Vatech EzRay Premium VEX-S100W User Manual Download Page 11

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1. General and Regulatory Information

EzRay Premium User Manual

EN
G

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

Summary of Contents for EzRay Premium VEX-S100W

Page 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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Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

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

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

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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