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BeON fHIT 1.0, Инструкция по эксплуатации

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FHIT  TEC_FHIT_M Rev.1 11/2016

 

36 

 

8.  PEO

PLE’S INJURY ADVISORY 

 
Dir. 93/42/CEE  All. II (D.G. 2/1 Rev. 0) 
 
 
CUSTOMER NAME ____________________________________________________________________  
ADDRESS ___________________________________________________________________________  
N° SERIAL NUMBER  __________________________________________________________________  
INJURY DESCRIPTION  ________________________________________________________________  
 ____________________________________________________________________________________  
 ____________________________________________________________________________________  
DAMAGE HEALTH OF THE PATIENT OR THE USER ________________________________________  
 ____________________________________________________________________________________  
 ____________________________________________________________________________________  
Date _______________________________   
Sign _______________________________   
 
 
SPACE RESERVED FOR THE COMPANY (QUALITY INSURANCE) 
POSSIBLE CAUSES OF INJURY: 

 

Disfunction 

 

Characteristics and/or performance deterioration 

 

Instruction for use deficiency  

 

Other  _______________________________________________________________________________  
DAMAGE GRAVITY  ___________________________________________________________________ 
 ____________________________________________________________________________________  
OPERATIVE DECISION PROPOSED  _____________________________________________________ 
 ____________________________________________________________________________________  
Date _______________________________   
Sign _______________________________   
 
 
 

RESERVED COMPANY SPACE (GENERAL DIRECTION) 
OPERATIVE DECISION  ________________________________________________________________  
 ____________________________________________________________________________________ 
 ____________________________________________________________________________________  
 ____________________________________________________________________________________ 
 ____________________________________________________________________________________  
CORRECTIVE ACTION _________________________________________________________________ 
 ____________________________________________________________________________________  
 ____________________________________________________________________________________  
 ____________________________________________________________________________________ 
 ____________________________________________________________________________________  
Date _______________________________   
Sign _______________________________   
 
 
In case of injury send this form to BEON SOLUTIONS SRL AS SOON AS POSSIBILE 
 

Содержание fHIT 1.0

Страница 1: ...FHIT TEC_FHIT_M Rev 1 11 2016 data AQ Dir Tecnica Dir Generale 28 11 2016 1 1 1 1 1 1 BEON SOLUTIONS SRL Instruction for Use fHIT 1 0 ...

Страница 2: ...FHIT TEC_FHIT_M Rev 1 11 2016 2 ...

Страница 3: ...ZIONI SEGNALAZIONI Errore Il segnalibro non è definito 4 1 SOFTWARE 13 5 MANTENANCE 28 5 1 PULIZIA E DISINFEZIONE 28 5 2 REGOLAZIONI 29 5 3 MANUTENZIONE PROGRAMMATA Errore Il segnalibro non è definito 5 4 EXTRAORDINARY MAINTENANCE 31 6 POTENZIALE ELETTROMAGNETICO 32 7 REMOVAL DEVICE AT THE END OF THE LIFE 35 7 1 OTHER INFO ONLY FOR ITALY 35 8 PEPLE S INJURY ADVISORY 36 WARNING Before using the mac...

Страница 4: ...FHIT TEC_FHIT_M Rev 1 11 2016 4 ...

Страница 5: ...l testing of vestibular ocular reflex system will be referred to as fHIT abbreviation from English functional Head Impulse Test The fHIT product performs the analysis of the vestibular system function The product is composed of a sensor and a software managing the sensor and the entire medical examination The functional examination of the reflex vestibular oculomotor system needs to be connected t...

Страница 6: ...d guaranteed spare part DANGER Do not modify this device without the manufacturer authorization the use of unauthorized accessories and or non validated alteration could cause imminent danger or injury to people and material damage WARNING All the maintenance operations have to be performed after the device has been switched off and without the patient in the room DANGER Connection between sensor ...

Страница 7: ... and Test Memorandum provided with the device Guarantee is operational after the buyer s Installation and Test Memorandum is filled out and sent to BEON SOLUTIONS SRL The return of the Installation and Test Memorandum to BeOn Solutions srl by fax or PEC within TEN DAYS from the installation is the essential condition accessing to the guarantee or the guarantee will be void BEON SOLUTIONS S r l Via...

Страница 8: ...t Manufactured BEON SOLUTIONS SRL Via Bertoneria 16 D Italia Class II Type of part applicated B Sensor protection level IP50 POWER SOURCE USB 5 V max 500mA FUNCTIONAL TIME Uninterrupted device use VARIED USB sensor s long cable 3 m Full sensor weight strip included ca 50 g Sensor size 36 4 mm ...

Страница 9: ...rity and reliability of the device if the installation modification or reparation are not performed by authorized BEON SOLUTIONS SRL technician with instructions and spare component directly supplied by BEON SOLUTIONS SRL and if the electrical system isn t compliant with IEC standard and or the device isn t used with compliance to the instruction for use manual PLAQUE DATA An identify plaque on th...

Страница 10: ...IT TEC_FHIT_M Rev 1 11 2016 10 3 TECHNICAL INSTALLATION 3 1 PACKAGING The unit is shipped enclosed in a package which contains Headband Sensor USB cable 3m USB stick with FHIT software 1 0 and user manual ...

Страница 11: ...FHIT TEC_FHIT_M Rev 1 11 2016 11 ...

Страница 12: ...ed by the company in response to an email request sent to this address beonsolutions gmail com 3 3 TEST AND DEPLOYMENT Once installed the software verifies the system parameters including video The software can only be installed on hardware that meets the requirements defined by the company Minimum hardware requirements specifically dedicated to this exam The computer needs to be not connected to ...

Страница 13: ...v 1 11 2016 13 4 CONTROL REGOLATION ADVISORY 4 1 SOFTWARE Start the PC Double click the fHIT exe icon to start the fHIT software A screen asking whether to start a new test or open an existing file of a past exam appears ...

Страница 14: ...patient such as age and sex on the form below and choose if you want to perform the test with a black background or not If instead you want to open an existing file choose the icon shown below Select the file to open only the fhit files saved with this proprietary program and proceed to opening and displaying it ...

Страница 15: ...for the next stage To perform the static visual acuity test we position the patient one meter and a half 1 5 m away from the computer screen To initiate the visual acuity examination press Start Test Visual Acuity The software asks for confirmation of the visual distance of the current patient before starting 4 1 1 1 1 1 Use the computer keyboard to enter the patient s data 4 1 1 1 1 2 ...

Страница 16: ...pear on the screen he has seen Following correct answers for at least 3 out of 5 letters the letter size will shrink The patient can use the keypad to enter the correct number or tell it to the doctor who may select it via the keyboard The examination for visual acuity ends at the moment in which the patient is unable to identify three out of five optotypes or when the patient has given all the co...

Страница 17: ...otect the area of head where the elastic band with the sensor is positioned using a sterile gauze Tie the sensor on the patient s head making sure that the three LEDs are on the top The lights that flash on the sensor refer to its movement The lower blue light indicates that the sensor is turned on The red light in the center is used to indicate the proper functioning of the sensor Bring the cable...

Страница 18: ...oning problems a screen that verifies if the sensor is working properly will appear showing two traces that scroll across the screen with the data from the gyroscope and the accelerometer as shown below At the top of the screen is the button to start the ANALYSIS At this point a screen will appear asking which pair of semicircular canals the doctor wishes to study ...

Страница 19: ...FHIT TEC_FHIT_M Rev 1 11 2016 19 ...

Страница 20: ...etween the three exams in the examination is that RALP and LARP compared to LATERAL will prompt the doctor to first rotate the head 45 degrees It will still be the doctor who will decide the correct position in relation to the patient and the diagnosis he wants to achieve Below the suggestion presented between one exam and the following 4 1 1 1 1 5 Head position when it starts and when examining L...

Страница 21: ...to discontinue the examination when he sees fit In the two graphs at the sides under the movement counter a histogram appears that shows in detail the performed movements and tells the doctor which must still be done The histograms in red and in blue indicate the movements that are valid for the purposes of the test Histograms in gray indicate movements not valid for the purposes of the test but s...

Страница 22: ...be displayed at the center If the movement has been carried out from 0 to 7999 deg s 2 it will still appear in the histogram If it is outside this range then it will not appear The peak head angular acceleration reched in the last head rotation will also appear at the bottom of the screen below the two central panes If the movement is correct no warning screen will appear and the movement counters...

Страница 23: ...ements left and right or up and down or a number that may be set through the software you will see a pause screen Press on the Continue button to start again It is also possible to end the exam and save it by pressing on the End button at the bottom of the screen The moment you end the test on lateral channels you can begin testing LARP and RALP channels To stop the test wait for the appearance of...

Страница 24: ...ich you will be able to delete some of the movements if appropriate such as the highlighted movement in the figure above Form that screen it will be possible to discard trials regarding all the acquired channels i e from LATERAL RALP and LARP exams The software then returns to the screen allowing to choose the channels to be analyzed where those already analyzed will be highlighted and ticked You ...

Страница 25: ...y an overview screen so that you can view the test and remove some movements if you do not consider them appropriately performed Those will be removed from the analysis and statistics When complete the software will show the test results and allow to save or print the test results ...

Страница 26: ...FHIT TEC_FHIT_M Rev 1 11 2016 26 ...

Страница 27: ...xamination will remain the same as before only the head movement will differ To return to the main screen press the Close button at the top right of the screen Last step is to choose whether to Quit clicking the button to the right of the screen open an existing file or perform a new exam ...

Страница 28: ...ons using the various accessories available on stock and therefore must be applied depending on the options you chose when ordering the fHIT system 5 1 PULIZIA E DISINFEZIONE For hygiene purposes clean the sensor and the band after each session with a patient Also it notes that for the hygiene and cleanliness without risk of damage BEON SOLUTIONS recommends using products that contain Quaternary a...

Страница 29: ...he patient operator or third party safety in case of first failure for this it is necessary to frequently check the security level offered by the device It is necessary do safety test and check every two years to identify possible electrical damage ex damage to the isolation that could reduce the security level This control must be done by an Authorized BEON SOLUTIONS SRL technician with appropria...

Страница 30: ...FHIT TEC_FHIT_M Rev 1 11 2016 30 ...

Страница 31: ...LUTIONS SRL will supply under request all the electrical framework component list desciption setting instruction or other information that attend authorized BEON SOLUTIONS SRL technician in the device setting EXTRAORDINARY MAINTENANCE Activity Regularity Who do it Note reference Intervention for every nonfunctional breakdown or device stop When necessary Authorized technician Reference to technica...

Страница 32: ...ith other electric devices in its proximity RF Emission CISPR 11 Class B The device is suitable for the use in all the environment including at home and in those directly connected to low voltage public electricity supply such as the one provded to households Armonic emission IEC 61000 3 2 Class A Potential difference flicker flutuation emission IEC 61000 3 3 Compliant Guide and manufacturer decla...

Страница 33: ...60601 Conformity level Electromagnetic einvironment guide Pipe RF IEC 61000 4 6 Radiate RF IEC 61000 4 3 3 Veff From 150 kHz to 80 MHz 3 V m From 80 MHz to 2 5 GHz RF comunication device portable and fixed musten t used in the device part proximity also cable from the recomended separation distance recomended calcolated with the equation applicable to the trasmitter frequency Separation distance r...

Страница 34: ...vice The device has to operate in the electromagnetic field under the RF interference control Device customer or user could prevent the electromagnetic interference guarantee a minimal distance between mobile and portable RF comunication device trasmitter and the device as below recomended related to the radio comunication device power maximum exit Exit maximum power of the trasmitter W Separation...

Страница 35: ...02 96 EC and 2003 108 EC regarding the reduction of hazardous substances in electrical and electronic equipment as well as waste disposal For professional users companies or organizations in accordance with the rules cited above separate collection of this equipment at the end of its life is organized and managed a directly by the user in the case where this apparatus decides to discard without re...

Страница 36: ...________________________________________________ ____________________________________________________________________________________ OPERATIVE DECISION PROPOSED _____________________________________________________ ____________________________________________________________________________________ Date _______________________________ Sign _______________________________ RESERVED COMPANY SPACE GE...

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