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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 disinfectant. Individual
manufacturer's instruction should be followed for use of this disinfecting
agent to provide an appropriated level of cleanliness.
To avoid person-to-person cross contamination of communicable diseases
eartips should only be used one time.

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Summary of Contents for MI 34

Page 1: ...Operating Instructions MAICO MI 34...

Page 2: ...3 8 Getting familiar with the probe 14 3 9 Choose an appropriate ear tip 15 4 How to create a Tympanogram 17 4 1 The basics of the impedance measurement 17 4 2 Training of the test person 18 4 3 Prepa...

Page 3: ...the tympanometric test result 36 9 3 Abnormal Values 37 10 How to test children 39 11 Recommended literature 40 12 Individual Setup of the MI 34 41 12 1 The setup menu 41 12 2 The Tympanogram Setup M...

Page 4: ...Operating Instructions MI 34 MI 34 H 17 5 Patient Safety 53 18 Checklist for subjective device control 55 19 Technical Data and Accessories 56...

Page 5: ...aning 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 t...

Page 6: ...interface for data transfer to a connected computer is built in The MAICO MI 34 is laid out according to the EN of 60 601 1 medically electrical devices In order to ensure this also with attached comp...

Page 7: ...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 ar...

Page 8: ...arying 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 smal...

Page 9: ...on Please check that all accessories listed below are received in good condition If any accessories are missing or damaged immediately notify your MAICO Special Instrument Distributor Accessories 1 Di...

Page 10: ...into a power socket The instrument is now operational Your MI 34 is equipped with a contra receiver Plug the cable in the contra receiver socket 3 4 Switch the instrument on Switch the mains switch o...

Page 11: ...13 14 4 16 15 3 5 Getting familiar with the MI 34 Print key Right left ear key Reflex measurement off ipsi contra TYMP key ipsi contra Setting of high probe tone Menu key Left cursor control Down cur...

Page 12: ...est ipsi contra or Tympanogram if no reflex test is selected 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 ac...

Page 13: ...ith 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 AUT...

Page 14: ...alibration put the probe tip in the 2 ml cavity and proceed as described above After the successful calibration of the 5 ml volume the MI 34 switches automatically to the tympanometry mode The basic m...

Page 15: ...e To avoid damages on the sensitive measuring equipment only bent the probe toward fixation screw Transforming the Probe from Handheld to Clinical and Reverse To exchange the probe insert press the re...

Page 16: ...urement 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 o...

Page 17: ...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 s...

Page 18: ...er audiometrical tests such as sound or speech audiometry which serve the measurement of the hearing Furthermore the impedance measurement is an objective measuring method which does not depend on the...

Page 19: ...tinuous 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 n...

Page 20: ...the probe tip 4 4 Measuring the Tympanogram Take hold of the top of the outer ear and pull it back Insert the probe with the ear tip into the auditory canal until the control light of the probe is gre...

Page 21: ...ms You can change the area or switch it off For details see chapter 12 Individual Setup of the MI 34 In the middle of the top of the LCD display the word Right or Left indicates the ear chosen at the...

Page 22: ...for the test person Remarks Additional information about the test or patient can be stated here All other values and the Tympanogram correspond to those you have seen on the LCD display and which were...

Page 23: ...creen 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 select...

Page 24: ...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 s...

Page 25: ...light of the probe lights red If you want to measure the left ear change the side by pressing the L R key or the probe button Then the selected test ear shown in the middle of the top of the LCD disp...

Page 26: ...During the measurement of the Stapedius reflex the change of the compliance is represented in real time on the LCD display When the test is finished the curves for the changes of compliance for 500 H...

Page 27: ...more reliable results because the receiver emitting the test signal and the probe measuring the compliance are separated Continue as described previously for the ipsilateral measurement Press again th...

Page 28: ...ed the information FAIL 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 dat...

Page 29: ...ts by pressing the PRINTER button The quiet thermal printer prints out 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...

Page 30: ...e insert into the probe head until it fastens Place the black shoulder strap firmly over the patients shoulder Slip the probe into the holder of shoulder strap as shown in figure 25 Make sure you can...

Page 31: ...peak pressure for maximal compliance Instruct the patient not to talk swallow yawn or move until the test is over Any movement or sound will give unreliable results Press the ENTER button when ready...

Page 32: ...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...

Page 33: ...the MENU button highlight CALIBRATION and calibrate the diagnostic probe as described in chapter 3 5 The Eustachian tube test can be used in patients with intact TM or in patients who have a perforate...

Page 34: ...unreliable results Press the ENTER button when ready to begin the test The pressure value at the maximum compliance is shown under Pressure 1 Now the text Make the patient decrease middle ear pressur...

Page 35: ...s as pressure and the horizontal axis as time Highlight ETF Perforated from the main menu and and press the ENTER button or press the ETF key to advance to the Eustachian Function Test screen It is no...

Page 36: ...tient 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 0 daPa The test will stop after th...

Page 37: ...ta you need to interpret the test results A graph of the Tympanogram is provided Figure 32 to assist you in visual interpretation of the test This graph is a representation of the relative mobility of...

Page 38: ...nformation 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...

Page 39: ...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 will be displayed to the negativ...

Page 40: ...anal 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 bein...

Page 41: ...or Clinical Evaluation Jerger Susan and James Jerger Boston College Hill Press 1981 Handbook of Clinical Audiology Katz Jack Baltimore William Wilkins 1994 s Audiology Desk Reference Roeser Ross J New...

Page 42: ...nstrument 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 U...

Page 43: ...e 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 co...

Page 44: ...mal Tympanograms to a value between 0 1 ml and 1ml in steps of 0 1 ml Seal sensitivity Minimum This gives reproducible results Requires quiet probe handling Medium Quicker seal detection and less sens...

Page 45: ...flex threshold is switched on You can choose the maximum acoustic pressure levels from 80 dBHL till 120 dBHL in steps of 5 dB Reflex sensitivity With this option you select the sensitivity of the stap...

Page 46: ...mmon Setup Menu Select the menu option Common Setup Menu from the main setup menu as described before and the common setup menu will appear on the LCD display The common setup menu offers the followin...

Page 47: ...intout 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 OF...

Page 48: ...or probe openings Please use a new eartip for each patient Always use eartips from MAICO or Sanibel Each eartip should only be used one time 13 1 Cleaning of Probe Tip In order to secure correct imped...

Page 49: ...tic and air pressure channels from the transducer house Figure 40 Ribbed Plastic Nut Transducer House Transparent Sealing Probe Tip with the small acoustic and air pressure channels The cleaning of th...

Page 50: ...ure channels of the probe tip it can be reassembled Make sure that the Probe Tip is connected correctly onto the Transducer Housing a small flange will ensure correct positioning before the plastic nu...

Page 51: ...cted to standard disinfecting procedure between patients This includes physically cleaning and use of a recognized disinfectant Individual manufacturer s instruction should be followed for use of this...

Page 52: ...ust roll from 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 re...

Page 53: ...erly 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 p...

Page 54: ...rdance 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 17 3 Device control The user of t...

Page 55: ...from the patient Any person who connects external equipment to signal input signal output or other connectors has created a system and is therefore responsible for the system complying with the requi...

Page 56: ...ults with earlier measurements The printout should be filed together with the subjective test protocol to the documents of the instrument The test person should be healthy no otitis etc and should by...

Page 57: ...ge 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 method ipsi lateral contra latera...

Page 58: ...one Tympanogram to 12 s Tympanogram and Reflex for both ears Power supply Mains 100 240 V 50 60 Hz Power consumption app 25 VA Connection plugs Connection Specification mains connection socket left r...

Page 59: ...5ml 2ml 0 5ml with probe holder 1 printer paper roll for app 350 printouts Optional accessories Carrying case Part No 70 50 14 Soft side carrying case Part No 1035 3002 Consumables 1 roll printer pape...

Page 60: ...4 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 m...

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