Vatech EzRay Air VEX-P300 User Manual Download Page 84

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10. Appendix

EzRay Air Portable

(Model: VEX-P300) User Manual

Attach the EzRay Air Portable unit to the holder with the tripod, as shown in the
image below.

Connect one end of the Gender cable to the EzRay Air Portable device.

Connect the other end of the Gender cable connected to the holder to the
supplied exposure cable.

Summary of Contents for EzRay Air VEX-P300

Page 1: ...User Manual Model VEX P300 Version 1 48 Full Version English Postal Code 18449 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do Korea www vatech com User manual...

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Page 5: ...s and safety instructions if needed The illustrations photos of the device in this manual are only for illustration purposes The actual device may differ Due to continuous technological improvements t...

Page 6: ...Notice vi EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 7: ...d Regulations 6 2 Safety 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 Intend...

Page 8: ...ifications 69 9 1 Mechanical Specifications 69 9 2 Technical Specifications 70 9 3 Electrical Specifications 74 9 4 Environmental Specifications 74 10 Appendix 75 10 1 Combining the Holder and the dev...

Page 9: ...ial or local regulatory compliance and that VATECH its agents or representatives do not accept responsibility for 1 any injury or danger to personnel from X ray exposure 2 image over underexposure due...

Page 10: ...this document to prevent personal injury and damage to the device Indicates a potentially hazardous situation and improper handling may result in Serious bodily injury User or veterinary patient Subs...

Page 11: ...ts Main Label Dangerous voltage Powerboard X ray Generator Generator Label Off power disconnect from the main switch Battery bay access door outside On power connect to the main switch Battery bay acc...

Page 12: ...l indicates that electrical and electronic devices must not be disposed of as unsorted municipal waste and must be collected separately Main Label ESD susceptibility symbols indicate that an item is s...

Page 13: ...n EzRay Air Portable Model VEX P300 User Manual 5 ENGLISH 1 4 1 Label Locations 1 Generator Label 2 Main Label 3 UDI Label The labels design and contents may be different in some countries based on lo...

Page 14: ...60601 1 3 2008 IEC 60601 2 65 2012 ISO 13485 21 CFR 1020 30 1020 31 This is Class IIb equipment and obtained CE marking in April 2007 for regulation compliance by the revised European Union s MDD Med...

Page 15: ...ice is not in use Always disconnect the power supply before cleaning the device DO NOT keep the device or its parts in a humid place or a liquid substance Avoid placing the device near chemical storag...

Page 16: ...s may cause an electrical shock or otherwise damage the system DO NOT use spray cleaners on this device as this could cause a fire Never use this device in an environment that is susceptible to explos...

Page 17: ...ubject batteries to mechanical shock In a cell leaking event do not allow the liquid to meet the skin or eyes If the contact has been made wash the affected area with copious amounts of water and seek...

Page 18: ...sure to charge the battery frequently This helps to ensure the life of the battery Radiation Safety When using the device it is recommended that all users comply with the following radiation safety g...

Page 19: ...hnician for both adult and pediatric patients 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...

Page 20: ...ld and the Round Cover 1 2 Hand Neck Strap 1 3 Rectangular Cover 4x3 1 4 power cord 1 5 Battery Charger 1 6 User Manual 1 7 Cradle 1 8 Rectangular Cover 2x3 1 9 Rotating Rectangular Cover 4x3 1 10 Rot...

Page 21: ...ct a VATECH representative in your area 3 5 Features The device is an intra oral portable X ray system that offers safety reliability and greater functionality Lightweight and ergonomic design The con...

Page 22: ...s the button for X ray exposure 4 Handle Grip the handle securely when using the system 5 Power Button Power On Off button 6 Battery Rechargeable Lithium ion battery 7 Adaptor Connector Connect the ch...

Page 23: ...oling time and exposure angle 3 Adult Child Selection Indicates a patient type adult or child 4 Remaining Battery Indicator Indicates remaining battery level Battery Charging Indicator 1 Indicates tha...

Page 24: ...ight to select an X ray exposure setting press the jog dial to confirm the operating setting 10 AUTO Button Available only in countries that allow the auto mode for use The mode is not available in th...

Page 25: ...m 3x4cm This adaptor can be used as both 4x3 and 3x4 4 Rotating Rectangular Cover 2x3 3x2 FOV 2x3cm 3x2cm This adaptor can be used as both 2x3 and 3x2 5 Base Holder 6 Cradle 7 Tripod In case a tripod...

Page 26: ...3 System Overview 18 EzRay Air Portable Model VEX P300 User Manual Refer to Appendix 10 2 Using the Rotating Rectangular Cover for instructions for use...

Page 27: ...light up Current Angle Time display Tooth type selection display Adult Child selection display Remaining battery indicator X ray exposure indicator 3 Make sure that at least one battery indicator lig...

Page 28: ...o 5 3 4 Password mode On Off To change the password refer to 5 3 11 Password Setting 1 Enter the 3 digits numeric password using the jog dial default password 000 2 Turn the jog dial to choose a numbe...

Page 29: ...d in Manual Mode Manual Mode 1 When the 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 Bef...

Page 30: ...type selection Patient Type Symbol Type Adult Child After the tooth type and patient type are selected the exposure time is automatically displayed 3 When changing the exposure time turn the jog dial...

Page 31: ...process positioning the patient and the X ray imaging system exposing the phosphor plate or the intra oral sensor 1 Place a protective lead apron on the patient s chest 2 Have the patient sit on the c...

Page 32: ...clinic use the device with a tripod base holder and remote exposure switch To learn the proper use of each of these components see 4 5 1 Remote Exposure Switch and 10 1 Combining the Holder and the de...

Page 33: ...d angle technique The patient holds the phosphor plate or sensor in place with his her finger The X ray beam is directed perpendicularly towards an imaginary line which bisects the angle between the p...

Page 34: ...es of a 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 Te...

Page 35: ...EX P300 User Manual 27 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 A...

Page 36: ...ual Maxillary 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...

Page 37: ...EX P300 User Manual 29 ENGLISH Bitewing For a bitewing exposure the patient closes their teeth during exposure on the phosphor plate sensor holder The x ray beam is directed downward at 5 8 Teeth Angl...

Page 38: ...aph such as distorted teeth and roots elongation magnification and overlapping contacts The paralleling technique generally reduces the risk of such errors but if the sensor s position improperly angu...

Page 39: ...and the X ray beam it is recommended to use a PID Position Indicating Device as shown in the following figure When using the PID the X ray device s exit pattern should be aligned perpendicular to the...

Page 40: ...X ray device is prohibited must use a remote exposure switch See 4 5 1 Remote Exposure Switch for details 3 While X ray is being exposed The X ray Exposure Indicator lights up and an audible sound is...

Page 41: ...of the Remote Exposure Switch will abort image acquisition Pressing the Remote Exposure Switch activates the X ray Exposure Indicator to turn yellow This color indicates that the X ray is being emitte...

Page 42: ...battery immediately The figure below shows each battery indicator from level 1 to 3 Level 3 Level 2 Level 1 When the battery reaches Level 1 charge the battery at least for an hour to avoid a low vol...

Page 43: ...Not operated Battery Level Indicator Normal Normal Flickers Not displayed Battery Charging Indicator Not displayed Not displayed Flickers Not displayed Control panel Brightness Normal Normal Normal No...

Page 44: ...charge the battery after a complete discharge fully 3 When the battery charge is completed remove the battery charger from the device It is not able to perform an exposure while the battery charger is...

Page 45: ...battery contact your Service Representative to get a battery kit including a new battery and a Phillips screwdriver 1 Workforce One person 3 minutes 2 Tools required Phillips screwdriver size T20 3 R...

Page 46: ...cable by pressing the battery cable connector as shown in the following figure DO NOT pull excessively on the battery cable 4 Install the new battery in the reverse order of removal Press and disconn...

Page 47: ...default waiting time for Sleep Mode 1 see 5 3 6 Waiting Time Setting for the Sleep Mode 1 1 When Sleep Mode 1 starts the Control panel becomes lightly dark as shown in the right figure Brightness Nor...

Page 48: ...Time Setting for the Sleep Mode 2 If the battery charger is connected to the device Sleep Mode 1 is maintained 1 When the Sleep Mode 2 starts all displays are turned off on the Control panel as shown...

Page 49: ...the default waiting time for the Power Down Mode see 5 3 8 Waiting Time Setting for the Power Down Mode If the battery charger is connected to the device Sleep Mode 1 is maintained 1 All displays are...

Page 50: ...4 Operation 42 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 51: ...Default Settings 5 3 2 Exposure Time Settings 5 3 3 User Default Settings for each patient and tooth type 5 3 4 Password Mode On Off 5 3 5 Angle Increments Setting 5 3 6 Waiting Time Setting for the S...

Page 52: ...System Parameters To change system parameters 1 Press and hold the SET button and jog dial simultaneously for about 3 seconds 2 Enter the 3 digits numeric password using the jog dial default password...

Page 53: ...og dial again to save the setting 5 After entering the password is completed the service mode starts as shown in the figure below 6 The system provides 24 service modes To change each mode s settings...

Page 54: ...the previous move press the SET button on the right See 5 3 Service Mode Menu to learn more information on each mode 8 Each time you finish changing the system parameter press the jog dial and hold i...

Page 55: ...lt values except for n 24 Follow the procedures below to activate the settings Service Mode No Item n 01 Factory default settings To restore the system to the factory default settings 1 Select n 01 an...

Page 56: ...ult Canine n 04 Adult Molar Premolar n 05 Adult Bitewing n 06 Child Incisor n 07 Child Canine n 08 Child Molar Premolar n 09 Child Bitewing To set the exposure time for a specific patient and tooth ty...

Page 57: ...Incisor n 13 Canine n 14 Molar Premolar n 15 Bitewing To set the default setting for a specific patient type or a tooth type 1 Select a service mode number between n 10 Adult and n 11 Child for a spec...

Page 58: ...ce Mode No Item n 16 Password On n 17 Password Off To activate the password mode 1 Select n 16 and press the jog dial The message YES is displayed on the Control panel 2 Press the dial again and hold...

Page 59: ...the angle increments for the Auto Mode Service Mode No Item n 18 Angle increments setting When using the Auto Mode the angle value increases and decreases according to the increments setting default 1...

Page 60: ...me setting for the Sleep Mode 1 To change the waiting time for Sleep Mode 1 1 Select n 19 and press the jog dial The default time 001 1 minute is displayed on the control panel as shown in the right f...

Page 61: ...time setting for the Sleep Mode 2 To change the waiting time for Sleep Mode 2 1 Select n 20 and press the jog dial The default time 005 5 minutes is displayed on the control panel as shown in the righ...

Page 62: ...tting for the Power Down Mode To change the waiting time for the Power Down Mode 1 Select n 21 and press the jog dial The default time 300 300 minutes is displayed on the control panel as shown in the...

Page 63: ...lect n 22 and press the jog dial The default setting 002 Buzzer On for Power Down Mode only is displayed on the control panel as shown in the right figure 2 Turn the jog dial to select an option out o...

Page 64: ...own Mode On Off setting 1 Select n 23 and press the job dial The default setting 001 is displayed on the Control panel 001 On 000 Off 2 To turn off the Power Down Mode turn the dial to change the sett...

Page 65: ...e the password 1 Select n 24 and press the jog dial The default password 000 is displayed on the control panel as shown in the right figure 2 When the first digit flashes turn the jog dial to change t...

Page 66: ...5 Service Mode 58 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 67: ...o normal operations after a re boot If the problem persists please contact your Vatech representative E 03 E 04 E 05 A 06 Appears when the system needs cooling time due to continuous operation This al...

Page 68: ...nected Contact your Service Representative No X ray emission The generator is cooling Wait for the cooling time refer to Duty Cycle Defective Remote Exposure Switch Contact your Service Representative...

Page 69: ...6 Troubleshooting EzRay Air Portable Model VEX P300 User Manual 61 ENGLISH This page is intentionally left blank...

Page 70: ...6 Troubleshooting 62 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 71: ...If necessary wipe off surfaces with disinfectant If necessary wipe off surfaces with disinfectant Please observe the hygiene instructions of the phosphor plate scanner manufacturer When cleaning the s...

Page 72: ...evice For technical assistance contact the VATECH service center or your local VATECH representative Please observe the maintenance instructions of the phosphor plate scanner manufacturer Cautions and...

Page 73: ...an the outer covers of the device Daily Ensure that the signal is audible and the X ray emission light is visible when making an exposure Daily Ensure that the yellow exposure indicator light turns on...

Page 74: ...7 Cleaning and Maintenance 66 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 75: ...s Boards Cables and transformer Copper Packing Polystyrene Cardboard Paper X ray tube Battery Other parts Observe all regulations relevant to the disposal of waste in your country This symbol on the d...

Page 76: ...8 Disposing of the Unit 68 EzRay Air Portable Model VEX P300 User Manual This page is intentionally left blank...

Page 77: ...9 Device Specifications 9 1 Mechanical Specifications Dimensions Item Description Main Body Dimension mm 280 L x 296 H x 165 Weight kg 2 14 10 X ray Beam Limiting Device X ray Beam Area mm Round Type...

Page 78: ...Thermistor 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 6503...

Page 79: ...Specifications EzRay Air Portable Model VEX P300 User Manual 71 ENGLISH X ray Tube Characteristics 1 Maximum rating chart 2 Emission characteristics 3 Heating and cooling curves of X ray tube housing...

Page 80: ...9 Device Specifications 72 EzRay Air Portable Model VEX P300 User Manual 4 Tube Dimensions mm...

Page 81: ...ing an unauthorized battery may result in severe injury and device damage For details on using the battery see Battery Use Battery Charger Item Description Model XVE 2520200 Manufacturer JIN XIN YU PO...

Page 82: ...e with a fixed tube voltage specification based on the user selection Maximum exposures on a full charge about 600 times at 65 kV 2 5 mA 0 2 s 9 4 Environmental Specifications Item Description During...

Page 83: ...tions in this section The essential components for connecting the device to the tripod are packed shipped in a separate box as shown in the image below Remove all the box components and follow the pro...

Page 84: ...Attach the EzRay Air Portable unit to the holder with the tripod as shown in the image below 4 Connect one end of the Gender cable to the EzRay Air Portable device 5 Connect the other end of the Gende...

Page 85: ...gular Cover Rotating Rectangular Cover rotates at 360 degrees Rotating Rectangular Cover consists of the Outer Ring and the Inner Ring The Outer Ring rotates in 90 degree increments The Inner Ring rot...

Page 86: ...g Rectangular Cover 45 degrees and check the Click sound to ensure the assembly is complete 2 Turn the Outer Ring of the Rotating Rectangular Cover to adjust the angle roughly 3 Turn the Inner Ring of...

Page 87: ...espectively DIGITAL SENSOR 1 Option 1 60 kV 2 5 mA 0 05 1 0 sec Patient Teeth Angle of inclination SSD 200 mm 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 60 2 5 0 14 Canine Maxilla 45 Mandib...

Page 88: ...inches kV mA s Adult Incisor Maxilla 45 Mandible 25 65 2 5 0 12 Canine Maxilla 45 Mandible 20 65 2 5 0 14 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 16 Bitewing 5 8 65 2 5 0 18 Child Incisor Maxil...

Page 89: ...ination SSD 200 mm 8 inches kV mA s Adult Incisor Maxilla 45 Mandible 25 60 2 5 0 30 Canine Maxilla 45 Mandible 20 60 2 5 0 42 Molar Premolar Maxilla 30 Mandible 5 60 2 5 0 60 Bitewing 5 8 60 2 5 0 65...

Page 90: ...inches kV mA s Adult Incisor Maxilla 45 Mandible 25 65 2 5 0 28 Canine Maxilla 45 Mandible 20 65 2 5 0 40 Molar Premolar Maxilla 30 Mandible 5 65 2 5 0 58 Bitewing 5 8 65 2 5 0 63 Child Incisor Maxil...

Page 91: ...l Name DG S0101V1 Inverter type Loading Factor Option 1 60 kV 2 5 mA Option 2 65 kV 2 5 mA 10 4 1 X ray Dose Table Test Equipment Instrument Manufacturer Model S N Multi Dose Meter Raysafe Unfors Xi m...

Page 92: ...pe 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 cm2 of which no pri...

Page 93: ...ular 2x3 and rectangular 4x3 all the results have been ND Not Detected The raw data about the results are shown in the table below The result Horizontal Plane Direction Default type Rectangular 2x3 Re...

Page 94: ...mGy h 0 ND ND ND 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 315 ND ND ND 335 N...

Page 95: ...levant instructions shall be given in the ACCOMPANYING DOCUMENTS Results The following exposure timetables were established with a unit equipped with a cone that corresponds to a focus to skin distanc...

Page 96: ...ction Result Horizontal Plane R Without Shield With Shield 0 63 4 68 14 20 17 8 11 99 45 18 5 13 01 65 19 8 14 76 90 27 1 20 65 110 41 6 32 08 135 63 4 46 18 155 68 1 11 14 180 3 29 2 893 200 51 5 7 5...

Page 97: ...ection Result Vertical Plane R Without Shield With Shield 0 25 8 29 8 20 27 3 26 8 45 18 5 22 5 65 15 9 18 5 90 74 1 72 1 110 15 9 18 5 135 17 2 13 5 155 19 9 17 9 180 19 2 17 9 200 27 8 31 4 225 13 9...

Page 98: ...0 s Direction Result Horizontal Plane R Without Shield With Shield 0 58 8 85 2 20 22 5 30 4 45 39 6 42 7 65 47 6 40 3 90 46 9 42 9 110 47 6 66 7 135 92 5 48 9 155 87 9 34 3 180 11 9 11 9 200 94 5 28 4...

Page 99: ...ction Result Vertical Plane R Without Shield With Shield 0 64 7 55 4 20 42 8 44 3 45 26 3 34 8 65 36 8 36 4 90 57 9 82 4 110 42 3 38 2 135 20 7 25 9 155 27 7 31 9 180 36 2 52 6 200 94 6 63 2 225 64 2...

Page 100: ...VEX P300 make it suitable for use in industrial areas and hospitals CISPR 11 class A If used in a residential environment for which CISPR 11 class B is normally required this equipment might not offe...

Page 101: ...MHz 2 7 GHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz The VEX P300 is suitable to use in a professional healthcare environment Immunity to Proximity Fields from RF wireless Communicati ons Eq...

Page 102: ...e magnetic field of power frequency should coincide with the general level found in the business site or hospital environment Voltage dips and short interruptions IEC 61000 4 11 0 UT 0 5 cycle At 0 45...

Page 103: ...ty ESD Electrostatic Discharge FOV Field of View IEC International Electrotechnical Commission ISO International Standards Organization LED Light Emitting Diode ME Medical Electrical PMMA Poly Methyl...

Page 104: ...contact your VATECH representative Manufactured by VATECH Co Ltd Tel 82 1588 9510 Email gcs vatech co kr Website www vatech com Head Quarters Address 13 Samsung 1 ro 2 gil Hwaseong si Gyeonggi do 184...

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