Introduction; General; Intended Use Statement; Indications For Use Statement - Maico MA 41 Operation Manual

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


General

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 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

Intended Use Statement

The MA 41 is a portable or stand-alone 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 ANSI S3.1 / ISO 8253-1 or equivalent.

Indications for Use Statement

The MA 41 is a portable one and half channel air, bone, and speech audiometer. This
audiometer is used to screen, test, and diagnose hearing loss.

Contraindications of Use Statement

The patient is too young, sick or uncooperative to perform the tasks.
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Operation Manual MA 41
4 24/04/2017