Import User Settings Settings from SD-Card, provides the possibility to store the user settings on a SD-Card 8100460 Rev.7 Ver.1...

  • Page 55: Setup Date And Time

    Operation Manual MA 42 Setup Date and Time Select the item Date/Time in the User Menu by scrolling down with the left or right level control (1) and select the sub item Set Date/Time by the stimulus presenter bar (2). The following screen will appear: Figure 19 - Date and Time Settings Set the date format to International or US by the functional button (9).

  • Page 56: Set Printer Settings

    Operation Manual MA 42 Set Printer Settings Select the printer by turning the left or right level control (1) down. The color mode is automatically adjusted. Only if the color mode is wrong, adjust the color mode as well. Jump to the field Paper size by pressing the stimulus presenter bar (2) several times and select A4 or Letter format by using the Store button (3).

  • Page 57: Cleaning And Disinfection Recommendations

    Recommendations for cleaning and disinfection of MAICO device presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility.
  • Page 58 Operation Manual MA 42  Do not use hard or pointed objects on the device or its accessories  Use 70% isopropyl alcohol only on hard cover surfaces Discard single-use equipment after use! In case of re-use WARNING of the single-use equipment you enhance the risk of cross contamination! 8100460 Rev.7 Ver.1...

  • Page 59: Connection To The Pc

    Install the software on your PC. This will allow you to use your device with NOAH™ and/or the MAICO Database. Connect the MA 42 by USB cable to the PC and turn on the device. The required driver will be installed. Please follow the installation procedure.

  • Page 60: Technical Data

    Operation Manual MA 42 11. Technical Data Classification The MA 42 audiometer is an active, diagnostic medical product according to the class Ia of the EU medical directive 93/42/EEC. Technical Data Standards: ANSI S3.6: Type 2A IEC 60645-1: Type 2 IEC 60645-2: Type A ISO 389 Acoustics –...
  • Page 61 Operation Manual MA 42 Tones: - 10 dB to 90 dB Speech: - 10 dB to 70 dB Pure tone, Pulse tone, Warble tone Test Signal: Masking Signals: Narrow Band Noise: With the same center frequency resolution as pure tone...
  • Page 62 Operation Manual MA 42 Warm-up Time: Less than 10 min after power on Mode of Operation: Continuous Environment Conditions: Operation +15 ̊ C … +35 ̊ C / +59 ̊ F … +95 ̊ F Humidity: 30 % … 90 %, non- condensing(operation) 0 ̊...
  • Page 63 Operation Manual MA 42 8 9 10 11 12 13 14 15 16 17 Figure 23 – Connection sockets of the MA 42 Connection Sockets: Specification 1: On/Off Power 2: Power (100 ... 240 V~ 50/60 Hz) Ethernet 3: Network USB 2.0...

  • Page 64: Pin Assignment

    Operation Manual MA 42 Pin Assignment Socket No. Connector Pin L Pin G Pin N (left) (top) (right) DC socket L (Live) G (Ground) N (Neutral) Rated current international: 250 V/2,5 A Socket No. LAN Ethernet TX + Transmit Data...

  • Page 65: Warranty, Maintenance And After-Sales Service

    (1) year from date of delivery of the instrument to the original purchaser. The MA 42 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 66: Safety Regulations

    READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM. Electrical Safety The MA 42 audiometer is constructed to comply with protection class I of the international standard IEC 60601-1 (EN 60601-1). The instruments are not intended for operation in areas with an explosion hazard.

  • Page 67: Warnings And Statements

    Warnings and Statements No modification of this equipment is allowed. Maico will make available instructions and diagrams to repair devices that it deems appropriate to be repaired in the field. No adverse effects have been reported from the materials used in this device based on 50 plus years of use with many different patient populations.

  • Page 68: Appendix A: Checklist For Subjective Audiometer Testing

    Operation Manual MA 42 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? Serial No.:.........

  • Page 69: Appendix B: Calibration Values And Maximum Levels

    Operation Manual MA 42 Appendix B: Calibration Values and Maximum Levels Calibration values and Max Levels: Headphone DD45 Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC Tone Frequency Max Tone Max NBN RETSPL RETSPL [Hz] dB re 20µPa dB re 20µPa 47.5...
  • Page 70 Operation Manual MA 42 Calibration values and Max Levels: Headphone TDH39 Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC Tone Frequency Max Tone Max NBN RETSPL RETSPL [Hz] dB re 20µPa dB re 20µPa 45.0 49.0 25.5 29.5 11.5 15.5...
  • Page 71 Operation Manual MA 42 Calibration values and Max Levels: Headphone Holmco 8103 Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC Tone Frequency Max Tone Max NBN RETSPL RETSPL [Hz] dB re 20µPa dB re 20µPa 39.5 43.5 25.0 29.0 18.5...
  • Page 72 Operation Manual MA 42 Calibration values and Max Levels: Headphone HDA 300 Ear simulator IEC60318-1 with adapter, Force 8.8 N ± 0.5 N, ANSI and IEC Frequency Tone NBN RETSPL Max Tone Max NBN RETSPL [Hz] 27.0 31.0 20.0 24.0 12.0...
  • Page 73 Operation Manual MA 42 Calibration values: Insert phone IP30 Reference equivalent threshold sound pressure level Tone IEC NBN IEC Tone 60318-5 Frequency 60318-5 Max Level Max Level [Hz] RETSPL RETSPL dB re dB re 20µPa 20µPa 26.0 30.0 14.0 18.0...
  • Page 74 Operation Manual MA 42 Calibration values: Bone conductor Radioear B71 / B71W Force: 4.9 ... 5.9 N Mastoid placement Frequency Reference equivalent Air radiation Max level [Hz] threshold force level for tone ISO 389 - 3 ANSI S3.6 mean/max Tone [dB] (re 1µN)
  • Page 75 Operation Manual MA 42 Calibration values: Bone conductor Radioear B81 Force: 4.9 ... 5.9 N Mastoid placement Frequency Reference equivalent Air radiation Max level [Hz] threshold force level for tone ISO 389 - 3 ANSI S3.6 mean/max Tone [dB] (re 1µN) [dB] (re 1µN)
  • Page 76 Operation Manual MA 42 Calibration values: 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 Tone Max level...

  • Page 77: Appendix C: Emc Compatibility

    MA 42. Install and operate the MAICO MA 42 according to the EMC information presented on this page and the next 4 pages. The MAICO MA 42 has been tested for EMC emissions and immunity as a standalone instrument. Do not use the MAICO MA 42 adjacent to or stacked with other electronic equipment.
  • Page 78 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The MAICO MA 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the MAICO MA 42 should assure that it is used in such an environment. Emissions Test Compliance...
  • Page 79 RF Communications Equipment and the MAICO MA 42 The MAICO MA 42 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MAICO MA 42 can help prevent...
  • Page 80 Immunity The MAICO MA 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 42 should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level...
  • Page 81 If the measured field strength in the location in which the MA 42 is used exceeds the applicable RF compliance level above, the MA 42 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MA 42.
  • Page 82 Operation Manual MA 42 Specifications are subject to change MAICO Diagnostics GmbH Sickingenstr. 70-71 10553 Berlin Germany Tel.: + 49 30 / 70 71 46-50 Fax: + 49 30 / 70 71 46-99 E-mail: sales@maico.biz Internet: www.maico.biz 8100460 Rev.7 Ver.1...

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