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Summary of Contents for Vatech EzRay Chair
- Page 5 Phone: (+82) 1588 9510 E-mail: gcs@vatech.co.kr This document is originally written in English. The EzRay Chair (VEX-S300C) is referred to as Equipment or System in this manual. Manual Name: EzRay Chair (VEX-S300C) User Manual Document number: VDH-UM-076 Version: 1.43...
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Page 7: Table Of Contents
Cleaning and Disinfection ..............41 Cleaning ....................42 Disinfection .................... 42 Disposing of the Unit ................. 43 Product Specifications ..............45 Mechanical Specifications ..............45 Technical Specifications ................ 50 Electrical Specifications ................ 53 Environmental Specifications ..............54 EzRay Chair (VEX-S300C) User Manual... -
Page 8: Table Of Contents
Table of Contents Appendix ......................55 Using the rotating rectangular cover ............. 55 Tables of Exposure Times (Default) ............57 X-ray Dose Data ................... 58 Electromagnetic Compatibility (EMC) Information ........ 68 Abbreviations ..................71 EzRay Chair (VEX-S300C) User Manual... -
Page 9: General And Regulatory Information
The manufacturers and retailers of this equipment assume responsibility for the safe and healthy operation of this product only when: Genuine VATECH approved equipment and components have always been used. A VATECH authorized agent has performed all maintenance and repairs. -
Page 10: Conventions Used In This Manual
Indicates a potentially hazardous situation and improper handling may result in: Light injury Property damage Indicates a potentially harmful situation, and improper handling may result in: Property damage Indicates a usage and other valuable information. EzRay Chair (VEX-S300C) 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 Chair (VEX-S300C) 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 Chair (VEX-S300C) User Manual...
- Page 13 1. General and Regulatory Information 1.4.1 Label Locations UDI Label Main Label EzRay Chair (VEX-S300C) User Manual...
- Page 14 1. General and Regulatory Information Generator Label The labels in this manual are only for illustration purposes. Actual labels may differ. EzRay Chair (VEX-S300C) User Manual...
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Page 15: Standards And Regulations
1. General and Regulatory Information Standards and Regulations Standards: The EzRay Chair (VEX-S300C) is designed and manufactured to meet the following standards: IEC 60601-1, IEC/EN 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2- 65, IEC 62366 X-RAY EQUIPMENT for DENTAL INTRA-ORAL RADIOGRAPHY VEX-S300C ... - Page 16 1. General and Regulatory Information This page intentionally left blank. EzRay Chair (VEX-S300C) User Manual...
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Page 17: 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 Chair (VEX-S300C) User Manual... -
Page 18: Warnings And Safety Instructions
Children and pregnant women must consult with a doctor before X-ray exposure. Grave dangers may occur from electromagnetic interference (i.e., noise) between other equipment in the area during specific examinations or medical treatment. EzRay Chair (VEX-S300C) User Manual... - Page 19 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 64 in Appendix. EzRay Chair (VEX-S300C) User Manual...
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Page 21: System Overview
The operator must have understood: objectives and effects of treatment and diagnosis of dental disease using diagnostic medical radiation devices Experience normal operation of diagnostic medical radiation devices the contents of the user manual. EzRay Chair (VEX-S300C) User Manual... -
Page 22: Components
● standard Remote Exposure Switch can be additionally provided as an optional item if needed. For details on the Remote Exposure Switch and Power Cable Connections, please see ‘Section 4.4.1’ on page 38 and 39. EzRay Chair (VEX-S300C) User Manual... -
Page 23: Features
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 Chair (VEX-S300C) User Manual... -
Page 24: General View Of The Equipment
3. System Overview General View of the Equipment Main Body EzRay Chair (VEX-S300C) User Manual... - Page 25 Display for the X-ray exposure settings and operation Control Panel conditions Handle Grip the handle securely when using the system. Connection arm between the X-ray generator and the Generator Arm scissor arm assembly Middle Arm Adjust location of rotational direction EzRay Chair (VEX-S300C) User Manual...
- Page 26 X-ray exposure angle. AUTO Button (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.) EzRay Chair (VEX-S300C) User Manual...
- Page 27 ‘Remote Exposure (painted) (Doorbell type) Switch’ (only if needed) Used to connect the Remote Exposure Remote Switch to the Remote Exposure Switch Exposure Switch Cable (Doorbell Connector on the type) bottom of the Power Box Assembly EzRay Chair (VEX-S300C) User Manual...
- Page 28 Used to connect the Door Interlock Switch to Door Interlock the Door Interlock Cable Cable Connector on the bottom of the Power Box Assembly Refer to the Appendix A.1 ‘Using the rotating rectangular cover’ for instructions for use. EzRay Chair (VEX-S300C) User Manual...
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Page 29: Operation
Main Power On/Off switch The following displays light up. For further information, see ‘Control Panel’ on page 17. 1) Current Angle/Time Display 2) Adult/Child Selection Display 3) Tooth Type Selection Display 4) X-ray Exposure Indicator EzRay Chair (VEX-S300C) User Manual... -
Page 30: 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 Chair (VEX-S300C) User Manual... - Page 31 When the tooth type selection area is blinking, turn the jog dial to select the tooth type. Refer to the figure below before and after selecting the control panel. Before tooth type selection After tooth type selection Tooth Type Symbol Type Incisor Canine Molar/Premolar Bitewing EzRay Chair (VEX-S300C) User Manual...
- Page 32 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 Chair (VEX-S300C) User Manual...
- Page 33 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 Chair (VEX-S300C) User Manual...
- Page 34 Since the angles of inclination for the maxilla incisor and canine are same, the exposure time of the canine is applied to both the maxilla incisor and canine. Refer to the following figure to see the angle for molar/premolar. EzRay Chair (VEX-S300C) User Manual...
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Page 35: Positioning
Maxillary Incisor The x-ray beam is directed downward at 45°. Teeth Angle of inclination Incisor Maxilla +45˚ Mandibular Incisor The x-ray beam is directed upward at 25°. Teeth Angle of inclination Incisor Mandible -25˚ EzRay Chair (VEX-S300C) User Manual... - Page 36 Maxillary Canine The x-ray beam is directed downward at 45°. Teeth Angle of inclination Canine Maxilla +45˚ Mandibular Canine The x-ray beam is directed upward at 20°. Teeth Angle of inclination Canine Mandible -20˚ EzRay Chair (VEX-S300C) User Manual...
- Page 37 The x-ray beam is directed downward at 30°. Teeth Angle of inclination Molar and Premolar Maxilla +30˚ Mandibular Molar and Premolar The x-ray beam is directed upward at 5°. Teeth Angle of inclination Molar and Premolar Mandible -5˚ EzRay Chair (VEX-S300C) User Manual...
- Page 38 Bitewing For a bitewing exposure, the patient closes their teeth during exposure on the sensor holder. The x-ray beam is directed downward at 5° ~ 8°. Teeth Angle of inclination Bitewing exposure +5˚~ +8˚ EzRay Chair (VEX-S300C) User Manual...
- Page 39 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 Chair (VEX-S300C) User Manual...
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Page 40: Exposure
Yellow: X-ray ON Press and hold the Remote Exposure Switch if the acoustic signal can be heard. Otherwise, the exposure will be faulty, and there will be an error message on the Control Panel. EzRay Chair (VEX-S300C) User Manual... - Page 41 X-ray exposure will be stopped once the door of the 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 Chair (VEX-S300C) User Manual...
- Page 42 DIP switch setting Press (1). AC power cable Option 1 Not applicable (option) (1) Remote Exposure Switch (standard) Press (1). AC power cable Option 2 (option) (1) Remote (2) Door interlock Exposure Switch cable (option) (standard) EzRay Chair (VEX-S300C) User Manual...
- Page 43 (option) (1) Remote Exposure Switch (2) Door interlock (Doorbell type) cable (Option) (Standard) Press (1), (2) simultaneously. AC power cable Option 5 (option) (2) Remote (1) Remote Exposure Switch Exposure Switch (Doorbell type) (standard) (Option) EzRay Chair (VEX-S300C) User Manual...
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Page 45: Troubleshooting
Release the switch. The exposure button has been pressed and released before the X-ray exposure finished A.08 User with the default exposure time. Press and hold the exposure button for the duration of the exposure time. EzRay Chair (VEX-S300C) User Manual... - Page 46 The receptor is facing the Reposition the receptor. completely white. the wrong way. X-ray emission works, but Exposure time is too long. Decrease the exposure time. the exposure is too dark. EzRay Chair (VEX-S300C) User Manual...
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Page 47: 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 must be handled by a qualified person. Contact your Service Representative. EzRay Chair (VEX-S300C) User Manual... - Page 48 6. User Maintenance This page intentionally left blank. EzRay Chair (VEX-S300C) User Manual...
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Page 49: Cleaning And Disinfection
(2-propanol, isopropanol) or iodine- splitting agents. Comply with the specifications contained in the operating instructions of the Cleaners or disinfectant agents. Wear safety gloves. EzRay Chair (VEX-S300C) User Manual... -
Page 50: Cleaning
Damages to surfaces and materials due to the use of different products cannot be excluded even if they are not included in the exceptions mentioned above. Use a non-alcoholic chlorine dioxide-based disinfectant. Sample EzRay Chair (VEX-S300C) User Manual... -
Page 51: 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 Chair (VEX-S300C) User Manual... - Page 52 8. Disposing of the Unit This page intentionally left blank. EzRay Chair (VEX-S300C) User Manual...
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Page 53: Product Specifications
9. Product Specifications Product Specifications Mechanical Specifications Dimensions EzRay Chair (VEX-S300C) User Manual... - Page 54 9. Product Specifications EzRay Chair (VEX-S300C) User Manual...
- Page 55 9. Product Specifications EzRay Chair (VEX-S300C) User Manual...
- Page 56 9. Product Specifications EzRay Chair (VEX-S300C) User Manual...
- Page 57 ⌀80.15 x 10.2(T) X-ray Beam Area X-ray Beam Rectangular FOV: 20 x 30mm (30 x (mm) Limiting Device type 0.038 20), 40 x 30mm (Optional) 0.044 (30 x 40) SSD(Source to Skin Distance) Min. 200mm EzRay Chair (VEX-S300C) User Manual...
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Page 58: Technical Specifications
200 W Dissipation 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 Chair (VEX-S300C) User Manual... - Page 59 9. Product Specifications X-ray Tube Characteristics Maximum rating chart Emission characteristics Heating and cooling curves of the X-ray tube EzRay Chair (VEX-S300C) User Manual...
- Page 60 9. Product Specifications Tube Dimensions [mm] EzRay Chair (VEX-S300C) User Manual...
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Page 61: Electrical Specifications
The system will be available with a fixed tube current specification based on the user selection. Power Supply is specified as a part of ME EQUIPMENT. Power plugs may have various specifications for each country. EzRay Chair (VEX-S300C) User Manual... -
Page 62: Environmental Specifications
During operating 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 Chair (VEX-S300C) User Manual... -
Page 63: Appendix
A.1 Using the rotating rectangular cover Rotating rectangular cover rotates in 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. EzRay Chair (VEX-S300C) User Manual... - Page 64 Turn the Inner Ring of the rotating rectangular cover to fine-tune the angle. Disassembly method of the rotating rectangular cover is the same as the assembly method. Refer to the NOTE mentioned below stage 1. EzRay Chair (VEX-S300C) User Manual...
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Page 65: Tables Of Exposure Times (Default)
Maxilla: +30˚ Molar/ 0.18 Premolar Mandible: -5˚ Bitewing +5˚~ +8˚ 0.19 Sensor Maxilla: +45˚ Incisor 0.11 Mandible: -25˚ Maxilla: +45˚ Canine 0.13 Child Mandible: -20˚ Maxilla: +30˚ Molar/ 0.15 Premolar Mandible: -5˚ Bitewing +5˚~ +8˚ 0.16 EzRay Chair (VEX-S300C) User Manual... -
Page 66: A.3 X-Ray Dose Data
0. Appendix A.3 X-ray Dose Data The X-ray dose data is extracted from the X-ray Dose Test Report for the EzRay Chair (VEX-S300C). The IEC collateral standards have measured the X-ray doses of EzRay Chair (VEX-S300C) in the test report. The EzRay Chair (VEX-S300C) has been designed by Part 1. - Page 67 Appendix Dose Area Product (DAP) Table (65 kVp, 3.0 mA, SSD 200 mm) FOV: Ø 6 cm FOV: 4 x 3 cm FOV: 2 x 3 cm 0.45 30.32 12.87 6.44 0.50 33.78 14.34 7.17 EzRay Chair (VEX-S300C) User Manual...
- Page 68 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 Chair (VEX-S300C) User Manual...
- Page 69 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° 200° 225° EzRay Chair (VEX-S300C) User Manual...
- Page 70 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° EzRay Chair (VEX-S300C) User Manual...
- Page 71 Appendix Default type Rectangular 2x3 Rectangular 4x3 Direction [mGy/h] [mGy/h] [mGy/h] 200° 225° 245° 270° 290° 315° 335° ND: Not Detected. The detection limit is 0.00001 mGy per exposure. EzRay Chair (VEX-S300C) User Manual...
- Page 72 A.3.3 Scattered Dose Scope IEC 60601-2-65 203.13 Requirements ME EQUIPMENT shall be provided with means to optionally allow actuation of the IRRADIATION from a PROTECTED AREA after installation. Relevant instructions shall be given in the ACCOMPANYING DOCUMENTS. EzRay Chair (VEX-S300C) User Manual...
- Page 73 65 kVp, 3.0 mA, 0.5 s (Max. Exposure Condition) Measure point: 2,000 mm from PMMA Phantom The 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 EzRay Chair (VEX-S300C) User Manual...
- Page 74 225° 1.62 245° 2.20 270° 3.50 290° 2.87 315° 3.44 335° 3.78 The 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 Chair (VEX-S300C) User Manual...
- Page 75 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 EzRay Chair (VEX-S300C) User Manual...
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Page 76: A.4 Electromagnetic Compatibility (Emc) Information
Guidance and manufacturer’s declaration - electromagnetic emissions The EzRay Chair (VEX-S300C) is intended for use in the electromagnetic environment specified below. The customer or the user of the EzRay Chair (VEX- S300C) should assure that it is used in such an environment. - Page 77 Guidance and manufacturer’s declaration - electromagnetic immunity The EzRay Chair (VEX-S300C) is intended for use in the electromagnetic environment specified below. The customer or the user of the EzRay Chair (VEX- S300C) should assure that it is used in such an environment.
- Page 78 Guidance and manufacturer’s declaration - electromagnetic immunity The EzRay Chair (VEX-S300C) is intended for use in the electromagnetic environment specified below. The customer or the user of the EzRay Chair (VEX- S300C) should assure that it is used in such an electromagnetic environment.
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Page 79: A.5 Abbreviations
Electrostatic Discharge 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 EzRay Chair (VEX-S300C) User Manual... - Page 80 0. Appendix This page intentionally left blank. EzRay Chair (VEX-S300C) User Manual...
- Page 81 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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