Inventis PICCOLO User manual

PICCOLO
PORTABLE AUDIOMETER
USER MANUAL

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Read this manual thoroughly before using the device. Pay
particular attention to Chapter 1 (“Safety: warnings and
information”) and Chapter 3 (“Installation”).
Internal inspections and repairs must only be performed by
authorised personnel.
Copyright: Inventis srl has the copyright on this manual. It may not be
copied, reproduced or altered, in total or in any part, without the written
specific authorization from Inventis srl.
Inventis ® is a trademark of Inventis srl.
QuickSIN™ is copyrighted by Etymotic Research Inc. and licensed to
Inventis SRL, 2013.
Inventis srl
Corso Stati Uniti, 1/3
35127 Padova
Tel.: [phone]
Fax: [phone]
www.inventis.it
[e-mail]
Document title: AU1P-User Manual En
Revision: 15
Date: 2022.07.08

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Summary
Foreword..................................................................................................v
CHAPTER 1 Safety: warnings and information.....................................1
Operator manual................................................................................1
Operator responsibilities....................................................................1
Intended use........................................................................................2
Indication for use and end users.........................................................2
Precautions .........................................................................................2
Disposal...............................................................................................4
Conformity..........................................................................................4
Symbols on labels................................................................................5
CHAPTER 2 Introduction.......................................................................7
Main features......................................................................................7
Accessories..........................................................................................7
CHAPTER 3 Installation.........................................................................9
Precautions .........................................................................................9
Connections.........................................................................................9
Connection to computer/iPad...........................................................11
CHAPTER 4 Maintenance....................................................................13
Periodic checks .................................................................................13
Maintenance of transducers .............................................................14
Cleaning............................................................................................15
Replaceable parts..............................................................................15
Repairs and technical assistance ......................................................15
APPENDIX A Technical specifications.................................................17
APPENDIX B Troubleshooting.............................................................25
APPENDIX C Electromagnetic compatibility........................................27

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Foreword
Thank you for purchasing an Inventis audiology device.
Advantageously portable and lightweight, the Piccolo audiometer is a
powerful and versatile portable device, ideal for professionals on the move.
The Inventis company has always considered the use of its devices in
conjunction with computers to be a factor of key importance. Installing the
Maestro software suite, available with or without proprietary database or as
a Noah module, any Inventis audiology device can be connected to a
computer, and all examinations conducted then archived in the user's own
database.
Bear in mind also that Inventis has developed a complete line of audiology
devices: in addition to audiometers, the company's product line includes a
range of middle ear analyzers, REM and HIT hearing aid fitting devices, a
wireless video otoscope and much more.
For further information, and to report any problems of any kind, contact the
company at:
Inventis srl
Corso Stati Uniti, 1/3
35127 Padua Italy
Tel.: [phone] –Fax: [phone]
www.inventis.it [e-mail]

1
CHAPTER 1
Safety: warnings and
information
OPERATOR MANUAL
We recommend that you read this manual thoroughly to obtain maximum
efficiency and safety from your audiometer. It is particularly important that
you read this chapter in its entirety. It contains essential warnings and
important information on the safe and correct use of the instrument.
In this manual, the safety symbol shown below draws your attention to
information that is particularly important for safe and correct use.
OPERATOR RESPONSIBILITIES
The audiometer is guaranteed to work efficiently and reliably only if used
according to the instructions and procedures given in this manual.
If the instrument ever develops a malfunction or requires repair, disconnect
it from the electrical power supply and do not use it again until the necessary
repairs and servicing have been completed. Defective and malfunctioning
parts must only be replaced with original spare parts supplied by Inventis srl.
All repairs must be performed exclusively by Inventis or by personnel
authorised by Inventis.
No part of the instrument may be modified or replaced without the prior
written authorisation of Inventis.
Users are entirely responsible for any malfunctions caused by improper use,
or by maintenance or repairs performed by any party other than Inventis srl
or an authorised Service Centre. Inventis srl and its Service Centres accept
responsibility for the performance and reliability of the instrument only if:
1. all connections, adjustments, modifications and repairs are
performed exclusively by personnel authorised by Inventis;

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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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Use only original accessories supplied by Inventis srl, unless
specifically instructed otherwise.
Only use power adapters intended for medical equipment,
certified to IEC 60601-1. For further information, see
“APPENDIX A: Technical Specifications”.
The Piccolo audiometer is a medical device. Any other external
device to which it is connected (such as a computer or CD player)
within the “patient area” (as defined in IEC 60601-1) must also
be a medical device, or must be protected by an isolating
transformer in order to ensure that the complete combination
(computer or external device + audiometer) complies with IEC
standard 60601-1.
Piccolo needs special precautions regarding EMC and needs to
be installed and put into service according to the EMC
information provided in Appendix C.
Use of portable and mobile RF communications equipment can
affect the correct operation of Piccolo device. Make reference to
the EMC information in the Appendix C.
Calibration
The calibration of the audiometer is valid only for the transducers
supplied with the device. If a transducer is replaced, the
audiometer must be recalibrated.
The calibration of the audiometer is valid for the transducers
supplied with the audiometer only if these are connected directly
to the instrument without extension leads or other devices
between their connectors and the instrument (as habitually
occurs in soundproofed booth installations). If transducers are
not connected directly to the audiometer, the instrument must be
recalibrated before use.
Take note of the audiometer’s specified calibration interval. Use
of the instrument beyond its calibration expiry date can lead to
unreliable diagnoses.
In each test window, when you select a not-calibrated transducer,
the background of the ‘output’ area will be displayed in red color.
Moreover, you will not be able to send any stimulus through not-
calibrated transducers.

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Hygiene
The eartips of insert earphones are disposable. Do not use the
same eartip for different patients. Dispose of eartips after use.
Disinfect the cushions of headphones between one patient and the
next, following the procedure described in CHAPTER 4
“Maintenance”.
Use
The audiometer can generate tones at an intensity potentially
damaging to the patient. Take particular care to adjust the
intensity of the tone correctly before examinations.
DISPOSAL
Like all electronic devices, the Piccolo audiometer contains extremely small
quantities of certain hazardous substances such as cadmium or mercury. If
such substances are allowed to enter the normal waste disposal cycle without
suitable preliminary treatment, they can cause damage to the environment
and to health. All parts of the audiometer must therefore be disposed of
separately.
At the end of its life, dispose of the disused instrument through a civic waste
disposal and recycling facility, or return it to the reseller against the purchase
of an equivalent new instrument.
Separate waste collection and the subsequent operations of treatment,
recycling and disposal facilitate the manufacture of new devices from
recycled materials, limiting any negative impact on the environment and
public health that might otherwise derive from improper disposal.
CONFORMITY
The Piccolo audiometer is a class IIa medical device according to Annex IX
of the Medical Device Directive (MDD) 93/42/EEC as amended by directive
2007/47/EC.
Inventis Quality Management System is ISO 13485 certified.