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Rayos X Ekotron Epx-F2800 Manual de Servicio

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EPX-SERIES

Diagnostic X-ray System

Operator’s Manual

Ecotron Co., Ltd


Made by Korea
4F&5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea
Obelis S.A
Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:mail@obelis.net
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03

D/N: ECO-UM-EPX-001 Rev. J


EPX-SERIES OPERATOR’S MANUAL

(This page intentionally left blank)

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 ANODE THERMAL CHARACTERISTICS OF X-RAY TUBE _________ 73

Rev. J 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 X-
RAY 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 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

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 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.

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 X-RAYS. OBSERVE ALL SAFETY


PRECAUTIONS TO PROTECT PERSONNEL.

Use the procedure when the generator has not been used for several days. This procedure provides for
exposures at medium power before the tube is used at maximum mA or kV values. This will reduce the
possibility of damaging the X-ray tube and high voltage components. No test setup is required.
For maximum stability and reliability, use the following techniques at start up:

Select the following:

● 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 Clinical evaluation: Guide for manufacturers and notified bodies

Rev. J 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 1.6 kW

Voltage 100-120V / 200V-240V


Input Power
Phase & Frequency Single / 50/60 Hz

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


Radiography kV Range in 1kV steps
61KV ~ 70KV 20mA 0.4 ~ 20
(40KV ~ 90KV)
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

Model Name D-125 (Toshiba)


Focal Spot 1.2mm x 1.2mm
X-ray Tube
Target Angle 16 degree
Anode Heat Storage 50 KHU
Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
3.3 mm Al eq. @ 75kV

Type Double slit type, manual operation

Min. X-ray Field Size 0cm x 0cm @100cm SID


Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer Laser Pointer Class II

Timer Push button illuminator with 30 sec timer

Lamp LED 3.0V, 3A, 10W

Weight 13 Kg

Rev. J 26/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.2.2 EPX-F2400

Max Output Power 2.4 KW

Voltage 100-120V / 200V-240V


Input Power
Phase & Frequency Single, 50/60 Hz

Tube voltage Current mAs

40KV ~ 60KV 40mA 0.4 ~ 64

40KV ~ 60KV 35mA 80 ~ 100

61KV ~ 70KV 30mA 0.4 ~ 100


Radiography KV Range in 1KV steps
71KV ~ 80KV 30mA 0.4 ~ 32
(40KV ~ 100KV)
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

Model Name D-125 (Toshiba)

Focal Spot 1.2mm x 1.2mm


X-ray Tube
Target Angle 16 degree

Anode Heat Storage 50 KHU


Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
3.3 mm Al eq. @ 75kV

Type Double slit type, manual operation

Min. X-ray Field Size 0cm x 0cm @100cm SID

Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer Laser Pointer Class II

Timer Push button illuminator with 30 sec timer

Lamp LED 3.0V, 3A, 10W

Weight 13 Kg

Rev. J 27/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.2.3 EPX-F2800

Max Output Power 2.7 kW


Voltage 100-120V / 200V-240V
Input Power
Phase & Frequency Single / 50/60 Hz
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
Radiography kV Range in 1kV steps
(40KV ~ 120KV) 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
Model Name D-125 (Toshiba)
Focal Spot 1.2mm x 1.2mm
X-ray Tube
Target Angle 16 degree
Anode Heat Storage 50 KHU
Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
3.3 mm Al eq. @ 75kV
Type Double slit type, manual operation
Min. X-ray Field Size 0cm x 0cm @100cm SID

Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer Laser Pointer Class II
Timer Push button illuminator with 30 sec timer
Lamp LED 3.0V, 3A, 10W
Weight 13 Kg

Rev. J 28/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.2.4 EPX-F3200

Max Output Power 3.2 KW

Voltage 100-120V / 200V-240V


Input Power
Phase & Frequency Single / 50/60 Hz

Tube voltage Current mAs

40KV ~ 50KV 40mA 0.4 ~ 100

51KV ~ 60KV 40mA 0.4 ~ 80

61KV ~ 70KV 40mA 0.4 ~ 100

Radiography kV Range in 1KV steps 71KV ~ 80KV 40mA 0.4 ~ 32


(40KV ~ 100KV)
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

Model Name D-205B (Toshiba)

Focal Spot 2.0mmx2.0 mm


X-ray Tube
Target Angle 20 degree

Anode Heat Storage 40 kHU


Tube:0.8mmAl / collimator: 0.5mmAl / filter:2.0mmAl
Total Filtration
3.3 mm Al eq. @ 75kV

Type Double slit type, manual operation

Min. X-ray Field Size 0cm x 0cm @100cm SID

Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer
Laser Pointer Class II

Timer Push button illuminator with 30 sec timer

Lamp LED 3.0V, 3A, 10W

Weight 13 Kg

Rev. J 29/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.2.5 EPX-F4000
Max Output Power 4.0 KW
Voltage 200V-240V
Input Power
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
Model Name OX/110-15 (C.E.I.)
Focal Spot 1.8mmx1.8mm
X-ray Tube
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 @100cm SID
Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer Laser Pointer Class II
Timer Push button illuminator with 30 sec timer
Lamp LED 3.0V, 3A, 10W
Weight 13 Kg

Rev. J 30/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.2.6 EPX-F5000

Max Output Power 5.0 KW


Voltage 200V-240V
Input Power
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
Model Name OX/110-15 (C.E.I.)
Focal Spot 1.8mmx1.8mm
X-ray Tube
Target Angle 15 degree
Anode Heat Storage 42kHU

Rev. J 31/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

Tube:0.5mmAl / collimator: 0.5mmAl / filter:2.0mmAl


Total Filtration
3.0 mm Al eq. @ 75kV

Type Double slit type, Manually operation


Min. X-ray Field Size 0cm x 0cm @100cm SID
Collimator with Max X-ray Field Size 43cm x 43cm @ 100cm SID
Laser Pointer Laser Pointer Class II
Timer Push button illuminator with 30 sec timer
Lamp LED 3.0V, 3A, 10W
Weight 13 Kg

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

White Red Green


Cores
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 40KV ~ 50KV
mA 30 25
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
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 1.000 1.280
51KV ~ 60KV
25 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
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 1.250 1.600
61KV ~ 70KV
23 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
71KV ~ 80KV
18 14
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
0.022 0.028 0.033 0.044 0.056 0.072 0.089 0.111 0.139 0.178 0.222 0.278 0.356 0.444 0.556 0.722 0.889 1.111 1.786 2.286
81KV ~ 90KV
16 13
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
0.025 0.031 0.038 0.050 0.063 0.081 0.100 0.125 0.156 0.200 0.250 0.313 0.400 0.500 0.625 0.813 1.000 1.250 1.923 2.462

Rev. J 33/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.3.2 EPX-F2400

mAs TABLE
KV 40KV ~ 60KV
mA 40 35
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 0.010 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 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 1.600 2.000 2.560 3.200

81KV ~ 90KV
25 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
0.016 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
KV 40KV ~ 50KV
mA 30
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 27
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 2.963 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 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

Rev. J 35/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.3.4 EPX-F3200

mAs TABLE
KV 40KV ~ 50KV
mA 40
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 0.010 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
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 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

Rev. J 36/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.3.5 EPX-F4000

mAs TABLE
KV 50KV
mA 80 70 60
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 0.005 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
51KV ~ 60KV
60 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 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 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
0.008 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 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
0.008 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 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

Rev. J 37/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.3.6 EPX-F5000

mAs TABLE
KV 40KV ~ 50KV
mA 100 80 70
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 0.004 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
51KV ~ 60KV
80 70 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 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
61KV ~ 70KV
70 60 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 64 80 100
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 0.417 0.533 0.800 1.000 1.280 1.600 2.000
71KV ~ 80KV
60 50 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
0.007 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 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 80 100
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 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 80 100
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 30 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 80 100
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

Rev. J 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
mAs
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

4.6.4.2 EPX-F2400
Unit: μGy*㎡

kV 40 50 60 70 80 90 100
mAs
0.4 0.9 1.9 2.8 3.6 4.6 5.4 6.4
5 11.1 21.8 34.1 47.2 60.7 75.4 90.8

32 70.7 139 218.2 302.8 392.4 489 590.1

50

64

80 986 1231.2 1489.9

100 221.3 433.8 681.3 949.3

4.6.4.3 EPX-F2800

kV 40 50 60 70 80 90 100
mAs
0.4 0.9 1.9 2.8 3.6 4.6 5.4 6.4

5 11.1 21.8 34.1 47.2 60.7 75.4 90.8

32 70.7 139 218.2 302.8 392.4 489 590.1

50

64

80 986 1231.2 1489.9

100 221.3 433.8 681.3 949.3

Rev. J 39/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

4.6.4.4 EPX-F3200
Unit: μGy*㎡

kV 40 50 60 70 80 90 100
mAs
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

80 650.1 1198.9 1508.3 1843.9

100 261.7 522.7 1138.7

4.6.4.5 EPX-F4000
Unit: μGy*㎡

kV 50 60 70 80 90 100 110
mAs
0.4 0.9 1.9 2.5 3.2 4.3 4.4 5.4

5 19.4 32.2 46.7 61.4 77.5 92.8 110

32 132.5 217.8 310 406.6 513.9 615 737.8

80 1028.2 1307.3 1573.5 1914.7

100 429.9 693.6 974.4

4.6.4.6 EPX-F5000
Unit: μGy*㎡

kV 50 60 70 80 90 100 110
mAs
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

Rev. J 40/74 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 41/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

Hand Switch Dimension (unit: mm)

Mobile Stand Dimension (unit: mm)

Rev. J 42/74 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

Temperature range -25 °C ~ 60 °C (-13 °F ~ 140 °F)

Relative Humidity Range 10% ~ 95% RH

Rev. J 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: ecotron@ecotron.co.kr
Web-site: http://www.ecotron.co.kr

In USA
Contact DRGEM USA Inc.
TH
7018 NW 50 Terrace, Gainsville, Florida, 32653, USA
TEL:201-370-6672, FAX: 352-337-1271
E-mail: drgemusa@gmail.com

Obelis S.A
Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:mail@obelis.net
Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03

Rev. J 44/74 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 45/74 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
PC interface connecting
7 Lighted when EPX series is connected to PC
indicator
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 48/74 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 49/74 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)


Select kV value by tapping up (increase) or down (decrease)
2 kV value up/down control buttons
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.

Select sec value by tapping up/down buttons. Changing Sec


6 Sec value up/down control buttons
value automatically change mAs accordingly.

7 mA Indicator Filament current value determined by kV and mAs setting

8 Collimator lamp on/off button Switch for operation of the lamp inside the collimator

9 Laser pointer on/off button To turn on/off the dual laser to adjust exposure SID

Before any X-ray exposure, press this button for 3 seconds


to complete filament Pre-heating. When the preheating is
10 Ready button completed, this item (13) Ready indicator will light up. This is
the same function as half-pressing the exposure hand-
switch.

Rev. J 51/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

X-ray exposure is done by pressing this button. During


exposure, the X-ray Exposure indicator (14) will light up.
11 X-ray exposure button
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

Touch-and-drag the screen action (left-right or right-left


Scroll 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.
Hand Switch 2
nd
stage: The equipment exposes X-ray when the button is fully pressed
1
(Dead-man type)
with a thumb. It automatically turns off according to the value of mAs set
by the program or when the thumb is off the switch.

2 Handle Hand-Switch to grab with hands.

3 Connector Connector to connect X-ray equipment and a Hand-Switch

Rev. J 52/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

6.3 MOBILE STAND

No. Name Description

1 Arm Arm of a stand to fix X-ray equipment or change its direction

2 Height adjustment Handle or gearbox to adjust height of the equipment

3 Gantry Gantry to fix arm or height adjustment component


Rack to hold up X-ray device or stand components (wheels included for
4 Rack
carrying the equipment)

5 Caster 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


mA: (Lower than management standards of EN60601-2-54)
Should be within accuracy boundary of ±3%, with the voltage Service personnel with
1 1 Year
expertise
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 Service personnel with
2 1 Year
expertise
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 Service personnel with
3 1 Year
expertise
is between 40 kV and 120 kV.
Optical Maintenance:
When dirt appears on the image, remove dirt on Collimator Service personnel with
4 1 Year
expertise
window with soft brush.
Reproducibility of the RADIATION output Maintenance:
Service personnel with
5 The displayed value on the FND should not exceed 40% of the 1 Year
expertise
actual value for areas larger than 200 ㎠.

7.3 CLEANING
Keep the machine clean when it gets dirt.
To clean the main-body, turn off the power and pull the plug out from the outlet.
Scrub surfaces smoothly with soft fabric or gauze.

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 Cause Action


1. Try hand switch plug out and
1. Hand switch contact failure
If the X-ray does not be plug in
1 2. Hand switch malfunction
exposed, 2. Replacing the hand switch
3. HV mono block tank malfunction
3. Call for service
If the power switch down
2 FET Driver Board malfunction Call for service
automatically,
If the device dose not power 1. Main power board malfunction
3 Call for service
on, 2. SMPS malfunction
If the control button does not 1. Control button failure
4 Call for service
operate, 2. Main control board malfunction
1. Main power board or SMPS
If the console does not
5 malfunction Call for service
display,
2. Main control board malfunction
(Option) If the touch screen 1. Fail to initialize touch screen 1. Please turn it off and on again
6
does not operate incorrectly, 2. Touch screen malfunction 2. Call for service

7.5 THE EQUIPMENT OPERATION CHECKLIST FOR OPERATOR

Check Item Verdict

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 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 Verdict

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%.

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:_____________________ Check Date: _____________________

Rev. J 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 Requirement description

Minimum - At least graduate of medical college


Education
Maximum - No maximum
- Read and understand 'westernized Arabic' numerals when written
in Arial font
Minimum
- Can distinguish of human body
Knowledge
- Understands hygiene

Maximum - No maximum

Minimum - Local language


Language understanding
Maximum - Understanding of manual that is writing in English

Minimum - Have license of radiologist or have to meet local regulation


Experience
Maximum - No maximum
- Mild reading vision impairment or vision corrected to log MAR 0.2
- Average degree of aging-related short term memory impairment
Permissible impairments Minimum
- Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to
2 kHz

10.2 SERVICE PERSONAL PROFILE

Considerations Requirement description

Minimum - At least graduate of high school


Education
Maximum - No maximum
- Read and understand 'westernized Arabic' numerals when written
in Arial font
Minimum
- Can distinguish of human body
Knowledge
- Understands hygiene

Maximum - No maximum

Minimum - Local language


Language understanding
Maximum - Understanding of manual that is writing in English

Minimum - Only authorized and properly trained by ECOTRON


Experience
Maximum - No maximum
- Mild reading vision impairment or vision corrected to log MAR 0.2
- Average degree of aging-related short term memory impairment
Permissible impairments Minimum
- Impaired by 40 % resulting in 60 % of normal hearing at 500 Hz to
2 kHz

Rev. J 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 X-
ray System should check whether their systems are used in these settings.

Emission test Compliance Electromagnetic setting: guidelines


Since the Diagnostic X-ray System only uses RF energy
RF emission for internal functions, it has very low RF emissions and
Group 1
CISPR 11 normally cause no interference to neighboring electronic
devices.
RF emission
Class A
CISPR 11
The Diagnostic X-ray System is suitable not only in non-
Harmonic wave emission
Class A household facilities but can also be used by directly
CISPR 11
connecting to the common low-power network in a
Voltage changes/flicker
building.
emission Compliance
CISPR 11

Full compliance to the IEC 60601-1-2:2004 and the System’s tolerance to EM waves
The Diagnostic X-ray System is used in the following electromagnetic settings. Users of the Diagnostic X-
ray System should check whether their systems are used in these settings.
Electromagnetic
Tolerance test IEC 60601 test level Suitability level
setting: guidelines
The floor should be in
Static electricity +/- 6kV contact +/- 6kV contact wood, concrete or
discharge (ESD) 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 +/- 2kV power supply unit line The main power’s quality
electric oversprays unit line 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
commercial or hospital
<5% UT(<95%Dip at the <5% UT(<95%Dip at the UT),
Voltage loss in the settings.
UT), 0.5 cycles 0.5 cycles
power supply,
40% UT(60% Dip at the 40% UT(60% Dip at the UT), 5
short intermittence Note : Most components
UT), 5 cycles cycles
and voltage in the Diagnostic X-
70% UT(30% Dip at the 70% UT(30% Dip at the UT),
changes ray System have their
UT), 25 cycles 25 cycles
power supplied from the
uninterrupted power
<5% UT(>95% Dip at the <5% UT(>95% Dip at the UT),
IEC 61000-4-11 supply.
UT), 5 seconds 5 seconds

The IEC61000-4-11 only


applies to the Diagnostic
X-ray System Power Box.
Magnetic field in 3A/m 3A/m
The magnetic field in the
the source
source frequency should
frequency
be equivalent to the 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
IEC 60601 test level Suitability level Electromagnetic setting: guidelines
test
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 X-
ray System’s parts (including switches)
and its transmitter-receiver’s frequency.

Recommended intervals:

Conductive d = 1.17√p

RF 3Vrms d = 1.17√p80MHz ~ 800MHz


3Vrms
IEC61000-4-6 150kHz-80MHz d = 2.33√p800MHz ~ 2.5GHz,

Radioactive 3v/m where p is the transmitter-receiver’s


3v/m
RF 80MHz-2.5GHz maximum power rating in watts (W) and

IEC61000-4-3 d is the recommended interval.

The magnetic field strength in the fixed


RF receiver, which has been
1
determined in the EM wave walkdown ,
should be lower than the compliance
2
standards of each frequency range .

Interference may occur around the


equipment whose symbol is as follows.

Note 1: The high-frequency range is applied at 80MHz and 800MHz.


Note 2: This guideline does not apply in all situations. Electromagnetic waves may be affected through
absorption into and reflection from structures, objects and people.

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
Interval depending on the transceiver-receiver’s frequency
rating of the
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 transmitter-
receiver’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

Adults Pediatric
EXAMI-
NATION THICK- Dosimetry THICK- Dosimetry
KVP MAS Grid KVP MAS Grid
NESS (μGy*㎡) NESS (μGy*㎡)
2-4cm 50 2.0 NO
HAND 8.828 - 50 1.0 NO 4.498
5-7cm 50 2.0 NO
2-4cm 52 2.0 NO
WRIST 9.792 - 52 1.0 NO 4.498
5-7cm 52 2.0 NO
2-4cm 50 2.0 NO 8.828
FOREARM 5-7cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498
(AP)
8-10cm 60 2.5 NO 17.08
4-6cm 50 2.0 NO 8.828
FOREARM 7-9cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498
(LAT)
10-12cm 60 2.5 NO 17.08
5-7cm 60 2.5 NO 17.08
ELBOW (AP) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
4-6cm 60 2.5 NO 17.08
ELBOW
- 60 1.3 NO 8.92
(LAT) 7-9cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
HUMEROUS - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
ANKLE (AP) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
ANKEL (LAT) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
7-9cm 60 4.0 NO 17.08
KNEE - 60 2.0 NO 13.68
10-12cm 66 5.0 NO 41.96
2-4cm 50 2.0 NO 8.828
FOOT (AP) - 50 1.0 NO 4.498
5-7cm 54 2.5 NO 13.432
4-6cm 58 2.0 NO 12.716
FOOT (LAT) - 58 1.0 NO 6.406
7-9cm 64 2.5 NO 19.647
6-8cm 63 3.2 NO 24.348
FEMUR - 63 1.6 NO 12.172
12-14cm 66 4.0 NO 33.556
4-6cm 60 3.2 NO 21.84
SHOULDER - 60 1.6 NO 10.96
7-9cm 64 4.0 NO 31.452

L/SPINE (AP) 21-23cm 80 20 NO 245.05 - 80 8 NO 97.57

Rev. J 64/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

L/SPINE 32-34cm 100 32 YES 590.1 - 100 13 YES 238.72


(LAT)
12-14cm 73 10 YES 102.8

PELVIS/HIP 20-22cm 77 20 YES 228.25 - 73 4 YES 40.944


26-28cm 78 32 YES 374.48
12-16cm 80 1.0 NO 11.92

CHEST (AP) 22-24cm 80 1.6 NO 19.24 - 80 0.6 NO 7.04


30-34cm 80 2.5 NO 30.22
32-36cm 90 2.0 NO 29.752
CHEST (LAT) - 90 1.0 NO 14.532
36-40cm 90 2.5 NO 37.362
8-12cm 72 10 YES 100.05

ABDOMEN 18-22cm 77 20 YES 228.25 - 72 4.0 YES 39.872


28-32cm 80 32 YES 392.4

Rev. J 65/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

CR System: 40" SID

Adults Pediatric
EXAMI-
NATION THICK- Dosimetry THICK- Dosimetry
KVP MAS Grid KVP MAS Grid
NESS (μGy*㎡) NESS (μGy*㎡)
2-4cm 50 4.0 NO 50 2.0 NO
HAND 17.488 - 8.828
5-7cm 50 4.0 NO 50 2.0 NO
2-4cm 52 4.0 NO 52 2.0 NO
WRIST 19.432 - 9.792
5-7cm 52 4.0 NO 52 2.0 NO
2-4cm 50 4.0 NO 17.488 50 2.0 NO 8.828
FOREARM 5-7cm 56 5.0 NO 29.18 - 56 2.5 NO 14.641
(AP)
8-10cm 60 5.0 NO 34.1 60 2.5 NO 17.08
4-6cm 50 4.0 NO 17.488 50 2.0 NO 8.828
FOREARM 7-9cm 56 5.0 NO 29.18 - 56 2.5 NO 14.641
(LAT)
10-12cm 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
ELBOW (AP) -
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
ELBOW -
(LAT) 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
HUMEROUS -
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
ANKLE (AP) -
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
ANKEL (LAT) -
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
KNEE -
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
FOOT (AP) -
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
FOOT (LAT) -
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
FEMUR -
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
SHOULDER -
7-9cm 64 8.0 NO 62.98 64 4.0 NO 31.452

L/SPINE (AP) 21-23cm 80 32 NO 392.4 - 80 16 NO 195.89

Rev. J 66/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

L/SPINE 32-34cm 100 64 YES 1190.1 - 100 32 YES 590.1


(LAT)
12-14cm 73 20 YES 205.9 73 10 YES 102.8

PELVIS/HIP 20-22cm 77 32 YES 365.52 - 77 16 YES 182.49


26-28cm 78 64 YES 749.52 78 32 YES 374.48
12-16cm 80 2.0 NO 24.12 80 1.0 NO 11.92

CHEST (AP) 22-24cm 80 3.2 NO 38.76 - 80 1.6 NO 19.24


30-34cm 80 5.0 NO 60.7 80 2.5 NO 30.22
32-36cm 90 4.0 NO 60.192 90 2.0 NO 29.752
CHEST (LAT) -
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

ABDOMEN 18-22cm 77 32 YES 365.52 - 77 16 YES 182.49


28-32cm 80 64 YES 788.24 80 32 YES 392.4

Rev. J 67/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

DR System: Flap Panel with CSI Screen, 40" SID

Adults Pediatric
EXAMI-
NATION THICK- Dosimetry THICK- Dosimetry
KVP MAS Grid KVP MAS Grid
NESS (μGy*㎡) NESS (μGy*㎡)
2-4cm 50 2.0 NO
HAND 8.828 - 50 1.0 NO 4.498
5-7cm 50 2.0 NO
2-4cm 52 2.0 NO
WRIST 9.792 - 52 1.0 NO 4.498
5-7cm 52 2.0 NO
2-4cm 50 2.0 NO 8.828
FOREARM 5-7cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498
(AP)
8-10cm 60 2.5 NO 17.08
4-6cm 50 2.0 NO 8.828
FOREARM 7-9cm 56 2.5 NO 14.641 - 50 1.0 NO 4.498
(LAT)
10-12cm 60 2.5 NO 17.08
5-7cm 60 2.5 NO 17.08
ELBOW (AP) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
4-6cm 60 2.5 NO 17.08
ELBOW
- 60 1.3 NO 8.92
(LAT) 7-9cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
HUMEROUS - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
ANKLE (AP) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
5-7cm 60 2.5 NO 17.08
ANKEL (LAT) - 60 1.3 NO 8.92
8-10cm 63 2.5 NO 19.021
7-9cm 60 4.0 NO 17.08
KNEE - 60 2.0 NO 13.68
10-12cm 66 5.0 NO 41.96
2-4cm 50 2.0 NO 8.828
FOOT (AP) - 50 1.0 NO 4.498
5-7cm 54 2.5 NO 13.432
4-6cm 58 2.0 NO 12.716
FOOT (LAT) - 58 1.0 NO 6.406
7-9cm 64 2.5 NO 19.647
6-8cm 63 3.2 NO 24.348
FEMUR - 63 1.6 NO 12.172
12-14cm 66 4.0 NO 33.556
4-6cm 60 3.2 NO 21.84
SHOULDER - 60 1.6 NO 10.96
7-9cm 64 4.0 NO 31.452

L/SPINE (AP) 21-23cm 80 20 NO 245.05 - 80 8 NO 97.57

Rev. J 68/74 ECOTRON Co., Ltd.


EPX-SERIES OPERATOR’S MANUAL

L/SPINE 32-34cm 100 32 YES 590.1 - 100 13 YES 238.72


(LAT)
12-14cm 73 10 YES 102.8

PELVIS/HIP 20-22cm 77 20 YES 228.25 - 73 4 YES 40.944


26-28cm 78 32 YES 374.48
12-16cm 80 1.0 NO 11.92

CHEST (AP) 22-24cm 80 1.6 NO 19.24 - 80 0.6 NO 7.04


30-34cm 80 2.5 NO 30.22
32-36cm 90 2.0 NO 29.752
CHEST (LAT) - 90 1.0 NO 14.532
36-40cm 90 2.5 NO 37.362
8-12cm 72 10 YES 100.05

ABDOMEN 18-22cm 77 20 YES 228.25 - 72 4.0 YES 39.872


28-32cm 80 32 YES 392.4

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/Radiation-
EmittingProducts/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 Check points and Action

7 Ready SW ERR
a. Replace the hand switch
8 Exposure SW ERR

10 Standby Fil FB Error


a. If error repeats at the condition of 40kV 0.4mAs EXP, replace the OP
11 Standby EP FB Error
board

12 Standby IP FB Error

14 Run Fil FB Error


a. If error repeats at the condition of 40kV 0.4mAs EXP, check the followings
15 Run EP FB low ERR
by sequence.
1. Check TP in the power input of the OP board
16 Run IP FB High ERR
2. Check the Reference voltage value
17 Run EP FB High ERR 3. If the reference voltage is normal, replace the FET board
4. If replacing FET board does not solve the problem, the replace
18 Run IP FB low ERR
the HV tank.

28 Pulse by Pulse ERR

a. If error pops up right after the unit power is turned on, then replace the
30 KV_OVP ERR
OP board.

31 FIL_OC ERR FIL b. If error repeats at the condition of 40kV 0.4mAs EXP,
1. Replace the FET board
2. If replacing FET board does not solve the problem, the replace the HV
32 IP_OCP ERR
tank.

Warning Codes

Thermal ERR excess Wait until the temperature inside the monotank comes down to normal
2
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
29
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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