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Maico MA 42 Operation Manual

Other manuals for MA 42: Operation Manual
Manual is about: Audiometer

Summary of MA 42

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    Operation manual ma 42.

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    Operation manual ma 42 8100460 rev.7 ver.1 i 12/15 table of contents page 1. Introduction .................................................................................... 2 indications for use statement ..................................................... 2 intended use statement .................

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    Operation manual ma 42 8100460 rev.7 ver.1 ii 12/15 6.1.7.1 preparation of the sisi test ................................................... 24 6.1.7.2 training of the patient .......................................................... 24 6.1.7.3 performing the sisi test ................................

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    Operation manual ma 42 8100460 rev.7 ver.1 iii 12/15 set printer settings ................................................................... 51 9. Cleaning and disinfection recommendations ............................ 52 10. Connection to the pc ........................................................

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    Operation manual ma 42 8100460 rev.7 ver.1 1 12/15 title: ma 42 – operation manual 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 all rights reserved. No part of this publication m...

  • Page 7: 1. Introduction

    Operation manual ma 42 8100460 rev.7 ver.1 2 12/15 1. Introduction thank you for purchasing a quality product from the maico family. The audiometer ma 42 is manufactured to meet all quality and safety requirements. In designing the ma 42 we placed particular importance in making it a user- friendly ...

  • Page 8: 2. Description

    Operation manual ma 42 8100460 rev.7 ver.1 3 12/15 2. Description the ma 42 is a portable two-channel audiometer with pure tone, speech and sound field audiometric testing. The device also includes special test function which include master hearing aid, decay (carhart), sisi, ablb and mlb. It can be...

  • Page 9: 3. For Your Safety

    Operation manual ma 42 8100460 rev.7 ver.1 4 12/15 3. For your safety how to read this operation manual this operating manual contains information pertinent to the use of the maico ma 42 system including safety information as well as maintenance and cleaning recommendations. Read this entire manual ...

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    Operation manual ma 42 8100460 rev.7 ver.1 5 12/15 regulatory symbols symbol iec pub. Description 980 & 60601-1 serial number 980 & 60601-1 date of manufacture 980 & 60601-1 manufacturer 980 & 60601-1 caution, consult accompanying documents 980 & 60601-1 return to authorized representative, special ...

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    Operation manual ma 42 8100460 rev.7 ver.1 6 12/15 general precautions before measurement make sure, that the device works properly. Do not immerse the unit in any fluids. For cleaning and disinfection see chapter cleaning and desinfection recommendations on page 53. Use and store the instrument ind...

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    Operation manual ma 42 8100460 rev.7 ver.1 7 12/15 use of electrical medical devices in medical electrical systems. Any person who connects external equipment has created a system and is therefore responsible for the system complying with the requirements of en 60601- 1-1. If in doubt, contact your ...

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    Operation manual ma 42 8100460 rev.7 ver.1 8 12/15 12 warranty, maintenance and after-sales service on page 61. The use of non-calibrated devices can lead to incorrect test results and is not advisable. Us federal law restricts this device to sale by or on the order of a physician or licensed hearin...

  • Page 14: 4. Getting Started

    Operation manual ma 42 8100460 rev.7 ver.1 9 12/15 4. Getting started unpacking the instrument the ma 42 was carefully inspected and packed for shipping. However, it is a good practice to thoroughly inspect the outside of the shipping box for signs of damage. If any damage is noted, please notify th...

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    Operation manual ma 42 8100460 rev.7 ver.1 10 12/15 calibration of the device the instrument, headphones, bone conductor oscillator, as well as the optional insert phone and loudspeaker match one another and have the same serial number (e.G. Ma1234567). Use of transducers not calibrated to this part...

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    Operation manual ma 42 8100460 rev.7 ver.1 11 12/15 rear panel connections figure 1– rearview of the ma 42 1: power switch 10: cd input 2: power socket 100-240 vac / 50-60 hz 11: speaker left channel 3: network socket 12: speaker right channel 4: usb out socket 13: bone conduction receiver 5: usb in...

  • Page 17: 5. Working With The Ma 42

    Operation manual ma 42 8100460 rev.7 ver.1 12 12/15 5. Working with the ma 42 the hearing level can be easily adjusted independently for each channel with a dial on each side of the instrument (1). For optimal convenience these level control dials are usable from the top or the side of the instrumen...

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    Operation manual ma 42 8100460 rev.7 ver.1 13 12/15 device customization, an extensive user menu is available for advance users (see chapter 7). Functionality of operating elements the following table describes the main functions of each button for the tone and speech audiometry screen: figure 3 - c...

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    Operation manual ma 42 8100460 rev.7 ver.1 14 12/15 (7) functional selector button: function changes based on testing screen (i.E. Tone or speech). Tone: new, to delete all stored results and start a new session. Speech: reset the result percentage counter or play wave file. (8) channel stim button/...

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    Operation manual ma 42 8100460 rev.7 ver.1 15 12/15 (16) transducer selector button: to choose between phones, insert, bone and speaker (only calibrated receivers are available for selection). (17) functional selector button: to select left, right, or swap. (18) functional selector button: to switch...

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    Operation manual ma 42 8100460 rev.7 ver.1 16 12/15 the display of the ma 42 the instrument is set up to air conduction and pure tone by default. When starting the ma 42 the tone audiometry screen opens. The frequency is set to 1 khz and the level of the tone to 30 db hl for the right channel, and 0...

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    Operation manual ma 42 8100460 rev.7 ver.1 17 12/15 6. Measurement methods of audiometry 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 (e.G. Hair or eyeglasses). Ensure that...

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    Operation manual ma 42 8100460 rev.7 ver.1 18 12/15 6.1.1 pure tone testing in the pure tone audiometry, the hearing threshold of the patient is measured in comparison with the normal hearing threshold. The examination starts with air conduction on the ear with better hearing. Upon opening the tone ...

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    Operation manual ma 42 8100460 rev.7 ver.1 19 12/15 to present or interrupt the tone. The status led above the stim button will flash when the tone is presented. Follow your preferred procedure for the evaluation of the hearing threshold. Note: a warning prompt appears on the display in the event th...

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    Operation manual ma 42 8100460 rev.7 ver.1 20 12/15 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 th...

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    Operation manual ma 42 8100460 rev.7 ver.1 21 12/15 automatic masking with the manual masking, as described above, the masking level should be adjusted every time you change the test signal level. The ma 42 has a tracking function for easy masking. Set the tone level and the masking level to a desir...

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    Operation manual ma 42 8100460 rev.7 ver.1 22 12/15 perform the test the same way as for air conduction. For hygienic reasons it is important to clean the bone oscillator (see chapter 9). 6.1.4 sound field testing (optional) set the transducer selector (10) or (16) to speaker. Perform the test the s...

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    Operation manual ma 42 8100460 rev.7 ver.1 23 12/15 6.1.6 most comfortable loudness (mcl) testing of mcl can be measured using pure tone stimuli or speech. The purpose is to determine the most comfortable listening level for the patient for a given stimulus. The db level at which the stimulus is the...

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    Operation manual ma 42 8100460 rev.7 ver.1 24 12/15 6.1.7.1 preparation of the sisi test to start the test select sisi with the functional selector button (13), choose ot tests and sisi test. 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.7 ver.1 25 12/15 when the patient has understood the procedure of the test press the “inc” button (11) to select the increment level for the test (i.E. 1, 2, 3, 4, or 5 db increments). Once selected the increment level will be displayed at the top of the screen bel...

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    Operation manual ma 42 8100460 rev.7 ver.1 26 12/15 6.1.8 the threshold decay (carhart) test this examination is conducted as a fatigue test in cases of sensitivity loss. To start the test select decay with the functional selector button (13), choose ot tests. When the screen advances, select decay ...

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    Operation manual ma 42 8100460 rev.7 ver.1 27 12/15 6.1.9 ablb the ablb (alternate binaural loudness balance) test is a recruitment test. Alternating tones between the two ears with headphones are used. The intensity of the tone in the better hearing ear is varied until the loudness of the tone is j...

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    Operation manual ma 42 8100460 rev.7 ver.1 28 12/15 6.1.10 mlb the mlb (monaural level balance) 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 normal ...

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    Operation manual ma 42 8100460 rev.7 ver.1 29 12/15 6.1.11 stenger the stenger test is used 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 th...

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    Operation manual ma 42 8100460 rev.7 ver.1 30 12/15 speech audiometry the ma 42 supports speech audiometry. To conduct speech tests using speech test material you can use a cd player, wave files from sd memory card, or a microphone. Caution: if you are using a cd player powered by electrical current...

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    Operation manual ma 42 8100460 rev.7 ver.1 31 12/15 note: when multiple individuals use the device, input calibration will be required when switching to a new user. The device does store that last input calibration for ease of use. Store the calibration and leave the calibration mode with the exit b...

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    Operation manual ma 42 8100460 rev.7 ver.1 32 12/15 note: when the patient is sitting in the same room as the tester, cd or wave files is recommended for stimulus presentation. The signal can be set to microphone, cd, wave file, or switched off, for each channel independently by the functional selec...

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    Operation manual ma 42 8100460 rev.7 ver.1 33 12/15 6.2.4 speech audiometry with wave files if wave is selected by the speech signal selector (11) or (15), a menu will pop- up with available word lists which are stored on the sd memory card (see figure 12). A word list can be selected by using the l...

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    Operation manual ma 42 8100460 rev.7 ver.1 34 12/15 button play (7) is pressed, the selected word is presented. Increase or decrease the level when the patient has a correct or incorrect response until the srt is estimated and store the result by pressing the store (3) button. For the wrs test, tall...

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    Operation manual ma 42 8100460 rev.7 ver.1 35 12/15 speech-in-noise test, the quicksin tm , was developed to provide a quick estimate of signal-to-noise ratio (snr) loss. This test is incorporated into the ma 42, with selection made in the speech testing screen under the wave file lists (11) or (15)...

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    Operation manual ma 42 8100460 rev.7 ver.1 36 12/15 monitoring all signals presented to the patient can be monitored by the examiner via a monitoring headset or the speakers integrated in the device. For this purpose, press the monitor button (6) and the monitor screen will appear. The monitor level...

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    Operation manual ma 42 8100460 rev.7 ver.1 37 12/15 results of the measurement. 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. Note: usb flash drive is the default in the menu settings. It is recomm...

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    Operation manual ma 42 8100460 rev.7 ver.1 38 12/15 patient management the patient management enables storing the results of the audiological tests on the sd memory card. The results can be loaded later to be reviewed, edited or printed. The patients can be stored by numbers or by entering name and ...

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    Operation manual ma 42 8100460 rev.7 ver.1 39 12/15 figure 17 - new patient enter the characters of the name by scrolling through the alphabet by the level controls (1) and enter the selected character by the stim button (2). Jump to the next or previous field with the frequency up (4) or down (5) b...

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    Operation manual ma 42 8100460 rev.7 ver.1 40 12/15 each time you enter the patient list this pin must be entered by selecting the digit by the level dial and entering it by pressing the stim bar (2). Moving forward, the pin will be required to enter the patient list. To deactivate the pin, select l...

  • Page 46: 7. Quick Reference Guide

    Operation manual ma 42 8100460 rev.7 ver.1 41 12/15 7. Quick reference guide general setup 7.1.1 startup settings air conduction on both channels pure tone on both channels 30 db hl on right channel, 0 db hl on left channel presenter mode 7.1.2 transducer selection select the transducer to be used, ...

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    Operation manual ma 42 8100460 rev.7 ver.1 42 12/15 use the mode button (18) to switch between tone and speech mode. 7.2.2 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 receiver you h...

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    Operation manual ma 42 8100460 rev.7 ver.1 43 12/15 stim mode selection press stim button (8) key to switch between continuous presentation and presentation by pressing the stim button (2). When in continuous presentation mode the stim buttons (2) functions as interrupters. The light above the stim ...

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    Operation manual ma 42 8100460 rev.7 ver.1 44 12/15 speech calibration to calibrate the mic or cd speech input, select the input with the signal selector key (11) or (15). Press the monitor button (6), the monitor setting screen appears, press now the incal button (19) on the right side of the displ...

  • Page 50: 8. User Menu

    Operation manual ma 42 8100460 rev.7 ver.1 45 12/15 8. 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, an...

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    Operation manual ma 42 8100460 rev.7 ver.1 46 12/15 these menu items are available (bold reflects default setting): frequency settings frequency default frequency set (on/off): set default frequency if side, transducer or signal type has changed frequency roll back: frequency control jumps to 1000 h...

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    Operation manual ma 42 8100460 rev.7 ver.1 47 12/15 swap ears, the left and right ear is interchanged, the signals of the channels remain swap signals, only the signals are interchanged and the ears remain display of the left and right ear same, left dial controls level of the left ear, right dial c...

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    Operation manual ma 42 8100460 rev.7 ver.1 48 12/15 change level after store change in level after storing a threshold (stay at the same test level (0 db) or decrease by 10, 20, or 30 db) default transducer which transducers shall be used as default transducer headphones (on) or inserts (off) monito...

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    Operation manual ma 42 8100460 rev.7 ver.1 49 12/15 bone lines on/off, displays a dotted line, connecting the bone conduction results bone symbol setting int. Symbols/us symbols/ uk symbols import/export user settings export user settings to sd- card/import user settings from sd-card, provides the p...

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    Operation manual ma 42 8100460 rev.7 ver.1 50 12/15 setup date and time select the item date/time in the user menu by scrolling down with the left or right level control (1) and select the sub item set date/time by the stimulus presenter bar (2). The following screen will appear: set the date format...

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    Operation manual ma 42 8100460 rev.7 ver.1 51 12/15 set printer settings select the printer by turning the left or right level control (1) down. The color mode is automatically adjusted. Only if the color mode is wrong, adjust the color mode as well. Jump to the field paper size by pressing the stim...

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    Operation manual ma 42 8100460 rev.7 ver.1 52 12/15 9. 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 pati...

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    Operation manual ma 42 8100460 rev.7 ver.1 53 12/15 do not use hard or pointed objects on the device or its accessories use 70% isopropyl alcohol only on hard cover surfaces discard single-use equipment after use! In case of re-use of the single-use equipment you enhance the risk of cross contaminat...

  • Page 59: 10.  Connection To The Pc

    Operation manual ma 42 8100460 rev.7 ver.1 54 12/15 10. Connection to the pc install the software on your pc. This will allow you to use your device with noah™ and/or the maico database. Connect the ma 42 by usb cable to the pc and turn on the device. The required driver will be installed. Please fo...

  • Page 60: 11.  Technical Data

    Operation manual ma 42 8100460 rev.7 ver.1 55 12/15 11. Technical data classification the ma 42 audiometer is an active, diagnostic medical product according to the class ia of the eu medical directive 93/42/eec. Technical data standards: ansi s3.6: type 2a iec 60645-1: type 2 iec 60645-2: type a is...

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    Operation manual ma 42 8100460 rev.7 ver.1 56 12/15 tones: - 10 db hl to 90 db hl speech: - 10 db hl to 70 db hl test signal: pure tone, pulse tone, warble tone masking signals: narrow band noise: with the same center frequency resolution as pure tone white noise: speech noise:12 db/octave above 1 k...

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    Operation manual ma 42 8100460 rev.7 ver.1 57 12/15 warm-up time: less than 10 min after power on mode of operation: continuous environment conditions: operation +15 ̊c … +35 ̊c / +59 ̊f … +95 ̊f humidity: 30 % … 90 %, non- condensing(operation) storage 0 ̊c … +50 ̊c / +32 ̊f … +122 ̊f humidity: 10 ...

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    Operation manual ma 42 8100460 rev.7 ver.1 58 12/15 figure 23 – connection sockets of the ma 42 connection sockets: 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: pat (patient response switch) r i = 500  7: talk back micr...

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    Operation manual ma 42 8100460 rev.7 ver.1 59 12/15 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- transmit da...

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    Operation manual ma 42 8100460 rev.7 ver.1 60 12/15 12. Warranty, maintenance and after-sales service the maico ma 42 is guaranteed for two (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 ...

  • Page 66: 13.  Safety Regulations

    Operation manual ma 42 8100460 rev.7 ver.1 61 12/15 13. Safety regulations read this entire manual before attempting to use this system. Electrical safety the ma 42 audiometer is constructed to comply with protection class i of the international standard iec 60601-1 (en 60601-1). The instruments are...

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    Operation manual ma 42 8100460 rev.7 ver.1 62 12/15 warnings and statements no modification of this equipment is allowed. Maico will make available instructions and diagrams to repair devices that it deems appropriate to be repaired in the field. No adverse effects have been reported from the materi...

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    Operation manual ma 42 8100460 rev.7 ver.1 63 12/15 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? - a...

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    Operation manual ma 42 8100460 rev.7 ver.1 64 12/15 appendix b: calibration values and maximum levels calibration values and max levels: headphone dd45 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 ] max nbn [db hl ] 125 ...

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    Operation manual ma 42 8100460 rev.7 ver.1 65 12/15 calibration values and max levels: headphone tdh39 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 ] max nbn [db hl ] 125 45.0 49.0 90 75 250 25.5 29.5 110 95 500 11.5 15....

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    Operation manual ma 42 8100460 rev.7 ver.1 66 12/15 calibration values and max levels: headphone holmco 8103 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 ] max nbn [db hl ] 125 39.5 43.5 90 80 250 25.0 29.0 105 95 500 18...

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    Operation manual ma 42 8100460 rev.7 ver.1 67 12/15 calibration values and max levels: 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...

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    Operation manual ma 42 8100460 rev.7 ver.1 68 12/15 calibration values: insert phone ip30 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 ] nbn max level [db hl ] 125 26.0 30.0 90 90 250 1...

  • Page 74

    Operation manual ma 42 8100460 rev.7 ver.1 69 12/15 calibration values: bone conductor radioear b71 / b71w force: 4.9 ... 5.9 n mastoid placement frequency [hz] reference equivalent threshold force level for tone air radiation max level iso 389 - 3 [db] (re 1µn) ansi s3.6 [db] (re 1µn) mean/max [db]...

  • Page 75

    Operation manual ma 42 8100460 rev.7 ver.1 70 12/15 calibration values: bone conductor radioear b81 force: 4.9 ... 5.9 n mastoid placement frequency [hz] reference equivalent threshold force level for tone air radiation max level iso 389 - 3 [db] (re 1µn) ansi s3.6 [db] (re 1µn) mean/max [db] tone [...

  • Page 76

    Operation manual ma 42 8100460 rev.7 ver.1 71 12/15 calibration values: 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 frequency [hz] tone retspl [db spl ] nbn retspl...

  • Page 77

    Operation manual ma 42 8100460 rev.7 ver.1 72 12/15 appendix c: emc compatibility portable and mobile rf communications equipment can affect the maico ma 42. Install and operate the maico ma 42 according to the emc information presented on this page and the next 4 pages. The maico ma 42 has been tes...

  • Page 78

    Operation manual ma 42 8100460 rev.7 ver.1 73 12/15 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. 60601-1...

  • Page 79

    Operation manual ma 42 8100460 rev.7 ver.1 74 12/15 recommended separation distances between portable and mobile rf communications equipment and the maico ma 42 the maico ma 42 is intended for use in an electromagnetic environment in which radiated rf disturbances are controlled. The customer or the...

  • Page 80

    Operation manual ma 42 8100460 rev.7 ver.1 75 12/15 guidance and manufacturer’s declaration - electromagnetic immunity the maico ma 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the ma 42 should assure that it is used in such an environment. I...

  • Page 81

    Operation manual ma 42 8100460 rev.7 ver.1 76 12/15 guidance and manufacturer’s declaration - electromagnetic immunity the maico ma 42 is intended for use in the electromagnetic environment specified below. The customer or the user of the ma 42 should assure that it is used in such an environment. I...

  • Page 82

    Operation manual ma 42 8100460 rev.7 ver.1 77 12/15 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.