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Appendix

EzRay Air W (Model: VEX-S300W) User Manual

A-9

LISH

Scattered

Dose

Scope

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.

Summary of Contents for EzRay Air W

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Page 5: ...nual with the equipment at all times and review the operation procedures and safety instructions if needed The illustrations photos of the equipment in this manual are only for illustration purposes A...

Page 6: ...Notice vi EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 7: ...Indications for Use 11 3 2 Principles of Operation 11 3 3 Intended User Profile 11 3 4 Components 12 3 5 Features 12 3 6 General View of the Equipment 13 4 Operation 19 4 1 Power On Off 19 4 2 Operati...

Page 8: ...Table of Contents viii EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 9: ...manual The equipment damage or malfunction is not the result of an error on the part of the owner or operator 1 2 Owner and Operator s Obligations The owner of this equipment shall perform constancy t...

Page 10: ...specific hazard is known to exist which through inappropriate conditions or actions may cause Severe personal injury to the operator and or patient Substantial property damage CAUTION Indicates that...

Page 11: ...X ray Generator Generator Label Protective earth Ground Power Box Base Off power disconnected to the Main Power Switch Main Power Switch On power connected to the Main Power Switch Main Power Switch...

Page 12: ...Generator Label Date of manufacture Main Label Generator Label Serial Number Main Label Generator Label This symbol indicates that electrical and electronic equipment must not be disposed of as unsor...

Page 13: ...y Information EzRay Air W Model VEX S300W User Manual 5 ENGLISH 1 4 1 Label Locations 1 UDI Label 2 Main Label 3 Generator Label The labels in this manual are only for illustration purposes Actual lab...

Page 14: ...CAN CSA C22 2 No 60601 1 3 09 CAN CSA C22 2 No 60601 1 6 11 CAN CSA C22 2 No 60601 2 65 15 CAN CSA IEC 62366 14 ANSI AAMI ES60601 1 2005 R 2012 AND A1 2012 C1 2009 R 2012 AND A2 2010 R 2012 Consolida...

Page 15: ...rating instructions contained in this manual This equipment must only be operated by legally qualified persons Observe all local fire regulations Always keep a fire extinguisher near the equipment The...

Page 16: ...ds mists or sprays Exposing this equipment to liquids may cause an electrical shock or otherwise damage the system DO NOT use spray cleaners on this equipment as this could cause a fire Never use this...

Page 17: ...nt such as a lead apron thyroid collar etc Pregnant women should not be exposed to X rays unless it is strictly necessary All users should comply with the Radiation Protection Policies established by...

Page 18: ...2 Safety Instructions 10 EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 19: ...receptors 3 2 Principles of Operation X rays are emitted when high voltage is supplied to the X ray tube assembly which frees electrons from cathode They hit anode to produce X rays The equipment acq...

Page 20: ...izontal Arm Assembly 450 mm 1 16 Horizontal Arm Assembly 600 mm 1 17 Horizontal Arm Assembly 900 mm 1 The standard Remote Exposure Switch can be additionally provided as an optional item if needed For...

Page 21: ...ns 3 Main Power Switch Main Power On Off switch 4 Horizontal Arm Connection arm between the power box assembly and the scissor arm assembly 3 length options 450 mm 600 mm 900 mm 5 X ray Beam Limiting...

Page 22: ...VEX S300W User Manual No Item Description 10 Scissor Arm Assembly Adjusts the length of the entire arm by folding and unfolding the scissor arm assembly Connection arm assembly between the horizontal...

Page 23: ...remolar bitewing 5 X ray Exposure Indicator Indicates the X ray exposure status Green Ready Yellow X ray ON 6 SET Button with LED lamp Resets the X ray exposure angle SET button is pressed LED lamp fl...

Page 24: ...tangular area ABS Acrylonitrile butadiene styrene copolymer 3 Remote Exposure Switch if the Control Panel is installed to the wall framework Used to remotely perform exposure by pressing the Remote Ex...

Page 25: ...lonitrile butadiene styrene copolymer SPCC 9 Horizontal Arm 450 mm Used as a connection arm length 450 mm between the Power Box Assembly and the Scissor Arm Assembly AL6061 ABS Acrylonitrile butadiene...

Page 26: ...3 System Overview 18 EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 27: ...g to the following figure and table 2 The following displays light up For further information see Control Panel on page 15 Symbol Power On Off Status Power On Power Off Main Power On Off switch 1 Curr...

Page 28: ...00W User Manual 4 2 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 1 To start the Manual Mode check if the l...

Page 29: ...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 typ...

Page 30: ...selection Patient Type Symbol Type Adult Child After the tooth type and patient type are selected exposure time is automatically displayed 4 If you want to change the exposure time turn the jog dial t...

Page 31: ...ng AUTO the default angle is displayed as shown in the following figure To set the starting point during exposure press SET 2 Position the system to the teeth to perform exposure To see how to perform...

Page 32: ...he following table Tooth Type Angle of Inclination Incisor Maxilla 40 50 Mandible 22 28 Canine Maxilla 40 50 Mandible 17 23 Molar Premolar Maxilla 25 35 Mandible 2 8 Bitewing 3 12 Since the angles of...

Page 33: ...r 1 Place a protective lead apron on the patient s chest 2 Have the patient sit on the chair with the sagittal plane vertical For radiography of the upper maxillary the Frankfort Plane must be horizon...

Page 34: ...the teeth Bisected angle technique The patient holds the sensor in place with his her finger The X ray beam is directed perpendicularly towards an imaginary line which bisects the angle between the se...

Page 35: ...ctions for the tube head in order to take the best images of a particular tooth i e Bisected angle technique Position the receptor carefully not to damage the soft tissue of the patient s intra oral a...

Page 36: ...4 Operation 28 EzRay Air W Model VEX S300W User Manual Mandibular Incisor X ray beam is directed upward at 25 Teeth Angle of inclination Incisor Mandible 25...

Page 37: ...4 Operation EzRay Air W Model VEX S300W User Manual 29 ENGLISH Maxillary Canine X ray beam is directed downward at 45 Teeth Angle of inclination Canine Maxilla 45...

Page 38: ...4 Operation 30 EzRay Air W Model VEX S300W User Manual Mandibular Canine X ray beam is directed upward at 20 Teeth Angle of inclination Canine Mandible 20...

Page 39: ...4 Operation EzRay Air W Model VEX S300W User Manual 31 ENGLISH Maxillary Molar and Premolar X ray beam is directed downward at 30 Teeth Angle of inclination Molar and Premolar Maxilla 30...

Page 40: ...4 Operation 32 EzRay Air W Model VEX S300W User Manual Mandibular Molar and Premolar X ray beam is directed upward at 5 Teeth Angle of inclination Molar and Premolar Mandible 5...

Page 41: ...del VEX S300W User Manual 33 ENGLISH Bitewing 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 inclinat...

Page 42: ...ralleling technique generally reduces the risk of such errors but if you position the sensor improperly angulation errors may occur angulation of the sensor to the tooth itself Failure to align the im...

Page 43: ...ment between the imaging sensor and the X ray beam it is recommended to use a PID Position Indicating Device When using the PID the exit pattern of the X ray device should be aligned perpendicular to...

Page 44: ...ch allows the operator to control image acquisition from outside of the X ray room Pressing the Remote Exposure Switch activates the X ray Exposure Indicator to turn yellow This color indicates that t...

Page 45: ...ellow X ray ON Control Panel Remote Exposure Switch The Remote Exposure Switch is detachable Ensure that the Remote Exposure Switch cable is not detached out from the unit accidentally during the oper...

Page 46: ...nector The standard and optional Remote Exposure Switches and the Door Interlock Cable are connected to the Connector 1 2 and 3 Please check all seven possible options in the table below Option No Des...

Page 47: ...re Switch Standard 2 Remote Exposure Switch Doorbell type Option Option 4 Press 1 N A AC Power Cable Option 1 Remote Exposure Switch Standard 2 Door Interlock Cable Option Option 5 Press 1 or 2 N A AC...

Page 48: ...ription Connector 1 Connector 2 Connector 3 Connector 4 Option 7 Press 2 and 3 at the same time 1 Not used in this option AC Power Cable Option 1 Remote Exposure Switch Standard 3 Remote Exposure Swit...

Page 49: ...erator The kV feedback is higher than the set value during X ray irradiation E 04 X ray Generator The mA feedback is lower than the set value during X ray irradiation E 05 X ray Generator The mA feedb...

Page 50: ...le on page 51 Remote Exposure Switch is pressed but X ray exposure does not work Contact your Service Representative Internal cable disconnected Contact your Service Representative Defective generator...

Page 51: ...the equipment Daily Ensure the audible signal is audible and the X ray exposure light is visible when you perform an exposure Daily Ensure that the wall framework is securely attached to the wall Dail...

Page 52: ...The equipment surfaces can be cleaned with a soft cloth damped in an alcohol based non corrosive cleaning solution If necessary wipe off surfaces with disinfectant DO NOT spray any cleaner or disinfe...

Page 53: ...s Boards Cables and transformer Copper Packing Polystyrene Cardboard Paper X ray tube Other parts Observe all regulations relevant to the disposal of waste in your country This symbol on the product a...

Page 54: ...7 Disposing of the Unit 46 EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 55: ...8 Product Specifications EzRay Air W Model VEX S300W User Manual 47 ENGLISH 8 Product Specifications 8 1 Mechanical Specifications Dimensions...

Page 56: ...8 Product Specifications 48 EzRay Air W Model VEX S300W User Manual...

Page 57: ...8 Product Specifications EzRay Air W Model VEX S300W User Manual 49 ENGLISH...

Page 58: ...folded Scissor Arm minimum 1042 34 14 6 With unfolded Scissor Arm maximum 1855 38 Horizontal Arm 450 mm With folded Scissor Arm minimum 892 34 14 15 With unfolded Scissor Arm maximum 1705 38 Total Ar...

Page 59: ...4 H Horizontal Arm Assembly 900 mm 976 0 W x 151 24 L x 58 3 H 3 65 600 mm 676 0 W x 151 24 L x 58 3 H 2 8 450 mm 526 0 W x 151 24 L x 58 3 H 2 35 Scissor Arm Assembly 797 6 W x 184 0 L x 58 4 H 7 8...

Page 60: ...Thermistor 60 C Inherent Filtration 1 8 mm Al 65 kV Total Filtration Min 1 5 mm Al Type Inverter Type Tube Voltage 55 65 kV Tube Current 1 0 3 0 mA X ray Tube Manufacturer VATECH Co Ltd Model V1 65030...

Page 61: ...8 Product Specifications EzRay Air W Model VEX S300W User Manual 53 ENGLISH X ray Tube Characteristics 1 Maximum rating chart 2 Emission characteristics...

Page 62: ...8 Product Specifications 54 EzRay Air W Model VEX S300W User Manual 3 Heating and cooling curves of X ray tube 4 Heating and cooling curves of X ray tube housing assembly...

Page 63: ...8 Product Specifications EzRay Air W Model VEX S300W User Manual 55 ENGLISH 5 Tube Dimensions mm...

Page 64: ...e Current Option A 2 5 mA Option B 3 0 mA Accuracy Error kVp 10 mA 20 s 5 or 20 ms The input line voltage depends on the local electrical distribution system Allowable input voltage fluctuation requir...

Page 65: ...d not exceed 0 5 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 speci...

Page 66: ...8 Product Specifications 58 EzRay Air W Model VEX S300W User Manual This page intentionally left blank...

Page 67: ...inch respectively Option A 65 kV 2 5 mA Receptor Patient Teeth Angle of inclination SSD 200 mm 8 inch kV mA s Sensor Adult Incisor Maxilla 45 Mandible 25 65 2 5 0 20 Canine Maxilla 45 Mandible 20 65...

Page 68: ...A s Sensor Adult Incisor Maxilla 45 Mandible 25 65 3 0 0 18 Canine Maxilla 45 Mandible 20 65 3 0 0 20 Molar Premolar Maxilla 30 Mandible 5 65 3 0 0 22 Bitewing 5 8 65 3 0 0 23 Child Incisor Maxilla 45...

Page 69: ...odel Name VEX S300W Tube Model Name V1 650304 Generator Model Name DG S0102V1 Inverter type Loading Factor Option A 65 kV 2 5 mA Option B 65 kV 3 0 mA 1 X ray Dose Table Test Equipment Instrument Manu...

Page 70: ...15 11 95 5 98 Dose Table 65 kVp 3 0 mA FOV 6 cm SSD 200 mm at Al 6 mm t s Dose Gy 0 18 116 0 20 128 0 22 141 0 23 148 Dose Area Product DAP Table 65 kVp 3 0 mA SSD 200 mm FOV 6 cm FOV 4 x 3 cm FOV 2 x...

Page 71: ...ES 1 m from the FOCAL SPOT average over any area of 100 cm 2 of which no principal linear dimension exceeds 20 cm when operated at the NOMINAL X RAY TUBE VOLTAGE under condition of LOADING correspondi...

Page 72: ...eakage doses have been measured with each cover type default rectangular 2x3 and rectangular 4x3 all the results have been ND Not Detected The raw data about the results is shown in the table below Re...

Page 73: ...ctangular 4x3 mGy h mGy h mGy h 245 ND ND ND 270 ND ND ND 290 ND ND ND 315 ND ND ND 335 ND ND ND Result Vertical Plane Direction Default type Rectangular 2x3 Rectangular 4x3 mGy h mGy h mGy h 0 ND ND...

Page 74: ...0W User Manual Direction Default type Rectangular 2x3 Rectangular 4x3 mGy h mGy h mGy h 200 ND ND ND 225 ND ND ND 245 ND ND ND 270 ND ND ND 290 ND ND ND 315 ND ND ND 335 ND ND ND ND Not Detected Detec...

Page 75: ...H 3 Scattered Dose Scope 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 Relevan...

Page 76: ...onds to a focus to skin distance of 200 mm 8 inch respectively Method PMMA Phantom aligned to 280 mm away from Focal Spot with Position Indicating Device 80 mm 65 kVp 3 0 mA 0 5 s Max Exposure Conditi...

Page 77: ...Model VEX S300W User Manual A 11 ENGLISH Direction Gy h 200 0 48 225 1 62 245 2 20 270 3 50 290 2 87 315 3 44 335 3 78 Result Vertical Plane Direction Gy h 0 7 20 20 3 58 45 4 83 65 5 48 90 9 52 110 5...

Page 78: ...Appendix A 12 EzRay Air W Model VEX S300W User Manual Direction Gy 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...

Page 79: ...its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The VEX S300W is suitable for us...

Page 80: ...V line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Main power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions an...

Page 81: ...3 V m a Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpt...

Page 82: ...Electrostatic Discharge FOV Field of View IEC International Electro technical Commission ISO International Standards Organization LED Light Emitting Diode ME Medical Electrical PMMA PolyMethylMethAcry...

Page 83: ...representative Manufactured by VATECH Co Ltd Tel 82 1588 9510 Email gcs vatech co kr Website www vatech co kr Head Quarters Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Korea Factory Ad...

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