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EPX-SERISE USER MANUAL Rev. G

17

4.2.4 EPX-F3200

IDENTIFICATION LABEL-HIGH TENSION TANK

This is label is attached on side of the HV mono block tank inside of the diagnostic x-ray system.

(Example)

Output power: 3.2kW ,       KVP range: 40-100kVp
mA range: 25-60mA,
Line Power: 200-240V       , 50/60Hz

Obelis S.A
Avenue de Tervuren, 34, bte 44 1040 Brussels, Belgium / E-mail:[email protected]
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03

Ecotron Co., Ltd
Made by Korea

HV Mono Block Tank

#504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu,
Seoul, Korea

EMB-F3200 Series

Inserted X-ray Tube

Focal spot: 2.0mm x 2.0mm, Target angle: 20 degrees
Anode Heat Storage: 40kHU
Inherent Filtration: At least 0.8mmAl

D-205B

Certification Statement
▪ This product complies with 21 CFR 1020.30

–

1020.31

▪ This product complies with 21 CFR Subchapter J.

REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM

This label is attached to rear cover of the diagnostic x-ray system. (Example)

Input Power: 200-240V       , 50/60Hz, 4.5kVA, Standby 150VA
Output power: 3.2kW @ 80kV, 40mA
KVP range: 40-100kVp, mA range: 25-60mA, mAs Range: 0.4-100mAs
▪ Total Filtration: 3.3mmAl
    (Tube: 0.8mmAl, Fixed Added Filter: 2.0mmAl, Collimator: 0.5mmAl)
▪ Time interval between Max kV and Max mAs exposure: rest time 5min

Obelis S.A
Avenue de Tervuren, 34, bte 44 1040 Brussels, Belgium / E-mail:[email protected]
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03

Ecotron Co., Ltd
Made by Korea

Diagnostic X-ray System

#504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea

EPX-F3200 (S/W: Ver )

Inserted X-ray Tube

▪ Focal Spot: 2.0mm x 2.0mm, Inherent Filtration: At least 0.8mmAl
Target Angle: 20 degrees, Anode Heat Storage: 40kHU

D-205B

2015.03

Certification Statement
▪ This product complies with 21 CFR Subchapter J.
CAUTION
▪ Only an experienced expert should operate the unit.
▪ Do not use with wet hands.

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Summary of Contents for EPX Series

Page 1: ...Obelis S A Avenue de Tervuren 34 bte 44 1040 Brussels Belgium E mail mail obelis net Representative Mr Gideon ELKAYAM TEL 32 2 732 59 54 FAX 32 2 732 60 03 Ecotron Co Ltd Made by Korea 504 505Ho Hanshin IT Tower II 47 Digital ro 9 gil Geumcheon Gu Seoul Korea D N EPX SERISE Rev G ...

Page 2: ...EPX SERISE USER MANUAL Rev G 2 This page intentionally left blank ...

Page 3: ...TY 9 4 SAFETY AND SPECIFICATIONS 10 5 SYSTEM CONFIGURATION 47 6 OPERATION MODE 50 7 MAINTENANCE PROCEDURE 58 8 DISPOSAL OF WASTE 61 9 QUALITY WARRANTY 62 10 INTENDED OPERATOR AND SERVICE PERSONAL PROFILE 63 11 EMC DECLARATION 64 12 APPENDIX A TECHNICAL CHART 68 13 APPENDIX B PEDIATRICS AND SMALL PATIENTS 74 ...

Page 4: ... used throughout this manual Their application and meaning are described below WARNING Warning symbol used to indicate a potential hazard lead operators service personnel to serious injury death or radiation exposure CAUTION Caution symbol used to indicate a potential hazard lead operators service personnel to injury or damage of equipment NOTE Note symbol used to indicate important information ne...

Page 5: ...EPX SERISE USER MANUAL Rev G 5 This page intentionally left blank ...

Page 6: ... Intended use This product diagnostic X ray system is radiation medical equipment used by a qualified trained physician or technician on both adult and pediatric subjects for taking diagnostic X rays This product is used on hand wrist foot ankle shoulder elbow knee and other body parts Available the patient population for use Gender no gender restrictions Age no age restrictions The patient popula...

Page 7: ...part Main Power board SMPS Mono block X ray tank OP control board FET drive board Collimator 2 Accessories Hand switch Foot switch Option Operator s Manual Mobile Stand NOTE This manual contains important safety information An understanding of this information is critical to the safe operation of your equipment Please ensure that you read the warning notices before using the equipment ...

Page 8: ...is advisable to follow under mentioned rules to keep your additional safety and health 1 This product should be operated only by or under the supervision of legally qualified persons 2 EPX series is designed for the radiographic uses and not for fluoroscopy or other associated applications 3 EPX series should be used for the diagnosis not for the therapy 4 Do not modify the equipment at your discr...

Page 9: ...nce from the radiant sources and all the possible secondary radiation zones 3 Eliminate all unnecessary objects near the exposure zones 4 The distance from the focus to skin should be kept at least 8 inch 20cm 5 For the experimental uses apply the lowest possible values of kV mAs and exposure time 6 Be careful not to exceed the limited radiograms in the exposure area 7 The contraindications for pr...

Page 10: ...ed to indicate a potential hazard to operators service personnel or to the equipment It indicates a requirement to refer to the accompanying documentation for details Radiation symbol used to indicate the presence of radiation Laser radiation symbol used to indicate the presence of laser beam HV 3 MINUTES WARNING LABEL This label is attached on the main power board The DC link capacitor approximat...

Page 11: ...ally the DC link capacitors will remain charged for up to 3 minutes after the AC mains is disconnected or the AC switch is switched off LASER STARE CAUTION LABEL This label attached to side of the collimator case Laser pointer is present inside the collimator part of X ray system When X ray system shoot a laser beam there do not stare into beam because the eyes may be damaged from laser beam SAFE ...

Page 12: ...ess intensity than the primary beam that exposes the film No practical design can incorporate complete protection for operators or service personnel who do not take adequate safety precautions Service and operating personnel only authorized and properly trained by ECOTRON should be allowed to work with this X ray system equipment The appropriate personnel must be made aware of the inherent dangers...

Page 13: ...liquids coffee beverages flowers etc on the X ray system Do not operate the x ray system in direct sunlight or near any heat sources Do not operate the x ray system near strong magnetic fields microwave ovens speakers etc and avoid routing the x ray system near these devices The x ray system must be operated in locations that are clean free of excess dust dirt debris etc stable free of vibration O...

Page 14: ...mplies with 21 CFR Subchapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Obelis S A Avenue de Tervuren 34 bte 44 1040 Brussels Belgium E mail mail obelis net Representative Mr Gideon ELKAYAM TEL 32 2 732 59 54 FAX 32 2 732 60 03 Ecotron Co Ltd Made by Korea Diagnostic X ray System 504 505Ho Hanshin IT Tower II 47 D...

Page 15: ...bchapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Obelis S A Avenue de Tervuren 34 bte 44 1040 Brussels Belgium E mail mail obelis net Representative Mr Gideon ELKAYAM TEL 32 2 732 59 54 FAX 32 2 732 60 03 Ecotron Co Ltd Made by Korea Digital X ray System 504 505Ho Hanshin IT Tower II 47 Digital ro 9 gil Geumcheo...

Page 16: ...chapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Input Power 200 240V 50 60Hz 5 7kVA Standby 150VA Output power 2 8kW 80kV 35mA KVP range 40 120kVp mA range 14 35mA mAs Range 0 4 100mAs Total Filtration 3 3mmAl Tube 0 8mmAl Fixed Added Filter 2 0mmAl Collimator 0 5mmAl Time interval between Max kV and Max mAs exp...

Page 17: ...chapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Input Power 200 240V 50 60Hz 4 5kVA Standby 150VA Output power 3 2kW 80kV 40mA KVP range 40 100kVp mA range 25 60mA mAs Range 0 4 100mAs Total Filtration 3 3mmAl Tube 0 8mmAl Fixed Added Filter 2 0mmAl Collimator 0 5mmAl Time interval between Max kV and Max mAs exp...

Page 18: ...chapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Input Power 200 240V 50 60Hz 11kVA Standby 150VA Output power 4 0kW 50kV 80mA KVP range 50 110kVp mA range 20 80mA mAs Range 0 4 100mAs Total Filtration 3 0mmAl Tube 0 5mmAl Fixed Added Filter 2 0mmAl Collimator 0 5mmAl Time interval between Max kV and Max mAs expo...

Page 19: ...chapter J REPRESENTATIVE IDENTIFICATION LABEL X RAY SYSTEM This label is attached to rear cover of the diagnostic x ray system Example Input Power 200 240V 50 60Hz 11kVA Standby 150VA Output power 5 0kW 50kV 100mA KVP range 50 110kVp mA range 20 100mA mAs Range 0 4 100mAs Total Filtration 3 0mmAl Tube 0 5mmAl Fixed Added Filter 2 0mmAl Collimator 0 5mmAl Time interval between Max kV and Max mAs ex...

Page 20: ...Lamp 5V Laser Min X ray field size 0cm x 0cm at 100cm SID Max X ray field size 36cm x 36cm at 100cm SID Inherent Filtration 0 5mmAl Ecotron Co Ltd Made by Korea Beam Limiting Device Collimator 504 505Ho Hanshin IT Tower II 47 Digital ro 9 gil Geumcheon Gu Seoul Korea EPX Collimator Certification Statement This product complies with 21 CFR 1020 30 1020 31 This product complies with 21 CFR Subchapte...

Page 21: ...4 2 8 Symbol on the product label of X ray system SYMBOL Description Catalogue number Serial number Caution Consult instructions for use WEEE Symbol Manufacturer Date of manufactured Authorized representative in the European Community ...

Page 22: ...y from rain Fragile This symbol means do not drop of product UP This symbol means This way up WARNING THIS X RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED CAUTION INCORRECT CONNECTIONS OR USE OF UNAPPROVED EQUIPMENT MAY RESULT IN INJURY OR EQUIPMENT DAMAGE ...

Page 23: ... RAY SYSTEMS ARE THE RESPONSIBILITY OF THE USERS OF SUCH X RAY SYSTEMS ECOTRON Ltd PROVIEDS INFORMATION ON ITS PRODUCTS AND ASSOCIATED HAZARDS BUT ASSUMES NO RESPONSIBILITIES FOR AFTER SALE POERATING AND SAFETY PRACTICES ECOTRON Ltd ACCEPTS NO RESPONSIBILITY FOR ANY GENERATOR NOT MAINTAINED OR SERVICED ACCORDING TO THE SERVICE MANUAL OR ANY X RAY SYSTEM THAT HAS BEEN MODIFIED IN ANY WAY ECOTRON Lt...

Page 24: ...ORING OF FET DRIVE BOARD TO PROTECT THE EXCESSIVE HEAT BUILD UP IF THE X RAY SYSTEM DETECTS THE OVER HEAT OF FET DRIVE AN ERROR CODE E04 OR E05 WILL BE DISPLAYED EXPOSURE WILL BE INHIBITED WHEN THIS MESSAGE IS DISPLAYED AND IT SHOULD BE UNDERSTOOD THAT CONTINUING TO MAKE EXPOSURES MIGHT CAUSE X RAY SYSTEM DAMAGE DUE TO OVERHEATING THE GENERATOR SHOULD BE ALLOWED TO COOL SUFFICIENTLY SUCH THAT THIS...

Page 25: ...tube is used at maximum mA or kV values This will reduce the possibility of damaging the X ray tube and high voltage components No test setup is required For maximum stability and reliability use the following techniques at start up Select the following 60kV 5mA Make three to five exposures at 5 minute intervals NOTE THE FOLLOWING PROCEDURE PRODUCES X RAYS OBSERVE ALL SAFETY PRECAUTIONS TO PROTECT...

Page 26: ...ns will not adverse effect the operation of this x ray system If the other equipment has a comparatively high level of transmission power and is in close proximity to the generator these EMC concerns the risk of interference may as mobile telephones cordless microphones and other similar mobile radio equipment be restricted from the vicinity of this X ray system 3 OTHERS EN ISO 13485 2012 AC 2012 ...

Page 27: ...X0 Use conditions CONTINUOUS WORKING WITH INTERMITTENT LOAD The products have not been evaluated for use in the presence of flammable anaesthetic mixture with air or nitrous oxide CLASSIFICATION 93 42 EEC DIRECTIVE In according with Annex IX CLASS II b VERIFICATION IEC 60580 The EPX series measures data in accordance with the reference tube voltage and mAs values using DAP certified according to t...

Page 28: ...As Range 0 4mAs 32mAs 20steps Max kV Deviation 3 Max mAs Deviation 5 Max Accuracy of Loading Time 13 Max Reproducibility of the RADIATION output Coefficient of variation 0 01 Display KV mAs 7 segment LED X ray Tube Model Name D 125 Toshiba Focal Spot 1 2mm x 1 2mm Target Angle 16 degree Anode Heat Storage 50 KHU Total Filtration Tube 0 8mmAl collimator 0 5mmAl filter 2 0mmAl 3 3 mm Al eq 75kV Coll...

Page 29: ... KV accuracy 3 Max mAs Deviation 5 Max Accuracy of Loading Time 13 Max Reproducibility of the RADIATION output Coefficient of variation 0 01 Display KV mAs 7 segment LED X ray Tube Model Name D 125 Toshiba Focal Spot 1 2mm x 1 2mm Target Angle 16 degree Anode Heat Storage 50 KHU Total Filtration Tube 0 8mmAl collimator 0 5mmAl filter 2 0mmAl 3 3 mm Al eq 75kV Collimator with Laser Pointer Type Dou...

Page 30: ... 101KV 110KV 18mA 0 4 32 101KV 110KV 16mA 40 64 111KV 120KV 16mA 0 4 20 111KV 120KV 14mA 25 50 MAs Range 0 4mAs 100mAs 25steps Max kV Deviation 3 Max mAs Deviation 5 Max Accuracy of Loading Time 13 Max Reproducibility of the RADIATION output Coefficient of variation 0 01 Display KV mAs 7 segment LED X ray Tube Model Name D 125 Toshiba Focal Spot 1 2mm x 1 2mm Target Angle 16 degree Anode Heat Stor...

Page 31: ...64 80 MAs Range 0 4mAs 100mAs 25steps Max kV Deviation 3 Max mAs Deviation 5 Max Accuracy of Loading Time 8 Max Reproducibility of the RADIATION output Coefficient of variation 0 015 Display KV mAs 7 segment LED X ray Tube Model Name D 205B Toshiba Focal Spot 2 0mmx2 0 mm Target Angle 20 degree Anode Heat Storage 40 kHU Total Filtration Tube 0 8mmAl collimator 0 5mmAl filter 2 0mmAl 3 3 mm Al eq 7...

Page 32: ... 91KV 100KV 25mA 40 80mAs 101kV 110KV 25mA 0 4 32mAs 101kV 110KV 20mA 40 80mAs MAs Range 0 4mAs 100mAs Max kV Deviation 3 Max mAs Deviation 5 Max Accuracy of Loading Time 8 Max Reproducibility of the RADIATION output Coefficient of variation 0 02 Display KV mAs 7 segment LED X ray Tube Model Name OX 110 15 C E I Focal Spot 1 8mmx1 8mm Target Angle 15 degree Anode Heat Storage 42kHU Total Filtratio...

Page 33: ...10mAs 61KV 70KV 60mA 13 32mAs 61KV 70KV 50mA 40 100mAs 71KV 80KV 60mA 0 4 10mAs 71KV 80KV 50mA 13 32mAs 71KV 80KV 40mA 40 100mAs 81KV 90KV 50mA 0 4 10mAs 81KV 90KV 40mA 13 32mAs 81KV 90KV 30mA 40 100mAs 91KV 100KV 45mA 0 4 10mAs 91KV 100KV 40mA 13 32mAs 91KV 100KV 30mA 40 100mAs 101kV 110KV 40mA 0 4 10mAs 101kV 110KV 30mA 13 32mAs 101kV 110KV 20mA 40 100mAs MAs Range 0 4mAs 100mAs Max kV Deviation...

Page 34: ...ush button illuminator with 30 sec timer Lamp 24V 50W Halogen Weight 13 Kg 4 7 2 7 Hand Switch Two step X ray exposure hand switch Type Two stepping ready and exposure Working Voltage AC DC 125V 30V Working Current AC DC 1A 2A Wires and coil cord 3cores 2 2m Cores White Red Green Ready Common Exposure Shell Material White Engineering plastics Useful time 1 2 million times 4 7 2 8 Mobile Stand Two ...

Page 35: ...0 256 320 400 520 640 800 1250 1600 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 20 25 30 40 50 65 80 100 125 160 200 250 320 400 500 650 800 1000 1667 2133 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 22 28 33 44 56 72 89 111 139 178 222 278 356 444 556 722 889 1111 1786 2286 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16...

Page 36: ...333 1667 2133 2667 3333 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 13 17 20 27 33 43 53 67 83 107 133 167 213 267 333 433 533 667 833 1067 1600 2000 2560 3200 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 16 20 24 32 40 52 64 80 100 128 160 200 256 320 400 520 640 800 1000 1280 1600 2500 3200 4000 0 4 0 5 0 6 0 8 1 ...

Page 37: ... 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 13 17 20 27 33 43 53 67 83 107 133 167 213 267 333 520 640 800 1000 1280 1600 2500 3200 4000 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 16 20 24 32 40 52 64 80 100 128 160 200 256 320 400 520 800 1000 1250 1600 2000 2500 4000 5000 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4...

Page 38: ...64 80 100 10 13 15 20 25 33 40 50 63 80 100 125 160 200 250 325 400 500 625 800 1000 1250 1600 2000 2500 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 10 13 15 20 25 33 40 50 63 80 100 125 160 200 250 325 400 500 625 800 1143 1429 1829 2286 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 13 17 20 27 33 43 53 67 83 107 13...

Page 39: ...4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 9 11 13 18 22 29 36 44 56 71 89 111 142 178 222 325 400 500 625 800 1000 1250 1600 2000 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 11 14 17 23 29 37 46 57 71 91 114 143 183 229 286 371 457 571 714 914 1333 1667 2133 2667 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 ...

Page 40: ...3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 100 7 8 10 13 17 22 27 33 42 53 67 83 107 133 167 260 320 400 500 640 1000 1250 1600 2000 2500 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 32 40 50 64 80 100 8 10 12 16 20 26 32 40 50 64 80 100 128 160 200 325 400 500 625 800 1333 1667 2133 2667 3333 0 4 0 5 0 6 0 8 1 0 1 3 1 6 2 0 2 5 3 2 4 0 5 0 6 4 8 0 10 13 16 20 25 3...

Page 41: ...70 80 90 100 0 4 0 9 1 9 2 8 3 6 4 6 5 4 6 4 5 11 1 21 8 34 1 47 2 60 7 75 4 90 8 32 70 7 139 218 2 302 8 392 4 489 590 1 50 64 80 986 1231 2 1489 9 100 221 3 433 8 681 3 949 3 4 7 4 3 EPX F2800 Unit μGy kV mAs 40 50 60 70 80 90 100 110 120 0 4 0 9 1 9 2 8 3 6 4 6 5 4 6 4 7 7 8 9 5 11 1 21 8 34 1 47 2 60 7 75 4 90 8 107 4 123 8 32 70 7 139 218 2 302 8 392 4 489 590 1 692 7 803 7 50 1256 5 64 1392 ...

Page 42: ... 7 1138 7 4 7 4 4 EPX F4000 Unit μGy kV mAs 50 60 70 80 90 100 110 0 4 0 9 1 9 2 5 3 2 4 3 4 4 5 4 5 19 4 32 2 46 7 61 4 77 5 92 8 110 32 132 5 217 8 310 406 6 513 9 615 737 8 80 1028 2 1307 3 1573 5 1914 7 100 429 9 693 6 974 4 4 7 4 4 EPX F5000 Unit μGy kV mAs 50 60 70 80 90 100 110 0 4 0 9 1 9 2 5 3 2 4 3 4 4 5 4 5 19 4 32 2 46 7 61 4 77 5 92 8 110 32 132 5 217 8 310 406 6 513 9 615 737 8 100 4...

Page 43: ...EPX SERISE USER MANUAL Rev G 43 4 7 5 MECHANICAL SPECIFICATION EPX F1600 F2400 F2800 F3200 F4000 F5000 Dimension unit mm Side view Front view ...

Page 44: ...EPX SERISE USER MANUAL Rev G 44 Hand Switch Dimension unit mm Mobile Stand Dimension unit mm ...

Page 45: ...e the equipment is exposed to chemicals or gas For safe operation of the equipment it should be kept away from the place with strong vibration and maintain proper environment and conditions Operation Environment Temperature range 10 C 40 C 50 F 104 F Relative Humidity Range 30 75 RH Optimal Temperature and Humidity Temperature range 16 7 C 22 8 C 62 F 73 F Relative Humidity Range 40 60 RH For safe...

Page 46: ...orea TEL 82 2 2025 3760 FAX 82 2 2025 3764 E mail Ecotron ecotron co kr Web site http www ecotron co kr In USA Contact DRGEM USA Inc 7018 NW 50 TH Terrace Gainesville Florida 32653 USA TEL 201 370 6672 FAX 352 337 1271 E mail drgemusa yahoo com Obelis S A Avenue de Tervuren 34 bte 44 1040 Brussels Belgium E mail mail obelis net Representative Mr Gideon ELKAYAM TEL 32 2 732 59 54 FAX 32 2 732 60 03...

Page 47: ...e bed ask visitors to leave the room first and keep appropriate distance from the patient e Pay attention to the maintenance schedule of the device and keep up with it f Cumulative radiation dose usually does not exceed recommended maximum levels However if you make radiographic exposures using high kV and mAs quite often the evaluation of the specialist is needed to check whether extra protective...

Page 48: ... in row again Then high KV mAs values 90kV 5mAs will be applied without trouble CAUTION This X ray system has temperature monitoring of X ray tube to protect the excessive heat build up If the X ray system detects the over heat of X ray tube an error code E02 will be displayed Exposure will be inhibited when this message is displayed and it should be understood that continuing to make exposures mi...

Page 49: ...d on the body of the machine The level of input voltage fluctuation should be within 10 of the nominal values WARNING To avoid the risk of electric shock this equipment must only be connected to a supply main with protective earth WARNING 5 2 CONNECTION OF POWER CODE AND HAND SWITCH No Description Function 1 Power Connector inlet Connect the power cable 2 Power Switch Power on off switch 3 Hand Sw...

Page 50: ...e time for preparation 7 PC interface connecting indicator Lighted when EPX series is connected to PC 8 Exposure indicator Alert lamp during x ray exposure 9 Error lamp Lighted in case of system problem 10 Collimator lamp on Switch for operation of the lamp inside the collimator 11 Laser pointer To adjust exposure focus 12 Display reversal switch Help to read LED value of kV mAs reversed 13 mAs se...

Page 51: ... power switch c Select the APR memory out of 1 6 d Select the kV values using the KV up down switch e Select the mAs values using the mAs up down switch f Save the selected KV and mAs figures with pushing the save button g When the Ready LED sign appears press the hand switch again and make exposure During the x ray exposure the X ray LED will be lighted on h After the exposure is ended wait LED s...

Page 52: ...of each EPX models are as follows EPX F1600 EPX F2400 EPX F2800 EPX F3200 If 300 J Heat Value 1 000 J the CLT is 15 seconds If 1 000 J Heat Value 2 000 J the CLT is 30 seconds If 2 000 J Heat Value 4 000 J the CLT is 60 seconds If 4 000 J Heat Value 5 500 J the CLT is 90 seconds If 5 500 J Heat Value the CLT is 120 seconds EPX F4000 EPX F5000 If 300 J Heat Value 1 000 J the CLT is 15 seconds If 1 ...

Page 53: ...ue up down control buttons Select sec value by tapping up down buttons Changing Sec value automatically change mAs accordingly 7 mA Indicator Filament current value determined by kV and mAs setting 8 Collimator lamp on off button Switch for operation of the lamp inside the collimator 9 Laser pointer on off button To turn on off the dual laser to adjust exposure SID 10 Ready button Before any X ray...

Page 54: ...aration 14 X ray exposure indicator Alert lamp during X ray exposure 15 Error indicator When the system has error this Error indicator will light up ⓐ Equipment angle indicator Dispalys the horizontal vertical tilting status of the equipment Scroll Touch and drag the screen action left right or right left direction will display alternating screen kV mAs indicator vs sec and mA display ...

Page 55: ...e button is half pressed with a thumb 2 nd stage The equipment exposes X ray when the button is fully pressed with a thumb It automatically turns off according to the value of mAs set by the program or when the thumb is off the switch 2 Handle Hand Switch to grab with hands 3 Connector Connector to connect X ray equipment and a Hand Switch ...

Page 56: ...quipment or change its direction 2 Height adjustment Handle or gearbox to adjust height of the equipment 3 Gantry Gantry to fix arm or height adjustment component 4 Rack Rack to hold up X ray device or stand components wheels included for carrying the equipment 5 Caster Wheels for movement with the brake ...

Page 57: ...bile stand arm should be 0 position when moving Mobile stand casters should put on the brake when using Do not strongly push press and lean on the mobile stand side Do not use other products except specified products Do not use to exceed the maximum allowable weight Do not swing to the mobile stand arm and hanging on the mobile stand arm ...

Page 58: ...h the voltage set by 40kV and 120kV 1 Year Service personnel with expertise 2 mAs Lower than management standards of EN60601 2 54 Should be within accuracy boundary of 5 when the mAs value is between 0 4 mAs and 100 mAs 1 Year Service personnel with expertise 3 KV Lower than management standards of EN60601 2 54 Should be within accuracy boundary of 5 when the kV value is between 40kV and 120kV 1 Y...

Page 59: ...ontrol board malfunction Call for service 5 If the console does not display 1 Main power board or SMPS malfunction 2 Main control board malfunction Call for service 6 Option If the touch screen does not operate incorrectly 1 Fail to initialize touch screen 2 Touch screen malfunction 1 Please turn it off and on again 2 Call for service 7 5 The equipment operation checklist for operator Check Item V...

Page 60: ...thin boundary of 5 4 Check that reproducibility of the radiation output The displayed value on the FND should not exceed 40 of the actual value for areas larger than 200 5 Check that remove dirt on Collimator window with soft brush 6 Check that collimator mounting ring is tight 7 Check beam alignment SID 8 Check that all indicator lights are operating 9 Check that all hardware is tightly secured 1...

Page 61: ...pplicable collection point for the recycling of electrical and electronic equipment By ensuring this product is disposed of correctly you will help prevent potential negative consequences for the environment and human health which could otherwise be caused by inappropriate waste handling of this product For more detailed information about recycling this product please refer to local governing ordi...

Page 62: ...ghtning strikes Incidental or indirect loss caused during system manipulation Any or all defect or damages in appearance which do not affect the main functions of the product are not covered by this free of charge warranty Prerequisites for Repair Request When a defect is found stop the using immediately It is strongly recommended to refer to related material on the Service Manual Before a service...

Page 63: ...d to log MAR 0 2 Average degree of aging related short term memory impairment Impaired by 40 resulting in 60 of normal hearing at 500 Hz to 2 kHz 10 2 Service Personnel Profile Considerations Requirement description Education Minimum At least graduate of high school Maximum No maximum Knowledge Minimum Read and understand westernized Arabic numerals when written in Arial font Can distinguish of hu...

Page 64: ...R 11 Compliance Full compliance to the IEC 60601 1 2 2004 and the System s tolerance to EM waves The Diagnostic X ray System is used in the following electromagnetic settings Users of the Diagnostic X ray System should check whether their systems are used in these settings Tolerance test IEC 60601 test level Suitability level Electromagnetic setting guidelines Static electricity discharge ESD IEC ...

Page 65: ...e UT 5 seconds The main power s quality should be equal to the those of general commercial or hospital settings Note Most components in the Diagnostic X ray System have their power supplied from the uninterrupted power supply The IEC61000 4 11 only applies to the Diagnostic X ray System Power Box Magnetic field in the source frequency 50 60Hz IEC 61000 4 8 3A m 3A m The magnetic field in the sourc...

Page 66: ... These calculations should be made in accordance with all of the Diagnostic X ray System s parts including switches and its transmitter receiver s frequency Recommended intervals d 1 17 p d 1 17 p80MHz 800MHz d 2 33 p800MHz 2 5GHz where p is the transmitter receiver s maximum power rating in watts W and d is the recommended interval The magnetic field strength in the fixed RF receiver which has be...

Page 67: ...ile RF communications equipment The Diagnostic X ray System should be used in an electromagnetic setting where RF communication interferences are controlled Users of the Diagnostic X ray System should maintain the minimum intervals between the System and the portable or mobile RF communications equipments to prevent electromagnetic interferences more effectively Maximum output power rating of the ...

Page 68: ... 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 ELBOW LAT 4 6cm 7 9cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 HUMEROUS 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 ANKLE AP 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 ANKEL LAT 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 KNEE 7 9cm 10 12cm 60 66 4 0 5 0 NO NO 17 08 41 96 60 2 0...

Page 69: ...8 10 20 32 YES YES YES 102 8 228 25 374 48 73 4 YES 40 944 CHEST AP 12 16cm 22 24cm 30 34cm 80 80 80 1 0 1 6 2 5 NO NO NO 11 92 19 24 30 22 80 0 6 NO 7 04 CHEST LAT 32 36cm 36 40cm 90 90 2 0 2 5 NO NO 29 752 37 362 90 1 0 NO 14 532 ABDOMEN 8 12cm 18 22cm 28 32cm 72 77 80 10 20 32 YES YES YES 100 05 228 25 392 4 72 4 0 YES 39 872 ...

Page 70: ... 60 63 5 0 5 0 NO NO 34 1 38 03 60 63 2 5 2 5 NO NO 17 08 19 021 HUMEROUS 5 7cm 8 10cm 60 63 5 0 5 0 NO NO 34 1 38 03 60 63 2 5 2 5 NO NO 17 08 19 021 ANKLE AP 5 7cm 8 10cm 60 63 5 0 5 0 NO NO 34 1 38 03 60 63 2 5 2 5 NO NO 17 08 19 021 ANKEL LAT 5 7cm 8 10cm 60 63 5 0 5 0 NO NO 34 1 38 03 60 63 2 5 2 5 NO NO 17 08 19 021 KNEE 7 9cm 10 12cm 60 66 8 0 10 0 NO NO 54 56 84 01 60 66 4 0 5 0 NO NO 17 0...

Page 71: ...9 374 48 CHEST AP 12 16cm 22 24cm 30 34cm 80 80 80 2 0 3 2 5 0 NO NO NO 24 12 38 76 60 7 80 80 80 1 0 1 6 2 5 NO NO NO 11 92 19 24 30 22 CHEST LAT 32 36cm 36 40cm 90 90 4 0 5 0 NO NO 60 192 75 4 90 90 2 0 2 5 NO NO 29 752 37 362 ABDOMEN 8 12cm 18 22cm 28 32cm 72 77 80 20 32 64 YES YES YES 200 35 365 52 788 24 72 77 80 10 16 32 YES YES YES 100 05 182 49 392 4 ...

Page 72: ... 60 1 3 NO 8 92 ELBOW LAT 4 6cm 7 9cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 HUMEROUS 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 ANKLE AP 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 ANKEL LAT 5 7cm 8 10cm 60 63 2 5 2 5 NO NO 17 08 19 021 60 1 3 NO 8 92 KNEE 7 9cm 10 12cm 60 66 4 0 5 0 NO NO 17 08 41 96 60 2 0 NO 13 68 FOOT AP 2 4cm 5 7cm 50 54 2 0 2 5 NO...

Page 73: ... height 5 year old 21 kg 46 lb 113 cm 44 5 in standing height 1 year old 11 kg 24 lb recumbent length 100 cm 39 4 in NOTE The statistics and specifications of this unit and manual can be modified with or without notification for the improvement of performance and safety NOTE These subgroups are listed as a general guide Different subgroups that still cover the broad size range expected for pediatr...

Page 74: ...represent examples for procedures commonly conducted in radiography Based on the needs of a particular practice these protocols may be modified to optimize factors such as image quality or dose reduction Work with your team of Radiologists Medical Physicists and Technologists to evaluate techniques that may reduce radiation dose and provide adequate diagnostic information In addition to the recomm...

Page 75: ... Pediatric Positioning Accessories Approved Pediatric positioning accessories are often useful for certain patients and exams These may be helpful in decreasing motion that may contribute to repeat exposure Understand your facilities guidelines when implementing these devices Protective Apparel Barriers Shielding When applicable utilize proper protective measures as they comply with your facility ...

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