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- MI 34
- Operating Instructions Manual
Maico MI 34 Operating Instructions Manual
Summary of MI 34
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Operating instructions maico mi 34.
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Operating instructions mi 34 / mi 34 h table of contents page 1 introduction ............................................................................................ 4 2 description ............................................................................................. 5 2.1 purpose .........
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Operating instructions mi 34 / mi 34 h 6.5 preparing the contralateral measurement ........................................ 26 6.6 how to interpret the reflex display .................................................. 26 6.7 how to print out the test result .............................................
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Operating instructions mi 34 / mi 34 h 17.5 patient safety: .............................................................................. 53 18 checklist for subjective device control ................................................. 55 19 technical data and accessories ...............................
Page 5: 1 Introduction
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 4 850 232/14 08/11 1 introduction thank you very much for purchasing a quality product from the maico family. This automatic tympanometer maico mi 34 is manufactured to meet all quality and safety requirements, and has been certified with the...
Page 6: 2 Description
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 5 850 232/14 08/11 2 description 2.1 purpose the mi 34 is an automatic instrument designed for tympanometric screening and diagnostic applications. The instrument performs automatic impedance tests along with multi-frequency, multi-level refl...
Page 7: 2.3 Acoustic Reflex
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 6 850 232/14 08/11 figure 1 the middle ear hearing nerve ear canal middle ear bones ear drum middle ear eustachian tube cochle musculus stapedius the hand-held probe. This tone is used to measure the change in compliance in the middle ear sys...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 7 850 232/14 08/11 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...
Page 9: 3 Getting Started
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 8 850 232/14 08/11 figure 2 diagnostic probe with additional screening probe tip 3 getting started your mi 34 was carefully inspected and packed for shipping. However, it is good practice to thoroughly inspect the outside of the shipping cont...
Page 10: 3.4 Switch The Instrument On
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 9 850 232/14 08/11 figure 3 connectors at the rear of the mi 34 ¬ ¯ ® « «♣= mains connection socket ¬♦= probe tube connection = probe connection socket ® = usb pc-interface ¯ = contra receiver socket 3.3 connect mains cable and accessorie...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 10 850 232/14 08/11 figure 4 the controls of the mi 34 print l / r reflex menu enter print l / r reflex menu enter 2 1 3 10 9 11 8 12 13 14 4 16 15 3.5 getting familiar with the mi 34 Ã = print key Ä = right/left ear key Å = reflex measuremen...
Page 12: 3.6 The Display of The Mi 34
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 11 850 232/14 08/11 figure 5 the measurement screen of the mi 34 status ready ear volume compliance pressure gradient impedance ipsi right ml 3 2 1 0 -600 -300 300 dapa 1 500 hz i 4 4000 hz i 3 2000 hz i 2 1000 hz i auto db pressure 80 80 80 ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 12 850 232/14 08/11 found or the maximum level is reached. With the cursor up button Î or down button Ì 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...
Page 14: 3.7 Calibrate The Probe
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 13 850 232/14 08/11 3.7 calibrate the probe with the calibration test cavity you can adjust your impedance with measuring instrument. Do the same when you change the probe (from screening probe to diagnostic probe and vice versa). The calibra...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 14 850 232/14 08/11 figure 8 mi 34 probe with additional screening probe tip e m e n e o e p e q e r e s e x 3.8 getting familiar with the probe the probe of the mi 34 is shown in figure 8. The probe head is adjustable in three steps (0°, 60°...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 15 850 232/14 08/11 operation pauses also the test. The colour of the control light ¹ of the probe indicates in standby the selected ear and in operation the fitting of the probe in the auditory canal: a red control light ¹ indicates that the...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 16 850 232/14 08/11 by choosing an appropriate ear tip and placing it correctly on the probe you create the basic conditions for measurements without problems and mistakes. Now all preparations are concluded and you can start the impedance an...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 17 850 232/14 08/11 figure 10 the middle ear hearing nerve ear canal middle ear bones ear drum middle ear eustachian tube cochlea musculus stapedius figure 11 – principle of impedance measurement 4 how to create a tympanogram in the following...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 18 850 232/14 08/11 figure 12 – tympnaogram (normal curve area is hatched) figure 13 auditory canal before the eardrum. Another tube b is connected with the microphone in the probe which receives the sound. Both tubes are lead together with t...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 19 850 232/14 08/11 impedance right tympanogram status ready ml 3 2 1 0 -600 -300 300 dapa ear volume compliance pressure gradient figure 14 - measurement screen (only tympanogram) 4.3 preparing the measurement before you start a new measurem...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 20 850 232/14 08/11 figure 15 display of a 1000 hz tympanogram right tympanogram status ready ml 3 2 1 0 -600 -300 300 dapa ear volume compliance pressure tymp 1000 hz gradient 0.94 ml 0.81 ml - 37 dapa 32 dapa side by pressing the l/r-key Ä ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 21 850 232/14 08/11 0.94 ml 0.81 ml - 37 dapa 32 dapa ml 3 2 1 0 -600 -300 300 dapa right ear volume compliance pressure gradient 0.94 ml 0.81 ml -37 dapa 31 dapa tympanogram remarks: examiner: name: id no.: date: maico mi 34 figure 16 – prin...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 22 850 232/14 08/11 5 measurement with hightone (optional mi 34 h) in addition to the standard 226 hz probe tone tympanometry, the mi 34 h has a high frequency probe tone of 1000 hz that can be selected by the user. A tympanogram recorded usi...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 23 850 232/14 08/11 figure 17 the middle ear hearing nerve ear canal middle ear bones ear drum middle ear eustachian tube cochlea musculus stapedius figure 18 ipsilateral test figure 19 contra lateral test 6. How to measure the stapedius refl...
Page 25: 6.2 Training The Test Person
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 24 850 232/14 08/11 figure 20 display tympanogram + reflex (ready for measurement) status ready ear volume compliance pressure gradient impedance ipsi right ml 3 2 1 0 -600 -300 300 dapa 1 500 hz i 4 4000 hz i 3 2000 hz i 2 1000 hz i auto db ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 25 850 232/14 08/11 figure 21 example of a normal tympanogram with ipsilateral reflex results right status ready ml 3 2 1 0 -600 -300 300 dapa ear volume compliance pressure impedance gradient 0.94 ml 0.81 ml - 37 dapa 32 dapa ipsi 1 2 3 4 50...
Page 27: 6.6 How to Interpret The
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 26 850 232/14 08/11 figure 22 example of a normal tympanogram with contra- lateral reflex results figure 23 example of a normal tympanogram with ipsilateral reflex results right status ready ml 3 2 1 0 -600 -300 300 dapa ear volume compliance...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 27 850 232/14 08/11 registered at 100 db hl and for 4 khz at 95 db hl . If no reflex threshold was registered the information fail appears below the frequency. A correct interpretation of the measuring results can only follow in connection wi...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 28 850 232/14 08/11 0 .9 4 m l 0 .81 m l - 3 7 d ap a 3 2 d apa m l 3 2 1 0 -6 0 0 -3 00 30 0 d a pa r igh t ea r v olu m e c o m p lia nce pressure g ra d ien t 0 .9 4 m l 0 .8 1 m l -3 7 d a pa 3 2 da pa t y m p a n o g ra m r e m ark s: e ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 29 850 232/14 08/11 figure 25 fixation of the diagnostic probe 7 reflex decay test operation the diagnostic probe insert must be used for this test. If you are currently using the optional screening probe insert, do not use it for this test! ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 30 850 232/14 08/11 figure 26 the reflex decay screen with test result reflex ipsi decay 1000 hz rechts ml 0,15 0.10 0.05 0 1 80 1000 hz i 4 hz 3 2 hz s decay (+ 34 %) d 90 2000 set the desired volume level with the down-key Ì respectively th...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 31 850 232/14 08/11 when you finished all decay tests and have pressed the decay-key, you can print out the result for your documents by pressing the blue print key Ã..
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 32 850 232/14 08/11 figure 27 the etf screen right etf intact status ready ml 3 2 1 0 -600 -300 300 dapa ear volume impedance pressure 1 pressure 2 pressure 3 figure 28 the etf screen after first test cycle (pressure 1) right etf intact statu...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 33 850 232/14 08/11 figure 29 the etf screen after second test cycle (pressure 2) right etf intact status ready ml 3 2 1 0 -600 -300 300 dapa ear volume impedance pressure 1 pressure 2 pressure 3 - 12 dapa make patient increase middle ear pre...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 34 850 232/14 08/11 figure 31 the etf perforated screen right etf perforated status ready dapa 300 - 300 - 600 40 s 300 dapa impedance pressure 8.2 etf test for patients with perforated tm the test determines if the patient can open his/her e...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 35 850 232/14 08/11 once the peak pressure has been obtained ask the patient to swallow. If the eustachian tube opens, a drop in pressure will be recorded. Repeated attempts to swallow will display a ”stair step” effect, or a complete drop to...
Page 37: 9 Interpreting Test Results
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 36 850 232/14 08/11 0 .9 4 m l 0 .8 1 m l - 3 7 d ap a 3 2 d ap a m l 3 2 1 0 -6 0 0 -3 0 0 3 0 0 d a pa r ig h t ea r v o lu m e c o m p lia n ce pressure g rad ien t 0 .9 4 m l 0 .8 1 m l -3 7 d a pa 3 2 d a pa t y m p a n o g ra m r e m a ...
Page 38: 9.3 Abnormal Values
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 37 850 232/14 08/11 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 se...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 38 850 232/14 08/11 severe negative middle ear pressure. The ear canal volume is normal and the reflex is either absent or at an elevated level. Eustachian tube disfunction in the absence of fluid will show a normal compliance curve, but it w...
Page 40: 10 How to Test Children
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 39 850 232/14 08/11 10 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 t...
Page 41: 11 Recommended Literature
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 40 850 232/14 08/11 11 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 & wilkins, 1994 s...
Page 42: 12.1 The Setup Menu
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 41 850 232/14 08/11 setup menu tympanogram setup menu: reflex test setup menu: common setup menu: clinical setup menu: ↑ ↓ change item enter select item menu escape 12 individual setup of the mi 34 while getting familiar with the mi 34 in the...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 42 850 232/14 08/11 figure 35 tympnanogram setup menu tympanogram setup menu pump speed: automatic display limits: on press. Limit hi.: 150 dapa press. Limit lo.: -400 dapa comp limit hi.: 1.5 ml comp. Limit lo.: 0.1 dapa seal sensitivity: me...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 43 850 232/14 08/11 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: minimum: this gives reproducible results. Requires qui...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 44 850 232/14 08/11 12.3 the setup menu for reflex test select the menu option “reflex test setup menu”: from the main setup menu as described before for the tympanometry setup menu and the reflex setup menu will appear on the lcd display Ç. ...
Page 46: 12.4 The Common Setup Menu
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 45 850 232/14 08/11 2000 hz: with this option you can switch on and off the stapedius reflex test for 2000 hz. 4000 hz: with this option you can switch on and off the stapedius reflex test for 4000 hz. Ipsi agc: with this option you can switc...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 46 850 232/14 08/11 remote switch: with this option you can change the function of the probe button ·. You can choose between: l/r where the test ear can be selected with the probe button · pause where the test can be paused and restarted wit...
Page 48: 13.1 Cleaning of Probe Tip
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 47 850 232/14 08/11 13 care and maintenance of the instrument disconnect the power plug before cleaning! To clean the instrument, probe, contralateral receiver and other accessories use a soft cloth dampened with a little warm soapy water or ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 48 850 232/14 08/11 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 39: after unscrewing the small ribbed plastic nut it is possible to detach the sm...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 49 850 232/14 08/11 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 is...
Page 51: 14 Disinfection
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 50 850 232/14 08/11 14 disinfection it is recommended that parts which are in direct contact with the patient are subjected to standard disinfecting procedure between patients. This includes physically cleaning and use of a recognized disinfe...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 51 850 232/14 08/11 15 how to change the printer paper open the printer at the right side of the housing by pulling up the printer cover È using its finger mould in front. Remove the printer cover È. Remove the empty paper roll. Place the new...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 52 850 232/14 08/11 16 warranty, maintenance and service the mi 34 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 co...
Page 54: 17 Safety Regulations
Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 53 850 232/14 08/11 17 safety regulations 17.1 electrical safety: the mi 34 tympanometer is constructed to comply with protection class i, type bf of the international standard iec 601-1 (en 60601-1) . Protection from an electric shock is ens...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 54 850 232/14 08/11 and the iec 60601 series for medical electrical equipment). In addition, all such combinations - systems - shall comply with the standard 60601-1-1, safety requirements for medical electrical systems. Equipment not complyi...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 55 850 232/14 08/11 18 checklist for subjective device control according to the manufacturer requirement the user should control the instrument once a week to find errors immediately and to avoid wrong test results. He should test tympanogram...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 56 850 232/14 08/11 19 technical data and accessories the impedance meter mi 34 is an active, diagnostic medical product according to the class iia of the eu medical directive 93/42/eec. Impedance measurement: type: class 2 acc. To iec 645-5 ...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 57 850 232/14 08/11 figure 43 connectors on the rear ¬ ¯ ® « lcd-display: graphical display of the tympanograms and reflex curves, numeric display of max. Compliance, pressure at max. Compliance, canal volume, gradient and reflex thresholds...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 58 850 232/14 08/11 weight: app. 2,6 kg standard accessories: 1 hand-held probe with diagnostic probe insert 1 shoulder strap for diagnostic probe 1 screening probe insert 1 contra phone receiver with cord 1 mains cable 1 set of ear tips 1 ca...
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Operating instructions mi 34 / mi 34 h gebami34e.11a.Docx 59 850 232/14 08/11 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.