Vatech EzRay Air Portable VEX-P300 User Manual
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Vatech EzRay Air Portable VEX-P300 User Manual

X-ray system
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Postal Code: 18449
13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea
www.vatech.com
User Manual
Model : VEX-P300
Version : 1.48
English
Full Version

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Summary of Contents for Vatech EzRay Air Portable VEX-P300

  • Page 1 User Manual Model : VEX-P300 Version : 1.48 English Full Version Postal Code: 18449 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggi-do, Korea www.vatech.com...
  • Page 5 The actual device may differ. Due to continuous technological improvements, the manual may not contain the most updated information. For further information not covered in this manual, please contact us at: VATECH Co., Ltd. Phone: (+82) 1588 9510 E-mail: gcs@vatech.co.kr This document is originally written in English.
  • Page 6 Notice This page is intentionally left blank. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 7: Table Of Contents

    Notice Table of Contents Notice Table of Contents General and Regulatory Information Manufacturer's Liability ..................1 Owner and Operator's Obligations ..............1 Conventions Used in this Manual ..............2 Marks and Symbols ..................3 Standards and Regulations ................6 Safety Instructions General Safety Guidelines ................
  • Page 8 Notice Service Mode Menu ..................47 Troubleshooting Cleaning and Maintenance Cleaning ......................63 Maintenance ....................64 Disposing of the Unit Device Specifications Mechanical Specifications ................69 Technical Specifications ................. 70 Electrical Specifications ................. 74 Environmental Specifications ................. 74 Appendix 10.1 Combining the Holder and the devices using a tripod ........

  • Page 9: General And Regulatory Information

    (as well as any state, provincial, or local regulatory compliance) and that VATECH, its agents or representatives, do not accept responsibility for: 1) any injury or danger to personnel from X-ray exposure,...

  • Page 10: Conventions Used In This Manual

    1. General and Regulatory Information Conventions Used in this Manual The following symbols are used throughout this manual. Make sure that fully understand each symbol and follow the instructions which accompany it. Please observe all warnings and safety information included in this document to prevent personal injury and damage to the device.

  • Page 11: Marks And Symbols

    1. General and Regulatory Information Marks and Symbols The following table describes the purpose and location of safety symbols and other valuable information provided on the device. Mark/Symbol Description Location Alternate current Battery Charger Label Direct current Main Label Attention: Main Label Consult accompanying documents Powerboard,...
  • Page 12 1. General and Regulatory Information Caution: Federal law restricts this device to sale by or about a Main Label licensed healthcare practitioner. Main Label, Manufacturer’s name and address Generator Label Main Label, Date of manufacture Generator Label This symbol indicates that electrical and electronic devices must not be disposed of as unsorted municipal Main Label...
  • Page 13 1. General and Regulatory Information 1.4.1 Label Locations Generator Label Main Label UDI Label The labels' design and contents may be different in some countries based on local regulations and standards. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 14: Standards And Regulations

    1. General and Regulatory Information Standards and Regulations Standards: The device is designed and manufactured to meet the following standards:  MEDICAL - APPLIED ELECTROMAGNETIC RADIATION EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE, AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), CAN/CSA-C22.2 No.

  • Page 15: Safety Instructions

     30 cm (12 inches) to any part of the EzRay Air Portable(Model: VEX-P300), including cables specified by VATECH. This device is shipped with the backscatter shield attached (firmly fixed), so users can not replace the backscatter shield. If it is damaged or defective, contact your Service Representative for replacement.

  • Page 16: Warnings And Safety Instructions

    2. Safety Instructions Warnings and Safety Instructions This X-ray unit may be dangerous to patients and  operators unless safe exposure factors, operating instructions, and maintenance schedules are observed. It is essential to read this user manual carefully and strictly abide by all warnings and cautions stated.
  • Page 17 Make sure to use the battery only provided or approved by  VATECH. If non-standard or damaged batteries are used, there is a risk of fire and explosion. Make sure to use the battery charger only provided or ...
  • Page 18 Contact your Service Representative for battery replacement. - DO NOT charge a fully discharged battery, as this may cause fire or explosion. Be sure to replace the battery (provided by VATECH). Users can replace batteries.  When charging the battery, the exposure function is locked.

  • Page 19: System Overview

    3. System Overview System Overview The device, a portable dental X-ray system, operates on 21.6 V supplied by a rechargeable Li-ion battery pack. The portable X-ray system is an X-ray generating device designed for dental examination (teeth and jaw). The portable X-ray system is composed of an X-ray generating part with an X-ray tube including a device controller, a power controller, a user interface, a beam limiting part, a backscatter shield, and an optional Remote Exposure Switch.

  • Page 20: Components

    3. System Overview Components Item Standard Option Qty. Main Body ● (included the Backscatter Shield and the Round Cover) ● Hand/Neck Strap ● Rectangular Cover (4x3) ● power cord ● Battery Charger ● User Manual ● Cradle ● Rectangular Cover (2x3) ●...

  • Page 21: Features

    EzRay Air Portable (Model: VEX-P300) for users in the countries where a hand-held X-ray device is prohibited in the clinic. For more information, please contact a VATECH representative in your area. Features The device is an intra-oral portable X-ray system that offers safety, reliability, and greater functionality: ...

  • Page 22: General View Of The Device

    3. System Overview General View of the Device Main Body Item Description Backscatter Shield Shields from the backscattering radiation. Limits the X-ray exposure area. X-ray Beam Limiting Default type: Round Cone + Round Cover (FOV: Ø 6 Device X-ray Exposure Press the button for X-ray exposure.
  • Page 23 3. System Overview Control panel Item Description Tube Indicates the tube voltage and tube Voltage/Current current of the system. Indicator Angle/Time Displays the X-ray exposure time, error Display code, cooling time, and exposure angle. Adult/Child Indicates a patient type (adult or child). Selection Remaining Battery...
  • Page 24 3. System Overview X-ray Exposure Indicates the X-ray exposure status. Indicator (Green: Ready / Yellow: X-ray On) Turn the jog dial left (-) or right (+) to select an X-ray exposure setting, press Jog Dial the jog dial to confirm the operating setting.
  • Page 25 3. System Overview Available Option Items Figure Option name Rectangular Cover 2x3 (3x2) FOV: 2x3 cm, 3x2 cm (This cover can be used as both 2x3 and 3x2.) Remote Exposure Switch Rotating Rectangular Cover 4x3 (3x4) FOV: 4x3cm, 3x4cm (This adaptor can be used as both 4x3 and 3x4.) Rotating Rectangular Cover 2x3 (3x2)
  • Page 26 3. System Overview Refer to Appendix 10.2 Using the Rotating Rectangular Cover for instructions for use. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 27: Operation

    4. Operation Operation Power On/Off Turn on the system referring to the following figure. The following displays and indicators light up:  Current Angle/Time display  Tooth type selection display  Adult/Child selection display  Remaining battery indicator  X-ray exposure indicator Make sure that at least one battery indicator light comes on.

  • Page 28: Enter Password

    4. Operation Enter Password To turn on or off the password mode, refer to 5.3.4. Password mode On/Off. To change the password, refer to 5.3.11. Password Setting. Enter the 3 digits numeric password using the jog dial. (default password: 000) Turn the jog dial to choose a number and press the dial to move to the next digit.

  • Page 29: Operation Mode

    4. Operation Operation Mode This system can be operated in Manual Mode. Manual Mode When the tooth type selection area flickers, turn the jog dial to select the tooth type. To see the Control panel before and after selection, refer to the figures below.
  • Page 30 4. Operation After tooth type selection, a patient type should be selected. When the Adult/Child selection area flickers, turn the jog dial to select the patient type. To see the Control panel after selection, refer to the figure below. After patient type selection Patient Type Symbol Type...

  • Page 31: Positioning

    4. Operation Positioning Positioning the Patient To obtain high-quality intra-oral radiography with maximum details, take extra care in all steps of the radiography process: positioning the patient and the X-ray imaging system; exposing the phosphor plate or the intra-oral sensor. Place a protective lead apron on the patient’s chest.
  • Page 32 4. Operation Place the tube head cone in the area want to take an image. When using the device as a hand-held When holding the device, it is recommended to grip the handle by one hand and place the other on the underside of the device, as shown in the following figure.
  • Page 33 4. Operation Positioning Instructions Paralleling technique: The phosphor plate or sensor is placed in a holder used to align the phosphor plate or sensor parallel to the tooth' long axis. 1. Phosphor plate or Sensor 2. Long axis of the tooth Bisected angle technique: The patient holds the phosphor plate or sensor in place with his/her finger.
  • Page 34 4. Operation Here are the specific angulations and directions for the tube head to take the best images of a tooth (i.e., Bisected angle technique). Position the receptor carefully not to damage the soft tissue of the patient’s intra-oral area. ...
  • Page 35 4. Operation  Maxillary Canine The x-ray beam is directed downward at 45°. Teeth Angle of inclination +45˚ Canine Maxilla  Mandibular Canine The x-ray beam is directed upward at 20°. Teeth Angle of inclination Canine Mandible -20˚ EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 36 4. Operation  Maxillary Molar and Premolar The x-ray beam is directed downward at 30°. Teeth Angle of inclination +30˚ Molar and Premolar Maxilla  Mandibular Molar and Premolar The x-ray beam is directed upward at 5°. Teeth Angle of inclination Molar and Premolar Mandible -5˚...
  • Page 37 4. Operation  Bitewing For a bitewing exposure, the patient closes their teeth during exposure on the phosphor plate/sensor holder. The x-ray beam is directed downward at 5° ~ 8° Teeth Angle of inclination +5˚~ +8˚ Bitewing exposure EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 38 4. Operation Positioning the Imaging Sensor Using EzRay Air Portable(Model: VEX-P300), a portable dental X-ray system, you may create an X-ray image on different types of imaging receptors: • Digital sensors • Phosphor plate To ensure image quality, the digital imaging sensor must be appropriately positioned (for information about the imaging sensor's proper placement, please refer to ‘Positioning Instructions.’...
  • Page 39 4. Operation To ensure proper alignment between the imaging sensor and the X-ray beam, it is recommended to use a PID (Position Indicating Device), as shown in the following figure. When using the PID, the X-ray device's exit pattern should be aligned perpendicular to the target receptor, as shown in the following figure.

  • Page 40: Exposure

    4. Operation Exposure The operator MUST instruct the patient to refrain from moving during the entire exposure. Instruct the patient not to move. Press the Exposure Button for exposure duration. The operator in the countries where a hand-held X-ray device is prohibited must use a remote exposure switch.
  • Page 41 4. Operation 4.5.1 Remote Exposure Switch The Remote Exposure Switch allows the operator to control image acquisition from outside of the X-ray room. Press and hold the Remote Exposure Switch until the acquisition is completed. Premature release of the Remote Exposure Switch will abort image acquisition. Pressing the Remote Exposure Switch activates the X-ray Exposure Indicator to turn yellow.

  • Page 42: Using The Battery

    4. Operation Using the Battery The battery level indicator with a residual quantity is shown on the left side of the Control panel. When the battery indicator has one flickering light (level 1), charge the battery immediately. The figure below shows each battery indicator from level 1 to 3 Level 3 Level 2...
  • Page 43 DO NOT charge a fully discharged battery, as this may cause fire or explosion. Be sure to replace the battery (provided by VATECH). When the device is connected to the battery charger, the Battery Charging Indicator is always displayed except that the battery is fully discharged.
  • Page 44 4. Operation Charging the Battery Connect the battery charger to the battery charger connector, as shown in the following figure. When the battery charger is connected, the battery charging LED indicator light comes on. Charge the battery until all the three LED indicators are filled up. Usually, it takes about 3 hours to charge the battery after a complete discharge fully.
  • Page 45 4. Operation Battery Replacement Users can replace batteries. To replace the battery, contact your Service Representative to get a battery kit (including a new battery and a Phillips screwdriver). Workforce One person, 3 minutes Tools required Phillips screwdriver (size: T20) Removal Procedure Using a Phillips screwdriver, unscrew the battery bay access door.
  • Page 46 4. Operation Disconnect the device's battery cable by pressing the battery cable connector, as shown in the following figure. Press and disconnect the battery Battery cable connector cable connector After disconnecting the battery cable DO NOT pull excessively on the battery cable. Install the new battery in the reverse order of removal.
  • Page 47 4. Operation Sleep Mode 1 To minimize battery consumption, Sleep Mode 1 starts when the device stays inactive for one minute (To learn how to change the default waiting time for Sleep Mode 1, see 5.3.6 Waiting Time Setting for the Sleep Mode 1). When Sleep Mode 1 starts, the Control panel becomes lightly dark, as shown in the right figure.
  • Page 48 4. Operation Sleep Mode 2 Sleep Mode 2 starts when the device stays inactive for 5 minutes after entering Sleep Mode 1 (To change the default waiting time for Sleep Mode 2, see 5.3.7 Waiting Time Setting for the Sleep Mode 2). If the battery charger is connected to the device, Sleep Mode 1 is maintained.
  • Page 49 4. Operation Power Down Mode When the device stays inactive for 5 hours after entering Sleep Mode 2, the Power Down Mode starts. (To change the default waiting time for the Power Down Mode, see 5.3.8 Waiting Time Setting for the Power Down Mode). If the battery charger is connected to the device, Sleep Mode 1 is maintained.
  • Page 50 4. Operation This page is intentionally left blank EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 51: Service Mode

    5. Service Mode Service Mode Overview In the Service Mode, users can check and change the following settings:  5.3.1 Factory Default Settings  5.3.2 Exposure Time Settings  5.3.3 User Default Settings (for each patient and tooth type))  5.3.4 Password Mode On/Off ...

  • Page 52: Changing System Parameters

    5. Service Mode Changing System Parameters To change system parameters: Press and hold the SET button and jog dial simultaneously (for about 3 seconds). Enter the 3 digits numeric password using the jog dial. (default password: 000) Turn the dial to choose a number and press it to move to the next digit. EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 53 5. Service Mode When all three digits are set, press the jog dial again to save the setting. After entering the password is completed, the service mode starts, as shown in the figure below. The system provides 24 service modes. To change each mode's settings from n.01 to n.24, press the AUTO button on the left.
  • Page 54 5. Service Mode To move to the next mode, press the AUTO button again. Each time you press the button, the service mode number goes up by one. To return to the previous move, press the SET button on the right. (See 5.3 Service Mode Menu to learn more information on each mode) Each time you finish changing the system parameter, press the jog dial and hold it until you hear a beep.

  • Page 55: Service Mode Menu

    5. Service Mode Service Mode Menu See 5.2 Changing System Parameters for entering each service mode. 5.3.1 Factory Default Settings Factory default settings restore all system mode parameters to their default values except for n.24. Follow the procedures below to activate the settings. Service Mode No.
  • Page 56 5. Service Mode 5.3.2 Exposure Time Settings (for each patient and tooth type) Select a service mode from n.02 to n.09 to set up an exposure time for each patient and tooth type. See the table below for more information. Service Mode No.
  • Page 57 5. Service Mode 5.3.3. User Default Settings (for each patient and tooth type) User default settings are activated as the device starts. See the table to change each service mode number aligned with the patient or tooth type. Service Mode No. Item n.10 Adult...
  • Page 58 5. Service Mode 5.3.4 Password Mode On/Off Follow the procedure below to turn on and off the password mode. Service Mode No. Item n.16 Password On n.17 Password Off To activate the password mode, Select n.16 and press the jog dial. The message “YES” is displayed on the Control panel.
  • Page 59 5. Service Mode 5.3.5 Angle Increments Setting Available only in countries that allow the auto mode for use. The mode is not available in the United Kingdom, the United States, and some countries (Consult the sales representative in your country for details). When the auto button is pressed, only “NA”...
  • Page 60 5. Service Mode 5.3.6 Waiting Time Setting for the Sleep Mode 1 Follow the procedure below to set up the waiting time for Sleep Mode 1. Service Mode No. Item n.19 Waiting time setting for the Sleep Mode 1 To change the waiting time for Sleep Mode 1 Select n.19 and press the jog dial.
  • Page 61 5. Service Mode 5.3.7 Waiting Time Setting for the Sleep Mode 2 Follow the procedure below to set up the waiting time for Sleep Mode 2. Service Mode No. Item n.20 Waiting time setting for the Sleep Mode 2 To change the waiting time for Sleep Mode 2, 1.
  • Page 62 5. Service Mode 5.3.8 Waiting Time Setting for the Power Down Mode Follow the procedure below to set up the waiting time for the Power Down Mode. Service Mode No. Item n.21 Waiting time setting for the Power Down Mode To change the waiting time for the Power Down Mode, Select n.21 and press the jog dial.
  • Page 63 5. Service Mode 5.3.9 Buzzer On/Off Follow the procedure below to turn on/off the buzzer. Buzzer On mode has three options: Battery Level 1 (flickering) warning only, Power Down Mode warning only, and both. Service Mode No. Item n.22 Buzzer On/Off To change the setting, Select n.22 and press the jog dial.
  • Page 64 5. Service Mode 5.3.10 Power Down Mode On/Off Follow the procedure below to turn on/off the Power Down Mode. Service Mode No. Item n.23 Power Down Mode On/Off To change the Power Down Mode On/Off setting, Select n.23 and press the job dial. The default setting “001” is displayed on the Control panel.
  • Page 65 5. Service Mode 5.3.11 Password Setting Follow the procedure below to change the password. Service Mode No. Item n.24 Password setting To change the password, Select n.24 and press the jog dial. The default password “000” is displayed on the control panel, as shown in the right figure. When the first digit flashes, turn the jog dial to change the password and then save it by pressing the jog dial.
  • Page 66 5. Service Mode This page is intentionally left blank. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 67: Troubleshooting

    The device resumes to normal operations after X-ray Generator a re-boot. (If the problem persists, please E.05 contact your Vatech representative.) Appears when the system needs cooling time due to continuous operation. This alarm clears A.06 when the system temperature goes down to normal.
  • Page 68 6. Troubleshooting Troubleshooting Problem Cause Solution The power switch is not Turn the device power switch off turned on properly. and turn it back on. Recheck after charging the battery Battery discharged with a charger. The device is not turned on. Battery cable is not Contact your Service correctly connected.
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  • Page 70 6. Troubleshooting This page is intentionally left blank. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 71: Cleaning And Maintenance

    7. Cleaning and Maintenance Cleaning and Maintenance Cleaning Before cleaning the device, make sure to turn off the device. The device surfaces can be cleaned with a soft cloth damped in an alcohol-based,  non-corrosive cleaning solution. If necessary, wipe off surfaces with disinfectant. If necessary, wipe off surfaces with disinfectant.

  • Page 72: Maintenance

    7. Cleaning and Maintenance Maintenance VATECH requires periodic constancy tests to ensure image quality and the safety of the patient and operator. Only VATECH authorized technicians can perform the inspection and service of this device. For technical assistance, contact the VATECH service center or your local VATECH representative.
  • Page 73 7. Cleaning and Maintenance 7.2.1 Maintenance Task Checklist Always turn off the device before performing any maintenance. Tasks Period Before the operation, ensure that the device is clean and ready Daily for use. After using the device, make sure that the device has been Daily turned off.
  • Page 74 7. Cleaning and Maintenance This page is intentionally left blank. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 75: Disposing Of The Unit

    8. Disposing of the Unit Disposing of the Unit This device is designed to be as safe as possible to use and dispose of to reduce environmental contamination. Many components of this device are environment- friendly and can be recycled. All parts and components that contain hazardous materials must be disposed of by disposal regulations.
  • Page 76 8. Disposing of the Unit This page is intentionally left blank. EzRay Air Portable (Model: VEX-P300) User Manual...

  • Page 77: Device Specifications

    9. Device Specifications Device Specifications Mechanical Specifications Dimensions Item Description Dimension (mm) 280(L) x 296(H) x ø 165 Main Body Weight (kg) 2.14 (± 10 %) Round Type FOV: < ø 60 X-ray X-ray Beam Beam Area (mm) Rectangular Type FOV: 20 x 30, 40 x 30 Limiting Device...

  • Page 78: Technical Specifications

    Min. 1.5 mm Al Type Inverter Type Tube Voltage 55-65 kV Tube Current 1.0-3.0 mA Manufacturer VATECH Co., Ltd. Model V1-650304 (Stationary Anode type) Focal spot size 0.4 mm (IEC 60336) Anode heat contents Max. 2.7 kJ Maximum Anode Heat...
  • Page 79 9. Device Specifications X-ray Tube Characteristics Maximum rating chart Emission characteristics Heating and cooling curves of X-ray tube housing assembly EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 80 9. Device Specifications Tube Dimensions [mm] EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 81 2500 battery. The two battery specifications are identical. Make sure to use the battery only provided or approved by VATECH. Using an unauthorized battery may result in severe injury and device damage. For details on using the battery, see ‘Battery Use.’...

  • Page 82: Electrical Specifications

    9. Device Specifications Electrical Specifications Item Description Option 1: 60 kV fixed (± 5 %) Tube Voltage Option 2: 65 kV fixed (± 5 %) Tube Current 2.5 mA (± 10 %) Exposure Time 0.05-1.0 s (± 3 % or 10 ms) Rated Voltage 21.6 V The system will be available with a fixed tube voltage...

  • Page 83: 10. Appendix

    10. Appendix 10. Appendix 10.1 Combining the Holder and the devices using a tripod Using a hand-held X-rays are not available in some countries. The operators in these countries must mount the device on a tripod using a holder (Read the instructions in this section) The essential components for connecting the device to the tripod are packed/shipped in a separate box, as shown in the image below.
  • Page 84 10. Appendix Attach the EzRay Air Portable unit to the holder with the tripod, as shown in the image below. Connect one end of the Gender cable to the EzRay Air Portable device. Connect the other end of the Gender cable connected to the holder to the supplied exposure cable.

  • Page 85: Using The Rotating Rectangular Cover

    10. Appendix 10.2 Using the Rotating Rectangular Cover Rotating Rectangular Cover rotates at 360 degrees. Rotating Rectangular Cover consists of the Outer Ring and the Inner Ring. The Outer Ring rotates in 90-degree increments. The Inner Ring rotates in 10-degree increments. Assemble the Rotating Rectangular Cover to the Cone of the Main body.
  • Page 86 10. Appendix For assembling the Rotating Rectangular Cover to the Cone, turn the Rotating Rectangular Cover 45 degrees and check the Click sound to ensure the assembly is complete. Turn the Outer Ring of the Rotating Rectangular Cover to adjust the angle roughly.

  • Page 87: Tables Of Exposure Times (Default)

    10. Appendix 10.3 Tables of Exposure Times (Default) The following exposure timetables were established with a unit equipped with a cone that corresponds to a focus-to-skin distance of 200 mm (8 inches), respectively. DIGITAL SENSOR Option 1: 60 kV, 2.5 mA, 0.05~1.0 sec SSD: 200 mm (8 inches) Angle of Patient...
  • Page 88 10. Appendix Option 2: 65 kV, 2.5 mA, 0.05~1.0 sec SSD: 200 mm (8 inches) Angle of Patient Teeth inclination Maxilla: +45˚ Incisor 0.12 Mandible: -25˚ Maxilla: +45˚ Canine 0.14 Adult Mandible: -20˚ Molar/ Maxilla: +30˚ Premolar 0.16 Mandible: -5˚ Bitewing +5˚~ +8˚...
  • Page 89 10. Appendix PSP Scanner (VistaScan Nano Easy) Option 1: 60 kV, 2.5 mA, 0.05~1.0 sec SSD: 200 mm (8 inches) Angle of Patient Teeth inclination Maxilla: +45˚ Incisor 0.30 Mandible: -25˚ Maxilla: +45˚ Canine 0.42 Adult Mandible: -20˚ Molar/ Maxilla: +30˚ Premolar 0.60 Mandible: -5˚...
  • Page 90 10. Appendix Option 2: 65 kV, 2.5 mA, 0.05~1.0 sec SSD: 200 mm (8 inches) Angle of Patient Teeth inclination Maxilla: +45˚ Incisor 0.28 Mandible: -25˚ Maxilla: +45˚ Canine 0.40 Adult Mandible: -20˚ Molar/ Maxilla: +30˚ Premolar 0.58 Mandible: -5˚ Bitewing +5˚~ +8˚...

  • Page 91: X-Ray Dose Data

    10. Appendix 10.4 X-ray Dose Data The X-ray dose data is extracted from the X-ray Dose Test Report for the device. The IEC collateral standards measured the X-ray doses of the device in the test report. The device was designed by Part 1. General Requirements for Safety, IEC 60601-1-3. Test Condition Model Name VEX-P300...
  • Page 92 10. Appendix Dose Area Product (DAP) Table (60 kVp, 2.5 mA, SSD 200 mm) FOV: Ø 6 cm FOV : 3 x 4 cm FOV : 2 x 3 cm t (s) Dose (mGy.cm 0.30 14.7 0.42 20.1 0.60 29.2 12.4 0.65 31.6...
  • Page 93 10. Appendix Results The following exposure timetables were established with a unit equipped with a cone that corresponds to a focus-to-skin distance of 200 mm (8 inches), respectively. When the leakage doses have been measured with each cover type (default, rectangular 2x3, and rectangular 4x3), all the results have been ND (Not Detected).
  • Page 94 10. Appendix The result (Vertical Plane) 0° 335° 20° 315° 45° 290° 65° 270° 90° 245° 110° 225° 135° 200° 155° 180° Default type Rectangular 2x3 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 0° 20° 45° 65° 90° 110° 135° 155° 180°...
  • Page 95 10. Appendix 10.4.3 Scattered Dose Scope IEC 60601-2-65 203.13 Requirements ME EQUIPMENT shall be provided with means to optionally allow actuation of the EXPOSURE from a PROTECTED AREA after installation. Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS. Results The following exposure timetables were established with a unit equipped with a cone that corresponds to a focus-to-skin distance of 200 mm (8 inches), respectively.
  • Page 96 10. Appendix Option 1: 60 kV / 2.5 mA / 1.0 s Result (Horizontal Plane) [μR] Direction [°] Without Shield With Shield 63.4 68.14 17.8 11.99 18.5 13.01 19.8 14.76 27.1 20.65 41.6 32.08 63.4 46.18 68.1 11.14 3.29 2.893 51.5 7.557 47.5...
  • Page 97 10. Appendix Result (Vertical Plane) [μR] Direction [°] Without Shield With Shield 25.8 29.8 27.3 26.8 18.5 22.5 15.9 18.5 74.1 72.1 15.9 18.5 17.2 13.5 19.9 17.9 19.2 17.9 27.8 31.4 13.9 10.6 38.4 48.4 11.9 60.2 52.3 41.7 45.7 EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 98 10. Appendix Option 2: 65 kV / 2.5 mA / 1.0 s Result (Horizontal Plane) [μR] Direction [°] Without Shield With Shield 58.8 85.2 22.5 30.4 39.6 42.7 47.6 40.3 46.9 42.9 47.6 66.7 92.5 48.9 87.9 34.3 11.9 11.9 94.5 28.4 89.2...
  • Page 99 10. Appendix Result (Vertical Plane) [μR] Direction [°] Without Shield With Shield 64.7 55.4 42.8 44.3 26.3 34.8 36.8 36.4 57.9 82.4 42.3 38.2 20.7 25.9 27.7 31.9 36.2 52.6 94.6 63.2 64.2 49.8 42.9 18.4 11.2 11.3 24.6 52.8 26.5 79.1 72.2...

  • Page 100: Electromagnetic Compatibility (Emc) Information

    10. Appendix 10.5 Electromagnetic Compatibility (EMC) Information Guidance and manufacturer’s declaration - electromagnetic emissions The VEX-P300 is intended for use in the electromagnetic environment specified below. The customer or the user of the VEX-P300 should assure that it is used in such an environment. Electromagnetic environment - Emissions test Compliance...
  • Page 101 385-5785 MHz part of the VEX-P300, RF wireless according to table in according to including cables specified Communicati table 9 by VATECH Equipment according to Table 9 in IEC 60601- Electrical ± 2 kV for power ± 2 kV for power...
  • Page 102 10. Appendix Immunity to 3 V 0.15-80 MHz 3 V 0.15-80 The strength of the RF conducted field in the frequency range higher than 150 disturbances 6 V in ISM bands 6 V in ISM induced IEC kHz ~ 80 MHz, the between 0.15 and bands between 61000-4-6...

  • Page 103: Abbreviations

    10. Appendix 10.6 Abbreviations Acronym Name Aluminum Electromagnetic Compatibility Electrostatic Discharge Field of View International Electrotechnical Commission International Standards Organization Light-Emitting Diode Medical Electrical PMMA Poly Methyl Meth Acrylate Radio Frequency Source to Image receptor Distance Signal Input Part Signal Output Part Source to Skin Distance EzRay Air Portable (Model: VEX-P300) User Manual...
  • Page 104 No part of this manual may be reproduced, transmitted, or transcribed without the manufacturer's written permission. VATECH and EzRay have registered trademarks in the United States and other countries, and EzRay Air Portable is a trademark of VATECH Co., Ltd. worldwide.

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