Maico MA 27 Operation Manual
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Maico MA 27 Operation Manual

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Operation Manual
MA 27 / MA 27e

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

  • Page 3: Table Of Contents

    Operation Manual MA 27 / MA 27e Table of Contents Page Introduction Intended Use 2.1 Description 2.2 Extended Function Important Safety Note Getting started 4.1 Unpacking and Checking the MA 27 4.2 Standard Accessories 4.3 Optional Accessories 4.4 Connecting the Accessories Function of Buttons and Display 5.1 Power On and Power Off...
  • Page 4 Operation Manual MA 27 / MA 27e Setup Menu 7.1 Standard Menu Setup 7.2 Hughson Westlake Test Setup (only on MA 27e) Warranty, Maintenance After-Sales Service Hardware Care and Maintenance 10 Safety Regulations 10.1 Electrical Safety 10.2 Measurement Safety 10.3 Instrument Handling 10.4 Operation...
  • Page 5 Operation Manual MA 27 / MA 27e Title: MA 27 / MA 27e – Operation Manual 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...

  • Page 6: Introduction

    This operating manual aims to make learning and understanding the different MAICO MA 27 / MA 27e functions as quick and as easy as possible. Should you encounter any problems or have ideas for any further improvements, we are only a phone call away.

  • Page 7: Intended Use

    Operation Manual MA 27 / MA 27e 2 Intended Use The MA 27 / MA 27e audiometer is intended to be used by an audiologist, hearing healthcare professional, trained technician in a quiet environment for the purpose of hearing screening.
  • Page 8 Operation Manual MA 27 / MA 27e In addition to traditional manual testing, the MA 27e incorporates a Hughson-Westlake patient controlled automatic threshold test complying with ISO 8253. When the test is completed the results are easily recalled from the internal memory of the MA 27e.

  • Page 9: Important Safety Note

    Operation Manual MA 27 / MA 27e 3 Important Safety Note The MA 27 / MA 27e should always be operated in a quiet room with minimal magnetic influence, to ensure that examinations are not disturbed by external noise. Electro-medical instruments that emit strong electromagnetic fields (e.g.
  • Page 10 Operation Manual MA 27 / MA 27e Calibration of the instrument: The audiometer and the headphone complement each other and share the same serial number (i.e. 63252). Therefore, the instrument shall not be used with any other headphone prior to recalibration. Recalibration also needs to be conducted, when a defective headphone is replaced.
  • Page 11 Operation Manual MA 27 / MA 27e This equipment is intended to be connected to other equipment 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 12: Getting Started

    PLEASE KEEP ALL ORIGINAL PACKAGING FOR FUTURE USE! The MA 27 is packaged in a specially-designed box. Please keep the box as it will be useful for sending the instrument for the annual instrument check-up. Please contact your nearest responsible dealer should the annual instrument check-up be needed.

  • Page 13: Optional Accessories

    *Applied part according to IEC/EN 60601-1 4.4 Connecting the Accessories All the connection jacks can be found on the inside compartment of the MA 27/ MA 27e. All the cables and accessories have to be connected before the instrument is switched on.

  • Page 14: Function Of Buttons And Display

    Operation Manual MA 27 / MA 27e 5 Function of Buttons and Display 5.1 Power On and Power Off NOTE: Power on is only possible if headphones are plugged-in! Power On: To turn on the audiometer press the “Tone Switch”...

  • Page 15: Display

    Operation Manual MA 27 / MA 27e 5.3 Display Tone: A tone presentation indicator is provided in the top left corner of the display header. : No signal is being presented. : Signal is being presented. Response (Patient Response Switch required): When using the patient response switch, a response is indicated in the middle of the display header.

  • Page 16: Function Buttons

    Operation Manual MA 27 / MA 27e Frequency: : Frequency displayed on the screen reflects the frequency presented to the patient. To change, rotate the right rotary wheel. 5.4 Function Buttons Function Buttons are those buttons labeled with F1, F2, etc. The function of the button is displayed on the bottom of the display screen.

  • Page 17: Ma 27E Special Functions

    Operation Manual MA 27 / MA 27e 5.5 MA 27e Special Functions Talk Forward: On the MA 27e, Talk Forward is activated by holding down the “Hearing Level dB” rotary wheel. Rotating the dial while in the talk-forward mode will adjust the level of the talk- forward to the patient.
  • Page 18 Operation Manual MA 27 / MA 27e Start the Hughson-Westlake (HW) automatic test procedure. Please refer to the next chapter for instructions about how to setup the HW test. 8104818 Rev.2.0 04/16...

  • Page 19: Performing Tone Audiometric Tests

    Operation Manual MA 27 / MA 27e 6 Performing Tone Audiometric Tests 6.1 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 20: Screening

    Operation Manual MA 27 / MA 27e 6.3 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, 1000, 2000, and 4000 HZ in each ear.
  • Page 21 Operation Manual MA 27 / MA 27e Eliminate any obstructions which will interfere with the placement of the earphone cushions on the ear (i.e. hair, eyeglasses). Ensure that the headphones are positioned correctly: red side on the right ear, blue side on the left ear. Adjust the headband of the headphones so that the earphones are positioned at the correct height (i.e.

  • Page 22: Setup Menu

    Operation Manual MA 27 / MA 27e 7 Setup Menu To access the MA 27 / MA 27e Setup menu press F1 and F4 simultaneously for 2-3 seconds. Once in the Menu, the following function keys will direct you through the setup process.
  • Page 23 25 dB, 30 dB, 35 dB, 40 dB, 45 dB, and 50 dB. Intensity Steps: Choose between 1 dB, and 5 dB. Power Off Settings: The MA 27 / MA 27e requires an electrical outlet and will not power off on its own. 8104818 Rev.2.0 04/16...
  • Page 24 Operation Manual MA 27 / MA 27e Pulse Length: Press Change to toggle between 250 msec and 500 msec. Language: Press Change to toggle between English, German, Spanish, and French. LCD Contrast: Press Change to toggle between settings ranging from 0 (very bright) to 6 (very dark).
  • Page 25 Operation Manual MA 27 / MA 27e 10 frequencies are available to change: 125; 250; 500; 750; 1,500; 2,000; 3,000; 4,000; 6,000; and 8,000. Press Change to toggle between On or Off. Press Save to return to the main Setup menu.

  • Page 26: Hughson Westlake Test Setup (Only On Ma 27E)

    Operation Manual MA 27 / MA 27e About: Press Change to access the information in the “About” section. This will display the model and version information. 7.2 Hughson Westlake Test Setup (only on MA 27e) MA 27e incorporates the Hughson Westlake test. The automation of this test is configured in the Setup Menu.
  • Page 27 Operation Manual MA 27 / MA 27e Press Change to toggle between “2 correct out of 3 answers” and “3 correct out of 5 answers”. The conditions used before going to the next frequency. Select the frequencies to include in the HW test. Press Change to...

  • Page 28: Warranty, Maintenance And After-Sales Service Hardware

    8 Warranty, Maintenance and After-Sales Service Hardware The MA 27 / MA 27e audiometer is guaranteed for 2 years. This warranty is extended to the original purchaser of the instrument by MAICO through the Distributor from whom it was purchased...

  • Page 29: Care And Maintenance

    Operation Manual MA 27 / MA 27e 9 Care and Maintenance Disconnect the unit’s energy source before cleaning! If the surface of the instrument or parts of it is contaminated, it can be cleaned using a soft cloth moistened with a mild solution of water and dish washing cleaner or similar.

  • Page 30: Safety Regulations

    Operation Manual MA 27 / MA 27e 10 Safety Regulations 10.1 Electrical Safety The MA 27 / MA 27e is in compliance with Class B of EN 60601- 1. The instrument is not to be used in environments dealing with explosive material or equipment.

  • Page 31: Technical Data

    Operation Manual MA 27 / MA 27e 11 Technical Data Classification according EEC The product is graded as active diagnostic medical product in class IIa, see also rule 10 of the 93/42/EEC (Appendix IX). Standards: Audiometer : EN 60645-1/ANSI S3.6, Type 4...
  • Page 32 Operation Manual MA 27 / MA 27e 4000 6000 8000 Inputs: Patient response switch (MA 27e), USB-Power-Supply Outputs: Left AC, Right AC 10 ohm impedance Attenuator: -10 to 100 dBHL in 5 or 1 dB steps (chosen in set-up menu).
  • Page 33 Operation Manual MA 27 / MA 27e Distortion: 0.3% typical at full intensity 1% maximum at full intensity Rise/fall Times: ~35 msec. Display Header Indicators: Tone On Patient Response Power Status Modulation: Warble +/- 5% 5 Hz sinusoidal Calibration: Air Conduction: ISO 389-1/ANSI S3.6...
  • Page 34 Operation Manual MA 27 / MA 27e Environmental conditions: +15 °C … +35 °C / +59 °F … +95 °F Operation: Humidity: 30 % … 90 %, non-condensing Ambient pressure: 98 kPa … 104 kPa The instrument is not intended to be used above 2000 meter from sea-level 0 °C …...
  • Page 35 Operation Manual MA 27 / MA 27e equipment except that the whole system shall comply to safety regulations in IEC 60601 8104818 Rev.2.0 04/16...

  • Page 36: Regulatory Symbols

    Operation Manual MA 27 / MA 27e 12 Regulatory Symbols Label or International Reference Placement Symbol Serial Number Registration Label Date of Manufacture Registration Label yyyy Address of Manufacturer Registration Label Package Label Return to Authorized Registration Label Representative B Patient Applied Part...
  • Page 37 Operation Manual MA 27 / MA 27e Label or International Reference Placement Symbol Logo Front Label EU Authorized Package Label EC REP Representative CE Mark – EU Only Directly on Product Package Label 8104818 Rev.2.0 04/16...

  • Page 38: Appendix A: Emc Compatibility

    27 / MA 27e according to the EMC information presented on this page and the next 5 pages. The MAICO MA 27 / MA 27e has been tested for EMC emissions and immunity as a standalone instrument. Do not use the MAICO MA 27 / MA 27e adjacent to or stacked with other electronic equipment.
  • Page 39 Operation Manual MA 27 / MA 27e Essential Performance To generate and present stimulus signals in the audio range as specified in the applicable IEC 60645 series in normal conditions. Absence of these performance features can lead to failure in diagnosis which is considered as an unacceptable risk to the patient.
  • Page 40 Operation Manual MA 27 / MA 27e Electromagnetic Compatibility Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones, etc. If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears.
  • Page 41 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The MAICO MA 27/ MA 27e is intended for use in the electromagnetic environment specified below. The customer or the user of the MAICO MA 27 / MA 27e should assure that it is used in such an environment.
  • Page 42 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the MA 27/MA 27e The MAICO MA 27/ MA 27e is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MAICO MA 27/ MA 27e can help prevent electromagnetic...
  • Page 43 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MAICO MA 27/ is intended for use in the electromagnetic environment MA 27e specified below. The customer or the user of the MA 27/ should assure that it is MA 27e used in such an environment.
  • Page 44 Operation Manual MA 27 / MA 27e (>95% dip powered from an in UT) for uninterrupted power 5 sec supply. Power Frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should be at levels IEC 61000-4-8 characteristic of a...
  • Page 45 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The MAICO MA 27/ is intended for use in the electromagnetic environment MA 27e specified below. The customer or the user of the MA 27/ should assure that it is MA 27e used in such an environment.
  • Page 46 If the measured field strength in the location in which the MA 27/ MA 27e is used exceeds the applicable RF compliance level above, the MA 27/ MA 27e 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 27/ MA 27e.
  • Page 47 Operation Manual MA 27 / MA 27e 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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Ma 27e

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