Operation Manual touchTymp MI 26 and MI 36 Version
8511780 Rev. 4
4
30/06/2021
1 Introduction
This section offers you important information about:
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the intended use of the device
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indications and contraindications of use
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essential performance
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features and benefits
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a description of the device
1.1 General
This operation manual is for the touchTymp MI 26 and MI 36 versions. If sections or
parts of sections of this operation manual apply only to certain versions of the device,
they are marked with "MI 26" or "MI 36 ". 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.
The touchTymp Tympanometer with Audiometry intended to be used for the
identification of hearing loss and the factors that contribute to the occurrence of the
hearing loss in the age range of children to adults. Output and specificity of this type
of device are based on the test characteristics defined by the user, and may vary
depending on environmental and operating conditions. Testing for hearing loss using
this type of audiometer requires interaction with the patient.
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, Acoustic
Reflex and Audiometry 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 8253-1 or equivalent.
Summary of Contents for touchTymp MI 26
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