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Mi26 Op Manual

The document provides operating instructions for the MI 26 tympanometer. It includes: 1) An introduction and description of the device's functions including tympanometry, acoustic reflex testing, and audiometric pure tone screening. 2) Instructions on unpacking and checking the included accessories as well as environmental conditions for operation. 3) Details on device setup, calibration, maintenance, and safety regulations.

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MohamedKeciba
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© © All Rights Reserved
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Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
98 views51 pages

Mi26 Op Manual

The document provides operating instructions for the MI 26 tympanometer. It includes: 1) An introduction and description of the device's functions including tympanometry, acoustic reflex testing, and audiometric pure tone screening. 2) Instructions on unpacking and checking the included accessories as well as environmental conditions for operation. 3) Details on device setup, calibration, maintenance, and safety regulations.

Uploaded by

MohamedKeciba
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 51

MI 26

Operating Instructions

MAICO Diagnostics | 10393 West 70th Street | Eden Prairie, MN 55344, USA | Toll Free 888.941.4201
Operating Instructions MI 26

Table of Contents Page


1. Introduction 1
2. Description 2
3. Getting started 4
4. How to create a tympanogram 14
5. How to measure the Stapedius reflex 19
6. Interpreting test results 24
7. How to test children 27
8. Audiometric pure tone screening 28
9. Additional reading 31
10. Individual setup of the MI 26 32
11. Care and maintenance of the instrument 37
12. How to change the printer paper 38
13. Warranty, maintenance and after-sales service 39
14. Safety regulations 42
15. Subjective checklist 43
16. Technical data 44

i
Operating Instructions MI 26
1 Introduction
Thank you very much for purchasing a quality product from the family. This
automatic Tympanometer MI 26 is manufactured to meet all quality and safety
requirements.
This user manual should make it as easy as possible for you to become familiar
with the functions of the MI 26. The description of the position (e.g., 5 ) of
controls, displays and connections, found again in the text, will make it easier
for you to learn how to operate the MI 26.
If you have problems or have ideas for further improvements, please get in
touch with us. Simply call.
Your MAICO team

1
Operating Instructions MI 26
2 Description
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.
PC-Interface: A USB interface for data transfer to a connected computer is built in.
2.1 Tympanometry musculus
stapedius hearing
nerve
middle
Tympanometry is the objective ear
bones

measurement of middle ear ear canal

mobility (compliance) and pressure ear drum


middle ear
cochlea

within the middle ear system. eustachian tube

During the test, a low-pitched


probe tone (226 Hz) is presented to
the ear canal by means of the
hand-held probe. This tone is used
to measure the change in
compliance in the middle ear
system while the air pressure is
varied automatically from a positive
value (+200 daPa) to a negative Figure 1
value (-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 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.

2
Operating Instructions MI 26
2.2 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/No response, 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.
2.3 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.

3
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.
3.1.1 Accessories Supplied
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.
Description Part No.
Hand-held probe 570G-14
24-count eartips kit: 6613
(4) yellow, 7 mm 6643
(4) green, 9 mm 6644
(4) white, 11 mm 6645
(4) yellow, 13 mm 6646
(4) green, 15 mm 6647
(4) blue, 18 mm 6648
Thermal printer paper 5529
Calibration test cavity 5533
TDH 39 headset 4687
Patient response switch 2169
Operating Instructions 1162-0322
Optional Accessories:
Soft-sided carrying case 1035-3002
Contra button phone and cable 4796
Contra TDH 39 phone and cable 4682

4
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 3 on the rear of
the instrument.
- 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  4 and press
it until it is secure on the socket.
- Put the enclosed main cable into the power connection
socket 1 and its main plug into a power socket.
The instrument is now operational.
- Connect the headset cable to socket 6 and 7 on
the rear of the instrument.
- Connect the cable of the patient response switch to
socket 8 on the rear of the instrument.

Figure 2
The probe of the MI 26

5
Operating Instructions MI 26

6
Operating Instructions MI 26
3.4 Getting familiar with the MI 26

7 12 8

13 2 3

4 5 6 1 9 10 11 1
Figure 3
The controls of the MI 26

3.4.1 The MI 26 Front Panel Controls


1. Presents tone stimulus during audiometric testing.
2. PULSE = Turns pulse tone on or off for audiometric testing.
3. TY/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. MENU = Enters the main menu screen.
8. ENTER = Enters the highlighted menu or the highlighted option.
9. = Decreases the frequency (Hz) for audiometric testing.
10. = Decreases the intensity level (dB) of reflex or audiometric testing.
11. = Increases the frequency (Hz) for audiometric testing.
12. = Increases the intensity level (dB) of reflex or audiometric testing.
13. MODE =Changes mode from Presenter to Interuptor.
How to use the extended functions is described in chapter 10: “Individual Setup of
the MI 26."

7
Operating Instructions MI 26
3.4.2 The MI 26 Rear Panel Connections
12 11 8 10 7 6

4 5 3 1
9
Figure 4
Connectors at the rear of the RC

1. AC POWER - Connection for AC power cord.


2. ON/OFF SWITCH - Power switch; 1 is ON, 0 is OFF.
3. PROBE - Connection for probe cable to rear panel.
4. PROBE PRESSURE - Pneumatic connection for the probe cable.
5. CONTRA - Jack for contralateral reflex phone.
6. AC (R) - Jack for right (red) audiometer phone.
7. AC (L) - Jack for left (blue) audiometer phone.
8. PAT - Jack for patient response switch .
9. USB INTERFACE - Connection for computer interface.
10. BC – Connection for Bone Conductor.
11. MIC – Jack for Talk Back Microphone.
12. CD (L) and (R) – inputs for external CD player.
3.4.3 Switch the instrument on
Switch the main switch 2 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.

8
Operating Instructions MI 26
3.4.4 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

3
ml
Right

Status
READY
Ipsi

Ear Volume
2

In figure 5 the initial empty


Compliance
1

Pressure
0

-600 -300 300 daPa Gradient

measurement screen is shown. 1

80
500 Hz I
2

80
1000 Hz I
AUTO
3

80
2000 Hz I
dB
4

80
4000 Hz I

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). 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.

9
Operating Instructions MI 26
3.5 Calibrate the probe
Adjust the impedance measuring instrument Main Menu
every day to the actual atmospheric
Tympanometry :
pressure by means of the enclosed Audiometry:
calibration volume. The calibration is very Calibration :
Setup :
easy and takes only 20 seconds.
Press the menu key 7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 Change item
7. ENTER Select item

Put the probe tip S without ear tip into


Figure 6
the hole of the test cavity labeled 0.5 ml. The MI 26 main menu
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. Calibration
The MI 26 will automatically change into Place the probe in the .5 ml cavity.
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 information appears
Figure 7
again, the probe or the instrument are
The calibration screen
probably in need of service. Inform your
Maico Special Instrument Distributor to get
immediate help.

10
Operating Instructions MI 26
3.6 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 bottom
of the probe using a coin or a screw driver.
Adjust the probe head P by 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.
O EL C
N D
T EP R
E G
S
The color of the control
light changes accordingly to
red (right ear) or blue (left
ear).
The color of the control light EL M
B C
N O
D P Q
E E E G
R S

on the probe indicates your


current operation.
A red control light indicates
that the right ear is selected.
The system is ready for
measurements. As soon as Figure 8
you have put the probe into The probe of the MI 26
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.
Q
The complete probe insert can be changed by pressing the release button .
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

11
Operating Instructions MI 26
fastening the fixation ring.
3.7 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 end near the end of the ear tip. It should not
be inserted more than about 1 mm in the ear tip or protrude out of the ear tip (see
Figure 9).
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.

min 0 mm
max 1 mm

Figure 9
Proper placement
of ear tip

12
Operating Instructions MI 26
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
section 4.3 “Preparing the Measurements.”
4.1 The basics of the impedance measurement
The impedance measurement assists musculus
stapedius hearing
nerve

in diagnosing of the condition of the middle


ear
bones

middle ear and can therefore not be ear canal

compared directly with other ear drum


middle ear
cochlea

audiometric tests such as sound or eustachian tube

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 Figure 10
measuring methods possible with The middle ear
your MI 26 are tympanometry and
the measurement of the Stapedius
reflex which is discussed in chapter 5:
“How to measure the Stapedius
reflex.”

Figure 11
Principle of the impedance measurement

13
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.
When performing tympanometry during a 2,0
2.0
1,6
measurement, a continuous change of 1,2
Compliance ( ml)

positive and negative pressure is produced 0,8


0,4
1.6
by the pump of the instrument in the 0

outer auditory canal. The compliance is 1.2


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

measured simultaneously and shown in a 0.8


diagram (the tympanogram) which
illustrates the compliance in ml over the 0.4
pressure in daPa. In (Figure 12), the area
for normal tympanogram curves is 0
hatched. Here you can see that the
highest compliance is reached with
normal pressure. When you create
positive and negative pressure the Figure 12
eardrum stiffens - the compliance Tympanogram
decreases. (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.

14
Operating Instructions MI 26
4.2 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.
4.3 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 Reflex key 6 .
The word Tympanometer must appear at the right top of the display. Make sure the
auditory canal is clear. Choose an ear tip according to the size of the auditory canal
and put it firmly onto the probe tip (see Figure 9 in chapter 3.7).
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 Impedance

3
ml
Right Tympanometer

Status

the control light of the probe is


READY
Ear Volume
2

Compliance
1

Pressure

green indicating the start of the 0

-600 -300 300 daPa

Scale
Gradient

test. Do not move the probe until


the green light goes out; the
patient must not swallow or
speak during the measurement.
During the test the LCD will
display the tympanogram on the
left side while the test is running
and then the values will appear
on the right side. After about 4-5
seconds the test is completed Figure 13
and the green light turns off. Measurement screen (only Tympanogram)
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/R key or the
probe buttonand repeat the measuring procedure described above with the other
ear.

15
Operating Instructions MI 26
4.5 How to evaluate the tympanogram display
After having completed a Impedance

3
ml
Right Tympanometer

Status
READY

measurement you can see the 2

1
Ear Volume
0.94 ml
Compliance
0.81 ml
Pressure

results on the LCD.


0 - 37 daPa

-600 -300 300 daPa Gradient


32 daPa

Scale

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.”
Figure 14
In the top-middle of the LCD, Display of a normal Tympanogram
the words Right or Left indicate
the ear chosen at the moment.
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).

16
Operating Instructions MI 26
4.6 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
Id No.: Date:
Name:
Examiner:
Remarks:
MI 26

Date: Actual test date.


Tympanogram
Right
ml
3

2 0.94 ml

Name: Name of the patient.


1 0.81 ml

0 - 37 daPa

-600 -300 300 daPa


32 daPa
Ear Volume 0.94 ml
Compliance 0.81 ml

Examiner: Name of the examiner.


Pressure -37 daPa
Gradient 31 daPa

Remarks: Additional information


about the test or patient.
All other values and the tympano-
gram 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.
If you have saved two
tympanograms (for example, both
Figure 15
the left and the right ear) they are Printout of a normal tympanogram
printed side by side.
You can produce as many printouts as you want by pressing the Print button several
times.
4.7 How to delete the test results
By holding down the L/R 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.

17
Operating Instructions MI 26
5 How to measure the Stapedius reflex
5.1 The basics of the Stapedius reflex measurement
While tympanometry measures the musculus
stapedius hearing
change of the compliance caused by middle
nerve

ear
changing pressure in the outer bones

auditory canal, the Stapedius reflex ear canal

ear drum
cochlea

measurement works with a changing middle ear

eustachian tube
compliance caused by contraction of
the Stapedius muscle in the middle
ear. The contraction - called Stapedius
reflex - causes a decrease in
compliance and is caused by loud
acoustic stimuli. Regardless whether
the acoustic stimulus is active on the
left or on the right or on both sides Figure 16
the Stapedius reflex is always The middle ear
binaural, i.e. it occurs in both ears at
the same time. The Stapedius reflex is caused in ears of adults with normal hearing
with sound pressure levels between 70 and 105 dB.
In the probe ear, the reflex method continuously measures the compliance with the
pressure which was caused before the highest compliance measurement.
Simultaneously the stimulus ear is irritated by the sound which causes the contraction
of the Stapedius muscle.
The ipsilateral reflex measurement uses the same ear for
the probe and the stimulus. The contra-lateral
measurement uses different ears for the probe and the
stimulus. The acoustic stimulus is applied to the ear
opposite the probe ear. Figure 17
Ipsilateral test
If the applied stimulus causes a reflex, the impedance
measuring instrument registers a decrease in
compliance in the “probe ear” which indicates a
Stapedius reflex at the actual test frequency and the test
level. The test level which was set when the reflex
occurred is called reflex threshold and is shown in dBHL
(dB hearing level). Figure 18
Contralateral test
5.2 Preparing the patient
In addition to the general introduction described in chapter 4.2, explain to the patient
that loud test sounds will occur during the reflex measurement. It is very important
that the patient does not move because a reflex can be registered with a change of
compliance of 0.05 ml.

18
Operating Instructions MI 26

19
Operating Instructions MI 26
5.3 Preparing the ipsilateral measurement
The LCD shows the empty tympanogram for the right ear and the control light of the
probe is red. Impedance Right Ipsi

ml Status
3
READY

To measure the left ear, change


Ear Volume
2

Compliance
1

Pressure

the side by pressing the L/R key


0

-600 -300 300 daPa Gradient

1 2 3 4

or the probe button. The


80 80 80 80
500 Hz I 1000 Hz I 2000 Hz I 4000 Hz I
AUTO dB

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.
Turn the reflex measurement on
by pressing the Reflex key. The
word Ipsi must appear at the
right top of the display. The
sound stimuli for the reflex
measurement are reproduced by
Figure 19
the receiver integrated in the Display Tympanogram + Reflex
probe. (ready for measurement)

Set the desired intensity level with the down/up keys. On the LCD below the reflex
boxes at the bottom, the selected level in dB (Figure 19: 80 dB) appears. The “I”
indicates that an ipsilateral test is selected. You can choose between the fixed levels
70, 75, 80, 85, 90, 95 and 100 dBHL and Auto with a starting level of 70 or 80 dBHL.
If you choose Auto, the MI 26 starts with the lowest level 70 dBHL to 100 dBHL and
increases the level automatically until a reflex is registered or the maximum value is
reached. You can choose your individual starting level and maximum level. If you
have chosen a fixed level, the instrument measures only with this level.
Make sure the auditory canal is clear.
Choose the correct ear tip according to the size of the auditory canal and put it firmly
onto the probe tip (see chapter 3.7 Figure 9).

20
Operating Instructions MI 26
5.4 Taking the ipsilateral measurement
Impedance Right Ipsi

Carry out the measurement as 3

2
ml Status
READY
Ear Volume
0.94 ml
Compliance

described in chapter 4.4 “Recording


1 0.81 ml
Pressure
0 - 37 daPa

-600 -300 300 daPa Gradient


32 daPa
1 2 3 4

the Tympanogram.” The Stapedius 100


500 Hz I
PASS
100
1000 Hz I
PASS
AUTO
100
2000 Hz I
PASS
dB Scale
95
4000 Hz I
PASS

reflex is measured after the


measurement of the tympanogram.
During the measurement of the
Stapedius reflex the change of the
compliance is represented in real
time on the LCD. When the test is
finished the curves for the changes
of compliance at 500 Hz, 1000 Hz,
2000 Hz and 4000 Hz are shown in
four separate graphs at the bottom
of the measurement screen (see
Figure 20). Below each curve is the Figure 20
Example of a normal tympanogram
test level where a Stapedius reflex with ipsilateral reflex results
was registered automatically. This is
indicated by a Pass below the frequency. If no reflex was detected, a Fail is reported
and the maximum level is shown.
You can judge this by watching the real time graph if you have a real Stapedius reflex
or only disturbance and artifacts. The lower dotted zero-line of a graph indicates the
measured compliance without a test sound. All the positive or negative changes of
compliance are shown as deviation from the zero-line. If a Stapedius reflex occurs,
the compliance increases and the curve rises. The box which appears during the test
symbolizes the threshold at which the MI 26 accepts a change of compliance as a
valid Stapedius reflex.

21
Operating Instructions MI 26
5.5 Preparing the contralateral measurement (optional)
Impedance Right Contra

Switch on the contralateral reflex 3

2
ml Status
READY
Ear Volume
0.94 ml
Compliance

measurement by pressing the Reflex


1 0.81 ml
Pressure
0 - 37 daPa

-600 -300 300 daPa Gradient


32 daPa
1 2 3 4

key (the word Contra must appear on 100


500 Hz C
PASS
100
1000 Hz C
PASS
AUTO
100
2000 Hz C
PASS
dB Scale
95
4000 Hz C
PASS

the right top of the LCD). Here the


highest fixed level is 110 dBHL (with
TDH 39 contra phone only).
The contralateral measurement
produces more reliable results because
the receiver emitting the test signal
and the probe measuring the
compliance are separated.
If you are using an insert phone for
contalateral measurement, put an Figure 21
appropriate ear tip on the insert phone Example of a normal Tympanogram
with contralateral reflex results
and insert it in the contalateral ear.
Continue now as described previously
for the ipsilateral measurement. Impedance

2
ml
Right

Status
READY
Ear Volume
0.94 ml
Ipsi

Compliance
1 0.81 ml

5.6 How to interpret the reflex


Pressure
0 - 37 daPa

-600 -300 300 daPa Gradient


32 daPa
1 2 3 4

display
100 100 100 95
500 Hz I 1000 Hz I 2000 Hz I 4000 Hz I
PASS PASS PASS PASS
AUTO dB Scale

After having carried out a measurement


you can read the recorded values on
the LCD.
In addition to the tympanogram shown
on the left side and the values shown
on the right, the results of the reflex
measurement appear in the lower part
of the display. In the four boxes marked
1 to 4 the Stapedius response is shown
graphically. Below each box the test Figure 22
level, the test frequency and the type of Example of a normal Tympanogram
with ipsilateral reflex results
the test (I=ipsi, C=contralateral) are
shown. The test result is also shown as Pass or Fail. In the example in (Figure 22), for
500 Hz a Stapedius reflex was registered at 100 dBHL and for 4 kHz at 95 dBHL. If no
reflex threshold is registered, Fail appears below the frequency.
Correct interpretation of the reflex results should be made in conjunction with the
tympanogram, the graphic reflex display and other audiometric data.

22
Operating Instructions MI 26
How to print the test result
After a test, print the results for Id No.:
Name:
Examiner:
MAICO MI 24
Date:

MI 26
your documents by pressing the
Remarks:

Tympanogram
Right

Print button. The printer prints


ml
3

2 0.94 ml

out the example used in


1 0.81 ml

0 - 37 daPa

-600 -300 300 daPa


32 daPa

paragraph 5.6 in only 12 Ear Volume


Compliance
Pressure
Gradient
0.94 ml
0.81 ml
-37 daPa
31 daPa
Reflex

seconds.
Right
ml Ipsi 500 Hz PASS
0,15
0,10
0,05 s
0
100 dBHL
ml Ipsi 1000 Hz PASS
0,15
0,10
0,05 s

While the printer is working no


0
100 dBHL
ml Ipsi 2000 Hz PASS
0,15
0,10
0,05 s
0
100 dBHL

key action is possible and the 0,15


0,10
0,05
0
ml Ipsi

95
4000 Hz PASS

dBHL
s

probe is inactive.
In addition to printing the text as
seen in chapter 4.6 the result of
the reflex test is printed out.
The level value (dBHL) at which a
reflex had been measured
appears below the graph.
If no reflex was registered, Fail is
printed on the top of the graph
behind the test frequency.

Figure 23
Printout of a normal tympanogram
with ipsilateral reflex measurement

23
Operating Instructions MI 26
6 Interpreting test results
6.1 Understanding the printout
The printout contains the following
MAICO MI 24
Id No.: Date:
Name:
Examiner:
Remarks:
MI 26
information: 3
ml
Right
Tympanogram

 Ear volume
2 0.94 ml

1 0.81 ml

0 - 37 daPa

-600 -300 300 daPa


32 daPa

 Compliance
Ear Volume 0.94 ml
Compliance 0.81 ml
Pressure -37 daPa
Gradient 31 daPa

Right Reflex
ml Ipsi 500 Hz PASS
0,15
0,10
0,05 s

 Pressure
0
100 dBHL
ml Ipsi 1000 Hz PASS
0,15
0,10
0,05 s
0
100 dBHL
ml Ipsi 2000 Hz PASS
0,15
0,10

 Gradient
0,05 s
0
100 dBHL
ml Ipsi 4000 Hz PASS
0,15
0,10
0,05 s
0
95 dBHL

 Reflex Test Results (Pass, Fail)


and ipsi, contra or tympano-
gram (depending on the test
you have performed).
This information provides the data
you need to interpret the test
results.
A graph of the tympanogram is
provided (Figure 24) to the test.
This graph is a representation of
the relative mobility of the middle
ear system. The horizontal axis
shows the changes in air pressure
and the resulting mobility of the
system. The compliance is recorded
on the vertical axis. This mobility is
expressed as a change in the
volume of the ear canal in ml.
The reflex is shown in up to four
graphics with time on the
horizontal axis and the change of
the compliance on the vertical axis.

Figure 24
Printout of a normal tympanogram

24
Operating Instructions MI 26
6.2 Interpreting the tympanometric test result
As a general rule, values for ear canal volume should be between 0.2 and 2.0 ml
(children and adults). A variance will be seen within this range depending on the age
and ear structure of the person. For example, a 2.0 ml or larger reading in a small
child could indicate a perforation in the tympanic membrane, while it may be a
normal reading in an adult. You will become more familiar with the normal ranges
when you use the instrument.
The normal range for compliance is 0.2 ml to approximately 1.8 ml. A compliance
peak within the range indicates normal mobility of the middle ear system. A peak
found outside of these limits may be indicative for one of several pathologies.
Middle ear pressure should be equivalent to ambient air pressure (0 daPa on an air
pressure scale). Minor shifts of the peak compliance to the negative may occur with
congestion and are rarely to the positive side. Establish criteria for abnormal negative
pressure when you become more familiar with using the equipment. It is generally
accepted that negative pressure of greater than -150 daPa indicates a referral for
medical evaluation. A normal tympanogram is seen on the previous page in figure
24.
6.3 Abnormal Values
It is the purpose of this section to provide samples of tympanograms which reflect
abnormal states of the middle ear mechanism. It is not the intention of this section to
provide you with a complete guide to interpreting results. Complete information
regarding pathologies and abnormal impedance testing can be found in the literature
referenced.
A perforation in the tympanic membrane will cause a high ear canal volume
measurement because the instrument will measure the volume of the entire middle
ear space. The MI 26 may refuse to run the test, with the probe indicating a volume
out of tolerance by illuminating the red light, or a flat tympanogram will be recorded
since no movement will occur with a change in air pressure. Without a peak
compliance of at least 0.1 ml, the reflex test will not initiate.
An extremely flaccid tympanic membrane or an ossicular chain discontinuity will yield
a very high peak compliance in the presence of normal middle ear pressure. Ear canal
volume will be normal and the reflex will be absent.
A fixation of the ossicular chain, as in otosclerosis, will produce a tympanogram with
very low compliance in the presence of normal middle ear air pressure. Ear canal
volume is normal and the reflex is absent.

25
Operating Instructions MI 26
Middle ear fluid such as serious otitis media will yield a very flat tympanogram with
no definite peak and negative air pressure. A resolving case or beginning case may
produce a reduced peak in the presence of severe negative middle ear pressure. The
ear canal volume is normal and the reflex is either absent or at an elevated level.
Eustachian tube problems in the absence of fluid will show a normal compliance
curve, but it will be displayed to the negative side of the tympanogram. Ear canal
volume will be normal and the reflex may be present, depending on the degree of
impairment.

26
Operating Instructions MI 26
7 How to test children
When practicing impedance measurement with small children, be aware of problems
caused by the child being restless or afraid of the examination or reacting sensitively
to the change of pressure and the loud test sound. There are also different
conditions of the eardrum and the middle ear which do not appear in ears of adults.
It may be difficult to create a probe seal with restless children. If the child yawns or
cries, the instrument will not have stable pressure in the outer auditory canal. In
addition, speaking causes Stapedius muscle reflexes which lead to a change in the
compliance of the eardrum.
The child should be made familiar with the surroundings and the ear being touched
by the probe in order to carry out a successful impedance measurement. This could
be done by getting in touch with the child and by playfully touching the ear with the
probe. If you can touch the ear without problems, the child will normally accept the
probe being inserted.

27
Operating Instructions MI 26
8 Audiometric pure tone screening
8.1 Preparing the patient for the test
Before any kind of hearing testing, a brief patient orientation is required. Simply tell
the patient to "press the stimulus response button whenever you hear a "beep",
then quickly release the button. The beeps may be very soft, and have different
pitches, so you need to listen very carefully". Then place the earphones on the
patient’s head making sure the center of the opening of the phones are directly over
the opening of the ears. The red phone is for the right ear and the blue phone is for
the left ear. The headband should then be tightened so the phones do not slip. Do
not let the patient adjust the headset for him or herself.
8.2 Audiometer function recommended procedures
Turn the Power switch on the rear panel on, and let warm up 5-10 minutes. Press
the TYMP/AUD key to change from the tympanogram mode to the audiogram
mode.
Pass/Fail Method:
The initial setting on the LCD screen will indicate a frequency of 1 KHz and an
intensity of 30 dB. Pressing the  keys will change the intensity levels. Pressing the
keys will change the frequencies. Holding down these keys will let you scroll
through the selections. Pressing the PULSE key chooses either pulsed or steady tone.
1. Set the dB level at a predetermined level for a Pass or Fail criteria. (e.g. a level at
20 dB).
2. Present the tone stimulus at 4 different frequencies (e.g. 500, 1000, 2000 and
4000 Hz). You will only present one stimulus per frequency. Instruct the patient
to respond by pressing the response switch or raising their hand when they hear
the tone. The Response Box on the LCD screen will light if the patient response
switch is pressed.
3. If the patient fails at any frequency you may choose to do a presentation at 10
dB higher (30 dB). The patient may then be referred or rescheduled if they fail
at two or more frequencies.
NOTE: This is an example only. You must develop a method that fits your situation.

28
Operating Instructions MI 26
8.3 Hearing threshold method
The most commonly used hearing threshold procedure is called a modified
Hughson-Westlake procedure.
1. Start at 1000 Hz with a level of 0 dB and present a signal for at least 1-second.
If no response, increase in 10 dB steps until the patient responds.
2. Increase another 10 dB for a confirmation and orientation. If the patient
responds again, decrease the presentations in 10dB steps until the patient no
longer responds.
3. Increase in 5 dB steps until the patient responds. Once the patient responds,
descend 10dB until there is no response. Increase again in 5 dB steps.
4. Repeat until you have 2 out of 3 ascending responses at the same level.
Change the frequency and repeat the above procedure until you have the
thresholds for the number of frequencies you wish to test.
The hearing threshold is defined as the lowest hearing level at which the patient
responds to two out of three ascending stimuli at the same level.

29
Operating Instructions MI 26
8.4 MI 26 LCD Screen - Audiometer
Audiometry Right
RESPONSE
1000 Hz STIMULUS
30 dB
Hz 125 250 500 750 1K 1.5k 2K 3K 4K 6K 8K

R dB -- -- -- -- -- -- -- -- -- -- --

L db -- -- -- -- -- -- -- -- -- -- --

  Hz  dB ENTER - NR

Figure 25
Audiometer LCD Screen
RESPONSE:
Indicates when the Patient Response Switch has been pressed.
STIMULUS:
Indicates when the operator is pressing either Tone Presentation key, presenting
the stimulus. When the PULSE key is pressed it enables or disables pulsed tone.
When in pulsed tone mode, the STIMULUS box will flash; in continuous mode the
box will highlight until the STIMULUS button is released.
8.5 Audiometric pure tone screening results
Pass/fail criteria for audiometric pure tone screening can be determined by following
individual established standards. Since standard levels can vary, a normal or abnormal
response level will not be given in this manual. The test results in (Figure 26) are an
example of a MI 26 audiometric printout.

Audiometry

Hz 125 250 500 750 1K 1.5k 2K 3K 4K 6K 8K

R dB 20 20 20 20 20 20 20 20 20 20 20
L db 20 20 20 20 20 20 20 20 20 20 20

Figure 26
Audiometric Printout

30
Operating Instructions MI 26
9 Additional Reading

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

Roeser´s Audiology Desk Reference


Roeser, Ross J.
New York / Stuttgart: Thieme, 1996

Auditory Diagnosis
Silam, Shlomo and Carol A. Silvermann
San Diego / London: Singular Publishing Group, 1997

31
Operating Instructions MI 26
10 Individual Setup of the MI 26
The MI 26 offers many options for the experienced user to adapt the instrument to
individual demands.
Main Menu
The settings shown in the figures are the Tympanometry :
standard settings. If you have altered a
Audiometry:
value by accident, you just have to return to
SetupCalibration :
the standard setting shown here and the
Setup :
instrument will work as before.
By pressing the Menu key 7 you can
return from every sub-menu to the main
menu and to the tympanometry mode.
Change item
You can change the menu options with the
ENTER Select item
up/down/left/right cursor keys. The menu
option selected is highlighted on the LCD Figure 27
(Setup in Figure 27). Accept the chosen MI 26 main menu
menu option by pressing Enter.
10.1 The setup menu
Select the menu option Setup as illustrated in (Figure 27) and the main setup menu
will appear on the LCD. You can make different settings for the measurement of the
tympanogram and the Stapedius reflex as well as the instrument setup (for example
the contrast of the LCD). All your settings are saved permanently until you will
change them again. The settings also remain when the instrument is switched off.

32
Operating Instructions MI 26
10.2 The Tympanometer setup
Select the menu option Tympanometry Setup Menu as illustrated in (Figure
28) and the Tympanometer setup Menu will appear on the LCD.
Change the menu options with the up/down cursor keys.
Change the displayed item with the left/right cursor keys. The following settings are
possible: Main Setup Menu

Pump speed: Tympanometry Setup Menu :

With this option you can set the Setup Menu :

measurement speed. With Automatic, Common Setup Menu :

the pump speed adjusts automatically to the Audiometry Setup Menu :

test conditions. It is possible to choose: Clinic Setup Menu:

Minimum, Medium or Maximum as well.


A lower pump speed creates a higher
precision of the measurement but needs Change item
more test time. ENTER Select item MENU Exit

Display limits: Figure 28


MI 26 setup menu
On displays normative boundaries in the
tympanogram screen. Off turns it off.
Press. Limit hi: Tympanometry Setup Menu
With this option you can set the right limit Pump Speed
Pump Speed
: Automatic
: Automatic
of the normative box displayed on the
Display Limits : On
tympanogram test screen. Values can be
Press. Limit Hi : 100 daPa
set between 0 daPa and +200 daPa in steps
Press. Limit Lo : -200 daPa
of 25 daPa.
Compl. Limit Hi : 1.5 ml
Press. Limit lo: Compl. Limit lo : 0.1 daPa
With this option you can set the left limit of
the normative box displayed on the
 Change item
tympanogram test screen. Values can be
 Change item setting MENU Exit
set between -400 daPa and -25 daPa in
steps of 25 daPa. Figure 29
Comp. limit hi: MI 26 Tympanometer Setup Menu
(pump speed selected)
With this option you can set the upper limit (display limits setup selected)
of the normative box displayed on the
tympanogram test screen. Values can be
set between 0.1 ml and 3 ml in steps of 0.1 ml.
Comp. limit lo:
With this option you can set the lower limit of the normative box displayed on the
tympanogram test screen. Values can be set between 0.1 ml and 1.0 ml in steps of

33
Operating Instructions MI 26
0.1 ml. To leave the Tympanometry Setup Menu press the Menu button.

34
Operating Instructions MI 26
10.3 The Setup menu for Reflex Test
Select the menu option Setup Menu for Reflex Test from the main setup menu as
described before for the Tympanometry Setup Menu. The reflex setup menu will
appear on the LCD.
The reflex setup menu offers the following options:
Auto start dB :
Setup Menu for Reflex Test
With this option you can choose the starting Auto. Start dB : 80
acoustic pressure level if the automatic Auto. Maximum dB : 105
identification of the reflex threshold is switched Reflex sensitivity : Normal
on. You can choose the acoustic pressure levels Print graphic : On
500 Hz : On
from 70 dBHL to 100 dBHL in steps of 5 dB.
1000 Hz : On
Auto maximum dB: 2000 Hz : On
4000 Hz : On
With this option you can choose the maximum
acoustic pressure level the MI 26 uses if the
 Change item
automatic identification of the reflex threshold is
 Change item setting MENU Exit
switched on. You can choose the maximum
acoustic pressure levels from 80 dBHL to 110 Figure 30
dBHL in steps of 5 dB. MI 26 Reflex Setup Menu
(auto start dB setup selected)
Reflex sensitivity:
With this option, select the sensitivity of the Stapedius reflex detection.
The Sensitive setting will achieve Pass as test results with very small compliance
changes. (i.e. 0.03)
The Normal setting is the default setting. (i.e. 0.05ml)
With the Robust setting a larger compliance change is needed to detect a Pass.
(i.e. 0.08ml)
Print graphic:
With this option the printout of the graphic reflex display can be turned on or off for
documentation.
500 Hz : The Stapedius reflex test can be turned on and off with this option.
1000 Hz : The Stapedius reflex test can be turned on and off with this option.
2000 Hz : The Stapedius reflex test can be turned on and off with this option.
4000 Hz : The Stapedius reflex test can be turned on and off with this option.
To leave the Setup Menu for reflex, press the Menu button.

35
Operating Instructions MI 26
10.4 The Common Setup Menu
Select the menu option Common Setup Menu from the main setup menu.
The common setup menu offers the following options.
Power-up:
Common Setup Menu
Choose the test mode of the MI 26 after
Power-up : Tymp and Reflex
switching on. With the Tymp setting, only
Baud Rate : 57600
tympanometry is tested after power-up. Remote switch : L/R
Subject Data Printout : On
With Tymp and Reflex, tympanometry and
Clinic Data Printout : On
reflex are tested after power-up. Print after Test : Off

Baud Rate: Language : English


Display adjust :
Set the transmission speed of the serial data
interface. Possible settings are 57600  Change item
Baud or 38400 Baud.  Change item setting MENU Exit

Remote Switch: Figure 31


Change the function of the probe button. MI 26 Reflex setup menu
(Auto start dB setup selected)
You can choose between:
L/R: the test ear can be selected with the probe button.
Pause: the test can be paused and restarted with the probe button.
L/R or Pause: both the test ear and the test can be selected, paused and restarted
with the probe button M or off.
Subject Data Printout :
Turn the printout of the headline (data entry area at the top) on or off.
Clinic Data Printout :
If you entered your clinic data the printout of the entered data can be switched on
And off with this option.
Print after test :
With this option you enable an automatic printout after you finished a test by setting
it on. With the setting off, printout will be processed after you press the Print
button.

36
Operating Instructions MI 26
Language :
You can choose one of the following languages: German, French, English or
Spanish for the text on the LCD and the printout. After selection all the texts appear
in the chosen language.
Display adjust :
The contrast of the LCD can be changed with this option.
10.5 Audiometer Setup Menu Audiometer Setup Menu

Interrupter: Interrupter : Off


Frequency Start : Off
OFF: when selected the stimulus key is in
Init. Frequency : Off
the presentation mode, and will present a
Audiogram : Off
tone when pressed. Start Level 0 dB : Off
ON: the stimulus key is in the interrupt Swap dB Buttons : Off
mode, with the tone always on until the
stim key is pressed.
Frequency Start:
ON: the dB level will drop 20 dB from the  Change item
current level when changing frequencies.  Change item setting MENU Exit

Init. Frequency: Figure 32


OFF: while scrolling through audiometer MI 26 Audiometer setup menu
frequencies using the keys, the next
available frequency will roll from 8000 to 125 Hz or from 125 to 8000 Hz.
ON: while scrolling through frequencies using the keys, the next available
frequency will roll from 8000 to 1000 Hz or from 125 to 1000 Hz.
Audiogram:
OFF: test data is displayed in tabular form
ON: test data is displayed as an audiogram.
Start Level 0 dB:
OFF: the starting dB test level at each new frequency setting starts where initially set.
ON: at each new frequency setting the starting dB will drop to 0 dB.
Swap dB Buttons:
OFF: buttons operate as marked on the front panel.
ON: buttons operate in reverse of how they are marked on the front panel.
10.6 Insert your personal printout data
Select the menu option Clinic Setup Menu from the main setup menu, (see Figure
28), to enter all required data for your clinic. The data will be printed out with the
test results and the patient data.

37
Operating Instructions MI 26

11 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, damp cloth (use warm soapy water; no liquids containing alcohol or ammonia
should be used) to gently wipe the area clean.
During cleaning, please ensure that no liquid runs into the switches, level control or
probe openings.

38
Operating Instructions MI 26
12 How to change the printer paper
At the right side of the housing, pull the printer cover up using its finger recess in the
front of the printer cover.
Remove the printer cover.
Remove the empty paper roll.
Place the new paper roll in the paper compartment in such a way that the paper
unrolls from the bottom side of the roll.
Pull the blue lever, which is located on the right front of the printer, forward into
position.
The paper must feed from the bottom because it is only coated on one side. If it is
inserted wrong, no printout will be visible!
Gently insert the paper end in between the rubber roll and the black plastic part at
the rear of the printer.
Feed the printer paper until it appears from the upper part of the rubber roll.
Feed about 4 – 5 inches of paper from the roll.
Push the blue lever back into its backward position.
Guide the paper end through the paper slot of the printer cover.
Close the printer cover by putting the two guide rails at the end of the printer cover
into their appropriate slots in the paper compartment of the housing of the MI 26.
Press the front of the printer cover down until it fastens.
You are now ready to print.

39
Operating Instructions MI 26
13 Warranty, maintenance and after-sales service
13.1 Warranty
This warranty is extended to the original purchaser of the MI 26 by Maico, through
the authorized Special Instrument Distributor from whom it was purchased, and
covers defects in material and workmanship for a period of one year from date of
delivery of the MI 26.
Should the Maico MI 26 require service due to a defect in material or workmanship,
Maico, at its option, will repair or replace the instrument at no charge except for
transportation to and from the point of service. It is the purchaser’s responsibility to
return the MI 26 to the Maico Special Instrument Distributor from whom it was
purchased or directly to Maico after receiving a return authorization.
This warranty does not cover breakage or failure caused by tampering, misuse,
carelessness, accident or modification. The warranty is void if the instrument is
serviced by other than an authorized Maico Special Instrument Service Center.
NOTE:
Specifications in this manual are in effect at the time of printing. Maico reserves the
right to modify or change specifications or design at any time without notice or
incurring obligation.

WARNING:
The Maico MI 26 is designed to be used with a hospital grade outlet. Injury to
personnel or damage to equipment can result when a three-prong to two-prong
adapter is connected between the power plug and an AC outlet or extension
cord.

40
Operating Instructions MI 26
13.2 Maintenance
The MI 26 is designed to require minimal maintenance and should provide you with
years of trouble-free use. The following suggestions may assist you in avoiding
and/or solving problems.
Calibration:
The optimum length of time between recalibrations for impedance meters or
audiometers varies, depending upon the treatment given the instrument and the
headphones/probe. It is recommended that the instrument have a laboratory
calibration at least once every year. Since rough handling, such as dropping the
probe, can easily cause calibration errors it is advisable to establish a biological
calibration check as soon as you receive the instrument.
Should you feel at a later date that the impedance or audiometer’s calibration may
be in error, perform a biological check on a known ear. If all retests show major
changes, calibration is probably in error.
All repair and recalibration should be done at an authorized Maico Special
Instruments Distributor service center. This assures the use of quality materials by
trained and experienced technicians using the proper, accurate equipment.
Maico Special Instruments Distributors are located in major cities throughout the
world. To minimize costs and time delays, contact the Distributor that you
purchased the instrument from. If you don’t know who that is, or need to find the
Distributor closest to you, contact the factory at:
Maico Diagnostics
10393 West 70th St
Eden Prairie, MN 55344
Toll free 888-941-4201
Phone 952-941-4200
Fax 952-903-4200

Customers outside of North America and South America may contact:

Maico Diagnostic GmbH


Sickingenstr 70/71
10553 Berlin, Germany
phone ++030 70 71 46 50
fax ++030 70 71 46 99

41
Operating Instructions MI 26
Care of eartips:
The eartips supplied with your instrument are latex-free silicone rubber and can be
cleaned with a mild soap and water, chlorine bleach or with alcohol. Dry the tips
thoroughly before replacing them on the probe.
Care of headset:
Always handle earphones with care. Never drop them or permit them to snap
together. Mechanical shock may change the earphone’s electrical and operational
characteristics and require recalibration of the instrument. Ear cushions are latex-
free neoprene rubber and may be cleaned with a mild soap and water.
Care of accessory connections:
Avoid sharp bending or twisting any of the connecting cords. Unplug headset and
patient response cords by grasping the barrel of the connecting plug. Never pull on
the cord itself.
Shipping instructions for recalibration or repair
In the event it becomes necessary to return the instrument for recalibration or
repair, please follow these instructions:
1. Place the instrument in the original shipping carton, using the packaging
provided. Be sure to include all accessories, as they are required for proper
calibration.
2. Enclose an explanatory letter describing the service you require, carefully
detailing any operational problems. Be sure to include your name, phone
number, the serial number and your full return address for return shipping.
3. Ship, prepaid, to your Maico Special Instrument service center.

NOTE: Warranty service is provided by your authorized Maico Special Instruments


Distributor.

DO NOT ATTEMPT TO REMOVE THE INSTRUMENT CASE YOURSELF.


THIS SHOULD ONLY BE DONE BY AN AUTHORIZED MAICO SERVICE TECHNICIAN.

42
Operating Instructions MI 26
14 Safety regulations
14.1 Electrical safety:
The MI 26 tympanometer is constructed to comply with protection class II of the
international standard IEC 601-1 (EN 60601-1).
The instruments are not intended for operation in areas with an explosion hazard.
14.2 Measuring accuracy:
To guarantee that the tympanometer works properly, the instrument has to be
checked and calibrated at least once a year.
The service and calibration must be performed by an authorized service center.
14.3 Device control:
The user of the instrument should perform a subjective instrument check once a
week. This check can be completed following the list for subjective instrument
check (see next page). For your own security, you should copy the enclosed list, fill it
in once a week and store it in your files.

43
Operating Instructions MI 26
15 Checklist for subjective device control
According to the manufacturer requirements, the user should test the instrument
once a week. This is to find errors immediately and to avoid inaccurate test results.
This test should test tympanogram and reflex with an otologic normal person and
compare the results with earlier measurements. The printout should be filed
together with the subjective test protocol to document the instrument test. The test
person should be healthy (no otitis etc.) and should not be exposed to loud noise for
at least 12 hours before the test. The instrument must be calibrated according to
chapter 3.5 of the operating intstuctions. An example of the printout data is below.

Instrument type:

Serial No.:

Test person:
Connectors and cables OK?
Instrument and probe?
Is the green light O of the probe blinking?
Probe tip and ear tip clean?
Are all controls easy to use?
Are the test signals clear and non-distorted?

Reflex test 500 Hz 1000 Hz 2000 Hz 4000 Hz


right ear
90 dBHL
Reflex test 500 Hz 1000 Hz 2000 Hz 4000 Hz
left ear 90
dBHL

If significant differences or damages are found, please send in for service


repair.

Tested by: Date:

44
Operating Instructions MI 26
16 Technical Data and Accessories
Impedance measurement:
Type: Class 2 acc. to ANSI S3.39
Tympanometer:
Test frequency: 226 Hz ± 1%
Test level: 85 dBSPL in 2 cm3
Pressure range: +200 ... -400 daPa
Volume range: 0.1 ... 6.0 ml
Accuracy: ± 5 % or ± 10 daPa
Test time: Less than 3.0 seconds typical
Compliance range: 0.2 to 3 ml
Reflex measurement:
Test frequencies: 500 Hz, 1 kHz, 2 kHz, 4 kHz ± 2%
Test method: ipsilateral, contralateral (optional)
Test level ipsilateral: 70 dBHL ... 105 dBHL
(Optional) (for 4 kHz ... 100 dBHL)
Test level contralat.: 70 dBHL ...110 dBHL
(Optional) (for 4 kHz ... 105 dBHL)
Attack/release time: typical 10 ms
ON/OFF Ratio: Greater than 70 dB
Pressure at test: Pressure @ max. Compliance
Pure Tone Screener:
Air conduction frequencies and HL ranges:
Frequency Air HL Range
125 Hz -10 - 70 dBHL
250 Hz -10 - 90 dBHL
500 Hz -10 - 90 dBHL
750 Hz -10 - 90 dBHL
1000 Hz -10 - 90 dBHL
1500 Hz -10 - 90 dBHL
2000 Hz -10 - 90 dBHL
3000 Hz -10 - 90 dBHL
4000 Hz -10 - 90 dBHL
6000 Hz -10 - 90 dBHL
8000 Hz -10 - 90 dBHL
Frequency accuracy:  3% of indicated frequency
SPL calibration accuracy:  3 dB
Tone envelope: rise time: 40 msec. typical

45
Operating Instructions MI 26
fall time: 40 msec. typical

Calibrated per ANSI S3.6 1996.


General:
Memory: Storage of two complete test result sets
LCD-display: Graphical display of the tympanograms and the reflex
curves
Numeric display of max. compliance, pressure at max.
Compliance, canal volume, gradient and reflex
thresholds
Printer: Thermal printer, paper roll width 110 mm
Printing time: Between 4 seconds (one tympanogram) and 12
seconds (tympanogram and reflex for both ears)
Voltage: 96 - 240 V / 50/60 Hz
Power consumption: appr. 65 VA

46
Operating Instructions MI 26
12 11 8 10 7 6

4 5 3 1
9
Figure 4
Connectors at the rear of the MI 26

Connection plugs:
1. AC POWER
2. ON/OFF SWITCH
3. PROBE
4. PROBE PRESSURE
5. CONTRA PHONE
6. AUDIOMETER PHONE (R)
7. AUDIOMETER PHONE (L)
8. PATIENT RESPONSE SWITCH
9. USB INTERFACE
10. BC (Future option)
11. MIC (Future option)
12. CD (L) and (R) (Future option)
Warm up time: less than 10 min after power on
Environment
conditions: + 15 to + 35 °C / + 59 to + 95 °F (operation)
+ 5 to + 50 °C / + 41 to + 122 °F (storage)
Maximum humidity 90 % (storage and operation)
Dimensions: 15 ¼“ W x 11 1/2“ D x 4 ¼“ H
(39 cm W x 29 cm D x 11 cm H)
Weight: 5.5 Lbs (2.6 kg)

47
Operating Instructions MI 26
Accessories:
Standard: 1 hand-held probe
1 power cable
1 set of ear tips
1 calibration cavities (cavities 5ml, 2ml, 0.5ml)
1 printer paper roll (for app. 350 printouts)

Consumable: 1 roll printer paper Part No. 5529


4 pc. ear tips yellow (7 mm) Part No. 6643
4 pc. ear tips green (9 mm) Part No. 6644
4 pc. ear tips white (11 mm) Part No. 6645
4 pc. ear tips yellow (13 mm) Part No. 6646
4 pc. ear tips green (15 mm) Part No. 6647
4 pc. ear tips blue (18 mm) Part No. 6648

Specifications are subject to change.

MAICO Diagnostics
10393 West 70th St
Eden Prairie, MN 55344
Tel.: 888.941.4201
Fax: 952.278.4481
E-mail: [email protected]
Internet: www.maico-diagnostics.com

48
1162-0322 REV. D 09/07

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