ECHODIA AudioSchool User manual
Instructions for use
&
Technical description
Please read these instructions carefully before using your new device!
This manual is an integral part of the device and must be kept until it is
destroyed.
This equipment has been designed and manufactured for audiological test use.
Use is restricted to professionals who have undergone appropriate training.
If you have a problem or do not understand this manual, please contact
your distributor (see stamp on the last page) or contact Électronique du
Mazet at :
Tel: (33) 4 71 65 02 16 - Fax: (33) 4 71 65 06 55
A brand of
Table des matières
1Information and safety 5
1.1 About this manual 5
1.2 Presentation of the device 5
1.2.1
Intended use 5
1.2.2
Target population 6
1.2.3
Expected performance 6
1.2.4
Contraindications 6
1.2.5
Side effects 6
1.2.6
Units of measure: 6
1.2.7
Accessories 6
1.3 Warnings 7
1.4 Potential risks 8
1.4.1
Stopping the device during operation 8
1.4.2
Special case of use 8
1.5 Installing the device 8
1.5.1
Charging the device 8
1.6 Symbols used 8
1.7 Nameplate label 10
1.8 Confidentiality of patient data 10
1.9 Cybersecurity 11
1.9.1
Good practices for computer security 11
1.9.2
Technical Information 11
2General information about using AUDIOSCHOOL 12
2.1 Initial Start-up of the device 12
2.1.1
Powering up / starting 12
2.1.2
Touch screen calibration 12
2.1.3
Password 12
2.1.4
Home screen 13
2.1.5
Switching off the device 13
2.2 General configurations 14
2.2.1
Selection of the headset connected to the jack 15
3Introduction and set up of the patient 16
3.1 Material 17
3.2 Set up of the patient 17
4Measure in ambulatory mode 18
4.1 Patient management 18
4.1.1
Creating a patient 18
4.1.2
Patient follow-up 19
4.2 Audiometry 20
4.2.1
Automatic modes 20
4.2.2
Manual threshold measurement mode 21
4.2.3
Consultation of the measure 22
5The use of ECHOSOFT software 23
5.1 Minimum system requirements 23
5.2 Installing 23
5.2.1
Installing the application 23
5.2.2
Installing the USB drivers 24
5.3 Patient management 25
5.3.1
Creating a new patient 25
5.3.2
Importing a patient 25
5.3.3
Deleting a patient 27
5.4 Configuration 28
5.4.1
Database 28
5.4.2
Medical
software 29
5.4.3
Audiometry 29
5.4.4
Printing 30
5.5 Update 30
5.5.1
Update the device AUDIOSCHOOL 31
5.6 Audiometry on ECHOSOFT 31
5.7 Operation on ECHOSOFT 33
5.7.1
Opening a measure 33
5.7.2
Description of the consultation window 34
5.7.3
Using the microphone 35
5.7.4
Using the keyboard 35
6Maintenance and servicing 36
6.1 Periodic checks 36
6.2 Cleaning 36
6.2.1
Device case 36
6.2.2
Accessories 37
6.3 Malfunction 37
6.3.1
Possible malfunctions 37
6.3.2
After-sales service and warranty 37
6.4 Transport and storage 39
6.5 Disposal 39
7Technical specifications 40
7.1 General technical data of the device 40
7.1.1
Test parameters: 41
7.2 Standards/Certifications 42
7.2.1
EMC compliance table 42
7.2.2
CE declaration 44
7.3 Manufacturer 44
Chapter 1
Information and safety
1.1
About this manual
This user and maintenance manual is published to facilitate the handling of your AUDIOSCHOOL device from the
initial reception phase, then the commissioning to the successive stages of use and maintenance.
If you have any difficulty in understanding this manual, contact your dealer/distributor or the manufacturer, Élec-
tronique du Mazet.
This document must be kept in a safe place, protected from atmospheric agents, where it cannot be damaged.
This document guarantees that the devices and their documentation are technically up-to-date at the time of marketing.
However, we reserve the right to make changes to the device and its documentation without any obligation to update
these documents.
In the event of the transfer of the device to a third party, it is mandatory to inform Électronique du Mazet of the details
of the new owner of the device. It is imperative to provide the new owner with all documents, accessories and packaging
relating to the device.
Only personnel who have been informed of the contents of this document may use the device. Failure to comply with
any of the instructions contained in this document will release Électronique du Mazet and its distributors from the conse-
quences of accidents or damage to personnel or third parties (including patients).
1.2
Presentation of the device
Audiometry is a behavioural test for the rapid assessment of hearing ability. Using an acoustic stimulator, sounds,
words or sentences at different sound intensities are presented to the subject. The subject reports his or her perception to
the operator who, depending on the test used, can determine an absolute threshold of perception or an intelligibility
threshold.
1.2.1
Intended use
The AUDIOSCHOOL is designed for screening, documentation and monitoring of hearing function. It is intended for
use by health care personnel in schools and workplaces who require a screening approach (large-scale screening cam-
paign). Screening audiometry is a behavioural test for rapid assessment of hearing ability. The subject is presented with
sounds of varying loudness via a stimulator. The subject transmits his or her perception to the operator, who can detect
normal hearing (20db threshold), or a decrease in hearing acuity by determining an absolute threshold of perception. In
screening, transduction is performed via the normal auditory pathway using an air conduction transducer.
The AUDIOSCHOOL is intended for the following audiological tests:
Audiometry :
-Air conduction (AC)
Chapter 1. Information and safety 1.2 Presentation of the device
1.2.2
Target population
Ages: The device can be used on any type of patient with the ability to respond to the presence or absence of an
acoustic stimulus (>5 years)
Patient types: men / women / children
Consultation context: ENT diagnosis / occupational medicine
1.2.3
Expected performance
The devices are designed to perform audiological tests according to ISO 60645 standards:
Families
Audiological tests
Standards
Audiometry:
- Tonal Air conduction (AC)
IEC 60645-1:2017 - Type 4
1.2.4
Contraindications
We recommend not to diagnose (or to take precautions when diagnosing) patients with injured skin, open wounds or
acoustic hypersensitivity
The contraindications are not exhaustive and we advise the user to seek advice in case of doubt.
1.2.5
Side effects
No side effects identified to date
1.2.6
Units of measure:
For all these devices, the units of measure are expressed in the units of the international system:
Basic size
Unit
Name
Symbol
Frequency
Hertz
Hz
Intensity (Decibel)
Acoustics
Perceived
dB SPL
dB HL
1.2.7
Accessories
This device is delivered as standard with the following accessories:
- Mini-USB cable 2m
The device is in contact with the patient through applied parts, some of which can be supplied by Electronique du
Mazet. These accessories can be single use or reusable.
The use of accessories not recommended by the manufacturer does not engage his responsibility
List of compatible accessories:
Name
ref
Manufacturer
Headset DD45
301765
Radioear
Headset DD65
301475
Radioear
Screening headset (HD206)
302956
Sennheiser
Screening headset (H840)
301785
Building
Inserts earphones
040070
Electronique du Mazet
Patient response switch audiometry
040084
Electronique du Mazet
Mini-USB cable 2m
300618
Lindy
Acoustic tubes
040054
Electronique du Mazet
USB power adapter (EU)
301526
CUI
USB power adapter (USA)
040048
CUI
USB power adapter (UK)
040047
CUI
Chapter 1. Information and safety 1.3 Warnings
ER3-14A 13mm foam earplugs (50 pcs)
40116
3M
ER3-14B foam earplugs 10mm (50 pcs)
40117
3M
1.3
Warnings
In this manual the warnings and information given have the following meaning:
The warning label indicates conditions or procedures that may put the patient and/or user at
risk.
The warning label indicates conditions or procedures that could cause the equipment to mal-
function.
The information label refers to notices or information that are not related to accident hazards
or device malfunction.
CAUTION: The device must be handled by a qualified operator (hospital staff, doctor, etc.).
The patient must not come into contact with the device other than through the accessories.
CAUTION: The device must be connected to a computer with a certified medical power
supply (double insulation according to ISO 60601-1)
CAUTION: No changes to the device are permitted. It is strictly forbidden to open the de-
vice case.
CAUTION: The device complies with applicable electromagnetic compatibility standards. If
you experience interference or other problems with another device, contact Électronique du
Mazet or the distributor for advice on how to avoid or minimize the problem.
CAUTION: Operation in close proximity (e.g., 1 m) to shortwave or microwave therapy EM
DEVICES may cause instabilities in the output power of the STIMULATOR
CAUTION: The device must be used with the accessories determined by the manufacturer
to be compatible with the device (see 1.2.7).
CAUTION: The device must not be accessible to the patient.
It should not be placed in contact with the patient.
CAUTION: the computer must never be located in a space accessible to the patient
CAUTION: Be sure to follow the maintenance instructions listed in the 6.Maintenance and
servicing
CAUTION: The battery can only be replaced by Électronique du Mazet technicians or their
distributors.
The device collects data. It is the responsibility of the user to apply and comply with the Eu-
ropean Parliament's General Data Protection Regulation 2016/679. When returning to the af-
ter-sales service, the user must delete the data so that it is not disclosed.
Chapter 1. Information and safety 1.4 Potential risks
1.4
Potential risks
Applied parts that are too old or of poor-quality can impair the quality of contact with the patient and cause discomfort.
Make sure to regularly change the parts.
Microbes or viruses can be transmitted from one patient to another via the applied parts. Make sure that the hygiene
conditions recommended by the manufacturer of the applied part are observed.
If water enters the device, it may not function properly. In this case, unplug the device and disconnect the cables. In
any case, avoid the presence of water in the vicinity of the device.
1.4.1
Stopping the device during operation
In case the device is shutdown during its operation,
- In stand-alone mode: the measurement in progress will stop; the continuous saving of the measured data avoids
losing the measurements made up to that point.
- When connected to the computer: the computer continuously saves the data, the measurement can be saved before
closing the software.
1.4.2
Special case of use
No specific cases identified. See section1.2.4 for contraindications
1.5
Installing the device
Check that the device is not damaged; if you have any doubtsabout the integrity of the device and its correct operation,
contact Électronique du Mazet or your distributor.
If the device was stored in a cold place and there was a risk of condensation, let the device rest for at least 2 hours at
room temperature before switching it on.
Before using the device for the first time, it is advisable to clean it and its accessories, see 6.Maintenance and ser-
vicing
1.5.1
Charging the device
The device is delivered with a USB cable. There are two ways to charge your device, via a computer or via the USB
power adapter (see 1.2.7). Once plugged in, charging starts automatically and an electrical plug logo is displayed in the
title bar. This logo appears in grey when the AUDIOSCHOOL is charging and in green when the battery is fully charged.
The battery of the device is charged before shipment, however it is recommended to charge it before the first use (we
advise you to charge for 12 hours before the first use).
When using the solution of connecting the device to a computer via the USB cord, charging will be slower than via a
USB power adapter (see 1.2.7).
1.6
Symbols used
Front panel (differs depending on the device)
Device name
It is preferable to charge/discharge the battery as fully as possible to ensure a long service life. Charge the
device to its maximum capacity and only charge it when it has reached a critical battery level.
To disconnect the device from the power supply, the USB power adapter must be disconnected.
Chapter 1. Information and safety 1.6 Symbols used
Upper part of the device
Caution: Switching the device on/off
USB
Mini-USB port for charging the device, or connecting to a computer (data exchange)
Lower part of the device
AUX
-Connecting the patient response switch in audiometry
Audio
-Connecting the stimulator
Headset connection
Rear panel
Warning: this logo draws your attention to a specific point
Operating instructions: this logo informs you that the operating instructions must be
read to use the device safely
Type BF applied part: applied parts not supplied by Electronique du Mazet are in elec-
trical contact with the patient, floating and not connected to earth.
Recycling: This device should be disposed of at an appropriate collection and recycling
facility. Consult the manufacturer.
Direct Current
Serial number
Manufacturer
Chapter 1. Information and safety 1.7 Nameplate label
Year of manufacture
Country of production
Product reference
CE marking
1.7
Nameplate label
Information and specifications are given on the back of each device on a nameplate label.
Device :
Device type label
AUDIOSCHOOL
ECH001KP150-A0
1.8
Confidentiality of patient data
The device collects data. It is the responsibility of the user to apply and comply with the European Parliament's
General Data Protection Regulation 2016/679. When returning to the after-sales service, the user must delete patient data
from the device so that it is not disclosed. The user has the possibility to make a backup copy of the data by saving them
in the ECHOSOFT software (see paragraph 5.3.2) before deleting the patients from the device (see paragraph 5.3.3.2).
In this regard, the AUDIOSCHOOL device is intended to be used only by authorised healthcare professionals. In order
to ensure the confidentiality of patient data and to prevent disclosure to unauthorised third parties, a password can be set
when the device is first started. Please refer to section 2.1.3for more information.
ECHODIA advises you to regularly renew the password of your device. It is also advisable to activate the
lock mechanism of the computers on which you have installed the ECHOSOFT software after a short pe-
riod of inactivity.
1.9
Cybersecurity
As the device and its ECHOSOFT software are computer-based systems that are integrated into larger information
systems, certain rules and good practices must be put in place to ensure the safety of patients and users.
Électronique du Mazet does not provide or control the operating environment of its products, so it is the responsibility of
the practitioner to ensure that the following recommendations are followed.
1.9.1
Good practices for computer security
-Keep your software up to date, including the operating system (Windows or MacOs)
-Use operating system accounts to manage access.
-Use strong passwords to access accounts
-Lock down the computer when not in use
-Back up the ECHOSOFT database regularly (see 5.4.1)
-Verify the authenticity of any third-party software you install
-Use anti-virus software and a firewall
-Since the device and ECHOSOFT do not need to access the Internet, isolate the computer from the network as much as
possible.
-Check echodia.com periodically to see if updates are available.
1.9.2
Technical Information
-The ECHOSOFT software is a Java program
-It embeds its own java execution environment (JRE+JVM) in order not to interfere with other software. (installed in the
same folder, by default : C:\Program Files\Echodia\Echosoft\jre)
-The configurations of the software as well as the database are saved in the .echosoft folder of the user folder (ex: C:\Us-
ers\romain\.echosoft).
-The software uses the port 32145 of the local loop (localhost / 127.0.0.1) in order to check that there are not several in-
stances of the software launched at the same time.
-The software uses a proprietary USB driver to communicate with the device
Chapter 2
General information about using
AUDIOSCHOOL
2.1
Initial Start-up of the device
2.1.1
Powering up / starting
The device can be turned on without any other device connected.
Turn on the device using the switch on top of the device (if it does not start, make sure the device battery is charged)
2.1.2
Touch screen calibration
During the first start-up, a calibration step of the touch
screen is necessary. The following window appears:
This is a five-point calibration of the screen. Simply
hold the stylus down on the crosses in the centre of each
of the circles that appear in succession.
2.1.3
Password
After the screen has been calibrated, the password setting windows appear. If you choose to set a password, you will
be asked for it every time you start the device. To do this, click on "Lock device with password" and then set your
password by clicking on "Change password". The password must be between 1 and 15 characters long, and you will be
asked twice to ensure that you have entered it correctly.
You can access the password configuration window later from the "Config" menu and then "System". This window
allows you to change the password, but also to activate or deactivate the lock. If you forget your password, please contact
Electronique du Mazet to receive an unlock code.
Calibration is important for user comfort. It is strongly recommended to perform it by placing the device
on a table and using the stylus.
Chapter 2. General information about using AUDIOSCHOOL 2.1 Initial Start-up of the device
2.1.4
Home screen
Once this step is completed, the home page appears:
Several pieces of information appear on this page. It contains the three main choices available when starting the
device:
•
USB: Allows you to activate the device's USB port in order to retrieve, store and analyse measurements made with
the device on a computer. The activation of the USB port of the device is also necessary to perform measurements
from a computer via the ECHOSOFT software.
•
Measure: main mode, it allows to make and consult measures.
•
Config: general configuration of the different options of the device.
The home page allows you to choose the language of the system. This choice is made by clicking on the flag at the
bottom left of the screen.
At the bottom right is the serial number of your device.
A title bar is present on all windows of the device. From left to right are :
•
The title of the current window.
•
The charging indicator (Grey: device charging. Green: device charged).
•
The date and time.
•
Battery level.
•
A button to return to the previous window (in the case of the home screen, it turns the device off).
2.1.5
Switching off the device
To turn off the device, you can click on the back button
at the top right of the home screen. A shutdown confir-
mation message will appear:
It is also possible to press the power button at the top of
the device to bring up this screen from any browser win-
dow.
Power save mode: when not measuring, the device will
automatically turn off after 5 minutes of inactivity.
The device can be forced to shut down by holding down the power button on the top of the device for 4
seconds.
Chapter 2. General information about using AUDIOSCHOOL 2.2 General configurations
2.2
General configurations
Some of the general operating parameters of the device
are configurable. For example, the time, date, brightness
and orientation of the screen can be configured. To do
this, simply enter the configuration menu from the home
screen.
The date and time can be configured from the "Date
and Time" window.
The "LCD" menu allows you to adjust the brightness
of the screen with an adjustable gauge. The " Rotation
" button allows the display to be rotated by 180°. This
can be useful depending on the location and position in
which the device is used. It is also possible to recalibrate
the touch screen.
The "System" menu provides information about the
hardware and software versions of the device, as well as
the amount of free memory on the AUDIOSCHOOL de-
vice.
The "Data factory reset" button resets the measure pa-
rameters to the default values.
If you choose to set up a password lock, you will be
prompted for it every time you start the device (see
2.1.3).
The "Settings" button provides access to the menu for
activating optimised start-up modes for operators who
use (mainly) the device connected to the computer
(ECHOSOFT). The settings allow the device to be
started directly in "USB mode" as well as the possibility
of an automatic start as soon as the connection with the
computer has been recognised.
The summer/winter time change is not automatic.
It is possible that after a certain period of use (several months), the touch screen may drift (e.g. the click
on the buttons becomes less precise). It is advisable to recalibrate the screen.
Chapter 2. General information about using AUDIOSCHOOL 2.2 General configurations
The "About" menu contains the contact details of the
company Electronique du Mazet.
The "Calibration" menu allows you to consult the
acoustic calibration values set on your device.
2.2.1
Selection of the headset connected to the jack
In most cases, the device is delivered with only one
headset, which is correctly configured at the factory.
However, you have the option of changing the type of
headset that will be recognised when connected to the
jack. The settings window will open. Click on "Head-
set" to access the selection of the headset that will be
recognised when connected to the jack. Select the head-
set model you will use and click "Save".
Do not change these values, only ECHODIA or your dealer are authorised to perform this calibration.
A calibration of the AUDIOSCHOOL device should be performed once a year to ensure the quality of the
measures. Please contact your distributor to schedule this calibration.
Some of these options require a password to be changed. This is the serial number of your device, which is
shown on the back of the device in the S/N line. This number is also displayed on the bottom right of the
start page.
Never connect a headset that has not been calibrated for your device!
It is extremely important to choose the right headset model to ensure that the calibration is correctly taken
into account when using it.
Stimulators connected to the "Audio" input are automatically recognised by the device.
Chapter 3
Introduction and set up of the patient
Pure-tone audiometry is the basic hearing test. This test allows a quick check of the entire sound transmission chain
to the brain in a discriminating manner. The measure is obtained by emitting a frequency-calibrated sound wave, the
power of which is reduced as long as the patient hears it. The sounds are emitted by an acoustic stimulator in one ear and
then in the other.
The AUDIOSCHOOL provides a simple, reliable and quick test of a patient's hearing acuity in a frequency range from
125Hz to 8kHz. This range of frequencies corresponds to that of speech. The interpretation of the result is easily done
through a table with coloured boxes according to the patient's hearing threshold. In addition, the device allows you to
perform a hearing threshold search and display the corresponding audiogram.
Chapter 3. Introduction and set up of the patient 3.1 Material
3.1
Material
To perform a pure-tone audiometry measure, you need the following equipment:
1 device
AUDIOSCHOOL
1 Audiometry headset
•
Connect the audiometry headset to the "Audio" connector or to the jack of the AUDIOSCHOOL device.
3.2
Set up of the patient
•
Explain to the patient the procedure for performing an audiometry,
•
Place the audiometry headset on the patient's head.
Use an otoscope to ensure that the ear canal is not blocked by earwax. This procedure must be carried out
by a qualified person.
Chapter 4
Measure in ambulatory mode
4.1
Patient management
The AUDIOSCHOOL device allows a good organization
of the measures thanks to its advanced patient manage-
ment system.
From the home page, select the "Measure" mode: this
gives you the choice to search for an existing patient or
to create a new one.
4.1.1
Creating a patient
When creating a new patient, four pieces of information
are requested: name, first name, date of birth and gen-
der.
To enter this information, simply click on the required
field and the keyboard will appear on the screen.
It is possible to use a numeric keypad by clicking on the
"123" key at the bottom left.
Here, the patient information is brief. You will be able to fill in more details when exporting the data to the ECHO-
SOFT software. Please refer to the paragraph 5.3
Entering the patient's date of birth and gender allows the audio metric normals to be traced.
To create a new patient, it is imperative to indicate a Name and a First Name. Note that it is still advisable
to enter the date of birth to enable ECHOSOFT to organise the patients in the database.
The input format for the date must be in the form DD/MM/YYYY. The AUDIOSCHOOL
device automati-
cally formats the entry.
Chapter 4. Measure in ambulatory mode 4.1 Patient management
4.1.2
Patient follow-up
Once a patient has been created, his or her record is saved
on the
memory
card.
It is then possible to find it by click-
ing on the "Search" button.
A table is displayed with the list of patients sorted in
reverse order of their registrations (the last patient added
appears at the top of the list).
The list of patients is displayed with their name, first
name and date of birth. It is possible to search by click-
ing on the magnifying glass at the bottom of the screen.
To select a patient, click on the corresponding row. A new
page will appear with the patient's details.
Now you have the choice of taking a new measure or view-
ing previously saved measures.
The "Consultation" button gives access to a table of
measures allowing to go back to the diagnoses previ-
ously made for this patient.
In order to find the measures of the selected patient, their
main information is displayed (type, date, time and ear).
The "Diagnosis" button is used to start a new measure.
If the patient does not yet have an associated measure, only the "Diagnosis" button is visible.
Chapter 4. Measure in ambulatory mode 4.2 Audiometry
4.2
Audiometry
Refer to paragraph 4.1 for instructions on how to create a patient and start a new measure.
When you start a new diagnosis, the configuration win-
dow
appears. It allows you to choose between three diag-
nostic modes
. The "Graph" button allows you to view
the graph viewing of the current curves at any time. The
last button allows you to see which stimulator is active
and to switch between the two audio outputs.
4.2.1
Automatic modes
4.2.1.1 Screening Mode vs. Auto Threshold Measurement
The automatic threshold measure mode searches for a patient's hearing threshold over a pre-selected frequency range.
The device performs automatic power transitions (using the ascending threshold method) and frequency transitions.
Throughout the test, the device displays the current stimulation power and frequency. This mode allows the operator to
easily perform an accurate measure of the patient's hearing ability.
In the screening mode, the hearing thresholds are not checked, only whether the threshold is above or below the target
value. The starting power and the target value are selected in the "Settings" menu. The test starts with the selected sound
power and is increased by 5dB until a response is obtained from the patient. When the patient validates a frequency, the
test moves to the next frequency. This allows for a screening of both ears in less than one minute.
4.2.1.2 Setting the measure
Click on "Frequency Selection" to pre-configure the frequencies to be scanned during the test. Once the frequencies
have been chosen, click on "OK" to validate.
The "Settings" button opens a window allowing you to
set the start power of the automatic protocols, the mask-
ing noise level and the target power to validate the
screening. Click on "OK" to confirm.
After selecting the ear, click the "Start" button to begin the measure.
The small floppy disk icon at the bottom of this screen is used to save the frequencies selected above.
These will become the default frequencies for this type of measure.
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Table of contents
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