10 Technical Data ........................................................................................18
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Instruction for Use MA 25 / MA 25e
8012238-5_IFU_MA25_e_15b
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1 Introduction
Thank you for selecting one of our quality products from the MAICO family
range. The MA 25 is designed and manufactured to meet all quality and safety
requirements, and has been certified with the CE-symbol according to Medical
Directive.
Particular attention has been taken during the designing phase of the MA 25
to ensure its user-friendliness, meaning that its operation is simple, easy to learn
and to understand. As all the functions are software-controlled, upgrading the
software and/or adding additional functions at a later date will be simple and
cost-effective. By purchasing the MAICO MA 25, you have made a decision
towards long-term investment.
This operating manual aims to make learning and understanding the different
MAICO MA 25 functions as quick and as easy as possible. Should you
encounter any problems or have ideas for any further improvements, we are
only a phone call away. Please do not hesitate to contact us.
Your MAICO-Team
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Instruction for Use MA 25 / MA 25e
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2 Description
2.1 Intended Use
The MA 25 / MA 25e screening audiometer is designed to be a device for
screening for hearing loss. Output and specificity of this type of device are
based on the test characteristics defined by the user, and may vary depending
on environmental and operating conditions. The screening for hearing loss
using this kind of audiometer depends on the interaction with the patient.
“Normal hearing” result should not allow for ignoring other contra indications.
A full audiologic evaluation should be administered if concerns about hearing
sensitivity persist.
The MA 25/MA 25e audiometer is intended to be used by an audiologist,
hearing healthcare professionals, or technicians who have been trained by a
hearing healthcare professional, in a quiet environment.
Extended Functions
The MA 25e extends the MA 25 functionalities with the following two extra
features:
In addition to traditional manual testing, the MA 25e incorporates a Hughson
Westlake patient controlled automatic threshold test complying with ISO 8253.
When the test is completed the results are easily recalled from the internal
memory of the MA 25.
Talk Forward function that makes the MA 25e easy to work with particularly in
sound booth installations.
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Instruction for Use MA 25 / MA 25e
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2.2 Important Safety Note
The MA 25 should always be operated in a quiet room with minimal magnetic
influence, to ensure that examinations are not disturbed by external noise.
Electro-medical instruments that emit strong electromagnetic fields (e.g.
microwaves, radiotherapy devices) can affect the operation of the MA 25.
Therefore, the operation of these instruments in close proximity to the MA 25
should be avoided at all times.
The examination room should have a normal temperature between 15˚C/ 59˚F
and 35˚C/ 95˚F. If the instrument has cooled down during transportation,
please wait for it to warm up to room temperature before operation.
MAICO MA 25 is specified according to EN 60 601-1.
Attention
PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE
OPERATING THIS INSTRUMENT.
Please only use this instrument as described in the manual.
Please familiarize yourself with the instrument and its operation
before using.
Should defects or damages be suspected, please do not, under any
circumstances, use or attempt to fix the instrument yourself.
Calibration of the instrument: The audiometer and the headphone complement
each other and share the same serial number (i.e. 7663252). Therefore, the
instrument shall not be used with any other headphone prior to recalibration.
Recalibration also needs to be conducted, when a defected headphone is
replaced.
Uncalibrated instruments may lead to faulty measurements and sometimes
even damage the hearing of the examinee.
Take note to ensure that all the accessories have been properly connected.
To avoid person-to-person cross contamination of communicable diseases,
parts that come in direct contact with the patient (i.e. earphone cushions)
should be disinfected using commercial disinfectant after each use.
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Instruction for Use MA 25 / MA 25e
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In accordance with the Electronic Equipment Act for disposal of
electronic equipment, the customer is obliged to dispose of the
used consumables, according to appropriate regulation at own
cost.
To observe the CE-mark with an external power supply, the power supply must
be CE-medical approved according to EN 60601-1.
2.3 Unpacking and Checking the MA 25
Checking for packaging and content damage
Thoroughly inspect the exterior of the shipping box for any sign of damage or
tempering. Should any damage be noted, please notify the carrier immediately.
If the content box has been damaged during transportation, the instrument
should be checked for any electrical or mechanical defects. Should any defects
be identified, please contact the responsible dealer. Keep all original packaging
to facilitate any insurance claims against the damages.
PLEASE KEEP ALL ORIGINAL PACKAGING FOR FUTURE USE!
The MA 25 is packaged in a specially-designed box. Please keep the box as it
will be useful for sending the instrument for the instrument check-up, as
required by law.
Please contact your nearest responsible dealer when the check-up is needed.
2.4 Accessories
Audiometer MA 25
Audiometric Headset.
1 Pad with 50 audiogram charts
Operating Instructions
3 batteries inside the device
MA 25 e - same like MA 25
Patient response switch
Test Hughson-Westlake
Optional
Carrying bag
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Instruction for Use MA 25 / MA 25e
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Position:
Symbol:
Function:
1
Battery
Compartment for three batteries AA/LR6
2
Power / USB
Socket for external power supply
3
Patient Resp.
Socket for patient response switch
4
Right
Socket for right headphone
5
Left
Socket for left headphone
Figure 1 Rear and bottom of the MA 25
2.5 Connecting the Accessories
All the connection jacks can be found on the rear side of the MA 25. All the
cables and accessories have to be connected before the instrument is switched
on.
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Instruction for Use MA 25 / MA 25e
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Frequency
Hearing Level
Tone
3 Function of buttons and display
Power On and Power Off
Attention: Power on is only possible if headphones are plugged-in!
To turn on the audiometer press the Tone Switch button.
To power off the audiometer press the level dialer and frequency dialer for a
few seconds. The audiometer will also automatically power off after 3, 4, 5
minutes (or not) depending on the settings.
Pure Tone Presentation
Frequency: Turn the Frequency Hz dialer to select another frequency
Level: Rotate the Hearing Level dB dialer to increase or decrease the level
Present tone: Touch the Tone Switch
3.1 Function Buttons
F1 - MA 25 - Select the Right ear. MA 25e: Toggle between Right and Left.
F2 - MA 25 - Select the Left ear. MA 25e: Store threshold.
F3 – Pulse – Pulse Off: Manual tone presentation; Pulse On: Pulsing Tone will
be presented.
F4 – Warble - Warble off: Pure tones will be presented. Warble on: Warble
tones will be presented.
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Instruction for Use MA 25 / MA 25e
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3.2 Special functions of MA 25e
Talk Forward: Talk Forward is activated by holding down the
Hearing Level db dialer.
While holding down the Tone Switch the talk forward level can be adjusted.
Hughson-Westlake: The following MA 25e F-key functionalities can be
accessed by pressing the frequency dialer.
F1 - Delete all thresholds stored in the internal memory of the MA 25e.
F2 - Store a Not Heard threshold point.
F3 - Display the L/R thresholds stored in the internal memory of the MA 25e.
F4 - Start the Hughson Westlake (HW) automatic test procedure. Please refer
to the chapter 5 for instructions about how to setup the HW test.
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Instruction for Use MA 25 / MA 25e
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3.3 Display
Tone: A tone presentation indicator is provided in the top left corner of the
display header.
Response: When using the patient response switch, a response is indicated in
the middle of display header.
Power On or Battery status: The power status of the MA 25/MA 25e is
indicated in the top right corner of the display header.
The icon will change depending on whether the instrument is powered via an
external source (power supply or USB connection to computer) or batteries.
When powered by batteries, the battery icon will change depending on the
battery power level. When batteries are running low the display will read Low
Battery and flash.
The Power Off settings of the instrument can be adjusted at different time
intervals or set to never power off – please see Setup section for details.
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Instruction for Use MA 25 / MA 25e
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4 Performing Tone Audiometric Tests
Hearing threshold levels can be determined by presenting test signals to the
test subject with the included earphones (air conduction – AC). The purpose of
AC audiometry is to establish the hearing sensitivity at various frequencies. The
test can specify the AC loss but cannot distinguish between abnormality in the
conductive mechanism and sensor neural mechanism.
The patient should sit at a distance of at least 1 m from the device.
Eliminate any obstructions which will interfere with the placement of the
earphone cushions on the ear (i.e. hair, eyeglasses).
Ensure that the headphones are positioned correctly: Red side on the right, blue
side on the left. Adjust the headband of the headphones so that the earphones
are positioned at the correct height (i.e. the sound output grid exactly facing
the ear canal).
Prior to hearing threshold level measurements, the following instructions
should be given. "You will now hear a variety of pitches with various loudness
levels. Please push the response switch when you hear a tone and release the
button when you no longer hear it. If not using the response switch, ask the
patient to “raise their left or right hand when you hear the tone in the left or
right ear".
Threshold Determination: The test normally starts at 1000 Hz on the patient's
better ear with the L/R switch adjusted accordingly.
Attention: Background noise can produce false test results, especially at lower
frequencies.
For hygienic reasons, it is important to clean the headphone ear cushions after
testing.
4.1 Performing Automatic Tone Audiometric Test (MA 25e)
Another form of threshold search is using the Hughson Westlake automatic
tests procedure, also known as the “10 down, 5 up” method.
Prepare and instruct the test person as described above.
Press the Frequency Hz dialer and F4 to start the automatic Hughson Westlake
test. If Familiarization is activated the HW tests starts with 1000 Hz at 40 dB
and proceeds in 10 dB steps in a familiarization phase before the Hughson
Westlake test itself starts.
If the hearing level is confirmed the value will be stored and the next frequency
is selected automatically. The level decreases for 10 dB.
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Instruction for Use MA 25 / MA 25e
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F1
Change setting
F2
Browse up in the setup menu
F3
Browse down in the setup menu
F4
Save settings and Back to previous screen display – see below
for details
5 Setup Menu
To access the MA 25/MA 25e setup menu press F1 and F4 simultaneously for
2-3 seconds.
Power Up Tone
Press Change to toggle between Manual and Reverse. Man: Tone is presented
as long as the Tone Switch is activated. Rev: Tone will be interrupted if Tone
Switch is activated.
Power Up Ear
Press Change to toggle between Right and Left ear as the default ear for Power
Up
Default Intensity
The default intensity when changing ear side is 20 dB.
Battery Mode: Press Change to toggle between Never, 1, 2, 3, 4 or 5 minutes.
With batteries this device will shut down after “power –off time” as entered in
the settings.
USB-Power Supply: With power supplying from USB cable the device will NOT
turn off. This setup is mainly to save the battery power.
Pulse Length
Press change to toggle between 250 msec and 500 msec.
Language
Press Change to toggle between English, German, Spanish and French.
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Instruction for Use MA 25 / MA 25e
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LCD Contrast
Press Change to toggle between settings ranging from 0 (very bright) to 6 (very
dark).
HW Test (only MA 25e)
Press Change to go to the Hughson Westlake (HW) automatic test procedure
setup.
Press Change to toggle between Familiarization On/Off. Familiarization is used
to train the patient.
Press Change to toggle between “2 correct out of 3 answers” and “3 correct
out of 5 answers”. The conditions used before saving the hearing threshold
and going to the next frequency.
Select the frequencies to include in the HW test. Press Change to toggle
between frequencies On/Off. Press Save to return to the main HW setup menu.
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Instruction for Use MA 25 / MA 25e
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Frequencies
Press Change to access the default frequency range from 125 Hz to 8 kHz for
daily operation.
10 frequencies are available to change: 125; 250; 500; 750; 1,500; 2,000;
3,000; 4,000; 6,000 and 8,000.
Press Change to toggle between On or Off. Press Save to return to the main
setup menu
License
Press Change to access the license key of the MA 25/MA 25e.
Press Change to enter and modify the license key. Use the Hearing Level dB
dialer to change the letter and Frequency Hz dialer to move the cursor. Press
Save to return to the main setup menu.
About
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Instruction for Use MA 25 / MA 25e
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Press Change to access the information in the About section.
6 Warranty and Disclaimer
Warranty, Maintenance and After-Sales Service Hardware
The MA 25 audiometer 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 2 years from date of delivery of the instrument to the original
purchaser.
The audiometer may be repaired only by your dealer or by a service center
recommended by your dealer. We urgently advise you against attempting to
rectify any faults yourself or commissioning non-experts to do so.
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 audiometer should be checked and calibrated at least once a year.
This check-up needs to be conducted by your dealer.
When returning the instrument for repairs it is essential to also send the
headphone and other accessories. Send the device to your dealer or to a service
center authorized by your dealer. Please also include a detailed description of
the faults.
In order to prevent damage in transit, if possible please use the original packing
when returning the instrument.
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Instruction for Use MA 25 / MA 25e
8012238-5_IFU_MA25_e_15b
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7 Care and Maintenance
Disconnect the power plug before cleaning!
If the surface of the instrument or parts of it is contaminated, it can be cleaned
using a soft cloth moistened with a mild solution of water and dish washing
cleaner or similar. The use of organic solvents and aromatic oils must be
avoided.
After each examination of a patient, it should be ensured that there is no
contamination on the parts in connection with the patient. General precautions
must be observed in order to avoid that disease from one patient is conducted
to others. If ear cushions are contaminated, it is strongly recommended to
remove them from the transducer before they are cleaned. By frequent cleaning
water should be used, but by severe contamination it may be necessary to use
a disinfectant. The use of organic solvents and aromatic oils must be avoided.
Always disconnect the mains conductor during the cleaning process, and be
careful that no fluid is entering the inside of the instrument or the accessories;
no alcohol or spirits should be used.
8 Disinfection
It is recommended that parts which are in direct contact with the patient (e.g.
earphone cushions or patient response switch) are subjected to standard
disinfecting procedure between patients. This includes physically cleaning and
use of a recognized disinfectant. Individual manufacturer's instruction should
be followed for use of this disinfecting agent to provide an appropriated level
of cleanliness. If ear cushions are contaminated, it is strongly recommended to
remove them from the transducer before they are cleaned
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Instruction for Use MA 25 / MA 25e
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9 Safety Regulations
8.1 Electrical Safety: The MA 25 / MA 25e is in compliance with Class B of
EN 60601-1.
The instrument is not to be used in environments
dealing with explosive material or equipment.
8.2 Measurement Safety: In order to ensure safety and quality of the
measurement, an annual inspection and calibration
should be performed. The annual check-ups can be
performed by one of MAICO’s authorized service
centers. MAICO will not be liable for any failure to
comply with the specified inspection date, according
to the Medical Product Law. The use of uncalibrated
and uninspected audiometer is strictly prohibited.
8.3 Instrument Handling: The instrument should be checked once a week.
8.4 Operation: The instrument should only be handled and operated
by trained personnel (audiologists, ENT doctors or
personnel with similar qualifications).
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Instruction for Use MA 25 / MA 25e
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Maximum
Intensities
Frequency
125 Hz
250Hz
500Hz
750Hz
1KHz
1.5KHz
2KHz
3KHz
4KHz
6KHz
8KHz
DD45
70
90
100
100
100
100
100
100
100
100
90
DD65
65
75
90
95
95
95
95
95
95
90
85
10 Technical Data
Standards
Audiometer : EN 60645-1/ANSI S3.6, Type 4
Safety : EN 60601-1
EMC : EN 60601-1-2
Frequencies and Maximum Intensities:
Inputs: Patient response switch, USB-Power-Supply
Outputs: Left AC, Right AC
Attenuator: -10 to 100 dB HL in 5 dB steps.
Tone Presentation: Manual or reverse (chosen in Setup Menu);
Multiple pulses 250 or 500 msec (chosen in Setup
Menu); On/Off; pure tone or warble tone
Talk Forward (MA 25e): Built in talk forward microphone
0-100 dB
Auto Threshold (MA 25e): Patient controlled Hughson Westlake
procedure according to ISO 8253-1.
Store Function (MA 25e): Soft key (F2-key) store button and internal
memory for AC L/R. Stored measurements can be
viewed on the build in display.
Modulation: Warble +/- 5% 5 Hz.
adjustable.
SPL
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Instruction for Use MA 25 / MA 25e
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Frequency [Hz]
Reference equivalent threshold according to
ISO 389-1 with coupler IEC 60 318-3
[dB] (re 20 Pa)
125
47.5
250
27.0
500
13.0
750
6.5
1000
6.0
1500
8.0
2000
8.0
3000
8.0
4000
9.0
6000
20.5
8000
12.0
Frequency [Hz]
Reference equivalent threshold sound
pressure level according to WDH-Standard
with coupler IEC 60318-3
[dB] (re 20 Pa),
125
52,5
250
39,5
500
19,5
750
11,0
1000
8,5
1500
13,0
2000
9,0
3000
11,5
4000
10,5
5000
14,5
6000
29,0
8000
14,0
Calibration
Air Conduction: ISO 389-1/ANSI S3.6 (DD45).
Calibration values: AC-Headphone DD45 Force 4-5 N
Calibration Values: AC Headphone Radioear DD65 Force 10,1... 11,1 N
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Instruction for Use MA 25 / MA 25e
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Frequency [Hz]
Equivalent Threshold
Reference Level
according to ISO 389 - 2
Measured with Coupler
IEC 60 318-3 [dB] (re 20
Pa)
Sound Masking
[dB]
125
39.5
12.5
250
25
14.5
500
18.5
18.5
750
13.5
-
1000
12.0
25
1500
10.0
-
2000
9.5
36.5
3000
9.0
-
4000
9.0
44
6000
19.5
-
8000
20.0
35
Frequency [Hz]
Reference equivalent threshold according to
ISO 389-1 with coupler IEC 60 318-3
[dB] (re 20 Pa)
125
45
250
25.5
500
11.5
750
7.5
1000
7
1500
6.5
2000
9
3000
10
4000
9,5
6000
15.5
8000
13
Calibration values: AC Headphone Holmco 8103 B 26
Force 13...16 N
Calibration values:AC-Headphone TDH39
Force 4-5 N
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Instruction for Use MA 25 / MA 25e
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Dimensions
W x D x H: 22.5 x 18 x 5.5 cm / 8.9 x 7.1 x 2.2 inches
Weight: 1.0 kg/2.2 lbs – including batteries and headset.
(1.6 kg/3.5 lbs – including carrying bag headset,
audiogram charts etc.)
Power3 type AA batteries / External Power supply
Batteries Automatic battery on/off switching
Automatic battery status indication
External Power Supply 5V DC 100 - 240 V AC, 50 – 60 Hz.
USB-Connector 5VDC minimum 150 mA
The power supply must fulfill the medical device standard EN 60601-1
Battery life: Standby: 6 months
Tone presentations: 70.000
Construction: Plastic cabinet
Additional parts: Response switch 8011091
Carrying case 8100796
Medical Power supply 8006061
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Instruction for Use MA 25 / MA 25e
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- 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)?
All the test frequencies in the below table indicate typical hearing level and can be changed when necessary:
Test these frequencies and enter the following abbreviations, if necessary: “B” for Buzz tone, “G” for Noise, “V” for signaldistortion, “S” for switching masking noise.
* When noise “B”, “G”, “V” or “S” has been checked, please inform your service center!
* If conduction test signals are also audible in the non-test ear, please inform your service center!
Air Conduction Audiogram with test person
* Target value is the value measured in the last audiogram of the test person
**Repeat the measurement with headphones the wrong way around
If the difference between target and actual value at a particular frequency or between right and left headphones is more than 10 dB,
please inform your service center!