Maico MA 28 Operation Manual
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Maico MA 28 Operation Manual

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Operation Manual
MA 28

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  • Page 1 Operation Manual MA 28...

  • Page 2: Table Of Contents

    4 Unpacking and Hardware Orientation ................13 4.1 Unpacking the System ....................13 4.2 Hardware Orientation ....................15 5 Operating the Device .......................19 5.1 Getting started with the MA 28 ...................19 5.2 Switching On the Device ....................19 5.3 Switching Off the Device ....................20 5.4 Device Layout ......................20 5.5 Display ........................21...
  • 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

    1.1 Intended Use Statement The MA 28 audiometer is designed to be a portable device for testing 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 5: 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 6: 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 7: Regulatory Symbols

    Operation Manual MA 28 2.4 Regulatory Symbols The following Table 11 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 8: 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 9 The device is not intended for operation in areas with an WARNING explosion hazard. Do NOT use the MA 28 in a highly oxygen-enriched environment, such as a hyperbaric chamber, oxygen tent, etc. If the device is not used switch it off and disconnect it from the power supply.

  • Page 10: Device Control

    30 cm (12 inches) to any part WARNING of the MA 28, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result in improper operation.

  • Page 11: 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 12: Cleaning And Disinfection Recommendations

    • Before cleaning always switch off and disconnect the device from the power supply. • For cleaning use a lightly dampened cloth with soap water solution. • Disinfect the plastic housing of the MA 28 and its accessories by wiping the ®...

  • Page 13: Disposables

    Operation Manual MA 28 3.4 Disposables Use only the Sanibel Supply disposable supplies that are supplied with your MA 28 system. Foam eartips are intended for single-use only. These should be discarded after use. They cannot be cleaned. In case of re-use of the single-use disposables, you enhance the...

  • 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 28 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 Operation Manual MA 28 The MA 28 comes with different components (see Table 22). The availability of configurations with the following components are country specific. Contact your local distributor for more information. See also Table 33 for replacement parts and disposables.

  • Page 16: Hardware Orientation

    4.2 Hardware Orientation 4.2.1 MA 28 Device Figure 11 shows the MA 28 device. The device has a main device layout, a case to store headsets and cables and a handle to easily carry the device (Figure 22). The connections are located in the case (Figure 33).
  • Page 17 Operation Manual MA 28 4.2.2 Connections for Headphones, Power Supply and USB Devices Figure 55 shows the connections on the inside panel of the device. The connections are explained in Table 44. Insert the plugs before turning on the device.
  • Page 18 Operation Manual MA 28 4.2.3 Thermal Printer (Optional Accessory) Connect the included USB cord to the printer and to the MA 28 device. Push the printer power button for three seconds to power ON or OFF. Three short beeps will be heard at power ON and OFF.
  • Page 19 PC. 4.2.6 Storage When the MA 28 is not in use, store it in a location where it will be safe from damage to sensitive components such as the acoustic transducers and cables. Store according to the recommended temperature conditions described in section 6.1.

  • Page 20: Operating The Device

    5.1 Getting started with the MA 28 Place the MA 28 on a stable counter or table. Plug the power cord into the power socket. Connect all accessories with the appropriate sockets as shown in section 4.2.2.

  • Page 21: Switching Off The Device

    Operation Manual MA 28 5.3 Switching Off the Device The device can be shut down by pressing the Power key for about 3 seconds. 5.4 Device Layout Figure 99 shows the device layout. Table 66 gives further explanation. Figure 9...

  • Page 22: Display

    5.5 Display Figure 1111 shows the main display. See the explanation of the screen areas below. NOTE: 2 Audiogram view is the default setting for the MA 28. See section 5.10 for review of different setting options for the display.

  • Page 23: Function Keys

    Operation Manual MA 28 5.6 Function Keys Function keys are the buttons below the screen. A label above the button displays the function of that key. These buttons are labeled F1, F2, F3 and F4. See Figure 1212 and Table 77 for the selections available for each function key in the testing mode.

  • Page 24: Preparing For Testing

    Operation Manual MA 28 5.7 Preparing for Testing 5.7.1 Preparing the Patient The patient should sit at a distance of at least 1 m from the device. Prior to hearing threshold level measurements, the following instructions should be given: "You will now hear a variety of tones with various loudness levels, raise your hand, or press the response switch, as soon as you hear the tone in either ear“.

  • Page 25: Performing Tone Audiometric Tests

    Operation Manual MA 28 5.8 Performing Tone Audiometric Tests 5.8.1 Air Conduction Testing 5.8.1.1 Pretest Set-up and Instructions Hearing threshold levels can be determined by presenting test signals to the test subject with the included headphones (air conduction – AC). The purpose of AC audiometry is to establish the hearing sensitivity at various frequencies.
  • Page 26 ISO 8253 for air conduction thresholds only. Hughson-Westlake is a procedure used to determine pure tone thresholds. The MA 28 utilizes this procedure to perform an automatic pure tone test procedure (air conduction only).

  • Page 27: Managing Test Results

    1. Save the result to the internal database 2. Print the result (optional printer required) 3. Transfer the result to PC software (optional MAICO Sessions software required) 5.9.2 Completed Results With the first stored response, the function keys, Print and Save DB, are active for selection as described in section 5.6...
  • Page 28 Operation Manual MA 28 5.9.4 View Database Saved test results can be viewed from the internal database by selecting View DB within the third Function Key Menu, see section 5.6. This selection will enter the list of patients/sessions saved to the device.
  • Page 29 Operation Manual MA 28 Table 11 Explanation of Function Keys for View Database Function Label Description Back Return to View database screen. No function Delete Deletes selected session. View Opens session to view results. See section 5.9.6. NOTE: The entire session list can be deleted by selecting the buttons Delete and Store/NR at the same time.
  • Page 30 Operation Manual MA 28 5.9.7 Edit Patient Record To input patient information, select Edit from the function key list of the Save to database or View database screens. Figure 22 Once the Edit screen is entered, the fields to input include: •...
  • Page 31 Operation Manual MA 28 5.9.8 Deleting Test Results Results are deleted by using the function keys of the device. The delete options are found within the 2 menu screen of the Function Key list. Select More to access these functions. See section 5.6.
  • Page 32 • Device must be connected to Power Unit Supply (not USB) for power to be supplied to printer. 5.9.10 Understanding the Print-Out The print-out displays the following information: MAICO logo and name of device Facility: provides field name to write in facility information after printout. Patient data: provides the field names Patient ID, Last name, First name, Date of birth and Sex, to manually enter.
  • Page 33 MAICO Sessions software properly according to the separately delivered operation manual. Before establishing the PC connection you will have to consider the recommendations given in section 4.2.4 in case the MA 28 is connected to a non-medical device.

  • Page 34: Setup Menu

    5.10 Setup Menu Figure 27 Accessing the MA 28 Setup menu can be completed in 2 ways: 1. Select F4 from the function keys until Menu is seen (F3). 2. Press F1 and F4 for 2-3 seconds simultaneously from the First menu function key list.
  • Page 35 Operation Manual MA 28 Setup Menu Description Display type The display of the test screen. Options include: 2 audiogram, 2 audiogram/mask, 1 audiogram, 1 audiogram/mask, None, Table. 2 audiogram (default): 2 audiogram/mask: 1 audiogram: 1 audiogram/mask: None: Table: Symbol set To select the country specific symbols to be plotted on the audiogram displays.
  • Page 36 See section 5.10.3 License key… See section 5.10.4 About To view relevant information to the device (i.e. Serial number, firmware version, etc.). Press Change to access the license information of the MA 28. Database See section 5.10.5 password… 8506915 Rev. 5 05/05/2021...
  • Page 37 Operation Manual MA 28 5.10.1 Hughson-Westlake Test (HW)… The MA 28 incorporates the 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 38 Figure 31 To load an image to the device, follow the instruction below for configuring the image correctly. To create an image for use on the MA 28 printout: 1. Requires a minimum 32 MB USB flash drive. 2. Insert USB into PC and go to My Computer. Right click on the USB flash drive and select “Format”...
  • Page 39 Figure 33 6. Enter facility information into window size. Note: The MA 28 printout uses: arial narrow, bold, and font size 14. Anything placed in this window can be printed (i.e. text, logo), but printer only supports monochrome. For best quality, only use black font/images.
  • Page 40 Operation Manual MA 28 7. Select Save as and select BMP picture Figure 35 8. Save to a USB flash drive. Save the created file as follows: • File name: FCI.bmp • Save as type: Monochrome Bitmap (*.bmp;*.dib) Figure 36 9.
  • Page 41 5.10.4 License key… The License key screen allows licensed functions to be added to the device. Contact MAICO or your local distributor for more information. Highlight License key… and select Change to enter License key screen (See Figure 4038). Use the Hearing Level dB and Masking Level dB dials to navigate the internal keyboard.
  • Page 42 Highlight Database password… and select Change to enter the screen (See Figure 4341). A confirming message appears as once a password is turned ‘On’ it cannot be turned ‘Off’ without a MAICO service technician and possession of the device. 8506915 Rev. 5...
  • Page 43 Operation Manual MA 28 Figure 43 Enter the password, use the Hearing Level dB and Masking Level dB dials to navigate password fields. Press Save to continue setting up the database password. Press Back to return to the Setup menu without saving the Database password.

  • Page 44: 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 45 Operation Manual MA 28 Calibration information and instructions are located in the MA 28 Calibration Service Manual. Air Conduction DD45 MAICO Standard Values IP30 ISO 389-2, ANSI S3.6 DD450 MAICO Standard Values DD65 v2 MAICO Standard Values Bone ISO 389-3, ANSI S3.6 Conduction ISO 389-3, ANSI S3.6...

  • Page 46: Connections

    Operation Manual MA 28 6.2 Connections Figure 46 Table 19 Connections on Backside CONNECTIONS Connection- Specification socket 5.0 V, 0,4 A Part No. Power Supply UES18LCPU-050200SPA USB out USB 2.0 USB in USB 2.0 Response RI = 330R ZA= 10 Ω, UA= 3 Veff...

  • Page 47: Calibration Values And Maximum Levels

    Operation Manual MA 28 6.4 Calibration Values and Maximum Levels Calibration values and Max Levels: Headphone DD45 Coupler IEC 60318-3 FRE- TONE TONE SOUND QUENCY IEC 60318-3 IEC 60318-3 ATTENUA- [HZ] TION [DB] RETSPL DB RETSPL DB LEVEL LEVEL ISO 4869-1 RE 20µPA...
  • Page 48 Operation Manual MA 28 Calibration values: High Frequency Headphone DD450 Coupler IEC 60318-1 TONE TONE SOUND IEC 60318-1 IEC 60318-1 ATTENUA- FREQUENCY TION [DB] [HZ] RETSPL DB RETSPL DB LEVEL LEVEL ISO 4869-1 RE 20µPA RE 20µPA [DB HL] [DB HL] 30.5...
  • Page 49 Operation Manual MA 28 Calibration values: AC-Headphone Radioear DD65 v2 Coupler IEC 60318-1 TONE TONE SOUND IEC 60318-1 IEC 60318-1 ATTENUA- FREQUENCY TION [DB] [HZ] RETSPL DB RETSPL DB LEVEL LEVEL ISO 4869-1 RE 20µPA RE 20µPA [DB HL] [DB HL] 30.5...

  • Page 50: Electromagnetic Compatibility (Emc)

    The MA 28 has been tested for EMC emissions and immunity as a standalone device. Do not use the MA 28 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 51 Operation Manual MA 28 Guidance and manufacturer’s declaration - electromagnetic emissions The MA 28 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 28 should assure that it is used in such an environment.
  • Page 52 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MA 28 is used exceeds the applicable RF compliance level above, the MA 28 should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MA 28.

  • Page 53: Electrical Safety, Emc And Associated Standards

    Operation Manual MA 28 6.6 Electrical Safety, EMC and Associated Standards 1. IEC 60601-1:2012/ ANSI/AAMI ES 60601-1: 2005 / A2:2010: Medical Electrical Equipment, Part 1 General Requirements for Safety 2. CAN/CSA-C22.2 No. 60601-1:2008: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance 3.

  • Page 54: Checklist For Subjective Audiometer Testing

    Operation Manual MA 28 6.7 Checklist for subjective Audiometer Testing 8506915 Rev. 5 05/05/2021...
  • Page 55 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...

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