Ecotron EPX Series User manual

EPX-SERIES
Diagnostic X-ray System
Operator’s Manual
Obelis S.A
Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:[email protected]
Representative: Mr.Gideon ELKAYAM / TEL:[phone], FAX:[phone]
Ecotron Co., Ltd
Made by Korea
4F&5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea
D/N: ECO-UM-EPX-001 Rev. J

EPX-SERIES OPERATOR’S MANUAL
Rev. J 2/74 ECOTRON Co., Ltd.
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EPX-SERIES OPERATOR’S MANUAL
Rev. J 3/74 ECOTRON Co., Ltd.
CONTENTS
1. INTRODUCTION _______________________________________________________ 7
1.1 COMPOSITION _______________________________________________________________________________ 8
2. NOTICE OF THE SAFE OPERATION ______________________________________ 9
3. RADIATION SAFETY __________________________________________________ 12
4. SAFETY AND SPECIFICATIONS _________________________________________ 13
4.1 SAFETY AND WARNING SYMBOLS _______________________________________________________ 13
4.2 COMPOSITION LABEL _____________________________________________________________________ 17
4.2.1 EPX-F1600 _____________________________________________________________________________ 17
4.2.2 EPX-F2400 _____________________________________________________________________________ 17
4.2.3 EPX-F2800 _____________________________________________________________________________ 18
4.2.4 EPX-F3200 _____________________________________________________________________________ 18
4.2.5 EPX-F4000 _____________________________________________________________________________ 19
4.2.6 EPX-F5000 _____________________________________________________________________________ 19
4.2.7 EPX-SERIES COLLIMATOR ___________________________________________________________ 20
4.2.8 SYMBOL ON THE PRODUCT LABEL OF X-RAY SYSTEM ___________________________ 21
4.3 EPX-SERIES DUTY CYCLE LIMIT _________________________________________________________ 22
4.4 DAILY X-RAY TUBE WARM-UP PROCEDURE _____________________________________________ 23
4.5 APPLICABLE STANDARDS _____________________________________________________________ 24
4.6 SPECIFICATION ____________________________________________________________________________ 25
4.6.1 CLASSIFICATION OF THE DEVICE ___________________________________________________ 25
4.6.2 SPECIFICATION TABLE _____________________________________________________________ 26
4.6.3 kV, mAs, mA TABLE ___________________________________________________________________ 33
4.6.4 DOSIMETRY DATA TABLE _____________________________________________________________ 39
4.6.5 MECHANICAL SPECIFICATION _______________________________________________________ 41

EPX-SERIES OPERATOR’S MANUAL
Rev. J 4/74 ECOTRON Co., Ltd.
4.7 WORKING ENVIRONMENT ________________________________________________________________ 43
4.8 CUSTOMER SUPPORT_____________________________________________________________________ 44
5. SYSTEM CONFIGURATION _____________________________________________ 45
5.1 PREPARATION FOR OPERATION _________________________________________________________ 45
5.1.1 OPERATION PRATICES _______________________________________________________________ 45
5.1.2 POSITIONING OF THE PATIENT AGAINST THE COLLIMATOR ______________________ 45
5.2 CONNECTION OF POWER CODE AND HAND SWITCH __________________________________ 47
6. OPERATION MODE ___________________________________________________ 48
6.1 EPX-F1600 / F2400 / F2800 / F3200 / F4000 / F5000 _______________________________________ 48
6.1.1 NORMAL MODE ________________________________________________________________________ 49
6.1.2 APR MODE _____________________________________________________________________________ 49
6.1.3 DOSIMETRY DATA DISPLAY MODE ___________________________________________________ 49
6.1.4 COOLING TIME DISPLAY MODE ______________________________________________________ 50
6.1.5 TURN OFF ______________________________________________________________________________ 50
6.2 TOUCH MAIN SCREEN OF OPERATION MODE (OPTION) _______________________________ 51
6.2.1 NORMAL MODE OF TOUCH MAIN SCREEN __________________________________________ 51
6.3 HAND SWITCH _____________________________________________________________________________ 52
6.3 MOBILE STAND ____________________________________________________________________________ 53
7. MAINTENANCE PROCEDURE ________________________________________ 54
7.1 GENERAL CAUTION _______________________________________________________________________ 54
7.2 MAINTENANCE SCHEDULE _______________________________________________________________ 54
7.3 CLEANING __________________________________________________________________________________ 54
7.4 TROUBLESHOOTING ______________________________________________________________________ 54
7.5 THE EQUIPMENT OPERATION CHECKLIST FOR OPERATOR ___________________________ 55
7.6 MAINTENANCE CHECKLIST ______________________________________________________________ 56
8. DISPOSAL OF WASTE_________________________________________________ 57

EPX-SERIES OPERATOR’S MANUAL
Rev. J 5/74 ECOTRON Co., Ltd.
9. QUALITY WARRANTY _________________________________________________ 58
10. INTENDED OPERATOR AND SERVICE PERSONAL PROFILE________________ 59
10.1 OPERATOR PROFILE _____________________________________________________________________ 59
10.2 SERVICE PERSONAL PROFILE __________________________________________________________ 59
APPENDIX A EMC DECLARATION________________________________________ 60
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

EPX-SERIES OPERATOR’S MANUAL
Rev. J 6/74 ECOTRON Co., Ltd.
REVSON HISTORY
Revision Number
Date
Description
A
SEP 11, 2013
First Edition
B
SEP 30, 2014
European Authorized Representative Change
C
JAN 12, 2015
Manual Update
D
Mar 23, 2015
Manual Update
E
JUN 11, 2015
Manual Update
F
SEP 01, 2015
Manual Update
G
JUN 21, 2016
Manual Update
H
SEP 22, 2016
Manual Update for UDI Label
I
AUG 23, 2018
Manual Update
J
MAR 24, 2020
Manual Update
ADVISORY SYMBOLS
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.
NOTE
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 7/74 ECOTRON Co., Ltd.
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 x-ray
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 8/74 ECOTRON Co., Ltd.
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
NOTE
● ASSEMBLY INFORMATION: NO ASSEMBLY IS REQUIRED.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 9/74 ECOTRON Co., Ltd.
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 low-temperature
burns if the operator contacts with a certain part(control panel, collimator knob, metal enclosure etc.) for a
long time.
EPX-SERIES should be used to plug the power cord into the wall socket.
CAUTION
NO PROTECTION AGAINST THE INGRESS OF THE LIQUIDS

EPX-SERIES OPERATOR’S MANUAL
Rev. J 10/74 ECOTRON Co., Ltd.
WARNING
DO NOT ALLOW OPERATION OF THIS APPARATUS BY ANY PERSON OTHER THAN
QUALIFIED PERSONNEL (PHYSICIANS, RADIOTHERAPY ENGINEERS AND CLINICAL X-
RAY ENGINEERS) OR UNDER OBSERVATION BY THEM.
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 Co., Ltd PROVIEDS INFORMATION ON ITS PRODUCTS AND ASSOCIATED
HAZARDS, BUT ASSUMES NO RESPONSIBILITIES FOR AFTER-SALE POERATING AND
SAFETY PRACTICES.
ECOTRON Co., 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 Co., Ltd ALSO ASSUMES NO RESPONSIBILITY FOR X-RAY RADIATION
OVEREXPOSURE OF PATIENTS OR PERSONNEL RESULTING FROM POOR OPERATING
TECHNIQUES OR PROCEDURS.
WARNING
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE
EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.
WARNING
DO NOT CONNECT ADDITIONAL EXTENSION CORD TO EQUIPMENT.
WARNING
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED
TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 11/74 ECOTRON Co., Ltd.
CAUTION
DO NOT CONNECT ANY OTHER ELECTRICAL DEVICE EXCEPT FOLLOWING
ELECTRICAL DEVICES.
• 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
CAUTION
DO NOT EXCEED THE TUBE MAXIMUM OPERATING LIMITS SHOWN IN THE X-RAY
TUBE DATA SECTION AT THE END OF THE OPERATOR’S MANUAL.
INTENDED LIFE AND RELIABILITY WILL NOT BE OBTAINED UNLESS X-RAY SYSTEMS
ARE POERATED WITHIN PUBLISHED SPECIFICATION.
CAUTION
INCORRECT CONNECTIONS OR USE OF UNAPPROVED EQUIPMENT MAY RESULT IN
INJURY OR EQUIPMENT DAMAGE.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 12/74 ECOTRON Co., Ltd.
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 13/74 ECOTRON Co., Ltd.
4. SAFETY AND SPECIFICATIONS
4.1 SAFETY AND WARNING SYMBOLS
Never allow unqualified personnel to operate the X-
ray 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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 14/74 ECOTRON Co., Ltd.
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.
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 x-ray 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
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 15/74 ECOTRON Co., Ltd.
Protection earth symbol
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.
Second phase line power among the three phase line
powers.
Third phase line power among the three phase line
powers.
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 16/74 ECOTRON Co., Ltd.
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.
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.

EPX-SERIES OPERATOR’S MANUAL
Rev. J 17/74 ECOTRON Co., Ltd.
4.2 COMPOSITION LABEL
4.2.1 EPX-F1600
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)

EPX-SERIES OPERATOR’S MANUAL
Rev. J 18/74 ECOTRON Co., Ltd.
4.2.3 EPX-F2800
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)

EPX-SERIES OPERATOR’S MANUAL
Rev. J 19/74 ECOTRON Co., Ltd.
4.2.5 EPX-F4000
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)

EPX-SERIES OPERATOR’S MANUAL
Rev. J 20/74 ECOTRON Co., Ltd.
4.2.7 EPX-SERIES COLLIMATOR
COMMON LABEL TO ALL MODELS - COLLIMATOR
This is label is attached on side of the collimator of the diagnostic x-ray system. (Example)
▪Input Power: 3V(LED) / 5V(Laser)
▪Min. X-ray field size: 0cm x 0cm at 100cm SID
Max. X-ray field size: 43cm x 43cm at 100cm SID
▪Inherent Filtration: 0.5mmAl
Ecotron Co., Ltd
Made by Korea
Beam Limiting Device(Collimator)
4F & 5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul
08511, Korea
EPX-Collimator
Certification Statement
▪This product complies with 21 CFR 1020.30 –1020.31
▪This product complies with 21 CFR Subchapter J.