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Vatech EzRay Premium VEX-S100W, Руководство пользователя

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1. General and Regulatory Information 

EzRay Premium User Manual 

3 

EN
G

L

ISH
 

1.4 

Marks and Symbols

 

 

Symbols 

Description 

Location 

 

Alternate current 

 

 

Attention: consult accompanying documents 

Label 

 

Dangerous voltage 

Power board 

 

Protective earth (Ground) 

Power board 

 

Off (power: disconnect from the main switch) 

Main switch 

 

On (power: connect to the main switch) 

Main switch 

 

IEC60601-1 

The degree of Protection from Electric Shock 

TYPE B Equipment 

Label 

 

Radiation hazard 

Label 

 

EC representative 

Label 

 

The CE symbol indicates that this product 
complies with the European Directive for 
Medical Devices 93/42/EEC as amended by 
2007/47/EC as a class IIb device. 

Label 

 

CSA mark 

No.266436 

Label 

 

Address where the equipment was 
manufactured 

Label 

Содержание EzRay Premium VEX-S100W

Страница 1: ...Full version User manual Model VEX S100W Version 1 35 English Postal code 18449 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do Korea www vatech co kr User manual...

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Страница 5: ...f this equipment Observe all cautions safety messages and warnings that appear in this manual Due to continuous technological improvements the manual may not contain the most updated information For f...

Страница 6: ...Notice vi EzRay Premium User Manual Left blank intentionally...

Страница 7: ...Safety Instructions 7 2 1 General Safety Guidelines 7 2 2 Warnings and Safety Instructions 7 3 The System Overview 9 3 1 Indication for Use 9 3 2 Features 9 3 3 General View of the Equipment 10 3 4 Co...

Страница 8: ...9 Service 37 10 Disposing of the Unit 39 11 Technical Specifications 41 11 1 Mechanical Specifications 41 11 2 Technical Specifications 43 11 3 Electrical Specifications 46 11 4 Environmental Specific...

Страница 9: ...rized agent The equipment has been used normally in accordance with the user s manual The equipment damage or malfunction is not the result of an error on the part of the owner or operator 1 2 Owner a...

Страница 10: ...information included in this document WARNING Indicates information that should be followed with the utmost care Failure to comply with a warning may result in severe damage to the equipment or physi...

Страница 11: ...ower disconnect from the main switch Main switch On power connect to the main switch Main switch IEC60601 1 The degree of Protection from Electric Shock TYPE B Equipment Label Radiation hazard Label E...

Страница 12: ...regulations Label Date of manufacture Label Refer to the Instruction manual Label Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner Label Indic...

Страница 13: ...tory Information EzRay Premium User Manual 5 ENGLISH Classifications IEC60601 1 6 1 Protection against the ingress of water Ordinary Equipment IPX0 Protection against electric shock Class I equipment...

Страница 14: ...1 General and Regulatory Information 6 EzRay Premium User Manual Left blank intentionally...

Страница 15: ...ment is not in use Always disconnect the power supply before cleaning the equipment 2 2 Warnings and Safety Instructions X Ray equipment is hazardous to the patient and the operator if proper exposure...

Страница 16: ...res It must be installed and operated as specified in the Installation Requirements document For more details refer to Chapter 12 Electromagnetic Compatibility Information Never try to modify this equ...

Страница 17: ...maging system 3 1 Indication for Use The EzRay Premium VEX S100W is an extraoral source of X rays intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth...

Страница 18: ...ays 3 4 Articulating Arm Extends the arm 5 Horizontal Arm 3 length options 450 mm 600 mm 900 mm 6 On Off switch Turns the equipment ON OFF 7 Control Panel Controls and manages the system Anatomical se...

Страница 19: ...ypes Shape Length from the focal spot to edge of the cone Diameter Round 200 mm default 60 2 mm 300 mm optional 60 2 mm Rectangular optional FOV 2 X 3 cm FOV 3 X 4 cm optional FOV 2 X 3 cm FOV 3 X 4 c...

Страница 20: ...Control Panel 2 4 6 7 9 8 1 3 5 No Description 1 Exposure Button 2 X Ray Emission Indicator 3 LCD kV mA Time Error Code DAP 4 Power Status Indicator 5 Parameter Adjustment Button 6 Save Button 7 Toot...

Страница 21: ...quipment requires a cooling time equal to 15 times the exposure time before taking another image The cooling time is displayed on the LCD You can use the Exposure button only after the cooling time ha...

Страница 22: ...ec in a cycle Up Down for the kV mA and sec The adjustable range allowed Tube voltage kV 60 70 Tube current mA 4 0 7 0 Exposure time sec 0 04 2 Resolution Tube voltage current exposure time 1 kV 1 0 m...

Страница 23: ...3 The System Overview EzRay Premium User Manual 15 ENGLISH 8 Adult Child selector Icon Meaning Adult Child 9 Receptor selector Icon Meaning Film Digital...

Страница 24: ...3 The System Overview 16 EzRay Premium User Manual Left blank intentionally...

Страница 25: ...GLISH 4 Preparations for Exposure 4 1 Turning the Equipment On Turn ON the equipment The following displays light up Power status indicator Anatomical selector Adult or Child selector Receptor selecto...

Страница 26: ...osition by pushing it into the short cone and rotating it so that the guidelines on the short cone and long cone line up In position guidelines line up Assembling the Cone Rectangular Collimator The r...

Страница 27: ...r time from the preset values for one exposure To do so a Press the parameter adjustment key b Increase or decrease the values by using the up or down button c Press any other button Tooth Film or Pat...

Страница 28: ...ng the Cone Type 1 Guide the patient to the equipment 2 Place a protective lead apron over the patient s chest 3 Have the patient sit on the chair with the sagittal plane vertical For radiography of t...

Страница 29: ...with his her finger The X ray beam is directed perpendicularly towards an imaginary line which bisects the angle between the film plane and the long axis of the tooth 1 Film or Sensor 2 Long axis of...

Страница 30: ...em 22 EzRay Premium User Manual Maxillary Incisor The x ray beam is directed downward at 45 Mandibular Incisor The x ray beam is directed upward at 25 Teeth Angle of inclination Incisor Maxilla 45 Inc...

Страница 31: ...ual 23 ENGLISH Maxillary Molar and Premolar The x ray beam is directed downward at 30 Mandibular Molar and Premolar The x ray beam is directed upward at 5 Teeth Angle of inclination Molar and Premolar...

Страница 32: ...hosphor plate Placing the receptor properly is important Check your dental radiography text for information about the proper placement of the imaging receptor Improperly positioning the film or sensor...

Страница 33: ...ile X Ray is being exposed The X ray emission indicator lights up and an audible sound is produced Keep pressing until the X ray emission light goes out and the audible sound stops The DAP value is di...

Страница 34: ...M Incisor 60 7 0 08 70 6 0 13 Premolar 60 7 0 12 70 6 0 18 Molar 60 7 0 17 70 6 0 25 Bitewing 60 7 0 18 70 6 0 27 SENSOR Incisor 60 7 0 07 70 6 0 11 Premolar 60 7 0 10 70 6 0 16 Molar 60 7 0 13 70 6 0...

Страница 35: ...ameter you set exceeds the safety limit the Over Value message is displayed on the top left of the LCD Unless this message is cleared you cannot perform irradiation Tube Voltage kV Tube Current mA Exp...

Страница 36: ...5 Using the System 28 EzRay Premium User Manual Left blank intentionally...

Страница 37: ...tank block temperature exceeds the error limit 50 degrees Turn off the equipment let the mono tank block cool down sufficiently and turn on the equipment again error limit 50 degrees E09 The high volt...

Страница 38: ...rradiation E60 The exposure switch is already pressed when you turned on the equipment Check if the exposure switch is already pressed when you turned on the equipment Once the switch is released the...

Страница 39: ...rator is cooling Wait for the COOLING message to disappear Exposure button is defective Call a qualified service technician Exposure switch failure Check if exposure switch is properly connected to th...

Страница 40: ...6 Emergency Measures 32 EzRay Premium User Manual Left blank intentionally...

Страница 41: ...he 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 the eq...

Страница 42: ...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 unsuitable Cleane...

Страница 43: ...ot use detergents or solvents to clean the outer covers of the equipment Daily Ensure sure that the main power switch has been turned off after using the equipment Daily Ensure that the equipment is f...

Страница 44: ...8 Maintenance 36 EzRay Premium User Manual Tasks Period Ensure there is no wear or damage to the exposure switch cable Monthly Always turn off the equipment before performing any maintenance...

Страница 45: ...eriodic constancy tests to ensure image quality and the safety of the patient and operator Only VATECH authorized technicians can perform inspection and service of this equipment For the technical ass...

Страница 46: ...9 Service 38 EzRay Premium User Manual Left blank intentionally...

Страница 47: ...e recycled All parts and components that contain hazardous materials must be disposed of in accordance with disposal regulations IEC 60601 1 6 8 2 j Part Material Recyclable Waste Disposal Site Hazard...

Страница 48: ...10 Disposing of the Unit 40 EzRay Premium User Manual Left blank intentionally...

Страница 49: ...11 Technical Specifications EzRay Premium User Manual 41 ENGLISH 11 Technical Specifications 11 1 Mechanical Specifications Dimensions Wall mounted Type...

Страница 50: ...r arm 16 8 kg 37 0 lb Horizontal Arm 4 0kg 8 8 lb Control Unit With power box 6 0kg 13 2 Ib Beam limiting Cone Collimator size Round L 200 mm Diameter 60 2 mm Round L 300 mm Diameter 60 2 mm Rectangul...

Страница 51: ...age Generator Tube Voltage kV 50 70 Tube Current mA 4 0 7 0 sec 0 04 2 kV Accuracy 5 mA Accuracy 5 Cooling Automatically controlled Protect 50 Cooling Fan Optional Inherent Filtration At least 1 0 mm...

Страница 52: ...11 Technical Specifications 44 EzRay Premium User Manual...

Страница 53: ...remium User Manual 45 ENGLISH Tolerances of the focal spot on the reference axis X 0 4 mm sideways Y 0 4 mm in depth Z 0 4 mm in height Reference axis to which the target angle and the focal spot char...

Страница 54: ...power 1 2kVA The input line voltage depends on the local electrical distribution system Allowable input voltage fluctuation requirement 10 11 4 Environmental Specifications Item Description During op...

Страница 55: ...t 1 General Requirements for Safety IEC 60601 1 3 Test Condition Brand Name Model EzRay Premium VEX S100W Tube type Toshiba D 041SB Loading Factor 60 kV 6 0 mA Tube type Inverter type DG 10A05T3 INV 0...

Страница 56: ...ctorian 660 101114 101377 Test Condition Distance from focal point m 1 Applied Tube Voltage Peak kVp 70 Applied Tube Current mA 6 0 Applied Exposure time s 0 5 Direction Basic Cone mGy hr Transverse L...

Страница 57: ...zRay Premium User Manual 49 ENGLISH The tested area on the plane of radiation is defined within a radius at 1 m from the focal spot Measurement Points Transverse Longitudinal Beam Direction Measuremen...

Страница 58: ...12 X Ray Dose Data 50 EzRay Premium User Manual Measurement Values Longitudinal...

Страница 59: ...The EzRay Premium in combination with the shielded location The EzRay Premium must be used only in a shielded location with a minimum RF shielding effectiveness and for each cable that exits in the s...

Страница 60: ...61000 4 5 1 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 int...

Страница 61: ...IEC 61000 4 5 1 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...

Страница 62: ...d be less than 3 V m a Interference may occur near equipment marked with the following symbol NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorpt...

Страница 63: ...ch co kr Website www vatech co kr Head Quarters Address 13 Samsung 1 ro 2 gil Hwaseoung si Gyeonggi do KOREA Factory Address 13 Samsung 1 ro 2 gil Hwaseoung si Gyeonggi do KOREA The CE symbol grants t...

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