Stephanix Movix 4.0 Service Manual
Technical Publication
OM-0269R5
Operation
Movix 4.0 E+
Portable X-ray Units
0459
STEPHANIX
10 rue Jean Moulin, Z.I. du Bayon
42150 LA RICAMARIE
FRANCE
Tel: 0033477478160
Fax: 0033477375519
Le marquage CE qui se trouve sur ce produit indique que celui-ci est en conformité avec la directive européenne des dispositifs médicaux 93/42/CEE
This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD dated June 14, 1993.
¡ IMPORTANTE ! ... Protección ante los rayos-X
LOS EQUIPOS DE RAYOS-X SON PELIGROSOS PARA EL PACIENTE Y EL OPERADOR
A MENOS QUE LAS MEDIDAS DE PROTECCION SEAN ESTRICTAMENTE OBSERVADAS
Si el equipo de rayos-X no se usa adecuadamente, puede causar lesiones. Por este motivo, las instrucciones
aquí incluidas se deben leer y comprender en su totalidad antes de intentar poner el equipo en funcionamiento.
Estaremos gustosos de asistir y cooperar en poner el equipo en marcha.
Aunque el equipo está construido según las normas de s eguridad más estrictas y presenta un alto grado de protección contra las
radiaciones-X, ningún diseño practico puede ofrecer una protección completa. Tampoco ningún diseño practico puede obligar al operador
a tomar las precauciones adecuadas para prevenir la posibilidad de que cualquier persona de manera descuidada, poco sensata o
ignorante, se exponga a radiaciones directas o indirectas.
Es importante que cualquier persona relacionada con radiaciones-X esté debidamente entrenada y tome las medidas adecuadas para
asegurar la protección contra posibles lesiones.
El fabricante asume que todo operador y personal de servicio autorizado para manejar, instalar, calibrar o mantener este equipo, es
consciente del peligro que conlleva la exposición excesiva a las radiaciones-X, está suficientemente entrenado y posee los conocimiento
necesarios para ello. Por lo tanto, el equipo aquí descrito se vende entendiendo que el fabricante, sus agentes y representantes
no tienen ninguna responsabilidad en caso de lesiones o daños que puedan resultar de la exposición a dichas radiaciones.
Existen diversos materiales y dispositivos protectores, cuyo uso es recomendable.
IMPORTANT ! ... X-ray Protection
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR
UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED
X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughly
read and understood before attempting to place this equipment in operation. We will be glad to assist and
cooperate in placing this equipment in use.
Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against X-radiation other
than the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the
operator to take adequate precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves
or others to X-radiation.
It is important that everyone working with X-radiation be properly trained and take adequate steps to insure protection against injury.
The manufacturer assumes that all operator and service personnel authorized to use, install, calibrate and maintain this equipment
is cognizant of the danger of excessive exposure to X-radiation, is sufficiently trained and has the required knowledges for it. The
equipment herein described is sold with the understanding that the manufacturer, its agents, and representatives are not liable for
injury or damage which may result from exposure to X-radiation.
Various protective material and devices are available. It is recommended that such materials and devices be used.
IMPORTANT ! ... Protection contre les rayons-X
L’EQUIPEMENT RAYONS-X EST DANGEREUX A LA FOIS POUR LE PATIENT ET POUR L’OPERATEUR
A MOINS D’OBSERVER STRICTEMENT LES CONSIGNES DE PROTECTION
L’équipement à rayons-X peut provoquer des blessures s’il n’est pas correctement utilisé. En conséquence,
les instructions de ce manuel doivent être lues attentivement et bien assimilées avant de tenter de mettre en
route ce matériel. Nous serons heureux de vous assister et de coopérer à l’installation de ce matériel.
Bien que cet équipement soit construit selon les normes de construction les plus sévères et qu’il comporte un haut degré de protection
contre le rayonnement-X en dehors du rayon utile, aucune conception n’apporte une protection totale. De même qu’aucune conception
ne peut obliger l’opérateur à prendre les précautions adéquates afin d’éviter que toute personne ne s’expose ou n’expose les autres
au rayonnement sans précaution, de façon imprudente et inconsciente.
Il est important que toutes les personnes travaillant avec le rayonnement-X soit correctement formées et prennent les mesures adéquates
afin de se protéger contre toute blessure.
Le constructeur suppose que tous les utilisateurs et le personnel d’entretien autorisé à utiliser, installer, calibrer et entretenir cet équipemen t
est conscient du danger de l’exposition excessive au rayonnement-X, est suffisamment formé et possède les connaissances nécessaires
pour cela. L’équipement décrit dans le présent manuel est vendu sous réserve que le fabricant, ses agents et représentants ne soient
pas tenus pour responsables des blessures ou dommages qui pourraient résulter d’une exposition aux rayons-X.
Plusieurs matériels de protection et systèmes sont disponibles. L’utilisation de ces matériels et systèmes de protection est recommandée.
DECLARACION AMBIENTAL
SOBRE LA VIDA UTIL DEL EQUIPO O SISTEMA
Este equipo o sistema contiene componentes y materiales peligrosos para el medioambiente (tales
como tarjetas de circuito impreso, componentes electrónicos, aceite dieléctrico usado, plomo,
baterías, etc), los cuales se consideran y son residuos peligrosos al finalizar la vida útil del equipo o
sistema, según establecen las normas internacionales, nacionales y locales.
El fabricante recomienda que al finalizar la vida útil de equipo o sistema, se contacte con un
representante autorizado delfabricante o con un gestor autorizadode residuos para la retirada de este
equipo o sistema.
ENVIRONMENTAL STATEMENT
ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM
This equipment or system contains environmentally dangerous components and materials (such as
PCB‘s, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the
equipment or system comes to an end, becomes dangerous and need to be considered as harmful
waste according to the international, domestic and local regulations.
The manufacturer recommends to contact an authorized representative of the manufacturer or an
authorized waste management company once the life-cycle of the equipment or system comes to an
end to remove this equipment or system.
DECLARATION D’ENVIRONNEMENT
SUR LA VIE UTILE DE L’EQUIPEMENT OU SYSTEME
Cet équipement ou système contient des composants et matériaux dangereux pour l’environnement
(ex: électroniques cartes, composants électroniques, huile diélectrique usée, plomb, batteries, etc.),
lesquels sont considérés comme résidus dangereux en cycle terminal de vie d’un équipement ou
système, en accord avec les normes internationales, nationales et locales en vigueur.
Le fabricant recommande une fois le cycle terminal de l’équipement ou système atteint, de contacter
un représentant autorisé du fabricant ou les autorités compétentes en la matière afin d’organiser et
de gérer le recyclage adéquat de cet équipement ou appareil.
Portable X-Ray Units
REVISION HISTORY
REVISION DATE REASON FOR CHANGE
0 JAN 29, 2004 First edition.
1 APR 1, 2004 UL Classified, Automatic Power Line Detection.
2 JUNE 1, 2004 IEC declaration and dimensions.
3 SEP 10, 2004 Error Code “E50”
4 APR 18, 2005 Duty Cycle update
Operation
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This Document is the English original version, edited and supplied by the manufacturer.
The Revision state of this Document is indicated in the code number shown at the bottom of this page.
OCT 27, 2005 Technical Specifications
ADVISORY SYMBOLS
The following advisory symbols will be used throughout this manual. Their
application and meaning are described below.
DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT
IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS
PERSONAL INJURY OR DEATH.
ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT
HEEDED OR AVOIDED COULDCAUSE SERIOUS PERSONAL
INJURY, OR CATASTROPHIC DAMAGE OF EQUIPMENT OR
DATA.
Note . Alert readers to pertinent facts and conditions. Notes represent
OM-0269R5
Advise of conditions or situations that if not heeded or
avoided could causepersonal injury or damage to equipment
or data.
information that is important to know but which do not necessarily
relate to possible injury or damage to equipment.
Portable X-Ray Units
Operation
SAFETY SYMBOLS
The following safety symbols will be used in the equipment.
Their meaning is described below.
Attention, consult accompanying documents.
Ionizing radiation.
Type B equipment.
Dangerous voltage.
Ground.
This symbol indicates that the waste of electrical and
electronic equipment must not be disposed as unsorted
municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer or
an authorized waste management company for information
concerning the decommissioning of your equipment.
OM-0269R5
Portable X-Ray Units
Operation
TABLE OF CONTENTS
Section Page
1 INTRODUCTION 1.........................................................
1.1 General Features 2...................................................
1.2 Product Identification 3................................................
1.3 Certifications 4.......................................................
1.4 Classification 4.......................................................
2SAFETY 5................................................................
2.1 General 5...........................................................
2.2 Responsibilities 6.....................................................
2.3 Maximum Permissible Dose (MPD) 8...................................
2.4 Radiation Protection 8................................................
2.5 Monitoring of Personnel 9.............................................
2.6 Protection against Electric Shock Hazards 9.............................
2.7 Protection against Hazards from Unwanted or Excessive Radiation 10........
2.8 Designated Significant zones of Occupancy 10............................
3 OPERATING CONTROLS 13.................................................
3.1 Mobile Unit 15........................................................
3.1.1 Parking Position of the Arm 16....................................
3.1.2 Unfolding the Unit 17............................................
3.1.3 Folding the Unit 18..............................................
3.2 X-Ray Unit 19........................................................
3.2.1 Power ON / OFF 19.............................................
3.2.2 Automatic Power Line Detection System 20........................
3.2.3 Manual Power Reduction 21.....................................
3.2.4 Control Panel 22................................................
3.2.4.1 Focal Spot Indicators 22.................................
3.2.4.2 Radiographic Parameters 23.............................
3.2.4.3 Exposure Controls 25...................................
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Portable X-Ray Units
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Section Page
3.3 Collimator 26.........................................................
3.4 X-ray Handswitch 28...................................................
3.5 Heat Units and Temperature of Power Module 28..........................
3.6 Error Codes 29........................................................
4 OPERATING SEQUENCES 31...............................................
4.1 Start-up Routine 31....................................................
4.2 X-ray Tube Seasoning and X-ray Tube Warm-up 31.......................
4.2.1 Seasoning Procedure 32........................................
4.2.2 Warming-up Procedure 32.......................................
4.3 Radiographic Operation 33.............................................
5 PERIODIC MAINTENANCE 35...............................................
5.1 Operator Tasks 35.....................................................
5.2 Service Tasks 36......................................................
6 TECHNICAL SPECIFICATIONS 37...........................................
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OM-0269R5
SECTION 1 INTRODUCTION
This manual contains all the necessary information to understand and operate
this Portable X-Ray Unit. It provides a general description, safety and
regulatory information,operating instructions andspecifications concerning the
equipment.
This Unit operates from single phase power supplies and provide all the
Generator advantages of constant potential waveform including lower patient
dose, shorter exposure times and greater accuracy and consistency.
The Unit is controlled by microprocessor providing increased exposure
consistency, efficient operation and extended Tube life. A high level of
self-diagnostics greatly increases serviceability and reduces down time.
Portable X-Ray Units
Operation
Illustration 1-1
Portable X-Ray Unit
OM-0269R5
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Portable X-Ray Units
Operation
All functions, displays and controls are logically arranged, are easilyaccessible
and identified to prevent confusion. Radiographic technique factors and
functions are selected by touch sensitive push-buttons and displayed on the
Control Panel.
The equipment consists of:
• Control Panel with controls and displays for radiographic operations.
• Handswitch.
• Power Module containing control and power components.
• HV Tank that comprises:
G High Voltage Transformer.
G Filament Transformer.
• Collimator with controls to limit the X-ray beam.
• SID Guard (optional).
• Mobile Unit with an Articulated Arm and a Cassettes Basket .
1.1 GENERAL FEATURES
The main features of this Portable X-Ray Unit are:
• Safe and easy operation.
• Constant potential high frequency operating on single phase lines.
• Two point control by s electing kVp and mAs.
• Tube protection circuitry prolongs Tube life and increases system
• Equipped with closed loop control of X-Ray Tube current, kVp and
G X-ray Tube.
performance.
filaments, which minimize potential errors and the need for
readjustments.
• Standard electric outlet operation from 100 to 240 ¦10% VAC.
• Automatic line voltage compensation due to closed loop operation of
X-ray Tube current and kVp.
• Heat Unit storage for the X-ray Tube.
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1.2 PRODUCT IDENTIFICATION
Identification labels of the Portable X-Ray Units provide information on:
• Product.
• Model.
• Volts (V), Line Phases, Frequency (Hz), and Power (kVA, kW).
• Date of manufacture.
• Serial number.
• Reference.
• Manufacturer.
Portable X-Ray Units
Operation
• Manufacturing location.
• Certifications.
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Portable X-Ray Units
Operation
1.3 CERTIFICATIONS
1.4 CLASSIFICATION
The X-ray Unit covered by this Operation Manual is authorized to be marked
with CE MARKING in accordance with the provisions of the Council Directive
93 / 42 / EEC concerning Medical Devices.
The X-Ray Unit covered by this Operation Manual is classified as:
• Protection against Electric Shock: Class I -- Type B applied parts.
• Protection against Harmful Ingress of Water: Ordinary.
• Degree of Safety in the presence of Flammable Anesthetics Mixture with
air or with oxygen or with nitrous oxide: Not suitable for use in the
presence of Flammable Anesthetics Mixture with air or with oxygen or
with nitrous oxide.
• Mode of Operation: Continuous with intermittent loading.
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SECTION 2 SAFETY
2.1 GENERAL
Keep this Operating Manual with the equipment at all times and periodically
review the Operating and Safety instructions.
For continue safe use of this equipment follow the
instructions in this Operating Manual. Study this manual
carefully before using the equipment and keep it at hand for
quick reference.
Portable X-Ray Units
Operation
THE EQUIPMENT DESCRIBED IN THIS MANUAL MUST BE
ONLY HANDLE BY QUALIFIED PERSONNEL PREVIOUSLY
TRAINED IN IT.
X-RAY EQUIPMENTIS DANGEROUS TO BOTH PATIENT AND
OPERATOR UNLESS PROTECTION MEASURES ARE
STRICTLY OBSERVED.
IT IS VITALLY IMPORTANT THAT EVERYONE ASSOCIATED
WITH X-RAY RADIATION IS FAMILIAR WITH THE SAFETY
AND REGULATORY INSTRUCTIONS CONTAINED WITHIN
THIS MANUAL, IN PARTICULAR, THE STATEMENT AT THE
BEGINNING OF THIS MANUAL ENTITLED “IMPORTANT!...
X-RAY PROTECTION”.
THESE INSTRUCTIONS SHOULD BE THOROUGHLY READ
AND UNDERSTOOD BEFORE ATTEMPTING TO PLACE THIS
EQUIPMENT IN OPERATION.
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Although X-radiation can be hazardous, X-ray equipment does not pose any
danger when it is properly used. Please ensure that all service and operating
personnel are properly trained and informed on the hazards of radiation. Those
responsible for the system must understand the safety requirements for X-ray
operation. Please study this manual and the manuals for each system
component to be fully aware of all the safety and operational requirements.
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Portable X-Ray Units
Operation
FOR DIAGNOSTIC X--RAY EQUIPMENT SPECIFIED TO BE
USED IN COMBINATION WITH ACCESSORIES OR OTHER
ITEMS NOT FORMING PART OF THE SAME; ATTENTION TO
THE POSSIBLE ADVERSE EFFECT ARISING FROM
MATERIALS LOCATED IN THE X--RAY BEAM. (SEE BELOW
TABLE OF MAXIMUM ATTENUATION EQUIVALENT OF
POSSIBLE MATERIALS LOCATED IN THE X--R AY BEAM).
MAXIMUM ATTENUATION EQUIVALENT mm AL
ITEM
21 CFR IEC 60601--1--3
FRONT PANEL OF WALL SUPPORT OR BUCKY 1.0 1.2
PATIENT SUPPORT, MOVABLE, WITHOUT ARTICULATED JOINTS 1.5 1.7
PATIENT SUPPORT, CANTILEVERED 2.0 2.3
2.2 RESPONSIBILITIES
ENSURE THAT ALL PERSONNEL AUTHORIZED TO USE THE
EQUIPMENT ARE AWARE OF THE DANGER OF EXCESSIVE
EXPOSURE TO X-RAY RADIATION.
THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THE
UNDERSTANDING THEMANUFACTURER,ITS AGENTS,AND
REPRESENTATIVES ARE NOT LIABLE FOR INJURY OR
DAMAGE WHICH MAY RESULT FROM OVEREXPOSURE OF
PATIENTS OR PERSONNEL TO X-RAY RADIATION.
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Portable X-Ray Units
Operation
THE MANUFACTURER DOES NOT ACCEPT ANY
RESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS OR
PERSONNEL TO X-RAY RADIATION GENERATED BY THIS
EQUIPMENT WHICH IS A RESULT OF POOR OPERATING
TECHNIQUES OR PROCEDURES.
NO RESPONSIBILITY WILL BE ASSUMED FOR ANY
EQUIPMENT THAT HAS NOT BEEN SERVICED AND
MAINTAINED IN ACCORDANCE WITH THE MANUFACTURER
INSTRUCTIONS, OR WHICH HAS BEEN MODIFIED OR
TAMPERED WITH IN ANY WAY.
IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE
THE SAFETY OF THE PATIENT WHILE THE X-RAY
EQUIPMENT IS IN OPERATION BY VISUAL OBSERVATION,
PROPER PATIENT POSITIONING, AND USE OF THEDEVICES
THAT ARE INTENDED TO PREVENT PATIENT INJURY.
ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFY
THAT THERE IS NO INTERFERENCE AND NO POSSIBILITY
OF COLLISION WITH THE PATIENT OR WITH OTHER
EQUIPMENTS.
MAKE SURE THAT THE X-RAY TUBE IS PLACED IN TO
WORKING POSITION WITH THE REFERENCE AXIS (X-RAY
BEAM) POINTING TO THE RECEPTION AREA.
SHOULD ANY INTERFERENCE (EMC) BE DETECTED WITH
OTHER EQUIPMENT, PLEASE POSITION OTHER
EQUIPMENT AWAY FROM THIS ONE.
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