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Appendix

EzRay Air Wall (VEX-S300W) User Manual

LISH

2. Leakage Dose

Scope

IEC 60601-2-65 203.12.4

Requirements

In the LOADING STATE, the AIR KERMA due to LEAKAGE RADIATION from X-RAY

SOURCE ASSEMBLIES, 1 m from the FOCAL SPOT, average over an area of 100

of which no principal linear dimension exceeds 20 cm when operated at the

NOMINAL X-RAY TUBE VOLTAGE under the condition of LOADING corresponding to

the reference LOADING conditions, shall not exceed 0.25 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

Duty Cycle 1 : 60

< 0.25 mGy/h

Test Equipment

Instrument

Manufacturer

Model

S/N

X / Gamma

Survey Meter

Radcal Co.

9015/10X5-180

91-1470/19069

Содержание EzRay Air Wall

Страница 1: ...English User Manual Model VEX S300W Version 1 38 Full version...

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Страница 6: ...ith the equipment and review the operating procedures and safety instructions if needed The illustrations photos of the equipment in this manual are only for illustration purposes The actual equipment...

Страница 7: ...Notice vi EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 8: ...ty Instructions 7 2 1 General Safety Guidelines 7 2 2 Warnings and Safety Instructions 8 3 System Overview 11 3 1 Indications for Use 11 3 2 Principles of Operation 11 3 3 Intended User Profile 11 3 4...

Страница 9: ...l VEX S300W User Manual 8 Disposing of the Unit 45 9 Product Specifications 47 9 1 Mechanical Specifications 47 9 2 Technical Specifications 52 9 3 Electrical Specifications 55 9 4 Environmental Speci...

Страница 10: ...nual 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 tes...

Страница 11: ...cific hazard is known to exist which through inappropriate conditions or actions may cause Severe personal injury to the operator and patient Substantial property damage CAUTION Indicates that a poten...

Страница 12: ...y 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 IEC60...

Страница 13: ...or Label Date of manufacture Generator Label Manufacture Label Serial Number Generator Label Manufacture Label This symbol indicates that electrical and electronic equipment must not be disposed of as...

Страница 14: ...ual 5 ENGLISH 1 4 1 Label Locations 1 UDI Label 2 Main Label 3 Generator and manufacture Label The labels in this manual are only for illustration purposes Actual labels may differ The Canadian warnin...

Страница 15: ...CAN CSA C22 2 No 60601 1 2014 IEC 60601 1 3 2008 IEC 60601 2 65 2012 21 CFR 1020 30 1020 31 ISO 13485 This is Class IIb equipment and obtained CE marking in April 2007 for regulations compliance by th...

Страница 16: ...operate this equipment Observe all local fire regulations Always keep a fire extinguisher near the equipment The equipment must be installed maintained and serviced by qualified service personnel acco...

Страница 17: ...use an electrical shock or otherwise damage the system Never use this equipment in an environment that is susceptible to explode Never touch the patient while also touching the SIP SOP connectors Neve...

Страница 18: ...uch 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 the...

Страница 19: ...2 Safety Instructions 10 EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 20: ...age receptors 3 2 Principles of Operation X rays are emitted when a high voltage is supplied to the X ray tube assembly which frees electrons from the cathode They hit the anode to produce X rays The...

Страница 21: ...pe USA Only 1 10 Door Interlock Cable 1 11 AC Power Cable 1 12 Rectangular Cover 2x3 1 13 Rectangular Cover 4x3 1 14 Double Stud USA Only 1 15 Horizontal Arm Assembly 450 mm 1 16 Horizontal Arm Assemb...

Страница 22: ...l dental X ray system that offers safety reliability and greater functionality Ergonomic design and shape for the safety and comfort of patients Easy to use Control Panel that provides a straightforwa...

Страница 23: ...ssembly and the scissor arm assembly 3 length options 450 mm 600 mm 900 mm 5 X ray Beam Limiting Device Limits the X ray exposure area Default type Round Cone Round Cover FOV 6 cm 6 Control Panel Disp...

Страница 24: ...olar 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 The LED lamp f...

Страница 25: ...e styrene copolymer 3 Rotating Rectangular Cover 2x3 3x2 FOV 2x3cm 3x2cm This adaptor can be used as both 2x3 and 3x2 Performs the same function as the Rectangular Cover Moreover Rectangular Cover rot...

Страница 26: ...ing the power box on the wooden wall in the North America regions ABS Acrylonitrile butadiene styrene copolymer SPCC 11 Horizontal Arm 450 mm Used as a connection arm length 450 mm between the Power B...

Страница 27: ...3 System Overview 18 EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 28: ...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 Curre...

Страница 29: ...UTO button is not pressed or the jog dial is not turned for 5 minutes the DISPLAY turns OFF In the Sleep mode the LEDs of the SET button and AUTO button blink at 1 second intervals To off the Sleep mo...

Страница 30: ...Manual 21 ENGLISH 4 3 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...

Страница 31: ...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 sel...

Страница 32: ...pe selection Patient Type Symbol Type Adult Child After the tooth type and patient type are selected the exposure time is automatically displayed 4 If you want to change the exposure time turn the jog...

Страница 33: ...TO 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 the...

Страница 34: ...the 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...

Страница 35: ...lace 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 horizontal F...

Страница 36: ...f 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...

Страница 37: ...rticular tooth i e Bisected angle technique Position the receptor carefully not to damage the soft tissue of the patient s intra oral area Maxillary Incisor The x ray beam is directed downward at 45 T...

Страница 38: ...0W User Manual 29 ENGLISH 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...

Страница 39: ...axillary Molar and Premolar 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 Teet...

Страница 40: ...VEX S300W User Manual 31 ENGLISH 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 inclina...

Страница 41: ...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...

Страница 42: ...nt 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 th...

Страница 43: ...ure duration The Remote Exposure Switch 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 tu...

Страница 44: ...n Ready Yellow X ray ON Control Panel The Remote Exposure Switch is detachable Ensure that the Remote Exposure Switch cable is not detached out from the unit accidentally during the operation Keep voc...

Страница 45: ...rlock Cable are connected to the Connector 1 2 and 3 Please check all seven possible options in the table below Option No Description Connector 1 Connector 2 Connector 3 Connector 4 Option 1 Press 1 N...

Страница 46: ...Press 1 or 2 N A AC Power Cable Option 1 Remote Exposure Switch Standard 2 Remote Exposure Switch Option Option 6 Press 1 or 2 N A AC Power Cable Option 1 Remote Exposure Switch Standard 2 Remote Expo...

Страница 47: ...4 Operation 38 EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 48: ...cription E 02 X ray Generator An error related to X ray exposure is not possible to exposure X ray in the state while E 02 E 03 E 04 E 05 where power is maintained After an X ray exposure related erro...

Страница 49: ...r Service Representative No X ray emission The generator is cooling Wait for the cooling time refer to Duty Cycle on page 70 Defective Remote Exposure Switch Contact your Service Representative Intern...

Страница 50: ...y 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 Daily Ensure that the...

Страница 51: ...6 User Maintenance 42 EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 52: ...llow the Cleaners or disinfectant agents instructions for use When cleaning or disinfect the surfaces always disconnect the equipment from mains Do not use spray cleaner or disinfectant directly onto...

Страница 53: ...hly for items that have been in frequent contact with patients and operators Do not use UV systems to disinfect the equipment as exposed parts of the device can turn yellow or discolor The use of unsu...

Страница 54: ...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 and accom...

Страница 55: ...8 Disposing of the Unit 46 EzRay Air Wall VEX S300W User Manual This page intentionally left blank...

Страница 56: ...9 Product Specifications EzRay Air Wall VEX S300W User Manual 47 ENGLISH 9 Product Specifications 9 1 Mechanical Specifications Dimensions...

Страница 57: ...9 Product Specifications 48 EzRay Air Wall VEX S300W User Manual...

Страница 58: ...9 Product Specifications EzRay Air Wall VEX S300W User Manual 49 ENGLISH...

Страница 59: ...9 Product Specifications 50 EzRay Air Wall VEX S300W User Manual With Horizontal Arm 900 mm With Horizontal Arm 600 mm With Horizontal Arm 450 mm...

Страница 60: ...ssor Arm 900 mm Folded 1077 0 L x892 6 H x58 4 W 11 45 Unfolded 2338 7 L x327 0 H x58 4 W 600 mm Folded 777 0 L x892 6 H x58 4 W 10 6 Unfolded 2038 7 L x327 0 H x58 4 W 450 mm Folded 627 0 L x892 6 H...

Страница 61: ...r 65 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 650304 Station...

Страница 62: ...9 Product Specifications EzRay Air Wall VEX S300W User Manual 53 ENGLISH X ray Tube Characteristics 1 Maximum rating chart 2 Emission characteristics 3 Heating and cooling curves of the X ray tube...

Страница 63: ...9 Product Specifications 54 EzRay Air Wall VEX S300W User Manual 4 Tube Dimensions mm...

Страница 64: ...kV fixed 3 Tube Current 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 requirement 10 M...

Страница 65: ...not exceed 0 5 The system is available with a fixed tube current specification based on the user s choice Power Supply is specified as a part of the ME EQUIPMENT Power plugs may have various specifica...

Страница 66: ...dix 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 deg...

Страница 67: ...ng Rectangular Cover 45 degrees and check the Click sound to make sure the assembly is complete 2 Turn the Outer Ring of the Rotating Rectangular Cover to adjust the angle roughly 3 Turn the Inner Rin...

Страница 68: ...hes respectively 65 kV 3 0 mA Receptor Patient Teeth Angle of inclination SSD 200 mm 8 inches kV mA s Sensor Adult Incisor Maxilla 45 Mandible 25 65 3 0 0 14 Canine Maxilla 45 Mandible 20 65 3 0 0 16...

Страница 69: ...S300W Tube Model Name V1 650304 Generator Model Name DG S0102V1 Inverter type Loading Factor 65 kV 3 0 mA 1 X ray Dose Table Test Equipment Instrument Manufacturer Model S N Multi Dose Meter Raysafe U...

Страница 70: ...of which no principal linear dimension exceeds 20 cm when operated at the NOMINAL X RAY TUBE VOLTAGE under the condition of LOADING corresponding to the reference LOADING conditions shall not exceed...

Страница 71: ...easured with each cover type default rectangular 2x3 and rectangular 4x3 all the results have been ND Not Detected The raw data about the results are shown in the table below Result Horizontal Plane D...

Страница 72: ...mGy h mGy h mGy h 180 ND ND ND 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 Result Vertical Plane Direction Default type Rectangular 2x3 Rectangular 4x3...

Страница 73: ...Rectangular 4x3 mGy h mGy h mGy h 20 ND ND ND 45 ND ND ND 65 ND ND ND 90 ND ND ND 110 ND ND ND 135 ND ND ND 155 ND ND ND 180 ND ND ND 200 ND ND ND 225 ND ND ND 245 ND ND ND 270 ND ND ND 290 ND ND ND 3...

Страница 74: ...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 i...

Страница 75: ...200 mm 8 inches respectively Test Equipment Instrument Manufacturer Model S N X Gamma Survey Meter Radcal Co 9015 10X5 180 91 1470 19069 Method PMMA Phantom aligned to 280 mm away from Focal Spot with...

Страница 76: ...ir Wall VEX S300W User Manual 67 ENGLISH 90 4 02 110 2 75 135 1 80 155 0 46 180 0 17 200 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...

Страница 77: ...Appendix 68 EzRay Air Wall VEX S300W User Manual 90 9 52 110 5 77 135 4 15 155 4 12 180 5 86 200 3 35 225 0 89 245 0 43 270 0 09 290 0 31 315 1 43 335 4 85...

Страница 78: ...for 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 f...

Страница 79: ...kV 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 a...

Страница 80: ...s than 3 V m an 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...

Страница 81: ...ectrostatic Discharge FOV Field of View IEC International Electrotechnical Commission ISO International Standards Organization LED Light Emitting Diode ME Medical Electrical PMMA PolyMethylMethAcrylat...

Страница 82: ...l 82 1588 9510 Email gcs vatech com Website www vatech com Head Quarters Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 18449 Korea Factory Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do...

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