Safety; Intended Use; Directions For Use - Sibelmed SIBELSOUND DUO Manual De Uso

SIBELSOUND

1. SAFETY

DUO
is a 'screening' audiometer which allows users to perform audiometric explorations in a fast, simple, and reliable
SIBELSOUND
manner, for determining hearing thresholds both through air and bone conduction, and without masking.
The SIBELSOUND DUO audiometer has been designed to offer maximum security. Please, read all the instructions for use before
using the equipment. Otherwise, this may result in user or patient injuries, or damage to the equipment and/or accessories.
For further technical information, or information about the product, please contact SIBEL, S.A.U. or your regular supplier.

1.1. INTENDED USE

DUO
The SIBELSOUND audiometer is a desktop unit designed to diagnose and follow-up patients with hearing loss (hypoacusis) caused
by noise, disease or trauma, by generating sound and vibration stimuli.
The following considerations must be noted.
• For the exclusive use of health professionals, supervised and/or trained by a doctor.
• For use in a health center or similar (unfit for outdoor use)
• Not intended for use in moving transport vehicles

1.2. DIRECTIONS FOR USE

Continuous exposure to high-level sounds, sound-intensity peaks, traumatic injuries, or some diseases may deteriorate the hearing
function or cause hypoacusis. The
performing tonal tests, both through air and bone conduction (with and without masking, with narrow-band white noise). Optionally,
automatic tests can be performed, based on the Hughson-Westlake protocol.
DUO
SIBELSOUND is a desktop unit powered by 4 AA batteries or by an external power supply, and it includes air conduction headphones,
a bone vibrator and a response button for the patient. The unit can connect to a PC and be used together with the W50 audiometry
software in order to conduct real-time tests or to download data. Optionally, it can connect to a network via Ethernet, to allow for
its integration into the Clinical Information System by exporting result files in standard formats (PDF, XML, CSV).
The audiometer is not designed for other conditions of use, nor for power sources other than those specified in this manual.
520-800-MUM · Rev 1.01
DUO
· User's manual
DUO
audiometer is an electromedical device designed to diagnose hearing loss by
SIBELSOUND
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