Maico MA 41 Operating Instructions Manual

MAICO Diagnostic GmbH

Operating Instructions MA 41


•

Salzufer 13/14

• D

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10587 Berlin • Tel.: +49 30 707146-50 • Fax: 99

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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

5 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 .................... 50

Appendix B: Calibration values and maximum levels .......................... 51

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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 userfriendly 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 dB

HL

to 120 dB

HL

. Bone conduction (BC) can be tested with 10 test frequencies from 250 Hz to 8 kHz with levels from -

10 dB

HL

to 80 dB

HL

(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

1 2

Figure 1– Rear View of the MA 41

3 4 5 6 7 8 9 11 13

10 12

15

14 16

17

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

5 : USB in socket

6 : Patient response switch socket

13 : Bone conduction receiver

14 : Insert phone left channel

15 : Insert phone right channel

7 : Talk-back microphone socket

8 : Mic live voice microphone socket

9 : Monitor phone output socket

16

17

: Phone left channel

: Phone right channel

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

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Operating Instructions MA 41 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.

Figure 2 - Control Buttons

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.

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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.

Figure 4 - Start Screen Tone Audiometry Example

The default frequency is set to 1 kHz and the level of the tone is set to 30 dB

HL 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.

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5 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).

5.1 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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5.1.1 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.

Figure 5 - Pure Tone Audiometry Screen Example

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 dB

HL

can be changed with the attenuator dials on both sides (1) of the instrument.

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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 dB

HL

. 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.

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5.1.1.1 Masking

Masking is required if there is a notable threshold difference between the left and right ears. It is possible for sound to be transmitted to both ears via bone conduction while testing the poorer ear. This is called “crossover.”

Crossover occurs often while testing bone conduction, but it can also occur during air conduction testing. Relevant to crossover is the sound level received by the opposite ear. The difference between the original test signal in the test ear and the received signal in the opposite ear is called “interaural attenuation.”

For bone conduction measurements the interaural attenuation is 0 to 15 dB.

Bone conduction crossover is therefore possible even with a slight difference in hearing loss between ears.

To ensure that the patient will not experience crossover, mask the opposite ear.

Masking increases the hearing threshold of the opposite ear. For bone conduction the masking signal is automatically routed to the opposite output of the phones or inserts.

The masking is done with a noise signal which is transmitted by the headphone.

For pure tone audiometry a narrowband noise is used. This noise changes its center frequency according to the frequency of the test signal.

Manual Masking

The masking is switched on by pressing the Masking On/Off button (15). The channel of the non-test ear is switched on and set to noise with a level of 0 dB

HL

.

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Figure 6 - Tone Audiometry with Masking

Adjust the level of the masking noise by the right-hand level control dial. If the

Store button on either side of the instrument is pressed, the hearing threshold value will be stored in the audiogram with the corresponding masking symbol.

The masking sound should be continuously presented for effective masking by pressing the STIM button. You can interrupt the masking signal by pressing the corresponding stimulus button (2).

Automatic Masking

With the manual masking, as described before, the masking level should be adjusted every time you change the test signal level. The MA 41 has a tracking function for easy masking.

Set the tone level and the masking level to a desired difference for effective masking. Press the TRACK button (14) to implement the automatic masking feature. The masking level is automatically changed if you adjust the test signal level (e.g. if the test level is at 30 dB

HL

and the masking level 50 dB

HL

and you change the test level to 45 dB

HL

the masking level will automatically adjust to

65 dB

HL

).

5.1.2 Bone Conduction Testing

Place the bone conduction oscillator so that the flat, circular side of the transducer is placed on the mastoid, at the noticeable ledge of the cranial bone behind but not touching the pinna. The other side of the headband is placed in front of the opposite ear. Set the receiver selector to Bone and select the testing ear.

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Perform the test utilizing the same method as air conduction testing.

If you are using bone conductor with contra lateral masking like the BKH 10, connect the contra phone to the left insert phone socket (14, Fig. 1). If masking is switched on, the masking noise will be routed to this output.

For hygienic reasons it is important to disinfect the bone conduction oscillator following each patient (see chapter 8).

5.1.3 Sound Field Testing (optional)

Set the transducer selector (10) to Speaker. Perform the test utilizing the same method as air conduction testing.

Warble tones should be used in the sound field as pure tones may provide inaccurate results in the typical test room.

Perform the test in the same way as described in the air conduction section above.

5.1.4 Uncomfortable Loudness (UCL) Testing

Testing of UCL can be measured using pure tone or speech stimuli. The purpose is to determine the dB

HL

level at which the stimuli becomes uncomfortable to the patient. The UCL is described as the level between very loud and too loud as perceived by the patient when listening to the test signal. This information is valuable for determining the limits of a patient's dynamic range.

Warning! Because this test uses high sound pressure levels, it is extremely important to perform this test using the utmost caution to avoid causing hearing loss. To prevent the possibility of extreme discomfort by the patient, it is important to start the test at a comfortable level.

Press and release the test mode selector key (13) below the display to select

UCL. The LCD-display in the bottom row changes from HL to UCL. Start with a test level of 60 dB

HL and present the tone briefly (max. 1s). If the signal was recognized by the patient as “not uncomfortable,” increase the level and proceed as described before. If the signal was uncomfortable for the patient store the value. Proceed accordingly with other test frequencies.

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5.1.5 Stenger

The Stenger test is a test to confirm the presence of pseudohypacusis. During this test two tones of the same frequency will be presented simultaneously to both ears, and only the louder tone will be perceived. Select HL to perform the

Stenger test and select both ears (9). Instruct the patient to press the response button when the tone is heard. Present a tone to the better hearing ear 10 dB above threshold and wait for the patient to indicate the tone has been heard.

Now present the tone to the poorer ear 10 dB below the indicated threshold

(the patient may “ignore” this tone). Present the tones simultaneously by pressing the lock functional button (14) and the STIM Mode button (8) to set it to interrupter mode. If the patient responds it is a negative. If the patient does not respond it is a positive Stenger, indicating that the tone is heard in the poorer ear and the patient is ignoring the stimulus.

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5.2 Speech Audiometry

The MA 41 supports speech audiometry. To conduct speech tests using speech test material you can use a CD player, wave files from the SD memory card, or a microphone.

Caution: If you are using a CD player powered by electrical current, the player must meet electrical safety requirements, such as IEC 601-1 or

UL. This is to avoid electrical shock of either the patient or you. If you are not sure if your player meets these requirements it is safer to use battery power.

5.2.1 Input Calibration

The MA 41 must be calibrated to the particular speech test to ensure valid test levels. That means every time you change the speech test CD you must recalibrate the instrument.

To calibrate the CD speech input, select CD with the signal selector key (11).

Press the Monitor button (6) and then InCal (17) and the calibration screen appears (see figure 7b).

Figure 7a – Monitor settings Figure 7b – Input Calibration

On every CD with speech test material there is a reference signal, such as a reference tone or speech simulating noise. Play back the reference signal with the CD. Use the left or right level control (1) and adjust the levels until the VUmeter (19) shows all yellow lights and one green light.

If one or more red lights are on, reduce the level using the level control dial (1).

To calibrate the microphone for live voice testing, select MIC with the signal selector key (11). Press the Monitor button (6) and then InCal (17) and the calibration screen appears. Use the left or right level control (1) and adjust the levels until the VU-meter (19) shows all yellow lights and one green light.

Store the calibration and leave the calibration mode by pressing the OK button on the left side of the display.

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5.2.2 Performing Speech Testing

Use the functional button for Speech on the right side of the tone screen (16) to switch to speech testing. The speech test screen will open, and the unit will default to the right ear and the level will be set to the default value.

The speech recognition threshold (SRT) is a test indicating the lowest level in which speech is understood using a closed set of spondaic words. Speech testing can be done via recorded speech test material from CD or wave files or with the microphone and live voice using standardized word lists.

Ask the patient to repeat each word. Often times a carrier phrase such as, “Say the word _______” may be used. The patient should sit at a distance of at least

1 meter from the device. Additionally, any obstructions which will interfere with the placement of the earphone cushions on the ear (i.e. hair, eyeglasses) should be removed. Ensure the headphones are put on correctly. Adjust the headband of the headphones so that the receivers are at the correct height (the sound output grid should be placed directly over the ear canal).

Select the ear to be tested by pressing Right, Left, or Both by the function selector button (9) on the control panel underneath the screen.

Figure 8 - Speech Test Screen

Next, select the transducer to be used, Phones, Insert, or Speaker by pressing the Transducer button (10). Toggle to the required signal by the selector button

(11) to MIC/CD/Wave.

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5.2.3 Speech Audiometry with Microphone or CD player

Connect the microphone or CD player to the corresponding input (10). Select the test ear (9) and MIC or CD as signal source by the functional button (11).

Make sure that the input signal is calibrated correctly, as described above. Select the test SRT, WRS or UCL with the functional button (13).

For the SRT test familiarize the patient with a closed set of spondaic words at a level loud enough for them to hear and understand. Begin the test and decrease the level as the patient repeats the word. Once the threshold has been found press the Store button (3) to save the result.

For the WRS test, the level remains fixed and correct or incorrect answers can be entered by the Frequency Plus (4) and Frequency Minus (5) button. Once the word list has been completed by the patient, press the Store button to save the established WRS score. To clear the word counter, press the Reset key (6) on the left side of the display.

For the UCL testing the level is increased until the patient indicates the level is uncomfortable and the result can be saved by pressing the Store button (3).

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5.2.4 Speech Audiometry with Wave Files

If Wave is selected by the speech signal selector (11) a menu will pop-up with the available word lists, stored on the SD memory card. A word list can be selected by using the level controls to scroll through the list. A list can be loaded by pressing the Stimulus button. The word list will then be displayed on the speech audiometry screen.

Figure 9 – Speech Audiometry with Wave Files

The level is displayed as a numerical value at the top of the screen. The level can be changed with the level controls (1) on both sides of the instrument.

Before starting the playback of the wave files, the first word can be selected by the Frequency Up and Down buttons (4) and (5). Press the functional button

Play (7) to start or pause the wave file playback.

The procedure for the SRT, WRS and UCL test is the same as the procedure for

CD or microphone testing. For the SRT test a word needs to be selected in the wordlist by the frequency up (4) or down (5) key. When the Play button (7) is pressed, the selected word is presented.

For the WRS test score, tally the correct words by pressing the frequency up (4) key and the incorrect words by pressing the frequency down (5) key. The next word will be played back automatically. Press the functional button Pause (7) to interrupt the playback.

The percentage of the speech discrimination score will be displayed and stored in the speech table or audiogram as soon as the Store button (3) is pressed.

Press the functional button List (6) to load another word list.

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5.2.5 Masking

Speech audiometry masking can be used in the same manner as described in chapter 5.1.1.1 for pure tone audiometry. Instead of narrowband noise, speech noise (SN) is applied when masking is turned on. Masking noise is activated in the non-test ear by pressing the functional button Masking On/Off (15). Adjust the level of the masking channel by the corresponding level control (1) for effective masking.

5.2.6 Master Hearing Aid (MHA)

After you have completed the speech audiometry testing you may wish to demonstrate to the patient the difference a hearing aid can make. Use the MA

41 master hearing aid to adjust various frequency slopes for speech.

The Master Hearing Aid (MHA) feature utilizes input signals from the Live Voice

(Mic), external CD/MP3 player or with Wave files. These signals are then filtered to simulate the benefit of hearing aids in the case of a high frequency hearing loss. The level of the low frequencies can be reduced by 6 dB, 12 dB, 18 dB per octave.

Begin by selecting a signal source in the speech mode with the functional selector button (11). Start the MHA function by pressing the Test Selection button (13). Change the dB presentation levels with the level control dials (1).

The influence of the filters can be changed by using the Frequency Up (4) and

Down (5) keys. The MHA function can be performed using monaural or binaural presentations.

8100456_OI_MA41_EN_15a

Figure 10 - Display Master Hearing Aid

24 8100456-8 04/15


5.3 Monitoring

All signals presented to the patient can be monitored by the examiner via a monitoring headset or the internal speakers. For this purpose, press the Monitor button (6) and the monitor screen will appear.

Enable monitoring by pressing the functional button Monitor On/Off (9).

Monitoring by the integrated speaker is switched on by pressing the button

(13) and the external headset is activated for monitoring via button (11). Then the monitor level of the left and right channel can be adjusted with the corresponding level control dial (1). In order to hear the signal given to the patient, make sure to activate monitoring (9).

Figure 11 - Display Monitor Settings

The talk back microphone is activated by the button (15) and its level adjusted by the frequency up and down buttons (4), (5).

5.4 Talk Forward

Connect the gooseneck microphone or the microphone headset to the microphone socket (8) on the rear side of the device. To talk to the patient press and hold the STIM mode/TALK button and speak into the microphone. Adjust the level by turning the left or right level control (1) while the STIM mode/TALK button is pressed and held.

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5.5 Documentation of the Results

All stored results can be directly printed via the USB printer. Make sure that a compatible printer is connected via the USB port (4) and the device is configured according to the connected printer settings; refer to menu settings in chapter

7.2.

The results can also be stored as a PDF file on a SD memory card or USB flash drive to be later transferred to a PC for further usage. The PDF file contains the measurement results. An SD memory card needs to be inserted in the SD card slot (20) or a USB flash drive connected to the USB socket (4) on the rear side of the device.

When the examination has been completed, press the Menu button (17) in the tone or speech test mode. The user menu is opened and the functionality of the functional buttons (11), (13) and (15) changes to PDF, Print, and Patients, respectively.

To printout the results press the Print button (13). Make sure that a compatible printer is connected and the printer settings are correct.

To store the results on the SD memory card or USB flash drive, press the PDF button (11). A PDF will be created and stored on for further transfer to a PC or printout via a PC connected printer. Make sure that a SD memory card is inserted in the SD memory card slot (18).

After printing or creating a PDF you will automatically return to the tone or speech test mode. Enter the patient list by pressing the Patient button (15) to store the results.

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5.6 Patient Management

The patient management option allows the results of the audiological tests to be stored on the SD memory card. The results can be reloaded at a later time to be reviewed, edited, or printed. Patients can be stored by a number ID or by entering the name and birth date. The demographic patient information can be entered using the level controls (1) or a connected USB keyboard.

Enter the User Menu by pressing the Menu button (17) in the tone or speech audiometry screen. Press the button Patients (15) to display the patient list.

Figure 12 – Patient List

Select a patient using the level controls and press the Stimulus button (2) to display the stored sessions. Select a session and press the PDF button (11) to save the PDF on the SD memory card or USB flash drive. To print the results to a connected printer press Print (13). The patient information will only be included on the printout if it is done in the patient list, or if the PDF is created in the patient list screen.

Current results can be stored to a numbered patient or to a named patient.

Entering the Patient List, automatically a new numbered patient with a new number will be selected. Just press the Save button (9) to save the current session to the new patient number. To save the results to an existing patient, select a patient by the level controls and press the Save button.

To save the current results to a new patient with a new patient name, press the button New Patient (15) and a screen appears to enter the patients last name, first name, ID and date of birth.

8100456_OI_MA41_EN_15a 27 8100456-8 04/15


Figure 13 – New Patient

Enter the characters of the name by scrolling through the alphabet with the level controls and enter the selected character by using the Stimulus button (2).

Jump to the next or previous field by using the Frequency Up (4) or Down (5) button. The date can be entered in the same manner with the level controls.

Delete the last character or number by pressing the Delete button (17).

A USB keyboard can also be utilized to enter the patient information. Connect it to the USB connector (4) and type in the characters. Jump to the next field with the tab key. Press the functional button OK (6) to save the new patient and go back to the patient list. The new patient is selected and the current measurement results can be saved to this new patient by pressing the functional button Save (9).Press the button No Name (9) to store the results only by a patient number, without entering a name or use Cancel (6) to go back to the

Patient List without saving.

There is a possibility available to lock the database and to enter a log-in PIN if the language is set to English. Enter the Patient List and select New Patient by pressing the New Patient button (15). Select Log-In On by pressing the functional button Log-In On/Off (15). A screen will appear to set your personal four digit log-in PIN. Select four numbers between 0 and 9 by the level dial and enter each by pressing the STIM bar (2) and confirm your personal log-in PIN by pressing the button Set (9). Remember the PIN very well otherwise it is not possible to enter the patient list anymore! Each time you enter the patient list this PIN need to be entered by selecting the digit by the level dial and entering it by pressing the STIM bar (2).

Enter the New Patient screen and select Log-In Off by button (15) to switch off the patient list log-in.

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6 Quick Reference Guide

6.1 General Setup

6.1.1 Startup settings

•

Air conduction

•

Pure tone on the right channel, left channel is switched off

•

30 dBHL tone

•

Presenter mode

6.1.2 Transducer Selection

Select the transducer to be used, headphones (Phones) or insert phones (Insert), by pressing the appropriate button (10). The display shows the selected transducer at the top of the display screen below the presentation levels.

6.1.3 Signal Selection

For tone testing the test signal is always tone. For speech audiometry the signal can be selected by the SIGNAL key (11). The type of NOISE signal is dependent upon the opposite channel’s signal.

6.1.4 Masking

Use the Masking On/Off button (15) to activate masking in the non test ear.

For tone audiometry narrow band noise is used as the masking signal and for speech audiometry, speech noise is used.

6.2 Tone and Speech Audiometry

6.2.1 How to Select Tone or Speech Audiometry Mode

There are two audiometry modes.

Tone audiometry: shows level and frequency on the display

Speech audiometry: shows level, correct and incorrect words, and speech discrimination percentage on the display

Use the MODE button (16) to switch between tone and speech mode.

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6.2.2 Tone Audiometry

Frequency Selection

Use one of the two sets of frequency keys (4) or (5) to select the frequency. The maximum and minimum frequency depends on the transducer you have selected.

Warble Tone

Press the Test Signal button (12) to activate the warble tone. The LED will highlight Warble.

Pulse Tone

Press the Test Signal button (12) to activate the pulse tone. The LED will highlight Pulse.

Tracking Function

Press the TRACK key (14) to activate tracking. Both channels will adjust when only one attenuator is adjusted.

Lock Function

Press the LOCK/UNLOCK (14) key to activate the interlock function. Signals from both channels will be presented simultaneously with the press of only one

STIM button (2). If both ears are selected, LOCK is automatically activated.

Select L&T (14) to interlock the stimulus presentation of both channels as well as the tracking of the levels.

STIM Mode Selection

Press STIM MODE (8) key to switch between continuous presentation and presentation by pressing the STIM button (2). When in continuous presentation mode the STIM buttons function as interrupters. The light above the STIM

MODE key is on if continuous presentation is selected.

CD and Wave speech signals are always in continuous presentation.

Talk Forward Microphone

Press and hold the STIM MODE (8) to activate Talk Forward. Adjust the level by turning one of the attenuator dials (1) while in the mode.

Talkback Microphone and Monitor Volume Control

Press the Monitor key on the left side of the display and the volume control bars for talkback and monitor are shown.

Adjust the monitor volume with the right and left dials (1). Adjust the talkback microphone volume with the plus/minus keys (4) or (5).

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To store the actual settings press OK (19).

6.2.3 Speech Audiometry

To select speech audiometry, select Speech (16) and the test SRT or WRS (13).

Use the frequency up (4) and down (5) key to select a word in the word list.

For the WRS test the display shows the percentage of correctly repeated words.

To count the word as correct press the frequency key (4) up.

To count the word as incorrect press the frequency key (5) down.

To clear the counter, press the Reset key (7) on the left side of the display.

Speech Calibration

To calibrate the MIC or CD speech input, select the input with the SIGNAL selector key (11). Press the Monitor button (6), so that the monitor setting screen appears. Now press the InCal button (17) on the right side of the display and the calibration screen appears.

Play the reference signal with the CD player or speak into the microphone. Use the left or right intensity dial (1) and adjust the levels until both VU-meters show all yellow and one green light. If one or more red lights are displayed, reduce the level using the corresponding dial (1).

Store the calibration and leave the calibration mode by pressing the OK (6) button on the left side of the display.

6.2.4 Documentation of the Results

Printout

Enter the user Menu by pressing the functional button (17) and press the Print

(13) button to printout the results.

Store Results as a PDF

Enter the user Menu by pressing the functional button (17) and press the button

PDF (13) to save the results as PDF file on SD memory card or USB flash drive.

Store the Result in the Patient List

Enter the User Menu by pressing the functional button (17) and press the button Patient (15) to enter the patient list. Enter a new patient by pressing the button New Patient (15). It is also possible to print a result from the patient list or to create a PDF of the result. Select a stored session of a patient in the patient list and press then the button PDF (11) or Print (13). In this case, the patient information will be included in the PDF or printout. Press the button New (7) in the patient list to start a new session.

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7 User Menu

The User Menu enables the user to customize the device to meet their specific needs. Additionally, the menu allows the user to printout the results via USB printer, store the results as a PDF on an SD memory card or USB flash drive, and the ability to enter the patient list. To enter the User Menu press the Menu button (17) on the right side of the display.

Figure 14 - User Menu Screen

To choose an item from the menu use the level control dials. A short description of the selected setting item will be displayed below the user menu list.

To display the sub items or change the setting of the selected item press the

STIM Presenter button (2).

To confirm the change press the OK button (7) on the left side of the display, or press Cancel (6) to return without any change.

These menu items are available:

Frequency

Settings

Frequency

Frequency Roll

Default Frequency Set

(On/Off): Set default frequency if side, transducer or signal type has changed

Back: Frequency control jumps to 1,000 Hz if the

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Level


Standard

Frequencies

Default Level

Level Steps

Inverse Dialing

Speech Level Unit highest and lowest frequency was reached

Stop: Frequency control function stops at highest and lowest frequency

Wrap: Jumps to the lowest/highest frequency when the highest/lowest frequency

Select/deselect

On/Off: Set default level after changing signal type

5; 2; 1

Change effect on dialing an encoder dBSPL/dBHL: Select the level unit for speech signals

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Signal

PTA

CD Channel


Controller

Assignment

Assign ear side fixed to the left or right controller;

Same, left dial controls level of the left ear, right dial the level of the right ear

- Interchanged, left and right dial controls the level of the opposite ear

Assign signals fixed to the left and right controller

Test signal always on the left hand side or always on the right hand side

This setting requires a restart

Presenter Duration Unlimited, signal is presented as long as the

STIM bar is pressed

1.5 Seconds, signal is switched off after 1.5 seconds

Interrupter /

Presenter Mode

Pulse

User defined duration, user can define a maximum presentation duration

Default Presenter or

Interrupter Mode

500 ms, slow pulsing

Select the CD

Channel

250 ms, fast pulsing

Select/deselect frequencies for the calculation of the

PTA value for the default transducer

Both/Channel A/Channel B

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Store Properties

Display

Brightness

Language

Diagram Settings

Change Frequency

After Store

Change Level After

Store

Diagram in Speech

Test

Moves to next test frequency after storing a threshold (on) or stays on same frequency after storing (off)

Change in level after storing a threshold (stay at the same test level (0) or decrease by 10, 20, or

30 dB)

Headphones or Inserts Default

Transducer

Selection of Default

Transducer

Monitoring Monitoring

Tests Start Test Tone/Speech, defines test which will load after startup

Printer Settings Set Printer Settings Opens a dialog to select a printer and configure its settings

PDF Save Option Save on SD Card

Monitor only speech signals

(off) or all signals (on)

Device

Information

Save on USB

Show Information

Stores PDF files to an SD memory card

Stores PDF files to a USB flash drive

Shows device information

Date/Time Set Date/Time Opens a dialog to change the date, time, and the date format to US or

International

Change the display brightness from 1 – 100%, store new value by pressing the Store button (3)

English/German/Italian/

French/Spanish, etc.

Diagram or Table

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Import/Export

User Settings

Number of Diagrams in Tone Test

No audiogram, only the level and frequency, one combined audiogram or two separate audiograms for left and right

Bone Lines On/Off, displays a dotted line, connecting the bone conduction results

Bone Symbol Setting Int Symbols/US Symbols/

UK Symbols

Export User Settings to SD

Card/Import User Settings from SD Card.

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7.1 Set up Date and Time

Select Date/Time in the user menu by scrolling down with the left or right level control (1) and select Set Date/Time by using the stimulus presenter bar. The following screen will appear:

Figure 15 - Date and Time Settings

Set the date format to International or US by the functional button (9). Jump to the required position of the date or the time by the left Frequency Up/Down button (4) or (5) and change the value by the right Frequency Up/Down button

(4) or (5) or left level control. Press the functional button OK (6) to store the changes or Exit (7) to leave the Date/Time setting screen without saving the changes.

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7.2 Set Printer Settings

Select the printer by turning the left or right level control (1) down. The color mode is automatically adjusted. If the color mode is wrong adjust the color mode as well. Jump to the field paper format by pressing the stimulus presenter bar several times and select A4 or Letter format by using the level controls. If the printer is connected to your Ethernet network select Ethernet as port.

Additionally, the IP address of the printer needs to be entered in the field “IP

Address.” Select the number of the IP address by rotating the level controls and press the STORE button to enter the selected number.

Save the settings and return to the user menu by pressing the functional button

OK (7).

Figure 16 - Printer Settings

Test your printer settings by a sample print before starting the audiological assessment. Incorrect settings may require a restart of the device.

Enter the field clinic name by using the STIM button. Select letters by rotating the level control and enter the selected letter by pressing the STORE button (3).

Save the settings and return to the user menu by pressing the functional button

OK (7).

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8 Disinfection

It is recommended that parts which are in direct contact with the patient (e.g. earphone cushions or patient response switch) be disinfected between patients.

This includes physically wiping down the equipment which comes in contact with the patient using a recognized disinfectant. Individual manufacturer's instruction should be followed for use of this disinfecting agent to provide an appropriate level of cleanliness. If ear cushions are contaminated, it is strongly recommended that you remove them from the transducer before they are cleaned.

To avoid person-to-person cross contamination of communicable diseases, ear tips should only be used one time for insert earphones.

9 Activation of Optional Features

Optional features like the MHA or Patient Management can be activated by a license key. Contact your local MAICO dealer and provide the serial number of your audiometer to obtain the required license key.

After receiving the key, store it as text file with the name Key.txt on your SD memory card, then insert the card to the SD card slot of your MA 41 and switch it on. The feature will be activated automatically and the functionality will be available.

10 Device Update

Insert the SD memory card into your computer and copy the update file Maico

MA 4x series.CAB to the SD memory card. Switch off the MA 41, insert the SD memory card into the MA 41, and then switch the device on. The update will be installed automatically. Wait until the update is finished and follow the instructions. Remove the SD memory card from the MA 41, it will boot up normally. Following the update, please use your computer to delete the update file from the SD memory card in order to have normal use of the card.

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11 Connection to the PC

Install the included software on your PC. The driver for the device will be installed automatically. Connect the MA 41 by USB cable to the PC and turn on the device. The required driver will be installed. Please follow the installation procedure. When the installation program asks you how to search for software, choose “Yes, this time only” and click on the Next button.

Figure 17 - Installation Advice

Select automatic installation in the next dialog window and click the Next button. Wait till the MAICO MA 4x family driver is installed and the operating system updated. Click on the Finish button when the installation of the driver is completed. The new hardware is now ready to use.

Figure 18 - Software Installation

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Once the instrument is linked to the PC audiometry software, you are able to record the results while performing your audiological assessment. Make sure that the software is running and that a connection is built up before starting a new session.

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12 Technical Data

The MA 41 audiometer is an active, diagnostic medical product according to the class IIa of the EU medical directive 93/42/EEC.

Standards: IEC60645-1 / EN 60645-1: Type 2

IEC60645-2: Type B

ANSI S3.6-1996 / ANSI S3.6-2010:

Type 3 B

ISO 389

UL 60601-1 American Standards for

Medical Electrical Equipment

IEC/EN 60601-1 class I, protection class B, International Standards for

Medical Electrical Equipment

CAN/CSA C22.2 NO. 60601-1-08

Medical Device Directive (MDD) to comply with “EC Directive”

93/42/EEC

Test Frequencies: 125 Hz – 8,000 Hz

Level Step: 5 dB, 2 dB or 1 dB level steps (user selectable)

Maximum Sound Pressure Level:

AC with earphone DD45: - 10 dB

HL

to 120 dB

HL

BC with B71W Bone Conductor: - 10 dB

HL

to 80 dB

HL

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Insert earphones Ear 3A:

Sound field speaker:

Test Signal:

Masking Signals:


- 10 dB

HL

... 120 dB

HL

- 10 dB

HL

... 90 dB

HL

, for CD 220

Speech Signals:

Modulation:

Pulse Tone:

Warble Tone:

Tests:

Tone:

Speech:

Patient Response:

Monitor:

Communication:

Data Connection:

Pure tone, Pulse tone, Warble tone

Narrow Band Noise: 5/12 Octave filter with the same center frequency resolution as pure tone

Speech Noise: 125 to 6,000 Hz falling 12 dB/octave above 1 kHz

(+/-5 dB)

External CD-Player, Microphone,

Wave file from SD memory card

0.25/0.5 s on time

5% sinus frequency modulation, repetition rate 5 Hz

HL, UCL

SRT, WRS, UCL

Handheld response switch

Build in monitor speaker, headset

Talk forward and talk back

USB, LAN Ethernet

8100456_OI_MA41_EN_15a 43 8100456-8 04/15

External Devices:


Stimulus Functions:

Warm-up Time:

Mode of Operation:

Environment Conditions:

Dimensions:

Weight:

Power Supply:

Power Consumption:

Device Fuses:

Supported printers:

HP (PCL 3 and PCL 5e)

Epson (ESC/P2, LQ, Stylus Color)

Canon (iP100, iP90, BubbleJet)

USB keyboard

Tone Presenter / Interrupter

Interlock (tone presentation of both channels simultaneously)

Tracking (fixed level difference between both channels)

Masking

Less than 10 min after power on

Continuous

15 - 35 ̊ C / 59 - 95 ̊ F (operation)

5 - 50 C / 41 - 122 ̊ F (transport)

Humidity: 30-90%

W x D x H: 34.5 x 20 x 8 cm /

13.4” x 7.9” x 3.2”

1.5 kg / 2.7 lbs

100 - 240 V~ 50/60 Hz ±10 %

Approximately 60 VA

2 x 1A slow blow

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1 2 3 4 5 6 7 8 9

10

11 13

12 14

15

16

17

Figure 19 – Connection Sockets of the MA 41

Connection sockets

1 Power switch on/off

2 Power

3 Network

4 USB out

5 USB in

6 Patient response switch

7 Talk Back microphone

8 Microphone

9 Monitor phone

10 CD Input

11 Speaker left

12 Speaker right

13 Bone (bone conductor)

Specification

(100 ... 240 V~ 50/60 Hz)

Ethernet

USB 2.0

USB 2.0

RI= 500 

ZI= 1 k, UI= 0.38 - 500 mVeff

ZI= 1 k, UI= 0.38 - 500 mVeff

ZA= 250 , UA= 8 Veff

ZI= 47 k, UI= 0.04 - 5 Veff

ZA= 4 , UA= 8 Veff



14 Insert phone left

15 Insert phone right

ZA=10 , UA=1 Veff

ZA=10 , UA=1 Veff

16 Phone left (headphone) ZA=10 , UA=1 Veff

17 Phone right (headphone) ZA=10 , UA=1 Veff

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Standard Accessories:

Items

MA 41 audiometer includes:

DD45 headphones

B71W bone conductor

Patient response switch

Power cable

Gooseneck microphone

SD memory card (2 GB)

Optional Accessories:

Item

HDA300 headphones

HOLMCO 8103 headphones

TDH39 headphones

Ear 3A insert phones

Canton CD220 speaker (single unit)

Cable for Canton CD 220

SBC speakers

Monitor headset with microphone

Single ear monitor phone

USB cable

Carrying case

Sound room patch cords

Talk-back microphone

NOAH audiometry module

MHA License

Item Number

8013739

88010880

8102514

8011091

8011237

8006479

8010775

Item Number

8103867

8010878

8010806

8010959

8110906

8004229

8111951

8010870

8111857

8011241

8100797

8111839

8011233

8112043

8110670

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13 Warranty, Maintenance and After-Sales Service

The MAICO MA 41 is guaranteed for 2 years.

This warranty is extended to the original purchaser of the instrument by

MAICO through the distributor from whom it was purchased and covers defects in material and workmanship for a period of two years from date of delivery of the instrument to the original purchaser.

The MA 41 may be repaired and serviced only by your dealer or by an authorized service center. We urgently advise you against attempting to rectify any faults by yourself or commissioning non-experts to do so.

Do not modify this equipment without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.

WARNING: No modification of this equipment is allowed.

In the event of repair during the guarantee period, please enclose evidence of purchase with the instrument.

In order to ensure that your instrument works properly, the MA 41 should be checked and calibrated at least once a year. This check has to be carried out by your dealer.

When returning the instrument for repairs it is essential to send the headphones and bone conductor, as well. Send the device to your dealer or to a service center authorized by your dealer. Please include a detailed description of faults. In order to prevent damage in transit, please use the original packing if possible when returning the instrument.

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Within the European Union it is illegal to dispose 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 electrical and 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 legal regulations to our customers.

Date of Manufacture

14 Safety Regulations

READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS

SYSTEM.

14.1 Electrical Safety

The MA 41 audiometer is constructed to comply with protection class I of the international standard IEC 601-1 (EN 60601-1).

The instruments are not intended for operation in areas with an explosion hazard.

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 supply mains with protective earth.

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14.2 Measuring Security

To guarantee that the audiometer works properly, the instrument has to be checked and calibrated at least once a year.

The service and calibration must be performed by an authorized service center.

In accordance with the regulations of the EU Medical Directive, warranties may be void if these checks are not done.

The use of non-calibrated audiometers can lead to incorrect test results and is not advisable.

14.3 Device Control

The user of the instrument should perform a subjective instrument check once a week.

14.4 Operation

The instrument should only be handled and operated by trained personnel

(audiologists, ENT doctors or personnel with similar qualifications).

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Appendix A: Checklist for subjective audiometer testing

- Clean the ear and head cushion!

- Untangle all lines when necessary!

- Are the headphone cushions in good condition?

If not replace.

- Are plugs and leads in good condition/ undamaged?

- Are all controls working properly?

- Is the Patient Response Key working properly (if available)?

- Check batteries and renew if necessary!

Instrument:........................................

Manufacturer:…................................

Serial No.:.........................................

Examiner:........................................

Test Signal Quality

All the test frequencies in the below table indicate typical hearing level and can be changed when necessary:

Masking: “B” for Buzz tone, “G” for Noise, “V” for signal distortion, “S” for switching masking noise.

Right Ear Level Left Ear kHz 0,25 0,5 1 2 3 4 6 8

AC

30 dB

50 dB

HL

HL

0,25 0,5

70 dB

HL

30 dB

HL

BC

50 dB

HL

* When noise “B”, “G”, “V” or “S” is blocked, inform the service center!

* When the test tone is heard at the masking ear, contact the service center!

Air Conduction Audiogram

Right Ear Level Left Ear

1 2 3 4 6 8 kHz kHz 0,25 0,5 1 2 3 4 6 8 0,25 0,5 1 2 3 4 6 8 kHz

Should dB

HL*

Left

Earpiece

Is dB

HL Left Earpiece

Right

Earpiece

**

Is dB

HL

* Should is the last measurement of the patient

**For inverted measurement please reattach the headphone

If the frequency difference between „Should“ and „Is“ for one ear averages more than 10 dB, contact the SERVICE CENTER!

Bone Conduction Audiogram

Right Ear Level Left Ear

Right Earpiece

** kHz 0,25 0,5 1 2 3 4 6 8

Should dB

HL

*

Is dB

HL

0,25 0,5 1 2 3 4 6

If the frequency difference between „Should“ and „Is“ for one ear averages more than 10 dB, contact the SERVICE CENTER!

Tested.............................................................................................

Date:...............................................................................................

8 kHz

8100456_OI_MA41_EN_15a 50 8100456-8 04/15


Appendix B: Calibration values and maximum levels

Headphone DD45 with Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC

Frequency

Hz

Tone RETSPL dB re 20µPa

NBN RETSPL dB re 20µPa

Max Tone dB

HL

125

47.5 51.5

90

250

27.0 31.0

110

500 13.0 17.0 120

750

6.5 11.5

120

1000

6.0 12.0

120

1500

8.0 14.0

120

2000

8.0 14.0

120

3000 8.0 14.0 120

4000

9.0 14.0

120

6000

20.5 25.5

120

12.0 17.0

110 8000

Signal

Speech

IEC60645-2

RETSPL

20.0

IEC Max Level dBHL

110

Max NBN dB

HL

75

95

110

110

110

110

110

110

110

110

100

ANSI S3.6 RETSPL ANSI Max Level dBHL

18.5 100

SN 20.0 110 18.5 100

Headphone TDH39 withCoupler IEC 60318-3, Force 4-5 N, ANSI and IEC

Frequency

Hz



Max Tone dB

HL

125 45.0 49.0 90

250

500

750

1000

1500

2000

3000

4000

6000

8000

Signal

Speech

SN

25.5

11.5

7.5

7.0

6.5

9.0

10.0

9.5

15.5

13.0

IEC60645-2

RETSPL

20.0

20.0

29.5

15.5

12.5

13.0

12.5

15.0

16.0

14.5

20.5

18.0

110

120

120

120

120

120

120

120

120

110

110

110

110

110

110

110

100

Max NBN dB

HL

75

95

110

110

IEC Max Level dB

HL

ANSI S3.6 RETSPL ANSI Max Level dB

HL

110

110

19.5

19.5

110

110

WN 0.0 110 0.0 110

8100456_OI_MA41_EN_15a 51 8100456-8 04/15


Headphone Holmco 8103 with Coupler IEC 60318-3, Force 4-5 N, ANSI and IEC

Frequency

Hz

125


39.5


43.5

Max Tone dB

HL

90

Max NBN dB

HL

80

250 25.0 29.0 105 95

500

18.5 22.5 110 100

750

13.5 18.5 120 105

1000 12.0 18.0 120 110

1500

10.0 16.0 120 110

2000

9.5 15.5 120 110

3000

9.0 15.0 115 110

4000

9.0 14.0 110 110

6000

19.5 24.5 100 110

8000

20.0 25.0 100 110

Signal

Speech

IEC60645-2

RETSPL dB

SPL

20.0

IEC Max Level dB

HL

110

ANSI S3.6 RETSPL dB

SPL

24.5

ANSI Max Level dB

HL

110

SN

WN

20.0

0.0

110

110

24.5

0.00

110

110

8100456_OI_MA41_EN_15a 52 8100456-8 04/15


Headphone HDA 300/ Ear simulator IEC60318-1 with adapter,

Force 8.8 N ± 0.5 N, ANSI and IEC

Frequency

Hz

Tone RETSPL dB

SPL

NBN RETSPL dB

SPL

Max Tone dB

HL

Max NBN dB

HL

125 27.0 31.0 115 80

250

20.0

24.0

120 90

500 8.0 12.0 120 100

750

4.5

9.5

120 100

1000 2.0 8.0 120 105

1500

3.0

9.0

120 105

2000 0.0 6.0 120 105

3000 -3.0 3.0 120 110

4000

-0.5

4.5

120 110

6000

8000

9000

10000

11200

21.0

23.0

27.5

18.0

22.0

26.0

28.0

32.5

23.0

27.0

110

110

100

105

105

95

95

90

95

90

12500

14000

16000

18000*

20000*

27.0

33.5

32.0

38.5

50.5

88.0

100

90

85

75

*Calibration values for 18 kHz and 20 kHz are not covered by the norm ISO389-5 and defined by MAICO Diagnostic

GmbH

Signal

Speech

SN

WN

45.5

83.0

105.0

IEC60645-2

RETSPL

20.0

20.0

0.0

110.0

IEC Max Level dB

HL

95

90

115

75

35

10

60

20

0

ANSI S3.6 RETSPL ANSI Max Level

18.0

18.0

0.0 dB

HL

100

95

115

8100456_OI_MA41_EN_15a 53 8100456-8 04/15


250

500

750

1000

1500

2000

3000

4000

6000

8000

Insert phone Eartone 3A

Reference equivalent threshold sound pressure level

Frequency Hz Tone IEC

60318-5

RETSPL dB re

20µPa

NBN IEC 60318-

5

RETSPL dB re

20µPa

Tone

Max Level dB

HL

125 26.0 30.0 90

250

500

750

1000

1500

2000

3000

14.0

5.5

2.0

0.0

2.0

3.0

3.5

18.0

9.5

7.0

6.0

8.0

9.0

9.5

105

110

115

120

120

120

120

4000

6000

8000

5.5

2.0

-1.0

10.5

7.0

4.0

115

100

95

NBN

Max Level dB

HL

90

105

110

110

110

110

110

110

110

100 sound damping dB

32.5

36

37.5

-

36.5

-

33

-

39.5

-

95 42.5

Signal

Speech

SN

WN

IEC60645-2

RETSPL

20.0

20.0

0.0

Bone conductor Radioear B71W Force: 4.9 ... 5.9 N, ANSI and IEC

Mastoid placement

Frequency Hz Reference equivalent threshold force level for tone

Air radiation

ISO 389 - 3 dB (re 1 N)

IEC Max Level dB

HL

100

100

100

ANSI S3.6 dB (re 1 N)


HL

12.5 100

12.5

0.0

100

100 mean/max dB

Max level

Tone dB

HL

67

58

48.5

42.5

36.5

31

30

35.5

40

40

67

58

48.5

42.5

36.5

31

30

35.5

40

40

-

-

-

-

-

-

4 / 18

-

10.5 / 31

-

70

75

80

80

45

60

70

70

50

50

8100456_OI_MA41_EN_15a 54 8100456-8 04/15


Signal

Speech

SN

Frequency Hz

125

250

500

750

1000

1500

2000

3000

4000

6000

8000

IEC60645-2

RETSPL

35.00

35.00

IEC Max Level dB

HL

75

75


HL

55.00

55.00

75

75

Sound field (0 degree incidence)

Reference equivalent threshold sound pressure level and maximum hearing levels

For Canton CD 220 / Maico SBC speaker

ISO 389 – 7 and ANSI S3.6-1996

Tone RETSPL dB

SPL

22.0

11.0

4.0

2.0

2.0

0.5

-1.5

-6.0

-6.5

2.5

11.5

NBN RETSPL dB

SPL

22.0

11.0

4.0

2.0

2.0

0.5

-1.5

-6.0

-6.5

2.5

11.5

Max level Tone dB

HL

CD220 / SBC

65 / -

75 / -

85 / 85

85 / 85

85 / 85

90 / 85

90 / 85

90 / 90

95 / 90

85 / 90

80 / 75

Max level NBN dB

HL

CD220 / SBC

55 / -

70 / -

75 / 75

75 / 75

75 / 75

80 / 75

85 / 75

85 / 80

85 / 80

80 / 80

70 / 65

Signal

Speech

SN

WN

IEC60645-2

RETSPL dB

SPL

0.0

0.0

0.0

IEC Max Level dB

HL

CD220 / SBC

90 / 80

90 / 75

90 / 75

ANSI S3.6 RETSPL dB

SPL

14.5

14.5

0.0

ANSI Max Level dB

HL

CD220 / SBC

90 / 80

90 / 75

90 / 75

8100456_OI_MA41_EN_15a 55 8100456-8 04/15


Specifications are subject to change without notice.


Salzufer 13/14

10587 Berlin

Germany

Phone: +49 30 70 71 46 50

Telefax: +49 30 70 71 46 99

E-mail: [email protected]

Internet: www.maico.biz

8100456_OI_MA41_EN_15a 56 8100456-8 04/15

Maico MA 41 Operating Instructions Manual

MAICO Diagnostic GmbH

Operating Instructions MA 41

1 Introduction

2 Intended Use

3 Getting Started

4 Working with the MA 41

5 Measurement Methods of Audiometry

6 Quick Reference Guide

7 User Menu

8 Disinfection

9 Activation of Optional Features

10 Device Update

11 Connection to the PC

12 Technical Data

13 Warranty, Maintenance and After-Sales Service

14 Safety Regulations

Appendix A: Checklist for subjective audiometer testing

Appendix B: Calibration values and maximum levels

Related manuals

Table of contents

Maico MA 41 Operating Instructions Manual

MAICO Diagnostic GmbH

Operating Instructions MA 41

1 Introduction

2 Intended Use

3 Getting Started

4 Working with the MA 41

5 Measurement Methods of Audiometry

6 Quick Reference Guide

7 User Menu

8 Disinfection

9 Activation of Optional Features

10 Device Update

11 Connection to the PC

12 Technical Data

13 Warranty, Maintenance and After-Sales Service

14 Safety Regulations

Appendix A: Checklist for subjective audiometer testing

Appendix B: Calibration values and maximum levels

Related manuals

Maico

MA 41

Maico

MA 42

Maico

MA 50

Gima

53551

Table of contents