Maico MA 2 Series User manual

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

Operation Manual MA 25/MA 25e
MA 27/MA 27e
8104818 Rev. 4
1
19/10/2017
Table of Contents
1 Introduction............................................................................................................ 3
1.1 General..........................................................................................................................3
1.2 Intended Use Statement................................................................................................3
1.3 Indications for Use Statement........................................................................................3
1.4 Contraindications of Use ...............................................................................................3
1.5 Features and Benefits of the MA 25/MA 25e and MA 27/MA 27e.................................4
1.6 Description.....................................................................................................................4
2 For Your Safety...................................................................................................... 5
2.1 How to Read this Operation Manual..............................................................................5
2.2 Customer Responsibility................................................................................................6
2.3 Manufacturer’s Liability..................................................................................................6
2.4 Regulatory Symbols ......................................................................................................7
2.5 General Precautions......................................................................................................8
2.6 Electrical Safety and Measuring Security......................................................................8
2.7 Device Control.............................................................................................................10
2.8 Electromagnetic Compatibility (EMC)..........................................................................10
3 Warranty, Maintenance and After-Sales Service .............................................. 11
3.1 Warranty......................................................................................................................11
3.2 Maintenance................................................................................................................11
3.3 Cleaning and Disinfection Recommendations.............................................................11
3.4 Disposables.................................................................................................................12
3.5 Accessories/Replacement Parts..................................................................................12
3.6 Recycling and Disposal ...............................................................................................13
4 Unpacking and Hardware Orientation................................................................ 14
4.1 Unpacking the System.................................................................................................14
4.2 Hardware and Accessories..........................................................................................15
5 Operating the Device........................................................................................... 20
5.1 Getting started with the MA 25/MA 25e and the MA 27/MA 27e.................................20
5.2 Function Keys..............................................................................................................21
5.3 MA 25e/MA 27e Special Functions .............................................................................21
5.4 Screens .......................................................................................................................22
5.5 Performing Tone Audiometric Tests............................................................................23
5.6 Tone Setup Menu........................................................................................................24
5.7 Managing Test Results................................................................................................27
6 Technical Data ..................................................................................................... 29
6.1 MA 25/MA 25e/MA 27/MA 27e Hardware ...................................................................29
6.2 Connections.................................................................................................................31
6.3 Pin Assignment............................................................................................................32
6.4 Calibration Values .......................................................................................................32
6.5 Electromagnetic Compatibility (EMC)..........................................................................34
6.6 Electrical Safety, EMC and Associated Standards......................................................36
6.7 Checklist for subjective Audiometer Testing................................................................37

Operation Manual MA 25/MA 25e
MA 27/MA 27e
8104818 Rev. 4
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19/10/2017
Title: Operation Manual MA 25/MA 25e –MA 27/MA 27e
Date of issue/last revision: 19/10/2017
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
FOR NORTH- AND SOUTH AMERICA
Diagnostic Group LLC DBA MAICO Diagnostics
10393 West 70th Street
Eden Prairie, MN 55344
United States
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: www.maico-diagnostics.com
Copyright © 2017 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.
Compliance
MAICO Diagnostics GmbH 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

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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19/10/2017
1 Introduction
This section offers you important information about:
the intended use of the device
indications and contraindications of use
features and benefits
a description of the device
1.1 General
Thank you for selecting one of our quality products from the MAICO family range. The
MA 25/MA 25e and MA 27/MA 27e are designed and manufactured to meet all quality
and safety requirements, and has been certified with the CE-Marking according to
Medical Device Directive” (Directive 93/68/EEC).
Particular attention has been taken during the designing phase of the MA 25/MA 25e
and MA 27/MA 27e 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 25/MA 25e and MA 27/MA 27e, you have
made a decision towards long-term investment.
This operation manual aims to make learning and understanding the different MAICO
MA 25/MA 25e and 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. Please, do not hesitate to contact us.
Your MAICO-Team
1.2 Intended Use Statement
Screening audiometers are designed for determine hearing thresholds levels. The
instrument is intended for all patient populations over 3 years age and able to respond
to test signal in a rational way.
Audiometers are intended to be used by an audiologist, hearing healthcare
professional, or trained technician.
1.3 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. It is used as part of
a totaltest battery to determine hearing acuity by audiologists, ENTs,hearing healthcare
professionals, or other trained technicians in a hospital, clinic, healthcare facility or other
suitable quiet environment as defined in ISO 8253-1 or ANSI S3.1 or equivalent.
1.4 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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1.5 Features and Benefits of the MA 25/MA 25e and MA 27/MA 27e
1.5.1 General Information About the MA 25/MA 25e and MA 27/MA 27e
The MA 25/MA 25e and the MA 27/MA 27e gives you the benefit of:
Portable audiometer
Multiple transducer options
Air Conduction
Pure, Pulse and Warble Tone
Built-in handle and storage compartment –MA 27 and MA 27e version
1.5.2 Extended Functions of the MA 25e and MA 27e
The MA 25e and the MA 27e extends the functionalities with the following extra features:
Communication with a computer, to save and print results with the use of the
Audiometry module.
Automatic 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 device.
Talk Forward function allows easy communication with the patient while
wearing the headphone and/or in sound booth installations.
1.6 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
operatingconditions.Thescreeningforhearinglossusingthiskindofaudiometerdepends
on the interaction with the patient. As with any type of hearing screening, a “pass” result
should not overrule any additional concerns regarding hearing ability. A full audiologic
evaluation should be administered if concerns about hearing sensitivity persist.

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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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 device
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE 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 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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MA 27/MA 27e
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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 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 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 the customer responsibility can lead to
limitations of Manufacturer’s Liability and Warranty (see sections 2.3 and 3.1).
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

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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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
DESCRIPTION
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Warning, consult accompanying documents
Return to authorized representative, special disposal
required
Reference number
Patient applied part type B according to IEC 60601-1
Refer to instruction manual (mandatory)
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Voltage transformer
Electrostatic sensitive devices
Do not reuse
Conforms to European Medical Device Directive
93/42/EEC
ETL listed mark
Logo

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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2.5 General Precautions
Before starting a measurement make sure, that the device
works properly.
Use and store the device indoors only. For operation, storage
and transport conditions see table in section Technical Data.
No modification of this equipment is allowed.
Equipment is not user repairable. Repairs must be performed
by a qualified service representative only. 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.
Do not drop or otherwise cause undue impact to this device.
If the device is dropped or otherwise damaged, return it to the
manufacturer for repair and/or calibration. Do not use the
device if any damage is suspected.
Calibration of the device: The audiometer and the
transducers complement each other and share the same
serial number (i.e. 7663252). Therefore, the device shall not
be used with any other transducer prior to recalibration.
Recalibration also needs to be conducted, when a defected
headphone is replaced.
Uncalibrated devices may lead to faulty measurements and
sometimes even damage the hearing of the examinee.
2.6 Electrical Safety and Measuring Security
This icon indicates that patient applied parts of the device
conform to IEC 60601-1 Type B requirements.
In Case of Emergency
In case of emergency, disconnect the device from the
computer.
In Case of Emergency
In caseofemergency,disconnectthedevicefrompowersupply.
Do not position the device in a way that it is difficult to
operate the disconnection device. The power supply and the
power socket shall be accessible at all times.
Do not use the device if the power supply and/or the outlet
is damaged.
WARNING
WARNING
WARNING
WARNING
WARNING

Operation Manual MA 25/MA 25e
MA 27/MA 27e
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Totransferdata toa PC,establishinga PC-connectionvia USB
is required. See section 4.2.5 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.
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. IEC 60950-1 for IT equipment
and the IEC 60601-series for medical electrical equipment.
In addition, all such combinations –Medical Electrical
Systems –shall comply with the safety requirements stated
the general standard IEC 60601-1, edition 3, clause 16. Any
equipment not complying with the leakage current
requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient
support or shall be supplied via a separation transformer to
reduce the leakage currents. Any person who connects
external equipment to signal input, signal output or other
connectors has formed a Medical Electrical System and is
therefore responsible for the system to comply with the
requirements. If in doubt, contact qualified medical
technician or your local representative. If the device is
connected to a PC (IT equipment forming a system) ensure
not to touch the patient while operating the PC.
If the device is connected to a PC (IT equipment forming a
system) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601.
The device is not intended for operation in areas with an
explosion hazard.
Never short-circuit the terminals.
To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally
delivered by MAICO. Using another power supply can also
lead to electrical damage on the device.
In order to maintain a high level of safety and to ensure the
device works properly, it is necessary to have the device and
its power supply checked according to the medical electrical
safety standard IEC 60601-1 by a qualified service technician
at least once a year. For more information see section 3.2.
The use of non-calibrated devices can lead to incorrect test
results and is not advisable.
Prevent cable breakage: cables must not be bent or buckled.
WARNING
WARNING
WARNING
CAUTION