Summary of MA 41
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Operation manual ma 42.
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Operation manual ma 42 8100460 rev. 8 2 24/04/2017 table of contents introduction ................................................................................................................. 4 1.1 general .............................................................................................
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Operation manual ma 42 8100460 rev. 8 3 24/04/2017 title: ma 42 – operation manual date of issue/last revision: 24/04/2017 maico diagnostics gmbh sickingenstr. 70-71 10553 berlin germany tel.: + 49 30 / 70 71 46-50 fax: + 49 30 / 70 71 46-99 e-mail: sales@maico.Biz internet: www.Maico.Biz for north-...
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Operation manual ma 42 8100460 rev. 8 4 24/04/2017 introduction this section offers you important information about: the intended use of the device indications and contraindications of use essential performance features and benefits a description of the device 1.1 general thank you for purchasing a ...
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Operation manual ma 42 8100460 rev. 8 5 24/04/2017 1.5 essential performance the following is considered essential performance: to generate and present stimulus signals in the audible range as specified in the applicable iec 60645 series in normal condition record and store a patient response 1.6 de...
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Operation manual ma 42 8100460 rev. 8 6 24/04/2017 for your safety this section offers you important information about: how to read the operation manual where to spend special attention the customer responsibility the explanation of all regulatory symbols used important cautions and warnings that ha...
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Operation manual ma 42 8100460 rev. 8 7 24/04/2017 2.2 customer responsibility all safety precautions given in this operation manual must be observed at all times. Failure to observe these precautions could result in damage to the equipment and injury to the operator or subject. The employer should ...
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Operation manual ma 42 8100460 rev. 8 8 24/04/2017 2.4 regulatory symbols the following table 1 gives an explanation of the symbols used on the device itself, on the packaging and the accompanying documents including the operation manual. Table 1 regulatory symbols regulatory symbols symbol descript...
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Operation manual ma 42 8100460 rev. 8 9 24/04/2017 2.5 general precautions before starting a measurement make sure, that the device works properly. Use and store the instrument indoors only. For operation, storage and transport conditions see table in section 6 technical data. For operation in certa...
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Operation manual ma 42 8100460 rev. 8 10 24/04/2017 this equipment is intended to be connected to other equipment thus forming a medical electrical system. External equipment intended for connection to signal input, signal output or other connectors shall comply with the relevant product standard e....
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Operation manual ma 42 8100460 rev. 8 11 24/04/2017 2.7 device control the user of the device should perform a subjective device check once a week according iso 8253-1. See section 6.7 for a checklist. For annual calibration please see sections 2.6 and 3.1. 2.8 electromagnetic compatibility (emc) el...
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Operation manual ma 42 8100460 rev. 8 12 24/04/2017 warranty, maintenance and after-sales service this section offers you important information about: warranty conditions maintenance cleaning and disinfection recommendations accessory and replacement parts recycling and disposal of the device 3.1 wa...
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Operation manual ma 42 8100460 rev. 8 13 24/04/2017 3.3 cleaning and disinfection recommendations it is recommended that parts (device and accessories like headphones, ear cushions) which come in direct contact with the patient be subjected to standard cleaning and disinfecting procedure between pat...
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Operation manual ma 42 8100460 rev. 8 14 24/04/2017 3.4 accessories and replacement parts some reusable components are subject to wear with use over time. Maico recommends that you keep these replacement parts available (as appropriate for your ma 42 device configuration). Ask your authorized local ...
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Operation manual ma 42 8100460 rev. 8 15 24/04/2017 unpacking and hardware orientation this section provides information on: unpacking the device components becoming familiar with the hardware inclusive connections how to store the device rear panel 4.1 unpacking the system check box and contents fo...
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Operation manual ma 42 8100460 rev. 8 16 24/04/2017 the availability of configurations with the following components is country specific. Contact your local distributor for more information. Components dd45 headphones * tdh39 headphones * dd450 headphones for high frequency audiometry (with high ton...
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Operation manual ma 42 8100460 rev. 8 17 24/04/2017 4.2 hardware orientation 4.2.1 where to setup the ma 42 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 va...
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Operation manual ma 42 8100460 rev. 8 18 24/04/2017 4.2.3 rear panel connections figure 2 : power switch : cd input : power socket 100-240vac/50-60hz : speaker left channel : network socket : speaker right channel : usb out socket : bone conduction receiver : usb in socket : insert phone left channe...
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Operation manual ma 42 8100460 rev. 8 19 24/04/2017 table 2 pc-connections pc connections pc connection 1: medical device – medical device pc connection 2: medical device – non-medical device pc connection 3: medical device – non-medical device pc connection 4: medical device – laptop (battery-drive...
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Operation manual ma 42 8100460 rev. 8 20 24/04/2017 operating the device this section offers you information about: how to get started with the ma 42 the device layout the function keys performing the measurement methods of audiometry patient management documentation of results changing settings in ...
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Operation manual ma 42 8100460 rev. 8 21 24/04/2017 the following table describes the main functions of each button for the tone and speech audiometry screen: figure 3 (1) level control: adjusts the hearing level for the left/right ear. (2) stim bar: presents or interrupts the signal for the left/ri...
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Operation manual ma 42 8100460 rev. 8 22 24/04/2017 (9) function button: to select left, right or swap (10) transducer selector button: to choose between phones, insert, bone and speaker (only calibrated transducers are available) (11) function button: function is displayed on the screen based on te...
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Operation manual ma 42 8100460 rev. 8 23 24/04/2017 5.3 the display of the ma 42 the device is set to air conduction and pure tone by default. When starting the ma 42 the tone audiometry screen opens. Figure 4 the default frequency is set to 1 khz and the level of the tone is set to 30 db hl for the...
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Operation manual ma 42 8100460 rev. 8 24 24/04/2017 5.4.1 tone audiometry the ma 42 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 device. Air conduction testing bone conduction testing high tone...
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Operation manual ma 42 8100460 rev. 8 25 24/04/2017 the db hl level can be changed with the level control dial on both sides (1) of the device. Set the level control dial to a value just below expected hearing loss and turn down the level of the other ear. Use the frequency up (4) or down (5) keys t...
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Operation manual ma 42 8100460 rev. 8 26 24/04/2017 5.4.1.2 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.” cr...
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Operation manual ma 42 8100460 rev. 8 27 24/04/2017 5.4.1.3 high tone audiometry (configuration dependent) when available, pure tone hearing threshold of high frequencies from 8 khz to 16 khz can be tested. The high tone option must be activated and a separate high tone transducer must be calibrated...
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Operation manual ma 42 8100460 rev. 8 28 24/04/2017 5.4.1.6 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 ...
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Operation manual ma 42 8100460 rev. 8 29 24/04/2017 5.4.1.8.1 preparation of the sisi test to start the test select sisi with the function button (13), choose ot tests and sisi test. Figure 6 select the test frequency with the frequency keys (4), (5). For the test you should choose the frequency whe...
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Operation manual ma 42 8100460 rev. 8 30 24/04/2017 5.4.1.8.3 performing the sisi test when the patient is ready, set the increment to 1 db and press the start (19) button to run the sisi test. Now 20 increments are presented to the patient. You can delay the test by pressing the pause (9) button. T...
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Operation manual ma 42 8100460 rev. 8 31 24/04/2017 the patient response led lights and a stopwatch counts the seconds as long as the patient response switch is pressed. As soon as the patient releases the response switch, the level is increased for 5 db. The test stops automatically if the patient ...
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Operation manual ma 42 8100460 rev. 8 32 24/04/2017 5.4.1.11 mlb the mlb ( m onaural l evel b alance) test is used to detect perceived loudness differences between two frequencies in the same ear. A tone with two alternating frequencies is presented to the same ear. The level of the frequency with n...
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Operation manual ma 42 8100460 rev. 8 33 24/04/2017 5.4.1.12 stenger the stenger test is used to confirm the presence of pseudohypacusis. During this test, two tones of the same frequency are presented simultaneously to both ears, and only the louder tone is perceived. Select hl to perform the steng...
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Operation manual ma 42 8100460 rev. 8 34 24/04/2017 figure 10 figure 11 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 from the cd. Use the left or right level control (1) and adjust the levels un...
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Operation manual ma 42 8100460 rev. 8 35 24/04/2017 figure 12 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). Note : when the patient is sitting in ...
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Operation manual ma 42 8100460 rev. 8 36 24/04/2017 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). To delete a stored test result, select the corresponding level, then press both frequenc...
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Operation manual ma 42 8100460 rev. 8 37 24/04/2017 press the function button list (6) to load another word list. Mcl and ucl measurements are best performed with the passage wave file included with the device. Select the ear for testing and wave as the speech signal. A menu pops up with available w...
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Operation manual ma 42 8100460 rev. 8 38 24/04/2017 5.4.2.7 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 42 master hearing aid (mha) to adjust various frequency slopes for ...
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Operation manual ma 42 8100460 rev. 8 39 24/04/2017 5.4.3 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 appears. Then the monitor level of the l...
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Operation manual ma 42 8100460 rev. 8 40 24/04/2017 5.5 user menu the user menu enables the user to customize the device to meet their specific needs. Additionally, the menu allows the user to print out the results via usb printer, store the results as a pdf on an sd memory card or usb flash drive, ...
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Operation manual ma 42 8100460 rev. 8 41 24/04/2017 these menu items are available: setup menu description frequency settings default frequency default frequency set (on/off): set default frequency to 1,000 hz if side, transducer or signal type has changed. Frequency roll back: frequency control jum...
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Operation manual ma 42 8100460 rev. 8 42 24/04/2017 setup menu description noise interrupter/presenter default presenter or interrupter mode pure tone average (pta) select/deselect frequencies for the calculation of the pta value for the default transducer (500, 1000, 2000). Cd channel select the cd...
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Operation manual ma 42 8100460 rev. 8 43 24/04/2017 5.5.1 setup 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 (2). The following screen appears: figure 17 set the date format to ...
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Operation manual ma 42 8100460 rev. 8 44 24/04/2017 test your printer settings by a sample print before starting the audiological assessment. The wrong settings may require a restart of the device. Enter the field clinic name by using the stim button (2). Select letters by rotating the level control...
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Operation manual ma 42 8100460 rev. 8 45 24/04/2017 5.7 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. The patients can be stored by a nu...
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Operation manual ma 42 8100460 rev. 8 46 24/04/2017 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. Figure 20 enter the characters of the name by scrolling ...
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Operation manual ma 42 8100460 rev. 8 47 24/04/2017 technical data this section offers you important information about the ma 42 hardware specifications connections the pin assignment calibration values electromagnetic compatibility (emc) electrical safety, emc and associated standards 6.1 the ma 42...
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Operation manual ma 42 8100460 rev. 8 48 24/04/2017 weight: 1.5 kg/2.7 lbs dimensions: w x d x h: 34.5 x 20 x 8 cm / 13.4” x 7.9” x 3.2” monitor: build in monitor speaker, headset device fuses: 2 x 1a slow blow warm-up time: less than 10 min after power on communication: talk forward and talk back m...
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Operation manual ma 42 8100460 rev. 8 49 24/04/2017 6.2 connections figure 21 table 3 connections on backside connections no connection socket specification 1 on/off power 2 power (100 ... 240 v~ 50/60 hz) 3 network ethernet 4 usb out usb 2.0 5 usb in usb 2.0 6 patient response switch r i = 500 Ω 7 ...
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Operation manual ma 42 8100460 rev. 8 50 24/04/2017 6.3 pin assignment socket no. Connector pin l (left) pin g (top) pin n (right) 2 dc socket rated current international: 250 v/2,5 a l (live) g (ground) n (neutral) socket no. Lan ethernet 3 rj45 socket rj45 cable plug tx + transmit data tx- transmi...
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Operation manual ma 42 8100460 rev. 8 51 24/04/2017 6.4 calibration values and maximum levels calibration values and max levels: headphone dd45 coupler iec 60318-3, force 4-5 n, ptb-dtu report 2009-2010 frequency [hz] tone retspl db re 20µpa nbn retspl db re 20µpa max tone [db hl ] max nbn [db hl ] ...
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Operation manual ma 42 8100460 rev. 8 52 24/04/2017 calibration values and max levels: headphone tdh39 coupler iec 60318-3, force 4-5 n, ansi s3.6 and iso 389-1 frequency [hz] tone retspl db re 20µpa nbn retspl db re 20µpa max tone [db hl ] max nbn [db hl ] 125 45.0 49.0 90 75 250 25.5 29.5 110 95 5...
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Operation manual ma 42 8100460 rev. 8 53 24/04/2017 calibration values and max levels: headphone holmco 8103 coupler iec 60318-3, force 4-5 n, ptb frequency [hz] tone retspl db re 20µpa nbn retspl db re 20µpa max tone [db hl ] max nbn [db hl ] 125 39.5 43.5 90 80 250 25.0 29.0 105 95 500 18.5 22.5 1...
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Operation manual ma 42 8100460 rev. 8 54 24/04/2017 calibration values and max levels: headphone dd450 ear simulator iec60318-1 with adapter, force 8.8 n ± 0.5 n, ansi 3.6 and iso 389-8/iso 389-5 frequency [hz] tone retspl [db spl ] nbn retspl [db spl ] max tone [db hl ] max nbn [db hl ] 125 30.5 34...
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Operation manual ma 42 8100460 rev. 8 55 24/04/2017 calibration values: insert phone eartone 3a and ip30 reference equivalent threshold sound pressure level coupler iec 60318-5, ansi 3.6 and iso 389-2 frequency hz tone iec 60318-5 retspl db re 20µpa nbn iec 60318-5 retspl db re 20µpa tone max level ...
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Operation manual ma 42 8100460 rev. 8 56 24/04/2017 calibration values: bone conductor radioear b71/b71w/b81/bkh10 force: 4.9 ... 5.9 n mastoid placement coupler iec 60318-6, ansi 3.6-2010 and iso 389-3 signal iec 60645-2 retspl iec max level [db hl ] ansi s3.6 retspl ansi max level [db hl ] speech ...
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Operation manual ma 42 8100460 rev. 8 57 24/04/2017 calibration values: sound field (0 degree incidence) reference equivalent threshold sound pressure level and maximum hearing levels for canton cd220 iso 389 – 7 and ansi s3.6-1996 frequency [hz] tone retspl [db spl ] nbn retspl [db spl ] max level ...
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Operation manual ma 42 8100460 rev. 8 58 24/04/2017 6.5 electromagnetic compatibility (emc) portable and mobile rf communications equipment can affect the ma 42. Install and operate the ma 42 according to the emc information presented in this section. The ma 42 has been tested for emc emissions and ...
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Operation manual ma 42 8100460 rev. 8 59 24/04/2017 power frequency (50/60 hz) iec 61000-4-8 3 a/m 3 a/m power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or residential environment. Note: u t is the a.C. Mains voltage prior to applicati...
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Operation manual ma 42 8100460 rev. 8 60 24/04/2017 6.6 electrical safety, emc and associated standards 1. Ul 60601-1: medical electrical equipment, part 1 general requirements for safety 2. Iec/en 60601-1: medical electrical equipment, part 1 general requirements for safety 3. Can/csa-c22.2 no. 606...
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Operation manual ma 42 8100460 rev. 8 61 24/04/2017 6.7 checklist for subjective audiometer testing.
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Operation manual ma 42 8100460 rev. 8 62 24/04/2017 specifications are subject to change maico diagnostics gmbh sickingenstr. 70-71 10553 berlin germany tel.: + 49 30 / 70 71 46-50 fax: + 49 30 / 70 71 46-99 e-mail: sales@maico.Biz internet: www.Maico.Biz.