Ecotron EPX-F2800, EPX-F4000 User Manual
Ecotron EPX-F4000 delivers powerful performance with a 4.0kW output. It features a wide kV range (50-110kVp) and mA range (20-80mA) for a great variety of applications. The EPX-F4000 utilizes a D-125 X-ray tube with a 1.8mm focal spot and 15 degrees target angle. This system is suitable for diagnostic imaging, particularly in environments requiring high image quality and throughput.
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EPX-SERISE USER MANUAL Rev. G EPX-Series Diagnostic X-ray System User Manual Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 D/N: EPX-SERISE, Rev. G 1 EPX-SERISE USER MANUAL Rev. G (This page intentionally left blank) 2 EPX-SERISE USER MANUAL Rev. G CONTENTS 1. INTRODUCTION----------------------------------------------------------------------------------------- 6 2. NOTICE OF THE SAFE OPERATION ------------------------------------------------------------- 8 3. RADIATION SAFETY ----------------------------------------------------------------------------------- 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 3 EPX-SERISE USER MANUAL Rev. G REVISON HISTORY Revision Number Date Description A SEP 11, 2013 First Edition B SEP 30, 2014 European Authorized Representative Change C JAN 12, 2015 Manual Updates D Mar 23, 2015 Manual Updates E JUN 11, 2015 Manual Updates F SEP 01, 2015 Manual Updates G JUN 21, 2016 Manual Updates ADVISORY SYMBLOS The following advisory symbols are 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 need to proper use and right operation of equipment. Keep this service manual with the equipment at all times, and review the important information whenever required. 4 EPX-SERISE USER MANUAL Rev. G (This page intentionally left blank) 5 EPX-SERISE USER MANUAL Rev. G 1.INTRODUCTION The EPX Series Innovation diagnostic X-ray system features excellent x-ray Image, quality, accuracy, reproducibility and long-term stability. Fast kV rising time minimize unnecessary patient dose and supply superior Image quality, fast Image response. The operator control console is designed to be simple and user-friendly and one can select or change xray parameters easily using a large soft membrane switch. Indications for use / 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 population for use - Adults - Pediatric patients NOTE Federal law restricts this device to sale by or on the order of physician or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use of order the use of the device. 6 EPX-SERISE USER MANUAL Rev. G 1.1 COMPOSITION This product is composed of the X-ray component part, accessories part. Detail information of each component follows below. (1) X-ray component 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 7 EPX-SERISE USER MANUAL Rev. G 2. NOTICE OF THE SAFE OPERATION This user’s guide is designed to ensure correct use and operation of EPX series. Please read all the lines thoroughly before you use this equipment. Incorrect use and operation exceeding described conditions in this manual may occur damage of the machine and shorten its life. Particular attention must be paid to all the warnings, cautions and notes incorporated herein. This equipment should be used only by the legally qualified persons and practitioners. EPX series is designed with the due consideration for users’ safety and product reliability. It, however, 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 discretion and in case any modification is required unavoidably, ask the help of Ecotron or its authorized dealer for the service. 5. This system has been calibrated for optimal operations. 6. The outside temperature of the device is not as high as burns, but there watch out for a lowtemperature burns if the operator contacts with a certain part(control panel, collimator knob, metal enclosure etc.) for a long time. 7. EPX series should be used to plug the power cord into the wall socket. CAUTION No protection against the ingress of the liquids 8 EPX-SERISE USER MANUAL Rev. G 3. RADIATION SAFETY 1. Users and operators should wear appropriate protecting devices and clothes. 2. Stay distance 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 pregnant patient or children to avoid unnecessary ionizing radiation exposure. CAUTION The ionizing radiation could be dangerous for patients and operators unless following safety regulations are strictly observed. 9 EPX-SERISE USER MANUAL Rev. G 4. SAFETY AND SPECIFICATIONS 4.1 SAFETY AND WARNING SYMBOLS Never allow unqualified personnel to operate the X-ray X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED system. High voltage symbol used to indicate the presence of high voltage. Warning symbol used 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(approximately 325 VDC with line voltage at 230VAC) will remain charged for up to 3 minutes after the AC mains is disconnected or the AC switch is switched off. 10 EPX-SERISE USER MANUAL Rev. G DANGER HIGH VOLTAGE LABEL This label attached to the main fuse cover, main noise filter cover and FET driver board. Main voltage is present inside the xray system whenever the main disconnect is switched on. Additionally, 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 USE WARNING LABEL WARNING This label attached to a control panel. This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. This X-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed. 11 EPX-SERISE USER MANUAL Rev. G Protection earth symbol L N L1 Live line among the single phase line powers. Neutral line among the single phase line powers. First phase line power among the three phase line powers. L2 Second phase line power among the three phase line powers. L3 Third phase line power among the three phase line powers. V~ Single phase AC line voltage. X-ray radiation exposure may be damaging to health, with some effects being cumulative and extending over periods of many months or even years. X-ray operators should avoid any exposure to the primary beam and take protective measures to safeguard against scatter radiation. Scatter radiation is caused by any object in the path of the primary beam and may be of equal or less 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 associated with the servicing of high voltage equipment and the danger of excessive exposure to X-ray radiation during system operation. ● Wear protective clothing. Protective aprons and gloves with an equivalent of a minimum of 1/64”(0.35mm) of lead are recommended. ● To protect the patient against radiation, always use radiation protection accessories in addition to devices which are fitted to the X-ray system ● Keep as large a distance as possible away from the object being exposed and the X-ray tube assembly. 12 EPX-SERISE USER MANUAL Rev. G ● Never operate this X-ray system in areas where there is a risk of explosion. Detergents and disinfectants, including those used on patients, may create explosive mixtures of gases. Please observe the relevant regulations. ● The operator console or anything electrically connected to it, must never be used within 6ft(1.8m) of the patient environment. ● Do not place 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). ● Only trained maintenance staff may remove the covers of the x-ray system. ● Contain an instruction not to position the ME EQUIPMENT so that it is difficult to operate the disconnection device. 13 EPX-SERISE USER MANUAL Rev. G 4.2 COMPOSITION LABEL 4.2.1 EPX-F1600 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) HV Mono Block Tank EMB-F1600 Series Output power: 1.6kW , mA range: 12-30mA, Line Power: 200-240V KVP range: 40-90kVp , 50/60Hz Inserted X-ray Tube D-125 Focal spot: 1.2mm x 1.2mm, Target angle: 16 degrees Anode Heat Storage: 50kHU Inherent Filtration: At least 0.8mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Diagnostic X-ray System EPX-F1600 (S/W: Ver ) Input Power: 200~240V, 50/60Hz Output power: 1.6kW @ 50kV, 30mA KVP range: 40-90kVp, mA range: 12-30mA, mAs Range: 0.4-32mAs ▪ 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 Inserted X-ray Tube D-125 ▪ Focal Spot: 1.2mm x 1.2mm, Inherent Filtration: At least 0.8mmAl Target Angle: 16 degrees, Anode Heat Storage: 50kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 14 EPX-SERISE USER MANUAL Rev. G 4.2.2 EPX-F2400 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) HV Mono Block Tank EMB-F2400 Series Output power: 2.4kW , mA range: 16-40mA, Line Power: 200-240V KVP range: 40-100kVp , 50/60Hz Inserted X-ray Tube D-125 Focal spot: 1.2mm x 1.2mm, Target angle: 16 degrees Anode Heat Storage: 50kHU Inherent Filtration: At least 0.8mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Digital X-ray System EPX-F2400 (S/W: Ver ) Input Power: 200~240V , 50/60Hz, 5.7kVA, Standby 150VA Output power: 2.4kW @ 60kV, 40mA KVP range: 40-100kVp, mA range: 16-40mA, 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 Inserted X-ray Tube D-125 ?Focal Spot: 1.2mm x 1.2mm, Target Angle: 16 degrees, Inherent Filtration: At least 0.8mmAl Anode Heat Storage: 50kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 15 EPX-SERISE USER MANUAL Rev. G 4.2.3 EPX-F2800 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) HV Mono Block Tank EMB-F2800 Series Output power: 2.8kW , mA range: 14-40mA, Line Power: 200-240V KVP range: 40-120kVp , 50/60Hz Inserted X-ray Tube D-125 Focal spot: 1.2mm x 1.2mm, Target angle: 16 degrees Anode Heat Storage: 50kHU Inherent Filtration: At least 0.8mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Diagnostic X-ray System EPX-F2800 (S/W: Ver ) 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 exposure: rest time 5min Inserted X-ray Tube D-125 ▪ Focal Spot: 1.2mm x 1.2mm, Target Angle: 16 degrees, Inherent Filtration: At least 0.8mmAl Anode Heat Storage: 50kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 16 EPX-SERISE USER MANUAL Rev. G 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) HV Mono Block Tank EMB-F3200 Series Output power: 3.2kW , mA range: 25-60mA, Line Power: 200-240V KVP range: 40-100kVp , 50/60Hz Inserted X-ray Tube D-205B Focal spot: 2.0mm x 2.0mm, Target angle: 20 degrees Anode Heat Storage: 40kHU Inherent Filtration: At least 0.8mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Diagnostic X-ray System EPX-F3200 (S/W: Ver ) 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 Inserted X-ray Tube D-205B ▪ Focal Spot: 2.0mm x 2.0mm, Target Angle: 20 degrees, Inherent Filtration: At least 0.8mmAl Anode Heat Storage: 40kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 17 EPX-SERISE USER MANUAL Rev. G 4.2.5 EPX-F4000 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) HV Mono Block Tank EMB-F4000 Series Output power: 4.0kW , mA range: 20-80mA, Line Power: 200-240V KVP range: 50-110kVp , 50/60Hz Inserted X-ray Tube OX/110-15 Focal spot: 1.8mm x 1.8mm, Target angle: 15 degrees Anode Heat Storage: 42kHU Inherent Filtration: At least 0.5mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Diagnostic X-ray System EPX-F4000 (S/W: Ver ) 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 exposure: rest time 5min Inserted X-ray Tube OX/110-15 ▪ Focal Spot: 1.8mm x 1.8mm, Target Angle: 15 degrees, Inherent Filtration: At least 0.5mmAl Anode Heat Storage: 42kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 18 EPX-SERISE USER MANUAL Rev. G 4.2.6 EPX-F5000 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) HV Mono Block Tank EMB-F5000 Series Output power: 5.0kW , mA range: 20-100mA, Line Power: 200-240V KVP range: 50-110kVp , 50/60Hz Inserted X-ray Tube OX/110-15 Focal spot: 1.8mm x 1.8mm, Target angle: 15 degrees Anode Heat Storage: 42kHU Inherent Filtration: At least 0.5mmAl Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Diagnostic X-ray System EPX-F5000 (S/W: Ver ) 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 exposure: rest time 5min Inserted X-ray Tube OX/110-15 ▪ Focal Spot: 1.8mm x 1.8mm, Target Angle: 15 degrees, Inherent Filtration: At least 0.5mmAl Anode Heat Storage: 42kHU 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. Ecotron Co., Ltd Made by Korea 2015.03 #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 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 19 EPX-SERISE USER MANUAL Rev. G 4.2.7 EPX-SERIES COLLIMATOR COMMON LABEL TO ALL MODELS- COLLIMATOR This is label is attached on side of collimator of the diagnostic x-ray system. (Example) Beam Limiting Device(Collimator) EPX-Collimator ▪ Input Power: 24V(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 Certification Statement ▪ This product complies with 21 CFR 1020.30 – 1020.31 ▪ This product complies with 21 CFR Subchapter J. Ecotron Co., Ltd Made by Korea #504~505Ho, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul, Korea 20 EPX-SERISE USER MANUAL Rev. G 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 21 EPX-SERISE USER MANUAL Rev. G 4.3 Symbol on the Packing of X-ray system SYMBOL Description KEEP DRY: This symbol means keep away from rain Fragile: This symbol means do not drop of product UP: This symbol means “This way up” CAUTION INCORRECT CONNECTIONS OR USE OF UNAPPROVED EQUIPMENT MAY RESULT IN INJURY OR EQUIPMENT DAMAGE. WARNING THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE EXPOSURE FACTORS AND OBSERVED. 22 OPERATING INSTRUCTIONS ARE EPX-SERISE USER MANUAL Rev. G WARNING PROPER USE AND SAFE OPERATING PRACTICES WITH RESPECT TO X-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 AFTERSALE 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.,Ltd ALSO ASSUMES NO RESPONSIBILITY FOR X-RAY RADIATION OVEREXPOSURE OF PATIENTS OR PERSONNEL RESULTING FROM POOR OPERATING TECHNIQUES OR PROCEDURS. CAUTION DO NOT EXCEED THE TUBE MAXIMUM OPERATING LIMITS SHOWN IN THE XRAY TUBE DATA SECTION AT THE END OF THE OPERATOR’S MANUAL. INTENDED LIFE AND RELIABILITY WILL NOT BE OBTAINED UNLESS X-RAY SYSTEMS ARE OPERATED WITHIN PUBLISHED SPECIFICATION. 23 EPX-SERISE USER MANUAL Rev. G 4.4. EPX-Series DUTY CYCLE LIMIT NOTE THE FOLLOWING SECTION CONTAINS IMPORTANT INFORMATION. PLEASE READ AND UNDERSTAND THIS MATERIAL BEFORE CONTINUING. Internal X-ray system components will heat up during normal use of the x-ray system. This is similar to X-ray tube heating during normal x-ray system operation. The amount of heat produced is proportional to the product of kV,mA and time. CAUTION THIS X-RAY SYSTEM HAS TEMPERATURE MONITORING 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 MESSAGE IS NO LONGER DISPLAYED. 24 EPX-SERISE USER MANUAL Rev. G 4.5 DAILY X-RAY TUBE WARM-UP PROCEDURE NOTE THE FOLLOWING PROCEDURE PRODUCES X-RAYS. OBSERVE ALL SAFETY PRECAUTIONS TO PROTECT PERSONNEL. Use the procedure when the generator has not been used for several days. This procedure provides for exposures at medium power before the 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. 25 EPX-SERISE USER MANUAL Rev. G 4.6 APPLICABLE STANDARDS The EPX series comply with the regulatory requirements and design standards in this section as follows: This product complies with DHHS requirements of 21 CFR Subchapter J. 1) SAFETY ● EN 60601-1:2006/A1:2013 ● EN60601-1-3:2008 ● EN60601-1-6:2010 ● EN62366:2008 ● EN60601-2-28:2010 ● EN60601-2-54:2009 2) EMC ● EN60601-1-2:2007 The EPX series X-ray system with CE marking comply with the European Council Directive concerning Medical Devices. One of the harmonized standards of this Directive defines the permitted levels of electromagnetic emission from this equipment and its required immunity from the electromagnetic emission of other devise. It is not possible, however to exclude with absolute certainty the possibility that other high frequency electronic equipment, which is fully compliant to the EMC regulations, 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 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) ● EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) ● EN980:2008 Symbols for use in the labelling of medical devices ● EN1041:2008 ● EN62304:2006 Information supplied by the manufacturer of medical devices Medical device software - Software life-cycle processes IEC 62304:2006 ● MEDDEV 2.12.1/Rev.8 Medical Devices Vigilance System ● MEDDEV 2.12.2/Rev.2 Post Market Clinical Follow-up studies 4) CLINICAL EVALUATION ● MEDDEV 2.7.1/Rev.3 Clinical evaluation: Guide for manufacturers and notified bodies 26 EPX-SERISE USER MANUAL Rev. G 4.7 SPECIFICATION 4.7.1 CLASSIFICATION OF THE DEVICE CLASSIFICATION – EN 60601-1 ● Type of protection against short circuit: CLASS I ● Degree of protection against direct and indirect contact: TYPE B ● Degree of protection against ingress of water and particulate matter: IPX0 ● 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 the requirements of IEC60580, and displays output doses by calculating the measured reference data. 27 EPX-SERISE USER MANUAL Rev. G 4.7.2 SPECIFICATION TABLE 4.7.2.1 EPX-F1600 Max Output Power 1.6 kW Voltage 200V-240V Phase & Frequency Single / 50/60 Hz Input Power Radiography kV Range in 1kV steps (40KV ~ 90KV) Tube voltage current mAs 40KV ~ 50KV 30mA 0.4 ~ 20 40KV ~ 50KV 25mA 25~32 51KV ~ 60KV 25mA 0.4 ~ 20 51KV ~ 60KV 20mA 25~32 61KV ~ 70KV 20mA 0.4 ~ 20 61KV ~ 70KV 15mA 25~32 71KV ~ 80KV 18 mA 0.4 ~ 20 71KV ~ 80KV 14 mA 25~32 81KV ~ 90KV 16 mA 0.4 ~ 20 81KV ~ 90KV 12 mA 25~32 MAs 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 Collimator Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl 3.3 mm Al eq. @ 75kV Type Double slit type, manual operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp 24V, 50W Halogen @100cm SID @ 100cm SID with Laser Pointer Weight 13 Kg 28 EPX-SERISE USER MANUAL Rev. G 4.7.2.2 EPX-F2400 Max Output Power 2.4 KW Input Power Voltage 200V-240V Phase & Frequency Single, 50/60 Hz Radiography KV Range in 1KV steps (40KV ~ 100KV) Tube voltage current mAs 40KV ~ 60KV 40mA 0.4 ~ 64 40KV ~ 60KV 35mA 80 ~ 100 61KV ~ 70KV 30mA 0.4 ~ 100 71KV ~ 80KV 30mA 0.4 ~ 32 71KV ~ 80KV 25mA 40 ~80 81KV ~ 90KV 25mA 0.4 ~ 40 81KV ~ 90KV 20mA 50 ~ 80 91KV ~ 100KV 20mA 0.4 ~ 80 mAs Range 0.4mAs – 100mAs, 25steps Max. 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 Collimator Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl 3.3 mm Al eq. @ 75kV Type Double slit type, manual operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp 24V, 50W Halogen @100cm SID @ 100cm SID with Laser Pointer Weight 13 Kg 29 EPX-SERISE USER MANUAL Rev. G 4.7.2.3 EPX-F2800 Max Output Power 2.8 kW Voltage 200V-240V Phase & Frequency Single / 50/60 Hz Input Power Radiography kV Range in 1kV steps (40KV ~ 120KV) Tube voltage current mAs 40KV ~ 60KV 40mA 0.4 ~ 100 61KV ~ 70KV 30mA 0.4 ~ 64 61KV ~ 70KV 25mA 80 ~ 100 71KV ~ 80KV 35mA 0.4 ~ 10 71KV ~ 80KV 30mA 13 ~ 32 71KV ~ 80KV 25mA 40 ~ 80 81KV ~ 90KV 30mA 0.4 ~ 10 81KV ~ 90KV 25mA 13 ~ 40 81KV ~ 90KV 20mA 50 ~ 80 91KV ~ 100KV 25mA 0.4 ~ 13 91KV ~ 100KV 20mA 16 ~ 50 91KV ~ 100KV 16mA 64 ~ 80 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 Model Name D-125 (Toshiba) Focal Spot 1.2mm x 1.2mm Target Angle 16 degree Anode Heat Storage 50 KHU X-ray Tube Total Filtration Collimator Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl 3.3 mm Al eq. @ 75kV Type Double slit type, manual operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II @100cm SID with Laser Pointer 30 @ 100cm SID EPX-SERISE USER MANUAL Rev. G Timer Push button illuminator with 30 sec timer Lamp 24V, 50W Halogen Weight 13 Kg 4.7.2.4 EPX-F3200 Max Output Power 3.2 KW Voltage 200V-240V Phase & Frequency Single / 50/60 Hz Input Power Radiography kV Range in 1KV steps (40KV ~ 100KV) Tube voltage current mAs 40KV ~ 50KV 60mA 0.4 ~ 100 51KV ~ 60KV 50mA 0.4 ~ 80 61KV ~ 70KV 40mA 0.4 ~ 100 71KV ~ 80KV 40mA 0.4 ~ 32 71KV ~ 80KV 35mA 40 ~80 81KV ~ 90KV 30mA 0.4 ~ 80 91KV ~ 100KV 30mA 0.4 ~ 50 91KV ~ 100KV 25mA 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 Collimator Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl 3.3 mm Al eq. @ 75kV Type Double slit type, manual operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp 24V, 50W Halogen @100cm SID @ 100cm SID with Laser Pointer Weight 13 Kg 31 EPX-SERISE USER MANUAL Rev. G 4.7.2.5 EPX-F4000 Max Output Power 4.0 KW Voltage 200V-240V Phase & Frequency Single / 50/60 Hz Input Power Tube voltage current mAs 50KV 80mA 0.4~16mAs 50KV 70mA 20~32mAs 50KV 60mA 40~100mAs 51KV ~ 60KV 60mA 0.4~32mAs 51KV ~ 60KV 50mA 40~100mAs 61KV ~ 70KV 50mA 0.4~32mAs Radiography kV Range in 1KV steps 61KV ~ 70KV 40mA 40~100mAs (50KV ~ 110KV) 71KV ~ 80KV 45mA 0.4~10mAs 71KV ~ 80KV 40mA 13~80mAs 81KV ~ 90KV 35mA 0.4~32mAs 81KV ~ 90KV 30mA 40~80mAs 91KV ~ 100KV 30mA 0.4~32mAs 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 Model Name OX/110-15 (C.E.I.) Focal Spot 1.8mmx1.8mm Target Angle 15 degree Anode Heat Storage 42kHU X-ray Tube Total Filtration Collimator with Laser Pointer Tube:0.5mmAl / collimator: 0.5mmAl / filter:2.0mmAl 3.0 mm Al eq. @ 75kV Type Double slit type, manual operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II Timer Push button illuminator with 30 sec timer 32 @100cm SID @ 100cm SID EPX-SERISE USER MANUAL Rev. G Lamp Weight 24V, 50W Halogen 13 Kg 4.7.2.6 EPX-F5000 Max Output Power 5.0 KW Voltage 200V-240V Phase & Frequency Single / 50/60 Hz Input Power Tube voltage current mAs 50KV 100mA 0.4~10mAs 50KV 80mA 13~32mAs 50KV 70mA 40~100mAs 51KV ~ 60KV 80mA 0.4~10mAs 51KV ~ 60KV 70mA 13~32mAs 51KV ~ 60KV 60mA 40~100mAs 61KV ~ 70KV 70mA 0.4~10mAs 61KV ~ 70KV 60mA 13~32mAs 61KV ~ 70KV 50mA 40~100mAs Radiography kV Range in 1KV steps 71KV ~ 80KV 60mA 0.4~10mAs (50KV ~ 110KV) 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 ±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.) 33 EPX-SERISE USER MANUAL Rev. G Focal Spot 1.8mmx1.8mm Target Angle 15 degree Anode Heat Storage 42kHU Tube:0.5mmAl / collimator: 0.5mmAl / filter:2.0mmAl Total Filtration Collimator with Laser Pointer 3.0 mm Al eq. @ 75kV Type Double slit type, Manually operation Min. X-ray Field Size 0cm x 0cm Max X-ray Field Size 36cm x 36cm Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp 24V, 50W Halogen Weight @100cm SID @ 100cm SID 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 White Red Green Ready Common Exposure Cores Shell Material White, Engineering plastics Useful time 1.2 million times 4.7.2.8 Mobile Stand Two step X-ray exposure hand switch Available products EPX Series only Arm angle 0° ~ 150° Max arm vertical 1.4 m Wt. Load(허용무게) 30 kg Wheel size 50Ø, 24mm Weight(Mobile Stand) 11.6 kg 34 EPX-SERISE USER MANUAL Rev. G 4.7.3 kV, mAs, mA TABLE 4.7.3.1 EPX-F1600 mAs & Time TABLE 40KV ~ 50KV KV 30mA Tube Current[mA] mAs 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 Current Time[ms] 13 17 20 27 33 43 53 67 83 25mA 3.2 4.0 5.0 6.4 8.0 10 13 16 20 25 32 107 133 167 213 267 333 433 533 667 1000 1280 51KV ~ 60KV 25mA 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 16 20 24 32 40 52 64 80 100 20mA 3.2 4.0 5.0 6.4 8.0 10 13 16 20 25 32 128 160 200 256 320 400 520 640 800 1250 1600 61KV ~ 70KV 20mA 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 20 25 30 40 50 65 80 100 125 15mA 3.2 4.0 5.0 6.4 8.0 10 13 16 20 25 32 160 200 250 320 400 500 650 800 1000 1667 2133 71KV ~ 80KV 18mA 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 22 28 33 44 56 72 89 111 139 14mA 3.2 4.0 5.0 6.4 8.0 10 13 16 20 25 32 178 222 278 356 444 556 722 889 1111 1786 2286 81KV ~ 90KV 16mA 12mA 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 25 31 38 50 63 81 100 125 156 200 250 313 400 500 625 813 1000 1250 2083 2667 35 EPX-SERISE USER MANUAL Rev. G 4.7.3.2 EPX-F2400 mAs & Time TABLE 40KV ~ 60KV KV mAs 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 4.0 5.0 8.0 10 13 16 20 25 32 40 50 64 80 40mA Tube Current[mA] Current Time[ms] 6.4 10 13 15 20 25 33 40 50 63 80 100 125 100 35mA 160 200 250 325 400 500 625 800 8.0 10 13 16 20 25 32 267 333 433 533 667 833 8.0 10 13 16 20 25 1000 1250 1600 2286 2857 61KV ~ 70KV 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 40 50 64 80 100 30mA 13 17 20 27 33 43 53 67 83 107 133 167 213 1067 1333 1667 2133 2667 3333 71KV ~ 80KV 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 32 40 50 30mA 13 17 20 27 33 43 53 67 83 107 64 80 25mA 133 167 213 267 333 433 533 667 833 8.0 10 13 16 20 25 1067 1600 2000 2560 3200 81KV ~ 90KV 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 32 40 50 25mA 16 20 24 32 40 52 64 80 100 128 160 64 80 20mA 200 256 320 400 520 640 800 8.0 10 13 16 20 400 500 650 800 1000 1280 1600 2500 3200 4000 91KV ~ 100KV 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 25 32 40 50 64 80 20mA 20 25 30 40 50 65 80 100 125 160 200 250 36 320 1000 1250 1600 2000 2500 3200 4000 EPX-SERISE USER MANUAL Rev. G 4.7.3.3 EPX-F2800 mAs & Time TABLE KV mAs 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 Tube Current[mA] Current Time[ms] 10 13 15 20 25 33 40 50 63 80 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 3.2 13 17 20 27 33 43 53 67 83 107 0.4 0.5 0.6 0.8 1.0 1.3 1.6 3.2 11 14 17 23 29 37 46 2.0 2.5 35mA 57 71 40KV ~ 60KV 4.0 5.0 6.4 8.0 40mA 100 125 160 200 61KV ~ 70KV 4.0 5.0 6.4 8.0 30[mA} 133 167 213 267 71KV ~ 80KV 4.0 5.0 6.4 8.0 91 114 0.4 0.5 0.6 0.8 1.0 1.3 1.6 3.2 4.0 13 17 20 27 33 43 53 2.0 2.5 30mA 67 83 107 133 0.4 0.5 0.6 0.8 1.0 1.3 1.6 3.2 4.0 16 20 24 32 40 52 64 2.0 2.5 25mA 80 100 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 22 28 33 44 56 72 89 111 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 25 31 38 50 63 81 100 125 10 13 16 20 25 32 250 325 400 500 625 800 10 13 16 20 25 32 40 50 333 433 533 667 833 10 13 16 32 40 50 143 183 229 81KV ~ 90KV 5.0 6.4 8.0 286 433 533 20 25 30mA 667 833 10 13 16 167 213 267 91KV ~ 100KV 5.0 6.4 8.0 333 520 640 25 32 40 50 64 80 25mA 20mA 800 1000 1280 1600 2500 3200 4000 10 13 16 20 25 320 400 520 800 8.0 10 13 16 20 25 32 444 556 722 889 8.0 10 13 16 20 25 32 500 625 813 128 160 200 256 101KV ~ 110KV 2.5 3.2 4.0 5.0 6.4 18mA 139 178 222 278 356 111KV ~ 120KV 2.5 3.2 4.0 5.0 6.4 16mA 156 200 250 313 400 37 40 50 64 80 100 1000 1250 1600 2000 2500 64 80 100 25mA 1067 1333 1667 2133 3200 4000 64 80 25mA 1067 1600 2000 2560 3200 20 32 40 50 64 80 20mA 16mA 1000 1250 1600 2000 2500 4000 5000 40 50 64 16mA 1111 1389 1778 2500 3125 4000 40 50 14mA 1000 1250 1786 2286 2857 3571 EPX-SERISE USER MANUAL Rev. G 4.7.3.4 EPX-F3200 mAs & Time TABLE 40KV ~ 50KV KV mAs 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 Current Time[ms] 8.0 10 13 16 20 25 32 40 50 64 133 167 217 267 333 417 533 667 833 8.0 10 13 16 20 25 32 40 50 160 200 260 320 400 500 640 800 8.0 10 13 16 20 25 32 40 200 250 325 400 500 625 800 8.0 10 13 16 20 25 32 80 100 60mA Tube Current[mA] 7 8 10 13 17 22 27 33 42 53 67 83 107 1067 1333 1667 51KV ~ 60KV 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 64 80 50mA 8 10 12 16 20 26 32 40 50 64 80 100 128 1000 1280 1600 61KV ~ 70KV 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 50 64 80 100 40mA 10 13 15 20 25 33 40 50 63 80 100 125 160 1000 1250 1600 2000 2500 71KV ~ 80KV 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 40 50 40mA 10 13 15 20 25 33 40 50 63 80 64 80 35mA 100 125 160 200 250 325 400 500 625 800 8.0 10 13 16 20 25 32 267 333 433 533 667 833 8.0 10 13 16 20 25 1143 1429 1829 2286 81KV ~ 90KV 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 40 50 64 80 30mA 13 17 20 27 33 43 53 67 83 107 133 167 213 1067 1333 1667 2133 2667 91KV ~ 100KV 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 30mA 13 17 20 27 33 43 53 67 83 107 133 167 38 32 40 50 64 80 25mA 213 267 333 433 533 667 833 1067 1333 1667 2560 3200 EPX-SERISE USER MANUAL Rev. G 4.7.3.5 EPX-F4000 mAs & Time TABLE KV mAs 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 Tube Current[mA] Current Time[ms] 5 6 8 10 13 16 20 25 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 7 8 10 13 17 22 27 33 42 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 8 10 12 16 20 26 32 40 50 0.4 0.5 0.6 0.8 1.0 1.3 1.6 9 11 13 18 22 29 36 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 11 14 17 23 29 37 46 57 71 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 13 17 20 27 33 43 53 67 83 0.4 0.5 0.6 0.8 1.0 1.3 1.6 2.0 2.5 16 20 24 32 40 52 64 80 100 2.5 3.2 80mA 31 40 2.0 2.5 45mA 44 56 4.0 5.0 50 63 50KV 6.4 40 50 667 833 32 40 50 417 533 800 20 25 32 40 320 400 500 640 13 16 20 25 222 325 400 500 625 32 40 50 64 80 40mA 800 1000 1250 1600 2000 10 13 16 20 25 32 143 183 229 91KV ~ 100KV 5.0 6.4 8.0 286 371 457 571 714 914 10 13 16 20 25 167 213 267 101KV ~ 110KV 3.2 4.0 5.0 6.4 8.0 25mA 128 160 200 256 320 333 433 533 667 833 10 13 16 20 25 400 520 640 800 3.2 4.0 60mA 53 67 3.2 4.0 50mA 64 80 3.2 4.0 71 89 3.2 4.0 35mA 91 114 3.2 4.0 30mA 107 133 8.0 10 13 16 20 80 100 51KV ~ 60KV 5.0 6.4 8.0 125 163 200 286 10 13 16 20 25 83 107 133 61KV ~ 70KV 5.0 6.4 8.0 167 217 267 333 10 13 16 100 128 160 71KV ~ 80KV 5.0 6.4 8.0 200 260 10 111 142 178 81KV ~ 90KV 5.0 6.4 8.0 39 25 32 70mA 357 457 64 80 100 60mA 1067 1333 1667 64 80 100 50mA 1000 1280 1600 2000 50 64 80 100 40mA 1000 1250 1600 2000 2500 40 50 64 80 30mA 1333 1667 2133 2667 32 40 50 32 40 50 64 80 25mA 1067 1600 2000 2560 3200 64 80 20mA 1000 1280 2000 2500 3200 4000 EPX-SERISE USER MANUAL Rev. G 4.7.3.6 EPX-F5000 mAs & Time TABLE KV mAs 0.4 0.5 0.6 0.8 1.0 1.3 1.6 Tube Current[mA] Current Time[ms] 4 5 6 8 10 13 16 0.4 0.5 0.6 0.8 1.0 1.3 1.6 5 6 8 10 13 16 20 0.4 0.5 0.6 0.8 1.0 1.3 1.6 6 7 9 11 14 19 23 0.4 0.5 0.6 0.8 1.0 1.3 1.6 7 8 10 13 17 22 27 0.4 0.5 0.6 0.8 1.0 1.3 1.6 8 10 12 16 20 26 32 0.4 0.5 0.6 0.8 1.0 1.3 1.6 9 11 13 18 22 29 36 0.4 0.5 0.6 0.8 1.0 1.3 1.6 10 13 15 20 25 33 40 2.0 2.5 100mA 20 25 3.2 4.0 5.0 32 40 50 2.0 2.5 80mA 25 31 3.2 50KV 6.4 8.0 10 13 16 100 163 200 4.0 64 80 51KV ~ 60KV 5.0 6.4 8.0 10 13 16 40 50 63 125 186 229 2.0 2.5 70mA 29 36 3.2 4.0 80 100 61KV ~ 70KV 5.0 6.4 8.0 10 13 16 46 57 71 143 217 267 2.0 2.5 60mA 33 42 3.2 4.0 91 114 71KV ~ 80KV 5.0 6.4 8.0 10 13 16 53 67 83 167 260 320 2.0 2.5 50mA 40 50 3.2 4.0 107 133 81KV ~ 90KV 5.0 6.4 8.0 10 13 16 64 80 200 325 400 2.0 2.5 45mA 44 56 3.2 4.0 100 128 160 91KV ~ 100KV 5.0 6.4 8.0 10 13 16 71 89 222 325 400 2.0 2.5 40mA 50 63 3.2 4.0 111 142 178 101KV ~ 110KV 5.0 6.4 8.0 10 13 16 80 100 125 250 433 533 40 160 200 20 25 80mA 250 313 20 25 70mA 286 357 20 25 60mA 333 417 20 25 50mA 400 500 20 25 40mA 500 625 20 25 40mA 500 625 20 25 30mA 667 833 32 40 50 400 571 714 32 40 50 457 667 833 32 40 50 533 800 32 40 50 40 50 40 50 40 50 640 32 800 32 800 32 64 80 100 70mA 914 1143 1429 64 80 100 60mA 1067 1333 1667 64 80 100 50mA 1000 1280 1600 2000 64 80 100 40mA 1000 1250 1600 2000 2500 64 80 100 30mA 1333 1667 2133 2667 3333 64 80 100 30mA 1333 1667 2133 2667 3333 64 80 100 20mA 1067 2000 2500 3200 4000 5000 EPX-SERISE USER MANUAL Rev. G 4.7.4 Dosimetry Data TABLE 4.7.4.1 EPX-F1600 Unit: μGy*㎡ kV 40 50 60 70 80 90 0.4 0.9 1.9 2.8 3.6 4.6 5.4 5 11.1 21.8 34.1 47.2 60.7 75.4 32 70.7 139 218.2 302.8 392.4 489 mAs 4.7.4.2 EPX-F2400 Unit: μGy*㎡ kV 40 50 60 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 70.7 139 218.2 302.8 392.4 489 590.1 986 1231.2 1489.9 mAs 50 64 80 100 221.3 433.8 681.3 949.3 4.7.4.3 EPX-F2800 Unit: μGy*㎡ kV 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 mAs 50 1256.5 64 1392.7 80 100 986 221.3 433.8 681.3 949.3 41 1231.2 1489.9 EPX-SERISE USER MANUAL Rev. G 4.7.4.4 EPX-F3200 Unit: μGy*㎡ kV 40 50 60 70 80 90 100 0.4 0.8 1.7 2.8 4 5.3 6.3 7.5 5 12.6 25.4 40.1 56.5 74.2 93 112.8 32 81.9 165.8 259.1 363.7 479.6 601.9 731.1 1198.9 1508.3 1843.9 mAs 80 650.1 100 261.7 522.7 1138.7 4.7.4.4 EPX-F4000 Unit: μGy*㎡ kV 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 1028.2 1307.3 1573.5 1914.7 mAs 80 100 429.9 693.6 974.4 4.7.4.4 EPX-F5000 Unit: μGy*㎡ kV 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 32 132.5 217.8 310 406.6 513.9 615 737.8 100 429.9 693.6 974.4 1287.3 1637.7 1973 2405.2 mAs 42 EPX-SERISE USER MANUAL Rev. G 4.7.5 MECHANICAL SPECIFICATION EPX-F1600/F2400/F2800/F3200/F4000/F5000 Dimension (unit : mm) Side view Front view 43 EPX-SERISE USER MANUAL Rev. G Hand Switch Dimension (unit : mm) Mobile Stand Dimension (unit : mm) 44 EPX-SERISE USER MANUAL Rev. G 4.8 WORKING ENVIRONMENT Avoid the following places for the normal operation and safe storage: a. where the equipment is exposed to water vapor. b. where the equipment is exposed to direct sunlight. c. where the equipment is exposed to dust. d. where the equipment is exposed to high humidity. e. where there is a ventilation problem. f. where the equipment is exposed to salty atmosphere. g. where 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 storage and transportation, the following range of temperature and humidity must be kept while using. Environment for storage and transportation Temperature range -25°C ~ 60°C (-13°F ~ 140°F) Relative Humidity Range 10% ~ 95% RH 45 EPX-SERISE USER MANUAL Rev. G 4.9 CUSTOMER SUPPORT Address any questions regarding X-ray system operation to: ECOTRON Co.,Ltd #505Ho, Hanshin IT Tower II, 60-18, Gasang-Dong, Geumcheon-Gu, Seoul 153-023, Korea TEL:+82-2-2025-3760, FAX:+82-2-2025-3764 E-mail:[email protected] 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:[email protected] 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 46 EPX-SERISE USER MANUAL Rev. G 5. SYSTEM CONFIGURATION EPX Series is a radiological device for professional radiologist uses. It should be applied for the radiographic diagnosis and operated by qualified practitioners. Users have to comply with safety and health regulations concerning the ionizing radiation protection and the electrical and mechanical safety of the veterinary medical devices. 5.1 PREPARATION FOR OPERATION 5.1.1 Operation Practices a. Wear a lead apron while making exposures. b. Stay at least 6.5feet (2m) away from the unit or extend the cord of hand switch as long as possible in order to secure enough space for your safety. c. Use proper field size and technical values for each procedure to minimize x-ray exposure dose and obtain the best radiographic result. d. When you make exposure to the patient on the 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 devices are necessary for the user or not. 5.1.2 Positioning of the patient against the collimator a. Place a loaded cassette on the patient’s backside. b. Arrange the SID (Source to Image Receptor Distance) using a tape measure (2 meter) located on the side of the collimator. When the SID is 1 meter, the device is shown the best performance. c. Turn on the collimator lamp and laser pointer by the pushing collimator/laser switch is on. d. Adjust the size of the x-ray beam in accordance with the film size using the x-ray field adjustment knobs. The collimator and laser pointer will be turned off after 30 seconds by internal timer. 47 EPX-SERISE USER MANUAL Rev. G The operation of the machine should not be started unless all CAUTION verifications and connections are fully checked. For the first time installation of the (machine) or operation after long period of non-use, it needs to be preheated to secure long service life of the tube. Following method of pilot test will relieve the damage on the x-ray tube. Operate the (machine) with low KV/mAs CAUTION values (50KV/5mAs) three times in row and execute with higher values (70KV/5mAs) three times in row again. Then high KV/mAs values (90kV/5mAs) will be applied without trouble. 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 might cause X-ray system damage due to overheating. The generator should be allowed to cool sufficiently such that this message is no longer CAUTION displayed. If the operator uses to continue two times that is high tube voltage and high mAs condition, it is recommended to use again after 5 minute rest time. 48 EPX-SERISE USER MANUAL Rev. G 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 Switch Connector Connect the hand switch cable Please check whether the voltage and frequency of the input power are in accordance with the figures written in the system labels, which attached on the body of the machine. The level of input WARNING voltage fluctuation should be within ±10% of the nominal values. Always power switch is off before connected the power cable. CAUTION To avoid the risk of electric shock, this equipment must only be WARNING connected to a supply main with protective earth. 49 EPX-SERISE USER MANUAL Rev. G 6. OPERATION MODE 6.1 EPX-F1600/F2400/F2800/F3200/F4000/F5000 No. Description Function 1 KV indicator Display KV value 2 mAs indicator Display mAs value 3 mAs & sec indicator Display mAs & sec indicator 4 KV up/down control switch Select KV value by up or down buttons 5 mAs up/down control switch Select mAs value by up or down buttons 6 Ready indicator Lighted push the hand switch one 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 & sec select switch The switch select between mAs and sec 14 Wait lamp Lighted until the second exposure started 15 APR Switch (1-6) Memory setting is available for 6 APR data 16 Save APR Data Save the selected APR Data 50 EPX-SERISE USER MANUAL Rev. G 6.1.1 Normal Mode a. Connect power plug into the device. b. Turn on the power switch located on the back of the equipment. c. Select the KV values using the KV up/down switch. d. Select the mAs values using the mAs up/down switch. e. Positioning the machine at the ready condition by pushing the hand one time switch. f. When the “Ready LED” lighted, press the hand switch again and make exposure. During the x-ray exposure, “X-ray LED” will be lighted on. g. After the exposure is ended, “wait LED” sign will be lighted on for the waiting time and beep sound will be heard. 6.1.2 APR Mode a. Connect power plug into the device. b. Turn on the 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” sign will be lighted on for the waiting time and beep sound will be heard. 6.1.3 Dosimetry Data Display Mode a. After the exposure is ended, dosimetry data will be displayed on the FND for two seconds. b. Push the button 1 for two seconds, there will be displayed a dosimetry data for current kV and mAs value. c. Push the button 2 for two seconds, there will be displayed the total exposed dose. d. Push the button 3 for two seconds, there will be reset to zero. 51 EPX-SERISE USER MANUAL Rev. G 6.1.4 Cooling Time Display Mode EPX-series have the cooling time function for protecting the device. The cooling time function is to stop the device when operator uses the device over standard. EPX-series will start automatically the cooling time procedure when operator shoots x-ray twice in a row. If the cooling time has more than 60 seconds, the cooling time will be extended after shooting twice consecutive. But the cooling time doesn’t excess more than 300 seconds. - The Cooling time range: 15 seconds ~ 300 seconds Cooling time(CLT) basis 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 1,000[J] < Heat Value ≤ 2,000[J], the CLT is 30 seconds. • If 2,000[J] < Heat Value ≤ 3,200[J], the CLT is 60 seconds. • If 3,200[J] < Heat Value ≤ 5,000[J], the CLT is 90 seconds. • If 5,000[J] < Heat Value ≤ 6,500[J], the CLT is 120 seconds. • If 6,500[J] < Heat Value, the CLT is 180 seconds. 6.1.5 Turn off a. Set to the minimum kV and mAs value. b. Turn off the power switch. c. Unplug the power cable from the device. 52 EPX-SERISE USER MANUAL Rev. G 6.2 Touch Main Screen of Operation Mode (Option) 6.2.1 Normal Mode of Touch Main Screen After Start-up Screen is successfully launched, the following Touch Main Screen will be displayed. No. Description 1 kV Indicator 2 kV value up/down control buttons Function Display kV Value (1KV increment) Select kV value by tapping up (increase) or down (decrease) buttons 3 mAs Indicator Display mAs Value 4 mAs value up/down control buttons Select mAs value by up or down buttons 5 Sec indicator kV, mAs set values calculate the time automatically. 6 Sec value 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 Before any X-ray exposure, press this button for 3 seconds to complete filament Pre-heating. When the preheating is completed, 10 Ready button this item (13) Ready indicator will light up. This is the same function as half-pressing the exposure hand-switch. X-ray exposure is done by pressing this button. During exposure, 11 X-ray exposure button the X-ray Exposure indicator (14) will light up. This function also 53 EPX-SERISE USER MANUAL Rev. G can be accomplished by pressing down the hand-switch completely. 12 Menu button Reserved 13 Ready indicator Lighted push the hand switch one time for preparation 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 Touch-and-drag the screen action (left-right or right-left direction) Scroll will display alternating screen (kV, mAs indicator vs. sec and mA display) 54 EPX-SERISE USER MANUAL Rev. G 6.2 Hand Switch No. Name Description st 1 Hand Switch (Dead-man type) 2 Handle 3 Connector 1 stage: The equipment gets ready when the button is half pressed with a thumb. nd 2 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. Hand-Switch to grab with hands. Connector to connect X-ray equipment and a Hand-Switch 55 EPX-SERISE USER MANUAL Rev. G 6.3 Mobile Stand No. Name 1 Arm 2 Height adjustment 3 Gantry 4 Rack 5 Caster Description Arm of a stand to fix X-ray equipment or change its direction Handle or gearbox to adjust height of the equipment Gantry to fix arm or height adjustment component Rack to hold up X-ray device or stand components (wheels included for carrying the equipment) Wheels for movement with the brake 56 EPX-SERISE USER MANUAL Rev. G The operator must keep the precautions when using mobile stand CAUTION with device Precautions for use ● Mobile 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. 57 EPX-SERISE USER MANUAL Rev. G 7. MAINTENANCE PROCEDURE 7.1 General caution It is recommended to follow the maintenance procedure described below, for the reliable operation. The routine inspection should be committed by a trained expert There may cause serious injury by conducting unauthorized service or changing the instrument and manufacturer shall not be WARNING responsible for the resulting compensation. If operator has any questions about the equipment, please let manufacture or the agent know the model name and serial number(S/N) indicated on the device, can provide a rapid service. 7.2 Maintenance Schedule Maintenance/control item Period mA : (Lower than management standards of EN60601-2-54) 1 Should be within accuracy boundary of ±3% , with the voltage 1 Year set by 40kV and 120kV. mAs : (Lower than management standards of EN60601-2-54) 2 Should be within accuracy boundary of ±5%, when the mAs 1 Year value is between 0.4 mAs and 100 mAs. KV : (Lower than management standards of EN60601-2-54) 3 Should be within accuracy boundary of ±5%, when the kV value 1 Year is between 40kV and 120kV. Optical Maintenance : 4 When dirt appears on the image, remove dirt on Collimator 1 Year window with soft brush. Reproducibility of the RADIATION output Maintenance: 5 The displayed value on the FND should not exceed 40% of the 1 Year Inspector Service personnel with expertise Service personnel with expertise Service personnel with expertise Service personnel with expertise Service personnel with expertise actual value for areas larger than 200㎠. 7.3 Cleaning ● Keep the machine clean when it gets dirt. ● To clean the main-body, turn off the power and pull the plug out from the outlet. ● Scrub surfaces smoothly with soft fabric or gauze. 58 EPX-SERISE USER MANUAL Rev. G 7.4 Troubleshooting These are the information about indicating a system malfunction to do not appear in the message window. If the device occurs a problem to except on the below troubleshooting table, consult manufacture or the agent. The troubleshooting table does not put it for all problems. Problem Item Cause 1. Hand switch contact failure 1 If the X-ray does not be exposed, 2. Hand switch malfunction 3. HV mono block tank malfunction 2 3 4 If the power switch down automatically, If the device dose not power on, FET Driver Board malfunction 1. Main power board malfunction 2. SMPS malfunction If the control button does not 1. Control button failure operate, 2. Main control board malfunction Action 1. Try hand switch plug out and plug in 2. Replacing the hand switch 3. Call for service Call for service Call for service Call for service 1. Main power board or SMPS 5 If the console does not display, malfunction Call for service 2. Main control board malfunction 6 (Option) If the touch screen does 1. Fail to initialize touch screen 1. Please turn it off and on again not operate incorrectly, 2. Touch screen malfunction 2. Call for service 7.5 The equipment operation checklist for operator Check Item 1 kV and mAs values display on the console when power on. 2 kV and mAs up/down button operation. 3 Collimator lamp on/off operation 4 Laser pointer on/off operation 5 Display reversal button operation 6 Ready indicator light on when the hand switch push one time for preparation 7 Exposure indicator light on during x-ray exposure 8 Wait indicator light on after x-ray exposure 9 Occur beep sound after x-ray exposure 10 Display APR data when push APR 1~6 button 11 Save APR data when push save button 12 Movement of knob on the collimator 13 Movement of handle on the equipment 14 (Option) Check touch screen operation 59 Verdict EPX-SERISE USER MANUAL Rev. G 7.6 Maintenance Checklist MAINTENACE CHECKLIST MODEL: ___________________ SERIAL NUMBER: ___________________ Measuring tool: - Oscilloscope (EP: 1V = 20kV, IP: 1V = 5.8mA) - Dose Area Product Meter Checklist 1 Check that mA accuracy within boundary of ±3%. 2 Check that mAs accuracy within boundary of ±5%. 3 Check that kV accuracy within boundary of ±5%. Verdict Check that reproducibility of the radiation output. The displayed value on the FND should not 4 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. 10 Check all interconnect cables for broken or frayed wires. 11 Make sure all bolts are secure. Service Engineer: ___________________ Date: ___________________ 60 EPX-SERISE USER MANUAL Rev. G 8. DISPOSAL OF WASTE 8.1 Disposal of old Electrical & Electronic Equipment This symbol indicates that this product shall not be treated as household waste. Instead, it shall be handed over to the applicable 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 ordinances and recycling plans. 61 EPX-SERISE USER MANUAL Rev. G 9. QUALITY WARRANTY Scope & Duration of Warranty EPX seriese manufactured by Ecotron Co.,Ltd are warranted to be free from defects for a period of two years after purchase date. If during the warranty period the product you purchased is found to be defective, it will be repaired free of charge. In the case of one of the following, however, a certain amount of service fees will be charged. • Defect or damage found after the warranty period. • Defect or damage in appearance which is not related to main function of the system. • Damage caused by a natural disaster; such as fire, earthquake, or lightning strikes. • Damage resulting from either improper movement or inattention to the precautions. • Damage resulting from repair or modification by someone other than Ecotron or the authenticated by Ecotron Co.,Ltd. • Damage caused by a natural disaster; such as fire, earthquake, or lightning 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 request, must power off the entire system and check the model number, serial number, and the purchase date. Then contact an authorized service office. Any product with a defect in appearance only shall not be returned to nor replaced by Ecotron Co.,Ltd. Ecotron Co.,Ltd. shall not be liable any incidental or consequential damages arising out of or relating to the use of the product. Ecotron Co.,Ltd. shall not be liable for any damages or losses occurring after the warranty period. This Quality Warranty prevails over the detailed Warranty for fitness or all other warranties in relation to the product. When a problem occurs with the product, customer should pay to the shipping cost of the product. 62 EPX-SERISE USER MANUAL Rev. G 10. INTENDED OPERATOR AND SERVICE PERSONAL PROFILE 10.1 Operator Profile Considerations Requirement description Minimum - At least graduate of medical college Maximum - No maximum Education - Read and understand 'westernized Arabic' numerals when written Minimum Knowledge in Arial font - Can distinguish of human body - Understands hygiene Maximum - No maximum Minimum - Local language Maximum - Understanding of manual that is writing in English Minimum - Have license of radiologist or have to meet local regulation Maximum - No maximum Language understanding Experience - Mild reading vision impairment or vision corrected to log MAR 0.2 Permissible impairments Minimum - 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 Minimum - At least graduate of high school Maximum - No maximum Education - Read and understand 'westernized Arabic' numerals when written Minimum Knowledge in Arial font - Can distinguish of human body - Understands hygiene Maximum - No maximum Minimum - Local language Maximum - Understanding of manual that is writing in English Minimum - Only authorized and properly trained by ECOTRON Maximum - No maximum Language understanding Experience - Mild reading vision impairment or vision corrected to log MAR 0.2 Permissible impairments Minimum - Average degree of aging-related short term memory impairment - Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to 2 kHz 63 EPX-SERISE USER MANUAL Rev. G 11. EMC DECLARATION Guidelines and manufacturers: electromagnetic emission 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. Emission test Compliance Electromagnetic setting: guidelines Since the Diagnostic X-ray System only uses RF energy RF emission Group 1 CISPR 11 for internal functions, it has very low RF emissions and normally cause no interference to neighboring electronic devices. RF emission Class A CISPR 11 The Diagnostic X-ray System is suitable not only in nonHarmonic wave emission CISPR 11 Class A household facilities but can also be used by directly connecting to the common low-power network in a Voltage changes/flicker emission building. Compliance CISPR 11 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 +/- 6kV contact +/- 6kV contact discharge (ESD) The floor should be in wood, concrete or +/- 8kV in the air +/- 8kV in the air IEC 61000-4-2 ceramic tiles. If the floor is in a synthetic material, the relative humidity should be at least 30%. Suitability in +/- 2kV power supply electric unit line +/- 2kV power supply unit line should be equal to the oversprays those of general +/- 1kV input/output line +/- 1kV input/output line IEC 61000-4-4 Surge The main power’s quality commercial or hospital settings. +/- 1kV line-line +/- 1kV line-line The main power’s quality should be equal to the IEC 61000-4-11 +/- 2kV line-earth +/- 2kV line-earth those of general commercial or hospital settings. 64 EPX-SERISE USER MANUAL Rev. G Voltage loss in the <5% UT(<95%Dip at <5% UT(<95%Dip at the UT), The main power’s quality power supply, the UT), 0.5 cycles 0.5 cycles should be equal to the short 40% UT(60% Dip at the 40% UT(60% Dip at the UT), those of general intermittence and UT), 5 cycles 5 cycles commercial or hospital voltage changes 70% UT(30% Dip at the 70% UT(30% Dip at the UT), settings. UT), 25 cycles 25 cycles <5% UT(>95% Dip at <5% UT(>95% Dip at the Note : Most components the UT), 5 seconds UT), 5 seconds in the Diagnostic X- IEC 61000-4-11 ray System have their power supplied from the uninterrupted power supply. The IEC61000-4-11 only applies to the Diagnostic Xray System Power Box. Magnetic field in 3A/m 3A/m The magnetic field in the the source source frequency should frequency be equivalent to the (50/60Hz) those of general commercial or hospital IEC 61000-4-8 settings. Note: The UT is the main AC voltage before the test standards have been applied. 65 EPX-SERISE USER MANUAL Rev. G Guidelines and manufacturers: electromagnetic tolerance 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 When using a portable or a mobile RF communication equipment, the recommended intervals, which have been calculated using the equations, should be maintained. These calculations should be made in accordance with all of the Diagnostic Xray System’s parts (including switches) and its transmitter-receiver’s frequency. Recommended intervals: d = 1.17√p Conductive RF 3Vrms IEC61000-4-6 150kHz-80MHz Radioactive 3v/m RF 80MHz-2.5GHz 3Vrms d = 1.17√p80MHz ~ 800MHz d = 2.33√p800MHz ~ 2.5GHz, where p is the transmitter-receiver’s 3v/m maximum power rating in watts (W) and IEC61000-4-3 d is the recommended interval. The magnetic field strength in the fixed RF receiver, which has been 1 determined in the EM wave walkdown , should be lower than the compliance 2 standards of each frequency range . Interference may occur around the equipment whose symbol is as follows. Note 1 : The high-frequency range is applied at 80MHz and 800MHz. Note 2 : This guideline does not apply in all situations. Electromagnetic waves may be affected through absorption into and reflection from structures, objects and people. 66 EPX-SERISE USER MANUAL Rev. G Guidelines and manufacturers: electromagnetic tolerance It is very difficult to accurately predict the magnetic field strength of wireless (mobile/wireless) telephones, land mobile radio base station, amateur wireless, AM, FM wireless and TV broadcasting systems. To assess electromagnetic settings using fixed RF receivers, area walkdown is needed. If the magnetic field strength measured at the point where the Diagnostic X-ray System is used exceeds the applicable RF compliance level, you should check whether the Diagnostic X-ray System is operating normally. Should any performance abnormality is observed, additional action may be needed such as changing the Diagnostic X-ray System’s direction or location. At the frequency range between 150kHz and 80MHz, the magnetic field strength should be less than 3v/m. Recommended intervals between the Diagnostic X-ray System and the portable or mobile 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 Interval depending on the transceiver-receiver’s frequency transceiver-receiver meters Watts 150kHz ~ 80MHz 80MHz ~ 800MHz 800MHz ~ 2.5GHz d = 1.17√p d = 1.17√p d = 2.33√p 0.01 0.117 0.117 0.233 0.1 0.37 0.37 0.737 1 1.17 1.17 2.33 10 3.7 3.7 7.36 100 11.7 11.7 23.3 For maximum power voltages of receivers not on the above list, the recommended interval, d(m), can be calculated by using the equation used for the receiver’s frequency. The p is the transmitterreceiver’s maximum power rating in watts (W). Note 1 : The high-frequency range is applied at 80MHz and 800MHz. Note 2 : This guideline does not apply in all situations. Electromagnetic waves may be affected through absorption into and reflection from structures, objects and people. 67 EPX-SERISE USER MANUAL Rev. G 12. APPENDIX A: TECHNICAL CHART Film Screen: Lanex Regular Screen (400 speed) 40" SID Adults EXAMINATION HAND WRIST FOREARM (AP) FOREARM (LAT) ELBOW(AP) ELBOW(LAT) HUMEROUS ANKLE(AP) ANKEL(LAT) KNEE FOOT(AP) FOOT(LAT) FEMUR SHOULDER L/SPINE(AP) Pediatric THICKNESS KVP MAS Grid Dosimetry (μGy*㎡) THICKNESS KVP MAS Grid Dosimetry (μGy*㎡) 2-4cm 50 2.0 NO 5-7cm 50 2.0 NO 8.828 - 50 1.0 NO 4.498 2-4cm 52 2.0 NO 5-7cm 52 2.0 NO 9.792 - 52 1.0 NO 4.498 2-4cm 50 2.0 NO 8.828 5-7cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498 8-10cm 60 2.5 NO 17.08 4-6cm 50 2.0 NO 8.828 7-9cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498 10-12cm 60 2.5 NO 17.08 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 - 60 1.3 NO 8.92 4-6cm 60 2.5 NO 17.08 7-9cm 63 2.5 NO 19.021 - 60 1.3 NO 8.92 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 - 60 1.3 NO 8.92 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 - 60 1.3 NO 8.92 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 - 60 1.3 NO 8.92 7-9cm 60 4.0 NO 17.08 10-12cm 66 5.0 NO 41.96 - 60 2.0 NO 13.68 2-4cm 50 2.0 NO 8.828 5-7cm 54 2.5 NO 13.432 - 50 1.0 NO 4.498 4-6cm 58 2.0 NO 12.716 7-9cm 64 2.5 NO 19.647 - 58 1.0 NO 6.406 6-8cm 63 3.2 NO 24.348 12-14cm 66 4.0 NO 33.556 - 63 1.6 NO 12.172 4-6cm 60 3.2 NO 21.84 7-9cm 64 4.0 NO 31.452 - 60 1.6 NO 10.96 21-23cm 80 20 NO 245.05 - 80 8 NO 97.57 68 EPX-SERISE USER MANUAL Rev. G L/SPINE(LAT) PELVIS/HIP CHEST(AP) CHEST(LAT) ABDOMEN 32-34cm 100 32 YES 590.1 12-14cm 73 10 YES 102.8 20-22cm 77 20 YES 228.25 26-28cm 78 32 YES 374.48 12-16cm 80 1.0 NO 11.92 22-24cm 80 1.6 NO 19.24 30-34cm 80 2.5 NO 30.22 32-36cm 90 2.0 NO 29.752 36-40cm 90 2.5 NO 37.362 8-12cm 72 10 YES 100.05 18-22cm 77 20 YES 228.25 28-32cm 80 32 YES 392.4 69 - 100 13 YES 238.72 - 73 4 YES 40.944 - 80 0.6 NO 7.04 - 90 1.0 NO 14.532 - 72 4.0 YES 39.872 EPX-SERISE USER MANUAL Rev. G CR System: 40" SID Adults EXAMINATION Pediatric THICKNESS KVP MAS Grid Dosimetry (μGy*㎡) THICKNESS 2-4cm 50 4.0 NO 17.488 - 5-7cm 50 4.0 NO 2-4cm 52 4.0 NO 19.432 - 5-7cm 52 4.0 NO 2-4cm 50 4.0 NO 17.488 5-7cm 56 5.0 NO 29.18 8-10cm 60 5.0 NO 4-6cm 50 4.0 7-9cm 56 10-12cm Dosimetry (μGy*㎡) KVP MAS Grid 50 2.0 NO 50 2.0 NO 52 2.0 NO 52 2.0 NO 50 2.0 NO 8.828 56 2.5 NO 14.641 34.1 60 2.5 NO 17.08 NO 17.488 50 2.0 NO 8.828 5.0 NO 29.18 56 2.5 NO 14.641 60 5.0 NO 34.1 60 2.5 NO 17.08 5-7cm 60 5.0 NO 34.1 60 2.5 NO 17.08 8-10cm 63 5.0 NO 38.03 63 2.5 NO 19.021 4-6cm 60 5.0 NO 34.1 60 2.5 NO 17.08 7-9cm 63 5.0 NO 38.03 63 2.5 NO 19.021 5-7cm 60 5.0 NO 34.1 60 2.5 NO 17.08 8-10cm 63 5.0 NO 38.03 63 2.5 NO 19.021 5-7cm 60 5.0 NO 34.1 60 2.5 NO 17.08 8-10cm 63 5.0 NO 38.03 63 2.5 NO 19.021 5-7cm 60 5.0 NO 34.1 60 2.5 NO 17.08 8-10cm 63 5.0 NO 38.03 63 2.5 NO 19.021 7-9cm 60 8.0 NO 54.56 60 4.0 NO 17.08 10-12cm 66 10.0 NO 84.01 66 5.0 NO 41.96 2-4cm 50 4.0 NO 17.488 50 2.0 NO 8.828 5-7cm 54 5.0 NO 26.72 54 2.5 NO 13.432 4-6cm 58 4.0 NO 25.336 58 2.0 NO 12.716 7-9cm 64 5.0 NO 39.34 64 2.5 NO 19.647 6-8cm 63 6.4 NO 48.684 63 3.2 NO 24.348 12-14cm 66 8.0 NO 67.19 66 4.0 NO 33.556 4-6cm 60 6.4 NO 43.648 60 3.2 NO 21.84 7-9cm 64 8.0 NO 62.98 64 4.0 NO 31.452 L/SPINE(AP) 21-23cm 80 32 NO 392.4 - 80 16 NO 195.89 L/SPINE(LAT) 32-34cm 100 64 YES 1190.1 - 100 32 YES 590.1 HAND WRIST FOREARM (AP) FOREARM (LAT) ELBOW(AP) ELBOW(LAT) HUMEROUS ANKLE(AP) ANKEL(LAT) KNEE FOOT(AP) FOOT(LAT) FEMUR SHOULDER 70 - - - - - - - - - - - - 8.828 9.792 EPX-SERISE USER MANUAL Rev. G PELVIS/HIP CHEST(AP) CHEST(LAT) ABDOMEN 12-14cm 73 20 YES 205.9 73 10 YES 102.8 20-22cm 77 32 YES 365.52 77 16 YES 182.49 26-28cm 78 64 YES 749.52 78 32 YES 374.48 12-16cm 80 2.0 NO 24.12 80 1.0 NO 11.92 22-24cm 80 3.2 NO 38.76 80 1.6 NO 19.24 30-34cm 80 5.0 NO 60.7 80 2.5 NO 30.22 32-36cm 90 4.0 NO 60.192 90 2.0 NO 29.752 36-40cm 90 5.0 NO 75.4 90 2.5 NO 37.362 8-12cm 72 20 YES 200.35 72 10 YES 100.05 18-22cm 77 32 YES 365.52 77 16 YES 182.49 28-32cm 80 64 YES 788.24 80 32 YES 392.4 71 - - - - EPX-SERISE USER MANUAL Rev. G DR System: Flap Panel with CSI Screen, 40" SID Adults EXAMI- Pediatric THICKNESS KVP MAS Grid 2-4cm 50 2.0 NO 5-7cm 50 2.0 NO 2-4cm 52 2.0 NO 5-7cm 52 2.0 NO 2-4cm 50 2.0 NO 8.828 5-7cm 56 2.5 NO 14.641 8-10cm 60 2.5 NO 17.08 4-6cm 50 2.0 NO 8.828 7-9cm 56 2.5 NO 14.641 10-12cm 60 2.5 NO 17.08 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 4-6cm 60 2.5 NO 17.08 7-9cm 63 2.5 NO 19.021 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 5-7cm 60 2.5 NO 17.08 8-10cm 63 2.5 NO 19.021 7-9cm 60 4.0 NO 17.08 10-12cm 66 5.0 NO 41.96 2-4cm 50 2.0 NO 8.828 5-7cm 54 2.5 NO 13.432 4-6cm 58 2.0 NO 12.716 7-9cm 64 2.5 NO 19.647 6-8cm 63 3.2 NO 24.348 12-14cm 66 4.0 NO 33.556 4-6cm 60 3.2 NO 21.84 7-9cm 64 4.0 NO 31.452 L/SPINE(AP) 21-23cm 80 20 NO L/SPINE(LAT) 32-34cm 100 32 YES NATION HAND WRIST FOREARM (AP) FOREARM (LAT) ELBOW(AP) ELBOW(LAT) HUMEROUS ANKLE(AP) ANKEL(LAT) KNEE FOOT(AP) FOOT(LAT) FEMUR SHOULDER Dosimetry (μGy*㎡) THICKNESS KVP MAS Grid Dosimetry (μGy*㎡) 8.828 - 50 1.0 NO 4.498 9.792 - 52 1.0 NO 4.498 - 50 1.0 NO 4.498 - 50 1.0 NO 4.498 - 60 1.3 NO 8.92 - 60 1.3 NO 8.92 - 60 1.3 NO 8.92 - 60 1.3 NO 8.92 - 60 1.3 NO 8.92 - 60 2.0 NO 13.68 - 50 1.0 NO 4.498 - 58 1.0 NO 6.406 - 63 1.6 NO 12.172 - 60 1.6 NO 10.96 245.05 - 80 8 NO 97.57 590.1 - 100 13 YES 238.72 72 EPX-SERISE USER MANUAL Rev. G PELVIS/HIP CHEST(AP) CHEST(LAT) ABDOMEN 12-14cm 73 10 YES 102.8 20-22cm 77 20 YES 228.25 26-28cm 78 32 YES 374.48 12-16cm 80 1.0 NO 11.92 22-24cm 80 1.6 NO 19.24 30-34cm 80 2.5 NO 30.22 32-36cm 90 2.0 NO 29.752 36-40cm 90 2.5 NO 37.362 8-12cm 72 10 YES 100.05 18-22cm 77 20 YES 228.25 28-32cm 80 32 YES 392.4 - 73 4 YES 40.944 - 80 0.6 NO 7.04 - 90 1.0 NO 14.532 - 72 4.0 YES 39.872 The patient population can be divided into several subgroups which are defined according to age and approximate average height and weight measurements: Adult [~80kg (176lb); standing height 170cm (67.0in)] Pediatrics 12 year old [~52 kg (115 lb); 156 cm (61.5 in) standing 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 These subgroups are listed as a general guide. Different subgroups that still cover the broad size range expected for pediatric patients may be appropriate. The instructions covering pediatric use of radiographic imaging systems was referred to the FDA Pediatric X-ray Imaging website. http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm If the X-ray system is used for elderly patients; pregnant women; children and patients who require support, additional care may be required for safety such as changing X-ray setting by an expert. NOTE The statistics and specifications of this unit and manual can be modified with or without notification for the improvement of performance and safety. 73 EPX-SERISE USER MANUAL Rev. G 13. APPENDIX B: PEDIATRICS AND SMALL PATIENTS ECOTRON strongly suggests reducing radiation dose to As Low As Reasonably Achievable (ALARA) in all patients, especially pediatric and small patients, whenever it is determined that an x-ray is necessary. X-ray is an extremely valuable tool for diagnosing injury and disease, but its use is not without risk. This section discusses the importance of minimizing the radiation dose in children and small adults consistent with ALARA principles. Topics covered include: Pediatric Use Optimize Pediatric Protocols for your facility What Do I Need to Know About? Pediatric Use Radiation exposure is a concern in both adults and children. However, children are more sensitive to radiation. Using the same exposure parameters on a child as used on an adult may result in larger doses to the child. X-ray settings can be adjusted to reduce dose significantly while maintaining diagnostic image quality. Optimize Pediatric Protocols for your facility The protocols supplied with the system 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 recommended protocols installed on your system and suggestions in this guide, the following websites offer excellent sources of additional information on how to optimize protocols safely and effectively: American College of Radiology (ACR): www.acr.org Society of Pediatric Radiology (SPR): www.pedrad.org National Cancer Institute (NCI): www.nci.nih.gov/aboutnci Image Gently: www.imagegently.org US Food and Drug Administration (FDA): http://www.fda.gov/Radiation-EmittingProducts/ RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm What Do I Need to Know About? This section presents the concepts necessary to understand Pediatric x-ray imaging. The concepts you need to understand are: Radiation Exposure Sensitivity Suggestions for Minimizing Unnecessary Dose Guidelines for Adjusting Individual Exposure Parameters by patient Patient Dose Reporting 74 EPX-SERISE USER MANUAL Rev. G Dose Index Reporting Considerations Protocol Database Edit Everyone shares the responsibility of minimizing pediatrics dose. There are several steps that can be taken to reduce the amount of radiation that pediatrics and small patients receive from x-ray examinations. Radiation Exposure Sensitivity Radiation exposure is a concern in all people of all ages, however, pediatrics are more sensitive to radiation exposure. Radiation risk is higher in the young as they have more rapidly dividing cells than adults. The younger the patient, the more sensitive they are. Suggestions for Minimizing Unnecessary Dose Image the Anatomical Region Indicated (Collimation): Collimation and anatomical coverage should be carefully considered prior to each exposure. Follow your facility imaging guidelines to determine appropriate collimation. Check Technical Factors Before Exposure: Review technical display carefully before making an exposure to verify selected and intended technique are the same. Pay particular attention to placement of decimal point in display of numerical values. • Use 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: W hen applicable, utilize proper protective measures as they comply with your facility guidelines. Consider Patient Radiation Safety Protocols: Ensure understanding and conformance of Patient Radiation/Protection Safety and ALARA principles as required by your facility. This includes patient shielding to reduce exposure to unintended areas. Guidelines for Adjusting Individual Exposure Parameters by patient Adjust Parameters: The single most important thing you can do is to always use pediatric protocols to avoid over exposure. Protocols based on patient type; adult and pediatric patients. These protocols should be considered a baseline. ECOTRON strongly recommends that you work with your Radiologist and Physicist to determine the lowest possible dose for the desired image quality. Once patient size is selected, further adjustments to kVp, MAS, Filtration and Grid can be made to further minimize patient dose. For questions or further information, contact your local ECOTRON representative. 75 ">
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Key features
- 4.0kW output
- 50-110kVp range
- 20-80mA range
- 1.8mm focal spot
- 15 degrees target angle
- D-125 X-ray tube
Frequently asked questions
The maximum output power is 4.0kW.
The mA range is 20-80mA.
The EPX-F4000 uses a D-125 X-ray tube.
