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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:   [email protected]
Internet: www.maico.biz

All rights reserved. No part of this publication may be reproduced or
transmitted in any form or by any means without the prior written permission
of MAICO. The information in this publication is proprietary to MAICO.

MAICO Diagnostics is an ISO 13485 certified corporation.

Copyright © 2015 MAICO Diagnostics.

Compliance

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Содержание MA 42

Страница 1: ...Operation Manual MA 42...

Страница 2: ......

Страница 3: ...C 8 4 Getting Started 9 Unpacking the Instrument 9 Calibration of the Device 10 Where to Setup 10 Rear Panel Connections 11 5 Working with the MA 42 12 Using the Control Panel of the MA 42 12 Function...

Страница 4: ...crophone or CD Player 32 6 2 4 Speech Audiometry with Wave Files 33 6 2 5 Masking 34 6 2 6 Speech in Noise Tests 34 6 2 7 Master Hearing Aid MHA 35 Monitoring 36 Talk Forward 36 Documentation of the R...

Страница 5: ...Classification 55 Technical Data 55 Pin Assignment 59 12 Warranty Maintenance and After Sales Service 60 13 Safety Regulations 61 Electrical Safety 61 Measuring Security 61 Device Control 61 Operation...

Страница 6: ...70 71 46 99 E mail sales maico biz Internet www maico biz All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permis...

Страница 7: ...r further improvements please get in touch with us Your MAICO team Indications for Use Statement The MA 42 is a portable two channel air bone and speech audiometer This audiometer is used to screen te...

Страница 8: ...ional speakers Built in test signals include pure tone pulse tone warble tone narrow band noise white noise and speech noise Inputs include ports for live speech and a CD player for speech test materi...

Страница 9: ...ING TO USE THIS SYSTEM Use this device only as described in this manual In this manual the following two labels identify potentially dangerous or destructive conditions and procedures The WARNING labe...

Страница 10: ...60601 1 Return to Authorized Representative Special Disposal Required 980 60601 1 Reference Number 60601 1 B Patient Applied Part According to EN 60601 1 980 60601 1 Consult Operating Instructions 60...

Страница 11: ...1 and conforms with type B applied part and protection class I Safety against electrical hazard is guaranteed only when the connected notebook computer is powered by batteries respectively the compute...

Страница 12: ...power supply can also lead to electrical damage on the instrument In case of emergency disconnect the instrument from the supply mains by pulling the plug out of the power socket Do not position the...

Страница 13: ...ee Appendix A for a checklist Electromagnetic compatibility EMC Electrostatic discharge ESD according to IEC 61000 4 2 Use the device only in an electrostatic controlled environment To avoid the risk...

Страница 14: ...damage is noted please notify the carrier immediately 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...

Страница 15: ...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 whi...

Страница 16: ...ce the MA 42 on a stable counter or table Plug the power cord into the power socket on the rear panel Connect all accessories with the adequate sockets as shown above Plug the power cord into a ground...

Страница 17: ...upter mode The corresponding LED lights up when a signal is presented The frequency is changed with the Plus 4 and Minus 5 buttons for both channels together Using the Control Panel of the MA 42 The m...

Страница 18: ...or the left right ear or no response if button is pressed for 3 seconds 4 Frequency Up change to higher frequency for tone audiometry enters a correct answer for word recognition score WRS testing or...

Страница 19: ...h select microphone external CD player Wave file or speech noise as signal source 12 Test signal selector button for Steady Pulse Warble or P W pulse and warble tone 13 Functional selector button func...

Страница 20: ...p 18 Functional selector button to switch from the tone screen to the speech screen and back 19 Functional selector button Menu to enter the User Menu for settings to be adjusted results can be printe...

Страница 21: ...ft All settings are shown on the display as well as the function of the control panel buttons on the left and right side of the display The level limits of the chosen transducer are marked by shading...

Страница 22: ...ivers are at the correct height the sound output grid should be exactly facing the ear canal Instruct the patient to press the patient response button when he hears the test tone For hygienic reasons...

Страница 23: ...independently to tone narrow band noise or white noise by the functional selector buttons 11 and 15 Select the ear to be tested by pressing the Right or Left key 9 17 on the control panel underneath t...

Страница 24: ...e Set the test signal button 12 on Pulse and the pure tone will be switched to a pulsing tone Warble Tone If required the test can also be performed with a warble tone Press the button 12 and the pure...

Страница 25: ...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 selecting the signal source as noise 11 or 1...

Страница 26: ...sing the functional button 13 until High Tone is highlighted The high tone diagram is displayed combining the left and right ears results Additional frequencies from 8 kHz to 16 kHz can be selected no...

Страница 27: ...peech stimuli The purpose is to determine the dB level at which the stimuli become uncomfortable to the patient The UCL is described as the level between very loud and loud perception of the test sign...

Страница 28: ...st The SISI Short Increment Sensitivity Index is guided by the principle that patients with cochlear impairment are hypersensitive to small intensity increments The continuous test tone is increased b...

Страница 29: ...o resume the test 6 1 7 2 Training of the Patient Only with careful training during the following conditioning phase can a valid test result can be achieved The training starts with level steps of 5 d...

Страница 30: ...to the patient You can delay the test by pressing the Pause 9 button This could be helpful in determining if the patient malingers The test will end automatically after 20 presented increments The num...

Страница 31: ...The level should be set to a value 5 dB above the individual pure tone hearing threshold at this frequency Instruct the patient to hold the response switch while the tone is heard and to release the s...

Страница 32: ...creen The test can be performed at all frequencies between 125 Hz and 8 kHz Select the test frequency by the frequency up and down key 4 and 5 Set the level of the better hearing ear 5 dB above the th...

Страница 33: ...t screen will be displayed Figure 9 MLB Screen Select the left or right ear by the functional selector button 9 Then select left and or right frequency up or down buttons 4 or 5 for selection of the f...

Страница 34: ...taneously 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 S...

Страница 35: ...ibrate the instrument To calibrate the CD speech input select CD with the signal selector key 11 15 Press the Monitor button 6 and then InCal 19 and the calibration screen appears see Input Calibratio...

Страница 36: ...et to the default value The Speech Recognition Threshold SRT is the hearing threshold for speech It is the lowest level at which the patient correctly recognizes 50 of the speech Speech testing can be...

Страница 37: ...on 11 15 Make sure that the input signal is calibrated correctly as described above Select the test SRT WRS MCL or UCL by the functional button 13 For the SRT test familiarize the patient with a close...

Страница 38: ...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 wor...

Страница 39: ...stored on the SD memory card select Passages Press the function button Play 7 to start the presentation Rotate the level control 1 to increase the volume until the patient reports this is uncomfortab...

Страница 40: ...to the patient the difference a hearing aid can make Use the MA 42 Master Hearing Aid MHA to adjust various frequency slopes for speech signals The MHA feature utilizes input signals from the Live Voi...

Страница 41: ...up and down buttons 4 5 Talk Forward Connect the microphone headset to the microphone socket 8 on the rear side of the device A gooseneck microphone can also be connected Note Only connect the microp...

Страница 42: ...s 11 13 and 15 changes to PDF Print and Patients To print out the results press the Print button 13 Make sure that a compatible printer is connected and the printer settings are correct To store the r...

Страница 43: ...d sessions Select a session and press the PDF button 11 to store 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 wil...

Страница 44: ...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 th...

Страница 45: ...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 deactiva...

Страница 46: ...one on both channels simultaneously After a new selection the level will be reset to 30 dBHL 7 1 3 Signal Selection Press either the right 11 or left 15 Signal key to select the signal The display sho...

Страница 47: ...threshold Tests Press the Test mode button 13 until OT Tests is selected The functional selector buttons below the display will show the available over threshold tests The selection of OT tests includ...

Страница 48: ...lk Forward Adjust the level by turning one of the attenuator knobs 1 while in the mode Talkback Microphone and Monitor Volume Control Press the Monitor key 6 on the left side of the display and the vo...

Страница 49: ...button 19 and press the button PDF 11 to save the results as PDF file on the SD memory card or USB flash drive Note SD memory card or USB must be inserted into the device for saving to occur System co...

Страница 50: ...19 on the right side of the display To choose an item from the menu use the level control dials 1 A short description of the selected setting item will be displayed below the user menu list To display...

Страница 51: ...frequency when the highest lowest frequency is reached Standard frequencies Select deselect Lists available frequencies in device all on Level Default level On Off Set default level after changing si...

Страница 52: ...as the STIM bar is pressed 1 5 Seconds signal is switched off after 1 5 sec User defined duration user can define a maximum presentation duration Interrupter Presenter Mode Default presenter or Inter...

Страница 53: ...r and configure its settings PDF Save Option Save on SD Card Stores PDF files always on a SD memory card Save on USB flash drive Stores PDF files always on a USB flash drive Device Information Show in...

Страница 54: ...splays 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...

Страница 55: ...following screen will appear 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...

Страница 56: ...ress 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 3 to enter the selected number Save the se...

Страница 57: ...htly dampened cloth with soap water solution Disinfect the instrument and its accessories by wiping the surfaces with wet Sani Cloth Active wipes or a comparable product and allow them to take effect...

Страница 58: ...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 equipme...

Страница 59: ...ly and click on the Next button Figure 21 Installation Advice Select automatic installation in the next dialog window and click again on the Next button Wait until the MAICO MA4x family driver is inst...

Страница 60: ...rotection class B International Standards for Medical Electrical Equipment Medical Device Directive 93 42 EEC Test Frequencies 125 Hz 8 000 Hz 8 000 Hz 16 000 Hz optional Level Step 5 dB 2 dB or 1 dB...

Страница 61: ...Tone 5 sinus frequency modulation repetition rate 5 Hz Tests Tone HL MCL UCL Speech SRT WRS MHA MCL UCL Over Threshold Test Decay SISI ABLB MLB Patient Response Handheld response switch Monitor Build...

Страница 62: ...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 95 non condensing Transport 20 C 50 C 4 F 122 F Humidity 10 95 non condensing Dimensions W x D x H...

Страница 63: ...7 Talk Back microphone ZI 1 k UI 0 38 500 mVeff 8 Mic Microphone ZI 1 k UI 0 38 500 mVeff 9 Mon Monitor Phone ZA 250 UA 8 Veff 10 CD Input ZI 47 k UI 0 04 5 Veff 11 Speaker Left ZA 4 UA 8 Veff 12 Spea...

Страница 64: ...G Ground N Neutral Socket No LAN Ethernet 3 RJ45 Socket RJ45 Cable Plug TX Transmit Data TX Transmit Data RX Receive Data Not connected RX Receive Data 4 1 5 VDC 2 Data 3 Data 4 Ground 5 1 5 VDC 2 Da...

Страница 65: ...nclose evidence of purchase with the instrument In order to ensure that your instrument works properly the MA 42 should be checked and calibrated at least once a year This check has to be carried out...

Страница 66: ...o 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 acc...

Страница 67: ...ams to repair devices that it deems appropriate to be repaired in the field No adverse effects have been reported from the materials used in this device based on 50 plus years of use with many differe...

Страница 68: ...Left Ear kHz 0 25 0 5 1 2 3 4 6 8 0 25 0 5 1 2 3 4 6 8 kHz AC 30 dBHL 50 dBHL 70 dBHL BC 30 dBHL 50 dBHL When noise B G V or S is blocked inform the service center When the test tone is heard at the m...

Страница 69: ...N RETSPL dB re 20 Pa Max Tone dBHL Max NBN dBHL 125 47 5 51 5 90 75 250 27 0 31 0 110 95 500 13 0 17 0 120 110 750 6 5 11 5 120 110 1000 6 0 12 0 120 110 1500 8 0 14 0 120 110 2000 8 0 14 0 120 110 30...

Страница 70: ...Tone dBHL Max NBN dBHL 125 45 0 49 0 90 75 250 25 5 29 5 110 95 500 11 5 15 5 120 110 750 7 5 12 5 120 110 1000 7 0 13 0 120 110 1500 6 5 12 5 120 110 2000 9 0 15 0 120 110 3000 10 0 16 0 120 110 400...

Страница 71: ...dBHL Max NBN dBHL 125 39 5 43 5 90 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...

Страница 72: ...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 21 0 26 0 110 95 8000 23 0 28 0 110 95 9000 27 5 32 5 100 90 10000 18 0 23 0 105 95 11200 22 0 27 0 105 90 12500 27 0 32...

Страница 73: ...20 Pa Tone Max Level dBHL NBN Max Level dBHL 125 26 0 30 0 90 90 250 14 0 18 0 105 105 500 5 5 9 5 110 110 750 2 0 7 0 115 110 1000 0 0 6 0 120 110 1500 2 0 8 0 120 110 2000 3 0 9 0 120 110 3000 3 5...

Страница 74: ...tone Air radiation Max level ISO 389 3 dB re 1 N ANSI S3 6 dB re 1 N mean max dB Tone dBHL 250 67 67 45 500 58 58 65 750 48 5 48 5 70 1000 42 5 42 5 70 1500 36 5 36 5 70 2000 31 31 75 3000 30 30 4 18...

Страница 75: ...e Air radiation Max level ISO 389 3 dB re 1 N ANSI S3 6 dB re 1 N mean max dB Tone dBHL 250 67 67 50 500 58 58 70 750 48 5 48 5 75 1000 42 5 42 5 85 1500 36 5 36 5 90 2000 31 31 90 3000 30 30 4 18 85...

Страница 76: ...l Tone dBHL CD220 SBC Max level NBN dBHL CD220 SBC 125 22 0 22 0 65 55 250 11 0 11 0 75 70 500 4 0 4 0 85 85 75 75 750 2 0 2 0 85 85 75 75 1000 2 0 2 0 85 85 75 75 1500 0 5 0 5 90 85 80 75 2000 1 5 1...

Страница 77: ...s may result in increased EMISSIONS or decreased IMMUNITY of the device Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601 1 2 standard Anyone...

Страница 78: ...Restriction of the use of certain Hazardous Substance 8 WEEE Waste Electrical Electronic Equipment Legislation Guidance and Manufacturer s Declaration Electromagnetic Emissions The MAICO MA 42 is int...

Страница 79: ...utput Power of Transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 17 80 MHz to 800 MHz d 1 17 800 MHz to 2 5 GHz d 2 23 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0...

Страница 80: ...ge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial hospital or residential environment Voltage...

Страница 81: ...m Field Strengthens from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicini...

Страница 82: ...2 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 In...

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