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Operating Instructions MA 41

1. D 0106002 61 8120525 2 Operating Instructions MA 41 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 represented 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 corr
2. 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 6 The dry wax protects the deep scratch SAN D eee 6 Twist the valve and release hot steam rd 25 5 TOTAL _____ SNR loss TOTAL ____ D 0106002 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 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 da
3. TOTAL _ List 4 TRACKS 6 27 39 55 oo A wee 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 2090 gt WIAL _ __ 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 69 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 WN 25 _ yN 20 oN 15 ON 10 __ yN 5 S N 0 TOTAL Score Score SN 25 S o S N 20 ___ S N 15 _ ONTO S N 5 S N O TOTAL __ S N 25 ___ oN 20 WN 1S ON TWO SNS SN O TOTAL __ Score 8120525 2 Operating Instructions MA 41 LISTS 7 12 List 7 TRACKS 9 30 42 58 1 The kite dipped and swayed but stayed al
4. audiometer Therefore it is not recommended to the use these instruments in close proximity to the audiometer as it may lead to incorrect test results The test room must be at a normal temperature usually from 15 C 59 F to 35 C 95 F and the instrument should be switched on approximately 10 minutes before the first measurement If the device has been cooled down e g during transport please wait until it has warmed to room temperature before using 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 0106002 4 8120525 2 Operating Instructions MA 41 3 4 Rear Panel Connections looo 00000 IPPP PPPOE ICAI 1 2 345 6 7 8 910 1112 13 14 15 16 1 Figure 1 Rear View of the MA 41 9 Monitor phone output socket Lo o oS O Place the MA 41 on a stable counter or table Plug the power cord into the power socket on the rear panel Connect all accessories with the appropriate sockets as shown above Plug the power cord into a grounded outlet Turn on the instrument with the power switch which is located on the rear panel of the MA 41 The device will perform its initialization and boot up Please wait until the test screen appears this can take up to 60 seconds If an error is detect
5. x 3 2 1 5 kg 2 7 lbs 100 240 V 50 60 Hz 10 Approximately 60 VA 2 x 1A slow blow 43 8120525 2 Operating Instructions MA 41 345 1 2 6 7 8 910 1112 13 14 15 16 17 Figure 19 Connection Sockets of the MA 41 Connection sockets On Off Power Network USB out USB in Patient response switch Talk Back Microphone NOUR WN 8 Mic Microphone 9 Monitor phone 10 CD Input 11 Speaker lett 12 Speaker right 13 Bone bone conductor 14 Insert phone left 15 Insert phone right 16 Phone lett headphone 17 Phone right headphone D 0106002 Specification Power 100 240 V 50 60 Hz Ethernet USB 2 0 USB 2 0 R 500 Q Zi 1 kQ U 0 38 500 MVeff Zi 1 kQ Ul 0 38 500 MVeff ZA 250 Q Ua 8 Veff Zi 47 kO U 0 04 5 Veff ZA 4 Q Ua 8 Veff ZA 4 Q Ua 8 Veff ZA 4 Q Ua 8 Veff ZA 10 Q UA 1 Veff ZA 10 Q UA 1 Veff ZA 10 Q UA 1 Veff ZA 10 Q UA 1 Veff 8120525 2 Operating Instructions MA 41 Standard Accessories DD45 Headphones Patient Response Switch Adaptor Stereo 1 8 to 1 4 Optional Accessories D 0106002 45 8120525 2 Operating Instructions MA 41 13 Warranty Maintenance and After Sales Service The MAICO MA 41 is guaranteed for 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 workm
6. 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 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 equival
7. D 0106002 23 8120525 2 Operating Instructions MA 41 5 6 Patient Management The patient management option allows the results of the audiological tests to be stored on the SD memory card The results can be reloaded at a later time to be reviewed edited or printed Patients can be stored by a number ID or by entering the name and birth date The demographic patient information can be entered using the level controls 1 or a connected USB keyboard Enter the User Menu by pressing the Menu button 17 in the tone or speech audiometry screen Press the button Patients 15 to display the patient list To comply with patient privacy laws the option to add a PIN code for entry to this list has been offered To activate this feature press the New Patient button 15 followed by the Login button 15 Enter the desired 4 digit PIN using the level control dials 1 and the Stim button 2 Once the 4 digits have been entered press the Set button 9 and the device will return to the patient list Moving forward the PIN will be required to enter the patient list To deactivate the PIN select Login Off after following the same steps as listed above Patient List Finke Lena 14 03 2003 ID 245224 Session 16 01 2012 Hirsch Franziska 27 02 1997 ID 254478 Kalman Nadine 30 11 1986 ID 215442 Kant Frida 21 01 1985 ID 124555 Katharina Nolte 10 01 1981 ID 246785 Lange Elias 16 01 2008 ID 221542 Maico Mike 01 01 1937 ID 12345
8. L amp T 14 to interlock the stimulus presentation of both channels as well as the tracking of the levels STIM Mode Selection Press STIM MODE 8 key to switch between continuous presentation and presentation by pressing the STIM button 2 When in continuous presentation mode the STIM buttons function as interrupters The light above the STIM MODE key is on if continuous presentation is selected CD and Wave speech signals are always in continuous presentation Talk Forward Microphone Press and hold the STIM MODE 8 to activate Talk Forward Adjust the level by turning one of the attenuator dials 1 while in the mode Talkback Microphone and Monitor Volume Control Press the Monitor key on the left side of the display and the volume control bars for talkback and monitor are shown Adjust the monitor volume with the right and left dials 1 Adjust the talkback microphone volume with the plus minus keys 4 or 5 To store the actual settings press OK 19 D 0106002 2 8120525 2 Operating Instructions MA 41 6 2 3 Speech Audiometry To select soeech audiometry select Soeech 16 and the test SRT or WRS 13 Use the frequency up 4 and down 5 key to select a word in the word list For the WRS test the display shows the percentage of correctly repeated words To count the word as correct press the trequency key 4 up To count the word as incorrect press the frequency key 5 down To clear the counter press the Rese
9. 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 lists 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 representat
10. Operating Instructions MA 41 Sound field speaker from MA 41 using SP90 Speaker Kit Tones 10 dBHL 90 dBHL Speech 10 dBHL 70 dBHL Test Signal Pure tone Pulse tone Warble tone Masking Signals Narrow Band Noise 5 12 Octave filter with the same center frequency resolution as pure tone Speech Noise 125 to 6 000 Hz falling 12 dB octave above 1 kHz 5 dB Modulation Pulse Tone 0 25 0 5 s on time Warble Tone 5 sinus frequency modulation repetition rate 5 Hz Tests Tone HL UCL Speech SRT WRS UCL Patient Response Monitor Communication Data Connection D 0106002 Handheld response switch Build in monitor speaker headset Talk forward and talk back USB LAN Ethernet 42 8120525 2 Operating Instructions MA 41 External Devices Stimulus Functions Warm up Time Mode of Operation Environment Conditions Dimensions Weight Power Supply Power Consumption Device Fuses D 0106002 USB keyboard CD player Supported USB printers 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 Less than 10 min after power on Continuous 15 35 C 59 95 F operation 5 50C 41 122 F transport Humidity 30 90 W x D x H 34 5 x 20x8cm 13 4 x 7 9
11. 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 D 0106002 56 8120525 2 Operating Instructions MA 41 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 thresholds 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
12. are software controlled allowing for easy upgrades of new features and functions in the future The user manual should make it as easy as possible for you to become familiar with the functions of the MA 41 If you have questions or ideas for further improvements please contact us Your MAICO Team 1 1 Intended Use Statement The MA 41 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 the age range of children to adults It is intended to be used by audiologists ENTs hearing healthcare protessionals or other trained technicians in a hospital clinic healthcare facility or other suitable quiet environment as defined 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 a patient response D 0106002 8120525 2 Operating Instructions MA 41 2 Description The MA 41 is a portable one and halt channel audiometer with pure tone speech and optional sound field audiometric testing Additionally it has limited special audiology test capabilities such as Stenger and Master Hearing Aid It can be used as a portable audiometer or a desktop unit for ENT diagnostics hearing aid fittings in the office and tor mobile audiom
13. as a Standalone instrument Do not use the MAICO MA41 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 trom mobile phones etc If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears D 0106002 70 8120525 2 Operating Instructions MA 41 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 3 CAN CSA C22 2 No 60601 1 Medical Electrical Equipment Part 1 General Requirements tor Safety Electrical Equipment tor Laboratory Use 4 IEC EN 60601 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems 5 IEC EN 60601 1 2 Medical Electrical Equipment Par
14. 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 required 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
15. ear for testing 9 Press the function button Play 7 to start the presentation to the patient Rotate the attenuator wheel 1 to increase the volume until the patient reports this is uncomfortable loud Press Store 3 to save the results 5 2 5 Masking Speech audiometry masking can be used in the same manner as described in chapter 5 1 1 1 for pure tone audiometry Instead of narrowband noise speech noise SN is applied when masking is turned on Masking noise is activated in the non test ear by pressing the function button Masking On Off 15 Adjust the level of the masking channel by the corresponding level control 1 for effective masking D 0106002 20 8120525 2 Operating Instructions MA 41 5 2 6 Master Hearing Aid MHA The Master Hearing Aid MHA feature utilizes input signals trom the Live Voice Mic external CD MP3 player or with the wave Tiles These signals are then filtered by various high pass filters to simulate a hearing aid Begin by selecting a signal source in the speech mode with the function button 11 Start the MHA function by pressing the Test Selection button 13 When using wave Tiles begin testing by pressing the Play button 7 to play back the imbedded wave files Press the stimulus mode 8 indicator to alternate between signal sources like the microphone or the CD Change the dB presentation levels with the level control dials 1 and control the filtering options by using the frequency Up 4 an
16. ends at about 2 5 kHz gives as good or better scores the clinician can abandon the feedback fight without guilt D 0106002 68 8120525 2 Operating Instructions MA 41 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 wall 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 __ _ SSN loss D 0106002 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 ONT ONTO ONG VNO
17. 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 can be entered by the Frequency Plus 4 and Frequency 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 6 on the left side of the display If no counter is set the Reset key 6 is displayed grey For the UCL testing the level is increased until the patient indicates the level is uncomfortable and the result can be saved by pressing the Store button 3 5 2 4 Speech Audiometry with Wave Files If Wave is selected by the speech signal selector 11 a menu will pop up with the available word lists stored on the SD memory card A word list can be selected by using the level controls 1 to scroll through the list A list can be loaded by pressing the Stimulus button 2 The word list will then be displayed on 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 function button Play 7 to Start Once the spee
18. presentations of the same lists D 0106002 65 8120525 2 Operating Instructions MA 41 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 available 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 0106002 66 8120525 2 Operating Instructions MA 41 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 confid
19. 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 D 0106002 52 8120525 2 D 0106002 Operating Instructions MA 41 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 pai
20. the display as well as the type of the function buttons shown on the display The display has an energy saving function the backlight of the display is automatically dimed after approximately three minutes Any action with the MA 41 such as pressing a button or rotating the dial will immediately illuminate the backlight D 0106002 9 8120525 2 Operating Instructions MA 41 5 Measurement Methods of Audiometry Remove any obstructions that will interfere with the earphone cushion placement over the ear e g hats eyeglasses Always use the headphones with appropriate padded ear cushions Ensure the headphones are placed correctly over the patient s ears and that the red is over the right ear and the blue is over the left ear Adjust the headband of the headphones so that the receivers are at the correct height the sound output grid on the inside of the headphone should be directly over the ear canal Ask the patient to press the button on the patient response switch when the tone is heard even if it is barely audible For hygienic reasons it is important to disinfect the ear cushions on the headphone between patients see chapter 8 5 1 Tone Audiometry The MA 41 supports tone audiometric testing methods The following testing methods can be started in the tone audiometry mode and the results can be saved to the instrument Air conduction testing Bone conduction testing Sound field testing Pure tone hearing threshold U
21. 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 needed Consider FM system D 0106002 51 8120525 2 Operating Instructions MA 41 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
22. 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 hearing 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 0106002 5 8120525 2 Operating Instructions MA 41 GUILT FREE QuickSiIN TEST for ski slope loss High Frequency
23. 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 meter from the device Additionally any obstructions which may interfere with the placement of the earphone cushions on the ear i e hair eyeglasses should be removed 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 should be placed directly over the ear canal Select the ear to be tested by pressing Right Left or Both by the function button 9 on the control panel underneath the screen 30 dBHL MIC SRT Off dBHL Phone Phone Speech Test Figure 8 Speech Test Screen Next select the transducer to be used Phones Insert or Soeaker by pressing the Transducer button 10 Toggle to the required signal by the selector button 11 to MIC CD Wave D 0106002 18 8120525 2 Operating Instructions MA 41 5 2 3 Speech Audiometry with Microphone or CD player Connect the microphone or CD player to the corresponding input 10 Select the test ear 9 and MIC or CD as signal source by the function button 11 Make sure that the input signal is calibrated correctly as described above Select the test SRT WRS or UCL with the function button 13 For the SRT test familiarize the patient with a closed set of soondaic words at a level loud enough for them to
24. 02 36 8120525 2 Operating Instructions MA 41 9 Device Update Insert the SD memory card into your computer and copy the update file MaicoMAA4xseries CAB to the SD memory card Switch off the MA 41 insert the SD memory card into the MA 41 and then switch the device on The update will be installed automatically Wait until the update is finished and follow the instructions Remove the SD memory card from the MA 41 it will boot up normally Following the update please use your computer to delete the update file from the SD memory card in order to have normal use of the card D 0106002 3 8120525 2 Operating Instructions MA 41 10 Connection to the PC Install the included software on your PC This will allow you to use your device with NOAH and the MAICO Database The driver for the device will be installed automatically Connect the MA 41 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 you how 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 curent 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 e
25. 0525 2 Operating Instructions MA 41 14 5 Warnings and Statements No modification of this equipment is allowed Maico will make available instructions and diagrams to repair devices that it deems 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 0106002 48 8120525 2 Operating Instructions MA 41 Appendix A QuickSIN Speech in Noise Test Manual QuickSIN is a trademark of Etymotic Research Inc Reprinted with permission from Etymotic Research Inc D 0106002 49 8120525 2 Operating Instructions MA 41 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 MiS GD siipra aR Aiai 5 How bo use MiS GD iniinom 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 fro
26. 3 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 kHz cal tone 8120525 2 Operating Instructions MA 41 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 you 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 necess
27. 6 Marc Walter 14 11 2001 ID 2525245 Pfeifer Albert 01 04 2005 ID 221133 Scheman Hans 05 03 2009 ID 223311 Treindl Gabriel 17 12 1986 ID 204795 Figure 12 Patient List Select a patient using the level controls and press the Stimulus button 2 to display the stored sessions Select a session and press the PDF button 11 to save 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 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 automatically a new numbered patient with a new D 0106002 24 8120525 2 Operating Instructions MA 41 number will be selected Just press the Save button 9 to save the current session to the new patient number To save the results to an existing patient select a patient by the level controls and press the Save button 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 New Patient 23 07 2012 Figure 13 New Patient Enter the characters of the name by scrolling through the alphabet with the level controls and enter the selected character by using the Stimulus button 2 Ju
28. 7a Monitor Settings Figure 7b Input Calibration On every CD with speech test material there is a reference signal such as a reference tone or speech simulating noise Play back the reference signal with the CD Use the lett or right level control 1 and adjust the levels until the VU meter 19 shows all yellow lights and one green light If one or more red lights are on reduce the level using the level control dial 1 To calibrate the microphone for live voice testing select MIC with the signal selector key 11 Press the Monitor button 6 and then InCal 17 and the calibration screen appears Use the lett or right level control 1 and adjust the levels until the VU meter 19 shows all yellow lights and one green light Store the calibration and leave the calibration mode by pressing the OK button on the left side of the display D 0106002 17 8120525 2 Operating Instructions MA 41 5 2 2 Performing Speech Testing Use the function button tor Speech on the right side of the tone screen 16 to switch to speech testing The speech test screen will open and the unit will default to the right ear and the level will be set to the default value The speech recognition threshold SRT is a test indicating the lowest level in which speech is understood using a closed set of soondaic words Speech testing can be done via recorded speech test material from CD or wave files or with the microphone and live voice using standardized
29. 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 D 0106002 74 8120525 2 Operating Instructions MA 41 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 2001 2006 ERO2Z9002A 0206 D 0106002 ee E i Designed 8120525 2 Operating Instructions MA 41 Appendix B EMC Compatibility Portable and Mobile RF communications equipment can affect the MAICO MA41 Install and operate the MAICO MA41 according to the EMC information presented on this page and the next 4 pages The MAICO MA41 has been tested for EMC emissions and immunity
30. 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 1 1 Power Frequency 50 60 Hz IEC 61000 4 8 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 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 0106002 80 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 that of a typical commercial hospital or residential environment If the user of the MAICO MA41 requires continued operation d
31. E 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 D 0106002 58 8120525 2 Operating Instructions MA 41 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 from 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 li
32. 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 amplification 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 HF
33. METY 0 0 ce ccc cece cece cceeece eect eeceeeeeeeeeeeeeeeseeeseeeeteeeeseeeeneeeneeens 10 5 2 Speech AUGIOMETY cece ceccceccecceeeceeeeeeeeeeeeeeeeeeeeeseeeeeeeeeeeaeeeeeeeeneeens 17 5 3 MONItOTINO sir cnciccusonedsceomessarnedassedhugedons yeas ebm adtanenvedapsetioadieaewageboasostecdeas 22 5 4 Talk Forward arastenccatictaensieeetngsenstieisien teenie sue cie san deamdeseenieanecanaessacnianandian secur 22 5 5 Documentation of the R SUItS ccccccceccee cece ceeeeseeeeeeueseeneetaeenn estan 23 5 6 Patient ManagGeMe Mt 0 ccc cece cece cece eee ee eee eee eee een sensed een een een eeneenes 24 6 Quick Reference Guide ccecececcececececececececeecececeaucucecacaeeeceeaeausueaeaeeeeeaees 26 6 1 General Setup ae ne ee 26 6 2 Tone and Speech Audiometry s esnesiesiesrusrusrrsrrrrrrrrnrrerrerrerrerrerrenn 26 T USEF NIONU ios eeren E 29 7 1 Setup Date and TIME ec cce ccc ccc ce cce cece eee eeceeeeeeeeeeeeeueseaeseeeetaeseaeseaees 34 7 2 Set Printer SQttinS cece cece cc eee eeaeeeeeceeeeeceeceeceee cece eeneeeeeneeneenes 35 8 Cleaning and disinfection recomMMendatiOns c scccceeeeseeeeeeeeeeeeenees 36 9 Device WGA Sica aceawre ceevectsanesiecweceesecssmagveuueceasectaneessececessecesqussccusdetsuetanesses 37 10 CONNECTION to the PC 0 ce ceeeceeeee cece eeeeeeeeeeeeeeneeeneeenseeneseneeenesenesenessneees 38 11 Reg latory SVU ONG api ccrc cise cape cocs cee ete naiean Ran 40 12 Technic
34. T MAICO MA 41 Operating Instructions a MAICO Diagnostics 10393 West 70t Street Eden Prairie MN 55344 USA Toll Free 888 941 4201 Operating Instructions MA 41 Table of Contents Page DAVEE OCC OU ror aicecree seers cas E 1 1 1 Intended Use Statement cece cc ccce cece eeeeeeeeeeese seen seen seen seen eeen seen eean 1 1 2 Essential PErfOrmMance ccccccecccecceeneeeeeeeeeceeeeseeneceeeseenestueseeneseaeenneseans 1 ZS CEO UO sce irase SEENA ETNEA EEE EEEren 2 3 Getting Started acess noses ec eens seer seca necsheee en cenceeevecseoussseecsnecsaeuexse 3 3 1 Unpacking the Instrument 0c cece ccc ecc cece ee eeeeeeee seen eeeneeen seen eeen seen nena 3 3 2 Calibration Of the Device 00 ccc ccce ccc ccccceeceeeeeeeeceeeeeeeeeeueeeeneetaeeunesnneetans 4 3 3 Where to SQtUD 0 cce ccc ecc cn cceeeceeeeeeeeeeeeeeeeeeeeeeeeee sean rrene rreren erreren 4 3 4 Rear Panel CONMECUONS cco sscscccnecenceassrtunactieniesmnnvationsestadsanieteaawsmaeeacnnieness 5 A Working With the MA 4T scicieec tien pseseecesvediigececesesins ede usaia 6 4 1 Using the Control Panel of the MA 41 0 ccccecccecceeeeeeeeeeeeeeaeenneeeens 6 4 2 Functionality of Operating Elements cece cecceeeceeeceeeeeeeneeeeeeenneeeans 7 4 3 The Display of the MA 41 oo ccecceccccc cee e este eeseee seen estan eeeaesten seen estan 9 5 Measurement Methods of AUdGIOMEtLrY sccceseeeeeeeeeeeeeeeeneeeeeeeees 10 5 1 Tone AUCIO
35. al DAU Oise ceccwacaccantenecccncssacceaeesnvesneocacceateaesdenwociaveeveaesesiwesieesetaeenves 41 13 Warranty Maintenance and After Sales Service c ccsseseeeeeeeeees 46 D 0106002 8120525 2 Operating Instructions MA 41 14 Safety Regulations ccccccceseccensceenscecnneecnseeceneecessecensesonseeoaseeoneeseas 47 14 1 Electrical SaTEtY ee ee er 47 14 2 Measuring SCCUMILY 0 cece ccc cc cece ence ccc eee n eee eee een eee eee een eee eeeeeeneeneeeeennens 47 14 3 Device Control 0 ccc ccce cece cece eeee seen seen eeeeeeeeeeeneeeeeseaesteeseaeeeaess 47 14 4 Operation s snensnsnsisiusisisiunrsrsrrririsrrrrrrertrrrrrrtrt rror ertrrrrertrrrinrerrrrrreni 47 14 5 Warnings and Statements ccccceccc cece cceecceeeeeueeeeeeeeeseeeeeaeeeeeeeeeees 48 Appendix A QuickSIN Speech in Noise Test Manual 00sss0ceee 49 Appendix B EMC Compatibiit y vcsisisincwesaveccductnevievsaneieaseinenvessawscstecieenierenans 76 D 0106002 I 8120525 2 Operating Instructions MA 41 1 Introduction Thank you for purchasing a quality product trom MAICO Diagnostics The Audiometer MA 41 is manufactured to meet all quality and safety requirements and has been certified with the CE symbol according to Medical Directive 93 42 EEC In designing the MA 41 we placed particular importance on making it a user friendly device meaning its operation is simple and easy to understand All functions of the MA 41
36. and store the results in NOAH or the MAICO Database In order to remain current with present and future technologies the MA 41 is compatible with PCs easy to use extremely reliable and is adaptable to future develooments It is also designed to be easily serviced as the need arises Automatic test programs make trouble shooting and the yearly calibration as effortless as possible The speaker outputs can also be used as line level outputs for an external amplifier or active speaker Please contact your authorized service center to change to line output levels D 0106002 2 8120525 2 Operating Instructions MA 41 3 Getting Started 3 1 Unpacking the Instrument Prior to shipping the MA 41 was carefully packed and inspected However it is good practice to thoroughly inspect the outside of the shipping box Tor signs of damage If any damage is noted please notify the carrier immediately Please remove the MAICO instrument from the shipping box by litting the case completely out of the box The instrument can now be easily removed trom the plastic packaging without the use of scissors or other sharp tools SAVE ALL THE ORIGINAL PACKING MATERIAL AND THE SHIPPING CONTAINER SO THE INSTRUMENT CAN BE PROPERLY PACKED IF IT NEEDS TO BE RETURNED FOR SERVICE OR CALIBRATION Notify the carrier immediately if any mechanical damage is noted This will insure that a proper claim is made Save all packing material so the claim adjuster can inspect
37. anship for a period of one year trom date of delivery of the instrument to the original purchaser The MA 41 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 yourself or commissioning non experts to do so 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 41 should be checked and calibrated at least once a year This check should be carried out by your dealer When returning the instrument for repairs it is essential that all transducers headphones inserts and bone conduction oscillators are sent in as well Please send the device to your dealer or to a service center authorized by your dealer and include a detailed description of any defects the equipment is exhibiting In order to prevent damage in transit please use the original packing whenever possible to return the instrument Within the European Union it is illegal to dispose 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 pr
38. arked D 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 from structures objects and people a Field strengths from 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 MA41 is used exceeds the applicable RF compliance level above the MA41 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MA41 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m D 0106002 81 8120525 2 Specifications are subject to change without notice T MAICO Maico Diagnostics 10393 West 70th Street Eden Prairie MN 55344 Phone 888 841 4201 Fax 852 903 4100 www maico diagnostics us 8120525 2 D 0106002 08 15
39. ary 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 sentence 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 D 0106002 54 8120525 2 Operating Instructions MA 41 PRACTICE LISTS Tracks 21 23 contai
40. by turning the left or right level control 1 down The color mode is automatically adjusted If the color mode is wrong adjust the color mode as well Jump to the field paper format by pressing the stimulus presenter bar several times and select A4 or Letter format by using the level controls If the printer is connected to your Ethernet network select Ethernet as port Additionally the IP address of the printer needs to be entered in the field IP Address Select the number of the IP address by rotating the level controls and press the STORE button to enter the selected number Save the settings and return to the user menu by pressing the function button OK 7 Canon_IP100 Figure 16 Printer Settings Test your printer settings by a sample print before starting the audiological assessment Incorrect settings may require a restart of the device Enter the field clinic name by using the STIM button Select letters by rotating the level control and enter the selected letter by pressing the STORE button 3 Save the settings and return to the user menu by pressing the function button OK 7 D 0106002 35 8120525 2 Operating Instructions MA 41 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
41. ch test is started the test can only be stopped by pressing the Cancel 16 or Store 3 The procedure for the SRT WRS and UCL test is the same as the procedure for CD or microphone testing For the SRT test a word needs to be selected in the wordlist by the frequency up 4 or down 5 key When the Play button 7 is pressed the selected word Is presented D 0106002 19 8120525 2 Operating Instructions MA 41 For the WRS test score 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 Tile has been selected the intensity cannot be changed Select the presentation level before selecting Play 7 30 dBHL Wave 50 Off dBHL Phone 1 2 Phone 1 please 2 great EEN pants 5 rat 6 bad 7 pinch 8 such 9 bus 10 need 11 ways 12 five 13 mouth 14 rag 15 put 16 fed SRT Mask Signal WRSMask Condition Figure 9 Speech Audiometry with Wave Files The percentage of the speech discrimination score will be displayed and stored in the speech table or audiogram as soon as the Store button 3 is pressed Press the function button List 6 to load another word list UCL measurements are best performed with the Passage wave file include with the device Select the
42. d Down 5 keys 60 dBSPL CD MHA cp 60 dBsPL Phone Phone 18 dB octave 18 dB foctave Lo o ia SRT Mask Signal WRSMask Condition wa Figure 10 Display Master Hearing Aid D 0106002 21 8120525 2 Operating Instructions MA 41 5 3 Monitoring All signals presented to the patient can be monitored by the examiner via a monitoring headset or the internal speakers For this purpose press the Monitor button 6 and the monitor screen will appear Enable monitoring by pressing the function button Monitor On Off 9 Monitoring by the integrated speaker is switched on by pressing the button 13 and the external headset is activated tor monitoring via button 11 Then the monitor level of the lett and right channel can be adjusted with the corresponding level control dial 1 In order to hear the signal given to the patient make sure to activate monitoring 9 Figure 11 Display Monitor Settings 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 or optional gooseneck microphone to the microphone socket 8 on the rear side of the device To talk to the patient press and hold the STIM mode TALK button and speak into the microphone Adjust the level by turning the left or right level control 1 while the STIM mode TALK button is pressed and held D 0106002 22 8120525 2 Operatin
43. e to confirm all changes are implemented D 0106002 29 8120525 2 Operating Instructions MA 41 These menu items are available Bold represents default setting Frequency Settings Frequency Frequency Roll Standard Frequencies Level Default Level Level Steps Inverse Dialing Speech Level Unit D 0106002 30 Default Frequency Set On Off Set default trequency if side transducer or signal type has changed Back Frequency control jumps to 1 000 Hz if the highest and lowest frequency was reached Stop Frequency control function stops at highest and lowest frequency Wrap Jumps to the lowest highest frequency when the highest lowest frequency Select deselect On Off Set default level after changing signal type 5 2 1 Change effect on dialing an encoder Dial Down dBSPL dBHL Select the level unit Tor speech signals 8120525 2 Signal PTA CD Channel D 0106002 Operating Instructions MA 41 Controller Assignment Presenter Duration Interrupter Presenter Mode Pulse Select the CD Channel 31 Assign ear side fixed to the left or right controller Same left dial controls level of the lett ear right dial the level of the right ear Interchanged left and right dial controls the level of the opposite ear Assign signals fixed to the left and right controller Test signal always on the left hand side or always on the right hand side This setting requires a
44. eat 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 pulsating tone Warble Tone If required the test can also be performed with a warble frequency modulated tone Press the test signal button 12 and the pure tone will frequency modulate The warble tone can also be pulsed as described above D 0106002 12 8120525 2 Operating Instructions MA 41 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 For bone conduction the masking signal is automatically routed to the
45. ect 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 developing practice guidelines for speech quality measurements to help communication engineers assess speech transmission systems The 720 IEEE D 0106002 62 8120525 2 Operating Instructions MA 41 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
46. ed the startup is stopped and a description of the error will be shown on the display In this case please contact your local dealer for service D 0106002 5 8120525 2 Operating Instructions MA 41 4 Working with the MA 41 The hearing level can be easily adjusted with the level dials on each side of the instrument 1 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 Stimulus Presenter buttons 2 and Store buttons 3 are located beside the left and right level control dials 1 With the STIM mode button 8 you can change from presenter to interrupter mode The corresponding LED lights up when a Signal is presented The frequency can be adjusted with the Plus 4 and Minus 5 buttons on both sides of the instrument The ergonomic design of the MA 41 makes it easy to control the dB level signal presentation and frequency adjustments with one hand 4 1 Using the Control Panel of the MA 41 The main functions of the MA 41 are directly accessible by using the Function buttons which are located around the display As the buttons have changing functionality the actual function of each button is shown in the blue boxes on the screen above the button To change the function of buttons 9 11 13 and 15 which have several functions press the corresponding button and a list of alternative functions will appear Quickly press and release the butt
47. els will affect normal usage of these tracks D 0106002 73 8120525 2 Operating Instructions MA 41 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 Journal 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 Devel
48. ence 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 D 0106002 64 8120525 2 Operating Instructions MA 41 Beta Site Protocol CD recordings of the beta version QuieckSIN 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
49. ence 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 twenty 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 de
50. etry The MA 41 audiometer delivers 11 air conduction AC test frequencies trom 125 Hz to 8 kHz with levels trom 10 dBHL to 120 dBHL Bone conduction BC can be tested with 10 test frequencies trom 250 Hz to 8 kHz with levels from 10 dBHL to 80 dBHL using the B 71 bone conductor As an upgrade option the MA 41 is also capable of high frequency audiometry up to 16 kHz The large back lighted LCD color display shows level frequency transducer signal tyoe audiograms and other intormation for each channel The MA 41 performs tests using DD 45 headphones B 71 bone conduction oscillator optional insert phones and optional speakers Built in test signals include pure tone pulse tone warble tone narrow band and speech noise Inputs include ports for a live speech microphone and a CD player for speech test material Soeech tests can also be imported via 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 HAD 200 HDA 300 Furthermore the patient management feature provides the ability to store results in the device for further evaluation and documentation Results can print directly via the USB printer or stored as a PDF Tile on the included SD memory card or USB flash drive The MA 41 can be connected to the PC via USB to track the session
51. g Instructions MA 41 5 5 Documentation of the Results All stored results can be directly printed via the USB printer Make sure that a compatible printer is connected via the USB port 4 and the device is configured according to the connected printer settings refer to menu settings in chapter 7 2 The results can also be stored as a PDF tile on aSD memory card or USB flash drive to be later transferred to a PC for further usage The PDF file contains the measurement results 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 When the examination has been completed press the Menu button 17 in the tone or speech test mode The user menu is opened and the functionality of the function buttons 11 13 and 15 changes to PDF Print and Patients respectively To printout 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 for further transter to a PC or printout via a PC connected printer Make sure that a SD memory card is inserted in the SD memory card slot 18 After printing or creating a PDF you will automatically return to the tone or speech test mode Enter the patient list by pressing the Patient button 15 to store the results
52. g Instructions MA 41 WHAT IS SNA 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 babble 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
53. ified 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 40 Special Disposal Required IEC60601 1 Keep Dry Logo Registration Label Return to Authorized Representative B Patient Applied Part According to Consult Operating Instructions Transport and Storage Temperature range EU Authorized Representative 8120525 2 Operating Instructions MA 41 12 Technical Data EU Authorized Representative EC REP Standards Test Frequencies Level Step Maximum Sound Pressure Level AC with earphone DD 45 BC with B 71 B 71W Bone Conduction Oscillator Insert earohones Ear 3A Sound field speaker from Amp Tones Speech D 0106002 MAICO Sickingenstr 70 71 D 10553 Berlin Germany ANSI 3 6 ANSI 3 43 IEC 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 125 Hz 8 000 Hz 9 000 Hz 16 000 Hz upgrade 5 dB 2 dB or 1 dB level steps user selectable 10 dBHL to 120 dBHL 10 dBHL to 80 dBHL 10 dBHL 120 dBHL 10 dBHL 100 dBHL 10 dBHL 90 dBHL 41 8120525 2
54. it as well Notity your dealer or MAICO when the adjuster has completed the Inspection Please check that all accessories listed below have been received in good condition If any accessories are missing or damaged immediately notify your dealer or MAICO Standard Accessories See page 43 for accessory listing D 0106002 3 8120525 2 Operating Instructions MA 41 3 2 Calibration of the Device The instrument headphones bone conduction oscillator as well as the optional insert phones and speakers will come calibrated to the instrument 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 which will invalidate the test If a transducer needs to be replaced the instrument must be recalibrated with the new transducer The use of non calibrated audiometers can lead to incorrect measurements 3 3 Where to Setup The MA 41 should be operated in a quiet room so that the audiometric examinations are not influenced by outside noises Ambient sound pressure levels in an audiometric test room shall not exceed the values specified in the norm ISO 8253 1 2010 or ANSI S3 1 1999 For use in noisier environments headphones with optional sound insulation muffs are available Electro medical instruments which emit strong electromagnetic fields e g microwaves or radiotherapy devices can influence the function of the
55. 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 the device from 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 01060
56. ive 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 QuickS 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 is what it sounds like to have a hearing loss and try to listen in a noisy place D 0106002 63 8120525 2 Operating Instructions MA 41 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
57. li becomes uncomfortable to the patient The UCL is described as the level between very loud and too loud as perceived by the patient when listening to the test signal This information is valuable for determining the limits of a patient s dynamic range Warning Because this test uses high sound pressure levels it is extremely important to perform this test using the utmost caution to avoid causing hearing loss To prevent the possibility of extreme discomfort by the patient it is important to start the test at a comfortable level Press and release the test mode selector key 13 below the display to select UCL The LCD display in the bottom row changes from HL to UCL Start with a test level of 60 dBHL and present the tone briefly max 1s If the signal was recognized by the patient as not uncomfortable increase the level and proceed as described before If the signal was uncomfortable tor the patient store the value Proceed accordingly with other test frequencies D 0106002 15 8120525 2 Operating Instructions MA 41 5 1 5 Stenger The Stenger test is a test 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 select both ears 9 Instruct the patient to press the response button when the tone is heard Present a tone to the better hearing ear 10 dB above th
58. m 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 D 0106002 50 8120525 2 Operating Instructions MA 41 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
59. mited 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 rotated to face the opposite wall and the speech and babble switched to the opposite speakers D 0106002 59 8120525 2 Operating Instructions MA 41 Directional Comparisons Continued Figure 3 Figure 4 D 0106002 60 8120525 2 Operating Instructions MA 41 lf the loudspeakers are located at O and 180 you may test each ear separately or
60. mp to the next or previous field by using the Frequency Up 4 or Down 5 button The date can be entered in the same manner with the level controls Delete the last character or number by pressing the Delete button 17 A USB keyboard can also be utilized to enter the patient information Connect it to the USB connector 4 and type in the characters Jump to the next field with the tab key Press the function button OK 6 to save the new patient and go back to the patient list The new patient Is selected and the current measurement results can be saved to this new patient by pressing the function 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 D 0106002 25 8120525 2 Operating Instructions MA 41 6 Quick Reference Guide 6 1 General Setup 6 1 1 Startup Settings Air conduction Pure tone on the right channel left channel is switched off 30 dBHL tone Presenter mode 6 1 2 Transducer Selection Select the transducer to be used headphones Phones or insert phones Insert by pressing the appropriate button 10 The display shows the selected transducer at the top of the display screen below the presentation levels 6 1 3 Signal Selection For tone testing the test signal is always tone For soeech audiometry the signal can be selected by the SIGNAL key 11 The type of NOISE signal is dependen
61. n 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 moh he The lake sparkled in the red hot sun Tend the sheep while the gog wanders Jake 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 whe 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 D O A why D 0106002 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 the 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 J3 Score Score Score 8120525 2 Operatin
62. ncomfortable Loudness UCL Aided sound field thresholds Aided D 0106002 10 8120525 2 Operating Instructions MA 41 5 1 1 Pure Tone Testing During pure tone audiometry the patient s hearing threshold is measured Typically the threshold search begins with air conduction testing in the ear with better hearing While viewing the tone screen the following settings will be displayed 30 dBHL Tone 1000 uz Off dBHL Phone Steady Phone 10 10 20 20 30 30 40 40 60 60 70 70 80 80 90 90 100 100 110 110 0 5 1 2 4 0 125 0 5 1 2 4 3 Figure 5 Pure Tone Audiometry Screen Example The default setting is the right channel set to air conduction pure tone and the left channel is switched off The frequency is automatically set at 1 000 Hz 0 125 The audiometer provides one and a half channels one for the test signal and the other for the masking signal The test signal can be routed to the left right or both ears If masking is on the masking signal is routed to the non test ear through the primary transducer established in the set up menu Select the ear to be tested by pressing the function button 9 on the control panel underneath the screen Press several times to toggle between Right Left and Both 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 Press the button several times un
63. oft 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 0106002 List 10 TRACKS 12 33 45 61 Dots of light betrayed the black cat Put the 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 fo
64. on until the desired function Is selected D 0106002 6 8120525 2 Operating Instructions MA 41 An extensive user menu for the customization of the MA 41 is available for advanced 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 screens ON mu mS AN IS Ss No NA NA Figure 3 Control Panel MA 41 Level control adjusts the hearing level for the left right ear STIM bar presents or interrupts the signal for the left right ear STORE button stores results for the left right ear Frequency up change to higher frequency for 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 with wave files 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 with wave Tiles Monitor with options to adjust monitor and talk back settings for speech the input calibration for microphone or CD player can be adjusted Function button function is displayed on the screen based on test screen D 0106002 8120525 2 Operating Instructions MA 41 Tone Select New to delete all stored results and start a new session Speech Reset the result percentage counter or Play wave Tile Channel STIM Mode but
65. oper collection and treatment according legal regulations to our customers Date of Manufacture D 0106002 4o 8120525 2 Operating Instructions MA 41 14 Safety Regulations Consult operating instructions before using this device 14 1 Electrical Safety The MA 41 audiometer is a B patient applied part according to N international standard IEC 60601 1 EN 60601 1 The instruments are not intended for operation in areas with an explosion hazard Electrostatic discharge ESD according to IEC 61000 4 2 It is recommended that you use this device in an electrostatically controlled environment To avoid the risk of electric shock this equipment 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 warranties may be void if these checks are not done The use of non calibrated audiometers can lead to incorrect test results and is not advisable 14 3 Device Control The user of the instrument should perform a subjective instrument check once a week 14 4 Operation The instrument should only be handled and operated by trained personnel audiologists ENT doctors or personnel with similar qualifications D 0106002 4 812
66. opment 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 Adult 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
67. 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 Note Masking Is only available in when Right or Left ear is selected When Both is selected the Masking Off key is greyed out i e Masking Off I D 0106002 13 8120525 2 Operating Instructions MA 41 Manual Masking The masking is switched on by pressing the Masking On Off button 15 The channel of the non test ear is switched on and set to noise with a level of O dBHL 30 dBHL Tone 1000 xz Noise O dBHL Phone Steady Phone Figure 6 Tone Audiometry with Masking Adjust the level of the masking noise by the right hand level control dial If the Store button on either side of the instrument is pressed 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 You can interrupt the masking signal by pressing the corresponding stimulus button 2 Automatic Masking With the manual masking as described before the masking level should be adjusted every time you change the test signal level The MA 41 has a tracking function for easy masking Set the tone level and the masking level to a desired difference for effec
68. red 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 practically 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
69. reshold 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 function button 14 and the STIM Mode button 8 to set it to interrupter mode If the patient responds it is a negative If the patient does not respond it Is a positive Stenger indicating that the tone is heard in the poorer ear and the patient Is ignoring the stimulus D 0106002 16 8120525 2 Operating Instructions MA 41 5 2 Speech Audiometry The MA 41 supports speech audiometry To conduct speech tests using speech test material you can use a CD player wave Tiles from the 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 of 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 41 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 Press the Monitor button 6 and then InCal 17 and the calibration screen appears see figure 7b Figure
70. restart Unlimited signal is presented as long as the STIM bar is pressed 1 5 Seconds signal is switched off after 1 5 seconds User defined duration user can define a maximum presentation duration Default Presenter or Interrupter Mode 500 ms slow pulsing 250 ms fast pulsing Select deselect frequencies for the calculation of the PTA value for the default transducer Both Channel A Channel B 8120525 2 Operating Instructions MA 41 Store Properties Default Transducer Monitoring Tests Printer Settings PDF Save Option Device Information Date Time Display Brightness Language D 0106002 Change Frequency After Store Change Level After Store Selection of Default Transducer Monitoring Start Test Set Printer Settings Save on SD Card Save on USB Show Information Set Date Time 32 Moves to next test frequency after storing a threshold on or Stays on same frequency after storing oft Change in level after storing a threshold stay at the same test level 0 or decrease by 10 20 or 30 dB Headphones or Inserts Monitor only speech signals off or all signals on Tone Speech defines test which will load after start up Opens a dialog to select a printer and configure its settings Stores PDF files to an SD memory card Stores PDF files to a USB flash drive Shows device information Opens a dialog to change the date time and the date format to US or In
71. rs 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 constant 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 53 Tracks 48 51 Two list pairs with 30 dB HFE List pairs 1
72. rt 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 71 TOTAL S N O 8120525 2 Operating Instructions MA 41 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 0106002 2 8120525 2 Operating Instructions MA 41 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 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 lev
73. s this time only Yes now and every time connect a device No not this time Click Next to continue Figure 17 Installation Advice Select automatic installation in the next dialog window and click the Next button Wait till the MAICO MA4x family driver is installed and the operating system 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 the wizard installs the software EJ MAICO Mads Family WdfColnstaller01 005 dll To CAWINDOWS aystems2 Figure 18 Software Installation D 0106002 38 8120525 2 Operating Instructions MA 41 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 Review the Audiometry Module User Manual tor complete instructions of software use This is located on the included CD and USB D 0106002 39 8120525 2 Operating Instructions MA 41 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 X 980 amp 60601 1 RPP 980 amp 60601 1 Reference Number maco EEr XK a lb LISTED Intertek 4005727 D 0106002 Medical Equipment Class
74. ser of the MAICO MA41 can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MAICO MA41 as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation distance according to frequency of transmitter Output Power of m Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 d 1 17VP d 1 17VP GHz d 2 23VP 100 11 70 11 70 23 30 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 from structures objects and people D 0106002 719 8120525 2 Operating Instructions MA 41 Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAICO MA41 is intended for use in the electromagnetic environment specified below The customer or the user of the MA41 should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment Guidance Electrostatic
75. t upon the opposite channel s signal 6 1 4 Masking Use the Masking On Off button 15 to activate masking in the non test ear 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 audiometry modes Tone audiometry shows level and frequency on the display Speech audiometry shows level correct and incorrect words and speech discrimination percentage on the display Use the MODE button 16 to switch between tone and speech mode D 0106002 26 8120525 2 Operating Instructions MA 41 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 transducer 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 Tracking Function Press the TRACK key 14 to activate tracking Both channels will adjust when only one attenuator is adjusted 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 If both ears are selected LOCK Is automatically activated Select
76. t 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 D 0106002 7 8120525 2 Operating Instructions MA 41 Guidance and Manufacturer s Declaration Electromagnetic Emissions The MAICO MA41 is intended for use in the electromagnetic environment specified below The customer or the user of the MAICO MA41 should assure that It is used in such an environment Emissions Test Compliance Electromagnetic environment Guidance RF Emissions Group 1 The MAICO MA41 uses RF energy only for its internal function Therefore its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B Limits The MAICO MA4 1 is suitable for use in all commercial industrial business hospital and CISPR 11 residential environments Harmonic Emissions Class A Category IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 D 0106002 78 8120525 2 Operating Instructions MA 41 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the MAICO MA41 The MAICO MA41 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the u
77. t key 7 on the left side of the display Speech Calibration To calibrate the MIC or CD speech input select the inout with the SIGNAL selector key 11 Press the Monitor button 6 so that the monitor setting screen appears Now press the InCal button 17 on the right side of the display and the calibration screen appears Play the reference signal with the CD player or speak into the microphone Use the left or right intensity dial 1 and adjust the levels until both VU meters show all yellow and one green light If one or more red lights are displayed reduce the level using the corresponding dial 1 Store the calibration and leave the calibration mode by pressing the OK 6 button on the lett side of the display 6 2 4 Documentation of the Results Printout Enter the user Menu by pressing the function button 17 and press the Print 13 button to printout the results Store Results as a PDF Enter the user Menu by pressing the function button 17 and press the button PDF 13 to save the results as PDF file on SD memory card or USB flash drive Store the Result in the Patient List Enter the User Menu by pressing the function button 17 and press the button Patient 15 to enter the patient list Enter a new patient by pressing the button New Patient 15 It is also possible to print a result trom the patient list or to create a PDF of the result Select a stored session of a patient in the patient list and press then the bu
78. ternational Change the display brightness from 1 100 store new value by pressing the Store button 3 English German Italian French Spanish etc 8120525 2 Operating Instructions MA 41 Diagram Settings Diagram in Speech Diagram or Table Test Number of Diagrams No audiogram only the level in Tone Test and frequency one combined audiogram or two separate audiograms for lett and right Bone Lines On Off displays a dotted line connecting the bone conduction results Bone Symbol Setting Int Symbols US Symbols UK Symbols Import Export User Export User Settings to SD Settings Card Import User Settings from SD Card D 0106002 33 8120525 2 Operating Instructions MA 41 7 1 Setup Date and Time Select Date Time in the user menu by scrolling down with the left or right level control 1 and select Set Date Time by using the stimulus presenter bar The following screen will appear Figure 15 Date and Time Settings Set the date format to International or US by the function button 9 Jump to the required position of the date or the time by the left Frequency Up Down button 4 or 5 and change the value by the right Frequency Up Down button 4 or 5 or left level control Press the function button OK 6 to store the changes or Exit 7 to leave the Date Time setting screen without saving the changes D 0106002 34 8120525 2 Operating Instructions MA 41 7 2 Set Printer Settings Select the printer
79. til the LED indicates the required transducer Only calibrated transducers are available The level and frequency is displayed as a numerical value at the top of the screen and is also indicated by the cursor within the audiogram The dBHL can be changed with the attenuator dials on both sides 1 of the Instrument Use the frequency plus 4 or minus 5 keys to increase or decrease the frequency Press the STIM button the blue button touching the attenuator dials to present D 0106002 11 8120525 2 Operating Instructions MA 41 or interrupt the tone The status LED for the stimulus mode button 8 will illuminate when the tone Is presented Follow your preferred procedure for the hearing threshold evaluation Note A warning prompt appears on the display in the event that the hearing level exceeds 100 dBHL The warning prompt disappears after approximately 3 seconds As long as the prompt is visible on the display no further entries can be made Test the frequencies Starting at 1 000 Hz test the higher frequencies first then the lower frequencies Use the frequency up key 4 to select the next higher frequency and use the frequency down key 5 to select the next lower frequency Once a threshold value is established at the desired frequency press the store button 3 to store the threshold The appropriate symbol will be plotted in the audiogram on the display Once all frequencies are tested select the other ear and rep
80. tion button Menu to enter the user menu where settings can be adjusted results can be printed out or stored as PDF on SD memory card or USB flash drive or the patient list can be entered SD memory card slot Level meter Note When a Function button is grey this identifies it as an inactive button with the current test set up ex Ca D 0106002 8 8120525 2 Operating Instructions MA 41 4 3 The Display of the MA 41 The instrument is set up by default to display the tone audiometry screen 30 dBHL Tone 1000 nz Off dBHL 30 dBHL Tone 1000 xz Off dBHL Phone Steady Phone Phone Steady Phone 1 1 E D E ane sai aaa a imi Se a x E E takes E hae coe cacy Ga SA Ga m a T n See beseenebneteeneedeenenedinernennespeanesn 40 40 a a A 50 50 50 so i P eee el PEET res ER ETE E psec CE PA _ 70 70 i aaa a e aa Ga faa a ache Gea aaa 80 s0 a Ca a ee ee bee E TETE E T en E E ones E heecetns 100 7 7 3 7 110 100 Cees a Ge GOs GS ER es Gees eet a RN anna ee 110 110 SSBRSRSeSSSRSeese Ss ean sesesseeseessecaescess pesase sss6ss5sasseserassecenessssereocssssapacosssssssen4sseeereshsssssesassssnpesessses 0 125 4 8 0 125 0 8 EE ee E Emm Figure 4 Start Screen Tone Audiometry Examples Dual and Single Audiogram The default frequency is set to 1 KHz and the level of the tone is set to 30 dBHL in the right ear masking in the other ear is switched off All channel information is shown on
81. tive 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 CBHL D 0106002 14 8120525 2 Operating Instructions MA 41 5 1 2 Bone Conduction Testing 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 behind but not touching the pinna The other side of the headband is placed in front of the opposite ear Set the receiver selector to Bone and select the testing ear Perform the test utilizing the same method as air conduction testing For hygienic reasons it is important to disinfect the bone conduction oscillator following each patient see chapter 8 5 1 3 Sound Field Testing optional Set the transducer selector 10 to Speaker Perform the test utilizing the same method as air conduction testing Warble tones should be used in the sound field as pure tones may provide inaccurate results in the typical test room Perform the test in the same way as described in the air conduction section above 5 1 4 Uncomfortable Loudness UCL Testing Testing of UCL can be measured using pure tone or speech stimuli The purpose is to determine the dBHL level at which the stimu
82. ton TALK to change trom presenter to interrupter mode or to talk to the patient by pressing and holding the button down Function button to select left right or both ears Transducer selector button to choose between Phones Insert Bone and Speaker only calibrated transducers are available Function button function Is displayed on the screen based on test screen Tone No response stores value with arrow below the symbol Speech Select microphone external CD player or wave Tile as signal source Test Signal selector button Steady Pulse Warble or P amp W pulse and warble tone Function button function is displayed on the screen based on test screen Tone Selects test for selected receiver either the pure tone threshold Hearing Level HL or Uncomfortable Loudness UCL if Speaker is selected as the transducer an option for aided sound field threshold Aided is also made available Speech Select Soeech Recognition Threshold SRT Word Recognition Score WRS UCL or Master Hearing Aid MHA Select Unlock Lock locks the presentation of the signal in both channels Track activates the masking noise to automatically increase and decrease level in relationship to the signal L amp T Lock and Track Function button function is displayed on the screen Masking on off activates masking in the opposite ear Function button to switch trom tone to speech and back the current function is displayed on the screen Func
83. tton PDF 11 or Print 13 In this case the patient information will be included in the PDF or printout Press the button New 7 in the patient list to start a new session D 0106002 28 8120525 2 Operating Instructions MA 41 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 17 on the right side of the display User Menu s Frequency Settings Level Signal Pure Tone Average CD Channel Store Properties Default Transducer Monitoring Tests Printer Settings PDF Save Option Device Information Date Time Display Brightness Language Diagram Settings Import Export User Settings Settings Bees EED Gis ee Figure 14 User Menu Screen To choose an item from the menu use the level control dials A short description of the selected setting item will be displayed below the user menu list To display the sub items or change the setting of the selected item press the STIM Presenter button 2 To confirm the change press the OK button 7 on the left side of the display or press Cancel 6 to return without any change Note When changes have been made to the menu and saved restart the devic
84. ur 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 70 The steady drip is worse than a drenching rain S N 25 S N 20 ofl 15 oN 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 8120525 2 Operating Instructions MA 41 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 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 _
85. uring power mains interruptions It is recommended that the MA41 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 8120525 2 Operating Instructions MA 41 Guidance and Manufacturer s Declaration Electromagnetic Immunity The MAICO MA41 is intended for use in the electromagnetic environment specified below The customer or the user of the MA41 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 MA41 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF 3 V m 80 MHz to Recommended separation distance IEC 61000 4 3 2 5 GHz 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 a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment m
86. 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 Subjects 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
87. viation 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 D 0106002 6 8120525 2 Operating Instructions MA 41 COMPARISON BETWEEN TWO CONDITIONS Averaging the results of several QuiekSIN lists improves the reliability compared to a single list This is particularly 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 requi

Operating Instructions MA 41

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