Maico MA 41 User manual

MAICO Diagnostic GmbH
MAICO Diagnostic GmbH • Salzufer 13/14 • D-10587 Berlin • Tel.: [phone] • Fax: -99
Operating Instructions MA 41

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Operating Instructions MA 41
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Table of Contents Page
1 Introduction ............................................................................................ 1
2 Intended Use ........................................................................................... 2
3 Getting Started ....................................................................................... 3
3 1 Unpacking the Instrument 3
3 2 Calibration of the Device 4
3 3 Where to setup 4
3 4 Rear Panel Connections 5
4 Working with the MA 41 ....................................................................... 7
4 1 Using the Control Panel of the MA 41 7
4 2 Functionality of Operating Elements 9
4 3 The Display of the MA 41 12
Measurement Methods of Audiometry ............................................... 13
5 1 Tone Audiometry 13
5 1 1 Pure Tone Testing 14
5 1 2 Bone Conduction Testing 17
5 1 3 Sound Field Testing (optional) 18
5 1 4 Uncomfortable Loudness (UCL) Testing 18
5 1 5 Stenger 19
5 2 Speech Audiometry 20
5 2 1 Input Calibration 20
5 2 2 Performing Speech Testing 21
5 2 3 Speech Audiometry with Microphone or CD player 22
5 2 4 Speech Audiometry with Wave Files 23
5 2 5 Masking 24
5 2 6 Master Hearing Aid (MHA) 24
5 3 Monitoring 25
5 4 Talk Forward 25
5 5 Documentation of the Results 26
5 6 Patient Management 27

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6 Quick Reference Guide ......................................................................... 29
6 1 General Setup 29
6 1 1 Startup settings 29
6 1 2 Transducer Selection 29
6 1 3 Signal Selection 29
6 1 4 Masking 29
6 2 Tone and Speech Audiometry 29
6 2 1 How to Select Tone or Speech Audiometry Mode 29
6 2 2 Tone Audiometry 30
6 2 3 Speech Audiometry 31
6 2 4 Documentation of the Results 31
7 User Menu ............................................................................................. 32
7 1 Set up Date and Time 37
7 2 Set Printer Settings 38
8 Disinfection ........................................................................................... 39
9 Activation of Optional Features .......................................................... 39
10 Device Update..................................................................................... 39
11 Connection to the PC .......................................................................... 40
12 Technical Data..................................................................................... 42
13 Warranty, Maintenance and After-Sales Service .............................. 47
14 Safety Regulations ............................................................................. 48
14 1 Electrical Safety 48
14 2 Measuring Security 49
14 3 Device Control 49
14 4 Operation 49
Appendix A: Checklist for subjective audiometer testing .................... 0
Appendix B: Calibration values and maximum levels .......................... 1

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Operating Instructions MA 41
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1 Introduction
Thank you for purchasing a quality product from MAICO Diagnostic The
Audiometer MA 41 is manufactured to meet all quality and safety
requirements, and has been certified with the CE-symbol according to Medical
Directive 93/42/EEC
In designing the MA 41 we placed particular importance on making it a user-
friendly device, meaning its operation is simple and easy to understand All
functions of the MA 41 are software controlled, allowing for easy upgrades of
new features and functions in the future
The user manual should make it as easy as possible for you to become familiar
with the functions of the MA 41
If you have questions or ideas for further improvements, please contact us
Your MAICO Team

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2 Intended Use
The MA 41 is a portable one and half channel audiometer with pure tone,
speech, and optional sound field audiometric testing Additionally, it has limited
special audiology test capabilities such as Stenger and Master Hearing Aid It
can be used as a portable audiometer or a desktop unit for ENT diagnostics,
hearing aid fittings in the office, and for mobile audiometry The MA 41 is
intended to be used by hearing healthcare professionals (i e ENT doctors,
audiologists) and/or technicians, and school nurses who have been trained by
a hearing healthcare professional
The MA 41 audiometer delivers 11 air conduction (AC) test frequencies from
125 Hz to 8 kHz, with levels from -10 dBHL to 120 dBHL Bone conduction (BC)
can be tested with 10 test frequencies from 250 Hz to 8 kHz with levels from -
10 dBHL to 80 dBHL (using the B71W bone conductor) As an upgrade option,
the MA 41 is also capable of high frequency audiometry up to 20 kHz
The large back lighted LCD-color display shows level, frequency, transducer,
signal type, audiograms, and other information for each channel
The MA 41 performs tests using DD45 headphones, B71W bone conduction
oscillator, optional insert phones, and optional speakers Built-in test signals
include pure tone, pulse tone, warble tone, narrow band and speech noise
Inputs include ports for a live speech microphone and a CD player for speech
test material Speech tests can also be imported via a removable SD memory
card Outputs have separate jacks for air conduction headphones, bone
conduction transducer, optional insert phones and optional sound field
speakers
Furthermore, the patient management feature provides the ability to store
results in the device for further evaluation and documentation
Results can also print directly via the USB printer or stored as a PDF file on the
included SD memory card or USB flash drive The MA 41 can be connected to
the PC via USB to track the session and store results in NOAH or the MAICO
Database
In order to remain current with present and future technologies the MA 41 is
compatible with PCs, easy to use, extremely reliable, and is adaptable to future
developments It is also designed to be easily serviced as the need arises
Automatic test programs make trouble shooting and the yearly calibration as
effortless as possible
The speaker outputs can also be used as line level outputs for an external
amplifier or active speaker Please contact your authorized service center to
change to line output levels

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3 Getting Started
3.1 Unpacking the Instrument
Prior to shipping, the MA 41 was carefully packed and inspected However, it
is good practice to thoroughly inspect the outside of the shipping box for signs
of damage If any damage is noted, please notify the carrier immediately
Please remove the MAICO instrument from the shipping box by lifting the
cardboard package on the end flaps Holding the package securely, fold the
side flaps upwards to loosen the tension in the plastic film The instrument can
now be easily removed from the plastic packaging without the use of scissors
or other sharp tools
SAVE ALL THE ORIGINAL PACKING MATERIAL AND THE SHIPPING CONTAINER
SO THE INSTRUMENT CAN BE PROPERLY PACKED IF IT NEEDS TO BE RETURNED
FOR SERVICE OR CALIBRATION
Notify the carrier immediately if any mechanical damage is noted This will
insure that a proper claim is made Save all packing material so the claim
adjuster can inspect it as well Notify your dealer or MAICO when the adjuster
has completed the inspection
Please check that all accessories listed below have been received in good
condition If any accessories are missing or damaged, immediately notify your
dealer or MAICO
Standard accessories:
- Headphones DD45
- Bone conduction receiver B71W with headband
- Gooseneck microphone
- SD memory card – inserted into the SD card slot
- Patient response switch
- Power cable
- Operating Instructions

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3.2 Calibration of the Device
The instrument, headphones, bone conduction oscillator, as well as the
optional insert phones and speakers, will come calibrated to the instrument and
have the same serial number (e g 0021520) Use of transducers not calibrated
to this particular instrument will likely lead to incorrect thresholds causing
incorrect test results which will invalidate the test If a transducer needs to be
replaced, the instrument must be recalibrated with the new transducer
The use of non-calibrated audiometers can lead to incorrect results!
3.3 Where to setup
The MA 41 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 8253-1:2010 or ANSI S3 1-1999 For use in noisier environments,
headphones with optional sound insulation muffs are available
Electro-medical instruments, which emit strong electromagnetic fields (e g
microwaves or radiotherapy devices), can influence the function of the
audiometer Therefore, it is not recommended to the use these instruments 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 instrument 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
Caution: External devices such as a computer, printer or Ethernet which are
connected to the device must meet electrical safety requirements, such as
IEC/EN 60601-1 or UL 60601-1 This is to avoid electrical shock to the user or
the patient

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3.4 Rear Panel Connections
Figure 1– Rear View of the MA 41
1
: Power switch
10
: CD Input
2
: Power socket 100-240VAC / 50-60Hz
11
: Speaker left channel
3
: Network socket
12
: Speaker right channel
4
: USB out socket
13
: Bone conduction receiver
: USB in socket
14
: Insert phone left channel
6
: Patient response switch socket
1
: Insert phone right channel
7
: Talk-back microphone socket
16
: Phone left channel
8
: Mic live voice microphone socket
17
: Phone right channel
9
: Monitor phone output socket
Place the MA 41 on a stable counter or table Plug the power cord into the
power socket on the rear panel Connect all accessories with the appropriate
sockets as shown above Plug the power cord into a grounded outlet
Turn on the instrument with the power switch, which is located on the rear
panel of the MA 41 The device will perform its initialization and boot up Please
wait until the test screen appears, this can take up to 60 seconds If an error is
11 13
14 16
15
12
9
10
8
7
6
5
4
2
1
3
17

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detected the startup is stopped and a description of the error will be shown on
the display In this case please contact your local dealer for service

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4 Working with the MA 41
The hearing level can be easily adjusted with the level dials on each side of the
instrument (1) The instrument’s default setting is in 5 dB steps and can be
adjusted to 2 dB or 1 dB steps, as needed
The Stimulus Presenter buttons (2) and Store buttons (3) are located beside the
left and right level control dials (1) With the STIM mode button (8) you can
change from presenter to interrupter mode The corresponding LED lights up
when a signal is presented The frequency can be adjusted with the Plus (4) and
Minus (5) buttons on both sides of the instrument The ergonomic design of
the MA 41 makes it easy to control the dB level, signal presentation, and
frequency adjustments with one hand
4.1 Using the Control Panel of the MA 41
The main functions of the MA 41 are directly accessible by using the Functional
buttons which are located around the display As the buttons have changing
functionality, the actual function of each button is shown in the blue boxes on
the screen above the button To change the function of buttons (9), (11), (13)
and (15), which have several functions, press the corresponding button and a
list of alternative functions will appear Quickly press and release the button
until the desired function is selected
Figure 2 - Control Buttons

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An extensive user menu for the customization of the MA 41 is available for
advanced users (see chapter 7)

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4.2 Functionality of Operating Elements
The following table describes the main functions of each button for the tone
and speech audiometry screens:
Figure 3 - Control Panel MA 41
(1) Level control: adjusts the hearing level for the left/right ear
(2) STIM bar: presents or interrupts the signal for the left/right ear
(3) STORE button: stores results for the left/right ear
(4) Frequency up: change to higher frequency for tone audiometry, enters a
correct answer for word recognition score (WRS) testing, or selects the
next word in the word list for speech recognition threshold (SRT) testing
with wave files
(5) Frequency down: change to lower frequency for tone audiometry, enters
an incorrect answer for WRS testing, or selects a previous word in the
word list for SRT testing with wave files
(6) Monitor with options to adjust monitor and talk back settings; for
speech, the input calibration for microphone or CD player can be
adjusted
(7) Function selector button: function is displayed on the screen

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Tone: Select New, to delete all stored results and start a new session
Speech: Reset the result percentage counter or Play wave file
(8) Channel STIM Mode button/TALK: to change from presenter to
interrupter mode, or to talk to the patient by pressing and holding the
button down
(9) Functional selector button: to select left, right or both ears
(10)
Transducer selector button: to choose between Phones, Insert, Bone and,
Speaker (only calibrated transducers are available)
(11)
Functional selector button: function is displayed on the screen
Tone: No response, stores value with arrow below the symbol
Speech: Select microphone, external CD player or wave file as signal
source
(12)
Test Signal selector button: Steady, Pulse, Warble, or P&W (pulse and
warble tone)
(13)
Function selector button: function is displayed on the screen
Tone: Selects test for selected receiver, either the pure tone threshold,
Hearing Level (HL) or Uncomfortable Loudness (UCL); if Speaker is
selected as the transducer an option for aided sound field threshold
(Aided) is also made available
Speech: Select Speech Recognition Threshold (SRT), Word Recognition
Score (WRS), UCL or Master Hearing Aid (MHA); if Speaker is selected as
the transducer Aided can be selected to record aided sound field test
results
(14)
Select Unlock: Lock (locks the presentation of the signal in both
channels), Track (activates the masking noise to automatically increase
and decrease level in relationship to the signal), L&T (Lock and Track)
(15)
Functional selector button: function is displayed on the screen: Masking
on/off, activates masking in the opposite ear
(16)
Functional selector button: to switch from tone to speech and back; the
current function is displayed on the screen

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(17)
Functional selector button Menu: to enter the user menu, where settings
can be adjusted, results can be printed out or stored as PDF on SD
memory card or USB flash drive or the patient list can be entered
(18)
SD memory card slot
(19)
Level meter

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4.3 The Display of the MA 41
The instrument is set up by default to display the tone audiometry screen
The default frequency is set to 1 kHz and the level of the tone is set to 30 dBHL
in the right ear, masking in the other ear is switched off All channel information
is shown on the display, as well as the type of the function selector buttons
shown on the display
The display has an energy saving function; the backlight of the display is
automatically dimed after approximately three minutes Any action with the
MA 41, such as pressing a button or rotating the dial, will immediately
illuminate the backlight
Figure 4 - Start Screen Tone Audiometry Example

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Measurement Methods of Audiometry
Remove any obstructions which will interfere with the earphone cushion
placement over the ear (e g hats, eyeglasses) Always use the headphones with
appropriate padded ear cushions
Ensure the headphones are placed correctly over the patient’s ears and that the
red is over the right ear and the blue is over the left ear Adjust the headband
of the headphones so that the receivers are at the correct height (the sound
output grid on the inside of the headphone should be directly over the ear
canal)
Ask the patient to press the button on the patient response switch when the
tone is heard, even if it is barely audible
For hygienic reasons it is important to disinfect the ear cushions on the
headphone between patients (see chapter 8)
.1 Tone Audiometry
The MA 41 supports tone audiometric testing methods The following testing
methods can be started in the tone audiometry mode and the results can be
saved to the instrument
•Air conduction testing
•Bone conduction testing
•Sound field testing
•Pure tone hearing threshold
•Uncomfortable Loudness (UCL)
•Aided sound field thresholds (Aided)

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.1.1 Pure Tone Testing
During pure tone audiometry, the patient’s hearing threshold is measured
Typically the threshold search begins with air conduction testing in the ear with
better hearing
While viewing the tone screen the following settings will be displayed
The default setting is the right channel set to air conduction pure tone and the
left channel is switched off The frequency is automatically set at 1,000 Hz
The audiometer provides one and a half channels, one for the test signal, and
the other for the masking signal The test signal can be routed to the left, right,
or both ears If masking is on, the masking signal is routed to the non-test ear
Select the ear to be tested by pressing the functional selector button (9) on the
control panel underneath the screen Press several times to toggle between
Right, Left and Both
Next, select the transducer to be used, headphones (Phones), insert phones
(Insert), bone conductor (Bone), or sound field speaker (Speaker) by pressing
the appropriate button (10) Press the button several times until the LED
indicates the required transducer Only calibrated transducers are available
The level and frequency is displayed as a numerical value at the top of the screen
and is also indicated by the cursor within the audiogram
The dBHL can be changed with the attenuator dials on both sides (1) of the
instrument
Figure 5 - Pure Tone Audiometry Screen Example

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Use the frequency plus (4) or minus (5) keys to increase or decrease the
frequency Press the STIM button (the blue button touching the attenuator
dials) to present or interrupt the tone The status LED for the stimulus mode
button (8) will illuminate when the tone is presented
Follow your preferred procedure for the hearing threshold evaluation
Note: A warning prompt appears on the display in the event that the
hearing level exceeds 100 dBHL. The warning prompt disappears after
approximately 3 seconds. As long as the prompt is visible on the
display, no further entries can be made.
Test the frequencies: Starting at 1,000 Hz, test the higher frequencies first, then
the lower frequencies
Use the frequency up key (4) to select the next higher frequency and use the
frequency down key (5) to select the next lower frequency
Once a threshold value is established at the desired frequency, press the store
button (3) to store the threshold The appropriate symbol will be plotted in the
audiogram on the display
Once all frequencies are tested, select the other ear and repeat the hearing
threshold test
Pulse Tone
If required, the test can also be performed with a pulsed tone Set the test signal
button (12) on PULSE and the pure tone will be switched to a pulsating tone
Warble Tone
If required, the test can also be performed with a warble (frequency modulated)
tone Press the test signal button (12) and the pure tone will frequency
modulate The warble tone can also be pulsed as described above