Ecotron EPX Series Manuale utente

EPX-SERIES

Diagnostic X-ray System

Operator’s Manual

Obelis S.A

Bd. General Wahis 53, 1030 Brussels, Belgium / E-mail:[email protected]

Representative: Mr.Gideon ELKAYAM / TEL:32.2.732.59.54, FAX:32.2.732.60.03

Ecotron Co., Ltd

Made by Korea

4F&5F, Hanshin IT Tower II, 47, Digital-ro 9-gil, Geumcheon-Gu, Seoul 08511, Korea

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

EPX-SERIES OPERATOR’S MANUAL

Rev. J 2/74 ECOTRON Co., Ltd.

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EPX-SERIES OPERATOR’S MANUAL

Rev. J 3/74 ECOTRON Co., Ltd.

CONTENTS

1. INTRODUCTION _______________________________________________________ 7

1.1 COMPOSITION _______________________________________________________________________________ 8

2. NOTICE OF THE SAFE OPERATION ______________________________________ 9

3. RADIATION SAFETY __________________________________________________ 12

4. SAFETY AND SPECIFICATIONS _________________________________________ 13

4.1 SAFETY AND WARNING SYMBOLS _______________________________________________________ 13

4.2 COMPOSITION LABEL _____________________________________________________________________ 17

4.2.1 EPX-F1600 _____________________________________________________________________________ 17

4.2.2 EPX-F2400 _____________________________________________________________________________ 17

4.2.3 EPX-F2800 _____________________________________________________________________________ 18

4.2.4 EPX-F3200 _____________________________________________________________________________ 18

4.2.5 EPX-F4000 _____________________________________________________________________________ 19

4.2.6 EPX-F5000 _____________________________________________________________________________ 19

4.2.7 EPX-SERIES COLLIMATOR ___________________________________________________________ 20

4.2.8 SYMBOL ON THE PRODUCT LABEL OF X-RAY SYSTEM ___________________________ 21

4.3 EPX-SERIES DUTY CYCLE LIMIT _________________________________________________________ 22

4.4 DAILY X-RAY TUBE WARM-UP PROCEDURE _____________________________________________ 23

4.5

APPLICABLE STANDARDS

_____________________________________________________________ 24

4.6 SPECIFICATION ____________________________________________________________________________ 25

4.6.1 CLASSIFICATION OF THE DEVICE ___________________________________________________ 25

4.6.2

SPECIFICATION TABLE

_____________________________________________________________ 26

4.6.3 kV, mAs, mA TABLE ___________________________________________________________________ 33

4.6.4 DOSIMETRY DATA TABLE _____________________________________________________________ 39

4.6.5 MECHANICAL SPECIFICATION _______________________________________________________ 41

EPX-SERIES OPERATOR’S MANUAL

Rev. J 4/74 ECOTRON Co., Ltd.

4.7 WORKING ENVIRONMENT ________________________________________________________________ 43

4.8 CUSTOMER SUPPORT_____________________________________________________________________ 44

5. SYSTEM CONFIGURATION _____________________________________________ 45

5.1 PREPARATION FOR OPERATION _________________________________________________________ 45

5.1.1 OPERATION PRATICES _______________________________________________________________ 45

5.1.2 POSITIONING OF THE PATIENT AGAINST THE COLLIMATOR ______________________ 45

5.2 CONNECTION OF POWER CODE AND HAND SWITCH __________________________________ 47

6. OPERATION MODE ___________________________________________________ 48

6.1 EPX-F1600 / F2400 / F2800 / F3200 / F4000 / F5000 _______________________________________ 48

6.1.1 NORMAL MODE ________________________________________________________________________ 49

6.1.2 APR MODE _____________________________________________________________________________ 49

6.1.3 DOSIMETRY DATA DISPLAY MODE ___________________________________________________ 49

6.1.4 COOLING TIME DISPLAY MODE ______________________________________________________ 50

6.1.5 TURN OFF ______________________________________________________________________________ 50

6.2 TOUCH MAIN SCREEN OF OPERATION MODE (OPTION) _______________________________ 51

6.2.1 NORMAL MODE OF TOUCH MAIN SCREEN __________________________________________ 51

6.3 HAND SWITCH _____________________________________________________________________________ 52

6.3 MOBILE STAND ____________________________________________________________________________ 53

MAINTENANCE PROCEDURE

________________________________________ 54

7.1 GENERAL CAUTION _______________________________________________________________________ 54

7.2 MAINTENANCE SCHEDULE _______________________________________________________________ 54

7.3 CLEANING __________________________________________________________________________________ 54

7.4 TROUBLESHOOTING ______________________________________________________________________ 54

7.5 THE EQUIPMENT OPERATION CHECKLIST FOR OPERATOR ___________________________ 55

7.6 MAINTENANCE CHECKLIST ______________________________________________________________ 56

8. DISPOSAL OF WASTE_________________________________________________ 57

EPX-SERIES OPERATOR’S MANUAL

Rev. J 5/74 ECOTRON Co., Ltd.

9. QUALITY WARRANTY _________________________________________________ 58

10. INTENDED OPERATOR AND SERVICE PERSONAL PROFILE________________ 59

10.1 OPERATOR PROFILE _____________________________________________________________________ 59

10.2 SERVICE PERSONAL PROFILE __________________________________________________________ 59

APPENDIX A EMC DECLARATION________________________________________ 60

APPENDIX B TECHNICAL CHART ________________________________________ 64

APPENDIX C PEDIATRICS AND SMALL PATIENTS __________________________ 70

APPENDIX D ACTION TO CORRECT THE ERROR OF EPX-SERIES ____________ 72

APPENDIX E ANODE THERMAL CHARACTERISTICS OF X-RAY TUBE _________ 73

EPX-SERIES OPERATOR’S MANUAL

Rev. J 6/74 ECOTRON Co., Ltd.

REVSON HISTORY

Revision Number

Date

Description

SEP 11, 2013

First Edition

SEP 30, 2014

European Authorized Representative Change

JAN 12, 2015

Manual Update

Mar 23, 2015

Manual Update

JUN 11, 2015

Manual Update

SEP 01, 2015

Manual Update

JUN 21, 2016

Manual Update

SEP 22, 2016

Manual Update for UDI Label

AUG 23, 2018

Manual Update

MAR 24, 2020

Manual Update

ADVISORY SYMBOLS

The following advisory symbols are used throughout this manual.

Their application and meaning are described below.

WARNING

Warning symbol used to indicate a potential hazard lead operators, service personnel to serious injury, death

or radiation exposure.

CAUTION

Caution symbol used to indicate a potential hazard lead operators, service personnel to injury or damage of

equipment.

NOTE

Note symbol used to indicate important information need to proper use and right operation of equipment.

NOTE

KEEP THIS OPERATOR’S MANUAL WITH THE EQUIPMENT AT ALL TIMES, AND REVIEW

THE IMPORTANT INFORMATION WHENEVER REQUIRED.

THE STATISTICS AND SPECIFICATIONS OF THIS UNIT AND MANUAL CAN BE MODIFIED

WITH OR WITHOUT NOTIFICATION FOR THE IMPROVEMENT OF PERFORMANCE AND

SAFETY.

EPX-SERIES OPERATOR’S MANUAL

Rev. J 7/74 ECOTRON Co., Ltd.

1. INTRODUCTION

The EPX-SERIES Innovation diagnostic X-ray system features excellent x-ray Image, quality, accuracy,

reproducibility and long-term stability. Fast kV rising time minimize unnecessary patient dose and supply

superior Image quality, fast Image response.

The operator control console is designed to be simple and user-friendly and one can select or change x-ray

parameters easily using a large soft membrane switch.

Indications for use / Intended use

This product, diagnostic X-ray system, is radiation medical equipment used by a qualified / trained physician or

technician on both adult and pediatric subjects for taking diagnostic X-rays.

This product is used on hand (wrist), foot (ankle), shoulder, elbow, knee, and other body parts.

Available the patient population for use

Gender: no gender restrictions

Age: no age restrictions

The patient population for use

- Adults

- Pediatric patients

NOTE

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF

PHYSICIAN OR WITH THE DESCRIPTIVE DESIGNATION OF ANY OTHER PRACTITIONER

LICENSED BY THE LAW OF THE STATE IN WHICH HE PRACTICES TO USE OF ORDER

THE USE OF THE DEVICE.

EPX-SERIES OPERATOR’S MANUAL

Rev. J 8/74 ECOTRON Co., Ltd.

1.1 COMPOSITION

This product is composed of the X-ray component part, accessories part. Detail information of each

component follows below.

(1) X-ray component part

Main Power board

SMPS

Mono block X-ray tank

OP control board

FET drive board

Collimator

(2) Accessories

Hand switch

Foot switch(Option)

Operator’s Manual

Mobile Stand

NOTE

THIS MANUAL CONTAINS IMPORTANT SAFETY INFORMATION. AN UNDERSTANDING

OF THIS INFORMATION IS CRITICAL TO THE SAFE OPERATION OF YOUR EQUIPMENT.

PLEASE ENSURE THAT YOU READ THE WARNING NOTICES BEFORE USING THE

EQUIPMENT

NOTE

● ASSEMBLY INFORMATION: NO ASSEMBLY IS REQUIRED.

EPX-SERIES OPERATOR’S MANUAL

Rev. J 9/74 ECOTRON Co., Ltd.

2. NOTICE OF THE SAFE OPERATION

This user’s guide is designed to ensure correct use and operation of EPX-SERIES. Please read all the lines

thoroughly before you use this equipment.

Incorrect use and operation exceeding described conditions in this manual may occur damage of the machine

and shorten its life. Particular attention must be paid to all the warnings, cautions and notes incorporated

herein.

This equipment should be used only by the legally qualified persons and practitioners.

EPX-SERIES is designed with the due consideration for users’ safety and product reliability. It, however, is

advisable to follow under mentioned rules to keep your additional safety and health.

1. This product should be operated only by or under the supervision of legally qualified persons.

2. EPX-SERIES is designed for the radiographic uses and not for fluoroscopy or other associated

applications.

3. EPX-SERIES should be used for the diagnosis, not for the therapy.

4. Do not modify the equipment at your discretion and in case any modification is required unavoidably, ask

the help of Ecotron or its authorized dealer for the service.

5. This system has been calibrated for optimal operations.

6. The outside temperature of the device is not as high as burns, but there watch out for a low-temperature

burns if the operator contacts with a certain part(control panel, collimator knob, metal enclosure etc.) for a

long time.

EPX-SERIES should be used to plug the power cord into the wall socket.

CAUTION

NO PROTECTION AGAINST THE INGRESS OF THE LIQUIDS

EPX-SERIES OPERATOR’S MANUAL

Rev. J 10/74 ECOTRON Co., Ltd.

WARNING

DO NOT ALLOW OPERATION OF THIS APPARATUS BY ANY PERSON OTHER THAN

QUALIFIED PERSONNEL (PHYSICIANS, RADIOTHERAPY ENGINEERS AND CLINICAL X-

RAY ENGINEERS) OR UNDER OBSERVATION BY THEM.

WARNING

PROPER USE AND SAFE OPERATING PRACTICES WITH RESPECT TO X-RAY SYSTEMS

ARE THE RESPONSIBILITY OF THE USERS OF SUCH X-RAY SYSTEMS.

ECOTRON Co., Ltd PROVIEDS INFORMATION ON ITS PRODUCTS AND ASSOCIATED

HAZARDS, BUT ASSUMES NO RESPONSIBILITIES FOR AFTER-SALE POERATING AND

SAFETY PRACTICES.

ECOTRON Co., Ltd ACCEPTS NO RESPONSIBILITY FOR ANY GENERATOR NOT

MAINTAINED OR SERVICED ACCORDING TO THE SERVICE MANUAL OR ANY X-RAY

SYSTEM THAT HAS BEEN MODIFIED IN ANY WAY.

ECOTRON Co., Ltd ALSO ASSUMES NO RESPONSIBILITY FOR X-RAY RADIATION

OVEREXPOSURE OF PATIENTS OR PERSONNEL RESULTING FROM POOR OPERATING

TECHNIQUES OR PROCEDURS.

WARNING

THIS X-RAY UNIT MAY BE DANGEROUS TO PATIENT AND OPERATOR UNLESS SAFE

EXPOSURE FACTORS AND OPERATING INSTRUCTIONS ARE OBSERVED.

WARNING

DO NOT CONNECT ADDITIONAL EXTENSION CORD TO EQUIPMENT.

WARNING

TO AVOID RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED

TO A SUPPLY MAINS WITH PROTECTIVE EARTH.

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