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Maico MA 41, Руководство по эксплуатации

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Operation Manual MA 41

 

 

 

8100456 Rev.9 

46 

01/16 

 

11 Technical Data 

11.1 Classification 

 

The  MA  41  audiometer  is  an  active, 
diagnostic medical product according 
to  the  class  Ia  of  the  EU  medical 
directive 93/42/EEC.  

11.2 Technical Data 
 

 

Standards:  

ANSI S3.6: Type 3B  

 

IEC 60645-1: Type 2 

 

IEC 60645-2: Type B 

 

 

ISO 389 Acoustics – Reference zero for 
calibration of audiometric equipment 

 

 

IEC 60601-1 class I, protection class B, 
International  Standards  for  Medical 
Electrical Equipment 

 

 

 

Medical Device Directive 93/42/EEC  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Содержание MA 41

Страница 1: ...Operation Manual MA 41...

Страница 2: ......

Страница 3: ...8 3 6 Electromagnetic compatibility EMC 8 4 Getting Started 9 4 1 Unpacking the Instrument 9 4 2 Calibration of the Device 10 4 3 Where to Setup 10 4 4 Rear Panel Connections 11 5 Working with the MA...

Страница 4: ...PC 44 11 Technical Data 46 11 1 Classification 46 11 2 Technical Data 46 11 3 Pin Assignment 51 12 Warranty Maintenance and After Sales Service 52 13 Safety Regulations 53 13 1 Electrical Safety 53 13...

Страница 5: ...0 70 71 46 99 E mail sales maico biz Internet www maico biz Copyright 2016 MAICO Diagnostics All rights reserved No part of this publication may be reproduced or transmitted in any form or by any mean...

Страница 6: ...vements please contact us Your MAICO Team 1 1 Indications for Use Statement The MA 41 is a portable two channel air bone and speech audiometer This audiometer is used to screen test and diagnose heari...

Страница 7: ...ignals include pure tone pulse tone warble tone narrow band and speech noise Inputs include ports for a live speech microphone and a CD player for speech test material Speech tests can also be importe...

Страница 8: ...NG 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 label...

Страница 9: ...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 606...

Страница 10: ...e device complies with international standard EN 60601 1 and conforms with type B applied part and protection class I Safety against electrical hazard is guaranteed only when the connected notebook co...

Страница 11: ...zard The terminals must under no circumstances be short circuited To avoid the risk of electric shock this equipment must only be connected to the medical power supply originally delivered by MAICO Us...

Страница 12: ...icensed hearing care professional 3 5 Device Control The user of the instrument should perform a subjective instrument check once a week ISO 8253 1 See Appendix A for a checklist 3 6 Electromagnetic c...

Страница 13: ...d from the plastic packaging without the use of scissors or other sharp tools SAVE ALL THE ORIGINAL PACKING MATERIAL AND THE SHIPPING CONTAINER SO THE INSTRUMENT CAN BE PROPERLY PACKED IF IT NEEDS TO...

Страница 14: ...e 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 which emit st...

Страница 15: ...MA 41 on a stable counter or table Plug the power cord into the power socket on the rear panel Connect all accessories with the appropriate sockets as shown above Plug the power cord into a grounded o...

Страница 16: ...instrument The ergonomic design of the MA 41 makes it easy to control the dB level signal presentation and frequency adjustments with one hand 5 1 Using the Control Panel of the MA 41 The main functio...

Страница 17: ...word in the word list for speech recognition threshold SRT testing with wave files 5 Frequency down change to lower frequency for tone audiometry enters an incorrect answer for WRS testing or selects...

Страница 18: ...cer an option for aided sound field threshold Aided is also made available Speech Select Speech Recognition Threshold SRT Word Recognition Score WRS UCL or Master Hearing Aid MHA 14 Select Unlock Lock...

Страница 19: ...the other ear is switched off All channel information is shown on the display as well as the type of the function buttons shown on the display The display has an energy saving function the backlight o...

Страница 20: ...ight the sound output grid on the inside of the headphone should be directly over the ear canal Ask the patient to press the button on the patient response switch when the tone is heard even if it is...

Страница 21: ...he primary transducer established in the set up menu Select the ear to be tested by pressing the function button 9 on the control panel underneath the screen Press several times to toggle between Righ...

Страница 22: ...he frequency up key 4 to select the next higher frequency and use the frequency down key 5 to select the next lower frequency Once a threshold value is established at the desired frequency press the s...

Страница 23: ...l attenuation 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 en...

Страница 24: ...ing the STIM button You can interrupt the masking signal by pressing the corresponding stimulus button 2 Automatic Masking With the manual masking as described before the masking level should be adjus...

Страница 25: ...4 Uncomfortable Loudness UCL Testing Testing of UCL can be measured using pure tone or speech stimuli The purpose is to determine the dBHL level at which the stimuli becomes uncomfortable to the patie...

Страница 26: ...n when the tone is heard Present a tone to the better hearing ear 10 dB above threshold and wait for the patient to indicate the tone has been heard Now present the tone to the poorer ear 10 dB below...

Страница 27: ...nitor button 6 and then InCal 17 and the calibration screen appears see figure 7b On every CD with speech test material there is a reference signal such as a reference tone or speech simulating noise...

Страница 28: ...ld sit at a distance of at least 1 meter from the device Additionally any obstructions which may interfere with the placement of the earphone cushions on the ear i e hair eyeglasses should be removed...

Страница 29: ...uncomfortable and the result can be saved by pressing the Store button 3 6 2 4 Speech Audiometry with Wave Files If Wave is selected by the speech signal selector 11 a menu will pop up with the availa...

Страница 30: ...ess the function button List 6 to load another word list UCL measurements are best performed with the Passage wave file include with the device Select the ear for testing 9 Press the function button P...

Страница 31: ...f the Wave files on the MA 41 No input calibration is required 6 2 7 Master Hearing Aid MHA The Master Hearing Aid MHA feature utilizes input signals from the Live Voice Mic external CD MP3 player or...

Страница 32: ...tor level of the left and right channel can be adjusted with the corresponding level control dial 1 In order to hear the signal given to the patient make sure to activate monitoring 9 Figure 11 Displa...

Страница 33: ...ear side of the device When the examination has been completed press the Menu button 17 in the tone or speech test mode The user menu is opened and the functionality of the function buttons 11 13 and...

Страница 34: ...desired 4 digit PIN using the level control dials 1 and the Stim button 2 Once the 4 digits have been entered press the Set button 9 and the device will return to the patient list Moving forward the...

Страница 35: ...the next or previous field by using the Frequency Up 4 or Down 5 button The date can be entered in the same manner with the level controls Delete the last character or number by pressing the Delete bu...

Страница 36: ...signal is always tone For speech audiometry the signal can be selected by the SIGNAL key 11 The type of NOISE signal is dependent upon the opposite channel s signal 7 1 4 Masking Use the Masking On Of...

Страница 37: ...s automatically activated Select L T 14 to interlock the stimulus presentation of both channels as well as the tracking of the levels STIM Mode Selection Press STIM MODE 8 key to switch between contin...

Страница 38: ...ers show all yellow and one green light If one or more red lights are displayed reduce the level using the corresponding dial 1 Store the calibration and leave the calibration mode by pressing the OK...

Страница 39: ...enu button 17 on the right side of the display To choose an item from the menu use the level control dials A short description of the selected setting item will be displayed below the user menu list T...

Страница 40: ...jumps to 1 000 Hz if the highest and lowest frequency was reached Stop Frequency control function stops at highest and lowest frequency Wrap Jumps to the lowest highest frequency when the highest low...

Страница 41: ...on the left hand side or always on the right hand side This setting requires a restart Presenter Duration Unlimited signal is presented as long as the STIM bar is pressed 1 5 Seconds signal is switche...

Страница 42: ...ls off or all signals on Tests Start Test Tone Speech defines test which will load after start up Printer Settings Set Printer Settings Opens a dialog to select a printer and configure its settings PD...

Страница 43: ...audiogram only the level and frequency one combined audiogram or two separate audiograms for left and right Bone Lines On Off displays a dotted line connecting the bone conduction results Bone Symbol...

Страница 44: ...g screen will appear Set the date format to International or US by the function button 9 Jump to the required position of the date or the time by the left Frequency Up Down button 4 or 5 and change th...

Страница 45: ...ess 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 to enter the selected number Save the setti...

Страница 46: ...supply For cleaning use a lightly 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...

Страница 47: ...service technician 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...

Страница 48: ...ware choose Yes this time only and click on the Next button Figure 17 Installation Advice Select automatic installation in the next dialog window and click the Next button Wait till the MAICO MA4x fam...

Страница 49: ...Operation Manual MA 41 8100456 Rev 9 45 01 16 Review the Audiometry Module User Manual for complete instructions of software use This is located on the included CD and USB...

Страница 50: ...ding to the class Ia of the EU medical directive 93 42 EEC 11 2 Technical Data Standards ANSI S3 6 Type 3B IEC 60645 1 Type 2 IEC 60645 2 Type B ISO 389 Acoustics Reference zero for calibration of aud...

Страница 51: ...ion Oscillator 10 dBHL to 80 dBHL Insert earphones IP30 10 dBHL 120 dBHL Sound field speaker from Amp Tones 10 dBHL 100 dBHL Speech 10 dBHL 90 dBHL Sound field speaker from MA 41 using SP90 Speaker Ki...

Страница 52: ...ch Monitor Build in monitor speaker headset Communication Talk forward and talk back Data Connection USB LAN Ethernet External Devices USB keyboard CD player Supported USB printers HP PCL 3 and PCL 5e...

Страница 53: ...of Operation Continuous Environment Conditions 15 35 C 59 95 F operation 5 50 C 41 122 F transport Humidity 30 90 Dimensions W x D x H 34 5 x 20 x 8 cm 13 4 x 7 9 x 3 2 Weight 1 5 kg 2 7 lbs Power Su...

Страница 54: ...Talk Back Microphone ZI 1 k UI 0 38 500 mVeff 8 Mic Microphone ZI 1 k UI 0 38 500 mVeff 9 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 Speaker r...

Страница 55: ...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 Dat...

Страница 56: ...the instrument In order to ensure that your instrument works properly the MA 41 should be checked and calibrated at least once a year This check should be carried out by your dealer When returning the...

Страница 57: ...ly be connected to supply mains with protective earth 13 2 Measuring Security To guarantee that the audiometer works properly the instrument has to be checked and calibrated at least once a year The s...

Страница 58: ...ms 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 differen...

Страница 59: ...t 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 mask...

Страница 60: ...ETSPL 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 3000...

Страница 61: ...ne 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 4000 9...

Страница 62: ...HL 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 0...

Страница 63: ...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 0...

Страница 64: ...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 9 5...

Страница 65: ...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 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 80...

Страница 66: ...ir 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 85 400...

Страница 67: ...one 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 5 9...

Страница 68: ...and cables other than those specified with the exception of servicing parts sold by MAICO as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the d...

Страница 69: ...Restriction of the use of certain Hazardous Substance 8 WEEE Waste Electrical Electronic Equipment Legislation Guidance and Manufacturer s Declaration Electromagnetic Emissions The MAICO MA41 is inten...

Страница 70: ...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 74 1...

Страница 71: ...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 Dip...

Страница 72: ...eld 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 vicinity o...

Страница 73: ...A 41 8100456 Rev 9 69 01 16 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 Inter...

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