Operation Manual MB 11 BERAphone
®
/Classic
8100496 Rev. 6
3
23/10/2019
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
General
Thank you for purchasing a quality product from the MAICO product family.
The MB 11 is designed and manufactured to meet all quality and safety requirements. When
designing the MB 11, 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 MB 11 BERAphone
®
and Classic versions. If sections or
parts of sections of this operation manual apply only to certain versions of the device,
they are marked with the version names.
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
MB 11 when performing
automated ABR tests. If you have questions or suggestions for further improvements,
please do not hesitate to contact MAICO.
Intended Use Statement
The MAICO MB 11 BERAphone
®
and MB 11 Classic are intended for use in the
audiologic evaluation and documentation of ear and nerve disorders using auditory
evoked potentials from the auditory nerve and the brainstem.
The devices are intended to be used for Newborn Hearing Screening (NHS) using
automated auditory brainstem response tests. The aim is to detect those babies with
possible auditory or hearing-related deficits and to refer them on for further testing to
confirm or rule out a disorder.
Target population
The MB 11 Classic is intended to be used for hearing screening of newborns and infants up
to 6 months.
The MB 11 BERAphone
®
includes components that are optimized in size and shape
for newborns up to approximately 3 months of age. Older infants with larger ears may
be difficult to test with the BERAphone
®
. The key to an acceptable fit is to achieve
contact of the ear cushion all around its edge with no gaps between the skin and the
cushion. Any gaps can lead to a reduction in the stimulus intensity, increasing test time
and the chance of a Refer outcome.
Summary of Contents for MB 11 BERAphone
Page 1: ...Operation Manual MB 11 BERAphone Classic ...
Page 2: ......
