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10. Appendix

EzRay Air Portable

(Model: VEX-P300) User Manual 95

EN
G

ISH

10.6

Abbreviations

Acronym

Name

Aluminum

EMC

Electromagnetic Compatibility

ESD

Electrostatic Discharge

FOV

Field of View

IEC

International Electrotechnical Commission

ISO

International Standards Organization

LED

Light-Emitting Diode

Medical Electrical

PMMA

Poly Methyl Meth Acrylate

Radio Frequency

SID

Source to Image receptor Distance

SIP

Signal Input Part

SOP

Signal Output Part

SSD

Source to Skin Distance

Содержание EzRay Air VEX-P300

Страница 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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Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

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

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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