Maico MA 28 User manual

Operation Manual
MA 28

Operation Manual MA 28
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Table of Contents
1 Introduction ...................................................................................................................... 3
1.1 Intended Use Statement ............................................................................................. 3
1.2 Contraindications of Use............................................................................................. 3
1.3 Description.................................................................................................................. 3
2 For Your Safety................................................................................................................. 4
2.1 How to Read this Operation Manual ........................................................................... 4
2.2 Customer Responsibility ............................................................................................. 5
2.3 Manufacturer’s Liability ............................................................................................... 5
2.4 Regulatory Symbols.................................................................................................... 6
2.5 General Precautions................................................................................................... 7
2.6 Electrical Safety and Measuring Security.................................................................... 7
2.7 Device Control............................................................................................................ 9
2.8 Electromagnetic Compatibility (EMC).......................................................................... 9
3 Warranty, Maintenance and After-Sales Service...........................................................10
3.1 Warranty....................................................................................................................10
3.2 Maintenance..............................................................................................................10
3.3 Cleaning and Disinfection Recommendations............................................................11
3.4 Disposables...............................................................................................................12
3.5 Accessories/Replacement Parts ................................................................................12
3.6 Recycling and Disposal..............................................................................................12
4 Unpacking and Hardware Orientation............................................................................13
4.1 Unpacking the System...............................................................................................13
4.2 Hardware Orientation.................................................................................................15
5 Operating the Device.......................................................................................................19
5.1 Getting started with the MA 28...................................................................................19
5.2 Switching On the Device............................................................................................19
5.3 Switching Off the Device............................................................................................20
5.4 Device Layout............................................................................................................20
5.5 Display.......................................................................................................................21
5.6 Function Keys............................................................................................................22
5.7 Preparing for Testing .................................................................................................23
5.8 Performing Tone Audiometric Tests...........................................................................24
5.9 Managing Test Results ..............................................................................................26
5.10 Setup Menu .............................................................................................................33
6 Technical Data.................................................................................................................43
6.1 MA 28 Hardware........................................................................................................43
6.2 Connections...............................................................................................................45
6.3 Pin Assignment..........................................................................................................45
6.4 Calibration Values and Maximum Levels ...................................................................46
6.5 Electromagnetic Compatibility (EMC).........................................................................49
6.6 Electrical Safety, EMC and Associated Standards.....................................................52
6.7 Checklist for subjective Audiometer Testing...............................................................53

Operation Manual MA 28
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Title: Operation Manual MA 28
Date of issue/last revision: 05/05/2021
All available operation manuals can be found in the
download center on the MAICO homepage:
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: www.maico.biz
Germany:
https://www.maico-
diagnostics.com/german/support/resources/
International:
https://www.maico-
diagnostics.com/support/resources/
Copyright © 2021 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 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.
1.2 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.3 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 andavoid 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 shouldnot 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: Inthe unlikely case of a serious incident, inform MAICO as well as the competent
authority in the country where the user is established.
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 11 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
Medical Device
Patient applied part type B according to IEC 60601-1
Refer to operation 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 Medical Device Regulation (EU) 2017/745
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. MA1234567). 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.
Position the device in such a way that it can be easily
disconnected from the power plug at any time.
Do not use the device if the power supply and/or the plug is
damaged.
WARNING
WARNING
WARNING
WARNING
WARNING

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To transfer data toa PC, establishing aPC-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) orto a battery-driven laptop.
This equipment is intendedto 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 60601-1shall 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) assembly and modifications shall be evaluated by
qualified medical technician according to safety regulations
in IEC 60601-series.
The consequence of not following this warning could be a
too high leakage current to the patient.
Do not touch the contacts of the device and the patient at the
same time. When connected to computer equipment do not
simultaneously touch the computer equipment and the patient
atthesametime.Theconsequencecouldbeatoohighleakage
currentto the patient.
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.
Prevent cable breakage: cables must not be bent or buckled.
WARNING
WARNING
WARNING
WARNING

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2.7 Device Control
The user of the device should perform a subjective device check once a week
according to 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)
This device is suitable in hospital environments except for
near active HF surgical equipment and RF shielded rooms of
systems for magnetic resonance imaging, where the intensity
of electromagnetic disturbance is high.
The device fulfills the relevant EMC requirements. Avoid
unnecessary exposure to electromagnetic fields, e.g. from
mobile phones etc.
Use of this device adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this device and
the other equipment should be observed to verify that they
are operating normally.
Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and
result in improper operation.
The list of accessories, transducers and cables can be found
in the section 6.5 of this instruction.
Portable RF communications equipment (including
peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part
of the MA 28, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result in improper operation.
WARNING
WARNING
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 after each patient.
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 cleaningalwaysswitchoffanddisconnectthedevicefromthe powersupply.
•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 diseases
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.
CAUTION

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3.4 Disposables
Use only the Sanibel Supply disposable supplies that are supplied with your MA 28
system.
Foam eartips 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 disposables, you enhance the
risk of cross-contamination!
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 ensure 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 22). The availability of
configurations with the following components are country specific. Contact your local
distributor for more information. See also Table 33 for replacement parts and
disposables.
Table 2 List of Components
Available Components
Base Unit
Power Supply UES18LCPU-050200SPA
USB Cable
DD45 Audiometric Headphones*
DD65 v2 Audiometric Headphones*
DD450 High Frequency Headphones*
IP30 Insert Phones*
B71 Bone Conduction Headphones*
B81 Bone Conductor Headphones*
Patient Response Switch*
Thermal Printer HM-E300 Kit (Optional Accessory)
MAICO Sessions Kit (USB)
Operation Manual
Quick Guide
Audiogram Pad
*Applied part according to IEC 60601-1.
Table 3 Replacement Parts and Disposables
Replacement Parts and Disposables
Ear Cushion Cover
Foam Eartips**
Printer Paper
Audiogram Pad
**Only for use with Insert Phones.

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4.2 Hardware Orientation
4.2.1 MA 28 Device
Figure 11 shows the MA 28 device. The device has a main device layout, a case to
store headsets and cables and a handle to easily carry the device (Figure 22). The
connections are located in the case (Figure 33).
Figure 1
Figure 2
Figure 3
NOTE: See section 5.4 detailed information about the device layout.
Adjusting feet height
Figure 4
To adjust the height, turn the device over. Adjust the two feet
by turning them in a counterclockwise to increase height, or
in a clockwise direction to decrease height (Figure 44.)

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4.2.2 Connections for Headphones, Power Supply and USB Devices
Figure 55 shows the connections on the inside panel of the device. The connections
are explained in Table 44. 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 UES18LCPU-050200SPA
2
USB Host (Printer or Keyboard)
3
USB Connection for PC Communication
4
Patient Response Switch
5
Bone Conduction
6
No Function
7
Left Phone or Left Insert
8
Right Phone or Right Insert
9
No Function
CAUTION
1 2 3 4 5 6 7 8 9

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4.2.3 Thermal Printer (Optional Accessory)
Connect the included USB cord to the printer and to the MA 28 device. Push the printer
power button for three seconds to power ON or OFF. Three short beeps will be heard
at power ON and OFF. Inactivity of the printer does turn printer OFF.
In order to change paper rolls:
•Pushthemarkerontherightsideofthethermalprintertoopentheprintercover(Figure66).
•Insert a paperrollin the compartment with its loose end to the front of the printer.
•Hold the end of the printing paper and close the printer cover (Figure 77).
Figure 6
Figure 7
NOTE: Use of the printer requires the device to be connected to the AC power supply.
Printer is only charged when the MA 28 device is plugged in and on.
4.2.4 Establishing a PC-Connection
Infection of the device or the software used with the device can
lead to system failure and data misuse.
Ensure that yourPC is adequately protected against cyber-attacks.
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 5,
PC-Connection 1), make sure to establish the PC-connection in one of the following
ways (see Table 5, 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).
WARNING
WARNING

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Table 5 PC Connections
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 MAICO Sessions operation manual for complete installation
instruction and 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 6.1.

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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 ortable. Plug the power cord into the power socket.
Connect all accessories with the appropriate sockets as shown in section 4.2.2.
5.1.1 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.
5.1.2 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 ISO 8253 series or ANSI S3.1.
Electronic 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.Ifthedevicehasbeencooleddown(e.g.duringtransport),pleasewaituntil
it has warmed to room temperature before using.
NOTE: For temperature and warm-up time see Section 6.1
5.2 Switching On the Device
Figure 8
NOTE: The warm-up time for the device including boot up
process takes about 1 minute.
Briefly press the Power key on the MA28 to turn on the device
(Figure 88).