Maico easyTymp User manual

Operation Manual
easyTymp

Operation Manual easyTymp
8108757 Rev. 3.0
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15/11/2016
Contents
1 Introduction .............................................................................................................2
1.1 General ............................................................................................................2
1.2 Intended Use....................................................................................................2
1.3 Indications for Use............................................................................................2
1.4 Contraindications of Use ..................................................................................2
1.5 Essential Performance.......................................................................................3
1.6 Features and Benefits of the easyTymp .............................................................3
1.7 Description.......................................................................................................4
2 For your Safety .........................................................................................................6
2.1 How to read this Operation Manual..................................................................6
2.2 Customer Responsibility....................................................................................7
2.3 Manufacturer’s Liability ....................................................................................7
2.4 Regulatory Symbols ..........................................................................................8
2.5 General Precautions..........................................................................................9
2.6 Electrical Safety and Measuring Security............................................................9
2.7 Device Control ...............................................................................................11
2.8 Electromagnetic Compatibility (EMC) ..............................................................11
3 Warranty, Maintenance and After-Sales Service ......................................................12
3.1 Warranty........................................................................................................12
3.2 Maintenance ..................................................................................................12
3.3 Cleaning and Disinfection Recommendations..................................................13
3.4 Troubleshooting .............................................................................................17
3.5 Recycling and Disposal....................................................................................19
4 Unpacking and Installation......................................................................................20
4.1 Unpacking the system ....................................................................................20
4.2 System Installation..........................................................................................22
4.3 Software ........................................................................................................28
5 Operating the Device ..............................................................................................29
5.1 Preparing for Testing ......................................................................................29
5.2 Operating Panel .............................................................................................32
5.3 Start the Test..................................................................................................32
5.4 Probe Status Indication ...................................................................................32
5.5 Testing ...........................................................................................................33
5.6 Managing Test Results....................................................................................44
6 Technical Specifications ..........................................................................................46
6.1 Classification according EEC ...........................................................................46
6.2 Technical Data................................................................................................46
6.3 Connections and Pin Assignment....................................................................50
6.4 Reference values for stimulus calibration.........................................................51
6.5 Electromagnetic Compatibility ........................................................................52
6.6 Electrical Safety, EMC and Associated Standards.............................................55
6.7 Test Protocols.................................................................................................56
7 Appendix................................................................................................................58

Operation Manual easyTymp
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15/11/2016
Title: easyTymp –Operation Manual
Date of issue/last revision: 15/11/2016
MAICO Diagnostics
10393 West 70th Street
Eden Prairie, MN 55344
USA
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
Internet: www.maico-diagnostics.com
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.
Caution for USA: Federal Law restricts this device to sale by or on the order of a licensed
medical professional.

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1 Introduction
1.1 General
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, MAICO 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 Impedance
tests. If you have questions or suggestions for further improvements, please, do not
hesitate to contact MAICO.
This operation manual provides instruction about different versions of the easyTymp.
Please, confirm your version for relevant sections to your purchased device.
1.2 Intended Use
The tympanometer is used to obtain information on medical conditions affecting the
middle ear and to assess hearing.
1.3 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.
1.4 Contraindications of Use
Testing should not be performed on patients with one of the following symptoms without
a medical doctor’s approval:
Recent stapedectomy or other middle ear surgery
Discharging ear
Acute external auditory canal trauma
Discomfort (e.g. severe otitis externa)
Occlusion of the external auditory canal
Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may
contraindicate testing when high intensity stimuli are used
Visual inspection for obvious structural abnormalities of the external ear structure and
positioning as well as the external ear canal should be performed before testing.

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1.5 Essential Performance
The following is considered essential performance:
To generate and present stimulus signals in the audio and pressure ranges as specified
in the applicable IEC 60645/ANSI S3.39 series in normal condition.
It is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other
trained technicians in a hospital, clinic, healthcare facility or other suitable quiet
environment as defined in standard ISO 8253-1.
The easyTymp can be used on patients in the age range of infants, children and adults.
1.6 Features and Benefits of the easyTymp
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 dependent on the country
and service partner. Each version provides specific testing functionalities dependent upon
the user needs.
easyTymp (as Standard Version)
Rapid Tympanometry measurement
Ipsilateral Acoustic Reflexes at several frequencies
1 kHz probe tone (option)
easyTymp Pro Version (Contra probe required)
Rapid Tympanometrymeasurement
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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1.7 Description
1.7.1 General
Dependent on the configuration the easyTymp offers the following Impedance
measurements:
Tympanometry
Acoustic Reflex
Contralateral Acoustic Reflex
Acoustic Reflex Decay
Eustachian Tube Function Test
Further information on the different tests are given in sections 1.7.2 to 1.7.6.
1.7.2 Tympanometry
Tympanometryis the objective measurement of middle ear mobility (compliance
1
) and
pressure
2
within the middle ear system (Figure 1). 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 (i.e. +200 daPa) to a negative value
(i.e. -400 daPa max).
Figure 1
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 normative box is
available on both the display and printout to aid in diagnosis.
NOTE: 1.02 mmH2O = 1.0 daPa.
1
Compliance is measured with respect to an equivalent volume of air, with the scientific quantity milliliter (ml).
2
Air pressure is measured in deca-Pascals (daPa).

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1.7.3 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 is made in the opposite ear of where the measurement is made,
this acoustical reflex is referred to as a Contralateral Acoustic Reflex.
For best results, this reflex measurement is automatically conducted at the air pressure
value where the compliance peak occurred during the Tympanometric test. Stimulus
tones of varying intensities at 500 Hz, 1000 Hz, 2000 Hz or 4000 Hz are presented as
short bursts. If a change in compliance greater than the selected value is detected, a
reflex is considered present. Because this is an extremely small compliance change, any
movement of the probe during the test may produce an artifact (false response). The test
result is recorded as Pass/No Response, and in graphical form.
If the Tympanometric results display any abnormal findings, the results of the Acoustic
Reflex testing may be inconclusive and should be interpreted with care. Theoretically, a
compliance peak is necessary to observe a reflex at peak pressure.
1.7.4 Contralateral Acoustic Reflex
A Contralateral Acoustic Reflex is available with the easyTymp Pro Version. When the
stimulus presentation and measurement are made in the different ears by means of the
Contra Probe.
1.7.5 Acoustic Reflex Decay
An Acoustic Reflex Decay is available with the easyTymp Pro. 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.
1.7.6 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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2 For your Safety
2.1 How to read this Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO easyTymp
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 ofpossible confusion and avoid potential problems
during system operation.
WARNING
CAUTION

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2.2 Customer Responsibility
All safety precautions given in this operation manual must be observed at all times.
Failure to observe these precautions could result in damage to the equipment and injury
to the operator or subject.
The employer should instruct each employee in the recognition and avoidance of unsafe
conditions and the regulations applicable to his or her work environment to control or
eliminate any hazards or other exposure to illness or injury.
It is understood that safety rules within individual organizations vary. If a conflict exists
between the material contained in this manual and the rules of the organization using this
instrument, the more stringent rules should take precedence.
This product and its components willperform reliably only when
operated and maintained in accordance with the instructions
contained in this manual, accompanying labels, and/or inserts.
A defective product should not be used. Make sure all
connections to external accessories are snug and secured
properly. Parts which may be broken or missing or are visibly
worn, distorted, or contaminated should be replaced
immediately with clean, genuine replacement parts
manufactured by or available from MAICO.
NOTE: Customer responsibility includes proper maintenance and cleaning of the device
(see sections 3.2 and 3.3). Breach of the customer responsibility can lead to limitations
of Manufacturer’s Liability and Warranty (see sections 2.3 and 3.1).
2.3 Manufacturer’s Liability
Usage of the device in a way deviant from the intended use will lead to a limitation or
termination of the manufacturer’s liability in case of damage. Improper use includes
disregarding the operation manual, the operation of the device by underqualified
personnel as well as making unauthorized alterations on the device.
WARNING