Operation - Sound Installation...

SEDECAL

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

Technical PublicationOM-0246R2

OperationHF Series Generators

RAD Console

¡ IMPORTANTE ! ... Protección ante los rayos-X

LOS EQUIPOS DE RAYOS-X SON PELIGROSOS PARA EL PACIENTE Y EL OPERADORA 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 instruccionesaquí 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 lasradiaciones-X, ningún diseño practico puede ofrecer una protección completa. Tampoco ningún diseño practico puede obligar al operadora tomar las precauciones adecuadas para prevenir la posibilidad de que cualquier persona de manera descuidada, poco sensata oignorante, se exponga a radiaciones directas o indirectas.

Es importante que cualquier persona relacionada con radiaciones-X esté debidamente entrenada y tome las medidas adecuadas paraasegurar la protección contra posibles lesiones.

El fabricante asume que todo operador y personal de servicio autorizado para manejar, instalar, calibrar o mantener este equipo, esconsciente del peligro que conlleva la exposición excesiva a las radiaciones-X, está suficientemente entrenado y posee los conocimientonecesarios para ello. Por lo tanto, el equipo aquí descrito se vende entendiendo que el fabricante, sus agentes y representantesno 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 OPERATORUNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED

X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughlyread and understood before attempting to place this equipment in operation. We will be glad to assist andcooperate 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 otherthan the useful beam, no practical design of equipment can provide complete protection. Nor can any practical design compel theoperator 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 equipmentis cognizant of the danger of excessive exposure to X-radiation, is sufficiently trained and has the required knowledges for it. Theequipment herein described is sold with the understanding that the manufacturer, its agents, and representatives are not liable forinjury 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 enroute 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 protectioncontre le rayonnement-X en dehors du rayon utile, aucune conception n’apporte une protection totale. De même qu’aucune conceptionne peut obliger l’opérateur à prendre les précautions adéquates afin d’éviter que toute personne ne s’expose ou n’expose les autresau 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 adéquatesafin 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 équipementest conscient du danger de l’exposition excessive au rayonnement-X, est suffisamment formé et possède les connaissances nécessairespour cela. L’équipement décrit dans le présent manuel est vendu sous réserve que le fabricant, ses agents et représentants ne soientpas 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.

HF Series Generators -- RAD Console

Operation

OM-0246R2

REVISION HISTORY

REVISION DATE REASON FOR CHANGE

0 APR 1, 2002 First edition.

1 JUN 1, 2003 Documentation update.

2 MAY 10, 2004 General improvements.

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.

ADVISORY SYMBOLS

The following advisory symbols will be used throughout this manual. Theirapplication and meaning are described below.

DANGERS ADVISE OF CONDITIONS OR SITUATIONS THATIF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUSPERSONAL INJURY OR DEATH.

ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOTHEEDEDORAVOIDEDCOULDCAUSESERIOUSPERSONALINJURY, OR CATASTROPHIC DAMAGE OF EQUIPMENT ORDATA.

Advise of conditions or situations that if not heeded oravoidedcould causepersonal injury or damage to equipmentor data.

Note . Alert readers to pertinent facts and conditions. Notes representinformation that is important to know but which do not necessarilyrelate to possible injury or damage to equipment.


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OM-0246R2

SAFETY SYMBOLS

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

Attention, consult accompanying documents.

Ionizing radiation.

Type B equipment.

Dangerous voltage.

Ground.


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OM-0246R2 i

TABLE OF CONTENTS

Section Page

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

1.1 General Features 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.2 Options 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.3 Product Identification 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.4 Certifications 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1.5 Classification 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2 SAFETY 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.1 General 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.2 Responsibilities 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.3 Máximum Permissible Dose (MPD) 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.4 Radiation Protection 7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.5 Monitoring of Personnel 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2.6 Protection against Electric Shock Hazards 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3 OPERATING CONTROLS 9. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1 Radiography and General Controls 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1.1 Power ON / OFF 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1.2 Workstations Selection 10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1.3 Focal Spot Indicators 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.1.4 Radiographic Parameters 12. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.2 Automatic Exposure Control (AEC) 14. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.3 Anatomical Programmer (APR) 15. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.4 Exposure Controls and Indicators 23. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.5 Heat Units 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.6 Exposure Counters 24. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.7 Self-Diagnosis Indicators 25. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.8 Error Codes 26. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


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OM-0246R2ii

Section Page

4 OPERATING SEQUENCES 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.1 Start-up Routine 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.2 X-Ray Tube Warm-up Procedure 29. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.3 Radiographic Operation 30. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.4 AEC Operation 31. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4.5 APR Operation 32. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 PERIODIC MAINTENANCE 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.1 Operator Tasks 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5.2 Service Tasks 34. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6 TECHNICAL SPECIFICATIONS 35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.1 Factors 35. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.2 Range of Radiographic Parameters 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.3 Duty Cycle 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6.4 Physical Characteristics 36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


Operation

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SECTION 1 INTRODUCTION

This manual contains all the information necessary to understand and operatethe High Frequency Generators with the RAD Console. It provides a generaldescription, safety and regulatory information, operating instructions andspecifications concerning the equipment.

This high frequency X-ray Generator is designed for general radiography. Itprovides all the advantages of high frequency waveform Generators includinglower patient dose, shorter exposure times and greater accuracy andconsistency.

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

All functions, displays and controls are logically arranged, easily accessibleand identified to prevent confusion. Technique factors and functions areselectedby touchsensitivepush-buttonsanddisplayedon theControlConsole.

Illustration 1-1RAD Console


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The Generator consists of the following essential parts:

• Control Console, operator controls and displays for radiographicoperations. The Console is designed for ease of operation. It is theinterface with the Power Cabinet and other related X-ray systems.

• Power Cabinet, that comprises:

G Power Module, which contains the power and controlcomponents.

G High Voltage Transformer.

1.1 GENERAL FEATURES

The main features of this high frequency Generator are:

• Constant potential high frequency, operating on three phase and singlephase lines.

• Three point control by selecting kVp,mAandExposure time, or two pointcontrol by selecting kVp and mAs, or one point control by selecting kVpwith AEC operations.

• Two Buckys can be directly connected to the Generator (standard).

• Self-diagnosis indicators identify malfunctions in the system.

• 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.

• Automatic line voltage compensation due to closed loop operation ofX-ray Tube current and kVp.

• Independent Heat Unit storage for each X-ray Tube, even after turningOn / Off the equipment.


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1.2 OPTIONS

In addition to the features described above, the Generator can be configuredwith the following options:

• Anatomical Programmer (APR) for six patient sizes (three adults andthree children), with pre-programmed anatomical views for automaticselection. The operator may introduce modifications manually in all theoriginal APR techniques and store them for later use.

• Automatic Exposure Control (AEC),which accommodates most popularexposure detectors. A total of up to four detectors (Ionization or SolidState types) can be installed on the system. Each one can beindependently calibrated.

• Third / Fourth Bucky, this option allows to connect of up to four Buckysto the Generator.

• Tomography, an adaptation to interface with the Tomo device.

• Second X-ray Tube, which extends the system for using two X-rayTubes.

• High Speed Rotor Controller, an optional digital controller consisting ofa module which is fitted within the Power Cabinet.

1.3 PRODUCT IDENTIFICATION

The major items in the Generator have some identification labels attached tothem which provide the following manufacturer and product information.

• Product.

• Model.

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

• Date of manufacture.

• Serial number.

• Reference.

• Manufacturer.

• Place of manufacture

• Certification.


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1.4 CERTIFICATIONS

The X-ray Unit covered by this Operation Manual is authorized to be markedwith CE MARKING in accordance with the provisions of the Council Directive93 / 42 / EEC concerning Medical Devices.

1.5 CLASSIFICATION

The X-ray Generator 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 withair 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.

• Permanently Installed Equipment.


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OM-0246R2 5

SECTION 2 SAFETY

2.1 GENERAL

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

For continue safe use of this equipment follow theinstructions in this Operating Manual. Study this manualcarefully before using the equipment and keep it at hand forquick reference.

THE EQUIPMENT DESCRIBED IN THIS MANUAL MUST BEONLY HANDLE BY QUALIFIED PERSONNEL PREVIOUSLYTRAINED IN IT.

X-RAYEQUIPMENT ISDANGEROUSTOBOTHPATIENT ANDOPERATOR UNLESS PROTECTION MEASURES ARESTRICTLY OBSERVED.

IT IS VITALLY IMPORTANT THAT EVERYONE ASSOCIATEDWITH X-RAY RADIATION IS FAMILIAR WITH THE SAFETYAND REGULATORY INSTRUCTIONS CONTAINED WITHINTHIS MANUAL, IN PARTICULAR, THE STATEMENT AT THEBEGINNING OF THIS MANUAL ENTITLED “IMPORTANT!...X-RAY PROTECTION”.

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

Although X-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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2.2 RESPONSIBILITIES

ENSURE THATALLPERSONNELAUTHORIZED TOUSETHEEQUIPMENT ARE AWARE OF THE DANGER OF EXCESSIVEEXPOSURE TO X-RAY RADIATION.

THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THEUNDERSTANDINGTHEMANUFACTURER, ITSAGENTS,ANDREPRESENTATIVES ARE NOT LIABLE FOR INJURY ORDAMAGE WHICH MAY RESULT FROM OVEREXPOSURE OFPATIENTS OR PERSONNEL TO X-RAY RADIATION.

THE MANUFACTURER DOES NOT ACCEPT ANYRESPONSIBILITY FOR OVEREXPOSURE OF PATIENTS ORPERSONNEL TO X-RAY RADIATION GENERATED BY THISEQUIPMENT WHICH IS A RESULT OF POOR OPERATINGTECHNIQUES OR PROCEDURES.

NO RESPONSIBILITY WILL BE ASSUMED FOR ANYEQUIPMENT THAT HAS NOT BEEN SERVICED ANDMAINTAINED INACCORDANCEWITHTHEMANUFACTURERINSTRUCTIONS, OR WHICH HAS BEEN MODIFIED ORTAMPERED WITH IN ANY WAY.

IT IS THERESPONSIBILITYOF THEOPERATOR TOENSURETHE SAFETY OF THE PATIENT WHILE THE X-RAYEQUIPMENT IS IN OPERATION BY VISUAL OBSERVATION,PROPERPATIENTPOSITIONING,ANDUSEOFTHEDEVICESTHAT ARE INTENDED TO PREVENT PATIENT INJURY.

ALWAYS WATCH ALL PARTS OF THE SYSTEM TO VERIFYTHAT THERE IS NO INTERFERENCE AND NO POSSIBILITYOF COLLISION WITH THE PATIENT OR WITH OTHEREQUIPMENTS.

SHOULD ANY INTERFERENCE (EMC) BE DETECTED WITHOTHER EQUIPMENT, PLEASE POSITION OTHEREQUIPMENT AWAY FROM THIS ONE.


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2.3 MAXIMUM PERMISSIBLE DOSE (MPD)

Various studies of the effects of X-ray radiation have provided a foundation forestablishing the Maximum Permissible Dose (MPD) of X-ray radiation. Theresults of these studies have been used by the ICRP to developrecommendations for MPD. These limits are certainly not easy to define andfrom time to time must be updated as new information becomes available.

For occupational exposures, the ICRP recommends that theMPDaccumulatedshould not exceed of the following limits:

• Annual effective dose 50 mSv

• Annual dose for the lens of the eye 150 mSv

• Annual dose for all other areas 500 mSv(i.e. red bone marrow, breast, lung,gonads, skin, and extremities)

2.4 RADIATION PROTECTION

Becauseexposure toX-ray radiationmaybedamaging tohealth, usegreat caretoprovideprotectionagainst exposure to theprimary beam. Someof theeffectsof X-ray radiation are cumulative and may extend over a period of months oryears. The best safety rule for X-ray operator is “Avoid exposure to the primarybeam at all times”.

Any object in the path of the primary beam produces secondary (scattered)radiation. The intensity of the secondary radiation is dependent upon theenergy and intensity of the primary beam and the atomic number for the objectmaterial struck by the primary beam. Secondary radiation may be of greaterintensity than that of the radiation reaching the film. Take protective measuresto safeguard against it.

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. The lead screen should contain aminimumof 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 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 of personnel to determine theamount of radiation towhich theyhavebeen 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.

Themost effectivemethod of determiningwhether 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 type-B ( ) in accordance with IEC 60601-1.

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

ACCORDING TO MDD/93/42/CEE, THIS UNIT IS EQUIPPEDWITH EMC FILTERS. THE LACK OF THE PROPERGROUNDING MAY PRODUCE ELECTRICAL SHOCK TO THEUSER.


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SECTION 3 OPERATING CONTROLS

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

Use the operating controls as described in this manual, any otherno-indicated combinationmay cause an incorrect operation of theequipment.

Illustration 3-1Rad Console

8. Film / Screen Combination9. AEC Reset10. Patient Size Selection (APR)11. Body Regions / Anatomical View Selection (APR)12. Self-Diagnosis Indicator13. Exposure Indicators

1. Power On2. Power Off3. Workstations Selection4. Focal Spots Indicators5. Radiographic Values6. AEC Density Values7. AEC Field Selection

12

3

5

11

12

9

7

8

4

10

12

6

11

13

Note .


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3.1 RADIOGRAPHY AND GENERAL CONTROLS

3.1.1 POWER ON / OFF

ON: The Generator is turned ON by pressing this push-button. This starts apower-up routine which is shown on the Console (a.e. P05.3 = Vers.5, Rev.3).After the power-up routine the last workstation used will be automaticallyselected.

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

For Generators equipped with “High Speed Rotor Controller”, if the X-ray Tubeis rotating when pressing the “OFF” push-button, the Generator will stop theanode immediately and then the unit will be turned off (approx. 3 seconds). Theequipment only turns off if “Preparation” is not activated.

IN THE EVENT OF AN EMERGENCY, ISOLATE THE X-RAYGENERATOR FROM THE MAINS POWER BY FORCIBLYDEPRESSING THE X-RAY ROOM “EMERGENCY OFFSWITCH” (USUALLYAREDMUSHROOM-SHAPEDSWITCH).

THIS SWITCH SHOULD BE LOCATED ON OR NEAR TO THEX-RAY ROOM MAINS POWER PANEL, USUALLY PLACEDNEAR TO THE GENERATOR CONTROL CONSOLE. MORETHANONEOFTHESESWITCHESMAYBEPLACEDAROUNDTHE ROOM FOR GREATER ACCESSIBILITY.

3.1.2 WORKSTATIONS SELECTION

The workstations are configured according to the customer preferences duringthe installation procedure. The following push-buttons select their respectiveworkstation (illuminated push-buttons).

If a push-button is not configured during the installation, the respectivepush-button(s) can not be selected during operation.


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Note in the following table the configuration of the Workstation assigned foreach push-button.

PUSH-BUTTONS WORKSTATION (Tube, Bucky, etc.)

1

+1 1

+1 2

+1

2

+2 1

+2 2

+2

Note.-- Workstation data such as X-ray Tube, Bucky, Tomo, Fluoro, Spot Film, Cine, DSI, DSA, Ion Chambers, etc... must beregistered.

3.1.3 FOCAL SPOT INDICATORS

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

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

The Focal Spot is automatically selected according to the mAstation. ThemAstation set for theFocal Spot change is configuredby the field engineer during the installation.

The Focal Spot may also be selected (keeping kV andmAs constant) pressing:

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

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

ConstantmAs set themaximummAavailable and theminimumexposure time.

The Focal Spot change can be done whenever the presentconditions of the X-ray Tube allow it.

Note .

Note .

kV

mAs

mA

s


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3.1.4 RADIOGRAPHIC PARAMETERS

kV DISPLAY can show:

• The radiographic kV value selected for the technique.

• TheactualX-rayTubeheat unit valueafter pressing the “On” push-button(Refer to Section 3.5).

• The error messages during a system fault, preceded by the letter “E”(a.e., E02) (Refer to Section 3.8).

mAs DISPLAY can show:

• The radiographic mAs value selected for the technique.

• When an exposure ismadewith AEC, it shows the actual mAs at the endof the exposurewhenever the “Prep” push-button has 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 radiographic 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 3.6).


Operation

OM-0246R2 13

INCREASE / DECREASE: Radiographic technique values are increased ordecreased by pressing the respective push-buttons. The values increase ordecrease step-by-step each time the corresponding push-button is pressed,and changes faster when either of them is pressed continuously.

• kV: 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 6 for Factor ranges)

If after pressing any of these push-buttons, the technique value isblocked and an acoustic signal is emitted it could mean that:

Radiographic Parameters Blockage. When any of themaximum orminimum radiographic parameter limit is reached, itsrelated Display blinks.

Generator Power Limit. If the power limit (kV x mA) is reachedby increasing the mA up to a maximum possible value, the mAvalue is blocked. Flashing values on kV andmADisplays will alertoperator about the situation.

If required, kV could be increased up to its maximum value whilemA value may automatically decrease, as long as mAs value iskept the same.

Space Charge. If a variation of the kV or mA induces to reachspace charge limit in the selected Tube, the parameter is blocked,and flashing value on the kV Display will alert operator about thesituation.

Maximum Energy (60 kJ). If a variation of the parametersinduces to exceed the maximum energy allowed for the X-rayTube (60kJ), theparameter is blocked. Flashing valuesonkVandmAs Displays will alert operator about the situation.

X-ray Tube Ratings or X-ray Tube Overheating. If a techniquereaches the X-ray Tube ratings limit or the X-ray Tube ismomentarily overheated, some technique could not be selected.Flashing values on the kV / mAs Displays will alert operator aboutthe situation.

Note .


Operation

OM-0246R214

3.2 AUTOMATIC EXPOSURE CONTROL (AEC)

Automatic Exposure Control (AEC) produces consistent film density withexcellent contrast regardless of the radiographic technique selected. The AECmodule comprises the controls for the selection of theExposureDetector Fields(Ion Chamber), the Film/Screen Combination, FilmDensity Compensation andAEC Reset.

TheAECmode is selectedbypressinganyof the threeAECFieldpush-buttons.To exit the AEC mode, press all the illuminated AEC Field push-buttons untilnone 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 at a greatervalue than the previously considered for the exposure time (ormAs). A value above 50% of the considered value is therecommended. Very extreme values of back-up time (or mAs)should be avoided to prevent patient from excessive exposurewhen a control error is produced.

FIELD SELECTION: Each push-button indicates its related physical locationof the selected field in the AEC Exposure Detector, and it may be selected ordeselected by pressing it. Any combination of fields can be selected and thepush-buttons illuminate when active.

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

DENSITY: These push-buttons are used to adjust the radiographic filmdensity.Normal film density (0) is the automatic default value when AEC is selected.

Film density can be proportionally increased or decreased in steps. Thevariation percentage density between steps can be changed during theequipment calibration by the engineer according to customer preferences (thepercentage by default is 25%).

Note .


Operation

OM-0246R2 15

AECRESET: If the exposure is aborted by theAECback-up timer, the indicatoron the “AECReset” push-button blinks accompanied of an audible alarm. Nextexposure is inhibiteduntil theAEC function is reset by pressing the “AECReset”push-button. When the Generator is in “Prep”mode, the AEC function can notbe reset.

The “AECReset” push-buttonmay blink when the kVp value, AECDensity andFilm / Screen Combination select a technique that is out of the operative rangewithAEC, it inhibits the next exposure. Changeany parameter (kVp value,AECDensity or Film / Screen Combination) in order to obtain a technique enabledfor AEC.

3.3 ANATOMICAL PROGRAMMER (APR)

Anatomical Programmer (APR) module is comprised of the controls whichselect thePatientSizeandDisplaySelectors. Theprocess is shownon theAPRDisplay.

The APR techniques are factory pre-programmed according to differentstandard technique sets in a X-Y matrix format that combines eight BodyRegions (Y-axis) with eight Anatomical Views (X-axis). Besides theradiographic parameters, selections of the workstation or AEC (density, fieldsand film / screen combination) can be assigned to the APR techniques. Theseselections will be always common for all the patient sizes of each AnatomicalView. These techniques may be modified and stored anew into non-volatilememory by the operator.

The APR techniques are intended as a guide line only. Accurate exposurefactors are dependent among other things on Bucky grid factors, table topabsorption, screen film combinations and film processing.

TheAPR is activatedwhenoneof the threePatientSize (small,mediumor largesize) is selected (push-button lighted), and it is deactivatedwhen all of themaredeselected.

APR language may be changed, just after selecting one of thepatient size (APR activation), pressing the “Power ON”push-button. Language selected remains stored even after theequipment is turned Off. (Only for Generators equipped with thisoption).

If an APR technique is to be stored with AEC parameters, asuitable back-up time (and/or mAs) MUST be stored in theprogramme by the operator.

Note .

Note .


Operation

OM-0246R216

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 (one onlyilluminated when selected). The left-hand paediatric push-button changes thefunction of the right-hand three push-buttons from adult patient size topaediatric patient size. (In this mode, the paediatric push-button and one of theother three buttons may be illuminated at the same time).

ANATOMICAL VIEW SELECTORS: Each push-button is related with thenearest areaof theAPRDisplay and theyareused to select oneof thedisplayedBody Regions and Anatomical Views.

The APR Display shows the following Body Regions: “Skull”, “Facial”, “UpperTrunk”, “Lower Trunk”, “Chest”, “Extremity on Bucky”, “Extremity on Table Top”and “Special”.When aBodyRegion has been selected, theAPRDisplay showsdirectly all its respective Anatomical Views. In some cases an Anatomical Viewmay show a sub-menu with its respective Anatomical Views. (Refer toTable 3-1).

When the APR selection is finished, the APRDisplays shows the final selection(Body Region and Anatomical View) and the Console indicates the respectiveposition, the AEC selections and the technique parameters.

Press on the push-buttons related to the final Body Region and/or AnatomicalView selection showed on the APR Display, to go back to the previousAnatomical Views level or to the Body Regions level.


Operation

OM-0246R2 17

Table 3-1APR Matrix (English)

APR MATRIXANATOMICAL VIEWS

APR MATRIXView-1 View-2 View-3 View-4 View-5 View-6 View-7 View-8

SKULL AP / PA LATERAL TOWNES MASTOIDMASTOIDLATERAL

TEMPORO-MANDIBULAR

JOINT

SELLATURCICA

AP

SELLATURCICALATERAL

FACIAL AP / PA LATERAL WATERSZYGOMAARCH

OPTICFORAMINA

MANDIBLELATERAL STENVERS LAW’S

UPPER TRUNK CERVICALAP

CERVICALLATERAL

THORACICAP

THORACICLATERAL

THORACICSWIMMER

SCAPULALATERAL SHOULDER CLAVICLE

LOWER TRUNK LUMBARAP

LUMBARLATERAL

PELVISAP

SACRUMAP

SACRUMLATERAL

ABDOMENAP

ABDOMENLATERAL

PELVI-METRY

CHEST AP / PA LATERAL 60” CARTUPPERRIBS

LOWERRIBS STERNUM

STERNUMLATERAL LORDOTIC

EXTREM BUCKY HIP AP HIP FROG FEMURKNEEAP

KNEELATERAL

KNEEAXIAL HUMERUS

HUMERUSTRANS-

THORACIC

EXTREM TBL TOP HAND WRIST FOREARM ELBOW FOOT ANKLE TIBIA KNEE

SPECIAL TOMO AUXCHANGER

1CHANGER

2 USER-1 USER-2 USER-3 CONTRAST

SUB-MENU OFEXTREME TBL

ANATOMICAL VIEWSEXTREME TBLTOP View-1 View-2 View-3 View-4 View-5 View-6 View-7 View-8

HAND PA LATERAL OBLIQUE FINGERS -- -- -- --

WRIST PA LATERAL OBLIQUE -- -- -- -- --

FOREARM PA LATERAL OBLIQUE -- -- -- -- --

ELBOW PA LATERAL AXIAL -- -- -- -- --

FOOT PA LATERAL OBLIQUE TOES -- -- -- --

ANKLE PA LATERAL OBLIQUE -- -- -- -- --

TIBIA PA LATERAL OBLIQUE -- -- -- -- --

KNEE PA LATERAL AXIAL -- -- -- -- --

SUB-MENU OF ANATOMICAL VIEWSSUB-MENU OFSPECIAL View-1 View-2 View-3 View-4 View-5 View-6 View-7 View-8

CONTRAST GALLBLADDER

STOMACHAP

STOMACHLATERAL COLON

AIRCONTRAST IVP ESOPH 40 ESOPH 72


Operation

OM-0246R218

Table 3-1 (cont.)APR Matrix (Spanish)

MATRIZ DEL APRVISTAS ANATOMICAS

MATRIZ DEL APRVista-1 Vista-2 Vista-3 Vista-4 Vista-5 Vista-6 Vista-7 Vista-8

CRANEO AP / PA LATERAL TOWNES MASTOIDES MASTOIDESLATERAL

ARTICULAC.TEMPORO-MANDIBULAR

SILLATURCAAP

SILLATURCALATERAL

CARA AP / PA LATERAL SENOSWATERS

ARCOCIGOMATICO

AGUJEROSOPTICOS

MANDIBULALATERAL

STENVERS LAW’S

TRONCOSUPERIOR

CERVICALAP

CERVICALLATERAL

DORSALAP

DORSALLATERAL

CERVICO--DORSAL

ESCAPULALATERAL

HOMBRO CLAVICULA

TRONCOINFERIOR

LUMBARAP

LUMBARLATERAL

PELVISAP

SACROAP

SACROLATERAL

ABDOMENAP

ABDOMENLATERAL

PELVI-METRIA

PECHO AP / PA LATERAL 60” CART COSTILLASSUPERIOR

COSTILLASINFERIOR

ESTERNON ESTERNONLATERAL

LORDOTIC

EXTREMIDADESSOBRE BUCKY

CADERAAP

CADERAFROG

FEMUR RODILLAAP

RODILLALATERAL

RODILLAAXIAL

HUMEROHUMEROTRANS-

TORACICA

EXTREMIDADESSOBRE TABLERO

MANO MUÑECA ANTEBRAZO CODO PIE TOBILLO TIBIA RODILLA

ESPECIAL TOMO AUXILIAR CAMBIADOR1

CAMBIADOR2

USUARIO-1 USUARIO-2 USUARIO-3 CONTRASTE

SUB-MENUEXTREMIDAD

VISTAS ANATOMICASEXTREMIDADSOBRE TABLERO Vista-1 Vista-2 Vista-3 Vista-4 Vista-5 Vista-6 Vista-7 Vista-8

MANO PA LATERAL OBLICUO DEDOS -- -- -- --

MUÑECA PA LATERAL OBLICUO -- -- -- -- --

ANTEBRAZO PA LATERAL OBLICUO -- -- -- -- --

CODO PA LATERAL AXIAL -- -- -- -- --

PIE PA LATERAL OBLICUO DEDOS -- -- -- --

TOBILLO PA LATERAL OBLICUO -- -- -- -- --

TIBIA PA LATERAL OBLICUO -- -- -- -- --

RODILLA PA LATERAL AXIAL -- -- -- -- --

SUB-MENUVISTAS ANATOMICAS

SUB-MENUESPECIAL

Vista-1 Vista-2 Vista-3 Vista-4 Vista-5 Vista-6 Vista-7 Vista-8

CONTRASTE VESICULABILIAR

ESTOMAGOAP

ESTOMAGOLATERAL COLON CONTRASTE IVP

ESOFAGO40”

ESOFAGO72”


Operation

OM-0246R2 19

Table 3-1 (cont.)APR Matrix (French)

MATRICE APRVUES ANATOMIQUES

MATRICE APRVue-1 Vue-2 Vue-3 Vue-4 Vue-5 Vue-6 Vue-7 Vue-8

CRANE AP / PA LATERAL TOWNES MASTOIDE MASTOIDELATERAL

ARTICULAT.TEMPOROMAXILAIRE

SELLETURCIQUE

AP

SELLETURCIQUELATERAL

FACIAL AP / PA LATERAL SINUSWATERS

ARCADEMALAIRE

ORIFICEOCULAIRE

MAXILAIRELATERAL

STENVERS LAW’S

TRONCSUPERIEUR

CERVICALAP

CERVICALLATERAL

THORACIQUEAP

THORACIQUELATERAL

THORACIQUESWINNER

OMOPLATELATERAL

EPAULE CLAVICULE

TRONCINFERIEUR

LOMBAIREAP

LOMBAIRELATERAL

BASSINAP

SACRUMAP

SACRUMLATERAL

ABDOMENAP

ABDOMENLATERAL

PELVI-GRAPHIE

POITRINE AP / PA LATERAL 60”CARTILAGE

COTESSUPERIEUR

COSTESINFERIEUR

STERNUM STERNUMLATERAL

LORDOTIQUE

EXTREMITESBUCKY

HANCHEAP

HANCHEOB

FEMUR GENOUAP

GENOULATERAL

GENOUAXIAL

HUMERUSHUMERUSTRANS-

THORACIQUE

EXTREMITESTABLE

MAIN POIGNET AVANT BRAS COUDE PIED CHEVILLE TIBIA GENOU

SPECIAL TOMOGRAPH AUXILIAIRE CHANGEUR1

CHANGEUR2

UTILISATEUR1

UTILISATEUR2

UTILISATEUR3

CONTRASTE

SUB-MENUEXTREMITES

VUES ANATOMIQUESEXTREMITESTABLE Vue-1 Vue-2 Vue-3 Vue-4 Vue-5 Vue-6 Vue-7 Vue-8

MAIN PA LATERAL OBLIQUE DOIGTS -- -- -- --

POIGNET PA LATERAL OBLIQUE -- -- -- -- --

AVANT BRAS PA LATERAL OBLIQUE -- -- -- -- --

COUDE PA LATERAL AXIAL -- -- -- -- --

PIED PA LATERAL OBLIQUE ORTEILS -- -- -- --

CHEVILLE PA LATERAL OBLIQUE -- -- -- -- --

TIBIA PA LATERAL OBLIQUE -- -- -- -- --

GENOU PA LATERAL AXIAL -- -- -- -- --

SUB-MENUSPECIAL

VUES ANATOMIQUESSPECIAL --CONTRASTE Vue-1 Vue-2 Vue-3 Vue-4 Vue-5 Vue-6 Vue-7 Vue-8

CONTRASTE VESICULEBILIAIRE

ESTOMACAP

ESTOMACLATERAL COLON

CONTRASTEAIR IVP

OESOPHAGE40”

OESOPHAGE72”


Operation

OM-0246R220

Table 3-1 (cont.)APR Matrix (German)

APR MATRIZEANATOMISCHE SICHT

APR MATRIZESicht-1 Sicht-2 Sicht-3 Sicht-4 Sicht-5 Sicht-6 Sicht-7 Sicht-8

SCHÄEDEL AP / PA SEITLICH TOWNES MASTOID MASTOIDSEITLICH

CONDYLUS SELLAAP

SELLASEITLICH

GESICHT AP / PA SEITLICH WATERS JOCHBEIN OPT--ÏFFN UKIEFERS STENVERS LAW’S

OBERER RUMPF ZERVIKALAP

ZERVIKALSEITLICH

BWSAP

BWSSEITLICH

BWSDORSAL

SCAPULASEITLICH

SCHULTER SCHLOSBN

UNTERER RUMPF LENDEMAP

LENDEM-SEITLICH

BECKENAP

SAKRUMAP

SAKRUMSEITLICH

ABDOMENAP

ABDOMENSEITLICH

BECKENMASS

BRUST AP / PA SEITLICH 60” KAR UNTERERRIPPEN

OBERERRIPPEN

STERNUM STERNUMSEITLICH

LORDOTIC

EXTREMITÄTENBUCKY

HUEFTEAP

HUEFTEOB

SCHENKEL KNIEAP

KNIESEITLICH

KNIEAXIAL

OBERARM-BEIN

OBERARM-BEIN

TRANS-BRUST

EXTREMITÄTENOBERTISCH

HAND HAND--GELENK

UNTERARM ELLBOGEN FUSS KHÏCHEL TIBIA KNIE

SPEZIAL TOMO HILFS WECHSL 1 WECHSL 2 BENUTZ-1 BENUTZ-2 BENUTZ-3 KONTRAST

UNTER-SPEISEKARTE

ANATOMISCHE SICHTSPEISEKARTEEXTREMITÄTENOBERTISCH Sicht-1 Sicht-2 Sicht-3 Sicht-4 Sicht-5 Sicht-6 Sicht-7 Sicht-8

HAND PA SEITLICH SCHEIF FINGER -- -- -- --

HANDGELENK PA SEITLICH SCHEIF -- -- -- -- --

UNTERARM PA SEITLICH SCHEIF -- -- -- -- --

ELLBOGEN PA SEITLICH AXIAL -- -- -- -- --

FUSS PA SEITLICH OBLIQUE ZEHE -- -- -- --

KHÏCHEL PA SEITLICH SCHEIF -- -- -- -- --

TIBIA PA SEITLICH SCHEIF -- -- -- -- --

KNIE PA SEITLICH AXIAL -- -- -- -- --

UNTER-SPEISEKARTE

ANATOMISCHE SICHTSPEISEKARTESPEZIAL --KONTRAST Sicht-1 Sicht-2 Sicht-3 Sicht-4 Sicht-5 Sicht-6 Sicht-7 Sicht-8

KONTRAST GALLENBLASE MAGEN AP

MAGENSEITLICH KOLON

LUFTKON-TRASTE IVP

SPEIROH40”

SPEIROH72”


Operation

OM-0246R2 21

Table 3-1 (cont.)APR Matrix (Russian)


Operation

OM-0246R222

APR TECHNIQUE CHANGES

The APR techniques are factory pre-programmed to standard technique sets.All parameters of the APR techniques may be manually modified by theoperator 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. Simultaneously press the push-buttons 2--6 of the APR Display to storethe new technique. (Refer to Illustration 3-2.)

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

This procedure only changes the technique values of the selectedpatient size, repeat the procedure for other patient sizes.

Illustration 3-2APR Storage Push-buttons

APR Storage Push-buttons

3

2

4 8

7

6

51

Note .


Operation

OM-0246R2 23

3.4 EXPOSURE CONTROLS AND INDICATORS

Radiographic exposures from the Control Console are made with the “Prep”(preparation) and “Expose” (X-ray exposure) handswitch. The status of theexposure is indicated by the “Ready” and “X-ray On” indicators for the durationof the exposure.

Tomographic exposures controlled from theGenerator are performed also withthe Handswitch.

PREP:Press the handswitch half-way (”Prep” position) to prepare the selectedX-ray Tube for exposure. The “Ready” indicator on the Console will light whenthe X-ray Tube is prepared and there are no interlock failure or system faults.

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

• Anode rotation.

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

Press “Prep” only when the technique has been selected on theConsole and the Patient is ready for the exposure. The HighSpeed Generators can be configured so that the anode remainsrunning for approximately one minute when “Prep” is pressedthree consecutive times in a minute.

EXP: After the “Ready” indicator is illuminated,fully press the handswitch tostart aX-ray exposure. If thebutton is releasedbefore theGenerator completesthe selected time or the AEC time, the exposure will be prematurely terminatedand the actual mAs and Exposure Time will be displayed.

The “X-ray On” indicator remains illuminated during the length of exposure.

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-RAYON: Indicates that the X-ray exposure is in progress. At the same timethat radiographic exposures are being made, an audible signal sounds.

Prep

OFF

Exp

Note .


Operation

OM-0246R224

3.5 HEAT UNITS

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

To view the remaining Heat Units, press the “On” push-button. The kVpDisplayshows the percentage of Heat Units that remain preceded by the letter “H”. Forexample, a display of “H75” would indicate that 75% of Heat Units capacity oftheX-ray Tube remains. “H -- -- ” indicates that all the capacity remains. The kVpDisplay reverts to its normal function after releasing the “On” push-button.

3.6 EXPOSURE COUNTERS

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

RAD EXPOSURESIN TUBE-1

Press and hold and press once

RAD EXPOSURESIN TUBE-2

Press and hold and press once

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

= 123.456 exposures

kV mAs


Operation

OM-0246R2 25

3.7 SELF-DIAGNOSIS INDICATORS

Self-Diagnosis indicators identify a malfunction in the system alerting operatorabout error existence that inhibits exposure. During normal operation of thesystem, these indicators are directly shown on the APR Display or as an errorcode on the kV Display. (Also refer to Section 3.8).

ERROR INDICATOR: Lights when a malfunction is detected in the system,alerting the operator that one of the following error exists preventing X-rayexposures. This indicator is shown on the Console.

DOOROPEN: Indicates theX-ray roomdoor is openwhen theX-ray equipmentis in use.

GENERATOR OVERLOAD: Indicates that the exposure has been interruptedbecause during exposure has been produced arcing or bad function on the HVcircuitry (X-ray Tube, HV Transformer and/or HV Cables) or a failure of IGBTmodule (overheated or defective IGBTs) has been detected.

It can be also shown making a high power and long exposure with the X-rayTube cool (X-ray Tube has not been warmed-up).

TUBE OVERLOAD: Indicates that either the technique selected is beyond theX-ray Tube ratings or the present conditions of the X-ray Tube inhibit theexposure (anode overheated). Parameters for next exposure may betemporally limited by theGenerator (change the exposure values or wait for theX-ray Tube to cool).

Check that heat units available are lower than the calculated for the nextexposure (heat units close to zero). Reduce exposure factors or wait for theX-ray Tube to cool. (To display the Heat Units refer to Section 3.5).

ROTOR ERROR: Indicates that the X-ray Tube anode is not rotating while“Prep” is active, then exposures are inhibited.

HEAT: Indicates that the X-ray Tube thermostat / pressurestat is open due tooverheating of theTubehousing (housing is too hot,wait for the housing to cool)or to a thermostat / pressurestat mal-function (housing is cool). Heat units mayraise to any value.

DOORDOOR

G.OVL

T.OVL

ROTOR

HEAT


Operation

OM-0246R226

TECHNIQUE ERROR: If activates during exposure it means that:

The exposure has been interrupted by “Security Timer”because of a failure in the system. Call Field Service.

This error can also be shown:

• after an APR technique selection to advise that exposure parametersdisplayed on the Console are not the values stored for this APRtechnique. Exposure parameters are adapted by the Generator toanother enable values.

• if a failure on the Automatic Collimator has been detected (blades are fullopen or in movement during exposure, etc.). In this case the indicatorlight will blink.

3.8 ERROR CODES

Error codes indicate the potential cause of a system failure. Error codes areshown on the kVp Display at the same time an audio signal is emitted. Correctthe error cause and keep pressed the “AECReset” push-button till the Consoleindication disappears. (Refer to Table 3-2).

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.

TECH


Operation

OM-0246R2 27

Table 3-2Error 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.T th G t OFF d ON

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 during exposure has been producedarcing or bad function on the HV circuitry (X-ray Tube, HVTransformer and/or HV Cables) or a failure of IGBT module(overheated or defective IGBTs) has been detected.

It can be also shown making a high power and longexposure with the X-ray tube cool (X-ray Tube has not beenwarmed-up).

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. Press the “AEC Reset” push-button.Repeat with same technique values, If the error code persists try with

E13 No kV during exposure or kV value is out of range.

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 rotating 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.

E21, E22 Incorrect selection of the X-ray Tube.Press the “AEC Reset” push button

E23 System failure.Press the “AEC Reset” push-button.If the error code persists, turn the Generator OFF and ON.

O SE24 Bucky not ready for an exposure.

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


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Table 3-2 (cont.)Error Codes

ERROR DESCRIPTION WHAT TO DO

E25Battery Fault. The batteries charge level is momentarilylow, or some batteries are discharged or damaged. (Only inGenerators working with batteries).

Press the “AEC Reset” push-button.Wait 5 minutes before making a new 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.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.

E33 Serial Communication error.

Press the “AEC Reset” push-button.Check that communication cable between Generator and console isproperly connected.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 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 technique selection to advise that exposureparameters displayed on the console are not the valuesstored for this APR technique. Exposure parameters areadapted by the Generator to another enable values.-- after the “ABC” push-button selection, when ABC is notenable.

E35Door Open error. The X-ray room door is open when theX-ray equipment is in use. These errors do not require to press the “AEC Reset” push-button, theirs

i dicatio s disappea a to aticall

E36

Heat Units error. The X-ray Tube thermostat / pressurestatis open due to the tube housing is overheated (housing istoo hot, wait for the housing to cool) or a thermostat /pressurestat mal-function (housing is cool). Heat units mayraise to any value.

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.

E41 to E46 System failure related to Dosimeter.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.

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 Capacitor charging before activating “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 full open or in movement duringexposure, etc. ) Press the “AEC Reset” push-button.

If the error code persists turn the Generator OFF and ONE50 Exposure has been aborted by the Operator.

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

E51 to E93 System failure related to High Speed Rotor Controller.

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, E97System failure related to Capacitor charge (only forCapacitor Powered Generator).

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.

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


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SECTION 4 OPERATING SEQUENCES

4.1 START-UP ROUTINE

Systempower is appliedbypressing the “PowerOn” push-buttonon theControlConsole. The Generator will go through a start-up routine conducting anautomatic self-test thatwill showon theRADkVDisplay information usable onlyby service 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 kV Display specifying the fault.

Some indicators on the Console are used to provide serviceinformation during the start-up process. These indicators shouldbe ignored by the operator until the unit has completed itspower-up sequence.

4.2 X-RAY TUBE WARM-UP PROCEDURE

Before effecting X-ray exposures ensure that the Tube isproperly warmed-up. Make sure that no persons will beinadvertently exposed to unnecessary X-rays during thisprocedure.

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

It is recommended that the following procedurewill be performed for X-ray Tubewarm-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 theactual Tube in use, comparing its recommendationswith thisprocedure. If there is conflict with this procedure, complywith the Tube manufacturer’s instructions.

Note .


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Perform X-ray Tube warm-up as follows:

• Close the collimator blades fully.

• Select 70 kV, 100 mAs, 200 mA and 500 ms exposure.

• Insure that no one will be exposed.

• Make a total of three exposures, 15 seconds apart.

Excessive filament evaporation shortens X-ray Tube life.Minimize evaporation by keeping Exposure “Preparation”time to an absolute minimum.

4.3 RADIOGRAPHIC OPERATION

RAD operation can be performed in the following modes:

• Three point control by selecting kVp, mA and Exposure Timeindependently.

• Two point control by selecting kVp and mAs independently. mAsselection sets the maximum mA available for the selected Focal Spotand the respective Exposure Time. In this control mode, when kVp valueis increased, the Generator will automatically look for the adequatecombination of mA and Exposure Time factors to avoid the “TubeOverload” warning, keeping constant mAs.

• One point control by selecting kVp with AEC operations.

• Anatomical Programs (APR).


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A typical RAD examination sequence is as indicated below:

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

2. Position the patient for the examination.

3. Select the “workstation”, and technique parameters using the RADcontrols on the Console.

4. Instruct patient tomaintain the required position. Prepare theX-ray Tubeby pressing the handswitch push-button to the “Prep” position andmaintain it until the “Ready” indicator is illuminated.

5. Instruct patient to remain still and to hold his breath as required, thenmake the X-ray exposure by pressing the handswitch push-button fullyto the “Exp” position andmaintain it throughout the exposure. The “X-rayOn” indicator will light and an audible signal will sound during theexposure.

6. When the exposure is finished, release the handswitch push-button.

7. Repeat the procedure if additional exposures are desired.

4.4 AEC OPERATION

The proper use of AEC requires accurate patient positioning. For examinationusing AEC, the operator will need to select the desired AEC parameters asfollows:



3. Select the “workstation” and enter in AECmode by selecting at least oneArea Detector “Field” on the Console.

4. If required, choose another “Film Screen Combination” and adjust the“Film Density” setting (“0” is the normal setting).

5. Select the technique parameters (back-up time / mAs) using the RADcontrols on the Console.

6. Continuewith the radiographic operation. (Refer to Section 4.3 -- step 4.)


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4.5 APR OPERATION

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



3. Select the “Patient Size” corresponding to the patients anatomy. Thisoperation starts the APRmode. Select the “Pediatric” push-button if thepatient is not an adult.

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

5. Technique parameters, Workstation information, Focal Spot, AEC, etc...corresponding to the APR selection are displayed and indicated on theControl Console. If needed, the parameters and selections can bedirectly modified by the operator.

6. Continue with the normal procedure for a typical RAD examination.(Refer to Section 4.3 - step 4.)


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SECTION 5 PERIODIC MAINTENANCE

In order to assure continued safe performance of the X-ray Generator, aperiodic maintenance program must be established. It is the owner’sresponsibility to supply or arrange for this service.

There are two levels of maintenance, the first consists of tasks which areperformed by the user/operator, and the second are those tasks to beperformed by qualified X-ray service personnel.

The first periodicmaintenance service should be performed six (6)months afterinstallation, and the subsequent services at twelve (12) month intervals.

The manufacturer undertakes to have available spare parts for this equipmentat least for five (5) years after the unit manufacturing.

5.1 OPERATOR TASKS

The tasks of this periodic maintenance shall include the following items:

DO NOT REMOVE ANY COVER, DISASSEMBLE ORMANIPULATE INTERNAL COMPONENTS IN THE UNIT.THESE ACTIONS COULD CAUSE SERIOUS PERSONALINJURIES AND / OR EQUIPMENT DAMAGE.

NEVERATTEMPTTOCLEANANYPARTOFTHEUNIT WHENIT ISSWITCHEDON. ALWAYSSWITCHOFFTHEEQUIPMENTAND ISOLATE THE MAINS ELECTRICAL SUPPLY BEFORECLEANING.

1. Switch the Generator OFF.

2. Externally, check the proper cable connections between each majorcomponent in the X-ray system (Power Cabinet, Consoles, etc ... ).

3. Clean the equipment frequently, particularly if corroding chemicals arepresent. Clean external covers and surfaces, specially parts in contactwith patients, with a cloth moistened in warmwater with mild soap.Wipewith a cloth moistened in clean water. Do not use cleaners or solventsof any kind.


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5.2 SERVICE TASKS

Only service personnel specifically trained on this medical X-ray equipmentshould work on service tasks or maintenance of the equipment. (Refer to“Maintenance” document.)


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SECTION 6 TECHNICAL SPECIFICATIONS

6.1 FACTORS

GENERATOR MODEL

FACTORS SHF-310SHF-320SHF-330

SHF-315SHF-325SHF-335



Maximum Power kW 32 kW 40 kW

Maximum mA 400 mA 500 mA

Maximum kVp 125 kVp 150 kVp 125 kVp 150 kVp

Power Output (@ 0.1 s)400 mA @ 80 kVp320 mA @ 100 kVp250 mA @ 125 kVp

400 mA @ 80 kVp320 mA @ 100 kVp250 mA @ 128 kVp200 mA @ 150 kVp

500 mA @ 80 kVp400 mA @ 100 kVp320 mA @ 125 kVp


GENERATOR MODEL

FACTORS SHF-510SHF-520SHF-530


SHF-630 SHF-635 SHF-835

Maximum Power kW 50 kW 64 kW 80 kW

Maximum mA 640 mA 640 mA 800 mA

Maximum kVp 125 kVp 150 kVp 125 kVp 150 kVp 150 kVp

Power Output (@ 0.1 s)640 mA @ 78 kVp500 mA @ 100 kVp400 mA @ 125 kVp


640 mA @ 100 kVp500 mA @ 125 kVp




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6.2 RANGE OF RADIOGRAPHIC PARAMETERS

PARAMETER RANGEPARAMETER RANGE

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

mAFrom 10 mA to 800 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, 640, 800.(Depending on the Generator model)

mAs Product of mA x Time values from 0.1 mAs to 500 mAs (640 mAs on request)

Exposure Time

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.

AECmAs: 0.1mAs to 500 mAs

AECExposure Time: Nominal shortest irradiation Time = 1ms

6.3 DUTY CYCLE

The Generator duty cycle is continuous, but limits should be set duringinstallation depending on the capacity of the X-ray Tube.

6.4 PHYSICAL CHARACTERISTICS

COMPONENTDIMENSIONS

WEIGHTCOMPONENTLength Width Height

WEIGHT

LINE POWERED GENERATORS

Vertical Generator Cabinetwith LF-RAC (LSS) or DRAC (HSS)

506 mm 468 mm 1101 mm 148 kg

Compact Generator Cabinet(for only 1 Tube (LSS))

445 mm 360 mm 568 mm 72 kg

Compact Generator Cabinet(for 1 or 2 Tubes (LSS or HSS))

592 mm 360 mm 690 mm 95 kg

CONTROL CONSOLE

RAD Console Graphic Displaywith Handswitch support 545 mm 290 mm 50 mm 6 kg

RAD Console Graphic Displayw/o Handswitch support 430 mm 290 mm 50 mm 6 kg

Fabricado por:Manufactured by:

SEDECALSociedad Española de Electromedicina y Calidad S.A.

Pelaya, 9. Pol. Ind. Río de Janeiro.Algete - 28110 Madrid - España (Spain)

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

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