Maico MA 41 Operation Manual Download Page 10

Operation Manual MA 41

 

 

 

8100456 Rev.9 

01/16 

 

3.3 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 
9 Cleaning and Desinfection Recommendations on page 42. 

Use and store the instrument indoors only. For operation, storage and transport 
conditions see table beginning on page 46. 

 

No modification of this equipment is allowed.  

Do not drop or otherwise cause undue impact to this 
device.  If  the  instrument  is  dropped  or  otherwise 
damaged,  return  it  to  the  manufacturer  for  repair 
and/or  calibration.  Do  not  use  the  instrument  if  any 
damage is suspected. 

 

 

3.4 Electrical Safety and measuring security 

 

The  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 computer is powered 
by batteries respectively the computer´s power supply 
accords  to  the  EN    60601-1  or  EN    60950-1  safety 
regulations. 

 

 

External devices such as computer, printer or Ethernet 
which are connected to the device must meet electrical 
safety  requirements,  such  as  EN  60601-1  series  for 
medical  electrical  equipment  or  EN    60950  for  IT 
equipment. This is to avoid electrical shock to the user 
or patient. 

 

This complete system consisting of the MAICO device, 
computer and isolation transformer, is suitable for use 
in the patient environment.  Equipment not complying 
with  EN    60601  shall  be  kept  outside  the  patient 
environment, as defined in the standard (at least 1.5 
m from the patient). 

 

WARNING 

WARNING 

Summary of Contents for MA 41

Page 1: ...Operation Manual MA 41...

Page 2: ......

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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