Operation Manual MA 25/MA 25e
MA 27/MA 27e
8104818 Rev. 4
3
19/10/2017
1 Introduction
This section offers you important information about:
the intended use of the device
indications and contraindications of use
features and benefits
a description of the device
1.1 General
Thank you for selecting one of our quality products from the MAICO family range. The
MA 25/MA 25e and MA 27/MA 27e are designed and manufactured to meet all quality
and safety requirements, and has been certified with the CE-Marking according to
Medical Device
Directive” (Directive 93/68/EEC).
Particular attention has been taken during the designing phase of the MA 25/MA 25e
and MA 27/MA 27e to ensure its user-friendliness, meaning that its operation is simple,
easy to learn and to understand. As all the functions are software-controlled, upgrading
the software and/or adding additional functions at a later date will be simple and cost-
effective. By purchasing the MAICO MA 25/MA 25e and MA 27/MA 27e, you have
made a decision towards long-term investment.
This operation manual aims to make learning and understanding the different MAICO
MA 25/MA 25e and MA 27/MA 27e functions as quick and as easy as possible. Should
you encounter any problems or have ideas for any further improvements, we are only
a phone call away. Please, do not hesitate to contact us.
Your MAICO-Team
1.2 Intended Use Statement
Screening audiometers are designed for determine hearing thresholds levels. The
instrument is intended for all patient populations over 3 years age and able to respond
to test signal in a rational way.
Audiometers are intended to be used by an audiologist, hearing healthcare
professional, or trained technician.
1.3 Indications for Use Statement
The MA 25/MA 25e/MA 27/MA 27e 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 used as part of
a total test battery to determine hearing acuity 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 ANSI S3.1 or equivalent.
1.4 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
