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Operation Manual: Impedance Audiometer AT235h

The document is an operation manual for the AT235h impedance audiometer. It provides instructions on intended use, safety precautions, general theory of impedance measurements, interpretation of test results, basic functions of the device, reflex and tympanometry testing procedures, automatic and manual audiometry functions, maintenance procedures, and technical specifications.

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0% found this document useful (0 votes)
297 views

Operation Manual: Impedance Audiometer AT235h

The document is an operation manual for the AT235h impedance audiometer. It provides instructions on intended use, safety precautions, general theory of impedance measurements, interpretation of test results, basic functions of the device, reflex and tympanometry testing procedures, automatic and manual audiometry functions, maintenance procedures, and technical specifications.

Uploaded by

mendezoswaldo
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/ 102

Operation Manual

Impedance Audiometer AT235h

Valid from serial no. 160252 and software version 1.18116


58979 - vers . 07/2005
Table of Contents
Table of Contents ............................................................................... 1
Introduction......................................................................................... 3
Intended Use ..................................................................................... 3
Precautions........................................................................................ 3
General Theory of Impedance Measurements................................. 5
Understanding Tympanograms ......................................................... 6
Classification of Tympanograms ....................................................... 7
Interpretation of Test Results.......................................................... 10
Tympanometric Curves And Pathologies ........................................ 10
Reflex Interpretation ........................................................................ 11
Pathways for the Stapedius Reflexes .............................................. 13
Reflex Decay Interpretation ............................................................. 15
Examples of Interpretation............................................................... 16
Basic Functions ................................................................................ 21
Preparing the Test ........................................................................... 21
Test Procedure ................................................................................ 24
Printing Test Results ....................................................................... 26
Reflex and Tympanometry............................................................... 29
Modifying reflex Test A and B.......................................................... 32
Ipsilateral and Contralateral reflexes ............................................... 33
Tympanometry - only....................................................................... 33
Tympanometry with High Probe Tone ............................................. 35
Automatic Reflex Test - only............................................................ 37
Manual Reflexes.............................................................................. 39
Editing Automatic and Manual Reflexes.......................................... 40
Manual Reflex Decay....................................................................... 42
Eustachian Tube Function............................................................... 44
Automatic and Manual Audiometry................................................. 47
”Child” Function ............................................................................... 49
Handling of Ear Tips......................................................................... 50
Cleaning of Ear Tips ........................................................................ 50
Cleaning of Probe Tip...................................................................... 50
Functions of Buttons........................................................................ 53

AT235h Operation Manual Page 1


Technical Specifications.................................................................. 55
Impedance Measuring system......................................................... 56
Reflex and Audiometer Functions ................................................... 57
Parts ................................................................................................ 59
Connection to PC ............................................................................ 59
Connection Panel ............................................................................ 60
Transforming the Probe................................................................... 60
Installing Printer Paper .................................................................... 61
Unpacking / Inspection .................................................................... 63
Contents of Shipment ...................................................................... 63
Reporting Imperfections .................................................................. 64
Care and Maintenance .................................................................... 64
Trouble Shooting .............................................................................. 66
Frequently Asked Questions ........................................................... 68
Recommended Literature ................................................................ 71
Dictionary .......................................................................................... 73
Appendix A: Main Menu and Setup................................................. 77
Main Setup Menu............................................................................. 78
Tympanometry Setup Menu ............................................................ 79
Setup Menu for Reflex Test A and B ............................................... 82
Reflex Methods................................................................................ 83
Common Setup Menu...................................................................... 90
Appendix B: General Maintenance Procedures............................. 96
Return Report.................................................................................... 99
Drawing of Front Plate ................................................................... 101

AT235h Operation Manual Page 2


Introduction
Intended Use
The AT235h is an automatic impedance audiometer well suited for
screening, as well as diagnostic work. Neonatal screening programs
will particularly appreciate the presence of high probe tone
tympanometry, allowing more reliable tympanometric results in
neonates.

The AT235h tympanometer is intended to be used by an audiologist,


hearing healthcare professional, or trained technician in a quiet
environment (tymp and reflexes) and extremely quiet environment
(Audiometry).Careful handling of instrument whenever in contact with
patient should be of high priority. Calm and stable positioning while
testing is preferred for optimal accuracy. It is recommended that the
instrument be operated within an ambient temperature range of 15-35
degree Celsius (59-95 degrees Fahrenheit)

Precautions
Notice - Be sure to insert the probe tip in a way which will assure an
airtight fit without causing any harm to the patient. Using a proper and
clean ear tip is mandatory.
Notice - We recommend using a new ear tip for each patient. If the
clinician rinses the ear tips they should be subjected to standard
disinfecting procedure between patients. This includes physically
cleaning the ear tip and use of a recognised disinfectant. Individual
manufacturer's instruction should be followed for use of this
disinfecting agent to provide an appropriated level of cleanliness.
Notice - Be sure to use only stimulation intensities acceptable for the
patient.
Notice - The transducers (headphones, bone conductor, etc.) supplied
with the instrument are calibrated to this instrument - exchange of
transducers requires a re-calibration.

AT235h Operation Manual Page 3


If this apparatus is connected to one or more other
devices with medical CE marking, to make up a system
or pack, the CE marking is only valid also for the
combination if the supplier has issued a declaration
stating that the requirements in the Medical Device
Directive article 12 are fulfilled for the combination.

Notice - Never clean the transducer housing with water or insertion


instruments.

Note!
Within the European Union it is illegal to dispose electric and electronic
waste as unsorted municipal waste. Electric and electronic waste may
contain hazardous substances and therefore has to be collected
separately. Such products will be marked with the crossed-out
wheeled bin shown below. The cooperation of the user is important in
order to ensure a high level of reuse and recycling of electric and
electronic waste. Failing to recycle such waste products in an
appropriate way may endanger the environment and consequently the
health of human beings.

AT235h Operation Manual Page 4


General Theory of Impedance
Measurements
To understand impedance measuring from a popular point of view it is
sufficient to know that a sound of 226 Hz. presented into a cavity like
the human ear will produce different SPLs depending on the volume of
the cavity. By measuring changes in the SPL, equivalent volume
changes can be established.

Presenting a high positive or negative air pressure to the outer ear


canal will stiffen the tympanic membrane, thus creating a cavity
acoustically consisting of only the outer ear canal. In this way the
equivalent volume of the outer ear canal can be established.

By gradually varying the air pressure from a positive pressure to a


negative the tympanic membrane and the attached ossicular chain will
gradually become more and more mobile, showing more compliance
to the sound pressure waves. The sound passage to the middle ear
will then be less and less reduced or impeded by the tympanic
membrane, and the impedance is said to be lower. The lowest
impedance will be obtained when the air pressure is equal on both
sides of the tympanic membrane, thus showing the highest
compliance to the sound waves. In this state, the cavity responding to
the introduced sound will be comprised of the outer ear canal as well
as the middle ear. This will reveal the total equivalent volume of the
outer- and middle ear.

The equivalent volume of the middle ear, also called the compliance,
is easily derived by subtracting the two volume measurements above.
This is done automatically on the MT10 and the result is presented as
"Compliance", measured in ml.

The impedance curve, drawn by a gradual sweep across a wide


pressure range, can reveal a great deal of information about the state
of the middle ear, the tympanic membrane, and the ossicular chain.

The above principle for measuring the stiffness of the tympanic


membrane can also be used to detect tympanic membrane stiffness,
caused by contraction of the middle ear muscles. This is usually
referred to as the "Stapedius Reflex". The normal ear will, when
subjected to loud signals, reflexively contract the Stapedius muscle

AT235h Operation Manual Page 5


(and in some cases the tensor tympani muscle). This will immobilise
the tympanic membrane somewhat and this change of impedance is
detectable as explained above and a reflex recording of the
impedance change can be presented. Such a reflex is called a
Stapedius reflex, as the Stapedius muscle contraction is the dominant
factor in creating this impedance change. Reflex measurements are
normally carried out with air pressure in the outer ear canal set for
maximum compliance.

This Stapedius reflex can be elicited both ipsilateral and contralateral,


and has great diagnostic value. Together with the impedance curve
measurement the integrity of the complete middle ear system can be
evaluated.

Understanding Tympanograms
General Considerations:
A given curve drawn in a co-ordinate system will always have its
shape dictated by the vertical and horizontal graduations. The
printout of the MT10 complies with the international standards in
this respect, and therefore may not produce tympanogram
shapes directly comparable to other instruments if these do not
meet the standard requirements.

The Peak:
The peak of the tympanogram will horizontally be placed at the
air pressure of the middle ear, as equal pressures on both sides
of the tympanic membrane produces the highest compliance of
the system. A slight deviation of the peak in the direction of the
air pressure sweep may be experienced, due to an inherent
hysteresis of the middle ear and the test equipment. A slower
sweep speed may diminish the offset.

The Height:
The height of the tympanogram from its more or less horizontal
bottom line (measurements made from start pressure) to the top
shows the difference in compliance between stiffened tympanic
membrane and max. compliance. This difference is referred to
as "compliance" and is a measure for the equivalent volume of
the middle ear.

AT235h Operation Manual Page 6


Equivalent Volume:
The term "Equivalent Volume", in which compliance is
measured, should be understood clearly in order to avoid
3
misinterpretation of test results. The unit of measurement is cm
(or ml.) but this does not mean that e.g. the middle ear has this
exact internal volume. It means that the middle ear, as seen
from the outer surface of the tympanic membrane, reacts the
same way as a hard walled cavity of this exact volume would
react.

Compared to a hard walled cavity a normal middle ear


incorporates at least three major differences. One is friction due
to the ligaments connected to the ossicles (resistance). The
second is stiffness caused by the elastic qualities of the
eardrum and the enclosed air and by a fluid pressure from the
inner ear exerted on the stapes (stiffness reactance). The third
is the mass of the eardrum and the ossicles (mass reactance).

At 226 Hz the stiffness component is by far the most dominant


factor and is therefore the subject of measurement.

The Shape:
The shape of the tymp curve will change when the stiffness of
the system is changed (e.g. by ossicular chain disruption, otitis
media, etc.), and this is a primary reason for the diagnostic
value of this measurement. However, normal ears show a great
variety of tymp shapes so this should never be taken as the only
basis for making a diagnosis. Furthermore, two different
abnormalities may have opposing effects, resulting in a normal
shape of the tymp curve.

Classification of Tympanograms
Tympanograms can be classified according to compliance (height,
3
measured in ml. or cm ), pressure at compliance maximum
(measured in daPa), rate of compliance change (gradient in %), and
shape. Please refer to the chapter "Examples of Interpretations" in this
manual for illustrations of the classic curve categories, and the names
given to them by Liden and Jerger. On the following pages a more
detailed description of each category is presented.

AT235h Operation Manual Page 7


Type "A" characteristics:
The tymp curve shows a clear compliance peak within the
pressure range of ± 50 daPa for adults. For children the middle
ear pressure may be considered normal down to
-150 daPa negative pressure.

Normal ears often show type "A" tympanograms.

Type "AD" characteristics:


The type AD tympanogram is essentially a type A tympanogram
in which the curve is very high and may be outside the range of
the instrument / recording chart. Peak is within the pressure
range of type A of ± 50 daPa. The very mobile eardrum can
reproduce various curves.

It can represent ossicular discontinuity, flaccid eardrum or a


combination of both. Peaking and notching outside the test
range is possible. Note: The type AD curve may reveal itself as
being a type D curve, if a higher probe tone, e.g. 800 Hz, is
used.

Type "AS" characteristics:


The type As tympanogram is essentially a type A tympanogram
in which the curve is much shallower than usual. Peak is within
the pressure range of type A of ± 50 daPa. For children the
middle ear pressure may be acceptable down to -150 daPa
negative pressure. The pathology could be immobile stapes due
to otosclerosis (no reflexes), some form of otitis media, thick or
scarred eardrum, or just a normal variant. Infants’ ears may
show this small compliance.

Type "B" characteristics:


Low compliance without peak identification. Middle ear pressure
is unknown, probably negative. The type "B" is flat, going slightly
upwards by negative pressure. It may be associated with ears
having extremely stiffened middle ear systems. Indication of
fluid (serous or adhesive otitis media), retracted eardrum,
blockage of the external ear canal, or perforated eardrum e.g.
with drainage tube. Note: Ears with type B tympanograms
should be tested for peak identification down to -600 daPa.

Type "C" characteristics:

AT235h Operation Manual Page 8


Normal compliance peak with peak identification in the negative
pressure range, e.g. below -50 daPa for adults (Bluestone) and
below -150 daPa for infants (Liden) .The type C curve shows all
the characteristics of normal type A, AD and AS curves.

The type C curve indicates poor Eustachian tube function with


possible developing or resolving middle ear effusion.

Type "D" characteristics:


Depicted by a deep curve with a small notch at the peak. Middle
ear pressure ± 100 daPa. This curve does not necessarily
indicate a pathological ear. Healed perforation of tympanic
membrane, fixation of parts of the bones after ossicular
discontinuity, flaccid eardrum with ear wax, or maybe a
ventilation tube blocked with ear wax and healed middle ear,
can cause peaking and notching, resulting in many shapes at
the top of the maximum compliance curve. The curve could also
be a narrow type E (W shaped) tympanogram. Note: May be
better detected with an 800 Hz probe tone.

Type "E" characteristics:


Depicted by a broad, deep, often multiple notching. "W" shaped.
This tympanogram is usually caused by ossicular discontinuity,
but may also indicate restored ossicular chain one year or more
after stapedectomy. Note: May be better detected with an 800
Hz probe.

AT235h Operation Manual Page 9


Interpretation of Test Results
Tympanometric Curves And Pathologies
- According to Feldmann -

Peak Pressure
Negative Normal Pressure: Positive Absence of
Pressure: Pressure: Pressure
Peak:
1) Blocked 1) Ossicular bone 1) Early
Eustachia fixation acute 1) Middle ear
n tube 2) Adhesive fixation otitis effusion
2) Serous 3) Ossicular media 2) Open tymp.
otitis discontinuity membrane
media 4) Middle ear tumour 3) Artifact
5) Eardrum
abnormality

Amplitude
Increased Decreased Unchanged
Amplitude: Amplitude: Amplitude:

1) Eardrum 1) Ossicular fixation 1) Blocked Eustachian


abnormality bony or adhesive tube
2) Ossicular 2) Serous otitis media 2) Early acute otitis
discontinuity 3) Cholesteatoma, media
polyps, granuloma
4) Glomus tumours

Shape
........................Slopes....................... Smoothness:
Decreased / Increased slope: Altered smoothness:
Flattened slope:
1) Eardrum 1) Eardrum
1) Serous otitis abnormality abnormality
2) Ossicular fixation 2) Ossicular 2) Ossicular
3) Tumours of middle discontinuity discontinuity
ear 3) Vascular tumours
4) Patulous
Eustachian tube

AT235h Operation Manual Page 10


Reflex Interpretation
Figure 1:

Onset and Offset:


As judged on the normal reflex these measurements have little
or no diagnostic value (See Decay Test). The attention should
be drawn to the fact that instrument variation exists in these
parameters. Roughly, it can be said that the more steep the
onset and offset slopes, the faster is the instrument. Especially
older instruments had rather flat slopes.

Noise:
Acoustical signals showing up in the reflex recording, yet
irrelevant to the Stapedius reflex. As the reflex measurements
are based on observing the change in sound intensity of a 226
Hz tone, as explained in "Popular Introduction to Impedance", it
is possible that environmental noise of this frequency entering
the ear will show up as part of the test result. This is a problem
inherent to the measuring method and therefore common to all
normal impedance meters. Heart beat, talking and external
noises are common causes of noise peaks seen on the reflex
curve.

A negative reflex may occur due to the following interference of


noise: Prior to recording the reflex activity an acoustic reference
level is measured in the ear canal without any Stapedius activity.
The difference between this reference level and the level

AT235h Operation Manual Page 11


present when the Stapedius muscle is active is recorded as a
reflex. If, however, external noise was entering the ear only
during reference level measurement, and not during reflex
measurement, the level may actually be lower during the reflex,
thus resulting in a negative reflex. This is of course not a valid
measurement. The negative reflex is an extreme situation, but
noise will always distort the measurements to a certain degree
and should therefore be avoided.

Negative Onset:
It is quite common to see reflexes start out with a small negative
deflecting dip. In ears with stapedial otosclerosis this dip with an
additional dip at the end of the stimulation can be the only
reaction left from the contraction of the Stapedius muscle. Some
tumour ears have been reported to give only the negative onset,
but no further reaction.

Reflex Threshold:
For a given stimulus the lowest level that elicits a detectable
reflex. This is not an absolute measurement as no exhausting
norm exits defining stimuli and related reflex characteristics.
Therefore, differences in test setups and reflex evaluation will
produce somewhat different results. It is not uncommon to
report the reflex threshold as the intensity which produces a 1%
or 2% change in equivalent volume (Test "A" with 2%
sensitivity).

It should be noted that a visual examining of reflex test might


reveal some Stapedius muscle action, also at slightly lower
stimulus intensities. This procedure (see "Example of Popular
Fixed Intensity Reflex Test") is recommended for establishing
the absolute reflex threshold.

Generally, noise stimuli elicit reflexes at lower levels than pure


tones do.

AT235h Operation Manual Page 12


Pathways for the Stapedius Reflexes
Figure 2:

The Nature of the Reflex:


The Stapedius muscle reflex is elicited binaurally via monaural
stimulation (Ipsilateral stimulation via the impedance probe -
contralateral stimulation via the headphone). The average reflex
threshold is 85 dB HL (70 dB - 100 dB) for normal ears of 20
year old patients when pure tones are used as stimulus.

Noise as stimulus produces a threshold approx. 10-20 dB lower


as noise is made out of many simultaneous tones together
carrying more energy. Increased stimulation level will produce a
stronger reflex. Cochlear and retrocochlear pathology may show
less rapid growth of reflex amplitude versus stimulation
amplitude.

AT235h Operation Manual Page 13


Primarily, a reflex test shall answer these questions:
• Is the reflex absent or present?
• If present, is it present both contralateral and ipsilateral?
• What is the threshold of the reflex?

If the test shows normal reflex thresholds and a normal


tympanogram is present, the middle ear will usually be classified
as healthy. One exception, though, is the early stage of
otosclerosis.

Non Acoustic Stimulation:


The Tensor Tympany muscle of the middle ear can produce a
reflex elicited by a non acoustic stimulus or by an acoustic
stimulation loud enough to have a startling effect on the patient.
As the tensor reflex is a startle response, it will decrease and
disappear after a few equal stimulations. Even though the
tensor reflex is regarded late and unstable compared to the
Stapedius reflex, it may be useful in testing deaf or hard of
hearing patients. Below is shown the tactile sensitive area of the
face to be stimulated with e.g. a piece of wool. Stimulation may
also be a blow of air into the eye region of the patient.

Figure 3:

Air

Touch

AT235h Operation Manual Page 14


Reflex Decay Interpretation
Figure 4:

Reflex Decay:
Reflex decay is calculated as the reduction of size of the
acoustic reflex during the first 10 seconds of muscular
contraction. Most normal ears will be able to maintain a
Stapedius contraction for 10 seconds or longer for frequencies
below 1000Hz, at a level 10dB above reflex threshold. A high
reflex decay score could indicate VIIIth nerve disorders.
Another way of stating the reflex decay is by finding the number
of seconds it takes before the Stapedius contraction falls to 50%
of its initial maximum.

Note: If a decay score is obtained, you should assure that it is


not due to an improper seal, which might produce an artefact
similar to a decaying curve. See the chapter “Preparing the
Test” for details of fitting the probe.

The fact that the light band of the probe goes off, and the test
starts is not an absolutely certain indication of a fit good enough
to produce valid decay test results. This is due to the prolonged
test time and the high sensitivity of the test.

Also great care should be taken to have the probe kept in a very
fixed position relative to the ear during testing.

AT235h Operation Manual Page 15


Examples of Interpretation
In the following, some typical compliance curves, reflex curves and the
possibly associated pathology are shown. The curves are idealised
and only one expected pathology is described for each combination of
tympanogram and reflex.

A combination of variables always has to be taken into consideration.


E.g. the combination of a stiff middle ear system and a floppy eardrum
may result in a tympanogram falling within the normal category. The
interpretations stated here are generalised examples taken from the
currently available literature and they can, of course, vary with each
individual case.

The diagnostic value of tympanograms showing a "D" or "E" shape is


reduced today. A probe tone higher than 226 Hz has been preferred
for these particular tympanograms.

Pathology : Normal ear.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Present.
Audiogram : No hearing loss.

Pathology : Cochlea lesion.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Present or absent.
Audiogram : Sensory neural hearing loss.

AT235h Operation Manual Page 16


Pathology : Retrocochlear lesion.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : (Abnormal Decay.)
Audiogram : Sensory neural hearing loss
(May be unilateral).

Pathology : Supranormal eardrum


(floppy) or atrophic/scarred
eardrum.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Present.
Audiogram : Normal.

Pathology : Disrupted ossicular chain


peripheral to stapes muscle
attachment.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Absent.
Audiogram : Conductive loss.

Pathology : Disrupted ossicular chain


medial to stapes muscle
attachment.

Volume :
Normal.
Pressure :
-100 daPa to +100 daPa.
Ventilation :
Present.
Reflex :
Absent (Present by contra-
lateral stimulation).
Audiogram : Conductive loss.

Pathology : Disruption of ossicular


chain with bones fixated to
the tympanic membrane,
resonating. Supranormal
eardrum (floppy).

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Absent / Present.
Audiogram : Conductive loss.

AT235h Operation Manual Page 17


Pathology : Scarred and healed
(abnormal) eardrum.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Present.
Audiogram : Normal.

Pathology : Fluid in the middle ear, or


serous otitis media.

Volume : Normal.
Pressure : Peak not obtainable.
Ventilation : -
Reflex : Absent or elevated (rare).
Audiogram : Mild to moderate conductive
loss.

Pathology : Ear wax in the external ear


canal (Obturating
cerumen).

Volume : Low
Pressure : Normal.
Ventilation : -
Reflex : Absent.
Audiogram : Mild to moderate conductive
loss.

Pathology : Perforated tympanic


membrane - defect or
ventilated tympanotomy.
Traumatic rupture.

Volume : Normal / High


Pressure : Not obtainable.
Ventilation : -
Reflex : Absent (peaks).
Audiogram : Mild to moderate conductive
loss (20 dB).

Pathology : Otosclerosis or stapes


fixation.

Volume : Normal.
Pressure : -100 daPa to +100 daPa.
Ventilation : Present.
Reflex : Absent or elevated (rare).
Audiogram : Moderate conductive loss.

AT235h Operation Manual Page 18


Pathology : Adhesive otitis media.
Adhesive ossicular
fixation (glue ear).

Volume : Normal.
Pressure : Negative / moderate.
Ventilation : -
Reflex : Absent.
Audiogram : Moderate conductive loss.

Pathology : Moderate fluid in the


middle ear.

Volume : Normal.
Pressure : Negative / negative.
Ventilation : -
Reflex : -
Audiogram : Mild conductive loss.

Pathology : Impact fluid in the middle


ear.

Volume : Normal.
Pressure : Not obtainable.
Ventilation : -
Reflex : Absent.
Audiogram : Moderate conductive loss.

Pathology : Blockage of Eustachian


tube; fluid in the middle
ear may be present.

Volume : Normal.
Pressure : Negative.
Ventilation : Absent or poor
Reflex : Absent or elevated (rare).
Audiogram : Mild to moderate
conductive loss.

Pathology: Acute Serous Otitis Media:


Positive middle ear pressure is rarely observed in
tympanometry. Usually it is a consequence of sneezing or
valsalvation. One pathological condition that may cause positive
pressure in the middle ear is acute serous otitis media in the
early stage.

AT235h Operation Manual Page 19


A typical acute serous otitis media may develop according
to the tympanograms outlined below:

Status of middle ear drainage tubes:


Otoscopic or "visual" inspection of the drainage tube is
difficult, as it can easily be blocked from the inside.

All three situations below will result in a mild conductive loss.

AT235h Operation Manual Page 20


Basic Functions
Preparing the Test
AT235h must warm up:
After approximately 10 minutes the AT235h will reach operation
temperature. At this time it will automatically calibrate itself to
actual ambient barometric pressure. Tests carried out before
this automatic calibration has been performed by the AT235,
may show slightly wrong pressure results.

If the AT235h has been subject to very high or low temperatures


e.g. from being kept in a hot or cold car, the temperature of the
AT235h must be normalised to between 15 and 35 °C / 60 and
95 °F before accurate result can be assured.

Patient Instruction:
Place the patient in a comfortable chair or on an examining
table if necessary. Small children may feel more comfortable
sitting on a parent's or nurse's lap. Show the probe to the patient
and then explain the following:

• That the aim of the test is to test the mobility of the eardrum.
• That the tip of the probe will be inserted into the ear canal,
and that it has to make a perfect seal.
• That a small amount of air will flow through the probe to
move the eardrum; this will produce a sensation equal to
pressing a finger slightly into the ear canal.
• That one or more tones will be heard during the test.
• That no participation is expected from the patient.
• That coughing, talking and swallowing will ruin test results.

Visual Inspection:
Check the external ear canal for wax with an otoscope and remove
excessive wax to prevent probe opening from clogging which will
inhibit testing. Excessive hairs may have to be cut.

Also check for a perforated eardrum as this may give a tymp curve
which may be mistaken for a fluid filled middle ear.

AT235h Operation Manual Page 21


Ear Tip Selection:
The probe shall be fitted with an ear tip of suitable size before
testing. Be sure to insert the probe tip completely into the ear
tip.

Transforming the Probe from Handheld to Clinical and Reverse:


The probes are easily exchanged by pressing the button and
pulling the probe.

Picture 1:

Pull

Push

The squared hole


should face in the
same direction as
the push-button

The other probe is then pushed into the socket until a distinct
"click" is heard. Note! The squared hole in the probe connection
should face in the same direction as the push-button.

Fitting the Clinical Headset – see picture 2


A) Place the head band over the patient's head. The
audiometric headphone TDH39 is placed over the non test-
ear (or contralateral reflex ear).

B) Slide the transducer house downwards in the head band


holder. Try to position the transducer holder slightly behind
the ear. This will ensure free space for inserting the probe tip
with the ear tip into the ear canal.

Note: A shoulder strap is also available for performing clinical


tympanometry. See this shoulder strap in picture 3.

AT235h Operation Manual Page 22


Picture 2: Picture 3:

C) Press "Pause" (9) in order to prevent the instrument from


automatically starting the test as soon as an airtight fit is
obtained.

D) Insert the probe tip into the ear canal until you have an
airtight fit. Pull the transducer house upwards again, until the
probe in the ear is hanging by the tubes from the transducer.

Pause
The pause function operated from “Pause” (9) has been built
into AT235h to prevent the instrument from automatically
starting the test as soon as an airtight fit has been obtained. The
pause function is mainly used when using the clinical headset or
shoulder strap on the patient.

When the pause function is activated it can be released from


the remote switch on the probe or from the “Pause” key (9) on
the instrument. A red or a blue light symbolising the right or the
left ear will be blinking on the probe when the pause function is
on standby mode ready to be activated by the operator. Also,
the “Pause” key (9) will be blinking.

The various functions of the remote switch are defined in the


Common Setup Menu. If the pause function is wanted as a
default setting, this can be selected in the Common Setup
Menu, too.

AT235h Operation Manual Page 23


Making a Good Probe Seal:
Most ear canals are more or less curved. To get a good fit of the
ear tip, pull back the pinna to straighten out the ear canal during
insertion of the probe as indicated in figure 5.

Figure 5:

Hair coming out of the ear canal may make an airtight fit difficult
to obtain. Therefore, ideally, excessive should be removed prior
to testing. Also, a clinical ear tip covered with Vaseline may be
helpful. Make sure the ear tip does not have its opening closed
by the wall of the ear canal or clogged by Vaseline or cerumen.

For the decay test an absolutely airtight fit is needed to avoid


test results indicating decay, where the test result is actually just
an artefact caused by a poor fit.

Test Procedure
Before every test is performed it is recommended to delete all stored
patient data from the instrument. This is done by holding down “shift”
(17) while pressing “new subject” (9). After this action the following
message will appear on the screen:

AT235h Operation Manual Page 24


Figure 6:

If AT235h has a keyboard connected and the Common Setup Menu


parameter “Keyboard Connected” is set to “Yes” the below “Subject
Screen” in figure 7 will appear:

Figure 7:

Press F1 “New” to delete all stored data from the previous patient and
use the keyboard to type in new patient data.

Finally, press “Back” (7) to return to the test screens.

AT235h Operation Manual Page 25


Printing Test Results
To print test results obtained by the AT235h press "Print" (8) and the
internal thermal printer or the external printer will start printing. It is
possible to print the present screen only by holding down “shift” (17)
while pressing “print screen” (8).
Please see below some typical examples of printouts from the internal
printer:

Printout 1: Printout 2:

AT235h Operation Manual Page 26


Printout 3: Printout 4:

Printout 1:
Printout 1 contains the following:
• Tympanogram.
• Reflexes (sequence method with individual reflexes starting at 80
dB at 4 different frequencies).
• ETF 1 test (Eustachian Tube Function test).

Printout 2:
Printout 2 contains the following:
• Tympanogram.

AT235h Operation Manual Page 27


• Reflexes (sequence method with 5 individual reflexes starting at
80 dB at 4 different frequencies). Unlike the reflexes from printout
1, the reflexes from printout 2 have been printed with the special
paper saving function. This function is activated by holding down
“shift” while pressing “Print” (8).
• In the top of the printout “Clinic” data and “Subject” data have
been printed.

Printout 3:
Printout 3 contains the following:
• Tympanogram.
• Reflexes (sequence method with 5 individual reflexes starting at
80 dB at 4 different frequencies).
• Audiogram with stored threshold for right and left ear.

Printout 4:
Printout 4 contains the following:
• ETF 1 test (Eustachian Tube Function test).

AT235h Operation Manual Page 28


Reflex and Tympanometry
When the instrument is switched on it automatically powers-up in

1) Reflex and Tympanometry Test mode

or

2) Tympanometry mode

(depending on the Power-up setting selected in the Common Setup


Menu).

In order to choose between Tympanometry Test, Reflex Test and


Reflex and Tympanometry Test, browse with the “Tymp/Reflex” key
(10).

Figure 8 shows the Reflex and Tympanometry Test Screen:

Figure 8:

In the Reflex and Tympanometry mode both indication lights of the


“Tymp/Reflex” key (10) will be active.

1. Select test ear by means of “Right” (20) or “Left“(21).


2. Select the wanted reflex test “Test A” or “Test B” with (F4).

AT235h Operation Manual Page 29


Note: In the Setup Menu of AT235h it is possible to pre-program two
separate reflex tests “Test A” and “Test B”. When starting a test
procedure “Test A” is always default. Therefore if “Test B” is wanted
press F4 “Test A B”.

3. Place the probe in the test ear.

The probe will have an airtight fit when the indication light on the probe
is green. When the status “Leaking” or “Blocked” is displayed in the
upper right hand corner of the screen under the Status Bar, the
indication light on the probe will be yellow. This indicates a bad fitting
or a blocked ear tip.

When a correct fit has been obtained a tympanometric test is


automatically performed on the first ear. By means of the
tympanometric test, AT235h establishes the correct pressure in the
ear canal for the subsequent reflex test.

3a) If clinical headset is used:


When using the clinical headset, select "Pause" (9) in order
to prevent the instrument from automatically starting the test
as soon as an airtight fit has been obtained.

Now, place the clinical headset over the patient's head or


use the shoulder strap and insert the probe tip into the ear
canal. When an airtight fit has been obtained the
tympanometric test is ready to be performed. To start the
test, select "Pause" (9) once again and the test will be
carried out automatically.

Note: From the Common Setup Menu it is possible to set up “Pause”


key (9) to be controlled from the Remote Switch of the probe.

On the screen the tymp test can be followed on-line. When the tymp
curve has been drawn, the AT235h will automatically continue with the
selected reflex test “Test A” or “Test B”.

4. Remove the probe from the first ear when the test sequence
has finished. Select the other ear “Right” (20) or “Left” (21)
and move the probe to the second ear and repeat the test
sequence once again.
5. To print out the test result, simply press “Print” (8).

AT235h Operation Manual Page 30


Changing Scale:
When performing Tympanometry situations might occur where
the compliance peak will exceed the standard 3 ml
tympanogram. When the compliance peak exceeds the 3 ml
scale like in the below figure 9 AT235h will give the operator the
possibility to change the 3 ml scale to a 6 ml scale.

Figure 9:

When the tympanogram with the 6 ml scale is activated the 6 ml


scale will be present for both right and left ear:

Figure 10:

AT235h Operation Manual Page 31


Modifying reflex Test A and B
Before starting the test procedure the selected reflex Test A or B can
be modified in order to meet the exact demands which are needed for
the individual patient:

To modify reflex “Test A or B” press (F6):

Figure 11:

Figure 12 shows the Modify Menu for Reflex Test A – it is similar for
Reflex Test B:

Figure 12:

To modify the individual reflex settings of Test A or B hold down “shift”


(17and press F1 to F6 depending on the reflex that needs modifying.

AT235h Operation Manual Page 32


When highlighted, it is possible to select between “Ipsi” (18) and
“Contra” (19). The frequency can be changed by means of the
“Frequency Decr / Incr” keys (14 and 15). The intensity can be change
by means of the “Intensity Decr / Incr” keys (23 and 24). Finally it is
possible to switch on or off the highlighted reflex by pressing the F-key
underneath the highlighted reflex.

When the individual reflex for Test A or B has been modified to the
special personal needs, hold down “shift” (10) while pressing the F-key
underneath the highlighted reflex once again.

In the same way all the reflexes for Test A or B can be modified.
Finally, press “Back” (7) to return to the test screen.

Ipsilateral and Contralateral reflexes


AT235h is capable of performing ipsilateral as well as contralateral
reflexes.

In the Setup Menu for Reflex A or B it is possible to set up a reflex test


procedure to perform either ipsilateral or contralateral reflexes only.
Alternatively AT235h can be set up to perform ipsilateral and
contralateral in the same test procedure.

By pressing “Ipsi” (18) or “Contra” (19) it is possible to switch on or off


the ipsilateral or contralateral reflexes. This means that it is possible to
manually overrule (meaning switch off) e.g. a contralateral reflex that
was selected as default for Reflex Test A or B simply by pressing
“Contra” (19).

The idea is that light indication in the “Ipsi” (18) and “Contra” (19) keys
indicates whether or not the ipsilateral and / or contralateral reflexes
will be performed in a preceding test session.

Tympanometry - only
When the instrument is switched on it automatically powers-up in

1) Reflex and Tympanometry Test mode

AT235h Operation Manual Page 33


or

2) Tympanometry mode

(depending on the Power-up setting selected in the Common Setup


Menu).

In order to choose between 1) Tympanometry Test, 2) Reflex Test and


3) Reflex and Tympanometry Test, browse with the “Tymp/Reflex” key
(10). Figure 13 shows the Tympanometry Test Screen:

Figure 13:

In the Tympanometry mode the left indication light only on the


“Tymp/Reflex” key (10) will be active.

1. Select test ear by means of “Right” (20) or “Left” (21).


2. Place the probe in the test ear.

The probe will have an airtight fit when the indication light on the probe
is green. When the status “Leaking” or “Blocked” is displayed in the
upper right hand side of the screen the indication light on the probe will
be yellow. This indicates a bad fitting or a blocked ear tip.

When a correct fit has been obtained a tympanometric test is


automatically performed on the first ear.

AT235h Operation Manual Page 34


2a) If clinical headset is used:
When using the clinical headset select "Pause" (9) in order
to prevent the instrument from automatically starting the test
as soon as an airtight fit has been obtained.

Now place the clinical headset over the patient's head or use
the shoulder strap and insert the probe tip into the ear canal.
When an airtight fit has been obtained the tympanometric
test is ready to be performed. To start the test, select
"Pause" (9) once again and the test will be carried out
automatically.

Note: From the Common Setup Menu it is possible to set up the


“Pause” key (9) to be controlled from the Remote Switch of the probe.

On the screen the tymp test can be followed on-line.

3. Remove the probe from the first ear when the test sequence
has finished. Select the other ear “Right” (20) or “Left” (21)
and move the probe to the second ear and repeat the test
sequence once again.

Extend Function
When being in the Tympanometry mode it is possible to extend
the pressure range to go from +300 daPa to –600 daPa by
pressing F6. When the Extend Function is active “Extend” in
lower right hand corner of the screen is highlighted. The
pressure range is indicated by two small, bold, vertical lines on
the horizontal 0 ml line. To go back to the standard pressure
range press F6 once again.

The standard pressure range is set up in the Tympanometry


Setup Menu where Start Pressure and Stop Pressure are
defined.

Tympanometry with High Probe Tone


When the instrument is switched on it automatically powers-up in 1)
the Reflex and Tympanometry Test mode or in 2) the Tympanometry
mode (depending on the Power-up setting selected in the Common
Setup Menu).

AT235h Operation Manual Page 35


In order to choose Tympanometry with High Probe Tone select “High
Probe Tone” (25). Figure 14 shows the Tympanometry Test Screen:

Figure 14:

The Tympanometry mode for High Probe Tone looks very similar to
the normal Tympanometry mode; however, the following differences
can be seen on the screen:

• The scaling is now measured in memo.


• The pre-selected frequency (678, 800 or 1000 Hz) for the High
Probe Tone test is displayed in the upper left hand side of the
screen.

The Tympanometry test with High Probe Tones is performed in the


exact same way as a normal Tympanometry test.

It is possible to perform normal Tympanometry and High Probe Tone


Tympanometry in one test session and thus print out the test results
for comparison. When the first tympanometry curve has been drawn
(with normal or High Probe Tone) press “High Probe Tone” (25) in
order to enter or exit “High Probe Tone” mode. Now the next curve will
be drawn automatically. Press “Print” (1) and a printout presenting
both curves will appear:

AT235h Operation Manual Page 36


Figure 15:

Note: It is not possible to perform reflexes on the basis of a High


Probe Tone Tympanogram.

Automatic Reflex Test - only


When the instrument is switched on it automatically powers-up in 1)
the Reflex and Tympanometry Test mode or in 2) the Tympanometry

AT235h Operation Manual Page 37


mode (depending on the Power-up setting selected in the Common
Setup Menu).

To choose between 1) Tympanometry Test, 2) Reflex Test and 3)


Reflex and Tympanometry Test browse with the “Tymp/Reflex” key
(10).

Figure 16 shows the Reflex Test Screen:

Figure 16:

In the Reflex Test mode the right indication light only on the
“Tymp/Reflex” key (10) will be active.

Note: It is recommended always to make a preceding tympanometry


test in order to establish the correct middle ear pressure which is the
optimal basis for precise reflex test.

If a reflex test is performed without first making a tympanometry curve,


the reflex will be performed at 0 daPa and not at the correct middle ear
pressure.

1. Select test ear by means of “Right” (20) or “Left” (21).


2. Place the probe in the test ear.

AT235h Operation Manual Page 38


The probe will have an airtight fit when the indication light on the probe
is green. When the status “Leaking” or “Blocked” is displayed in the
upper right hand side of the screen the indication light on the probe will
be yellow. This indicates a bad fitting or a blocked ear tip. When a
correct fit has been obtained the reflex test will begin.

2a) If clinical headset is used:


When using the clinical headset select "Pause" (9) to prevent
the instrument from automatically starting the test as soon as
an airtight fit has been obtained.

Place the clinical headset over the patient's head or use the
shoulder strap and insert the probe tip into the ear canal.
When an airtight fit has been obtained the reflex test is ready
to be performed. To start the test, select "Pause" (9) once
again and the test will be carried out automatically.

Note: From the Common Setup Menu it is possible to set up the


“Pause” key (9) to be controlled from the Remote Switch of the probe.

On the screen the reflex test can be followed on-line.

3. Remove the probe from the first ear when the test sequence
has finished. Select the other ear “Right” (20) or “Left” (21),
move the probe to the second ear and repeat the test
sequence once again.

Manual Reflexes
With AT235h there are two different ways to perform manual reflexes.
Manual reflexes can be performed subsequently to an automatic test
session or on their own.

After an automatic session where a number of reflexes have been


recorded, there might be a need for making one or more manual
reflexes. This can be performed by pressing “Man” (13). An empty
reflex box will appear and below it the default intensity and frequency
will be highlighted like in figure 17. With the “Frequency Decr / Incr”
buttons (14 and 15) and the “Intensity Decr / Incr” buttons (23 and 24)
it is possible to change the parameters for the manual reflex.

AT235h Operation Manual Page 39


Figure 17:

When ready, press the “Tone Switch” (22) and the manual reflex will
be performed and appear on the display. The parameters for the
manual reflex can be changed once again if the result is not
satisfactory. When satisfied, press “Store” (16) to store the manual
reflex next to the automatic reflexes in the lower right hand corner of
the screen and AT235h will automatically prepare for performing
another manual reflex.

The number of manual reflexes available depends on the number of


automatic reflexes recorded. 18 reflex boxes per ear can be stored. If
for instance 6 automatic reflexes are store there are 12 manual
reflexes available and if for instance 12 automatic reflexes are stored
there are 6 manual reflexes available.

Editing Automatic and Manual Reflexes


After a session of automatically or manually recorded reflexes you
have the following possibilities to edit and work with the reflexes:

• Browsing between the reflexes.


• Repeating reflexes.
• Deleting reflexes

AT235h Operation Manual Page 40


The idea of browsing between the automatically recorded reflexes is to
see the individual reflex not only in the small reflex boxes, but also on
the full screen. After the automatic test procedure press “Man” (13)
and an empty reflex box will appear and below it the default intensity
and frequency will be highlighted like in figure 18.

Figure 18:

Just above the F1 and F2 keys there are two small arrows pointing to
the left and the right hand respectively. By pressing the F1 and F2
keys it is possible to browse between the recorded reflexes.

Repeating and Deleting reflexes


When browsing between the recorded reflexes it is possible to
manually repeat the previously recorded reflexes. This is done
by pressing the ”Tone Switch” (22). Now the reflex is repeated
at the same frequency and intensity as the previously recorded
reflex. This action can be repeated several times. When
satisfied press “Store” (16) to store the reflex.

Figure 19:

When repeating a reflex, it is possible to change the frequency


by pressing “Frequency Decr / Incr” (14 and 15) and intensity by
pressing “Intensity Decr / Incr” (23 and 24). This action can be
repeated several times. When satisfied press “Store” (16) to
store the reflex.

AT235h Operation Manual Page 41


Note: If you do not press “Store” (16) the original automatically
recorded reflex will come back.

To delete a reflex use the F1 and F2 key to go to the reflex


which needs to be deleted. When the selected reflex is
highlighted, simply press F4 “Delete” to delete this reflex.

Manual Reflex Decay


There are two different ways to perform reflex decay tests with AT235.
Reflex decay tests can be performed subsequently to an automatic
test session or on their own.

After an automatic session where a number of reflexes have been


recorded, there might be a need for making one or more manual reflex
decay tests. This can be performed by pressing “Man” (13). Now an
empty and highlighted reflex box will appear and below it the default
intensity and frequency will be highlighted like in figure 20. Also
“Decay” above the F5-key will be highlighted.

Figure 20:

Note: To ensure the right basis for performing a reflex decay test it is
necessary to find the reflex threshold for the frequency to be tested.

AT235h Operation Manual Page 42


When the reflex threshold has been found 10 dB must be added to
this threshold to get the correct starting point.

When ready, press the “Tone Switch” (22) and the manual reflex
decay will be performed and appear on the screen. The parameters for
the manual reflex can be changed by pressing the “Frequency Decr /
Incr” keys (14 and 15) and the “Intensity Decr / Incr” keys (23 and 24).
Press “Store” (16) to store the manual reflex decay. AT235h
automatically prepares for performing another manual reflex decay.

In Figure 21 an example of the decay test result can be seen. The


decay result is expressed graphically and numerically in percent (%).

Figure 21:

When a reflex decay test has been accepted and stored it will be put
into one of the small reflex boxes. A small “D” (see figure 22) will
indicate that a Decay test has been performed.

Figure 22:

AT235h Operation Manual Page 43


By storing the test result the instrument automatically prepares for
performing another manual reflex or reflex decay test.

Eustachian Tube Function


With AT235h it is possible to perform a Eustachian Tube Function test
for non-perforated ear drums, the so-called Williams Test. With
AT235h the test is semi automatic and will suggest the operator how
to operate the instrument and how to instruct the patient.

To choose the Eustachian Tube Function test press the “ETF” key (11)

Figure 23:

In the Eustachian Tube Function test mode the indication light on the
“ETF” key (11) will be active and at the same time the indication light
on the “Pause” key (9) will start blinking in order to tell the operator
that his/hers action is now needed.

1. Select test ear by means of “Right” (20) or “Left” (21).


2. Place the probe in the test ear.

The probe will have an airtight fit, when the indication light on the
probe is green. When the status “Leaking” or “Blocked” is displayed in

AT235h Operation Manual Page 44


the upper right hand side of the screen the indication light on the probe
will be yellow. This indicates a bad fitting or a blocked ear tip.

To perform the test the operator will have to press the blinking “Pause”
key (9) to make a tympanometric curve.
After the first sweep an information window appears on the screen:

Follow this instruction. To decrease the middle ear pressure (create a


negative middle ear pressure) make the patient swallow while closing
his/hers nose with two fingers.

Now press the blinking “Pause” (9) key once again and the test will
make its second sweep. When the second sweep has been carried
out another information window will appear on the screen:

Follow this instruction. To increase the middle ear pressure (create a


neutral middle ear pressure) make the patient blow softly with the
mouth closed while also closing his/hers nose with two fingers.

Press the blinking “Pause” (9) key once again as told in the
information window and the test will make its final and third sweep.

Now three tympanometric curves can be viewed in the screen where a


change in peak pressure graphically will indicate the function of the
Eustachian tube.

To the right of the tympanogram under Pressure 1, Pressure 2 and


Pressure 3 the peak pressures of the three tympanometric curves are
also expressed numerically in daPa.

AT235h Operation Manual Page 45


If the three peak pressures are the same, it has not been possible for
the patient to operate his Eustachian tube to change the middle ear
pressure. This means that the Eustachian tube is temporarily or
permanently out of function.

Note: From the Common Setup Menu it is possible to set up the


“Pause” key (9) to be controlled from the Remote Switch of the probe.

AT235h Operation Manual Page 46


Automatic and Manual Audiometry
When the instrument is switched on it automatically powers-up in

1) the Reflex and Tympanometry Test mode

or

2) the Tympanometry mode

(depending on power-up setting selected in Common Setup Menu).

To select automatic tone audiometry, press the “Audiometry” key


(12). The automatic audiometry threshold test is according to the
Hughson Westlake (HW) test procedure. The HW test procedure is
defined as 2 out of 3 correct responses at a certain level in a 5 dB
increase and 10 dB decrease test procedure.

Figure 24:

In the Automatic Audiometry Test mode the indication light of the


“Audiometry” key (10) will be active and the indication light of the
“Pause” key (9) will be blinking.

AT235h Operation Manual Page 47


Test Procedure:
Instruct the patient that he will hear tones with different
frequencies and that he is supposed to push the patient
response button whenever a tone is audible to him.

1. Select desired test ear “Right” (20) or “Left“(21).

2. Select “Famili” to familiarise the patient with the HW


procedure. When the familiarisation procedure is
succeeded the HW test will start automatically. If the
familiarisation procedure is not needed simply press
“Pause” (9) to start the HW test.

When the audiogram for the first test ear has been completed
the test will automatically continue testing the other ear.

In the horizontal bar above the right and the left audiogram it is
possible to follow the test procedure see figure 23. To the left
there is a small circle, which is highlighted whenever a tone is
audible to the patient. Next to the circle there is a small
rectangle, which is highlighted whenever the patient presses
the patient response button.

The present dB value and frequency is expressed numerically.

Figure 25:

Manual Audiometry:
To perform manual audiometry select “Audiometry” (12) and
press “Man” (13). Now, manual audiometry can be performed.
Select frequency by pressing “Frequency Decr / Incr” (14 and
15) and intensity by pressing “Intensity Decr / Incr” (23 and
24). To store thresholds for the audiogram press “Store” (16).

AT235h Operation Manual Page 48


”Child” Function
AT235h has been equipped with a special Child Function. The
intention of this function is to help the operator keeping the child
concentrated for the short while it takes to perform the test.

The Child Function is available from the 1) Tympanometry Test, 2)


Reflex Test and 3) Reflex and Tympanometry Test.

To activate the Child Function press F3.

Figure 26 shows the Reflex and Tympanometry Test with the Child
Function activated:

Figure 26:

The train will continue moving until the selected reflex test session
has finished. When the test session has finished the train will
automatically disappear.

AT235h Operation Manual Page 49


Handling of Ear Tips
Cleaning of Ear Tips
We recommend using a new ear tip for each patient. If the clinician
rinses the ear tips they should be subjected to standard disinfection
procedure between patients. This includes physically cleaning the ear
tip and use of a recognized disinfectant. Individual manufacturer's
instruction should be followed for use of this disinfecting agent to
provide an appropriated level of cleanliness.

Cleaning of Probe Tip


In order to secure correct impedance measurements it is important to
make sure that the probe system is kept clean at all times. Therefore
please follow the below illustrated instruction on how to remove e.g.
cerumen from the small acoustic and air pressure channels of probe
tip.

For AT235h two different probe systems exist; the AT235-ATP


Standard Probe System and the AT235h-ATP Clinical Probe System.

The two different probe systems can be seen in the below picture 11:

Picture 11:

AT235h Operation Manual Page 50


To clean the small acoustic and air pressure channels of probe tip
unscrew the small ribbed plastic nut that holds the probe tip:

Picture 12:

After unscrewing the small ribbed plastic nut it is possible to detach


the small probe tip with the small acoustic and air pressure channels
from the transducer house:

Picture 13:

Ribbed Plastic Nut Transducer House

Probe Tip with the small acoustic


and air pressure channels

The cleaning of the acoustic and air pressure channels of the probe
tip must be performed by means of the cleaning wire (nylon wire)
which can be found in the Ear tips Assortment provided with the
AT235.

AT235h Operation Manual Page 51


When cleaning the acoustic and air pressure channels of the probe
tip the cleaning wire must be inserted from the back of the probe tip
according to picture 14:

Picture 14:

After cleaning all the acoustic and air pressure channels of the probe
tip it can be reassembled. Make sure that the Probe Tip is connected
correctly onto the Transducer Housing – a small flange will ensure
correct positioning - before the plastic nut is gently tightened.

Picture 15:

AT235h Operation Manual Page 52


Functions of Buttons
The numbers below refer to the drawing in the back of this manual.

1-6) F1 – F6 The six Function Keys hold functions


displayed in the screen right above the
individual F-key.

7) F7 - Back Will always take you back one level.

8) Print Prints out the obtained test data.

Shift + print screen Prints out the present screen.

9) Pause Selects pause function when clinical


headset is used.

Shift + new subject Deletes test results and if a keyboard


is installed new patient data can be
typed.

10) Tymp/Reflex Selects:


1) Tympanometry.
2) Reflex and Tympanometry.
3) Reflexometry.

11) ETF Selects Eustachian Tube Function


test.

12) Audiometry Selects Audiometry.

13) Man Activates manual testing.

14) Frequency Decr Browses between the different


frequency options in manual
reflexometry and manual audiometry.

15) Frequency Incr Browses between the different


frequencies options in manual
reflexometry and manual audiometry.

AT235h Operation Manual Page 53


16) Store Stores manually obtained data.

17) Shift The shift key activates the sub


functions of the other keys (9 – 24)
written in italic.

18) Ipsi Activates and deactivates the


ipsilateral reflex stimulus, which is
presented through the probe.

19) Contra Activates and deactivates the


contralateral reflex stimulus, which is
presented through the TDH39.

20) Right Selects right test ear.

21) Left Selects left test ear.

22) Tone Switch Stimulus presentation switch for


manual audiometry and manual reflex
mode.

23) Intensity Decr Decreases the intensity chosen for


manual reflex testing or manual
audiometry.

24) Intensity Incr Increases the intensity chosen for


manual reflex testing or manual
audiometry.

25) High Probe Tone Selects High Probe Tone.

AT235h Operation Manual Page 54


Technical Specifications
Standards:
Safety : EN60601-1, Class 1, Type B
EMC : EN60601-1-2
Impedance : EN61027/ANSI S3.39, Type 2
Audiometer : EN60645-1/ANSI S3.6, Type 4 Tone
Audiometer

Medical CE-mark
The CE-mark indicates that Interacoustics A/S meets the
requirements of Annex II of the Medical Device Directive
93/42/EEC. TÜV Product Service, Identification No. 0123,
has approved the quality system.

Power, UPS400
Consumption : 15VA
Mains voltage/fuses: 100-240V AC, 50-60Hz, 40VA

Operation Environment:
Temperature : 15 – 35 °C / 65 – 95 °F
Rel. Humidity : 30 – 90%

Temperatures below 0 °C and above 50 °C may cause


permanent damage on the instrument and its accessories.

Warm up time : 10min at room temperature (20 °C)

Printer (Optional)
Type : Thermal printer with recording paper
in rolls.
Printing Time : Depending on the test printed.

Paper Rolls:
Width : 112 (+/- 0.5) mm
Diameter : 45 (+2.0) mm
Basis weight : 58.5 +/- 3g/m2
Thickness : 62 +/- 3 u
Tensile : Min. 3.2 kN/m

AT235h Operation Manual Page 55


Impedance Measuring system
Probe tone:
Frequency : 226, 678, 800 and 1000 Hz.
Level : 85 dB SPL with AGC, assuring
constant level at different volumes.
Air Pressure
Control : Automatic.
Indicator : Measured value is displayed on the
graphical display.
Range : -600 to +300 daPa.
Pressure Limitations: -800 daPa and +600 daPa.
Pressure Change Rate: Minimum (50 daPa/s), medium,
maximum or automatic with
minimum speed at compliance
peak. Selectable in the setup.

Compliance
Range : 0.1 to 6.0 ml (Ear volume: 0.1 to 8.0
ml).

Types
Tympanometry : Automatic, where the start and stop
pressure can be user-programmed
from the setup menu.
Eustachian Tube Function: Williams test (automatic
function).

Indicators
Graphical display : Compliance is indicated as ml and
pressure as daPa. Stimulus level is
indicated as dB Hearing Level.

Memory
Tympanometry : 2 curves per ear (one of them from
the High Probe Tone.
Eustachian Tube Function: 3 curves per ear.

AT235h Operation Manual Page 56


Reflex and Audiometer Functions
Signal Sources
Tone – Contra, Reflex: 250, 500, 1000, 2000, 3000, 4000,
6000 and 8000Hz.
Tone – Contra, Audiometry: 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000 and 8000Hz
Tone – Ipsi, Reflex: 500, 1000, 2000, 3000 and 4000Hz.
Noise – Contra, Reflex: Wide Band, High Pass, Low Pass
Noise – Ipsi, Reflex: Wide Band, High Pass, Low Pass.

Inputs
Patient Response : Connection for patient response
switch.

Output
Contra Earphone : TDH39, earphone for reflex and
audiometry measurements.
Ipsi Earphone : Probe earphone incorporated in
probe system for reflex
measurements.
Air : Connection for air system to the
probe.
RS232 : Input/output for PC connection. An
external PC can be setup to both
monitor and control the instrument.
The control actions can be followed
on the display and the operation
panel. Online communication can be
selected, where the measured data
will be sent to an external PC.
Keyboard : Connection for external keyboard,
standard PC type.

Printer : Connection for external printer using


HP PCL L3 and Canon Bubble Jet
codes.

Attenuator
Range : 0 to 130 dB in 1 or 5 dB steps.
Typical range is –10 to 120 dB HL.

AT235h Operation Manual Page 57


Range is individual for different
modes – see below table.

Test Types
Manual Audiometry: Manual control of all functions.
Automatic Audiometry: Auto threshold according to ISO
8253-1 (Patient controlled Hughson
Westlake). The threshold is
determined by the activation of the
patient response.
Manual Reflex : Manual control of all functions.
Reflex Decay : Manually controlled with stimulus
duration of 10 seconds.

Memory
6 ipsilateral and 6 contralateral graphs / curves. Each of them
can hold up to 6 pulses. There is an additional capacity for 6
manual tests.

Table 1: Frequencies and intensity ranges


Frequenc Reflex Audiometry
y
Contralateral Ipsilateral TDH39
Min Max* Min Max* Min Max
Hz dB HL dB HL dB HL DB HL dB HL dB HL
250 10 110 - - -10 110
500 10 120 10 105 -10 120
1000 10 120 10 110 -10 120
2000 10 120 10 105 -10 120
3000 10 120 10 100 -10 120
4000 10 120 10 100 -10 120
6000 10 120 - - -10 120
8000 10 110 - - -10 110
WB noise 10 120 10 105
LP noise 10 120 10 105
HP noise 10 110 10 105

AT235h Operation Manual Page 58


Parts
Included Parts:
ATP-AT235u Universal probe system with shoulder strap and
wrist strap
TSH39 Single contralateral headset
UPS400 external switch mode power supply
Power cable
BET50 Box of 65 assorted ear tips
TPR26 3 rolls of recording paper
PCR-AT235h dust cover
Operation Manual.
Multilingual CE instructions for use

Additional Parts:
TDH39 audiometric headsetACC226 Carrying Case
EARtone 5A Audiometric Insert Phones
ACC25 carrying case
CIR22 contralateral insert phone
APS2 patient signal
CAT40 calibration unit 0.2-0.5-2.0-5.0 ml
CAT227 calibration unit 0.2-0.5-1-2-3-4-5 ml
IES impedance ear simulator

Connection to PC
The data from AT235h can be transfer to a PC by means of an IFC59
cable (25 pin computer COM-port) or IFC69 (9 pin computer COM-
Port).

The software needed for AT235h for transferring data to a PC is one


the following Windows compatible software:

• IaBaseII Database Program


• PrintView for PC monitoring and printing
• IA-NOAH-Imp Module for interfacing to NOAH

The Baud Rate (data transfer speed) of AT235h must selected in the
Common Setup Menu to match that of the used software.

AT235h Operation Manual Page 59


Connection Panel

Connection for Connection for Connection Connection Power


Contra Phone TDH39 Phones for Patient for Keyboard On/Off
response
button

Connection for Connection Connection Socket for


Probe System for RS232 Port for external
port External power supply
Printer. (UP400 or
Connection Piece for equivalent)
supply to probe system
Printer compartment for
internal printer

To maintain the validity of the CE-mark of the AT235h the power


supply must be CE-medical approved.

Transforming the Probe


The probes are easily exchanged by pressing the button and pulling
the probe.

AT235h Operation Manual Page 60


Picture 6:

Pull

Push

The squared hole


should face in the
same direction as
the push-button

The other probe is then pushed into the socket until a distinct "click"
is heard. Note! The squared hole in the probe connection should
face in the same direction as the push-button.

Installing Printer Paper


1. Open the plastic cover of the paper compartment of AT235.

2. Place the new paper roll in the paper compartment in such a way
that the paper ascends from the lower part of the paper roll. With
a pair of scissors cut two triangles of paper away. This will make
the feeding of the paper easier – see picture 7.

Picture 7: Picture 8:

AT235h Operation Manual Page 61


3. Pull the blue lever (See picture 8) in the direction of the
instrument in order to open the pathway of paper travel.

4. Gently insert the paper between the lower part of the black
rubber platen and the black plastic – see picture 8.

Picture 9: Picture 10:

5. When the paper appears between the upper part of the rubber
platen and the paper cutter, pull out an extra 10 to 15 centimetres
of paper and return the small blue lever to its original position.
Make sure that the paper is aligned correctly – see picture 9 and
10.

6. Now guide the paper through the slot of the cover of the paper
compartment.

7. Close the plastic cover of the paper compartment again. AT235h


is now ready to print.

AT235h Operation Manual Page 62


Unpacking / Inspection
Check box and contents for damage:
When the instrument has been received, please check the
shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment
have been checked mechanically and electrically. If the
instrument is faulty, please contact the nearest service office.
Keep the shipping material for the carrier’s inspection and
insurance claim.

Store carton for future shipment


The AT235h comes in its own shipping carton, which is
specially designed for the AT235. Please store this carton. It
will be needed if the instrument has to be returned for service.

If service is required, please contact your nearest sales and


service office.

Contents of Shipment
When AT235h is delivered as a standard unit the case contains the
following:

Quantity Item Order No.

1 Instrument AT235
1 Universal Probe System ATP-AT235U
1 Single Contralateral Earphone TDH39
1 External Switch Mode Power Supply UPS400
1 Power Cable
1 Box of 65 Assorted Ear tips BET50
3 Rolls of Recording Paper TRP35
1 Dust Cover PCR-AT235
1 Operation manual
1 CE-manual

Check numbers on AT235h and Manual:


The identification label on the connection panel holds the serial

AT235h Operation Manual Page 63


number. This should be checked with the manual number and
written down for later service claims.

Write down serial number:


To maintain the validity of the CE-mark of the AT235, the
power supply must be CE-medical approved. When AT235h is
supplied with the external power supply model UPS400 write
down serial number located on the bottom plate.

Reporting Imperfections
Inspect before connection:
Prior to connecting AT235h to the Power Supply it should once
more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and
missing parts.

Report immediately any faults:


Any missing part or malfunction should be reported
immediately to the supplier of the instrument together with the
invoice, serial number and a detailed report of the problem. In
the back of this manual you will find a "Return Report" where
you can describe the problem.

Please use "Return Report":


Please realise that if the service engineer does not know what
problem to look for, he may not find it. Therefore using the
Return Report will be of great help to us and at the same time
it is your best guarantee that the correction of the problem will
be to your satisfaction.

Care and Maintenance


The performance and reliability of the AT235h will be prolonged if the
following recommendations for care and maintenance are adhered
to:

AT235h Operation Manual Page 64


Using an External power Supply e.g. UP400 - turn off at the
mains socket.

Great care when handling the transducers:


Great care should be exercised when handling the transducers of
AT235h as dropping them may alter the calibration.

Annual calibration:
The AT235h has been designed to provide many years of
reliable service, but annual calibration is recommended due to
possible impact on transducers.

We do also recommend to calibrate the AT235h if something


drastic happens to a part of it (e.g. if headset or bone
conductor is dropped on a hard surface).

AT235h Operation Manual Page 65


Trouble Shooting
AT235h does not turn on:
The power cable from the mains to the power supply and from
the power supply to the instrument must be correctly
connected.

The mains switch must be "on" and the power switch on the
rear panel of the AT235h must also be "on".

If still nothing happens a fuse may be blown in the power


supply. The power supply for AT235h is designed with two
changeable fuses.

Data is not transmitted to the computer:


The correct COM port must be selected in the computer, and
this COM port must be chosen in the computer program.

The right connection cable must be used - not all RS232C


cables are the same!! The Interacoustics cable used to
connect the AT235h to a computer must be either IFC59 (25
pin) or IFC69 (9 pin), depending on your computer.

The baud rate set on AT235h and the computer program must
always be the same.

Your computer may not be able to handle the baud rate


chosen. Try a lower baud rate in computer as well as in
AT235.

No Tymp curves are drawn:


The probe system has to make a perfect seal to the ear canal.
This has not been obtained if the display shows "Leaking" or
"Blocked" and the indication light on the probe is yellow. A
perfect seal is indicated with a green light on the probe.

Check if the transducer / probe system is connected on the


connection panel of AT235.
Also the small rubber tube of the probe cable must be
connected on the connection panel of AT235.

AT235h Operation Manual Page 66


"Blocked" is displayed in Tymp mode:
The probe is blocked at the ear tip, either by wrong insertion
into the ear canal, or by cerumen. Any accumulated cerumen
at the probe tip opening should be removed very carefully.
Please refer to the chapter "Cleaning Probe and Ear tips" of
this manual for details.

Test starts despite a blocked ear tip:


The instrument must warm up for 10 minutes for calibration to
be accurate.

If the problem is still present a calibration of this feature by


means of a 0.2ml cavity calibrator is needed to match the
altitude related air pressure of the installation site. This is a job
for a technician.

Printer does not respond:


The printer might be out of paper!

Please refer to “Installing Printer Paper” in order to see how to


change the paper roll.

Maybe the wrong printer setting is selected in the Common Set


Up under Printer.

Printer responds, but nothing is printed on the paper:


The printer paper has been installed incorrectly meaning that
the backside of the paper is facing the printer head.
Simply turn around paper roll. Please refer to the chapter
“Installing Printer Paper”.

Display is too bright or too dark:


From the Main Menu it is possible to adjust the brightness by
means of “LCD-“ and “LCD+” (F5 and F6).

AT235h Operation Manual Page 67


Frequently Asked Questions
My Reflex Test (A or B) is pre-programmed to ipsilateral
reflexes. Is it possible also to have contralateral reflexes in the
same session or simply contralateral reflexes only?
Yes and yes!
In the Reflex and Tympanometry test menu the indication
lights of the “Ipsi” key (18) and the “Contra” key (19) will inform
you which reflex method is selected, Ipsilateral and / or
contralateral.

Normally, only the indication light of the “Ipsi” key (18) will be
active informing that only the ipsilateral reflex test will be
performed during the subsequent test procedure. Press the
“Contra” key (19) to activate also the contralateral reflex test
for the subsequent.

In case only contralateral reflexes are wanted, press the “Ipsi”


key (18) to switch off the indication light in the “Ipsi” key and
deactivate the ipsilateral reflexes.

Sometimes I would like to temporarily change the pre-


programmed reflex setup. How can I do that?
It is always possible to modify the pre-programmed reflex test
A or B in the Reflex and Tympanometry test menu. All previous
data must be deleted by pressing “new subject” (9) while
holding “shift” (17).

In the lower right hand corner of the display it is now possible


to activate the Modify Menu by pressing “Modify” (F6). In the
Modify Menu the selected Reflex Method (Fixed, Screening,
Auto or Sequence) can now be modified to personal need. It is
possible to select between ipsilateral or contralateral reflexes,
frequency and intensity can be changed and finally reflexes
can be switched on or off according to the number of reflexes
needed.

It is important to know that the modifications carried out in the


Modify Menu are current only until all previous data have been
deleted by pressing “new subject” (9) while holding down “shift”
(17).

AT235h Operation Manual Page 68


Why is the light on the probe sometimes yellow?
When the light on the probe is yellow this indicates that the
probe tip is blocked e.g. against the wall of the ear canal or
that an airtight fit of the ear tip cannot be obtained.

Why does the test not start automatically?


Please check if the indication light on the “Pause” key (9) is
blinking!

AT235h is designed with a Pause Function, which is very


convenient especially in connection with the use of the clinical
probe.

The Pause Function can be chosen as power-up under


“Pause” in the Common Setup Menu or it can be selected from
the operation panel when needed when simply by pressing the
“Pause” key (9).

When the Pause Function is selected either manually or as


power-up the indication light will be active on the “Pause” key
(9).

The Remote Switch on the probe does not allow me to change


between right and left ear:
The function of the remote switch on the probe is defined
under Remote Switch in the Common Setup Menu of AT235. It
is possible to set up the remote switch to:
a. “L/R” – in this way you can select between left and right
ear.
b. “Pause” – in this way the Pause Function can be
controlled.
c. “L/R or Pause” – in this way you can select between left
and right ear, when the probe with the ear tip is out of the
ear. And the Pause Function can be controlled when the
probe with the ear tip is inside the ear.
d. The remote switch is set to “Off”.

The Remote Switch on the probe does not allow me to control


the Pause Function:
See previous paragraph!

AT235h Operation Manual Page 69


The instrument only performs Tympanometry:
This is probably because of the fact “Tymp” has been selected
in Power-up under the Common Setup Menu instead of “Reflex
and Tymp”.

Can I review recorded reflexes?


Yes!
After a test session it is possible to review the recorded
reflexes. All recorded reflexes can be viewed in the small reflex
boxes in the lower part of the display. However, by pressing
“Man” (13) two small arrows “←” and “→” (F1 and F2) makes it
possible to browse between all recorded reflexes from the
small reflexes. When a specific reflex is viewed in the small
reflex box, the numerical data for the reflex test is highlight and
the graphical data of the reflex test is shown in a large window
above the reflex box.

What is Gradient?
Gradient is explained in the chapter “Tympanometry Setup
Menu” of this manual.

My AT235h only displays 4 reflexes boxes. I need 6 reflex boxes:


In the Common Setup Menu under Reflex Icon Boxes it is
possible to select between either 4 or 6 reflex boxes. Make
sure that you select the right number of reflex boxes according
to personal preferences.

I find the sensitivity of the reflex recording unsuitable! Can it be


modified?
Yes!
In the following Reflex Methods: Screening, Auto and
Sequence (Sequence only when Test Stop Criteria is set to
Automatic) it is possible to set the Reflex Sensitivity to
Sensitive, Normal or Robust.
In the chapter “Reflex Methods” in this manual, the three
settings are explained in detail.

AT235h Operation Manual Page 70


Recommended Literature
Arlinger, Stig:
Manual of Practical Audiometry, Vol.1 (Taylor & Francis. 1989.)

Bess, Fred H. and Hall III, James W.:


Screening Children for Auditory Function. (Bill Wilkersen
Center Press 1992)

Biswas, Anirban:
Clinical Audiovestibulometry, (Bhalani Medical Book House,
Bombay, India 1995)

Borg, Erik et al.:


Audiological Aspects of Secretary Otitis Media. (Scand. Aud.
Supp. 26. 1985)

Brask, T.:
Extratympanic Manometry in Man. (Scandinavian Audiology,
supp. 7. 1978)

Feldmann and Laura Ann Wilber:


Acoustic Impedance Admittance - the measurement of middle
ear function. (Williams & Wilkins 1976)

Fiellau-Nikolajsen, Mogens:
Tympanometry and Secretary Otitis Media. (Acta Oto-L. 1983)

Harford, Earl R.:


Impedance Screening for Middle Ear Disease in Children.
(Grune & Stratton. 1978)

Jerger, J.:
Clinical Experience with Impedance Audiometry. (1970)

Katz:
Handbook of Clinical Audiology, Fourth Edition 1994 (Williams
& Wilkins 1985)

AT235h Operation Manual Page 71


Kunov, H.:
The "Eardrum Artifact" in Ipsilateral Reflex Measurements.
(Scand. Aud. 6. 1977)

Liden, G. et al.:
International Symposium on Impedance Audiometry and
Pediatric Audiology Göteborg 1982. (Scandinavian Audiology
supp. 17. 1983)

Liden, G. et. al.:


Automatic Tympanometry in Clinical Practice. (Audiology 13.
1974)

Liden, G. et. al.:


Tympanometry for the Diagnosis of Ossicular Disruption. (Arch
Otolaryngol vol.79 1974).

Liden, G.:
Audiology (Almqvist & Wiksell. 1985) (Swedish language)

Popelka, G. R. et al.:
Hearing Assessment with the Acoustic Reflex. (Grune &
Stratton 1981)

AT235h Operation Manual Page 72


Dictionary
Acoustic Admittance:
The ease with which sound waves flow through a medium, as
the eardrum membrane. See Acoustic Immitance.

Acoustic Compliance:
Another term for Acoustic Admittance.

Acoustic Immitance:
Refers collectively to acoustic impedance and / or acoustic
admittance.

Compliance:
1) Ease with which air moves (e.g. influenced by the
eardrum and middle ear mechanism).
2) Often used to indicate the equivalent volume of air in
the middle ear.

Contra lateral Reflex:


The middle ear muscle reflex that occurs in the ear, contra
lateral to the stimulus ear.

Dynamic Acoustic Compliance:


See Dynamic Acoustic Immitance.

Dynamic Acoustic Immittance:


The acoustic immittance as observed with a continuous
change in air pressure (tympanometry) and/or during the
activation of the middle ear muscle(s) (reflex measurements)

Ear Tip: A cuff which is used to seal the probe into the external
auditory canal.

ETF: (Eustachian Tube Function). This function is tested by trying to


force air through the Eustachian tube and then by
tympanogram recordings checking if the expected change of
middle ear pressure has occurred.

AT235h Operation Manual Page 73


Ipsilateral Reflex:
The middle ear muscle reflex which occurs in the stimulus ear.

Memo:
memo is a unit for measuring acoustical impedance:

226 Hz 1 ml = 1 mmho (1 ml x 1/ohm)


678 Hz 1 ml = 3.0 mmho
800 Hz 1 ml = 3.5 mmho
1000 Hz 1 ml = 4.5 memo

Myringoplasty:
Surgical repair of the eardrum membrane.

Myringotomy:
(tympanotomy) A small incision made in the eardrum
membrane to remove fluid from the middle ear.

Non Acoustic Reflex:


A middle ear muscle reflex elicited by a non-acoustic stimulus.

Ossicular Chain Disruption:


(Ossicular chain interruption, discontinuity or disarticulation) A
break in the three connected bones (ossicles) in the middle
ear.

Pascal (Pa):
2
A unit of pressure or stress, equal to one Newton per m .

Static Acoustic Compliance:


See Static Acoustic Immitance.

Peak Static Acoustic Immittance:


The static acoustic immittance obtained with a specific air
pressure in the external auditory canal as adjusted to produce
an extreme in the measured acoustic immittance.

Probe:
A coupling device that is inserted into the external auditory
canal, to connect it to the acoustic immittance meter.

AT235h Operation Manual Page 74


Probe Ear:
The ear into which the probe is inserted.

Probe Signal:
An acoustic signal that is emitted into the external auditory
canal by means of a probe. The signal is used to measure
acoustic immittance.
Probe Tip:
The upper part of the probe tip on which the ear tip, a cuff
which is used to seal the probe into the external auditory canal,
is placed.

Reflex Activated Acoustic Immittance:


The acoustic immittance measured with the middle ear muscle
reflex activated by a defined stimulus at a specified air
pressure and with a constant tonus of the middle ear muscle.

Static Acoustic Immittance:


1) The acoustic immittance as observed at a constant
specified air pressure and with a constant tonus of the
middle ear muscles.
2) The volume of air that is equivalent in acoustic
compliance to that of the middle ear. Measured in
2
millilitres or cm .

Stimulus Ear:
The ear to which the reflex activating stimulus is presented in
order to elicit a middle ear muscle reflex. Note: If a bone
vibrator or a loudspeaker is used to deliver an acoustic reflex it
may not be possible to define the stimulus ear.

Toynbee Test:
Test designed to determine the function of the Eustachian tube
in ears with perforated eardrums.

Toynbee's Manoeuvre:
See Valsalvation.

Tympanogram:
A chart of the results of tympanometry - compliance
measurements at the eardrum.

AT235h Operation Manual Page 75


Tympanometry:
The measurement of the ability of the eardrum and ossicular
chain to transmit sound pressure waves. An intact eardrum is
subjected to air pressure changes to determine its stiffness
(impedance) and compliance (admittance).

Valsalvation:
Swallowing with the mouth and nose closed to draw air out of
the middle ear. Syn.: Toynbee's manoeuvre.

Valsalva's Manoeuvre:
Blowing forcibly to open Eustachian tube by holding nose and
closing mouth. Named for its originator, Antonio Valsalva.
Sometimes called Valsalva's experiment.

Williams Test:
Test designed to determine the function of the Eustachian tube
in ears with non-perforated eardrums.

AT235h Operation Manual Page 76


Appendix A: Main Menu and Setup
When the instrument is switched on it automatically powers-up in the
Reflex and Tympanometry Test mode or Tympanometry Test mode.

To go to AT235h’s Main Menu press “Back” (7) one or more times, or


simply hold down “shift” (17) while pressing “Back” (7) – the latter will
bring you to the Main Menu from wherever you are in the instrument.

Figure 27:

From the main menu it is possible to adjust the contrast of the display
by means of “LCD-“ (F5) and “LCD+” (F6). The instrument will always
remember the last setting.

When holding down “shift” (17) the writing above F5 and F6 changes
to “LED-“ and “(LED+)”. Now the brightness of the LEDs (indication
lights) of the instrument keys can be adjusted. Also here the
instrument will remember the last setting.

Pressing “Test” (F1) will bring you back to the Test Screens. Pressing
“Setup” (F2) will bring you to the Main Setup Menu.

The program version is written in the middle of the screen.

AT235h Operation Manual Page 77


Main Setup Menu
The internal Main Setup Menu of AT235h is reached from the Main
Menu by pressing “Setup” (F2) and then pressing F1 to F5:
• Tympanometry Setup
• Setup for Reflex Test A and B
• Common Setup
• Clinic Setup

Figure 28:

With the F-keys (F2 to F5) representing arrow keys “↓, ↑, ←, →” it is


possible to browse through the different setup points. Parameters
can be changed with “Change” (F1) when highlighted.

To leave the individual setup menus press “Back” (7). This key will
always take you back one level. If one or more parameters have
been changed the message on the next page appears on the screen.

AT235h Operation Manual Page 78


To confirm the changes press F1 for “Yes”, else press F6 for “No”.

Tympanometry Setup Menu


The Tympanometry Setup Menu is reached from the Main Menu by
pressing “Setup” (F2) and “Tymp” (F1):

Figure 29:

Start Pressure:
The pressure established as the starting point for the pressure
sweep for the tympanometric curve. The Start Pressure runs
from 25 daPa to 300 daPa.

Stop Pressure:
The pressure where the sweep for the tympanometric curve
stops.

Pump Speed:
There are four different pump speed settings:
• Minimum (17 daPa/sec).
• Medium (50 daPa/sec).
• Maximum (>150 daPa/sec).

AT235h Operation Manual Page 79


• Automatic (see below).

A slow speed will be more time consuming, but may give more
detailed information. The horizontal displacement of the
tympanometric curve’s peak in the sweeping direction caused
by inherent hysteresis of the system and the middle ear itself
will be smaller with lower speed.

With the Automatic setting speed and precision is combined in


the tympanometric sweep. At the start of the sweep the pump
speed will be at maximum due to the fact that the information
derived from the first part of the sweep only contains little
information of diagnostic value.

The speed will gradually be reduced to minimum speed when


coming closer to the peak. Just before and just after the peak
the pump speed will be at minimum since this part of the
sweep diagnostically is the most important part. At the final
part of the sweep the speed will gradually increase again to
reach maximum at the end of the sweep.

Compensated Mode:
AT235h can be set to either Compensated Mode or Non
Compensated Mode. Compensated Mode is used when you
want the tympanometric curve to be displayed at the floor of
the co-ordinate system of the tympanogram. See figure 30.

Figure 30: Compensated Figure 31: Non-Compensated

Non Compensated Mode is used when you want the


tympanometric curve to be displayed including the ear canal
volume. See figure 31.

AT235h Operation Manual Page 80


Gradient Unit:
The Gradient unit is an expression of the shape of the
tympanometric curve; Narrow or wide. It is possible to select
between daPa and ml.

If ml is selected the gradient will be calculated the following


way: The program will go 50 daPa to each side from
compliance value and save the two ml values. The gradient is
the average of the two ml values subtracted from the
compliance value.

If daPa is selected the gradient will be calculated the following


way: The program searches from each end of the tymp curve
and stores the pressure at the point where the tymp curve is
equal to compliance value divided by 2. Gradient is equal to
the two stored pressures subtracted from one another.

High probe tone frequency:


Three different high probe tones; 678, 800 and 1000 Hz can be
presented.

Figure 32:

From the Tympanometry Setup Menu it is possible to select


which High Probe Tone Frequency that should be assigned to
the “High Probe Tone” button (25).

AT235h Operation Manual Page 81


Setup Menu for Reflex Test A and B
The Setup Menu for Reflex Test A and B is reached from the Main
Menu by pressing “Setup” (F2 and “Test A” (F2) or “Test B” (F3).
Choose from four different Reflex Methods:
• Fixed Intensity
• Screening (10 dB Steps)
• Auto (5 dB Steps)
• Sequence

Figure 33:

Each Reflex Method can hold up to six individually pre-programmed


reflexes.

Figure 34:

AT235h Operation Manual Page 82


With the four arrow keys (F2 to F5) it is possible to browse between
the parameters of the individual reflex. Each reflex parameter can be
changed by pressing “Change” (F1) or the dedicated keys “frequency
Decr / Incr” (14 and 15) and the “Intensity Decr / Incr” (24 and 25).
The changeable parameters are pointed out in figure 34 and
described below:

Output:
It is possible to select between ipsilateral and contralateral
reflexes as output.

Stimuli Frequency:
For ipsilateral reflexes the stimuli frequency options are the
following:
500, 1000, 2000, 3000 and 4000 Hz. Including the noise
stimuli WN, LP and HP.

For contralateral reflexes the stimuli frequency options are the


following:
125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000
and 8000 Hz. Including the noise stimuli WN, LP, and HP.

Level:
The intensity level for the reflexes goes from 60 dB to
maximum. Maximum depends on the selected frequency and
the selected transducer. In the final line of the table it is
possible to switch on or off the reflexes according to the
number of reflexes needed.

Note: Because of the possibilities of the Modify Function it


might be relevant to set reflexes which are only rarely used to
“off”. When used now and then these reflexes can be turned
“on” via the Modify Menu.

Reflex Methods
There are four different reflex methods to choose from in the Setup
Menu for Reflex Test A and B. In the following these reflex methods
will be described in details:

AT235h Operation Manual Page 83


Fixed Intensity Method:
With the Fixed Intensity Method the parameters of the
individual reflex (frequency and intensity) are fixed.

Figure 35:

Reflex Sensitivity:
In order to fully understand the reflex search procedure of the
following three Reflex Methods it is important to know about
the Reflex Sensitivity idea. Reflex Sensitivity appears under
the Reflex Method line when Screening, Auto or Sequence
Method are selected.

The software of AT235h uses an algorithm to determine if a


reflex is acceptable or not. There is a selection of three
different algorithms to choose from, each representing its
individual level of Reflex Sensitivity. These three Reflex
Sensitivities are referred to as Sensitive, Normal and Robust
and they are expressed in ml.

When searching for the reflex by means of the following three


Reflex Methods the algorithms in the software will continue to
search for the reflex until the intensity has reached the
maximum level for the selected transducer at the given
frequency. Therefore, a reflex can be accepted in two ways:

AT235h Operation Manual Page 84


1. The reflex does not touch the pass box (the pass box is
normally invisibly). Concerning “Pass Box” (figure 33 - 35).
2. Intensity is at maximum level.

To understand what is meant by pass box see the figures


below. The pass box is the dotted rectangle in the middle of
the figures.

Figure 36: Sensitive (0.03 ml) Figure 37: Normal (0.05 ml)

Figure 38: Robust (0.08 ml) Figure 39: Robust (0.08 ml)

Figure 36 to 39 show examples of how the Reflex Sensitivity


system functions. The first three reflexes are examples of
reflexes that have been accepted according to the different
algorithms (sensitive, normal and robust). They are accepted
because they do not touch the pass box.

Figure 39 shows an example of a reflex that is not accepted


according to the chosen algorithm. The reflex is not accepted
because it goes through the pass box.

Sensitive makes the search algorithm accept small reflexes,


elicited by a relatively low stimulus intensity.
Unfortunately, the test is easily disturbed by noise and
movements of the probe.

AT235h Operation Manual Page 85


Robust needs more compliance change for the initial search
function to trigger - this will ensure a test which can be carried
out with a less than perfect test situation, but will also run
relatively high in intensity and provide similarly larger reflexes.

Normal is a compromise suitable for most applications - it is


relatively forgiving for the accuracy of the test procedure, and
still does not run excessively loud in intensities.

Note: The pass box is not shown in the screen of AT235h but
serves as an example of what sensitivity is and how it is used.

Screening (10 dB steps):


The Screening (10 dB steps) Reflex Method is an automatic
test for detecting reflexes. The reflex parameters in the
Screening Method can be set up to personal needs from the
reflex table in the lower part of the screen.

Figure 40:

The Screening Method starts with the selected Output, Stimuli


Level and Intensity Level from the parameter table in figure 40
as starting point for the reflex test. It will automatically search
for the reflex in steps of 10 dB according to the selected
Reflex Sensitivity. If the reflex is above the above mentioned

AT235h Operation Manual Page 86


pass box it will be accepted and drawn on the screen. The test
will then automatically proceed to the next reflex.

If the reflex goes through the pass box it is not accepted. The
intensity level automatically increases with 10 dB for another
reflex. This procedure continues until the reflex is above the
selected pass box or the maximum intensity level is reached.

Auto (5 dB steps):
Figure 41 shows the screen for the Auto (5 dB steps) Reflex
Method. The Auto test is used for testing where only one reflex
is needed per frequency, but a reflex of a certain size is
preferred (see “Reflex sensitivity” above). The Auto test then
searches for suitable stimulus intensity before each reflex is
tested.

Figure 41:

The automatic procedure for determining which intensity to use


for the reflex test follows these guidelines:
1) A stimulus where the intensity quickly increases is
presented to the ear. Simultaneously the instrument
monitors at which intensity a change of compliance
(typically caused by the reaction of the Stapedius muscle)
occurs.

AT235h Operation Manual Page 87


2) Now the actual reflex test will be performed, using the
intensity found in 1).

3) The recorded reflex will be checked automatically to


ensure that it meets the criteria (see “Reflex sensitivity”
above). If it does, the test at this frequency is completed.

4) If the reflex does not pass the criteria, automatically 1) 2)


and 3) is repeated.

5) If the reflex found the second time also does not meet the
pass criteria, a new reflex is recorded at 5dB higher
intensity. Consecutively higher intensities are then used
until a reflex is accepted. (If a pass cannot be obtained,
the reflex recorded at maximum intensity will be displayed
as the test result for the test).

Sequence:
Figure 42 shows the screen for the Sequence Reflex Method:

Figure 42:

With the Sequence Method it is possible to have up to six


single reflexes in one reflex window. The reflex parameters in
the Sequence Method can be set up to the personal needs

AT235h Operation Manual Page 88


from the reflex table in the lower part of the screen. In the
Sequence Method the intensity levels are marked with small
arrows pointing right indicating that a number of reflexes are
expected to come at a pre-selected increasing intensity.

Reflex pr. Sequence:


There is a choice between 2,3,4,5 or 6 reflexes per sequence.
The higher the number of reflexes selected per sequence the
less detailed the graphic in the small reflex windows will be.

Figure 43:

Figure 43 shows an example of a sequence with six reflexes


starting from 70 dB with 5dB intensity increases per reflex:

Level Increase:
Selects how many dB the intensity increases between each
single reflex. It is possible to choose between 5, 6, 8, 9, or 10.

Note: A warning pops up when too high a Level Increase has


been chosen together with too high a start intensity level. This
will violate the maximum output capabilities of AT235.

Compensate for General Drifting:


While searching for reflexes with the Sequence Method the
compliance may drift a little. When the instrument is set to

AT235h Operation Manual Page 89


“Normal” in the setup parameter Compensated for General
Drifting, the drifting will mathematically be compensated for,
illustrated in figure 45:

Figure 44: Off Figure 45: Normal

Figure 44 illustrates what may happen when the setup


parameter Compensated for General Drifting is set to “Off”.

Test Stop Criteria:


When Test Stop Criteria is set to “Off” the Sequence test will
continue recording reflexes even after a reflex has been
identified and accepted. When set to “Automatic” the
Sequence test will automatically stop as soon as a reflex has
been identified and accepted.

Reflex Sensitivity (when Test Stop Criteria is set to Automatic):


Reflex Sensitivity appears in the line just below Test Stop
Criteria when Automatic is selected. Reflex Sensitivity
functions in the same way as in the Screening and Auto Reflex
Methods.

The Reflex Sensitivity can be set to “Sensitive”, “Normal” or


“Robust”.

Common Setup Menu


The Common Setup Menu is reached from the Main Menu by
pressing “Setup” (F2) and “Common” (F4):

AT235h Operation Manual Page 90


Figure 46:

Power-up:
Select between “Tymp”, “Tymp and Reflex”, or “High Probe
Tone” as power up. See figure 47:

Figure 47:

AT235h Operation Manual Page 91


Pause:
If “On” is selected the “Pause” key (9) is pre-selected as
default for 1) the Tympanometry Test, 2) the Reflex Test and
3) the Reflex and Tympanometry Test.

When “Off “ is selected the Pause Function must be switched


on manually. The Pause Function can be activated from for 1)
the Tympanometry Test, 2) the Reflex Test and 3) the Reflex
and Tympanometry Test.

Baud rate:
Selects the Baud rate level for the serial communication
RS232. Select between “57600”, “38400” and “38400 MPT10”

Remote Switch:
Selects the function of the Remote Switch of the probe. Select
between “Off”, “L/R”, “Pause” and “L/R or Pause”.

1. When “Off” is selected the Remote Switch is out of


function.

2. When “L/R” is selected it is possible to shift between left


and right ear with the Remote Switch.

3. When “Pause” is selected it is possible to control the


“Pause” key (9) from the Remote Switch.

4. When “L/R or Pause” is selected the “Pause” key (9) can


be controlled from the Remote Switch of the probe when
the probe tip is in the ear canal, and the “Right” (20) and
“Left” (21) keys can be controlled when the probe tips is
not in the ear canal.

Manual Reflex Attenuator:


Selects the intensity increase and decrease levels for manual
reflexes when pressing the “Intensity Decr / Incr” keys (23 and
24). It is possible to choose between 1, 2 and 5 dB.

Reflex Icon Boxes


With Reflex Icon Boxes it is possible to select between 4 or 6
reflex. See the appearance of the two possibilities below:

AT235h Operation Manual Page 92


Figure 48: 4 Reflex Boxes Figure 49: 6 Reflex Boxes

Printer:
There are three different “Printer” settings; “Off”, “Internal” and
“HP PCL L3”:

1. “Off” means that there will be no printing possibilities.

2. “Internal” means that the internal printer of AT235h is


activated and can be used, if an internal printer is installed.

3. With “HP PCL L3” it is possible to print on an external


printer. HP PCL L3 supports most Hewlett Packard laser
and Ink Jet printers. Other brands supporting the HP PCL
L3 language can be used too.

Subject Data Printout (when “Printer” is set to “Internal”):


Subject Data Printout can be set to either “On” or “Off”. When
set to “On” the Subject Screen in figure 46 appears when
holding down “shift” (17) while pressing “new subject” (9).

To enter the Subject Screen, a keyboard must be connected to


the AT235h and the “Keyboard Connected” point in the
Common Setup Menu must be set to “Yes”.

AT235h Operation Manual Page 93


Figure 50:

Clinic Data Printout:


If “On” is selected the Clinic data will be printed. To enter the
individual clinic data go to the Main Setup Menu and press F5.

To enter the Clinic screen, a keyboard must be connected to


the AT235h and the “Keyboard Connected” point in the
Common Setup Menu must be set to “Yes”

To enter your own Clinic data press F1 “Edit”. The Clinic data
is edited by pressing F2.

Figure 51:

AT235h Operation Manual Page 94


Print After Test:
Print After Test can be set to either “On” or “Off”.

When set to “On” the test result will be printed automatically


when both right and left ear have been tested. This automatic
printing possibility is directly related to the “Power-up” chosen –
“Tymp” or “Reflex and Tymp”.

When set to “Off” the print function must be addressed


manually.

Keyboard Connected:
It is possible to connect a keyboard to AT235.

If a keyboard is connected “Keyboard Connected” must be set


to “Yes”. When a keyboard is connected it is possible to fill in
data in the “Clinic” and “Subject” screens.

When no keyboard is connected “Keyboard Connected” should


be left “Off”.

AT235h Operation Manual Page 95


Appendix B: General Maintenance
Procedures
The performance and safety of the instrument will be kept if the
following recommendations for care and maintenance are observed:

− It is recommended to let the instrument go through at least one


annual overhaul, to ensure that the acoustical, electrical and
mechanical properties are correct. This should be made by an
authorized workshop in order to guaranty proper service and
repair.

− Before the connection to the mains network, be sure that the local
mains voltage corresponds to the voltage labeled on the
instrument. Always disconnect the power cord if the instrument is
opened or by control / replacement of the mains fuses.

− Observe that no damage is present on the insulation of the mains


cable or the connectors and that it is not exposed to any kind of
mechanical load, which could involve damage.

− Consult the Operating Manual for the instrument in question to


see how long time it takes from turning on the instrument until it is
stabilised and ready to use.

− For maximum electrical safety, turn off the power from a mains
powered instrument when it is left unused.

− Do not site the instrument next to a heat source of any kind, and
allow sufficient space around the instrument to ensure proper
ventilation.

− To ensure that the reliability of the instrument is kept, it is


recommended that the operator at short intervals, for instance
once a day, perform a test on a person with known data. This
person could be the operator him/herself.

AT235h Operation Manual Page 96


− A plastic cover can be provided to protect the instrument against
the accumulation of dust. The cover should only be used when the
instrument is left unused with the power turned off.

− If the surface of the instrument or parts of it are contaminated, it


can be cleaned using a soft cloth moistened with a mild solution of
water and dish washing cleaner or similar. The use of organic
solvents and aromatic oils must be avoided. Always disconnect
the mains conductor during the cleaning process, and be careful
that no fluid is entering the inside of the instrument or the
accessories.

− After each examination of a patient, it should be ensured that


there is no contamination on the parts in connection with the
patient. General precautions must be observed in order to avoid
that disease from one patient is conducted to others. If ear
cushions or ear tips are contaminated, it is strongly recommended
to remove them from the transducer before they are cleaned. By
frequent cleaning water should be used, but by severe
contamination it may be necessary to use a disinfectant. The use
of organic solvents and aromatic oils must be avoided.

− Great care should be exercised by the handling of earphones and


other transducers, as mechanical shock may cause change of
calibration.

AT235h Operation Manual Page 97


AT235h Operation Manual Page 98
Return Report – Form 001

Opr. date: 2003-02-24 by: EC Rev. date: 2003-02-24 by: EC Rev. no.: 1

Address
Company: Drejervænget 8
DK-5610 Assens
Address: Denmark

Phone
(+45) 63713555
Phone:
Fax
(+45) 63713522
Fax:
Date :
Contact person:

Following item is reported to be:


returned to INTERACOUSTICS for: repair, exchange, other:
defective as described below with request of assistance
repaired locally as described below
showing general problems as described below

Item: Type: Quantity:


Serial No.: Supplied by:
Included parts:

Description of problem or the performed local repair:

Returned according to agreement with: Interacoustics, Other :


Date : Person :
1
The above mentioned item is reported to be dangerous to patient or user

To ensure instant and effective treatment of returned goods, it is important that this
form is filled in and placed together with the item.
Please note that the goods must be carefully packed, preferably in original packing, in
order to avoid damage during transport. (Packing material may be ordered from
Interacoustics.

1
EC Medical Device Directive rules require immediate report to be sent, if the device by malfunction
deterioration of performance or characteristics and/or by inadequacy in labelling or instructions for use, has
caused or could have caused death or serious deterioration of health to patient or user.
Page 99
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Drawing of Front Plate

Page 101

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