Maico MI 24 User manual

Operation Manual
touchTymp
MI 24 and MI 34 Version

Operation Manual touchTymp MI 24 and MI 34 Version
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Table of Contents
1 Introduction............................................................................................................ 4
1.1 General.............................................................................................................. 4
1.2 Intended Use Statement .................................................................................... 4
1.3 Contraindications of Use.................................................................................... 4
1.4 Essential Performance....................................................................................... 5
1.5 Features and Benefits of the touchTymp ........................................................... 5
1.6 Description......................................................................................................... 6
2 For Your Safety...................................................................................................... 8
2.1 How to Read this Operation Manual .................................................................. 8
2.2 Customer Responsibility .................................................................................... 9
2.3 Manufacturer’s Liability ...................................................................................... 9
2.4 Regulatory Symbols..........................................................................................10
2.5 General Precautions .........................................................................................11
2.6 Electrical Safety and Measuring Security..........................................................11
2.7 Device Control ..................................................................................................13
2.8 Electromagnetic Compatibility (EMC)................................................................13
3 Warranty, Maintenance and After-Sales Service .............................................. 14
3.1 Warranty ...........................................................................................................14
3.2 Maintenance .....................................................................................................14
3.3 Cleaning and Disinfection Recommendations...................................................14
3.4 Disposables ......................................................................................................17
3.5 Components/Replacement Parts ......................................................................18
3.6 Troubleshooting ................................................................................................18
3.7 Recycling and Disposal.....................................................................................19
4 Unpacking and Installation................................................................................. 20
4.1 Unpacking the System......................................................................................20
4.2 Hardware and Accessories...............................................................................22
5 Operating the Device........................................................................................... 29
5.1 Getting Started with the touchTymp..................................................................29
5.2 Power-Saving Mode and Automatic Power-Off.................................................30
5.3 The Home Screen.............................................................................................31
5.4 Immittance Testing............................................................................................31
5.6 Settings.............................................................................................................48
6 Technical Data ..................................................................................................... 59
6.1 touchTymp Hardware........................................................................................59
6.2 Connections......................................................................................................63
6.3 Pin Assignment.................................................................................................64
6.4 Calibration Values.............................................................................................65
6.5 Electromagnetic Compatibility (EMC)................................................................66
6.6 Electrical Safety, EMC and Associated Standards............................................68
Appendix A Literature............................................................................................ 69

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Title: Operation Manual touchTymp –MI 24 and MI 34 Version
Date of issue/last revision: 03/09/2018
Copyright © 2018 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 Diagnostics. The
information in this publication is proprietary to MAICO Diagnostics.
Compliance
MAICO Diagnostics GmbH 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.
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

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1 Introduction
This section offers you important information about:
the intended use of the device
indications and contraindications of use
essential performance
features and benefits
a description of the device
1.1 General
Thank you for purchasing a quality product from the MAICO product family.
The touchTymp is designed and manufactured to meet all quality and safety
requirements. When designing the touchTymp, 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 operation manual is for the touchTymp MI 24 and MI 34 versions. If sections or
parts of sections of this operation manual apply only to certain versions of the device,
they are marked with "MI 24" or "MI 34 ". This operation manual is meant to make it as
easy as possible for the operator to become familiar with the operation and functions
of the touchTymp when performing Immittance tests. If you have questions or
suggestions for further improvements, please, do not hesitate to contact MAICO.
1.2 Intended Use Statement
The touchTymp Tympanometer is used to obtain information on medical conditions
affecting the middle ear and to assess hearing.
Indications of Use Statement
The touchTymp Tympanometer is an electroacoustic test instrument that produces
controlled levels of test tones and signals intended for use in conducting screening or
diagnostic middle ear function or hearing evaluations. It features Tympanometry and
Acoustic Reflex to assist in the diagnosis of possible otologic disorders.
The touchTymp Tympanometer is intended to be used by an audiologist, ENT, hearing
healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility
or other suitable quiet environment as defined in ANSI S3.1 / ISO 8253-1or equivalent.
1.3 Contraindications of Use
Tympanometry and Acoustical Reflex 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)

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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.
1.4 Essential Performance
There is no essential performance as defined in IEC 60601-1.
1.5 Features and Benefits of the touchTymp
1.5.1 General Information About the touchTymp
The touchTymp is available as a version with or without a printer. The touchTymp gives
you the benefit of:
Full touchscreen operation
Screening Immittance test battery –MI 24 version (i.e. Tympanometry, Acoustic
Reflex Tests)
Diagnostic Immittance test battery –MI 34 version (i.e. Tympanometry, Acoustic
Reflex, Reflex Decay, Eustachian Tube Function)
Optional high frequency probe tone
Optional RaceCar animation
Multiple transducer options for contralateral reflex testing
Automatic test function in Immittance modules
Included test cavities for quick and easy calibration verification
Print directly from device with built-in printer
Automatic printing cability with placement of probe in holder
1.5.2 Licenses
The touchTymp comes with some optional measurements which can be activated by
entering a license key. In the settings (see section 5.6.16) this key can be added.
The following functions are available:
Tympanometry 1000 Hz (all versions)
Acoustic Reflexes Contra (MI 24 version only, included in MI 34 version)
RaceCar (all versions)
It might appear that the touchTymp already contains licenses due to the version you
ordered (e.g. if ordered touchTymp MI 24 version comes with a probe tone of 1000 Hz
for Tympanometry and Acoustic Reflexes).
NOTE: Each license key is specific for the serial number of your device.
In case you want to purchase another license, please, contact MAICO or your local
distributor to determine eligibility.

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1.5.3 Printing Options
Printing test results from the touchTymp are accomplished in a variety of ways:
Use the build-in printer to directly print results.
TransfertouchTymp testdataintothePC-softwareandprintresultsonyourPC-printer.
1.6 Description
1.6.1 General
The touchTymp is designed for Immittance testing as Tympanometry and Acoustic
Reflex (i.e. Ipsilateral and Contralateral) testing ( and MI 34 version).
MI 34 version also includes Reflex Decay and Eustachian Tube Function (ETF) tests.
The functions are described in detail in the following sections.
1.6.2 Tympanometry
Tympanometry is 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 mmho ≙1 ml for 226 Hz probe tone
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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1.6.3 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 (NR), 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.
1.6.4 Acoustic Reflex Decay (MI 34 Version Only)
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.
1.6.5 Eustachian Tube Dysfunction (ETF) (MI 34 Version Only)
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.
ETF Intact: performed on patients with normal tympanic membrane (TM).
ETF Perforated: determines if the patient can open his/her Eustachian tube when
the TM is perforated or an open PE-tube is in place.

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2 For Your Safety
This section offers you important information about:
how to read the operation manual
where to spend special attention
the customer responsibility
the explanation of all regulatory symbols used
important cautions and warnings that have to be considered during
the whole time handling and operating your device
2.1 How to Read this Operation Manual
This Operation Manual contains information pertinent to the use of the MAICO device
system including safety information as well as maintenance and cleaning
recommendations.
READ THIS ENTIRE OPERATION MANUAL BEFORE
ATTEMPTING TO USE THIS SYSTEM!
Use this device only as described in this manual.
All images and screenshots are only examples and may differ in
appearance from the actual device settings.
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 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 device, the more stringent rules should take precedence.
This product and its components will perform 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).
NOTE: In the unlikely case of a serious incident, inform MAICO as well as your local
distributor.
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