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EPX-SERIES Diagnostic X-ray System Operator’s Manual Ecotron Co., Ltd Made by Korea 4F&5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea Obelis S.A Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:mail@obelis.net Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03...
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APPENDIX B TECHNICAL CHART ________________________________________ 64 APPENDIX C PEDIATRICS AND SMALL PATIENTS __________________________ 70 APPENDIX D ACTION TO CORRECT THE ERROR OF EPX-SERIES ____________ 72 APPENDIX E ANODE THERMAL CHARACTERISTICS OF X-RAY TUBE _________ 73 Rev. J 5/74 ECOTRON Co., Ltd.
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KEEP THIS OPERATOR’S MANUAL WITH THE EQUIPMENT AT ALL TIMES, AND REVIEW THE IMPORTANT INFORMATION WHENEVER REQUIRED. THE STATISTICS AND SPECIFICATIONS OF THIS UNIT AND MANUAL CAN BE MODIFIED WITH OR WITHOUT NOTIFICATION FOR THE IMPROVEMENT OF PERFORMANCE AND SAFETY. Rev. J 6/74 ECOTRON Co., Ltd.
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. Rev. J 7/74 ECOTRON Co., Ltd.
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 NOTE ● ASSEMBLY INFORMATION: NO ASSEMBLY IS REQUIRED. Rev. J 8/74 ECOTRON Co., Ltd.
EPX-SERIES should be used for the diagnosis, not for the therapy. 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. This system has been calibrated for optimal operations.
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PROPER USE AND SAFE OPERATING PRACTICES WITH RESPECT TO X-RAY SYSTEMS ARE THE RESPONSIBILITY OF THE USERS OF SUCH X-RAY SYSTEMS. ECOTRON Co., Ltd PROVIEDS INFORMATION ON ITS PRODUCTS AND ASSOCIATED HAZARDS, BUT ASSUMES NO RESPONSIBILITIES FOR AFTER-SALE POERATING AND SAFETY PRACTICES.
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• MEDICAL ELECTRICAL DEVICES WHICH CONFORM TO IEC60601-1 • NON-MEDICAL ELECTRICAL DEVICES WHICH CONFORM TO RELATED IEC SAFETY STANDARDS • NON-MEDICAL ELECTRICAL DEVICES WHICH HAVE SAFETY EQUAL TO DEVICES CONFORM TO IEC SAFETY STANDARDS Rev. J 11/74 ECOTRON Co., Ltd.
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. Rev. J 12/74 ECOTRON Co., Ltd.
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. Rev. J 13/74 ECOTRON Co., Ltd.
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SAFE USE WARNING LABEL 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. Rev. J 14/74 ECOTRON Co., Ltd.
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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.
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(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. Rev. J 16/74 ECOTRON Co., Ltd.
REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) 4.2.2 EPX-F2400 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Rev. J 17/74 ECOTRON Co., Ltd.
REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) 4.2.4 EPX-F3200 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Rev. J 18/74 ECOTRON Co., Ltd.
REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) 4.2.6 EPX-F5000 REPRESENTATIVE IDENTIFICATION LABEL X-RAY SYSTEM This label is attached to rear cover of the diagnostic x-ray system. (Example) Rev. J 19/74 ECOTRON Co., Ltd.
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 4F & 5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea Rev.
4.2.9 SYMBOLS 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” Rev. J 21/74 ECOTRON Co., Ltd.
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. Rev. J 22/74 ECOTRON Co., Ltd.
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: ● 60 kV / 5 mAs ● Make three to five exposures at 5 minute intervals. Rev. J 23/74 ECOTRON Co., Ltd.
● 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. Rev. J 25/74 ECOTRON Co., Ltd.
Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID Laser Pointer Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp LED 3.0V, 3A, 10W Weight 13 Kg Rev. J 26/74 ECOTRON Co., Ltd.
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Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID Laser Pointer Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp LED 3.0V, 3A, 10W Weight 13 Kg Rev. J 27/74 ECOTRON Co., Ltd.
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Max X-ray Field Size 43cm x 43cm @ 100cm SID Collimator with Laser Pointer Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp LED 3.0V, 3A, 10W Weight 13 Kg Rev. J 28/74 ECOTRON Co., Ltd.
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Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID Laser Pointer Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp LED 3.0V, 3A, 10W Weight 13 Kg Rev. J 29/74 ECOTRON Co., Ltd.
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Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID Laser Pointer Laser Pointer Class II Timer Push button illuminator with 30 sec timer Lamp LED 3.0V, 3A, 10W Weight 13 Kg Rev. J 30/74 ECOTRON Co., Ltd.
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±5 % Coefficient of variation < 0.02 Max. Reproducibility of the RADIATION output Display KV /mAs: 7-segment LED Model Name OX/110-15 (C.E.I.) Focal Spot 1.8mmx1.8mm X-ray Tube Target Angle 15 degree Anode Heat Storage 42kHU Rev. J 31/74 ECOTRON Co., Ltd.
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1.2 million times 4.6.2.8 MOBILE STAND Mobile Stand for EPX-SERIES Available products EPX-SERIES only 0° ~ 150° Arm angle Max arm vertical 1.4 m Wt. Load 30 kg Wheel size 50Ø, 24mm Weight(Mobile Stand) 11.6 kg Rev. J 32/74 ECOTRON Co., Ltd.
For safe storage and transportation, the following range of temperature and humidity must be kept while using. Environment for storage and transportation -25 °C ~ 60 °C (-13 °F ~ 140 °F) Temperature range Relative Humidity Range 10% ~ 95% RH Rev. J 43/74 ECOTRON Co., Ltd.
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. Rev. J 45/74 ECOTRON Co., Ltd.
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TO COOL SUFFICIENTLY SUCH THAT THIS MESSAGE IS NO LONGER 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. Rev. J 46/74 ECOTRON Co., Ltd.
FLUCTUATION SHOULD BE WITHIN ±10% OF THE NOMINAL VALUES. CAUTION ALWAYS POWER SWITCH IS OFF BEFORE CONNECTED THE POWER CABLE. WARNING TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. Rev. J 47/74 ECOTRON Co., Ltd.
Select mAs value by up or down buttons Ready indicator Lighted push the hand switch one time for preparation PC interface connecting Lighted when EPX series is connected to PC indicator Exposure indicator Alert lamp during x-ray exposure Error lamp...
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. Rev. J 49/74 ECOTRON Co., Ltd.
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. Rev. J 50/74 ECOTRON Co., Ltd.
Before any X-ray exposure, press this button for 3 seconds to complete filament Pre-heating. When the preheating is Ready button completed, this item (13) Ready indicator will light up. This is the same function as half-pressing the exposure hand- switch. Rev. J 51/74 ECOTRON Co., Ltd.
It automatically turns off according to the value of mAs set by the program or when the thumb is off the switch. Handle Hand-Switch to grab with hands. Connector Connector to connect X-ray equipment and a Hand-Switch Rev. J 52/74 ECOTRON Co., Ltd.
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. Rev. J 53/74 ECOTRON Co., Ltd.
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. Rev. J 54/74 ECOTRON Co., Ltd.
Occur beep sound after x-ray exposure Display APR data when push APR 1~6 button Save APR data when push save button Movement of knob on the collimator Movement of handle on the equipment (Option) Check touch screen operation Rev. J 55/74 ECOTRON Co., Ltd.
Check that all indicator lights are operating. Check that all hardware is tightly secured. Check all interconnect cables for broken or frayed wires. Make sure all bolts are secure. Service Engineer:_____________________ Check Date: _____________________ Rev. J 56/74 ECOTRON Co., Ltd.
Epoxy fiberglass circuit board materials, tracks are soldering on copper. Wire, tinned copper. Insulated with PVC or silicone. Steel and / or aluminum (x-ray system body and console chassis). Plastic (console membrane). Electrical and electronic components: IC’s, transistors, diodes, resistors, capacitors, etc. Rev. J 57/74 ECOTRON Co., Ltd.
Scope & Duration of Warranty EPX-SERIES 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.
- Local language Language understanding Maximum - Understanding of manual that is writing in English Minimum - Only authorized and properly trained by ECOTRON Experience Maximum - No maximum - Mild reading vision impairment or vision corrected to log MAR 0.2...
+/- 1kV input/output line settings. The main power’s quality Surge +/- 1kV line-line +/- 1kV line-line should be equal to the those of general IEC 61000-4-11 +/- 2kV line-earth +/- 2kV line-earth commercial or hospital settings. Rev. J 60/74 ECOTRON Co., Ltd.
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(50/60Hz) of general commercial or hospital settings. IEC 61000-4-8 Note: The UT is the main AC voltage before the test standards have been applied. Rev. J 61/74 ECOTRON Co., Ltd.
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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. Rev. J 62/74 ECOTRON Co., Ltd.
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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. Rev. J 63/74 ECOTRON Co., Ltd.
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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. Rev. J 69/74 ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL APPENDIX C 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.
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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.
(Once the temperature drop to normal, the Warning Message will disappear) FET-OTP FET board Wait until the temperature inside the FET board comes down to normal overheat (Once the temperature drop to normal, the Warning Message will disappear) Rev. J 72/74 ECOTRON Co., Ltd.
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