FIM MEDICAL Audiolyser ADL20 User manual

USER MANUAL
Audiolyser®
ADL20®
FIM Medical
51, rue Antoine Primat
CS60194
69625 Villeurbanne cedex
00 33 4 72 34 89 89
www.fim-medical.com
Ce document est la propriété de la Société FIM Medical. Il ne peut être reproduit ou communiqué sans son autorisation. This document is the property of FIM Medical. Its contents cannot be reproduced or divulged without the company’s approval.
V01.13.00
July 2021

2
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
Table des matières
1. Introduction................................................................................................................................................... 5
1.1. List of equipment supplied ...................................................................................................................... 5
1.2. Audiometer presentation.......................................................................................................................... 5
1.3. Technical features..................................................................................................................................... 6
1.4. Multilingual Vocal Assistant (MVA)......................................................................................................... 7
1.5. Symbols...................................................................................................................................................... 7
2. Safety............................................................................................................................................................. 8
2.1. General ....................................................................................................................................................... 8
2.2. Description................................................................................................................................................. 8
2.3. Intended use .............................................................................................................................................. 8
2.4. Planned operators..................................................................................................................................... 9
2.5. Patient population..................................................................................................................................... 9
2.6. Medical containdications ......................................................................................................................... 9
2.7. Environment of use................................................................................................................................... 9
2.8. Clinical benefits and risks associated with using this device............................................................. 9
2.9. Serious incidents or risk of incident....................................................................................................... 9
3. Installation................................................................................................................................................... 10
3.1. Minimum configuration........................................................................................................................... 10
3.2. Software use condition........................................................................................................................... 10
3.3. Prerequisites............................................................................................................................................ 10
3.4. Installation procedure............................................................................................................................. 10
3.5. The database.............................................................................................................................................13
3.5.1. The database for Audiowin®20............................................................................................................13
3.5.2. Retrieving a former database..............................................................................................................13
3.6. Connecting & disconnecting the device ...............................................................................................13
3.7. De-installation...........................................................................................................................................14
4. Use ................................................................................................................................................................14
4.1. Using the hygienic single-use earpad covers ......................................................................................14
4.2. Preliminary explinations to the patient..................................................................................................14
4.2.1. Positionning of the headset ................................................................................................................14
4.2.2. MVA (Multilingual Vocal Assistant)....................................................................................................15
4.2.3. Most frequent errors.............................................................................................................................15
4.3. Software use.............................................................................................................................................15
4.3.1. Presentation..........................................................................................................................................15
4.3.2. Checking function ................................................................................................................................15
4.3.3. Tool bar..................................................................................................................................................16
4.3.4. Menu bar................................................................................................................................................16

3
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
4.3.4.1. File ......................................................................................................................................................16
4.3.4.2. Tests...................................................................................................................................................16
4.3.4.3. Options...............................................................................................................................................16
4.3.4.4. Help.....................................................................................................................................................16
4.4. Patient identification................................................................................................................................17
4.4.1. Identification..........................................................................................................................................17
4.4.2. Viewing predictions..............................................................................................................................17
4.5. Open a patient/file test.............................................................................................................................17
4.5.1. Open a file..............................................................................................................................................17
4.5.2. Open an exam .......................................................................................................................................18
4.6. Parameter the software............................................................................................................................18
4.6.1. Screening...............................................................................................................................................18
4.6.2. Window parameters..............................................................................................................................18
4.6.2.1. General tab.........................................................................................................................................18
4.6.2.2. Automatism tab.................................................................................................................................19
4.6.2.3. Calculation tab ................................................................................................................................. 20
4.6.2.4. Export tab.......................................................................................................................................... 20
4.6.2.5. User tab..............................................................................................................................................21
4.7. Display areas categorization...................................................................................................................21
4.8. Manual mode............................................................................................................................................ 22
4.8.1. Operation.............................................................................................................................................. 22
4.8.2. Keyboard keys ..................................................................................................................................... 23
4.9. Automatic mode ...................................................................................................................................... 24
4.9.1. Parameteres ......................................................................................................................................... 24
4.9.2. Creation of sequences........................................................................................................................ 25
4.9.3. Run automatic test .............................................................................................................................. 25
4.10. Display of results................................................................................................................................. 26
4.11. Print results.......................................................................................................................................... 26
4.11.1. Simple printing................................................................................................................................. 26
4.11.2. Selective printing............................................................................................................................. 27
5. Maintenance................................................................................................................................................ 28
5.1. List of generic bactericidal fungicides validated by FIM Medical..................................................... 28
5.2. Cleaning of the Audiolyser®ADL20®..................................................................................................... 28
5.3. Annual maintenance............................................................................................................................... 28
5.4. Garantee................................................................................................................................................... 29
5.5. Lifetime..................................................................................................................................................... 29
6. Available accesories.................................................................................................................................. 29
7. F.A.Q. ........................................................................................................................................................... 30

4
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
7.1. No sound is perceived............................................................................................................................ 30
7.2. Error message appears at recording.................................................................................................... 30
7.2.1. « Identification incomplete ».............................................................................................................. 30
7.2.2. « Operation must use updateable query » ....................................................................................... 30
7.3. Patient identification file found but not the test.................................................................................. 30

5
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
1. Introduction
1.1. List of equipment supplied
The following equipment should be present in the packaging:
- Audiolyser®ADL20 device with headset and USB lead (in the cover)
- CD Rom containing user manual and Audiowin®20 software
- Information sheet
- Calibration certificate
- Transport cover
Note: The Audiolyser® ADL20 should be returned to the After Sales Service (for calibration or other services) in its original
packaging and padding. Guarantee repairs will not be accepted without the original packaging box.
1.2. Audiometer presentation
The Audiolyser® ADL20 is a computerized digital audiometer. The electronics are integrated into the patient response button,
rendering the device lightweight and easy to transport.
The Audiolyser® ADL20 can be set up with different headsets depending on user needs (refer §1.3).
One of the innovations of the Audiolyser® ADL20 is the Multilingual Vocal Assistant (MVA) which gives the patient the
necessary instructions for the test and signals, if necessary, incorrect patient handling.
The DSP (Digital Signal Processor) located in the patient response button ensures communication with both the computer
and the sound generation.
The Audiolyser® ADL20 is driven by the Audiowin®20 software, a simple and intuitive interface. Audiowin® 20 stores
information in a data base, which can also be printed, recorded and exported to other software.
Storage of audiometric curves and results enables consultation of files at a later date as well as statistics processing of
results.
With all its features, the Audiolyser® ADL20 is a reliable, high-performance and progressive tool.
Analog signal
generated by the
electronics in the
patient response
button
Patient response
button with lead
Bi-directional
digital signal

6
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
1.3. Technical features
Audiolyser®ADL20 features
Modes of use
Manual or automatic
Sound transmission
Continuous, inversed or pulsed mode
Harmonic distortion
± 3%
Frequency accuracy
± 2.5%
Headset soundproofing
10 - 40 dB (depending on model)
Length of lead
3 metres
Storage temperature
0 - 50°C
Temperature for use
15 - 35°C
Humidity
75% maximum
Altitude of operation
< 2000 metres
Voltage
5VDC (via USB port)
Supply current
210mA maximum
Reference standards
EN 60601-1, EN 60601-1-2, IEC 60601-1-6, EN 62366-1, EN ISO 10993-1, EN ISO 10993-
5, EN ISO 10993-10, NF EN ISO 14971, IEC 60645-1, ISO 8253-1, NF, ISO 389-1, ISO
389-8, ISO 7029, EN 62304, NF EN 1041+A1, EN ISO 15223-1
Type of audiometer
4
Medical class
IIa (rule 10)
GMDN Code Audiometer
41187
Applied part
BF Type
Dimensions in packaging
255 x 210 x 100 mm
Total weight of device
500 - 850g approximately (depending on model)
Altitude of operation
< 2000 metres
Year of 1st EC marking: 2010
NB: Under normal conditions of use, no heating time required for the equipment (§5.4 IEC 60645-1: 2012).
Specific features of each headset
Type
Beyer Dynamic
DT 48
Telephonics
TDH 39
Sennheiser
HDA 200
Sennheiser
HDA 300
Holmco
PD-81
Calibration
standard
ISO 389-1
ISO 389-1
ISO 389-5
ISO 389-8
ISO 389-5
ISO 389-8
Manufacturer
Headset weight
600 g
430 g
445 g
490 g
725 g
Intensity limit for each headset (dB)
Frequencies (Hz)
125
250
500
750
1000
1500
2000
3000
4000
6000
8000
Beyer Dynamic
DT 48
70
90
100
110
110
110
110
110
110
90
80
Telephonics
TDH 39
70
90
100
110
110
110
110
110
100
90
80
Sennheiser
HDA 200
70
90
100
100
100
100
100
100
90
90
80
Sennheiser
HDA 300
70
90
100
110
110
110
110
110
110
110
100
Holmco PD-81
70
80
90
100
100
100
100
100
100
90
80
Biocompatible single use earpad covers
Material
Unwoven PP (Polypropylene) 35g
Diameter
11 cm
Reference standards
EN 62366-1, EN ISO 10993-1, EN ISO 10993-5, EN ISO 10993-10, NF EN ISO 14971, IEC
60645-1, ISO 8253-1, NF EN 1041+A1, EN ISO 15223-1
Medical class
I (rule 1)
Earpad covers GMDN code
63091
Year of 1st EC marking: 2018

7
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
1.4. Multilingual Vocal Assistant (MVA)
The Audiolyser®ADL20 possesses a multilingual vocal assistance (MVA) system. By default, only the language of the
country in which the product was purchased is available, but other languages are available and may be specified at the
time of purchase (French, English, Arabic, German, Mandarin Chinese, Dutch, Italian, Portuguese, etc.)
1.5. Symbols
Serial number labels display the following information:
CE Marking Directive 93/42/EEC + N° of notified body
0459
BF type applied part
Device should not be discarded with general household waste. Return it to the
manufacturer for disposal.
Consult the accompanying documents
SN Serial number
Manufacturer identification
Do not re-use. Single use.
Lot number
Expiration date of use
(01)XXXXXXXXXXXXXX UDI Identification
Unique identification number of the product
(10)XXXXXX UDI Identification
Batch number
(11)XXXXXX UDI Identification
Date of manufacture
(17)XXXXXX UDI Identification
Expiry date

8
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
2. Safety
2.1. General
Attention :
- Do not use the Audiolyser®ADL20 in a non-medical environment.
- Do not expose a person to levels above 100 dB without having read the safety instructions (or without authorization).
- Do not dismantle or interfere with the internal components.
- Do not plug in or use the Audiolyser®ADL20 in an explosive environment or in the presence of anaesthetic gases.
- Do not drop the headset or the device.
- Do not immerse, splash or wet the device, even only slightly (beware of aerosol sprays and disinfectants), when
cleaning or during any other operation.
- Do not pull on the headset leads.
- Do not make sudden movements while wearing the headset.
- Do not let the PC and Audiolyser®ADL20 leads dangle on the ground and become entwined. This may cause it to
fall, or degrade electrical connections.
- The operator should know whether the patient has an ear impairment and if a particular frequency or intensity could
damage them. If this is the case, the operator should not perform the audiometry, or should be assisted by an
authorized person who would be responsible for the test.
- The operator should ask the patient to remove glasses, hair accessories and/or hearing devices prior to an
audiometry.
- Always use the Audiolyser®ADL20 connected to a computer according to IEC 60950-1
- In the conditions of use of the ambient test environment (see section 1.3), the Audiolyser®ADL20 does not need
warm-up period.
- For hygiene and biocompatibility reasons, it is compulsory to use the FIM Medical brand of single-use earpad
covers with audiometric headphones.
- These earpad covers have been developed specifically to meet ISO 10993 material biocompatibility requirements
as well as guaranteeing perfect sound transmission whilst respecting IEC 60645-1.
Caution: to meet ISO 10993 material biocompatibility requirements, it is compulsory to use the FIM Medical brand
of hygienic single-use earpad covers with Holmco PD-81, Sennheiser HDA200 and HDA300 audiometric
headphones.
2.2. Description
The Audiolyser®ADL20 is an electromedical device composed of:
- The ADL20 device
- Audiowin®20 software (integrated into Audiolyser®)
- The single-use earpad covers
2.3. Intended use
The Audiolyser®ADL20 is a computerized audiometer intended solely for the exploration of hearing function. It is a tool for
detecting possible defects in the patient's hearing.
The biocompatible single-use earpad covers are adapted to the ADL20® headphones for biocompatibility between the skin
and the eyecups, and ensure protection against bacteriological risks between two patients.

9
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
2.4. Planned operators
The Audiolyser®ADL20 should be used exclusively by healthcare professionals such as medical secretaries, nurses,
doctors, ENT or other specialist doctors who have received recognized and comprehensive training in the use of
audiometers and the interpretation of audiometric results. Through their medical curriculum, healthcare professionals are
made aware of the rules of hygiene and bacterial contamination.
Users must be trained and experienced in the elementary manipulations required to use a computer. They should take all
the steps necessary to prevent software piracy, to safeguard confidential data, to prevent computer virus attacks and to
avoid incorrect software and hardware manipulations.
They will take particular care to take regular back-ups on reliable media of the data recorded on the computer. It is
recommended that this operation is carried out on a daily basis.
Users are reminded that the Audiowin®20 software is delivered under a licence contract which defines the conditions of use.
This licence is granted for installation and use of the software on a single workstation. Any new installation will require the
purchase of a supplementary licence.
In case of doubt, the healthcare professional should refer to the user manual and / or contact FIM Medical or its distributor.
2.5. Patient population
The patient population that can use this device is:
• People over 4 years old
• Anyone able to press the button to give their answer, or, if they are unable to do so, to give the answer to the operator
• All people not suffering from a contraindication related to their hearing condition
2.6. Medical containdications
- Do not perform an audiometry on patients with auditory prostheses.
- Do not perform an audiometry without prior otoscopic examination.
2.7. Environment of use
A noisy environment can disturb audiometry tests and results. In this case, we recommend an audiometric booth.
2.8. Clinical benefits and risks associated with using this device
The audiometer must be able to analyze the patient's hearing function in order to assess the level of hearing. The device
assesses the patient's hearing loss by comparing audiometric curves with those of a statistical distribution of hearing
thresholds as a function of age and sex (predicted by ISO 7029). Audiometric tests are used to detect occupational hearing
loss using audiometric calculations and interpretation aids. Periodic follow-up of patients makes it possible to assess the
impact of the work environment on hearing.
The performance, technical characteristics, measurement precision and IEC 60645-1 compliance of the Audiolyser®ADL20
and its Audiowin®20 software confer a qualitative clinical benefit for the patient in the area of diagnosis. The audiometric
measurement precision associated with interpretation aids enable measuring the state of a patient’s hearing and its
progression over the long term.
There is no limitation on the number of examinations per patient using the Audiolyser®ADL20.
2.9. Serious incidents or risk of incident
If any serious incident or risk of a serious incident is detected, the healthcare professionals should make an appropriate
declaration to the competent authorities of the Member State. In all such cases, the manufacturer must be informed as
quickly as possible so that a material vigilance declaration can be made and acted upon.

10
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
3. Installation
3.1. Minimum configuration
•Operating system supported by the Audiolyser®ADL20: Windows XP, Windows Vista, Windows 7,
Windows 8 et Windows 10.
•PC with a 1 GHz processor at least
•512 Mo of RAM
•500 Mo free space on the hard disk
•A graphic card (or graphic chipset) accepting a resolution of at least 1024x748
•A keyboard
•A mouse
•A USB port
•A screen with a resolution accepting a minimum resolution of 1024x748
3.2. Software use condition
The Audiowin®20 software is licenced under the conditions defined below. If, before installation, or 48 hours after
receiving the software, these conditions are refused, please return it to the distributor to receive a refund.
Software use implies total agreement with the following conditions:
The software supplied under licence remains the property of FIM Medical who grants the right to use this product as long
as the present conditions are respected.
This licence is granted for installation and use at one workstation only (desk top computer, lap top or terminal).
All new installations require the purchase of a new licence or uninstallation from the initial workstation.
The licence for use is nominative and should not be passed on or sold without the written agreement of FIM Medical.
Copy or reproduction of FIM Medical software supplied under licence is prohibited. Reproduction, even partial, of original
screens or computer processes constitutes a violation of this agreement. The user accepts to take the necessary measures
to avoid pirate copies or use by non-authorized third parties.
The FIM Medical company cannot be held responsible in any way for malfunctions related to the installation of one of their
programmes on a computer. Neither can the FIM Medical company be held responsible for any consequences related to
the installation of one of their programmes, such as partial or total loss of data.
The user should be trained in the basic rules of handling computers. All precautions should be taken to guard against the
risks of pirating programmes, divulging confidential data, attack by whatever type of computer virus or incorrect handling.
Special care should be taken to back up data recorded on the computer as often as possible, on a reliable media; we
recommend performing this every day.
3.3. Prerequisites
Components required to be installed with the software:
- Adobe Reader
- Silicon Labs drivers for CP210x (component which ensures the device’s USB communication)
3.4. Installation procedure
Note: To be able to install Audiowin®20 you need to be in administrator mode.
The operator must possess all the administration rights on the workstation to be installed. Installation should be made in a
clear space on a stable desk or table. The patient should not be able to see the screen, or the operator actions.
1. Switch on the computer.
2. Insert the Audiowin®20 software installation CD Rom into the CD reader.
3. Proceed to the software installation phase.
4. If your computer is set up for auto run, the installation procedure will run automatically.
5. If not, open Windows Explorer and search for "setup.exe" file in the root of the CD Rom, and run it.
6. Once the installation programme is run, follow the instructions.
7. Choose your installation language then click OK:

11
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
8. Click Next:
9. Enter the user code located on the back of the CD sleeve, then click Next:
10. Accept the agreement and click « Next »:
11. Choose the Audiowin®20 software installation path (optional), then click Next:

12
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
12. Choose the data base installation path (optional), then click Next :
13. Click Next:
14. Click Install:

13
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
15. Wait while install :
16. Click Finish :
Locate a USB connector on the computer and plug in the ADL20.
The USB lead can pass through the wall of a booth. Request information from your booth manufacturer or distributor.
3.5. The database
3.5.1. The database for Audiowin®20
Audiowin®20 uses a specific database format:
- A local Microsoft Access database (*.mdb)
3.5.2. Retrieving a former database
If you are updating from Audiowin®to Audiowin®20, there is no need for any action to transfer the database as this is done
automatically.
3.6. Connecting & disconnecting the device
After installation set up, you may connect the Audiolyser®ADL20 to the PC using the USB cable.
If the installation has been correctly carried out, the device should be recognised at the first connection (the connection is
displayed in the right-hand bottom corner where the icon becomes blue):

14
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
If this is not the case, check that the device is properly plugged in, then de-install the Audiowin®20 and carry out a manual
installation of the drivers. The set-up modules are in the ‘Drivers’ directory on the CD-ROM. Double click on
CP210xVCPInstaller.exe and follow the instructions.
Then connect the Audiolyser®ADL20, which should be recognised automatically by the operating system.
To stop the audiometer, close the Audiowin®20 software window. If you are closing down the system for a lengthy period,
disconnect the USB cable from the headphones which should then be stored in their packaging.
3.7. De-installation
If you have no further use for the Audiowin®20 software, you may de-install it from your computer. To de-install programs
consult ‘Programmes and Functions’.
1- Open ‘Programmes and Functions’. In the Windows control panel, click on ‘Programmes’, then on ‘Programmes
and Functions’’. Note: Access to the de-installation panel may differ depending on the Windows version.
2- Select Audiowin®20, then click on ‘De-install’.
3- De-install the ‘Silicon Labs. CP210x USB to UART Bridge’ drivers.
Note: Before de-installing any driver, make sure no other software uses it.
4. Use
4.1. Using the hygienic single-use earpad covers
The FIM Medical company has specifically developed hygienic single-use earpad covers to be used with the Audiolyser®
ADL20 audiometer.
Caution: These hygienic single-use earpad covers should be systematically used for each test, and
changed after each patient. If disposable covers are re-used for subsequent patients, there is a risk of cross-
contamination (bacterial or viral contamination) on contact with the ears.
Caution: For hygiene and biocompatibility reasons, it is compulsory to use the FIM Medical brand of
single-use earpad covers with these audiometric headphones.
These earpad covers have been developed specifically to meet ISO 10993 material biocompatibility requirements,
as well as guaranteeing perfect sound transmission whilst respecting IEC 60645-1.
Using the single-use earpad covers:
Place a single-use earpad cover over each of the audiometric headphone earpads (speaker side)
Adjust the earpad covers so that there are no material folds between the headphone and the patient
4.2. Preliminary explinations to the patient
4.2.1. Positionning of the headset
Seat the patient comfortably and help them position the headset over the ears correctly. The pads should be centred over
the ear holes, with the headband resting on top of the head, without forcing it. Hair and bulky earrings should be removed
to prevent sound leakage.
Red earphone
On the right ear
Blue earphone
On the left ear

15
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
4.2.2. MVA (Multilingual Vocal Assistant)
Using software commands the MVA (multilingual vocal assistant) sends vocal instructions to the patient via the headset.
These instructions come in several languages (optional), thus making audiometry screening accessible to a wide range of
the public.
The MVA explains the test procedure as well as using the patient response button. It will also intervene if there is a usage
error, during the familiarization phase.
4.2.3. Most frequent errors
1- Continuous press on the response button.
2- Repeated and untimely presses on the response button.
3- Pressing too lightly.
If the patient is unable to get used to the response button, the perception of sound can be confirmed by raising an arm. In
this case, the operator validates the threshold by clicking “Validate”, or pressing “Enter”.
4.3. Software use
4.3.1. Presentation
4.3.2. Checking function
When the Audiowin®20 interface is run, the presence indicator turns from grey to blue. If this does not happen, check
that:
1. The USB lead is correctly inserted.
2. The software has not been run twice.
3. Installation of drivers was correctly done.
100 dB
Indicator
Automatism
Indicator
Frequency
setting
Sound transmission
Intensity
setting
Validation
Automatism
MVA Indicator
Patient response
indicator
Headset indicator
presence
Left & Right
Audiogram
Manu
bar
Tool bar
Pause

16
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
As soon as the presence indicator colours, click onthe graph of the left or right ear at the intersection of an audible frequency
and intensity.
Transmit the sound by pressing on the keyboard space bar; the chosen sound should be perceived.
4.3.3. Tool bar
To access main functions:
4.3.4. Menu bar
4.3.4.1. File
Fonction
Description
New
Create a new file
Open
Open a patient file and/or test
Record
Record the current file and test
Export
Export the test performed to the computer
Compare
Compare several curves from the same patient recorded in the data base
Follow up
Follow a patient on an index or frequency over time
Identification
Input or consultation of patient identification
Print
Print the test in progress
Selective print
Print a selection of the test according to certain criteria
Print preview
Display entire pages
Print set up
Choose and set up the printer
Exit
Exit the programme
4.3.4.2. Tests
Fonction
Description
Automatism
Start/stop automatism
Pause
Automatism pause, or rerun
MVA repeat
Repeat last MVA message to the patient
MVA
List of available languages
Comment
Post a comment related to the test
Results
Display audiometry result and the calculated indexes
+90d Authorization
Tick this menu to go over 90 dB value
4.3.4.3. Options
Fonction
Description
Parametres
Parameter the software
Parametres Import/Export
Allows to duplicate data from one workstation to another
4.3.4.4. Help
Fonction
Description
About
Version and copyright information
System information
Environment and device information
User manual
Access to the PDF version of the device's user manual
TeamViewer
Allows you to connect remotely with our teams if necessary
New
Record
Imprimer
Open
Identification
Automatism
Parameters
MVA
Sequence
Results
Export
Comment
Help

17
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
4.4. Patient identification
4.4.1. Identification
Patient identification is required to record test results in the data base, but also to calculate and display the predicted
response limits according to the age and gender of the patient (cf. ISO 7029).
Click "Identification" button before or after the audiometry.
Fill in the required fields (fields with a red asterisk are compulsory). Go from one field to another by clicking on the box, or
by pressing the “Tab” button.
Use the small 3-points button (…) located on the right of the last name to check if the patient has already been recorded,
using only the first letters of the last name.
Date of birth can be input with or without spaces. The year can be 2 or 4 numbers, e.g.: 21/04/1981 or 21/04/81.
4.4.2. Viewing predictions
After identification, the graph appears as such:
Calculation of predicted values is based on the ISO 7029 standard.
The colour can be changed in the "Parametres" window, "General" tab.
4.5. Open a patient/file test
4.5.1. Open a file
To locate the data of a recorded patient, proceed as follows:
Click “Open”. The following screen appears:
Predicted values

18
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
Enter the first letters of the patient’s surname in the “By name” box, then click “Search”. The list of names starting with
these letters appears. Then click “New exam”. A patient search can also be carried out by identification number or date of
recording.
4.5.2. Open an exam
To visualize or print an old test, the operator can call up a file.
Proceed as seen before. A small + sign is displayed next to the patient name, indicating that tests were done. Click on this
+ sign.
A list of dates and times are shown.
Double click on one of these dates or click “Load exam” to display the audiogram performed on this date.
4.6. Parameter the software
4.6.1. Screening
Recommended settings to perform a screening test:
"General" tab.
1. Amplitude variation 5 dB
2. Sound transmission Pulsed
"Automatism" tab.
1. Frequency 1000 Hz, 2000 Hz, 4000 Hz, 6000 Hz, 8000 Hz, 500 Hz, 250 Hz.
2. Lowest hearing level 0 dB
3. Presentation level 50 dB
"Automatism" tab.
1. Number of tests 3 successive tests achieved
2. Tolerance of doubtful test 10 dB
3. Duration per level Choose a range between 15 - 30 tenths of a second.
All these settings are programmed only once, but can be changed at any time.
4.6.2. Window parameters
To define software parameters:
Click on the parameters icon in the tool bar or select Option in the menu bar, then Parameters.
4.6.2.1. General tab
Function of transmission button on main interface.
Sound is automatically transmitted when the mouse
cursor is pointed over the button.

19
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
Modify the data base path. Caution: Do not modify this
parameter without knowledge of the consequences.
Display, printing and colour of predicted value.
Action of high and low keyboard arrows.
Modify Audiowin®20 language.
Type of sound transmitted: pulsed or continuous.
Audiowin®20 can print the audiogram in colour (if
printer is a colour printer) and choose the logo on the
printing sheet.
Date format.
Inhibition of patient response button. The patient
signals sound perception by raising one hand. The
operator validates the measurement with the Enter key
or the Validate button.
Variation of sound amplitude.
Parametering of right and left arrows function on an
audiogram. Each frequency is swept in order, or only
the selected sequence.
Changing the display areas categorization of
audiograms.
4.6.2.2. Automatism tab
Use this tab to:
•Know the criteria used in the sequence by default
•Create and manage sequences for automatic mode (refer § 4.9 automatic mode)

20
Ce document est la propriété de la Société FIM MEDICAL. Il ne peut être reproduit ou communiqué sans son autorisation.
This document is the property of FIM MEDICAL. Its contents cannot be reproduced or divulged without the company's approval.
V01.13.00
July 2021
4.6.2.3. Calculation tab
Calculations of MP423(Legal index table n°42 of Occupational Diseases of the general scheme), of PAM3(Average Hearing
Loss), of IPA3(Early Warning Indicator), and DP42.01 (Doenças profissionais 42.01), or asymmetric hearing loss, HSE1+3
categorization, Merluzzi 19792+3 categorization, MPB 20023categorization, SNCF3aptitude criterion are performed by
Audiowin®20.
1For more information, you can consult "The Control of Noise at Work Regulations 2005"
2For more information, you can consult "La prevenzione dei danni uditivi da rumore in ambiente di lavoro - linee guida
proposte dalla società italiana di medicina del lavoro e igiene industrial"
3For more information, you can consult the document "Calculations and indicators in audiometry".
4.6.2.4. Export tab
Use this tab to parameter the destination of the exported file when pressing on the F12 key. Choose the name of the file as
well as the format by default.