Maico MA 33 User manual

Operation Manual
MA 33

Operation Manual MA 33
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Table of Contents
1Introduction...........................................................................................................................4
1.1 General...........................................................................................................................4
1.2 Intended Use and Indications for Use...........................................................................4
1.3 Contraindications of Use................................................................................................4
1.4 Features and Benefits....................................................................................................4
1.5 Description......................................................................................................................5
1.6 PC-System Requirements.............................................................................................6
2For your Safety.....................................................................................................................7
2.1 How to Readthis Operation Manual.............................................................................7
2.2 Customer Responsibility................................................................................................8
2.3 Manufacturer’s Liability ..................................................................................................8
2.4 Regulatory Symbols.......................................................................................................9
2.5 Device Control ...............................................................................................................9
2.6 General Precautions....................................................................................................10
2.7 Electrical Safety and Measuring Security...................................................................10
2.8 Electromagnetic Compatibility (EMC).........................................................................11
3Warranty, Maintenance and After-Sales Service..........................................................13
3.1 Warranty.......................................................................................................................13
3.2 Maintenance.................................................................................................................15
3.3 Cleaning and Disinfection Recommendations...........................................................15
3.4 Components and Replacement Parts ........................................................................16
3.5 Recycling and Disposal................................................................................................16
4Unpacking and Installation...............................................................................................17
4.1 Unpacking the System.................................................................................................17
4.2 Hardware and Components........................................................................................19
4.3 MA 33 Software Installation.........................................................................................20
5Operating the MA 33..........................................................................................................24
5.1 Getting Started with the MA 33...................................................................................24
5.2 Starting the MA 33 Software........................................................................................24
5.3 Turning Off the MA 33..................................................................................................31
5.4 Using the MA 33 Software...........................................................................................31
5.5 Tone Audiometry..........................................................................................................33
5.6 Speech Audiometry (MA 33 Speech).........................................................................54
5.7 Pilot Test.......................................................................................................................64

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6Technical Specifications...................................................................................................74
6.1 MA 33 Hardware and Software...................................................................................74
6.2 Calibration Values and Maximum Levels...................................................................77
6.3 Connections..................................................................................................................80
6.4 Steckerbelegung..........................................................................................................80
6.5 Electromagnetic Compatibility (EMC).........................................................................81
6.6 Electrical Safety, EMC and Associated Standards....................................................84
6.7 Checklist for subjective Audiometer Testing ..............................................................85

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Title: MA 33 –Operation Manual
Date of issue/last revision: 19/08/2019
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: [e-mail]
Internet: www.maico.biz
Copyright © 2019 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.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
Caution for USA
Federal Law restricts this device to sale by or on the order of a licensed
medical professional.
Trademark Notice
Windows is a registered trademark of Microsoft Corp.

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1 Introduction
This section offers you important information about:
▪the intended use of the device and indications for use
▪contraindications
▪features and benefits
▪a description of the device functions
1.1 General
Thank you for selecting one of our quality products from the MAICO family range. The
MA 33 is designed and manufactured to meet all quality and safety requirements, and
has been certified with the CE-symbol according to Medical Device Directive
(93/42/EEC).
Particular attention has been taken during the designing phase of the MA 33 to ensure its
user-friendliness, meaning that its operation is simple, easy to learn and to understand.
As all the functions are software-controlled, upgrading the software and/or adding
additional functions at a later date, will be simple and cost-effective. By purchasing the
MAICO MA 33, you have made a decision towards long-term investment.
This operation manual aims to make learning and understanding the different MAICO MA 33
functionsasquickandaseasyaspossible.Shouldyouencounteranyproblemsorhaveideasfor
anyfurther improvements,weareonlya phone callaway.Pleasedo nothesitate tocontactus.
Your MAICO-Team
NOTE: Operation of the MA 33 requires knowledge of the Windows operating system.
1.2 Intended Use and Indications for Use
Screening audiometers are designed for determine hearing thresholds levels. The
instrument is intended for all patient populations over 5 years age and able to response
to test signal in a rational way.
Audiometers are intended to be used by an audiologist, hearing healthcare professional,
or trained technician.
1.3 Contraindications of Use
The patient is too young, sick oruncooperative toperform the tasks.
1.4 Features and Benefits
1.4.1 General
The MA 33 is available in 3 versions:
•MA 33 AC
•MA 33 BC
•MA 33 Speech

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The MA 33 gives the benefit of:
•PC-controlledaudiometerforAirConduction
•BoneConduction(MA33BConly)
•Pulse and Warble Tone
•Masking
•Individual test configurations
•Compatibility with MAICO Database, Noah 4, EssiConnect, or your existing
practice management software via BDT/GDT
•Power supply via USB
•Keyboard and/or mouse operation
•SISI (MA 33 BC and MA 33 Speech only)
•Speech Audiometry (MA 33 Speech only)
•German, English, French, Italian, Spanish, Netherlands, Polish
Additionally available tests for each version are:
•Module Pilot Test (Select Picture Audiometry for children)
•Module Hughson-Westlake (automatic test according to Hsughson-Westlake)
1.4.2 Language Pack for Module Pilot Test
The MA 33 with the Module Pilot Test comes with the following languages
•International configuration: Afrikaans, Arabic, Basque, Catalan, Croatian, Czech,
Danish, Dutch, English, Finnish, French, Galician, German, Greek, Hungarian,
Italian, Japanese, Korean, Norwegian, Polish/Polish (Audifon), Portuguese,
Romanian, Russian, Serbian, Slovakian, South Sotho, Spanish, Swedish, Swiss
German, Turkish, Vietnamese, Xhosa, Zulu
•US configuration: English (US) and Spanish (US)
1.5 Description
1.5.1 General
1.5.2 Air Conduction Testing
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. The test can specify the AC
loss but cannot distinguish between a conductive versus a sensorineural abnormality.

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1.5.3 Bone Conduction Testing
Hearing threshold levels can be determined by presenting test signals to the test subject
with the included bone conductor (Bone Conduction –BC). The purpose of BC
audiometry is to establish the hearing sensitivity at various frequencies. The test can
specify the BC loss in combination with AC loss it can distinguish between conductive
versus a sensorineural abnormality.
1.5.4 Speech Audiometry
Speech recognition screening incorporates the child listening to a series of words at
different decibel levels and point to the picture. The purpose of speech audiometry is to
establish an ear specific hearing level when standard pure tone testing cannot be
performed. The level at which a patient can understand spoken language can be a valuable
screening tool, especially with young children. This speech recognition level can be
determined easily by the MA 33.
1.5.5 Masking
Masking is required if there is a notable threshold difference between the left and right
ears. It is possible for sound to be transmitted to both ears via bone conduction while
testing the poorer ear. This is called “crossover”.
Crossover occurs often while testing bone conduction, but it can also occur during air
conduction testing. Relevant to crossover is the sound level received by the opposite ear.
The difference between the original test signal in the test ear and the received signal in
the opposite ear is called “interaural attenuation”.
For Bone Conduction measurements the interaural attenuation is 0 dB to 15 dB. Bone
Conduction crossover is therefore possible even with a slight difference in hearing loss
between ears.
1.6 PC-System Requirements
PC connection: USB port
Operating system: Windows®10 SP1 (x86 and x64)
Windows®8 / 8.1 (x86 and x64)
Windows®7 SP1 (x86 and x64)
.NET Framework 3.5
Processor: 2 GHz Intel Core 2 Duo CPU
Memory: 2 GB RAM
Graphic display: 1280 x 1024 (optimal), min. 1024 x 768
Silent PC for use in audiometric room
Optional use of a touchscreen for certain functions.

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2 For your Safety
This section offers you important information about:
▪how to read the operation manual
▪where to spend special attention
▪the customer responsibility
▪the explanation of all regulatory symbols used
▪important cautions and warnings that have to be considered during
the whole time handling and operating your device
2.1 How to Read this Operation Manual
This operation manual contains information pertinent to the use of the MAICO MA 33
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING
TO USE THIS SYSTEM!
Use this device only as described in this manual.
All images and screenshots are only examples and may differ in
appearance from the actual device settings.
In this operation manual, the following two labels identify potentially dangerous or
destructive conditions and procedures:
The WARNING label identifies conditions or practices that may
present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could
result in damage to the equipment.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
WARNING
CAUTION

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2.2 Customer Responsibility
All safety precautions given in this operation manual must be observed at all times.
Failure to observe these precautions could result in damage to the equipment and injury
to the operator or subject.
The employer should instruct each employee in the recognition and avoidance of unsafe
conditions and the regulations applicable to his or her work environment to control or
eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists
between the material contained in this operation manual and the rules of the organization
using this device, the more stringent rules should take precedence.
This product and its components will perform reliably only when
operated and maintained in accordance with the instructions
contained in this operation manual, accompanying labels,
and/or inserts. A defective product should not be used. Make
sure all connections to external accessories are snug and
secured properly. Parts which may be broken or missing or are
visibly worn, distorted, or contaminated should be replaced
immediately with clean, genuine replacement parts
manufactured by or available from MAICO.
NOTE: Customer responsibility includes proper maintenance and cleaning of the device
(see sections 3.2 and 3.3). Breach of 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 your local
distributor.
2.3 Manufacturer’s Liability
Usage of the device in a way deviant from the intended use will lead to a limitation or
termination of the manufacturer’s liability in case of damage. Improper use includes
disregarding the operation manual, the operation of the device by underqualified
personnel as well as making unauthorized alterations on the device.
WARNING