User's Manual

The user of the device assumes full responsibility for any malfunction

resulting from improper use or operation, likewise from maintenance or

repair work performed by third parties other than Inventis s.r.l. or Service

Centres approved by Inventis. Inventis s.r.l. and approved Service Centres

will answer for the performance and reliability of the equipment only if:

1. adjustments, modifications or repairs have been entrusted to

persons authorized by Inventis;

2. the electrical system and earthing of the installation are in

compliance with the specifications of standards for electro-medical

appliances.

1.3 INTENDED USE OF THE DEVICE

Trumpet is a real ear measurement system. A real ear measurement system

allows the determination of the intensity of sounds reaching the tympanic

membrane of the patient. To this end it uses a couple of microphones, one

located at the level of the patient’s earlobe (the reference microphone), and

one inserted in the patient ear canal through a silicon tube (the probe

microphone). The operator, using the system, delivers to the patient sound

stimuli different in intensity and in frequency content, and measures the

intensity of the sound received by the two microphones. A real ear

measurement system is generally used to quantify the gain provided by a

hearing aid, when this is worn by the patient.

Trumpet can be 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.

1.4 INDICATION FOR USE AND END USERS OF THE

DEVICE

Trumpet is intended for use by healthcare ENT professionals in hospitals,

ENT clinics and audiology offices or by hearing care professionals in

conducting hearing evaluations, in assisting in diagnosis of possible

otologic disorders, and in performing the verification of fitting of a hearing

aid.

There is no patient population restriction in the use of the device; always be

sure to perform an otoscopy before using the device.