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Vatech EzRay Air Wall User Manual Download Page 14

 

 

1. General and Regulatory Information 

EzRay Air Wall (VEX-S300W) User Manual 

5 

EN

G

LISH

 

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 warning label (See below) is attached only to 

products sold in Canada. 

 

2       

1 

2 

3 

Summary of Contents for EzRay Air Wall

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

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Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

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

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

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

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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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