Inventis FLUTE & VIOLA Guia De Inicio Rapido página 19

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I
NTENDED USE
Flute and Viola middle ear analyzers are medical devices intended to
measure biomechanical characteristics of the patient's middle ear to aid the
operator to evaluate its functional condition for diagnostic purposes.
Viola is also an audiometer. An audiometer is a device that helps the
operator in defining the patient's auditory sensitivity by generating and
delivering to the patient sound stimuli of different types and intensities for
diagnostic purposes.
I
NDICATION FOR USE AND END USERS
Flute and Viola are intended for use by healthcare ENT professionals in
hospitals, ENT clinics and audiology offices in conducting hearing
evaluations and assisting in diagnosis of possible otologic disorders. There
is no patient population restriction in the use of the device; always be sure
to perform an otoscopy before using the device.
These tests – especially the audiometric tests – must be conducted in a quiet
environment to avoid artifacts and to ensure that errors are not committed
when determining the hearing threshold.
P
RECAUTIONS
Users are entirely responsible for any malfunction caused by
improper use, or by maintenance or repair operations performed
by any party other than Inventis srl or an authorized Service
Centre.
Installation
If the middle ear analyser is connected to other devices, making up
an electromedical system, the resulting system must comply with
IEC standard 60601-1.
Avoid installing and using Flute & Viola instruments close to any
sources of strong electromagnetic fields: these could interfere with
the operation of the device.
Calibration
The calibration is valid only for the transducers supplied with the
device. If a transducer is replaced, the audiometer must be
recalibrated.
Use
Be sure to set a suitable intensity of stimulus before presenting it
to the patient.
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UIDE NGLISH