Safety; Intended Use; Indications For Use - Sibelmed S-PREMIUM Manual Del Usuario

EN 4
S-PREMIUM User's manual

1. SAFETY

The S-PREMIUM booth has been designed and manufactured according the
Quality manual of SIBEL S.A.U., which agrees with the quality norms of
EN 13485 e ISO 9001 and European Medical Device Directive 93/42/EEC.
According to this directive, this is a Class I product.
The materials and finishing of the booth are made with the highest quality and
has been tested by SounLab laboratories.
S-PREMIUM has been designed to guarantee the maximum safety. The
instruction for use must be read before its use. Failure to do so may result in
injuries to the user or patient and damage to the product and/or accessories.
However, accidents may occur in the transport or storage, so it is recommended
an initial check up of the booth and its accessories before the installation.

1.1. INTENDED USE

Test booth for the attenuation of external ambient noise intended for
audiometric tests aiming at the detection, diagnosis, monitoring or treatment
of hearing loss. It is intended to be used in combination with an audiometer.
Not intended for outdoor use.

1.2. INDICATIONS FOR USE

The audiometric test booth SIBELMED S-PREMIUM is an individual chamber
that attenuates the sound waves. This attenuation characteristics allows
making audiometric tests according to standards ANSI S3.1 and ISO 8553-
1. These standards specify that the audiometric tests must be performed in
conditions where the external noise does not mask the results.
The booth can be used by patients older than 3 years old that are able to
follow the instructions of the medical staff and have an appropriate mental
state that allows being closed in a reduced enclosure during the test. The
booth can be used by people in wheelchair with the optional ramp.
The medical staff must have the training in audiometric tests, know the
functioning of the booth before its use and instruct the patient about the use
of the booth.
501-900-MUM · Rev 1.01