Vatech EzRay Air W User Manual
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Vatech EzRay Air W User Manual

Intra-oral dental x-ray system
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  • Page 5 E-mail: gcs@vatech.co.kr This document is originally written in English. The VEX-S300W is referred to as Equipment or System in this manual. Manual Name: EzRay Air W (Model: VEX-S300W) User Manual Version: 1.0 Publication Date: 2016-10 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 6 Notice This page intentionally left blank. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 7: Table Of Contents

    Product Specifications ............... 47 Mechanical Specifications ............... 47 Technical Specifications ..............52 Electrical Specifications..............56 Environmental Specifications ............57 Appendix ......................A-1 Tables of Exposure Times (Default)………………………………………………A-1 X-ray Dose Data…………………………………………………………………………A-3 Electromagnetic Compatibility (EMC) Information…………………………A-13 Abbreviations…………………………………………………………………………. A-16 EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 8: Table Of Contents

    Table of Contents This page intentionally left blank. viii EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 9: General And Regulatory Information

    Genuine VATECH approved equipment and components have been used  at all times. All maintenance and repairs have been performed by a VATECH authorized  agent. The equipment has been used normally in accordance with the user's manual.

  • Page 10: Conventions Used In This Manual

    IMPORTANT cause: Property damage.  Indicates precautions or recommendations that should be used in the operation of the system, specifically: NOTE Using this Manual  Notes to emphasize or clarify a point.  EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 11: Marks And Symbols

    The CE symbol indicates that this product complies with the European Directive for Main Label Medical Devices 93/42/EEC as amended by 2007/47/EC as a class IIb device. CSA mark Main Label No.266436 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 12 ESD susceptibility symbols indicate that an item is susceptible to damage from Board package electrostatic discharges. Refer to the User Manual. Main Label Cone’s upper This symbol indicates the direction of cover attachment/detachment. part EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 13 1. General and Regulatory Information 1.4.1 Label Locations UDI Label Main Label Generator Label The labels in this manual are only for illustration purposes. Actual labels may differ. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 14: Standards And Regulations

    2007/47/EC as a class IIb device. Classifications (IEC60601-1 6.1): Protection against the ingress of water: Ordinary Equipment (IPX0) Protection against electric shock: Class I equipment, Type B Applied Parts: Cone head EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 15: Safety Instructions

    Always disconnect the power supply before cleaning the equipment.  Don’t keep the equipment or its parts in a humid place or near a liquid substance.  Avoid placing the equipment near chemical storage and gas-filled storage  facilities. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 16: Warnings And Safety Instructions

    Children and pregnant women must consult with a doctor before X-ray exposure.  Serious dangers may occur from electromagnetic interference (i.e. noise)  between other equipment in the area during specific examinations or medical treatment. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 17 This equipment should be operated at least 2 m away from the operator when  operated in or outside of the room. For details on the Scattered Dose data, please see ‘Scattered Dose’ on page A-9 in Appendix. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 18 2. Safety Instructions This page intentionally left blank. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 19: System Overview

    Indications for Use The EzRay Air W (Model: VEX-S300W) is an intra-oral dental X-ray system (extra-oral X-ray source system) intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

  • Page 20: Components

    Ergonomic design and shape for safety and comfort of patients  Easy-to-use Control Panel that provides a straightforward process  Full-swivel revolution in all directions  Tube head revolves freely around the sphere  Compact, lightweight components  EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 21: General View Of The Equipment

    Includes the X-ray tube and the high-voltage X-ray Generator generator. Handle Grip the handle securely when using the system. Connection arm between the X-ray generator and the X-ray Generator Arm scissor arm assembly EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 22 3. System Overview Item Description Adjusts the length of the entire arm by folding and unfolding the scissor arm assembly. Connection arm Scissor Arm Assembly assembly between the horizontal arm and the X-ray generator assembly. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 23 (1. If the AUTO button is pressed, the LED lamp (with LED lamp) flickers one time. 2. If the AUTO Mode is ON, the LED lamp is ON.) Speaker Sound alarm for X-ray exposures EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 24 Connector on the (Doorbell type) bottom of the Power Box Assembly Used to connect the Door Interlock Switch to Door Interlock the Door Interlock Cable Cable Connector on the bottom of the Power Box Assembly EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 25 Assembly and the butadiene Scissor Arm Assembly styrene) Used as a connection AL6061 + arm (length: 900 mm) Horizontal Arm between the Power Box (Acrylonitrile 900 mm Assembly and the butadiene Scissor Arm Assembly styrene) EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 26 3. System Overview This page intentionally left blank. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 27: Operation

    Main Power On/Off switch The following displays light up. For further information, see ‘Control Panel’ on page 15. 1) Current Angle/Time Display 2) Adult/Child Selection Display 3) Tooth Type Selection Display 4) X-ray Exposure Indicator EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 28: Operation Mode

    This system can be operated with Manual Mode and Auto Mode, and you can set up the mode by using the AUTO button. Manual Mode To start the Manual Mode, check if the lamp under the AUTO button is turned off. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 29 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. Before tooth type selection After tooth type selection Tooth Type Symbol Type Incisor Canine Molar/Premolar Bitewing EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 30 If you press the jog dial after adjusting the exposure time in Manual Mode, the exposure time is returned to the default setting. To save the exposure time as default in Manual Mode, press and hold the jog dial for about 3 seconds. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 31 To set the starting point during exposure, press SET. Position the system to the teeth to perform exposure. To see how to perform the patient positioning, refer to Section 4.3 Positioning. (The following figure is an example of the maxilla incisor.) EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 32 Since the angles of inclination for the maxilla incisor and canine are same, the exposure time of the canine is applied for both the maxilla incisor and canine. Refer to the following figure to see the angle for molar/premolar. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 33: Positioning

    Place the tube head cone on the area you want to take an image. For further information about the patient positioning and beam angle for each mode, refer to the following Positioning Instructions. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 34 1. Sensor 2. Long axis of the tooth Position the tube head to the patient using the accepted standard positioning procedures. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 35 (i.e. Bisected angle technique). Position the receptor carefully not to damage the soft tissue of the patient’s intra-oral area. Maxillary Incisor  X-ray beam is directed downward at 45°. Teeth Angle of inclination Incisor Maxilla +45˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 36 4. Operation Mandibular Incisor  X-ray beam is directed upward at 25°. Teeth Angle of inclination Incisor Mandible -25˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 37 4. Operation Maxillary Canine  X-ray beam is directed downward at 45°. Teeth Angle of inclination Canine Maxilla +45˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 38 4. Operation Mandibular Canine  X-ray beam is directed upward at 20°. Teeth Angle of inclination Canine Mandible -20˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 39 4. Operation Maxillary Molar and Premolar  X-ray beam is directed downward at 30°. Teeth Angle of inclination Molar and Premolar Maxilla +30˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 40 4. Operation Mandibular Molar and Premolar  X-ray beam is directed upward at 5°. Teeth Angle of inclination Molar and Premolar Mandible -5˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 41  For a bitewing exposure, the patient closes their teeth during exposure on the sensor holder. X-ray beam is directed downward at 5° ~ 8°. Teeth Angle of inclination Bitewing exposure +5˚~ +8˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 42 Please refer to the following figure as an example of cone-cuts. Cone-cut The following figure indicates how the cone-cut occurred by showing the position of the imaging sensor and the radiation area. Cone-cut Position of the sensor Radiation area EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 43 PID (Position Indicating Device). When using the PID, the exit pattern of the X-ray device should be aligned perpendicular to the target receptor. Once the PID is properly aligned, instruct the patient not to move. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 44: Exposure

    Press and hold the Remote Exposure Switch as long as the acoustic signal can be heard. Otherwise the exposure will be faulty and there will be an error message on the Control Panel. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 45 X-ray room is opened. As described in step 2 and 3 above, the X-ray Exposure Indicator is included both on the Control Panel and the Remote Exposure Switch. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 46 Option 1 Press (1). (1) Remote (Option) Exposure Switch (Standard) Press AC Power (1) and (2) Cable Option 2 at the same (1) Remote (2) Remote (Option) time. Exposure Exposure Switch Switch (Standard) (Option) EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 47 (1) Remote (2) Remote (Option) Exposure Exposure Switch Switch (Standard) (Option) AC Power Press Cable Option 6 (1) or (2). (Option) (2) Remote (1) Remote Exposure Exposure Switch Switch (Doorbell (Standard) type) (Option) EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 48 AC Power the same time. Cable Option 7 (Option) (1): Not used (3) Remote (2) Remote in this option. (1) Remote Exposure Exposure Exposure Switch Switch Switch (Doorbell (Doorbell (Standard) type) type) (Option) (Option) EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 49: Troubleshooting

    1) The Remote Exposure Switch was turned off earlier than the exposure time. E.08 User 2) The door of the X-ray room was opened during X-ray exposure when the door has the Door Interlock Switch (option) installed. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 50 Increase the exposure time. exposure is too light Receptor is facing the Reposition the receptor. completely white. wrong way. X-ray emission works, but Exposure time is too long. Decrease the exposure time. exposure is too dark. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 51: User Maintenance

    DO NOT use detergents or solvents to clean the outer covers of the equipment. If any defects are found, do not operate the equipment since it has to be handled by a qualified person. Contact your Service Representative. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 52 DO NOT spray any cleaner or disinfectant directly into the equipment, as this could cause a fire. The soft cloth should be damp, but not dripping wet. The cloths or wipes cannot be re-used. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 53: Disposing Of The Unit

    For disposal in countries outside of the European Union This symbol is only valid in the European Union (EU). If you wish to discard this product, please contact your local authorities or dealer and ask for the correct method of disposal. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 54 7. Disposing of the Unit This page intentionally left blank. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 55: Product Specifications

    8. Product Specifications Product Specifications Mechanical Specifications Dimensions EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 56 8. Product Specifications EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 57 8. Product Specifications EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 58 1705.38 (maximum) With folded Scissor 1077.0(W)x892.56(L)x58.4(H) (minimum) Horizontal 11.45 With 900 mm unfolded Scissor 2338.7(W)x326.98(L)x58.4(H) (maximum) Total Arm Assembly With folded Scissor 777.0(W)x892.56(L)x58.4(H) (minimum) Horizontal 10.6 With 600 mm unfolded Scissor 2038.7(W)x326.98(L)x58.4(H) (maximum) EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 59 Round Type 0.013 Beam X-ray Area FOV: 20 x 30 (30 x 20), Beam Rectangular Type 0.013 (mm) 40 x 30 (30 x 40) Limiting Device SSD(Source to Skin Distance) Min. 200 (mm) EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 60: Technical Specifications

    X-ray Tube Target Material Tungsten ° Target Angle 12.5 Inherent Filtration Min. 1.5 mm Al X-ray Coverage 70 mm at SID 200 mm Tube Voltage Max. 65 kV Tube Current Max. 3.0 mA EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 61 8. Product Specifications X-ray Tube Characteristics Maximum rating chart Emission characteristics EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 62 8. Product Specifications Heating and cooling curves of X-ray tube Heating and cooling curves of X-ray tube housing assembly EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 63 8. Product Specifications Tube Dimensions [mm] EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 64: Electrical Specifications

    Mode of operation: Continuous operation with intermittent loading—This  equipment needs a rest time of at least 60 times the exposure time before starting the next exposure. Standard: Permanently installed, Option: AC Power Cable  EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 65: Environmental Specifications

    Relative humidity 30 ~ 75 % Atmospheric pressure 860 ~ 1060 hPa Temperature -10 ~ 60 ℃ Transport and storage Relative humidity 10 ~ 75 % non-condensing Atmospheric pressure 860 ~ 1060 hPa EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 66 8. Product Specifications This page intentionally left blank. EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 67: Appendix

    0.24 Premolar Mandible: -5˚ Bitewing 0.25 +5˚~ +8˚ Sensor Maxilla: +45˚ Incisor 0.16 Mandible: -25˚ Maxilla: +45˚ Canine 0.18 Child Mandible: -20˚ Maxilla: +30˚ Molar/ 0.20 Premolar Mandible: -5˚ Bitewing 0.22 +5˚~ +8˚ EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 68 0.22 Premolar Mandible: -5˚ Bitewing 0.23 +5˚~ +8˚ Sensor Maxilla: +45˚ Incisor 0.14 Mandible: -25˚ Maxilla: +45˚ Canine 0.16 Child Mandible: -20˚ Maxilla: +30˚ Molar/ 0.18 Premolar Mandible: -5˚ Bitewing 0.19 +5˚~ +8˚ EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 69: X-Ray Dose Data

    FOV : 2 x 3 cm FOV: Ø 6 cm t (s) Dose (mGy.cm 0.05 2.19 0.93 0.47 0.08 3.92 1.67 0.83 0.10 5.08 2.16 1.08 0.15 7.96 3.38 1.69 0.20 10.84 4.30 2.60 0.25 13.73 5.83 2.91 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 70 0.56 0.08 4.71 2.00 1.00 0.10 6.09 2.59 2.29 0.15 9.55 4.06 2.03 0.20 13.01 5.53 2.76 0.25 16.47 6.99 3.50 0.30 19.93 8.45 4.23 0.45 30.32 12.87 6.44 0.50 33.78 14.34 7.17 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 71 LOADING conditions, shall not exceed 0.2 mGy in one hour. Leakage Dose Permissive Range 65 kVp, 3.0 mA, 0.5 s (Max. Exposure Condition) At Focal Spot to Distance 1 m < 0.2 mGy/h Duty Cycle 1 : 60 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 72 The raw data about the results is shown in the table below. Result (Horizontal Plane) Default type Rectangular 2x3 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 0° 20° 45° 65° 90° 110° 135° 155° 180° 200° 225° EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 73 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 245° 270° 290° 315° 335° Result (Vertical Plane) Default type Rectangular 2x3 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 0° 20° 45° 65° 90° 110° 135° 155° 180° EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 74 Appendix Default type Rectangular 2x3 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 200° 225° 245° 270° 290° 315° 335° ND: Not Detected. Detection limit is 0.00001 mGy per exposure.  EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 75 IEC 60601-2-65 203.13 Requirements ME EQUIPMENT shall be provided with means to optionally allow actuation of the IRRADAIATION from a PROTECTED AREA after installation. Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS. EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 76 65 kVp, 3.0 mA, 0.5 s (Max. Exposure Condition) Measure point: 2,000 mm from PMMA Phantom Result (Horizontal Plane) Direction [°] [μGy/h] 0° 11.41 20° 3.90 45° 3.97 65° 2.24 90° 4.02 110° 2.75 135° 1.80 155° 0.46 180° 0.17 A-10 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 77 245° 2.20 270° 3.50 290° 2.87 315° 3.44 335° 3.78 Result (Vertical Plane) Direction [°] [μGy/h] 0° 7.20 20° 3.58 45° 4.83 65° 5.48 90° 9.52 110° 5.77 135° 4.15 155° 4.12 EzRay Air W (Model: VEX-S300W) User Manual A-11...
  • Page 78 Appendix Direction [°] [μGy/h] 180° 5.86 200° 3.35 225° 0.89 245° 0.43 270° 0.09 290° 0.31 315° 1.43 335° 4.85 A-12 EzRay Air W (Model: VEX-S300W) User Manual...

  • Page 79: Electromagnetic Compatibility (Emc) Information

    IEC 61000-3-3 purposes. NOTE) It is essential that the actual RF shielding effectiveness and filter attenuation of the shielded location be verified to ensure that they meet or exceed the specified minimum values. EzRay Air W (Model: VEX-S300W) User Manual A-13...
  • Page 80 IEC 61000-4-8 location in a typical commercial or hospital environment. NOTE: Uт is the V a.c. mains voltage prior to application of the test level. A-14 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 81 VEX-S300W should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as relocating the VEX-S300W or using a shielded location with a higher RF shielding effectiveness and filter attenuation. EzRay Air W (Model: VEX-S300W) User Manual A-15...

  • Page 82: Abbreviations

    Field of View International Electro technical Commission International Standards Organization Light-Emitting Diode Medical Electrical PMMA PolyMethylMethAcrylate Radio Frequency Source to Image receptor Distance Signal Input Part Signal Output Part Source to Skin Distance A-16 EzRay Air W (Model: VEX-S300W) User Manual...
  • Page 83 No part of this manual may be reproduced, transmitted, or transcribed without the expressed written permission of the manufacturer. We reserve the right to make any alterations which may be required due to technical improvement. For the most current information, contact your VATECH representative. Manufactured by VATECH Co., Ltd. Tel: (+82) 1588 9510 Email: gcs@vatech.co.kr...

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