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Technical Publication OM-0298R1 Operation Mobile X-ray Unit TRANSPORTIX TX-16-MLP / TX-20-MLP / TX-32-MLP

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Technical Publication

OM-0298R1

OperationMobile X-ray Unit

TRANSPORTIX TX-16-MLP / TX-20-MLP / TX-32-MLP

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This product bears a CE marking in accordance with the provisions of the 93/42/EEC MDD dated June 14, 1993.

Este producto ostenta una marca CE de acuerdo con las disposiciones de la Directiva 93/42/CEE del 14 de Junio de 1993 sobre Productos Médicos.

Ce produit porte la marque CE de conformité aux réglements de la Directive 93/42/CEE du 14 juin 1993 relative aux Produits médicaux.

Manufactured by:

Fabricado por:

SEDECAL

Sociedad Española de Electromedicina y Calidad S.A.

Pelaya, 9 -- 13. Polígono Industrial “Río de Janeiro”28110 Algete, Madrid -- España (Spain)

Phone: +34 916 280 544 Fax: +34 902 190 385 www.sedecal.com

The information comprised in this manual applies to the following equipments

La información contenida en este manual se aplica a los siguientes equipos

L’information contenue dans ce manuel est appliquée aux équipements suivants

TX-16-MLP, TX-20-MLP,TX-32-MLP

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¡ 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 seguridad 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 themselvesor 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’OPERATEURA 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 quetous les utilisateurs et le personneld’entretienautorisé à utiliser, installer, calibrer et entretenir cetéquipement

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.

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DECLARACION AMBIENTALSOBRE LA VIDA UTIL DEL EQUIPO O SISTEMA

Este equipo o sistema contiene componentes y materiales peligrosos para el medioambiente (talescomo 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 osistema, según establecen las normas internacionales, nacionales y locales.

El fabricante recomienda que al finalizar la vida útil de equipo o sistema, se contacte con unrepresentanteautorizado delfabricante o con un gestor autorizadode residuos para la retirada de esteequipo o sistema.

ENVIRONMENTAL STATEMENT

ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

This equipment or system contains environmentally dangerous components and materials (such asPCB‘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 harmfulwaste according to the international, domestic and local regulations.

The manufacturer recommends to contact an authorized representative of the manufacturer or anauthorized waste management company once the life-cycle of the equipment or system comes to anend 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 ousystème, 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 contacterun représentant autorisé du fabricant ou les autorités compétentes en la matière afin d’organiser etde gérer le recyclage adéquat de cet équipement ou appareil.

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Mobile X-ray Unit

Operation

OM-0298R1

REVISION HISTORY

REVISION DATE REASON FOR CHANGE

0 OCT 04, 2006 First Edition

1 APR 29, 2010 Removed Line Selector Board

This Document is the original English 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.

ADVISORY SYMBOLS

The following advisory symbols will be used throughout this manual. Theirapplication 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 NOTHEEDEDOR AVOIDED COULD CAUSE SERIOUS PERSONALINJURY, OR CATASTROPHIC DAMAGE OF EQUIPMENT ORDATA.

Advise of conditions or situations that if not heeded or

avoided could cause personal injury or damage to equipment

or data.

Note . Alert readers to pertinent facts and conditions. Notes represent

information that is important to know but which do not necessarily

relate to possible injury or damage to equipment.

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SAFETY SYMBOLS

The following safety symbols will be used in the equipment.Their meanings are described below.

Attention, consult accompanying documents.

Ionizing radiation.

Type B equipment.

Dangerous voltage.

Ground.

This symbol indicates that the waste of electrical andelectronic equipment must not be disposed as unsortedmunicipal waste and must be collected separately. Pleasecontact an authorized representative of the manufacturer oran authorized waste management company for informationconcerning the decommissioning of your equipment.

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TABLE OF CONTENTS

Section Page

1 INTRODUCTION 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.1 General Features 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.2 Product Identification 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.3 Certifications 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.4 Classification 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 SAFETY 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.1 General 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.2 Responsibilities 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.3 Maximum Permissible Dose (MPD) 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.4 Radiation Protection 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.5 Monitoring of Personnel 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.6 Protection against Electric Shock Hazards 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.7 Protection against Hazards from Unwanted or Excessive Radiation 11. . . . . . . .

2.8 Designated Significant Zones of Occupancy 12. . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.9 Electromagnetic Compatibility (EMC) 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3 GENERAL AND MOTION CONTROLS 19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1 Mains connection and Line Circuit Breaker 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.2 Generator Control Console 20. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.3 Front Panel 21. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.4 Bucky / AEC External Connection (Optional) 22. . . . . . . . . . . . . . . . . . . . . . . . . . .

3.5 X-ray Handswitch 22. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.6 Infrared Remote Control (optional) 23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.6.1 Operation 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.6.2 The “Remote Finder” Device 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Section Page

3.7 Motion Controls 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.7.1 Control for Arm Positioning 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.7.2 Parking Position 27. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.7.3 Displacement Controls 28. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.8 Collimator Controls 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.9 Dosimetry (optional) 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4 CONTROL CONSOLE 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.1 Power ON / OFF 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2 Exposure Indicators 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.3 Workstation 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.4 Focal Spot Indicators 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.5 Radiographic Parameters 34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.6 Automatic Exposure Control (AEC) (optional) 36. . . . . . . . . . . . . . . . . . . . . . . . . .

4.7 Anatomical Programmer (APR) 37. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.8 Heat Units 46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.9 Exposure Counters 46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.10 Self-diagnosis Indicators 46. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.11 Error Codes 47. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 OPERATING SEQUENCES 51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.1 Start-up Routine 51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.2 X-ray Tube Warm-up Procedure 51. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.3 Radiographic Operation 52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5.4 AEC Operation 53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.5 APR Operation 54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6 PERIODIC MAINTENANCE 55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.1 Operator Tasks 55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.2 Service Tasks 56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7 TECHNICAL SPECIFICATIONS 57. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Mobile X-ray Unit

Operation

OM-0298R1 1

SECTION 1 INTRODUCTION

This manual contains all the information necessary to understand and operatethe Mobile X-ray Unit. It provides a general description, safety and regulatoryinformation, operation instructions and specifications concerning theequipment.

This equipment is designed for general radiography. It provides all theadvantages of high frequency waveform Generators including lower patientdose, shorter exposure times as well as greater accuracy and consistency.

The Generator is controlled by multiple microprocessors providing increasedexposure consistency, efficient operation and extended Tube life. A high levelof self-diagnostics greatly increases serviceability and reduces down time.

All functions, displays and controls are logically arranged, easily accessible andidentified to prevent confusion. Technique factors and functions are selectedon the Control Console.

Illustration 1-1Mobile X-ray Unit

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Mobile X-ray Unit

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The Unit consists of the following fundamental parts:

• Control Console, operator controls and displays for radiographicoperations and general functions. The Console is designed for easeoperation.

• Generator that includes:

G Power Module, which contains the Power and Controlcomponents.

G High Voltage Transformer .

G Capacitor Module, with the Energy Storage Capacitors and thecharge / control components.

• Tube-Collimator Assembly, that comprises the X-ray Tube and theCollimator.

• Column and Arm, holding the Tube-Collimator Assembly and allows itspositioning.

• X-ray Cassette Basket for cassettes of 35 x 43 cm or smaller sizes.

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Mobile X-ray Unit

Operation

OM-0298R1 3

1.1 GENERAL FEATURES

The main features of this equipment are:

• A solid and ergonomic design. Easy operation, security and precision ofall positioning movements relative to the position of the patient.

• Constant potential high frequency.

• Tube-Collimator Assembly rotation in relation to its transverse axis(¦90o) and horizontal axis (205o). Collimator rotation in relation to itsvertical axis (¦90o).

• ThreepointcontrolbyselectingkVp,mAandExposureTime,ortwopointcontrol by selecting kVp and mAs, or one point control by selecting kVpwith AEC operations.

• Anatomical Programmer (APR), for six patient sizes (three adults andthree children), with pre-programmed anatomical views for automatic

selection. The operator may introduce modifications manually in all theoriginal APR techniques and store them for later use.

• Automatic Exposure Control (AEC) (optional), which accommodatesmost popular exposure detectors.

• Direct connection for one Bucky / Ion Chamber (optional).

• X-ray Handswitch for making Radiographic X-ray exposures.

• Remote infrared X-ray Handswitch (optional).

• Manual Collimation.

• Heat Unit storage for the X-ray Tube, even after turning On / Off theequipment.

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• Tube protection circuitry prolongs Tube life and increases systemperformance.

• Equipped with closed loop control of X-ray Tube current, kVp andfilaments, which minimize potential errors and the need forreadjustments.

• Standard electrical outlet operation with single-phase line at 100 / 110 / 120 / 208 / 230 / 240 ¦10% VAC.

• Under normal operating conditions, the Storage Capacitors are kept at

an optimum charge level by the Capacitor Charger which controls thelevel and performs charges periodically.

The Capacitors Module undergoes the charge-up process in thefollowing conditions (a whistle sounds during charge-up inside theGenerator).

G When the Unit is turned ON and makes the first charge. The totalcharge time depends on both the input voltage of mains where theUnit is plugged-in and the initial charge level of the Capacitors(maximum 4 seconds for a line of 230 VAC with selection of 16 Ain the Generator; or maximum 40 seconds for a line of 110 VAC

with selection of 8 A in the Generator).

G During X-ray exposures.

G During periodic charges with the Generator turned ON (instand-by), approximately every 150 seconds.

The mAs value is limitedand dependson the selected kVp and mA

values.Higher mAs values are obtained when selecting lower kVp

and mA values.

Note .

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1.2 PRODUCT IDENTIFICATION

To provide manufacturer and product information, each major item in theequipment has identification labels attached. The labels contain the followinginformation:

• Product

• Model.

• Volts (V), Line Phases, Frequency (Hz), and Power (kVA, kW).

• Date of manufacture.

Serial number.• Manufacturer.

• Place of manufacture.

• Certification

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Operation

OM-0298R16

1.3 CERTIFICATIONS

The Mobile X-ray Unit covered by this Operation Manual is authorized to bemarked with CE MARKING in accordance with the provisions of the CouncilDirective 93 / 42 / EEC concerning Medical Devices.

1.4 CLASSIFICATION

The Mobile 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 thepresence of Flammable Anesthetics Mixture with air or with oxygen orwith nitrous oxide.

• Mode of Operation: Continuous operation with intermittent loading.

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Mobile X-ray Unit

Operation

OM-0298R1 7

SECTION 2 SAFETY

2.1 GENERAL

Keep this Operating Manual with the equipment at all times and periodicallyreview the Operating and Safety instructions.

For a continuous and 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.

THEEQUIPMENT DESCRIBEDIN THIS MANUAL MUST ONLY BE HANDLED BY PREVIOUSLY TRAINED AND QUALIFIEDPERSONNEL.

X-RAY EQUIPMENTIS DANGEROUSTOBOTH PATIENT ANDOPERATOR UNLESS PROTECTIVE MEASURES ARE

STRICTLY OBSERVED.

EVERYONE ASSOCIATED WITH THIS EQUIPMENT MUST BEFAMILIAR WITH THE SAFETY AND REGULATORY INSTRUCTIONS CONTAINED WITHIN THIS MANUAL AND INPARTICULAR,THESTATEMENTATTHEBEGINNINGOFTHISMANUAL ENTITLED “IMPORTANT!... X-RAY PROTECTION”.

THESE INSTRUCTIONS SHOULD BE THOROUGHLY READAND UNDERSTOOD BEFORE ATTEMPTING TO PLACE THISEQUIPMENT IN OPERATION.

Although X-ray radiation can be hazardous, X-ray equipment does not pose anydanger when it is properly used. Please ensure that all service and operatingpersonnel are properly trained and informed on the hazards of radiation. Thoseresponsible for the system must understand the safety requirements for X-rayoperation. Please study this manual and the manuals for each systemcomponent to be fully aware of all the safety and operational requirements.

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SPECIAL ATTENTION MUST BE GIVEN TO DIAGNOSTIC X--RAY EQUIPMENT SPECIFIED TO BE USED IN

COMBINATION WITH ACCESSORIES OR OTHER ITEMS. BEAWARE OF POSSIBLE ADVERSE EFFECT ARISING FROMTHESE MATERIALS LOCATED IN THE X--RAY BEAM. (SEETHE TABLE BELOW FOR THE MAXIMUM EQUIVALENTATTENUATION OF MATERIALS POSSIBLY LOCATED IN THE

X-RAY BEAM).

MAXIMUM ATTENUATION EQUIVALENT mm ALITEM

21 CFR IEC 60601--1--3

FRONT PANEL OF WALL SUPPORT OR BUCKY 1.2 1.2

PATIENT SUPPORT, MOVABLE, WITHOUT ARTICULATED JOINTS 1.7 1.7

PATIENT SUPPORT, CANTILEVERED 2.3 2.3

2.2 RESPONSIBILITIES

ENSURE THAT ALL PERSONNEL AUTHORIZED TO USE THEEQUIPMENTARE AWAREOF THEDANGERSOFEXCESSIVEEXPOSURE TO X-RAY RADIATION.

THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THEUNDERSTANDING THAT THE MANUFACTURER, ITSAGENTS, AND REPRESENTATIVES ARE NOT LIABLE FORINJURY OR DAMAGE WHICH MAY RESULT FROMOVEREXPOSURE OF PATIENTS OR PERSONNEL TO X-RAY RADIATION.

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THE MANUFACTURER DOES NOT ACCEPT ANY RESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS OR

PERSONNEL TO X-RAY RADIATION GENERATED BY THISEQUIPMENT WHICH IS A RESULT OF POOR OPERATINGTECHNIQUES OR PROCEDURES.

NO RESPONSIBILITY WILL BE ASSUMED FOR ANY EQUIPMENT THAT HAS NOT BEEN SERVICED ANDMAINTAINEDIN ACCORDANCEWITHTHEMANUFACTURERINSTRUCTIONS, OR WHICH HAS BEEN MODIFIED ORTAMPERED WITH IN ANY WAY.

IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURETHE SAFETY OF THE PATIENT WHILE THE X-RAY EQUIPMENT IS IN OPERATION BY VISUAL OBSERVATION,PROPER PATIENT POSITIONING, AND USE OF DEVICESTHAT ARE INTENDED TO PREVENT PATIENT INJURY.

ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFY THAT THERE IS NEITHER INTERFERENCE NORPOSSIBILITY OF COLLISION WITH THE PATIENT OR WITHOTHER EQUIPMENT.

MAKE SURE THAT THE X-RAY TUBE IS SET IN WORKINGPOSITION WITH THE REFERENCE AXIS (X-RAY BEAM)POINTING TO THE RECEPTION AREA.

2.3 MAXIMUM PERMISSIBLE DOSE (MPD)

Before operation, persons qualified and authorized to operate this equipmentshould be familiar with the Recommendations of the International Commissionon Radiological Protection, contained in Annals Number 60 of the ICRP, withapplicable National Standards; and should have been trained in use of theequipment.

THE OPERATOR SHALL USE THE LARGEST POSSIBLEFOCAL SPOT TO SKIN DISTANCE IN ORDER TO KEEP THEABSORBED DOSEAS LOWAS REASONABLY ACHIEVABLE.

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Mobile X-ray Unit

Operation

OM-0298R110

2.4 RADIATION PROTECTION

Because exposure to X-ray radiation can be damaging to the health, use greatcare to ensure protection against exposure to the primary beam. Some of theeffects of X-ray radiation are cumulative and may extend over a period ofmonths or years. The best safety rule for an X-ray operator is “Avoid exposure

to the primary beam at all times” .

Any object in the path of the primary beam produces secondary (scattered)radiation. The intensity of secondary radiation depends on the energy andintensity of the primary beam and the atomic number of the object materialstruck by the primary beam. Secondary radiation may be of greater intensitythan that of the radiation reaching the film. Take protective measures tosafeguard against this.

An effective protective measure is the use of lead shielding. To minimizedangerous exposure, use such items as lead screens, lead impregnatedgloves, aprons, thyroid collars, etc. Lead screens should contain a minimumof 2.0 mm of lead or equivalent and personal protective devices (aprons,gloves, etc.) must contain a minimum of 0.25 mm of lead or equivalent. Forconfirmation of the local requirements at your site, please refer to your “LocalRadiation Protection Rules” as provided by your Radiation Protection Advisor.

WHILE OPERATING OR SERVICING X-RAY EQUIPMENT,ALWAYS KEEP A DISTANCE OF NOT LESS THAN 2 METERSFROM THE FOCAL SPOT AND X-RAY BEAM, PROTECTBODY AND DO NOT EXPOSE HANDS, WRISTS, ARMS OROTHER PARTS OF THE BODY TO THE PRIMARY BEAM.

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2.5 MONITORING OF PERSONNEL

Monitoring personnel to determine the amount of radiation to which they havebeen exposed provides a valuable cross check to determine whether or notsafety measures are adequate. It may reveal inadequate or improper radiationprotection practices and potentially serious radiation exposure situations.

The most effective method of determining whether or not the existing protectivemeasures are adequate is the use of instruments to measure the exposure.These measurements should be taken at all locations where the operator, orany portion of the body may be exposed. Exposure must never exceed theaccepted tolerable dose.

A frequently used, but less accurate, method of determining the amount ofexposure is the placement of film at strategic locations. After a specified periodof time, develop the film to determine the amount of radiation.

A common method of determining whether personnel have been exposed toexcessive radiation is the use of personal radiation dosimeters. These consistof X-ray sensitive film or thermoluminescent material enclosed within a holderthat may be worn on the body. Even though this device only measures theradiation which reaches the area of the body on which they are worn, they doprovide a reasonable indication of the amount of radiation received.

2.6 PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

This X-ray Unit has been classified as a type-B ( ) device in accordance withIEC 60601-1.

This equipment meet the following Safety Standards: IEC 60601-1,IEC 60601-1-1, IEC 60601-2-7.

ACCORDING TO MDD/93/42/CEE, THIS UNIT IS EQUIPPED

WITH EMC FILTERS. THE LACK OF PROPER GROUNDING

MAY PRODUCE ELECTRICAL SHOCK TO THE USER.

2.7 PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVERADIATION

Statement of compliance: X-ray Unit with radiation protection in accordancewith IEC 60601-1-3.

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Mobile X-ray Unit

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OM-0298R112

2.8 DESIGNATED SIGNIFICANT ZONES OF OCCUPANCY

X--RAY EQUIPMENT specified for any RADIOLOGICAL examination shallhave at least one SIGNIFICANT ZONE OF OCCUPANCY for the use of theOPERATOR and staff, designated as follow:

100 Minimum 200

M i n i m u m

2 0 0

X--RAY UNIT

CHEST UNIT

S I G N I F I C A N T Z O N E

O F O C C U P A N C

Y

P R O T E C T I V E D E V

I C E

Dimensions in cm

100 Minimum 200

M i n i m u m

8 0 X--RAY UNIT

CHEST UNIT

S I G N I F I C A N T Z O N E O F O C C U P A N C Y

P R O T E C T I V E

D E V I C E

Min. 60

T U B E S T A N D

TUBE STAND

RADIOGRAPHIC EXAMINATION ON THE CHEST UNIT OR FRONT PANEL

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1 0 0

Minimum 200

M i n i m u m

2 0 0

T U B E

S T A N D

S I G

N I F I C A N T Z O N E O F O C C U P A N C Y

Dimensions in cm

EXAMINATION TABLE

X--RAY UNIT

Minimum 200

S I G

N I F I C A N T Z O N E O F O C C U P A N C Y

M i n i m u m

2 0 0

Minimum 200

TUBE STAND

EXAMINATION TABLEM

i n i m u m

8 0

S I G

N I F I C A N T Z O N E O F O C C U P A N C Y

Min. 60

X--RAY UNIT

Minimum 200

M i n i m u m

8 0

S I G

N I F I C A N T Z O N E O F O C C U P A N C Y

Min. 60

Minimum 80

SIGNIFICANT ZONE OF OCCUPANCY M i n .

6 0

M i n i m u m

2 0 0

M i n i m u m

2 0 0

Minimum 80

SIGNIFICANT ZONE OF OCCUPANCY M i n .

6 0

RADIOGRAPHIC EXAMINATION ON ANY PATIENT SUPPORT ORA NY TABLE

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Mobile X-ray Unit

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OM-0298R114

2.9 ELECTROMAGNETIC COMPATIBILITY (EMC)This equipment generates, uses, and can radiate radio frequency energy. Theequipment may cause radio frequency interference to other medical or nonmedical devices and radio communications. To provide reasonable protectionagainst such interference, this product complies with emissions limits for aGroup 1, class A Medical Devices Directive as stated in EN 60601--1--2.However, there is no guarantee that interference will not occur in a particularinstallation.

If this equipment is found to cause interference (which may be determined byturning the equipment on and off), the operator (or qualified service personnel)

should attempt to correct the problem by oneor more of thefollowingmeasures:

• reorient or relocate the affected device,

• increase the separation between the equipment and the affected device,

• power the equipment from a source different from that of the affecteddevice,

• consult the service engineers for further suggestions.

To comply with the regulations on electromagnetic interference for a Class AFCC Device, this equipment must be used in shielded areas and allinterconnect cables to peripheral devices must be shielded and properlygrounded. Use of cables not properly shielded and grounded may result in theequipment causing radio frequency interference in violation of the FCCregulations.

Before using this equipment make sure that all requirements

about EMC included in this manual are accomplished.

It is customer responsibility to assure that this equipment

and vicinity equipment complies the value of radio frequency

interferences shown in General Regulation for safety

according to IEC 60601 - 1- 2 Tables as described in this

section.

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Mobile X-ray Unit

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Do not use devices which intentionally transmit RF Signals

(Cellular Phones, Transceivers or Radio Controlled

Products) in the vicinity of this equipment as it may cause

performance outside the published specifications. Keep the

power to these type devices turned off when near this

equipment. Is the responsibility of the operator to instruct

patients and other people who may be around this equipment

to fully comply with the above requirement.

The manufacturer is not responsible for any interference

caused by using other than recommended interconnect

cables or by unauthorized changes or modifications to this

equipment.

GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC EMISSIONS

This Mobile Unit is intended for use in the electromagnetic environment specified below.The customer or the user of this Mobile Unit should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment -- guidance

RF emissionsCISPR 11 Group 1

This Mobile Unit uses RF energy only for itsinternal function. Therefore, its RF emissions arevery low and are not likely to cause anyinterference in nearby electronic equipment.

RF emissionsCISPR 11 Class A

Harmonic emissionsIEC 61000--3--2 N/A

is o i e nit i s suita e or use i n aestablishments other than domestic and thosedirectly connectedto thepublic low--voltage powersupply network that supplies buildings used for

Voltage fluctuations/flicker emissionsIEC 61000--3--3 N/A

domestic purposes.

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Mobile X-ray Unit

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OM-0298R116

GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY

This Mobile Unit is intended for use in the electromagnetic environment specified below.The customer or the user of this Mobile Unit should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliancelevel Electromagnetic environment -- guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

¦ 6kV contact

¦ 8kV air

¦ 6kV

N/A

Floors should be wood, concrete or ceramictile.If floors are coveredwithsynthetic material,the relative humidity should be at least 30%.

Electrical fast transient/burst

IEC 61000-4-4

¦ 2kV for power supply lines

¦ 1kV for input/output lines

¦ 2kV

¦ 1kV

Mains power quality should be that of a typicalcommercial or hospital environment.

Surge

IEC 61000--4--5

¦ 1kV line(s) to line(s)

¦ 2kV line(s) to earth

¦1kV

¦ 2kV

Mains power quality should be that of a typicalcommercial or hospital environment.

Voltage dips, shortinterruptions and voltagevariations on power supplyinput lines.

IEC 61000--4--11

< 5% UT(>95% dip in UT)

for 0.5 cycle

40% UT(60% dip in UT)

for 5 cycles

70% UT(30% dip in UT)

for 25 cycles

< 5% UT(>95% dip in UT)

for 5s

> 95%for 0.5 periods

N/A

N/A

> 95%for 250 periods

Mains power quality should be that of a typicalcommercial or hospital environment. If the userof theMobile Unit requires continuedoperationduring power mains interruptions, it isrecommended that the MobileUnit be poweredfromauninterruptiblepowersupplyorabattery.

Power frequency (50/60 Hz)magnetic field

IEC 61000--4--8

3 A/m 3 A/mPower frequency magnetic fields should be atlevels characteristic of a typical location in atypical commercial or hospital environment.

NOTE -- UT is the a.c. mains voltage prior to application of the test level.

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GUIDANCE AND MANUFACTURER’S DECLARATION -- ELECTROMAGNETIC IMMUNITY

This Mobile Unit is intended for use in the electromagnetic environment specified below.The customer or the user of this Mobile Unit should assure that it is used in such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment -- guidance

Conducted RFIEC 61000--4--6

Radiated RFIEC 61000--4--3

3Vrms150kHz to 80MHz

3V/m80MHz to 2.5GHz

3Vrms150kHz to 80MHz

3V/m80MHz to 2.5GHz

Portable and mobile RF communicationsequipmentshould be used no closerto anypartof this Mobile Unit, including cables, than therecommended separation distance calculatedfromtheequationapplicabletothefrequencyofthe transmitter.

Recommended separation distance

where ’P’ is the maximum output power ratingof the transmitter in watts (W) according to thetransmitter manufacturer and ’d’ is therecommended separation distance in meters(m).

Field strengths from fixed RF transmitters, asdetermined by an electromagnetic sitesurvey a), should be less than the compliancelevel in each frequency range b).

Interference may occur in the vicinity ofequipment marked with the following symbol:

d =

1.2 P

d = 2.3 P , 800 MHz to 2.5 GHz

d = 1.2 P , 80 MHz to 800 MHz

NOTE 1 -- At 80MHz and 800MHz, the higher frequency range applies.

NOTE 2 -- These guidelines may not apply in al l situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, suchas base stations forradio (cellular/cordless) telephones andland mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagneticenvironment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the

location in which this Mobile Unit is used exceeds the applicable RF compliance level above, this Mobile Unit should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re--orienting or relocating thisMobile Unit.

b) Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.

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Mobile X-ray Unit

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OM-0298R118

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND

THE MOBILE UNIT

This Mobile Unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.The customer or the user of this Mobile Unit can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF communications equipment (transmitters) and this Mobile Unit as recommended below, according tothe maximum output power of the communications equipment.

Rated maximum output power ofSeparation distance according to frequency of transmitter

mtransmitter

W 150KHz to 80MHz

d = 1.2 P

80MHz to 800MHz

d = 1.2 P

800MHz to 2.5GHz

d = 2.3 P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance ’d’ in metres (m) can beestimated using theequationapplicable to thefrequency ofthe transmitter,where’P’ is themaximum outputpower ratingof thetransmitter

in watts (W) according to the transmitter manufacturer.

NOTE 1 -- At 80MHz and 800MHz, the separation distance for the higher frequency range applies.

NOTE 2 -- These guidelines may not apply in al l situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Mobile X-ray Unit

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OM-0298R1 19

SECTION 3 GENERAL AND MOTION CONTROLS

Operation is carried out from the different controls:

• Front Panel with controls to turn ON / OFF the Unit, Line ConnectionIndicator and Collimator Lamp control.

• Generator Control Console.

• Handswitch.

• Remote Infrared Handswitch (optional).

• Line Circuit Breaker.

• Connection for a Bucky / Ion Chamber (optional).

• Controls for Unit motion.

• Manual Collimator Panel with controls for opening or closing theCollimator blades and to switch ON the Collimator Lamp.

Arm Security Hook for Parking Position

Front Handle

Handles of Tube-Collimator AssemblyFront Panel

Control Console

Collimator Panel

Bucky / AEC External Connection (optional)

Cassette Basket

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Mobile X-ray Unit

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OM-0298R1 20

3.1 MAINS CONNECTION AND LINE CIRCUIT BREAKER

The Unit should be plugged into a wall socket that complies with localregulations and electrical requirements for the equipment ( refer to Section 7 for

Technical Specifications).

FOR SAFETY REASONS AND FOR PROPER FUNCTIONING,MAKE SURE THAT THE UNIT IS CONNECTED TO ASTANDARD OUTLET WITH GND.

TheLineCircuitBreakermustalwaysbeintheONposition( refer to “Power Line

Connector Lamp” to check the status of the Line Circuit Breaker ). This deviceis located underneath the Console Cover. If access to the Line Circuit Breakeris necessary, remove the 6 screws of the Console Cover, carefully lift the coverand check its position.

ALWAYS IN “ON” POSITION

OPERATION ALWAYS REQUIRES A CONTINUOUS MAINS

CONNECTION AND THE CIRCUIT BREAKER IN THE “ON”POSITION.

3.2 GENERATOR CONTROL CONSOLE

The Generator Control Console includes the controls, indicators and displaysneeded to perform radiographic exams. It is also equipped with an AnatomicProgrammer and an optional Automatic Exposure Control (AEC). (Refer to

Section 4 for its description).

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3.3 FRONT PANEL

SWITCH ON BUTTON OF COLLIMATOR LAMP

EMERGENCY SWITCH OFF

POWER LINE CONNECTION LAMP

SWITCH ON / OFF KEY

GENERAL CIRCUIT BREAKER / EMERGENCY SWITCH OFF: In the eventof an emergency, the equipment is turned OFF by forcibly pressing this switch(red mushroom-shaped switch).

SWITCH ON / OFF KEY : This key is used to switch ON the Generator forradiographic operation.

The key in “OFF ” position switches OFF all equipment functions, including theCharging Circuits.

POWER LINECONNECTION LAMP: Whenever illuminated, this indicates thatthe Unit is connected to the mains.

COLLIMATOR LAMP: ThisbuttonisusedtoturnONtheCollimatorLampfromthe Front Panel whenever the Key is in the “ON” position. The Lamp remains

illuminated for a few seconds before automatically switching off.

PROLONGED LIGHTING WITHOUT ALLOWING SUFFICIENTTIME FOR THE LAMP TO COOL CAUSES THE COLLIMATORTO OVERHEAT IN THE INTERNAL AREA NEAR THE LAMP.

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3.4 BUCKY / AEC EXTERNAL CONNECTION (OPTIONAL)

This connector is used to connect an external Bucky and/or Ion Chamber(AEC). Do not remove the connector security cover unless the Bucky / AECconnection is going to take place.

Bucky / AEC External Connection

3.5 X-RAY HANDSWITCH

Radiographic exposures are made with the “Prep” (preparation) and “Exp”(X-ray exposure) Handswitch. The status of the exposure is shown by the“Ready ” and “ X-ray On” indicators for the duration of the exposure.

PREP: Press the Handswitch button half-way (”Prep” position) to prepare theselected X-ray Tube for exposure. The “Ready” indicator on the Console will

light when the X-ray Tube is prepared and there are no interlock failures orsystem faults.

After pressing this push-button, the following functions are activated:

• Anode rotation.

• Filament current switches from stand-by to the selected mA.

EXP: After the “Ready ” indicator is illuminated, fully press the Handswitch

button to startan X-ray exposure. If thebutton is released before theGeneratorcompletes the selected time or the AEC time, the exposure will be prematurelyterminated and the actual mAs and Exposure Time will be displayed.

The “ X-ray On” indicator remains illuminated and a sound is emitted during thelength of exposure.

COLLIMATOR LAMP: This X-ray Handswitch includes a button to turn on theCollimator Lamp.

OFF / Prep / Exp

Collimator Lamp

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3.6 INFRARED REMOTE CONTROL (OPTIONAL)

TheInfraredRemoteControlallowstheoperatortoperformexposuresatalongdistance from the X-Ray Tube which helps to protect the operator againstradiation.

Collimator Lamp Button Infrared Window

Exposure Button

Battery Level Indicator

Batteries Compartment

Remote Finder Compartment

Prior to starting the exposure, make sure there are no other

equipment operating with an Infrared Remote Control at the

same time, neither close to it nor behind leaded glasswindows or partitions. Before performing an exposure with

this device, turn off any other units operating with Infrared

Remote Control that could be affected by this Exposure

Control.

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3.6.1 OPERATION

Take the Remote Exposure Control device out of its cradle. Aim the RemoteControlatthesensorontheMobileUnitfromamaximumdistanceof10meters.

COLLIMATOR LAMP: Press this button to turn on the Collimator Lamp. Thiscontrol is disabled with Manual Collimators.

EXPOSURE CONTROL : Press this button once to prepare the X-ray Tube forexposure (”Prep” position). When the green light is on, press this button asecondtimeandholditdownuntiltheX-rayUnitcompletestheexposure(”Exp”

position).When the exposure is completed the green light indicator turns off. Return theControl Remote device back to its cradle on the Mobile Unit.

A built-in remote beeping feature will alert the operator when the

Remote Control device is left uncradled.

The preparation cycle is automatically interrupted and returns to stand-by notonly when an exposure is not initiated within 15 seconds after the “Prep” action

but also when the Collimator Lamp is turned on.

If the “Exposure” button is released while making an exposure, the exposure isautomatically aborted.

3.6.2 THE “REMOTE FINDER” DEVICE

The Remote Exposure Control has a built-in remote finder which is very usefulfor locating the remote control device should it become misplaced.

If the Remote Exposure Control is not returned back to its cradle within threeminutes after use, the device will repeat a series of beeps. This series of beepswill continue indefinitely until the device is located and put back into its cradle.

Note .

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3.7 MOTION CONTROLS

UNIT TRAVEL MUST BE PERFORMED IN PARKINGPOSITION. FOR SAFETY REASONS, OPERATIONAL ANDTRAVELSURFACESSHOULDNOTEXCEED5 O INCLINATIONRAMPS.

MONITOR THESYSTEMMOVEMENTS WITH SPECIAL CARE.AVOID ANY IMPACT OF THEUNIT WITH WALLS, FURNITUREOR OTHER ELEMENTS IN THE ROOM THAT MAY CAUSEDAMAGE TO THE EQUIPMENT.

DO NOT DRIVE THE MOBILE UNIT OVER WET SURFACESAND / OR IMPREGNATED WITH CLEANING PRODUCTS(SPECIALLY BLEACH, AMMONIA, ETC.), THE UNIT COULDSLIP AND MOMENTARILY LOSE CONTROL. IT ALSO MAY BLEACHTHEWHEELSCAUSINGDAMAGESTOTHEFLOOR.

MONITOR WITH SPECIAL CARE THE PATIENT POSITION ORANYONE PRESENT, TO AVOID INJURY CAUSED BY UNITMOVEMENTS.

INTRAVENOUS TUBING, CATHETERS AND OTHER PATIENTCONNECTED LINES SHOULD BE ROUTED AWAY FROMMOVING EQUIPMENT.

3.7.1 CONTROL FOR ARM POSITIONING

Both Handgrips of the Tube-Collimator Assembly are used to position theTube-Collimator Assembly in relation to the position of the patient.

ALWAYS USE THESE HAND-GRIPS TO DRIVE THE ARMMOVEMENTS, NEVER PUSH DIRECTLY ON X-RAY TUBE ORCOLLIMATOR.

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The Arm can be turned up to 106o from its vertical position to allow a maximumFocal Distance of 2020 mm (79.5“) from the Floor.

m a

x .

2 0 2 0 ( 7 9 . 5

” )

106o

m i n .

5 0 0 ( 1 9 . 6

” )

The Tube-Collimator Assembly can rotate from its vertical position in:

• +165o / -- 40o in relation to its horizontal axis.

• ¦90o inrelationtoitstransversalaxis.Thismovementhasdetentsevery90o. The performed angle is indicated in the rotation indicator located onthe X-Ray Tube.

The Collimator can rotate ¦90o respect to its vertical axis while the Tuberemains in the same position. This movement has detents every 90o and it isperformed by manually turning the Collimator.

90o

75o

40o

90o 90o

¦ 90o

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3.7.2 PARKING POSITION

The parking position of the unit provides a safe and easy motion and transport.Bend the Arm and block it with the Arm Safety Hook.

Parking Position

Arm Safety Hook

ALWAYS KEEP THE ARM IN PARKING POSITION EXCEPTWHEN PERFORMING RADIOGRAPHIC EXAMS. THIS WILLPREVENT INJURIES OR UNIT DAMAGE DURINGDISPLACEMENT.

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3.7.3 DISPLACEMENT CONTROLS

The only displacement controls of the Unit are the Front Handle Bar, the BrakeControl Bar and the Blocking Button.

Thebrakes are released by grippingand holding the Brake ControlBar towardstheFrontHandleBar.TheUnitismanuallymovedpushingorpullingitfrombothBars. The front steering wheels and the back main wheels provide comfortabledriving as well as easy positioning of the Unit.

Also, the Unit is provided with a Blocking Button that keeps brakes released forlonger distances. Grip Front Handles and press Blocking Button to releasebrakes and start motion. Press on both Bars to release the Blocking Button andthen release both Bars to stop motion.

TAKE SPECIAL CARE WHEN GRIPPING BOTH BARS TOPREVENT INJURIES CAUSED BY FINGER PINCH .

Blocking ButtonFront Handle Bar

Brake Control Bar

The Unit can be transported over floor differences of up to 50 mm (curbs, steps,elevator gaps, etc). Step down on the base of the Unit to raise the directionalwheels, as shown in the picture below.

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3.8 COLLIMATOR CONTROLS

Collimator controls consist of a push-button to switch ON the Collimator Lampand two knobs to open or close the internal blades. (Also refer to the Collimator

Manual).

After pressing the push-button, the Collimator Lamp remains illuminated for afew seconds before automatically switching OFF.

PROLONGED LIGHTING WITHOUT ALLOWING SUFFICIENTTIME FOR THE LAMP TO COOL CAUSES THE COLLIMATORTO OVERHEAT IN THE INTERNAL AREA NEAR THE LAMP.

The exposure field is adjusted by setting the two knobs (shown below). Thetable on the Collimator Panel shows the number to set with the knobs to openthe blades according to the SID and cassette size to be used.

Collimator Lamp Push-button

Knobs to open or close the Collimator blades

3.9 DOSIMETRY (OPTIONAL)

The Radiation Meter VacuDAP 2000 (optional) consists of an IonizationChamber installed under the Collimator. This shows the radiation measure asthe Dose Area Product (DAP = Dose Area Product) in mGy*cm2.

Press the “Reset ” button to set the radiation value to zero for every new patient.(Refer to the Radiation Meter Manual for further information).

The radiation measure must be performed without any accessory

installed between the Collimator and the patient (filters or

diaphragms).

Radiation Meter (optional)

Note .

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SECTION 4 CONTROL CONSOLE

All controls, indicators and displays located on the Control Console arepositioned depending upon their functions.

The Radiographic module consists of: Power On / Off, Bucky / No BuckySelection, Focal Spot Indicators, RAD Displays, Controls to Increase orDecrease the Radiographic Parameters, Self-diagnostics and X-ray ExposureStatus Indicators.

Use the operating controls as described in this manual. Any other

non-indicated combination may cause an incorrect operation of

the equipment.

8. Film / Screen Combination9. AEC Reset10. Patient Size Selection (APR)11. APR Display Selectors12. Self-Diagnosis Indicator13. Exposure Indicators

1. Power On2. Power Off3. Bucky Selection4. Focal Spots Indicators5. Radiographic Values6. AEC Density Values

7. AEC Field Selection

1 2

3

5

11

12

9

7

8

4

10

12

6

11

13

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4.1 POWER ON / OFF

ON: Console and the Generator are turned ON by pressing this push-button.This starts a power-up routine, displaying the software version on the Console.

After the power-up routine, the last Workstation used (Bucky or No-Bucky) willbe automatically selected.

OFF: The Console / Generator is turned OFF by pressing this push-button.

4.2 EXPOSURE INDICATORS

READY : Indicates that the technique selected is properly set, there are nointerlock failures or system faults, the anode is rotating and the X-ray Tube isready for exposure.

X-RAY ON: Indicates that the X-ray exposure is in progress. An audible signalwill be heard during the exposure.

4.3 WORKSTATIONS SELECTION

BUCKY SELECTOR: Selects the Bucky (push-button lighted) or No-Bucky.

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4.4 FOCAL SPOT INDICATORS

SMALL FOCAL SPOT: Indicates that the “Small Focal Spot ” of the X-ray Tubehas been selected.

LARGE FOCAL SPOT: Indicates that the “Large Focal Spot ” of the X-ray Tubehas been selected.

The Focal Spot is automatically selected according to the mA

station. The mA station set for the Focal Spot change is

configured by the field engineer during the installation.

The Focal Spot may also be selected (keeping kVp and mAs constant) bypressing:

• “ON” + “ mA or mAs Increase” push-buttons to select Large Focal Spot.

• “ON” + “ mA or mAs Decrease” push-buttons to select Small Focal Spot.

Constant mAs set the maximum mA available and the minimum exposure time.

The Focal Spot change can be done whenever the present

conditions of the X-ray Tube allow it.

Note .

Note .

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4.5 RADIOGRAPHIC PARAMETERS

Refer to section 6.3 for Radiographic Operation Modes

kVp DISPLAY can show:

• The radiographic kVp value selected for the technique.

• The actual X-ray Tube heat unit value after pressing the “On”push-button ( refer to Section 4.8).

• The error messages during a system fault, preceded by the letter “E ”(e.g. E02) ( refer to Section 4.11).

mAs DISPLAY can show:

• The radiographic mAs value selected for the technique.

• When an exposure is made with AEC, it shows the actual mAs at the endof theexposure whenever the “Prep” push-buttonhas not been released.

• If an exposure is aborted by releasing the “Exp” push-button during theexposure, it shows the actual mAs value until the “AEC Reset”

push-button is pressed to reset the error condition.

mA DISPLAY : Shows the radiographic mA value selected for the technique.

Time DISPLAY can show:

• The Time value (in seconds) selected for the technique.

• When an exposure is made with AEC, it shows the back-up Time duringthe exposure and the actual Time at the end of the exposure wheneverthe “Prep” push-button has not been released.

• If an exposure is aborted by releasing the “Exp” push-button during theexposure, it shows the actual Time until the “AEC Reset” push-button ispressed to reset the error condition.

RAD Displays can also show:

• The actual Time, the calculated mAs, and the selected kVp and mAradiographic parameters of the last exposure, with or without AEC, afterpressing the “ AEC Reset ” push-button (values flashing).

• The exposure counters ( refer to Section 4.9).

Note .

kVp

mAs

mA

s

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INCREASE / DECREASE: Radiographic technique values are increased ordecreased by pressing the respective push-buttons. The values increase or

decrease step-by-step each time the corresponding push-button is pressed,and changes faster when either of them is pressed continuously.

• kVp: Selects the X-ray Tube voltage.

• mAs: Selects the exposure in mAs.

• mA: Selects the X-ray Tube current.

• s: Selects the exposure time in seconds.

(Refer to Section 7 for Factor ranges)

If after pressing any of these push-buttons, the technique value is

blocked and an acoustic signal is emitted it could mean that:

Radiographic Parameters Blockage. Whenever the maximum

or minimum limit for any radiographic parameter is reached, the

related Display blinks.

Generator Power Limit. If the power limit (kV x mA) is reached

by increasing the mA up to a maximum possible value, the mA

value is blocked. Flashing values on kV and mA Displays will alert

operator about the situation.

If required, kV could be increased up to its maximum value while

mA value may automatically decrease, as long as mAs value is

kept the same.

Space Charge. If a variation of the kV or mA induces to surpass

the space charge limit in the selected tube, the parameter is

blocked, and a flashing value on the kV Display will alert the

operator about the situation.

Maximum Energy (60 kJ). Only in AEC mode, if a variation of the parameters means that the maximum energy (60 kJ) will be

exceeded, the parameter is blocked. Flashing values on kV and

mAs Displays will alert operator about the situation.

Instantaneous Power. If a technique reaches the instantaneous

power limit of the X-ray Tube (ratings limit or the X-ray Tube is

momentarily overheated), some techniques cannot be selected.

Flashing values on kV and mAs Displays will alert operator about

the situation.

Note .

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4.6 AUTOMATIC EXPOSURE CONTROL (AEC) (OPTIONAL)

Automatic Exposure Control (AEC) produces consistent film density withexcellent contrast regardless of the selected radiographic technique. The AECmodule comprises the controls to activate the Exposure Detector (IonChamber), the Film/Screen Combination, Film Density Compensation and

AEC Reset.

The AEC mode is selected by pressing any of the three AEC Fieldpush-buttons. To exit the AEC mode, press all the illuminated AEC Fieldpush-buttons until none are lit.

In AEC mode the back-up time (or back-up mAs) MUST BE SET MANUALLYby the operator using the Console controls.

The value of the back-up time (or mAs) must be set greater than

the previously considered value for the exposure time (or mAs).

A value above 50% of the considered value is the recommended.

Very extreme values of back-up time (or mAs) should be avoided

to prevent patient from excessive exposure when a control error

is produced.

EXPOSURE DETECTOR: Press central push-button to activate or deactivatethe Mobile-AID Ion Chamber. Buttons at right and left are not used to select theMobile-AID Ion Chamber.

FILM / SCREEN COMBINATION: Each of these push-buttons allowsadjustment of the mAs in relation to a programmed Film / Screen combinationthat may be in use: slow, medium, or fast respectively (200, 400, 800). Eachtime a Film / Screen push-button is selected (illuminated), the others areautomatically deselected.

DENSITY: These push-buttonsareusedto adjust the radiographic film density.

Film density canbe proportionally increased or decreased inseveral steps.Theselected value is shown in the Density Display. The variation percentagedensity between steps can be changed during the equipment calibration by theengineer according to customer preferences (the percentage by default is25%).

Note .

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AECRESET: If theexposure is abortedbytheAEC back-uptimer, theindicatoronthe“ AEC Reset ” push-button blinks accompanied by an audible alarm. The

next exposure is inhibited until the AEC function is reset by pressing the “ AECReset ” push-button. When the Generator is in “Prep” mode, the AEC functioncan not be reset.

The “ AEC Reset ” push-button may blink when the kVp value, the AEC Densityand the Film/Screen Combination select a technique that is out of the operativerange with AEC, inhibiting the next exposure. Change any parameter (kVpvalue, AEC Density and/or Film/Screen Combination) in order to obtain atechnique enabled for AEC.

4.7 ANATOMICAL PROGRAMMER (APR)

The Anatomical Programmer (APR) module is comprised of the controls whichselect the Patient Size and Display Selectors. The process is shown on the

APR Display.

The APR techniques are factory pre-programmed according to differentstandard techniques that combines six Body Regions with their AnatomicalViews (Organ + Projection). Besides the radiographic parameters, selectionsof the workstation or AEC can be assigned to the APR techniques. Theseselections will always be common for all the patient sizes of each Anatomical

View. These techniques may be modified and stored again by the operator inthe “ APR working File” .

The APR techniques are intended as a guide only. Accurate exposure factorsdepend, among other things, onBucky grid factors, table topabsorption, screenfilm combinations and film processing.

APR modeactivates when one of the three Patient Size (small, medium or largesize) is selected (push-button lighted), and deactivates by deselecting any ofthem.

APR language may be changed by pressing the “Power On”

push--button immediately after selecting one of the patient size

(APR activation). Language selected remains stored even after

the equipment is turned Off. Different languages available

according to order specifications.

If an APR technique is to be stored with AEC parameters, a

suitable back-up time (and/or mAs) MUST be stored in the

programme by the operator.

Note .

Note .

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APR DISPLAY : Shows the different Body Regions and Anatomical Viewsavailable for each APR technique, and the final APR selection.

Because each area of the APR Display is limited in length to eight characters,some regions and views are abbreviated.

PATIENT SIZE: These push-buttons are used to adapt the APR techniquechosen according to patient size. Six patient sizes are available. The threeright-hand push-buttons select Small, Medium and Large adult sizes (only oneis illuminated when selected). The left-hand paediatric push-button changesthe function of the right-hand three push-buttons from adult patient size topaediatric patient size. (In this mode, the “Paediatric” push-button and one of

the other three buttons may be illuminated at the same time).

ANATOMICAL VIEW SELECTORS: Each push-button is related with thenearestareaof theAPR Display and they areusedto selectone of thedisplayedBody Regions, Organs and Projections. The selected Region and Viewsappears in negative block ( SKULL ).

The APR display shows the Body Regions, Organs and Projections. When a

Body Region has been selected its indication is locked on the screen and the APR Display shows directly all its respective Organs. In some cases, an Organmay show several Projections.

When theAPR selection is finished, the Consoleshows thefinal selection(APRDisplay), its respective parameters (RAD Display), the Workstation and AECcontrols related to the technique.

To go back to the previous level, press on the right-lower APR push-buttonwhich displays the “ return” symbol.

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APR TECHNIQUE CHANGES

The APR techniques are factory pre-programmed to standard technique sets. All parameters of the APR techniques may be manually overridden as requiredby the operator and stored in the non-volatile memory for later use.

If the operator determines that some factors in an APR technique should bere-programmed, use the following procedure:

1. Select an APR technique and modify the factors and selections ofWorkstations or AEC which require to be re-programmed.

2. Verify that all factors of the technique are at the required values.

3. Store the new technique by first pressing the selected Patient Size andwithout releasing it press the Projection selected. (Refer to

Illustration 4-1).

The newly selected technique is now stored in the memory and can berecalled for future examinations.

This procedure only changes the technique values of the selected

patient size; repeat the procedure for other patient sizes.

Illustration 4-1APR Storage Push-buttons

3

2

4 8

7

6

51

Example : press push-buttons: 1 st Medium Patient Size and Lateral Projection, to store the APR technique selected.

LATERAL

SKULL

SKULL

SEMIAX.

LATERAL

AXIAL

AP/PA SPECIAL

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Table 4-1APR Projections (English version)

BODY REGION / ORGAN / PROJECTION

SKULL

AP/PA

LATERAL

SEMIAXIAL

AXIAL

SPECIAL

THORAX AP

LATERALODONTOID AP

ORBITA -- UPPER RIBS AP/PA

OBLIQUEC-SPINE

AP

LATERAL

OBLIQUE

SKULL

PETROUSBONES

/ STENVERS--

THORAX LOWER RIBS

AP/PA

OBLIQUE SPINET-SPINE

AP

LATERAL

OBLIQUE

MASTOID -- STERNUMLATERAL

OBLIQUEL-SPINE

AP

LATERAL

OBLIQUE

PARANASALSINUSES

-- SCAPULA

AP/PA

LATERAL

OBLIQUE

L5--S1 AP

LATERAL

SELLA LATERAL CLAVICLE AP/PA SACRUM AP

LATERAL

NOSE LATERAL

ABDOMEN

AP/PA

LATERAL

DECUBITUS

STANDING

FEMUR AP

LATERALSHOULDER

AP

SEMIAXIAL

OBLIQUE

KIDNEY AP KNEE AP

LATERALHUMERUS

AP

LATERAL

KIDNEY / URETER

AP PATELLALATERAL

AXIALELBOW

PA

LATERAL

ABDOMEN / PELVIS

GALL-BLADDER

AP

OBLIQUE

LOWEREXTREMITIES

LOWER LEG AP

LATERAL

UPPEREXTREMITIES

FOREARM PA

LATERAL

PELVIS AP

LATERALANKLE

AP

LATERAL

OBLIQUE

WRIST

AP

LATERAL

OBLIQUE

HIP

AP

MED / LAT

AXIAL

FOOT

AP

LATERAL

OBLIQUE

HAND

AP

LATERAL

OBLIQUE

TOES AP/LAT/OBLIQ FINGER AP

LATERAL

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Table 4-1 (cont.)APR Projections (Spanish version)

ZONA CUERPO / ORGANO / PROYECCION

CRANEO

AP/PA

LATERAL

SEMIAXIAL

AXIAL

ESPECIAL

TORAX AP

LATERALODONTAL AP

ORBITA -- COSTILLASSUPERIORES

AP/PA

OBLICUO

COLUMNACERVICAL

AP

LATERAL

OBLICUO

CRANEOPEÑASCO --

TORAX

COSTILLASINFERIORES

AP/PA

OBLICUO COLUMNA

COLUMNADORSAL

AP

LATERAL

OBLICUO

MASTOID -- ESTERNONLATERAL

OBLICUO

COLUMNALUMBAR

AP

LATERAL

OBLICUO

SEN. PAR. -- ESCAPULA

AP/PA

LATERAL

OBLICUO

L5--S1 AP

LATERAL

SILLA TURCA LATERAL CLAVICULA AP/PA SACRO AP

LATERAL

NARIZ LATERAL

ABDOMEN

AP/PA

LATERAL

DECUBIT0

CARGA

FEMUR AP

LATERALHOMBRO

AP

SEMIAXIAL

OBLICUO

RIÑON AP RODILLA AP

LATERALHUMERO

AP

LATERAL

RIÑON / URETRA

AP ROTULALATERAL

AXIALCODO

PA

LATERAL

ABDOMEN / PELVIS

VESICULABILIAR

AP

OBLICUO

EXTREMIDADESINFERIORES

PIERNAINFERIOR

AP

LATERAL

EXTREMIDADESSUPERIORES

ANTEBRAZO PA

LATERAL

PELVIS AP

LATERALTOBILLO

AP

LATERAL

OBLICUO

MUÑECA

AP

LATERAL

OBLICUO

CADERA

AP

MED / LAT

AXIAL

PIE

AP

LATERAL

OBLICUO

MANO

AP

LATERAL

OBLICUO

DEDOSDEL PIE

AP/LAT/OBL DEDOS DELA MANO

AP

LATERAL

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Table 4-1 (cont.)APR Projections (French version)

REGION DU CORPS / ORGANE / PROJECTION

CRANE

AP/PA

LATERAL

SEMIAXIAL

AXIAL

SPECIAL

THORAX AP

LATERALATLAS AP

ORBITAE -- COTES SUP. AP/PA

OBLIQUECOL. CERV

AP

LATERAL

OBLIQUE

CRANEM. PEDRO --

THORAX COTES INF.

AP/PA

OBLIQUE COLONNECOL. DORS

AP

LATERAL

OBLIQUE

MASTOID -- STERNUMLATERAL

OBLIQUECOL. LOMB

AP

LATERAL

OBLIQUE

SINUS -- OMOPLATE

AP/PA

LATERAL

OBLIQUE

L5--S1 AP

LATERAL

SELLA LATERAL CLAVICLE AP/PA SACRUM AP

LATERAL

NEZ LATERAL

ABDOMEN

AP/PA

LATERAL

DECUBITUS

DEBOUT

FEMUR AP

LATERALEPAULE

AP

SEMIAXIAL

OBLIQUE

REINS AP GENOU AP

LATERALHUMERUS

AP

LATERAL

URETERE AP ROTULELATERAL

AXIALCOUDE

PA

LATERAL

ABDOMEN / BASSIN

VES. BIL. AP

OBLIQUE

EXTREMITESINFERIEUR

JAMBE INF. AP

LATERAL

EXTREMITESSUPERIEUR

BRAS. INF. PA

LATERAL

PELVIS AP

LATERALCHEVILLE

AP

LATERAL

OBLIQUE

POIGNET

AP

LATERAL

OBLIQUE

HANCHE

AP

MED / LAT

AXIAL

PIED

AP

LATERAL

OBLIQUE

MAIN

AP

LATERAL

OBLIQUE

ORTEIL AP/LAT/OBLIQ DOIGTS AP

LATERAL

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Table 4-1 (cont.)APR Projections (German version)

REGION / ORGAN / PROJEKTION

SCHÄEDEL

AP/PA

LATERAL

HALBAX.

AXIAL

SPEZIAL

THORAX AP

LATERALDENS AP

ORBITA -- OBERERRIPPEN

AP/PA

OBLIQUEHWS

AP

LATERAL

OBLIQUE

SCHÄEDELSTENVERS --

THORAX

UNTERERRIPPEN

AP/PA

OBLIQUE W. SAEULEBWS

AP

LATERAL

OBLIQUE

MASTOID -- STERNUMLATERAL

OBLIQUELWS

AP

LATERAL

OBLIQUE

NNH -- SCAPULA

AP/PA

LATERAL

OBLIQUE

L5--S1 AP

LATERAL

SELLA LATERAL CLAVICUL AP/PA SAKRUM AP

LATERAL

NASE LATERAL

ABDOMEN

AP/PA

LATERAL

DECUBIT.

STEHEND

O. SCHENKEL AP

LATERALSCHULTER

AP

HALBAX.

OBLIQUE

NIERE AP KNIE AP

LATERALOBERARM

AP

LATERAL

NIERE / UR AP PATELLALATERAL

AXIALELLENBOGEN

PA

LATERAL

ABDOMEN / BECKEN

GALLEN-BLASE

AP

OBLIQUE

UNTEREREXTREM.

U. SCHENKEL AP

LATERAL

OBEREREXTREM.

UNTERARM PA

LATERAL

BECKEN AP

LATERALSPRGEL.

AP

LATERAL

OBLIQUE

HANDGELENK

AP

LATERAL

OBLIQUE

HUEFTE

AP

MED / LAT

AXIAL

FUSS

AP

LATERAL

OBLIQUE

HAND

AP

LATERAL

OBLIQUE

ZEHEN AP/LAT/OBLIQ FINGER AP

LATERAL

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Mobile X-ray Unit

Operation

OM-0298R1 44

Table 4-1 (cont.)APR Projections (Polish version)

REGION APR / ORGAN / PROJEKCJA

CZASZKA

AP/PA

BOCZNE

POLOSIOWE

OSIOWE

SPECIAL

KLATKA P AP

BOCZNEOBROTNIK AP

OCZODOLY -- ZEBRA G. AP/PA

SKOSKR. SZYJ.

AP

BOCZNE

SKOS

CZASZKAUSZY SR. --

KLATKA PZEBRA D.

AP/PA

SKOS KREGOSL.KR. PIER.

AP

BOCZNE

SKOS

PODSTAWA -- MOSTEK BOCZNE

SKOSKR. LEDZ.

AP

BOCZNE

SKOS

ZATOKI -- LOPATKA

AP/PA

BOCZNE

SKOS

C. L5--S1 AP

BOCZNE

SIODELKO BOCZNE OBOJCZYK AP/PA K. KRZYZ. AP

BOCZNE

NOS BOCZNE

J. BRZUSZ

AP/PA

BOCZNE

BOK-LEZ

BOK-STOJ

UDO AP

BOCZNEBARK

AP

POLOSIOWE

SKOS

NERKI AP KOLANO AP

BOCZNERAMIE

AP

BOCZNE

P. MOCZ. AP RZEPKABOCZNE

OSIOWELOKIEC

PA

BOCZNE

J. BRZUSZ P. ZOLCI. AP

SKOSKONCZ D. GOLEN AP

BOCZNEKONCZ G. PRZEDR. PA

BOCZNE

MIEDNICA AP

BOCZNESTAW ZK.

AP

BOCZNE

SKOS

NADGARS.

AP

BOCZNE

SKOS

BIODRA

AP

BOCKNE

OSIOWE

STOPA

AP

BOCZNE

SKOS

DLON

AP

BOCZNE

SKOS

PALCE AP/BOK PALCE AP

BOCZNE

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Mobile X-ray Unit

Operation

OM-0298R1 45

Table 4-1 (cont.)APR Projections (Turkish version)

VÜCUT KISMI / ORGAN / PROJEKSIYON

KAFA

AP/PA

LATERAL

SEMIAKSIYAL

AKSIYAL

ÖZEL

TORAKS AP

LATERALODONTOID AP

GÖZ ÇUK -- Ü. KABUR. AP/PA

OBLIK C. OMUR

AP

LATERAL

OBLIK

KAFASTENVERS --

TORAKSA. KABUR.

AP/PA

OBLIK OMURGAT. OMUR

AP

LATERAL

OBLIK

MOSTOID -- STERNUMLATERAL

OBLIK L. OMUR

AP

LATERAL

OBLIK

SIN.PAR. -- SKAPULA

AP/PA

LATERAL

OBLIK

L5--S1 AP

LATERAL

SELLA LATERAL KLAVICU. AP/PA SAKRUM AP

LATERAL

BURUN LATERAL

BATIN

AP/PA

LATERAL

DEKUBIT

AYAKTA

FEMUR AP

LATERALOMUZ

AP

SEMIAKS

OBLIK

BÖBREK AP DIZ AP

LATERALKOL

AP

LATERAL

ÜRINER AP PATELLALATERAL

AKSIYALDIRSEK

PA

LATERAL

BATIN/PELVIS SAFRA K. AP

OBLIK

A.EXTREM

CRURAL AP

LATERAL

Ü.EXTREM

ÖN KOL PA

LATERAL

PELVIS AP

LATERALA. BILEGI

AP

LATERAL

OBLIK

BILEK

AP

LATERAL

OBLIK

KALÇA

AP

MED / LAT

AKSIYAL

AYAK

AP

LATERAL

OBLIK

EL

AP

LATERAL

OBLIK

A. PARMAK AP/LAT/OBLIK PARMAK AP

LATERAL

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OM-0298R1 46

4.8 HEAT UNITS

This X-ray Generator is equipped with a Heat Unit Calculator. Duringexposures, the Heat Units are calculated and totalled.

To view theremainingHeat Units,press and hold the“On” push-button.ThekVpDisplay shows the percentage of Heat Units that remain preceded by the letter“H”. For example, a display of “H75” would indicate that 75% of Heat Unitscapacity of the X-ray Tube remains. “H -- -- ” indicates that all the capacityremains. The kVp Display reverts to its normal function after releasing the “On”push-button.

4.9 EXPOSURE COUNTERS

The operator can read the number of exposures made by the Generator, asindicated below:

Press and hold and press once

The number of exposures are shown on the kVp and mAs Displays, up to amaximum of 999,999 exposures.

kVp mAs

= 123,456 exposures

4.10 SELF-DIAGNOSIS INDICATORS

ERROR INDICATOR: Lights when a malfunction is detected in the system,alerting the operator that one of the following error inhibits X-ray exposures.Duringnormaloperation of the system, theseerror indicators are directlyshownon the APR Display or as an error code on the kVp Display. (Refer to Section

4.11).• Tube Overload (T.OVL): Indicates that either technique selected is

beyond the X-ray Tube ratings or the present conditions of the X-rayTube inhibit the exposure (anode overheated). Parameters for nextexposure may be temporally limited by the Generator (change theexposure values or wait for the X-ray Tube to cool).

Check that heat units available are lower than the ones calculated for thenext exposure (heat units close to zero). Reduce exposure factors orwait for the X-ray Tube to cool. (To display Heat Units refer to Section

4.8).

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OM-0298R1 47

• Generator Overload (G.OVL): Indicates that the exposure wasinterrupted because arcing or malfunctioning occurred during exposure

on the HV circuitry (X-ray Tube, HV Transformer and/or HV Cables) ora failure of IGBT module (overheated or defective IGBTs) was detected.

It can also appear when making a lengthy or high powered exposure withthe X-ray Tube cool (X-ray Tube has not been sufficiently warmed-up).

• Rotor Error (ROTOR) : Indicates that the X-ray Tube anode is notrotating while “Prep” is active, then exposures are inhibited.

• Heat Unit (HEAT): Indicates that the X-ray Tube thermostat /

pressurestat is open due to overheating of the Tube housing (housing istoo hot; wait for the housing to cool) or to a thermostat / pressurestatmalfunction (housing is cool). Heat units may rise to any value.

• Technique Error (TECH): If activated during exposure it means that:

EXPOSURE HAS BEEN INTERRUPTED BY THE “SECURITY TIMER” BECAUSE OF A FAILURE IN THE SYSTEM. TURNTHE GENERATOR OFF AND CALL FIELD SERVICE.

This error can be also shown after an APR technique selection to advisethat exposure parameters displayed on the Console are not the valuesstored for this APR technique. Exposure parameters are adapted by theGenerator to enable other permitted values.

4.11 ERROR CODES

Error codes indicate the potential cause of a system failure. They areintermittently shown on the kVp Display at the same time an alarm sounds. Ingeneral, to remove the error indication on the Console keep pressed the “ AEC

Reset ” push-button till the alarm goes off. (Refer to Table 4-2).

All these error codes are preceded by the letter “E ” (i.e., E01) and they willenable the operator to indirectly convey the possible source of error to servicepersonnel. This may prevent the need for a service call or enable servicepersonnel to anticipate corrective actions prior to arriving on site.

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Mobile X-ray Unit

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OM-0298R1 48

Table 4-2Error Codes

ERROR DESCRIPTION WHAT TO DO

-- -- -- -- -- --on Display

System failure. This indication may appear together with anerror on the Console, and indicates that the error is notcorrectable unless the equipment is turned OFF.

Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E01, E02 Communication error.Turn the Generator OFF, check the proper external cable connectionsand then turn the Generator ON. If the equipment remains inoperative,turn it OFF and call Field Service.

E03 System failure.

E04The Power Cabinet has activated “Preparation” without aConsole command intervention.

Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E05 External exposure activated during power-up.

Release any external exposure device or push-buttons.

Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E06“Exposure” or/and “Preparation” orders are activated duringpower-up.

Release all the controls.Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E07, E08 X-ray Tube configuration error.Press the “ AEC Reset ” push-button.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E09

Generator Overload error. The exposure has beeninterrupted because an arcing or malfunction on the HVcircuitry (X-ray Tube, HV Transformer and/or HV Cables)has occurred during the exposure; or a failure of IGBTmodule (overheated or defective IGBTs) has been detected.

A lengthy and high powered exposure with the X-ray tubecool (X-ray Tube has not been warmed-up) will also showthis error.

This error does not require to press the “ AEC Reset ” push-button, itsindication disappears automatically.If the error code persists, turn the Generator OFF and wait 30 minutesbefore turning it ON again.

If the equipment remains inoperative, turn it OFF and call Field Service.

E10, E11 System failure.Press the “ AEC Reset ” push-button.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E12 No mA during exposure or mA value is out of range.

E13

No kV during exposure or kV value is out of range.

This error may be due to the value introduced in memoryE69 (line current) and the configuration of the line current jumper on the Capacitors Charging Board not coinciding.

Press the “ AEC Reset ” push-button.Repeat with same technique values, If the error code persists try withanother combinations of kV and mA values.If the equipment remains inoperative, turn it OFF and call Field Service.

E14, E15 System failure.

Press the “ AEC Reset ” push-button.

If the error code persists, turn the Generator OFF and ON again.If the equipment remains inoperative, turn it OFF and call Field Service.

E16 Invalid value of: kV, mA or kW.Decrease kV, mA or both. Press the “ AEC Reset ” push-button.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E17 Communication error or system failure.Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E18Rotor error. The X-ray tube anode is not rotating while“Prep” is active, then exposures are inhibited, or the X-raytube anode is r otating without console command.

This error does not require to press the “ AEC Reset ” push-button, itsindication disappears automatically.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E19, E20 System failure.Turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

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OM-0298R1 49

Table 4-2 (cont.)Error Codes

ERROR DESCRIPTION WHAT TO DO

E21, E22 Incorrect selection of the X-ray Tube.

E23 System failure. Press the “ AEC Reset ” push-button.

E24 Bucky not ready for an exposure.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E26, E27 System failure.

, .

E33 Serial Communication error.

Press the “ AEC Reset ” push-button.Check that communication cable between Generator and console isproperly c onnected.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E34

Technique error. If it activates during the exposure it meansthat the exposure has been interrupted by the “SecurityTimer” because of a system failure. Call Field Service.This error can also be shown after an APR techniqueselection to advise that exposure parameters displayed onthe console are not the values stored for this APRtechnique. Exposure parameters are adapted by theGenerator to enable other values.

E36

Heat Units error. The X-ray Tube thermostat / pressurestatis open due to an overheated tube housing (housing is toohot, wait for the housing to cool) or a thermostat / pressurestat malfunction (housing is cool). Heat units mayrise to any value.

These errors do not require the “ AEC Reset ” push-button to be pressed,their indications disappear automatically.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E37

Tube Overload error. The technique selected is beyond theX-ray tube ratings or present conditions of the X-ray tubeinhibit the exposure (anode overheated). Parameters fornext exposure may be temporally limited by the Generator(change the exposure values or wait for the X-ray tube tocool). Check that heat units available are lower than thecalculated for the next exposure (heat units close to zero).Reduce exposure factors or wait for the X-ray tube to cool.

E47Capacitors are not charged when “Prep” control is activated.The exposure is inhibited until the Capacitors are charged.

Press the “ AEC Reset ” push-button.Wait one minute for the Capacitor to charge-up before activating the“Prep” control.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E48Collimator Error. A failure on the Automatic Collimator hasbeen detected (blades are fully open or in movement duringexposure, etc. )

Press the “ AEC Reset ” push-button.If the error code persists, turn the Generator OFF and ON.

E50 Exposure has been aborted by the Operator.If the equipment remains inoperative, turn it OFF and call Field Service.

E95 Exposure aborted by the AEC Rapid Termination.Press the “ AEC Reset ” push-button. Select the correct Ion Chamber ormodify parameters. Repeat the exposure.If the equipment remains inoperative, turn it OFF and call Field Service.

E96 Voltage missing in the Capacitors Charger Board. Press the “ AEC Reset ” push-button.

E97 Unbalanced charge level in Capacitors.If the error code persists, turn the Generator OFF and ON.If the equipment remains inoperative, turn it OFF and call Field Service.

E98 Service Mode Active.Press the “ AEC Reset ” push-button and call Field Service. This errordoes not inhibit normal operation.

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Operation

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OM-0298R1 51

SECTION 5 OPERATING SEQUENCES

5.1 START-UP ROUTINE

After turning ON the Console, the Generator will go through a start-up routineconducting an automatic self-test that will show information usable only byservice personnel.

After the power-up has been completed the Console should display normalradiographic factors. If there is a malfunction, error messages will be displayedon the RAD kVp Display specifying the fault.

Some indicators on the Console are used to provide service

information during the start-up process. These indicators should

be ignored by the operator until the unit has completed its

power-up sequence.

5.2 X-RAY TUBE WARM-UP PROCEDURE

Before effecting X-ray exposures ensure that the Tube is

properly warmed-up. Make sure that no persons will be

inadvertently exposed to unnecessary X-rays during this

procedure.

Routine exposures should not be effected unless the Tube is previouslywarmed-up, this prolongs X-ray Tube life.

ItisrecommendedthatthefollowingprocedurewillbeperformedforX-rayTubewarm-up, at the start of each day and when the Tube selected has not been inuse for approximately one hour.

This warm-up procedure is used for a typical X-ray Tube.

Consult the X -ray Tube manufacturer instructions for the

actual Tube in use, comparing its recommendations with this

procedure. If there is conflict with this procedure, comply

with the Tube manufacturer’s instructions.

Note .

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Mobile X-ray Unit

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OM-0298R1 54

5.5 APR OPERATION

An examination using an APR technique could consist of the following:

1. Make sure that the X-ray Tube is properly warmed-up.

2. Position the patient for the examination.

3. Select the “Patient Size” corresponding to the patients anatomy. ThisoperationstartstheAPRmode. Selectthe“Pediatric”buttonifthepatientis not an adult.

4. Select a general “Body Region” and an “ Anatomical View ” of theindicated on the APR Display.

5. Techniqueparameters,Focal Spot, AEC,etc...corresponding tothe APRselection are displayed and indicated on the Control Console. If needed,the parameters and selections can be directly modified by the operator.

6. Continue with the normal procedure for a typical RAD examination.(Refer to Section 5.3 - step 4.)

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OM-0298R1 57

SECTION 7 TECHNICAL SPECIFICATIONS

Maximum Power kW(Refer to Identification Label)

16 kW 20 kW 32 kW

40 to 125(40 to 150 optional)

40 to 125(40 to 150 optional)

40 to 150

kVp Range

From 40 kV to 125 kV or 150 kV in 1 kV steps.(Depending on the Generator model)

0.1 to 250 0.1 to 320 0.1 to 500

mAs Range

Product of mA x Time values from 0.1 mAs to 250, 320 or 500 mAs(Depending on the Generator model)

(Maximum mAs are only available with Power Lines or at least 16A at 230 VAC;

for Lines with lower Voltage and/or current, maximum mAs is reducer)

(The mAs value is limited depending on the selected kVp and mA values.

The higher mAs values are obtained when selecting low kVp and mA values).

10 to 250 10 to 320 10 to 500

mA Range From 10 mA to 250, 320 or 500 mA through the following mA stations:10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100, 125, 160, 200, 250, 320, 400, 500.

(Depending on the Generator model)

Exposure Time Range

From 1 millisecond to 10 seconds through the following Time stations:Milliseconds: 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 25, 32, 40, 50, 64, 80,

100, 125, 160, 200, 250, 320, 400, 500, 640, 800.Seconds: 1, 1.25, 1.6, 2, 2.5, 3.2, 4, 5, 6.4, 8, 10.

0.1 mAs to 250 mAs 0.1 mAs to 320 mAs 0.1 mAs to 500 mAs

AEC

Exposure Time: Nominal shortest irradiation Time = 1ms

Power Output (@ 0,1s)

125 kVp @125 mA100 kVp @ 160 mA80 kVp @ 200 mA64 kVp @ 250 mA

125 kVp @ 160 mA100 kVp @ 200 mA80 kVp @ 250 mA62 kVp @ 320 mA

150 kVp @ 200 mA128 kVp @ 250 mA100 kVp @ 320 mA80 kVp @ 400 mA64 kVp @ 500 mA

The Duty Cycle is continuous, but limits depend on the capacity of the X-ray TubeDuty Cycle

Maximum leakage radiation depends on the type of X-ray Tube

Collimator Manual with electronic timer and meter

Standard X-ray Tube

Low Speed -- Rotating AnodeFocal Spots: 0.3 mm / 1.0 mm

Anode kHU / kVp: 140 kHU / 150 kVpTarget Angle: 12°

Inherent Filtration of X-ray Source (Tube + Collimator): refer to Identification LabelOther X-ray Tubes available on request

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OM-0298R1 58

Maximum Power kW(Refer to Identification Label)

16 kW 20 kW 32 kW

100 / 110 / 120 / 208 / 230 / 240 VAC -- Single-Phase, 50 / 60 Hz

Automatic Line Compensation¦10% VACPower Line Adaptation for local conditions from 8 to 16 A

Connection to standard outlets with GND that accomplishes local regulations

Power Line Operation

The Line Circuit Breaker installed in the Mobile Unit is 10 A (1P+N curve type D),the Power Line Installation should be provided with a Differential of 30 mA Sensitivity

and with a Thermomagnetic Interruptor / Circuit Breaker of:² 13 A (curve type D) or ² 20 A (curve type C) or ² 32 A (curve type B)

Line Impedance should comply with Standard IEC--60601.2.7.Maximum Line Impedance depends on the Line Voltage as follows:

for Vrms of 240 V Max. Line Impedance is 0.38 Ωfor Vrms of 230 V Max. Line Impedance is 0.36 Ωfor Vrms of 208 V Max. Line Impedance is 0.31 Ωfor Vrms of 120 V Max. Line Impedance is 0.11 Ω

for Vrms of 110 V Max. Line Impedance is 0.10 Ωfor Vrms of 100 V Max. Line Impedance is 0.09 Ω

Minimum kW required 2.0 kW

Maximum Input Power 4 kVA

Maximum Input Current 16 A

Energy Storage Capacity 8400 Joules 11200 Joules 14000 Joules

Storage Capacitors DischargeEnergy Storage Capacitors are automatically discharged below 50 V

in less than 150 minutes after turning Off the Mobile Unit and unplugging it from mains.

Environmental Conditions

Storage / Transport:Temperature from --40 oC to 70 oC; Relative Humidity from 10% to 100%.

Atmospheric Pressure range of 500 hPa to 1060 hPa

Operating:Temperature from 10 oC to 40 oC; Relative Humitidy (no condensing) from 30% to 75%.

Atmospheric Pressure range of 700 hPa to 1060 hPa

PHYSICAL CHARACTERISTICS

LENGTH WIDTH HEIGHT WEIGHT

minimum 1050 mmmaximum 1910 mm

700 mmminimum 1690 mmmaximum 2130 mm

235 Kg

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Mobile X-ray Unit

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OM-0298R1 59

Illustration 7-1Dimensions

1 0 9 8 ( 4 3 . 2

2 ) 1

6 9 0 ( 6 6 . 5

” )

9 5 0 ( 3 7 . 2

” )

2 1 3 0 ( 8 3 . 8

” )

m a x .

S I D

- - 2 0 2 0 ( 7 9 . 5

” )

90o

R e f e r e n c e A x i s

Reception Area

75o

40o

Focal Spot

106o

5 8 ( 2 . 2

” )

m i n

. 4 3 0 ( 1 6 . 9

” )

max.1150 (45.3”)

max. 1910 (79.9”)

1050 (41.3”)

7 0 0 ( 2 7 . 5 ” )

Focal Spot

90o 90o

¦ 90o

Rotation of Tube-Collimator Assembly

Rotation of Collimator

Rotation of Tube-Collimator Assembly

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Mobile X-ray Unit

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