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Summary of Contents for ECHODIA AUDIOSMART
- Page 1 USER GUIDE AUDIOSMART CHODIA a brand of Électronique du Mazet ZA Route de Tence 43520 Le Mazet Saint Voy FRANCE Tél. : +33 4 71 65 02 16 Email : contact@electroniquedumazet.com Firmware 1.8.0x Web : www.electroniquedumazet.com Software 2.4.0.x ECH001XN141-A4 – 07/2022...
- Page 2 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 use in otologic diagnosis.
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Page 3: Table Of Contents
Patient data confidentiality ............................ 10 Cybersecurity ................................. 10 1.9.1 Good practices for computer security ...................... 10 1.9.2 Technical Information ..........................10 AUDIOSMART General information about using ....................11 Initial Start-up of the device ..........................11 2.1.1 Switching on / starting ..........................11 2.1.2... - Page 4 TABLE DES MATIÈRES TABLE DES MATIÈRES 5.4.1 Medical software ............................32 5.4.2 Puretone audiometry settings ........................32 5.4.3 Impression ..............................33 Update ................................... 33 AUDIOSMART 5.5.1 update ........................34 ECHOSOFT Audiometry with ..........................34 5.6.1 Pure tone audiometry ..........................35 5.6.2 Speech audiometry ...........................
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Page 5: Information And Safety
Chapter 1 Information and safety 1.1 About this manual AUDIOSMART This user and maintenance manual is published to help you to get started with your device from the initial receipt, through commissioning, use and maintenance. If you have any difficulty in understanding this manual, contact your dealer/distributor or the manufacturer, Élec- tronique du Mazet. -
Page 6: Target Population
DD450 headset 302427 Radioear Insert Earphones 040070 Electronique du Mazet Bone vibrator B71 040060 Electronique du Mazet Patient response switch 040084 Electronique du Mazet Mini-USB cable 2m 300618 Lindy USB power adapter (EU) 301526 AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 7: Warnings
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 servi- cing AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 8: Potential Risks
USB power (see Erreur ! Source du renvoi introuvable.). Once plugged in, the charge starts automatically AUDIOSMART and an electrical plug logo is displayed in the title bar. This logo appears in grey when the is charging and in green when the battery is fully charged. -
Page 9: Applicable Symbols
BF type 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. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 10: Identification Label
Year of manufacture Country of production Product reference CE marking 1.7 Identification label Information and specifications are given on the back of each device on an identification label: Device : Device identification label AUDIOSMART ECH001KP140-A0 AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 11: Patient Data Confidentiality
ECHOSOFT -Since the device and 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 ECHOSOFT -The software is a Java program -It embeds its own java execution environment (JRE+JVM) in order not to interfere with other software. -
Page 12: General Information About Using Audiosmart
Chapter 2 AUDIOSMART General information about using 2.1 Initial Start-up of the device 2.1.1 Switching on / starting The device can be turned on without any other part connected. Turn on the power using the switch on top of the device (if it does not start, make sure the device's battery is charged) 2.1.2 Touch screen calibration... -
Page 13: Home Screen
Chapter 2. General information about using AUDIOSMART 2.1 Initial Start-up of the device 2.1.4 Home screen Once this step completed, the homepage appears: Several items of information appear on this page. First, it contains the 3 possible selection parameters when the device is starting: •... -
Page 14: General Device Configurations
Chapter 2. General information about using AUDIOSMART 2.2 General device configurations General device configurations Some of the device general operating parameters can be configured. Accordingly, it is possible to set the time, date, brightness and orientation of the screen. To do this, just enter the configuration menu from the main screen. -
Page 15: Selection Of The Connected Jack Headphone
Chapter 2. General information about using AUDIOSMART 2.2 General device configurations The «About» menu contains the contact details of the company Electronique du Mazet. The “Calibration” menu allows the consultation of the acoustic calibration values defined for your device. Electronique du Mazet... -
Page 16: Introduction And Test Setup
3.1 Equipment To make a Audiometry measurement you need the following equipment: Common elements for all configurations AUDIOSMART unit Air conduction audiometry 1 audiometric headset or the insert earphone... -
Page 17: Setup
Using an otoscope, make sure that the ear canal is not obstructed by ear-wax. This operation must be carried out by a qualified person. • To make measurement with headset, connect the cable on the Jack plug of the AUDIOSMART (indicated with the headset icon •... -
Page 18: Handheld Mode Measurement
Chapter 4 Handheld mode measurement Patient management AUDIOSMART offers ideal measurement organization thanks to an advanced patient-based management sys- tem. From the home page, select the "Measure" mode, lead- ing to the choice of seeking an existing patient or creat- ing a new one. -
Page 19: Patient Follow-Up
To find the desired measurements, the main information is displayed (type, date, time and ear). The "Diagnosis" button allows to start a new measurement. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 20: Audiometry
The icon of a floppydisk at the bottom right of the screen is used for recording the parameters defined above. They then become the default parameters for this type of measurement. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... - Page 21 Chapter 4. Handheld mode measurement 4.2 Audiometry AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
- Page 22 “OK” to validate. All frequencies can be selected, however, the maximum and minimum stimulation frequencies may be limited at the time of the test depending on the characteristics of the stimulator. AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
- Page 23 Measurement The bellow windows give access to the stimulation configuration. Frequency selection Power setting Ear side Start stimulation Power of contralateral Patient answer masking and choice of available frequency Curve consultation Connected transmitter AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
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Page 24: High Frequency Audiometry
The headset must be selection in the menu « headset » under the configuration window (see 2.2.1). It is extremely important to choose the correct headset model to ensure that the calibration is correctly ap- ply when making measurement. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 25: Speech Audiometry
When you start a new diagnosis, the configuration window appears. It lets you choose the type of list used, for example the disyllabic lists of Fournier. AUDIOSMART is designed to allow you to easily perform a Speech audiometry. At the launch of the test, the device displays the words from the list on the screen. - Page 26 You can switch at any time between performing a new point and the graph by clicking the on the “Graph” button. When the test is finished, click on “Graph” to see the curve. You can then save it or make other Pure Tone audiom- etry or Speech audiometry measurements. AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
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Page 27: Measurement Consultation
• The dotted red curve with brackets is for bone conduction measurement on the right ear. • The dotted white curve with red and blue brackets is for the Weber test. - Headsets used for aerial and bone audiometry Click on the graph to see the chart legend. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 28: Echosoft
When installation begins, you must accept the license agreement. You can then choose to place an icon in the start menu or on the desktop. Then you can choose the location where the application files will be installed. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 29: Installation Des Pilotes Usb
Chapter 5. The use of the software ECHOSOFT 5.3 Patient management By default, it is "C:/Program Files/Echodia/EchoSoft" Click on “Install” and then “close” to complete the installation. Once the software is launched, the following window appears: 5.2.2 Installation des pilotes USB... -
Page 30: Create New Patient
Chapter 5. The use of the software ECHOSOFT 5.3 Patient management ECHOSOFT AUDIOSMART software is capable of reading measurements made using . it incorporates a database in which the patient data and measurements can be stored. 5.3.1 Create new patient After installing the software, there is no patient in the database, before starting a new measurement, a patient must be created. - Page 31 5.3.2.2 Synchronize all patients with the database ECHOSOFT AUDIOSMART This option lets you add all of the patients to the database. The software will automatically ECHOSOFT...
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Page 32: Delete A Patient
The "Delete" button is used to defini- tively delete the patient from the E database. AUDIOSMART 5.3.3.2 Delete a patient from AUDIOSMART A patient can be deleted from the memory card via the "Data"... -
Page 33: Settings
The backup file name contain the data and time. *In the case of a network shared folder, it is not recommended to have write access (create patient, record measures ...etc...) by several users in the same time. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 34: Medical Software
The "Response Time" is the time limit after the stimulus presentation during which the patient's response is considered valid. The intervals between two stimuli are randomly modified according to the maximum and minimum intervals set. 3. The modifications must be validated by clicking on « Save ». AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 35: Impression
5.5 Update Echodia tries to answer to day to day user’s expectations and to improve its products. As such, the company makes updates available regularly and free of charge that includes new features or contributes to the improvement of your products. -
Page 36: Audiometry With Echosoft
Chapter 5. The use of the software ECHOSOFT 5.6 Audiometry with ECHOSOFT AUDIOSMART 5.5.1 update AUDIOSMART If your is connected in USB mode to ECHOSOFT your computer, when the software is launched, a verification of your version is performed. If a newer version is available, the software offers you to automatically update. -
Page 37: Pure Tone Audiometry
8. The whole green area is dedicated to the masking noise. In the upper part, the power and frequency band of the noise are indicated. Just below, the box "Continuous masking" allows to have a permanent masking (if it is not AUDIOSMART User guide... -
Page 38: Speech Audiometry
3. Control starting, pausing and stopping a list. The gauge below shows the progression of the current list, 4. By default, the word list are played randomly but by clicking on this button it is possible to choose which list must be play, AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 39: Exploitation Sur Echosoft
5.7 Exploitation sur ECHOSOFT 5. This button allows you to import new lists on the software (If you have no list installed, click on this button to import lists previously downloaded from http://echodia.fr/firmware/vocal/). 6. This option will pause the list after each word. - Page 40 Chapter 5. The use of the software ECHOSOFT 5.7 Exploitation sur ECHOSOFT AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
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Page 41: Description Of The Measurement Window
• The dotted red curve with brackets is for bone conduction measurement on the right ear. 5. Note input. • Excel export of the measurement, • Print options, 7. If a device is connected, it is possible to resume the measurement, AUDIOSMART 8. Information about the used for the measurement. AUDIOSMART User guide... -
Page 42: Masking Calculation Help
AC and BC thresholds of both ears for at least one frequency (between 500Hz and 2 kHz) are required. The calculation of the applied differential is performed as described in the section Erreur ! Source du renvoi introuvable.. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 43: Color Code
In order to calculate masking for speech audiometry, the AC and BC thresholds of both ears for at least one frequency (between 500 Hz and 2 kHz) are required. The results obtained at 250 Hz are not taken into account for the calculations. AUDIOSMART User guide... -
Page 44: Merge Measurement
- Focus on threshold: data indicating a lower hearing loss will be preserved. - Focus on the date: the data of the oldest measurement will be replaced by the data of the most recent measurement AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 45: Using Keyboard Shortcuts
It is possible to adjust the input gain (this will depend on the computer and the sound card).Finally, you need to adjust the power at which the sound will be sent in the patient headphone. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... - Page 46 The volume is indicative, it may vary depending on the microphone, computer and speech of the operator. To use the microphone, keep the “A” key pressed and speak (the light indicator at the bottom left then turns red). AUDIOSMART User guide...
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Page 47: Maintenance And Servicing
• The general functioning of the device. Replace the unit and its peripherals in the original case after each use. AUDIOSMART device is reliable and safe for the patient. In order to maintain this safety, it is imperative to follow the operating instructions provided in this manual. -
Page 48: Accessories
Source du renvoi introuvable.. You can order the consumables from your distributor or directly from our online shop at www.echodia-store.com 6.3 Malfuction If you notice a malfunction that is not commented on in the documents accompanying the appliance (see below), please inform your dealer or the manufacturer. -
Page 49: After-Sales Service And Warranty
Shipping address : Électronique du Mazet ZA Route de Tence 43520 Le Mazet St Voy France Tel : (33) 4 71 65 02 16 Fax : (33) 4 71 65 06 55 E-Mail : sav@electroniquedumazet.com AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 50: Transport And Storage
As part of its commitment to the environment, Électronique du Mazet finances the recycling channel dedicated to WEEE Pro, which takes back free of charge electrical lighting equipment, control and monitoring equipment and used medical devices (more information on www.ecosystem.eco). AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 51: Technical Specifications
Backlight level selection, display rotation Recording on internal memory of the device (> 2000 measurements) Data storage ECHOSOFT Data transfer Copy of data via the software through USB Medical Class IIa equipment. Applied part type BF. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 52: Test Parameters
* Depending on the type of stimulator chosen, the device is capable of achieving slightly higher maximum values than those indicated Information about the transducers and the calibration method used can be found on the calibration certificate. AUDIOSMART User guide ECH001XN141-A4 – 07/2022... -
Page 53: Standards/Certifications
EMC compliance according to IEC 60601-1-2 (2014) 4th Edition (EN 60601-1-2: 2015) The Echodia range of products are intended for use in the electromagnetic environment specified below. The cus- tomer or user of the equipment should ensure that it is used in such an environment. - Page 54 To assess the electromagnetic environment due to fixed RF transmitters, an on-site electromagnetic investi- gation should be considered. If the field strength, measured at the location where the Echodia Series equipment is used, exceeds the applicable RF compliance level above, the Echodia Series equipment should be observed to verify normal operation.
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Page 55: Ce Declaration
Today, Electronique Du Mazet studies, develops, manufactures and markets pressotherapy, depressotherapy and elec- trotherapy (urological rehabilitation) equipment. Electronique du Mazet also owns the Echodia brand, which has a dedi- cated R&D office specialized in functional exploration in the field of otorhinolaryngology and neuroscience. It develops several hearing measurement devices specifically adapted to the needs of ENT doctors and other health professionals (audiologists, school and occupational doctors, family doctors, hospitals, etc.). - Page 56 Your dealer / distributor AUDIOSMART User guide ECH001XN141-A4 – 07/2022...
- Page 57 AUDIOSMART ECH001XN141-A4 – 07/2022 Certificate of Guarantee This form must be returned to Electronique du Mazet within 15 days of installation or receipt of the equipment. I, ................Organization: ............Address: ....................................... Declares that it has received the device ......n° ....in working order.
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