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DECLARACION AMBIENTAL

SOBRE LA VIDA UTIL DEL EQUIPO O SISTEMA

Este equipo o sistema contiene componentes y materiales peligrosos para el medioambiente (tales

como tarjetas de circuito impreso, componentes electrónicos, aceite dieléctrico usado, plomo,

baterías, etc), los cuales se consideran y son residuos peligrosos al finalizar la vida útil del equipo o

sistema, según establecen las normas internacionales, nacionales y locales.
El fabricante recomienda que al finalizar la vida útil de equipo o sistema, se contacte con un

representante autorizado del fabricante o con un gestor autorizado de residuos para la retirada de este

equipo o sistema.

ENVIRONMENTAL STATEMENT

ON THE LIFE CYCLE OF THE EQUIPMENT OR SYSTEM

This equipment or system contains environmentally dangerous components and materials (such as

PCB‘s, electronic components, used dielectric oil, lead, batteries etc.) which, once the life-cycle of the

equipment or system comes to an end, becomes dangerous and need to be considered as harmful

waste according to the international, domestic and local regulations.
The manufacturer recommends to contact an authorized representative of the manufacturer or an

authorized waste management company once the life-cycle of the equipment or system comes to an

end to remove this equipment or system.

DECLARATION D’ENVIRONNEMENT

SUR LA VIE UTILE DE L’EQUIPEMENT OU SYSTEME

Cet équipement ou système contient des composants et matériaux dangereux pour l’environnement

(ex: électroniques cartes, composants électroniques, huile diélectrique usée, plomb, batteries, etc.),

lesquels sont considérés comme résidus dangereux en cycle terminal de vie d’un équipement ou

système, en accord avec les normes internationales, nationales et locales en vigueur.
Le fabricant recommande une fois le cycle terminal de l’équipement ou système atteint, de contacter

un représentant autorisé du fabricant ou les autorités compétentes en la matière afin d’organiser et

de gérer le recyclage adéquat de cet équipement ou appareil.

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Содержание HF Series

Страница 1: ...SEDECAL Technical Publication OM 0279R1 Operation HF Series Generators RAD Console ...

Страница 2: ...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 This manual covers the following equipments Este manual cubre los siguientes equipos Ce manuel couvre les équipements suivants SHF 310 SHF 315 S...

Страница 3: ...ity of any persons carelessly unwisely or unknowingly exposing themselves or others to X radiation It is important that everyone working with X radiation be properly trained and take adequate steps to insure protection against injury The manufacturer assumes that all operator and service personnel authorized to use install calibrate and maintain this equipment is cognizant of the danger of excessi...

Страница 4: ...le of the equipment or system comes to an end becomes dangerous and need to be considered as harmful waste according to the international domestic and local regulations The manufacturer recommends to contact an authorized representative of the manufacturer or an authorized waste management company once the life cycle of the equipment or system comes to an end to remove this equipment or system DEC...

Страница 5: ...ut this manual Their application and meaning are described below DANGERS ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT HEEDED OR AVOIDED WILL CAUSE SERIOUS PERSONAL INJURY OR DEATH ADVISE OF CONDITIONS OR SITUATIONS THAT IF NOT HEEDED OR AVOIDED COULD CAUSE SERIOUS PERSONAL INJURY OR CATASTROPHIC DAMAGE OF EQUIPMENT OR DATA Advise of conditions or situations that if not heeded or avoided could ca...

Страница 6: ...uments Ionizing radiation Type B equipment Dangerous voltage Ground This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer or an authorized waste management company for information concerning the decommissioning of your equipment ...

Страница 7: ...sible Dose MPD 7 2 4 Radiation Protection 7 2 5 Monitoring of Personnel 8 2 6 Protection against Electric Shock Hazards 8 2 7 Electromagnetic Compatibility EMC 9 3 OPERATING CONTROLS 15 3 1 Radiography and General Controls 16 3 1 1 Power ON OFF 16 3 1 2 Workstations Selection 16 3 1 3 Focal Spot Indicators 17 3 1 4 Radiographic Parameters 18 3 2 Automatic Exposure Control AEC 20 3 3 Anatomical Pro...

Страница 8: ...31 4 OPERATING SEQUENCES 35 4 1 Start up Routine 35 4 2 X Ray Tube Warm up Procedure 35 4 3 Radiographic Operation 36 4 4 AEC Operation 37 4 5 APR Operation 38 5 PERIODIC MAINTENANCE 39 5 1 Operator Tasks 39 5 2 Service Tasks 40 6 TECHNICAL SPECIFICATIONS 41 6 1 Factors 41 6 2 Range of Radiographic Parameters 42 6 3 Duty Cycle 42 6 4 Physical Characteristics 42 ...

Страница 9: ...ides all the advantages of high frequency waveform Generators including lower patient dose shorter exposure times and greater accuracy and consistency The Generator is controlled by multiple microprocessors providing increased exposure consistency efficient operation and extended Tube life A high level of self diagnosis greatly increases serviceability and reduces down time All functions displays ...

Страница 10: ...y operating on three phase and single phase lines Three point control by selecting kVp mA and Exposure time or two point control by selecting kVp and mAs or one point control by selecting kVp with 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 syst...

Страница 11: ...olid State types can be installed on the system Each one can be independently calibrated Third Fourth Bucky this option allows to connect of up to four Buckys to the Generator Tomography an adaptation to interface with the Tomo device Second X ray Tube which extends the system for using two X ray Tubes High Speed Rotor Controller an optional digital controller consisting of a module which is fitte...

Страница 12: ...rator covered by this Operation Manual is classified as Protection against Electric Shock Class I Type B applied parts Protection against Harmful Ingress of Water Ordinary Degree of Safety in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide Not suitable for use in the presence of Flammable Anesthetics Mixture with air or with oxygen or with nitrous oxide ...

Страница 13: ... VITALLY IMPORTANT THAT EVERYONE ASSOCIATED WITH X RAY RADIATION IS FAMILIAR WITH THE SAFETY AND REGULATORY INSTRUCTIONS CONTAINED WITHIN THIS MANUAL IN PARTICULAR THE STATEMENT AT THE BEGINNING OF THIS MANUAL ENTITLED IMPORTANT X RAY PROTECTION THESE INSTRUCTIONS SHOULD BE THOROUGHLY READ AND UNDERSTOOD BEFORE ATTEMPTING TO PLACE THIS EQUIPMENT IN OPERATION Although X radiation can be hazardous X...

Страница 14: ...ENT WHICH IS A RESULT OF POOR OPERATING TECHNIQUES OR PROCEDURES NO RESPONSIBILITY WILL BE ASSUMED FOR ANY EQUIPMENT THAT HAS NOT BEEN SERVICED AND MAINTAINED IN ACCORDANCE WITH THE MANUFACTURER INSTRUCTIONS OR WHICH HAS BEEN MODIFIED OR TAMPERED WITH IN ANY WAY IT IS THE RESPONSIBILITY OF THE OPERATOR TO ENSURE THE SAFETY OF THE PATIENT WHILE THE X RAY EQUIPMENT IS IN OPERATION BY VISUAL OBSERVAT...

Страница 15: ... of the primary beam produces secondary scattered radiation The intensity of the secondary radiation is dependent upon the energy and intensity of the primary beam and the atomic number for the object material struck by the primary beam Secondary radiation may be of greater intensity than that of the radiation reaching the film Take protective measures to safeguard against it An effective protecti...

Страница 16: ...of determining the amount of exposure is the placement of film at strategic locations After a specified period of time develop the film to determine the amount of radiation A common method of determining whether personnel have been exposed to excessive radiation is the use of personal radiation dosimeters These consist of X ray sensitive film or thermoluminescent material enclosed within a holder ...

Страница 17: ... measures 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 affected device consult the service engineers for further suggestions To comply with the regulations on electromagnetic interference for a Class A FCC Device this equipment must be used in shielded areas and all interc...

Страница 18: ...MAGNETIC EMISSIONS 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 Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 This X Ray Generator uses RF energy only for its internal function Therefore its RF emissions ...

Страница 19: ...ent 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 typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input 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 during 10 ms 60 duri...

Страница 20: ...angeb Interference may occur in the vicinity of equipment marked with the following symbol d 1 2 P d 2 3 P 800 MHz to 2 5 GHz d 3 5 E1 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 all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note In the 3rd equatio...

Страница 21: ...tance according to frequency of transmitter m of transmitter W 150KHz to 80MHz d 1 2 P 80MHz to 800MHz d 3 5 E1 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12 0 23 0 1 0 38 0 73 1 1 2 2 3 10 3 8 7 3 100 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter wh...

Страница 22: ...HF Series Generators RAD Console Operation OM 0279R1 14 This page intentionally left blank ...

Страница 23: ...al any other no indicated combination may cause an incorrect operation of the equipment Illustration 3 1 Rad Console 7 Radiographic Values 8 AEC Density Values 9 Patient Size Selection APR 10 Body Regions Anatomical View Selection APR 11 Focal Spot Indicators and Selectors 12 Exposure Indicators and Controls 1 Power On 2 Power Off 3 Workstations Selection 4 AEC Reset 5 AEC Field Selection 6 Film S...

Страница 24: ...x 3 seconds The equipment only turns off if Preparation is not activated IN THE EVENT OF AN EMERGENCY ISOLATE THE X RAY GENERATOR FROM THE MAINS POWER BY FORCIBLY DEPRESSING THE X RAY ROOM EMERGENCY OFF SWITCH USUALLY A RED MUSHROOM SHAPED SWITCH THIS SWITCH SHOULD BE LOCATED ON OR NEAR TO THE X RAY ROOM MAINS POWER PANEL USUALLY PLACED NEAR TO THE GENERATOR CONTROL CONSOLE MORE THAN ONE OF THESE ...

Страница 25: ...AL SPOT Indicates that the Small Focal Spot of the X ray Tube has been selected FOCAL SPOT SELECTORS Each push button selects the related Focal Spot of the X ray Tube keeping kVp and mAs constant maximum mA available and minimum Exposure Time The Focal Spot change can be done whenever the present conditions of the X ray Tube allow it The mA station set for the Focal Spot change is configured by th...

Страница 26: ...ual 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 during the exposure and the actual Time at the end of the exposure whenever the Prep push button...

Страница 27: ...t 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 reach space charge limit in the ...

Страница 28: ...es of back up time or mAs should be avoided to prevent patient from excessive exposure when a control error is produced FIELD SELECTION Each push button indicates its related physical location of the selected field in the AEC Exposure Detector and it may be selected or deselected by pressing it Any combination of fields can be selected and the push buttons illuminate when active FILM SCREEN COMBIN...

Страница 29: ... that combines eight Body Regions Y axis with eight Anatomical Views X axis Besides the radiographic parameters selections of the workstation or AEC density fields and film screen combination can be assigned to the APR techniques These selections will be always common for all the patient sizes of each Anatomical View These techniques may be modified and stored anew into non volatile memory by the ...

Страница 30: ...be illuminated at the same time ANATOMICAL VIEW SELECTORS Each push button is related with the nearestarea ofthe APR Display and they are used to select one of the displayed Body Regions and Anatomical Views The APR Display shows the following Body Regions Skull Facial Upper Trunk Lower Trunk Chest Extremity on Bucky Extremity on Table Top and Special When a Body Region has been selected the APR D...

Страница 31: ...T AP PA LATERAL 60 CART UPPER RIBS LOWER RIBS STERNUM STERNUM LATERAL LORDOTIC EXTREM BUCKY HIP AP HIP FROG FEMUR KNEE AP KNEE LATERAL KNEE AXIAL HUMERUS HUMERUS TRANS THORACIC EXTREM TBL TOP HAND WRIST FOREARM ELBOW FOOT ANKLE TIBIA KNEE SPECIAL TOMO AUX CHANGER 1 CHANGER 2 USER 1 USER 2 USER 3 CONTRAST SUB MENU OF ANATOMICAL VIEWS SUB MENU OF EXTREM TBL TOP View 1 View 2 View 3 View 4 View 5 Vie...

Страница 32: ...ERIOR COSTILLAS INFERIOR ESTERNON ESTERNON LATERAL LORDOTIC EXTREMIDADES SOBRE BUCKY CADERA AP CADERA FROG FEMUR RODILLA AP RODILLA LATERAL RODILLA AXIAL HUMERO HUMERO TRANS TORACICA EXTREMIDADES SOBRE TABLERO MANO MUÑECA ANTEBRAZO CODO PIE TOBILLO TIBIA RODILLA ESPECIAL TOMO AUXILIAR CAMBIADOR 1 CAMBIADOR 2 USUARIO 1 USUARIO 2 USUARIO 3 CONTRASTE SUB MENU EXTREMIDAD VISTAS ANATOMICAS EXTREMIDAD S...

Страница 33: ...AGE COTES SUPERIEUR COSTES INFERIEUR STERNUM STERNUM LATERAL LORDOTIQUE EXTREMITES BUCKY HANCHE AP HANCHE OB FEMUR GENOU AP GENOU LATERAL GENOU AXIAL HUMERUS HUMERUS TRANS THORACIQUE EXTREMITES TABLE MAIN POIGNET AVANT BRAS COUDE PIED CHEVILLE TIBIA GENOU SPECIAL TOMOGRAPH AUXILIAIRE CHANGEUR 1 CHANGEUR 2 UTILISATEUR 1 UTILISATEUR 2 UTILISATEUR 3 CONTRASTE SUB MENU EXTREMITES VUES ANATOMIQUES EXTR...

Страница 34: ...H LORDOTIC EXTREMITÄTEN BUCKY HUEFTE AP HUEFTE OB SCHENKEL KNIE AP KNIE SEITLICH KNIE AXIAL OBERARM BEIN OBERARM BEIN TRANS BRUST EXTREMITÄTEN OBERTISCH 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 SICHT SPEISEKARTE EXTREMITÄTEN OBERTISCH Sicht 1 Sicht 2 Sicht 3 Sicht 4 Sicht 5 Sich...

Страница 35: ...HF Series Generators RAD Console Operation OM 0279R1 27 Table 3 1 cont APR Matrix Russian ...

Страница 36: ...t an APR technique and modify the factors and selections of Workstations 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 store the new technique Refer to Illustration 3 2 The newly selected technique is now stored in memory and can be recalled for future examinations Thi...

Страница 37: ...ter the Ready indicator is illuminated press this push button to start a X ray exposure If the push button is released before the Generator completes the selected time or the AEC time the exposure will be prematurely terminated and 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 ...

Страница 38: ...a display of H75 would indicate that 75 of Heat Units capacity of the X ray Tube remains H indicates that all the capacity remains The kVp Display reverts to its normal function after releasing the On push button 3 7 EXPOSURE COUNTERS The operator can read the number of exposures made by the Generator as indicated below RAD EXPOSURES IN TUBE 1 Press and hold and press once RAD EXPOSURES IN TUBE 2 ...

Страница 39: ...ure with the X ray Tube cool X ray Tube has not been warmed up TUBE OVERLOAD Indicates that either the technique selected is beyond the X ray Tube ratings or the present conditions of the X ray Tube inhibit the exposure anode overheated Parameters for next exposure may be temporally limited by the Generator change the exposure values or wait for the X ray Tube to cool Check that heat units availab...

Страница 40: ...has been detected blades are full open or in movement during exposure etc In this case the indicator lights continuously 3 9 ERROR CODES Error codes indicate the potential cause of a system failure Error codes are shown on the kVp Display at the same time an audio signal is emitted Correct the error cause and keep pressed the AEC Reset push button till the Console indication disappears Refer to Ta...

Страница 41: ...he error code persists turn the Generator OFF and wait 30 minutes before 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 ran...

Страница 42: ... remains inoperative turn it OFF and call Field Service E37 Tube Overload error The technique selected is beyond the X ray tube ratings or present conditions of the X ray tube inhibit the exposure anode overheated Parameters for next exposure may be temporally limited by the Generator change the exposure values or wait for the X ray tube to cool Check that heat units available are lower than the c...

Страница 43: ...should be ignored by the operator until the unit has completed its power up sequence 4 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 previously warmed up this prolongs X ray Tube ...

Страница 44: ... 4 3 RADIOGRAPHIC OPERATION RAD operation can be performed in the following modes Three point control by selecting kVp mA and Exposure Time independently Two point control by selecting kVp and mAs independently mAs selection sets the maximum mA available for the selected Focal Spot and the respective Exposure Time In this control mode when kVp value is increased the Generator will automatically lo...

Страница 45: ...ut the exposure The X ray On indicator will light and an audible signal will sound during the exposure 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 examination using AEC the operator will need to select the desired AEC parameters as foll...

Страница 46: ...This operation starts the APR mode Select the Pediatric push button if the patient is not an adult 4 Select a general Body Region and an Anatomical View of the indicated on the APR Display 5 Technique parameters Workstation information Focal Spot AEC etc corresponding to the APR selection are displayed and indicated on the Control Console If needed the parameters and selections can be directly mod...

Страница 47: ...east 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 OR MANIPULATE INTERNAL COMPONENTS IN THE UNIT THESE ACTIONS COULD CAUSE SERIOUS PERSONAL INJURIES AND OR EQUIPMENT DAMAGE NEVER ATTEMPT TO CLEAN ANY PART OF THE UNIT WHEN ITISSWITCHEDON ALWAYSSWITCHOFFTHEEQUIPMENT AND ISO...

Страница 48: ...s RAD Console Operation OM 0279R1 40 5 2 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 ...

Страница 49: ... 128 kVp 200 mA 150 kVp GENERATOR MODEL GENERATOR MODEL FACTORS SHF 410 SHF 420 SHF 430 SHF 415 SHF 425 SHF 435 SHF 510 SHF 520 SHF 530 SHF 515 SHF 525 SHF 535 Maximum Power kW 40 kW 50 kW Maximum mA 500 mA 640 mA Maximum kVp 125 kVp 150 kVp 125 kVp 150 kVp Power Output 0 1 s 500 mA 80 kVp 400 mA 100 kVp 320 mA 125 kVp 500 mA 80 kVp 400 mA 100 kVp 320 mA 125 kVp 250 mA 150 kVp 640 mA 78 kVp 500 mA...

Страница 50: ...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 AEC mAs 0 1 mAs to 500 mAs AEC Exposure Time Nominal shortest irradiation Time 1ms 6 3 DUTY CYCLE The Generator duty cycle is continuous but limits should be set during installation depending on the capacity of the X ray Tube 6 4 PHYSICAL CHARACTERISTICS COMPONENT DIMENSIONS WEIGHT COMPONENT L...

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