Ecotron EPX Series, EPX-F3200 Operator's Manual

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:[email protected]
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03
D/N: ECO-UM-EPX-001 Rev. J
EPX-SERIES OPERATOR’S MANUAL
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Rev. J
2/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
Rev. J
3/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
Rev. J
4/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
Rev. J
ANODE THERMAL CHARACTERISTICS OF X-RAY TUBE _________ 73
5/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
6/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
7/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
8/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
Rev. J
9/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
WARNING
TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED
TO A SUPPLY MAINS WITH PROTECTIVE EARTH.
WARNING
DO NOT CONNECT ADDITIONAL EXTENSION CORD TO EQUIPMENT.
WARNING
THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE
EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.
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
DO NOT ALLOW OPERATION OF THIS APPARATUS BY ANY PERSON OTHER THAN
QUALIFIED PERSONNEL (PHYSICIANS, RADIOTHERAPY ENGINEERS AND CLINICAL XRAY ENGINEERS) OR UNDER OBSERVATION BY THEM.
Rev. J
10/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
CAUTION
INCORRECT CONNECTIONS OR USE OF UNAPPROVED EQUIPMENT MAY RESULT IN
INJURY OR EQUIPMENT DAMAGE.
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
DO NOT CONNECT ANY OTHER
ELECTRICAL DEVICES.
ELECTRICAL DEVICE
EXCEPT
FOLLOWING
• 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.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
12/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4. SAFETY AND SPECIFICATIONS
4.1 SAFETY AND WARNING SYMBOLS
Never allow unqualified personnel to operate the Xray 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.
Rev. J
13/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
14/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
15/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
16/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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)
Rev. J
17/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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)
Rev. J
18/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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)
Rev. J
19/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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)
Beam Limiting Device(Collimator)
EPX-Collimator
▪ 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
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. J
20/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
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.
EPX-SERIES OPERATOR’S MANUAL
4.3 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.
Rev. J
22/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.4 DAILY X-RAY TUBE WARM-UP PROCEDURE
NOTE
THE FOLLOWING PROCEDURE PRODUCES
PRECAUTIONS TO PROTECT PERSONNEL.
X-RAYS.
OBSERVE
ALL
SAFETY
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:
● 60 kV / 5 mAs
● Make three to five exposures at 5 minute intervals.
Rev. J
23/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.5 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 labeling of medical devices
● EN1041:2008
Information supplied by the manufacturer of medical devices
● EN62304:2006
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.4
Rev. J
Clinical evaluation: Guide for manufacturers and notified bodies
24/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6 SPECIFICATION
4.6.1 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.
Rev. J
25/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2 SPECIFICATION TABLE
4.6.2.1 EPX-F1600
Max Output Power
Input Power
1.6 kW
Voltage
100-120V / 200V-240V
Phase & Frequency
Single / 50/60 Hz
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. 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
Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
Collimator with
Laser Pointer
Weight
Rev. J
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
43cm x 43cm
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
@100cm SID
@ 100cm SID
13 Kg
26/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2.2 EPX-F2400
Max Output Power
Input Power
2.4 KW
Voltage
100-120V / 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. 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 with
Laser Pointer
Weight
Rev. J
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
43cm x 43cm
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
@100cm SID
@ 100cm SID
13 Kg
27/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2.3 EPX-F2800
Max Output Power
Input Power
2.7 kW
Voltage
100-120V / 200V-240V
Phase & Frequency
Single / 50/60 Hz
Radiography kV Range in 1kV steps
(40KV ~ 120KV)
Tube voltage
Current
mAs
40KV ~ 50KV
30mA
0.4 ~ 100
51KV ~ 60KV
30mA
0.4 ~ 100
61KV ~ 70KV
30mA
0.4 ~ 100
71KV ~ 80KV
30mA
0.4 ~ 64
71KV ~ 80KV
27mA
80 ~ 100
81KV ~ 90KV
30mA
0.4 ~ 40
81KV ~ 90KV
25mA
50 ~ 80
91KV ~ 100KV
25mA
0.4 ~ 40
91KV ~ 100KV
23mA
50 ~ 80
MAs Range
0.4mAs – 100mAs, 25steps
Max. kV Deviation
±3 %
Max. mAs Deviation
±5 %
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
Type
50 KHU
Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
3.3 mm Al eq. @ 75kV
Double slit type, manual operation
Min. X-ray Field Size
0cm x 0cm
Max X-ray Field Size
43cm x 43cm
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
Total Filtration
Collimator with
Laser Pointer
Weight
Rev. J
@100cm SID
@ 100cm SID
13 Kg
28/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2.4 EPX-F3200
Max Output Power
Input Power
3.2 KW
Voltage
100-120V / 200V-240V
Phase & Frequency
Single / 50/60 Hz
Radiography kV Range in 1KV steps
(40KV ~ 100KV)
Tube voltage
Current
mAs
40KV ~ 50KV
40mA
0.4 ~ 100
51KV ~ 60KV
40mA
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 ~ 40
81KV ~ 90KV
25
50 ~ 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. 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
Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
Collimator with
Laser Pointer
Weight
Rev. J
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
43cm x 43cm
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
@100cm SID
@ 100cm SID
13 Kg
29/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2.5 EPX-F4000
Max Output Power
Input Power
4.0 KW
Voltage
200V-240V
Phase & Frequency
Single / 50/60 Hz
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. Reproducibility of the RADIATION output
Coefficient of variation < 0.02
Display
KV /mAs: 7-segment LED
X-ray Tube
Model Name
OX/110-15 (C.E.I.)
Focal Spot
1.8mmx1.8mm
Target Angle
15 degree
Anode Heat Storage
42kHU
Tube:0.5mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
3.0 mm Al eq. @ 75kV
Type
Double slit type, manual operation
Min. X-ray Field Size
0cm x 0cm
Collimator with
Max X-ray Field Size
43cm x 43cm
Laser Pointer
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
Weight
Rev. J
@100cm SID
@ 100cm SID
13 Kg
30/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.2.6 EPX-F5000
Max Output Power
Input Power
5.0 KW
Voltage
200V-240V
Phase & Frequency
Single / 50/60 Hz
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. Reproducibility of the RADIATION output
Coefficient of variation < 0.02
Display
KV /mAs: 7-segment LED
X-ray Tube
Rev. J
Model Name
OX/110-15 (C.E.I.)
Focal Spot
1.8mmx1.8mm
Target Angle
15 degree
Anode Heat Storage
42kHU
31/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
43cm x 43cm
Laser Pointer
Class II
Timer
Push button illuminator with 30 sec timer
Lamp
LED 3.0V, 3A, 10W
Weight
@100cm SID
@ 100cm SID
13 Kg
4.6.2.7 HAND SWITCH
Two step X-ray exposure hand switch
Type
Two stepping(ready and exposure)
Working Voltage(AC/DC)
125V/30V
Working Current(AC/DC)
1A/2A
Wires and coil cord
3cores, 2.2m
Cores
White
Red
Green
Ready
Common
Exposure
Shell Material
White, Engineering plastics
Useful time
1.2 million times
4.6.2.8 MOBILE STAND
Mobile Stand for EPX-SERIES
Available products
EPX-SERIES only
Arm angle
0° ~ 150°
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.
EPX-SERIES OPERATOR’S MANUAL
4.6.3 kV, mAs, mA TABLE
4.6.3.1 EPX-F1600
mAs TABLE
KV
mA
mAs
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
Sec
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
0.016
0.020
0.024
0.032
0.040
0.052
0.064
0.080
40KV ~ 50KV
30
2.5
3.2
4.0
0.083
0.107
0.133
51KV ~ 60KV
25
2.5
3.2
4.0
0.100
0.128
0.160
25
5.0
6.4
8.0
10
13
16
20
25
32
0.167
0.213
0.267
0.333
0.433
0.533
0.667
1.000
1.280
20
5.0
6.4
8.0
10
13
16
20
25
32
0.200
0.256
0.320
0.400
0.520
0.640
0.800
1.250
1.600
61KV ~ 70KV
23
Rev. J
20
15
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
0.017
0.022
0.026
0.035
0.043
0.057
0.070
0.087
0.109
0.139
0.174
0.217
0.320
0.400
0.500
0.650
0.800
1.000
1.667
2.133
5.0
6.4
8.0
10
13
16
20
25
32
0.278
0.356
0.444
0.556
0.722
0.889
1.111
1.786
2.286
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
0.022
0.028
0.033
0.044
0.056
0.072
0.089
0.111
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
0.025
0.031
0.038
0.050
0.063
0.081
0.100
0.125
71KV ~ 80KV
18
2.5
3.2
4.0
0.139
0.178
0.222
81KV ~ 90KV
16
2.5
3.2
4.0
0.156
0.200
33/74
0.250
14
13
5.0
6.4
8.0
10
13
16
20
25
32
0.313
0.400
0.500
0.625
0.813
1.000
1.250
1.923
2.462
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.3.2 EPX-F2400
mAs TABLE
KV
40KV ~ 60KV
mA
40
mAs
Sec
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
35
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.010 0.013 0.015 0.020 0.025 0.033 0.040 0.050 0.063 0.080 0.100 0.125 0.160 0.200 0.250 0.325 0.400 0.500 0.625 0.800 1.000 1.250 1.600 2.286 2.857
61KV ~ 70KV
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.013 0.017 0.020 0.027 0.033 0.043 0.053 0.067 0.083 0.107 0.133 0.167 0.213 0.267 0.333 0.433 0.533 0.667 0.833 1.067 1.333 1.667 2.133 2.667 3.333
71KV ~ 80KV
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
25
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.013 0.017 0.020 0.027 0.033 0.043 0.053 0.067 0.083 0.107 0.133 0.167 0.213 0.267 0.333 0.433 0.533 0.667 0.833 1.067 1.600 2.000 2.560 3.200
81KV ~ 90KV
25
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
20
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.016 0.020 0.024 0.032 0.040 0.052 0.064 0.080 0.100 0.128 0.160 0.200 0.256 0.320 0.400 0.520 0.640 0.800 1.000 1.280 1.600 2.500 3.200 4.000
91KV ~ 100KV
20
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.020 0.025 0.030 0.040 0.050 0.065 0.080 0.100 0.125 0.160 0.200 0.250 0.320 0.400 0.500 0.650 0.800 1.000 1.250 1.600 2.000 2.500 3.200 4.000
Rev. J
34/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.3.3 EPX-F2800
mAs TABLE
40KV ~ 50KV
30
KV
mA
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
8.0
10
13
16
20
25
32
40
50
64
80
100
Sec
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
1.667
2.133
2.667
3.333
51KV ~ 60KV
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
1.667
2.133
2.667
3.333
61KV ~ 70KV
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
1.667
2.133
2.667
3.333
71KV ~ 80KV
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
27
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
1.667
2.133
2.963
3.704
81KV ~ 90KV
30
25
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
2.000
2.560
3.200
91KV ~ 100KV
25
Rev. J
23
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.016
0.020
0.024
0.032
0.040
0.052
0.064
0.080
0.100
0.128
0.160
0.200
0.256
0.320
0.400
0.520
0.640
0.800
1.000
1.280
1.600
2.174
2.783
3.478
35/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.3.4 EPX-F3200
mAs TABLE
40KV ~ 50KV
KV
40
mA
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
8.0
10
13
16
20
25
32
40
Sec 0.010 0.013 0.015 0.020 0.025 0.033 0.040 0.050 0.063 0.080 0.100 0.125 0.160 0.200 0.250 0.325 0.400 0.500 0.625 0.800 1.000
50
64
80
100
1.250
1.600
2.000
2.500
51KV ~ 60KV
40
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.010
0.013
0.015
0.020
0.025
0.033
0.040
0.050
0.063
0.080
0.100
0.125
0.160
0.200
0.250
0.325
0.400
0.500
0.625
0.800
1.000
1.250
1.600
2.000
61KV ~ 70KV
40
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
100
0.010
0.013
0.015
0.020
0.025
0.033
0.040
0.050
0.063
0.080
0.100
0.125
0.160
0.200
0.250
0.325
0.400
0.500
0.625
0.800
1.000
1.250
1.600
2.000
2.500
71KV ~ 80KV
40
35
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.010
0.013
0.015
0.020
0.025
0.033
0.040
0.050
0.063
0.080
0.100
0.125
0.160
0.200
0.250
0.325
0.400
0.500
0.625
0.800
1.143
1.429
1.829
2.286
81KV ~ 90KV
30
25
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
2.000
2.560
3.200
91KV ~ 100KV
30
Rev. J
25
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
1.333
1.667
2.560
3.200
36/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.3.5 EPX-F4000
mAs TABLE
50KV
KV
mA
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
8.0
10
13
16
20
70
25
32
40
50
60
64
80
100
Sec
0.005
0.006
0.008
0.010
0.013
0.016
0.020
0.025
0.031
0.040
0.050
0.063
0.080
0.100
0.125
0.163
0.200
0.286
0.357
0.457
0.667
0.833
1.067
1.333
1.667
80
51KV ~ 60KV
60
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
50
64
80
100
0.007
0.008
0.010
0.013
0.017
0.022
0.027
0.033
0.042
0.053
0.067
0.083
0.107
0.133
0.167
0.217
0.267
0.333
0.417
0.533
0.800
1.000
1.280
1.600
2.000
61KV ~ 70KV
50
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
40
64
80
100
0.008
0.010
0.012
0.016
0.020
0.026
0.032
0.040
0.050
0.064
0.080
0.100
0.128
0.160
0.200
0.260
0.320
0.400
0.500
0.640
1.000
1.250
1.600
2.000
2.500
71KV ~ 80KV
50
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
40
32
40
50
64
80
0.008
0.010
0.012
0.016
0.020
0.026
0.032
0.040
0.050
0.064
0.080
0.100
0.128
0.160
0.200
0.325
0.400
0.500
0.625
0.800
1.000
1.250
1.600
2.000
81KV ~ 90KV
40
30
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.010
0.013
0.015
0.020
0.025
0.033
0.040
0.050
0.063
0.080
0.100
0.125
0.160
0.200
0.250
0.325
0.400
0.500
0.625
0.800
1.333
1.667
2.133
2.667
91KV ~ 100KV
35
25
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.011
0.014
0.017
0.023
0.029
0.037
0.046
0.057
0.071
0.091
0.114
0.143
0.183
0.229
0.286
0.371
0.457
0.571
0.714
0.914
1.600
2.000
2.560
3.200
101KV ~ 110KV
30
Rev. J
20
0.4
0.5
0.6
0.8
1.0
1.3
1.6
2.0
2.5
3.2
4.0
5.0
6.4
8.0
10
13
16
20
25
32
40
50
64
80
0.013
0.017
0.020
0.027
0.033
0.043
0.053
0.067
0.083
0.107
0.133
0.167
0.213
0.267
0.333
0.433
0.533
0.667
0.833
1.067
2.000
2.500
3.200
4.000
37/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.3.6 EPX-F5000
mAs TABLE
40KV ~ 50KV
KV
mA
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
8.0
10
13
16
80
20
25
32
40
50
70
64
80
100
Sec
0.004
0.005
0.006
0.008
0.010
0.013
0.016
0.020
0.025
0.032
0.040
0.050
0.064
0.080
0.100
0.163
0.200
0.250
0.313
0.400
0.571
0.714
0.914
1.143
1.429
100
51KV ~ 60KV
80
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
70
20
25
32
40
50
60
64
80
100
0.005
0.006
0.008
0.010
0.013
0.016
0.020
0.025
0.031
0.040
0.050
0.063
0.080
0.100
0.125
0.186
0.229
0.286
0.357
0.457
0.667
0.833
1.067
1.333
1.667
25
32
40
50
50
64
80
100
0.417
0.533
0.800
1.000
1.280
1.600
2.000
61KV ~ 70KV
70
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
60
20
0.006
0.007
0.009
0.011
0.014
0.019
0.023
0.029
0.036
0.046
0.057
0.071
0.091
0.114
0.143
0.217
0.267
0.333
71KV ~ 80KV
60
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
50
20
25
32
40
50
40
64
80
100
0.007
0.008
0.010
0.013
0.017
0.022
0.027
0.033
0.042
0.053
0.067
0.083
0.107
0.133
0.167
0.260
0.320
0.400
0.500
0.640
1.000
1.250
1.600
2.000
2.500
81KV ~ 90KV
50
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
40
20
25
32
40
50
30
64
80
100
0.008
0.010
0.012
0.016
0.020
0.026
0.032
0.040
0.050
0.064
0.080
0.100
0.128
0.160
0.200
0.325
0.400
0.500
0.625
0.800
1.333
1.667
2.133
2.667
3.333
91KV ~ 100KV
45
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
40
20
25
32
40
50
30
64
80
100
0.009
0.011
0.013
0.018
0.022
0.029
0.036
0.044
0.056
0.071
0.089
0.111
0.142
0.178
0.222
0.325
0.400
0.500
0.625
0.800
1.333
1.667
2.133
2.667
3.333
101KV ~ 110KV
40
Rev. J
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
30
20
25
32
40
50
20
64
80
100
0.010
0.013
0.015
0.020
0.025
0.033
0.040
0.050
0.063
0.080
0.100
0.125
0.160
0.200
0.250
0.433
0.533
0.667
0.833
1.067
2.000
2.500
3.200
4.000
5.000
38/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.4 DOSIMETRY DATA TABLE
4.6.4.1 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
4.6.4.2 EPX-F2400
Unit: μGy*㎡
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
kV
mAs
50
64
80
100
221.3
433.8
681.3
949.3
4.6.4.3 EPX-F2800
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
kV
mAs
50
64
80
100
Rev. J
221.3
433.8
681.3
39/74
949.3
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.4.4 EPX-F3200
Unit: μGy*㎡
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
kV
mAs
80
650.1
100
261.7
522.7
1138.7
4.6.4.5 EPX-F4000
Unit: μGy*㎡
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
kV
mAs
80
100
429.9
693.6
974.4
4.6.4.6 EPX-F5000
Unit: μGy*㎡
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
kV
mAs
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.6.5 MECHANICAL SPECIFICATION
EPX-F1600/F2400/F2800/F3200/F4000/F5000 Dimension (unit: mm)
< Side View >
< Front View >
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
Hand Switch Dimension (unit: mm)
Mobile Stand Dimension (unit: mm)
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.7 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
Rev. J
Temperature range
-25 °C ~ 60 °C (-13 °F ~ 140 °F)
Relative Humidity Range
10% ~ 95% RH
43/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
4.8 CUSTOMER SUPPORT
Address any questions regarding X-ray system operation to:
ECOTRON Co.,Ltd
4F & 5F, Hanshin IT Tower II, 47, Digital-ro 9-gil,
Geumcheon-Gu, Seoul 08511, Republic of 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, Gainsville, Florida, 32653, USA
TEL:201-370-6672, FAX: 352-337-1271
E-mail: [email protected]
Obelis S.A
Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:[email protected]
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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 PRATICES
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.
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
CAUTION
THE OPERATION OF THE MACHINE SHOULD NOT BE STARTED UNLESS ALL
VERIFICATIONS AND CONNECTIONS ARE FULLY CHECKED.
CAUTION
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 VALUES (50 KV / 5
MAS) THREE TIMES IN ROW AND EXECUTE WITH HIGHER VALUES (70KV/5MAS)
THREE TIMES IN ROW AGAIN. THEN HIGH KV/MAS VALUES (90 KV / 5 MAS) WILL BE
APPLIED WITHOUT TROUBLE.
CAUTION
THIS X-RAY SYSTEM HAS TEMPERATURE MONITORING OF X-RAY TUBE TO PROTECT
THE EXCESSIVE HEAT BUILD-UP. IF THE X-RAY SYSTEM DETECTS THE OVER-HEAT OF
X-RAY TUBE, AN ERROR CODE “E02” WILL BE DISPLAYED.
EXPOSURE WILL BE INHIBITED WHEN THIS MESSAGE IS DISPLAYED, AND IT SHOULD
BE UNDERSTOOD THAT CONTINUING TO MAKE EXPOSURES 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.
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.
EPX-SERIES OPERATOR’S MANUAL
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
WARNING
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 VOLTAGE
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.
EPX-SERIES OPERATOR’S MANUAL
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
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
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ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
50/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
Function
1
kV Indicator
Display kV Value (1KV increment)
2
kV value up/down control buttons
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
Ready button
Before any X-ray exposure, press this button for 3 seconds
to complete filament Pre-heating. When the preheating is
completed, this item (13) Ready indicator will light up. This is
the same function as half-pressing the exposure handswitch.
10
Rev. J
51/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
11
X-ray exposure button
X-ray exposure is done by pressing this button. During
exposure, the X-ray Exposure indicator (14) will light up.
This function also 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
Scroll
Touch-and-drag the screen action (left-right or right-left
direction) will display alternating screen (kV, mAs indicator
vs. sec and mA display)
6.3 HAND SWITCH
No.
Name
Description
st
1 stage: The equipment gets ready when the button is half pressed with
a thumb.
1
Hand Switch
(Dead-man type)
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.
2
Handle
3
Connector
Rev. J
Hand-Switch to grab with hands.
Connector to connect X-ray equipment and a Hand-Switch
52/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
CAUTION
THE OPERATOR MUST KEEP THE PRECAUTIONS WHEN USING MOBILE STAND 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.
Rev. J
53/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
.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.
WARNING
THERE MAY CAUSE SERIOUS INJURY BY CONDUCTING UNAUTHORIZED SERVICE OR
CHANGING THE INSTRUMENT AND MANUFACTURER SHALL NOT BE 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
Inspector
1 Year
Service personnel with
expertise
1 Year
Service personnel with
expertise
1 Year
Service personnel with
expertise
1 Year
Service personnel with
expertise
1 Year
Service personnel with
expertise
mA: (Lower than management standards of EN60601-2-54)
Should be within accuracy boundary of ±3%, with the voltage
1
set by 40 kV and 120 kV.
mAs: (Lower than management standards of EN60601-2-54)
Should be within accuracy boundary of ±5%, when the mAs
2
value is between 0.4 mAs and 100 mAs.
kV: (Lower than management standards of EN60601-2-54)
Should be within accuracy boundary of ±5%, when the kV value
3
is between 40 kV and 120 kV.
Optical Maintenance:
When dirt appears on the image, remove dirt on Collimator
4
window with soft brush.
Reproducibility of the RADIATION output Maintenance:
The displayed value on the FND should not exceed 40% of the
5
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.
Rev. J
54/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
1
2
3
4
If the X-ray does not be
exposed,
If the power switch down
automatically,
If the device dose not power
on,
If the control button does not
operate,
5
If the console does not
display,
6
(Option) If the touch screen
does not operate incorrectly,
Cause
Action
1. Hand switch contact failure
2. Hand switch malfunction
3. HV mono block tank malfunction
1. Try hand switch plug out and
plug in
2. Replacing the hand switch
3. Call for service
FET Driver Board malfunction
Call for service
1. Main power board malfunction
2. SMPS malfunction
1. Control button failure
2. Main control board malfunction
1. Main power board or SMPS
malfunction
2. Main control board malfunction
1. Fail to initialize touch screen
2. Touch screen malfunction
Call for service
Call for service
Call for service
1. Please turn it off and on again
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
Rev. J
55/74
Verdict
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
7.6 MAINTENANCE CHECKLIST
MAINTENANCE CHECKLIST
MODEL: ___________________
SERIAL NUMBER: ___________________
Measuring tool:
-
Oscilloscope (EP: 1 V = 20 kV, IP: 1 V = 5.8 mA)
-
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
4
not exceed 40% of the actual value for areas larger than 200 ㎠.
5
Check that remove dirt on Collimator window with soft brush.
6
Check that collimator mounting ring is tight.
7
Check beam alignment.(SID)
8
Check that all indicator lights are operating.
9
Check that all hardware is tightly secured.
10
Check all interconnect cables for broken or frayed wires.
11
Make sure all bolts are secure.
Service Engineer:_____________________
Rev. J
Check Date: _____________________
56/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
8. DISPOSAL OF WASTE
If the X-ray system has completed its useful service life, local environmental
regulations must be complied with in regard to disposal of possible hazardous
materials used in the construction of the generator.
In order to assist with this determination, the noteworthy materials used in the
construction of this generator are itemized below:
ITEM
Electrical insulating oil in HT tank. This is a mineral oil with trace additives (1.8 Liter)
Solder (lead/tin).
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.
EPX-SERIES OPERATOR’S MANUAL
9. QUALITY WARRANTY
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.
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.
Rev. J
58/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
10. INTENDED OPERATOR AND SERVICE PERSONAL PROFILE
10.1 OPERATOR PROFILE
Considerations
Education
Requirement description
Minimum
- At least graduate of medical college
Maximum
- No maximum
- Read and understand 'westernized Arabic' numerals when written
Knowledge
Language understanding
Experience
Permissible impairments
Minimum
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
Minimum
- Mild reading vision impairment or vision corrected to log MAR 0.2
- Average degree of aging-related short term memory impairment
- Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to
2 kHz
10.2 SERVICE PERSONAL PROFILE
Considerations
Education
Requirement description
Minimum
- At least graduate of high school
Maximum
- No maximum
- Read and understand 'westernized Arabic' numerals when written
Knowledge
Language understanding
Experience
Minimum
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
- Mild reading vision impairment or vision corrected to log MAR 0.2
Permissible impairments
Rev. J
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
59/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
APPENDIX A EMC DECLARATION
Guidelines and manufacturers: electromagnetic emission
The Diagnostic X-ray System is used in the following electromagnetic settings. Users of the Diagnostic Xray 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
Harmonic wave emission
CISPR 11
The Diagnostic X-ray System is suitable not only in nonClass A
connecting to the common low-power network in a
Voltage changes/flicker
emission
household facilities but can also be used by directly
Compliance
building.
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 Xray System should check whether their systems are used in these settings.
Tolerance test
IEC 60601 test level
Suitability level
Electromagnetic
setting: guidelines
The floor should be in
Static
electricity
+/- 6kV contact
+/- 6kV contact
discharge (ESD)
wood, concrete or
ceramic tiles. If the floor is
in a synthetic material,
IEC 61000-4-2
+/- 8kV in the air
+/- 8kV in the air
the relative humidity
should be at least 30%.
Suitability in
+/- 2kV power supply
electric oversprays
unit line
+/- 2kV power supply unit line
The main power’s quality
should be equal to the
those of general
IEC 61000-4-4
commercial or hospital
+/- 1kV input/output line
+/- 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.
EPX-SERIES OPERATOR’S MANUAL
The main power’s quality
should be equal to the
those of general
Voltage loss in the
power
supply,
short intermittence
and
voltage
changes
IEC 61000-4-11
<5% UT(<95%Dip at the
<5% UT(<95%Dip at the UT),
UT), 0.5 cycles
0.5 cycles
40% UT(60% Dip at the
40% UT(60% Dip at the UT), 5
UT), 5 cycles
cycles
70% UT(30% Dip at the
70% UT(30% Dip at the UT),
UT), 25 cycles
25 cycles
<5% UT(>95% Dip at the
<5% UT(>95% Dip at the UT),
UT), 5 seconds
5 seconds
commercial or hospital
settings.
Note : Most components
in the Diagnostic Xray System have their
power supplied from the
uninterrupted power
supply.
The IEC61000-4-11 only
applies to the Diagnostic
X-ray System Power Box.
Magnetic field in
3A/m
3A/m
the source
The magnetic field in the
source frequency should
frequency
be equivalent to the those
(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.
EPX-SERIES OPERATOR’S MANUAL
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
d = 1.17√p80MHz ~ 800MHz
3Vrms
d = 2.33√p800MHz ~ 2.5GHz,
where p is the transmitter-receiver’s
3v/m
maximum power rating in watts (W) and
d is the recommended interval.
IEC61000-4-3
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.
Rev. J
62/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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.
Rev. J
63/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
APPENDIX B TECHNICAL CHART
Film Screen: Lanex Regular Screen (400 speed) 40" SID
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)
Rev. J
Adults
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
64/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
L/SPINE
(LAT)
PELVIS/HIP
CHEST (AP)
CHEST (LAT)
ABDOMEN
Rev. J
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
65/74
-
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
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
CR System: 40" SID
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)
Rev. J
Adults
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
21-23cm
80
32
NO
392.4
80
16
NO
195.89
66/74
-
-
-
8.828
9.792
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
L/SPINE
(LAT)
PELVIS/HIP
CHEST (AP)
CHEST (LAT)
ABDOMEN
Rev. J
32-34cm
100
64
YES
1190.1
12-14cm
73
20
YES
205.9
20-22cm
77
32
YES
365.52
26-28cm
78
64
YES
12-16cm
80
2.0
22-24cm
80
30-34cm
100
32
YES
590.1
73
10
YES
102.8
77
16
YES
182.49
749.52
78
32
YES
374.48
NO
24.12
80
1.0
NO
11.92
3.2
NO
38.76
80
1.6
NO
19.24
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
67/74
-
-
-
-
-
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
DR System: Flap Panel with CSI Screen, 40" SID
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)
Rev. J
Adults
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
8-10cm
60
2.5
NO
17.08
-
50
1.0
NO
4.498
4-6cm
50
2.0
NO
8.828
7-9cm
56
2.5
NO
14.641
10-12cm
60
2.5
NO
17.08
-
50
1.0
NO
4.498
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
68/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
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
-
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
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.
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. 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
Rev. J
70/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
Guidelines for Adjusting Individual Exposure Parameters by patient
Patient Dose Reporting
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.
Rev. J
71/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
APPENDIX D
ACTION TO CORRECT THE ERROR OF EPX-SERIES
Error Codes
7
Check points and Action
Ready SW ERR
a. Replace the hand switch
8
Exposure SW ERR
10
Standby Fil FB Error
11
Standby EP FB Error
12
Standby IP FB Error
14
Run Fil FB Error
15
Run EP FB low ERR
16
Run IP FB High ERR
a. If error repeats at the condition of 40kV 0.4mAs EXP, replace the OP
board
a. If error repeats at the condition of 40kV 0.4mAs EXP, check the followings
by sequence.
1. Check TP in the power input of the OP board
2. Check the Reference voltage value
17
Run EP FB High ERR
18
Run IP FB low ERR
28
Pulse by Pulse ERR
30
KV_OVP ERR
31
FIL_OC ERR FIL
3. If the reference voltage is normal, replace the FET board
4. If replacing FET board does not solve the problem, the replace
the HV tank.
a. If error pops up right after the unit power is turned on, then replace the
OP board.
b. If error repeats at the condition of 40kV 0.4mAs EXP,
1. Replace the FET board
32
IP_OCP ERR
2. If replacing FET board does not solve the problem, the replace the HV
tank.
Warning Codes
2
29
Thermal ERR excess
Wait until the temperature inside the monotank comes down to normal
from 60°C
(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.
EPX-SERIES OPERATOR’S MANUAL
APPENDIX E
ANODE THERMAL CHARACTERISTICS OF X-RAY TUBE
D-125
D-205B
Rev. J
73/74
ECOTRON Co., Ltd.
EPX-SERIES OPERATOR’S MANUAL
OX/110-15
Rev. J
74/74
ECOTRON Co., Ltd.
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