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BeON fHIT 1.0 Instructions For Use Manual

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fHIT 1.0
Instruction for Use
data
AQ
Dir. Tecnica
Dir. Generale
1.1.1.1.1.1.
BEON
28/11/2016
SOLUTIONS SRL
FHIT TEC_FHIT_M Rev.1 11/2016

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Summary of Contents for BeON fHIT 1.0

  • Page 1 1.0 Instruction for Use data Dir. Tecnica Dir. Generale 1.1.1.1.1.1. BEON 28/11/2016 SOLUTIONS SRL FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 2 FHIT TEC_FHIT_M Rev.1 11/2016...

  • Page 3: Table Of Contents

    REMOVAL DEVICE AT THE END OF THE LIFE ..................35 7.1. OTHER INFO ONLY FOR ITALY ........................35 PEPLE’S INJURY ADVISORY ........................36 WARNING Before using the machine, you must fully read the BEON SOLUTIONS Srl instructions and any instructions enclosed with the supplied accessories. FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 4 FHIT TEC_FHIT_M Rev.1 11/2016...

  • Page 5: Important

    1. IMPORTANT The functional examination of the vestibular-oculomotor system belongs to the category of medical devices used to perform diagnoses in the field of the treatment of vertigo. In the following, the device performing the functional testing of vestibular ocular reflex system will be referred to as fHIT (abbreviation from English functional Head Impulse Test).

  • Page 6: Security

    - DANGER: Always Check that the device is in good conditions - WARNING: Do not use the device if one of its parts is defective or worn out. In this case ask the intervention of BEON SOLUTIONS SRL authorized techincian.

  • Page 7: Garantee

    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.

  • Page 8: Caratteristiche Tecniche

    CARATTERISTICHE TECNICHE Model Functional head impulse test Manufactured BEON SOLUTIONS SRL Via Bertoneria, 16/D Italia Class Type of part applicated Sensor protection level IP50 POWER SOURCE USB 5 V- max 500mA FUNCTIONAL TIME Uninterrupted device use VARIED USB sensor’s long cable Full sensor weight, strip included ca.
  • Page 9 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.

  • Page 10: Technical Installation

    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 FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 11 FHIT TEC_FHIT_M Rev.1 11/2016...

  • Page 12: Installation

    3.2. INSTALLATION The software on the USB stick inside the case will have to be installed to C: \ on a computer with Windows 10. The fHIT software is installed starting from the setup.exe file located on the USB stick inside the case. You can then launch the program by either running the only .exe file inside the installed folder, or the link that the installation software will place in the programs or in the desktop menu.

  • Page 13: Software

    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. FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 14 If you choose "Run New Exam", the next step will to enter some information on the 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.
  • Page 15 PRAPARING FOR TESTING The first step before the execution of the actual test is the measurement of static visual acuity of the patient, which is necessary 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.
  • Page 16 PROCESS OF EXAMINATION– VISUAL ACUITY PART The examination begins When the software shows the following screen with a white dot in the center where the Landolt C optotype will appear. The doctor gives an indication to the patient to look at the white point until the optotype appears. Once the optotype has appeared the patient will indicate which of the 8 possible orientations, which then appear on the screen, he has seen.
  • Page 17 SECOND PART- fHIT EXAM  PREPARATION 4.1.1.1.1.3. Warning !: Do not practice impulses to the head of patients with neck injuries or patients that the doctor has advised to limit or avoid neck movements 4.1.1.1.1.4. Connect the sensor with a 3 meters USB cable. Switch on the sensor using the button next to the entrance of the USB cable on the sensor;...
  • Page 18 If the sensor is not positioned correctly on the patient's head a warning will appear on the computer screen. If there are no positioning 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.
  • Page 19 FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 20 The approach to examination shall be the same as for visual acuity The patient will have to keep his/her eyes on the white point while the doctor will impose the head impulses triggering the optotype appearance. As with static visual acuity, the patient will have to indicate, using the numeric keypad, the optotype that appeared among the eight proposed by the software.
  • Page 21 In the time that elapses between an impulse and another, the software will show a black screen where 4 graphics appear. The two numbers which appear in the upper right and left, are the movement counters that determine when the examination ends. The examination ends after completing 30 moves in the range between 3000 and 6000 °...
  • Page 22 The top and bottom central panels will show head impulse velocity and acceleration, respectively, highlighting in yellow the traces relative to the last impulse performed. If the movement was too slow or too fast compared to the range 3000 - 6000 a warning box will be displayed at the center. If the movement has been carried out from 0 to 7999 deg/s it will still appear in the histogram.
  • Page 23 The movements that are too fast or too slow also also appear in the counting histograms, yet these will be shown in gray bars, while the exact movements ones are blue for the left side, and red for the right side . After 10 movements left and right or up and down, or a number that may be set through the software, you will see a pause screen.
  • Page 24 Clicking on one of the two central graphs allows to enlarge it and assess whether the features are normal or not. If, however, the recoding is continued the movements already made to both right and left (or RA and LP, RP and LA) and the percentage of correct responses will appear on the left handside of the screen.
  • Page 25 After the save window the software will display 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 FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 26 FHIT TEC_FHIT_M Rev.1 11/2016...
  • Page 27 Once you select the next channels to be analyzed, the examination 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.

  • Page 28: Mantenance

    Do always refer to the instructions and safety data sheets of the manufacturer: The band should be washed and disinfected after use on a patient. BEON SOLUTIONS accepts no responsibility for problems arising from the use of substances other than those recommended.

  • Page 29: Regolazioni

    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 appropriate tools and equipment complying to precise standards; IEC 62353 standard is the reference for electromedical device check product compliance with IEC 60601-1 standard.
  • Page 30 FHIT TEC_FHIT_M Rev.1 11/2016...

  • Page 31: Extraordinary Maintenance

    Here are illustrated some extraordinary maintenance; we recomend that all this operations must done by authorized BEON SOLUTIONS SRL technician. BEON SOLUTIONS 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.

  • Page 32: Potenziale Elettromagnetico

    6. POTENZIALE ELETTROMAGNETICO The device is biult in observance of CEI EN 60601-1-2 (Electromedical device, collateral standard: Electromagnetic compatibility) and has an immunity and emission degree that not create warning interferences with device with the same standard. ATTENTION: It could happen interferences with electrical device that not have the immunity and emission not compliant to the CEI EN 60601 -1 -2 standard;...
  • Page 33 40% U interruption, we recomend (60% hole in U for 5 device fueling with a IEC 61000-4-11 70% U cycle) uninterruptible power supply 20 cycle (500mS) or with battery. 70% U <5% U (30% hole U for 20 cycle) <5% U (>95% hole U for 5S) Frequency magnetic...
  • Page 34 NOTE2: this guide line cannot be applied in all the situation. Electromagnetic propagation is conditioned by the structure, object and people incorporation and reflection. Field intensity for fixed trasmitter, as the base station for phone (mobile phone and cordless) and terrestrial mobile station, radio amateur device, AM and FM radio trasmitter and TV trasmitter cannot be with precision expected.To evaluate an electromagnetic field caused by fixed RF trasmitter is...

  • Page 35: Removal Device At The End Of The Life

    7. DISPOSAL OF THE DEVICE AT THE END OF ITS LIFE European directive 2002/96/CE and 2008/108/CE of Electric and Electronic device waste (RAEE). The crossed dumpster symbol on the device or on the box, show that at the end of its life it must be different rally from other waste.

  • Page 36: Peple's Injury Advisory

    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 FHIT TEC_FHIT_M Rev.1 11/2016...

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