ECHODIA AudioSchool Manuel utilisateur

USER GUIDE

AUDIOSCHOOL

ECHODIA a brand of Électronique du Mazet

ZA Route de Tence

43520 Le Mazet Saint Voy

FRANCE

Tel: +33 4 71 65 02 16

Email: contact@electroniquedumazet.com Firmware 1.3.0x

Web: www.electroniquedumazet.com Software 2.4.0.x

ECH001XN151-A3 - 01/2022

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

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

ER3-14B foam earplugs 10mm (50 pcs)

40117

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.

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