-
the electrical system and earthing of the installation are in compliance
with the specifications of standards for electro-medical appliances.
1.3
I
NTENDED USE
The Timpani tympanometer is a medical device intended to measure the
biomechanical characteristics of the patient's middle ear to aid the operator to
evaluate its functional conditions for screening purposes.
Timpani is also a pure tone audiometer: by generating and delivering to the
patient sound stimuli of different types and intensities, it helps the operator to
evaluate the patient's auditory sensitivity for screening purposes.
1.4
I
NDICATIONS FOR USE AND END USERS
Timpani is intended for use by healthcare ENT professionals in hospitals, ENT
clinics and audiology clinics as an instrument for auditory screening programs
and as an aid to the diagnosis of possible hearing 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.
1.5
M
AIN FEATURES
The Timpani is a portable device that can be used to conduct middle ear screening
tests simply, swiftly and accurately. Available with a range of optional licenses,
the device is able to meet the needs of private medical practices, clinics and
hospitals alike.
The device features:
-
backlit color display with touchscreen interface, allowing graphic
illustration of test results;
-
compact and ergonomic design, lightweight construction;
-
long endurance, with built-in rechargeable lithium battery;
-
interaction with computer using Maestro software.
Depending on the licenses activated, the main functionalities available are:
-
226 Hz tympanometry test;
-
1000 Hz tympanometry test (with 1 kHz Probe Tone license);
-
ipsilateral acoustic reflex test with 226 Hz probe tone and stimuli:
2