Maico easyTymp User manual

easyTymp® Operating Manual
MAICO Diagnostics | 10393 West 70th Street | Eden Prairie, MN 55344, USA | Toll Free 888.941.4201

easyTymp® Operating Manual
i
Table of Contents Page
1 Introduction.................................................................................. 1
1.1 Description ............................................................................................. 1
1.2 Safety Notes ........................................................................................... 2
2 Impedance measurements .......................................................... 3
2.1 Tympanometry ....................................................................................... 3
2.2 Acoustic Reflex ....................................................................................... 3
3 Getting started .............................................................................
3.1 PC system requirements .......................................................................... 4
3.2 Unpacking and inspecting ....................................................................... 4
3.2 System installation .................................................................................. 5
3.2.1 Hardware installation ............................................................................................ 5
3.3 Preparing the test ................................................................................. 11
3.3.1 Patient Instruction .............................................................................................. 11
3.3.2 Visual inspection of the ear canal ........................................................................ 11
3.3.3 Handling the eartips ........................................................................................... 11
3.4 Cleaning the probe tip .......................................................................... 12
Operating easyTymp® .............................................................. 13
4.1 Operating Panel .................................................................................... 13
4.2 Getting started ..................................................................................... 13
4.3 Probe status indication .......................................................................... 14
4.4 Operating easyTymp® .......................................................................... 14
4.4.1 Test .................................................................................................................... 15
4.4.2 Select Test Screen ............................................................................................... 17
4.4.3 Done .................................................................................................................. 17
4.4.4 Select Patient & Save .......................................................................................... 18
4.4.5 Edit New ............................................................................................................ 19
4.4.6 View Patients .................................................................................................... 20
4.4.7 View Details ....................................................................................................... 20
4.4.8 Edit Details ........................................................................................................ 21
4.4.9 View Results ....................................................................................................... 21
4.4.10 View Results ..................................................................................................... 21

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Table of Contents (cont.) Page
4.5 Setup ................................................................................................... 22
4.5.1 Setup Language ................................................................................................. 22
4.5.2 Setup Date & Time ............................................................................................. 22
4.5.3 Setup easyTymp® .............................................................................................. 23
4.5.4 Setup Printer ...................................................................................................... 23
4.5.5 Setup Clinic Info ................................................................................................. 23
4.5.6 Setup License ..................................................................................................... 24
4.5.7 Setup Patient Management ................................................................................ 24
4.5.8 About ................................................................................................................ 25
5 Warranty, Maintenance and Service ....................................... 26
6 Disinfection ................................................................................ 26
7 Safety Regulations ..................................................................... 27
7.1 Electrical safety: .................................................................................... 27
7.2 Measurement Safety: ............................................................................ 27
7.3 Operation: ............................................................................................ 27
7.4 Patient Safety: ...................................................................................... 27
8 Technical Data ............................................................................ 29

easyTymp® Operating Manual
1
1 Introduction
Thank you for selecting one of our quality products from the MAICO family range. The
easyTymp® is designed and manufactured to meet all quality and safety requirements, and
has been certified with the CE-symbol according to Medical Directive.
Particular attention has been taken during the designing phase of the easyTymp® to ensure its
user-friendliness, meaning that its operation is simple, easy to learn and to understand. As all
the functions are software-controlled, upgrading the software and/or adding additional
functions at a later date will be simple and cost-effective. By purchasing the easyTymp®, you
have made a decision towards long-term investment.
This operating manual aims to make learning and understanding the different easyTymp®
functions as quick and as easy as possible. Should you encounter any problems or have ideas
for any further improvements, we are only a phone call away. Please do not hesitate to
contact us.
Your
YourYour
Your MAICO
MAICOMAICO
MAICO-
--
-Team
TeamTeam
Team
1.1 Description
The easyTymp® is an automatic impedance unit, well suited to perform tympanometry and
screen acoustic reflexes on people of all ages, from infants to adults.
The easyTymp® is intended to be used by hearing healthcare professionals (i.e. ENT doctors,
audiologists), trained technicians, as well as neonatal nurses and school nurses in a quiet
environment.
The handheld unit also enables the transfer of data to a PC via USB-connection.
The easyTymp® cradle serves as a docking station and charger. It is available as a version with
ear tip box or integrated printer.

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1.2 Safety Notes
The easyTymp® should always be operated in a quiet room with minimal magnetic influence,
to ensure that examinations are not disturbed by external noise.
Electro-medical instruments that emit strong electromagnetic fields (e.g. microwaves,
radiotherapy devices) can affect the operation of the easyTymp®.
Therefore, the operation of these instruments in close proximity to the easyTymp® should be
avoided at all times.
The examination room should have a normal temperature between 15°C/ 59°F and 35°C/ 95°F.
If the instrument has cooled down during transportation, please wait for it to warm up to
room temperature before operation.
MAICO easyTymp® is specified according to EN 60 601-1.
Protection against electrical hazard is guaranteed only when the instrument is
connected to a grounded safety. Please note that during operation, the
instrument should always be connected to a battery-operated or mains-
operated notebook computer that complies with EN 60 601-1 or EN 60 950-
1. In the event that a main cable, connector or wall socket is damaged, please
do not use the instrument under any circumstance.
Attention
PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE OPERATING THIS
INSTRUMENT.
Please only use this instrument as described in the manual.
Please familiarize yourself with the instrument and its operation before using.
Should defects or damages be suspected, please do not, under any
circumstances, use or attempt to fix the instrument yourself.
To guarantee that the tympanometer works properly, the instrument has to
be checked and calibrated at least once a year.
The service and calibration must be performed by an authorized service
centre. In accordance with the regulations of the EU medical directive we will
drop our liability if these checks are not done.
The use of non-calibrated tympanometers is not allowed.
Un-calibrated instruments may lead to faulty measurements and sometimes
even damage the hearing of the examinee.
Take note to ensure that all the accessories have been properly connected.
To avoid person-to-person cross contamination of communicable diseases,
parts that come in direct contact with the patient (i.e. eartips) should only be
used one time.
In accordance with the Electronic Equipment Act for disposal of electronic
equipment, the customer is obliged to dispose of the used consumables,
according to appropriate regulation at own cost.

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2 Impedance measurements
2.1 Tympanometry
Tympanometry is the objective measurement of middle ear mobility (compliance) and pressure
within the middle ear system. During the test, a low-pitched probe tone (226 Hz) is presented
to the ear canal by means of the hand-held probe. This tone is used to measure the change in
compliance in the middle ear system while the air pressure is varied automatically from a
positive value (+200 daPa) to a negative value (-400 daPa max.).
Maximum compliance of the middle ear system occurs when the pressure in the middle ear
cavity is equal to the pressure in the external auditory canal. This is the highest peak of the
curve as it is recorded on the chart. The position of the peak on the horizontal axis and on the
vertical axis of the chart will provide diagnostic information regarding the function of the
middle ear system. Examples of normal and abnormal tympanograms can be found in a later
section of this manual.
Gradient calculations are reported as the Tympanogram width at half of peak compliance
expressed in daPa. A ”limits” box is available on both the display and printout to aid in
diagnosis.
2.2 Acoustic Reflex
An acoustic reflex, or contraction of the stapedial muscle, occurs under normal conditions
when a sufficiently intense sound is presented to the auditory pathway. This contraction of the
muscle causes a stiffening of the ossicular chain which changes the compliance of the middle
ear system. As in Tympanometry, a probe tone is used to measure this change in compliance.
When the stimulus presentation and measurement are made in the same ear by means of the
probe, this acoustical reflex is referred to as an ipsilateral acoustic reflex. When the stimulus
presentation and measurement are made in opposite ears, the reflex is referred to as a contra
lateral acoustic reflex.
For best results, this reflex measurement is automatically conducted at the air pressure value
where the compliance peak occurred during the tympanometric test. Stimulus tones of varying
intensities at 500, 1000, 2000 or 4000 Hz are presented as short bursts. If a change in
compliance greater than 0.05 ml is detected, a reflex is considered present. Because this is an
extremely small compliance change, any movement of the probe during the test may produce
an artifact (false response). The level at which a reflex occurs is recorded as a number, as
PASS/FAIL and in graph form.
If the tympanometric results display any abnormal findings, the results of the acoustic reflex
testing may be inconclusive and should be interpreted with care. If a ”flat” tympanogram is
observed, showing a non-mobile middle ear system, the easyTymp® will not perform an
acoustic reflex test. Theoretically, a compliance peak is necessary to observe a reflex at peak
pressure.

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3 Getting started
3.1 PC system requirements
Processor: Intel Pentium 4 / Celeron 1,4 GHz
Memory: 1 GB RAM
Graphic display: 1024 x 768
Operating system: Windows XP Professional (mit SP3)
Windows 7, Professional oder Ultimate Version für 32 und 64 Bit
Computer
Connection: USB 1.1 or higher
3.2 Unpacking and inspecting
Check the packaging and content for damage
Thoroughly inspect the exterior of the shipping for any sign of damage or tempering. Should
any damage be noted, please notify the carrier immediately.
If the content box has been damaged during transportation, the instrument should be
checked for any electrical or mechanical defects. Should any defects be identified, please
contact the responsible dealer. Keep all original packaging to facilitate any insurance claims
against the damages.
Keep the original packaging for future shipment!
The easyTymp® is packaged in a specially-designed box. Please keep the box as it will be
useful for sending the instrument for the annual instrument check-up.
Please contact your nearest responsible dealer should the annual instrument check-up be
needed.
Please check that all accessories listed below are received in good condition. If any accessories
are missing or damaged, immediately notify your MAICO Special Instrument Distributor
Standard Accessories
Part No
Probe 721-2
Rechargeable Battery Pack 721-4
Software CD 1156-2075
easyTymp® handheld unit 721-1
Probe Tip 721-3
Eartip Kit 721-5
Instruction Manual 1162-1100
Calibration Cavity 721-7
Power Supply (Handheld Unit)** 721-6
Power Supply (Cradle)** 721-9
USB Cable for Handheld* 1025-2097
USB Cable for Cradle* 1025-2092
*Will contain only one, depending on configuration ordered.
** Will contain only one, depending on configuration ordered.

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Standard tip configuration in Eartip box:
E
artip Ty
p
e
Size
Quantity
Flanged 3-5mm 10
Mushroom 9 mm 10
Mushroom 11 mm 10
Mushroom 13 mm 10
Mushroom 15 mm 5
Mushroom 19 mm 5
Umbrella 15 mm 5
Umbrella 19 mm 5
MAICO Probe Cleaning Tool 1
3.2 System installation
3.2.1 Hardware installation
3.2.1.1 Installing the cradle
Figure 1
Connectors at the rear bottom of the cradle
1 = USB in 2, 3, = USB out
5 = Power 6 = Follow the instructions for use
Put the enclosed mains cable into the power connection socket M5 and its mains plug into a
power socket.
Optional accessories
Part No
Cradle w/o Printer 721-10
Cradle w/ Printer 721-8
Wall Mount Kit 6699
Carry Case 1035-3024

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3.2.1.2 Cradle indication lights
Depending on the version (with or without printer) the cradle has up to three indication lights.
easyTymp®
LED
shows solid blue when the easyTymp®
is placed inside the cradle and the battery is fully charged.
The LED will flash as long as the battery is charging.
Battery LED shows solid blue when the spare battery in
the cradle is fully charged. The LED will flash as long as
the battery is charging.
Printer LED is red when a printer problem occurs.
3.2.1.3 Installing paper in the thermal printer
Step 1 - Push button to open the printer cover
Step 2 – Pull blue lever upwards
Insert paper roll in the compartment with its loose end
to the front of the printer. Position the loose end into
the printer roll and hoist it by rotating the printer roll
with your finger

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Push blue lever down
Close printer cover
3.2.1. Mounting the cradle on the wall
The easyTymp® cradle can be mounted on the wall via the optional wall-mount kit.
Instructions are provided inside the wall-mount kit. See pg. 5 for part number.

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3.2.1.5 Installing the easyTymp®
The battery compartment is opened by gently pressing
the indentation and pulling the cover downwards.
Place the battery inside the compartment. Make sure
the battery contacts are correctly placed.
Replace the lid on the easyTymp® and push it upwards
to close the battery compartment.
If not in operation for longer periods, it is recommended
to remove the battery from the instrument.
3.2.1.6 Charging the battery
The spare battery is stored in the charger in the back of
the cradle. Battery LED shows solid blue when the spare
battery in the cradle is fully charged. The LED will flash
as long as the battery is charging
Please observe the following precautions
Keep the battery fully charged.
Do not place the battery in fire or apply heat to the battery.
Do not damage the battery or use a damaged battery.
Do not expose the battery to water.
Do not short circuit the battery or reverse the polarity.
Use only the charger provided with the easyTymp®

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3.2.1.7 Changing probes
To release the probe press the button at the back and
pull the probe out.
Do not pull the cord of the extension cord as this can
damage the tubing connections!
Place the probe to the easyTymp® by lining up the red
triangles and pushing the probe into the unit.
The probe can be attached to the extension cord by
lining it up correctly and clicking the probe into the end
of the extension cord.

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3.2.1.8 Calibration cavities
The easyTymp® comes with a separate 2 cc cavity which can be used for a quick check of the
validity of the probe calibration. You can use 0.2 ml, 0.5 ml, 2.0 ml and 5.0 ml cylinders for
more extended checks.
To perform this check, select a protocol which measures a tympanogram.
Do not use an ear tip! Place the probe tip completely into the cavity. Perform the
measurement. Check the volume which was measured.
The allowed tolerance in the volume measurement is ± 0.1 ml for cavities up to 2 ml and ±
5% for bigger cavities. These tolerances count for all probe tone frequencies.
We strongly recommended calibrating each probe at least once a year. If a probe is handled
roughly (e.g. fallen onto a hard surface) it might need to be calibrated again. Calibration
values of the probe are stored in the probe itself. Therefore probes can be exchanged
between units.
3.2.2 Installation on Windows®
Power up your computer and launch the windows desktop screen, do not power up the
hardware or plug in the USB cable.
Insert the CD-ROM and the install shield wizard for the software suite comes up (you must
have administrator rights to install the software. If you do not have this, contact your
Administrator of the network).
Press Next and follow the on-screen instructions. When options are given between different
choices, please follow the default suggestion, to achieve a standard installation.
3.2.3 Installation of the driver
Connect the USB cable to your PC and make sure that the other end is either connected to
easyTymp® directly or that it is connected to the cradle and the easyTymp® is placed in the
cradle. Switch easyTymp® on by pressing the right or left arrow key. You will find a small
Windows message appearing on your screen saying “Windows found new hardware” and
after a short time, up to 2 minutes, the installation Wizard screen will come up:
The wizard will automatically find the USB drivers on the CD-ROM where the Impedance
Software is also located. Wait patiently until the process is completed. This can take several
minutes. Then click Finish. Now a small Windows message will say “You can now use the
hardware found by Windows.”
3.2. License
When you receive the product it already contains the license including the software you have
ordered. If you would like to add either one of the available software suite, please contact
your dealer.

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3.3 Preparing the test
3.3.1 Patient Instruction
Make sure that the patient is comfortable on a chair or on an examination table if necessary.
Small children may feel more comfortable sitting on a parent's lap. Show the probe to the
patient and then explain the following:
The aim of the test is to test the mobility of the eardrum.
The tip of the probe will be inserted into the ear canal, and that it has to make a seal.
A small amount of air will flow through the probe to move the eardrum; it produces a
sensation equal to pressing a finger slightly into the ear canal.
One or more tones will be heard during the test.
No participation is expected from the patient.
Coughing, talking and swallowing will disturb test results.
3.3.2 Visual inspection of the ear canal
Check the external ear canal for wax with an otoscope and remove excessive wax to prevent
the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut.
3.3.3 Handling the eartips
Choose an ear tip of the appropriate size from the ear tip set, depending on the size and
shape of the ear canal and ear. Put the ear tip tightly on the probe tip.
We recommend using a new ear tip for each patient. If the clinician rinses the ear tips they
should be subjected to standard disinfection procedures between patients. This includes
physically cleaning the ear tip and use of a recognized disinfectant. Individual manufacturer's
instructions should be followed for use of this disinfecting agent to provide an appropriate
level of cleanliness.

easyTymp®
3. Cleaning the 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 illustr
instructions on how to remove e.g. cerumen from the small acoustic and air pressure channels
of probe tip.
easyTymp®
Operating Manual
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3. Cleaning the 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 illustr
instructions on how to remove e.g. cerumen from the small acoustic and air pressure channels
Never clean the probe tip while the tip is still fitted on
the probe.
Unscrew the probe cap of the probe by turning counter
clock direction.
Take the probe tip out of the probe.
Take the cleaning tool apart to
find the thin brush and
thin rigid plastic cord.
Use the plastic cord or brush to push contamination out
of the probe tip. Always enter the probe tip from the
rear to avoid accumulation of contamination inside the
vents.
Place the probe tip back onto
the probe. Make sure that
the different holes fit in the corresponding cavities.
Screw the probe cap back on the probe. Finger force
will tighten the screw sufficiently. Never use tools to fix
the probe cap!
If any blockage or damage occurs to the sealing gasket,
the probe system can only be serviced by MAICO.
Operating Manual
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 illustr
ated
instructions on how to remove e.g. cerumen from the small acoustic and air pressure channels
Never clean the probe tip while the tip is still fitted on
Unscrew the probe cap of the probe by turning counter
find the thin brush and
Use the plastic cord or brush to push contamination out
of the probe tip. Always enter the probe tip from the
rear to avoid accumulation of contamination inside the
the probe. Make sure that
the different holes fit in the corresponding cavities.
Screw the probe cap back on the probe. Finger force
will tighten the screw sufficiently. Never use tools to fix
If any blockage or damage occurs to the sealing gasket,
the probe system can only be serviced by MAICO.

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Operating easyTymp®
.1 Operating Panel
Function Keys:
- Top buttons: Function of the keys is related to the
functions indicated in the display above the individual
function key. (e.g. Select Test, Patient, Stop …)
Arrow Keys: Turn on easyTymp® by
pressing the right or left arrow key.
Turn off easyTymp® by pressing both keys at the
same time.
Up and Down buttons: Scroll through the different
easyTymp® settings menu, test protocols or up and
down the display.
.2 Getting started
To get started, take the easyTymp® out of the cradle. In default setting it will turn on
automatically.
If you don’t store the easyTymp® in the cradle, press either red or blue arrow key to switch
the device on.
To switch easyTymp® off, press both red and blue arrow keys together and hold for one
second
easyTymp® will always start within the test screen, ready to start a measurement. It will use
the same protocol as previously used.

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.3 Probe status indication
If you use the optional external probe the light at the back of the probe indicates the probe
status with the following colors:
Red – Right ear is selected. Probe is out of ear.
Blue – Left ear is selected. Probe is out of ear.
Green – Probe is in the ear and is sealing.
Yellow – Probe is in the ear and blocked or leaking.
White – The probe has just been attached. Probe status is unknown. The probe status stays
white in hand held use if the easyTymp® is not monitoring the probe status. If the probe light
stays white in any other situation easyTymp® might need to be switched off and on again to
regain proper probe status.
Flashing color to off – easyTymp® is pausing during a protocol and is waiting for you to press
continue. The color in which the probe light is flashing indicates the probe status like above.
Flashing green to red/blue – easyTymp® just finished the protocol.
. Operating easyTymp®
After switching on the instrument, it will usually start in the Test screen and is ready to test
the same protocol as was used last. After disconnecting easyTymp® from a PC it will start in
the Select Protocol screen and you have to select which protocol should be used.
The battery status bar will show if the battery power runs down. If the battery is empty, you
will be warned and the measurement will be stopped and all recorded data will be stored. You
will have to shut down and change the battery. The measurement data will be recovered after
you start up again. In that way you can continue measurement without retesting.
The following paragraphs describe the precise operation of the different screens you will
observe during the use of easyTymp®.

easyTymp®
. .1 Test
Usually the
deleting or saving data after a measurement, you
return to this screen. The following information can be
viewed in the screen
The header shows the status of the probe, showing
leaking, blocked or in ear.
In the top at the right you find status of the battery
in the cradle, it will charge the battery and it will show a moving, charging battery icon.
In the upper right corner an icon shows if the
right ear .
When entering the Test screen, the second
name of the protocol which is used. As soon as
the ear, the second line will show which test of the protocol is running.
Here you find the graphics of the ongoing test. The box
indicates the normative area where the peak of the
tympanogram is expected under normal conditions. The
dimensions of the normative box are defined in the protocol
settings
Display of the
easyTymp®
Operating Manual
15
Usually the
easyTymp® starts with the
Test Screen
deleting or saving data after a measurement, you
return to this screen. The following information can be
viewed in the screen
The header shows the status of the probe, showing
ready
In the top at the right you find status of the battery
. When the
easyTymp®
in the cradle, it will charge the battery and it will show a moving, charging battery icon.
In the upper right corner an icon shows if the
easyTymp®
is testing either left ear
When entering the Test screen, the second
line shows the
name of the protocol which is used. As soon as
easyTymp®
detects that the probe is in
the ear, the second line will show which test of the protocol is running.
Here you find the graphics of the ongoing test. The box
indicates the normative area where the peak of the
tympanogram is expected under normal conditions. The
dimensions of the normative box are defined in the protocol
settings
.
Display of the
determined measurements:
Operating Manual
Test Screen
. When
deleting or saving data after a measurement, you
will also
return to this screen. The following information can be
ready
, in ear,
easyTymp®
is placed
in the cradle, it will charge the battery and it will show a moving, charging battery icon.
is testing either left ear
or
line shows the
detects that the probe is in
Here you find the graphics of the ongoing test. The box
indicates the normative area where the peak of the
tympanogram is expected under normal conditions. The
dimensions of the normative box are defined in the protocol

easyTymp® Operating Manual
16
Operating from this screen:
Putting the probe in an ear will automatically start the test.
Top left button will bring you into the Select Test screen from where you can select a
different test protocol.
Top middle button will bring you to the Patient screen from where patient data can be
viewed and changed and earlier sessions can be reviewed and/or printed.
Top right button will interrupt the test (Stop) and bring you to the Done! screen.
Right and Left buttons will select respectively right or left ear for testing.
If data on one or both ears is still available, the Up and Down buttons will bring you back to
the done screen and allow you scroll through the measurement results.