VSI CLAROX plus User Manual
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VSI CLAROX plus User Manual

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with fully digital X-ray source based on CNT nano technology
VX-100
User Manual
Ultra light
High speed driving
Wide usable
100 kV, 1 mA, 2.5 kg
plus

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Summary of Contents for VSI CLAROX plus

  • Page 1 plus with fully digital X-ray source based on CNT nano technology VX-100 User Manual Ultra light High speed driving Wide usable 100 kV, 1 mA, 2.5 kg...
  • Page 2 VX-100 User Manual(v01) Check the following before use; *Troubleshooting In instances of abnormal operation, error messages will be displayed on the Control Panel. If a problem persists, please request assistance from the customer support information services. E ? : An error occurred. Turn the power off, and then turn it back on. If the error persists, contact your Service Representative.
  • Page 3 VX-100 User Manual(v01) No X-ray emission Exposure Switch Please contact your service representative. Internal cable Please contact your service disconnection representative. Defective generator Please contact your service representative. X-ray emission works, but The device is Adjust the position of the equipment. exposure is too light or positioned incorrectly.

  • Page 4: Table Of Contents

    VX-100 User Manual(v01) Table of Contents 1. About User Manual ........................... 5 1.1 Cautions ............................ 5 1.2 Quality Assurance ........................5 1.3 Revision History ........................5 1.4 Symbols............................. 5 2. Precautions ............................6 2.1 General Cautions ........................6 2.2 General Prohibitions ......................6 2.3 General warnings ........................

  • Page 5: About User Manual

    This User Manual only pertains to the VX-100 and does not serve for any other products of the company. In the event of loss of or damage to this User Manual, please contact to service center of VSI Co., Ltd. This User Manual describes the precautions and possible risks that the user should be aware of and give attention to prior to use the VX-100.

  • Page 6: Precautions

    VX-100 User Manual(v01) 2. Precautions 2.1 General Cautions CAUTIONS This product is intended for use by a radiologist having received appropriate license. Please read and understand the instructions carefully and then use your device. Do not touch product, charger, and power plug with wet hands, otherwise, there is danger of getting electrical shocks.
  • Page 7 X-ray radiation. No modification of this equipment is allowed. If the product is modified or used for any purpose other than those specified in this User Manual, VSI will not be responsible for the safe operation of the VX-100. Please ensure not to exceed X-ray exposure dose required for image diagnosis.

  • Page 8: Appearance And Specifications

    VX-100 User Manual(v01) 3. Appearance and Specifications This device is a portable X-ray imaging device used to diagnose by generating and controlling X-rays. It is structured to be easily moved to other places. This device is composed of operation panel, high voltage generator (including X-ray tube), battery, etc. It does not include Detector, A/D Convert, image software, and computer for image output.

  • Page 9: Specification

    VX-100 User Manual(v01) 3.2 Specification Class IIb (Annex IX, Rule 10, Council Directive Classification 93/42/EEC as amended by Directive 2007/47/EC) Model VX-100 - Class Ⅱ equipment (Charging mode) Protection type from electrical shock - Internal power source equipment (Exposure mode) - Input: 100-240 Vac, 50/60 Hz, 0.4 A Rated power of AC/DC adapter - Output: 25.5 Vdc, 0.9 A...

  • Page 10: Safety Standards

    VX-100 User Manual(v01) 3.3 Safety Standards IEC 60601- Medical electrical equipment - Part 1: General 1:2005+CORR.1:2006+CORR.2:2007+A1:2012 requirements for basic safety and essential EN 60601-1:2006+A1:2013 performance Medical electrical equipment - Part 1-2: General IEC 60601-1-2:2014 requirements for basic safety and essential EN 60601-1-2:2015 performance –...

  • Page 11: Appearance

    VX-100 User Manual(v01) 3.4 Appearance 3.4.1 Main unit Name Description Cone When irradiating X-rays, limit the exposure range of the beam. Port used to download firmware by only authorized engineer Maintenance port Use only with IEC 60950-1 certified PC.) Adapter connection port Port for connecting the charging adapter X-ray exposure button Button to exposure X-ray...
  • Page 12 VX-100 User Manual(v01) 3.4.2 Cradle Name Description Cradle Used to mount the device when not in use. 3.4.3 Wrist strap Name Description Wrist strap When using the device, it is used by hanging the strap on the wrist, and it prevents the device falling.
  • Page 13 VX-100 User Manual(v01) 3.4.5 Control panel Name Description Tube voltage Display the sett tube voltage. indicator The user can turn the X-ray field lamp ON/OFF and display the ON/OFF Light field indicator status. Battery level The remaining battery charge is displayed in 4 stages, and in the 1st indicator stage, it blinks and X-rays are not irradiated.

  • Page 14: Dimension

    VX-100 User Manual(v01) 3.5 Dimension 3.5.1 Main unit - size: 413 mm(W) x 144 mm(D) x 284 mm(H) - weight: 2.5 kg...
  • Page 15 VX-100 User Manual(v01) 3.5.2 Cradle - size: 305.9 mm(W) x 223.7 mm(D) x 188.2 mm(H) - weight: 2.3 kg 3.5.3 Wrist strap - size: 200 mm(L) X 10 mm(W) 3.5.4 AC/DC adaptor - size: 46 mm(W) x 69 mm(D) x 70 mm(H), code length: 1840 mm...

  • Page 16: Operating Condition

    VX-100 User Manual(v01) 3.6 Operating condition - Temperature: +10 ℃ - +40 ℃ - Related Humidity: 30 %R.H. - 90 %R.H. (Non-condensing) - Atmospheric pressure: 80 kPa - 106 kPa - Altitude: Less than 2,000 m 3.7 Storage and transportation condition - Temperature: -40 ℃...
  • Page 17 VX-100 User Manual(v01) Package EC representative Product Label Package Manufacturer Product Label Package Storage temperature range Product Label Package Storage humidity range Product Label Package Storage Atmospheric pressure range Product Label CE marking, Complies with European medical Package devices directive Product Label Package WEEE Mark...

  • Page 18: Labels Of Main Unit And Packaging

    VX-100 User Manual(v01) 3.9 Labels of Main unit and packaging 1) Main unit Label location: On the Bottom of equipment 2) Packaging Label location: On the surface of the packaging box 3.10 Label of AC/DC adapter connector Label location: Near the AC/DC adaptor connector 3.11 Label of Radiation hazard (Physiological effects) Label location: On the bottom right of front of the device and the surface of package...

  • Page 19: Label Of Re-Chargeable Battery

    VX-100 User Manual(v01) 3.12 Label of re-chargeable battery Label location: On the battery pack 3.13 High voltage tank Label location: On the high voltage tank house(Inside the device) 3.14 X-ray tube assembly Label location: On the X-ray tube assembly(Inside the device)

  • Page 20: How To Use (Start-Up And Shutdown Procedure)

    VX-100 User Manual(v01) 4. How to use (Start-up and Shutdown procedure) 4.1 Frequently used functions - Connecting “Charging cable” - Checking “Charging condition” - Mounting “Cone” - Pushing “ON/OFF button” - Setting “Exposure time” - Setting “Tube voltage” - Checking “Display LCD” - Pushing “X-ray exposure button”...
  • Page 21 VX-100 User Manual(v01) F= Focal spot (0.6 mm) [Extra-focal radiation area: The geometry of the X-ray beam aligner in front of the tube tank is designed so that the end of the cone edge from the X-ray focus is aligned in almost straight line to reduce extra-focal radiation.
  • Page 22 VX-100 User Manual(v01) - The case thickness of water equivalent phantom is less than 10 mm, the material of it is PMMA. The size of it is 250 × 250 × 150 mm - In this area, the all performance of VX-100 can be used. - Operator Max.

  • Page 23: Operation Procedure

    VX-100 User Manual(v01) 4.3 Operation procedure Always use the device with the cone attached. The cone is fixed to the main unit. 1) If the Jog dial is pressed while the Control Panel is activated, the beep sounds once and the currently set tube voltage and exposure time is displayed.
  • Page 24 VX-100 User Manual(v01) [Figure 3] [Figure 3] 3) How to turn on/off the light field indicator - Power is ON, and if you press JOG DIAL once, the field is turned on. - “LIGHT” turns on the control panel. When 3 seconds elapse from the ON state, it will automatically turn off.
  • Page 25 VX-100 User Manual(v01) 7) If an error message is displayed on the display, the X-ray is not irradiated even if the X-ray exposure button is pressed, and measures such as A/S and charging must be taken. 8) When the charging adapter is connected while the power is ON, the power is OFF, and when the power button is pressed, the battery charging status is displayed for 10 seconds.

  • Page 26: Storage And Cleaning After Use

    VX-100 User Manual(v01) 4.4 Storage and Cleaning after use 1) Press “ON/OFF button” to turn off VX-100. When the power button is pressed for 2 seconds, the beep sounds twice and the Control Panel is deactivated. 2) Check the charging condition of battery after use. If the battery is not charged enough, charge the battery using the AC/DC adapter provided by the manufacturer.

  • Page 27: Technical Data

    VX-100 User Manual(v01) 5. Technical Data 5.1 Specifications - Electrical classification(Battery): Internally powered equipment - Electrical classification(AC/DC Adaptor): Class II - MDD(93/42/EEC) classification: Annex IX, rule 10, Class IIb - Mode of operation: Continuous operating - Radiation quantity: Max. entrance surface dose 6.319 mR at 100 kV / 1.0 mA / 1.0 s / SID 650 mm exposure condition.

  • Page 28: High Voltage Tank

    - Capacity: 1,460 mAh - Size: 66(Length)✕42(Height)✕39(Width) mm 5.7 AC/DC adapter Specification - AC/DC adapter provided by VSI is a part of VX-30. - Model name: FY2550900 - Rated input: 100-240 Va.c., 50/60 Hz, 0.4 A - Rated output: 25.5 Vd.c., 0.9 A 5.8 Software for VX-100...

  • Page 29: Characteristics Of The X-Ray Tube Voltage Waveform

    VX-100 User Manual(v01) 5.13 Characteristics of the X-ray tube voltage waveform - The rising phase: rise up to 100 kV within 20 ms, and kept it before push the exposure button. - The falling phase: fall down to 0 kV within 5 ms after push the exposure button. - The shape and amplitude of the X-ray tube voltage ripple: ripple is less than ±...

  • Page 30: Maintenance

    VX-100 User Manual(v01) 6. Maintenance 6.1 Replacement of Rechargeable battery - Unfasten bolts(See the [Figure 8] above.) from the battery cover located on the bottom of the device. - Take out the battery from the main unit. - Disconnect the battery connector and change the new battery. Use only specified battery provided by manufacturer.

  • Page 31: Disposal Of The Device

    The device shall be disposed of in accordance with a national law. Or it must be returned to the manufacturer for disposal. Please contact to Service Center of VSI Co., Ltd. 6.4 Circuit diagram, component part list, etc to repair certain parts of the device The circuit diagrams, component part lists and etc.

  • Page 32: Statements And Tables For Emc

    VX-100 User Manual(v01) 7. Statements and tables for EMC Table 1 – Enclosure port IMMUNITY TEST LEVELS Basic EMC Phenomenon standard or test Professional healthcare method facility environment ELECTROSTATIC ± 8 kV contact IEC 61000-4-2 DISCHARGE ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air 3 V/m f) Radiated RF EM IEC 61000-4-3...
  • Page 33 VX-100 User Manual(v01) Table 2 – Input a.c. power PORT (VX-100 has No a.c. power Port) IMMUNITY TEST LEVELS Basic EMC Phenomenon standard or test Professional healthcare method facility environment Not applicable Electrical fast IEC 61000-4-4 ± 2 kV transients/bursts a 100 kHz repetition frequency Surges a) b) j) o) Not applicable...
  • Page 34 VX-100 User Manual(v01) m) r.m.s., before modulation is applied. n) The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
  • Page 35 VX-100 User Manual(v01) Table 3 – Input d.c. power PORT IMMUNITY TEST LEVELS Basic EMC Phenomenon standard or test Professional healthcare method facility environment ± 2 kV Electrical fast transients/bursts a) g) IEC 61000-4-4 100 kHz repetition frequency Surges a) b) g) IEC 61000-4-5 ±...
  • Page 36 VX-100 User Manual(v01) Table 4– Patient coupling PORT (VX-100 has No Patient coupling Port) IMMUNITY TEST LEVELS Basic EMC Phenomenon standard or test Professional healthcare method facility environment Not applicable ELECTROSTATIC IEC 61000-4-2 ± 8 kV contact DISCHARGE c) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Not applicable 3 V b) Conducted...
  • Page 37 VX-100 User Manual(v01) Table 5– SIP/SOP PORT IMMUNITY TEST LEVELS Basic EMC Phenomenon standard or test method Professional healthcare facility environment ELECTROSTATIC ± 8 kV contact IEC 61000-4-2 DISCHARGE e) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air Electrical fast ±...

  • Page 38: Product Warranty Policy

    Tel: +32(2) 732 5954 Email: mail@Obelis.net VSI Co., Ltd. homepage is available to you and provides a page where you can let us know if you have any complaints. If you have experienced any inconveniences during the use of our product or have any suggestions for improvement, except for product defects, please feel free to contact us and help us incorporate your ideas.

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