Inventis PICCOLO User manual

PICCOLO
PORTABLE AUDIOMETER
USER MANUAL

iii
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

iv
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

v
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;

2
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.

3
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.

4
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.

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SYMBOLS ON LABELS
Name and address of the manufacturer.
Caution: specific warnings or precautions are associated with this device;
consult the accompanying documentation for safe use.
This symbol means this product is covered by the Directive 2012/19/EU on
waste electrical and electronic equipment (WEEE). It is required not to
dispose this product as unsorted municipal waste, but to collect it
separately.
Refer to instruction manual for use
Device with applied parts of type B (IEC 60601-1).
The Aero version of the device emits radiofrequency signals.
DC power supply
Product conforms to European Community Medical Device Directive
(MMD) 93/42/EEC, as amended by directive 2007/47/EC. Class IIadevice;
number of notified body: 0123 (TÜV SÜD Product Service GmbH).
Medical Device
Rx only
Caution: Federal law restricts this device to sale by or on the order of a
licensed healthcare practitioner.
IP20
IP (Ingress Protection) Code: this device is protected against the ingress of
objects sized > 12.5 mm; it is not protected against liquids.
REF
Catalogue number
Serial number of the device. This number is made up of 13 alphanumeric
characters indicating the model, year of manufacture and serial number. In
particular, the number comprises these segments:
-first 5 characters: Inventis product code
-characters 6 and 7: year of manufacture (e.g. “12” stands for 2012)
-characters 8… 13: incremental number
SN

6
UDI code

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CHAPTER 2
Introduction
This chapter describes the main features of the Inventis Piccolo audiometer,
and in particular, explains the differences between the model Basic, Plus and
Speech.
MAIN FEATURES
The Piccolo audiometer is a portable unit that can be controlled from a
computer or iPad. If connected to a computer, it can be controlled from
Maestro, the medical record manager software application developed by
Inventis able to interface also with Noah database. If connected to an iPad, a
dedicated App, available from the Apple App store, must be installed.
The Piccolo audiometer is available in 3 different versions:
-Basic: for pure tone audiometry via air conduction
-Plus: for pure tone audiometry via air conduction and bone conduction
-Speech: for pure tone audiometry, speech audiometry, Master Hearing
Aid test and, optionally, the QuickSIN™ test
All models are available with the Aero option, which allows the audiometer
to be controlled from an iPad.
ACCESSORIES
The following table lists the various accessories either supplied with or
obtainable on order for the Piccolo Basic, Plus and Speech audiometers.
Part
Piccolo
Basic
Piccolo
Plus
Piccolo
Speech
RadioEar DD45 or Telephonics TDH39
supra-aural headphones, DD65 circum-
aural headphones
•
•
•
ER-3 or IP30 insert earphones
opt.
opt.
opt.

8
Amplivox Audiocups or Silenta Supermax
noise excluding enclosures (fit only on
TDH-39 and DD45 headphones)
opt.
opt.
opt.
B71 bone vibrator
-
•
•
Patient response switch
•
•
•
Clip-on microphone for talk-over
•
•
•
Jack / jack cable (diam. 3.5 mm)
-
-
•
Inventis Maestro Software
•
•
•
USB cable
•
•
•
Medical grade power supply (6V)
•
•
•
User manual
•
•
•
QuickSIN® test license
-
-
opt.

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CHAPTER 3
Installation
Whilst the installation of a Piccolo audiometer is a relatively simple
procedure, it should be entrusted to a person with the requisite skills. If the
installation is not performed correctly, the system could be affected by safety
problems when in use.
This chapter describes the procedure for installing the system.
Keep the packaging materials, in case the audiometer should
need to be sent to the dealer or to Inventis for any reason.
PRECAUTIONS
Like any other electric or electronic device, the Piccolo audiometer will emit
electromagnetic waves. Even though its emissions are within the limits of
standards, other electronic devices close to the audiometer might be affected,
if particularly sensitive to electromagnetic interference.
Should this occur, check just by switching the audiometer OFF and ON and
try to eliminate the interference using one or more of the following solutions:
-change the orientation and/or the position of the device affected by
interference;
-distance the affected device from the audiometer;
-plug the affected device into a power socket on a circuit other than the
circuit to which the audiometer is connected;
-consult the manufacturer or a service centre for assistance.
CONNECTIONS
All connection points for accessories are located on the rear panel, as also is
the power switch. This section refers to the Piccolo Speech audiometer. The
Piccolo Plus does not have a LINE IN connector for an external sound source
(following reported as EXT1, EXT2). The Basic model also lacks a BC
connector (for a bone vibrator).

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Plug all transducers and accessories into their respective sockets as indicated
in the following table:
Connector
Accessory
Power supply. When the Piccolo is connected to a
computer USB port, the power supply is not needed.
USB port for connection to a PC
Patient response switch
Bone vibrator
Left headphone/insert earphone
Right headphone/insert earphone
Microphone for operator to patient communication
External line for speech audiometry with external
audio source
Only use power adapters intended for medical equipment,
certified to IEC 60601-1. For further information see “Appendix
A –Technical Specifications”.
If the Piccolo audiometer is powered via a USB cable, maximum
values (in AC and BC) are 10 dB lower than nominal values.
The green LED near the symbol indicates that the audiometer is powered
either from the mains power adapter or via the computer’s USB cable.
The LED near the symbol indicates the status of communications
between the audiometer and computer or iPad. This LED lights if the

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audiometer is communicating with its control device. The LED can assume
two different colours: green for communications with a PC (via a USB cable),
blue for communications with an iPad (over a Bluetooth connection).
CONNECTION TO COMPUTER/IPAD
To permit control from a computer, the Piccolo audiometer must be
connected to one of the computer’s USB ports using the cable provided (a
standard USB A/B cable). The connection is plug-and-play, and no special
drivers are required for for installation purposes: a few seconds after plugging
in, the operating system will recognize the device and install the drivers
automatically. The installation is complete when the following message
appears at the bottom right of the screen:
Piccoloaudiometer can be controlled from acomputer using Inventis Maestro
software: for further details about the use and the features of Maestro
software, and for minimum system requirements, refer to the Maestro user
manual.
Aero models permit to control the device via Bluetooth from an iPad using
Inventis Maestro app. available free of charge from the Apple App Store: for
further details about the use and the features of Maestro App, and for
minimum system requirements, refer to the Maestro –App User Manual.

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CHAPTER 4
Maintenance
Piccolo audiometer does not require any special periodic maintenance other
than calibration, checks and normal cleaning, all of which are described in
this chapter.
The performance and safety of the instrument will be maintained if the
recommendations for care and maintenance given in this chapter are
observed.
The instrument must be switched off and disconnected from the power supply
before commencing any kind of cleaning operation.
The inspection and servicing of internal components must be left
entirely to technicians approved by Inventis srl.
Transducers are manufactured utilizing ultra-fragile diaphragms
that could be damaged in the event of impact. Handle with care
during maintenance operations.
PERIODIC CHECKS
To maximize the audiometer life and all of its accessories service life, it’s
suggested to daily do the following tests.
The tests must be done with the audiometer in its installation position.
-Before switching on the instrument, check that no sign of damage is
visible in any part of the device, including accessories and the
external power supply; double check visual integrity of insulation of
the mains cable and the connectors, and verify that they are not
exposed to any kind of mechanical load that could involve damage;
verify that all the parts and cables are properly connected.
-Check subjectively that the air conduction and bone conduction
output is equal on both channels and all frequencies, In order to do

14
this 10 or 15 dB, just enough to hear is applied. The person who
carries out this check should have good hearing
-Check at a level of 60dB in AC and 40dB in BC that there is no
distortion, noise or parasitic signals in any of the frequencies
-Check that the patient response switch, the control panel and the
indicators function correctly
-Check the inputs of speech audiometry (MIC and EXT).
-Check the headband strain of headset and of bone vibrator
-Check the communication with the patient
Should any accessory not function correctly, consult Appendix B
“Troubleshooting”.
It’s basic also check that the calibration interval has not elapsed: the expiry
of the interval is indicated at the top left of Maestro software.
Calibration must be entrusted to technicians approved by Inventis
srl. The operation should be performed at least once every 12
months, and whenever a transducer is replaced.
MAINTENANCE OF TRANSDUCERS
Do not use liquids or sprays to clean the audiometer.
Do not allow dust to collect on the transducers. In addition:
-The headphone cushions are made of biocompatible material but are not
sterile: to prevent the spread of infection and guarantee the
biocompatibility of the material, whenever the headphones are to be
worn bya newpatient, the cushions must be wiped with, for DD45/TDH-
39 cushions, denatured alcohol wipe or denatured alcohol with a
microfiber cloth.
-The ear tips of insert earphones and the masking insert earphones (IME-
100) are made of biocompatible material and disposable: use once only
and dispose of in accordance with current health and safety regulations.
The eartips of insert earphones are not sterile. The use of unsterilized
earpieces can cause ear infections.