Mi26 Op Manual
Mi26 Op Manual
Operating Instructions
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Operating Instructions MI 26
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
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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
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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.
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Operating Instructions MI 26
3 Getting started
Your MI 26 was carefully inspected and packed for shipping. However, it is good
practice to thoroughly inspect the outside of the shipping container for signs of
damage. If any damage is noted, please notify the carrier immediately.
3.1 Unpacking
Remove the accessories. Carefully remove the instrument from the shipping carton.
Remove the instrument from the plastic bag and inspect the case for any damage.
Notify the carrier immediately if any mechanical damage is noted. This will assure that
a proper claim is made. Save all packing material so the claim adjuster can inspect it
as well. When the adjuster has completed the inspection, notify the MAICO Special
Instrument Distributor you purchased this unit from.
Save all the original packing material and the shipping container so the
instrument can be properly packaged if it needs to be returned for service or
calibration.
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
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Operating Instructions MI 26
3.2 Environmental conditions for the MI 26
The MI 26 should be operated in a quiet room.
The test room must be at normal temperature, usually 15° C / 59° F to 35° C / 95° F,
and the instrument should be switched on about 10 minutes before the first
measurement to guarantee precise measuring results. If the device has been cooled
down (e.g. during transport), please wait until it has warmed up to room
temperature
3.3 Preparing the MI 26 for use
3.3.1 Connect probe and accessories
- Connect the probe cable to socket 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
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Operating Instructions MI 26
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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
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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
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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
Pressure
0
80
500 Hz I
2
80
1000 Hz I
AUTO
3
80
2000 Hz I
dB
4
80
4000 Hz I
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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 7and 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
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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
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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
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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
Figure 11
Principle of the impedance measurement
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Operating Instructions MI 26
The impedance measurement examines the acoustic resistance of the middle ear. If
the eardrum is hit by a sound, part of the sound is absorbed and sent via middle ear
to the inner ear while the other part of the sound is reflected. The stiffer the eardrum
is the more sound is reflected and the less sound reaches the inner ear. Inside the
probe of the impedance measuring instrument a small loudspeaker is installed which
emits a low frequency sound through a tube (Figure 11: A) into the auditory canal
before the eardrum. Another tube (Figure 11: B) is connected to the microphone
inside the probe which receives the sound. Together with a third tube (Figure 11: C),
all three are inserted nearly to the eardrum and are made airtight against outside
pressure by the ear tip. A manometer and a pump, which can produce both positive
and negative pressure, are connected with tube C. Less sound is reflected to the
microphone when the eardrum is stiff and the eardrum transmits the majority of the
sound via the middle ear to the inner ear. The highest compliance is normally reached
with an air pressure corresponding to the outside pressure.
When performing tympanometry during a 2,0
2.0
1,6
measurement, a continuous change of 1,2
Compliance ( ml)
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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
Compliance
1
Pressure
Scale
Gradient
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Operating Instructions MI 26
4.5 How to evaluate the tympanogram display
After having completed a Impedance
3
ml
Right Tympanometer
Status
READY
1
Ear Volume
0.94 ml
Compliance
0.81 ml
Pressure
Scale
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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
2 0.94 ml
0 - 37 daPa
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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
ear drum
cochlea
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.
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Operating Instructions MI 26
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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
Compliance
1
Pressure
1 2 3 4
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).
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Operating Instructions MI 26
5.4 Taking the ipsilateral measurement
Impedance Right Ipsi
2
ml Status
READY
Ear Volume
0.94 ml
Compliance
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Operating Instructions MI 26
5.5 Preparing the contralateral measurement (optional)
Impedance Right Contra
2
ml Status
READY
Ear Volume
0.94 ml
Compliance
2
ml
Right
Status
READY
Ear Volume
0.94 ml
Ipsi
Compliance
1 0.81 ml
display
100 100 100 95
500 Hz I 1000 Hz I 2000 Hz I 4000 Hz I
PASS PASS PASS PASS
AUTO dB Scale
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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
2 0.94 ml
0 - 37 daPa
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
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
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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
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
Figure 24
Printout of a normal tympanogram
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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.
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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.
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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.
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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.
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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.
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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
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
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Operating Instructions MI 26
9 Additional Reading
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.
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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
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Operating Instructions MI 26
0.1 ml. To leave the Tympanometry Setup Menu press the Menu button.
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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
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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
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Operating Instructions MI 26
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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.
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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.
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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
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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.
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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.
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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?
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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
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Operating Instructions MI 26
fall time: 40 msec. typical
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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)
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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)
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
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1162-0322 REV. D 09/07