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Summary of Contents for Sedecal HF Series
- Page 1 SEDECAL Technical Publication OM-0279R1 Operation HF Series Generators RAD Console...
- Page 2 SHF- -510, SHF- -515, SHF- -520, SHF- -525, SHF- -530, SHF- -535 SHF- -630, SHF- -635, SHF- -835 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)
- Page 3 ¡ 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...
- Page 4 DECLARACION AMBIENTAL SOBRE LA VIDA UTIL DEL EQUIPO O SISTEMA Este equipo o sistema contiene componentes y materiales peligrosos para el medioambiente (tales como tarjetas de circuito impreso, componentes electrónicos, aceite dieléctrico usado, plomo, baterías, etc), los cuales se consideran y son residuos peligrosos al finalizar la vida útil del equipo o sistema, según establecen las normas internacionales, nacionales y locales.
- Page 5 HF Series Generators - - RAD Console Operation REVISION HISTORY REVISION DATE REASON FOR CHANGE MAY 18, 2004 First edition. SEP 27, 2010 Electromagnetic Compatibility (EMC) 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.
- Page 6 HF Series Generators - - RAD Console Operation 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. This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.
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Page 7: Table Of Contents
HF Series Generators - - RAD Console Operation TABLE OF CONTENTS Section Page INTRODUCTION ............ -
Page 8: Section Page
HF Series Generators - - RAD Console Operation Section Page Heat Units ............ -
Page 9: Introduction
HF Series Generators - - RAD Console Operation SECTION 1 INTRODUCTION This manual contains all the information necessary to understand and operate the High Frequency Generators with the RAD Console. It provides a general description, safety and regulatory information, operating instructions and specifications concerning the equipment. -
Page 10: General Features
HF Series Generators - - RAD Console Operation The Generator consists of the following essential parts: Control Console, operator controls and displays for radiographic • operations. The Console is designed for ease of operation. It is the interface with the Power Cabinet and other related X-ray systems. -
Page 11: Options
HF Series Generators - - RAD Console Operation OPTIONS In addition to the features described above, the Generator can be configured with the following options: Anatomical Programmer (APR) for six patient sizes (three adults and • three children), with pre-programmed anatomical views for automatic selection. -
Page 12: Certifications
HF Series Generators - - RAD Console Operation CERTIFICATIONS The X-ray Unit covered by this Operation Manual is authorized to be marked with CE MARKING in accordance with the provisions of the Council Directive 93 / 42 / EEC concerning Medical Devices. -
Page 13: Safety
HF Series Generators - - RAD Console Operation SECTION 2 SAFETY GENERAL Keep this Operating Manual with the equipment at all times and periodically review the Operating and Safety instructions. For continue safe use of this equipment follow the instructions in this Operating Manual. Study this manual carefully before using the equipment and keep it at hand for quick reference. -
Page 14: Responsibilities
HF Series Generators - - RAD Console Operation RESPONSIBILITIES ENSURE THAT ALL PERSONNEL AUTHORIZED TO USE THE EQUIPMENT ARE AWARE OF THE DANGER OF EXCESSIVE EXPOSURE TO X-RAY RADIATION. THE EQUIPMENT HEREIN DESCRIBED IS SOLD WITH THE UNDERSTANDING THE MANUFACTURER, ITS AGENTS, AND... -
Page 15: Máximum Permissible Dose (Mpd)
HF Series Generators - - RAD Console Operation MAXIMUM PERMISSIBLE DOSE (MPD) Before operation, persons qualified and authorized to operate this equipment should be familiar with the Recommendations of the International Commission on Radiological Protection, contained in Annals Number 60 of the ICRP, with applicable National Standards, and should have been trained in use of the equipment. -
Page 16: Monitoring Of Personnel
HF Series Generators - - RAD Console Operation MONITORING OF PERSONNEL Monitoring of personnel to determine the amount of radiation to which they have been exposed provides a valuable cross check to determine whether or not safety measures are adequate. It may reveal inadequate or improper radiation protection practices and potentially serious radiation exposure situations. -
Page 17: Electromagnetic Compatibility (Emc)
HF Series Generators - - RAD Console Operation ELECTROMAGNETIC COMPATIBILITY (EMC) This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause radio frequency interference to other medical or non medical devices and radio communications. To provide reasonable protection against such interference, this product complies with emissions limits for a Group 1, class A Medical Devices Directive as stated in EN 60601--1--2. - Page 18 HF Series Generators - - RAD Console Operation Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers 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.
- Page 19 HF Series Generators - - RAD Console Operation GUIDANCE AND MANUFACTURER’S DECLARATION - - ELECTROMAGNETIC IMMUNITY This X- -Ray Generator is intended for use in the electromagnetic environment specified below. The customer or the user of this X- -Ray Generator should assure that it is used in such an environment.
- Page 20 HF Series Generators - - RAD Console Operation GUIDANCE AND MANUFACTURER’S DECLARATION - - ELECTROMAGNETIC IMMUNITY This X- -Ray Generator is intended for use in the electromagnetic environment specified below. The customer or the user of this X- -Ray Generator should assure that it is used in such an environment.
- Page 21 HF Series Generators - - RAD Console Operation RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE X- -RAY GENERATOR This X- -Ray Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 23: Operating Controls
HF Series Generators - - RAD Console Operation SECTION 3 OPERATING CONTROLS All controls, indicators and displays located on the Control Console are positioned depending upon their functions. Use the operating controls as described in this manual, any other Note no-indicated combination may cause an incorrect operation of the equipment. -
Page 24: Radiography And General Controls
HF Series Generators - - RAD Console Operation RADIOGRAPHY AND GENERAL CONTROLS 3.1.1 POWER ON / OFF ON: The Generator is turned ON by pressing this push-button. This starts a power-up routine which is shown on the Console (a.e. P05.3 = Vers.5, Rev.3). -
Page 25: Focal Spot Indicators
HF Series Generators - - RAD Console Operation Note in the following table the configuration of the Workstation assigned for each push-button. PUSH-BUTTONS WORKSTATION (Tube, Bucky, etc.) Note.- - Workstation data such as X-ray Tube, Bucky, Tomo, Fluoro, Spot Film, Cine, DSI, DSA, Ion Chambers, etc... must be registered. -
Page 26: Radiographic Parameters
HF Series Generators - - RAD Console Operation 3.1.4 RADIOGRAPHIC PARAMETERS kV DISPLAY can show: The radiographic kV value selected for the technique. • The actual X-ray Tube heat unit value after pressing the “On” push-button • (Refer to Section 3.6). - Page 27 HF Series Generators - - RAD Console Operation INCREASE / DECREASE: Radiographic technique values are increased or decreased 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.
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Page 28: Automatic Exposure Control (Aec)
HF Series Generators - - RAD Console Operation AUTOMATIC EXPOSURE CONTROL (AEC) Automatic Exposure Control (AEC) produces consistent film density with excellent contrast regardless of the radiographic technique selected. The AEC module comprises the controls for the selection of the Exposure Detector Fields (Ion Chamber), the Film/Screen Combination, Film Density Compensation and AEC Reset. -
Page 29: Anatomical Programmer (Apr)
HF Series Generators - - RAD Console Operation AEC RESET: If the exposure is aborted by the AEC back-up timer, the indicator on the “AEC Reset” push-button blinks accompanied of an audible alarm. Next exposure is inhibited until the AEC function is reset by pressing the “AEC Reset”... - Page 30 HF Series Generators - - RAD Console Operation APR DISPLAY: Shows the different Body Regions and Anatomical Views available 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.
- Page 31 HF Series Generators - - RAD Console Operation Table 3-1 APR Matrix (English) ANATOMICAL VIEWS APR MATRIX APR MATRIX View-1 View-2 View-3 View-4 View-5 View-6 View-7 View-8 SELLA SELLA TEMPORO- MASTOID SKULL TURCICA TURCICA AP / PA LATERAL TOWNES MASTOID...
- Page 32 HF Series Generators - - RAD Console Operation Table 3-1 (cont.) APR Matrix (Spanish) VISTAS ANATOMICAS MATRIZ DEL APR MATRIZ DEL APR Vista-1 Vista-2 Vista-3 Vista-4 Vista-5 Vista-6 Vista-7 Vista-8 ARTICULAC. SILLA SILLA MASTOIDES CRANEO AP / PA LATERAL TOWNES...
- Page 33 HF Series Generators - - RAD Console Operation Table 3-1 (cont.) APR Matrix (French) VUES ANATOMIQUES MATRICE APR MATRICE APR Vue-1 Vue-2 Vue-3 Vue-4 Vue-5 Vue-6 Vue-7 Vue-8 ARTICULAT. SELLE SELLE MASTOIDE CRANE AP / PA LATERAL TOWNES MASTOIDE TEMPORO...
- Page 34 HF Series Generators - - RAD Console Operation Table 3-1 (cont.) APR Matrix (German) ANATOMISCHE SICHT APR MATRIZE APR MATRIZE Sicht-1 Sicht-2 Sicht-3 Sicht-4 Sicht-5 Sicht-6 Sicht-7 Sicht-8 MASTOID SELLA SELLA SCHÄEDEL AP / PA SEITLICH TOWNES MASTOID CONDYLUS SEITLICH...
- Page 35 HF Series Generators - - RAD Console Operation Table 3-1 (cont.) APR Matrix (Russian) OM-0279R1...
- Page 36 HF Series Generators - - RAD Console Operation 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 the operator and stored in the non-volatile memory for later use.
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Page 37: Exposure Controls And Indicators
HF Series Generators - - RAD Console Operation EXPOSURE CONTROLS AND INDICATORS Radiographic exposures from the Control Console are made with the “Prep” (preparation) and “Expose” (X-ray exposure) push-buttons or with the Handswitch. The status of the exposure is indicated by the “Ready” and “X-ray On”... - Page 38 HF Series Generators - - RAD Console Operation HEAT UNITS This X-ray Generator is equipped with a Heat Unit Calculator. During exposures, the Heat Units are calculated and totalled. To view the remaining Heat Units, press the “On” push-button. The kVp Display shows the percentage of Heat Units that remain preceded by the letter “H”.
- Page 39 HF Series Generators - - RAD Console Operation SELF-DIAGNOSIS INDICATORS Self-Diagnosis indicators identify a malfunction in the system alerting operator about error existence that inhibits exposure. During normal operation of the system, these indicators are directly shown on the APR Display or as an error code on the kV Display.
- Page 40 HF Series Generators - - RAD Console Operation TECHNIQUE ERROR: If activates during exposure it means that: TECH 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 parameters •...
- Page 41 HF Series Generators - - RAD Console Operation Table 3-2 Error Codes ERROR DESCRIPTION WHAT TO DO System failure. This indication may appear together with an -- -- -- -- -- -- Turn the Generator OFF and ON. error on the Console, and indicates that the error is not on Display If the equipment remains inoperative, turn it OFF and call Field Service.
- Page 42 HF Series Generators - - RAD Console Operation Table 3-2 (cont.) Error Codes ERROR DESCRIPTION WHAT TO DO Press the “AEC Reset” push-button. Battery Fault. The batteries charge level is momentarily Wait 5 minutes before making a new exposure. low, or some batteries are discharged or damaged. (Only in If the error code persists, turn the Generator OFF and ON.
- Page 43 HF Series Generators - - RAD Console Operation SECTION 4 OPERATING SEQUENCES START-UP ROUTINE System power is applied by pressing the “Power On” push-button on the Control Console. The Generator will go through a start-up routine conducting an automatic self-test that will show on the RAD kV Display information usable only by service personnel.
- Page 44 HF Series Generators - - RAD Console Operation 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. •...
- Page 45 HF Series Generators - - RAD Console Operation A typical RAD examination sequence is as indicated below: Make sure that the X-ray Tube to be used is properly warmed-up. Position the patient for the examination. Select the “workstation”, and technique parameters using the RAD controls on the Console.
- Page 46 HF Series Generators - - RAD Console Operation APR OPERATION An examination using an APR technique could consist of the following: Make sure that the X-ray Tube to be used is properly warmed-up. Position the patient for the examination. Select the “Patient Size” corresponding to the patients anatomy. This operation starts the APR mode.
- Page 47 HF Series Generators - - RAD Console Operation SECTION 5 PERIODIC MAINTENANCE In order to assure continued safe performance of the X-ray generator, a periodic maintenance program must be established. It is the owner’s responsibility to supply or arrange for this service.
- Page 48 HF Series Generators - - RAD Console Operation SERVICE TASKS Only service personnel specifically trained on this medical X-ray equipment should work on service tasks or maintenance of the equipment. (Refer to “Maintenance” document.) OM-0279R1...
- Page 49 HF Series Generators - - RAD Console Operation SECTION 6 TECHNICAL SPECIFICATIONS FACTORS GENERATOR MODEL GENERATOR MODEL SHF-210 SHF-215 SHF-310 SHF-315 FACTORS SHF-220 SHF-225 SHF-320 SHF-325 SHF-230 SHF-235 SHF-330 SHF-335 Maximum Power kW 20 kW 32 kW Maximum mA 320 mA...
- Page 50 HF Series Generators - - RAD Console Operation RANGE OF RADIOGRAPHIC PARAMETERS PARAMETER PARAMETER RANGE RANGE From 40 kV to 125 kV or 150 kV in 1 kV steps. (Depending on the Generator model) From 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.
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