Gima PICCOLO PLUS AERO DIAGNOSTIC AUDIOMETER User guide

PICCOLO

PORTABLE AUDIOMETER

USER MANUAL

ii

Read this manual thoroughly before using the device. Pay

particular attention to Chapter 1 (“Safety: warnings and
information”) and Chapter 2 (“The first steps”).

Internal inspections and repairs must only be performed by
authorised personnel.

Inventis srl
Corso Stati Uniti, 1/3
35127 Padova
Tel.: [phone]
Fax: [phone]
www.inventis.it
[e-mail]

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.

Document title: AU1P-User Manual En
Revision: 4
Date: 2014.02.06

iii

Summary

Summary ..................................................................................................... iii

CHAPTER 1 Safety: warnings and information ...................................... 1

Operator manual ................................................................. 1

Operator responsibilities .................................................... 1

Intended use ......................................................................... 2

Precautions .......................................................................... 2

Disposal ................................................................................ 4

Conformity ........................................................................... 4

Symbols on labels ................................................................ 5

CHAPTER 2 First steps ................................ ................................ .............. 7

Main features of the audiometer ........................................ 7

Accessories ........................................................................... 7

Connections.......................................................................... 8

Connection to a PC ........................................................... 10

Installation CD .................................................................. 10

Installing Daisy software .................................................. 11

Installing the Noah Maestro module ............................... 12

Maestro app ....................................................................... 13

CHAPTER 3 The audiometric testing ...................................................... 15

Pure tone audiometry ....................................................... 15

Auto Threshold .................................................................. 21

iv

Speech audiometry ............................................................ 22

CHAPTER 4 Using the Piccolo audiometer from a computer ................ 27

Maestro modules for Daisy and Noah ............................. 27

The pure tone audiometry control panel ........................ 28

The speech audiometry control panel ............................. 30

The auto threshold control panel ..................................... 33

The audiogram .................................................................. 34

Device specifications and parameter settings ................. 34

CHAPTER 5 Using the Piccolo audiometer from an iPad ...................... 39

Archive ............................................................................... 39

Bluetooth connection......................................................... 40

Pure tone exam .................................................................. 42

Speech exam....................................................................... 44

The Settings menu ............................................................. 48

The print/export menu...................................................... 50

CHAPTER 6 Maintenance ....................................................................... 53

Daily checks ....................................................................... 53

Cleaning ............................................................................. 54

Replaceable parts .............................................................. 54

Repairs and technical assistance ...................................... 55

APPENDIX A Technical specifications ................................................... 57

APPENDIX B Troubleshooting ............................................................... 65

APPENDIX C Electromagnetic emissions ............................................... 67

APPENDIX D Bibliography ..................................................................... 69

1

CHAPTER 1

Safety: warnings and

information

OPERATOR MANUAL

Please read this manual thoroughly to ensure 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.

2

Users are entirely responsible for any malfunctions caused by improper use,

Make sure that the required ambient conditions are met during
transport, storage and operation. See “APPENDIX A: Technical

Specifications”.

The Piccolo audiometer is not protected against exposure to
flammable anaesthetic gases or similar products during use. Risk
of explosion!

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. the electrical power supply and ground connections of the

installation comply with applicable standards for electro-medical
devices.

INTENDED USE

The Piccolo audiometer is designed for use by audiology specialists
conducting pure tone and speech audiometry examinations.
Audiometric exams must be conducted in a particularly quiet environment,
and preferably in a soundproof booth. If these conditions cannot be
provided, the patient should be given sound-isolating headphones to wear so
that ambient and background noise can be blocked out as far as possible.
The Piccolo audiometer is intended for use by persons who have a detailed
knowledge of the procedures involved in audiometric examinations; the
operator must therefore be either an audiologist (or a technician with
knowledge and experience of audiometry) or a doctor in possession of
specific skills (an audiology specialist or occupational physician).

PRECAUTIONS

To ensure correct and safe use of the audiometer, the following precautions
must be observed.

Installation and general precautions

3

Avoid installing and using the Piccolo audiometer close to sources
of strong electromagnetic fields, since this could interfere with the
operation of the device.

Use only original accessories supplied by Inventis srl, unless
specifically instructed otherwise.

Only use power adapters intended for medical equipment, certified
to EN 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 EN 60601-1-1) 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 EN
standard 60601-1-1.

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.

The eartips of ER-3A and ER-5A insert earphones are disposable.
Do not use the same eartip for different patients. Dispose of eartips
after use.

Hygiene

4

Disinfect the cushions of headphones between one patient and the
next, following the procedure described in CHAPTER 6
“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.
The Inventis Quality Management System is certified compliant to ISO
9001 and ISO 13485 standards by the prestigious TÜV organisation.

5

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.

The instrument is marked with this symbol to indicate that it is
electronic equipment covered by Directive 2002/96/EC on waste
electrical and electronic equipment (WEEE).

Device with applied parts of type BF (EN60601-1).

Product conforms to European Community Medical Device
Directive (MMD) 93/42/EEC, as amended by directive
2007/47/EC. Class IIa device; number of notified body: 0123 (TÜV
SÜD Product Service GmbH).

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.

MODEL

Device model.

REF

Catalogue number.

Serial number of the device. This number is made up of 13
alphanumeric characters indicating the model, series, 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)

- character 8: model series

- characters 9… 13: serial number

SN

7

CHAPTER 2

Part

Piccolo

Basic

Piccolo

Plus

Piccolo
Speech

Telephonics TDH-39 supra-aural headphones

  

ER-5A insert earphones

opt.

opt.

opt.

First steps

MAIN FEATURES OF THE AUDIOMETER

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 using
Daisy, the Inventis application for medical record management, or using the
dedicated module of Noah. 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 speech audiometry and pure tone audiometry
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.

8

ER-3A insert earphones

opt.

opt.

opt.

Amplivox Audiocups noise excluding
enclosures

opt.

opt.

opt.

B71 bone vibrator

-





Patient response switch

  

Clip-on microphone for patient-to-operator
communication

  

Jack / jack cable (diam. 3.5 mm)

-

-



Inventis Daisy Patient Record Manager, with
Daisy Maestro module

  

Noah Maestro module

  

USB cable

  

Medical grade power supply (6V)

  

User manual

  

CONNECTIONS

All power and accessory connections are located on the rear panel. This
section refers to the Piccolo Speech audiometer. The Piccolo Plus does not
have a LINE IN connector (for an external sound source). The Basic model
also lacks a BC connector (for a bone vibrator).

9

Plug all transducers and accessories into their respective sockets as

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

Right headphone

Microphone for operator to patient communications

External line for connecting a sound source for speech
audiometry

Only use power adapters intended for medical equipment, certified
to EN 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.

indicated in the following table:

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
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).

10

CONNECTION TO A PC

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 the installation. 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:

The Piccolo audiometer is compatible with computers running a Microsoft
Windows 32 or 64 bit operating system, XP SP3 or later.
The Piccolo audiometer can be controlled from a computer using Inventis
Daisy software or the dedicated module of Noah. It can also be controlled
from an iPad. The following chapters describe how to install the audiometer
software.

INSTALLATION CD

To control the Piccolo audiometer from a computer, you need to install
Daisy software or the Noah Maestro module.

Insert the Inventis CD that came with the audiometer in your computer’s
CD drive. After a few seconds the following window (Inventis Installer)
should appear. From this window you can choose to install either Daisy
software or the Noah Maestro module, as described in the following
sections. If the installation software fails to run automatically, you can run it
manually from the CD (“InventisInst.exe” file).

11

When the CD is inserted in the computer’s CD drive, a request to install
other software may appear in place of this window. When the CD is
inserted, the installation utility verifies the presence on the computer of the
Microsoft.NET 4.0 libraries needed for the correct functioning of Daisy and
Noah Maestro. If these libraries are not present, they are installed
automatically. Simply click on “Run” and wait. The Inventis Installer
window will open after the necessary libraries have been installed.
If the Microsoft.NET 4.0 libraries have not been installed automatically,
you will need to do so manually. Open My Computer and open “Daisy” (the
CD drive) to view CD content. Double-click on the “Start.bat” file.

INSTALLING DAISY SOFTWARE

Daisy is an application developed by Inventis for the computerised
management of medical records. Daisy can be used to store patients’
clinical details together with a variety of instrumental examinations,
acquired by connecting to the necessary instruments.
The Piccolo audiometer is controlled by Daisy’s Maestro module, which is
installed along with Daisy.
For further details of the features and capabilities of Daisy software, and for
minimum system requirements, refer to the Daisy operator manual.

To launch the installation of Daisy software and the Maestro module, click
on “Daisy software” and then on “Install Daisy”.

Follow the installation procedure, taking care to select “Maestro” in the
Modules window.

12

INSTALLING THE NOAH MAESTRO MODULE

If you wish to control your Piccolo audiometer using Noah software, you
need to install the Noah Maestro module.
Click on “Noah Modules”, then on “Noah Maestro” and follow the
installation procedure.

13

MAESTRO APP

Uninstalling the Maestro App entails the loss of all data from your
archive.

The Piccolo audiometer can be controlled from an iPad using the Maestro
app, which is available free of charge from the Apple App Store.
To install the Maestro app, simply download it from the App Store. Follow
the standard procedure. Launch the “App Store” app, search for the
keywords “Inventis Maestro” and download the App. Once installed, the
Maestro icon appears on your iPad screen.

If you want to uninstall the application, simply touch the Maestro icon until
all icons start to oscillate, then select “X”

15

CHAPTER 3

The audiometric testing

This chapter describes the pure-tone and speech audiometry tests and the
procedures to correctly perform these examinations.

PURE TONE AUDIOMETRY

Pure tone audiometry is the standard hearing test used in audiology clinical
practice: it allows to determine type and extent of the hearing loss at
different frequencies and, therefore, provides the basis for patient diagnosis
and management.

Hearing threshold

The hearing threshold is a basic concept in the field of audiology. Related
to a stimulus, the hearing threshold is the minimum intensity that will elicit
an auditory response.
In clinical hearing assessment, more exactly, this is referred to as the
audiometric threshold, that is, the weakest level of a stimulus signal that the
patient is able to hear at least 50% of the time.
In practice, pure tone audiometry is the test that determines the audiometric
threshold of the patient at different frequencies.
The tone signals generated by the audiometer, and the level of the
audiometric threshold, are measured in decibels (dB). In reality, the unit of
measure is the dB HL (Hearing Level); in contrast to the dB SPL (Sound
Pressure Level), which represents the actual intensity of the sound, the dB
HL includes a compensating factor whereby a person with normal hearing
tested under ideal conditions will have a hearing threshold of 0 dB HL at
every frequency. These compensating factors, which are different for each
frequency and each type of transducer, have been calculated from studies

16

conducted on a large number of patients and are published in international

Interaural attenuation with AC

Interaural attenuation with BC

standards (EN ISO 389-1, 389-2, 389-3, 389-4, 389-5 and 389-7).

Masking

When a signal is presented to one ear, the cochlea of the other ear can also
be stimulated, in dissimilar measure, as a result of the sound being
transmitted through the bones of the skull. The mechanism whereby a signal
presented to one ear stimulates the cochlea of the opposite ear is known as
cross-hearing. In situations where cross-hearing could occur, a masking
signal must be used.
Masking consists in raising the threshold of the contralateral ear by
presenting an appropriate masking signal (generally a narrow band noise,
NBN, centred on the current stimulation frequency) at a predetermined
level. This prevents the contralateral ear from sensing the stimulus
presented to the ear being tested, which could lead to the responses of the
patient registering false positives and affecting the measured threshold.
The unit of measure for narrow band masking noise (NBN) is dB EM
(Effective Masking). In contrast to dB HL, the correction factor introduced
into dB EM is such that when using a given stimulation frequency (e.g. 1
kHz), a narrow band noise of predetermined intensity (e.g. 20 dB EM) will
render inaudible any signal of intensity less than or equal to the noise in
question (or in the case of the example, any tone of 1 kHz frequency
generated at an intensity of up to 20 dB HL).

A fundamental concept applied in the selection of a suitable masking
strategy is that of interaural attenuation (IA): the reduction of energy in a
sound signal presented to one ear and transmitted by bone conduction to the
contralateral ear.

17

For air-conducted signals, the level of IA varies according to the frequency

Frequency (Hz)

125

250

500

1000

2000

4000

8000

IA (dB)

35

40

40

40

45

50

50

and the transducer adopted (supra-aural headphones or insert earphones)
and, to an extent, from one individual to another.
In the case of headphones, reference can be made to the following table,

taken from Goldstein BA, Newmann CW (1994) “Clinical masking: a
decision making process”, in the Handbook of Clinical Audiology by J Katz

(ed).

In the case of insert type earphones (EARTone models 3A and 5A), IA is
much higher (above 70 dB).
For bone-conducted signals, conversely, IA is near to 0 dB: consequently,
one can never be certain which cochlea has been stimulated by a BC tone,
irrespective of where the vibrator is positioned, which means that cross­hearing can always be a factor in bone conduction.

Having introduced the concept of interaural attenuation, instances of cross­hearing can be identified with the following formula, in which case a
masking signal becomes necessary:

ACTE – IA ≥ BC

NTE

where: ACTE = the air conduction threshold for the Test Ear

IA = interaural attenuation
BC

= bone conduction threshold for the Non-Test

NTE

(contralateral) Ear

In the same way as for a test tone, if the masking noise is of sufficiently
powerful intensity, it can be transmitted by bone conduction to the test ear.
If the intensity of the masking noise is sufficient to mask not only the non­tested ear but the test ear as well, the effect is referred to as overmasking.
The maximum intensity of masking noise above which overmasking occurs
(M

) is given by this formula:

max

M

= IA + BCTE

max

Accordingly, overmasking occurs when the level of the masking signal
(EML

) is as determined by this formula:

NTE

EML

≥ IA + BCTE + 5

NTE

18

Air conduction audiometry

The general rule when performing an audiometric test with air-conducted
signals is to use a pure tone input, which can be either continuous or pulsed.
Referring to the considerations of the previous section, the operator must
decide whether or not a masking signal is needed, and determine its level.
To ensure a dependable outcome, the test should be conducted in suitably
quiet surroundings, and preferably in a soundproof booth. If there is no such
enclosure available, the use of special sound-isolating headphones is
recommended, in particular Audiocups, which can be supplied as an
optional accessory with Piccolo audiometer. Standard EN ISO 8253-1
specifies the maximum permissible ambient noise level compatible with
dependable results.
Having invited the patient to put on the headphones, conduct the test in
accordance with the following procedure — taken from EN ISO 8253-1.

Instructions to the patient

Tell the patient to press the button (or raise a hand) when a sound is heard,
and release the button (or lower the hand) only when the sound is no longer
heard.

Presentation and interruption of test tones

The test tone should be presented for a duration of 1 or 2 seconds. When
there is a response from the patient, the interval between successive test
tones must be varied, although never reduced to a duration less than that of
the actual tone.

Initial familiarization

Before determining the hearing threshold, the patient must be familiarized
with the task by presenting a signal of intensity sufficient to elicit a precise
response. After this familiarization step, the operator can be confident that
the patient understands the procedure and is able to respond correctly.
The following method of familiarization can be used:

1. present a 1000 Hz tone at a clearly perceptible level, say, 40 dB HL for

a person with normal hearing;

2. reduce the level of the tone by steps of 20 dB until there is no longer

any response;

3. increase the level of the tone by steps of 10 dB until a response is

elicited;

19

4. present the tone again at the same level.

If the responses are consistent with the presentation of the tones, the
familiarization process is complete. If not, the procedure should be
repeated. Following a second failure, repeat the instructions.
In cases of profound deafness, these procedures may not be applicable.

Estimation of hearing threshold (ascending method)

Conduct the test initially on the ear that the patient considers to be the better
ear. The different frequencies should be tested in the following sequence:
1000, 2000, 4000, 8000, 500, 250 Hz, including half octaves if appropriate.
Perform the following sequence of steps.

1. Present the first tone of the test at a level 10 dB less than the lowest

level of the response given by the patient during the familiarization
session. Following each tone that fails to elicit a response, increase the
level of the test tone by steps of 5 dB until a response is forthcoming.

2. Following the response, reduce the level by degrees of 10 dB until

there is no response, then begin the ascending sequence again.
Continue until the patient produces three responses at the same level
on a maximum of five ascending sequences.
Using the ascending method, if less than three responses at the same
level are elicited on five ascending sequences (or less than two
responses on three ascending sequences, using the short method),
present a tone at a level 10 dB higher than the level of the last
response. Repeat the test procedure.
It has been shown that a shortened version of the ascending method
gives comparable results, and in certain instances can be considered
suitable for the purpose in question. Using the short method, continue
with the test until the patient gives at least two responses at the same
level on a set of three ascending sequences.

3. Move on to the next frequency, starting at a level that ought to be

audible on the basis of the previous responses, and repeat step 2).
Complete the test on one ear, at all the frequencies, in the sequence
indicated.
Repeat the measurement at 1000 Hz. If the results of the repeat test at
1000 Hz on the same ear are comparable with the first, registering a
difference of less than 5 dB from the previous level, then proceed with
the other ear. If there is an improvement of the order of 10 dB in
liminal hearing, repeat the test at other frequencies in the same order
until the values reflect a deviation equal to or less than 5 dB.

4. Continue until the test has been completed on both ears.

20

Bone conduction audiometry

Given that bone-conduction IA is near to 0 dB, the exact determination of
the hearing threshold for an ear using bone-conduction audiometry requires
masking of the non-test contralateral ear at all levels.
Follow the steps indicated below to establish the threshold level.

1. Position the bone vibrator on the patient’s mastoid, behind and as near

as possible to the conch, without touching, and place the masking
headphone over the non-test ear (the unused headphone should be
positioned forward of the test ear, leaving the cavity exposed). Make
certain that the head bands of the two transducers do not interfere with
one another.

2. Begin the test with the ear the patient considers to be the better ear, at

a frequency of 1000 Hz.

3. Establish the threshold level without the masking signal, using the

shortened ascending method described in the previous section.
Bear in mind that the result of this operation cannot serve as a true
estimate of the bone-conduction threshold, given the possibility that
the non-test ear could be affected by occlusion (see next section).

4. Activate the masking noise and establish the correct intensity of the

masking component — hence the hearing threshold — using the
Plateau method described in the next section.

5. Move on to the other frequencies, following the same sequence as

indicated for air-conduction testing. Continue until the test has been
completed on both ears.

How masking is applied

As mentioned previously, whenever cross-hearing could be an issue, a
masking noise must be applied to the non-test ear, delivered by way of the
headphones or a dedicated insert earphone.
The method described here for determining the level of the masking tone is
the so-called “plateau technique” described by J.D. Hood in 1960. This
involves gradually increasing the masking noise applied to the non-test ear
in such a way as to arrive at a plateau — that is to say, a range of masking
values across which there is no increase in the hearing threshold of the test
ear. The presence of the plateau suggests that, within the range of masking
intensity values in question, there is no undermasking (i.e. a level not
sufficient to prevent cross-hearing) and no overmasking.

The plateau technique involves the following three steps.

21

1. Find the threshold for the ear being tested, without masking.

2. Activate the masking noise at an initial level of 10 dB higher than the

air conduction threshold for the non-tested ear (in the case of bone
conduction, see the following note); except in certain particular cases,
this level will not produce overmasking.

3. Check the threshold of the test ear again. If the threshold of the test ear

has not changed, increase the intensity of the noise by steps of 5 (or

10) dB, checking the value after each increment; if there is no change
in the threshold over three successive increases in the intensity of the
noise (or two increases, for steps of 10 dB), this means that the plateau
has been found, and the value can be considered as the threshold.
Conversely, if there is a change in the threshold value, this indicates
that it was influenced by undermasking, and the procedure must be
repeated with the new threshold level.

If bone-conduction is being used for the test, the initial level of the masking
signal should be increased to compensate for the occlusion effect (OE). OE
— due to the headphone being placed over the non-test ear — causes an
increase of the bone-conduction tone threshold in the frequency range
between 250 and 1000 Hz; in particular, the threshold in question increases
by 15 dB at 250 Hz and 500 Hz, and by 10 dB at 1000 Hz. The initial value
of the masking noise therefore needs to be higher than the AC threshold of
the non-tested ear, by 25 dB at 250 Hz and 500 Hz, and by 20 dB at 1000
Hz.

AUTO THRESHOLD

Auto Threshold pure tone audiometry allows the operator to establish the
hearing threshold for different frequencies by way of an automatic
procedure. The method applied is the Hughson-Westlake technique, as
adapted by Martin, which provides a modified and shortened version of the
method indicated in ISO standard 8253-1 for determining the AC threshold
without masking.

The Auto Threshold test comprises an initial familiarization step serving to
train the patient in the threshold identification procedure. The patient must
press the response button every time the stimulus is heard, and release the
button thereafter. In particular, the stimulus is presented for a duration of

1.7 seconds, followed by a pause of random duration between 1.7 seconds
and 2.5 seconds.

22

The adopted method of determining the threshold envisages an increase of 5
dB in the level of the stimulus, and a reduction of 10 dB. The threshold is
established as the level for which at least 2 positive responses are elicited
from the patient over 3 sequences.

During the familiarization phase, the stimulus presented to the patient is
generated at a frequency of 1 kHz and an initial intensity of 40 dB HL
(which cannot be changed). Once the threshold has been identified, the
familiarization step ends, and the test begins automatically.
The first frequency examined in the Auto Threshold sequence is 1 kHz.
Once the hearing threshold has been identified for this frequency, the test
passes on to the next frequency. The order in which the selected frequencies
are analysed is as follows: first, frequencies higher than 1 kHz, in ascending
order, then frequencies lower than 1 kHz, in descending order, and finally,
the 1 kHz frequency again.
Once all these frequencies have been analysed for one ear, the test is
repeated automatically on the other ear.
In practice, if the patient is unable to hear a stimulus signal even at the
maximum permissible level for a given frequency and after it has been
presented 10 times, the signal in question will be identified as "not heard".
The audiogram will be updated in real time during the course of the test, to
show the results obtained.

SPEECH AUDIOMETRY

Pure tone audiometry provides only partial information on the abilities of
the patient to hear and understand the spoken voice, which is the most
important of audible signals. About this, further information can be obtained
by the speech audiometry, in which the patient is presented with a
succession of standardized speech stimuli, typically single syllables, words
or phrases. The goal is the assessment of certain aspects of the patient’s
hearing ability, like verbal intelligibility, i.e. the faculty to recognize these
inputs as sound stimuli with meaning. The speech material can be presented
directly by the operator, talking into a microphone (connected to the
“TALK OVER” input of the audiometer), or recorded on a CD or a tape
cassette and reproduced by a player connected to the LINE IN input of the
audiometer.

The following diagram illustrates how the speech material is presented to
the patient from the audiometer.

23

Adjustment of

input gain

Selection

of input

CD, computer

(LINE IN input)

Microphone

(TALK OVER

input)

Attenuator

Right and/or

left headphone

Selection of input
The input signal for speech audiometry can be the microphone (connected

to the TALK OVER input on the rear panel) or an external audio source
(PC, CD or cassette player) connected to the LINE IN input.

Adjustment of input gain
Before starting a speech audiometry test, the level of gain on the selected

input must be adjusted. The purpose of this operation is to ensure that
recorded speech material utilized for the test or the operator voice, in case
of live speech test, will be played back at the correct volume.
In case of recorded speech material, the input gain will be correct if, playing
the calibration tone supplied with the speech material, the loudness
measured on the VU-meters of the two channels — displayed on the pc or
iPad screen — touches 0 dB, that is to say, the point at which the meter
changes from green to red.
In case of live speech test, the gain will be correct if the mean value
measured by the VU-meter of channel 1 is 0 dB while you speak test words
and the distance between yourself and the microphone is the usual kept
during the test.
If the level is incorrect, press the GAIN button and make the necessary
adjustment on the window that will appear. The gain level for each input is
saved and will be set again at the same level even afterwards.

24

Attenuator
The speech signal is adjusted to the level set by the operator (level of

channel 1) and sent to the connected VA transducer (headphones or insert
earphones).

Masking and competing signal

As in pure tone audiometry, a masking signal can be used in speech
audiometry to avoid the eventuality of measurement errors being induced as
a result of cross-hearing. The masking signal is generated through channel 2
of the audiometer; the recommended signal for speech audiometry is speech
noise (SN), which produces an energy output concentrated in the frequency
band typical of the human voice. The Piccolo audiometer also features a
white noise (WN) as the masking signal.

To assess the ability of a patient to recognize speech in an environment with
background noise, in other words under conditions typical of everyday life,
speech audiometry can be conducted by presenting a competing sound
either to the tested ear or to the contralateral, non-tested ear. The competing
sound, which is generated through channel 2 of the audiometer, can be the
speech noise or white noise mentioned above, or a signal incorporated into
the audio track of the selected speech material, recorded on the channel
opposite to that containing the word lists.

Articulation function, Speech Recognition and
Speech Detection Thresholds

The articulation function (or performance-intensity function) is the curve
that describes the speech recognition score (average percentage of correct
answers) as a function of speech intensity level. The articulation function
provides information on how speech material of different types
(monosyllabic words, spondaic words, etc). is identified correctly by the
patient in relation to the intensity of presentation.
The following illustration provides an example of articulation functions.

25

The two curves in the graph relate to two different types of speech material,
and more exactly, lists of spondaic words (continuous line) and of
monosyllabic, phonetically balanced words (dotted line). The level of
intensity at which 50% of correct responses are obtained with lists of
spondaic words is known as the Speech Recognition Threshold (SRT). The
average SRT for adults with normal hearing is 20 dB SPL; standard EN
60645-2 defines this level as equivalent to 0 dB HL. In the case of speech
audiometry, accordingly, to convert a value of intensity expressed in dB
SPL to the corresponding value in dB HL, simply subtract 20 dB from the
value.

The articulation function in persons with normal hearing presents a steep
curve: on average, 100% of correct responses will be registered at a value as
low as 27.5 dB SPL (or 7.5 dB HL).

Also indicated in the foregoing graph is the Speech Detection Threshold
(SDT), that is, the intensity at which the patient detects the speech signal
(without comprehending it) 50% of the times it is presented. The SDT value
for a person with normal hearing is around 13 dB SPL (or –7 dB HL).

27

To avoid possible malfunctions, check that the USB cable,
transducers and other accessories are properly plugged in to their
respective connectors before you run the Maestro module.

CHAPTER 4

Using the Piccolo audiometer

from a computer

This chapter describes how to use the Piccolo audiometer through a
computer. It also describes the functions of the various buttons and explains
how to save examinations.

MAESTRO MODULES FOR DAISY AND NOAH

If used with a computer, the Piccolo audiometer can be controlled using
Daisy, the Inventis application for medical record management, or Noah
software. In either case, the audiometer is controlled by the Maestro
module, which is available for both Daisy and Noah. The two modules are
similar, and this chapter makes no distinction between them.
Daisy software and Maestro modules for Daisy and Noah are supplied with
the Piccolo audiometer. See Chapter 2 for a description of the installation
procedure.
When you open the Maestro module, the following screen appears.

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This screen is made up of three areas:

1. the audiometer control panel

2. the audiogram (pure tone and speech)

3. device specifications and parameter settings

The control panel differs depending on the type of exam selected: pure tone
or speech audiometry (WRS or SRT-MCL-UCL).

THE PURE TONE AUDIOMETRY CONTROL PANEL

The following figure illustrates the Piccolo audiometer’s control panel for
pure tone audiometry.

29

Output. Lets you select what type of transducer to use (AC or BC). The
masking signal is delivered by air-conduction.

Side. Lets you select the stimulation side: right (R) or left (L). Stimulation
side can also be changed by clicking directly on the audiograms or by
pressing the “Tab” key.

Response. Displays the status of the response switch. An orange light comes
on whenever the patient presses the button.

Interrupter. Lets you send a tone. The stimulus can be sent by placing the
mouse cursor on the screen button, thus avoiding unwanted noise, or by
clicking the right button on the mouse with the cursor inside the audiogram
area. You can also send the stimulus from the keyboard, by pressing the
pre-configured key (see Device specifications and parameter settings).

Norm On. Selecting “Normally On” reverses the operating logic of the
interrupter. Output is permanently active and pressing the interrupter turns it
off.

Input. You can select the type of stimulus (TONE or WARBLE), by
clicking on the corresponding area. You can also select stimulus
presentation mode: CONTINUOUS, PULSED 0.5 Hz, PULSED 1 Hz or
PULSED 2 Hz.
Stimulus intensity can be modified in five ways:

- by clicking on the corresponding arrows

- by using the mouse scroll wheel with the cursor inside the stimulus

area

- by using the mouse scroll wheel with the cursor over the currently

active audiogram

- by clicking on the target intensity on the audiogram (only if the

stimulus is not active)

- by pressing the pre-configured keys on the keyboard (see Device

specifications and parameter settings)

For reasons of safety, if the intensity of 100 dB is reached, a “HIGHER dB”
label is displayed. You must click on it before you can increase the dB
value further. Stimulus intensity changes in fixed steps of 5 dB.

Frequency. You can modify frequency in four ways:

- by clicking on the corresponding arrows

- by using the mouse scroll wheel with the cursor inside the

frequency area

- by clicking on the target frequency on the audiogram (only if the

stimulus is not active)

30

- by pressing the pre-configured keys on the keyboard (see Device

specifications and parameter settings)

Masking. The masking signal is narrow band noise (NBN), centred on the

stimulus frequency. You can modify the intensity of the masking signal:

- by clicking on the corresponding arrows

- by using the mouse scroll wheel with the cursor inside the masking

area

Enable. Lets you enable or disable the masking signal.
Tracking. If this function is active, the difference in current intensity

between stimulus and masking signal remains fixed when stimulus intensity
is changed.

Pulsed. Lets you switch to pulsed stimuli. Pulsation rates may be chose
between 0.5, 1, 2 Hz values.

Talk over. Permits patient-to-operator communications. Click and hold the
corresponding button or press and hold the “T” key on the keyboard. While
the communication channel is open, transmission of all other signals is
blocked. Releasing the TALK OVER button re-enables signal transmission.
You can adjust communication volume by clicking on the speaker icon to
the right of the button. Gain for the talk over microphone may be set by
pressing on ‘Talk’ label.

Store (No Resp). Lets you store the measured threshold level in the
audiogram. You can also do this by pressing the pre-configured key on the
keyboard (see Device specifications and parameter settings).
If the patient does not respond even when maximum stimulus intensity is
reached, you can mark the threshold level with a different symbol by
clicking on the NO RESP button.
Erase. Lets you delete a saved point or trace from the audiogram. Move to
the frequency of the point to be deleted and press the button. Full traces
may be deleted by clicking on the little arrow on the button and select
‘Erase Trace’.

Test type. Lets you select the type of pure tone audiometry: HL or UCL. In
UCL tests, the BC and Masking options are disabled.

THE SPEECH AUDIOMETRY CONTROL PANEL

The Piccolo speech audiometer lets you perform different types of speech
examination: Word Recognition Score (WRS), Speech Reception Threshold
(SRT), Most Comfortable Level (MCL) and Uncomfortable Level (UCL).

31

Speech audiometry exams can be performed using speech material from a

If speech material is saved on a computer, all computer sound
effects (e.g. Dolby effect) must be disabled, and computer output
volume on the Volume Control panel must be set to maximum.

CD, from a computer, or spoken by the examiner (live speech).
For live speech, a microphone must be connected to the Piccolo
audiometer’s TALK OVER input. If recorded material is used, the sound
source (computer or CD player) must be connected to the Piccolo
audiometer’s LINE IN input.
Material stored on a computer can be indexed. A table can be associated
with each sound track so that the examiner can see the word being
pronounced in the exam window without having to monitor the audio
signal.
To index your tracks, use the Inventis ATIT software on the CD supplied
with the Piccolo audiometer. The CD also contains the ATIT user manual.

The following figure illustrates the Piccolo control panel for speech exams.

If your speech material is saved on your computer, the top part of the
Control Panel will contain a material type and list selection box and
playback controls. If you are using Daisy Maestro, speech material must be
saved in the c: \Daisy\Application\OMMaestro\Material folder. If you are
using Noah Maestro, speech material must be saved in C:\Program Files
(x86)\Inventis\NoahMaestro\Material. This folder contains a number of
subfolders corresponding to different types of speech material (e.g.
Monosyllabic words or Disyllabic words). Each subfolder contains tracks
and word lists (.wav files).

32

If speech material is indexed, the last pronounced word (or sentence)

Rewind. If indexed speech material is being played back,
this button repeats the last pronounced word. If speech
material is not being played back, it moves to the
previous track.

Play/Pause. Begins or pauses speech material playback.

Forward. If indexed speech material is being played

back, this button moves on to the following word. If
speech material is not being played back, it moves to the
next track.

Stop. Ends playback.

appears to the right of the playback buttons.
The following table describes the functioning of the playback buttons.

VU-meter and Gain. The VU-meters over the channel controls show the
level of the selected sound source. These must be set in an appropriate way
to ensure correct results from the exam. (See the “Speech audiometry”
section in the previous chapter for a more exhaustive description of this
issue). Input signal level can be adjusted by clicking on GAIN.

Input. The stimulus signal controls are located in the left part of the Control
Panel. You can select input signals from EXT1, EXT2 or MIC, by clicking
on the corresponding areas. Stimulus intensity can be adjusted in four ways:

- by clicking on the corresponding arrows

- by using the mouse scroll wheel with the cursor inside the stimulus

area

- by clicking on the target intensity in the audiogram

- by pressing the pre-configured keys on the keyboard (see Device

specifications and parameter settings)

Score. This keeps count of the correct/incorrect answers given by the

patient. The way in which responses are scored depends on the “Speech
score mode” chosen in “Settings” (see Device specifications and parameter

settings).
MODE 1. If the answer is correct, click on the right arrow; otherwise, click

on the left arrow. You can also mark answers as correct/incorrect from the
keyboard, by pressing the pre-configured keys (see Device specifications
and parameter settings).

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MODE 2. The number of words in each list is fixed and only correct
answers are counted. Answers are marked in the same way as for MODE 1,
but clicking the button for an incorrect answer decreases the final score by
one.

Masking. The masking signal controls are located in the right part of
Control Panel. You can select masking signals from:

- EXT1 if the stimulus signal comes from EXT2

- EXT2 if the stimulus signal comes from EXT1

- MIC, if the stimulus signal comes from the microphone

- WN, white noise

- SN, speech noise

Masking signal intensity can be adjusted:

- by clicking on the corresponding arrows

- by using the mouse scroll wheel with the cursor inside the masking

signal area

Store. Lets you store the current score. You can also store the current score
by pressing the pre-configured key on the keyboard (see Device

specifications and parameter settings).
Erase. Lets you delete a saved score for the current intensity level. Press the

“Del” key on the keyboard or click the “Erase” button. Full traces may be
deleted by clicking on the little arrow on the button and select ‘Erase
Trace’.

The score is reset automatically when a new point is saved on the graph.

Reset Score. Lets you reset the score (only if “Speech mode score” is set to
“MODE 1” in the “Settings”).

Test type. Lets you select the type of speech audiometry: SRT, MCL or
UCL.

THE AUTO THRESHOLD CONTROL PANEL

The following figure illustrates the Piccolo control panel for WRS speech
exams.

34

To begin the test, simply press the START button. The test finishes
automatically once all the enabled frequencies have been analysed for both
ears. The procedure can be interrupted if necessary, by pressing the STOP
button (which replaces START once the test is in progress).
After pressing START, a message will appear warning the operator that any
air-conduction-related threshold data saved previously will be erased.
During the exam, it is possible to activate the TALK OVER function for the
operator to talk to the patient.
Before starting the exam, the initial side to be tested can be selected.

THE AUDIOGRAM

In pure tone audiometry examinations, you can select whether to display the
left and right audiograms overlapping or separate. (in Daisy: open the
Settings window from the main screen. In Noah: click on “Tools” and
“Preferences” in the Maestro module).

Some areas of the audiogram are highlighted. These correspond to
frequency/intensity values not obtainable with the selected transducer.
Important! if Piccolo is powered from a PC via a USB cable, maximum
values are 10 dB lower than theoretical ones.

By clicking on the pure tone audiogram with the left mouse button,
frequency and intensity are set to the corresponding values for the specific
point. In speech audiometry, stimulus intensity is modified instead.

You can overlap a previous exam over the current audiogram. This option is
only available if the patient has was selected before the Maestro module
was opened. The option is enabled from the left section of module panel, as
described in the following section.

DEVICE SPECIFICATIONS AND PARAMETER SETTINGS

This section of the screen contains, from top to bottom:

- the model of the connected device

- the date of last calibration

- the calibration expiry date

- the current air-conduction transducer

- the type of exam selected

- the label for opening the audiometer parameter settings window

- (only for Daisy Maestro) the option for overlapping audiograms of

previous exams (see the next section)

- the button for saving/ deleting the current exam

35

- a list of saved exams

Clicking on “Settings” opens a window in which you can modify a number
of parameters. These are described below.

The following figures illustrate the Piccolo control panel for pure tone and
speech exams.

Pure tone audiometry settings

Speech audiometry settings

GENERAL SETTINGS

AC transducer. The user can choose the headphones or insert-phones used
for exams via air conduction.

Default intensity (dB). Lets you set default intensity for the audiometer
(between 0 and 60 dB).

Maintain intensity. If this setting is enabled (YES), intensity is maintained
after switching to the next frequency. If it is disabled (NO), the default
intensity is automatically selected.

36

Take great care to ensure that the type of transducer selected
corresponds to the one actually used. Mismatches invalidate the
results of the audiometry exam.

PURE TONE AUDIOMETRY SETTINGS

Automatic frequency jump. Lets you enable or disable automatic switching
to the next frequency after saving the threshold level on the audiogram
(Store function).

Frequency jump mode. Lets you choose the next frequency value after
maximum frequency (8 kHz) is reached. Selecting 8k→1k returns you to
1kHz, whereas selecting 8k→125 returns you to 125 Hz.

Frequency selection. Lets you choose the set of frequencies to test.

SPEECH AUDIOMETRY SETTINGS (only for piccolo Speech)

Speech score mode. Lets you choose between two different modes of
scoring the patient’s answers.

- MODE1: the examiner records both correct and incorrect answers;

the current score therefore refers to the number of words already
presented.

- MODE2: the examiner only records correct answers; the current

score therefore refers to the total number of the words in the list.

Speech words number. If “Speech score mode” is set to “MODE2”, this
setting lets you select the number of words for each list (from 1 to 99).

Pause after each word. If the speech material is indexed, select YES to
pause playback automatically after each word or select NO to enable non­stop playback of words.

Enable WRS single point. Option for measuring a single score on WRS
speech mode.

Standard curves. Standard traces may be displayed on the speech graph as
references for normal response to such material. Up to 2 curves can be
shown and associated to a particular material.

37

KEYBOARD SHORTCUTS

Touch screen mode. (Only for Windows 7). Enable this function only if the
audiometer is controlled by a touch screen device.

Choose up or down arrow to increase intensity. Allows to select the
direction for increasing the intensity of stimulus, through the arrows on the
panel control or with the mouse scroll wheel.

The other items let you select what keyboard buttons to use for custom
keyboard shortcuts.

SERVICE INFO

Only for service purposes.

39

CHAPTER 5

Using the Piccolo audiometer

from an iPad

This chapter describes the Maestro app for using the Piccolo audiometer
from an iPad. The Maestro app is available free of charge from the Apple
App Store.

ARCHIVE

The following image illustrates the archive window of the Inventis Maestro
app.

40

The patient list is displayed on the left of the screen. To add a new patient,
touch the icon and enter the necessary patient information in the

PATIENT EDITOR window. Press Done when you have finished. First
name, last name, gender and birth date fields are mandatory. To delete a
patient from the archive, swipe the finger over the patient’s name then
select the Delete button when it appears.

The rest of the screen is divided into the following areas:

- The bottom of the screen contains a list of examinations performed on

the current patient, sorted by date. To delete an exam, swipe the finger
over the exam to delete then select the Delete button when it appears.

- The top of the screen displays the currently selected test. In case of pure

tone exams you can view the right and left graphs separately or
overlapped. To switch from two to one graph, touch the two graphs
simultaneously and drag them up to the centre. Drag a single graph in
the opposite direction to separate it into two overlapping graphs.

- The middle of the screen displays the current patient details (name and

age). To view and edit patient data, touch the patient’s name or the “i”
icon.

The upper part of this window also contains three function buttons. The

button on the left lets you open the settings menu (see the “The Settings”

section). The button lets you access the exam export menu (see the
“The Export menu” section). The New Exam button on the right lets you
open the Exam Window (pure tone or speech, as available).

BLUETOOTH CONNECTION

The Bluetooth connection must be enabled before your iPad can
communicate with the Piccolo audiometer. Bluetooth connectivity is
normally enabled by default, but if it is not, open the Settings menu (see the
“Settings” section), select Bluetooth, then Bluetooth and enable the
connection.

The iPad identifies the audiometer by means of its serial number (SN),
which is printed on a label underneath the device. Enter the SN in the
relevant field of the Bluetooth Communication screen.
Enter the complete number, i.e. the 13-digit alphanumeric code that appears
after the SN symbol on the device label. Once entered, the serial number is
saved in the app, and does not need to be re-entered (unless you need to
connect to a different device).

41

If Bluetooth Communication is enabled but the SN has not been
entered, when you press the “New exam” button, you will be asked
to enter the serial number for your audiometer.

The message Looking for device indicates that the iPad is searching for the
audiometer. If the device is found, a connection is established and the
connection LED on the Piccolo audiometer lights in blue. If the device has
not been not detected after 20 seconds, the No Device Found message
appears. Select Cancel to interrupt the operation or Retry to try to connect
again.

Connection failures (Connection Lost) may have several causes, but are
generally easy to rectify.

- iPad and audiometer too far apart.  Move the iPad and device closer

together.

- Obstacles interfering with communication.  Remove any objects

between the iPad and audiometer.

- The audiometer power supply has been disconnected while the

audiometer is connected to the iPad.  Re-connect the audiometer
power supply and select the Retry option in the Connection Lost
message box.

42

PURE TONE EXAM

The figure hereafter illustrates the exam window for pure tone audiometry.

The Archive button in the upper left corner of the screen lets you return to
the archive window. If you press this button, the “Save Exam” menu
appears. This lets you select the patient to whom you want to associate the
exam you have just performed, or delete the exam.

Output. Lets you select what type of transducer to use: headphones /
earphones (AC) or bone vibrator (BC). The masking signal is always sent
through AC.

Side. Lets you select the stimulation side: right (R) or left (L). Stimulation
side can also be changed by touching the audiograms. The masking signal is
automatically set as contralateral.

Off-line/Connected. Shows the status of the connection between the iPad
and the Piccolo audiometer: connected (light on) or disconnected (light off).

Interrupter. Delivers the stimulus.

43

Norm On. Selecting “Normally On” reverses the operating logic of the
interrupter. Output is permanently active and pressing the interrupter turns it
off.

Stimulus. You can change the type of stimulus (TONE or WARBLE) and
the presentation mode (PULSED or CONTINUOUS) by touching the
corresponding labels. The arrows let you adjust stimulus intensity in steps
of 5 dB.
For reasons of safety, if the stimulus intensity of 100 dB is reached, a

“HIGHER dB” warning is displayed. You must click on this warning before

you can increase the dB value further. (The intensity value becomes red in
colour.)

Frequency. You can increase/decrease frequency by touching the
corresponding arrows.

Masking. The masking signal is narrow band noise (NBN) centred on the
stimulus frequency. You can modify the intensity of the masking signal by
touching the corresponding arrows. Masking is always contralateral.

Enable. Lets you enable or disable the masking signal.
Tracking. If this function is active, the difference in current intensity

between stimulus and masking signal remains fixed when stimulus intensity
is changed.

Talk over. Press and hold this button to enable operator-to-patient
communications. While the communication channel is open, transmission of
all other signals is blocked. You can adjust communication volume by
touching the speaker icon to the left of the button.

Exam Mode. Lets you select the exam mode: UCL or HL
Response. Displays the status of the patient’s response switch: the light is

on when the patient presses the button.
Store / No Resp. Lets you store the measured threshold level in the

audiogram. If the patient does not respond even when maximum intensity is
reached, you can mark the threshold level with a different symbol by
touching the NO RESP button.

Delete. Deletes the threshold stored for the current frequency.

The icon in the lower right corner only appears if audiometer and iPad
are connected. Touching this symbol displays the Device Info menu. This
menu contains the following information.

Device Name. The name of the connected device.

44

Calibration date. The date of the last calibration.

Take great care to ensure that the type of transducer selected
corresponds to the one actually used. Mismatches invalidate the
results of the audiometry exam.

Calibration Exp. Date. Calibration expiry date (12 months after the last

calibration).
AC Transducer. The type of AC transducer currently used, selectable

between TDH-39 headphone and ER-3A / ER-5A insert earphone.

Fw. Rev. Firmware revision.
Hw. Rev. Hardware revision.
BT. Rev. Bluetooth module revision.
Service info. Only for service purposes.

SPEECH EXAM

The Piccolo speech audiometer lets you perform different types of speech
exam: Word Recognition Score (WRS), Speech Recognition Threshold
(SRT), Most Comfortable Level (MCL) and Uncomfortable Level (UCL).

SPEECH MATERIAL

Speech audiometry exams can be performed using material spoken by the
examiner (live speech) or recorded speech material, which can be stored on
the iPad or a different audio source (e.g. a CD player).
For live speech, a microphone must be connected to the Piccolo

audiometer’s TALK OVER input. If recorded material is used, the sound
source (iPad or CD player) must be connected to the Piccolo audiometer’s

LINE IN input

Speech material can be uploaded to your iPad from a PC. Speech material
must be in the form of wav or mp3 files, and your iPad must be able to
connect to your computer.
Proceed as follows to upload non indexed speech material:

- On your computer, create a new folder and name it according to

the type of material you want to place in it (e.g. Spondees).

- Copy all the tracks of this type of material (e.g. spondees) to this

folder.

45

- Zip this folder. You should obtain a zip file with a relevant name

The audio tracks import could take several seconds depending on
the number and size of the audio files. Do not turn off the iPad or
the app in the meantime.

(e.g. Spondees.zip).

- Repeat these three steps for all types of material you want to

upload (e.g., logotomes, complete phrases, etc)..

- Copy all the zip files just created into the “Maestro Documents”

folder on your iPad. To locate this folder, open iTunes and look for
Maestro in the list of apps installed in your iPad, as shown in the
picture below

- Disconnect the iPad from the computer. Open the Maestro app and

access the “Edit Speech Material” menu from the Main window

(see The Settings/Speech section). You should now be able to play
your speech material through your iPad.

Speech material can be indexed. A table can be associated with each sound
track so that the examiner can see the word being pronounced in the exam
window without having to monitor the audio signal.
To index your tracks, use the Inventis ATIT software on the CD supplied
with the Piccolo audiometer. Once completed, copy the zipped folder
obtained with ATIT into the Maestro Documents Folder, as described
above. See the ATIT user manual for further information.

46

THE SPEECH EXAM SCREEN

Play/Pause. Begins or pauses speech material playback.

Rewind. During playback, in case of indexed speech

material it jumps to the previous word, otherwise it jumps
5 seconds before. If speech material is not being played
back, it moves to the previous track.

Forward. During playback, in case of indexed speech
material it jumps to the next word, otherwise it jumps 5
seconds ahead. If speech material is not being played
back, it moves to the next track.

The figure below illustrates the speech exam screen.

The upper part of the screen contains a graph of the articulation function. If
the speech material is stored on your iPad, the current speech material, list
and word (only for indexed tracks) are displayed underneath.
The right section of the window contains the Response light, the current
exam type (WRS, SRT, MCL and UCL audiometry exams are available by
touching the exam name), Store and Delete keys and buttons for playback
control.

47

Stop. Stop playback.

The lower section of the screen contains the control panel, as illustrated
below.

Side. Side of stimulation.
Stimulus: Enable. Turns on the stimulus channel. The channel must be

turned on during examinations.
VU-meter and Gain. The VU-meters over the channel controls show the

level of the selected sound source. These must be set in an appropriate way

to ensure correct results from the exam. (See the “Speech audiometry”

section in the previous chapter for a more exhaustive description of this
issue). Input signal level can be adjusted by clicking on GAIN.

Stimulus. The stimulus signal controls are located in the left part of the
Control Panel. You can select input signals from EXT1, EXT2 or MIC, by
touching the corresponding areas. Stimulus intensity can be adjusted by
means of the arrows on the left.

Score. This keeps count of the correct/incorrect answers given by the

patient. The way in which responses are scored depends on the “Speech
score mode” chosen in “Settings” (see the Settings section).

Press the Reset button to reset the current score.
Masking. You can select masking signals from:

- MODE 1. The score is the percentage of correct answers versus the

total answers count.

- MODE 2. The score is the percentage of correct answers versus the

number of items selected in settings. Answers are marked in the
same way as for MODE 1, but clicking the button for an incorrect
answer decreases the final score by one.

- EXT1 if the stimulus signal is EXT2

48

- EXT2 if the stimulus signal is EXT1

- MIC if the stimulus signal is MIC

- WN, white noise

- SN, speech noise

Masking signal intensity can be adjusted using the corresponding arrows.
Store. Lets you store the current score. The score is reset automatically

when a new point is saved on the graph.
Delete. Lets you delete a stored score from the current intensity level.

THE SETTINGS MENU

The top-left of the archive window contains two icons. The former opens
the Settings menu described here while the latter opens the Print / Export
menu described in the next section.

PURE TONE

Maintain intensity. If this setting is enabled (ON), intensity is maintained
after switching to the next frequency. If it is disabled (OFF), the default
intensity is automatically selected.

Default intensity (dB). Lets you set default intensity for the audiometer
(between 0 and 60 dB).

Automatic frequency jump. Lets you enable or disable automatic switching
to the next frequency after saving the threshold level.

Frequency jump mode. Lets you choose the next frequency value after
maximum frequency (8 kHz) is reached. Selecting 8k→1k returns you to
1kHz, whereas selecting 8k→125 returns you to 125 Hz.

Frequency selection. Lets you choose the set of frequencies to test.
Up-arrow increases dB. If enabled, the channel intensity level may be

increased by pressing the up-arrow, otherwise the down-arrow.

SPEECH
Speech Score

Lets you choose between two different modes of scoring the patient’s

answers.

- MODE1: the examiner records both correct and incorrect answers;

the current score therefore refers to the number of words already
presented.

49

- MODE2: the examiner only records correct answers; the current

score therefore refers to the total number of the words in the list.
The total number of words may be changed by varying the items
number value.

Speech Words Number

Words Number. If “Speech score mode” is set to “MODE2”, this setting lets

you select the number of words for each list.

Pause after each word. If the speech material source is indexed, select ON
to pause playback automatically after each word or select OFF to enable
non-stop playback of words.

Speech Material. Lets you organise speech material on your iPad. Press a
heading to view the corresponding track list. You can delete a single list or
the whole folder by swiping the finger over the title and press the delete
button that appears.

Standard curves. Standard traces may be displayed on the speech graph as
references for normal response to such material. Up to 2 curves can be
shown and associated to a particular material.

BLUETOOTH COMMUNICATION

Bluetooth communication. You can enable (ON) or disable (OFF) Bluetooth
connection between your iPad and the Piccolo audiometer. Disable
Bluetooth communication only if you want to use the Maestro app offline.

Piccolo SN. This is the serial number of the Piccolo audiometer paired with
the iPad. To connect the iPad to another Piccolo audiometer, delete this SN
and enter that of the new audiometer instead.

EXAM DISPLAY OPTIONS

Different Symbols for AC Masked/Unmasked. AC masked and unmasked
points are represented with different symbols.

Different Symbols for BC Right/Left. BC right and left points are
represented with different symbols.

Link BC Symbols. Link BC symbols on audiograms.
BC symbol. Lets you select the BC symbol.
Symbol for Masked BC. Lets you select the symbol identifying the right BC

threshold with masking signal enabled.

50

PASSWORD

Password Protection. Lets you set a password to protect access to the app.
Password. Enter your chosen access password here.

PRINT/EXPORT
Export options.

Export To. Lets you select how to export exams using the “Documents
Folder” or “Email”. In the first case, exported files are stores in the Maestro

Documents folder and are accessible through iTunes. In the second case,
files are sent via e-mail, as attachments.

Default Recipient. Use this field to enter the default e-mail address to which
exported exams are to be sent.

Print Options.

Paper Size. Lets you choose the paper size for printing exam reports (A4 or
Letter).

Header Line 1. Header Line 2. Lets you edit the first and second lines of
report headers.

Backup.

New Backup. Creates a backup of the app, saving all patient data.

Restore Backup. Lets you restore the app from an old backup.

ABOUT

Information about the Maestro app.

THE PRINT/EXPORT MENU

EXPORT TO NOAH / DAISY

This function lets you export exams to a .nha / .dsy file that can be imported
into Noah / Daisy. You can choose whether to export exams only for the
current patient or for the whole archive. The file is sent via email to the
default recipient or stored in the Maestro documents folder, depending on
the export options setting (see previous section).

51

PDF REPORT

This function lets you generate a pdf report containing selected exams. The
document is automatically saved in the documents folder of the Maestro
app. Once the file has been generated, you can open it or send it via e-mail.

PRINT

This function lets you print a report containing one or more exams on an
AirPrint compatible printer.

53

For any cleaning operation, the device must be firstly switched off.

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.

DAILY CHECKS

CHAPTER 6

Maintenance

To ensure the audiometer correct functioning, it’s suggested to daily do the
following quick checks, before performing the first exam.

- Before switching on the instrument, check that all the contacts are

perfectly connected and that the cables and/or connectors as well
as all other elements do not appear to be broken or damaged
externally

- Check subjectively that the air conduction and bone conduction

output is equal on both channels and all frequencies, In order to do
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

54

- Check that the patient response switch, the control panel and the

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.

The eartips of insert earphones are not sterile.

All accessories of the audiometer are designed specifically for use
with the device. Only accessories supplied by Inventis should be
connected to the audiometer.

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

CLEANING

For cleaning the device, use a soft cloth moistened with ethyl alcohol.
The cushion of the headphones and the bone vibrator are made of
biocompatible material, but are not sterile. To avoid the infections spread, it
is necessary to disinfect them, before using these for another patient. For
whipping, use a commercial non-allergic disinfectant, following the
instruction given by the manufacturer.

The eartips of insert earphones and masking insert earphones are made of
biocompatible material and disposable: use once only and dispose of in
accordance with current health and safety regulations.

REPLACEABLE PARTS

The transducers and accessories can be disconnected from the device.
Should a fault develop in any one of these devices, the audiometer must be
switched off and isolated from the power supply, and the defective item
then disconnected from the device.

55

REPAIRS AND TECHNICAL ASSISTANCE

Before contacting the service department, make certain that all the possible
solutions in the “Troubleshooting” appendix have been tried.
There are no requirements for the sterilization or disinfection of parts being
returned to the manufacturer for repair and servicing (ISO 10940 §6 b).
Should the instrument need to be sent to the Inventis service department or
returned to the dealer, it is important that the original packing should be
used, and that all accessories and transducers are enclosed.

57

Technical specifications

AVAILABLE SIGNALS

Type

Basic

Plus

Speech

Pure tone

  

Warble tone

  

2 external inputs for speech audiometry

-

-



MIC input for live speech audiometry

-

-



Narrow-band noise (NBN)

  

White noise (WN)

-

-



Speech noise (SN)

-

-



Classification

Piccolo Basic

Type 4 pure tone audiometer (EN 60645-1 / ANSI S3.6)

Piccolo Plus and Speech

Type 3 pure tone audiometer (EN 60645-1 / ANSI S3.6)

APPENDIX A

58

SIGNALS SPECIFICATIONS

Attenuators step

5 dB

Presentation mode

Continuous
Pulsed, with rate of 0.5, 1 or 2 Hz

Frequency accuracy

0,1 %

Intensity accuracy

±3 dB between 125 Hz and 4 kHz
±5 dB above 4 kHz

Total Harmonic
Distortion (THD)

AC: less than 2,5 %
BC: less than 5,5 %

Warble tone

Frequency of the modulating signal: 5 Hz
Modulation waveform: sine wave
Modulation range: ±12%

NBN

Band: ½ octave, i.e.:

- lower cut-off frequency f l = f / 1.1892

- upper cut-off frequency f u = f · 1.1892
where f is the centre frequency

WN

Lower cut-off frequency: 100 Hz
Upper cut-off frequency: 24 kHz

SN

As specified in EN 60645-2 §13

External signals

EXT1 and EXT2 input: max 3 Vrms

AVAILABLE OUTPUTS

Output

Basic

Plus

Speech

Air conduction (TDH-39 or EARTone 3A / 5A
insert earphones)

  

Bone conduction (B-71 bone vibrator)

-





59

PURE AND WARBLE TONE

AVAILABLE FREQUENCIES AND MAXIMUM INTENSITES

Freq.

(Hz)

AC

TDH39

(dB HL)

AC

EARTone 3A

(dB HL)

AC

EARTone 5A

(dB HL)

BC

(dB HL)

125

80

90

90 - 250

100

105

100

45

500

110

110

110

65

750

115

115

120

70

1.000

120

120

120

75

1.500

120

120

120

80

2.000

120

120

115

80

3.000

120

120

115

75

4.000

120

110

110

75

6.000

105

95

100

55

8.000

95

90

90

50

SPEECH AUDIOMETRY

MAXIMUM INTENSITIES

AC

TDH39

(dB HL)

AC

EARTone 3A

(dB HL)

AC

EARTone 5A

(dB HL)

BC

(dB HL)

100

100

100

55

EXTERNAL SIGNALS LEVEL INDICATOR

(only for Speech model)

Type of indicator

VU-meter

Dynamic range

+3..-20dB

Input Voltage at 0 dB

1.5 Vrms

(*) Levels refer to devices powered by electricity network. In case they are
powered by USB, maximum levels decrease by 10 dB.

(*) Levels refer to devices powered by electricity network. In case they are
powered by USB, maximum levels decrease by 10 dB.

60

MASKING

AVAILABLE FREQUENCIES AND MAXIMUM INTENSITES

Freq.

(Hz)

AC

TDH39

(dB EM)

AC

EARTone 3A

(dB EM)

AC

EARTone 5A

(dB EM)

125

60

70

65

250

80

85

85

500

95

95

95

750

100

100

100

1.000

105

105

100

1.500

105

105

100

2.000

105

105

100

3.000

105

105

100

4.000

105

100

100

6.000

100

90

95

8.000

90

80

80

WN

90

80

80

SN

90

80

80

ACOUSTICAL SAFETY OF THE DEVICE

Alert condition

Tone intensity higher than 100 dB HL (EN 60645-1, §5.2)

Safety measures in
alert condition

1) The operator has to press “Higher dB” button to increase

the intensity over 100 dB HL

2) Warning on the display

3) “Normally on” function disabled

COMPATIBLE TRANSDUCERS

Type

Manufacturer

Model

Supra-aural headphones

Telephonics Corp.

TDH39

Insert earphones

Etymotic Research Inc.

ER-3A

Insert earphones

Etymotic Research Inc.

ER-5A

Bone vibrator

Radioear Corp.

B71

(*) Levels refer to devices powered by electricity network. In case they are
powered by USB, maximum levels decrease by 10 dB.

61

PATIENT – OPERATOR COMMUNICATION

Basic

Plus

Speech

Talk-over through external
microphone (not included)

  

Patient response trigger

  

AVAILABLE TESTS

Basic

Plus

Speech

Pure tone audiometry

  

Auto-threshold

  

Speech audiometry

-

-



AUDIOMETER CONTROL

Without AERO

option

With AERO

option

Through computer with Inventis Daisy
software and Maestro module.





Through computer with Noah software and
Noah Maestro module.





Through iPad with Piccolo app

-



COMUNICATION WITH THE AUDIOMETER

Computer

control

iPad control

USB 1.1



-

Bluetooth 4

-



62

MINIMUM REQUIREMENTS FOR THE CONTROL DEVICE

Computer

Operating system

Microsoft Windows XP SP3 or sup., 32 o 64 bit

Processor

Intel Core 2 Duo 1.6 GHz or sup.

RAM

1 GB (suggested 2 GB)

Minimum resolution

1024 x 600

iPad

Model

iPad 3 or following

POWER SUPPLY

Consumption

8 Watt

Power supply

6V, 1.67A cont., through an external 100-240 Vac 50/60
Hz power supply (included), compliant to EN 60601-1
standard

CALIBRATION

Calibration validity

12 months

ENVIRONMENTAL CONDITIONS

Use

Temperature: between 15°C (59°F) and 35°C (95°F)
Relative humidity: between 30% and 90% (non­condensing)

Transport and storage

Temperature: between -10°C (14°F) and 50°C (122°F)
Relative humidity: max. 90% non-condensing

Warm-up time

1 minute

MECHANICS

Size (LxDxH)

160 x 160 x 35 mm / 6.3 x 6.3 x 1.2 in

Weight (device only)

300 g / 10.6 oz

SOCKETS ON THE REAR PANEL

Description

Type

Connector

Power supply

In

DC plug 2.5 mm

L and R headphones

Out

2 audio jack, 1/4” mono

63

Bone vibrator (not in Piccolo Basic)

Out

Audio jack, 1/4” mono

Patient response trigger

In

Audio jack, 1/4” mono

External microphone for talk-over

In

Audio jack, 3.5 mm mono

USB

In - Out

USB type B

Only on Piccolo Speech

LINE IN 1 and LINE IN 2

In

Audio jack, 3.5 mm stereo

SPECS OF INPUT FACILITIES

Input

Electrical property

Power supply

Internal pin +6V, external pin 0V

Patient response

Switches 3V to logical input (switch current: 10mA)

LINE IN 1 and LINE IN 2.

Sensitivity: 3mV at max volume and 0Vu Impedance:
10K Ω
Freq. response: 75-12000Hz +/- 3dB

Microphone

Electret or 200 Ω dynamic microphone
Impedance: 47KΩ
Freq. response: 100-12KHz +/- 3dB
Electret Bias: 2.2V trough 2.2KΩ

SPECS OF OUTPUT FACILITIES

Output

Available Voltage

Nominal Impedance

L and R phones

8Vpp

10 Ω

Bone vibrator

8Vpp

10 Ω

SOUND ATTENUATION VALUES

Frequency

[Hz]

TDH 39 with MX41\AR or

PN 51 cushion

[dB]

ER 3A
ER 5A

[dB]

125

3

33.5

250

5

34.5

500

7

34.5

750

-

-

1000

15

35

1500

-

-

2000

26

33

3000

-

-

4000

32

39.5

64

6000

-

-

8000

24

43.5

REFERENCE EQUIVALENT THRESHOLD LEVELS

Freq

TDH 39

ER 3A

ER 5A

B71*

ISO 389-1

(ANSI S3.6)

ISO 389-2

(ANSI S3.6)

ISO 389-2

ISO 389-3

(ANSI S3.6)

[Hz]

[dB re 20µPa]

[dB re 20µPa]

[dB re 20µPa]

[dB re 1µN]

125

45

26

26

-

250

25.5

14

14

67

500

11.5

5.5

5.5

58

750

7.5 (8) 2 2

48.5

1000

7 0 0

42.5

1500

6.5 2 2

36.5

2000

9 3 3

31

3000

10

3.5

3.5

30

4000

9.5

5.5

5.5

35.5

6000

15.5 2 2

40

8000

13 0 0

40

APPLICABLE STANDARDS

Basic

Plus

Speech

EN 60645-1 / ANSI S3.6

Type 4

Type 3

Type 3

Calibration

AC: EN ISO 389-1 (TDH 39), EN ISO 389-2 (ER­3A e 5A),
BC: EN ISO 389-3

Electrical safety

EN 60601-1 Class IType BF

EMC

EN 60601-1-2

CE CERTIFICATE

93/42/EEC MDD classification

Class IIa

Classification rule
(Annex IX, 93/42/EEC)

10

Notified body

TÜV SÜD Product Service GmbH
Ridlerstrasse 65
D-80339 Műnchen

Number of the notified body

0123

Number of the Inventis CE certificate

G1 12 09 65346 006

(*) Calibration of bone vibrator (B71) refers to the placement on the mastoid.

65

APPENDIX B

Problem

Possible cause

Solution

No signal from a
transducer

Transducer not
connected to the
correct output

Connect the transducer to the
correct output

Transducer
damaged

Contact your dealer or service
provider

No signal from
patient response
button when
pressed

Wrong connection

Connect the patient response
button to the correct socket

Patient response
button damaged

Contact your dealer or service
provider

Connection
between PC and
audiometer
cannot be
established

Problems with USB
connection

Check the USB connection
between instrument and
computer

USB cable
damaged

Change the USB cable (standard
USB A/B cable)

Connection
between iPad and
audiometer
cannot be
established

Wrong Serial
Number

Check the serial number in the
Maestro app settings

iPad version not
compatible with the
audiometer

Substitute the iPad (it must be
the version 3 or successive)

Troubleshooting

66

The audiometer
does not feature the
Aero option

Substitute the audiometer

Faulty Bluetooth
module of
audiometer

Contact your dealer or service
provider

Unlikely exam
results

Expired calibration

Perform audiometer calibration

Wrong kind of
selected AC
transducer
(headphones or
earphones)

Modify the selection of current
AC transducer, from Maestro
module or app

When the audiometer is used in conjunction with a soundproof
booth, check that the connections both inside the booth and between
the booth and the instrument are correct and secure.

67

APPENDIX C

This device contains transmission module FCC ID: QOQBLE112
This device contains transmission module IC: 5123A-BGTBLE112

Electromagnetic emissions

The Piccolo audiometer is a Class B instrument according to IEC 60601-1-

2.
The Piccolo audiometer has been thoroughly tested and respects the limits
for electro-medical devices specified by IEC 60601-1-2 standards. These
limits ensure reasonable protection against hazardous interference in typical
medical installations.
The instrument generates, uses and radiates radio frequency energy. If not
installed and operated according to the instructions in this manual, it may
interfere with other nearby devices. No guarantee is given that interference
will not occur under certain conditions.
The existence of electromagnetic interference can be verified easily by
switching the instrument off and back on again. If it is proven that the
audiometer is indeed interfering with other devices, try to solve the problem
by adopting one of the following solutions:

- change the orientation and/or position of the affected device;

- move the two devices further away from each other;

- contact the manufacturer or authorised service organisation for

further assistance.

69

APPENDIX D

Bibliography

Pure Tone Audiometry

- Dirks D.D., Clinical Masking: a Decision-Making Process, Handbook

of Clinical Audiology, 132-146, Katz J. Editor, Williams & Wilkins
(1994).

- Hood JD. Principles and practices of bone conduction audiometry.

Laryngoscope; 70: 1211-1228 (1960).

- EN ISO 8253-1 standard, “Audiometric test methods. Basic pure tone

air and bone conduction threshold audiometry”.

Speech audiometry

- Penrod J.P., Speech Threshold and Word Recognition / Discrimination

Testing, Handbook of Clinical Audiology, 147-164, Katz J. Editor,
Williams & Wilkins (1994).

- EN ISO 8253-3 standard, “Audiometric test methods. Speech

audiometry”.

71