MI 26 Operating Instructions March 2010

Operating Instructions MI 26 Table of Contents

Page

1 Introduction ... 3 2 Description ... 4 2.1 Purpose ... 4 2.1.1 PC-Interface: ... 4 2.2 Tympanometry ... 4 2.3 Acoustic Reflex ... 6 2.4 Audiometric Pure Tone Screening ... 6 3 Getting started ... 7 3.1 Unpacking ... 7 3.2 Environmental conditions for the MI 26 ... 8 3.3 Preparing the MI 26 for use ... 8 3.3.1 Connect probe and accessories ... 8 4 Getting familiar with the MI 26... 9 4.1 The MI 26 Front Panel Controls ... 9 4.2 The MI 26 Rear Panel Connections ... 10 4.3 Switch the instrument on ... 10 4.3.1 The display of the MI 26 ... 11 4.4 Calibrate the probe ... 12 4.5 Getting familiar with the probe ... 13 4.6 Choose an appropriate ear tip... 14 5 How to create a Tympanogram... 15 5.1 The basics of the impedance measurement ... 15 5.2 Preparing the patient ... 17 5.3 Preparing the measurement ... 17 5.4 How to evaluate the tympanogram display ... 18 5.5 How to print the test result ... 19 5.6 How to delete the test results ... 19 6 How to measure the Stapedius reflex ... 20 6.1 The basics of the Stapedius reflex measurement ... 20 6.2 Preparing the patient ... 20 6.3 Preparing the ipsilateral measurement... 21 6.4 Taking the ipsilateral measurement ... 22 6.5 Preparing the contralateral measurement (optional) ... 23 6.6 How to interpret the reflex display ... 23 6.7 How to print the test result ... 24 7 Interpreting Test Results... 25 7.1 Understanding the printout... 25 7.2 Interpreting the tympanometric test result ... 26 7.3 Abnormal Values ... 26 8 How to test children ... 28 GEBAmi26e.10a.docx

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Operating Instructions MI 26 9 AUDIOMETRIC PURE TONE SCREENING ... 29 9.1 Preparing the Patient for the Test ... 29 9.2 Audiometer Function Recommended Procedures ... 29 9.3 Hearing Threshold Method (Air Conduction) ... 30 9.4 MI 26 LCD Screen - Audiometer... 30 9.5 Audiometric Pure Tone Screening Results ... 31 10 Additional Reading ... 32 11 Individual Setup of the MI 26 ... 33 11.1 The setup menu ... 33 11.2 The Tympanometer setup ... 34 11.3 The Setup menu for Reflex Test... 35 11.4 Audiometer Setup Menu... 37 11.5 Insert your personal printout data ... 38 12 Care and maintenance of the instrument ... 39 13 Care and maintenance of the instrument ... 40 10.1 Cleaning of Probe Tip ... 40 14 How to change the printer paper ... 43 14 Warranty, Maintenance and After-Sales Service ... 44 15 Safety Regulations ... 45 15.1 Electrical Safety: ... 45 15.2 Measuring security: ... 45 15.3 Device control: ... 45 15.4 Operation: ... 45 15.5 Patient Safety: ... 45 16 Checklist for subjective device control ... 47 17 Technical Data and Accessories ... 49

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Operating Instructions MI 26 1 Introduction Thank you very much for purchasing a quality product from the MAICO family. This automatic Tympanometer MAICO MI 26 is manufactured to meet all quality and safety requirements. In designing the MAICO MI 26 we placed particular importance on 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 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 MI 26. The description of the position 5 (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 MI 26. If you have problems or have ideas for further improvements, please get in touch with us. Simply call. Your MAICO team

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Operating Instructions MI 26 2 Description 2.1 Purpose The MI 26 is an automatic instrument that is designed for tympanometric and audiometric pure tone screening. Tests done in the tympanometric screening mode measure middle ear mobility and ipsilateral acoustic reflex. Contralateral acoustic reflex is available as an option. Test results are displayed on the front panel LCD (liquid crystal display) screen and may be printed. The MI 26 not only performs all of these impedance screening functions but has the capability of audiometric pure tone screening. Tests done in the audiometric pure tone screening mode measure hearing response levels. The MI 26 offers a full range of frequencies and levels for complete air conduction hearing screening The design of the MI 26 allows rapid and reliable measurements. This equipment is designed for middle ear function screening. 2.1.1 PC-Interface: An USB-interface for data transfer to a connected computer is built in. The MAICO MI 26 is laid out according to the EN of 60 601-1 „medically electrical devices “. In order to ensure this also with attached computer, the computer must correspond to the EN 60 601-1. If not, please look to chapter 15.5 Patient safety.

2.2 Tympanometry Tympanometry is the objective musculus measurement of middle ear stapedius hearing nerve mobility (compliance) and middle pressure within the middle ear ear system. During the test, a lowbones pitched probe tone (226 Hz) is presented to the ear canal by ear canal means of the hand-held probe. cochlea This tone is used to measure the ear drum change in compliance in the middle ear middle ear system while the air pressure is varied automatically eustachian tube from a positive value (+200 daPa) to a negative value Figure 1 (-400 daPa max.). The middle ear 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 GEBAmi26e.10a.docx

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Operating Instructions MI 26 recorded on the chart. The position of the peak on the horizontal axis and 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 half 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 scientific quantity milliliter (ml). Air pressure is measured in deca-Pascals (daPa). NOTE: 1.02 mm H2O = 1.0 daPa.

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Operating Instructions MI 26 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 contralateral acoustic reflex. 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 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 during the test may produce an artifact (false response). The test result is recorded as Pass/Fail, and in graphical 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. Theoretically, a compliance peak is necessary to observe a reflex at peak pressure.

2.4 Audiometric Pure Tone Screening The purpose of this test is to measure the intensities of pure tones of various frequencies that a listener is just barely able to detect in an otherwise quiet environment. During screening, tones can be presented at a determined frequency and intensity. The MI 26 can be used to find the lowest response level (threshold) at each frequency. Pass/fail criteria can be decided by following the established standards for your organization.

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Operating Instructions MI 26 3 Getting started Your MI 26 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 notify the carrier immediately.

3.1 Unpacking Remove the accessories. Carefully remove the instrument from the shipping carton. Remove the instrument from the plastic bag and inspect the case for any damage. Notify the carrier immediately if any mechanical damage is noted. This will assure that a proper claim is made. Save all packing material so the claim adjuster can inspect it as well. When the adjuster has completed the inspection, notify the MAICO Special Instrument Distributor you purchased this unit from. 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. Accessories Part No. Hand-held probe 24-count eartips kit: (4) yellow, 7 mm (4) green, 9 mm (4) white, 11 mm (4) yellow, 13 mm (4) green, 15 mm (4) blue, 18 mm Thermal printer paper Calibration test cavity TDH 39 headset Patient response switch Optional Accessories: Soft-sided carrying case

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802 172 705 069 705 056 705 057 705 058 705 059 705 060 705 061 705 078 705 167 4 687 801 012 1035-3002

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Operating Instructions MI 26 3.2 Environmental conditions for the MI 26 The MI 26 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.

3.3 Preparing the MI 26 for use 3.3.1 Connect probe and accessories - Connect the probe cable to socket of the instrument.

C

on the rear

-

Insert the plug into the socket and secure the connection by fastening the two screws of the connector.

-

Insert the pressure tube into the socket press it until it is secure on the socket.

-

Connect the headset cable to socket F and on the rear of the instrument.

-

Connect the cable of the patient response switch to socket H on the rear of the instrument.

-

Put the enclosed mains cable into the power connection socket A and its main plug into a power socket. The instrument is now operational.

B

and G

Figure 2 The probe of the MI 26

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Operating Instructions MI 26 4 Getting familiar with the MI 26

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4.1 The MI 26 Front Panel Controls 1. Mode = Changes Mode from Presenter to Interrupter. 2. PULSE = Turns pulse tone on or off for audiometric testing. 3. TYMP/AUD = Changes modes between tympanogram or audiometric testing 4. PRINT = Prints the test results. 5. L/R = Changes test ears from left to right, or right to left for tympanogram or audiogram. Press and hold for 2 seconds to erase stored tests.

6. REFLEX = Changes the reflex testing modes from IPSI to CONTRA or NO REFLEX. 7. LCD-Display 8. Printer cover 9. Paper slot with paper cutting edge 10. MENU – Enter the main menu screen 11. 3= Decreases the frequency (Hz) for audiometric testing. 12. 6= Decreases the intensity level (dB) of reflex or audiometric testing. 13.8= Increases the frequency (Hz) for audiometric testing. 14.5= Increases the intensity level (dB) of reflex or audiometric testing. 15. Enter  - Enter the highlighted menu or the highlighted option. 16. Presenter or interrupter button (depends on mode you have chosen) 17. =ON/OFF SWITCH – Power switch; 1 is ON, 0 is OFF

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Operating Instructions MI 26 How to use the extended functions is described in chapter 11: “Individual Setup of the MI 26."

4.2 The MI 26 Rear Panel Connections

²°± Ó ¬¯­®« Figure 4 Connectors at the rear of the MI 26

A. AC POWER - Connection for AC power cord. (100…240 V~50/60 HZ) B. PRESSURE TUBE CONNECTION - Pneumatic connection for the probe cable. C. PROBE CABLE CONNECTION - Connection for probe cable to rear panel. D. USB CONNECTOR - Connection for computer interface. E. CONTRALATERAL PHONE CONNECTION – Jack for contralateral reflex phone, (optional).

F. AC (R) - Jack for right (red) audiometer phone. G. AC (L) - Jack for left (blue) audiometer phone. H. PAT – Jack for patient response switch 4.3 Switch the instrument on Switch the main switch 17 on. The LCD will show the type of instrument and software version for a moment. Then the basic measuring Figure appears. The MI 26 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.

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Operating Instructions MI 26 4.3.1 The display of the MI 26 The test result is shown during the measurement on the LCD. The measurements are saved automatically and can be printed out in a fast and quiet way with the integrated printer. Impedance Right Ipsi In Figure 5 the initial empty measurement screen is shown. The measurement screen shows actual settings, test results and the graphical display of the tympanogram and reflexes. From left to right the top line shows the type of test (impedance is shown in Figure 5), the selected test ear (left or right) and the selected reflex test (ipsi, contra (optional) or tympanogram if no reflex test is selected).

3

Status READY

ml

Ear Volume 2

Compliance 1

Pressure 0

-600

-300

1

2

80 500 Hz I

Gradient

300 daPa 3

80 1000 Hz I AUTO

4

80 2000 Hz I dB

80 4000 Hz I

Figure 5 The measurement screen of the MI 26

At the left center, 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: READY - means that the instrument is ready for testing IN EAR - shows that the probe is inserted in the ear TESTING - means that the test is in progress BLOCKED - means that probe is blocked in the ear LEAKING - indicates that the ear tip does not have a proper seal The boxes below “Status” show the volume of the ear canal, the compliance, the pressure at maximum compliance and the gradient of the tympanogram when the test has been completed. The four boxes at the bottom of the screen, marked 1 to 4, show the graphical reflex curves after the test. Below each box the test level (Figure 5: 80 dB), and the test frequencies (Figure 5: 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz) are displayed. After the frequency an “I” shows that ipsilateral testing is selected. Finally, at the very bottom in Figure 5 the word “AUTO” and 80 dB scale is shown. This means that the reflex test level will increase automatically until a reflex is found or the maximum level is reached. With the arrow keys, the test levels 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 or Auto.

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Operating Instructions MI 26 4.4 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 calibration is very easy and takes only 20 seconds. Press the menu key 10 and the main menu (Figure 6) appears on the LCD. Select the menu option CALIBRATION with the arrow keys and press Enter. Follow the instructions on the LCD as shown in Figure 7.

Main Menu Tympanometry : Audiometry: Calibration : Setup :

↑ ↓ Change item ENTER Select item

Figure 6 Main Menu

Put the probe tip S without ear tip into the hole of the test cavity labeled 0.5 ml. The text on the display will request that the probe tip be inserted for the 2 ml calibration. Put the probe tip in the 2 ml cavity. Do this again for the 5 ml volume. The MI 26 will automatically change into 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 make sure the opening of the probe tip is clean and try to recalibrate the probe. If the error Calibration information appears again, the probe or the Place the probe in the .5 ml cavity. instrument are probably defective. Inform your distributor to get immediate help.

Figure 7 The Calibration screen

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Operating Instructions MI 26 4.5 Getting familiar with the probe The probe of the MI 26 is shown in Figure 8. The probe head is adjustable to three angles (0°, 60° and 80°). It is adjusted by turning the locking screw T at the Pby bottom of the probe using a coin or a screw driver. Adjust the probe head pulling it into the required position until it rests. After it is set to the required position tighten the locking screw again. The probe button M can be used to select the required test ear. The color of the O control light changes accordingly to red (right ear) or blue (left D T EL C N P E R E G S ear). The color of the control light on the probe indicates your current operation. A red control light indicates M B O D E G EL C N P Q E E R S that the right ear is selected. The system is ready for Figure 8 measurements. As soon as The probe of the MI 26 you have put the probe into the auditory canal the control light turns green. Now the test is in progress. Do not change the position of the probe until the green control light goes 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 probe into the auditory canal the control light turns green. Now the test is in progress. Do not change the position of the probe until the green control light goes out indicating the end of the measurement. A yellow control light indicates an error. The kind of the error is indicated on the LCD under status:

LEAKING: The ear tip is not sealed in the auditory canal. Change the position of the probe until the control light turns green. If you are not successful, use a bigger ear tip. BLOCKED: Indicates blockage in the probe opening. Change the position of the probe so that it points straight into the auditory canal until the control light turns green. If you are not successful, check that the probe is not blocked with ear wax. GEBAmi26e.10a.docx

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Operating Instructions MI 26 The complete probe insert can be changed by pressing the release button Q . If the probe tip is clogged, you can remove it by opening the fixation ring R . After cleaning the probe tip or attaching a new one, the tip must be fixed again by fastening the fixation ring.

4.6 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 tip or just out of the ear Tipp. 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 and reflex measurement. Please read the following chapters.

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Operating Instructions MI 26 5 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 section “Preparing the Measurements.”

5.1 The basics of the impedance measurement The impedance measurement assists in diagnosing of the condition of the middle ear and can therefore not be compared directly with other audiometrical tests such as sound or speech audiometry which assists in the measurement of 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 the patient. The two most important impedance measuring methods possible with your MI 26 are tympanometry and the measurement of the Stapedius reflex which is discussed in chapter: “How to measure the Stapedius reflex.”

musculus stapedius

hearing nerve

middle ear bones ear canal ear drum

cochlea

middle ear eustachian tube

Figure 9 The middle ear

Figure 10 Principle of the impedance measurement

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Operating Instructions MI 26 The impedance measurement examines the acoustic resistance of the middle ear. If the eardrum is hit by a sound, part of the sound is absorbed and sent via middle ear to the inner ear while the other part of the sound is reflected. The stiffer the eardrum is the more sound is reflected and the less sound reaches the inner ear. Inside the probe of the impedance measuring instrument a small loudspeaker is installed which emits a low frequency sound through a tube (Figure 11: A) into the auditory canal before the eardrum. Another tube (Figure 11: B) is connected to the microphone inside the probe which receives the sound. Together with a third tube (Figure 11: 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 stiff 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.

2,0 1,6 Compliance ( ml)

When performing tympanometry during a measurement, a continuous change of positive and negative pressure is produced by the pump of the instrument in the outer auditory canal. 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 11, the area for normal tympanogram curves is hatched. Here you can see that the highest compliance is reached with normal pressure. When you create positive and negative pressure the eardrum stiffens - the compliance decreases.

1,2 0,8 0,4 0

-300 -200 -100 0 +100 Pressure ( daPa )

Figure 11 Tympanogram (normal curve area is hatched)

So you can draw conclusions on the condition of the middle ear from the form and the values of the tympanogram.

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Operating Instructions MI 26 5.2 Preparing the patient Explain to the patient that the measurement is painless and that nothing enters the auditory canal. The patient does not have to respond when there are loud test sounds or when the pressure in the auditory canal changes. In no case should the patient swallow, chew or move during the measurement.

5.3 Preparing the measurement The LCD shows the empty measurement screen for the right ear and the control light of the probe turns red. To measure the left ear, change the side by pressing the L/R-key or the probe button M . Then the selected test ear shown in the middle-top of the LCD will change from Right to Left and the control light of the probe will turn blue. Switch off the reflex measurement by pressing the Reflexkey. 6 The word Tympanogram (see Figure 12) must appear at the right top of the display. Make sure the auditory canal is clear. Choose the right ear tip according to the size of the auditory canal and put it firmly onto the probe Tipp.

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 Impedance Right Tympanogram the control light of the probe is green indicating the start of Status ml 3 READY the test. Do not move the Ear Volume probe until the green light 2 goes out; the patient must not Compliance swallow or speak during the 1 measurement. During the test Pressure the LCD will display how the 0 tympanogram is written on Gradient -600 -300 300 daPa the left side and then how the values appear on the right Scale side. After about 4-5 seconds Figure 12 the test is completed and the Measurement screen (only Tympanogram) green light turns off. Now you can remove the probe from the ear. If an error occurs during the measurement the test will stop. If leakage occurs, the control light of the probe turns yellow and Leaking will appear under Status. If the probe is blocked, the control light of the probe turns yellow and Blocked will appear under Status. Please proceed as described in chapter 3.6 “Getting familiar with the probe.” To measure the other ear, change the side by pressing the L/Rkey or the probe button and repeat the measuring procedure described above with the other ear.

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Operating Instructions MI 26 5.4 How to evaluate the tympanogram display After having completed a measurement you can see the results on the LCD.

Impedance 3

On the left side of the display you see a graph of the tympanogram. The area surrounded by the box is valid for “normal” tympanograms. You can change the area or turn it off. For details see chapter 10 “Individual Setup of the MI 26.”

Right

Tympanogram Status READY

ml

2

Ear Volume 0.94 ml

1

Compliance 0.81 ml

0

Pressure - 37 daPa

-600

-300

300 daPa

Gradient 32 daPa

Scale

In the top-middle of the LCD, the words Right or Left indicate the ear chosen at the moment.

Figure 13 Display of a normal Tympanogram

Tympanometer (at the top right) - indicates that the reflex measurement has been switched off. In the boxes to the right the following test measurements are displayed: Ear Volume - indicates the volume of the section of the 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).

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Operating Instructions MI 26 5.5 How to print the test result After the end of a test you can print the results for your records by pressing the Print button 4 . The quiet thermal printer prints out the example used in the previous paragraph in only six seconds. While the printer is working, no key action is possible and the probe is inactive. Figure 15 shows the printout. Id No: Patient’s Id number.

MAICO MI 24 26

Date: Actual test date.

Id No.:

Date:

Name: Examiner: Remarks:

Name: Name of the patient. Examiner: Name of the examiner. Remarks: Additional information about the test or patient.

Tympanogram Right 3

All other values and the tympanogram correspond to those you have seen on the LCD (explained on the previous page under 4.5). The “intelligent” printer control helps you save paper. It will only print out what was actually measured. The printout in the example does not show reflex frequencies because only the tympanogram was measured.

ml

2

0.94 ml

1

0.81 ml

0

- 37 daPa

-600

-300

Ear Volume Compliance Pressure Gradient

300 daPa

32 daPa

0.94 ml 0.81 ml -37 daPa 31 daPa

Figure 14 Printout of a normal tympanogram

If you have saved two tympanograms (for example, both the left and the right ear) they are printed side by side. You can produce as many printouts as you want by pressing the Print button several times.

5.6 How to delete the test results By holding down the R/L-key the measurement memory will be deleted. On the LCD the message “Delete all Data?” appears. Press Enter to delete all patient data. Then the LCD shows an empty measurement screen. If you press the Menu button you return to the measurement screen without deleting the measurement data.

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