Maico MA 1 Operation Manual
  1. Manuals
  2. Brands
  3. Maico Manuals
  4. Measuring Instruments
  5. MA 1
  6. Operation manual

Maico MA 1 Operation Manual

Hide thumbs Also See for MA 1:
Table of Contents

Advertisement

Quick Links

Operation Manual
MA 1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the MA 1 and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for Maico MA 1

Summary of Contents for Maico MA 1

  • Page 1 Operation Manual MA 1...

  • Page 3: Table Of Contents

    5.1 Getting Started with the MA 1 ................13 5.2 Front Panel Controls ..................13 5.3 Preparing for Testing ..................14 5.4 Performing Tone Tests with MA 1 (Air Conduction Testing) ......14 5.5 Conducting a Hearing Screening ..............14 6 Technical Data ..................... 16 6.1 MA 1 Hardware ....................
  • Page 4 Copyright © 2023 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 5: Introduction

    1.2 Indications for Use Statement The MA 1 is a portable or hand-held device intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of hearing loss. It is used...

  • 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 1 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

    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: Device Control

    Operation Manual MA 1 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 see section 2.5 and 3.2. 2.8 Electromagnetic Compatibility (EMC)

  • 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: Disposables

    If there is not a high infection potential, MAICO recommends: • For cleaning use a lightly dampened cloth with soap water solution. • Disinfect the plastic housing of the MA 1 and its accessories by wiping the surfaces with disinfectant wipes or a comparable product. Follow the instructions on the specific disinfection product.

  • Page 13: Unpacking And Installation

    4.1 Unpacking the System Check Box and Contents for Damage • It is recommended that you unpack your MA 1 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 14: Hardware Orientation - Connection For Headphones

    Audiogram Pad 4.2 Hardware Orientation – Connection for Headphones The MA 1 has a single socket for both right and left earphones. While the device is off, insert the headphone into the socket ensuring it is completely seated prior to turning the device on.

  • Page 15: Battery Compartment

    4.5 Storage When the MA 1 is not in use, store 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 16: Operating The Device

    5.1.2 Switching the Device On and Off Switch on the device by pressing the black right/left button to turn on the MA 1. An automatic power shutoff occurs after 90 s of inactivity to conserve battery life.

  • Page 17: Preparing For Testing

    5.5 Conducting a Hearing Screening 5.5.1 Familiarize the patient with the test procedure 1. Press the black right/left button to turn on the MA 1. 2. Use this same button to select the right ear (red LED). 3. Press the up or down arrow keys to select 50 dB HL.
  • Page 18 Operation Manual MA 1 5.5.2 Perform the Hearing Screening Once the patient understands the task, continue to the screening process. 1. Change the hearing level to 20 dB HL and press the 1000 Hz button 1-2 seconds to present the tone to the patient.

  • Page 19: Technical Data

    IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012 Internally powered, Type B Applied Parts EMC Standard IEC 60601-1-2:2014 The MA 1 is not classified according to the standard EN 60645-1 and is not in conformity with this standard. DEVICE SPECIFICATIONS Mode of Operation...
  • Page 20 Operation Manual MA 1 Calibration Calibration information and instructions are located in the MA 1 Service Manual. Transducers Air Conduction DD45: RadioEar Standard Values DD65 v2: RadioEar Standard Values Transducers – DD45: Headband Static Force: 4.5 N ± 0.5 N...

  • Page 21: Connections

    Operation Manual MA 1 6.2 Connections Figure 5 CONNECTIONS No Connection-socket Specification ZA =10 Ω, UA = 7 Veff Phone 6.3 Pin Assignment SOCKET CONNECTOR PIN 1 PIN 2 Ground Phone Signal 3.5 mm Mono 8100216 Rev. 5 09/03/2023...

  • Page 22: Calibration Values And Maximum Levels

    Operation Manual MA 1 6.4 Calibration Values and Maximum Levels Table 5 Coupler Types COUPLER TYPES USED DURING CALIBRATION DD45: Calibrated using a IEC 60318-3 (6cc) acoustic coupler. Tested in accordance with ANSI S3.6:2010 / ISO 389-1:1998, Impedance: 10Ω DD65 v2: Calibrated using a IEC 60318-1 acoustic coupler.

  • Page 23: Electromagnetic Compatibility (Emc)

    Guidance and manufacturer’s declaration - electromagnetic emissions The MA 1 is intended for use in the electromagnetic environment specified below. The customer or the user of the MA 1 should assure that it is used in such an environment.
  • Page 24 FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MA 1 is used exceeds the applicable RF compliance level above, the MA 1 should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MA 1.

  • Page 25: Electrical Safety, Emc And Associated Standards

    Operation Manual MA 1 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. IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests 3.

  • Page 26: Checklist For Subjective Device Check

    Operation Manual MA 1 6.7 Checklist for Subjective Device Check 8100216 Rev. 5 09/03/2023...
  • Page 27 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...

Table of Contents