Operating Instructions RaceCar Tymp
Contents
1. MAICO Diagnostic GmbH MAICO Operating Instructions RaceCar Tymp MAICO Diagnostic GmbH Salzufer 13 14 D 10587 BERLIN Tel 49 30 70714650 Fax 49 30 70714699 Operating Instructions RaceCar Tymp 1 NEP OCI CON acto stacsisseeyaattioagneass sant atiiesseaeuacisaorssmumasnenediewondisacnestuisaaubyeatnamanestiewas 3 2 DeEScription sesucossevsicnenntinaridlnuotsddagidsumehaciansnabendariexnaasdadeevoswuptndidannatieeasaeiawes 4 Folk PODO e A EE EEE EE EAS E voc 4 2 1 1 PC Interface gn ee eee 4 2 1 2 Environmental conditions for the Race Car Tympanometer 4 2a VIDA OUNC UY ee a vias E A EE EE 4 2 3 Acoustic Reflex 0 2 0 ccc cc cccccccc ee ceee ee eeeeeeeeeeeeeeeeaeeeeeeeseesneseeaneseeanesenaneneas 5 3 Getting started 0 0 cec cece cee ee ee eee eee ee eeee essen eeegeeeeneeeeeesneeeaeeesneeenees 7 3 1 UNPACKING 0 0 c ccc cc cece cee ece ce eee acces eeeeeeeeeneeee estan eeeneeeeneeeaeseaneeenees 7 3 2 Preparing the Race Car Tympanometer for USC cccccceeceeeeeeee eens 7 3 2 1 Connect Probe and ACCESSOMIES ccecceeceeeeeeeeeeeeeeseeeseaeeeueeeaess 7 3 3 Connect mains Cable and accessories cceeec cc ecceeeecceeeeeeeeeeeeeeeeeen ees 8 3 4 Switch the INStrUMENT ON cece cece c cece cc ee ece ee eceneceee seen este eeeeeeeeaeeenees 8 3 5 Getting familiar with the Race Car Tympanometer cccceseeeeees 9 3 6 The display of the Race Car Tympanometer ccccceeecceeeeeee sense2. again Notice To avoid damages on the sensitive measuring equipment only bent the probe toward fixation screw Figure 9 Transforming the probe from screening to diagnostic and reverse optional accessories To exchange the probe insert press the release button of the probe with a tool or a pen Remove the screening probe insert Note The squared hole in the probe connection should face in the same direction as the push button Control lights and display The probe button can be used to select the required test ear The color of the control light changes accordingly to red right ear or blue lett ear If selected in the setup menu pressing the probe button during operation pauses also the test The color of the control light of the probe indicates in standby the selected ear and in operation the fitting of the probe in the auditory canal GEBARaceCar_Tymp_e 11a docx 13 850 274 3 11 11 Operating Instructions RaceCar Tymp A red control light indicates that the right ear is selected The system Is ready for measurements As soon as you have put the probe into the auditory canal the control light lights green Now the test runs off Do not change the position of the probe any more until the green control light is going out indicating the end of the measurement A blue control light indicates that the left ear is selected The system is ready for measurements As soon as you have put the prob
3. Gradient 32 daPa I n M 1000 Hz 2000 Hz 4000 Hz PASS PASS PASS AUTO N dB Scale Figure 23 Example of a normal Tympanogram with ipsilateral reflex results 850 274 3 11 11 Operating Instructions RaceCar Tymp threshold was registered the information NR appears below the frequency A correct interpretation of the measuring results can only follow in connection with the Tympanogram the graphic reflex display and other actual data But in principle you can say that a stapedius reflex indicates that the patient hears on the stimulus ear and that the sound lead on the orobe ear Tunctions 6 7 How to print out the test result After a test you can print out the result for your documents by pressing the PRINTER button aes The quiet thermal printer prints out Remarks oo the example used in the previous paragraph 6 6 in only 12 seconds While the printer is working no key action is possible and the probe is inactive In addition to the printing text treated in chapter 4 6 the result of MAICO RaceCar Tymp 600 300 300 daPa the reflex test is printed out ae aa The level value dBy at which a pesue 3 daa Gradient 32 daPa reflex had been measured appears m Reflex below the graph afl psi 500Hz PASS If no reflex had been registered FAIL is printed on the top of the graph behind the test frequency The printout supports you to saith si 2000H PASS evaluate
4. The reflex is shown in up to four graphics with ipsilateral reflex tests with time on the horizontal axis and the change of the compliance on the vertical axis 7 2 Interpreting the tympanometric test result As a general rule values for ear canal volume should be between 0 2 and 2 0 ml children and adults A variance will be seen within this range depending on the age and ear structure of the person For example a 2 0 ml or larger reading in a small child could indicate a perforation in the tympanic membrane while it may be a normal reading in an adult You will become more familiar with the normal ranges when you use the Instrument GEBARaceCar_Tymp_e 11a docx 28 850 274 3 11 11 Operating Instructions RaceCar Tymp The normal range for compliance is 0 2 ml to approximately 1 8 ml A compliance peak within the range indicates normal mobility of the middle ear system A peak found outside of these limits may be indicative for one of several pathologies Middle ear pressure should be equivalent to ambient air pressure 0 daPa on an air pressure scale Minor shifts of the peak compliance to the negative may occur with congestion and are rarely to the positive side Establish criteria for abnormal negative pressure when you become more familiar with using the equipment It is generally accepted that negative pressure of greater than 150 daPa indicates a referral for medical evaluation 7 3 Abnormal values It is the purpose of th
5. hold down the Reflex key for two seconds The screen for high probe tone tympanometry looks very similar to the normal tympanometry mode however the following differences will appear on the screen The scaling is now measured in mmho The pre selected trequency 1000 Hz is displayed in the upper lett hand side of the screen The tympanometry test with high probe tones is performed in the exact same way as a normal tympanometry test It is possible to perform normal tympanometry and high probe tone tympanometry in one test session and print the results for comparison When the first tympanometry curve has been drawn press the Reflex key for two seconds to switch to high probe tone tympanometry Now the next curve will be drawn automatically Press Print and a printout presenting both curves will appear Note It is not possible to perform reflex tests on the basis of a high probe tone tympanogram GEBARaceCar_Tymp_e 11a docx 22 850 274 3 11 11 Operating Instructions RaceCar Tymp 6 How to measure the stapedius reflex 6 1 The basics of the stapedius reflex measurement While the tympanometry method measures the change of the compliance caused by changing pressure in the outer musculus Stapedius hearing nerye middle ear auditory canal the stapedius 2 bones Ah retlex measurement works with CA aT a changing compliance caused ear canal DA by contraction of the stapedius or ear drum aes muscle in the mi
6. 0c cece ee cceeeeee eee e nena 24 6 4 Doing the ipsilateral MEASUFEMENL cc ecccc ce cceeeceeeeceeeeeeneeeneeeens 25 6 5 Preparing the contralateral MEASULEMENT cecccecce sees eeee eee nena 26 Operating Instructions RaceCar Tymp 6 6 How to interpret the reflex display cccecccccseeecceseceseeeeeeeesenanees 26 6 7 How to print out the test result ccc cceccc secs eee eeee esse een eeneeeans 27 7 Interpreting Test R SUItS ccccccccccc cece cceeeceeeeeseeceeeeeeeeeeaeeeeneeeeeeeaneees 28 7 1 Understanding the printout cccceccc cece ceeceeeee ee eeeeeeeeeeeeneeeneeeens 28 7 2 Interpreting the tympanometric test result ce cceeeceeneee neces 28 7 3 Abnormal VAIUCS ccc cece ccc cc ee eeeeeeceeeeeeneeeeeeeee seen eeeaeeeeneeeaeeean 29 8 HOW to test children 0 0 cece ccc cece ccc ce eeeeeeeeeeceaeeeeeeee essen eeegeeeaneeeeeeeans 30 9 Recommended literatUle cece c cece cece cce ee eee eee ee eeeeeeee essen eeeeeeeeneeeaeeeans 31 10 Individual setup of the Race Car Tympanometel cccecceeeeeee eee 32 10 1 The setup MENU cece cece cece cc cceeeeee eect eeeesneeee essen eeeneeeeeeeeneeeans 32 10 2 Tympanogram Setup MenU ssssssnsnsnnsnsisrrsnsrsrsrrrrersrrrrrrnrsrsrrrrsren 33 10 3 Setup Menu for Reflex TOSt oscxcnciocacnsenusnwestdecudssesnsiacgaanssbebetasnadens 35 10 4 The Common Setup MenU s sssssssssissrrsrissrrsrrerrsrrrrrrrrrerrerrerrrerrns 36 10
7. 11a docx 23 850 274 3 11 11 Operating Instructions RaceCar Tymp 6 2 Training the child In addition to the general introduction described in chapter 4 2 you should explain to the child that loud test sounds will occur during the reflex measurement It is very Important that he she does not move the head at all because a reflex can be registered already with a change of compliance of 0 05 ml 6 3 Preparing the ipsilateral measurement The LCD display shows the empty tympanogram for the rignt ear and the control light a Te Ear Volume Impedance Right Ipsi a E 8 8 8 of the probe lights red If o o E y E you want to measure the left Ei oe z Pe gt _ 4 y wo a o a ear change the side by pressing AARET the L R key or the probe pea he eg button M Then the selected i a ie i test ear shown in the middle of the top of the LCD display will change trom Right to fs ae a Left and the control light of 500 Hz 1000 Hz 2000 Hz A000 Hz AUTO t dB the probe lights blue Compliance Pressure Gradient tl Figure 20 Display Tympanogram Reflex ready for measurement Switch the reflex measurement on by pressing the REFLEX key The word Ipsi must appear at the right top of the display The sound stimuli for the reflex measurement are reproduced by the receiver integrated in the probe Set
8. Lely A cochlea ear drum middle ear eustachian tube Figure 10 The middle ear The impedance measurement examines the acoustic resistance of the hens A middle ear If the eardrum is hit by a ee ga rN h sound a part Is absorbed and sent via the middle ear to the inner ear while the other part is reflected The stiffer the eardrum is the more sound is reflected and the less sound reaches the inner ear In the probe of the impedance measuring instrument a small loudspeaker is installed which emits a sound of low frequency via a GEBARaceCar_Tymp_e 11a docx 16 microphone A Y Ave rea a sealing new 450 Ap manometer Figure 11 Principle of impedance measurement 850 274 3 11 11 Operating Instructions RaceCar Tymp tube A see Figure 11 into the auditory canal before the eardrum Another tube B is connected to the microphone inside the probe which receives the sound Together with a third tube C all three are inserted nearly to the eardrum and are made airtight against outside pressure by the ear tip A manometer and a pump which can produce both positive and negative pressure are connected with tube C Less sound is reflected to the microphone when the eardrum is agile high compliance and the eardrum transmits the majority of the sound via the middle ear to the inner ear The highest compliance is normally reached with an air pressure corresponding to the outside pressure When performing tympanome
9. RaceCar Tymp Standard accessories 1 hand held probe 1 mains cable 1 set of ear tips 1 calibration cavity cavities 5ml 2ml 0 5ml with probe holder 1 printer paper roll for app 350 printouts 1 sticker roll Race Car Optional accessories TDH 39 contra phone Part No 46 82 Carrying case Part No 70 50 14 Soft side carrying case Part No 1035 3002 Consumables 1 roll printer paper Part No 70 50 78 1 set of 10 Ear tips yellow 7 4 mm Part No 70 50 56 1 set of 10 Ear tips green 9 mm Part No 70 50 57 1 set of 10 Ear tips white 11 mm Part No 70 50 58 1 set of 10 Ear tips yellow 12 5 mm Part No 70 50 59 1 set of 10 Ear tips green 15 mm Part No 70 50 60 1 set of 10 Ear tips blue 18 mm Part No 70 50 61 GEBARaceCar_Tymp_e 11a docx 4 850 274 3 11 11 Operating Instructions RaceCar Tymp Specifications are subject to change MAICO Diagnostic GmbH Salzufer 13 14 D 10587 Berlin Telephone 49 30 70 71 46 50 Telefax 49 30 70 71 46 99 internet www maico biz e mail export maico biz GEBARaceCar_Tymp_e 11a docx 48 850 274 3 11 11
10. be repaired only by your dealer or by a service centre recommended by your dealer 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 Tympanometer should be checked and calibrated at least once a year This check has to be carried out by your dealer When returning the instrument for repairs it is essential to also send the probe and all other accessories Send the device to your dealer or to a service centre authorized by your dealer Please also include a detailed description of the faults In order to prevent damage in transit please use the original packing if possible when returning the instrument NOTE 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 of electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distribution costs we assign the responsibility for the proper collection SS and treatment according to legal regulations to our customers y x GEBARaceCar_Tymp_e 11a docx 42 850 274 3 11 11 Operatin
11. empty E aan T measurement screen is shown The a aS mear screen ons aud en e e E E E settings test results and the Aenea oe o t a y W e graphical display of the recie e E E E e E es ne SY The top line shows trom left to the eee eee 300 dapa Gradient Status READY Compliance Pressure 3 gt s S a y right the type of test in example 600 300 figure 5 Impedance the selected i test ear left or right and the HH selected reflex test ipsi contra sohen toed zobel a H m 4 or Tympanogram if no reflex test is selected Figure 5 Measurement screen of the Race Car Tympanometer At the left centre the graph of the tympanogram is shown At the right five boxes show the status and test values The upper box shows the actual status of the instrument e READY means that the instrument is ready for testing e IN EAR shows that the probe is inserted in the ear e TESTING means that the test is in progress e BLOCKED means that probe is blocked in the ear e LEAKING indicates that the air seal of the ear tip in the ear is not proper When the test is finished the boxes below show the volume of the ear canal the compliance the pressure at maximum compliance and the gradient of the tympanogram The four boxes below the tympanogram marked 1 to 4 show the graphical reflex curves after the test Below each box the test level and the test
12. method ipsilateral contralateral option Intensities ipsi 70 dBy 100 dBu Intensities contra 70 dB 110 dBy with TDH 39 contra phone Attack release time typical 10 ms Pressure at test Pressure at max compliance General Memory Storage of test results for both ears Probe Probe with screening insert LCD display Race Car animation graphical display of Tympanograms and reflex curves numeric display of max compliance pressure at max compliance canal volume gradient and reflex thresholds Printer Thermal printer paper roll width 110 mm Print time 4 s one Tympanogram to 12 s Tympanogram and Retlex for both ears Power supply Mains 100 240 V 50 60 Hz Power consumption app 25 VA GEBARaceCar_Tymp_e 11a docx 45 850 274 3 11 11 Operating Instructions RaceCar Tymp Connection plugs BOQ O A Figure 36 Connectors on the rear Connection Specification Mains connection socket lett right power 100 240 V 50 Hz Probe tube connection Probe connection socket PC interface Contra receiver socket Warm up time Environment Conditions Dimensions Weight USB sleeve GND tip out ZA 10 Q UA 8 Vee less than 10 min after power on 15 435 C 59 95 F operation 5 450 C 41 4 122 F storage Maximum humidity 90 storage and operation WxDxH 39x 29x11cm app 2 6 kg GEBARaceCar_Tymp_e 11a docx 46 850 274 3 11 11 Operating Instructions
13. normal tympanograms to a value between 400 daPa and 25 daPa in steps of 25 daPa Comp limit hi With this option you can set the upper limit of the box for normal tympanograms to a value between 0 1 ml and 3 ml in steps of 0 1 ml GEBARaceCar_Tymp_e 11a docx 33 850 274 3 11 11 Operating Instructions RaceCar Tymp Comp limit lo With this option you can set the lower limit of the box for normal tympanograms to a value between 0 1 ml and 1ml in steps of 0 1 ml Seal sensitivity Medium Quicker seal detection and less sensitive than the above selection Minimum This gives reproducible results Requires quiet probe handling Maximum Quick seal detection Robust Very quick seal detection To leave the Tympanometry Setup Menu presses the MENU button GEBARaceCar_Tymp_e 11a docx 34 850 274 3 11 11 Operating Instructions RaceCar Tymp 10 3 Setup Menu for Reflex Test Select the menu option Reflex Test Setup i Reflex Test Setup M Menu from the main setup menu as aie ihal i 1 Auto start dB 80 described before for the Tympanometry T TEET m setup menu and the reflex setup menu Reflex Sensitivity Sensitive l l Print graphic OFF will appear on the LCD display Reflex PASS NR OFF 500 Hz ON 1000 Hz ON 2000 Hz ON The reflex setup menu offers the following rebel i options T 4 Change item Auto start dB Change item setting MENU Exit With this option you can choose the acous
14. of varying intensities at 500 1000 2000 or 4000 Hz are presented as short bursts If a change in compliance greater than 0 05 ml is detected a reflex is considered present Because this is an extremely small compliance change any movement of the probe GEBARaceCar_Tymp_e 11a docx 5 850 274 3 11 11 Operating Instructions RaceCar Tymp during the test may produce an artifact false response The level at which a reflex occurs is recorded as a number as PASS FAIL and in graph form If the tympanometric results display any abnormal findings the results of the acoustic reflex testing may be inconclusive and should be interpreted with care If a flat tympanogram is observed showing a non mobile middle ear system the Race Car Tympanometer will not perform an acoustic retlex test Theoretically a compliance peak is necessary to observe a reflex at peak pressure GEBARaceCar_Tymp_e 11a docx 6 850 274 3 11 11 Operating Instructions RaceCar Tymp 3 Getting started Your Race Car Tympanometer was carefully inspected and packed for shipping However it is good practice to thoroughly inspect the outside of the shipping container for signs of damage If any damage is noted please notity the carrier immediately 3 1 Unpacking Save all the original packing material and the shipping container so the instrument can be properly packaged if it needs to be returned for service or calibration Please check that all accessories listed below
15. the desired volume level with the Down key respectively the Up key On the LCD display below the retlex boxes at the bottom the selected level in dB in example figure 20 80 dB appears The I indicates that an ipsilateral test is selected You can choose between the fixed levels 70 75 80 85 90 95 and 100 dB and AUTO with a starting level of 70 or 80 dBy If you choose AUTO the Race Car Tympanometer starts with the lowest level 70 dBu or 80 dB and increases the level automatically until a reflex is registered or the maximum value Is reached You can choose your individual starting level and maximum level 10 3 The Setup menu for Reflex Test If you have chosen a fixed level the instrument measures only with this level Check if the auditory canal is free Choose the right ear tip according to the size of the auditory canal and put it firmly onto the probe tip GEBARaceCar_Tymp_e 11a docx 24 850 274 3 11 11 Operating Instructions RaceCar Tymp 6 4 Doing the ipsilateral measurement Carry out the measurement as described in chapter 4 4 impedance Right i Measuring the Tympanogram The stapedius reflex is measured eee lea e after the measurement of the ee A AT Tympanogram During the Pe Pipes i measurement of the Sta pedius aga ase a id 0 81 ml E E re 237 daPa reflex the change of the compliance is represented in real time on the LCD display When the test is finished the
16. the test results correctly The graphs of tympanogram and HET age reflex are useful for interpretation The tympanogram displays the middle a mobility The horizontal Figure 24 Printout of a Tympanogram with axis shows the pressure the vertical ipsilateral reflex tests axis the compliance The reflex is displayed in four charts Here the x axis stands for time the y axis shows the changes of compliance GEBARaceCar_Tymp_e 11a docx 2 850 274 3 11 11 Operating Instructions RaceCar Tymp 7 Interpreting Test Results 7 1 Understanding the printout The printout contains the following information Ear volume Compliance Pressure Gradient Reflex Test Results PASS NR and IPSI CONTRA or Tympanogram depending on the test you have done This information provide the data you need to interpret the test results MAICO RaceCar Tymp 600 300 300 daPa A graph of the tympanogram is provided Parolun Oodin Compliance 0 81 ml Pressure 37 daPa Figure 25 to assist you in visual Gradient 32 daPa interpretation of the test This graph is a oe ia representation of the relative mobility of the middle ear system The horizontal axis shows the changes in air pressure and the resulting mobility of the system The compliance is recorded on the vertical axis This mobility is expressed as a change in the volume of the ear canal in ml ml Ipsi 500Hz PASS 0 15 Figure 25 Printout of a Tympanogram
17. you have invested in a device that will adjust to your future needs This user manual should make it as easy as possible for you to become familiar with the functions of the MAICO Race Car Tympanometer Please open out the flap of illustrations on the last page The description of the position e g of controls displays and connections found again in the text will make it easier for you to learn how to operate the MAICO Race Car Tympanometer If you have problems or have ideas for further improvements please get in touch with us Simply call Your MAICO team GEBARaceCar_Tymp_e 11a docx 3 850 274 3 11 11 Operating Instructions RaceCar Tymp 2 Description 2 1 Purpose The Race Car Tympanometer is an automatic instrument designed for tympanometric screening and diagnostic applications The instrument performs automatic impedance tests along with multi frequency multi level reflex screening Test results are displayed on the front panel LCD screen and may be printed 2 1 1 PC Interface An USB interface for data transfer to a connected computer is built in The MAICO Race Car Tympanometer produced according to the A N EN of 60 601 1 medically electrical devices In order to ensure this also with attached computer the computer must correspond to the EN 60 950 1 or EN 60 601 1 Further more the computer must at least one distance from 1 5 m keep to the patient 2 1 2 Environmental conditions for the Race Car Tymp
18. 10 3 7 Calibrate the Probe ccc cece cn cceeecee eee ee eeeeeeee estan eeeeeeeeneeeneeeans 12 3 8 Getting familiar with the Probe cee cececcceseecceeeeceeeeceeneeeeaneees 13 3 9 Choose an appropriate ear tip 0 ccc ec cece ceeece ee eeeeeeeeeeeeneeeaeeeens 14 4 HOW to create a tympanogram 0 ccccccccsccncceeceesccecsedssecnseeccdaseseteeseetaceess 16 4 1 The basics of the impedance MeasureMeNt cccceeeeeeeeeeeeeeeeee ees 16 4 2 Preparing the child for the tympanometry exa M 17 4 3 Preparing the measurement esnsieinesiusirerrerirsrrerrerrrrrrerrerrrern 18 4 3 1 Race Car Modus Tympanogram MOdu ccceceeeeeee ees 18 4 4 Measuring the tympanogramM es esieeinesisruerierrirrrerierrrrrrerrerrrern 18 4 5 Race Car MOUS 1 0 cccc cece eccceccee cece eceeee cess eeeseeeeeeeeeeeeseeeeeeeeaneeenees 19 4 6 How to evaluate the tympanometer results 20 4 7 How to print out the test result ccccceccc cece eeeeeeeee eee eeee enue eenns 2 1 4 8 How to delete the test results 00 0 cececccecceeceeeeeeeeseseeeeeeeeaeeenees 22 5 Measuring smaller children with high tone ccccccce cece cece eceeeeeen ees 22 6 How to measure the stapedius reflex cece cece eccceeeeceeeeceeeeeeeeneeeeanes 23 6 1 The basics of the stapedius reflex measurement 23 6 2 Training the CHIC ccc cc cece ncce ee eeeeeeeeeeeeeeeeee seen eeeeeeeeneeeaeeean 24 6 3 Preparing the ipsilateral measurement
19. 5 Insert your personal printout data eseeeieeeerrererrerrerrerrerrern 37 11 Care and maintenance of the INStrUMENT cece ccc ceecceeeeeeeeeeeeeeees 38 11 1 Cleaning of Ol OCU Oe ent ceensece inno crsccesnanae dotaniatsatasetaaeiaensnconateas 38 12 How to change the printer PaDer 0 cece ccc ccceecceeeeeeeeeee essen eeeneeeans 41 13 Warranty Maintenance and Service cccccccc cece eecee cece eeeneeeee seen eeeens 42 14 Safety Regulations ice casa cee aman eeeeaie eee auaenseecetaactataat cataarieinkadsseceusan esa 43 15 Checklist for subjective device control ccc ecccecccceeceeeeeeee essen eseeaeeenees 44 16 Technical Data and ACC SSOLNIGS ccccccceccecccceccuccccueeceuecucneeueentuneutnnens A5 Operating Instructions RaceCar Tymp 1 Introduction Thank you very much for purchasing a quality product from the MAICO family This automatic Race Car Tympanometer is manufactured to meet all quality and satety requirements and has been certified with the CE symbol according to Medical Directive 93 42 EEC Please note This medical instrument should only be operated by skilled personnel In designing the MAICO Race Car Tympanometer we placed particular importance in making it a user friendly device meaning its operation is simple and easy to understand And because all functions are software controlled upgrading later to new extended measurement functions will be simple and inexpensive That means that
20. ENTER 4 4 Measuring the tympanogram While the child is distracted by the graphics place the hand held probe with proper ear tip inside the child s ear while gently pulling the earlobe down Check for excess wax or obstructions Because children have very small ear canals this allows the operator to maintain a seal easily During the testing concentrate on holding the probe steady BLINKING RED Unit Is in stand by GREEN LIGHT Test is in progress SOLID RED with steady tone Probe is blocked FLASHING RED with three beeps broken probe seal GEBARaceCar_Tymp_e 11a docx 18 850 274 3 11 11 Operating Instructions RaceCar Tymp NOTE The ear tip does not need to go into the ear canal It should only seal the canal opening Attempt to point the end of the ear tip into the canal toward the eardrum Depending on the child a smaller or larger size ear tip may be needed to secure a proper seal 4 5 Race Car Modus During the car race on the integrated LCD screen the test is performed automatically in the background If the child does not move or is talking during the test it wins the race Bow i eS pis vd When the unit is first powered up the screen will show the cheering crowd and the race cars ready to start the race Figure 14 The cars will start the race when a correct probe seal is achieved and the test Is initiated Race car on track and crossing the finish line will illumina
21. a soft cloth dampened with a little warm soapy water or washing up liquid no alcohol or spirits should be used During cleaning please ensure that no liquid runs into the switches level control or probe openings Cleaning of Ear Tips We recommend using a new ear tip for each patient If the clinician rinses the ear tips they should be subjected to standard disinfection procedure between patients This includes physically cleaning the ear tip and use of a recognized disinfectant Individual manufacturer s instruction should be followed for use of this disinfecting agent to provide an appropriated level of cleanliness 11 1 Cleaning of probe tip In order to secure correct impedance measurements It is important to make sure that the probe system is kept clean at all times Therefore please follow the below illustrated instruction on how to remove e g cerumen trom the small acoustic and air pressure channels of the probe tip For the Race Car Tympanometer two different probe systems exist the Screening Probe System and the Diagnostic Probe System The two different probe systems can be seen in the below picture Figure 31 Screening and Diagnostic Probe System GEBARaceCar_Tymp_e 11a docx 38 850 274 3 11 11 Operating Instructions RaceCar Tymp To clean the small acoustic and air pressure channels of the probe tip unscrew the small ribbed plastic nut that holds the probe tip Figure a2 After unscrewing the small ribbed pla
22. anometer The Race Car Tympanometer should be operated in a quiet room The test room must be at normal temperature usually 15 C 59 F to 35 C 95 F and the instrument should be switched on about 10 minutes before the first measurement to guarantee precise measuring results If the device has been cooled down e g during transport please wait until it has warmed up to room temperature musculus stapedius hearing nerye middle ear bones 4 Ess i A As eee _ ae 1 rae er Vee ear canal 7 re i Seip Bel 4 cochle ear drum 2 2 Tympanometry Tympanometry is the objective measurement of middle ear mobility compliance and pressure within the middle ear system During the test a low pitched Figure 1 the middle ear probe tone 226 Hz is presented to the ear canal by means of the hand held probe This tone is used to measure the change in compliance in the middle ear system while the air GEBARaceCar_Tymp_e 11a docx 4 850 274 3 11 11 middle ear eustachian tube Operating Instructions RaceCar Tymp pressure is varied automatically trom a positive value 200 daPa to a negative value 400 daPa max Maximum compliance of the middle ear system occurs when the pressure in the middle ear cavity is equal to the pressure in the external auditory canal This is the highest peak of the curve as It is recorded on the chart The position of the peak on the horizontal axis an
23. are received in good condition If any accessories are missing or damaged immediately notify your MAICO Special Instrument Distributor Accessories Part No 1 Hand held probe with screening insert 705 150 24 count eartips kit 705 069 4 yellow 7 mm 705 056 4 green 9 mm 705 057 4 white 11 mm 705 058 4 yellow 13 mm 705 059 4 green 15 mm 705 060 4 blue 18 mm 705 061 Thermal printer paper 1 roll 705 078 Calibration test cavity 705 167 b Mains cable 8 694 400 528 Sticker roll Race Car 861014 3 2 Preparing the Race Car Tympanometer for use 3 2 1 Connect probe and accessories Connect the probe cable to socket on the rear of the instrument Insert the plug into the socket and protect the connection by fastening the two screws of the connector Figure 2 The probe of the Race Car Tympanometer GEBARaceCar_Tymp_e 11a docx 7 850 274 3 11 11 NN Operating Instructions RaceCar Tymp MAICO Figure 3 Connectors at the rear of the Race Car Tympanometer mains connection socket probe tube connection probe connection socket USB PC interface contralateral earphone socket Insert the pressure tube into the socket and press it until it has a safe fit on the socket 3 3 Connect mains cable and accessories Put the enclosed mains cable into the power connection socket and its mains plug into a power socket The instrument is now operational In case your Race Car Tympanometer is
24. ate the basic conditions for measurements without problems and mistakes GEBARaceCar_Tymp_e 11a docx 14 850 274 3 11 11 Operating Instructions RaceCar Tymp Now all preparations are concluded and you can start the Impedance and reflex measurement Please read the following chapters GEBARaceCar_Tymp_e 11a docx 15 850 274 3 11 11 Operating Instructions RaceCar Tymp 4 How to create a tympanogram In the following paragraph we will deal shortly with the principle and the background of the impedance measurement to create a_ better understanding If you want to begin the measurements immediately just skip this paragraph and continue reading with 4 3 Preparing the measurements 4 1 The basics of the impedance measurement The impedance measurement serves the diagnosis of the condition of the middle ear and can therefore not be compared Lo directly with other audiometrical 38 tests such as sound or speech i audiometry which serve the measurement of the hearing Furthermore the impedance measurement is an objective measuring method which does not depend on the cooperation of the test person and can therefore not be falsified by him The two most important impedance measuring methods possible with your Race Car Tympanometer are tympanometry and the measurement of the Stapedius reflex which is treated in chapter 6 How to measure the Stapedius reflex musculus stapedius hearing nerye middle ear bones ear canal
25. ce the new paper roll in the paper compartment in such a way that the paper ascends from the lower part of the paper roll Pull the blue lever which is located on the right front of the printer into its forward position The paper must roll trom the bottom because it is coated on one side only If it is inserted wrongly no printout is visible Gently insert the paper end between the rubber roll and the black plastic part at the rear of the printer Transport the printer paper until it appears trom the upper part of the rubber roll Pull then the paper end app 10 to 15 cm Push the blue lever into its backward position Guide the paper end through the paper slot of the printer cover Close the printer cover by putting the two guide rails at the end of the printer cover into the appropriate slot of the paper compartment of the housing of Race Car Tympanometer Press the front of the printer cover down until it fastens The instrument is now ready to print GEBARaceCar_Tymp_e 11a docx 41 850 274 3 11 11 Operating Instructions RaceCar Tymp 13 Warranty Maintenance and Service The Race Car Tympanometer is guaranteed for 1 year This warranty is extended to the original purchaser of the instrument by MAICO through the Distributor from whom it was purchased and covers defects in material and workmanship for a period of one year from date of delivery of the instrument to the original purchaser The Tympanometer may
26. curves for ee Gradient 300 daPa 32 daPa 4 3 the changes of compliance for 500 He 1000 He 2000 kz 4000 Hz 500 Hz 1000 Hz 2000 Hz and AUTO NdB scale 4000 Hz are shown in four Figure 21 Example of a normal Tympanogram with separate graphs at the bottom of ipsilateral reflex results the measurement screen see Figure 23 Below each curve you see the test level where a stapedius reflex was registered automatically This is indicated by a PASS below the frequency If no reflex was detected a NR is reported and the maximum level is shown You can judge watching the real time graph if you have a real stapedius reflex or only disturbance and artifacts The lower dotted zero line of a graph indicates the measured compliance without a test sound All the positive or negative changes of compliance are shown as deviation from the zero line If a stapedius reflex occurs the compliance decreases and the curve rises The box which occurs during the test symbolizes the threshold at which the Race Car Tympanometer accepts a change of compliance as valid stapedius reflex GEBARaceCar_Tymp_e 11a docx 25 850 274 3 11 11 Operating Instructions RaceCar Tymp 6 5 Preparing the contralateral measurement Switch on the contralateral reflex measurement by pressing again the red REFLEX key The word CONTRA must appear on the right top of the LCD display Here the highest fixed level is 110 dB
27. d on the vertical axis of the chart will provide diagnostic information regarding the function of the middle ear system Examples of normal and abnormal tympanograms can be found in a later section of this manual Gradient calculations are reported as the tympanogram width at halt of peak compliance expressed in daPa A limits box is available on both the display and printout to aid in diagnosis Compliance is measured with respect to an equivalent volume of air with the scientitic quantity milliliter ml Air is measured in deca Pascals daPa NOTE 1 02 mmH gt 0 1 0 daPa 2 3 Acoustic Reflex An acoustic reflex or contraction of the stapedial muscle occurs under normal conditions when a sufficiently intense sound is presented to the auditory pathway This contraction of the muscle causes a stiffening of the ossicular chain which changes the compliance of the middle ear system As in Tympanometry a probe tone is used to measure this change in compliance When the stimulus presentation and measurement are made in the same ear by means of the probe this acoustical reflex is referred to as an ipsilateral acoustic reflex When the stimulus presentation and measurement are made in opposite ears the reflex is referred to as a contra lateral acoustic retlex For best results this reflex measurement is automatically conducted at the air pressure value where the compliance peak occurred during the tympanometric test Stimulus tones
28. ddle ear The a i middle ear contraction called stapedius reflex causes a decrease in compliance and is caused by loud acoustic stimuli Regardless whether the acoustic stimulus is active on the left or on the right or on both sides the stapedius reflex is always binaural i e it occurs in both ears at the same time The stapedius reflex is caused in ears of adults with normal hearing by sine sounds with sound pressure levels between 70 and 105 qB eustachian tube Figure 17 The middle ear The reflex method measures continuously in one ear the probe ear the compliance with the pressure which caused before the highest compliance Simultaneously the stimulus ear is irritated by the sound which causes the contraction of the stapedius muscle The ipsilateral retlex measurement uses the same ear for the probe and the stimulus The contra lateral measurement uses different ears for the probe and the stimulus The acoustic stimulus is offered to the Figure 18 Ipsilateral test ear opposite to the probe ear If the offered stimulus causes a reflex the impedance measuring instrument registers a decrease in compliance in the probe ear which indicates a Stapedius reflex at the actual test frequency and the Figure 19 Contra lateral test test level The test level which was set when the reflex occurred is called reflex threshold and is shown in dBHL dB hearing loss GEBARaceCar_Tymp_e
29. e auditory canal between the ear tip and the eardrum in ml in the example 0 94 ml Compliance indicates the maximum value of the compliance from the Tympanogram in ml in the example 0 81 ml Pressure indicates the pressure with the highest measured Compliance in the example 37 daPa Gradient calculations are reported as the Tympanogram width at half of peak compliance expressed in daPa in the example 32 daPa GEBARaceCar_Tymp_e 11a docx 20 850 274 3 11 11 Operating Instructions RaceCar Tymp 4 7 How to print out the test result After the end of a test you can print out the results for your records by pressing the PRINT button The thermal printer MAICO RaceCar Tymp prints Out the result in 6 seconds Id No ee Date o While the printer is working no ie key action Is possible and the Remark eee ee probe is inactive Figure 16 shows eae the printout Id No Here you can put down the patients Social Id number Date Here the actual test date can be stated Name Here you can put down een toe the patients name ae a das Examiner State here the a wena reference for the test person ee Remarks Additional information re ante about the test or patient can be Stated here Tympanogram Figure 16 Printout of Tympanogram All other values and the j aie tympanogram correspond to those you have seen on the LCD display and which were explained on the previous page under 4 7 The intelligent printer contr
30. e ear pressure The ear canal volume is normal and the retlex is either absent or at an elevated level GEBARaceCar_Tymp_e 11a docx 29 850 274 3 11 11 Operating Instructions RaceCar Tymp Eustachian tube disfunction in the absence of fluid will show a normal compliance curve but it will be displayed to the negative side of the tympanogram Ear canal volume will be normal and the reflex may be present depending on the degree of involvement 8 How to test children The practice of the impedance measurement is difficult especially with small children You could have problems with the child being restless or afraid of the examination or reacting sensitively to the change of pressure and the loud test sound but also with different conditions of the eardrum and the middle ear which do not appear in ears of adults During the measurement the minimum compliance must come to 0 08 ml if it is less a straight line runs over the zero line It is difficult to reach a probe seal with restless children If the child yawns or cries it is impossible for the instrument to create a stable pressure in the outer auditory canal In addition speaking causes stapedius muscle reflexes which lead to a permanent change of the compliance of the eardrum So the child should be made familiar with the surroundings and the ear being touched by the probe in order to carry out a successful impedance measurement This could be done by getting in touch with the child and b
31. e into the auditory canal the control light lights green Now the test runs off Do not change the position of the probe any more until the green control light is going out indicating the end of the measurement A yellow control light indicates an error The kind of the error is indicated on the LCD display under status LEAKING The ear tip does not make the auditory canal airtight Change the position of the probe until the control light lights green If you are not successful use a bigger ear tip BLOCKED Indicates the seal of the probe opening Change the position of the probe which points maybe at the side of the auditory canal until the control light lights green If you are not successful please check if the probe is blocked with ear wax The complete probe insert can be changed by pressing the release button and removing the probe insert If the probe tip is clogged you can remove it by opening the fixation ring After cleaning of the probe tip or selection of a new one the tip must be fixed again by fastening the fixation ring 3 9 Choose an appropriate ear tip Choose an ear tip of the appropriate size from the ear tip set Put the ear tip tightly on the probe tip The probe tip should close up with the end of the ear tip It should not disappear with more than about 1 mm in the ear tio or just out of the ear tip By choosing an appropriate ear tip and placing it correctly on the probe you cre
32. ected and the test can be paused and restarted with the probe button Subject Data Printout With this option you can switch ON and OFF the printout of the headline which allows you to enter the data of the patient Clinic Data Printout If you entered your clinic data the printout of the entered data can be switched ON and OFF with this option Print after test With this option you enable an automatic printout after you finished a test by setting it ON With the setting OFF the printout will be only done after you press the PRINT button Race Car Race Car Animation ON or Tympanogram Language You can choose between the languages German Deutsch French Francais English and Spanish Espanol tor the text on the LCD display and the printout After selection all the texts appear in the chosen language Display adjust The contrast of the LCD display can be changed with this option 10 5 Insert your personal printout data Select the menu option Clinic Setup Menu from the main setup menu to enter all required data of your clinic These data will be printed out later together with the test result and the patient data This screen is self explaining GEBARaceCar_Tymp_e 11a docx 3 7 850 274 3 11 11 Operating Instructions RaceCar Tymp 11 Care and maintenance of the instrument Disconnect the power plug before cleaning To clean the Instrument probe contralateral earohone and other accessories use
33. equipped with a contra receiver Plug the cable in the contra receiver socket 3 4 Switch the instrument on Switch the mains switch on The LCD display shows for a moment the instrument type and the software version Then the basic measuring figure appears The Race Car Tympanometer should be switched on about 10 minutes before the first measurement to guarantee precise measuring results If the device has been cooled down e g during transport please wait until it has warmed up to room temperature GEBARaceCar_Tymp_e 11a docx 8 850 274 3 11 11 Operating Instructions RaceCar Tymp 3 5 Getting familiar with the Race Car Tympanometer 2 DW D 3 Figure 4 Controls of the Race Car Tympanometer Print key Left cursor control Right lett ear key Down cursor control Reflex measurement oft ipsi contra Right cursor control Setting of high probe tone Up cursor control Printer Cover Enter Paper slot Power switch Menu key The use of the extended functions is described in chapter 10 Individual Setup of the Race Car Tympanometer GEBARaceCar_Tymp_e 11a docx 9 850 274 3 11 11 Operating Instructions RaceCar Tymp 3 6 The display of the Race Car Tympanometer The test result is shown during the measurement on the LCD display The measurements are saved automatically and can be printed out in a fast and quiet way with the integrated printer In figure 5 the initial
34. frequency are shown After the frequency an I shows the ipsilateral testing is selected GEBARaceCar_Tymp_e 11a docx 10 850 274 3 11 11 Operating Instructions RaceCar Tymp At the bottom line in figure 5 the word AUTO and TJ dB Scale is shown It means that the reflex test level increases automatically until a reflex was found or the maximum level is reached With the cursor up button or down button the test level can be changed to a fixed level The dB values below the boxes change accordingly It is possible to have fixed levels from 70 dB to 100 dB and AUTO GEBARaceCar_Tymp_e 11a docx 11 850 274 3 11 11 Operating Instructions RaceCar Tymp 3 7 Calibrate the probe With the calibration test cavity you adjust your impedance of your tympanometer Do the same when you change the probe from screening probe to diagnostic probe and vice versa The calibration is very easy and takes only 20 seconds Press the menu key and the main menu figure 6 appears on the LCD display Select the menu option Calibration with the Down button Press Enter and follow the instructions on the LCD display as shown in Figure 7 Put the probe tip without ear tip into the hole of the test cavity labeled 0 5 ml and Main Menu Tympanometeranometrie Caibration Setup t 4 Change item ENTER Select item Figure 6 Display Race Car Tympanometer Main Menu wait When the text on the display change
35. g Instructions RaceCar Tymp 14 Safety Regulations 14 1 Electrical safety 14 2 Measuring security 14 3 Device control 14 4 Operation GEBARaceCar_Tymp_e 11a docx The Race Car Tympanometer is constructed to comply with protection class Type BF of the international standard IEC 601 1 EN 60601 1 Protection from an electric shock is ensured even without the system earth connection The instruments are not intended for operation in areas with an explosion hazard To guarantee that the Tympanometer 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 centre In accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done The use of non calibrated Tympanometers is not allowed The user of the instrument should perform a subjective instrument check once a week This check can be done following the list for Subjective instrument check see next page For your own security you should copy the enclosed list Till it in once a week and store it in your Tiles Only skilled personnel Audiologists ENT professionals or other with equivalent knowledge should operate the instrument 43 850 274 3 11 11 Operating Instructions RaceCar Tymp 15 Checklist for subjective device control According to the manufacturer requirement the user should control the inst
36. is section to provide samples of tympanograms which reflect abnormal states of the middle ear mechanism It is not the intention of this section to provide you with a complete guide to interpreting results Complete information regarding pathologies and abnormal impedance testing can be found in the literature referenced A perforation in the tympanic membrane will cause a high ear canal volume measurement because the instrument will measure the volume of the entire middle ear space The Race Car Tympanometer may refuse to run the test with the probe indicating a volume out of tolerance by illuminating the red light or a flat tympanogram will be recorded since no movement will occur with a change in air pressure Without a peak compliance of at least 0 1 ml the reflex test will not initiate An extremely flaccid tympanic membrane or an ossicular chain discontinuity will yield very high peak compliance in the presence of normal middle ear pressure Ear canal volume will be normal and the reflex will be absent A fixation of the ossicular chain as in otosclerosis will produce a Tympanogram with very low compliance in the presence of normal middle ear air pressure Ear canal volume is normal and the reflex is absent Middle ear fluid such as serious otitis media will yield a very flat tympanogram with no definite peak and negative air pressure A resolving case or beginning case may produce a reduced peak in the presence of severe negative middl
37. ol helps you to save paper It will only print out what has really been measured So the printout of the reflex frequencies misses in the example above because only the tympanogram was measured If you have saved two tympanograms for example tor both the left and the right ear both are printed out side by side You can produce as many printouts as you want by pressing several times the PRINT button GEBARaceCar_Tymp_e 11a docx 21 850 274 3 11 11 Operating Instructions RaceCar Tymp 4 8 How to delete the test results By pressing the L R key longer the measurement memory will be deleted On the LCD display the message Delete all Data occurs Press the ENTER button to delete all patient data Then the LCD display shows an empty measurement screen If you press the MENU button you return to the measurement screen without deleting the measurement data 5 Measuring smaller children with high tone In addition to the standard 226 Hz probe tone tympanometry the Race Car Tympanometer has a high frequency probe tone of 1000 Hz that can be selected by the user A tympanogram recorded using the high probe tone is generally better suited for screening newborns and small children and provides more accurate results for smaller ear canals To select high probe tone frequency When the instrument is switched on it automatically powers up in the Standard tympanometry mode In order to choose tympanometry with high probe tone
38. ou can carry out all normal measurements and print them out too In addition the Race Car Tympanometer TY Change Item offers many hidden chances for the ENTER Select Item Menu Escape experienced user to adapt the instrument to his individual demands Figure 26 Main Menu Setup activated In the following all the setup options are treated precisely The settings shown in the figures are the standard settings If you have altered a value by accident you just have to return to the standard setting shown here and the instrument will work as before By pressing the menu key you can return from every sub menu to the main menu and after all to the Tympanometry mode You can change the menu options with the cursor keys Up Left Down and Right The menu option actually selected is marked inverse on the LCD display SETUP in the example Figure 26 You select the chosen menu option by pressing Enter amp 10 1 The setup menu Main Setup Menu Select the menu option SETUP as illustrated in Figure 27 and the main a ai setup menu will appear on the LCD Clinical Setup Menu display You can make different settings for the measurement of the i lchencelnet Tympanogram and the stapedius retlex SFR clack enue for instrument setup for example the contrast of the LCD display All your ome settings are saved permanently until you will change them again The settings also survive when the instrument i
39. rt in the Race Car game Is to remain as still as possible so the race car on the screen can speed down the track and cross the finish line a WINNER Explain that this is the only way to win the race and avoid getting a flat tire GEBARaceCar_Tymp_e 11a docx 850 274 3 11 11 Operating Instructions RaceCar Tymp 4 3 Preparing the measurement Before you start a new measurement delete Impedance Right Tympanogram former test results see also chapter 4 8 The LCD display shows the empty measurement screen for the right ear and the control light of the probe lights red If you want to measure the lett ear change the side by pressing the L R key or the probe button Then the Figure 13 Measurement screen only Tympanogram selected test ear shown in the middle of the top of the LCD display will change from Right to Left and the control light of the probe lights blue Switch off the reflex measurement by pressing the REFLEX key The word Tympanogram must appear at the right top of the display Control if the auditory canal is free Choose the right ear tip according to the size of the auditory canal and put it firmly onto the probe tip Status READY Ear Volume Compliance Pressure Gradient a 4 3 1 Race Car Modus Tympanogram Modus You can switch between car race and tympanogram at any time To get from race to tympanogram press MENU To get back to the race press
40. rument once a week to find errors immediately and to avoid wrong test results He should test Tympanogram and Reflex with an otologic normal person and compare the results with earlier measurements The printout should be Tiled together with the subjective test protocol to the documents of the instrument The test person should be healthy no otitis etc and should by not be exposed to loud noise at least 12 hours Instrument type Serial No Test person Connectors and cables OK Instrument and probe OK Is the green light of the probe blinking Are Probe tip and ear tip clean Are all controls easy to use Are the test signals clear and non distorted If significant differences or damages are found please inform the service Tested by Date GEBARaceCar_Tymp_e 11a docx 44 850 274 3 11 11 Operating Instructions RaceCar Tymp 16 Technical Data and Accessories The Impedance meter Race Car Tympanometer Is an active diagnostic medical product according to the class lla of the 0123 EU medical directive 93 42 EEC Impedance measurement Type Class 2 acc to IEC 645 5 EN 60645 5 Tympanometer Test frequency 226 Hz 1 Test level 85 dBcp in 2 cm High frequency 1000 Hz 1 Test level 83 dBcp in 2 cm Pressure range 200 to 400 daPa Volume range 0 1 to 6 0 ml Accuracy 5 or 10 daPa Compliance range 0 1 to 6 0 ml Reflex measurement Test frequencies 500 Hz 1 kHz 2 kHz 4 kHz 2 Test
41. s switched off Main Setup Menu Setup activated GEBARaceCar_Tymp_e 11a docx 32 850 274 3 11 11 Operating Instructions RaceCar Tymp 10 2 Tympanogram Setup Menu Select the menu option Tympanogram Tympanogram Setup Menu Setup Menu As illustrated in Figure 28 and the Tympanogram setup menu will OE appear on the LCD display Press Limit hi 150 daPa Press Limit Lo 400 daPa Comp Limit hi 1 5 ml Comp Limitlo 0 1 daPa You change the menu options with the cursor keys DOWN respectively UP a I a You can change the invers displayed item l l tT J Change item with the cursor keys LEFT respectively Change item setting MENU Exit RIGHT The following settings are possible Figure 28 Tympanogram Setup Menu Pump speed With this option you can set the measurement speed With Automatic the pump speed adjusts automatically to the test conditions It is possible to choose also Minimum Medium or Maximum Of course a lower pump speed creates a higher precision of the measurement but needs more test time Display limits With ON you switch on the field tor normal curves surrounded by a broken line in the tympanogram With OFF you switch it off Press Limit hi With this option you can set the right limit of the box for normal tympanograms to a value between O daPa and 200 daPa in steps of 25 daPa Press Limit lo With this option you can set the left limit of the box for
42. s to the request for the 2 ml calibration put the probe tip in the 2 ml cavity and proceed as described above After the successful calibration of the 5 ml volume the Race Car Tympanometer switches automatically to the tympanometry mode The basic menu for the impedance measurement appears again and you are ready for measurements If the error information Cavity calibration out of range appears during the calibration please control if the opening of the probe tip is clean and try to recalibrate the probe For more information about cleaning the probe also read Chapter 11 1 Cleaning the probe If the error information appears again Calibration Place the probe in the 0 5 ml cavity the probe or the instrument is probably defect Inform your service to get immediate help GEBARaceCar_Tymp_e 11a docx 12 Figure 7 Display Race Car Tympanometer Calibration 850 274 3 11 11 Operating Instructions RaceCar Tymp 3 8 Getting familiar with the probe The probe of the Race Car Tympanometer is shown in figure 8 The probe head is adjustable in three steps 0 60 and 80 It is adjusted by releasing the fixation screw Figure 9 at the bottom of a ka ala the probe using a coin or a screw driver Adjust the probe head by pulling it into the required position until it rests To do this hold the probe handle with the other hand After it is set to the required position fasten the fixation screw
43. stic nut It is possible to detach the small probe tip with the small acoustic and air pressure channels trom the transducer house Plastic Nut Housing Probe Tipp with acoustic and air pressure channels Figure 33 The cleaning of the acoustic and air pressure channels of the probe tip must be performed by means of the cleaning wire nylon wire which can be found in the Ear tips Assortment provided with the Race Car Tympanometer GEBARaceCar_Tymp_e 11a docx 39 850 274 3 11 11 Operating Instructions RaceCar Tymp When cleaning the acoustic and air pressure channels of the probe tip the cleaning wire must be inserted from the back of the probe tip according to Figure 34 Figure 34 Transparent Sealing Besides cleaning the holes ensure also a proper surface cleaning of the transparent sealing After cleaning all the acoustic and air pressure channels of the probe tip it can be reassembled Make sure that the Probe Tip with the transparent sealing is connected correctly onto the Transducer Housing a small tlange will ensure correct positioning before the plastic nut is gently tightened Figure 35 GEBARaceCar_Tymp_e 11a docx 40 850 274 3 11 11 Operating Instructions RaceCar Tymp 12 How to change the printer paper Open the printer at the right side of the housing by pulling up the printer cover using its finger mould in front Remove the printer cover Remove the empty paper roll Pla
44. te while the testing is IN Process Figure 14 Start Screen When the test is completed Winner will illuminate followed quickly by a cheering crowd and the tympanometer results The screen flat tires will illuminate when a probe seal is oroken during the testing The child has lost the race As soon as the child understands the relation between not moving and winning the race testing will be easy GEBARaceCar_Tymp_e 11a docx 19 850 274 3 11 11 Operating Instructions RaceCar Tymp 4 6 How to evaluate the tympanometer results After having carried out a measurement YOU can Tymp 226 Hz Tympanogram see the Tympanometer Te results on the LCD Status display on BEE Ear Volume 0 94 ml On the left side of the eer oe nae compl 6 wee sill a ompliance display you see the 0 81 ml tympanogram The area See a Pressure surrounded by the box Sara ae 37 daPa is valid for normal l Gradient 32 daPa tympanograms You can change the area or switch it off For details see chapter 10 Individual Setup of the Race Car Tympanometer In the middle of the top of the LCD display the word Right or Left indicates the ear chosen at the moment Figure 15 Display of a 226 Hz Tympanogram Tympanogram at the right top indicates that the reflex measurement has been switched off In the boxes at the right the determined measurements are displayed Ear Volume indicates the volume of the section of th
45. tic pressure level the Race Car Figure 29 Tympanometer starts the reflex level Race Car Timpanometer Reiloretip measurement with if the automatic Menu identification of the reflex threshold is switched on You can choose the acoustic pressure levels from 70 dB till 100 dBy in steps of 5 dB Auto maximum dB With this option you can choose the maximal acoustic pressure level the Race Car Tympanometer uses if the automatic identification of the reflex threshold is switched on You can choose the maximum acoustic pressure levels from 70 dB till 110 dBu in steps of 5 dB Reflex sensitivity With this option you select the sensitivity of the stapedius reflex detection With the setting Sensitive small changes of the compliance will achieve PASS as test results With the setting Robust a larger compliance change is needed to detect a PASS The setting Normal is the default setting Print graphic With this option you can switch ON and OFF the printout of the graphic reflex display for documentation Reflex PASS NR The automatic retlex PASS NR analysis you can switch ON and OFF GEBARaceCar_Tymp_e 11a docx 35 850 274 3 11 11 Operating Instructions RaceCar Tymp 500 Hz With this option you can switch ON and OFF the stapedius reflex test for 500 Hz 1000 Hz With this option you can switch ON and OFF the stapedius reflex test for 1000 Hz 2000 Hz With this option you can switch ON and OFF the stapedi
46. try during a measurement a continuous change of over and under pressure is performed by the pump of the instrument in the outer auditory canal before the eardrum which is sealed by the ear tip in addition to the measurement with normal pressure The compliance is measured simultaneously and shown in a diagram the tympanogram which illustrates the compliance in ml over the pressure in daPa In figure 12 the area for normal tympanogram curves is hatched Here you can see that the highest compliance is reached with normal pressure When you create over or under pressure the eardrum stiffens the compliance decreases So you can draw conclusions on the condition of the middle ear trom the form and the values of the tympanogram lta tle a A a X ANA NAN DS mes RA ALC Sx a T 100 0 100 Pressure daPa Compliance ml Figure 12 Tympanogram normal curve area is hatched 4 2 Preparing the child for the tympanometry exam The best way to prepare a child is to pretend that he she is going to play a game Suggesting that the child is going to play a game will assist in reducing the anxiety that may be associated with the test Tympanometry can be performed while sitting or standing The most important consideration is to make the patient as comfortable as possible so he she can be still for just the Tew seconds necessary to perform the test The child should be told that his her pa
47. us reflex test for 2000 Hz 4000 Hz With this option you can switch ON and OFF the stapedius reflex test for 4000 Hz 10 4 The Common Setup Menu Select the menu option Common Setup Menu from the main setup Common Setup Menu_ menu as described before and the Coninianication USB R Switch L R common setup menu will appear on the Sta BL intue SON Clinic Data Printout ON LCD display Print After Test OFF RaceCar ON Language English The common setup menu offers the Display adjust following options T 4 Change item Power up Change Item setting MENU Exit With this option you can choose the test mode of the Race Car Tympanometer Figure 30 after switching on With the setting Race Car Tympanometer common Setup Menu Tympanometer only Tympanometry is tested after power up Choose Tympanometer and Reflex tympanometry and reflex are tested after power up High Probe Tone With this option you can choose the test mode OFF and ON If it is on you can measure with 1000 Hz GEBARaceCar_Tymp_e 11a docx 36 850 274 3 11 11 Operating Instructions RaceCar Tymp Communication This is only the reference to the USB interface Remote Switch With this option you can change the function of the probe button You can choose between L R test ear can be selected with the probe button Pause test can be paused and restarted with the probe button L R or Pause Test ear can be sel
48. y with optional TDH 39 contra phone only The contra lateral measurement produces more reliable results because the earphone emitting the test signal and the probe measuring the compliance are separated Continue now as described previously for the ipsilateral measurement Impedance Right Contra READY Ear Volume 0 94 ml Compliance 0 81 ml Pressure 37 daPa Gradient 32 daPa I 500 Hz 1000 Hz 2000 Hz 4000 Hz PASS PASS PASS PASS AUTO N dB Scale Figure 22 Example of a normal Tympanogram with contra lateral reflex results 6 6 How to interpret the reflex display After having carried out a measurement you can read the recorded values on the LCD display In addition to the Tympanogram shown on the left side and the values shown on the right you now see the results of the reflex measurement in the lower part of the display In four boxes marked 1 to 4 the Stapedius response is shown graphically Below each box the test level the test frequency and the type of the test l ipsi C contra lateral are shown Also the test result is shown as PASS or NR In the example in Figure 23 for 500 Hz a stapedius reflex was registered at 100 dBy and for 4 kHz at 100 dB If no reflex GEBARaceCar_Tymp_e 11a docx 26 Impedance Right Ipsi READY Ear Volume 0 94 ml Compliance 0 81 ml Pressure 37 daPa
49. y touching the ear in a playing way with the probe If you can touch the ear without problems the child will normally accept the probe being inserted If the child has accepted the surroundings and the touch of the ear it is important to distract the child s mind from the measurement Here you can succeed in diverting the child by many different methods Your phantasy is nearly unlimited you just have to avoid loud sound In case you measure very small children and have to calm them with e g a dummy or a teal feeding bottle the result might be slightly falsified maybe by a slightly irregular line of the Tympanogram GEBARaceCar_Tymp_e 11a docx 30 850 274 3 11 11 Operating Instructions RaceCar Tymp 9 Recommended literature Auditory Disorders A Manual for Clinical Evaluation Jerger Susan and James Jerger Boston College Hill Press 1981 Handbook of Clinical Audiology Katz Jack Baltimore William amp Wilkins 1994 Roeser s Audiology Desk Reference Roeser Ross J New York Stuttgart Thieme 1996 Auditory Diagnosis Silam Shlomo and Carol A Silvermann San Diego London Singular Publishing Group 1997 GEBARaceCar_Tymp_e 11a docx 31 850 274 3 11 11 Operating Instructions RaceCar Tymp 10 Individual setup of the Race Car Tympanometer While getting familiar with the Race Car E Tympanometer in the previous chapters you had the chance to find out how easy Calibration the instrument is to control Y
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