Operation Manual
touchTymp MI 24
and
MI 34
Version
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 8253-1 or 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)