Maico MA 28 Installation manual

Operation Manual
MA 28

Operation Manual MA 28
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Table of Contents
1 Introduction ...................................................................................................................... 3
1.1 General....................................................................................................................... 3
1.2 Intended Use Statement ............................................................................................. 3
1.3 Contraindications of Use............................................................................................. 4
1.4 Essential Performance................................................................................................ 4
1.5 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............................................................12
3.4 Disposables...............................................................................................................13
3.5 Accessories/Replacement Parts ................................................................................13
3.6 Recycling and Disposal..............................................................................................13
4 Unpacking and Hardware Orientation............................................................................14
4.1 Unpacking the System...............................................................................................14
4.2 Hardware and Accessories........................................................................................16
5 Operating the Device.......................................................................................................19
5.1 Getting started with the MA 28...................................................................................19
5.2 Use of Equipment After Transport and Storage..........................................................19
5.3 Device Layout............................................................................................................20
5.4 Function Keys............................................................................................................22
5.5 Preparing for Testing .................................................................................................23
5.6 Performing Tone Audiometric Tests...........................................................................24
5.7 Tone Setup Menu ......................................................................................................26
6 Technical Data.................................................................................................................31
6.1 MA 28 Hardware........................................................................................................31
6.2 Connections...............................................................................................................33
6.3 Pin Assignment..........................................................................................................33
6.4 Calibration Values......................................................................................................34
6.5 Electromagnetic Compatibility (EMC).........................................................................37
6.6 Electrical Safety, EMC and Associated Standards.....................................................39
6.7 Checklist for subjective Audiometer Testing...............................................................40

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Title: Operation Manual MA 28
Date of issue/last revision: 15/11/2017
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: [email protected]
Internet: www.maico.biz
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

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1 Introduction
This section offers you important information about:
the intended use of the device
indications and contraindications of use
essential performance
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 28 is designed and manufactured to meet all quality and safety requirements.
Particular attention has been taken during the designing phase of the MA 28 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 28, you have made a decision towards long-term
investment.
This operating manual aims to make learning and understanding the different MAICO
MA 28 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
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. Testing for hearing loss using this type of audiometer requires interaction
with the patient.
Indications for Use:
The MA 28 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 total test
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.

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1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Essential Performance
There is no essential performance as defined in IEC 60601-1.
1.5 Description
The MA 28 is an electroacoustic test device that produces sounds through a range of
frequencies and intensities to test for hearing loss. It features pure tone audiometric
testing with or without masking for measuring audibility thresholds. MA 28 is meant to
be used with headphones that are calibrated to the specific audiometer and are not
interchangeable with other devices.
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. The testing for hearing loss using this kind of audiometer depends on the
interaction with the patient.

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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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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).
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

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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

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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 tothe
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 case of emergency, disconnect the device from power
supply.
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

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Totransferdata toa PC, establishinga PC-connection via USB
is required. See section 4.2.4 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 otherequipment
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 60601-1shall 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
leakagecurrents.Anypersonwhoconnectsexternalequipment
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-series.
The device is not intended for operation in areas with an
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.
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 isnecessaryto have the device and its
powersupplycheckedaccordingtothemedicalelectricalsafety
standard IEC60601-1 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

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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 please see sections 2.5 and 3.1
2.8 Electromagnetic Compatibility (EMC)
Electrostatic discharge (ESD) according to IEC 61000-4-2.
Use the device only in an electrostatic controlled
environment.
To avoid the risk of electric shock, this equipment must
only be connected to the power supply delivered by
MAICO.
The device fulfills the relevant EMC requirements. 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.
The use of the accessories, transducers and cables with
medical equipment/system other than the MA 28 may
result in increased emissions or decreased immunity of the
medical equipment/system.
Please also refer to EMC consideration in section 6.5.
WARNING

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3 Warranty, Maintenance and After-Sales Service
This section offers you important information about:
warranty conditions
maintenance
cleaning and disinfection recommendations
accessory and replacement parts
handling disposables
troubleshooting
recycling and disposal of the device
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
the distributor from whom it was purchased and covers defects in material and
workmanship for a period of at least one year from date of delivery of the device to the
original purchaser.
The device shall only be repaired and serviced by your distributor or by an authorized
service center. Opening the device case will void the warranty.
No modification of this equipment is allowed.
In the event of repair during the guarantee period, please enclose evidence of
purchase with the device.
3.2 Maintenance
In order to ensure that the device works properly, it has to be checked and calibrated
at least once a year.
The service and calibration must be performed by your dealer or by a service center
authorized by MAICO.
When returning the device for repairs or calibration it is essential to send the acoustic
transducers with the device. Please include a detailed description of faults. In order to
prevent damage in transit, please use the original packing when returning the device.
WARNING

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3.3 Cleaning and Disinfection Recommendations
It is recommended that parts (device and accessories like headphones, ear cushions)
which come in direct contact with the patient be subjected to standard cleaning and
disinfecting procedure between patients.
Recommendations for cleaning and disinfection of MAICO device presented in this
document are not intended to replace or contradict policies in effect or procedures
required for infection control at the facility.
If there is not a high infection potential, MAICO recommends:
Before cleaningalways 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
surfaces with wet Sani-Cloth®Active wipes or a comparable product.Follow the
instructions on the specific disinfection product.
oWipe before and after each patient
oAfter contamination
oAfter infectious patients
To avoid damage of the device and its accessories, please
mind the following:
Do not autoclave or sterilize.
Do not use the device in the presence of fluid that
can come into contact with any of the electronic
components or wiring.
Should the user suspect fluids have contacted the system
components or accessories, the unit should not be used
until deemed safe by a MAICO certified service technician.
Do not use hard or pointed objects on the device or its
accessories.
Discard single-use equipment after use! In case of re-use
of the single-use equipment you enhance the risk of cross
contamination!
For more detailed cleaning recommendations see the following sections 3.3 to 3.5.
CAUTION
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3.4 Disposables
Operating the MA 28 with insert phones will require the
use of Insert Foam Eartips. They 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 equipment you
enhance the risk of cross contamination!
In case you want to purchase further disposables, please, contact MAICO or your local
distributor.
3.5 Accessories/Replacement Parts
Some reusable components are subject to wear with use over time. MAICO
recommends that you keep these replacement parts available (as appropriate for your
MA 28 device configuration). Ask your authorized local distributor when accessories
need to be replaced.
3.6 Recycling and Disposal
Within the European Union it is illegal to dispose of electric
and electronic waste as unsorted municipal waste. According
to this, all MAICO products sold after August 13, 2005, are
marked with a crossed-out wheeled bin. Within the limits of
Article (9)of DIRECTIVE 2002/96/EC on waste electricaland
electronic equipment (WEEE), MAICO has changed their
sales policy. To avoid additional distribution costs we assign
the responsibility for the proper collection and treatment
according to legal regulations to our customers.
Non-European countries
Outside the European Union, local regulations should be
followed when disposing of the product after its useful life.
WARNING

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4 Unpacking and Hardware Orientation
This section provides information on:
unpacking the system
components
becoming familiar with the hardware inclusive connections
how to store the device
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.
If any component is missing, contact your distributor immediately to report the
shortage.
If any component appears to be damaged in shipment, contact your distributor
immediately to report it. Do not attempt to use any component or device that
appears to be damaged.
Reporting Imperfections
Notify the carrier immediately if any mechanical damage is noted. This will insure that
a proper claim is made. Save all packaging material so the claim adjuster can inspect
it as well.
Report Immediately any Faults
Any missing part or malfunction should be reported immediately to the supplier of the
device together with the invoice, serial number, and a detailed report of the problem.
Keep Packaging for Future Shipment
Save all the original packing material and the shipping container so the device can be
properly packed if it needs to be returned for service or calibration (see section 3.2).

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The MA 28 comes with different components (see Table 2). The availability of
configurations with the following components are country specific. Contact your local
distributor for more information. See also Table 3 for replacement parts and
disposables.
Table 2 List of Components
Available Components
Base Unit
Database Software with Audiometry Module (CD and USB)
Power Supply UE10WCP1-050200SPA
USB Cable
DD45 Audiometric Headphones*
DD65 Audiometric Headphones*
DD450 High Frequency Headphones*
IP30 Insert Phones*
B71 Bone Conduction Headphones*
B81 Bone Conductor Headphones*
Patient Response Switch*
Operation Manual
Quick Guide
*Applied part according to IEC 60601-1.
Table 3 Replacement Parts and Disposables
Replacement Parts and Disposables
Ear Cushion Cover
Foam Eartips**
Audiogram Pad
**Only for use with Insert Phones.

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4.2 Hardware and Accessories
4.2.1 Where to Setup
The MA 28 should be operated in a quiet room, so that the audiometric examinations
are not influenced by outside noises. Ambient sound pressure levels in an audiometric
test room shall not exceed the values specified in the norm ISO 8253-1 or ANSI S3.1.
For use in noisier environments, headphones with optional sound insulation muffs are
available.
Electro-medical devices, which emit strong electromagnetic fields (e.g. microwaves or
radiotherapy devices), can influence the function of the audiometer. Therefore, it is not
recommended to use these devices in close proximity to the audiometer as it may lead
to incorrect test results.
The test room must be at a normal temperature, usually from 15° C/59 °F to 35° C/
95 °F, and the device should be switched on approximately 10 minutes before the first
measurement. If the device has been cooled down (e.g. during transport), please wait
until it has warmed to room temperature before using.
External devices such as a computer, printer or Ethernet which
are connected to the device must meet electrical safety
requirements, such as ANSI/AAMI ES/IEC/EN 60601-1. This is
to avoid electrical shock to the user or the patient.
4.2.2 MA 28 Device
Figure 1 shows the MA28 device. The device has a main device layout, a case to store
headsets and cables and a handle to easily carry the device (Figure 2). The
connections are located in the case (Figure 3).
Figure 1
Figure 2
Figure 3
NOTE: See section 5.3 detailed information about the device layout.
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Adjusting feet height
Figure 4
To adjust the height, turn the device over. Adjust the two feet
by turning them in a counter clockwise to increase height, or
in a clockwise direction to decrease height (Figure 4.)
4.2.3 Connections for Headphones, Power Supply and USB Devices
Figure 5 shows the connections on the inside panel of the device. The connections are
explained in Table 4. Insert the plugs before turning on the device.
Insert plugs with care into the appropriate connection. Do not
wiggle the plug or pull with force while connected. Disconnect
plugs cautiously.
Figure 5
Table 4 Connections on Inside Panel of Device
CONNECTIONS
1
Power Supply UE10WCP1-050200SPA
2
USB Host
3
USB Device for PC Communication
4
Patient Response Switch
5
Bone Conduction
6
No Function in Actual MA 28 Version
7
Left Phone or Left Insert
8
Right Phone or Right Insert
9
No Function in Actual MA 28 Version
4.2.4 Establishing a PC-Connection
To transfer data to a PC, establishing a PC-connection via USB is required. If the
MA 28 is used with office equipment that is not a medical device itself (see Table 4,
CAUTION
1 2 3 4 5 6 7 8 9

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PC-Connection 1), make sure to establish the PC-connection in one of the following
ways (see Table 4, PC Connection 2, 3 or 4).
Make sure you use only office equipment with the device that
is a medical device itself or meets the requirements of
IEC 60950. If a non-medical device is used within the patient
environment (1.5 m from patient as defined in IEC 60601-
series) a voltage transformer must be used (exception: a
battery driven laptop is used).
PC CONNECTIONS
PC Connection 1
Medical device –Medical Device
PC Connection 2
Medical device –Non Medical Device
PC Connection 3
Medical device –Non Medical Device
PC Connection 4
Medical device –Laptop (battery driven)
4.2.5 PC-Interface
Please refer to the Audiometry Module operation manual for transferring of results to
the 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 4.2.1.
WARNING

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5 Operating the Device
This section offers you information about:
how to get started with the MA 28
the device layout
the display
the function keys
performing Tone Audiometric testing
changing settings in the setup menu
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
4.2.3. Plug the power cord into a grounded outlet.
5.2 Use of Equipment After Transport and Storage
Make sure the device is functioning correctly before use. If the device has been stored
in a colder environment (even for shorter time) allow the device to become
acclimatized. This can take a long time depending on the conditions (like environmental
humidity). You can reduce the condensation by storing the device in its original
packaging. If the device is stored under warmer conditions than the use conditions no
special precaution are required before use. Always ensure proper operation of the
device by following routine check procedures for audiometric equipment.
5.2.1 Switching On the Device
Figure 6
NOTE: The warm up time for the device including boot up
process takes about 1 minute.
Briefly press the Power key on the MA 28 to turn on the
device (Figure 6).
5.2.2 Switching Off the Device
The device can be shut down by pressing the Power key for about 3 seconds.