1 Introduction
Thank you for purchasing a quality product from MAICO Diagnostics. The
Audiometer MA 41 is manufactured to meet all quality and safety
requirements, and has been certified with the CE-symbol according to Medical
Directive 93/42/EEC.
In designing the MA 41 we placed particular importance on making it a user-
friendly device, meaning its operation is simple and easy to understand. All
functions of the MA 41 are software controlled, allowing for easy upgrades of
new features and functions in the future.
The user manual should make it as easy as possible for you to become familiar
with the functions of the MA 41.
If you have questions or ideas for further improvements, please contact us.
Your MAICO Team
1.1 Indications for Use Statement
The MA 41 is a portable two-channel air, bone, and speech audiometer. This
audiometer is used to screen, test, and diagnose hearing loss
1.2 Intended Use Statement
The MA 41 is a portable or standalone audiometer 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. 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 ISO 8253-1 or equivalent.
1.3 Essential Performance
The following is considered essential performance:
To generate and present stimulus signals in the audio range as specified
in the applicable IEC 60645 series in normal condition
Record and store a patient response
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