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Operation Manual MA 33

8100092 Rev. 9

19/08/2019

6.6

Electrical Safety, EMC and Associated Standards

1. IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 +A1:2012 (or IEC

60601-1: 2012 reprint): Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance

2. ANSI/AAMI ES60601-1:2005+A2:2010+A1:2012: Medical Electrical Equipment - Part 1:

General Requirements For Basic Safety And Essential Performance

3. CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part 1: General

Requirements For Basic Safety And Essential Performance

4. IEC 60601-1-6:2010 Ed.3+A1: Medical Electrical Equipment - Part 1-6: General

Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability

5. UL/IEC/EN 60950-1: Information Technology Equipment - Safety - Part 1: General

Requirements

6. IEC/EN 60601-1-1: General requirements for safety; Collateral standard: Safety

requirements for medical electrical systems

7. IEC/EN 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements

for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements and tests

8. ISO 14971 - Application of risk management to medical devices

9. Essential Requirements of the current European Union Medical Device Directive

93/42/EEC

10. RoHS (Restriction of the use of certain Hazardous Substance)

11. WEEE (Waste Electrical & Electronic Equipment) Legislation

Summary of Contents for MA 33

Page 1: ...Operation Manual MA 33 ...

Page 2: ...Operation Manual MA 33 8100092 Rev 9 i 19 08 2019 ...

Page 3: ...ctrical Safety and Measuring Security 10 2 8 Electromagnetic Compatibility EMC 11 3 Warranty Maintenance and After Sales Service 13 3 1 Warranty 13 3 2 Maintenance 15 3 3 Cleaning and Disinfection Recommendations 15 3 4 Components and Replacement Parts 16 3 5 Recycling and Disposal 16 4 Unpacking and Installation 17 4 1 Unpacking the System 17 4 2 Hardware and Components 19 4 3 MA 33 Software Inst...

Page 4: ...ons 74 6 1 MA 33 Hardware and Software 74 6 2 Calibration Values and Maximum Levels 77 6 3 Connections 80 6 4 Steckerbelegung 80 6 5 Electromagnetic Compatibility EMC 81 6 6 Electrical Safety EMC and Associated Standards 84 6 7 Checklist for subjective Audiometer Testing 85 ...

Page 5: ...019 MAICO Diagnostics 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 Compliance MAICO Diagnostics is an ISO 13485 certified corporation Caution for USA Federal Law restricts this device to sale by or on the order of a licensed medic...

Page 6: ...and cost effective By purchasing the MAICO MA 33 you have made a decision towards long term investment This operation manual aims to make learning and understanding the different MAICO MA 33 functions as quick and as easy as possible Should you encounter any problems or have ideas for any further improvements we are only a phone call away Please do not hesitate to contact us Your MAICO Team NOTE O...

Page 7: ...estlake 1 4 2 Language Pack for Module Pilot Test The MA 33 with the Module Pilot Test comes with the following languages International configuration Afrikaans Arabic Basque Catalan Croatian Czech Danish Dutch English Finnish French Galician German Greek Hungarian Italian Japanese Korean Norwegian Polish Polish Audifon Portuguese Romanian Russian Serbian Slovakian South Sotho Spanish Swedish Swiss...

Page 8: ...sily by the MA 33 1 5 5 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 Crossover occurs often while testing bone conduction but it can also occur during air conduction testing Relevant to crossover is the sound lev...

Page 9: ...ion as well as maintenance and cleaning recommendations READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All images and screenshots are only examples and may differ in appearance from the actual device settings In this operation manual the following two labels identify potentially dangerous or destructive conditions and procedu...

Page 10: ...structions contained in this operation manual accompanying labels and or inserts A defective product should not be used Make sure all connections to external accessories are snug and secured properly Parts which may be broken or missing or are visibly worn distorted or contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from MAICO NOTE Cust...

Page 11: ...ing documents Return to authorized representative special disposal required Reference number Applied part type B according to IEC 60601 1 Refer to operation manual mandatory Keep away from rain Transport and storage temperature range Transport and storage humidity limitations Transport and storage atmospheric pressure limitations Voltage transformer Conforms to European Medical Device Directive 93...

Page 12: ...alibration of the device The device and the transducers complement each other and share the same serial number i e MA7663252 Therefore the device shall not be used with any other transducer prior to recalibration Recalibration also needs to be conducted when a defected headphone is replaced Uncalibrated devices may lead to faulty measurement results and could even damage the hearing of the examine...

Page 13: ...ed to a PC IT equipment forming a system ensure not to touch t he patient while operating the PC or PC equipment The device is not intended for operation in areas with an explosion hazard Do NOT use the device in a highly oxygen enriched environment such as a hyperbaric chamber oxygen tent etc If the device is not used switch it off and disconnect it from the power supply Never short circuit the t...

Page 14: ...isturbance is found in the operation of this or other equipment in proximity Please also refer to EMC consideration in Section 6 5 Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation The list ...

Page 15: ... Do not modify this equipment without authorization of the manufacturer In the event of repair during the guarantee period please enclose evidence of purchase with the device 3 1 2 Ownership Warranty and Disclaimer Software Ownership The MA 33 Software hereinafter the SOFTWARE is solely owned by MAICO Diagnostics GmbH Sickingenstr 70 71 D 10553 Berlin Germany By purchasing the SOFTWARE the buyer i...

Page 16: ...ng but not limited to loss of profit data or use of the SOFTWARE or special incidental or consequential damages or other similar claims even if MAICO has been specifically advised of possibility of such damages In no event will MAICO s liability for any damages to you or any other person ever exceed the lowest list price or the actual price paid for the license to use the SOFTWARE regardless of th...

Page 17: ...ibration it is essential to send the acoustic transducers with the device Please include a detailed description of faults In order to prevent damage in transit please use the original packing when returning the device 3 3 Cleaning and Disinfection Recommendations 3 3 1 General It is recommended that parts device and components like headphones ear cushions which come in direct contact with the pati...

Page 18: ...s and seams where plastic pieces connect Follow the instructions on the disinfection product 3 4 Components 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 33 device configuration Ask your authorized local distributor when accessories need to be replaced 3 5 Recycling a...

Page 19: ...or immediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the carrier immediately if any mechanical damage is noted This will insure that a proper claim is made Save all packaging material so the claim adjuster can ...

Page 20: ...ailable components Base Unit MAICO USB Flash Drive Kit with MAICO Database and MA 33 Software AC Headphones DD65v2 AC Headphones DD45 AC Headphones DD45 with HB7 headband BC Headphones B71W Patient Response Switch APS3 USB Cable Carrying Bag Living Speech Microphone Operation Manual Quick Guide Software Modules Module Pilot Test Module Hughson Westlake Applied parts according to IEC 60601 1 Table ...

Page 21: ...e Letter MA 33 AC A Bone Conduction Headphone B Air Conduction Headphone Red Plug C Air Conduction Headphone Blue Plug D Patient Response Switch E USB Connector F No function 4 2 2 Indication Lights Figure 2 The green indication lights on the front side of the device light up as soon as the device is successfully connected to a PC Figure 2 4 2 3 Storage When the MA 33 is not in use store in a loca...

Page 22: ...cess Close all open or running programs Insert the USB flash drive into the USB port The InstallShield Wizard will appear If the InstallShield Wizard does not appear automatically double click Setup exe from the CD It is possible to stop installation at any time by pressing Cancel The User Account Control asks if you want to allow this app to make changes to your PC Press Yes to proceed Figure 3 T...

Page 23: ...ult settings for Americas version preselected English language is selected by default and can be changed Essilor Default settings for Essilor version preselected French language Français is selected by default and can be changed Audiofon Default settings for Audiofon version preselected Polish language Polski is selected by default and can be changed Audioprotesi Default settings for Audioprotesi ...

Page 24: ...gurating Figure 9 Figure 8 Figure 9 The Device Driver Installation Wizard appears in order to install the software drivers that some computers may need Press Next to continue Figure 10 Figure 10 The device drivers are successfully installed Press Finish to complete the setup process Figure 11 Figure 11 Setup of the MA 33 Software is complete Press Finish to complete the installation Figure 12 Figu...

Page 25: ...a reinstallation of the MA 33 Software via InstallShield Wizard is required start the process with setup exe The InstallShield Wizard will ask you if you want to completely remove the selected application and all of its features Figure 13 Select one of the options to proceed Figure 13 Press Yes to remove the MA 33 Software Figure 14 Choose if you want to restart your computer now or later Start th...

Page 26: ...the audiometric examinations are not influenced by outside noises Ambient sound pressure levels in an audiometric test room shall not 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 Electronic devices which emit strong electromagnetic fields e g microwaves or radiotherapy devices...

Page 27: ... The MAICO Database offers multiple ways to make a selection These include using the mouse or using shortcut keys The shortcut keys are accessed by pressing Alt shortcut The shortcut is displayed by a letter being underlined i e or NOTE Figure 17 When accessing the Menu bar by using shortcuts shortcuts are still available within the menu selection Figure 17 Press the shortcut within the menu selec...

Page 28: ...ssions for a particular client Same function as Measurements button described in Section 5 2 2 5 Exit Closes the database application Programs MA 33 Opens the MA 33 Software Options Hardware Configuration Select communication comports between personal computer and MAICO audiometry and impedance hardware Select printer type color grey scale Figure 19 Figure 19 PC Configuration To network the databa...

Page 29: ...2 Figure 22 2 Type name of program as it should appear in the Programs menu and click OK 3 The following window will appear Open the MA33 folder and select the MA33i exe file for the program that is being added to the database Click OK Figure 23 Figure 23 4 The following window will appear If an argument for the program is required enter the code here and click OK Figure 24 Figure 24 ...

Page 30: ...ated at the top of the database screen A program file i e exe file may be typed into a field to activate the appropriate icon Figure 25 Figure 25 The program can then be selected by pressing the icon at the top of the screen instead of going to the Programs menu Figure 26 Figure 26 Info Shows the MAICO Database version and the MAICO contact information Figure 27 Figure 27 ...

Page 31: ...g a message box will request the data input Figure 28 If a client with the current data already exists a message box will appear asking if the client shall be loaded Figure 28 Press Load Client to load the data set or Cancel Select an Existing Client Use the Search button to choose an existing client This will display a list of clients which are already in the database Narrow the search by typing ...

Page 32: ...A message box will appear asking if a new client shall be saved or the client data shall be changed Select New client to save a new client or Change Client Datas to change the current client data Press Cancel to go back to the main screen Figure 33 5 2 2 6 Starting the MA 33 Software After having selected a client open the MA 33 Software using the menu Programs MA 33 the shortcut F2 or via mouse c...

Page 33: ...f the manufacturer 5 3 Turning Off the MA 33 In Case of Emergency In case of emergency disconnect the device from the computer Figure 35 Press Save exit or Exit to end the MA 33 Software Figure 35 Pull out the USB cable to end the connection between the MA 33 Hardware and the PC 5 4 Using the MA 33 Software Start the patient database load the patient to be tested and then start the MA 33 software ...

Page 34: ...nduction only for BC and Speech Version F7 Not used F8 Pulse tone on off F9 On off for left ear masking F10 100 dB F11 UCL MCL toggel only MA 33 Speech F12 Interrupter presenter Mode TAB Switching between left right ears Ctrl right Activates Interrupter Presenter for active channel Ctrl left Activates Interrupter Presenter for active channel Spacebar Interrupter Presenter adjustment for the active...

Page 35: ... 5 Tone Audiometry 5 5 1 General The following settings are displayed after opening the tone screen Figure 37 Figure 37 Note Figure 37 shows the Audiogram View The Table View can be activated in the Tone Audiometry Settings It is activated per default for Americas Explanation of the buttons are the same as the ones for the Audiogram View Figure 38 ...

Page 36: ...aring Level UCL Speech Stenger Test All SISI Test Speech optional for other versions Table 9 gives an overview over the different button functions of the Tone Audiometry screen Table 9 Tone Audiometry Screen Buttons Button Function Client Name selected from the patient database is displayed here Examiner Name chosen at start of module is displayed here and on printout Autotest Hughson Westlake pat...

Page 37: ...can also be performed with a warble tone Masking Activates Masking Figure 39 Stenger Activates binaural mode to conduct and score Stenger test PTA Displays Pure Tone Average from tone screen Figure 39 Track Activates the masking noise to automatically increase and decrease the level in relation to the signal It also increases and decreases the other ear only in binaural mode Lock Locks presentatio...

Page 38: ...ny obstructions which will interfere with the placement of the earphone cushions on the ear i e hair eyeglasses Ensure that the headphones are positioned correctly Red side on the right blue side on the left Adjust the headband of the headphones so that the earphones are positioned at the correct height i e the sound output grid exactly facing the ear canal Explain to the patient that he she needs...

Page 39: ...be adjusted using the cursor or per mouse click The left click lowers the frequency while the right increases it Test through the frequencies start at 1 kHz set the higher frequencies first then the lower frequencies Select the next frequency increase the level again and proceed with presenting the test signal as described above Once a threshold value has been established record the measured value...

Page 40: ...one Warble Tone If required the test can also be performed with a warble tone Click on the Warble tone button and the pure tone will modulate The warble tone can also be pulsed as described above 5 5 2 3 Automatic Threshold Test Hughson Westlake Another form of threshold search is using the Hughson Westlake automatic tests procedure also known as the 10 down 5 up method To open the automatic test ...

Page 41: ... After this threshold is established it is displayed in the corresponding audiogram and stored as a numerical value in a table for the appropriate ear The test will continue until all frequencies have been tested for both the right and the left ear Start Pause and Stop the test Figure 44 Activate Adoption start level to start with the previously recorded hearing threshold Deactivate to start with ...

Page 42: ...tic mode Choose from 0 dB to 90 dB in 5 dB steps Pause Pause duration between tone presentations in addition to the randomized time variable choose from 1 to 99 seconds Figure 49 Figure 49 5 5 2 4 Masking When measuring a pure tone audiogram you need to assume that the measured hearing threshold is correct But if you recognize that sound is also transmitted through bone conduction over the entire ...

Page 43: ...asure so that data may not be unintentionally deleted from the main test screen Changing hearing thresholds on the audiogram During a current test session hearing threshold levels can normally be changed by simply moving the cursor to the place on the audiogram where the correct level needs to be and then by pressing Enter key or center mouse click The stored symbol will move to this new level How...

Page 44: ...eases the frequency while the left j cursor decreases the frequency The test tone can be interrupted by pressing the Spacebar After the patient has pressed the patient response switch record the measured value by pressing the Enter key or use the centre mouse button The red marking O in the audiogram is for the right ear and the blue marking X is for the left ear 5 5 2 7 Speech Therapy Mode BPTA o...

Page 45: ...nvolves the transmission of sound waves through the skull directly to the inner ear provides information regarding the function of the inner ear For a neural hearing loss the values of air conduction and bone conduction are the same In this case a hearing loss of the middle ear can be eliminated Place the bone conduction transducer so that the flat circular side of the transducer is positioned on ...

Page 46: ...To mask when performing bone conduction testing place the headphone on the opposite ear so that the earphone sits at the correct height i e the sound output grid exactly faces the ear canal Adjust the headband of the headphones if necessary Then place the transducer of the bone conductor on the mastoid of the test ear i e on the noticeable flat area of the cranial bone behind the auricle 5 5 2 9 M...

Page 47: ... dB HL Present the tone briefly max 1s If the signal was recognized by the patient as not uncomfortable increase the level and proceed as described above If the signal was uncomfortable for the patient store the value Proceed accordingly with other test frequencies 5 5 2 11 SISI Test The SISI Short Increment Sensitivity Index is guided by the principle that patients with cochlear impairment are hy...

Page 48: ... measured as described in section 5 2 4 Select the level with the cursor The level should be set to a value 20 dB above the individual hearing threshold which was attained during measurement as described in section 5 2 2 It must reach at least 60 dB HL Take note that in the SISI mode the tone for the test is presented continuously You can interrupt the test by pressing S or by clicking on Stop Pre...

Page 49: ...n When the patient has understood the procedure of the test reduce the level to increase the increments to 3 dB and subsequently to 2 dB for further training and familiarization Performing the SISI Test Increase the intensity to 1 dB If the patient is responding correctly start the SISI test with increments of 1 dB by clicking the Start button The following 20 signals will be presented with increm...

Page 50: ...n the different setting options Click OK to apply the new setting 5 5 3 2 View R L Choose the side of the screen on which the right and left channel are to appear Table View activates the Table view instead of the Audiogram view default for Americas Combined Audio Changes display The combined audiogram displays both ears together on one audiogram Degrees HL Displays sample categories for different...

Page 51: ... being tested If Mouse wheel is activated level changes are changed by using the mouse wheel Interrupter Switch to interrupter mode Presenter Switch to presenter mode Store value with interrupter value is automatically stored when the sound is paused pressing the Enter key is not necessary Figure 59 5 5 3 5 Function Key Screening 20 dB By clicking this button a screen opens and enables the user to...

Page 52: ...vate the Reverse option to change the assignement of the up and down arrow keysonyourkeyboardforchoosingthefrequencies 5 5 3 6 Frequencies The following settings are available Figure 62 Block PTA Freq Certain frequencies can be blocked and hence will be skipped during audiometric testing this does not apply when a mouse is used Step by If you use the Enter key to confirm the data the cursor steps ...

Page 53: ... Tone Pressing the Start with Tone button opens a message box that allows for the selection of the test the programm shall start with Figure 65 Figure 65 5 5 3 7 Settings Figure 66 The following settings are available Figure 66 Permanent Pulse Permanent pulse can be activating by clicking the button Binaural Binaural measurement can be performed in addition to single left or right ear measurement ...

Page 54: ...t head by pressing the Load button Figure 68 Figure 68 Evaluation Setting for a pure evaluation workstation no device check IT Connection IT Connection Browse in the fields Import path and file OAS MAICO and Export path and file MAICO OAS to select the exchange data for the data based communication Database Changes will be activated after restart of the program Activate the Save to PDF function by...

Page 55: ...gure 71 Table 11 Explanation of Function Keys Button Function Ok By clicking Ok changes will be applied and the program returns to the start screen Ask for Examiner In the event that more than one examiner is using the program each examiner can save his her customized settings for future use and reference When the program starts enter the examiner s name Cancel Returns to start screen without savi...

Page 56: ...tons To conduct speech tests you can use a microphone WAVE files or CD ROM Use of unrecognized speech material can lead to faulty results and therefore wrong diagnosis Only recognized speech material can be used i e material with known relation to the calibration signal Figure 72 Table 12 Speech Audiometry Screen Explanation Button Function L B R Select left both or right ear Phones Stimuli will b...

Page 57: ...eech awareness threshold displays stored score as SAT in data table WRS Word recognition score displays the stored score in the table MCL Tests Most Comfortable Hearing Level displays stored score as MCL in data table UCL Tests Uncomfortable hearing Level displays stored score as UCL in data Table Reset Resets the word table Interval Select the amount of time in seconds between word presentations ...

Page 58: ...imination test Signal dB HL level at which a word list was presented to the test ear for a word recognition discrimination task Mask 2 dB HL level of masking noise presented to the non test ear during a word recognition discrimination task Condition Word List lists transducer ear and lists what was presented Notes the user may type comments into this field MCL dB HL value obtained for most comfort...

Page 59: ...nnected to PC 5 6 2 Performing the Speech Test 5 6 2 1 General The speech recognition threshold SRT is the hearing threshold for speech It is the lowest level at which the patient correctly recognizes the stimuli 50 of the time Usually recognition is indicated by repetition of the speech stimulus item The speech test can be done with recorded speech test material from CD ROM or WAVE file or with t...

Page 60: ...ropriate list stored in the data table Figure 80 If you use WAVE File this full list will then be displayed in the Word list and the list can be reviewed To change the level of the currently active signal use the keys To change the level of the currently active signal in binaural mode Right ear right mouse click in the audiogram or use the keys Left ear left mouse click in the audiogram or use the...

Page 61: ... light of the VU meter lights up Figure 83 If one or more red lights are on reduce the amplitude Store the calibration by clicking OK Figure 83 After preparing the test person start the speech test and proceed as described above Figure 84 You can choose any track directly by clicking on Track underneath the CD ROM list Figure 84 The length of the track is displayed next to the number Next tracks w...

Page 62: ...he table to be changed by clicking in the condition word list cell of that row The entire row will highlight blue Then edit a response answer in the word list and reselect the appropriate word with left mouse click so as to display the changed response i e highlight from green to red or from red to green This amendment will affect a change in the Speech Audiometric Table Use the cursor keys to cha...

Page 63: ...age relative to the number of words presented to the patient Absolute Displays the correct score result of a word list as a percentage in reference to the absolute i e total number of words Figure 90 5 6 4 4 Operation Mouse once activated enables the user to control volume setting by using the mouse Volume is adjusted per mouse by either clicking on the level in the corresponding audiogram or by p...

Page 64: ...activate to Reset Level Switch Off Noise default when switching ears Figure 93 Microphone Select a Sound device and Input via the drop down menu and adjust the Level Figure 94 Figure 94 Speech test Files Opens C Program Files x86 MAICO MA33 for selection of a speech test Start with Tone Start with Tone Pressing the Start with Tone button opens a message box that allows for the selection of the tes...

Page 65: ...aminer Note that these are not two separate lines So first fill in the first line completely and then write on the second line You can also select an image for the print head from your drive Activate the Header bitmap function and load an image for the print head by pressing the Load button Figure 97 Figure 97 Evaluation Setting for a pure evaluation workstation no device check IT Connection Chang...

Page 66: ...d saved for different examiners should more than one examiner be using the MA 33 program Language Displays current language 5 7 Pilot Test 5 7 1 General The Pilot Test is a fast and funny hearing test for children from the age of 2 years on After a short training the children will play the Pilot game to get the Pilot license A hearing test of speech recognition is included in the game Severe heari...

Page 67: ...icense sticker The Pilot will ask you to show him a certain picture on this picture board You will then point to the picture so that I know you understood him The Pilot will start out loud and get softer so you must listen very carefully The child will first need to learn the correct names for the pictures on the picture board e g teddybear instead of bear For this purpose you can use the function...

Page 68: ... the airplane Point to the toothbrush Where is the sailboat Point to the spoon Where is the ice cream Point to the ball If you are not sure the child knows the words point to the pictures and call them as they are called on the audiogram cards e g teddybear and not bear To be sure that the child understands the questions ask the child to identify the pictures in the same manner as the screening te...

Page 69: ...e the small pictures of the current word The current word is marked with a red frame see You can interrupt the test at any time by clicking the Start Pause button To restart the test click the Start Pause button again While the test is running it is possible to repeat or to skip test sentences by clicking the Forward Backward buttons The test can be finished at any time by clicking the Stop button...

Page 70: ...icking on the button 2nd Monitor Figure 76 It allows answering the test questions by touching the right picture on the screen If the little patient touches the correct picture a green check mark appears in the table If the patient touches the wrong picture a red cross is displayed If the child does not touch a picture at all a question mark is displayed in the table Figure 104 Choose a different t...

Page 71: ...orming a short hearing test beginning at 40 dB HL Figure 107 Figure 107 Please click on the Save button in order to save the test results When you click on the Exit button you are asked if you want to save the test results Figure 108 Figure 108 Saved test results can be recalled by clicking the Load button ...

Page 72: ...ing both ears at once binaural For this purpose please click on the Settings button Select Binaural in the opening menu Afterwards please click on OK Figure 109 Figure 109 Binaural testing must first be enabled by clicking the B button in the upper screen The test will then be presented on both ears Figure 110 Figure 110 ...

Page 73: ...icking on the different setting options Click OK to apply the new setting 5 7 6 1 View Figure 112 2nd Monitor Activates the 2nd Monitor button on the screen for touch screen operation touch screen necessary R L Choose on which side of the screen the right and left channel are to be displayed Figure 112 5 7 6 2 Information Help Opens the Operation manual Info Shows information such as serial number...

Page 74: ...ual to change the levels for the right and left ear individually Select Simultaneous if you want the left and right ear levels to match Figure 116 Figure 116 Print Offers different print settings such as Color Print Standard Setting B W DIN A5 Standard A4 and other print options Pressing Address Phone opens a window in which you can enter the data as well as the address and telephone number of the...

Page 75: ...s Button Function Ok By clicking Ok changes will be applied and the program returns to the start screen Ask for Examiner In the event that more than one examiner isusing the program each examiner can save his her customized settings for future use and reference When the program starts enter the examiner s name Cancel Returns to start screen without saving the changed settings Examiner Several diff...

Page 76: ...vice manuals at the disposal of authorized service companies STANDARDS Medical CE mark Yes Safety Standards IEC 60601 1 2005 A1 2012 Class IIa Type B applied parts EMC Standard IEC 60601 1 2 Audiometer Standards Tone and Speech IEC 60645 1 2017 ANSI S3 6 2010 Type 4 Air Conduction only Type 3 with Bone Speech class B DEVICE SPECIFICATIONS Environmental conditions Operation 15 C to 35 C 59 F to 95 ...

Page 77: ...2 Headband Static Force 10 0 N 0 5 N B71W Headband Static Force 5 4 N 0 5 N Tone Audiometry Tone Tests HL MCL UCL Stenger PTA SISI Hughson Westlake option Time window Pause selectable between 0 5 s and 3 5 s 5 dB steps increase 10 dB decrease Selection PTA selectable frequencies Inputs Sinus or warble tone pulsed and continuous Outputs Left Right Bone L R Accuracy Frequency 2 Level 3 dB Stimuli To...

Page 78: ...lician German Greek Hungarian Italian Japanese Korean Norwegian Polish Polish Audifon Portuguese Romanian Russian Serbian Slovakian South Sotho Spanish Swedish Swiss German Turkish Vietnamese Xhosa Zulu US configuration English US and Spanish US SISI Test Test signal Modulation 4 8 0 2 s 1 dB test 4 8 0 2 s 4 8 0 2 s 5 dB 3 dB 2 dB preparation PC REQUIREMENTS Operating system Windows 10 SP1 x86 an...

Page 79: ...e 20µPa NBN RETSPL dB re 20µPa Max Tone dB HL Max NBN dB HL SOUND ATTENUA TION dB ISO 4869 1 125 47 5 51 5 70 60 3 250 27 0 31 0 90 80 5 500 13 0 17 0 100 95 7 750 6 5 11 5 105 100 1000 6 0 12 0 105 100 15 1500 8 0 14 0 105 100 2000 8 0 14 0 105 100 26 3000 8 0 14 0 105 100 4000 9 0 14 0 105 100 32 6000 20 5 25 5 95 90 8000 12 0 17 0 90 90 24 Signal IEC 60645 1 RETSPL IEC Max Level dB HL ANSI S3 6...

Page 80: ...BN dB HL Sound Attenuation dB ISO 4869 1 125 30 5 34 5 70 60 8 3 250 17 0 21 0 90 80 15 5 500 8 0 12 0 100 90 26 1 750 5 5 10 5 105 95 1000 4 5 10 5 105 95 32 4 1500 2 5 8 5 105 95 2000 2 5 8 5 105 95 43 6 3000 2 0 8 0 105 95 4000 9 5 14 5 105 90 43 8 6000 21 0 26 5 95 80 8000 21 0 26 5 90 75 45 4 Signal IEC 60645 1 RETSPL IEC Max Level dB HL ANSI S3 6 RETSPL ANSI Max Level dB HL Speech 20 0 90 0 ...

Page 81: ...or Radioear B71W Force 4 9 5 9 N Mastoid placement Coupler IEC 60318 6 ANSI 3 6 2010 and ISO 389 3 Frequency Hz Reference equivalent threshold force level for tone Air radiation Max level dB re 1µN Min max dB Tone dB HL vcvcvc 250 67 0 35 500 58 0 60 750 48 5 65 1000 42 5 70 1500 36 5 70 2000 31 0 70 3000 30 0 4 18 70 4000 35 5 70 6000 40 0 10 5 31 45 ...

Page 82: ...ification A Bone Conduction Headphone ZA 10 Ω UA 2 Vrms B C Air Conduction Headphone L R ZA 10 Ω UA 2 Vrms D Patient Response Switch RI 500 Ω E PC Connection 1 x USB port F Connector not used 6 4 Pin Assignment Socket Connector Pin 1 Pin 2 A to D 6 3 mm Ground Signal E 1 5 VDC 2 Data 3 Data 4 Ground ...

Page 83: ...ect the MA 33 Install and operate the MA 33 according to the EMC information presented in this chapter The MA 33 has been tested for EMC emissions and immunity as a standalone MA 33 Do not use the MA 33 adjacent to or stacked with other electronic equipment If adjacent or stacked use is necessary the user should verify normal operation in the configuration The use of accessories transducers and ca...

Page 84: ...ty The MA 33 is intended for use in the electromagnetic environment specified below The customer or the user of the Instrument should assure that it is used in such an environment Immunity Test IEC 60601 Test level Compliance Electromagnetic environment guidance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If...

Page 85: ...ation distance in meters m Field strengths from fixed RF transmitters as deter mined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electrom...

Page 86: ... Electrical Equipment Part 1 6 General Requirements For Basic Safety And Essential Performance Collateral Standard Usability 5 UL IEC EN 60950 1 Information Technology Equipment Safety Part 1 General Requirements 6 IEC EN 60601 1 1 General requirements for safety Collateral standard Safety requirements for medical electrical systems 7 IEC EN 60601 1 2 2014 Medical Electrical Equipment Part 1 2 Gen...

Page 87: ...Operation Manual MA 33 8100092 Rev 9 85 19 08 2019 6 7 Checklist for subjective Audiometer Testing ...

Page 88: ...pecifications are subject to change without notice 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 ...

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