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Related Manuals for Électronique du Mazet ECHODIA Babyscreen
Summary of Contents for Électronique du Mazet ECHODIA Babyscreen
- Page 1 USER GUIDE BABYSCREEN 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 2.4.0x Web : www.electroniquedumazet.com Software 2.4.0.x ECH001XN121-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
Table of contents Information and safety ................................4 About this manual ..............................4 Presentation of the device ............................5 1.2.1 Intended Use .............................. 5 1.2.2 Target population ............................5 1.2.3 Expected performance ..........................5 1.2.4 Contraindications ............................5 1.2.5 Side effects ..............................5 1.2.6 Units of measurement .......................... - Page 4 Minimum configuration needed ..........................40 Installation ................................40 5.2.1 Installing the software ..........................40 5.2.2 Installation des pilotes USB ........................41 Patient management ............................... 42 5.3.1 Import patient from device ........................42 5.3.2 Delete a patient ............................44 Database ................................45 Printing ..................................
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Page 5: Information And Safety
Chapter 1 Information and safety 1.1 About this manual This user and maintenance manual is published to help you to get started with your BABYSCREEN 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: Presentation Of The Device
Chapter 1. Information and safety 1.2 Presentation of the device 1.2 Presentation of the device BABYSCREEN is designed for screening, documentation and monitoring of hearing function. It is intended for use by otolaryngologists, pediatricians and other healthcare professionals in offices and hospitals. The hearing of a subject can be evaluated objectively, without requiring the subject's participation, via evoked potentials or induced otoacoustic emissions. -
Page 7: Units Of Measurement
Chapter 1. Information and safety 1.2 Presentation of the device 1.2.6 Units of measurement For all these devices, the units of measurement are expressed in the units of the international system: Unit Base unit Name Symbol Frequency Hertz Voltage Tension Intensity (Decibel) Sound pressure level dB SPL... -
Page 8: Warnings
Chapter 1. Information and safety 1.3 Warnings 1.3 Warnings In this manual the warnings and information given have the following meaning: The caution label indicates conditions or process that may expose the patient and/or user to a risk. The warning label indicates conditions or process that could cause the device malfunction. The information label refers to notices or information that are not related to any risk of acci- dents or malfunction of the device. -
Page 9: Potential Risks
Chapter 1. Information and safety 1.4 Potential risks CAUTION: The device collects data. The practitioner is in charge to comply with the EU General Data Protection Regulation 2016/679 (or the local laws of the personal data protec- tion). When returning to the After Sales Service, the practitioner must delete the data so that it is not disclosed. -
Page 10: Applicable Symbols
Chapter 1. Information and safety 1.6 Applicable symbols 1.6 Applicable symbols Front side Name of the device Upper side Caution: Switching the device on/off Mini-USB port for recharging the device, or connection to a PC (data exchange) Lower side -Patient answer button connection for audiometry -EchoDif connection for electrophysiology -Acoustic stimulator connection for audiometry and electrophysiology Audio... -
Page 11: Identification Label
Chapter 1. Information and safety 1.7 Identification label Direct current Serial number Manufacturer 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 BABYSCREEN... -
Page 12: Patient Data Confidentiality
Chapter 1. Information and safety 1.8 Patient data confidentiality 1.8 Patient data confidentiality The device collects data. It is the practitioner's responsibility to apply and comply with the European Parliament's General Data Protection Regulation 2016/679. When returning the device to the after-sales service, the user must delete the patient data from it so that it is not disclosed. -
Page 13: General Information About Using Babyscreen
Chapter 2 General information about using BABYSCREEN 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 (OAE probe, EchoDif). 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 For the first start-up, it is necessary to calibrate the touch screen. -
Page 14: Home Screen
Chapter 2. General information about using BABYSCREEN 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 15: General Device Configurations
Chapter 2. General information about using BABYSCREEN 2.2 General device configurations 2.2 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 16: Advanced Configurations
Chapter 2. General information about using BABYSCREEN 2.3 Advanced configurations The “Calibration” menu allows the consultation of the acoustic calibration values defined for your device. Electronique du Mazet Don't modify this value, only or your reseller are approved to realize this cali- bration. - Page 17 Chapter 2. General information about using BABYSCREEN 2.3 Advanced configurations Config DP-gram : Access to the DP-gram measurement settings Config TEOAE : Access to the TEOAE measurement settings DP Frequency Config : set the frequency gap between the 2 stimulation frequency F1 and F2 for Shift-OAE and DPgram measurement.
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Page 18: Configuration Of The Click Stimulus
Chapter 2. General information about using BABYSCREEN 2.3 Advanced configurations relation between the two buffers, the stability of the re- sponse and the presence of an OAE signal. Thus, the settings for the minimum SNR value and the number of frequencies for validation are disabled. -
Page 19: Selection Of The Connected Jack Headphone
Chapter 2. General information about using BABYSCREEN 2.3 Advanced configurations • Click: Used for adjusting the interval between the physical power of the clicks (dB SPL) and the perceived intensity (dB HL) (25 by default). The adjusted coefficient corresponds to: Emitted power (dB HL) = Set power (dB SPL) + X (dB SPL) •... -
Page 20: Patient Management
Chapter 2. General information about using BABYSCREEN 2.4 Patient management 2.4 Patient management BABYSCREEN offers ideal measurement organization thanks to an advanced patient-based management system. From the home page, select the "Measure" mode, leading to the choice of seeking an existing patient or creating a new one. - Page 21 Chapter 2. General information about using BABYSCREEN 2.4 Patient management To select a patient, click on the corresponding line. This opens a new page summarizing information about the patient. Now, it becomes possible to choose to make a new measurement (diagnosis) or to consult those previously saved (consultation).
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Page 22: Abr Measurement
Chapter 3 ABR measurement 3.1 Presentation ABR: Auditory Brainstem Response Auditory Brainstem Response, also known as brainstem auditory evoked potentials are widely used both in the field of neu- rological exploration and ENT. It is a non-invasive electrophysiological technique based on the principle of electroenceph- alography (EEG), it provides objective test, reproducible information about the auditory function, from the cochlea to the brainstem. -
Page 23: Equipment
Chapter 3. ABR measurement 3.2 Equipment 3.2 Equipment To make a ABR measurement you need the following equipment: Common elements for all configurations BABYSCREEN unit unit Electrophysiology 4 surface electrodes cable Measurement with insert earphone 2 foam ear tips ER3-14A 13mm 2 foam ear tips ER3-14B 10mm Insert earphone 2 insert earphone tips ER3-14E 4mm... -
Page 24: Patient Setup
Chapter 3. ABR measurement 3.3 Patient setup 3.3 Patient setup Classical 4 points setup Simplified 3 points setup These instructions must be adapted depending of the ear(s) tested, in every case the color corresponds to the right ear, the blue color to the left ear. -
Page 25: Measurement
Chapter 3. ABR measurement 3.4 Measurement • In the case of the 4 points wiring, the electrodes must be attached behind the ear to be tested (on the mastoid). • In the case of the 3 points wiring, only the electrodes must be attached to the base of the neck. -
Page 26: Measurement
Chapter 3. ABR measurement 3.4 Measurement 3.4.2 Measurement When launching the measure, if the electrodes are not well placed or not well connected, an impedance verifi- cation window is shown. The impedance values have to be the smaller and the most balanced as possible to provide the most reliable If value V- is greater than 10kΩ, wipe the patient’s forehead again and reattach new electrodes. -
Page 27: Measurement Consultation
Chapter 3. ABR measurement 3.5 Measurement consultation In a normal use, the measure will automatically stop: If the maximum measurement time has been reached and wave V is not detected, then the device cannot val- idate the measurement. If the correlation between the two curves is good and the two markers for the wave V are placed at the same place, then the test validated. -
Page 28: Otoacoustic Emission (Teoae And Dp-Gram)
Chapter 4 Otoacoustic emission (TEOAE and DP-gram) 4.1 Presentation The cochlea, the peripheral organ of hearing, is capable of emitting low-amplitude sounds in response or not to acous- tic stimulation. These sounds are easily recorded in the external auditory canal using a sensitive miniaturized microphone. The genesis of these sounds coming from the cochlea, called otoacoustic emission, depends on the proper functioning of specific cells in the cochlea: the outer hair cells (OHC). - Page 29 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.1 Presentation By varying the frequencies of the 2 primaries f1 and f2, it is possible to gather together the different distortion products and establish a curve known as DP-gram (a graphic of the distortion products, similar to an audiogram). By observing the cochlear spectrum, from 1000 Hz to 5kHz, we can estimate the impairment severity of the OHCs and thus estimate the level of deafness.
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Page 30: Equipment
Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.2 Equipment 4.2 Equipment To make otoacoustic emissions measurement, you will need the following equipment: probe BABYSCREEN unit OAE ear tips T04 tree OAE partis Txx (xx size in mm) • Connect the Mini-DIN plug of the Probe to the «Audio»... - Page 31 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.3 Setup It must be hermetically sealed to prevent acoustic leaks and isolate from the noise. • Fit the to the probe. • Insert the probe in the patient's ear canal. User guide BABYSCREEN ECH001XN121-A4 –...
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Page 32: Teoae
Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.4 TEOAE 4.4 TEOAE Refer to paragraph to obtain the necessary instructions about the needed equipment and the setup. 4.4.1.1 Measurement BABYSCREEN is a screening device, so there is no special configuration required. After connecting the OAE Probe, all you have to do is select the ear when starting the measurement. - Page 33 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.4 TEOAE Rejection indicator TEOAE response area Stimulation curve Buffer A curve Buffer B curve Stimulation quality indicator Number of rejections Number of click done for per buffer each buffer Validation analysis Correlation between buffer •...
- Page 34 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.4 TEOAE At the end of the measurement, a popup shows if the test is valid or not. End of a valid test End of a test that can’t be validated For more details about the curve consulting options, please refer to the paragraph Erreur ! Source du renvoi introuvable.2.
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Page 35: Measurement Consultation
Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.4 TEOAE 4.4.2 Measurement consultation Refer to paragraph Erreur ! Source du renvoi introuvable.4 for more details about patient management. Repeatability between Signal level (dB SPL) Signal/noise ratio for buffer A and B for Stimulus curve each frequency each frequency... -
Page 36: Dp-Gram
Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.5 DP-gram 4.5 DP-gram Refer to paragraph to obtain the necessary instructions about the needed equipment and the setup. 4.5.1.0 Measurement BABYSCREEN is a screening device, so there is no special configuration required. After connecting the OAE Probe, all you have to do is select the ear when starting the measurement. - Page 37 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.5 DP-gram Progress bar Frequency in Hz Rejection indicator Current measurement Signal level in dB SPL Nest measurement Noise level Rejection level setting A progression bar informs you of the state of progress of a point. When the progression bar stops, the system updates the point corresponding to the frequency being tested.
- Page 38 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.5 DP-gram End of a test that can’t be validated For more details about the curve consulting options, please refer to the next paragraph The saved data can be consulted in the patient's "Consultation" menu. Please refer to the subsection 2.3.1.1 to modify the advanced settings of the screening mode.
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Page 39: Measurement Consultation
Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.5 DP-gram 4.5.2 Measurement consultation Refer to paragraph Erreur ! Source du renvoi introuvable.4 for more details about patient management. dB SPL scale Frequencies in Hz Signal level validation indicator Noise level Signal level in dB SPL Stimulation power PASS/REFER indicator (only in screening mode) - Page 40 Chapter 4. Otoacoustic emission (TEOAE and DP-gram) 4.5 DP-gram Point spectral analysis To run spectral analysis of the signal by a Fast Fourier Transform (FFT) click on the "Freq" button. The power distribution graph (abscissa) with respect to the frequency (ordinate) appears. The effective spectral energy zone is indicated by a vertical white line.
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Page 41: General Information About Echosoft
Chapter 5 ECHOSOFT General information about 5.1 Minimum configuration needed Intel or AMD – Dual Core 2 Ghz Processor RAM memory Free space on hard drive Display 1280*720 1 port USB 2.0 Operating system Windows 8/10/11, Mac OSX Power supply Class II compliant with EN 60601-1 5.2 Installation 5.2.1 Installing the software... -
Page 42: Installation Des Pilotes Usb
Chapter 5. General information about ECHOSOFT 5.2 Installation Then you can choose the location where the application files will be installed. 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 BABYSCREEN has a generic USB driver mass storage, it is recognized and installed automatically. -
Page 43: Patient Management
Chapter 5. General information about ECHOSOFT 5.3 Patient management 5.3 Patient management ECHOSOFT software is capable of reading measurements made using BABYSCREEN . it incorporates a database in which the patient data and measurements can be stored. 5.3.1 Import patient from device Connect the device to the computer to import patient data into the ECHOSOFT Start the device and connect it to the computer using the... - Page 44 Chapter 5. General information about ECHOSOFT 5.3 Patient management 5.3.1.1 Add a patient to the datebase Select the patient(s) to be imported from the list, then click on "Save to database". The software will then ask you for the information for the whole selection before importing the data. To register a patient in the database, it is necessary to indicate the doctor or the operator who performed the measurements.
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Page 45: Delete A Patient
Chapter 5. General information about ECHOSOFT 5.3 Patient management If you select some patients in the list before launching the registering in the database, the software only synchronizes the patients that have been selected. If you have a large amount of patient stored on the de- vice, making a selection enables to synchronize rapidly your data. -
Page 46: Database
Chapter 5. General information about ECHOSOFT 5.4 Database 5.4 Database ECHOSOFT software offers options to manage the database where all measurements, patient and doctor information is stored. These options are available in the "Settings" menu, "Database". The options are: • Select another database: select a database located in another folder. It is possible to select a database located on your computer, on a USB key or a network shared folder*. -
Page 47: Printing
Chapter 5. General information about ECHOSOFT 5.5 Printing 5.5 Printing There is two printing model in ECHOSOFT , one with a full note taking page first and measure results on the others pages (standard layout) and another model with the measure results first and the potential notes at the bottom of the page (compact layout). -
Page 48: Babyscreen Update
Chapter 5. General information about ECHOSOFT 5.6 Update 5.6.1 update BABYSCREEN BABYSCREEN If your is connected in USB mode to your computer, when the ECHOSOFT software is launched, a verification of your version is performed. If a newer ver- sion is available, the software offers you to automati- cally update. -
Page 49: Measurement Consultation On Echosoft
Chapter 5. General information about ECHOSOFT 5.7 Measurement consultation on ECHOSOFT ECHOSOFT 5.7 Measurement consultation on See subsection Erreur ! Source du renvoi introuvable. to install the ECHOSOFT and import meas- urement from the device. 5.7.1 Open a measurement Double click on a patient under the «List» window. A new measurement consultation window opens. - Page 50 Chapter 5. General information about ECHOSOFT 5.8 Measurement windows The Screening ABR window provides a quick view of the ear and power as well as whether or not the screening is validated. 1. Power set for this measurement. 2. Ear side. 3.
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Page 51: Dp-Gram
Chapter 5. General information about ECHOSOFT 5.8 Measurement windows 5.8.2 DP-gram 1. Graphic display area: • X-axis: frequency. • Y-axis: Power. • Green curve: effective signal power. • Black numbers: value in dB of the effective signal power. • Red curve: noise power. 2. - Page 52 Chapter 5. General information about ECHOSOFT 5.8 Measurement windows 5.8.2.0 Advenced analysis tool As the BABYSCREEN , the ECHOSOFT offer an advanced analysis tool for each DP-gram point. For this purpose, double click on the point to be analyzed. Time-related graphic of data corresponding to the selected point. Frequency-related graphic of data corresponding to the selected point.
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Page 53: Teoae
Chapter 5. General information about ECHOSOFT 5.8 Measurement windows 5.8.3 TEOAE Temporal click graphic A and B (buffer) temporal curve graphic as well as the noise one • Red: buffer A • blue: buffer B • green: noise (A-B) Click frequency graphic Noise frequency graph (red) and signal frequency graph (green) Measurement setting information Table of the signal on noise ratio and repeatability rate at different frequencies... -
Page 54: Bilateral Display And Printing
Chapter 5. General information about ECHOSOFT 5.9 Bilateral display and printing 5.9 Bilateral display and printing It is possible to display and print a left and a right measurement at the same time. To do this, select a first measurement, then hold down the "Ctrl"... -
Page 55: Maintenance And Servicing
Chapitre 6 Maintenance and servicing 6.1 Periodic checks Before testing, consider checking: • The presence of the acoustic stimulus and the correct power calibration. • The absence of interference in the incoming signals. • The general functioning of the device. Replace the unit and its peripherals in the original case after each use. -
Page 56: Accessories
Chapitre 6. Maintenance and servicing 6.3 Malfuction 6.2.2 Accessories In order to ensure perfect hygiene, it is essential to systematically clean all material and equipment in direct contact with the patient. All consumables (surface electrodes and ear tips) are disposable, discard them after use. Erreur ! The references of the consumables compatible with your device are listed in the subsection Source du renvoi introuvable.. -
Page 57: After-Sales Service And Warranty
Chapitre 6. Maintenance and servicing 6.3 Malfuction 6.3.2 After-sales service and warranty This device is guaranteed by your supplier under the conditions specified in this document, provided that: ▪ Only accessories supplied or qualified by Électronique du Mazet should be used ▪... -
Page 58: Transport And Storage
Chapitre 6. Maintenance and servicing 6.4 Transport and storage 6.4 Transport and storage When transporting and storing the device, it must be carefully stored in the case in which it was delivered its original packaging) or in packaging that protects it from external damage. Store in a clean, dry place at room temperature 6.5 Disposal As soon as any deterioration is detected, the product must be cleaned with a broad-spectrum disinfectant and returned... -
Page 59: Technical Specifications
Chapter 7 Technical specifications 7.1 General technical characteristic of the device Devices intended for use in locations where the ambient pressure is outside the range of 98kPa and 104kPa must be recalibrated to the location in question, under typical ambient pressure and temperature conditions, to avoid a shift in reference sound pressure levels. -
Page 60: Test Parameters
Chapter 7. Technical specifications 7.2 Standards/Certifications 7.1.1 Test parameters : Measurement Characteristic - Acoustic stimulation: 1kHz to 5kHz DP-gram - Digital resolution 16 bits @ 32kHz - Sound intensity: 50 to 75 dB SPL - 25 clicks per second - Alternating clicks by buffer of 4 TEOAE - Digital resolution 16 bits @ 32KHz - Sound intensity: 40 to 95 dB SPL... - Page 61 Chapter 7. Technical specifications 7.2 Standards/Certifications 0% UT: 0.5 cycle at 0% UT: 0.5 cycles at The quality of the power supply should 0, 45, 90, 135, 180, 0, 45, 90, 135, 180, be that of a typical commercial or hospi- 225, 270 and 315 de- 225, 270 and 315 de- tal environment.
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Page 62: Ce Declaration
Chapter 7. Technical specifications 7.3 Manufacturer Recommended separation distances between portable and mobile RF devices and the range device Echodia The Echodia range of devices is intended for use in an electromagnetic environment in which radiated RF interfer- ence is controlled. The customer or user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Echodia Series devices, as recommended below, based on the maximum transmit power of the communications equipment. - Page 63 Lexique DPMC Déphasage des Potentiels Microphoniques Cochléaires Phase shift of Cochlear Microphonic Potential DPOAE Produits de Distorsion des Otoémissions Acoustiques Distortion Product Otoacoustic Emission Shift-OAE Déphase des Produits de Distorsion des Otoémissions Acoustiques Phase shift of Distortion Product Otoacoustic Emission DPgramme Graphique des Produits de Distorsion des Otoémissions Acoustiques DP-gram...
- Page 64 Your dealer / distributor User guide BABYSCREEN ECH001XN121-A4 – 07/2022...
- Page 65 BABYSCREEN ECH001XN121-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. I have received all the necessary instructions for its use, maintenance, care, etc...