2. the installation’s electrical power supply and ground connections
comply with the applicable standards for electro-medical devices.
INTENDED USE
Piccolo medical device is 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.
INDICATION FOR USE AND END USERS
Piccolo is 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 must be conducted in a quiet environment to avoid artifacts and
to ensure that errors are not committed when determining the hearing
threshold.
PRECAUTIONS
To ensure correct and safe use of the audiometer, the following precautions
must be observed.
Installation and general precautions
Make sure that the required ambient conditions are met during
transport, storage and operation. See “APPENDIX A: Technical
Specifications”.
The Piccolo audiometer will not be protected if exposed during
use to flammable anaesthetic gases or similar products during
use. Risk of explosion.
Avoid installing and using the Piccolo audiometer close to
sources of strong electromagnetic fields, since this could interfere
with the operation of the device.
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