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Summary of Contents for ECHODIA OTOWIN
- Page 1 USER GUIDE OTOWIN 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 1.1.0.x ECH001XN161-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
Confidentiality of patient data ..........................9 Cybersecurity ................................. 10 1.9.1 Good practices for computer security ...................... 10 1.9.2 Technical Information ..........................10 OTOWIN General information on the use of ......................11 Handling the device ............................... 11 2.1.1 Powering up / starting up ......................... 11 2.1.2... - Page 4 Automatic mode ............................30 5.4.6 Audiometric indices ..........................30 5.4.7 Printing ..............................30 5.4.8 About us ..............................31 Update ................................... 31 Update of the device OTOWIN......................32 5.5.1 OTOWIN Audiometry on the software ........................ 32 OTOWIN Operation on ............................34 5.7.1...
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Page 5: Information And Safety
Chapter 1 Information and safety 1.1 About this manual OTOWIN This user and maintenance manual is published to facilitate the handling of your device from the initial acceptance phase, through 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. -
Page 6: Target Population
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 USB power adapter (USA) 040048 USB power adapter (UK) 040047 OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 7: Warnings
The device collects data. It is the responsibility of the practitioner to apply and comply with the Eu- ropean Parliament's General Data Protection Regulation 2016/679. When returning to the After Sales Service, the practitioner must delete the data so that it is not disclosed. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 8: Potential Risks
The device is delivered with a USB cable. You can choose between two ways of charging your device, via a computer or via the USB power adapter (see 1.2.7). Once plugged in, the charge starts automatically and an electrical plug logo is OTOWIN 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 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 appliance should be disposed of at an appropriate collection and recy- cling facility. Consult the manufacturer. Direct Current Serial number OTOWIN User Guide ECH001XN161-A4 - 07/2022...
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Page 10: Nameplate Label
Information and specifications are given on the back of each device on a nameplate label: Device : Device type label OTOWIN ECH001KP160-A0 1.8 Confidentiality of patient data The device collects data. It is the responsibility of the practitioner to apply and comply with the European Parliament's General Data Protection Regulation 2016/679. -
Page 11: Cybersecurity
-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\Otowin\jre) -The configurations of the software as well as the database are saved in the .otowin folder of the user folder (ex: C:\Us- ers\romain\.otowin). -
Page 12: General Information On The Use Of Otowin
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 ECHODIA to receive an unlock code. OTOWIN... -
Page 13: Home Screen
Chapter 2. General information on the use of OTOWIN 2.1 Handling 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: •... -
Page 14: General Configurations
Chapter 2. General information on the use of OTOWIN 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. -
Page 15: Audiometry Setup
Chapter 2. General information on the use of OTOWIN 2.2 General configurations The "About" menu contains the contact details of the company Electronique du Mazet. 2.2.1 Audiometry setup Click on "Frequency Selection" to pre-configure the frequencies to be scanned during the test. Once the frequencies have been chosen, click on "OK"... -
Page 16: Calibration
The "Calibration" menu allows you to consult the acoustic calibration values set on your device and the connected stimulator. Do not change these values, only ECHODIA or your dealer are authorised to perform this calibration. OTOWIN A calibration of the device should be performed once a year to ensure the quality of the meas- urements. -
Page 17: Introduction And Test Setup
3.1 Material To perform a Pure-tone audiometry, you need the following equipment: Elements common to the different configurations OTOWIN device Air conduction audiometry 1 audiometry headset or inserts earphones OTOWIN... -
Page 18: Patient Setup
Use an otoscope to ensure that the ear canal is not blocked by earwax. This procedure must be carried out by a qualified person. • Connect the headphones to the "Audio" connector or to the jack OTOWIN on the • Explain to the patient the procedure for performing an audiometry, •... -
Page 19: Measure In Ambulatory Mode
Chapter 4 Measure in ambulatory mode 4.1 Patient management OTOWIN device allows a good organisation of the measurements thanks to its advanced patient manage- ment system. From the home page, select the "Measure" mode: you can then choose to search for an existing patient or cre- ate a new one. -
Page 20: Patient Follow-Up
(each to one of the audio outputs) and switch between the two by clicking this button. For the configuration of the frequencies used, start power of the automatic proto- cols, please refer to paragraph 2.2.1. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 21: Patient Mode
"Save", or deleting it by leaving this window with the close button. For more details on the options for viewing the curves, please refer to paragraph 4.2.5. The saved data can be viewed in the patient's "Consultation" menu. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 22: Manual Doctor Mode
The aim is to determine for each frequency the threshold at which the patient can only hear on one side. For each stimulation, indicate whether the patient hears on the left, right or both sides. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 23: Consultation Of The Measure
• The white dotted lines with red and blue brackets represent the Weber test. Stimulators used for air conduction audiometry and bone conduction audiometry (or the operator) Click on the graph to display the legend. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 24: Otowin
The software installation file is available on the USB stick supplied with the device. At the start of the installation, you must accept the user licence agreement. You can then choose to place an icon in the start menu and on the desktop. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 25: Usb Drivers
Chapter 5. The use of the software OTOWIN 5.2 Installation Finally, you can choose the location where the application files will be installed (by default "C:/Program Files/Echo- dia/OTOWIN"). Click on "Install" and then "Close" to complete the installation. Once the software is launched, you will get the following window: 5.2.1 USB drivers... -
Page 26: Patient Management
Chapter 5. The use of the software OTOWIN 5.3 Patient management The software starts the driver installation. Once the installation is complete, it is necessary to disconnect and reconnect the device to finalise the installation process. OTOWIN In order to optimize the battery life of your , the screen will turn off after 2 minutes when the USB mode is activated and the device is connected to a computer. -
Page 27: Importing A Patient
Chapter 5. The use of the software OTOWIN 5.3 Patient management 5.3.2 Importing a patient software allows you to view the measurements taken from the device. Connect the device to the computer to import the patient data into the software. -
Page 28: Deleting A Patient
Chapter 5. The use of the software OTOWIN 5.3 Patient management OTOWIN The Save to Database mode without confirmation allows you to add patients from the device to the OTOWIN software database more quickly. The software will automatically scan the list of patients on the device and add them to the software. -
Page 29: Configuration
Chapter 5. The use of the software OTOWIN 5.4 Configuration 5.4 Configuration software offers a wide range of configurations to allow you to adjust the software to your needs. The configuration window can be accessed by clicking on the cogwheel at the top right of the main software window. -
Page 30: Medical Software
Chapter 5. The use of the software OTOWIN 5.4 Configuration 5.4.2 Medical software This section allows you to configure third party patient management software to import audiometry curves. A first drop-down menu allows to select the software used. Then you have to define the location where the software has to retrieve the patient's infor- mation. -
Page 31: Automatic Mode
Chapter 5. The use of the software OTOWIN 5.4 Configuration 5.4.5 Automatic mode This section allows you to change the automatic mode in audiometry. • Waiting response time: Defines the time the sys- tem will allow the patient to respond, this also cor- responds to the stimulation time. -
Page 32: About Us
5.5 Update ECHODIA strives every day to meet the expectations of users and to develop its products. As such, it regularly provides free updates integrating new features or contributing to the improvement of your products. -
Page 33: Update Of The Device Otowin
Chapter 5. The use of the software OTOWIN 5.6 Audiometry on the OTOWIN software OTOWIN 5.5.1 Update of the device OTOWIN If your device is connected in USB mode to your computer, when the software is started, a firmware check of the device is launched. If a newer version is available, the software will automatically prompt you to update. - Page 34 Chapter 5. The use of the software OTOWIN 5.6 Audiometry on the OTOWIN software There are three different modes for setting the acoustic stimulation characteristics: • Move the mouse cursor over the graphics and click to start the stimulation, • Control the interface with the keyboard (see paragraph 5.8), •...
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Page 35: Operation On Otowin
Chapter 5. The use of the software OTOWIN 5.7 Operation on OTOWIN 13. Summary of patient information. 14. Patient test history A double-click on a measurement allows it to be displayed shaded in the graph for comparison with the current measurement 15. -
Page 36: Description Of The Consultation Window
Chapter 5. The use of the software OTOWIN 5.7 Operation on OTOWIN 5.7.2 Description of the consultation window 1. Patient test history 2. Deletes the selected measurement. 3. Summary of patient information 4. Summary of information about the device used 5. -
Page 37: Using The Keyboard
Chapter 5. The use of the software OTOWIN 5.8 Using the keyboard 5.8 Using the keyboard In addition to the visual checks on the software, you can also perform the audiometry manually with your computer keyboard. Use the computer Validate patient... -
Page 38: Maintenance And Servicing
• The general functioning of the device. Replace the unit and its peripherals in the original case after each use. OTOWIN 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 39: Accessories
The references of the consumables compatible with your device are listed in the paragraph 1.2.7. You can order the consumables from your distributor or directly from our online shop at www.echodia-store.fr. 6.3 Malfunction 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 40: After-Sales Service And Warranty
Parliament's General Data Protection Regulation 2016/679. When returning to the After Sales Ser- vice, the practitioner must delete the data so that it is not disclosed. The practitioner has the possibility to OTOWIN make a backup copy of the data by saving them in the software (see paragraph 5.3.2) before... -
Page 41: 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). OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 42: Technical Specifications
Resistive screen usable with a finger, or with a stylus Tactile Energy/comfort Backlight level selection, display rotation Recording on internal memory of the device (> 2000 measurements) Data storage OTOWIN Data transfer Copy of data via the software via USB Medical Class IIa equipment. Applied part type BF. -
Page 43: 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. OTOWIN User Guide ECH001XN161-A4 - 07/2022... -
Page 44: 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 45 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 46: 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 design office specialising 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 47 Your dealer / distributor: OTOWIN User Guide ECH001XN161-A4 - 07/2022...
- Page 48 OTOWIN ECH001XN161-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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