Maico MI 34 User manual

Operating Instructions
MAICO MI 34

Operating Instructions MI 34 / MI 34 H
Table of Contents Page
1 Introduction............................................................................................4

2 Description .............................................................................................5 
2.1 Purpose ............................................................................................5 
2.1.1 PC-Interface: ..............................................................................5 
2.1.2 Environmental conditions for the MI 34 ......................................5 
2.2 Tympanometry .................................................................................5 
2.3 Acoustic Reflex .................................................................................6 
3 Getting started .......................................................................................8 
3.1 Unpacking........................................................................................8 
3.2 Connect probe .................................................................................8 
3.3 Connect Mains Cable and Accessories ..............................................9 
3.4 Switch the instrument on..................................................................9 
3.5 Getting familiar with the MI 34.......................................................10 
3.6 The display of the MI 34 .................................................................11 
3.7 Calibrate the probe.........................................................................13 
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 Preparing the measurement............................................................19 
4.4 Measuring the Tympanogram .........................................................19 
4.5 How to evaluate the Tympanogram display.....................................20 
4.6 How to print out the test result.......................................................21 
4.7 How to delete the test results .........................................................21 
5 Measurement with Hightone (optional MI 34 H) ...................................22 
6. How to measure the Stapedius reflex...................................................23 
6.1 The basics of the Stapedius reflex measurement .............................23 
6.2 Training the test person ..................................................................24 
6.3 Preparing the ipsilateral measurement ............................................24 
6.4 Doing the ipsilateral measurement..................................................25 

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.......................................................28 
7 Reflex Decay Test Operation .................................................................29 
8 Eustachian Tube Test Operation............................................................32 
8.1 ETF test for patients with intact TM.................................................32 
8.2 ETF test for patients with perforated TM .........................................34 
9 Interpreting Test Results........................................................................36 
9.1 Understanding the printout ............................................................36 
9.2 Interpreting 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 Menu....................................................42 
12.3 The Setup menu for Reflex Test ....................................................44 
12.4 The Common Setup Menu............................................................45 
12.5 Insert your personal printout data .................................................46 
13 Care and maintenance of the instrument ............................................47 
13.1 Cleaning of Probe Tip ...................................................................47 
14 Disinfection ........................................................................................50 
15 How to change the printer paper........................................................51 
16 Warranty, Maintenance and Service....................................................52 
17 Safety Regulations ..............................................................................53 
17.1 Electrical Safety:............................................................................53 
17.2 Measuring security:.......................................................................53 
17.3 Device control:..............................................................................53 
17.4 Operation:....................................................................................53 

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 

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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 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 MI 34 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 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 34. Please open out the flap of
illustrations on the last page. The description of the position (e.g. Ç) of
controls, displays and connections, found again in the text, will make it
easier for you to learn how to operate the MAICO MI 34.
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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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 reflex screening.
The MI 34 allows diagnostic testing of reflex decay and the Eustachian
Tube. Eustachian Tube function tests may be determined on patients with
intact or perforated eardrums.
The MI 34 H includes a high frequency probe tone of 1000 Hz which is
ideal for providing reliable results when testing newborns and young
children.
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 MI 34 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 17.5 Patient safety.
2.1.2 Environmental conditions for the MI 34
The MI 34 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.
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 probe tone (226 Hz) is presented to the ear canal by means of

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Figure 1 the middle ear
hearing
nerve
ear canal
middle
ear
bones
ear drum
middle ear
eustachian tube
cochl
e
musculus
stapedius
the hand-held probe. This tone is used to measure the change in
compliance in the middle ear system while the air pressure is varied
automatically from 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 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 is measured in deca-
Pascals (daPa).
NOTE: 1.02 mmH
2
O = 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.

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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 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 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 MI 34 will not perform an acoustic reflex test.
Theoretically, a compliance peak is necessary to observe a reflex at peak
pressure.

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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 container
for signs of damage. If any damage is noted, please notify 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 are received in good condition.
If any accessories are missing or damaged, immediately notify your MAICO
Special Instrument Distributor.
Accessories
1 Diagnostic probe
1 Screening probe insert
1 Shoulder strap for diagnostic probe
1 Contraphone with cord including
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 (1 roll)
Calibration test cavity
Main cable
3.2 Connect probe
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.
Insert the pressure tube into the socket ¬♦and press it until it has a safe fit
on the socket.

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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 Accessories
Put the enclosed mains cable into the power connection socket «and its
mains plug 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 Ðon. The LCD display Çshows for a moment the
instrument type and the software version. Then the basic measuring figure
appears. The MI 34 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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Figure 4 The controls of the MI 34
PRINT L / R REFLEX
MENU ENTE R
PRINT L / R REFLEX
MENU ENTE R
21 3 10911
812 13
14 41615
3.5 Getting familiar with the MI 34
à = Print key Ä= Right/left ear key
Å
= Reflex measurement off/ipsi/contra Æ= TYMP-key
ipsi+contra/Setting of high probe tone Ê
= Menu key
Ë
= Left (cursor control) Ì = Down (cursor control)
Í
= Right (cursor control) Î = Up (cursor control)
Ï=Enter Ð
= Power switch
Ñ= Reflex Decay key Ò
= ETF key
The use of the extended functions is described in chapter 12
“Individual Setup of the MI 34".

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Figure 5 The measurement screen of the MI 34
Status
READY
Ear Volume
Compliance
Pressure
Gradient
Impedance IpsiRight
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 80
3.6 The display of the MI 34
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 empty
measurement screen is shown. The
measurement screen shows actual
settings, test results and the
graphical display of the
tympanogram and reflexes.
The top line shows from left to the
right the type of test (in example
figure 5 Impedance), the selected
test ear left or right and the
selected reflex test “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 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 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 frequency are shown. After the frequency an “I” shows the ipsilateral
testing is selected.
At the bottom line in figure 5 the word “AUTO” and
 dB Scale is shown.
It means that the reflex test level increases automatically until a reflex was

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found or the maximum level is reached. With the cursor up button Îor
down button Ìthe 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.
The figures below each box mean:
test level (80 dB in example figure 5),
test frequency (500 Hz, ..),
ipsilateral testing (I).

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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 calibration is very
easy and takes only 20 seconds.
Press the menu key Êand the main
menu (figure 6) appears on the LCD
display Ç. Select the menu option
Calibration with the Down button Ì.
Press Enter Ïand follow the instructions
on the LCD display Ç, as shown in
Figure 7.
Put the probe tip Èwithout ear tip into
the hole of the test cavity labeled 0.5 ml
and wait. When the text on the display
Çchanges to the request for the 2 ml
calibration put the probe tip Èin 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 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 Èis clean
and try to recalibrate the probe. For
more information about cleaning the
probe also read Chapter 10: Cleaning
the probe.
If the error information appears again,
the probe or the instrument is probably
defect. Inform your service to get
immediate help.
Main Menu
Tympanometrie :
Reflex Decay:
ETF Intact
ETF Perforated
Caibration:
Setup :
↑ ↓ Change item
ENTER Select item
Figure 6
Display MI 34 Main Menu
Figure 7
Display MI 34 Calibration
Calibration
Place the porbe in the .5 ml cavity
Probe

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Figure 8 MI 34 probe with additional screening
probe tip
Â
EM EN E OEP EQ
ER ES
EX
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°
und 80°). It is adjusted by
releasing the fixation screw
(Figure 9 ¾) at the bottom of
the probe a few turns, using a
coin or a screw driver. Adjust the
probe head ºby 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 ¾again.
Notice! 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 release button ¹of the probe with
a tool or a pen. Remove the screening probe insert.
Insert the diagnostic probe insert ¿into the probe head º. Please
recognize the right position of the connector of the diagnostic probe insert
¿. Press the diagnostic probe insert ¿into the probe head ºuntil it
fastens.
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 colour
of the control light ¹changes accordingly to red (right ear) or blue (left
ear). If selected in the setup menu pressing the probe button ·during
¾
Figure 9

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operation pauses also the test.
The colour of the control light ¹of the probe indicates in standby the
selected ear and in operation the fitting of the probe in the auditory canal:
A red control light ¹indicates 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 ¹lights green. Now the test runs off. Do
not change the position of the probe any more until the green control light
¹is going out indicating the end of the measurement.
A blue control light ¹indicates 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 ¹lights green. Now the test runs off. Do
not change the position of the probe any more until the green control light
¹is going out indicating the end of the measurement.
A yellow control light ¹indicates an error. The kind of the error is indicated
on the LCD-display Çunder status:
LEAKING: The ear tip does not make the auditory canal airtight. Change the
position of the probe until the control light ¹lights 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 ¹lights 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 ½is clogged you can remove it by opening the fixation ring
¼. After cleaning of the probe tip ½or selection of a new one, the tip must
be fixed again by fastening the fixation ring ¼.
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
tip or just out of the ear tip.

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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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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 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
directly with other 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 cooperation
of the test person and can
therefore not be falsified by him.
The two most important impedance measuring methods possible with your
MI 34 are Tympanometry and the measurement of the Stapedius reflex
which is treated in chapter 5. “How to measure the stapedius reflex”.
The impedance measurement
examines the acoustic resistance of the
middle ear. If the eardrum is hit by a
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
tube A(see Figure 11) into the

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Figure 12 – Tympnaogram (normal curve
area is hatched)
Figure 13
auditory canal before the eardrum. Another tube Bis connected with the
microphone in the probe which receives the sound. Both tubes are lead
together with tube Cnearly to the eardrum and are made airtight against
the outside pressure by the ear tip. A manometer and a pump which can
produce both over- and under-pressure are connected with tube C. The less
sound is reflected by the eardrum to the microphone the more stiff the
eardrum is and with it the middle ear - the eardrum transmits the biggest
part 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 Tympanometry 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 from the form and the values of the Tympanogram.
4.2 Training of the test person
Explain to the test person that the measurement is painless,
that nothing gets into the auditory canal and that he does
not have to answer when he hears the faint and deep test
sound and the pressure in the auditory canal changes. In no
case the test person should swallow, chew or move his
head during the measurement.

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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
measurement, delete
former test results (see
also chapter 4.7.) 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 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 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 Tympanometry 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.
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 ¹of the probe is
green. In order to start the test press the Enter buttonÏand the control
light in the probe is lighting permanently green. The status in the display
changes to “Testing”. Do not move the probe until the green light goes
out; the patient may not swallow or speak during the measurement. During
the test you can watch on the LCD display how at first the Tympanogram is
written on the left side and then how the values are put down on the right
side. After about 4-5 seconds the test is completed, the green light turns
off. Now you can remove the probe from the ear.
If an error occurs during the measurement the test is stopped. If leakage
occurs, the control light ¹of the probe lights yellow and the display
Çunder status “LEAKING" is reported. If the probe is blocked, the control
light ¹of the probe lights yellow and at the display Çshows under status
“BLOCKED". Please proceed as described in chapter 3.6 “Getting familiar
with the probe”. If you want to measure the other ear, too, change the