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MA 42 Operating Instructions

1. D 0104914 86 8106778 5 MA 42 Operating Instructions 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 intormation presented on this page and the next 4 pages The MAICO MA 42 has been tested for EMC emissions and immunity as a Standalone instrument Do not use the MAICO MA 42 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 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 device Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601 1 2 standard Electromagnetic Compatibility Although the instrument fulfils the relevant EMC requirements precautions should be taken to avoid unnecessary exposure to electromagnetic fields e g from mobile phones etc If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears 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
2. T MAICO MA 42 Operating Instructions MAICO Diagnostics 10393 West 70th Street Eden Prairie MN 55344 USA Toll Free 888 941 4201 MA 42 Operating Instructions Table of Contents Page TnNTodu O octet ete cect tees tena EEE E E 1 1 1 Intended Use Statement c ccc ceccce cece cece eeeeeeeee ees eeee seen seen seen eee eenneees 1 1 2 Essential PErfOrmMance 0 ccccccecceeeccceceeeeeeeeeseeeeeeeeseeneeeeesteneceaeseeneetaneens 1 2 DESCEND CLOWN eaa coe eu emcee E E E ENEA 2 3 Cy 1 qd 9 0 SAN OU e E aE E EEE E ee ee eee 3 3 1 Unpacking the INStrUMeNt 0 cece cc ecce cece cece eeeee sean seen eeeeeeeneeeneenaeeeneees 3 3 2 Calibration Of the D VICE ccc eccccccccccceeecceeeeeeeeeeeeseeeeceuseeneeeueeenestaneens 4 3 3 Where to Setup 20 0 ce ccc ecce cece eee a eeee este este rt rt rt r sean seen seen seen eeeneeeneees 4 3 4 Rear Panel CONNMECTIONS cccccc cece cece cece eeeee cece eeeesese seen eeeneeee seen seen eeeneees 5 4 Working with the MA 42 sasssasnnsnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnne 6 4 1 Using the Control Panel of the MA 42 eeesiseriesrrerrerirsrrerrerrrerrerrren 6 4 2 Functionality of Operating Elements ccccccecceeceeeeceeeeeee esta seen estan 7 4 3 The Display of the MA 2 os ccayresete ter scteserteaseonenaet otek atarteasieaseaieuedayamonseastatene 10 5 Measurement Methods of AUdGIOMETTrY ccccceeeeeeeseeeeneeeeeeeeeeeeeeees 11
3. 5 sinus frequency modulation repetition rate 5 Hz HL MCL UCL SRT WRS MHA MCL UCL Decay SISI ABLB MLB Handheld response switch Build in monitor speaker headset Talk forward and talk back USB LAN Ethernet CD Player USB Printer USB keyboard HP PCL 3 and PCL 5e Epson ESC P2 LQ Stylus Color Canon iP100 iP90 BubbleJet Tone Presenter Interrupter Interlock tone presentation of both channels simultaneously Tracking fixed level difference between both channels Masking 8106778 5 MA 42 Operating Instructions Warm up Time Less than 10 min after power on Mode of Operation Continuous Environment Conditions 15 357 59 95 F operation 5 50 41 122 F transport Humidity 30 90 Dimensions WxDxH 34 5 x 20 x 8 cm 13 4 x 7 9 x 3 2 1 5 kg 2 7 lbs Weight 100 240 V 50 60 Hz 10 Power Supply Approximately 60 VA Power Consumption 2 x 1A slow blow Device Fuses D 0104914 52 8106778 5 MA 42 Operating Instructions 1 2 3 4 7 8 910 11 12 13 14 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 Ri 500 Q 7 Talk Back microphone Zi 1 kQ Ul 0 38 500 mVeft 8 Mic Microphone Zi 1 KQ Ul 0 38 500 mVeff 9 Mon Monitor Phone ZA 250 Q UA 8 Veff 10 CD Input Zi 47 KQ
4. Symbols US Symbols UK Symbols Import Export User Export User Settings to SD Settings Card Import User Settings from SD Card provides the possibility to store the user settings on a SD Card D 0104914 43 8106778 5 MA 42 Operating Instructions 7 1 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 51 02 2012 12 00 Figure 19 Date and Time Settings 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 change the value by the right frequency Up Down button 4 or 5 or left level control Press the functional button Ok 7 to store the changes or Exit 6 to leave the Date Time setting screen without saving the changes D 0104914 44 8106778 5 MA 42 Operating Instructions 7 2 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 stimulus presenter bar 2 several times and select A4 or Letter format by using the Store button 3 If the printer is connected to your Ethernet network select Ethernet as port Additionally the IP address
5. The resulting set of recordings became the Alpha 2 set of CDs At this point the sentences were subjected to a taste test committee that required the sentences to be grammatically acceptable and contemporary as opposed to the 1940s when the IEEE sentences were created Sentences surviving the taste test were subjected to the following statistical criteria for SNR equivalence 1 The standard deviation of the SNR 50 values across six normal hearing adult subjects was less than 1 5 dB on the Alpha 2 recordings 2 The mean SNR 50 value on six normal hearing adult subjects was within 1 5 dB of their grand average on the Alpha 2 recordings 3 The mean SNR 50 value on eight high frequency loss adult subjects was within 2 dB of their grand average on the Alpha 2 recordings 4 The range of individual word SNR 50 values within a given sentence exceeded 2 dB data from six randomly selected subjects from the 16 normal hearing adult subject pool on the Alpha 1 recordings Beta Version Starting with the original 360 sentences the procedure just described eliminated all but 89 sentences giving enough sentences for 14 lists of six sentences one each at 25 20 15 10 5 and dB SNR Lists 1 14 on the Beta version used these 14 lists Since we wanted at least 20 lists we obtained another seven lists by opening up the standard deviation in 2 from 1 5 to 2 0 dB Lists 15 21 on the Beta version of the QufckSiN test used the more lax criteria 15 810
6. 1 8th inch stereo plug can increase the crosstalk another 20 30 dB and most cassette players have even greater crosstalk between their magnetic playback heads Under normal conditions none of these levels will be audible but during silent periods on the sentence channel a faint babble can sometimes be heard in the background None of these crosstalk levels will affect normal usage of these tracks 34 8106778 5 D 0104914 MA 42 Operating Instructions REFERENCES Bentler R 2000 List Equivalency and Test Retest Reliability of the Speech in Noise Test Am J Audiol 9 2 84 100 Braida L 2000 Personal communication Egan JP 1944 Articulation Testing Methods Il Office of Research and Development Report 3802 PB 22848 Etymotic Research 1993 The SIN Test Compact Disk 61 Martin Lane Elk Grove Village Illinois 60007 Etymotic Research 1997 FIG 6 for Windows 3 5 diskette 61 Martin Lane Elk Grove Village Illinois 60007 Fikret Pasa S 1993 The Effects of Compression Ratio on Speech Intelligibility and Quality Northwestem University Ph D Dissertation University Microfilms Ann Arbor MI Killian M 1985 The Noise Problem There s Hope Hearing instruments 36 11 26 32 Killian M 2002 New Thinking on Hearing in Noise A Generalized Articulation Index Seminars in Hearing 23 1 57 75 Killion M Niquette P 2000 What Can the Pure Tone Auciogram Tell Us About A Patient s SNR Loss The Hearing Jour
7. 5 1 Tone AUCIOMETY 0 00 ccc cece cece cece cece eect a eeeeeeeeeeeeeeeeeeese esse eeeeeeeneeeneeeneenneees 11 5 2 Speech AUGIOMEUY ccc cccccc cece eccee cece eeee esse eeeeeeeeeeeee esse eeee seen eeeneeeeenneees 24 De IV OMT ORIG re EE E E EE E EE 30 5 4 Talk Forward cccccccceccc cece cceeeceeeeee cece eeeeeeeeeeeeeseeeeee esse eeeeeeeneeeneeeaeeneees 30 5 5 Documentation of the Results ccccecccccecceeeeeseeeeeeeceeeseeneeeeeseenestaeens 31 5 6 Patient ManaGeMe it 0 ccc ccc ccc cece eee e eee eec eee eee seen eee eee eee een een een een een een 32 6 Quick Reference Guide ccceccccecececececececcececececucececeenececeaeaususaeaeaeeeceneaeaes 35 6 1 General SETUD are emer nee ne ee 35 6 2 Tone and Speech AUGIOMETIY cccceccc cece cece eceeeeeeeeeeeseeeeeeeeeeeeeee sean 35 7 USET NIONU eana AEA E EE 39 7 1 Setup Date and TiMe esnssnesnesnesnesisrsrrrrrrrrrrrrrrerrrrrerrerrerrerrerrerrerren 44 7 2 Set Printer SCTUINGS it cicecesennaciceensovansnivevadenspbirenentssumseabsseuncarhemianss tensnsoueds 45 D 0104914 i 8106778 5 MA 42 Operating Instructions 8 Cleaning and Disinfection Recommendations cccsceeeeeeeeeeeeeneeeeees 46 9 Device UDGATE ee enor en neers ee eee 47 10 C nnection to the PG orireeeiacee sien cneecocaceaurasseonveenncnsemenneaeeoacceansacmeeassnens 48 11 Regulatory Symbols rcs cece rece ce ees ence res teqeeescece cee ce ceeennc pnceuesacqeeeececed 49 12 Tec
8. 60645 1 IEC 60645 2 ISO 389 UL 60601 1 American Standards for Medical Electrical Equipment IEC EN 60601 1 International Standards for Medical Electrical Equipment CSA C22 2 601 1 M90 Medical Device Directive MDD to comply with EC 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 GB level steps user selectable Maximum Sound Pressure Level AC with earphone DD 45 10 dBHL to 120 dBHL BC with B 71 B 71 W Bone Conduction 10 dBHL to 80 dBHL Oscillator Insert earphones Ear 3A 10 dBHL to 120 dBHL Sound field speaker from Amp using SP90 Speaker Kit with AP70 Amplifier Tones 10 dBHL to 100 dBHL Speech 10 dBHL to 90 dBHL Sound field speaker from MA 42 using SP90 Speaker Kit Tones 10 dBHL to 90 dBHL Speech 10 dBHL to 70 dBHL Pure tone Pulse tone Warble tone D 0104914 50 8106778 5 MA 42 Operating Instructions Test Signal Masking Signals Speech Signals Modulation Pulse Tone Warble Tone Tests Tone Speech Over Threshold Test Patient Response Monitor Communication Data Connection External Devices Supported Printers Stimulus Functions D 0104914 51 Narrow Band Noise With the same center frequency resolution as pure tone White Noise Speech Noise 12 dB octave above 1 kHz 5 dB External CD Player Microphone Wave File from SD memory card 0 25 0 5 s on time
9. Date Time Display Brightness Language D 0104914 Change frequency atter store Change level after store Which transducers shall be used as default transducer Monitoring w STIM key Start Test Set Printer Settings Save on SD Card Save on USB flash drive Show information Set Date Time 42 Moves to next test frequency after storing a threshold on or stays on same frequency after storing off Change in level after storing a threshold Stay at the same test level 0 dB or decrease by 10 20 or 30 dB Headphones on or Inserts off Monitor only speech signals or all signals Tone Speech defines test which is load after startup Opens a dialog to select a printer and configure its settings Stores PDF files always on a SD memory card Stores PDF files always on a USB flash drive Shows device information Opens a dialog to change the date time and the date format US or International Change the display brightness from 1 100 store new value by pressing the store button 3 English Germam ltalian French Spanish 8106778 5 MA 42 Operating Instructions Diagram Settings Display in speech test Diagram ott or Table on Number of diagrams in None audiogram only the tone test 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 Setting Int
10. In the event of repair during the guarantee period please enclose 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 by your dealer When returning the instrument for repairs it is essential to send all transducers headphones inserts and bone conduction oscillators Send the device to your dealer or to a service center authorized by your dealer Please include a detailed description of faults In order to prevent damage in transit please use the original packing if possible when returning the instrument Within the European Union it is illegal to dispose of electric and electronic waste as unsorted municipal waste According to this all MAICO products sold after August 13 2005 are marked with a crossed out wheeled bin Within the limits of Article 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distribution costs we assign the responsibility for the proper collection and treatment according legal regulations to our customers mi Date of Manufacture D 0104914 D5 8106778 5 MA 42 Operating Instructions 14 Safety Regulations READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM 14 1 Electrical Safety The MA 42 audiometer is constructed to comply with protection class of the
11. Score ON 25 _ SN 20 S N 15 S N 10 __ S N 5 S N 0 TOTAL Score GN25 o S N 20 SAN 15 _ SN 10 S N 5 S N o TOTAL __ Score SN 25 __ oN 20 _ OWN 15 _ N10 S N 5 S N 0 TOTAL ___ 8106778 5 MA 42 Operating Instructions LISTS 7 12 List 7 TRACKS 9 30 42 58 1 The kite dipped and swayed but stayed aloft S N 25 2 The beetle droned in the hot June sun S N 20 3 The theft of the pearl pin was kept secret S N 15 4 His wide grin earned many friends S N 10 5 Hurdle the pit with the aid of a long pole S N 5 6 Peep under the tent and see the clown S N O 25 5 TOTAL SNR loss TOTAL List 8 TRACKS 10 31 43 59 1 The sun came up to light the eastern sky SN 25 2 The stale smell of old beer lingers S N 20 3 The desk was firm on the shaky floor S N 15 4 A list of names is carved around the base ofN 10 5 The news struck doubt into restless minds SN 5 6 The sand drifts over the sill of the old house SN O 25 5 TOTAL ss SNR loss TOTAL List 9 TRACKS 11 32 44 60 1 Take shelter in this tent but keep still S N 25 2 The little tales they tell are false S N 20 3 Press the pedal with your left foot S N 15 4 The black trunk tell trom the landing S N 10 5 Cheap clothes are flashy but don t last S N 5 6 Atnight the alarm roused him fram a deep sleep S N 0 25 5 TOTAL SNR loss TOTAL D 0104914 List 10 TRACKS 12 33 45 61 Dots of light betrayed the black cat Put the
12. To prevent the possibility of extreme discomfort by the patient it is important to start the test with comfortable levels Press the test mode selector key 13 underneath the display repeatedly until UCL is highlighted The LCD display in the bottom row changes from HL to UCL to signal the test selection Start as described in chapter 5 1 1 with a test level of 60 D 0104914 16 8106778 5 MA 42 Operating Instructions dBHL Present the tone briefly max 1 s If the signal was recognized by the patient as not uncomfortable increase the level and proceed as described before If the signal was uncomfortable for the patient store the value Proceed accordingly with other test frequencies 5 1 6 Most Comfortable Loudness MCL Testing of MCL can be measured using pure tone stimuli or soeech 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 most comfortable is determined This level might be described as the level at which the patient would be comfortable listening for an extended period of time Press the test mode selector key 13 underneath the display and select MCL in order to test and store the Most Comfortable Loudness 5 1 7 The SISI Test 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 increa
13. Tone option must be activated and a separate high tone transducer must be calibrated for all frequencies First select the corresponding output Phones by the button 10 or 16 The item High Tone is now available at the functional button 13 Select High Tone by pressing the functional button 13 until High Tone Is highlighted The high tone diagram is displayed combining the left and right ears results Additional frequencies trom 8 kHz to 16 kHz can be selected now by the frequency Up 4 or Down 5 key The test procedure is identical to the description in chapter 5 1 1 Pure Tone Testing If a transducer is selected which is not calibrated tor high frequencies the standard diagram will be displayed and high frequencies will not be available On the printout pure tone audiometry results will appear in a high tone diagram combining left and right ear results 5 1 3 Bone Conduction Testing Bone conduction the transmission of sound waves through the skull directly to the inner ear provides information about 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 oscillator so that the flat circular side of the transducer is placed on the mastoid at the noticeable ledge of the cranial bone D 0104914 15 8106778 5 MA 42 Operating Instructions behind the pinna The other side
14. and the calibration screen appears see Input Calibration screen in Figure 10 Figure 10 Input Calibration On every CD with speech test material you have a reference signal such as a reference tone or speech simulating noise Play back the reference signal trom the CD Use the left or right level control 1 and adjust the levels until the VU meter 21 shows all yellow and one green light If one or more red lights are on reduce the level using the corresponding dials 1 D 0104914 24 8106778 5 MA 42 Operating Instructions To calibrate the microphone for live voice testing select MIC with the Signal selector key 11 15 Press the Monitor button 6 and then InCal 19 and the calibration screen appears Use the lett or right level control 1 and adjust the levels until the VU meter 21 shows all yellow and one green light 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 button on the left side of the display The Wave Tiles included with the device have been pre calibrated and no input calibration is required 5 2 2 Performing Speech Testing Use the functional button Speech on the right side of the tone screen 18 to switch to speech testing The speech test screen opens the right ear is selected and the lev
15. chart on the mantel and tack it down A flat pack takes less luggage space The gloss on top made it untit to read om E Q N Seven seals were stamped on great sheets 25 5 TOTAL SNR loss List 11 TRACKS 13 34 46 62 The marsh will freeze when cold enough A gray mare walked before the colt Bottles hold four kinds of rum He wheeled the bike past the winding road Throw out the used paper cup and plate Mm mm E Ww N The wall phone rang loud and often 25 5 TOTAL SNR loss List 12 TRACKS 14 35 47 63 The hinge on the door creaked with ald age The bright lanterns were gay on the dark lawn He offered proof in the form of a large chart Their eyelids droop for want of sleep There are many ways to do these things om FPF 0U N _ We like to see clear weather 25 5 TOTAL SNRA loss 81 The steady drip is worse than a drenching rain S N 25 S N 20 N15 S amp N 10 S N 5 SNo TOTAL S N 25 S N 20 ofN 15 of 10 oN 5 S N O TOTAL S N 25 S N 20 S N 15 S N 10 S N 5 S N O TOTAL 8106778 5 MA 42 Operating Instructions LISTS 13 18 PAIRS Lists 13 18 do not meet the criteria for equivalence as individual lists but do in the pairs shown The average scores from list pairs 13 14 15 16 and 17 18 are equivalent to lists 1 12 List 13 TRACKS 15 48 64 Score 1 The dusty
16. ear contact the service center D 0104914 58 8106778 5 MA 42 Operating Instructions Air Conduction Audiogram ee I pevel ken Ear PPL 0 250 TET PET a dBHL Is ink dBHL a Right Right Earpiec su Earplec e e kx Should Is the last measurement of the patient For inverted measurement please reattach the headphone If the frequency difference between Should and Is tor one ear averages more than 10 dB contact the SERVICE CENTER Bone Conduction Audiogram fight Far e e Level Left Ear LeftEar O S S khz 0 2505 H R B M 6 Ao 02505 f 2 B A ie l8 kHz tt tt k i Ea dBHL Siilid Boe i il dBHL If the frequency difference between Should and Is for one ear averages more than 10 dB contact the SERVICE CENTER D 0104914 59 8106778 5 MA 42 Operating Instructions Appendix B QuickSIN Speech in Noise Test Manual QuickSIN is a trademark of Etymotic Research Inc Reprinted with permission from Etymotic Research Inc D 0104914 60 8106778 5 D 0104914 MA 42 Operating Instructions TABLE OF CONTENTS AT e Ss CANE ais canta dave AE A T E N E A A 3 Purpose of the QuickSIN assssssssansannnnnannannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 4 QuickSIN methodology 00cesesssssssssscsssssscssscsesssssssssscscsesssssessansnssossssnsssssssssssesess 4 Whats on this GD ssssssnsssssnnannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnn
17. needed Consider FM system D 0104914 62 8106778 5 D 0104914 MA 42 Operating Instructions PURPOSE OF THE QuickSiN The primary complaint of hearing impaired persons is difficulty hearing in background noise The measurement of SNR loss signal to noise ratio loss is important because speech understanding in noise cannot be reliably predicted from the pure tone audiogram Killion amp Niquette 2000 The QuickSiN test was developed to e Provide a one minute estimate of SNR loss Provide a quick way for clinicians to quantify a patients ability to hear in noise Determine if extended high frequency emphasis improves or degrades understanding of speech in noise e Assist professionals in choosing appropriate amplification and other assistive technologies Demonstrate that hearing aids with directional microphones improve speech intelligibility in noise e Provide a large number of equivalent test lists for use in clinical and research work Provide information useful in counseling patients regarding realistic expectations QuickSiN METHODOLOGY A list of six sentences with five key words per sentence is presented in four talker babble noise The sentences are presented at pre recorded signal to noise ratios which decrease in 5 dB steps from 25 very easy to O extremely difficult The SNRs used are 25 20 15 10 5 and 0 encompassing normal to severely impaired performance in noise 63 8106778 5 MA 42 Operating In
18. new patient is selected and the current measurement results can be saved to this new patient by pressing the functional button Save 9 Press the button No Name 9 to store the results only by a patient number without entering a name or use Cancel 6 to go back to the Patient List without saving It is possible to lock the database and enter a login PIN if the language is set to English Enter the Patient List and select New Patient by pressing the New Patient button 17 Select Login On by pressing the functional button Login On Off 15 A screen will appear to set your personal four digit login PIN Select four numbers between 0 and 9 by the level dial and enter each by pressing the Stim button 2 and confirm your personal login PIN by pressing the button Set 9 Caution Remember the PIN very well otherwise it is not possible to enter the patient list anymore D 0104914 33 8106778 5 MA 42 Operating Instructions 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 Login Off after following the same steps as listed above D 0104914 34 8106778 5 MA 42 Operating Instructions 6 Quick Reference Guide 6 1 General Setup 6 1 1 Startup Settings Air conduction on both channels Pure tone on both channels 30 dBHL on right channel O dBH
19. of the headband is placed in front of the opposite ear Set the receiver selector to Bone 10 or 16 and the signal selector to Tone 11 or 15 Perform the test the same way as for air conduction For hygienic reasons it is important to clean the bone oscillator see chapter 8 5 1 4 Sound Field Testing optional Set the transducer selector 10 or 16 to Speaker Perform the test the same way as for air conduction Warble tones should be used in the sound field since pure tones may not provide reproducible results in the typical test room When results are stored using soundfield an S is displayed on the audiogram This signals soundfield speakers were used for testing and ear specific information cannot be determined Results may also be displayed with an A on the tone screen when speaker is selected as the transducer and Aided is selected from the functional button 13 5 1 5 Uncomfortable Loudness UCL Testing Testing of UCL can be measured using pure tone or speech 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 signal This information is valuable for determining the patient s upper dynamic range limit Warning Because this test uses high sound pressure levels it is extremely important to perform this test using the utmost caution to avoid damaging the ear
20. 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 Figure 20 Printer Settings Save the settings and return to the User Menu by pressing the functional button Ok 7 Test your printer settings by a sample print before starting the audiological assessment Wrong settings may require a restart of the device Enter the field clinic name by using the Stim button 2 Select letters by rotating the level control 1 and enter the selected letter by pressing the Store button 3 Save the settings and return to the User Menu by pressing the functional button Ok 7 D 0104914 45 8106778 5 MA 42 Operating Instructions 8 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 patients Please disinfect the instrument and its accessories in dependence on the specific existing infection potential Recommendations for cleaning and disinfection of MAICO device presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility If there is not a high infection potential MAICO recommends Before cleaning always switch off and disconnect
21. patient list or if the PDF is created in the patient list screen Current results can be stored to a numbered patient or to a named patient Entering the Patient List a new numbered patient with a new number is selected automatically Just press the Save button 9 to save the current session to this new patient number To save the results to an existing patient select a patient by the level controls and press the Save button 9 To save the current results to a new patient with a new patient name press the button New Patient 15 and a screen appears to enter the patients last name first name ID and date of birth D 0104914 32 8106778 5 MA 42 Operating Instructions New Patient 23 01 2013 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 button The date can be entered in the same manner with the level controls Delete the last character or number by pressing the Delete button 19 A USB keyboard can also be utilized to enter the patient information Connect it to the USB in connector 4 and type in the characters and jump to the next field by the tab key Press Enter to confirm the selected date and jump to the next date position Press the functional button OK 6 to save the new patient and go back to the patient list The
22. saved by pressing the Store button 3 D 0104914 26 8106778 5 MA 42 Operating Instructions 5 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 level control 1 to scroll through the list A list can be loaded by pressing the stimulus button Wave Lists Quicksin T Passages Figure 12 List of Speech Test Wave Files The words of the Wave Tile list will be displayed in the speech audiometry screen The level is 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 Tiles the first word can be selected by the frequency up and down buttons 4 and 5 Press the functional button Play 7 to start Once the speech test is started the test can only be stopped by pressing Cancel 18 or Store 3 30 dBHL 0 O dBHL Phone 0 0 Phone MEEN Daybreak 3 Northwest 4 Mushroom 5 Doormat 6 Eardrum 7 Iceberg 8 Padlock 9 Sunset 10 Duck pond 11 Cowboy 12 Inkwell 13 Baseball 14 Whitewash 15 Oatmeal 16 Greyhound SRT Mask Signal WRSMask Condition MCL UCL Figure 13 Display of Words D 0104914 2 8106778 5 MA 42 Operating Instructions The procedure for the SRT WRS MCL and UCL tests are the sa
23. to switch the channel off Speech select microphone external CD player Wave Tile or soeech noise as signal source 12 Test signal selector button for Steady Pulse Warble or P amp W pulse and warble tone 13 Functional selector button function changes based on testing screen i e Tone or Speech Tone selects test for selected receiver either the pure tone threshold Hearing Level HL Most Comfortable Loudness MCL Uncomfortable Loudness UCL or Over Threshold test Speech select Soeech Recognition Threshold SRT Word Recognition Score WRS Master Hearing Aid MHA Most Comfortable Level MCL or Uncomfortable Level UCL 14 Select Unlock Lock locks presentation of the signal in both channels together Track activates the masking noise to automatically increase and decrease level in relationship to the signal L amp T Lock and Track 15 Functional selector button Tunction changes based on testing screen i e Tone or Speech Tone signal selector to choose between tone narrow band noise white noise or to switch the channel off Speech select microphone external CD player Wave Tile or soeech noise as signal source D 0104914 8 8106778 5 MA 42 Operating Instructions 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 Fu
24. 3 CAN CSA C22 2 No 60601 1 Medical Electrical Equipment Part 1 General Requirements tor Safety Electrical Equipment tor Laboratory Use D 0104914 8 8106778 5 MA 42 Operating Instructions 4 IEC EN 60601 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems 5 IEC EN 60601 1 2 Medical Electrical Equipment Part 1 Electromagnetic Compatibility Requirements and Tests 6 Essential Requirements of the current European Union Medical Device Directive 93 42 EEC 7 ROHS Restriction of the use of certain Hazardous Substance 8 WEEE Waste Electrical amp Electronic Equipment Legislation Guidance and Manufacturer s Declaration Electromagnetic Emissions The MAICO MA 42 is intended for use in the electromagnetic environment specitied below The customer or the user of the MAICO MA 42 should assure that it is used in such an environment RF Emissions The MAICO MA 42 uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The MAICO MA 42 is suitable for use in all CISPR 11 commercial industrial business hospital and IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions SPS IEC 61000 3 3 D 0104914 88 8106778 5 MA 42 Operating Instructions Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the MAICO MA 42 The MAICO
25. 6778 5 MA 42 Operating Instructions Beta Site Protocol CD recordings of the beta version QuiekSIN lists 21 lists of six sentences each were sent to approximately two dozen sites The test protocol controlled for order and learning effects Test retest data were required for all 21 lists for both normal and hearing impaired subjects Normal subjects Beta version QuickSiN tests were analyzed for 26 normal hearing listeners 14 subjects from eleven sites and 12 subjects from a University of lowa clinic and 18 hearing impaired subjects from ten sites Some data were excluded from analysis if the test protocol was not followed correctly Analysis of list presentation order indicated that adequate counter balancing for list order was achieved The across subject average across lists for normal hearing subjects was SNR 50 1 9 dB nearly identical to the original SIN Test average of 2 dB Hearing Impaired simulated Normal subject results alone are not adequate to determine list equivalence since performance for normal hearing listeners is typically determined primarily by the sentences recorded at 0 and 5 dB SNR In order to check list equivalence for higher SNR levels we simulated varying degrees of high frequency hearing loss using filtering The 21 Beta test lists were re recorded using low pass brickwall filter settings of 750 Hz 850 Hz 1100 Hz 1400 Hz and 2000 Hz Each recording was presented to 25 normal hearing subjects Subje
26. L on lett channel Presenter mode 6 1 2 Transducer Selection Select the transducer to be used headphones Phones or insert phones Insert by pressing the appropriate button Press either the right 10 or lett 16 Transducer key to select the transducer Phones Insert Bone Speaker The display shows the selected transducer at the top of the display screen below the presentation levels Note Only those transducers calibrated to the device will be available for selection It is not possible to select Bone on both channels simultaneously After a new selection the level will be reset to 30 dBHL 6 1 3 Signal Selection Press either the right 11 or left 15 Signal key to select the signal The display shows the selected signal on the bottom line of the display The kind of Noise signal depends on the signal of the opposite channel 6 1 4 Masking Selection of masking noise will be activated by either the right 11 or left 15 Signal key 11 based on the non test ear and the audiometer set up For tone audiometry narrow band noise is used as the masking signal and for speech audiometry speech noise is used 6 2 Tone and Speech Audiometry 6 2 1 How to Select Tone or Speech Audiometry Mode There are two modes of audiometry Tone and Speech D 0104914 35 8106778 5 MA 42 Operating Instructions Tone audiometry shows level and frequency on the display Speech audiometry shows level correct and incorrect words and s
27. MA 42 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the MAICO MA 42 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MAICO MA 42 as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation distance according to frequency of transmitter m Output Power of 750 kHz to 80 MHz 80 MHz to 800 MHz 800 MHZ to 5 Transmitter d 1 17VP d 1 17VP GHz d 2 23VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitters where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and reflection trom structures objects and people D 0104914 89 8106778 5 MA 42 Operating Instructions Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAICO MA 42 is intended for use in the electromagnetic environment specitied below The customer or the user of the MA 42 should assure that it is used in such an environmen
28. O Ul 0 04 5 Veff 11 Speaker Left ZA 4 Q UA 8 Veff 12 Speaker Right ZA 4 Q Ua 8 Veff 13 Bone Bone Conductor ZA 4 Q Us 8 Veft 14 Insert Phone Left ZA 10 Q UA 1 Veff 15 Insert Phone Right ZA 10 Q UA 1 Veff 16 Phone Left Headphone ZA 10 Q UA 1 Veff 17 Phone Right Headphone ZA 10 Q UA 1 Veff D 0104914 53 8106778 5 MA 42 Operating Instructions Standard Accessories Optional Accessories High Frequency Option HDA200 and High 1000057 Tone License EAR 3A Insert Phones 8010959 TDH 39 Headphones 8010820 8111857 D 0104914 54 8106778 5 MA 42 Operating Instructions 13 Warranty Maintenance and After Sales Service The MAICO MA 42 is guaranteed for one 1 year This warranty is extended to the original purchaser of the instrument by MAICO through the distributor trom whom it was purchased and covers defects in material and workmanship for a period of one 1 year from date of delivery of the instrument to the original purchaser The MA 42 may be repaired and serviced only by your dealer or by an authorized service center We urgently advise you against attempting to rectify any faults by yourself or commissioning non experts to do so Do not modify this equipment without authorization of the manufacturer If this equipment is moditied appropriate inspection and testing must be conducted to ensure continued safe use of the equipment WARNING No modification of this equipment is allowed
29. Speech in Noise Test manual version 1 3 is provided in Appendix B MA 42 does not incorporate the entire QuickSIN lists but provides Standard QuickSIN lists 1 12 i e Track 3 14 from the CD recording Note Pre calibration of the QuickSIN lists was implemented into the recording and installation of the Wave Tiles on the MA 42 No input calibration is required 5 2 7 Master Hearing Aid MHA After you have completed the speech audiometry testing you may wish to demonstrate 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 60 aBsPL MHA 60 dBsPL Phone Phone 18 dB octave 18 dB octave So SF SRT Mask Signal WRSMask Condition MCL UCL Figure 14 Display Master Hearing Aid The MHA feature utilizes input signals from the Live Voice Mic external CD MP3 player or Wave files These signals are then filtered to simulate the D 0104914 29 8106778 5 MA 42 Operating Instructions benefit of hearing aids in the case of a high frequency hearing loss The level of the low frequencies can be reduced by 6 dB 12 dB and 18 dB per octave Begin by selecting a signal source in the soeech mode with the functional selector button 11 or 15 Start the MHA function by pressing the Test Selection button 13 Press the stimulus mode 11 or 15 indicator to alternate between signal sources like the microphone or the CD Change the dB pr
30. a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked 9 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and reflection trom structures objects and people a Field strengths trom fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MA 42 is used exceeds the applicable RF compliance level above the MA 42 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MA 42 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m D 0104914 91 8106778 5 Specifications are subject to change without notice T MAICO MAICO Diagnostics 10393 West 7Oth Street Eden Prairie MN 55344 Tel 888 941 4201 Fax 952 903 4100 E mail into maico diagnostics com Internet www maico diagnostics com 8106778 5 D 0104914 08 15
31. abble noise is identical in both tests Similarly when continuous speech spectrum noise is used the reported SNR will differ by about 7 dB between computed rms calibration and traditional frequent peak VU meter readings Ludvigsen and Killion 1997 We ve chosen to report QuickSIN scores in SNA Loss because it 100 is substantially independent of calibration and test material Calibration and or test material differences that affect the SNR 50 values Po Oo 40 equally for normal and i Kt wT NO hearing impaired subjects will s Ze TTT oT cancel out in the SNR Loss Sad calculation 5 gee g Fel 15 16 20 SIGNAL TO NOISE RATIO IN dB SNA LOSS 8 dB 2dB 6dB amp 0 CORRECT Figure 1 From Killian 2002 SCORING Five key words are scored in each sentence The key words are underlined on the score sheets One point is given for each key word repeated correctly The number of 6 8106778 5 MA 42 Operating Instructions correct words for each sentence should be written in the space provided at the end of the sentence and the total correct calculated for the list SNR Loss is calculated for each list by using the formula SNR Loss 25 5 Total Correct Note For greater accuracy two or more lists should be averaged see pp 19 20 WHERE DOES THE NUMBER 25 5 COME FROM First we need to explain where the number 27 5 comes from Following the Tillman Olsen 1973 recommended method for obtaining spondee threshold
32. all Dimes showered down from all sides Pick a card and slip it under the pack The store was jammed before the sale could start 255 TOTAL __ SNAIoss D 0104914 Score ON 25 OWN 20 WN TS WN TQ OWNS _ ONO TOTAL __ Score ON 25 ON 20 GSN _ YN 10 GNS ooo SNO TOTAL __ Score SIN 25 ON 20 ON 15 ONTO ONG ONQ TOTAL _ List 4 TRACKS 6 27 39 55 oo Se we The sense of smell is better than that of touch He picked up the dice for a second roll Drop the ashes on the warn old rug The couch cover and hall drapes were blue The stems of the tall glasses cracked and broke The cleat sank deeply into the soft turt 25 9 TOIAL _ ss SNR loss List 5 TRACKS 7 28 40 56 Q oo A U we To have is better than to wait and hope The screen betore the fire kept in the sparks Thick glasses helped him read the print The chair looked strong but had no bottom They told wild tales to frighten him A force equal to that would move the earth 25 5 TOTAL SNR loss List 6 TRACKS 8 29 41 57 om AeA wo M 80 The leat dritts along with a slow spin The pencil was cut to be sharp at both ends Down that road is the way to the grain farmer The best method is to fix it in place with clips it you mumble your speech will be lost A toad and a frog are hard to tell apart 25 5 TOTAL _ SNR loss
33. ant level babble on channel 2 These lists can be used to demonstrate directional microphone performance see page 11 Tracks 36 47 Lists 1 12 recorded with 30 dB high frequency emphasis HFE The HFE is used to make speech sounds audible for persons with ski slope loss 64 Tracks 48 51 Two list pairs with 30 dB HFE List pairs 13 14 and 15 16 Tracks 52 63 Lists 1 12 recorded with HFE plus 3 kHz low pass brickwall filter to be used in combination with the HFE lists to predict the outcome of fitting hearing aids with extended HFE see page 10 Tracks 64 67 Two list pairs with HFE LP List pairs 13 14 and 15 16 Track 68 Speech spectrum noise recorded at 0 VU re 1 KHz cal tone Track 69 Pink noise recorded at 0 VU re 1 kKHz cal tone 8106778 5 D 0104914 MA 42 Operating Instructions HOW TO USE THIS CD Every CD has two channels channel one left and channel two right The QuickSIN CD contains the identical recording on left and right channels on all tracks except for Tracks 24 35 which have the target talker on the left and the 4 talker babble on the right Setup Connect a CD player to the external input of the audiometer The Quick SiN test may be presented via loudspeaker insert earphones or TDH earphones When presenting the QuickSiN test via loudspeaker present it through one loudspeaker only with the subject seated facing the loudspeaker 0 azimuth When using insert earphones or TDH earphones yo
34. ard from the MA 42 it will boot up normally Delete the update Tile from the SD memory card by your computer for normal use of the SD memory card D 0104914 4 8106778 5 MA 42 Operating Instructions 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 follow the installation procedure When the installation program asks for permission to search for software choose Yes this time only and click on the Next button Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only Yes now and every time connect a device O No not this time Click Next to continue Figure 21 Installation Advice Select automatic installation in the next dialog window and click again on the Next button Wait until the MAICO MAAx family driver is installed and the operating system is updated Click on the Finish button when the installation of the driver is completed The new hardware is now ready to use Found New Hardware Wizard Please wait while t
35. 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 headphones are always used with appropriate padded ear cushions Ensure the headphones are placed correctly Red side on the right blue side on the lett Adjust the headband of the headphones so that the receivers are at the correct height the sound output grid should be exactly facing the ear canal Instruct the patient to press the patient resoonse button when he hears the test tone For hygienic reasons It is important to clean the ear cushions of the headphones see Chapter 8 after testing 5 1 Tone Audiometry The MA 42 supports the main tone audiometric testing methods The following testing methods can be started out of the tone audiometry mode and the results will be documented in the instrument Air conduction testing Bone conduction testing High tone audiometry optional Sound field testing Uncomfortable Loudness UCL Testing Most Comfortable Loudness MCL Over threshold test Decay SISI ABLB and MLB D 0104914 11 8106778 5 MA 42 Operating Instructions 5 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 screen the following settings are displ
36. ayed 1000 uz 30 dBHL Steady Phone 80 30 100 110 0 125 0 25 0 5 Figure 5 Start Screen Default setting right channel is set to air conduction pure tone and the left channel to air conduction narrow band noise with manual masking The frequency is automatically set to 1000 Hz The audiometer provides two channels which can be separately routed to the left or right ear Each channel can play back a signal and can be routed to one of the outputs The signal can be set for each channel 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 the screen Next select the transducer to be used headphones Phones insert phones Insert bone conductor Bone or sound field speaker Speaker by pressing the appropriate button 10 16 Only calibrated transducers are selectable The level and frequency of each channel is displayed as a numerical value at the top of the screen and also as a cursor within the audiogram itself D 0104914 12 8106778 5 MA 42 Operating Instructions The dBHL level can be changed with the attenuator knobs on both sides 1 of the instrument Set the level control dial to a value just below expected hearing loss and turn down the level of the other ear Use the frequency Plus 4 or Minus 5 keys to increase or decrease the frequency Press
37. beck noise audiometry investigates the hearing threshold of pure tones while masking noise is presented simultaneously to the same ear with a constant level for all frequencies The tone in noise hearing threshold is typically as high as the level of the noise The noise has a higher influence to neural hearing losses and the tone in noise hearing threshold will be increased Set the Signal of the first channel to tone and the signal of the second channel to noise and route both channels to the same ear Set the level of the noise to a fix value and test the hearing threshold D 0104914 23 8106778 5 MA 42 Operating Instructions 5 2 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 the player must meet electrical safety requirements such as IEC 60601 1 or UL This is to avoid electrical shock to either the patient or you If you are not sure if your player meets these requirements it is safer to use battery power 5 2 1 Input Calibration The MA 42 must be calibrated to the particular soeech test to ensure valid test levels That means every time you change the speech test CD you must recalibrate 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
38. bench stood by the stone wall co dl eats a 2 We dress to suit the weather of most days S N 20 3 The water in this well is a source of good health S N15_ lt 4 That guy is the writer of a few banned books SN 5 The door was barred locked and bolted aswell S N 5 _ _ lt 6 A big wet stain was on the round carpet SN 29 9 TOIAL _ sSSNRR loss TOTAL ______ List 15 TRACKS 17 50 66 Score 1 Poached eggs and tea must suffice 4 2 They sang ihe same tunes at each party S N 20 ee 3 A gold vase is both rare and costly ao ell _ 4 God is the main business of the north shore SNI 5 A round mat will cover the dull spot SN SE 6 A good book informs of what we ought to kaoow SNO _ _ o 25 5 TOTAL ______ SNR loss TOTAL List 17 TRACK 19 Score 1 The point of the steel pen was bent and twisted S N 25_ 2 There is a lag between thought and act gN 20 Z 3 Seed is needed to plant the spring corn S N 15 4 This horse will nose his way to the finish old 5 The dry wax protects the deep scratch SAN D eee 6 Twist the valve and release hot steam rd 25 5 01AL GSN loss TOTAL ____ D 0104914 List 14 TRACKS 16 49 65 7 The team with the best timing looks good 8 Sit an the perch and tell the others what to do 9 The early phase of life moves fast 10 Tea in thin china has a sweet taste 11 The latch on the back gate needs a nall 12 A whitt of it will
39. ce as possible NOTE When testing via loudspeaker the talkback microphone should be held close to the patient s mouth so that responses are clearly audible to the tester Pausing Use the PAUSE button between sentences if the patient responds slowly 65 8106778 5 D 0104914 MA 42 Operating Instructions PRACTICE LISTS Tracks 21 23 contain Practice Lists A C They can be used to familiarize the patient with the test protocol or to determine the loud but OK presentation level for persons with hearing loss of 50 dB HL and greater These lists are NOT equivalent to lists 1 12 or list pairs and do not reliably predict SNR Loss TRAGK 21 Practice List A D 0 A wh The lake sparkled in the red hot sun Tend the sheep while the gog wanders Take two shares as a fair profit North winds bring colds and fevers Asash of gold silk will trim her dress Fake stones shine but cost little TRAGK 22 Practice List B mort wh Wake and rise and step into the green outdoors Next Sunday is the twelfth of the month Every word and phrase he speaks is true Help the weak to preserve their strength Get the trust fund to the bank early A SIX comes Up more often than a ten TRAGK 23 Practice List C moot wry ne step more and the board will collapse Jake the match and strike it against your shoe The baby puts his right foot in his mouth The pup jerked th
40. change the status displayed in the test channel from Tone to Noise D 0104914 13 8106778 5 MA 42 Operating Instructions 5 1 1 1 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 level received by the opposite ear The difference between the original test signal in the test ear and the received signal in the opposite ear is called interaural attenuation For bone conduction measurements the interaural attenuation is O 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 the opposite ear Masking increases the hearing threshold of the opposite ear when crossover is occurring For bone conduction the masking signal is automatically routed to the opposite output of the phones or inserts The masking is done with a noise signal which is transmitted by the headphone For pure tone audiometry a 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 s
41. cts were tested in three sessions over several days and list number presentation order was varied to counterbalance for potential order effects The most difficult condition 750 Hz low pass was presented first followed in order by the less difficult conditions Testing was completed over several days thus learning effects were not expected despite repeated presentations of the same lists D 0104914 70 8106778 5 MA 42 Operating Instructions He C3 iu ce E O S a i uD tt ttt 9 10 111213141516 17 18 QUICK SIN LIST 750 Hz b 856 Hz gh 1160 Hz Figure 5 7d00 Az 200 Hz Unfiltered 264 _ Lu c O oO a D E Q Li g EE cn 4 2 6 e a e a a a a a nen a en ss s s 1 jij 3b api Sq Sp Fa Aja gii Logie tig 125 eii eth Be ib SIN TEST LIST s BETA TEST LIST s TED Hz m 50 Hz A 1100 Hz 1400 Hz 2000 H2 Unitiltered Figure 6 Figure 5 shows a plot of across subject QuickSIN Beta averages for 25 normal hearing adult subjects at each filtering condition The twelve lists without an X exhibited SNR 50 values at each filtering condition that fell within 2 2 dB of the grand average in addition three pairs of fists were found whose pair average met those criteria Typically one fist score wold be high and the other would be low under similar conditions By adding those paired fists a total of 15 equivalent lists became ava
42. cure the most stubborn cold 25 5 THAL SNRA loss List 16 TRACKS 18 51 67 7 The thaw came early and freed the stream 8 Ittakes alot of help to finish these 9 Roads are paved with sticky tar 10 It s a dense crowd in two distinct ways 11 Raise the sail and steer the ship northward 12 Jerk the dart from the cork target 25 5 TOTAL sCSSNR loss List 18 TRACK 20 7 Read just what the meter says 8 Clams are small round soft and tasty 9 The line where the edges join was clean Score S N 25 S N 20__ S N 15 ofN 10__ yN 5 N D TOTAL Score S N 25 SN 20 S N 15__ 10 A cound hole was drilled through the thin board S N 10 ___ 11 The cloud moved in a stately way and was gone S N 5 12 A plea for funds seems to come again 25 5 TOTAL SNR loss 82 TOTAL S N O 8106778 5 MA 42 Operating Instructions APPENDIX A CATEGORIES OF LOUDNESS 7 Uncomfortably Loud 6 Loud But OK 5 Comfortable But Slightly Loud 4 Comfortable 3 Comfortable But Slightly Soft 2 Soft 1 Very Soft Valente and Van Vliet 1997 D 0104914 83 8106778 5 D 0104914 MA 42 Operating Instructions APPENDIX B TECHNICAL NOTE CROSSTALK On Tracks 24 35 the target speech and the babble are recorded on separate channels but a small amount of interchannel crosstalk 65 dB exists on the QutekSiN CD The typical CD player with a
43. dult Hearing mpaired Individuals Am Acad Audiol 11 2 91 96 Tillman TW Olsen WO 1973 Speech Audiometry In Modern Developments in Audiology Second Edition Jerger J ed Academic Press New York Turner CW Cummings KJ 1998 Speech Audibility for Listeners With High Frequency Hearing Loss Am J Audiol 8 1 47 56 Valente M Van Vliet D 1997 The Independent Hearing Aid Fitting Forum IHAFF Protocol Fengs in Amplification 2 1 6 35 Villchur E 1982 The Evaluation of Amplitude Compression Processing for Hearing Aids In 7he Vanderbilt Hearing Aid Report Studebaker G amp Bess F eds Monographs in Contemporary Audiology Upper Darby PA 85 8106778 5 MA 42 Operating Instructions Track 1 Calibration Tone Track 2 Identification Tracks 3 14 QuickSIN Lists 1 12 Tracks 15 20 QuickSIN List Pairs 13 14 15 16 17 18 Tracks 21 23 Practice Lists A B C Tracks 24 35 Separated Speech and Babble Tracks 36 47 HFE Lists 1 12 30 dB high frequency emphasis Tracks 48 51 HFE List Pairs 13 14 15 16 Tracks 52 63 HFE LP Lists 1 12 HFE plus 3 kHz low pass Tracks 64 67 HFE LP List Pairs 13 14 15 16 Track 68 speech Spectrum Noise Recorded at 0 VU re cal tone on Track 1 Track 69 Pink Noise Recorded at 0 VU re cal tone on Track 1 ETYMOTIC RESEARCH INC 61 Martin Lane Elk Grove Village IL 60007 www elymatic com Re recording Larry Revit Revitronix E mi 2001 2006 ERO29002A 0206 Designed
44. e claim adjuster can inspect it Notify your dealer or MAICO when the adjuster has completed the inspection Please check that all accessories are received in good condition The list of standard and optional accessories are listed in Chapter 11 Only those accessories provided by MAICO Diagnostics are to be used to ensure product installations are respected and device failure avoided If any accessories are missing or damaged immediately notify your dealer or MAICO D 0104914 3 8106778 5 MA 42 Operating Instructions 3 2 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 0021520 Use of transducers not calibrated to this particular instrument will likely lead to incorrect thresholds causing incorrect test results If one of the acoustic transducers is replaced the instrument must be recalibrated The use of non calibrated audiometers can lead to incorrect measurements 3 3 Where to Setup The MA 42 should be operated in a quiet room so that the audiometric examinations are not influenced by outside noises Ambient sound pressure levels in an audiometry test room shall not exceed the values specitied in the norm ISO 8253 1 2010 or ANSI 3 1 1999 For use in noisier environments headphones with optional sound insulation muffs are available Electro medical instruments which emit strong electromag
45. e leash as he saw a feline shape Leave now and you will arrive on time She saw a cat in the neighbor s house S N 25 oN 20 ON 15 XN 10 S N 5 S N 0 TOTAL ON 25 S N 20 S N 15 N 10 XN 5 S N 0 TOTAL S N 25 S N 20 XN 15 S N 10 S N 5 N TOTAL 66 Score Score Score 8106778 5 D 0104914 MA 42 Operating Instructions WHAT IS SNR LOSS We are interested in the patient s performance in noise compared to normal hearing persons performance in noise We consider this difference in performance the SNR Loss Similar to the definition of pure tone hearing loss SNR Loss is defined as the dB increase in signal to noise ratio required by a hearing impaired person to understand speech in noise compared to someone with normal hearing A normal hearing person requires about 2 dB signal to noise ratio speech louder than the background noise by 2 dB to identify 50 of key words in sentences on the QuickSiN test The value of SNR Loss is derived from the SNR 50 signal to noise ratio for 50 correct score A hearing impaired person who requires speech to be 8 dB higher than the noise to achieve a 50 correct score would have a 6 dB SNR Loss see Figure 1 Different tests will give different values of SNR 50 for the same patient We have found that changing from a female to male talker and using easier sentences decreases the normal SNR 50 by 5 dB from 2 to 3 dB even though the b
46. earing persons is 2 dB we subtract 2 dB to derive the formula for a patient s SNR LOSS 25 5 Total words correct in 6 sentences SNR loss SNR 50 2 dB 27 5 total words correct 2 dB 25 5 total words correct D 0104914 68 8106778 5 D 0104914 MA 42 Operating Instructions GUILT FREE QuickSiIN TEST for ski slope loss High Frequency Lists amp Low Pass Filtered Lists FIGG PRESCRIBED GAIN FOR CONVERSATIONAL SPEECH Figure 2 shows the high frequency 50 j 4 emphasis added to the QuickSIN 40 lists to obtain the recordings labeled HFE This frequency response was obtained from FIG 6 1997 for 65 dB normal speech inputs for a patient with 60 70 dB ski slope loss 100 30 GAIN IN dB Data on ski slope hearing loss from Skinner 1980 Rankovic 1991 and Turner and Cummings 1999 indicate that some patients do worse with the extended high frequency emphasis prescribed by popular formulae than if the emphasis is restricted to regions of better hearing Other patients with similar audiograms seem to benefit from the extended high frequency amplification A new set of recordings labeled HFE LP were generated by low pass filtering the HFE recordings with a brickwall filter set at 2 5 kHz The resulting frequency response is also shown in Figure 2 By comparing the SNR results obtained with the HFE and HFE LP lists it is possible to determine whether or not extended high frequency amplifica
47. ed for a valid comparison to an accuracy of 1 5 dB at the 80 confidence level see page 20 If you find a difference greater than 4 dB with one list in each condition you have already reached the 95 confidence level Table 2 Channel 1 Channel 2 Dial dB HL Dial dB HL SNR dB sentence 1 sentence 2 sentence 3 oentence 4 sentence 5 sentence 6 D 0104914 72 8106778 5 D 0104914 MA 42 Operating Instructions TEST DEVELOPMENT The Original SIN Test The original Etymotic Research Speech In Noise SIN Test was designed to assess word recognition performance in noise with and without hearing aids Test results are reported as signal to noise ratio SNR for 50 correct This is consistent with normal audiometric practice where threshold is defined as the level at which the patient responds 50 of the time The recommended presentation levels for the SIN Test 70 dB HL and 40 dB HL were selected to represent the range of typically loud and quiet speech levels encountered by most people in everyday life SIN Test Format sentence materials were used in the SIN Test because sentences spoken with natural dynamics have greater dynamic range than monosyllabic words and are thus a more valid representation of real speech Villchur 1962 In the real world the speech dynamic range is increased by the stress given to some words and syllables vs the drop in level given to others The effects of co articulation are not well represe
48. el is set 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 done via recorded speech test material from CD Wave files or with the microphone and live voice using standardized word lists Ask the patient to repeat each word Often times a carrier phrase such as Say the word may be used The patient should sit at a distance of at least 1 m from the device Eliminate any obstructions which will interfere with the 0 dBHL SRT 30 dBHL Phone Phone Speech Test SRT Mask Signal WRSMask Condition MCL UCL Figure 11 Start Screen Speech Test D 0104914 25 8106778 5 MA 42 Operating Instructions placement of the earphone cushions on the ear e g hair or eyeglasses Ensure the headphones are put on correctly Adjust the headband of the headphones so that the receivers are at the correct height the sound output grid exactly facing the ear canal 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 Tile or switched off for each channel independently by the functional selector buttons 11 and 15 Each channel can be routed to the left or right ear by the functional selector buttons 9 or 17 this enables flexible mixing Select Phones Inser
49. ent 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 dB That means a continuous tone e g 65 dBuL Is briefly increased by 5 dB e g to 70 dBHL During the increment time a green box is shown in the middle of the LCD display The number of detected recognized increments is counted and shown on the display Furthermore the number of presented given increments is shown Instruct the patient to press the patient resoonse button when they hear a change in loudness trom the continuous presentation tone The response button must be pressed while the D 0104914 18 8106778 5 MA 42 Operating Instructions green box is displayed on the screen and thus the tone is being presented to the patient for this to be counted 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 below the frequency 5 1 7 3 Performing the SISI Test When the patient is ready set the increment to 1 dB and press the Start 19 button to run the SISI test Now 20 increments will be presented 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 presen
50. enty Table 3 below shows the number of lists required for a given accuracy for confidence levels of 80 90 and 95 Table 3 Number of Lists 1 2 3 4 5 6 7 8 9 95 C I in dB 2 7 1 9 16 14 1 2 11 10 10 09 90 G I in dB 2 2 1 6 1 3 11 10 09 08 0 8 0 7 80 G I in dB 1 8 1 3 1 0 09 08 O07 Of 06G 0 6 The numbers in Table 3 are based on the rms average standard deviation of 1 4 dB in SNR found for the hearing impaired subjects included in the Beta site testing This figure comes from two numbers a the 1 3 standard deviation derived from the combined individual test retest scores and b the across list standard deviation of 0 6 dB If only normal hearing subjects are used the appropriate standard deviation drops from 1 4 dB to 1 25 dB A standard deviation of 1 4 dB is slightly better than the standard deviation which would have been expected based on the original SIN Test That standard deviation of 0 7 dB multiplied by the square root of five would predict a standard deviation of 1 6 dB for the QuickSIN test which uses only one sentence at each level compared to five sentences at each level on the SIN Test The more careful preselection of sentences used in the QuickSIN test may have contributed to the slightly better result 78 8106778 5 D 0104914 MA 42 Operating Instructions COMPARISON BETWEEN TWO CONDITIONS Averaging the results of several QuiekSIN lists improves the reliability compared to a single list This is pa
51. esentation levels with the level control dials 1 The influence of the filters can be changed by using the Frequency Up 4 and Down 5 keys The MHA function can be performed using monaural or binaural presentations 5 3 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 of the left and right channel can be adjusted with the corresponding level control dial 1 The integrated speaker is switched on by pressing the button 13 and the external headset via the functional selector button 11 In order to hear the signal given to the patient make sure to activate the corresponding channel for monitoring buttons 9 and 17 Figure 15 Example for Monitoring Setting The talk back microphone is activated by the button 15 and its level adjusted by the frequency up and down buttons 4 5 5 4 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 D 0104914 30 8106778 5 MA 42 Operating Instructions Note Only connect the microphone when the unit is off To talk to the patient press and hold the Stim Talk button 8 and speak into the microphone Pressing only one Stim Talk button is required to activate this feature Adjust the level by t
52. h channels together 4 1 Using the Control Panel of the MA 42 The main functions of the MA 42 are directly accessible by using the functional buttons which are located around the display The buttons have changing functionality so the actual function of each button is shown in blue boxes adjacent to the button To change the actual function displayed 9 11 13 15 17 on the screen just press the corresponding button and a list of alternative functions will appear To select a desired function continue to press and release the button quickly until the test function is highlighted for selection D 0104914 6 8106778 5 MA 42 Operating Instructions to be made The blue boxes on the right and left side of the screen 6 7 18 and 19 also provide easy access to setting controls These functional buttons provide quick and easy access for test operation For device customization an extensive User Menu is available for advance users see Chapter 7 4 2 Functionality of Operating Elements The following table describes the main functions of each button for the tone and Speech audiometry screen Figure 3 Control Panel MA 42 1 Level control adjusts the signal level for the left right ear 2 Stim button presents or interrupts the signal for the left right ear 3 Store button stores results for the left right ear or no response if button is pressed for 3 seconds 4 Frequency Up change to higher frequency fo
53. he left or right level control 1 while holding down the Stim Talk button 5 5 Documentation of the Results All stored results can be directly printed by a USB printer Make sure that a compatible printer is connected to the USB port 4 and the device is correctly configured to the connected printer refer to Menu Settings chapter 7 2 The results can also be stored as PDF file on an SD memory card or USB flash drive to be transterred to a PC for further usage The PDF Tile contains all the 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 recommended using the USB flash drive for storing PDF results When the examination is complete press the Menu button 19 in the tone or speech test mode The User Menu is opened and the functionality of the functional buttons 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 results on the SD memory card or USB flash drive press the PDF button 11 A PDF will be created and stored on the SD memory card or USB flash drive for further transfer to a PC or printout via a PC connected printer Make sure that the setting PDF Save Option is set to correct sto
54. he office and tor mobile audiometry in clinics and abroad The MA 42 audiometer delivers 11 air conduction AC test frequencies trom 125 Hz to 8 kHz with levels from 10 dBHL to 120 dBHL Bone conduction BC can be tested with 10 test frequencies from 250 Hz to 8 kHz with levels trom 10 dBHL to 80 dBHL with the standard bone conductor B71 As an upgrade option the MA 42 is also capable of high frequency audiometry up to 16 kHz The large backlighted LCD color display shows level frequency transducer signal tyoe audiograms and other intormation for each channel The sound presented to the patient s ear can be monitored by the examiner with an internal monitor speaker or external monitor phone The MA 42 performs tests using DD45 headphones B71 bone conduction receiver and optional insert phones or optional 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 soeech and a CD player for speech test material Soeech tests can also be played by recorded Wave Tiles included on a removable SD memory card Outputs have separate jacks for air conduction headphones bone conduction transducer optional insert phones and optional sound field speakers Optional transducers available include TDH 39 insert phones B 71W B 81 HDA 200 and HDA 300 As an additional teature the patient management provides the possibility to store results in
55. he wizard installs the software KJ MAICO MA4s family WdfColnstaller01 005 dll To C WINDOWS system32 N Figure 22 Installation Once the instrument is linked to the PC audiometry software you are able to record the results while performing your audiological assessment Make sure that the software is running and that a connection is built up before starting a new session D 0104914 AS 8106778 5 MA 42 Operating Instructions 11 Regulatory Symbols o A 980 amp 60601 1 Serial Number 980 amp 60601 1 Date of Manufacture O AA 980 amp 60601 1 Caution Consult Accompanying Documents z Bwco D 0104914 x 4 lb LISTED Intertek 4005727 Medical Equipment Classified by Intertek Testing Services NA Inc with respect to electric shock fire and mechanical hazards only in accordance with UL 60601 1 Classified under the Medical Device Directive 93 42 EEC as a Class Ia device 49 Special Disposal Required IEC60601 1 Keep Dry Logo Registration Label Return to Authorized Representative 980 amp 60601 1 Reference Number B Patient Applied Part According to Consult Operating Instructions Transport and Storage Temperature range EU Authorized Representative 8106778 5 MA 42 Operating Instructions 12 Technical Data EU Authorized Representative MAICO EC Sickingenstr 70 71 D 10553 Berlin Germany Standards ANSI 3 6 ANSI 3 43 IEC
56. hnical D QUA cestecsanceesesnneccavesncsutesaecestosencsenesancsencocecsedtenersatwecateanesaeseuns 50 13 Warranty Maintenance and After Sales Service ccssecesseeeeeeeees 55 14 Safety Regulations cere os occ cece pene eee eee eentceeseeeteee ee 56 14 1 Electrical Safety 0c cccccccecccc cece eeeeeeeee essen eeeeeseeneeeeeseeneetaeseaneseaeeenaess 56 14 2 Measuring SOCUINY dicen sn onnnss tetteertaersesdearetiglaneccuntoetctatanicaedsansecgnachedinnenanownes is 56 14 3 DEVICE Control issn saiactirennisucsisnoawantienisn tow nesganlisiusntiausiiveamsebionneletavoanaetvemssnwas 56 14 4 Operation s onsnusnsnsiusnsnsirrrsisrrrrrisrtrrrirrrrtrrrrrrtrri ritit rrrrrrrrrrrererrrrrren 56 14 5 Warnings and Statements ccccccccccceecceneceeeeeeeceeeeeeeeeueseaeseaeseaeeenees 5 Appendix A Checklist for Subjective Audiometer Testing 00000 58 Appendix B QuickSIN Speech in Noise Test Manuall cscssssseeees 60 Appendix C EMC Compattibllity ccccsccseecsesceeeeeseceseeeseeeseeeneeenesenenens 87 D 0104914 i 8106778 5 MA 42 Operating Instructions 1 Introduction Thank you for purchasing a quality product trom the MAICO family The Audiometer MA 42 is manufactured to meet all quality and satety requirements In designing the MA 42 we placed particular importance in making it a user friendly device meaning its operation is simple and easy to understand All functions of the MA 42 a
57. ilable 12 fists plus 3 fist pairs Figure 6 shows a plot of the across subject average data renumbered lists for the lists included on the final QiuickSiN CD D 0104914 71 8106778 5 D 0104914 MA 42 Operating Instructions RELIABILITY STATISTICS MADE USEFUL A QutckSiN score obtained in one minute from a single list is accurate to about 1 8 dB at the 80 confidence level By about we mean that 80 of the time four times out of five the true score obtained from many lists will be within 1 8 dB of the single list test score Statisticians would say we have an 80 confidence level that the true QufekSiN score will be within 1 8 dB of the measured score To put these numbers in perspective a typical clinical threshold is accurate to about 5 dB at the 80 confidence level In other words one time out of five a threshold can be expected to be 5 dB or more above or below the recorded value An 80 confidence level is normally adequate for clinical testing where the results of any one test are used in context with other factors In the case of a test of SNR Loss for example the clinician will already have formed an idea of the patient s communication difficulty from conversations with the patient A 95 confidence level is common for research reporting where a reduced risk of error is normally required Using a statistical criterion that gives a 95 confidence level reduces the probability of error to one time in tw
58. ing practice guidelines for speech quality measurements to help communication engineers assess speech transmission systems The 720 IEEE 73 8106778 5 D 0104914 MA 42 Operating Instructions sentences 72 lists of 10 sentences each with five key words in each sentence were published as Appendix C in the 1969 document IEEE Recommended Practice for speech Quality Measurements According to Silbiger 2000 the sentences used in the IEEE document were originally published in 1944 Egan 1944 The IEEE sentences were designed to have few contextual cues to aid in understanding i e if a listener hears the first part of the sentence s he cannot likely fill in the remainder based on contextual cues and knowledge of the language As part of her doctoral dissertation Fikret Pasa 1993 obtained recordings of the IEEE sentences female talker from the Massachusetts Institute of Technology on DAT and equalized them to correct for the high frequency attenuation caused by the chest position of the recording microphone used at MIT This recording was used in generating sentences for both the SIN and the QuickSiN tests Problems with the SIN Test Many practitioners reported that administration of the SIN Test was too time consuming for clinical use and scoring the test was difficult and cumbersome After several in depth analyses of the SIN Test it was discovered that several of the lists were not equivalent resulting in too few lis
59. international standard IEC 60601 1 EN 60601 1 The instruments are not intended for operation in areas with an explosion hazard A Electrostatic discharge ESD according to IEC 61000 4 2 Use the device only in an electrostatic controlled environment To avoid the risk of electric shock this equioment must only be connected to supply mains with protective earth 14 2 Measuring Security To 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 accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done The use of non calibrated audiometers is not allowed 14 3 Device Control The user of the instrument should perform a subjective instrument check once a week This check can be done following the list for subjective instrument check see Appendix A For your own security you should copy the enclosed list Till it in once a week and store it in your Tiles 14 4 Operation The instrument should only be handled and operated by trained personnel audiologists ENT doctors or personnel with similar qualifications D 0104914 56 8106778 5 MA 42 Operating Instructions 14 5 Warnings and Statements No modification of this equipment is allowed Maico will make available instructions and diagrams to repair devices that it deem
60. ly significant In this case Table 4 indicates that three lists in each condition would suffice This will typically take six minutes which is relatively small compared to the time often taken fighting feedback A relaxed criterion of 1 8 dB would require only two lists in each condition or four minutes of testing If the test results indicate that high frequency emphasis which ends at about 2 5 kHz gives as good or better scores the clinician can abandon the feedback fight without guilt 79 8106778 5 MA 42 Operating Instructions LISTS 1 G List 1 TRACKS 3 24 36 52 A white silk jacket goes with any shoes The child crawled into the dense grass Footprints showed the path he took up the beach Avent near the edge brought in fresh air tis a band of steel three inches wide mm L wo NMN The weight of the package was seen on the high scale 2755 TOTAL s SNRioss List 2 TRACKS 4 25 37 53 Tear a thin sheet from the yellow pad cruise in warm waters in a sleek yacht is fun A streak of color ran down the left edge t was done before the boy could see it Crouch before you jump or miss the mark ma Oo A we M The square peg will settle in the round hole 25 5 TOTAL _ ss SNR loss List 3 TRACKS 5 26 38 54 Pitch the straw through the door of the stable The sink is the thing in which we pile dishes Post no bills on this office w
61. m the sides and rear can be obtained in a standard test booth with loudspeakers located in the corners at 45 and 45 or O and 180 azimuth It is important to remember that any test conducted in a sound booth will not precisely reflect results in the real world By design sound booths have minimal reverberation and testing is conducting using a limited number of loudspeakers usually two that are in fixed locations In this setup it is possible that the location of the speakers may interact with the null of the directional microphone s Therefore these measures should not be used to assess effectiveness of one directional microphone design vs another where differences are usually small but rather as a general measure comparing OMNI to Directional to verify that the directional microphones are working and providing directivity rejection of sound from the sides and rear Procedure lf the loudspeakers are located at 45 and 45 test each ear separately Position the patient in the sound booth so that speech is presented from in front at 45 and babble from behind at approximately 135 Direct the speech channel one to the loudspeaker at 45 and direct the babble channel two to the loudspeaker at 135 Note There are two possible 45 degree orientations for the patient The desired orientation places the aided ear between the loudspeakers See Figure 3 When the other ear is tested the patient will need to be ro
62. me for CD or microphone testing as described above For the SRT test a word must be selected in the word list by the frequency up 4 or down 5 key When the 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 tally the correct words by pressing the frequency up 4 key and the incorrect words by pressing the frequency down 5 key The next word will be played back automatically The correct word is displayed green while incorrect word is displayed red By pressing Repeat 7 the word will be repeated Once a wave file has been selected the intensity cannot be changed Select the presentation level before selecting Play 7 The percentage of the speech discrimination score is displayed and will be stored in the speech table or audiogram as soon as Store 3 is pressed Press the functional button List 6 to load another word list MCL and UCL measurements are best performed with the Passage wave Tile include with the device Select the ear for testing and Wave as the speech signal A menu will pop up with available word lists which are 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 uncomfortably loud Pres
63. n 2 When in continuous presentation mode the STIM buttons 2 functions as interrupters The light above the Stim button is On if continuous presentation is selected Noise CD and Wave Tile speech signals are always in continuous presentation except when both channels are selected as noise Lock Function Press the LOCK UNLOCK 14 key to activate the interlock function Signals from both channels will be presented simultaneously with the press of only one Stim button 2 Select L amp T 14 to interlock the stimulus presentation of both channels as well as the tracking of the levels Talk Forward Microphone Press and hold the Stim button 8 to activate Talk 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 volume control bars tor Talkback and Monitor are shown Adjust the monitor volume with the right and lett controls 1 Adjust the talkback microphone volume with the plus and minus keys 4 or 5 To store the actual settings press Ok 7 To cancel without saving press Cancel 6 6 2 3 Speech Audiometry To select soeech audiometry select Soeech 18 and SRT or WRS test 13 Note When using Wave Tiles for the SRT test use the frequency up 4 and down 5 key to select a word in the word list and press Play 7 to present the word to the patient For the WRS test the di
64. nal 53 3 46 53 Killian MC Niquette PA Gudmundsen GI Revit LJ and Banerjee S 2004 Development of a quick speech in noise test for measuring signal to noise ratio loss in nonnal hearing and hearing impaired listeners Acoust Soc Am 1 16 4 2395 2405 Killian MC Niquette PA Gudmundsen Gl Revit LJ and Banerjee S 2006 Erratum Development of a quick Speech in naise test for measuring signal to noise ratio loss in normal hearing and hearing impaired listeners J Acoust Soc Am 119 3 Ludvigsen Killion M 1997 Personal communication Martin FN Champlin CA Perez DD 2000 The Question of Phonetic Balance in Word Recognition Testing J Am Acad Audiol 11 9 489 493 Rabinowitz W Eddington D Gelhome L Cuneo P 1892 Relations Among Different Measures of Speech Reception in Subjects Using a Cochlear Implant J An Acousti Sec 92 1869 1881 Rankovic CM 1991 An Application of the Articulation Index to Hearing Aid Fitling J SP Hear Res 34 391 402 Silbiger H 2000 Personal communication Skinner MW 1980 Speech Intelligibility in Noise Induced Hearing Loss Effects of High Frequency Compensation J Am Acoust Soc 67 306 317 Sperry JL Wiley TL Chial M R 1997 Word Recognition Performance in Various Background Competitors J Am Acad Audiol 8 2 71 80 Stockley KB Green WB 2000 Interlist Equivalency of the Northwestern University Auditory Test No 6 in Quiet and Noise with A
65. nates where the results will be store and is set to USB from the factory It is recommended to store PDF results to USB Tor easy transter to a computer Store the Result in the Patient List Enter the User Menu by pressing the functional button 19 and press the button Patient 15 to enter the patient list Enter a new patient by pressing the button New Patient 15 or select a current patient by rotating the dial 1 to highlight the patient name and press 2 to select It is also possible to print a result from the patient list or to create a PDF of the result Select a stored session of a patient in the patient list and press the button PDF 11 or Print 13 In this case the patient information will be included in the PDF or printout Press the New button 7 in the patient list to start a new session New Session To clear and create a new session select the New button 7 from the tone audiometry mode D 0104914 38 8106778 5 MA 42 Operating Instructions 7 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 and the ability to enter the patient list To enter the User Menu press the Menu button 19 on the right side of the display User Menu Date Time Display Brightness Language Figure 18 User Menu Screen To cho
66. nctional 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 printed or stored as PDF on SD memory card or USB flash drive or the patient list can be entered 20 SD memory card slot 21 VU Level meter Note When a Function button Is grey this identities it as an inactive button with the current test set up E g Loa D 0104914 9 8106778 5 MA 42 Operating Instructions 4 3 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 Figure 4 Start Screen Tone Audiometry The frequency is set to 1 kHz and the level of the tone to 30 dBHL for the right channel and O dBHL noise for the lett 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 in the lower area of the audiogram The display has an energy saver function The backlight of the display is automatically dimmed after approximately three minutes Any action with the MA 42 such as pressing a button or rotating the dial switches the backlight immediately on again D 0104914 10 8106778 5 MA 42 Operating Instructions 5 Measurement Methods of Audiometry The patient should sit at a distance of
67. nd present the test signal to the patient The patient response LED lights and a stopwatch counts the seconds as long as the patient response switch is pressed As soon as the patient releases the response switch the level is increased for 5 dB The test stops automatically if the patient is able to hear the tone at the same level Tor 60 seconds or if the level is increased for 30 dB Press Stop 18 to terminate the test manually 5 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 D 0104914 20 8106778 5 MA 42 Operating Instructions of the tone in the better hearing ear is varied until the loudness of the tone is judged by the patient to be equivalent to a tone at a constant intensity in the normal ear This is called loudness balance To start the test select OT Test with the functional selector button 13 choose ABLB then the ABLB test screen will be displayed 50 dBHL Phone 1000 Hz R 0 20 Figure 8 ABLB Screen 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 threshold Present the lett or right Stim button 2 Adjust the level of the hearing impaired ear with the level control 1 until the loudness in both ears matches Press the left or right Sto
68. netic fields e g microwaves or radiotherapy devices can influence the function of the audiometer Therefore the use of these instruments is not allowed in close proximity to the audiometer The test room must be at normal temperature usually 15 C 59 F to 35 C 95 F and the instrument should be switched on about 10 minutes before the first measurement to guarantee precise measuring results If the device has been cooled down e g during transport please wait until it has warmed up to room temperature Caution External devices such as a computer printer or Ethernet which are connected to the device must meet electrical safety requirements such as IEC EN 60601 1 or UL 60601 1 This is to avoid electrical shock to the user or the patient D 0104914 4 8106778 5 MA 42 Operating Instructions 3 4 Rear Panel Connections pp i esetemet tatott IS 1000 0 00000 00 fies 1 2 3 4 5 6 7 8 9101112 13 14 15 16 17 Figure 1 Rearview of the MA 42 7 Talk back microphone socket 16 Phone left channel 8 Mic live voice microphone socket 17 Phone right channel 9 Mon monitor phone output socket 6 Pat patient response switch socket 15 Insert phone right channel Place 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 grounded ou
69. nnnnnnnnnanan 5 How O USE MiS GO nasienia iiien 6 Set up Calibration Presentation Level Test Instructions PracCnCe ISIS scasesnicceeceanaccnnesteaieunes cosanninieass aa a 7 What is SNR NOSS 2 sssssnssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnanan 8 SOONI ioraa aa EEEE a 8 9 Where does the number 25 5 come from saasssssasnsnsnnnnnnnnannnnnnnnnnnnnnnnnannnnnnnnan g The formula for SNR l0SS sssssssssssasnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn g Guilt Free QuickSIN test for ski slope l0SS ssssssssssnsnsnnnnnnnnnnnnnnnnnnonnnnnnnnnnnnns 10 High frequency Lists Low pass Filtered Lists Separated speech and noise channels sssssssssnsassnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnan 11 Directional comparisons ssssssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnnnnnnnnnnnan 11 13 Test development ccccccccsccscceccuecueeeceeceeecceaueeeuueeeesaeeeaueeueeeuuusaeesaueansaceaans 14 18 Original SIN Test SIN Test Format Origin of SIN Test Materials Problems with the SIN Test Background Noise QuickSiN Search for Sentence Equivalence Alpha Versions Beta Version Reliability Statistics made useful ssssssssssnsnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnan 19 20 SCOPE SMEETS manini E 21 23 Lists 1 6 Lists 7 12 Lists 13 18 pairs ANDONGO S ixccadicsaincctsecini tien edna ties asa rate 24 25 RN Ns onr a A a 26 61 8106778 5 MA 42 Operating I
70. nstructions QUICK START or tul instructions see page 6 Connect a CD player to the speech circuit of a standard audiometer Using the calibration tone on Track 1 adjust both channels of the audiometer to read OVU NOTE Except for tracks 24 35 the target speech and background talkers were recorded together on both channels Present the test with earphones or in a sound field with the attenuator dial set to 70 dB HL For subjects with PTA hearing losses greater than 45 dB HL set the attenuator dial to a level that is loud but OK Instruct the patient to repeat the sentences spoken by the target female talker When testing in a sound field have the patient hold the talkback microphone close enough so that responses are clearly audible to the tester e Score the five key words underlined in each sentence giving one point for each word repeated correctly Add the number of words repeated correctly totalled across all 6 sentences subtract the total correct from 25 5 to obtain SNR loss SNR Loss 25 5 Total Correct To interpret the SNR loss score see Table 1 Table 1 SNR LOSS DEGREE OF SNR LOSS EXPECTED IMPROVEMENT WITH DIRECTIONAL MIC 0 3 dB Normal near normal May hear better than normals hear in noise 3 7 dB Mild SNR loss May hear almost as well as normals hear in noise 7 15 dB Moderate SNR loss Directional microphones help Consider array mic gt 15 dB Severe SNR loss Maximum SNR improvement is
71. nted on monosyllabic word lists Monosyllabic words recorded and played back at specific intensity levels are not representative of speech in the real world One drawback of using sentence materials however is that tests which use sentence formats sometimes present an entire sentence to obtain one scorable item i e one word or the entire sentence is scored as correct or incorrect The result is that significantly greater test time is needed for a given reliability compared to word scoring The SIN and ufckSiN tests are words in sentences tasks in which 5 words are scored in each sentence providing a larger amount of scorable material in a given amount of time The sentence materials used in the SIN and QuickS N tests IEEE sentences use words that are typically not highly predictable from the surrounding context resulting in a performance intensity function that is not unlike that obtained with NU 6 monosyllables Rabinowitz et al 1992 Indeed an analysis of the relative independence of these words indicated that 25 words in five sentences using half word scoring give the equivalent of 27 independent words with whole word scoring Origin of SIN Test Sentence Materials The IEEE Institute of Electrical and Electronics Engineers sentences were derived from the Harvard Phonetically Balanced Sentences developed at Harvard University during World War I Braida 2000 The IEEE formed a subcommittee that was charged with develop
72. ose an item trom 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 the sub items or change the setting of the selected item press the Stim button 2 To contirm the changed setting press the Ok button 7 on the left side of the display or press Cancel 6 in order to return to the test screen without any change Note When changes have been made to the menu and saved retart the device to confirm all changes are implemented D 0104914 39 8106778 5 MA 42 Operating Instructions These menu items are available bold reflects default setting Frequency Settings Frequency Frequency roll Standard frequencies Level Default level Level Steps Inverse Dialing Speech level unit Signal Default signal types D 0104914 40 Default frequency Set On Off Set default frequency if side transducer or signal type has changed Back Frequency control jumps to 1000 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 lowest frequency is reached Select deselect Lists available frequencies in device all on On Off Set default level after changing signal type 5 2 1 Change effect on dialing an encoder This will change the direction of rotation of the dial required for increasing or decrea
73. ource as noise 11 or 15 and then pressing the Stim button 8 on the side presenting the noise Note Be cautious to set the noise to an appropriate level prior to selecting Stim 8 and turning on the masking noise to the patient Once the threshold has been established with the introduction of noise press the Store button on either side of the instrument The hearing threshold value will be stored in the audiogram with the corresponding masking symbol The masking sound should be continuously presented for effective masking by pressing the Stim button 2 You can interrupt or turn off the masking signal by pressing the Stim button 2 again D 0104914 14 8106778 5 MA 42 Operating Instructions 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 desired difference for effective masking Press the Track button 14 to implement the automatic masking feature The masking level is automatically changed if you adjust the test signal level e g if the test level is at 30 dBHL and the masking level 50 dBHL and you change the test level to 45 dBHL the masking level will automatically adjust to 65 dBHL 5 1 2 High Tone Audiometry optional When available pure tone hearing threshold of high frequencies from 8 kHz to 16 kHz can be tested The High
74. peech discrimination percentage on the display Use the MODE button 18 to switch between tone and speech mode 6 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 have selected Warble Tone Press the Test signal button 12 to activate the warble tone The LED will highlight Warble Pulse Tone Press the Test signal button 12 to activate the pulse tone The LED will highlight Pulse Overthreshold 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 include the Decay test 9 SISI test 11 ABLB test 13 and MLB test 15 Select the left or right ear and adjust the parameters For the Decay or SISI test press the Start button 19 on the right side of the display to start the test Stop the test by pressing the Stop button 18 on the right side of the display To end the selected test press the Exit button 6 on the left side of the display Tracking Function Press the Track key 14 to activate tracking Both channels will change level when only one attenuator is adjusted D 0104914 36 8106778 5 MA 42 Operating Instructions STIM Mode Selection Press Stim button 8 key to switch between continuous presentation and presentation by pressing the Stim butto
75. r tone audiometry enters a correct answer for word recognition score WRS testing or selects the next word in the word list for soeech recognition threshold SRT testing when the internal Wave Tiles are used 5 Frequency Down change to lower frequency for tone audiometry enters an incorrect answer for WRS testing or selects a previous word in the word list for SRT testing when the internal Wave files are used 6 Monitor allows adjustment of monitor levels and talk back level In the speech screen the input calibration for microphone or CD player can be adjusted D 0104914 7 8106778 5 MA 42 Operating Instructions 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 Tile 8 Channel Stim button Talk to change from presenter to interrupter mode or to talk to the patient by pressing and holding the button down only one Stim Talk button should be pressed for Talk Forward capability 9 Functional selector button to select left right or swap 10 Transducer selector button to choose between Phones Insert Bone and Speaker only calibrated receivers are available for selection 11 Functional selector button function changes based on testing screen i e Tone or Speech Tone signal selector to choose between tone narrow band noise white noise or
76. rage medium SD memory card or USB flash drive chapter 7 Enter the patient list by pressing the Patients button 15 to store the results After printing or creating a PDF you will automatically return to the tone or speech test mode D 0104914 31 8106778 5 MA 42 Operating Instructions 5 6 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 birthdate The demographic patient information can be entered by the level control 1 or a connected USB keyboard Enter the User Menu by pressing the Menu button 19 in the tone or speech audiometry screen Press the button Patients 15 to display the patient list Patient List Pa Patient 012 Patient 011 Patient 010 Patient 009 Patient 008 Patient 007 Patient 006 Patient 005 Patient 004 Patient 003 Patient 002 Patient 001 ustermann Max ID 123456 PDF Print Figure 16 Patient List Select a patient by the level control 1 and press the Stim button 2 to display the stored 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 will only be included on the printout if it is done in the
77. re button 3 Repeat the test for several levels To perform the test at another frequency press the frequency up or down key 4 or 5 A new ladder diagram appears Use the functional selector button 9 or 11 to jump to the previous or next diagram Select 500 ms or 1000 ms as modulation time by the functional selector button 13 To exit the ABLB test screen press the EXIT button 6 5 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 hearing threshold is adjusted until it matches the loudness of the other frequency The patient has to indicate if the loudness of both frequencies is equal D 0104914 2 1 8106778 5 MA 42 Operating Instructions To start the test select OT Test with the functional selector button 13 choose MLB 15 then the MLB test screen will be displayed 60 dBHL MLB 60 dBHL Phone Phone R 1000 Hz 1000 Hz 0 0 20 20 40 40 120 120 aa 2 Ea 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 frequencies to test Adjust the level by the level controls 1 Present the stimulus using the Stim button 2 Press the Store button 3 to save the level of equal loudness Repeat
78. re software controlled allowing easy upgrades of new features and function in the future That means that you have invested in a device that will meet your current and future needs The user manual should make it as easy as possible for you to become familiar with the functions of the MA 42 If you have problems or have ideas for further improvements please get in touch with us Your MAICO team 1 1 Intended Use Statement The MA 42 is a portable or standalone audiometer intended to be used for the identification of hearing loss and the factors that contribute to the occurrence of the hearing loss in patients of all ages It is intended to be used by audiologists ENTs hearing healthcare professionals or other trained technicians in a hospital clinic healthcare facility or other suitable quiet environment as detined in ANSI 3 1 or equivalent 1 2 Essential Performance The following is considered essential performance e To generate and present stimulus signals in the audio range as specified in the applicable IEC 60645 series in normal condition e Record and store patient response D 0104914 1 8106778 5 MA 42 Operating Instructions 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 used for ENT diagnostics and hearing aid fittings in t
79. rticularly important when QuickSIN lists are used to compare two conditions often two hearing aids or hearing aid adjustments In this case the real differences may not be large Table 4 below gives the number of lists required for the comparison between two conditions at an 80 90 or 95 confidence level For a critical difference of 1 9 dB for example four lists are required for each condition at the 95 level For a critical difference of 1 4 dB at the 95 confidence level eight lists are required for each condition For a simple example one list in each condition with the assumed standard deviation of 1 4 dB gives a 95 confidence level of 1 96 x 1 41 x 1 4 3 9 GB To improve from 80 to 95 confidence level at a given criterion requires an approximate doubling of test time Example Two lists in each condition gives a 1 8 dB critical difference at the 80 confidence level four lists in each condition provide 1 9 dB at the 95 confidence level and five lists in each condition provide 1 7 dB at the 95 confidence level Table 4 Lists per Condition 1 2 3 4 5 6 7 8 9 959 C D in dB 3 9 2 7 2 2 1 9 1 7 16 1 5 1 4 1 3 90 C D in dB 3 2 2 2 1 8 1 6 14 13 12 11 1 1 80 C D in dB 2 5 1 8 1 5 1 3 1 1 1 0 1 0 09 0 8 When comparing HFE and HFE LP conditions for a patient with ski slope loss one might well accept an 80 confidence level one in five chance of being wrong and consider anything less than 1 5 dB as not practical
80. s we have a simple method for estimating SNR 50 using nothing more than the total number of words correct In the Tillman Olsen method two spondees are presented at each level starting at a level where all spondees are repeated correctly and decreasing in two dB steps until no responses are obtained for several words The starting level plus 1 dB minus the total number of spondees repeated correctly is the spondee threshold The simple arithmetic comes from the use of 2 dB steps and 2 words per step If the audiometer only has 5 dB steps the corresponding method would use 5 words per step and take the starting level plus 2 5 dB half of the step size just as in the case of 2 dB steps minus the total number of spondees repeated correctly The QuickSiN has five words per step and 5 dB per step Qur highest SNR is 25 dB so we take 25 2 5 27 5 minus the total number of words repeated correctly This gives what we call SNR 50 the signal to noise ratio required for the patient to repeat 50 of the words correctly For example if someone repeats all the words correctly down to 15 dB SNR and then misses everything beyond that point they gave 15 correct responses five each at 25 20 and 15 dB SNR Since they scored 100 correct at 15 dB SNR and 0 correct at 10 dB SNR their SNR 50 would be about 12 5 dB halfway between 15 and 10 This is the value given by the formula 27 5 15 12 5 dB THE FORMULA FOR SNA LOSS Since SNA 50 for normal h
81. s Store 3 to save the results 5 2 5 Masking Speech audiometry has similar masking rules to those described in chapter 5 1 1 1 for pure tone audiometry The signal of the non testing ear is set to speech noise SN instead of narrowband noise by the functional selector button signal 11 or 15 This channel needs to be set to interrupter mode by pressing the channel Stim button 8 for continuous presentation of the masking noise Adjust the level of the masking channel by the corresponding level control 1 for effective masking 5 2 6 Speech in Noise Tests When performing speech in noise tests soeech and noise are given simultaneously in two channels but in the same ear The speech source can be provided by a microphone Wave Tiles or an external CD player Select the signal D 0104914 28 8106778 5 MA 42 Operating Instructions source on one channel button 11 or 13 and speech noise SN on the other channel To present the speech in noise in the same ear the noise channel has to be routed to the same ear the speech channel button 9 or 17 Please make sure that the speech is presented in interrupter mode 8 in order to present both Signals simultaneously Speech in noise test the QuickSIN 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 Tile lists 11 or 15 The complete QuickSIN
82. s appropriate to be repaired in the field No adverse effects have been reported trom the materials used in this device based on 50 plus years of use with many different patient populations The operation of the device can be safely terminated by using the power switch found on the rear of the device or by disconnecting the power cable D 0104914 5 8106778 5 MA 42 Operating Instructions Appendix A Checklist for Subjective Audiometer Testing Clean the ear and head cushion Instrument Untangle all lines when necessary Manufacturer Are the headphone cushions in good Serial No condition Examiner If not gt replace Are plugs and leads in good condition undamaged Are all controls working properly Is the Patient Response Key working properly if available Check batteries and renew if necessary Test Signal Quality All the test frequencies in the below table indicate typical hearing level and can be changed when necessary Masking B for Buzz tone G for Noise V for signal distortion S tor switching masking noise Rotta e e evel Left Ear rea ie GS NS 025051 2 B A ie B khz OS S S S f f f Bom f ee eee S S S S f f f oda f S S S S oo OS S S S S S y poa S S S S S S S ee OS S S S S f f podm f S S S S S S So o i bosu tT Tt When noise B G V or S is blocked inform the service center When the test tone is heard at hi masking
83. s what it sounds like to have a hearing loss and try to listen in a noisy place 14 8106778 5 D 0104914 MA 42 Operating Instructions QuickSiN Search for Sentence Equivalence Alpha Versions The original SIN Test used the first 360 sentences lists 1 36 of the 720 IEEE sentences The QuickSiN sentences were selected from among the remaining 360 sentences lists 37 72 and were re recorded along with the four talker babble on separate tracks of an eight track digital recorder Thus all subsequent re recordings of a given sentence had the same time locked sequence of babble This was important because the conversational ebb and flow of the natural conversational speech produced by the four babble talkers meant that the overall noise level varied from moment to moment Moreover not all of the IEEE sentences are equivalent in terms of difficulty In order to determine the SNR 50 of each sentence n its accompanying Dabble segment IEEE sentence lists 37 72 were recorded on the Alpha 1 version set of three CDs at nominal signal to noise ratios of 1 2 and 5 dB The sentences were presented to sixteen normal hearing subjects at 70 dB HL via ER 3A insert earphones The three signal to noise ratios 1 2 and 5 dB were presented in that order An across subject average SNR 50 was obtained for each sentence This value was used to adjust the SNR on a sentence by sentence basis to an expected value of 2 dB the grand average value
84. sed by 1 dB for a period of 0 2 seconds every 4 8 seconds Whenever the increment is heard the patient has to press the response switch The MA 42 calculates the percentage of detected increments The SISI test information and the test score are shown on the LCD display The test will end automatically after 20 presented increments The score is expressed as a percentage of ratio of the increments heard to the delivered increments all increments heard 100 and no increments heard 0 A high score indicates a cochlear impairment A low score is related to normal hearing or conductive or retrocochlear pathology D 0104914 1 8106778 5 MA 42 Operating Instructions 5 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 60 dBHL 1000 nz Phone Increment 1 dB Given 1 Recognized 0 Result 0 i j a Eee Figure 6 Start Screen SISI Test Select the test frequency with the frequency keys 4 5 For the test you should choose the frequency where the maximum bone conduction hearing loss is measured as described in chapter 5 1 3 Adjust the test intensity with the level control dial 1 to a value of 20 dB above the individual hearing threshold Recognize that in the SISI mode the test is presented continuously You can interrupt the test by pressing the Pause 9 button Press Start 19 to resume the test 5 1 7 2 Training of the Pati
85. sing the level of the signal Dial Up Dial Down dBSPL dBHL select the level unit for speech signals Defines which signals are selected by default Signal Noise or Signal Signal 8106778 5 MA 42 Operating Instructions Noise PTA Pure Tone Audiometry CD Channel D 0104914 Swap function Display of the left and right ear Presenter Duration Interrupter Presenter Mode Pulse Interrupter Presenter Select the CD Channel 41 Defines what happens if Swap is selected 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 Same left dial controls level of the left ear right dial controls the level of the right ear Interchanged left and right dial controls the level of the opposite ear Unlimited signal is presented as long 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 Default presenter or Interrupter mode 500 ms slow pulsing 250 ms fast pulsing Default presenter or interrupter mode Select deselect frequencies for the calculation of the PTA value for the default transducer 500 1k 2k Both Channel A Channel B 8106778 5 MA 42 Operating Instructions Store Properties Default Transducer Monitoring Tests Printer Settings PDF Save Option Device Information
86. splay shows the percentage of correctly repeated words once this is scored To count the word correct press one of the frequency up 4 keys To count the word wrong press one of the frequency down 5 keys To clear the counter press the Reset key 7 on the left side of the display D 0104914 3 8106778 5 MA 42 Operating Instructions 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 display and the calibration screen appears Play the reference signal with CD or talk into the microphone Use the left or right level control 1 and adjust the levels until the VU meter show all yellow and one green light If one or more red lights are on reduce the level using the corresponding dials 1 Store the calibration and leave the calibration mode with the Ok 6 button on the left side of the display 6 2 4 Documentation of the Results Printout Enter the User Menu by pressing the functional button 19 and press the button Print 13 to printout the results Store Results as PDF Enter the User Menu by pressing the functional 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 configuration desig
87. structions WHAT S ON THIS CD The QuiekSIN CD contains lists of sentences in noise 4 talker babble that can be used to determine SNR Loss signal to noise ratio loss Each list takes about one minute to administer There are eight blocks of recordings on this CD 12 standard equivalent lists for basic SNR Loss testing e 3 pairs of standard lists additional list pairs for research e 3 practice lists not equivalent to lists 1 12 for practice only e 12 lists with speech on channel 1 and constant level babble on channel 2 separated to demonstrate directional microphone effectiveness e 12 lists recorded with 30 dB high frequency emphasis HFE for use with ski slope losses 2 pairs of HFE lists additional list pairs for research e 12 lists recorded with 30 dB HFE and low pass filtering HFE LP for use in combination with the HFE lists to determine whether hearing aids with extended HFE will help or degrade speech intelligibility in noise 2 pairs of HFE LP filtered lists additional list pairs for research TRACKS Track 1 1 kHz calibration tone Track 2 Identification Tracks 3 14 Standard QuickSIN lists 1 12 These twelve lists are equivalent Tracks 15 20 List pairs Lists 13 14 15 16 and 17 18 Tracks 21 23 Practice lists A B and C These lists are for practice only and are not equivalent to the standard lists or list pairs Tracks 24 35 Lists 1 12 recorded with sentences on channel 1 and const
88. t Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short Interruptions and Voltage Variations on Power Supply Lines IEC 61000 4 11 Power Frequency 50 60 Hz IEC 61000 4 8 IEC 60601 Test Level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec Compliance 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec Note UT is the a c mains voltage prior to application of the test level D 0104914 90 Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be greater than 30 Mains power quality should be that of a typical commercial hospital or residential environment Mains power quality should be that of a typical commercial hospital or residential environment Mains power quality should be tha
89. t Bone or Speaker only calibrated receivers are available by the receiver select button 10 16 Toggle to the required signal by the selector button 11 or 15 to MIC CD Wave 5 2 3 Speech Audiometry with Microphone or CD Player Connect the microphone or CD player to corresponding input on the rear side of your MA 42 Set the signal of the test channel to microphone or CD by the functional selector button 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 closed set of spondaic words at a level loud enough for them to hear and understand Begin the test and decrease the level as the patient repeats the word Once the threshold has been found press the Store button 3 to save the result For the WRS test the level remains fixed and correct or incorrect answers are entered by the frequency plus 4 and minus 5 button Once the word list has been completed by the patient press the Store button to save the established WRS score To clear the word counter press the Reset key 7 on the left side of the display If MCL is selected the level is increased until the patient indicates the level is comfortable to listen to Store the value by pressing the Store button 3 For the UCL testing the level is increased until the patient indicates the level is uncomfortable and the result can be
90. t of a typical commercial hospital or residential environment If the user of the MAICO MA 42 requires continued operation during power mains interruptions It is recommended that the MA 42 be powered from an uninterrupted power supply Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 8106778 5 MA 42 Operating Instructions Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAICO MA 42 is intended for use in the electromagnetic environment specitied below The customer or the user of the MA 42 should assure that it is used in such an environment Immunity Test IEC 60601 Test Electromagnetic Environment Guidance Level Portable and mobile RF communications Conducted RF 3 Vrms 150 kHz equipment should be used no closer to any part IEC 61000 4 6 to 80 MHz of the MA 42 including cables than the recommended separation distance calculated Radiated RF 3 V m 80 MHz to from the equation applicable to the frequency of IEC 61000 4 3 2 5 GHz the transmitter Recommended separation distance d 1 17VP d 1 17VP 80 MHz to 800 MHz d 1 17VP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field Strengthens from fixed RF transmitters as determined by an electromagnetic site survey
91. tated to face the opposite wall and the speech and babble switched to the opposite speakers D 0104914 70 8106778 5 MA 42 Operating Instructions Directional Comparisons Continued Figure 3 Figure 4 D 0104914 71 8106778 5 MA 42 Operating Instructions lf the loudspeakers are located at O and 180 you may test each ear separately or both ears together Position the patient in the sound booth so that speech is presented from in front at O and babble from behind at 180 See Figure 4 Since the babble noise on Tracks 24 35 is at a constant level two types of demonstrations are possible 1 Subjective Calibrate both channels Have the patient set the hearing aid s to OMNI Adjust the speech to 50 dB HL 65 dB SPL conversational speech level and then adjust the noise to the level where the patient reports that it just prevents understanding the speech Have the patient switch back and forth between OMNI and Directional positions on the hearing aid s The improved intelligibility in the directional mode should be obvious 2 Objective Calibrate both channels Set the dial for channel one front speaker to 50 dB HL Set the dial for channel two to 25 dB HL for the first sentence and increase the dial setting for channel two babble by 5 dB for each succeeding sentence see Table 2 Score each list as before to obtain SNR Loss Test in OMNI and Directional A minimum of three lists in each condition six total is requir
92. ted increments The number of detected increments Is counted and indicated as percentage of the presented increments The result is only stored if a minimum 10 increments has been presented If you are sure that the result of the test is consistent you can abort the test at any time by pressing the Stop 18 button The result is then indicated accordingly Retrocochlear hearing impairment is represented by low scores lt 25 cochlear detects by high scores gt 70 Press the EXIT 6 button to leave the SISI test D 0104914 19 8106778 5 MA 42 Operating Instructions 5 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 Test Make sure that the correct transducer is selected in advance as you cannot change transducers in this screen 30 dBHL 1000 uz Phone 10 20 30 40 Figure 7 Start Screen Decay Test Select left or right ear 9 and the test frequency with the frequency keys 4 5 Adjust the test level with the intensity control dial 1 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 switch as soon as the tone Is no longer heard Press Start 19 to begin the test a
93. the STIM button the blue part next to the attenuator knobs 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 that the hearing level exceeds 100 dBHL The warning prompt disappears after approximately 1 second As long as the prompt is visible on the display no further entries can be made Once a threshold value is established press the Store 3 key in order to store the threshold The appropriate symbol will be plotted on the audiogram If the patient is not responding the current value can be marked as no response by holding the store button pressed for 3 seconds Once all frequencies are tested choose the poorer ear and repeat the hearing threshold test Pulse Tone If required the test can also be performed with a pulsed tone 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 tone will frequency modulate The warble tone can also be pulsed by selecting P amp W 12 Noise The signal may be changed from a pure tone to narrow band noise or white noise by pressing the signal key 11 15 underneath the display whichever one corresponds to the current test channel This will
94. the device for further evaluation and documentation Results can be printed directly by a USB connected printer or stored as a PDF Tile on the included SD memory card or USB flash drive The MA 42 can be connected to the PC via USB to track the session and store the results in NOAH or the MAICO Database In order to remain current with present and future technologies the MA 42 is compatible with PCs easy to use extremely reliable and is adaptable to future developments It is also designed to be easily serviced as the need arises Automatic test programs make troubleshooting and the yearly calibration as effortless as possible The soeaker outputs can also be used as line level outputs for an external amplifier or active speaker Contacting your authorized service center will allow a change to line output levels D 0104914 2 8106778 5 MA 42 Operating Instructions 3 Getting Started 3 1 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 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 OR CALIBRATION Notify the carrier immediately if any mechanical damage is noted This will assure that a proper claim is made Save all packing material so th
95. the device trom power 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 Clothe Active wipes or a comparable product and allow them to take effect for the duration related to the specific disinfection aim listed in product data sheet of the disinfection product Please follow also its instructions for cleaning e Wipe before and after each patient e After contamination e After infectious patients Disinfect computer keyboard transport trolley etc with Sani Cloth Active Wipes e once a week e after contamination e when polluted To avoid damage of the device and its accessories please mind the following Do not autoclave or sterilize Do not use the device in the presence of fluid that can come into contact with any of the electronic components or wiring Should the user suspect fluids have contacted the system components or accessories the unit should not be used until deemed safe by a MAICO certified service technician D 0104914 46 8106778 5 MA 42 Operating Instructions 9 Device Update Insert the SD memory card into your computer and copy the update Tile MaicoMAA4xseries CAB to the SD memory card Switch off the MA 42 and insert the SD memory card into the MA 42 and switch the device on The update will be installed automatically Wait until the update is finished and follow the instruction Remove the SD memory c
96. the procedure for several different levels To compare the loudness of further frequencies press the frequency up 4 or down button 5 a new ladder diagram will appear Use the functional selector button 9 or 11 to jump to the previous or next diagram Select 500 ms or 1000 ms as modulation time by the functional selector button 13 To exit the MLB test screen press the Exit button 6 5 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 the Stenger test and setup the audiometer to presetn a tone in both ears 9 11 15 17 Instruct the patient to press the response button 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 the indicated threshold the patient may ignore this tone Present the tones simultaneously by pressing the lock functional button 14 and the Stim Mode button 8 to set it to interrupter mode If the patient responds it D 0104914 22 8106778 5 MA 42 Operating Instructions is a negative If the patient does not respond it is a positive Stenger indicating that the tone is heard in the poorer ear and the patient is ignoring the stimulus 5 1 12 Langenbeck The Langen
97. tion is useful For a test accurate to 1 9 dB 95 confidence interval for the difference between the two conditions four HFE and four HFE LP lists are required a total of 8 independent lists used alternately Example Track 36 list 1 with HFE and Track 53 list 2 with HFE LP Track 38 list 3 with HFE and Track 55 list 4 with HFE LP Track 40 list 5 with HFE and Track 57 list 6 with HFE LP Track 42 list 7 with HFE and Track 59 list 8 with HFE LP Note The same list is never used twice in this example 69 8106778 5 MA 42 Operating Instructions SEPARATED SPEECH amp NOISE CHANNELS Tracks 24 35 contain the 12 standard uickS N lists recorded with the speech and noise on two separate channels target speech on channel one and 4 talker babble on channel two The purpose of these lists is to provide a quick way to verify the effectiveness of hearing aids that have switchable directional microphones On these tracks both speech and babble were recorded at constant levels therefore the tester must establish and control the signal to noise ratios by selecting the presentation levels for both speech and babble channels and manually change the level of the babble channel for each sentence to adjust the signal to noise ratio Directional Comparisons A complete measurement of a directional hearing aid requires extensive laboratory facilities but a good demonstration of the ability of directional hearing aids to reject sound fro
98. tlet Turn on the instrument with the power switch which is located at the right side of the MA 42 Note A device should always be off when inserting or removing an accessory from the rear panel connectors The device performs its initialization and auto calibration Please wait until the test screen appears this can take up to 60 seconds If an error is detected the test is stopped and a description of the error is shown on the display In this case please contact your local dealer or service D 0104914 5 8106778 5 MA 42 Operating Instructions 4 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 trom the top or the side of the instrument The instrument s default setting is in 5 dB steps and can be adjusted to 2 dB or 1 dB steps as needed Figure 2 Control Buttons The ergonomic design of the MA 42 makes it easy to control the dB level signal presentation and frequency with one hand The Stimulus presenter buttons 2 are the large blue button next to the dial Store buttons 3 are located beside the lett and right level control dials 1 and labeled with an S With the Stim button 8 you can change trom presenter to interrupter mode The corresponding LED lights up when a signal is presented The frequency is changed with the Plus 4 and Minus 5 buttons for bot
99. ts available for some clinical comparisons and research purposes Bentler 2000 Some subjects could not attain a 50 correct score even at the best 15 dB signal to noise ratio Background Noise The choice of background noise is an important component of any test The purpose of the SIN test was to obtain an estimate of difficulty hearing in noise that is representative of real world performance Sperry Wiley amp Chial 1997 found that a meaningful speech competitor had a significantly more adverse effect on word recognition performance compared to non meaningful competitors e g shaped noise or backward multitalker While the spectrum and masking effects of speech shaped noise are much easier to control speech shaped noise is not representative of the type of noise encountered by normal hearing persons in their everyday environments The SIN and QufckS N tests use a four talker babble recording Auditec of St Louis with one male and three females The four talker babble represents a realistic simulation of a social gathering in which the listener may tune out the target talker and tune in one or more of the background talkers It provides a good representation of the difficulty that patients face the situation in which what they want to hear is speech and what they don t want to hear is also speech During the QuickSin test development research subjects frequently commented This is what it sounds like to me this i
100. u may present the test either monaurally or binaurally Most normative data were collected using binaural presentation Calibration Using the 1 kHz calibration tone on Track 1 adjust the audiometer so that the VU meter reads 0 Some audiometers have two VU meters one for each channel When presenting the test via loudspeaker it is only necessary to set the VU meter for the channel being directed to the loudspeaker When presenting the test via earphones it may be necessary with some audiometers to adjust both VU meters NOTE Tracks 24 35 were recorded with speech on one channel and babble on the other When using these tracks calibrate both channels Presentation Level For pure tone average PTA lt 45 dB HL set the attenuator dial to 70 dB HL For PTA of 50 dB HL or greater set the attenuator dial to a level that is judged to be loud but OK The sound should be perceived as loud but not uncomfortably loud See Appendix A The practice lists on Tracks 21 23 can be used to determine the correct presentation level Test Instructions Imagine that you are at a party There will be a woman talking and several other talkers in the background The woman s voice is easy to hear at first because her voice is louder than the others Repeat each sentence the woman says The background talkers will gradually become louder making it difficult to understand the woman s voice but please guess and repeat as much of each senten

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