Maico easyTymp User manual

Operation Manual
easyTympTM

Operation Manual easyTymp
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Contents
1Introduction ........................................................................................2
1.1 Intended Use .................................................................................................3
1.2 Indications for Use .........................................................................................3
1.3 Essential Performance ....................................................................................3
1.4 Description ....................................................................................................3
2For your Safety ....................................................................................5
2.1 How to read this Operation Manual ...............................................................5
2.2 Regulatory Symbols........................................................................................6
2.3 General Precautions .......................................................................................7
2.4 Electrical Safety and Measuring Security .........................................................8
2.5 Device Control ...............................................................................................9
2.6 Electromagnetic compatibility (EMC) ..............................................................9
3Impedance Measurements.................................................................10
3.1 Tympanometry.............................................................................................10
3.2 Acoustic Reflex ............................................................................................10
3.3 Contralateral Acoustic Reflex .......................................................................11
3.4 Acoustic Reflex Decay ..................................................................................11
3.5 Eustachian Tube Function Test .....................................................................11
4Getting Started .................................................................................12
4.1 PC System Requirements..............................................................................12
4.2 Unpacking and Inspection............................................................................12
4.3 System Installation .......................................................................................15
4.4 Preparing the Test........................................................................................20
4.5 Operating Panel ...........................................................................................23
4.6 Start the Test ...............................................................................................23
4.7 Probe Status Indication ................................................................................23
5Operating easyTymp..........................................................................25
5.1 Test .............................................................................................................25
5.2 Select Test Screen ........................................................................................26
5.3 Done ...........................................................................................................27

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5.4 Select Patient & Save....................................................................................29
5.5 Edit New......................................................................................................30
5.6 View Patients...............................................................................................31
5.7 View Details.................................................................................................31
5.8 Edit Details...................................................................................................32
5.9 View Results ................................................................................................32
5.10 Setup...........................................................................................................33
5.11 easyTymp Plus and Pro Version: Contra Probe Button...................................37
6Connecting to a PC ...........................................................................38
7Cleaning and Disinfection Recommendations .....................................39
7.1 General Recommondations ..........................................................................39
7.2 Cleaning the probe tip .................................................................................40
8Warranty, Maintenance and After-Sales Service..................................43
8.1 Warranty .....................................................................................................43
8.2 Recycling and Disposal .................................................................................43
9Technical Specifications .....................................................................44
9.1 Classification according EEC.........................................................................44
9.2 Technical Data .............................................................................................44
9.3 Connections and Pin Assignment .................................................................49
9.4 Reference values for stimulus calibration ......................................................50
9.5 Electromagnetic Compatibility......................................................................51
10 Test Protocols....................................................................................55
11 Troubleshooting ................................................................................57
12 Appendix ..........................................................................................59

Operation Manual easyTymp
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Title: easyTymp –Operation Manual
EC REP
MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.: + 49 30 / 70 71 46-50
Fax: + 49 30 / 70 71 46-99
E-mail: [email protected]
Internet: www.maico.biz
Copyright © 2016 MAICO Diagnostics
All rights reserved. No part of this publication may be reproduced or transmitted in any
form or by any means without the prior written permission of MAICO. The information in
this publication is proprietary to MAICO.
Compliance
MAICO Diagnostics is an ISO 13485 certified corporation.
Trademark Notice
The easyTympTM is a registered trademark. For a better readability the TM sign is not
repeated throughout this manual.

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1 Introduction
Thank you for purchasing a quality product from the MAICO product family. The
easyTymp is designed and manufactured to meet all quality and safety requirements.
When designing the easyTymp we placed particular importance on making it a user-
friendly device. The intent was to make its operation easy to learn, thus making the device
simple and easy to operate. This user manual is meant to make it as easy as possible for
the operator to become familiar with the operation and functions of the easyTymp when
performing tympanometry and acoustic reflex tests. If you have questions or suggestions
for further improvements, please do not hesitate to contact us.
Your MAICO Team
NOTE: Although almost attention has been given to ensure the accuracy of the
Operation Manual, some minor errors may still exist. We apologize for any
inconvenience this may cause.

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1.1 Intended Use
The tympanometer is used to obtain information on medical conditions affecting the
middle ear and to assess hearing.
1.2 Indications for Use
The easyTymp is an electroacoustic test instrument that produces controlled levels of test
tones and signals intended for use in conduction diagnostic hearing evaluations and
assisting in the diagnosis of possible otologic disorders. It features tympanometry and
acoustics reflex.
1.3 Essential Performance
To generate and present stimulus signals in the audio range as specified in theapplicable
IEC 60645 series in normal conditions.
Absence of these performance features can lead to failure in diagnosis which is
considered as an unacceptable risk to the patient. Temporary loss of essential
performance is not considered an acceptable risk as long as the loss of performance is
detectable. This could be the loss of power, fuse blow of system halt with error message.
1.4 Description
The easyTymp is an automatic middle ear analyzer intended to be used for objective
testing the middle ear function and the factors that contribute to the occurrence of the
hearing loss in the age range of infants, children and adults It is intended to be used by
hearing healthcare professionals (i.e. ENT doctors, audiologists), and other trained
personal such as medical technicians, neonatal and school nurses. The instrument is
intended for professional use in a hospital, clinic, healthcare facility or other suitable quiet
environment as defined in standard ISO 8253-1.
The purpose of the easyTymp test system is to provide a rapid tympanometry and
acoustic reflex measurements to measure the middle ear status where a pass or refer
notation is identified. easyTymp provides an optional 1 kHz probe tone for testing newborns.
Factory defined protocols allow for simple screening measurements, and different versions
are available that provide diagnostic testing functions. As with any type of hearing
screening, a “pass” result should not overrule any additional concerns regarding middle
ear function. A referral to physician should be administered if concerns about middle ear
function persists.
The easyTymp cradle serves as a docking and recharging station for the handheld device
and can include an integrated printer or opening for placement of the eartip box.
Using the included Software, the handheld unit will transfer data to a PC via USB-
connection while in the docking station, or it can also transfer data directly via USB cable
when no docking station is available.
The easyTymp comes in multiple versions and configurations. Each version provides
specific functionalities dependent upon the user needs.

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easyTymp (as Standard Version)
Rapid tympanometry measurement
Ipsilateral acoustic reflexes at several frequencies
1 kHz probe tone (option)
easyTymp Plus Version (Contra probe required)
Rapid tympanometry measurement
Ipsilateral acoustic reflexes at several frequencies
Contralateral acoustic reflex measurements at several frequencies
1 kHz probe tone (option)
easyTymp Pro Version (Contra probe required)
Rapid tympanometry measurement
Ipsilateral acoustic reflexes at several frequencies
Contralateral acoustic reflex measurements at several frequencies
Acoustic reflex decay (ipsilateral and contralateral)
Eustachian tube function
1 kHz probe tone (option)

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2 For your Safety
2.1 How to read this Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO eayTymp
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS
SYSTEM!
Use this device only as described in this manual.
In this manual, the following two labels identify potentially dangerous or destructive
conditions and procedures:
The WARNING label identifies conditions or practices that may
present danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could
result in damage to the equipment
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
WARNING
CAUTION

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2.2 Regulatory Symbols
Symbol
Description
Serial number
Date of manufacture
Manufacturer
Caution, consult accompanying documents
Return to authorized representative, special disposal
required
Reference number
patient applied part type B according to IEC 60601-1
Refer to instruction manual (mandatory)
Read operation instructions
Keep away from rain
Transport and storage temperature range
Transport and storage humidity limitations
Transport and storage atmospheric pressure limitations
Electrostatic sensitive sevices
Do not reuse
REF

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Symbol
Description
EC REP
EU authorized representative
Conforms to European Medical Device Directive
93/42/EEC
Non-ionizing electromagnetic radiation
Logo
2.3 General Precautions
Before measurement make sure, that the device works properly.
Do not immerse the unit in any fluids. For cleaning and disinfection see chapter 7
Cleaning and Disinfection Recommendations.
Use and store the instrument indoors only. For operation, storage and transport
conditions see table in chapter Technical Data.
For operation in certain places, a recalibration may be necessary.
No modification of this equipment is allowed.
Do not drop or otherwise cause undue impact to this device.
If the instrument is dropped or otherwise damaged, return it
to the manufacturer for repair and/or calibration. Do not use
the instrument if any damage is suspected.
Calibration of the instrument: The audiometer and the headphone complement each other
and share the same serial number (i.e. 7663252). Therefore, the instrument shall not be
used with any other headphone prior to recalibration. Recalibration also needs to be
conducted, when a defected headphone is replaced.
Uncalibrated instruments may lead to faulty measurements
and sometimes even damage the hearing of the examinee.
WARNING
WARNING

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2.4 Electrical Safety and Measuring Security
This icon indicates that patient applied parts of the instrument
conform to IEC 60601-1 Type B requirements.
The protection class of the system depends on the used
power supply.
In Case of Emergency
In case of emergency, disconnect the instrument from the
power supply.
Do not position the instrument in a way that it is difficult to
operate the disconnection device. The supply mains and the
power socket shall be accessible at all times.
Do not use the instrument if the mains cable and/or the outlet
is damaged.
Safety against electrical hazard is guaranteed only when the
connected notebook computer is powered by batteries
respectively the computer´s power supply accords to the
IEC 60601-1 or IEC 60950-1 safety regulations.
External devices such as computer, printer or Ethernet which
are connected to the device must meet electrical safety
requirements, such as IEC 60601-1 series for medical
electrical equipment or IEC 60950 for IT equipment. This is
to avoid electrical shock to the user or patient.
This complete system consisting of the MAICO device,
computer and isolation transformer, is suitable for use in the
patient environment. Equipment not complying with
IEC 60601 shall be kept outside the patient environment, as
defined in the standard (at least 1.5 m from the patient).
It is possible to use IEC 60601-1 certified USB and Ethernet
insulators which allows the electrically safe use of electrical
medical devices in medical electrical systems.
Any person who connects external equipment has created a
system and is therefore responsible for the system complying
with the requirements of IEC 60601-1-1. If in doubt, contact
your service technician or local representative for help.
The instrument is not intended for operation in areas with an
explosion hazard.
Never short-circuit the terminals.
WARNING
WARNING
WARNING

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To avoid the risk of electric shock, this equipment must only
be connected to the medical power supply originally delivered
by MAICO. Using another power supply can also lead to
electrical damage on the instrument.
In order to maintain a high level of safety and to ensure the
instrument works properly, it is necessary to have the
instrument and its power supply checked according to the
medical electrical safety standard IEC 60601-1 by a qualified
service technician at least once a year. For more information
please see Warranty chapter.
The use of non-calibrated devices can lead to incorrect test
results and is not advisable.
Prevent cable breakage: cables must not be bend or buckled.
Remove batteries both in the hand held unit and the cradle if
the instrument will not be used for some time.
2.5 Device Control
The user of the instrument should perform an objective instrument check once a week
according ISO 8253-1.
See chapter 4.3.1.11 Test cavitiesfor volume check.
2.6 Electromagnetic compatibility (EMC)
The instrument fulfills the relevant EMC requirements. Avoid
unnecessary exposure to electromagnetic fields, e.g. from
mobile phones etc. If the device is used adjacent to other
equipment it must be observed that no mutual disturbance
appears.
Please also refer to EMC consideration in section Technical
Data.
CAUTION
WARNING

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3 Impedance Measurements
3.1 Tympanometry
Tympanometry is the objective measurement of the tympanic membrane (TM) andmiddle
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.
Gradient calculations are reported as the Tympanogram width at half of peak compliance
expressed in daPa. A “limits” box is available on both the display and printout to aid in
diagnosis.
Compliance is measured with respect to an equivalent volume of air, with the scientific
quantity milliliter (ml) for 226 Hz and mmho for 1000 Hz. Air is measured in deca-Pascals
(daPa).
NOTE: 1.02 mmH2O = 1.0 daPa.
3.2 Acoustic Reflex
An acoustic reflex, or contraction of the intratympanic muscles, 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.
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 0.03 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).

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3.3 Contralateral Acoustic Reflex
A Contralateral Acoustic Reflex is available with the easyTymp Plus and Pro Version.
When the stimulus presentation and measurement are made in the different ears by
means of the Contra Probe.
3.4 Acoustic Reflex Decay
Acoustic reflex decay, also known as adaptation, is the measurement of the acoustic
reflex response during sustained stimulus presentation. Ipsilateral and contralateral reflex
decay can be performed.
3.5 Eustachian Tube Function Test
The Eustachian tube connects the middle ear with the nasopharynx. Its function is to
equalize pressure between the middle ear and the atmosphere.
The Eustachian tube test can be used to determine if the Eustachian tube is functioning
properly in patients with an intact tympanic membrane or in patients who have a
perforated TM or pressure equalization tubes.

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4 Getting Started
4.1 PC System Requirements
Processor: Intel Dual Core 1,8 GHz
Memory: 2 GB RAM
Graphic display: 1280 x 1024 (optimal), mind. 1024 x 768
Operating system: Windows 7, Windows 8.1, Professional or Ultimate Version for
32 und 64 Bit Computer
.NET-Framework 3.5
free USB port
Connection: USB 1.1 or higher
4.1.1 Supported Software
Measuring module: MAICO Impedance Software
Patient Management Software: MAICO Database, GDT (Germany), NOAH 3, NOAH 4
4.2 Unpacking and Inspection
Check the packaging and content for damage.
Prior to shipping, the easyTymp was carefully packed and inspected. However, it is good
practice to thoroughly inspect the outside of the shipping box for signs of damage. If any
damage is noted, please notify the carrier immediately.
Please remove the MAICO instrument from the shipping box by lifting the cardboard
package on the end flaps. Holding the package securely, fold the side flaps upwards to
loosen the tension in the plastic film. The instrument can now be easily removed from the
plastic packaging without the use of scissors or other sharp tools.
NOTE: Save all the original packaging material and the shipping container so the
instrument can be properly packed if it needs to be returned for service or calibration.
Notify the carrier immediately if any mechanical damage is noted. This will insure that a
proper claim is made. Save all packing material so the claim adjuster can inspect it as
well. Notify your dealer or MAICO when the adjuster has completed the inspection.
Please check that all accessories listed on the next page have been received in good
condition. If any accessories are missing or damaged, immediately notify your dealer or
MAICO.

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Standard Accessories:
(1) easyTymp Handheld Unit
(1) Probe
(1) Cradle Kit based on configuration
(1) Power supply unit for easyTymp handheld unit based on configuration
(1) DC USB adapter for easyTymp handheld unit based on configuration
(1) Rechargeable Battery
(1) Eartip box (configuration see below)
(1) Test Cavity
(1) Software Kit MAICO Impedance Software
(1) Operation Manual
(1) Quick Guide
(1) Carrying case
(1) Probe cleaning kit
Standard Configuration of Eartip Box:
(10) Eartip flanged 3-5 mm (red)
(10) Eartip mushroom 7 mm (blue)
(10) Eartip mushroom 9 mm (green)
(10) Eartip mushroom 11 mm (blue)
(10) Eartip mushroom 13 mm (green)
(5) Eartip mushroom 15 mm (blue)
(5) Eartip mushroom 19 mm (yellow)
(5) Eartip umbrella 15 mm (red)
(5) Eartip umbrella 19 mm (blue)
(2) Probe Tip (replacement)
(1) MAICO cleaning tool for probe tip
(1) MAICO eartip removal tool
(1) Allen key SW: s = 2 mm (See chapter 4.3.1.5 Adjust the cradle)

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Cradle Kit
(1) Cradle with or without printer
(1) USB cable
(1) Power supply
(1) Rechargeable battery
(1) Roll of paper (with printer cradle)
Optional Accessories for easyTymp:
-External Probe (35cm)
-Wall Mount Kit for cradle with integrated eartip box, power supply unit and
additional rechargeable battery
Additional Accessories for easyTymp Plus and Pro Version:
-Contra Probe (140 cm)
-CIR55 (Contralateral Earphone)
-EARtone 3A (Contralateral Earphone)
-DD45 (Contralateral Headset)
-Quick Guide (Pro or Plus Version)
Additional Licenses:
-License for high frequency probe tone of 1 kHz
-License for contra reflexes
-License for acoustic reflex decay and ETF
Consumable Material:
-Printer paper
-Replacement eartips
-Probe tip
-Cleaning floss

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4.3 System Installation
4.3.1 Hardware Installation
4.3.1.1 Installing the Cradle
Figure 1
1 = USB in;
2 = USB out;
3 = USB out;
4 = USB out
5 = Power;
6 = Follow the
instructions for use
Put the enclosed mains cable into the power connection socket #5 and the mains plug
into a power socket.
4.3.1.2 Cradle Indication Lights
Depending on the version (with or without printer) the cradle has up to three indication
lights (Figure 2).
Figure 2
easyTymp LED shows solid blue when it is placed
inside the cradle. The battery will be charged
automatically and will be fully charged after
approximately three hours. The current battery
state of charge may be seen on the easyTymp
display.
Battery LED shows solid blue when the spare
battery in the cradle is fully charged. The LED will
flash while the battery is charging.
Printer LED is red when a printer problem occurs.
4.3.1.3 Installing Paper in the Thermal Printer
Figure 3
Step 1 –Push button to open the printer cover (Figure 3).

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Figure 4
Step 2 –Pull the blue lever upwards (Figure 4).
Figure 5
Step 3 –Insert paper roll into the compartment with its
loose end to the front of the printer. Position the loose end
into the printer roll and raise it by rotating the printer roll
with your finger (Figure 5).
Figure 6
Step 4 –Push the blue lever down (Figure 6).
Figure 7
Step 5 –Close the printer cover (Figure 7).
4.3.1.4 Mounting the Cradle on the Wall (optional accessory)
Figure 8
In order to mount the cradle on the wall, an optional wall
mount kit is available (Figure 8).