Maico MA 25 Operation Manual
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Maico MA 25 Operation Manual

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Operation Manual
MA 25/MA 25e
MA 27/MA 27e

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Summary of Contents for Maico MA 25

  • Page 1 Operation Manual MA 25/MA 25e MA 27/MA 27e...

  • Page 2: Table Of Contents

    1.1 Intended Use Statement ..................... 3 1.2 Indications for Use Statement ..................3 1.3 Contraindications of Use ..................... 3 1.4 Features and Benefits of the MA 25/MA 25e and MA 27/MA 27e ........ 3 1.5 Description ........................4 2 For Your Safety ...................... 5 2.1 How to Read this Operation Manual ................
  • Page 3 Copyright © 2021 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 Diagnostics. The information in this publication is proprietary to MAICO Diagnostics.

  • Page 4: Introduction

    1.2 Indications for Use Statement The MA 25/MA 25e/MA 27/MA 27e is a portable or standalone audiometer intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in the age range of children to adults.

  • Page 5: Description

    1.5 Description The MA 25/MA 25e and MA 27/MA 27e audiometers are designed to be a device for screening for hearing loss. Output and specificity of this type of device are based on the test characteristics defined by the user, and may vary depending on environmental and operating conditions.

  • Page 6: For Your Safety

    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.

  • Page 7: Customer Responsibility

    (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). NOTE: In the unlikely case of a serious incident, inform MAICO as well as the competent authority in the country where the user is established.

  • Page 8: Regulatory Symbols

    Operation Manual MA 25/MA 25e MA 27/MA 27e 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...

  • Page 9: General Precautions

    No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. No part of the equipment can be serviced or maintained while in use with the patient.
  • Page 10 Operation Manual MA 25/MA 25e MA 27/MA 27e To transfer data to a PC, establishing a PC-connection via USB WARNING is required. See section 4.2.4 on how to safely establish a connection with a power supplied PC or laptop (medical device/non-medical device) or to a battery-driven laptop.

  • Page 11: Device Control

    6.5 of this operation manual. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the MA 25/MA WARNING 25e/MA 27/MA 27e, including cables specified by the manufacturer.

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

    3.1 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 device by MAICO through...

  • Page 13: Disposables

    Operation Manual MA 25/MA 25e MA 27/MA 27e • Disinfect the plastic housing of the MA 25/MA 25e/MA 27/MA 27e and its accessories by wiping the surfaces with disinfectant wipes or a comparable product. Follow the instructions on the specific disinfection product.

  • Page 14: Unpacking And Hardware Orientation

    4.1 Unpacking the System Check Box and Contents for Damage • It is recommended that you unpack your MA 25/MA 25e/MA 27/MA 27e carefully making sure that all components are removed from the packing materials. • Verify that all components are included as shown on the packing slip included with your shipment.

  • Page 15: Hardware Orientation

    Table 3 Replacement Parts and Disposables Replacement Parts and Disposables Ear Cushion Cover Audiogram Pad 4.2 Hardware Orientation 4.2.1 MA 25/MA 25e and MA 27/MA 27e Devices MA 25/MA 25e Figure 1 shows the MA 25/MA 25e device. Figure 1 8104818 Rev. 5...
  • Page 16 Figure 5 4.2.2 Connections for Headphones, USB Devices and Power Supply Figure 6 and Figure 7 show the connections on the rear panel (MA 25/MA 25e) and the inside panel (MA 27/MA 27e) of the device. The connections are explained in Table 4.
  • Page 17 Socket for external power supply unit UES18LCPU-050200SPA 4.2.3 Only for MA 25/MA 25e: Battery Compartment For battery driven use of the MA 25/MA 25e 3x AA batteries have to be placed in the battery compartment on the backside of the device (Figure 8 and Figure 9).
  • Page 18 5.9.2. 4.2.6 Storage When the MA 25/MA 25e/MA 27/MA 27e is not in use, store it in a location where it will be safe from damage to the sensitive components such as the acoustic transducers and cables. Store according to the recommended temperature conditions described in Section 6.1.

  • Page 19: Operating The Device

    5.1.2 Where to Setup The MA 25/MA 25e and MA 27/MA 27e 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 20: Switching The Device On And Off

    Operation Manual MA 25/MA 25e MA 27/MA 27e 5.2 Switching the Device On and Off NOTE: All the cables and accessories have to be connected before the instrument is switched on. Power on is only possible if headphones are completely plugged-in! NOTE: The warm-up time for the device including boot up process takes about 1 minute.

  • Page 21: Function Keys

    These buttons are labeled F1, F2, F3 and F4. See Figure 10 and Figure 11 (4) well as Table 7 for the selections available for each function key in the testing mode. NOTE: The function buttons are dependent upon the version obtained, MA 25/MA 27 and MA 25e/MA 27e.

  • Page 22: Screens

    Operation Manual MA 25/MA 25e MA 27/MA 27e 5.6 Screens 5.6.1 General Figure 15 shows the main screen. See the explanation of the screen areas below. Figure 15 Tone: A tone presentation indicator is provided in the top left corner of the screen.

  • Page 23: Preparing For Testing

    Operation Manual MA 25/MA 25e MA 27/MA 27e MA 27/MA 27e The device is plugged into a power source. 5.6.4 Intensity Intensity displayed on the screen reflects the intensity/volume presented to patient. To change, rotate the Hearing Level dB dial.

  • Page 24: Tone Setup Menu

    Operation Manual MA 25/MA 25e MA 27/MA 27e 5.7.3.3 Screening A hearing screening utilizes a Pass or Refer result and is used to determine if further testing is required as a hearing problem may exist. Patients are typically screened at a level of 20 dB HL at 500 Hz, 1000 Hz, 2000 Hz, and 4000Hz in each ear.
  • Page 25 1 Min and 5 Min (1 Min steps). The device will shut down after Power Off time as entered in the settings. MA 25/MA 25e (USB power supply mode): With power supplying from USB cable the device will not turn off.
  • Page 26 Operation Manual MA 25/MA 25e MA 27/MA 27e Setup Menu Description Press Change to toggle between settings ranging from 0 (low LCD Contrast contrast) to 7 (strong contrast). HW Test… Hughson-Westlake test has a secondary menu. See Table 11 for more details.
  • Page 27 Operation Manual MA 25/MA 25e MA 27/MA 27e Automatic Hughson-Westlake Test (HW) The MA 25e and MA 27e incorporate the automatic Hughson-Westlake Test (HW). The automation of this test is configured in the Hughson-Westlake test setup menu. Press Change to access the Hughson-Westlake Tests setup menu. Press Change again to enter the single setting options.

  • Page 28: Managing Test Results

    5.5.2. 5.9.2 Transferring Test Results to PC (MA 25e/MA 27e Only) Before transferring data to a PC make sure that you have installed MAICO Sessions properly according to the separately delivered operation manual on the USB. Before establishing the PC-connection you will have to consider the recommendations given in section 4.2.3 in case the MA 25e/MA 27e is connected to a non-medical device.

  • Page 29: 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 every 12 months. MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies. STANDARDS...
  • Page 30 -20 °C to + 50 °C / -4 °F to +122 °F Humidity 10 % to 95 % (non-condensing) Calibration Calibration information and instructions are located in the MA 25/MA 25e/MA 27/MA 27e Service Manual. Air Conduction DD45: RadioEar Standard Values...

  • Page 31: Connections

    Frequency 125 Hz to 8000 Hz. Frequencies can be freely deselected range (except 1000 Hz) MA 25/MA 25e: 1.0 kg/2.2 lbs – including batteries and Weight headset. (1.6 kg/3.5 lbs – including carrying bag headset, audiogram charts etc.) MA 27/MA 27e:2.4 kg/5.28 lbs – including power supply, headset and audiogram pad.

  • Page 32: Pin Assignment

    Operation Manual MA 25/MA 25e MA 27/MA 27e 6.3 Pin Assignment SOCKET CONNECTOR PIN 1 PIN 2 Left Ground Signal Right 6.3 mm Mono Pat. Resp. USB A (OUT) USB B (IN) 1. +5 VDC 1. +5 VDC 2. Data - 2.
  • Page 33 Operation Manual MA 25/MA 25e MA 27/MA 27e Table 15 Reference Values for Stimulus Calibration REFERENCE VALUES FOR STIMULUS CALIBRATION Reference equivalent threshold sound pressure level [RETSPL, dB re. 20 Pa] according to: Fre- quency PTB Report 2009, PTB Report 2018,...

  • Page 34: Electromagnetic Compatibility (Emc)

    Operation Manual MA 25/MA 25e MA 27/MA 27e 6.5 Electromagnetic Compatibility (EMC) ESSENTIAL PERFORMANCE for this device is defined by the manufacturer as: • This device does not have an ESSENTIAL PERFORMANCE. • Absence or loss of ESSENTIAL PERFORMANCE cannot lead to any unacceptable immediate risk.
  • Page 35 EMC information presented in this chapter. The MA 25/MA27 has been tested for EMC emissions and immunity as a standalone MA 25/MA27. Do not use the MA 25/MA27 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 36 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MA 25/MA 27 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 25/ MA 27 should assure that it is used in such an environment.
  • Page 37 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MA 25/MA 27 is used exceeds the applicable RF compliance level above, the MA 25/MA 27 should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MA 25/MA 27.

  • Page 38: Electrical Safety, Emc And Associated Standards

    Operation Manual MA 25/MA 25e MA 27/MA 27e 6.6 Electrical Safety, EMC and Associated Standards 1. IEC 60601-1: 2012: Medical Electrical Equipment, Part 1 General Requirements for Safety and Essential Performance 2. AAMI ES60601-1:2005+A2+A1: Medical Electrical Equipment, Part 1 General Requirements for Safety and Essent ial Performance 3.

  • Page 39: Checklist For Subjective Audiometer Testing

    Operation Manual MA 25/MA 25e MA 27/MA 27e 6.7 Checklist for Subjective Audiometer Testing 8104818 Rev. 5 29/06/2021...
  • Page 40 Specifications are subject to change without notice. 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...

This manual is also suitable for:

Ma 27Ma 25eMa 27e

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