Maico MA 41 Operation Manual
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Maico MA 41 Operation Manual

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Operation Manual
MA 41

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Summary of Contents for Maico MA 41

  • Page 1 Operation Manual MA 41...

  • Page 2: Table Of Contents

    Unpacking the System ..................15 Hardware Orientation..................17 Operating the Device ..................20 Getting started with the MA 41 ............... 20 Functionality of Operating Elements ............... 20 The Display of the MA 41 ................23 Measurement Methods of Audiometry ............23 User Menu ......................
  • 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

    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 easy upgrades of new features and functions in the future.

  • 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 41 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

    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.

  • 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 41 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 DESCRIPTION...

  • Page 9: General Precautions

    Operation Manual MA 41 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 41 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 41 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. Electromagnetic Compatibility (EMC) Electrostatic discharge (ESD) according to IEC 61000-4-2.

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

     Warranty The MAICO device is guaranteed for at least one year. Ask your authorized local distributor for more information. This warranty is extended to the original purchaser of the instrument by MAICO through...

  • 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

    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 41 device configuration). Ask your authorized local distributor when accessories need to be replaced.

  • Page 15: Unpacking And Hardware Orientation

    Unpacking the System Check Box and Contents for Damage  It is recommended that you unpack your MA 41 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 41 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

    Hardware Orientation 4.2.1 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 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 41 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 41 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

    Getting started with the MA 41 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 in Section 4.2.3.
  • Page 21 Operation Manual MA 41 The following table describes the main functions of each button for the tone and speech audiometry screens: Figure 3         Level control: adjusts the hearing level for the left/right ear.
  • Page 22 Operation Manual MA 41 (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: Tone: No response (NR), stores value with arrow below the symbol.

  • Page 23: The Display Of The Ma 41

    Reset the device to return to the default settings. The display has an energy saving function; the backlight of the display is automatically dimmed after approximately three minutes. Any action with the MA 41, such as pressing a button or rotating the dial, immediately illuminates the backlight.
  • Page 24 Operation Manual MA 41 5.4.1 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 device.  Air conduction testing ...
  • Page 25 Operation Manual MA 41 The level and frequency is displayed as a numerical value at the top of the screen and is also indicated by the cursor within the audiogram. The dB level can be changed with the Level control dials on both sides (1) of the device.
  • 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 41 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 41 5.4.1.3 Bone Conduction Testing Place the bone conduction oscillator so that the flat, circular side of the transducer is placed on the mastoid, at the noticeable ledge of the cranial bone behind but not touching the pinna. The other side of the headband is placed in front of the opposite ear. Set the receiver selector to Bone and select the testing ear.
  • Page 28 5.4.2.1 Input Calibration The MA 41 must be calibrated to the particular speech signal when CD or MIC is used to ensure valid test levels. That means every time you change the speech test CD you must recalibrate the device.
  • Page 29 Operation Manual MA 41 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 30 Connect the microphone or CD player to the corresponding input (10) on the rear side of your MA 41. Select the test ear (9) and MIC or CD as signal source by the Function button (11). Make sure that the input signal is calibrated correctly, as described above.
  • Page 31 Operation Manual MA 41 5.4.2.4 Speech Audiometry with Wave Files If Wave is selected by the Speech Signal selector (11) a menu pops up with the available word lists, stored on the SD memory card. A word list can be selected by using the Level controls (1) to scroll through the list.
  • Page 32 ® signal-to-noise ratio (SNR) loss. Configuration dependent, this test is incorporated into the MA 41, 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 Speech-in-Noise ®...
  • Page 33 Operation Manual MA 41 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. The monitor level of the left and right channel can be adjusted with the corresponding Level control dial (1).

  • Page 34: User Menu

    Operation Manual MA 41 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 35 Operation Manual MA 41 These menu items are available: Setup Menu Description Default Frequency Set (On/Off): set Frequency Settings Default Frequency default frequency to 1,000 Hz if side, transducer or signal type has changed. Back: Frequency control jumps Frequency Roll to 1,000 Hz if the highest and lowest frequency was reached.
  • Page 36 Operation Manual MA 41 Setup Menu Description Select/Deselect frequencies for the Pure Tone Average calculation of the PTA value for the (PTA) default transducer (500, 1000, 2000). Both / Channel A / Channel B CD Channel Select the CD Channel...
  • Page 37 Operation Manual MA 41 5.5.1 Date and Time Setup 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 14 Set the date format to International or US by the Function button (9).

  • Page 38: Managing Test Results

    Operation Manual MA 41 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 39: Patient Management

    Operation Manual MA 41 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 40 Operation Manual MA 41 Current results can be stored to a numbered patient or to a named patient. Entering the Patient List, a patient with a new number is selected automatically. Just press the Save button (9) to save the current session to the new patient number. To save the results to an existing patient, select a patient by the Level controls and press the Save button.

  • Page 41: 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 42 Operation Manual MA 41 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...

  • Page 43: Connections

    Operation Manual MA 41 Connections Figure 18 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 Talk Back Microphone = 1 kΩ, U...

  • Page 44: Pin Assignment

    Operation Manual MA 41 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 TX- Transmit Data-...

  • Page 45: Calibration Values And Maximum Levels

    Operation Manual MA 41 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 46 Operation Manual MA 41 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 47 Operation Manual MA 41 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 48 Operation Manual MA 41 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 49 Operation Manual MA 41 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 50 Operation Manual MA 41 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 51 Operation Manual MA 41 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 52: Electromagnetic Compatibility (Emc)

    The MA 41 has been tested for EMC emissions and immunity as a standalone MA 41. Do not use the MA 41 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 53 Note: UT is the A.C. mains voltage prior to application of the test level. Guidance and manufacturer’s declaration — electromagnetic immunity The MA 41 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 41 should assure that it is used in such an environment,...

  • Page 54: Electrical Safety, Emc And Associated Standards

    Operation Manual MA 41 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 Equipment,...

  • Page 55: Checklist For Subjective Audiometer Testing

    Operation Manual MA 41 Checklist for Subjective Audiometer Testing 8100456 Rev. 10 24/04/2017...
  • Page 56 Operation Manual MA 41 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 8100456 Rev. 10...

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