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 2: Table Of Contents

    4.1 Unpacking the System ..................... 15 4.2 Hardware Orientation....................17 Operating the Device ....................20 5.1 Getting started with the MA 42 ................20 5.2 Functionality of Operating Elements ................ 20 5.3 The Display of the MA 42 ..................23 5.4 Measurement Methods of Audiometry ..............
  • Page 3 Copyright © 2017 MAICO Diagnostics. 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.

  • Page 4: Introduction

    1.1 General Thank you for purchasing a quality product from MAICO Diagnostics. The Audiometer MA 42 is manufactured to meet all quality and safety requirements, and has been certified with the CE-symbol according to Medical Directive 93/42/EEC. In designing the MA 42 we placed particular importance on making it a user-friendly device, meaning its operation is simple and easy to understand.

  • Page 5: Essential Performance

    Results can be printed directly via a USB 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 6: For Your Safety

     whole time handling and operating your device 2.1 How to read this Operation Manual This Operation Manual contains information pertinent to the use of the MAICO device 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 7: Customer Responsibility

    MAICO. NOTE: Customer responsibility includes proper maintenance and cleaning of the device (see Sections 3.2 and 3.3). Breach of the customer responsibility can lead to limitations of Manufacturer’s Liability and Warranty (see Sections 2.3 and 3.1).

  • Page 8: Regulatory Symbols

    Operation Manual MA 42 2.4 Regulatory Symbols The following Table 1 gives an explanation of the symbols used on the device itself, on the packaging and the accompanying documents including the Operation Manual. Table 1 Regulatory Symbols REGULATORY SYMBOLS SYMBOL...

  • Page 9: General Precautions

    Operation Manual MA 42 2.5 General Precautions Before starting a measurement make sure, that the device WARNING works properly. Use and store the instrument indoors only. For operation, storage and transport conditions see Table in Section 6 Technical Data. For operation in certain places, a recalibration may be necessary.
  • Page 10 Operation Manual MA 42 This equipment is intended to be connected to other equipment WARNING thus forming a Medical Electrical System. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e.g.

  • Page 11: Device Control

    Operation Manual MA 42 2.7 Device Control The user of the device should perform a subjective device check once a week according ISO 8253-1. See Section 6.7 for a checklist. For annual calibration please see Sections 2.6 and 3.1. 2.8 Electromagnetic Compatibility (EMC) Electrostatic discharge (ESD) according to IEC 61000-4-2.

  • Page 12: Warranty, Maintenance And After-Sales Service

    3.1 Warranty The MAICO MA 42 is guaranteed for at least one year. This warranty is extended to the original purchaser of the instrument by MAICO through the distributor from whom it was purchased and covers defects in material and workmanship for a period at least one year from date of delivery of the instrument to the original purchaser.

  • Page 13: 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 14: Accessories And Replacement Parts

    3.4 Accessories and Replacement Parts Some reusable components are subject to wear with use over time. MAICO recommends that you keep these replacement parts available (as appropriate for your MA 42 device configuration). Ask your authorized local distributor when accessories need to be replaced.

  • Page 15: Unpacking And Hardware Orientation

    4.1 Unpacking the System Check Box and Contents for Damage  It is recommended that you unpack your MA 42 carefully making sure that all components are removed from the packing materials.  Verify that all components are included as shown on the packing list included with your shipment.
  • Page 16 Operation Manual MA 42 The availability of configurations with the following components is country specific. Contact your local distributor for more information. Components DD45 Headphones TDH39 Headphones DD450 Headphones for high frequency audiometry (with High Tone License) B71 Bone Conductor...

  • Page 17: Hardware Orientation

    4.2 Hardware Orientation 4.2.1 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 audiometric test room shall not exceed the values specified in the norm ISO 8253-1:2010 or ANSI S3.1-1999.
  • Page 18 4.2.4 Establishing a Connection to a PC, USB Printer or CD Player To transfer data to a PC, establishing a PC connection via USB is required. If the MA 42 is used with office equipment that is not a medical device itself (see Table 2, PC Connection 1), make sure to establish the PC connection in one of the following ways (see Table 2, PC Connection 2, 3 or 4).
  • Page 19 Medical device – Laptop (battery-driven) 4.2.5 Storage When the MA 42 is not in use, store it in a location where it will be safe from damage to the screen or other sensitive components such as the acoustic transducers and cables.

  • Page 20: Operating The Device

    5.1 Getting started with the MA 42 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 appropriate sockets as shown in Section 4.2.3.
  • Page 21 Operation Manual MA 42 The following table describes the main functions of each button for the tone and speech audiometry screen:            Figure 3 Level control: adjusts the hearing level for the left/right ear.
  • Page 22 Operation Manual MA 42 Function button: to select left, right or swap (10) Transducer selector button: to choose between Phones, Insert, Bone and Speaker (only calibrated transducers are available) (11) Function button: Function is displayed on the screen based on test screen:...

  • Page 23: The Display Of The Ma 42

    Operation Manual MA 42 5.3 The Display of the MA 42 The device is set to air conduction and pure tone by default. When starting the MA 42 the tone audiometry screen opens. Figure 4 The default frequency is set to 1 kHz and the level of the tone is set to 30 dB...
  • Page 24 Operation Manual MA 42 5.4.1 Tone Audiometry The MA 42 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 device.  Air conduction testing ...
  • Page 25 Operation Manual MA 42 The dB level can be changed with the Level control dial on both sides (1) of the device. Set the Level control dial to a value just below expected hearing loss and turn down the level of the other ear.
  • Page 26 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 Operation Manual MA 42 5.4.1.3 High Tone Audiometry (configuration dependent) When available, pure tone hearing threshold of high frequencies from 8 kHz to 16 kHz can be tested. The High Tone option must be activated and a separate high tone transducer must be calibrated for all frequencies.
  • Page 28 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 Operation Manual MA 42 5.4.1.8.1 Preparation of the SISI Test To start the test select SISI with the Function button (13), choose OT Tests and SISI Test. Figure 6 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 Section 6.1.3.
  • Page 30 Operation Manual MA 42 5.4.1.8.3 Performing the SISI Test When the patient is ready, set the increment to 1 dB and press the Start (19) button to run the SISI test. Now 20 increments are presented to the patient. You can delay the test by pressing the Pause (9) button. This could be helpful in determining if the patient malingers.
  • Page 31 Operation Manual MA 42 The patient response LED lights and a stopwatch counts the seconds as long as the patient response switch is pressed. As soon as the patient releases the response switch, the level is increased for 5 dB.
  • Page 32 Operation Manual MA 42 5.4.1.11 MLB 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 33 5.4.2.1 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 device.
  • Page 34 Operation Manual MA 42 Figure 10 Figure 11 On every CD with speech test material there is a reference signal, such as a reference tone or speech simulating noise. Play back the reference signal from the CD. Use the left or right Level control (1) and adjust the levels until the VU-meter (19) shows all yellow lights and one green light.
  • Page 35 Connect the microphone or CD player to the corresponding input on the rear side of your MA 42. Set the signal of the test channel to microphone or CD by the Function button (11). Make sure that the input signal is calibrated correctly, as described above.
  • Page 36 Operation Manual MA 42 For the UCL testing the level is increased until the patient indicates the level is uncomfortable and the result can be saved by pressing the Store button (3). To delete a stored test result, select the corresponding level, then press both frequency down keys (5) at the same time.
  • Page 37 ® signal-to-noise ratio (SNR) loss. Configuration dependent this test is incorporated into the MA 42, with selection made in the speech testing screen under the Wave file lists (11) or (15). For more information refer to Etymotic Research’s QuickSIN ®...
  • Page 38 5.4.2.7 Master Hearing Aid (MHA) After you have completed the speech audiometry testing you may wish to demonstrate to the patient the difference a hearing aid can make. Use the MA 42 Master Hearing Aid (MHA) to adjust various frequency slopes for speech signals.
  • Page 39 Operation Manual MA 42 5.4.3 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 appears. Then the monitor level of the left and right channel can be adjusted with the corresponding Level control dial (1).

  • Page 40: User Menu

    Operation Manual MA 42 5.5 User Menu The User Menu enables the user to customize the device to meet their specific needs. Additionally, the menu allows the user to print out 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 41 Operation Manual MA 42 These menu items are available: Setup Menu Description Frequency Settings Default Frequency Default Frequency Set (On/Off): set default frequency to 1,000 Hz if side, transducer or signal type has changed. Back: Frequency control jumps to Frequency Roll 1,000 Hz if the highest and lowest frequency was reached.
  • Page 42 Operation Manual MA 42 Setup Menu Description Default presenter or interrupter mode Noise Interrupter/Presenter Pure Tone Average Select/Deselect frequencies for the calculation of the PTA value for the (PTA) default transducer (500, 1000, 2000). Both / Channel A / Channel B...
  • Page 43 Operation Manual MA 42 5.5.1 Setup 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 (2). The following screen appears: Figure 17 Set the date format to International or US by the Function button (9).

  • Page 44: Managing Test Results

    Operation Manual MA 42 Test your printer settings by a sample print before starting the audiological assessment. The wrong settings may require a restart of the device. Enter the field clinic name by using the STIM button (2). Select letters by rotating the Level control (1) and enter the selected letter by pressing the Store button (3).

  • Page 45: Patient Management

    Operation Manual MA 42 5.7 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. The patients can be stored by a number ID or by entering the name and birth date.
  • Page 46 Operation Manual MA 42 To save the current results to a new patient with a new patient name, press the button New Patient (15) and a screen appears to enter the patients last name, first name, ID and date of birth.

  • Page 47: Technical Data

    General Information About Specifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year. MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies. STANDARDS...
  • Page 48 Operation Manual MA 42 Weight: 1.5 kg/2.7 lbs Dimensions: W x D x H: 34.5 x 20 x 8 cm / 13.4” x 7.9” x 3.2” Monitor: Build in monitor speaker, headset Device Fuses: 2 x 1A slow blow Warm-up Time:...

  • Page 49: Connections

    Operation Manual MA 42 6.2 Connections Figure 21 Table 3 Connections on Backside CONNECTIONS Connection socket Specification On/Off Power Power (100 ... 240 V~ 50/60 Hz) Network Ethernet USB Out USB 2.0 USB In USB 2.0 = 500 Ω Patient Response Switch = 1 kΩ, U...

  • Page 50: Pin Assignment

    Operation Manual MA 42 6.3 Pin Assignment Socket No. Connector Pin L Pin G Pin N (left) (top) (right) L (Live) N (Neutral) DC socket (Ground) Rated current international: 250 V/2,5 A Socket No. LAN Ethernet TX + Transmit Data...

  • Page 51: Calibration Values And Maximum Levels

    Operation Manual MA 42 6.4 Calibration Values and Maximum Levels Calibration values and Max Levels: Headphone DD45 Coupler IEC 60318-3, Force 4-5 N, PTB-DTU Report 2009-2010 Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN [Hz] dB re 20µPa dB re 20µPa 47.5...
  • Page 52 Operation Manual MA 42 Calibration values and Max Levels: Headphone TDH39 Coupler IEC 60318-3, Force 4-5 N, ANSI S3.6 and ISO 389-1 Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN [Hz] dB re 20µPa dB re 20µPa 45.0 49.0 25.5...
  • Page 53 Operation Manual MA 42 Calibration values and Max Levels: Headphone Holmco 8103 Coupler IEC 60318-3, Force 4-5 N, PTB Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN [Hz] dB re 20µPa dB re 20µPa 39.5 43.5 25.0 29.0 18.5 22.5...
  • Page 54 Operation Manual MA 42 Calibration values and Max Levels: Headphone DD450 Ear simulator IEC60318-1 with adapter, Force 8.8 N ± 0.5 N, ANSI 3.6 and ISO 389-8/ISO 389-5 Frequency Tone RETSPL NBN RETSPL Max Tone Max NBN [Hz] 30.5 34.5 18.0...
  • Page 55 Operation Manual MA 42 Calibration values: Insert phone Eartone 3A and IP30 Reference equivalent threshold sound pressure level Coupler IEC 60318-5, ANSI 3.6 and ISO 389-2 Frequency Hz Tone IEC NBN IEC Tone 60318-5 60318-5 Max Level Max Level RETSPL dB...
  • Page 56 Operation Manual MA 42 Calibration values: Bone conductor Radioear B71/B71W/B81/BKH10 Force: 4.9 ... 5.9 N Mastoid placement Coupler IEC 60318-6, ANSI 3.6-2010 and ISO 389-3 Frequency [Hz] Reference Air radiation Max level equivalent threshold force level for tone [dB] (re 1µN)
  • Page 57 Operation Manual MA 42 Calibration values: Sound field (0 degree incidence) Reference equivalent threshold sound pressure level and maximum hearing levels For Canton CD220 ISO 389 – 7 and ANSI S3.6-1996 Frequency Tone RETSPL NBN RETSPL Max level Max level...

  • Page 58: Electromagnetic Compatibility (Emc)

    The MA 42 has been tested for EMC emissions and immunity as a standalone MA 42. Do not use the MA 42 adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration.
  • Page 59 RF transmitters, an electromagnetic site survey should be considered. 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 reorienting or relocating the MA 42.

  • Page 60: Electrical Safety, Emc And Associated Standards

    Operation Manual MA 42 6.6 Electrical Safety, EMC and Associated Standards 1. UL 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety 2. IEC/EN 60601-1: Medical Electrical Equipment, Part 1 General Requirements for Safety 3. CAN/CSA-C22.2 60601-1: Medical Electrical...

  • Page 61: Checklist For Subjective Audiometer Testing

    Operation Manual MA 42 6.7 Checklist for subjective Audiometer Testing 8100460 Rev. 8 24/04/2017...
  • Page 62 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. 8...

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