FLUTE & VIOLA

MIDDLE EAR ANALYZERS

USER MANUAL
 Read this manual thoroughly before using the device. Pay
particular attention to Chapter 1 (“Safety: warnings and
information”) and Chapter 3 (“Installation and power up”).

Internal inspections and repairs must only be performed by

authorized 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.

Document title: IM1D-User Manual En

Revision: 18
Date: 2021.12.03
 Summary
Foreword................................................................................................ vii
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 ............................................................................................... 5
Conformity.......................................................................................... 5
Symbols on labels................................................................................ 6
CHAPTER 2: Introduction...................................................................... 9
Main features ...................................................................................... 9
Basic configuration, accessories, optional parts, disposables ........... 13
CHAPTER 3: Installation and power-up ............................................... 17
Precautions ....................................................................................... 17
Connections....................................................................................... 18
Power-up and main screen ............................................................... 19
CHAPTER 4: Controls and probe ......................................................... 21
Controls for direct access to examinations ....................................... 21
Controls for conducting examinations ............................................. 22
Function buttons ............................................................................... 23
Dedicated pure tone and speech audiometry controls (Viola only).. 24
Gain control and playback of word lists (Viola Plus model only) .... 26
Patient - operator communication (Viola only) ................................ 28
The probe .......................................................................................... 29
CHAPTER 5: Tympanometry ................................................................ 33
The tympanometry window.............................................................. 33
Test parameters ................................................................................ 34

iii
 Test results ........................................................................................ 35
How the examination is conducted ................................................... 36
1000 Hz tympanometry (Flute Plus with optional license and Flute
HF) .................................................................................................... 37
CHAPTER 6: Acoustic Reflex, Reflex Decay and Quick tests ............... 39
Acoustic Reflex Test window ............................................................ 39
Modes of conducting the examination .............................................. 41
Manual pressure adjustment (Flute Plus only) ................................ 44
Reflex Decay test (Flute Plus and Viola Plus only) ........................... 45
Quick test A and Quick test B .......................................................... 46
CHAPTER 7: Eustachian Tube Function test (ETF) ............................ 49
ETF test with intact eardrum ........................................................... 49
ETF test with perforated eardrum ................................................... 52
CHAPTER 8: Pure tone audiometry...................................................... 55
Pure tone audiometry window.......................................................... 55
Presenting the tones and saving the reply ........................................ 57
UCL audiometry ............................................................................... 58
CHAPTER 9: Speech audiometry and QuickSIN™ test ........................ 59
Speech audiometry test ..................................................................... 59
Speech audiometry window .............................................................. 61
Use of internal speech material ........................................................ 65
QuickSIN Test .................................................................................. 66
CHAPTER 10: Interface with the computer ......................................... 69
Connection to PC .............................................................................. 69
CHAPTER 11: Settings ......................................................................... 71
Settings window ................................................................................ 71
User-settable parameters .................................................................. 71
CHAPTER 12: Maintenance ................................................................. 83
Periodic checks ................................................................................. 83
Calibration of compliance ................................................................ 85
Maintenance of Transducers ............................................................ 85

iv
 Cleaning the probe............................................................................ 86
Cleaning the instrument ................................................................... 88
Replaceable parts.............................................................................. 88
Loading the printer paper ................................................................ 88
Repairs and technical assistance ...................................................... 89
APPENDIX A: Technical specifications................................................ 91
APPENDIX B: Audiometric symbols................................................... 105
APPENDIX C: Troubleshooting ......................................................... 107
APPENDIX D: Electromagnetic Compatibility ................................... 111
APPENDIX E: Bibliography ............................................................... 117

v
 Foreword

Thank you for purchasing an Inventis audiology device.

Notwithstanding their compact dimensions and light weight, Flute middle ear
analyzers and Viola combo units are extremely powerful and versatile
devices, ideal for conducting fast and accurate diagnostic examinations of the
middle ear.
The Inventis company has always considered the use of its devices in
conjunction with computers to be a factor of key importance. Maestro
software, available with or without proprietary database or as Noah module,
can be used to connect any Inventis audiology device to a computer, so that
examinations can be archived in a database, and the examination currently in
progress can be displayed on the computer screen. We would also remind you
that Inventis has developed a complete line of audiology devices: in addition
to these middle ear analyzers, the company’s product line includes a range of
audiometers and a wireless video otoscope.

For further information, and to report any problems of whatever description

that may be encountered, contact the company at:

Inventis srl
Corso Stati Uniti, 1/3
35127 Padova (Padua, Italy)
Tel.: +39 049 8962844 – Fax: 049.8966343
[Link] info@[Link]

vii
 CHAPTER 1:

Safety: warnings and

information

OPERATOR MANUAL
Be sure to read this manual through completely, so that all of the features
offered by the instrument can be used to their full potential. In particular, be
sure to read this chapter in its entirety, as it contains information and warnings
that are of fundamental importance in ensuring safe and correct use of the
device.
The safety warning symbol illustrated below is used in this manual to draw
the attention of the reader to information of particular importance in matters
of safety, and to guard against incorrect use.

OPERATOR RESPONSIBILITIES
Flute and Viola middle ear analyzers guarantee consistent and dependable
performance only when used in accordance with the instructions and
procedures described in this manual.
Should the device need to undergo repair or maintenance work, it must be
disconnected from the electrical power supply, and not used again until after
this work has been completed. When defective or failed parts must be
renewed, accept only original replacement parts supplied by Inventis s.r.l.
Any repairs must be entrusted exclusively to Inventis or to service technicians
approved by Inventis.
No parts of the device must be modified or replaced without authorization
from Inventis.

1
The user of the device assumes full responsibility for any malfunction
resulting from improper use or operation, likewise from maintenance or
repair work performed by third parties other than Inventis s.r.l. or Service
Centers approved by Inventis. Inventis s.r.l. and approved Service Centers
will answer for the performance and reliability of the equipment only if:
1. adjustments, modifications or repairs have been entrusted to persons
authorized by Inventis;
2. the electrical power supply and ground connections of the system
comply with applicable standards for electromedical devices.

INTENDED USE
Flute and Viola middle ear analyzers are medical devices intended to measure
biomechanical characteristics of the patient’s middle ear to aid the operator
to evaluate its functional condition for diagnostic purposes.
Viola is also an audiometer. An audiometer is a device that helps the operator
in defining the patient’s auditory sensitivity by generating and delivering to
the patient sound stimuli of different types and intensities for diagnostic
purposes.

INDICATION FOR USE AND END USERS

Flute and Viola are 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 – especially the audiometric tests – must be conducted in a quiet
environment to avoid artifacts and to ensure that errors are not committed
when determining the hearing threshold.

PRECAUTIONS
To ensure correct and safe use of the middle ear analyzer, the following
precautions must be observed.

2
Installation and general precautions
Make certain that the required ambient conditions are met
(during transport, storage and operation) as indicated in
“APPENDIX A: Technical Specifications”.
Flute and Viola middle ear analyzers will not be protected if
exposed during use to flammable anesthetic gases or similar
products. Risk of explosion.
Avoid installing and using Flute and Viola middle ear analyzers
close to any sources of strong electromagnetic fields: these could
interfere with the operation of the instrument.
Use only original accessories supplied by Inventis s.r.l., unless
specifically indicated otherwise.
Use only power adapters intended for medical equipment,
certified to IEC 60601-1. For further information see “Appendix
A – Technical Specifications”.
Flute and Viola middle ear analyzers are medical devices: if
connected to a computer (or any external device) located within
the “patient area” (as defined in IEC 60601-1), this likewise must
be a medical device, or protected by an isolating transformer, in
order to ensure that the combination of computer (external
device) + middle ear analyzer is in compliance with IEC standard
60601-1.
Viola impedance-audiometers can be used in conjunction with a
soundproof booth to conduct tests under optimum acoustic
conditions. Before connecting the impedance-audiometer to a
soundproof booth, check that the sockets are compatible with the
specifications prescribed for each connector.
Flute & Viola need special precautions regarding EMC and
need to be installed and put into service according to the EMC
information provided in Appendix D.
Use of portable and mobile RF communications equipment can
affect the correct operation of Flute & Viola devices. Make
reference to the EMC information in the Appendix D.

3
Calibration
The calibration of the instrument is valid only for the transducers
supplied. If a transducer is replaced, the instrument must be
recalibrated.
The calibration is valid for transducers supplied with the
equipment, if connected directly to the instrument, without any
interposition of extension leads and without the passage from
connectors to panel (as habitually occurs in soundproof booth
installations). If the transducers are not connected directly to the
middle ear analyzer, a new calibration procedure will be
required before the instrument is used.
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.
Take note of the calibration interval indicated. Use of the
instrument beyond the calibration interval expiry date can lead
to unreliable diagnoses.

Hygiene
The ear tips of the middle ear analyzer probe are disposable,
likewise that of the insert earphone for contralateral stimulus,
and those of insert earphones; do not use the same ear tips for
different patients. Dispose of ear tips after use.
Disinfect the cushions of audio cups used for contralateral
stimulus or for audiometric testing between one patient and the
next, following the procedure described in Chapter 12:
Maintenance.

Use
The instrument is able to generate tones at an intensity potentially
damaging to the patient. Take particular care to set the intensity
of the tone correctly before it is presented.
Never insert the probe tip into the ear canal without affixing an
ear tip as this may damage the patient’s ear canal.

4
 Be sure to insert the probe tip in a way, which will assure an air
tight fit without causing any harm to the patient. Using a proper
and clean ear tip is mandatory.
Do not insert or in any way try to conduct measurements without
proper probe tip in place.
When conducting audiometry using Ear tone insert phones – do
not insert or in any way try to conduct measurements without
proper foam tip in place.
The desktop microphone shall be placed at a distance not greater
than 15 cm from the mouth to reduce the background noise

DISPOSAL
Like all electronic devices, Flute and Viola middle ear analyzers contain
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 middle ear analyzer must therefore
be disposed of separately.
At the end of its life, take or send the disused instrument to a public waste
collection 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 appliances from
recycled materials, limiting any negative impact on the environment and
public health that might otherwise derive from improper disposal.

CONFORMITY
Flute and Viola middle ear analyzers are class IIa medical device, according
to Annex IX of Medical Device Directive (MDD) 93/42/EEC, as amended by
directive 2007/47/EC.
The Inventis Quality Management System has been certified by leading
assessment body TÜV as compliant with ISO 13485 standard.

5
SYMBOLS ON LABELS
This symbol means that, for safe use of the device, it is important
that the user refers to the warnings contained in this manual.

Refer to instruction manual for 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.

Device with Body Floating applied parts (type BF- IEC 60601-1).

DC power supply

Product conforms to European Community Medical Device

Directive (MMD) 93/42/EEC, as amended by 2007/47/EC
directive. Class IIa device; number of notified body: 0123 (TÜV
SÜD Product Service GmbH).
Caution: Federal law restricts this device to sale by or on the order
Rx only
of a licensed healthcare practitioner
IP (Ingress Protection) Code: this device is protected against the
IP20
ingress of objects sized > 12.5 mm, not protected against liquids.
REF Catalogue number

Name and address of the manufacturer

Serial number of the device. The number is made up of 13

alphanumeric characters indicating the model, series, year of
manufacture and serial number. In particular, the number
SN comprises these segments:
- first 5 characters: Inventis product code
- characters 6 and 7: year of manufacture (“12” denotes 2012)
- characters 8… 13: incremental number

6
UDI code

7
 CHAPTER 2:

Introduction

This chapter describes the main features of the Inventis Flute middle ear
analyzer (Basic, Plus of HF version) and the Inventis Viola impedance-
audiometer, highlighting the differences between the models.

MAIN FEATURES
The Flute middle ear analyzer and the Inventis Viola impedance-audiometer
are portable devices with which tests can be performed on the middle ear
simply, swiftly and accurately. The two models, with their different
configurations, cover a wide range of needs, ranging from those of the private
medical practice to those of clinics and hospitals.
The main strengths of Inventis middle ear analyzers are:
- large and bright color graphics display, showing the results of
examinations graphically;
- highly ergonomic keyboard layout, reflecting thorough research and
extensive testing in the field;
- compact and intelligent design;
- interaction with computer, using Maestro software;
- (Flute HF, and Flute Plus with optional license) tympanometry at 1000
Hz, suitable for testing children
- (Viola Plus only) internal flash memory in which to store word lists used
for speech audiometry.

Flute middle ear analyzers are available in 3 versions, Basic, Plus and HF
offering these main features:
- Flute Basic: screening analyzer capable of performing tympanometry
and acoustic reflex tests in sequence and automatically.
- Flute Plus: provides the functions of the Basic model, plus the manual
tympanometry, the Eustachian tube function test for intact eardrums, the

9
 reflex decay test and the facility of conducting the acoustic reflex test in
manual mode. In addition, the pressure setting used for reflex tests can
be adjusted manually.
By means of an optional license to be enabled, it is possible to perform
also the 1000 Hz frequency tympanometry test.
- Flute HF: offers all features of the Basic model plus ETF (Eustachian
Tube Function) test for both intact and perforated eardrums. Can also be
used tympanometry testing at 1000 Hz.

The Viola impedance-audiometer combines the functions of the Flute Basic

middle ear analyzer (in the case of the Viola Plus, the reflex decay test is also
included) with the main audiometry tests, in particular:
- Viola Basic: pure tone audiometry using air and bone conduction.
- Viola Plus: pure tone and speech audiometry using air and bone
conduction.

All Flute and Viola models are available with or without built-in thermal
printer.

The following tables indicate the types of tests that can be performed with
each model.

Flute Basic
Exam Mode Outputs
TYMPANOMETRY Automatic --
Fixed intensity
IPSI,
ACOUSTIC REFLEX Automatic threshold
CONTRA
Growing intensity
Tympanometry + acoustic
IPSI,
QUICK A reflex (fixed intensity or
CONTRA
automatic threshold mode)
Tympanometry + acoustic
IPSI,
QUICK B reflex (fixed intensity or
CONTRA
automatic threshold mode)

Flute Plus
Exam Mode Outputs
Automatic
TYMPANOMETRY --
Manual

10
 Fixed intensity
Automatic threshold IPSI,
ACOUSTIC REFLEX
Growing intensity CONTRA
Manual
IPSI,
DECAY Manual
CONTRA
ETF TM intact --
Tympanometry + acoustic reflex
IPSI,
QUICK A and B (fixed intensity or automatic
CONTRA
threshold mode)

Flute HF
Exam Mode Outputs
TYMPANOMETRY Automatic --
Fixed intensity
IPSI,
ACOUSTIC REFLEX Automatic threshold
CONTRA
Growing intensity
TM intact
ETF --
TM perforated
Tympanometry + acoustic reflex
IPSI,
QUICK A and B (fixed intensity or automatic
CONTRA
threshold mode)

Viola Basic
Exam Mode Outputs Inputs
TYMPANOMETRY Automatic -- --
Fixed intensity
ACOUSTIC Automatic IPSI,
Pure tone
REFLEX threshold CONTRA
Growing intensity
Tympanometry +
acoustic reflex
IPSI,
QUICK A and B (fixed intensity or Pure tone
CONTRA
automatic
threshold mode)

11
 Stimulus:
pure tone,
PURE TONE AC, BC, warble
Manual
AUDIOMETRY Insert
Masking:
NBN, WN

Viola Plus
Exam Mode Outputs Inputs
TYMPANOMETRY Automatic -- --
Fixed intensity
ACOUSTIC Automatic IPSI,
threshold Pure tone
REFLEX CONTRA
Growing
intensity
IPSI,
DECAY Manual Pure tone
CONTRA
Tympanometry +
acoustic reflex
IPSI,
QUICK A and B (fixed intensity or Pure tone
CONTRA
automatic
threshold mode)
Stimulus:
pure tone,
PURE TONE AC, BC,
Manual warble
AUDIOMETRY Insert
Masking:
NBN, WN
Word
Recognition Stimulus:
Score (WRS) EXT1, EXT2,
Speech INT1, INT2,
SPEECH Recognition AC, BC, MIC
AUDIOMETRY Threshold (SRT) Insert
Most comfortable Masking:
Level (MCL) SN, WN,
Uncomfortable EXT1, EXT2,
Level (UCL) INT1, INT2
QuickSIN TEST - AC INT1, INT2
Inputs INT1 and INT2 denotes the internal flash memory, in which audio files
can be stored.

12
BASIC CONFIGURATION, ACCESSORIES, OPTIONAL
PARTS, DISPOSABLES

Basic configuration
Flute Flute Flute Viola Viola
Part
Basic Plus HF Basic Plus
Main unit (with or without
integrated thermal printer, • • • • •
according to the order code)
Control box with probe • • • • •
Shoulder strap for probe
• • • • •
control box
Wrist strap for probe control
• • • • •
box
Telephonics TDH-39 or
Radioear DD45 supra-aural
headphones for contralateral
stimulation • • • • •
OR
IME-100 insert earphone for
contralateral stimulation
Calibration cavities • • • • •

Assorted ear tips box • • • • •

Telephonics TDH-39 or
Radioear DD45 supra-aural - - - • •
headphones
B71 bone vibrator - - - • •

Patient response switch - - - • •

Monitor headphones with
- - - - •
microphone
Clip-on microphone for
patient-to-operator - - - - •
communication

13
 Flute Flute Flute Viola Viola
Part
Basic Plus HF Basic Plus
3pcs heat-sensitive paper
•1 •1 •1 •1 •1
rolls
Plastic cover sheet • • • • •
Medical grade power supply
• • • • •
(6V)
USB cable • • • • •

User manual • • • • •

Accessories

Flute Flute Flute Viola Viola

Part
Basic Plus HF Basic Plus
Etymotic ER-3C or RadioEar
- - - opt. opt.
IP30 insert earphones
IME-100 Insert masking
- - - opt. opt.
earphone
IME-100 Insert earphone for
opt. opt. opt. opt. opt.
contralateral stimulation
Desktop microphone for live
- - - - opt.
speech test

Optional parts
Flute Flute Flute Viola Viola
Part
Basic Plus HF Basic Plus
Carrying case opt. opt. opt. opt. opt.
Handheld adapter for
opt. opt. opt. opt. opt.
tympanometer probe
1 kHz probe tone license - opt. - - -

1
Only for printer equipped models
14
 Flute Flute Flute Viola Viola
Part
Basic Plus HF Basic Plus
QuickSIN® test license - - - opt. opt.
Amplivox Audiocups noise
- - - opt. opt.
excluding enclosures
Cable set for sound booth
- - - opt. opt.
with Jack sockets
Cable set for sound booth
- - - opt. opt.
with RCA sockets

Consumables
- Thermal paper for printer (box of 5)
- White tips (diam. 6 mm) – Set of 30
- Pink tips (diam. 7 mm) – Set of 30
- Violet tips (diam. 8 mm) – Set of 30
- Green tips (diam. 10 mm) – Set of 30
- Red tips (diam. 12 mm) – Set of 30
- Blue tips (diam. 14 mm) – Set of 30
- Orange tips (diam. 16 mm) – Set of 30
- Light blue tips (diam. 18 mm) – Set of 30
- Yellow tips (diam. 21 mm) – Set of 30
- Box with assorted tips – Set of 160
- Cleaning brushes for the tympanometers probe

15
 CHAPTER 3:

Installation and power-up

Whilst the installation of a Flute or Viola middle ear analyzer 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 instrument should need

to be sent to the dealer or to Inventis for any reason.

PRECAUTIONS
Like any other electrical or electronic device, the middle ear analyzer will
emit electromagnetic waves. Whilst the level of emissions is guaranteed to
be within statutory limits, other electronic devices operating in the immediate
vicinity could be affected, if particularly sensitive to electromagnetic
interference. If this should occur — interference is verifiable by switching off
the instrument and then switching on again — it may be possible to remedy
the problem by adopting 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 middle ear analyzer;
- plug the affected device into a power socket on a circuit other than
the circuit to which the middle ear analyzer is connected;
- consult the manufacturer or a service center for assistance.

17
CONNECTIONS
All connection points for accessories are located on the rear panel, as also is
the power switch. This section refers to the Viola Plus model. Certain of the
connectors mentioned are not present on Viola Basic and Flute models.

Plug all transducers and accessories into the respective sockets as indicated
in the following table:

Connector Accessory

PROBE Control box

AIR Air tube
Bone vibrator
Insert earphone for masking

Air conduction headphones right and left

Microphone used by operator for speech tests

Patient microphone

Operator microphone
Monitor headphones
Inputs and per for connection of external
audio sources used in speech audiometry
Patient response button
USB cable for connection to personal computer

Connect the power adapter to the input and to the relative power cord,
which should be plugged into an a.c. mains socket supplying the voltage
indicated on the adapter label.

18
 All connections must be made with the instrument switched off, that
is to say with the power switch set to position 0.
Use only the medical power adapter supplied with the device,
certified to IEC 60601-1. For further information see “Appendix A –
Technical Specifications”.

POWER-UP AND MAIN SCREEN

Once all cables and leads are connected, the instrument can be switched on
at the rear panel.

At the startup of the instrument, a pressure initialization is

performed: in order to complete initialization successfully the probe
must be steady and be kept outside of any cavity.

A few seconds after power-up, the display of the instrument will show the
main screen, illustrated below. The following screenshots are of the Flute
middle ear analyzer and the Viola impedance-audiometer.

Main screen of Flute (Plus) middle ear analyzer

19
 Main screen of Viola (Basic) impedance-audiometer

The main screen of the Flute model shows the examinations conducted for
each of the tests available. If no examination has been conducted, the label “-
--” is displayed.
In the case of Quick exams (a configurable sequential combination of
tympanometry and reflex test), the display shows the types of examination
that will be (or have been) conducted during the particular test.
To access an examination, simply press the corresponding button on the
keyboard.

On the Viola model, the main screen lists all the examinations available. To
run any one of these, select it by turning the left hand knob of the instrument
to highlight the name, then press the OK function button (or the STIMULUS
capacitive button).

The top part of the display shows the date, the current time and the Inventis
logo.
The bottom part of the display indicates the calibration interval expiry date
(12 months subsequent to the date of the last calibration) and, in the case of
the Viola model, the transducer selected for an air conduction test.

20
 CHAPTER 4:

Controls and probe

This chapter describes the controls incorporated into the keyboards of Flute
and Viola middle ear analyzers.

CONTROLS FOR DIRECT ACCESS TO EXAMINATIONS

To access the available examinations on Flute Basic, Plus and HF models,
press the relative button located in the top half of the keyboard, as illustrated
below. In order to select the ETF test and the 1000 Hz tympanometry test (if
enabled) on Flute Plus middle ear analyzers, it is necessary to access the
tympanometry test and press the function button 4 to enter, sequentially, the
1000 Hz tympanometry test and the ETF TM INTACT test.
Flute Basic

Flute Plus

Flute HF

21
The Led associated with the button will also light up to confirm the selection.
The Flute Plus and HF models have one button only for the selection of Quick
examinations. Pressing repeatedly, the appliance will toggle between Quick
A and Quick B, as indicated by the on/off status of the associated Led.

In the case of the Viola model, the examination is accessible only from the
main window of the instrument.

CONTROLS FOR CONDUCTING EXAMINATIONS

Right and Left. The Right and Left buttons are used to select the side being
examined.
Start/Stop. Used to initiate and terminate the examination currently selected.
As long as the examination is in progress, the associated Led remains alight.
Stimulus. Button active during acoustic reflex and reflex decay tests. This is
used to run (or repeat) the examination relative to the box currently selected
(yellow background), without having to repeat the entire test. This is a
capacitive type button: to run the test, simply touch the metal cap.
Left hand knob. Used to adjust the output strength of the stimulus. In practice,
these knobs are used in certain situations for other purposes; for example,
with the Settings menu activated, all the various settings of the instrument are
selected with the two knobs. When the knobs are used to perform a specific
function other than that of attenuating the channel output, the sector-shaped
indicator adjacent to the knob will light up.
Ipsi and Contra. These buttons can be used to select ipsilateral or
contralateral mode for the acoustic reflex test.
Stimulus Type. These buttons are used to select the type of stimulus presented
to the patient when conducting the acoustic reflex and decay tests.
Pressure. (Flute Plus only). Pressing the Pressure button, the tympanometry
test can be activated in manual mode or, if pressed internally of the acoustic
reflex decay or reflex latency screens, the instrument will show a screen
allowing adjustment of the pressure at which the test is conducted. The
pressure is changed by turning the right hand knob. The adjustment window
shows the current pressure, and the actual compliance value.

22
FUNCTION BUTTONS
The keyboards of Flute and Viola middle ear analyzers present two groups of
function buttons:
- four buttons associated with configurable soft keys, immediately below
the display;
- six dedicated function buttons, arranged across the top part of the
keyboard.
The function of the soft keys is changeable according to the status of the
instrument: for example, there will be one function when tympanometry is
enabled, and a different function when the acoustic reflex test is enabled. The
soft key functions are indicated at the bottom of the display window,
immediately above the buttons.
In this manual, the four buttons are denoted F1, F2, F3 and F4, from left to
right.

F1 F2 F3 F4

The six function buttons illustrated below are positioned uppermost in the
keyboard area.

Back. This is pressed to go back to the previous window. For example, if

Back is pressed during a tympanometry test, the main menu will reappear.
New Patient. Pressing the New Patient key will clear all examinations
conducted in the current session. If these have not been saved to a computer,
all the relevant data will be lost.

23
Erase data. Deletes data pertinent to the current graph of the examination. In
the case of tympanometry, for example, data relative to the selected side is
deleted, whereas in the case of the acoustic reflex test, only those items of
data pertinent to the current box and side are deleted.
Print. If the middle ear analyzer has a built-in thermal printer, pressing this
button will generate a printout of the current examination.
To PC. Sends the current examination to a computer, on which Maestro
software must be installed (refer to Maestro – Impedance-Audiometry
functionalities – User manual for more details).
Help. This button opens a context-sensitive window, i.e. displaying
information pertinent to the type of test being conducted. ‘Help’ provides
general information on the functions of the current window.

DEDICATED PURE TONE AND SPEECH AUDIOMETRY

CONTROLS (VIOLA ONLY)

Controls for the two channels

Viola impedance-audiometers have two separate and independent channels.
This section describes the controls used to operate the two channels, which
are identified as “stimulus channel” (left hand part of the keyboard) and
“masking channel” (right hand part).

Right and Left. The Right and Left buttons, provided only for the stimulus
channel, are used to select the side on which the stimulus is presented. The
masking signal will be presented automatically to the opposite side.
Output. The Output button is used to select the transducer utilized which,
depending on the type of test, can be:
- air conduction (AC –supra-aural headphones– / AC-INS –insert
earphones-)
- bone conduction (BC)
- insert type earphones for masking (INS).
Input. The Input button is used to select the input signal. The available signals
vary according to the channel. Possible inputs are:
- stimulus channel: tone and warble;
- masking channel: narrow band noise (NBN) and white noise (WN)
For speech audiometry, the possible inputs are:

24
- stimulus channel: external signals 1 or 2 (EXT1, EXT2), internal flash
memory (INT1, INT2) and external microphone (MIC);
- masking channel: external signals 1 or 2 (EXT1, EXT2), internal flash
memory (INT1, INT2), speech noise (SN) and white noise (WN).

Stimulus. This is the switch that turns on the stimulus channel. To eliminate
any possible mechanical switch noise completely — as this could influence
the response of the patient — the designers of the product opted for a
capacitive touch button: to present the stimulus, the operator needs only to
touch the metal cap.
Norm. ON. Selecting the “Normally ON” function for the channel (with the
green indicator alight), the relative output will be permanently active, unless
the channel is switched off by touching the switch. Activating the “Normally
ON” function, accordingly, the operating logic of the switch is inverted.
Enable. Switches the masking signal on or off. The masking function is also
activated by turning the right hand knob on the instrument.
Knobs. A knob associated with each channel is used by the operator to
attenuate the output.

Controls common to both channels

At the top of the keyboard there are three buttons, illustrated below,
controlling respective functions common to both channels.

Pulsed. Allows the selection of pulsed mode for presentation of the stimulus
signal. The pulse rate — 0.5 Hz, 1 Hz or 2 Hz — can be selected with the
relative function button.
Tracking. When the tracking option is selected, the difference between the
intensity of the stimulus and masking signals is maintained constant with any
variation in the intensity of the stimulus signal.
Lock. When the lock option is selected, the masking tone will be switched on
and switched off together with the stimulus tone. Selecting Lock has the
effect of deactivating the Enable button.

Frequency change and Store

25
The lower part of the keyboard on impedance-audiometer models includes
two frequency change buttons and the Store button, which are illustrated
below.

Frequency. The two frequency buttons are used to change to the previous
frequency and the next frequency. In the case of speech audiometry, these
two buttons are used to count the words recognized and not recognized by the
patient.
Store. Store is pressed to memorize the threshold at each frequency. The
instrument can be set in such a way that the test moves on to the next
frequency automatically, whenever the threshold is saved. For details on
configuration of the automatic frequency change, see Chapter 11: Settings

GAIN CONTROL AND PLAYBACK OF WORD LISTS (VIOLA

PLUS MODEL ONLY)
Grouped together at the top right of the Viola Plus keyboard are three buttons
controlling gain on external inputs, communications between patient and
operator, and the stimulus monitor, as illustrated below.

Talk. Pressing the Talk button, the display will show a volume control
window for communications between patient and operator. The left hand
knob controls the volume of communication from operator to patient, and the

26
right hand knob, communication from patient to operator. To quit the
window, press Talk a second time, or press function button F1.
The volume settings are retained even after the instrument has been switched
off.
Gain. Pressing the Gain button, which is active only when conducting tests
using speech audiometry inputs, the display will show a gain control window
for the speech material. Gain — controlled using the two knobs — determines
the level of the input signal currently selected, or the external input (EXT1 or
EXT2), or the internal flash memory (INT1 or INT2), or the microphone
(MIC). Gain values for each input are saved internally of the instrument, and
remain stored even after it has been switched off. See Chapter 8: Speech
audiometry, for a detailed description of the gain setting procedure.
Monitor. Pressing the Monitor button, the display will show a volume control
window for monitor signals used by the operator. Control is by way of the
two knobs, each serving one respective channel. To switch off the monitor on
either channel, simply turn the knob anti-clockwise right down to zero
volume. The monitor signal can be heard either on the internal speaker of the
instrument, or on headphones or external speakers connected to the Monitor
socket on the rear panel. The level of the monitor signal set during a speech
audiometry test is saved internally of the instrument and remains stored even
after the power has been switched off. For other examinations, the initial level
of the monitor signal can be the same as the level set for speech audiometry,
or can be set to zero, according to the type of setting selected (see Chapter
11: Settings).
The Viola Plus impedance-audiometer is equipped with an internal flash
memory of 2 GB capacity, where the operator can store lists of words in .wav
format for speech audiometry; accordingly, tests can be conducted without
the need for an external CD or cassette tape drive.
The top left of the keyboard on the Viola Plus model presents four buttons,
illustrated below, which are used to manage the playback of word lists stored
in the flash memory. The buttons are enabled in speech audiometry mode
only, when internal material (INT1 or INT2) is selected as the input signal.

27
Play / Pause. This button is pressed to start playing the current list (indicated
in the display), or to pause the list if already playing. The Led remains
permanently alight during Play, and blinks as long as Pause is selected. For a
detailed description of how word lists are organized in the internal memory,
see the final section of Chapter 8: Speech audiometry.
Stop. Terminates playback of the current list.
Previous. If there is no audio material being played currently, pressing the
Previous button will bring up the list preceding the current list. If there is a
list playing when the Previous button is pressed, the playback will jump back
either to the previous word (if the list is indexed), or by 5 seconds.
Next. If there is no audio material being played currently, pressing the Next
button will bring up the list that follows the current list. If there is a list
playing when the Next button is pressed, the playback will jump forward
either to the next word (if the list is indexed), or by 5 seconds.

PATIENT - OPERATOR COMMUNICATION (VIOLA ONLY)

The functions governing communication between the patient and the operator
are Talk over, Talk back (available on the Viola Plus model only), and the
Response Led.

Talk over. This enables the operator to talk to the patient, who will hear the
operator’s voice by way of the transducer currently selected. Communication
is enabled by pressing and holding the button, and disabled on release.
Viola impedance-audiometers have a microphone built into the chassis,
which can be used to communicate with the patient. If an external microphone
is plugged into the Talk over socket on the rear panel, the built-in microphone
will be disabled.
Pressing and holding the Talk over button, the operator can control the
communication volume by turning the stimulus channel knob.
If the MIC input is selected during speech audiometry so that the test can be
conducted using the operator’s own voice, the Talk over function is
automatically directed through the same input, given that in this instance the
operator will use the external microphone (connected to the MIC ot TALK
OVER input on the rear panel) to communicate with the patient.

28
Talk back. This function enables the patient to communicate with the
operator, and is available only on the Viola Plus model. Unlike Talk over,
Talk back remains enabled even after the control has been released; to
deactivate the function, the operator must press the button a second time.
The voice of the patient can be heard:
1) through the speaker incorporated into the chassis;
2) through headphones or external speakers connected to the “Monitor”
socket on the rear panel, which when plugged in will disable the internal
speaker.
To adjust the talk back volume, press the Talk button and turn the right hand
knob (refer to section on “Gain control and playback of word lists”).
Response. The Response Led, located in the middle of the keyboard, will light
up whenever the patient presses the response button.

THE PROBE
Flute and Viola middle ear analyzers feature a miniature probe, connected by
a signal lead and a small-bore air tube to the compact Control Box (CB),
which in turn is connected to the instrument. Despite being very small and
light, the probe is an active type, in other words incorporating speakers for
the probe tone and ipsilateral stimulation signals, and a microphone for
measuring compliance.

Probe status
The window for each examination presents an area on the left of the screen,
below the name of the test (see the figure below), showing information
relative to the current status of the probe (when there is no test in progress)
or to the test in progress.

29
The items that can be displayed are indicated below.

Indication in display Explanation

READY The examination is ready to start

Probe open: the compliance measured is

OPEN above the upper limit of the measurement
range
Probe blocked: the compliance measured
CLOSED is below the lower limit of the
measurement range
PRESSURIZATION / Pressurization / depressurization of ear
DEPRESSURIZATION canal in progress
Compliance is verified before starting an
COMPLIANCE CHECK acoustic reflex test. The stimulus will be
presented only when compliance is stable

IN PROGRESS Test in progress

Lack of airtight seal between probe and

PRESSURE LEAKAGE
ear canal

It will be noted that you may even start the test in the OPEN and CLOSED
situation. The PRESSURE LEAKAGE status is displayed on an orange
background and it terminates the examination in progress.

30
Control box (CB)
There are two buttons on the CB. The first has the same function as the
START/STOP button on the keyboard of the analyzer, described previously,
which starts and stops the examination. The second button can be pressed to
select the side on which the stimulus is presented.
There are also two LEDs, one of which indicates the ear being tested (red:
right ear; blue: left ear), the other indicating the status of the probe.
The colors and the frequency at which this second LED lights up indicate the
current status of the probe and of the examination, as indicated on the screen
(see description above).
In particular:

Green blinking: examination READY status

examination in progress
Green permanently (IN PROGRESS, COMPLIANCE
alight: CHECK, PRESSURIZATION,
DEPRESSURIZATION)
Yellow blinking: probe blocked (CLOSED)
Yellow permanently probe open, or lack of airtight seal
alight: (OPEN, PRESSURE LEAKAGE)

31
 CHAPTER 5:

Tympanometry

This chapter describes the tympanometry test. The test is the same for all
versions of Flute and Viola middle ear analyzers.

THE TYMPANOMETRY WINDOW

To conduct the tympanometry test, the operator simply presses the relative
button on the keyboard (in the case of the Viola model, the test must be
accessed from the corresponding item of the main menu).

The graphic interface of the tympanometry window is illustrated below.

226 Hz tympanometry test window

The name of the current test is indicated at the top left of the screen, and
immediately below, items of information relating both to the status of the
probe and to the progress of the test, as described in the previous chapter.

33
Lower down, the screen shows information specific to this particular test,
namely:
- the stimulation side;
- the mode in which the tympanogram is represented (compensated or
absolute);
- the rate at which the pressure sweep occurs during the course of the test.

The central area of the screen is occupied by the tympanogram relating to the
ear currently selected. Pressure values indicated at the ends of the horizontal
scale correspond to the initial positive value and the final negative value of
the sweep (selected via the instrument settings, see Chapter 11). When the
tympanogram is represented in absolute mode, a small triangle appears on the
right of the graph, indicating the current compliance measurement.
The right hand side of the screen shows the results of the test, which will be
described in detail in the relative section.

TEST PARAMETERS
The pressure sweep adopted during the course of the examination varies at a
rate that can be changed by way of function button 1 (P. RATE); the values
selectable for this parameter are: 50, 100, 200, 300 daPa/sec and 100-300
daPa/sec. In this latter mode, the rate of variation is regulated automatically
at 100 daPa/sec or at 300 daPa/sec according to the compliance measurements
acquired; the rate is higher when the variation in compliance is low, and lower
when the variation is high.

To adjust the compliance scale on the graph, simply press function button 2
(SCALE). The selectable values of the scale differ according to the current
method of representing the tympanogram (compensated or absolute). In
either case, it is also possible to select the option “auto”, in which case the
scale utilized will be selected automatically, so as to represent the acquired
data at the highest resolution possible. The indication of the scale currently
selected is provided by the relative soft key.

Function button 3 (COMP./ABS.) can be used to toggle the tympanogram

representation mode between compensated or absolute. In absolute mode, the
measured values of compliance are displayed directly, whereas in
compensated mode, these values are shown minus the equivalent volume of
the ear canal.

34
All the parameters mentioned above are saved automatically by the
instrument, and maintained at each successive power-up.

The function button 4 has different functionality depending on the model and
version of the instrument. On Flute Plus models, you can access the
Eustachian tube function test for intact eardrums by pressing the function
button ETF TM INTACT. If the license for the 1000 Hz tympanometry has
been enabled, the button allows to access the 1000 Hz tympanometry test
(“1000 Hz”) and, then, to the Eustachian tube function test for intact eardrums
(ETF TM INTACT).
On Flute HF models, the frequency of the probe tone can be changed by
pressing function button 4 “226 / 1000 Hz”: this will bring up the screen for
tympanometry tests conducted at high frequency, i.e. 1000 Hz. On the Viola
impedance-audiometer, function button REFLEX is also active, and gives
direct access to the acoustic reflex test window when pressed.

TEST RESULTS
The results of the examination are shown on the right of the window. The
following values are calculated:

ECV (Ear Canal Volume)

This is the compliance value measured at the pressure set for the start of the
test, or rather the highest pressure of the range selected for the test. This value
is also called the “equivalent volume”.

Compliance / Compliance (Abs)

Amplitude of the tympanogram peak measured against the ECV. In absolute
mode, this corresponds to compliance at the tympanogram peak.

Pressure
The pressure value registering at the tympanogram peak;

Gradient
This is the gradient of the tympanogram. It can be calculated by two different
methods, the selection of which is made from the settings screen (see Chapter
11).
The two calculation criteria are indicated below. Letter a indicates the peak
amplitude of the tympanogram, and b the difference between a and ECV:
- width of the tympanogram at 50% of b (expressed in daPa);

35
- letter c is the average of compliance values measured at pressures of +50
daPa and -50daPa, relative to the tympanogram peak. The gradient is
determined by the following formula: Gradient = (a - c) / b

In the event that it is not possible to determine the compliance or the

tympanogram pressure peak, the letters “N.F.” (NOT FOUND) will be
displayed in place of the value.

HOW THE EXAMINATION IS CONDUCTED

The first step is to select the ear tip best suited to the patient being examined,
and introduce the probe together with the ear tip into the patient's ear canal,
to the point at which a tight pressure seal is assured.
Having selected the ear to test, left or right, the automatic procedure can be
started simply by pressing the START/STOP button, or the corresponding
button on the CB.
Selecting the preferred option from the test settings (see Chapter 11), the
examination can be made to start automatically as soon as the instrument
detects that the probe has been positioned correctly in the ear canal.

Once the test is under way, the instrument raises the pressure in the ear canal
to the established maximum positive value, whereupon the recording of the
tympanogram will commence and continue until the pressure drops to the
minimum value, at the selected rate.

Only on Flute Plus models, it is possible to conduct the test in the manual
mode; simply press the PRESSURE button to prime the system and start the
test. Once maximum pressure has been established as indicated in the settings
(see chapter 11), the actual value can be adjusted by turning the right hand
knob on the instrument. With each change, the current compliance value will
be drawn on the graph.

When the pressure minimum value is reached, the indices described in the
previous heading are now calculated and displayed, and pressure in the ear
canal is returned to atmospheric, terminating the examination.

The current pressure value is indicated throughout the duration of the test by
the symbol “▲”, below the “x” axis of the tympanogram. The graph is
displayed normally in absolute (uncompensated) mode and will appear in
compensated mode — if selected — only at the end of the test.

36
1000 HZ TYMPANOMETRY (FLUTE PLUS WITH OPTIONAL
LICENSE AND FLUTE HF)
To conduct a tympanometry test using a 1000 Hz probe tone, simply press
function button function 4 (226 / 1000 Hz) in the tympanometry window. The
frequency setting currently selected will reappear when the window is next
opened.

The graphic interface of the 1000 Hz tympanometry window is illustrated

below.

1000 Hz tympanometry test window

The graphic interface is almost identical to that of the 226 Hz tympanometry

test window. The only difference is in the unit of measure used to indicated
compliance, namely mmho

The test parameters and results are the same as for the low frequency
tympanometry test, except for the tympanogram gradient, which does not
appear in this mode.

To start the test, simply press the START/STOP button or the relative button
on the control box, in exactly the same way as for the low frequency
tympanometry test.

The tympanometry test using a 1000 Hz probe tone can be enabled, by means
of a licence code, also on Flute Plus. To enable this functionality, it is
necessary to insert the license code inside the activation window, attainable
from the setup menu by accessing the Tympanometry submenu and selecting
“Enable tymp. HF” (see CHAPTER 11: “Settings”).

37
Once the license is enabled, to perform a 1000 Hz tympanometry test simply
press the function button 4 (“1000 Hz”) on the tympanometry window. The
same button, in the high frequency tympanometry window, allows to enter
the window for the Eustachian tube function test for intact eardrums (ETF
TM INTACT).

38
 CHAPTER 6:

Acoustic Reflex, Reflex Decay

and Quick tests

This chapter describes the Acoustic Reflex Test and the Reflex Decay Test,
which is available only on Flute and Viola Plus versions.

ACOUSTIC REFLEX TEST WINDOW

To conduct the acoustic reflex test, the operator simply presses the relative
button on the keyboard (in the case of the Viola model, the relative window
must be accessed from the main menu).

The graphic interface of the acoustic reflex window is illustrated below.

Acoustic Reflex Test window

This test can be conducted in different modes, which will be described in

detail further on. The current mode is indicated at the top left of the screen,
on a grey background. To change the test mode, simply press function button

39
1 (EXAM MODE); the last mode to be selected will be memorized by the
instrument.
Independently of the current mode, the bottom-left part of the display will
show items of information relating to the ear (side) being examined, to the
pressure used during the course of the test (Press.), and to the current
stimulus, namely:
- the transducer (Out), Ipsi or Contra;
- the frequency of the stimulus tone (Stim.);
- the intensity of the stimulus tone (Lev.).

As concerning pressure, the operator can choose whether to conduct the test
entirely at atmospheric pressure (the label “Atm.” is displayed), at the peak
pressure of the tympanogram (“Tymp. peak”) or at a pressure value resulting
from the difference between the tympanogram peak pressure and its width
(see Chapter 11). If no tympanometry test has been conducted, the pressure
is set in any event to 0 daPa.
When performing the reflex test with the Flute Plus model, the pressure at
which the test is conducted can be adjusted manually (the caption “Man.”
appears alongside the pressure value displayed); this functionality is
described further on.

Most of the screen is taken up by eight boxes, each one showing the curve of
the reflex obtained with a given stimulation signal. Pressing function button
2 (SCALE — Flute models only), the operator can vary the scale of the
compliance axis; possible intervals are -0.05 to 0.2 ml and -0.1 to 0.4 ml. It
is also possible to change the polarity of the reflex curve, as described in
Chapter 10.
The green bar internally of each box represents the stimulus on-time, in other
words the duration for which the stimulus is active. The duration of the on-
time is configurable (see Chapter 11).
Indicated under each box are details of the stimulus to which the curve relates
(side, frequency and intensity).
For greater visual clarity, reflex curves produced with ipsilateral signals are
represented in a color darker than that in which contralateral signals are
displayed.
The current box is highlighted by a yellow background; to navigate from one
box to another, simply turn the right hand knob.
Pressing function button 3 (ZOOM), the current box can be viewed in full
screen mode; this allows the operator to view the curve of the reflex in greater
detail. Also in this mode, the amplitude of the reflex is indicated. To exit full
screen mode, press “ZOOM” again, or use the BACK button.

40
Pressing function button 4 (SETTINGS), the operator accesses a window that
will allow the selection of settings relative to the method of conducting the
reflex tests.

In the case of Viola impedance-audiometer, pressing function button 4

(TYMP.) gives direct access to the tympanometry window, whereas to access
the settings, function button 2 must be used.

MODES OF CONDUCTING THE EXAMINATION

As mentioned in the previous section, the acoustic reflex test can be
conducted in various ways. Remember that the instrument will always default
to the configuration of the last test mode selected, for each ear.
Listed below are the different test modes that can be selected, which vary
according to the model and version of the instrument.

Fixed intensity
In this mode, the patient is presented with a single stimulus signal for each
box. All the boxes are preconfigured, and to set the types of stimulus, the
operator needs only press function button 4 to access the settings window.
The window with settings for the “fixed intensity” mode is illustrated below.

Window with settings for “fixed intensity” mode

As indicated in the table, which is the same for both stimulation sides, each
of the 8 boxes can be configured independently, applying the following
parameters:
- Enable: indicates the possibility of examining the box (Yes / No);
- Out: type of output utilized (IPSI / CONTRA);

41
- Stim.: type of stimulus, i.e. frequency of the tone;
- Int.: intensity of the stimulus tone.

It is also possible to enable and disable all the boxes in which the selected
outputs are the ipsilateral / contralateral by pressing the IPSI / CONTRA
button.

For reasons of safety, a warning appears whenever the operator selects a

stimulus signal of intensity higher than 100 dB HL.
Also, when exiting this screen, if at least one parameter has been changed,
the operator will be prompted to save the changes or retain the previous
settings (confirming, all data relating to the examination will be deleted).

The reflex test is started in the same way as other examinations, by pressing
the START/STOP on the instrument, or the relative button of the control box.
Once the pressure reaches the target value, all of the enabled boxes will be
examined, starting from the first. The test is terminated automatically once
all the boxes have been examined. Importantly, the stimulus is presented after
a step in which the stability of the measured compliance value is checked, as
described in Chapter 10.
If the examination is interrupted due to lack of pressure or because of “open”
/ “closed” status of the probe being detected, the sequence can be restarted
from the last box examined, simply by pressing the START/STOP button
again.
It is also possible to examine a single box. This is done by selecting the box
in question and pressing the STIMULUS button.

Automatic threshold
This mode differs to fixed intensity mode in that the minimum intensity of a
given stimulus able to induce the reflex — in short, the Acoustic Reflex
Threshold (ART) — can be found automatically.

Likewise in this mode, the boxes are preconfigured and, for each one, the
level displayed indicates the intensity at which the test is started, if there is
no existing data, or the intensity of the stimulus used to obtain the curve
represented.

To configure the boxes, the operator must press function button 4

(SETTINGS) to access the settings window. The characteristics of the boxes
are selected in the same way as for the fixed intensity mode, except for the
inclusion of the “Start” and “Stop” items indicating, respectively, the initial
level and the final level of the stimulus in the intensity threshold search.

42
Also from this window, the operator can select the intensity increment to
apply to the stimulus during the threshold search. Possible values are 5 dB
and 10 dB.

The procedure for starting the test on a single box, or examining all of the
enabled boxes in sequence, is the same as described in the previous section.
Considering the examination of a single box, the method adopted for
determining the threshold is described below.
The patient is presented with the stimulus at the set initial intensity and the
operator verifies — referring to a check-box alongside the stimulus on-time
— whether the measured compliance has varied in relation to the initial value
obtained with no stimulus, by at least an amount correlated to the selected
sensitivity (see Chapter 11). If there has been a significant variation, a further
check is made on the stability of the measurements in order to limit the
identification of false positives (artifacts).
When both these conditions are established, the ART has been found and the
test ends automatically. If this is not the case, once the box has been
completed, the stimulus is increased by the value of the selected increment,
and presented to the patient. This algorithm continues until such time as the
reflex is identified, or until the final intensity selected at the outset has been
reached.
If the examination should in fact continue to the point that the final intensity
value is reached without the threshold intensity being identified, this will be
indicated by the “N.F.” label (NOT FOUND).

Growing intensity
In this mode, the variation in amplitude of the reflex can be analyzed in
relation to the increase in intensity of the stimulus.
Up to two different stimulus signals can be examined on each side (particular
combination of output / type of stimulus). There are 4 boxes associated with
each signal, which show the reflex measured at progressively increasing
intensity.

The operator can select both the value of the increment (selectable values are
1 dB, 2dB and 5 dB) and the maximum possible intensity of the stimulus.
These parameters are established in the settings window, which is accessed
by pressing function button 4.
The method of starting the procedure is the same as for the other types of
reflex test. During the examination, the patient is presented with four stimulus
signals generated automatically at increasing intensity. If the intensity
exceeds the maximum set value, or the maximum value permitted by the type
of stimulus/transducer, the test will be interrupted.

43
Manual (Flute Plus only)
In manual mode, unlike the modes in which the boxes are preconfigured, the
details of the stimulus signal to be presented to the patient are selected
directly from the screen showing the test, using the dedicated buttons. In this
mode it is possible to perform the exam without sending any stimulus (“NO
STIM.”).

Pressing the START/STOP button the test will begin, or rather, a pressure
equal to that indicated in the display is established in the ear canal. The
characteristics of the current stimulus are displayed as captions over the
active box. Pressing STIMULUS, the stimulus signal is presented to the
patient, and at the same time, data will be acquired and displayed. The
pressure will be maintained until the operator ends the examination (by
pressing the START/STOP button).
The operator can navigate from box to box during the test, and examine other
conditions. Also, if the type of stimulus is changed, then as one box finishes,
the test will pass on to the next box automatically.
Parameters associated with this mode are the facility of maintaining the
current level unaltered when the type of stimulus is changed and the
opportunity to set a default level for the stimulus (access is gained by pressing
function button 4).

MANUAL PRESSURE ADJUSTMENT (FLUTE PLUS ONLY)

To access the window allowing adjustment of the pressure level, illustrated
below, the operator must press the PRESSURE button.

Pressure adjustment window

44
The area at the top left of the screen indicates the status of the probe, whilst
the central area is occupied by two horizontal bars indicating the measured
compliance values and the current target pressure.
If a tympanometry test was conducted beforehand, the peak value of the
tympanogram will be indicated above the compliance bar.

To set the pressure at a desired value, the operator turns the right hand knob.
Also, if the operator wishes to set the pressure value swiftly to atmospheric,
this can be done by pressing function button 3 (0 daPa).

Pressing the BACK button, the previous screen reappears and the target
pressure of the test is set to the value selected immediately beforehand.

REFLEX DECAY TEST (FLUTE PLUS AND VIOLA PLUS

ONLY)
To run the acoustic reflex decay test, simply press the corresponding button
on the keyboard.
The decay test window is illustrated below.

Acoustic reflex decay test window

The organization of the interface is similar to that of the acoustic reflex test,
with the left hand part of the display showing information on the current
stimulus, and the remaining area occupied by graphs.

Four graphs are available for each ear, in exactly the same way as for the
acoustic reflex test. With two of the four graphs shown in the test screen, the
operator can navigate from one to another using the right hand knob.

45
As regards conducting the examination, the method applied is the same as
that used for the acoustic reflex test in manual mode. Furthermore, it is
possible to perform the exam without sending any stimulus (“NO STIM.”).
Once the test is under way, the following information will be superimposed
on the current graph: number of test, threshold intensity (ART) associated
with the current stimulus (obtained during the course of the reflex test in
“threshold search” mode), and the characteristics of the stimulus.
The ART information is useful as the decay test is conducted generally at
10dB above the reflex threshold.
The stimulus on-time can be set at 10 or 20 seconds (see Chapter 11) and is
represented in the graph as a green bar.

In the case of the Flute Plus model, if the intention is to change the pressure
value, the operator can simply press the PRESSURE button to access the
pressure adjustment screen.
At the end of the examination, the results are shown below the corresponding
graph together with the characteristics of the stimulus. The indices shown are:
- T(50%)
The moment (in seconds) at which the reflex registers a decay equivalent
to 50% of the maximum amplitude. Also, the region of the graph in
which the decay is less than 50% appears in a light shade of green;
- C (10s) or C(20s)
Percentage reduction in reflex amplitude at the end of the stimulus,
compared to the maximum value.

The indices will appear with the label “--” if the test has not yet been
conducted, or if they cannot be calculated.

QUICK TEST A AND QUICK TEST B

Quick A and Quick B are sequential tests in which the tympanometry test and
then the acoustic reflex test are run automatically in sequence. From the
settings window (see Chapter 11), the operator can configure the mode of
conducting the acoustic reflex test (choice between fixed intensity and
automatic threshold modes) and the type of stimulus to be presented to the
patient for each of the 8 boxes.

Access to the Quick tests will differ according to the instrument model, as
described in previous chapters.

46
The graphic interface of the test reflects that of the tympanometry and
acoustic reflex tests described under previous headings. To change the type
of test displayed, simply press function button 4.

To start a Quick test, the operator must press the START/STOP button (or
the relative button on the CB) from one of the two screens of the test; the
tympanometry test and the acoustic reflex test will then be run in sequence.
The sequence terminates automatically on completion of the last test.

The data obtained from Quick tests will not overwrite the data acquired
conducting the tympanometry and acoustic reflex tests individually.

47
 CHAPTER 7:

Eustachian Tube Function test

(ETF)

This chapter describes the Eustachian Tube Function (ETF) tests, which are
available on Flute Plus and Flute HF models. The test can be conducted both
on patients whose eardrums are intact, and on patients having a perforated
eardrum (the latter mode is available on Flute HF only).

ETF TEST WITH INTACT EARDRUM

On Flute HF middle ear analyzers, you can access the ETF test simply by
pressing the corresponding button on the keyboard. Function button 4 is used
to select the type of test, i.e. with intact eardrum (ETF- TM intact) or with
perforated eardrum (ETF – TM perforated). On Flute Plus models, it is
possible to access the ETF test from the tympanometry test window by
pressing the function button 4 (ETF TM INTACT). On Flute Plus with the
1000 Hz tympanometry license enabled, the exam is accessible with the F4
button (ETF TM INTACT) from the 1000 Hz tympanometry window.
The graphic interface of the ETF intact eardrum window is illustrated below.

Window for ETF test with intact eardrum

49
The graphic interface is very similar to that of the tympanometry test; the
only differences are in the right hand side of the screen, showing the results
of the examination, which are described in detail on the following pages.

The central area of the screen is occupied by the graph relating to the ear
currently selected. Pressure values indicated at the ends of the horizontal
scale correspond to the initial positive value and the final negative value of
the sweep (selected via the instrument settings, see Chapter 11). As in the
case of the tympanometry test, when the tympanogram is represented in
absolute mode, a small triangle appears on the right of the graph, indicating
the current compliance measurement.

Test parameters
The parameters that can be set directly from the ETF screen are the same as
those described for the tympanometry test In particular, the user can:

- change the rate of the pressure sweep adopted during the course of the
examination, by way of function button 1 (P. RATE);
- adjust the compliance scale on the graph, pressing function button 2
(SCALE). Remember that the selectable values of the scale differ
according to the current method of representing the tympanogram
(compensated or absolute);
- toggle the tympanogram representation mode between compensated or
absolute, using function button 3 (COMP./ASS.). In absolute mode, the
measured values of compliance are displayed directly, whereas in
compensated mode, these values are shown minus the equivalent volume
of the ear canal.

All the parameters mentioned above are saved automatically by the

instrument, and retained at each successive power-up.

How the examination is conducted

The first step is to select the ear tip best suited to the patient being examined,
and introduce the probe together with the ear tip into the patient's ear canal,
to the point at which a tight pressure seal is assured.
Having selected the ear to test, left or right, the procedure can be started
simply by pressing the START/STOP button, or the corresponding button on
the control box.

50
The test is based on the automatic acquisition of three tympanograms under
different patient conditions, as follows:

First tympanogram
For the acquisition of this first tympanogram, the patient is allowed to remain
entirely passive. Both the initial positive pressure and the final negative
pressure can be configured from the settings window (see Chapter 11).

Second tympanogram
On completion of the first tympanometry test, the pressure in the ear canal is
raised automatically to +400 daPa. Once the higher pressure has been
established, the patient is asked to swallow several times, thereby forcing
open the Eustachian tube. Once the patient has complied with the instruction,
simply press and hold the CONTINUOUS function button or the START
button on the probe control box to record the second tympanogram.

Third tympanogram
As soon as the second tympanogram has been recorded, the pressure in the
ear canal is lowered automatically to –400 daPa. In the same way as for the
previous step, the patient is asked to swallow several times so that the
Eustachian tube will be forced open. To record the third tympanogram,
simply press and hold the CONTINUOUS function button or the START
button on the probe control box as before.

It will be noted that the three tympanograms are represented in varying shades
of red (if the stimulus is presented to the right ear) or blue (if the stimulus is
presented to the left ear).

Test results
The results of the examination are shown on the right of the window. The
following values are calculated:

ECV (Ear Canal Volume)

This is the compliance value measured at the pressure set for the start of the
test, or rather the highest pressure of the range selected for the test. This value
is also called the “equivalent volume”.

Pressure
The pressure values registering at the tympanogram peak. The pressure
indicated in the box named Pressure 1 is the level recorded during the first

51
acquisition; Pressure 2 indicates the peak pressure measured during the
second recording (the patient is asked to swallow when pressure in the middle
ear registers at +400 daPa); Pressure 3 indicates the peak pressure measured
during the third recording (the patient is asked to swallow when pressure in
the middle ear registers at -400 daPa).

In the event that it is not possible to determine one of the tympanogram

pressure peaks, the letters “N.F.” (NOT FOUND) will be displayed in place
of the value.

ETF TEST WITH PERFORATED EARDRUM

The graphic interface of the ETF perforated eardrum window is illustrated
below.

Window for ETF test with perforated eardrum

The organization of the interface is the same as for all other tests. The left
hand part of the window shows information relative both to the status of the
probe and to the examination: progress, maximum pressure value and
duration.

The central area of the screen is occupied by the graph relating to the ear
currently selected. The graph shows a curve representing the pressure level
in the ear canal during the course of the test.

52
Test parameters
All the parameters of this test can be set directly from the ETF screen,
whereupon they will be saved automatically by the instrument and
maintained at each successive power-up. In particular, the user can select the
maximum pressure (function button PRESS. MAX) or rather, the pressure
that must be established in the middle ear of the patient to allow an assessment
of Eustachian tube function. Pressure values between –600 daPa and +400
daPa can be selected, in 100 daPa increments (it is not possible to select
atmospheric pressure).

To adjust the duration of the test, simply press function button 3

(DURATION). Selectable values are 20, 30, 40 or 50 seconds.

As indicated previously, the user can switch to the window for ETF testing
with intact eardrum by pressing function button 4 (TM INTACT).

How the examination is conducted

Having selected the ear tip best suited to the patient being examined, and
introduced the probe together with the ear tip into the patient's ear canal,
simply select the side, left or right, and press the START/STOP button (or
the relative button on the control box) to start the test.

Once the test has been started, the patient’s ear canal is pressurized to the
selected value, whereupon the pressure pump shuts off automatically.
Thereafter, the patient will be asked to swallow repeatedly so that the
Eustachian tube can be forced open. If this occurs, the user will see a drop in
the pressure level measured by the instrument.

Test results
Results are calculated automatically and displayed in the right hand side of
the window. The screen shows a table with three pairs of values, each pair
consisting in two pressures of which the first indicates the measurement of a
significant variation in pressure, and the second is the same value when
stabilized. Accordingly, these pairs of values can identify the pressures at
which the Eustachian tube opens (indicated by the label “O”) and closes
(indicated by the label “C”).

53
 CHAPTER 8:

Pure tone audiometry

The Viola impedance-audiometer is capable of performing pure tone

audiometry tests both by air and bone conduction, as described in this chapter.

PURE TONE AUDIOMETRY WINDOW

To conduct a pure-tone audiometry test, the operator must first bring up the
relative window from the main menu.
Once accessed, the window in question can be presented in one of two ways,
depending on the viewing mode selected.

Viewing mode with audiogram

55
 Viewing mode without audiogram

To toggle between these two modes, in the case of the Viola Basic, simply
press the F4 (DISPLAY) button; the current mode will be “remembered” by
the instrument when it is next powered up. On Viola Plus models, conversely,
the viewing mode is selected from the settings menu of the instrument (see
CHAPTER 11: Settings); the speech audiometry window can be accessed
directly by pressing function button 4.
Selecting the first mode, the screen will show the audiogram for the
stimulation side currently selected, with the various items of information
displayed in smaller characters to accommodate the graph.
In either mode, the left- and right-hand sides of the screen will show the
information, on a grey background, relating respectively to stimulus channel
and to masking channel, namely:
- level of intensity;
- status of channel (active or inactive);
- input signal (IN);
- transducer (OUT);
- stimulation side.
Also displayed, at the bottom right and left in the case of the audiogram
viewing mode, or centrally in the case of text-only mode, are:
- stimulation frequency;
- presentation mode (continuous or pulsed, with or without the pulse
frequency);
- type of threshold selected (HL or UCL, available only in the case of air
conduction), which in text-only mode can also be accompanied by the
threshold level saved for the current type of transducer, side and
frequency of the stimulus channel;
- status of patient response button.

56
In the graphic viewing mode, the central area of the screen is occupied by the
audiogram relating to the stimulation side currently selected. The horizontal
and vertical lines on the audiogram indicate the frequency and sound intensity
values currently selected for the stimulus channel. The grey area in the lower
part of the audiogram indicates the frequency and intensity values that cannot
be covered with the selected transducer.
There are two others possible viewing modes (see CHAPTER 11: Settings):
- separated audiograms: left and right ear are on separated audiograms
(default);
- single audiogram: both ears are on the same audiogram.

PRESENTING THE TONES AND SAVING THE REPLY

Before commencing a pure tone audiometry test, the stimulation parameters
must be set, and in particular:
1) the input signal on the stimulus channel: tone or warble;
2) the input signal on the masking channel: NBN or WN;
3) the transducer for the stimulus channel: headphone (AC), bone vibrator
(BC);
4) the transducer that delivers the masking signal: headphone (AC), bone
vibrator (BC) or insert earphone (INS);
5) the method of presenting the stimulus — continuous or pulsed (PULSED
button); in the case of pulsed mode, the pulse frequency (0.5, 1 or 2 Hz)
can be selected with function button F2 (PULSE RATE);
6) the side to which the stimulus is presented: right (R), left (L) or bilateral
(BIL, not available if the output is BC);
7) the intensity and the frequency of the stimulus and of the masking signal.

Remember that the masking signal is automatically set as contralateral to that

of the stimulus. Once these parameters have been set, the stimulus signal can
be presented by touching the STIMULUS button, or the [Link] button
can be pressed to keep the signal constantly active (in this instance, touching
the STIMULUS button will have the effect of discontinuing the signal). The
masking signal can be constantly activated by means of the ENABLE button.
For a description of the TRACKING and LOCK functions on the masking
channel, see Chapter 4: Controls and probe.

Remember that for safety reasons, if the intention is to present a stimulus

signal stronger than 100 dB HL, the operator must first press the F1 function

57
button (HIGHER dB), which is active only when the intensity of the stimulus
reaches 100 dB HL.

Having identified the audiometric threshold of the current frequency, it can

be saved by pressing the STORE button. In graphic viewing mode, a symbol
will appear on the audiogram, corresponding to the signal presented at the
frequency and intensity currently selected (see Appendix B for a list of the
symbols utilized). In text-only viewing mode, on the other hand, the hearing
threshold saved for the frequency in current use is indicated below the
frequency display field.
If, at a given frequency, the tone presented is not heard by the patient even at
the maximum available intensity, the signal can be marked as “not heard” by
pressing the F1 function button (NO RESP), which will be active only when
the intensity of the signal is at its maximum value.

Should an error occur when saving a threshold, the operator can press the
STORE button a second time, at the correct intensity — which will have the
effect of repositioning the threshold at the new value — or delete the
threshold value using the ERASE DATA button.

UCL AUDIOMETRY
The UCL (Uncomfortable Level) test is used to determine the sound intensity
at which acoustic stimuli become intolerable to the patient. This information
is important in establishing the upper limit of the patient’s hearing range,
typically for the purpose of fitting hearing aids, as well as for detecting
instances of recruitment.
To run a UCL test, which is possible only by air conduction, simply press the
F3 function button (HL/UCL); the audiometer display will indicate the type
of threshold currently selected.

58
 CHAPTER 9:

Speech audiometry
and QuickSIN™ test

In addition to pure tone audiometry, the speech audiometry exam can be

conducted on the Viola Plus model. This chapter explains how to conduct a
speech audiometry test.

SPEECH AUDIOMETRY TEST

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. To understand how a patient hears the spoken voice,
speech stimuli must be utilized, and the testing method is referred to as
“speech audiometry”.
In speech audiometry, the patient is presented with a succession of
standardized speech stimuli, typically single syllables, words or phrases,
designed to assess certain aspects of the patient’s hearing ability. The speech
material can be presented directly by the operator, talking into a microphone,
or recorded on a CD or a tape cassette and reproduced by a player connected
to the EXT inputs of the impedance-audiometer, or alternatively, stored in a
flash memory with which the instrument is equipped.

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

59
 CD, cassette (inputs Microphone
EXT 1 and 2) (MIC input)

Selection
of input
Flash memory
(INT1 and INT2 inputs)

Adjustment of
input gain

Attenuator

Selection
of ouput
Right or left
Bone vibrator
headphone

Selection of input
The input signal for speech audiometry can be the microphone (connected to
the MIC or TALK OVER input on the rear panel depending on the setup), an
external audio source (CD or cassette player) connected to inputs EXT1 and
EXT2 or the internal flash memory (INT1 or INT2), on which the speech
material is already stored. The signal is selected by pressing the INPUT
button on the impedance-audiometer.

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 voice of the operator in
the case of a live speech test) will be played back at the correct volume. In

60
the case of recorded speech material, the input gain will be correct if, applying
a calibration tone supplied with the speech material, the loudness measured
on the VU-meters of the two channels — displayed on the Viola screen —
touches 0 dB, that is to say, the point at which the meter changes from green
to red.
In the case of a live speech test, the gain will be correct if the mean value
measured by the VU-meter of the stimulus channel is 0 dB when the test
words are spoken and the distance between mouth and microphone is the
distance maintained normally during the test.
If the level is incorrect, press the GAIN button and make the necessary
adjustment using the two knobs.
The gain level for each input is saved by the instrument and will be set again
at the same level even when the instrument is switched off and powered up
subsequently.

Attenuator
The speech signal is adjusted to the level set by the operator (level of stimulus
channel).

Selection of output
The speech signal can be presented to the patient though headphones (AC),
or by way of the bone vibrator (BC). In the case of headphones, the operator
can select the side to which the stimulus is directed, namely right, left or
bilateral (pressing the LEFT and RIGHT buttons simultaneously). To select
the output transducer, press the OUTPUT button.

SPEECH AUDIOMETRY WINDOW

To run a speech audiometry test, the relative window must be opened from
the main menu.
The Viola Plus impedance-audiometer can perform four different speech
tests:
- Word Recognition Score (WRS)
- Speech Recognition Threshold (SRT)
- Most comfortable Level (MCL)
- Uncomfortable Level (UCL)

To change the current test, simply press function button F3.

WRS test

61
Depending on the current viewing mode (see Chapter 11: Settings), the WRS
window will appear as in one of the following illustrations.

Viewing mode with articulation function

Viewing mode without articulation function

In the graphic viewing mode, the screen will show the articulation curve for
the stimulation side currently selected, with the various items of information
displayed in smaller characters to accommodate the graph.
The items of information relating to the stimulus channel (channel 1) and to
the masking channel (channel 2), i.e.:
- level of intensity,
- status of channel (active or inactive),
- input signal (IN),
- transducer (OUT),
- stimulation side,

62
are grouped together in an area with a grey background located, in the graphic
viewing mode, on the left hand side of the screen, whereas in text-only
viewing mode the items are displayed on the left (channel 1) and on the right
(channel 2) of the screen.
The remaining part of the screen shows:
- number of correct and incorrect responses elicited from the patient;
- percentage of correct responses. This value is determined on the basis of
the method selected in the settings (see Chapter 11: Settings);
- VU-meters relative to the two channels (or stimulus channel only, if the
input of the masking channel is SN or WN).

If the input selected for the stimulus channel is the internal flash memory, the
following information will also be displayed:
- speech material currently selected;
- number of the current list;
- the last word presented to the patient (only if the material is indexed: see
next section);
- symbol indicating the status of the player (play, pause or stop).

The furnished talk over microphone or the optional desktop microphone can
be used to perform live speech audiometry, depending on the option selected
on the instrument settings at the “Live speech microphone” item (see
CHAPTER 11: Settings).

The desktop microphone shall be placed at a distance not greater

than 15 cm from the mouth to reduce the background noise

The responses given by the patient are saved by pressing the two frequency
selection buttons, which are also labeled CORRECT and INCORRECT. The
mode in which the responses are saved will depend on the “Speech score
mode” option selected in the settings for the instrument (see Chapter 11:
Settings).
Whatever the counting method selected, a correct response is recorded by
pressing the CORRECT button. In the event of an incorrect response, press
INCORRECT if Mode 1 is selected; if Mode 2 is selected, do not press any
button. With Mode 2, in effect, pressing the INCORRECT button will have
the effect of reducing the ‘correct’ count by one; accordingly, this is used
only to rectify an error, when an incorrect response has been identified
mistakenly as correct.
With Mode 1, the function key F2 (RESET SCORE) is active; this resets the
current correct / incorrect answer counters and the percentage.

63
If the option ‘WRS single point’ has been enabled from the setting menu, the
Word Recognition Score is calculated as a single point instead of using a
graph. In this case, when the current output is air conduction, you can select
the same input for both channels. Therefore, it is possible to simultaneously
send the stimulus to the right and left ear at different levels.

Pressing the F4 function button (PTA), the user can go directly to the pure
tone audiometry window.

SRT, MCL and UCL tests

Selecting any one of these tests, the articulation function and information on
the number of correct answers will not be displayed. Instead, the screen
shows the results for the current test — left ear and the right ear — as
illustrated below.

SRT test window (Numerical view)

64
 SRT test window (Graphic view)

Remember that if the Free Field equivalent filter for the supra-aural
headphone (TDH-39 or DD45) output has been enabled in the settings, this
information will appear in the top part of the window. The purpose of this
filter (the pertinent specifications are indicated in reference standards) is to
make the results of speech audiometry conducted through headphones as
similar as possible to those obtained in free field conditions.

USE OF INTERNAL SPEECH MATERIAL

The Viola Plus impedance-audiometer is equipped with a 2 GB flash
memory, on which preferred speech material can be stored using the Audio
Tracks Indexing Tool (ATIT), included in the Inventis Software Suite.
The use of material stored in this way has two key advantages:
1) CD players or external cassette tape machines can be avoided (these tend
to be delicate and cumbersome, and are not medical devices);
2) if the material is indexed using the ATIT software application, each word
will be displayed on the screen as it is presented, and there is no need to
activate the monitor signal.
To use material stored in the flash memory, simply select INT1 (or INT2) as
the input on the stimulus channel, and possibly on the masking channel if a
competing sound is to be utilized for the test.
The internal flash memory is organized as follows:
- a directory with a set of folders, each one identifying the type of material
stored (for example, logotomes, spondees, phrases, etc.);
- each folder contains a set of wave files, corresponding to the lists of
words of the type identified by the name of the folder; the filename,
attributed by the ATIT software, will generally be a label such as “Track
1”, “Track 2”, etc.
Bear in mind that the organization of the flash memory is entrusted to the user
(or the dealer) and implemented by means of the ATIT software;
consequently, it could be different to that described above.
Before playing a list from the flash memory, the required material must first
be selected by pressing the F1 function button (MATERIAL). Pressing F1
repeatedly has the effect of scrolling cyclically through the folders. The folder
currently selected appears in the display.
Once the material has been selected, the files of the first list in the folder can
be played by pressing the relative button — “Play” — located at the top left
of the Viola keyboard. For a detailed description of the controls used to play
word lists, see Chapter 4: Controls and probe.

65
Remember that the GAIN levels for internal inputs 1 and 2 (carrying the
speech material and the competing sound, respectively) are calibrated in the
same way as adopted normally for the external inputs, that is to say presenting
a test tone, which in the case of the internal inputs will be a wave file stored
in the flash memory, pressing the GAIN button and adjusting the levels so
that the volume of the sound registering on the two VU-meters is 0 dB. This
level is saved by the audiometer, consequently there will be no need to repeat
the operation after the instrument has been switched off.

QUICKSIN TEST
Difficulty with hearing in background noise is a common complaint among
hearing-impaired persons. The measurement of SNR loss (signal-to-noise-
ratio) is important because speech understanding in noise cannot be reliably
predicted from the pure tone audiogram. (Killion & Niquette, 2000).
The QuickSIN™ test was developed to provide a quick estimate of SNR loss
and it is comprised of sentences recorded in four-talker babble. Each of the
lists has six sentences with five key words per sentence, one sentence at each
SNR of 25, 20, 15, 10, 5 and 0. SNR loss can be estimated scoring the five
key words in each sentence, giving one point to each word repeated correctly.

QuickSIN™ sentences are loaded in the flash memory of the audiometer

which is organized as described in previous section. Before playing a list from
the flash memory, the required material must first be selected by pressing the
MATERIAL function button. Once the QuickSIN material has been selected,
the sentences of the first list in the folder are displayed on the screen and the
list can be played by pressing the PLAY button located at the top left of the
keyboard. If there is no audio material being played currently, pressing
PREVIOUS/NEXT buttons will bring up the precedent/following list.
Once the desired list has been selected and is playing, PREVIOUS/NEXT
buttons can be used to jump back/forward among the sentences of the list,
currently played sentence is highlighted in the audiometer’s screen. Each
sentence is presented at pre-recorded signal-to-noise ratios which decrease in
5-dB steps from 25 (very easy) to 0 (extremely difficult). At the end of each
sentence the list pauses and the score of the sentence can be stored using
CORRECT/INCORRECT buttons: CORRECT button to increase the score
and INCORRECT button to decrease it. Pressing PLAY button will advance
to next sentence and play.

66
After all six sentences are scored, SNR loss can be estimated and saved using
STORE button. To interpret the SNR loss score, see the following table.

SNR LOSS DEGREE OF EXPECTED IMPROVEMENT WITH

SNR LOSS DIRECTIONAL MIC
Normal/near
0-3 dB May hear better than normal hear in noise
normal
May hear almost as well as normals hear in
3-7 dB Mild SNR loss
noise
Moderate SNR Directional microphones help. Consider array
7-15 dB
loss mic
Severe SNR Maximum SNR improvement is needed.
>15 dB
loss Consider FM system

In Viola Plus models, QuickSIN™ lists can be presented only through

headphones (AC). Presentation level can be set to 70 dB HL for pure tone
average (PTA) ≤ 45 dB HL, for PTA of 50 dB HL or greater set the attenuator
dial to a level that is judged to be “loud, but OK”.
QuickSIN™ window is illustrated below.

QuickSIN™ window

Before starting QuickSIN™ test, adjust the level of gains using the 1-kHz
calibration tone so that the VU-meters of the two channels read “0”. Once the
gain values for QuickSIN™ input have been set, they are saved internally on
the audiometer, and remain stored even after the instrument has been
switched off.

67
QuickSIN™ material include:
- 1-kHz calibration tone
- 12 standard lists with speech and 4-talker babble noise combined on the
same channels for basic SNR loss testing.
- Practice lists A, B and C that can be used to familiarize the patient with
the task. These lists are not equivalent to the standard lists and cannot be
used to calculate SNR loss.
- 12 standard split-track lists recorded with sentences on channel 1 and
babble noise on channel 2. These lists can be used to verify the
effectiveness of hearing aids that have switchable directional
microphones. Two types of demonstrations are possible and can be
selected using the MODE function button:
o Subjective: both speech and noise levels can be manually
adjusted. Having the patient switch back and forth between
OMNI and directional positions on the hearing aid/s gets a basic
measure of directional benefits. In this mode SNR loss can’t be
estimated.
o Objective: once the speech level has been set, the noise level is
automatically adjusted so that the SNR decreases from 25 to 0
by 5 dB for each succeeding sentence. In this mode lists can be
scored to obtain SNR loss, and SNR loss obtained in OMNI and
Directional positions can be compared.
- 12 HFE lists recorded with 30 dB high-frequency emphasis (HFE). The
HFE is used to make speech sounds audible for persons with ski-slpoe
loss.
- 12 HFE-LP lists recorded with HFE plus 3-kHz low-pass brickwall filter,
these lists can be used in combination with the HFE lists to predict the
outcome of fitting hearing aids with extended HFE.

How to enable the QuickSIN™ test

In order to enable the QuickSIN™ test, access the test window from the main
menu, press the ENABLE function button and fill in the licence number.

68
 CHAPTER 10:

Interface with the

computer

The Flute middle ear analyzer and the Viola impedance-audiometer can be
interfaced with a computer by way of a USB connection. Maestro software
must be installed on the computer with or without proprietary database or as
Noah module. Refer to Maestro – General Functionalities – User Manual for
a detailed description of how to install Maestro on your computer, and for
minimum system requirements, and to Maestro – Functionalities for
audiometry and impedance testing – User manual for more information about
how to use Flute and Viola by the computer.

CONNECTION TO PC
The Flute middle ear analyzer and Viola impedance-audiometer are
connected to one of the USB ports on the computer using the cable supplied
(standard USB A/B cable). The connection is plug-and-play, with no special
drivers required for installation purposes: a few seconds after plugging in, the
operating system will recognize the devices and install the drivers
automatically. The installation is complete when the following message
appears at the bottom right of the screen:

69
 CHAPTER 11:

Settings

Flute and Viola instruments have a number of configuration parameters that

can be changed in the settings window. This chapter describes the parameters
available, and how to change them.

SETTINGS WINDOW
To access the settings window, simply press the SETTINGS function button
shown on the main screen of the instrument.
Once the settings window appears, the left hand knob can be used to scroll
through the available items, whereas to change the value of the selected item,
either rotate the right hand knob or press the CHANGE button.
Certain items, such as specific test settings and adjustment of the date and
time, require access to a particular window if changes are to be made; in these
cases, press the SELECT button to access the changes window.
The settings window also includes an INFO function button, which opens a
window containing certain items of information on the instrument, such as
the serial number and the version of the internal software.
When exiting the settings window, if at least one parameter has been changed,
the instrument will prompt whether to save the new settings or maintain the
previous settings.

USER-SETTABLE PARAMETERS
All configuration parameters that can be set by the user are listed below. A
default value is indicated for each parameter. This represents the factory
setting.
Not all of the items listed are available on every model.

71
Language
Selection of the interface language used by the instrument.
Default value: English (it may vary according to destination)

Viewing mode (Viola Plus only)

Selection of the viewing mode, numerical (text-only) or graphic, for pure tone
and speech audiometry examinations.
Default value: graphic

Contralateral transducer
Selection of the transducer used to present the stimulus via the contralateral
output. The operator can choose between the supra-aural headphone and the
insert earphone.
Default value: supra-aural headphone

Enable live view feature

If enabled, allows the operator to follow the progress of the test on the
computer screen as well as on the instrument display.
Default value: Yes

Tympanometry setup menu

This window shows the parameters relating to the tympanometry test,
namely:

Auto start:
Enables / disables automatic start of the tympanometry test as soon as the
probe is inserted correctly in the ear canal.
Default value: No

Start pressure
Initial positive test pressure, expressed in daPa. Values between 50 and 400
daPa can be selected, in 50 daPa increments.
Default value: 200

72
Stop pressure
Final negative test pressure, expressed in daPa. Values between -50 and -600
daPa can be selected, in 50 daPa increments.
Default value: -400

Gradient
Method of calculating the tympanogram gradient. This can be calculated as
the width of the peak (in daPa) or as a ratio between compliance values, as
described in detail in the chapter on tympanometry.
Default value: Peak width

Show normal range

Enables / disables display of the tympanometry normality range (ASHA, 32,
Suppl. 2, 1990, 17-24) in the tympanogram.
Default value: Yes

Fast test
If enabled, the tympanometry examination is terminated as soon as the
measured compliance is equal to the initial test value.
Default value: No

Enable tymp. HF
It allows to type in the license code to enable the 1000 Hz tympanometry.
In order to get the activation license please contact the Inventis technical
support (support@[Link]).

Reflex setup menu

This screen presents the parameters for the acoustic reflex test, namely:

Data polarity
This parameter determines the method of representing data in the graph.
Selecting negative polarity, the reduction in compliance caused by the reflex
is represented as a downward movement of the reflex curve; selecting
positive, the reduction is represented as an upward movement of the curve.
Default value: Negative

Pressure

73
Selects the pressure utilized during the test. The operator can elect to conduct
the test at atmospheric pressure (Atm), at the peak pressure of the
tympanogram (Tymp. peak) or at a pressure value resulting from the
difference between the tympanogram peak pressure and its width (T. Peak -
TW).
Default value: Tymp peak

Stimulus ON-Time
The length of time for which the stimulus is presented during each test,
expressed in ms. The setting can be selected between 500 and 2500 ms, with
a resolution of 500 ms.
Default value: 500

Stimulus OFF-Time
The interval of time, after the end of the stimulus on-time, during which data
acquisition continues, expressed in ms. The setting can be selected between
500 and 2500 ms, with a resolution of 500 ms.
Default value: 500

Recognition sensitivity
Sets the level of sensitivity when identifying the reflex, used in threshold
mode. Possible values are: sensitive, normal, robust.
Selecting “sensitive”, the reflex is classified as being identified if, during the
stimulus on-time, there is a reduction in compliance of at least 0.025 ml;
selecting “normal” the reduction must exceed 0.05 ml; and selecting “robust”
there must be a reduction of 0.08 ml.
Default value: Sensitive

Compliance check
Enables / disables a check — run at the start of data acquisition — on the
stability of compliance measurements. The examination can start as long as
compliance values remain stable for a duration of one second. If enabled, and
compliance measurements are found not to be stable, the start of the test can
be forced by pressing the STIMULUS button.
Default value: No

74
Quick exams setup menu
Accesses the window for the configuration of acoustic reflex tests associated
with Quick Test A and Quick Test B. For each of these, the operator can
select the mode of inducing the reflexes, and the types of stimulus to present
to the patient (8 boxes).

Decay setup menu (Flute Plus and Viola Plus only)

This window shows the parameters relating to the decay test, namely:

Stimulus ON-Time
The length of time for which the stimulus is presented during each test,
expressed in seconds. Possible values are 10 and 20 seconds.
Default value: 10

Stimulus OFF-Time
The interval of time, after the end of the stimulus on-time, during which data
acquisition continues, expressed in seconds. The interval can be set between
1 and 5 seconds.
Default value: 1

ETF-TM intact setup menu (Flute Plus and Flute HF

only)
This window shows the parameters relating to the ETF test used when the
eardrum of the patient is intact, namely:

Start pressure
Initial positive test pressure, expressed in daPa. Values between 50 and 400
daPa can be selected, in 50 daPa increments.
Default value: 200

Stop pressure
Final negative test pressure, expressed in daPa. Values between -50 and -600
daPa can be selected, in 50 daPa increments.
Default value: -400

75
Pure tone audiometry setup menu (Viola only)
This window shows the parameters relating to the pure tone audiometry test,
namely:

AC transducer
Selects the type of transducer used for air-conducted stimuli. The options are
supra-aural headphone and insert-type earphone.
Default value: Headphones

Link BC symbols
Enables / disables the display of lines interconnecting bone conduction
symbols in pure tone audiometry.
Default value: No

Symbol for BC-Right

Selects the symbol for pure tone audiometry using bone conduction, right
hand side.
The symbols that can be selected are.

a)

b)
Default value:

Symbol for masked BC-Right

Selects the symbol for pure tone audiometry with masking, using bone
conduction (right hand side).
The symbols available when selecting the symbol identified by letter a for
right bone conduction are indicated in the following illustration by the letters
c and d; if the symbol selected for right bone conduction is that identified by
letter b, then the symbols available are e and f.

c) d)

e) f)

Default value:

76
Symbol for UCL
Selects the symbol for UCL threshold in the pure tone audiometry, right ear.
The symbols that can be selected are:

a)

b)

c)

Default value:

Automatic frequency jump

In pure-tone audiometry, enables / disables automatic transition to the next
frequency after a value has been saved by pressing the STORE button. The
order in which frequencies are scanned will depend on the “Frequency jump
mode” parameter, described below.
Default value: Yes

Frequency jump mode

Sets the sequence in which frequencies are scanned for pure-tone audiometry,
when automatic jump mode is selected.
There are 2 options:
1) 8k → 125: saving the threshold at 8 kHz (or 12.5 kHz if this is the active
frequency), the 125 Hz frequency is tested first, followed by each of the
higher frequencies in turn.
2) 8k → 1k: saving the threshold at 8 kHz (or 12.5 kHz if this is the active
frequency), the program jumps to 1 kHz, then moves sequentially
through the lower frequencies, down to 125 Hz. This is the frequency
scanning method prescribed by standard ISO 8253-1.
Default value: 8k → 1k

Default intensity (dB)

In pure-tone audiometry, selects the default level for the stimulus on the
primary channel, in other words the intensity at which channel 1 is set when
changing the stimulation side, the output, the input or the frequency. The
initial intensity can be set between 0 and 60.
Default value: 40 dB

77
Maintain intensity
If enabled, the level of the stimulus on the primary channel in pure-tone
audiometry stays the same (i.e. does not revert to the default value) when
changing the stimulation side, output, input or frequency.
Default value: No

Maintaining the previous intensity of the stimulus when changing

frequency, transducer or stimulation side can result in potentially
harmful signals being presented to the patient.

Frequency selection
Access to the window allowing selection of the frequencies to examine in the
pure tone audiometry test.

Beep at patient response

Enables or disables the beep generated when the patient presses the patient
response switch.
Default value: No

Single graph for R-L

If enabled, it is possible to display and print both ears on the same audiogram
(pure tone and speech audiometry exams).
Default value: No

Speech audiometry setup menu (Viola Plus only)

This window shows the parameters relating to the speech audiometry test,
namely:

Speech score mode

Selects the method of calculating the percentage of correct responses in
speech audiometry.

Mode 1: calculates the percentage of correct responses in relation to the total

number of responses given. More exactly, indicating the words recognized
successfully by the patient as correct, and the number of words not recognized
by the patient as incorrect, the percentage is calculated as follows:

78
 percentage = 100 * correct / (correct + incorrect)
Mode 2: calculates the percentage of correct responses in relation to the total
number of words in the list. This parameter is configurable from the settings
window.

The percentage in this instance is calculated as:

percentage = 100 * correct / total number of words
Default value: Mode 1

Speech words number

Sets the total number of words in the lists; this parameter is used only when
Mode 2 is selected as the method of calculating the outcome of a speech
audiometry test.
The number of words can be set between 1 and 99.
Default value: 10

Pause after each word

If enabled, the playback of the current list is paused after the presentation of
each word
Default value: No

Monitor off after speech

If enabled, sets the strength of the monitor signal to zero when the speech
audiometry window is closed. When the window reopens, the previous levels
will be restored.
Default value: Yes

Enable EQ. filter for AC (TDH-39 / DD45)

Enables / disables the Free Field Equivalent filter applied to air-conducted
speech audiometry output signals when using supra-aural headphones.
Default value: No

79
Enable WRS single point
Option for measuring the Word Recognition Score as a single point instead
of using a graph. Furthermore, if enabled, you may select the same input for
both channels during the speech audiometry.
Default value: No

Live speech microphone

Selects the microphone input used to perform the live speech audiometry:
MIC or TALK OVER. After having selected the input, the microphone must
be plugged in the corresponding connector on the rear panel.
Default value: TALK OVER

Printer menu
This window shows the settings for the print function, namely:

Print patient data header

Enables / disables printout of the heading with details of the patient.
Default value: Yes

Clinic data menu

Access to a window in which the user can enter details of the clinic, for
inclusion in the header of the printed document. The user can also enable or
disable printout of the window.

Extended printout
If enabled, printout of the examinations is generated in greater detail, which
means in turn that more paper will be used.
Default value: No

Reflexes (threshold): print data only

If enabled, the printout of the acoustic reflex tests conducted in automatic
threshold mode will show only numerical results (graphs will not be printed).
Default value: No

80
Blank reflex boxes printout
If enabled, the blank reflex boxes, regarding not performed tests, are printed.
The printout corresponds to the boxes displayed on the device.
Default value: No

Calibration menu
Access to the menu for calibration of the instrument. The operator may elect
to calibrate the probe tone, compliance measurement, stimulus signals and
pressure sensors.

Date and time menu

Access to the window in which the date and the time are set. The time is
written, by default, in the 24-hour notation: by accessing this windows it is
possible to switch to the 12-hour time format.

Service tests
Access to the window from which service tests are run on the instrument. For
maintenance purposes only.

81
 CHAPTER 12:

Maintenance

Flute middle ear analyzers and Viola impedance-audiometers do 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 before commencing any kind of
cleaning operation.

The inspection and servicing of internal components must be left

entirely to technicians approved by Inventis s.r.l.
Transducers are manufactured utilizing ultra-fragile diaphragms
that could be damaged in the event of impact. Handle with care
during maintenance operations.

PERIODIC CHECKS
The procedure described under this heading must be carried out
when the instrument is used for the first time each day.

The tests must be done with the instrument 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.

83
 - Check the compliance measured by the device. To this end, carry
out the following sequence of steps:
o Insert the probed (without ear tip) into the 2.0 ml test
cavity;
o Launch the tympanometry test screen;
o Make certain that the current compliance value shown by
the relative indicator is equal to the size of the cavity in
question, i.e. 2 ml; the indicator, located on the right of the
graph, is of triangular shape and can be seen only in
absolute viewing mode. In the event that the measured
value does not correspond to the volume of the cavity,
proceed with calibration of the probe as described under
the next heading.
Moreover, on Viola impedance-audiometers
- 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

- Check that the interrupter key(s), the patient response switch(es) and
the keyboard indicators function correctly

- Check that the attenuator knobs function correctly without noises or

interference between channels

- Check the speech audiometry inputs by doing a speech test with

every speech input

- Check the headband strain of headset and of bone vibrator

- Check the communication with the patient

Should any accessory not function correctly, consult Appendix C

“Troubleshooting”.

84
It’s basic also check that the calibration interval has not elapsed: the expiry
of the interval is indicated at the bottom of the main presentation screen.

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.

CALIBRATION OF COMPLIANCE
The procedure described below is carried out whenever the needs arises to
recalibrate the measurement of compliance by the probe.
Access the main “Settings” menu by pressing the relative function button.
Now select the item "Calibration Menu", and thereafter “Compliance
calibration”. The following screen appears:

As indicated, locate the probe (without ear tip) in the 2.0 ml tet cavity and
press “STORE” to save the reading. Check that on pressing the button, the
new value measured is consistent with the amplitude of the cavity in question.
Repeat the operation for all cavities, following the order indicated by the
procedure.

MAINTENANCE OF TRANSDUCERS
Do not use liquids or sprays to clean the middle ear analyzer.

Do not allow dust to collect on the transducers. Also:

85
 - 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 by a new patient, the cushions must be wiped with:
o For DD45/TDH-39 cushions: denatured alcohol wipe or
denatured alcohol with a microfiber cloth.
o For all other cushions: hypoallergenic proprietary
disinfectant, following the maker’s instructions.
- The ear tips of the probe, the 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 ear tips are not sterile. The use of unsterilized ear tips can cause
ear infections.

To avoid damaging the DD45/TDH39 headphones, do not push it

against a flat straight surface as this can create vacuum and cause a
damage to the transducer (suction cup effect).

CLEANING THE PROBE

To guarantee accurate compliance measurements, the three channels
incorporated into the probe must be kept properly clean. In effect, these three
channels accommodate the compliance measurement system (microphone),
the speaker carrying the stimulus signals, and the pressurization system.
As illustrated below, the probe consists in a main body, a tip (to which the
ear tip is attached) and a screw collar, which keeps the tip firmly associated
with the body.
Screw collar

Ear tip

Tip Main body

The procedure for cleaning the probe will now be described.

86
First of all, remove the ear tip, loosen the screw collar and separate the tip of
the probe from the main body.

The three channels in the tip of the probe can be cleaned using thin nylon
threads. Insert the thread into each of the channels in turn, from the base, and
push through until it can be pulled out from the top.

1 2

Having cleaned the channels thoroughly, the tip of the probe must be refitted.
Offer the tip of the probe to the main body, being careful to align the guide
element A, in the body, with the hole B provided in the tip, as illustrated in
the figure below. Retighten the screw collar.

For external cleaning use a lint-free soft cloth moistened with a solution of
water and mild detergent; in case of sanitization wipe the cloth with hydrogen
peroxide at a 3% concentration.

Do not immerse the probe or part of it in any kind of liquid

87
In the event of the probe being broken or malfunctioning, contact an Inventis
service technician. The replacement of the probe must be entrusted
exclusively to Inventis or to a service technician authorized by Inventis. If the
probe is replaced, it must be calibrated before being used with the instrument.

CLEANING THE INSTRUMENT

To prevent the accumulation of dust on the instrument, always fit the
protective cover when the analyzer is not in use. Also, ensure that dust
collecting underneath the instrument is cleaned away regularly.
All parts not mentioned specifically in the previous section can be cleaned
using a soft cloth moistened with a solution of water and mild detergent; in
case of sanitization wipe the cloth with hydrogen peroxide at a 3%
concentration.

REPLACEABLE PARTS
The probe, transducers and accessories can be disconnected from the
instrument. Should a fault develop in any one of these devices, the middle ear
analyzer must be switched off and isolated from the power supply, and the
defective item then disconnected from the instrument.

All accessories of the middle ear analyzer are designed specifically

for use with the instrument. Only accessories supplied by Inventis
should be connected to the analyzer.

LOADING THE PRINTER PAPER

To load a new roll of paper in the printer, the rear cover must first be opened
and the empty spool removed.

The heat-sensitive side of the paper is located externally of the

winding mechanism: the paper must be positioned so that the heat-
sensitive face does not come into contact with the rubber pinch roller.

Raise the lever and offer the paper to the bottom part of the roller. Feed the
paper through until it emerges from the top part at the required height. Lower
the lever.

88
 Make certain that the paper is correctly aligned. If this is not the
case, follow the manual loading instructions to correct the
alignment.

Slip the paper through the slot in the cover, and close the cover.

REPAIRS AND TECHNICAL ASSISTANCE

Before contacting the service department, make certain that all the possible
solutions in the “Troubleshooting” appendix have been tried.

All the parts being returned to the manufacturer for repair and service shall
be cleaned and sanitized. Transducers should be sealed in a transparent bag.

Important: should the instrument need to be sent to the Inventis service

department or returned to the dealer, make certain that the original packing is
used, and that all accessories and transducers are enclosed.

89
 APPENDIX A:

Technical specifications

Classification
All:
Type 2 middle ear analyzer (IEC 60645-5 / ANSI S3.39)
Viola Basic:
Type 3 pure tone audiometer (IEC 60645-1 / ANSI S3.6)
Viola Plus:
Type 3, Class B/B-E audiometer (IEC 60645-1 / ANSI S3.6)

COMPLIANCE MEASUREMENT SYSTEM

Probe Tone
Frequency 226 Hz ± 1% 1000 Hz ± 1%

Level * 85 dB SPL ± 1.5 dB SPL 75 dB SPL ± 1.5 dB SPL

Compliance
Tympanometry Acoustic Reflex
226 Hz 1000 Hz 226 Hz
Maximum Absolute: Absolute:
range** 0.2 – 8 ml 0.9 – 15 mmho -0.2 – 0.05 ml
Compensated: Compensated: -0.4 – 0.1 ml
-0.5 – 5 ml -2 – 6 mmho

Scale Manual and Automatic Manual

Accuracy ± 0.1 ml or ± 5%, whichever is greater

Influence of
ambient -0.003 ml/°C
temperature
Influence of
atmospheric -0.0002 ml/daPa
pressure

91
Note:
(*) Nominal values on calibration coupler; probe tone has AGC (Automatic
Gain Control) to optimize the level at different ear canal volumes
(**) Under standard reference conditions using a probe tone of 226 Hz, the
volume of trapped air in a hard-walled cavity is equal to the acoustic volume
of that same cavity. In other words, 1 cubic centimeter (cc) or milliliter (ml)
of trapped air equals the acoustic admittance of 1 mmho in a hard-walled
cavity.
This equivalency is the reason for representing admittance in cc or ml.

PRESSURE MEASUREMENT SYSTEM

Maximum range -600 daPa – +400 daPa

Safety limits -800 daPa and +600 daPa

Accuracy ±10 daPa or ±5 %, whichever is greater

-600 daPa – +400 daPa

Test range
selectable by 50 daPa increments
50, 100, 200, 300 daPa/s,
Change rates AUTO (test starts and stops at 300 daPa/s, slows to100
daPa/s at the tympanogram peak)
Automatic
Control
(Flute Plus only) Automatic and manual

IMPEDANCE – AVAILABLE SIGNALS

Flute Basic, Flute HF, Viola Basic and Viola Plus
Stimulus Pure tones

500, 1000,
Ipsilateral
2000, 4000 Hz
Pure tone frequencies 250, 500,
Contralateral 1000, 2000,
4000 Hz
Flute Plus
Stimulus Pure tones and noises

92
 500, 1000,
Ipsilateral 2000, 3000,
4000, 6000 Hz
Pure tone frequencies 250, 500, 1000,
2000, 3000,
Contralateral
4000, 6000,
8000 Hz
Broadband Noise (BBN),
Types of noise Low Pass Noise (LPN),
High Pass Noise (HPN)

IMPEDANCE - SIGNAL SPECIFICATIONS

Attenuators step 5 dB
Presentation mode Continuous
Frequency accuracy 0,1 %
Intensity accuracy ±3 dB
Total Harmonic Distortion (THD) Less than 2,5 %
As specified in
Broadband Noise (BBN)
IEC 60645-5 / ANSI S3.39
Same as BBN with
Low Pass Noise (LPN)
1600 Hz, 6° order Low Pass Filter
Same as BBN with
High Pass Noise (HPN) 1600 Hz, 6° order High Pass
Filter
Acoustic Reflex
Automatic threshold increment: 5, 10 dB selectable
Growing intensity increment: 1, 2, 5 dB selectable
from 0.5 to 2.5 s
ON – Time
selectable by 0.5s increments
from 0.5 to 2.5 s
OFF – Time
selectable by 0.5s increments
lowest detectable
Reflex sensitivity
volume change: 0.001 ml
Reflex tests: the risk of artifacts at higher stimulus levels in compliance
measurements are negligible and will not activate the reflex detection system.
Reflex Decay
ON – Time 10 or 20 s selectable
OFF – Time 1, 2, 3, 4, 5 s selectable
ETF – TM perforated

93
 -600 daPa – +400 daPa selectable
Maximum pressure
by 100daPa increments
Duration of test. 20, 30, 40, 50 s selectable

IMPEDANCE – AVAILABLE OUTPUTS

Flute Flute Flute Viola Viola
Output
Basic Plus HF Basic Plus
Ipsilateral • • • • •
Contralateral
(TDH-39 or DD45 headphone or • • • • •
IME-100 insert earphone)

AUDIOMETRY – AVAILABLE SIGNALS

Flute Flute Flute Viola Viola
Type
Basic Plus HF Basic Plus
Pure tone - - - • •
Warble tone - - - • •
2 external inputs for speech
audiometry (EXT1 and EXT2) - - - - •
MIC input for live speech
audiometry - - - - •
Internal input (flash memory) for -
speech audiometry - - - •
Narrow-band noise (NBN) - - - • •
White noise (WN) - - - • •
Speech noise (SN) - - - - •

AUDIOMETRY - SIGNAL SPECIFICATIONS

Attenuator step 5 dB
Continuous
Presentation mode
Pulsed, with rate of 0.5, 1 or 2 Hz
Frequency accuracy 0,1 %
±3 dB between 125 Hz and 4 kHz
Intensity accuracy
±5 dB above 4 kHz
Total Harmonic AC: less than 2,5 %
Distortion (THD) BC: less than 5,5 %
Frequency of the modulating signal: 5 Hz
Warble tone Modulation waveform: sine wave
Modulation range: ±12%

94
 Band: ½ octave, i.e.:
- lower cut-off frequency f l = f / 1.1892
NBN
- upper cut-off frequency f u = f · 1.1892
where f is the centre frequency
Lower cut-off frequency: 100 Hz
WN
Upper cut-off frequency: 24 kHz
SN As specified in IEC 60645-1 §6.5

External signals EXT1 and EXT2 input: max 3 Vrms

Speech material
Pure tone at 1 kHz
calibration signal

AUDIOMETRY – AVAILABLE OUTPUTS

Flute Flute Flute Viola Viola
Output
Basic Plus HF Basic Plus
Air conduction (TDH-39 or DD45
headphones or ER-3 / ER-5 / IP30 - - - • •
insert earphones)
Bone conduction (B-71 bone
vibrator) - - - • •
Insert masking earphone - - - opt. opt.

IMPEDANCE
STIMULI: AVAILABLE FREQUENCIES AND MAXIMUM LEVELS
CONTRA CONTRA
Freq. IPSI
TDH-39 / DD45 IME-100
(Hz) (dB HL)
(dB HL) (dB HL)
250 - 100 -
500 100 120 110
1.000 110 120 115
2.000 105 120 110
3.000* 105 120 110
4.000 100 120 110
6.000* 100 105 100
8.000* - 100 -
BBN* 95 115 105
LPN* 95 115 105
HPN* 95 115 105
(*) available on Flute Plus only

95
 AUDIOMETRY – PURE AND WARBLE TONE:
AVAILABLE FREQUENCIES AND MAXIMUM LEVELS
AC AC
AC BC
Freq. TDH-39 ER-3
ER-5 B71
(Hz) DD45 IP30
(dB HL) (dB HL)
(dB HL) (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 AC
AC BC
TDH-39 / DD45 TDH-39 / DD45
ER-3 / ER-5 / IP30 B71
(dB HL) (dB HL)
(dB HL) (dB HL)
(*) (**)
100 80 100 55
(*) Free Field Equivalent filter OFF
(**) Free Field Equivalent filter ON

EXTERNAL SIGNAL LEVEL INDICATOR

(Viola Plus only)
Type of indicator VU-meter
Dynamic range +3..-20dB
Input Voltage at 0 dB 1.5 Vrms
Increase: 60 dB/s
Speed of volume tracking
Decrease: 60 dB/s

AUDIOMETRY
NARROW BAND NOISE (NBN)):
AVAILABLE FREQUENCIES AND MAXIMUM LEVELS
AC AC
AC Insert
Freq. TDH-39 ER-3
ER-5 earphone
(Hz) DD45 IP30
(dB EM) (dB EM)
(dB EM) (dB EM)

96
 125 60 70 65 80
250 80 85 85 95
500 95 95 95 105
750 100 100 100 110
1.000 105 105 100 115
1.500 105 105 100 115
2.000 105 105 100 115
3.000 105 105 100 115
4.000 105 100 100 110
6.000 100 90 95 95
8.000 90 80 80 95

WHITE NOISE (WN)

MAXIMUM INTENSITES
AC AC
Insert Mask
TDH-39 / DD45 ER-3 / ER-5 / IP30
WN (Pure Tone
110 dB SPL 100 dB SPL 100 dB SPL
Audiometry)
WN (Speech 90 dB EM - (*)
80 dB EM 80 dB EM
Audiometry) 70 dB EM - (**)
(*) Free Field Equivalent filter OFF
(**) Free Field Equivalent filter ON

SPEECH NOISE (SN)

MAXIMUM LEVELS
AC AC AC
TDH-39 / DD45 TDH-39 / DD45 ER-3 / ER-5 / Insert earphone
(dB EM) (dB EM) IP30 (dB EM)
(*) (**) (dB EM)
90 70 80 80
(*) Free Field Equivalent filter OFF
(**) Free Field Equivalent filter ON

ACOUSTIC SAFETY OF INSTRUMENT

Alert condition Tone intensity higher than 100 dB HL (IEC 60645-1, §5.2)

1) In pure tone audiometry, if the intention is to present a

stimulus signal stronger than 100 dB HL, the operator
Safety measures
has to press “Higher dB” button
in alert condition
2) Warning on the display
3) “Normally on” function disabled (Viola models)

97
 COMPATIBLE TRANSDUCERS
Type Manufacturer Model Impedance
Supra-aural headphone
10 ohm
for contralateral Telephonics Corp. TDH-39
(1 kHz)
stimulation
Supra-aural headphone
10 ohm
for contralateral Radioear Corp. DD45
(1 kHz)
stimulation
Insert earphone for 100 ohm
Inventis srl IME-100
contralateral stimulation (1 kHz)
10 ohm
Supra-aural headphones Telephonics Corp. TDH-39
(1 kHz)
10 ohm
Supra-aural headphones Radioear Corp. DD45
(1 kHz)
10 ohm
Insert earphones Etymotic Research Inc. ER-3
(1 kHz)
10 ohm
Insert earphones Etymotic Research Inc. ER-5
(1 kHz)
10 ohm
Insert earphones Radioear Corp. IP30
(1 kHz)
10 ohm
Bone vibrator Radioear Corp. B71
(1 kHz)
Insert earphone for 100 ohm
Inventis srl IME-100
masking (1 kHz)

AVAILABLE TESTS
Flute Flute Flute Viola Viola
Basic Plus HF Basic Plus
Tympanometry • • • • •
Manual 226 Hz - • - - -
Automatic 226 Hz • • • • •
Manual 1000 Hz - opt. - - -
Automatic 1000 Hz - opt. • - -
Acoustic reflex
Fixed intensity • • • • •
Growing intensity • • • • •
Automatic threshold • • • • •
Manual - • - - -

98
Reflex Decay - • - - •
ETF
TM intact - • • - -
TM perforated - - • - -
Quick A • • • • •
Quick B • • • • •
Pure tone audiometry - - - • •
Speech audiometry - - - - •
QuickSIN test - - - - opt.

PATIENT – OPERATOR COMMUNICATION

Flute Flute Flute Viola Viola
Basic Plus HF Basic Plus
Talk-over:
- Embedded microphone,
or - - - • •
- External microphone
(opt.)
Talk back:
- Embedded speaker, or
- Monitor headphones - - - - •
(included)
Patient response button - - - • •

DATA MANAGEMENT
Flute Flute Flute Viola Viola
Basic Plus HF Basic Plus
Integrated thermal printer
opt. opt. opt. opt. opt.
(paper size: 112 mm)
Communication with pc USB
Maestro installed with or without proprietary
Management software
database or as Noah module

DISPLAY
Type TFT LCD color graphics
Size diagonal 4,3”, 95 mm x 54 mm
Resolution 480 x 272

POWER SUPPLY

99
 Model without printer
Main unit: 6V, 1.2A (Viola 1.3A) d.c.
External adapter: SL POWER MENB1010A0603F02
Power supply
100-240Vac 50/60 Hz 0.9-0.34A (included)
responding to IEC 60601-1 standard
Model with printer
Main unit: 6V, 3.2A d.c.
External adapter: SINPRO MPU31-103
Power supply
100-240Vac 50/60 Hz 0.9-0.34A (included)
responding to IEC 60601-1 standard

CALIBRATION
Calibration validity 12 months

ENVIRONMENTAL CONDITIONS
Temperature: between 15°C (59°F) and 35°C (95°F)
Relative humidity: between 30% and 90% (non-
Operation
condensing)
Pressure: between 700 hPa and 1060 hPa
Temperature: between -10°C (14°F) and 50°C (122°F)
Transport and
Relative humidity: max. 90% non-condensing Pressure:
storage
between 500 hPa and 1060 hPa
Warm-up time 1 minute

MECHANICAL SPECIFICATIONS
Model without printer
Size (LxDxH) 32 x 32 x 9 cm / 12.6 x 12.6 x 3.5 in
Weight (instrument only) 1,9 kg / 4.19 lb
Weight (including transducers and
package)
4,3 kg / 9.48 lb
Model with printer
Size (LxDxH) 32 x 39 x 9 cm / 12.6 x 15.4 x 3.5 in
Weight (instrument only) 2,4 kg / 5.29 lb
Weight (including transducers and
4,8 kg / 10.58 lb
packaging)

SOCKETS ON REAR PANEL

Description Type Connector
Power supply In DC plug, 2.5 mm
Control Box (CB) Out DB-15F
Air tube Out -

100
Headphone for contralateral stimulation
Out Audio jack, 3.5 mm mono
(on CB)
USB In - Out USB type B
Only on Viola models
L and R headphones Out 2 audio jack, 1/4” mono
Bone vibrator Out Audio jack, 1/4” mono
Insert masking earphone Out Audio jack, 1/4” mono
Patient response button In Audio jack, 1/4” mono
External microphone for talk-over In Audio jack, 3.5 mm mono
Monitor headphone Out Audio jack, 3.5 mm stereo
Microphone for live speech test In Audio jack, 1/4” mono
Patient microphone for talk-back In Audio jack, 1/4” mono
EXT1 and EXT2 In 2 RCA

INPUT SPECIFICATIONS
Input Connector Electrical property
Power supply DC plug, 2.5 mm Internal pin +6V, external pin 0V
Patient response Switches 3V to logical input (switch
Jack, 1/4” mono
button current: 10mA)
Sensitivity: 3mV at max volume and
External inputs
0Vu
for speech 2 RCA
Impedance: 10K Ω
audiometry
Freq. response: 75-12000Hz +/- 3dB
Microphone Jack, 1/4” mono
Talk over Jack, 3.5mm mono Electret or 200 Ω dynamic microph.
Impedance: 47KΩ
Freq. response: 100-12KHz +/- 3dB
Talk back Jack, 1/4” mono
Electret Bias: 2.2V trough 2.2KΩ

OUTPUT SPECIFICATIONS
Available Nominal
Output Connector
Voltage Impedance
Control Box (CB) DB-15F 8Vpp 10 Ω
Contra TDH-
Jack, 3.5mm mono 8Vpp 10 Ω
39/DD45
Contra IME-100 Jack, 3.5mm mono 8Vpp 32 Ω
AC (headphones,
Jack, 1/4” mono 8Vpp 10 Ω
earphones)
BC Jack, 1/4” mono 8Vpp 10 Ω
Insert mask Jack, 1/4” mono 8Vpp 32 Ω
Monitor Jack, 3.5mm stereo 1Vrms with 32 Ω load

101
 NOISE ATTENUATION VALUES
TDH-39 / DD45
Freq with MX41\AR or PN 51 ER-3 / ER 5/ IP30
cushion
[Hz] [dB] [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
6000 - -
8000 24 43.5

REFERENCE EQUIVALENT THRESHOLD LEVELS

ER-3
Freq IPSI IME-100 TDH-39 DD45 ER 5 B71*
IP30
ISO 389-2 ISO 389-1 ISO 389-1 ISO 389-2 ISO 389-3
ISO 389-2 (ANSI (ANSI (ANSI (ANSI ISO 389-2 (ANSI
S3.6) S3.6) S3.6) S3.6) S3.6)
[dB re [dB re [dB re [dB re [dB re [dB re [dB re
[Hz]
20µPa] 20µPa] 20µPa] 20µPa] 20µPa] 20µPa] 1µN]
125 - - 45 47.5 26 26 -
250 - - 25.5 27 14 14 67
500 11 5.5 11.5 13 5.5 5.5 58
750 - - 7.5 (8) 6.5 2 2 48.5
1000 5.5 0 7 6 0 0 42.5
1500 - - 6.5 8 2 2 36.5
2000 7 3 9 8 3 3 31
3000 4 3.5 10 8 3.5 3.5 30
4000 2 5.5 9.5 9 5.5 5.5 35.5
6000 1 2 15.5 20.5 2 2 40
8000 - - 13 12 0 0 40
BBN 6 6 2 2 - - -
LPN 9 9 6 6 - - -
HPN 6 6 2 2 - - -
(*) Calibration of bone vibrator (B71) refers to mastoid placement.

APPLICABLE STANDARDS
Flute Flute Flute Viola
Viola Plus
Basic Plus HF Basic

102
IEC 60645-5 / ANSI Type Type Type Type
Type 2
S3.39 2 2 2 2
Type Type 3,
IEC 60645-1 / ANSI S3.6 - - -
3 Class B/BE
AC: ISO 389-1 (TDH-39 / DD45), ISO 389-2 (ER-
3 / ER-5 / IP30)
BC: ISO 389-3
Calibration INSERT MASK: ISO 389-2 (IME-100)
IPSI: ISO 389-2
CONTRA: ISO 389-1 (TDH-39 / DD45), ISO 389-
2 (IME-100)
Electrical safety IEC 60601-1, Class I, Type BF
EMC IEC 60601-1-2

CE CERTIFICATE
93/42/EEC MDD
Class IIa
classification
Classification rule
10
(Annex IX, 93/42/EEC)
TÜV SÜD Product Service GmbH
Notified body Ridlerstrasse 65
D-80339 Műnchen, Germany
Number of notified body 0123

103
 APPENDIX B:

Audiometric symbols

Air Conduction
Right Left Bilateral
HL threshold without masking

HL threshold with masking

or
UCL threshold
or

Bone Conduction
Right Left
HL threshold without masking / /
/ /
HL threshold with masking or

/ /
The direction of the symbols used for BC and the symbol used for masked
BC can be selected in the instrument setup window (see Chapter 11: Settings).

When there is no response, a downwardly directed diagonal arrow is added

to the lower part of the symbol.

105
 APPENDIX C:

Troubleshooting

Problem Possible cause Solution

Probe lead not Attach the probe lead to the
properly connected designated connector
No probe tone
Holes of the probe Unscrew the probe tip and
tip blocked clean internally

Pressure air-line
Attach the pressure air-line to
not properly
the designated connector
connected
No pressurization
Probe not inserted
Change the tip and reinsert
hermetically into
the probe into the ear
the ear channel

Probe not
Reposition the probe so as to
accurately
Compliance minimize vibrations
positioned
measurements
affected by noise
Holes of the probe Unscrew the probe tip and
tip blocked clean internally

Transducer not
Connect the transducer to the
connected to the
correct output
No signal from a correct output
transducer
Transducer Contact Inventis service
damaged department or dealer

107
 Problem Possible cause Solution

Connect the patient response

No signal from Wrong connection
button to the correct socket
patient response
button when
pressed
Patient response Contact Inventis service
button damaged department or dealer

Connect the monitor

Wrong connection headphones to the correct
No signal from
socket
monitor
headphones
Headphone volume Press the MONITOR button
too low to increase the volume

Problems with
Check the connection to the
TALKBACK input
TALKBACK input
Patient’s voice connection
cannot be heard
TALKBACK Adjust the TALKBACK
volume too low volume control

Check the USB connection

Connection Problems with
between instrument and
between PC and USB connection
computer
middle ear
analyzer cannot
be established USB cable Change the USB cable
damaged (standard USB A/B cable)

Internal memory Verify that your own model

INT1 or INT2
not enabled has an internal memory
inputs cannot be
selected in
No speech material Use ATIT software to check
speech
stored in the that the internal memory
audiometry mode
internal memory contains speech material

108
Problem Possible cause Solution
Date and time
Contact Inventis service
prompt appears Internal battery
department or dealer to have
when instrument failure
the battery replaced
is powered up

Check the connection to the

Instrument not
power supply and make
powered up
certain the switch is in
Display remains correctly
position “1”
blank
Contact Inventis service
Adapter damaged
department or dealer

Contact your reference

You cannot Optional test not technical service to obtain the
access to a test enabled licence, communicating the
device serial number

109
 APPENDIX D:

Electromagnetic Compatibility

Flute & Viola have 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 used 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.
This instrument is suitable for use in professional healthcare facility
environment, i.e. in hospital environments, except for near active HF surgical
equipment and RF shielded rooms of systems for magnetic resonance
imaging, where the intensity of electromagnetic disturbance is high.
Flute & Viola should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, Flute & Viola
should be observed to verify normal operation in the configuration
in which it will be used.
The existence of electromagnetic interference can be verified easily by
switching the instrument off and back on again. If it is proven that the device
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.

List of cables, transducers and accessories

Cables, transducers and accessories with which Inventis claims the
compliance with the IEC 60601-1-2 standard are those ones supplied with the
device, in particular the followings:
1) Control Box with Probe (Manufactured by Inventis)
2) 6Vdc Medical grade Power Supply

111
3) Power supply cable (maximum length: 1.8 m)
4) Single TDH-39 or DD45 contralateral headset with 60cm shielded cable
5) IME-100 contralateral insert earphone with 50cm shielded cable
6) TDH-39 or DD45 supra-aural headphones with 2 m double signal
shielded cable
7) Insert earphones: ER-3 or ER-5 (manufacturer: Etymotic), IP30
(manufacturer: RadioEar); with 2 m double signal shielded cable
8) Bone vibrator B-71 transducer with 2m twisted not shielded double
signal cable
9) IME-100 Insert masking earphone with 2m shielded cable
10) Monitor headset with boom microphone, manufacturer: Sennheiser,
model: PC3
11) Talk back microphone with 2m shielded cable
12) Patient response switch (manufactured by Inventis) with 2 m shielded
cable
13) USB cable, shielded, maximum length: 2 m

The use of accessories, transducers and cables other than those

specified, except for transducers and cables sold by the manufacturer
as spare parts for internal components, could result in increased
emissions or decreased electromagnetic immunity of the device and
result in improper operation.

Portable RF communications equipment (including peripherals such

as antenna cables and external antennas) should be used no closer
than 30 cm (12 inches) to any part of Flute & Viola, including cables
specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.

Anyone connecting additional equipment is responsible for making sure the

system complies with the IEC 60601-1-2 standard.

The instrument has no ESSENTIAL PERFORMANCE as related to IEC

60601-1

112
Note: All necessary instruction for maintaining compliance with regard to
electromagnetic compatibility can be found in the maintenance section in this
manual. No further steps are required.

Guidance and manufacturer’s declaration – electromagnetic emissions

Flute & Viola are intended for use in the electromagnetic environment specified
below. The customer or the user of Flute & Viola should assure that they are used
in such an environment.
Electromagnetic environment-
Emissions test Compliance
guidance
Flute & Viola use RF energy only for
their internal function. Therefore, their
RF emissions
Group 1 RF emissions are very low and not likely
CISPR11
to cause any interference in nearby
electronic equipment.
RF emissions
Class B
CISPR11
Harmonic Flute & Viola are suitable for use in
emissions Class A professional healthcare facility
IEC 61000-3-2 environment and directly connected to
Voltage the public low-voltage power supply
fluctuations / network.
Complies
flickers emissions
IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity

Flute & Viola are intended for use in the electromagnetic environment specified
below. The customer or the user of Flute & Viola should assure that they are used
in such an environment.
Electromagnetic
IEC 60601 Compliance
Immunity Test Environment -
test level Level
Guidance
Floors should be
wood, concrete or
± 8 kV contact ± 8 kV contact (1) ceramic tile. If
Electrostatic floors are covered
discharge (ESD) ± 2 kV, ± 4 kV, ± 2 kV, ± 4 kV, with synthetic
± 8 kV, ± 15 kV ± 8 kV, ± 15 kV material, the
IEC 61000-4-2
air air (1) relative humidity
should be at least
30%
Mains power
± 2 kV for power ± 2 kV for power
Electrical fast quality should be
supply lines supply lines that of a
transient / burst
professional
± 1 kV for input / ± 1 kV for input /
IEC 61000-4-4 healthcare facility
output lines output lines environment.

113
 Mains power
± 1 kV ± 1 kV quality should be
Surge differential mode differential mode that of a
IEC 61000-4-5 professional
±2 kV common ±2 kV common
healthcare facility
mode mode environment.
Mains power
< 5% UT (2) < 5% UT (2) quality should be
(> 95% dip in UT) (> 95% dip in UT) that of a
for 0,5 cycle. for 0,5 cycle. professional
Voltage dips, healthcare facility
40% UT 40% UT environment. If the
short
(60% dip in UT) (60% dip in UT) user of Flute &
interruptions and Viola requires
for 5 cycles. for 5 cycles.
voltage variations continued operation
on power supply 70% UT 70% UT during power mains
input lines (30% dip in UT) (30% dip in UT) interruptions, it is
for 25 cycles. for 25 cycles. recommended that
IEC 61000-4-11 Flute & Viola be
<5% UT <5% UT powered from an
(> 95% dip in UT) (> 95% dip in UT) uninterruptible
for 5 s. for 5 s. power supply or a
battery.
Power frequency
Power frequency magnetic field
(50/60 Hz) should be at levels
magnetic field 30 A/m 30 A/m characteristic of a
professional
IEC 61000-4-8 healthcare facility
environment.
Note:
(1)
A lock or reboot of the device with no permanent damage is acceptable
(2)
UT is the a.c. main voltage prior to application of the test level.

114
 Guidance and manufacturer’s declaration – electromagnetic immunity
Flute & Viola are intended for use in the electromagnetic environment specified
below. The customer or the user of Flute & Viola should assure that it is used in such
an environment.
Immunity Test IEC 60601 Compl. Level Electromagnetic environment
Test Level – Guidance
Portable and mobile RF
communications equipment should
be used no closer than 30cm (12
inches) to any part of Flute &
3 Vrms 3 Vrms Viola, including cables specified by
0.15 MHz to 0.15 MHz to the manufacturer.
80 Mhz 80 Mhz
Conducted RF
6 Vrms 6 Vrms Field strengths from fixed RF
IEC 61000-4-6 in ISM bands in ISM bands transmitters, as determined by an
between 0.15 between 0.15 electromagnetic site survey,a
should be less than the compliance
MHz and MHz and
level in each frequency range. b
80 MHz 80 MHz
Interference may occur in the
vicinity of equipment marked with
the following symbol:

Radieted RF 3 V/m 3 V/m

IEC 61000-4-3 80 Mhz to 80 Mhz to 2,7

2,7 Ghz Ghz

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / Cordless)

telephones and land mobile, amateur radio, AM and FM radio broadcast and TV broadcast cannot
be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If measured field strength
in the location in which Flute & Viola are used exceeds the applicable RF compliance level
above, Flute & Viola should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating Flute &
Viola.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

115
 APPENDIX E:

Bibliography

- Cynthia G. Flower and Janet E. Shank, Tympanometry, Handbook of

Clinical Audiology, 175-202, Katz J. Editor, Williams & Wilkins (2002).

- Stanley A. Gelfand, The Acoustic Reflex, Handbook of Clinical

Audiology, 205-229, Katz J. Editor, Williams & Wilkins (2002).

- Jackie L. Clark, Ross J. Roeser, Marissa Mendrygal, Middle Ear

Measures, Audiology Diagnosis, 380-398, Ross J. Roeser, Michael
Valente, Holly Hosford-Dunn Editors, Thieme (2007).

- Goldstein B.A. and Newman V.W., Clinical Masking: a Decision-

Making Process, Handbook of Clinical Audiology, 109-131, Katz J.
Editor, Williams & Wilkins (1994).

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

Laryngoscope; 70: 1211-1228 (1960).

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

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

- Taylor, Brian. "Speech-in-noise tests: How and why to include them in

your basic test battery." The Hearing Journal 56.1 (2003): 40-42.

117
118
119
120