Électronique du Mazet ECHODIA Babyscreen, Instructions For Use And Technical Description

Page 1: ...a brand of lectronique du Mazet ZA Route de Tence 43520 Le Mazet Saint Voy FRANCE T l 33 4 71 65 02 16 Email contact electroniquedumazet com Firmware 2 4 0x Web www electroniquedumazet com Software 2...

Page 2: ...ntil it is destroyed This equipment has been designed and manufactured for use in otologic diagnosis Use is restricted to professionals who have undergone appropriate training If you have a problem or...

Page 3: ...itial Start up of the device 12 2 1 1 Switching on starting 12 2 1 2 Touch screen calibration 12 2 1 3 Password 12 2 1 4 Home screen 13 2 1 5 Switching off the device 13 2 2 General device configurati...

Page 4: ...en a measurement 48 5 8 Measurement windows 48 5 8 1 ABR 48 5 8 2 DP gram 50 5 8 3 TEOAE 52 5 9 Bilateral display and printing 53 Maintenance and servicing 54 6 1 Periodic checks 54 6 2 Cleaning 54 6...

Page 5: ...evices and their documentation are technically up to date at the time of marketing However we allow ourselves to make changes on the device and its documentation without any obligation to update these...

Page 6: ...s young children or even adults It allows for rapid and automated measurements of PEA TEOAE and DPgram The launching of the measurement as well as the reading of the result in the form of PASS REFER a...

Page 7: ...e 040058 PlasticsOne Mini USB cable 2m 300618 Lindy Acoustic tube 040054 Electronique du Mazet OAE eartips T03 6mm 100 pcs 301360 Grason Associates OAE eartips T04 4mm 100 pcs 301361 Grason Associates...

Page 8: ...g CAUTION This equipment complies with applicable electromagnetic compatibility stand ards If you experience interference or other problems with another device contact lec tronique du Mazet or the dis...

Page 9: ...section Erreur Source du renvoi introuvable for contraindications 1 5 Commissioning Check that the device is not damaged if you have any doubts about the integrity of the device and its proper func ti...

Page 10: ...Acoustic stimulator connection for audiometry and electrophysiology OAE probe connection for otoacoustic emissions Headset connection Back side Warning this logo draws your attention to a specific poi...

Page 11: ...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...

Page 12: ...esponsibility of the practitioner to ensure that the following recommendations are followed 1 9 1 Good practices for computer security Keep your software up to date including the operating system Wind...

Page 13: ...ssively 2 1 3 Password After the screen calibration the password definition windows appear If you choose to set up a password it will be asked to you each time you start the device To do this click on...

Page 14: ...creen At the bottom right the serial number of your device is displayed A title bar is present on all windows of the device From left to right it contains The current window title The charge indicator...

Page 15: ...nding on the location and position in which the device is used It is also possible to recalibrate the touch screen The System button informs you about the hardware and software version of the device a...

Page 16: ...change the default settings The password is the 8 digits of the de vice serial number The serial number can be fund on the label located on the back of the device or at the bot tom right of the home...

Page 17: ...t window Max Test Time Maximum test duration for each frequency in screening mode in case of no response Min SNR Minimum value in dB of the signal level compared to the noise level to consider the dis...

Page 18: ...uration for each frequency in screening mode in case of no response Power Screening The intensity in dB in screening mode if Protected access to settings is activated Otherwise the intensity is adjust...

Page 19: ...headset which is properly configured at the factory However you have the option of changing the type of headphones that will be recognized when connected to the jack socket If you have several headph...

Page 20: ...vable 2 4 2 Patient follow up After you have created the patient his or her record is recorded on the memory card You can then find it by clicking on the Search button This brings up a table containin...

Page 21: ...osis or to consult those previously saved consultation The Consultation button opens a table of measure ments allowing to consult the diagnoses previously made for this patient To find the desired mea...

Page 22: ...g intensity ABR s make it possible to objective hearing threshold for each ear threshold ABR The ABR s inform us about the possible presence of cochlear pathologies perception deftness with a rise of...

Page 23: ...F unit Electrophysiology cable 4 surface electrodes Measurement with insert earphone Insert earphone 2 foam ear tips ER3 14A 13mm or 2 foam ear tips ER3 14B 10mm or 2 insert earphone tips ER3 14E 4mm...

Page 24: ...dset cable on the Jack plug of the BABYSCREEN indicated with the headset icon Clean the surface of the skin where the electrodes will be attached with abrasive gel This decreases the impedance of the...

Page 25: ...ally done 3 4 Measurement 3 4 1 Setting up the measurement parameters Once the screening ABR diagnosis has been selected its configuration window appears Those parameters are described below Power con...

Page 26: ...t stays locked on red it means that the patient muscular activity is too high When the patient will be more relaxed the measurement will automatically resume If this problem remains the electrode even...

Page 27: ...ive diagnosis about the patient hearing The wave plotting and the measure validation is automatically done during the acquisition but the device also provides some consultation tools to fine tune the...

Page 28: ...ation of newborns because if otoacoustic emissions are present it means that the newborn hearing does not have a deafness higher than 30 40 dB This is a routine screening test more and more used in th...

Page 29: ...0 Hz to 5kHz we can estimate the impairment severity of the OHCs and thus estimate the level of deafness This makes the DP gram a simple and fast test which can be reproduced and which above all is no...

Page 30: ...Setup The choice of the right EarTip is particularly important for the quality of the measurement You can choose from 10 different sizes The tip must provide the following functionalities 1 It must e...

Page 31: ...21 A4 07 2022 30 Chapter 4 Otoacoustic emission TEOAE and DP gram 4 3 Setup 3 It must be hermetically sealed to prevent acoustic leaks and isolate from the noise Fit the tip to the probe Insert the pr...

Page 32: ...to low compared to his set value at least 5dB to low This may be due to the wrong positioning of the probe more precisely a sealing problem between plug s probe and the ear canal It is advised to clic...

Page 33: ...ion between the A and B buffers o Number of rejections for each buffer o Detection analysis which works only in detection mode It shows how many frequencies have been validated or how many statistical...

Page 34: ...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 T...

Page 35: ...anner the previous information Namely the ratio between the signal and the noise as well as the reproducibility rate for each frequency The sheet cases become green or red to indicate that the ear cor...

Page 36: ...t the measurement parameters as best as possible Low signal Check leak Continue The signals F1 and F2 and are too low compared to their set value at least 20dB too low This may be due to the wrong pos...

Page 37: ...ejection threshold has been calibrated too low Exit from the measurement by clicking on Stop then restart a new measurement 2 The probe is incorrectly positioned It is possible that the probe moves du...

Page 38: ...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 m...

Page 39: ...ormance tool palette that giving you the opportunity of analyzing directly on the touch screen without any computer support all the data you have collected Click on one of the points of the curve A wi...

Page 40: ...hite line In the opposite example 3 other spectral rays can be identified with high power levels to the right of the ef fective spectral energy zone From left to right stimula tion frequency F1 follow...

Page 41: ...compliant with EN 60601 1 5 2 Installation 5 2 1 Installing the software The ECHOSOFT is supplied as an executable software file designed for automatic installation of the application on your compute...

Page 42: ...ftware 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 This driver will enable...

Page 43: ...ect it to the computer using the supplied USB cable From the homepage screen select the USB The device should be detected by the com puter For the first plug of the device the USB driver should be aut...

Page 44: ...f choosing the corresponding patient or simply creating a new one 5 3 1 2 Synchronize all patients with the database This option lets you add all of the BABYSCREEN patients to the ECHOSOFT database Th...

Page 45: ...atient selected in the list The Delete button is used to definitively de lete the patient from the ECHOSOFT database 5 3 2 2 Delete a patient from BABYSCREEN A patient can be deleted from the BABYSCRE...

Page 46: ...ting the database move the current database to another folder It is possible to select a local folder a USB key or a network shared folder Create a new database create an empty database in a new folde...

Page 47: ...ibutes to the improvement of your products To take advantage of these updates check our website http echodia fr en downloads regularly to see if the latest version available corresponds to your curren...

Page 48: ...oftware is launched a verification of your version is performed If a newer ver sion is available the software offers you to automati cally update Click on Yes to start downloading the new version When...

Page 49: ...nt under the List window A new measurement consultation window opens Select the test from the drop down list at the top left of the window The measurements are displayed chronologically in the Left Ri...

Page 50: ...nt 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 Validation or not of t...

Page 51: ...er of L2 Frequency F1 Frequency F2 Measured power of L1 Measured power of L2 Distortion product frequency Distortion product power Average level of noise Signal noise ratio 3 Information about the sel...

Page 52: ...Frequency related graphic of data corresponding to the selected point The breakdown into frequency is obtained by a fast Fourier transformation of the time related signal The effective spectral energy...

Page 53: ...ency graphic 4 Noise frequency graph red and signal frequency graph green 5 Measurement setting information 6 Table of the signal on noise ratio and repeatability rate at different frequencies 7 Print...

Page 54: ...s select a first measurement then hold down the Ctrl key on the keyboard and select a measurement on the opposed side in the measurement browser window Thus the two measurements are displayed in the s...

Page 55: ...ty it is imperative to follow the operating instructions provided in this manual BABYSCREEN devices are designed to have a service life of 5 years 6 2 Cleaning 6 2 1 Device case The device case only r...

Page 56: ...connected Connecting the stimulator Stimulator is out of order Contact your distributor to initiate the after sales service procedure Gas and or liquid leakage from the case during opera tion or not...

Page 57: ...rranty is void if the operating instructions in this manual are not strictly followed The warranty period is 24 months from the date of delivery of the device Transport and packaging costs are not inc...

Page 58: ...emperature 6 5 Disposal As soon as any deterioration is detected the product must be cleaned with a broad spectrum disinfectant and returned to the manufacturer If the product becomes inoperative or u...

Page 59: ...from a computer or the power adapter see Erreur Source du renvoi introuvable Resolution 320 x 240 65000 colours Touch screen Resistive screen usable with a finger or with a stylus Energy comfort Back...

Page 60: ...emissions CISPR 11 Class B The Echodia range is suitable for use in all premises including domestic premises and those directly connected to the public low voltage power supply to domestic buildings...

Page 61: ...y to wireless devices 3 Vrms 150 kHz to 80 MHz 6 Veff in the ISM bands between 0 15 MHz and 80 MHz 80 AM at 2 Hz 3 V m 80 MHz to 2 7 GHz 80 AM at 2 Hz in cluding clause 8 10 table 9 for proximity to w...

Page 62: ...ns Electromagnetic propagation is affected by absorption and reflections from structures objects and people 7 2 1 CE declaration LECTRONIQUE DU MAZET can provide the CE declaration for this device on...

Page 63: ...ues DP gram Distortion Product Otoacoustic Emission Graphic TEOAE Oto Emissions Acoustiques par Transition Transient Evoked Otoacoustic Emissions PEAp Potentiels Evoqu s Auditifs pr coces ABR Auditory...

Page 64: ...User guide BABYSCREEN ECH001XN121 A4 07 2022 Your dealer distributor ELECTRONIQUEDU MAZET ZA ROUTE DE TENCE 43520 LE MAZET SAINT VOY T l 33 4 71 65 02 16 Mail sav electroniquedumazet com...

Page 65: ...care etc I have read the instruction manual and noted the warranty and service conditions In the event that Electronique du Mazet or its distributors do not receive this form duly completed and signed...