MA 25 Operating Manual Rev B March 2011

MA 25 Operating Manual Table of Contents

Page

1. Introduction ... 1 2. Description... 2 2.1 Important safety note ... 3 2.2 Unpacking and checking the MA 25... 5 2.3 Standard accessories ... 5 2.4 Optional accessories... 5 2.5 Connecting the accessories ... 6 3. Function of buttons and display... 7 3.1 Function buttons ... 7 3.2 Display ... 8 4. Performing tone audiometric tests ... 9 5. Setup menu ... 10 6. Warranty and disclaimer ... 13 7. Care and maintenance ... 14 8. Safety regulations ... 15 8.1 Electrical Safety... 15 8.2 Measurement safety ... 15 8.3 Instrument handling... 15 8.4 Operation ... 15 9. Technical data... 16

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MA 25 Operating Manual 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. 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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MA 25 Operating Manual 2. Description The MA 25 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. As with any type of hearing screening, a “pass” result should not overrule any additional concerns regarding hearing ability. A full audiologic evaluation should be administered if concerns about hearing sensitivity persist. The MA 25 audiometer is intended to be used by an audiologist, hearing healthcare professionals, or trained technicians in a quiet environment.

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MA 25 Operating Manual 2.1. 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 15̊C/ 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. 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. 63252). Therefore, the instrument shall not be used with any other headphone prior to recalibration. Recalibration also needs to be conducted, when a defective headphone is replaced. NOTE: Uncalibrated instruments may lead to faulty measurements.

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MA 25 Operating Manual 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. 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.

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MA 25 Operating Manual 2.2. 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 tampering. 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 annual instrument check-up. Please contact your nearest responsible dealer should the annual instrument check-up be needed. 2.3. • • • • • •

Standard accessories DD 45 Audiometric Headset Audiogram pad Operation Manual 3 AA batteries Carrying bag AC power adapter

2.4. Optional accessories • Patient response switch • Audiocup headset

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MA 25 Operating Manual 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.

Figure 1 Rear and bottom of the MA 25

Position:

Symbol:

Function:

1 2 3 4 5

Battery Power / USB Patient Resp. Right Left

Compartment for three AA batteries Socket for external power supply Socket for patient response switch Socket for right headphone jack Socket for left headphone jack 6

MA 25 Operating Manual 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. F2 - MA 25 - Select the Left ear. F3 – Pulse – Pulse Off: Manual tone presentation; Pulse On: Pulsing Tone will be presented when tone switch is pressed. F4 – Warble - Warble off: Pure tones will be presented. Warble on: Warble tones will be presented. 7

MA 25 Operating Manual 3.2. 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 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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MA 25 Operating Manual 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 sensorineural 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 ear, blue side on the left ear. 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. A procedure of “down 10dB, up 5dB” is typically utilized to establish a threshold at each frequency. Screening: A hearing screening produces a “pass” or “refer” result and is used to determine if a patient should receive further evaluation to determine if a hearing problem exists. Patients are typically screened at a level of 20dB HL at 500, 1000, 2000, and 4000HZ in each ear. If a patient hears all the tones in each ear, the result would be considered a “pass.” Failure to hear any of the tones in either ear would result in a “refer”. This is an example of one screening protocol. Each state may have their own screening protocol. Please contact your state health department for guidelines in your area. 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.

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MA 25 Operating Manual 5. Setup menu To access the MA 25 Setup menu press F1 and F4 simultaneously for 2-3 seconds. F1 F2 F3 F4

Change setting Browse up in the setup menu Browse down in the setup menu Save settings and Back to previous screen display – see below for details

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. Choose between: Off, -10dB, -5dB, 0dB, 5dB, 10dB, 15dB, 20dB, 25dB, 30dB, 35dB, 40dB, 45dB, and 50dB. Intensity Steps Choose between 1 dB, and 5 dB.

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MA 25 Operating Manual Power Off Settings Press Change to toggle between Never, 1, 2, 3, 4, or 5 minutes.

Pulse Length Press Change to toggle between 250 msec and 500 msec. Language Press Change to toggle between English, German, Spanish, and French. LCD Contrast Press Change to toggle between settings ranging from 0 (very bright) to 6 (very dark).

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

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MA 25 Operating Manual License Press Change to access the license key of the MA 25.

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 Press Change to access the information in the About section.

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MA 25 Operating Manual 6. Warranty and disclaimer Warranty, Maintenance and After-Sales Service Hardware The MA 25 audiometer is guaranteed for 1 year. 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 one year 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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MA 25 Operating Manual 7. Care and maintenance Disconnect the unit’s energy source 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 severely contaminated, it is strongly recommended to remove them from the transducer before they are cleaned with a disinfectant. The use of organic solvents and aromatic oils must be avoided. Always disconnect the unit’s energy source before the cleaning process, and be careful that no fluid enters the inside of the instrument or the accessories; no alcohol or spirits should be used.

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MA 25 Operating Manual 8. Safety regulations 8.1. Electrical safety: The MA 25 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. 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 trained technicians).

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MA 25 Operating Manual 9. Technical data Standards: Audiometer : Safety : EMC :

EN 60645-1/ANSI S3.6, Type 4 EN 60601-1 EN 60601-1-2

Frequencies and Maximum Intensities: Freq. Hz.

AC (Air Condition) dB HL

125 250 500 750 1000 1500 2000 3000 4000 6000 8000

70 90 100 100 100 100 100 100 100 100 90

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

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MA 25 Operating Manual Modulation:

Warble +/- 5% 5 Hz.

Calibration: Air Conduction:

ISO 389-1/ANSI S3.6.

Dimensions: W x D x H: Weight:

22.5 x 18 x 5.5 cm / 8.9 x 7.1 x 2.2 inches 1.0 kg/2.2 lbs – including batteries and headset. (1.6 kg/3.5 lbs – including carrying bag headset, audiogram charts etc.)

Power:

3 AAbatteries, External Power Supply 5V DC 100, 110 – 120V AC 10%, 50 – 60 Hz. 220 - 240 VAC 10% 50 , – 60 Hz.

Construction:

Plastic cabinet

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MA 25 Operating Manual Checklist for Subjective Audiometer Testing Instrument:... Manufacturer:…... Serial No.:... Examiner:...

- 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?

Quality of test signals

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 signal distortion, “S” for switching masking noise.

kHz

Right Ear 0,25 0,5

Level 1

2

3

4

6

Left Ear 0,25 0,5

8

1

2

3

4

6

8

kHz

30dB HL 50dB HL 70dB HL

AC

* 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 kHz

Right Ear 0,25 0,5

Level 1

2

3

4

6

8

Left Ear 0,25 0,5

1

2

3

4

6

8

kHz

Target dBHL* Left Earpiece Right Earpiece

Actual dBHL ** Is dBHL **

Left Earpiece Right Earpiece

* 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!

Tested... Date:...

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