Instr nstrucci ucciones ones para el uso u so Esterilizador de Vapor (Autoclave)
STERIVAP 0036
STERIVAP_np_es STERIV AP_np_es 1205_V3.02
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CONTENIDO:
31. 5. 2012
1
APLICACIONES Y EXPLICACIONES..............................................................................................................3
2
GENERALIDADES...........................................................................................................................................3 2.1 INDICACIÓNES IMPORTANTES .................................................................................................................................3 2.2 USO DETERMINADO............................................................................................................................................4 2.3 INSTALACIÓN DEL EQUIPO....................................................................................................................................4 2.4 ESTERILIZACIÓN...........................................................................................................................................4
3
ESTERILIZACIÓN POR MEDIO DE VAPOR...................................................................................................4 3.1 CONTROL DE ESTERILIZACIÓN...............................................................................................................................4 3.1.1 CONTROL POR UN TEST QUÍMICO DE PROCESO...............................................................................................4 3.1.2 CONTROL POR UN TEST QUÍMICO DE ESTERILIZACIÓN......................................................................................5 3.1.3 PRUEBA SEGÚN BOWIE DICK........................................................................................................................5 3.1.4 DOCUMENTACIÓN DE LAS CARGAS ESTERILIZADAS...........................................................................................5 3.1.5 CONTROL POR LOS INDICATORES BIOLÓGICOS................................................................................................5 3.2 PREPARACIÓN DEL MATERIAL PARA ESTERILIZAR.......................................................................................................5 3.2.1 TEXTILES............. .......................... .......................... .......................... .......................... ......................... ......................... .......................... .......................... ........................ ........................ ...............5 ..5 3.2.2 INSTRUMENTOS........................................................................................................................................5 3.2.3 ARTÍCULOS DE HULE..................................................................................................................................5 3.2.4 PIEZAS ESPECIALES...................................................................................................................................5 3.2.5 LÍQUIDOS...............................................................................................................................................6 3.3 QUE ES LO QUE SI PUEDE SER ESTERILIZADO..........................................................................................................6 3.4 LO QUE NO SE DEBE ESTERILIZAR.......................................................................................................................6
4
INFORMACIONES TÉCNICAS..........................................................................................................................6 4.1 DESCRIPCIÓN TÉCNICA.........................................................................................................................................6 4.2 CONTENEDOR DE PRESIÓN.................................................................................................................................7 4.2.1 EL CONJUNTO DE LOS EQUIIPOS DE PRESIÓN DE ESTERILIZADOR.....................................................................7 4.2.1.1 L A CÁMARA DE PRESIÓN...................................................................................................................7 4.2.1.2 GENERADOR ELÉCTRICO DE VAPOR....................................................................................................7 4.2.1.3 L A TUBERÍA....................................................................................................................................7 4.2.1.4 EL EQUIPO DE SEGURIDAD Y DE PRESIÓN............................................................................................7 4.3 PUERTAS................................................... ............................................................................................................. ...........................................................................................8 .................................8 4.4 PUESTA Y SACAMIENTO........................................................................................................................................8 4.5 CONTROL AUTOMÁTICO DEL EQUIPO....................................................................................................................8 4.6 ARCIVAMIENTO DE DATOS, EXPORTACIÓN DE DATOS.................................................................................................8 4.7 SIMCON...........................................................................................................................................................8 4.8 ALIMENTACIÓN A VAPOR.......................................................................................................................................9
5
INFORMACIONES TÉCNICAS..........................................................................................................................9 5.1 D AT ATOS OS TÉCNICOS...............................................................................................................................................9 5.2 COMPONENTES DE CONTROL Y DESPLIEGUE (PUPITRE DE MANDO)............................................................................9 5.2.1 L ADO DE CARGA Y CONTROL......................................................................................................................9 5.2.2 L ADO DE DESCARGA.................................................................................................................................10
6
PROGRAMAS - BÁSICOS....................................................................................................... BÁSICOS.................................................... ...........................................................................10 ........................10 6.1 PRECALENTAMIENTO........... ........................ .......................... .......................... .......................... .......................... .......................... ......................... ......................... .......................... .....................10 ........10 6.2 UNIVERSAL....................................................................................................................................................10 6.3 UNIVERSAL CONTENEDOR...................................................................................................................................10 6.4 HULE............................................................................................................................................................10 6.5 PRUEBA BD.....................................................................................................................................................10
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7
MANEJO DEL EQUIPO...................................................................................................................................11 7.1 M ANEJO BÁSICO............................ ...............................................................................................................................................11 ...................................................................................................................11 7.1.1 DISPLAY TÁCTIL......................................................................................................................................11 7.2 PUESTA EN MARCHA DIARIA...............................................................................................................................11 7.3 INSTRUCCIONES PARA EL USO DEL EQUIPO.............................................................................................................11 7.3.1 C ARGA DEL MATERIAL PARA ESTERILIZAR Y PUESTA EN MARCHA......................................................................11 7.3.2 DESCARGA DE MATERIAL DE ESTERILIZACIÓN............................................................. ..............................................................................................12 .................................12 APAGAR GAR EL EQUIPO.............................................................................................................13 7.4 INSTRUCCIONES PARA APA 7.5 INTERRUPCIÓN DE PROGRAMA.............................................................................................................................14 7.6 INFORMACIÓN NFORMACIÓN ADICIONAL ADICIONAL - INDICACIÓN...................................................................................................................14 7.6.1 INFORMACIÓN ACTUAL DE OPERACIÓN.......................................................................................................14 7.6.2 CURSO DEL CICLO – INFORMACIÓN..................... ..............................................................................................................14 .........................................................................................14 7.7 MENÚ – FUNCIONES DE SERVICIO.......................................................................................................................15 7.7.1 AJUSTE DE DISPLAY................................................................................................................................15 7.7.2 FECHA Y TIEMPO............................................. ....................................................................................................................................16 .......................................................................................16 7.7.3 IMPRESORA - AJUSTE..............................................................................................................................16 7.7.4 ENCENDIDO AUTOMÁTICO..................................... .........................................................................................................................17 ....................................................................................17 7.7.5 C AMBIO DE LOS PARÁMETROS DEL PROGRAMA............................................................................................18 7.7.6 SUMARIO DE ENTRADAS Y SALIDAS......................... .........................................................................................................19 ................................................................................19 7.7.7 VERSIÓN DEL SISTEMA............................................................................................................................19 7.7.8 DETECTOR DE AIRE ( AIR DETECTOR)....................................... )........................................................................................................19 .................................................................19 7.7.9 CHIP TARJETA .......................................................................................................................................19 7.7.10 BLOQUEO DE LA PUERTA DE CÁMARA................... .........................................................................................................20 ......................................................................................20 DE ALIMENT ALIMENTACIÓN ACIÓN DE VAPOR..................................................................21 7.7.11 FUENTE DE VAPOR – CAMBIO DEL MODO DE 7.7.12 COMENTARIO SUPLEMENTARIO ..................................................................................................................21 7.7.13 HISTORIAL DE PROTOKOLOS, TARJETA DE MEMORIA... .........................................................................................22 ......................................................................................22 7.7.14 HISTORIAL DE ERRORES........................................................ ..........................................................................................................................22 ..................................................................22 7.7.15 APERTURA AUTOMÁTICA DE LA PUERTA.................................. ....................................................................................................22 ..................................................................22 7.7.16 TIEMPO DE LA DESACTIVACION AUTOMÁTICA............................ ..............................................................................................23 ..................................................................23 7.8 DERECHOS DE ACCESO (LOGIN)........................................................................................................................23 7.8.1 USO LIBRE ( FREE USER)..........................................................................................................................23 7.8.2 DERECHOS DE ACCESO INDIVIDUALES.......................................................................................................23 7.8.2.1 LOGIN - CAMBIO DEL NIVEL.............................................................................................................23 7.8.2.2 ADMINISTRADOR .....................................................................................................................23 7.8.2.2.1 AJUSTO DEL MODO - DERECHOS DE ACCESO INDIVIDUALES/USO LIBRE...........................................24 7.8.2.2.2 COMPROBACIÓN DE LA CONTRASEÑA PARA LA PUERTA BLOQUEADA.............................................24 7.8.2.2.3 ADMINISTRACIÓN DE LA CONTRASEÑAS Y PROTECCIÓ DEL ACCESO...............................................24 7.8.2.2.4 EL CONTADOR DIARIO DE LAS DOSIS......................................................................................26 7.8.2.2.5 L A OPCIÓN DE LA TERCERA MAGNITUD DE LA TABULLA DE REGISTROS...............................................26 7.9 STEAM MANAGER ( GUARDA DEL MÁXIMO ENERGÉTICO).............................................................................................26 7.10 AUDIT TRAIL.....................................................................................................................................................27 7.11 TIPO DE LA TRANSITABILIDAD DEL MATERIAL POR LA CÁMARA....................................................................................27
8
FALLOS DE OPERACIÓN...........................................................................................................................27 8.1 ELEMENTOS TÉCNICOS DE SEGURIDAD.................................................................................................................27 8.1.1 MENSAJES DE ERROR, DESCARGA EN EL CASO DE AVERÍA..............................................................................27 8.1.2 MENSAJES DE OPERACIÓN....................................... .........................................................................................................................28 ..................................................................................28 8.2 CORTE DE ENERGÍA ELECTRICA..........................................................................................................................28 8.3 CORTE DE AGENTES DE ENTRADA (MONITORIZACIÓN DE AGENETES).........................................................................28 8.4 BLOQUEO DE OPERACIÓN EN EL CASO DE ENERGÍA ELÉCTRICA INSUFICIENTE............................................................28
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9.2.2 INDICACIÓN DEL ESTADO DE IMPRESORA.....................................................................................................29 9.2.3 INSERCIÓN DE PAPEL.................................................................................................................................29 9.3 INTERVALOS PARA REALIZAR LIMPIEZA...................................................................................................................30 9.4 INTERVALOS DEL MANTENIMIENTO DEL GENERATOR DE VAPOR..................................................................................30 9.5 INSCRRIPCIÓN AL LIBRO DE OPERACIÓN DEL AP APARAT ARATO O SANITARIO .............................................................................31 9.6 LUBRICACIÓN, LIMPIADURA Y RECAMBIO DE LA OBTURACIÓN DE PUERTA.....................................................................31 9.7 P ARADA DE MÁQUINA DE SERVICIO......................................................................................................................31 10 GENERATOR DE VAPOR VAPOR ELÉCTRICO................................................................ ...................................32 10.1 M ARCHA DEL GENERATOR...................................................................................................................................32 10.1.1 PUESTA EN MARCHA DESPUÉS DE VACIAR Y DURANTE PRIMER RELLENO...........................................................32 10.1.2 RETIRO DE OPERACIÓN DEL GENERATOR POR UN PLAZO LARGO.....................................................................33 10.1.3 ENCENDIDO DEL GENERATOR.......................................................................................................................33 11 INST INSTAL ALACIÓN ACIÓN DEL ESTERILIZA ESTERILIZADOR................................................................................... DOR................................................................................... ......................33 11.1 PREPARATIVOS Y REQUISITOS DE LA OBRA CIVIL....................................................................................................33 11.2 REQUISITOS DE LOS AGENTES OPERATIVOS ...........................................................................................................33 11.2.1 AQUA DE ENFRIAMIENTO PARA LA BOMBA DE VACIO – KW.............................................................................33 11.2.2 AQUA PARA EL GENERADOR DE VAPOR – DW..............................................................................................33 11.2.3 DESAGUE – A..........................................................................................................................................33 11.2.4 CONEXIÓN ELÉCTRICA – E.........................................................................................................................33 11.2.5 AIRE DE PRESIÓN – DL.............................................................................................................................34 11.2.6 V APOR DE DISTRBUIDOR CENTRAL – FD.......................................................................................................34 11.2.7 AGUA ABLANDADO (PARA REFRIGERACIÓN DE CAMISA) – EW...........................................................................34 11.2.8 V APOR PARA EL CALENTAMIENTO DE LA CAMISA (VAPOR CALEFACTOR ) – FDT.......................................................34 ALIMENTACIÓN ACIÓN PARA LA GENERACIÓN INTERNA DE VAPOR.................34 11.3 P ARÁMETROS PARA MEDIR LA CALIDAD DEL AGUA DE ALIMENT 11.4 MONTAJE Y PUESTA EN MARCHA DEL EQUIPO......................................................................................................34 11.5 CONSEJOS PARA MOVER Y COLOCAR EL EQUIPO..................................................................................................35 12 TRANSPORTE Y AL ALMACENA MACENAJE.................... JE..................................................................................................................35 ..............................................................................................35 12.1 TRANSPORTE ................... ...................................... ...................................... ...................................... ...................................... ...................................... ................................ ............................35 ...............35 12.2 ALIMACENAJE ....................... ................................................ .................................................. .................................................. .................................................. .......................................... ..................35 .35 13
ELIMINACIÓN..................................... ELIMINACIÓN......................... ....................... ....................... ........................ ........................ ........................ ........................ ...................... ...................... ........................ ..............35 ..35 13.1 ELIMINACIÓN DEL MATERIAL DE EMPAQUE............................................................................................................35 13.2 E QUIPO.................................................................................................................................35
14
ADVERTENCIAS Y NORMAS.................................... ...................................................................................36
15
GARANTÍA, GARA NTÍA, SERVICIO...................................................................................................................................36
16
ANEXO............................................................................................................................................................36 16.1 ESTERILIZACIÓN DE LÍQUIDOS EN BOTELLAS ABIERT ABIERTAS AS...........................................................................................36 16.2 ESTERILIZACIÓN DE SOLUCIONES CON PARÁMETRO FO.........................................................................................36 16.3 ESTERILIZACIÓN DE SOLUCIONES CON REFRIGERACIÓN DE CAMISA FORZADA.............................................................37 16.4 PROGRAMAS DE TRATAMIENTO DE VAPOR DE TIPO „ ARNOLD“..................................................................................37 ANTALLA LLA GRANDE (LCD) TAMBIÉN EN LA DESCARGA...........................................................................................37 16.5 P ANTA 16.6 PROTOCOLO DEL PROGRAMA DE ESTERILIZACIÓN................................................................................................38 16.7 MENSAJES DE ERROR......................................................................................................................................39
ANEXOS: LIBRO OPERATIVO DEL DEL APA APARAT RATO O DE SANIDAD PLAN DE INSTALACIÓN DE STERIVAP HP:
446-1, 446-2, 636-1, 636-2, 666-1, 666-2, 669-1, 669-2, 6612-1, 6612-2, 6618-2, 9612-1, 9612-2, 9618-2,
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Instrucciones para el uso
1 APLICACIONES
esterilizadores de vapor y para los trabajos de servicio en el producto SP HP tiene la autorización escrita expedida por la empresa productora.
Estas instrucciones de uso del esterilizador tienen la vigencia para más abajo indicados modelos: Nombre: STERIVAP HP Tipo: SP HP
2 GENERALIDADES
Y EXPLICACIONES
puertas PED (l)
Modelo
MD D
2.1
INDICACIÓNES IMPORTANTES
SP HP E 446-1
FD,ED,FDED
148
SP HP E 446-2
FD,ED,FDED
148
SP HP E 559-1
FD,ED,FDED
254
SP HP E 559-2
FD,ED,FDED
254
SP HP E 636-1
FD,ED,FDED
160
SP HP E 636-2
FD,ED,FDED
160
SP HP E 666-1
FD,ED,FDED
314
ser capacitadas para esta tarea y conocer el manual de uso. La responsabilidad para la capacitación en el uso
SP HP E 666-2
FD,ED,FDED
314
comprador). Los nombres de las personas capacitadas
SP HP E 669-1
FD,ED,FDED
453
SP HP E 669-2
FD,ED,FDED
453
●
SP HP E 6612-1
FD,ED,FDED
610
SP HP E 6612-2
FD,ED,FDED
610
SP HP E 6618-2
FD,ED,FDED
885
seguridad del personal en cualquier momento. ● Antes de la primera puesta en en marcha es obligatorio leer el capítulo 6 del manual. Un manejo incorrecto puede dañar al equipo ¡!
SP HP E 9612-1
FD,ED,FDED
868
SP HP E 9612-2
FD,ED,FDED
868
SP HP E 9618-1
FD,ED,FDED
1260
SP HP E 9618-2
FD,ED,FDED
1260
SP HP E 9621-2
FD,ED,FDED
1490
Ad verten Adver ten ci cias as y ley end enda a de símb s ímb ol olos os ut utilil izad os en el manual: FD Alimentación por vapor de fuente central ED Alimentación por vapor de generador de vapor propio FD ED modo combinado de alimentación de distribución
esterilizar – ver la directiva no 93/42/EEC, art. 13.1, 13.3 Los equipos de esterilización por vapor (Autoclaves) deben ser manejados únicamente por personas que
por su enseñanza, sus conocimientos y su experiencia práctica con estos equipos garantizan un manejo seguro y adecuado de los mismos. Estas personas tienen que de esterilizadores queda en manos del hospital (clinica, y autorizadas para el manejo del equipo deberán
asentarse en la bitácora del esterilizador.
●
El equipo debe de usarse según las indicaciónes
y descripciones del manual de uso para asegurar la
El usuario (personal de operación, mantenimiento)
debe de asegurarse que todas los sistemás de seguriad
esten en buenas condiciones y funcionando, antes de la puesta en marcha. ● Caso de usar el equipo de modo diferente del
uso determinado puede causar que la protección proporcionada por el equipo se estropeará. ● Mientras el equipo esté conectado a la corriente eléctrica, está prohibido al personal operativo abrir o quitar tapas o partes de las cubiertas. Cualquier servicio al equipo
debe de realizarse únicamente por personal capacitado y experimentado en este tipo de aparatos.
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Instrucciones para el uso
●
Requisitos a los medios de servicio deben cumplir las características indicadas en la documentación.
Esterilización de soluciones Esterilización ● Caso de esterilización de soluciones de agua convenzanse si la ajustada temperatura final para abrir la puerta y aflojar la carga de cámara corresponde a l a
actual altura sobre el nivel de mar de la colocación de equipo.
Esta temperatura se visualiza como el parámetro de ciclo de esterilización cuando se elige. ●
At enc ió Atenc ión! n! ¡Si la temperatura al abrir la puerta no corresponde a los valores mencionados más abajo, no se puede usar el programa de esterilización hasta el
momento de su ajuste correcto!
tejidos expuestos sin protección (p.ej. quemaduras)
reacciones inmunológicas (p.ej. después de transplantes).
Equipos de Esterilización son para esterilizar todas las cosas que deben de mantenerse estériles hasta el momento en que son utilizadas.
3 ESTERILIZACIÓN POR MEDIO DE VAPOR Durante el proceso de la esterilización se condensa el vapor saturado en el material a esterilizar, el cual se calienta. El vapor condensado traspasa las células de los microorganismos a combatir y llega hasta el núcleo de las células, las cuales serán destruidas por la energía térmica
Hay que llamar el servicio.
Temperatura al abrir la puerta caso de la esterilización de líquidos – correción a la altura sobre el nivel de mar:
Altura sobre el nivel de mar 0 – 400 m 401 – 800 m 801 – 1200 m 1201 – 1600 m 1601 – 2000 m 2001 – 2400 m 2400 – 2800 m >2800 m
● ●
Botellas abiertas 94 °C 92,5 °C 91 °C 90 °C 88,5 °C 87 °C 86 °C 85 °C
2.2 USO DETERMINADO Los esterilizadores a vapor vapor STERIV STERIVAP AP son equipos
determinados al uso en la sanidad a efectuar las esterilizaciones a calor húmedo de los medios no embalados y empaquetados icluyendo medios invasivos,
(calor) aplicada. Con esto se explica el efecto esterilizante del vapor saturado aún con relativamente corto tiempo y a baja temperatura. El proceso de Esterilización por medio de Vapor se usa en
textiles de algodón y fibras sintéticas que soportan altas temperaturas, artículos metálicos que no se oxidan, y artículos fabricados con hule, plásticos, cerámica o vidrio a una temperatura de 134 grados celsius. Todos los artículos que no soporten esta temperatura podrán ser esterilizados a
una temperatura menor de 121 grados celsius.
Se tiene que evaluar si los materiales por esterilizar podrán
soportar las diferentes presiones y temperaturas a las cuales serán expuestas durante el proceso.
Al aforar los objetos que se deben esterilizar en el saturado
vapor de agua sigan las Instrucciones de Uso del fabricante de los aparatos. En casos discutibles hay que convencerse si aquellos objos son resistentes a las temperaturas más altas, humedad y contra los cambios térmicos y de presión que resultan del transcurso del proceso de la esterilización.
Si no se reconoce bien esta facultad en casos individuales hay que convencerse realizando la esterilización de prueba.
según la directiva EU no. 93/42/EEC, determinados por sus fabricantes a la esterilización a calor húmedo.
2.3 INSTALACIÓN DEL EQUIPO El montaje, la instalación y la primera puesta en marcha tienen que llevarse a cabo según las indicaciónes del
Algúnos materiales orgánicos como son lana, gamuza, sistemás ópticos y artículos termolabiles, no se deben de
exponer a vapor saturado. Para estos materiales o piezas es indispensable observar las indicaciónes de los fabricantes.
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Instrucciones para el uso
3.1.2 CONTROL POR TEST QUÍMICO DE ESTERILIZACIÓN ●
Tests químicos químicos de esterilización esterilización reaccionan por cambio
de color al llegar a algunos o todos parámetros de ciclo de esterilización. ●
Utilicen solo tests químicos destinados para
●
Este test no sirve como prueba de que el material
esterilización de vapor y método de evaluación de test (cambios de color) de su productor. esterilizado sea estéril !
3.1.3 PRUEBA SEGÚN BOWIE DICK (BD) ●
La prueba según BD se efectúa diariamente después de haber realizado un ciclo ciclo de esterilización esterilización sin material (cámara vacía) y antes de empezar a esterilizar,
Esta prueba demostrará si el grado de ventilación de materiales porosos (textiles) y el grado de saturación por vapor son lo suficiente para lograr que el material de
prueba sea expuesto a la temperatura correcta durante el tiempo necesario. La prueba BD debe de llevarse a cabo estrictamente según las indicaciónes del fabricante. ●
Caso que en el equipo se esteriliza el material poroso, es suficiente hacer el BD-test según la norma EN ISO
11140-4. ●
Caso que que en el equipo se esterilizan esterilizan los objetos cavernosos es necesario hacer el BD-test con el uso del
cuerpo de ensayos PCD según la norma EN 867-5.
3.1.4 DOCUMENTACIÓN DE LAS CARGAS ESTERILIZADAS STERIVAP HP – que es un equipo de esterilización por medio de vapor, tiene integrada una impresora para protocolizar los procesos y registrar los valores de temperatura y presión durante la esterilización. Esta documentación comprueba la validación de procesos
●
El grado de absorción de calor del material,
●
calentamiento, mása y factor calorífico. Per fil del flujo de aire, un factor que influye en la
velocidad del aire alrededor del material ●
Una distribución dispareja de la humedad debido al
goteo del vapor condensado durante la esterilización de instrumentos.
3.2.1 TEXTILES Los textiles doblados absorben mucho calor. Debido a una gran resistencia al flujo de aire, estos encierren mucho aire. Para paquetes con textiles que son encimados en forma horizontal, es recomendable usar programas de esterilización que incluyen ciclos de vacío fraccionado. Si los paquetes son colocados en forma vertical, es más fácil extraer el aire entre los paquetes, siempre y cuando no se hayan colocado a presión. Las telas no deben ser apretadas, tienen que estar colocados libremente
en el espacio del contenedor de esterilización. Las telas empaquetadas de la manera usual tienen el peso de medición de aproximadamente 0,11 kg/dm3, el que
corresponde a 5-6 kg/STJ aproximadamente. (STJ = Unidad de esterilización ).
3.2.2 INSTRUMENTOS Al calentar instrumentos pesados se genera mucha mucha condensación de vapor en la super ficie, lo cual gotea hacia
el material debajo de estos instrumentos y lo mantiene
húmedo. Para evitar eso es recomendable colocar el instrumental en una charola tipo coladera hasta abajo en la
cámara de esterilización. La cantidad de agua condensada dependerá del tipo y mása de los instrumentos. Todos los instrumentos que tengan partes movibles se
deben colocar en forma abierta y si es posible, desarmados. Esto facilitará el paso del aire y evitará acumulacion de vapor condensado en áreas críticas dentro de los
repetitivos dentro de los límites especificos. El manejo de
instrumentos, como son bisagras, perforaciones, ranuras etc. La temperatura del instrumento también calentará el
esta documentación es responsabilidad de una persona designada por parte del usuario.
vapor condesado dentro de estas partes, pero mucho más despacio que el contacto directo con el vapor saturado.
3.1.5 CONTROL POR LOS INDICADORES
3.2.3 ARTÍCULOS DE HULE
BIOLÓGICOS
El hule es basicamente un aislante térmico. Esterilizar hule
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Instrucciones para el uso
También en piezas planas (p.ej. instrumental) con muy poca distancia entre las piezas se estanca fácilmente el aire y el vapor condensado. Por eso es recomendable usar programas de esterilización con vacío fraccionado y con suficiente tiempo de
compensación para este tipo de cargas. Cuando se colocan varios Contene Contenedores dores encimados encimados con con material a esterilizar, es importante colocar textiles entre las diferentes capas para facilitar la penetración del vapor y del aire, ya que sin esta separación las charolas se pegan entre sí debido a la acumulación del vapor condensado. Es mejor colocar instrumental con forma de cuchara hacia
abajo.
pero sin perforaciones
para aire y vapor se pueden deformar debido a los cambios que estan expuestos entre presión y vacío, aparte que su contenido no queda estéril. Este tipo de contenedores no
es apto para esterilización con vapor saturado. Es mejor colocar las Botellas vacías con la apertura hacia abajo usando un programa de 121 grados celsius, de la otra forma el condensado se enfria muy rápido en el piso de la botella y puede originar tensiones en el vidrio que harán que las botellas se rompan de imprevisto.
Prótesis de silicón así como ciertas marcas de pueden esterilizarse en vapor, eso depende de las recomendaciones de los fabricantes.
sellados pueden sellados pueden esterilizarse con vapor únicamente
cuando contienen suficiente agua en su interior, las paredes calientadas por el vapor exterior harán que el agua en el interior se evapore, hay que tomar en cuenta los
tiempos de compensación de temperatura.
que estar limpio antes de ser esterilizado. El material de embalaje debe ser resistente a las temperaturas hasta 140 °C y a los cambios de presión hasta 1000 kPa/min.
3.4 LO QUE NO SE DEBE ESTERILIZAR
sacarlas! Además no se deben esterilizar las soluciones agresivas y productos químicos que puedan causar la corrosión de la
cámara de esterilización. En vapor de agua no es posible esterilizar materiales orgánicos como lana, cueros, fibras ópticas y objetos
termoinestables.
Si el aparato se usa por otro modo de al que está destinado,
la protección dada por aparato puede ser infringida.
4 INFORMACIONES TÉCNICAS 4.1 DESCRIPCIÓN TÉCNICA
3.2.5 LÍQUIDOS
El equipo SP HP es un moderno esterilizador por medio de
El programa para la esterilización de l íquidos en botellas
abiertas es opciónal, los tiempos y temperaturas se controlan por medio de un sensor móvil adicional.Es posible esterilizar solo líquidos en botellas abiertas mediante un
programa correspondiente destinado especialmente para este esterilización!
3.3
QUE ES LO QUE SI PUEDE SER ESTERILIZADO
vapor saturado con un volumen útil de 1-21 STJ. ● ● ●
Modelo de una o dos puertas, generador de vapor propio o fuente de vapor externo proceso de esterilización fraccionado por medio de vacío
● ● ● ●
cámara de esterilización de acero inoxidable con la camisa calentada, material de la cámara - AISI 316L, control automático por microprocesadores (dos microprocesadores master y slave), control de fases de esterilización durante todo ciclo,
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Instrucciones para el uso
4.2
Información para la comprobación continua de la vasija de presión al estar en servicio:
EQUIPO DE PRESIÓN
Mecanismos de presión del esterilizador son construidos, fabricados y revisados según métodos de la EU directiva No.97/23/EC. La seguridad del funcionamiento de este conjunto determina la seguridad de funcionamiento de todo el esterilizador.
Tipo de es este teri rililizzad ado or
Núm Nú mer ero o per permi miti tid do de de cic ciclo loss de de esterilización
SP HP
30 000
De ello hablan los siguientes capítulos de este manual.
4.2.1.2 GENERADOR ELÉCTRICO DE VAPOR
Los métodos del mantenimiento, limpieza, cuidado de
las partes de presión, hasta los intervalos de realización
recomendados, están incluidos en este manual. La aceptación y el control periódico de los equipos de presión
de esterilizador para el usuario están dirigidos por las reglas internacionales para el funcionamiento de los equipos de
presión.
4.2.1 EL CONJUNTO DE LOS EQUIPOS DE PRESIÓN DE ESTERILIZADOR
El generador eléctrico de vapor está diseñado para la producción de vapor puro del agua totalmente desalada. Es un conjunto adicional al esterilizador. El vapor fabricado no debe contener ninguna hidracina (N2H4) ni otras sustancias químicas votátiles, ni inhibidores de la corrosión.
El generador eléctrico de vapor puede ser alimentado sólo de la manera correspondiente del agua totalmente desalada. Se recomienda la preparación a principios de la ósmosis reversible. ● ●
La cámara de presión de esterilizador El generador eléctrico de vapor La tubería El equipo de seguridad y de presión. ●
● ●
marcha de bomba de alimentación y protección de cuerpos caloríferos al faltar agua de alimentación.
4.2.1.1 LA CÁMARA DE PRESIÓN
●
Tipo
KOM 446 –1V-N KOM 446 –2V-N KOM 559 –1V-N KOM 559 –2V-N KOM 636 - 1V-N KOM 636 - 2V-N
144 °C 3,2/-1 bar 3,0 bar 8,1 bar 10,3 bar 10,3 bar
volúmen volúmen de la del del cámara casco casco en litros (I) en (II) en litros litros 148 24 4,5 148 24 4,5 254 77 4 254 77 4 160 24 4 160 24 4
volúmen
Medidor de nivel de seguro sirve como protección
de generador y cuerpos caloríferos al faltar agua de
Máx. temperatura permitida: Máx. presión permitida (de cálculo): Máx. presión de trabajo: Presión de prueba cámara: Presión de prueba camisa I: Presión de prueba camisa II:
Manómetro digital para ver presión de generador. Captador de presión para regular sobrepresión de vapor. Interruptor de seguro para limitar sobrepresión de vapor a los 300 kPa Medidor de nivel en generador sirve para puesta en
●
alimentación. (el. generador vapor). Regulación de nivel de agua en depósito de agua de alimentación sirve para regulación de reservas de agua.
●
El medidor del nivel para el control del nivel mínimo del
●
agua de alimentación en el contenedor La caldera está asegurada, según las regulaciones,
mediante una válvula de seguridad que ha sido probada
por tipo. Categoría
según 97/23/EC II II II II II II
Máx. temperatura permitida: Máx. presión permitida (de cálculo): Máx. presión de trabajo: Presión de prueba: Más datos – ver capítulo 5.1.
4.2.1.3 LA TUBERÍA
144 °C 3,2 bar 3,0 bar 7,1 bar
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Instrucciones para el uso
●
●
●
●
La válvula de seguridad V1. Válido para STERIV STERIVAP AP 9612, 9618, 9621 Tipo: HEROSE, 06-380, G 1“. Diámetro nominal DN 18. Presión de apertura 3,2 bar. La válvula de seguridad V2. Válido para STERIV STERIVAP AP 446, 636, 666, 669, 6612, 6618. Tipo: HEROSE, 06-390, G 1/2“. Diámetro nominal DN 15. Presión de apertura 3,2 bar. La válvula de seguridad V2. Válido para STERIV STERIVAP AP 9612, 9618, 9621 Tipo: HEROSE, 06-380, G 1“. Diámetro nominal DN 18. Presión de apertura 3,2 bar. B90 (HW) – sirve a la desconexión de avería. Hoja de tipo: B90_B91.jpg. Ajusta el nivel de trabajo del agua en el generador. generador. La altura del nivel está ajustada a los 70 mms sobre el extremo superior de la espiral de calefacción. La histéresis (el campo de regulación del nivel de
●
trabajo) es 4 mms. Al alcanzar el valor regulado del nivel, el contacto del indicador de nivel se conecta. B91 (NW) – sirve a la desconexión de avería. Hoja de tipo: B90_B91.jpg. Sirve para desconectar la calefacción en el caso del nivel bajo en el generador El nivel del agua está ajustado a los 32 mms sobre el extremo superior de la espiral de calefacción. Al alcanzar este nivel, el contacto del indicador de nivel está interrumpido y el sistema automático Master/Slave apaga la calefacción. El error está indicado en el display,, hay que llamar al personal de servicio. display
Al recorrer el nivel, el contacto del indicador se conecta. JUMO.
●
El sistema automático de medición, dirección y regulación de tipo Master-Slave está diseñado en la base de dos sistemas independientes según DIN VDE 0801 para las computadoras que trabajan en los
sistemas con las operaciones de seguridad.
4.3 PUERTAS La cámara de esterilización está equipada según el modelo,
con una o dos puertas verticales deslizables. Apertura y cerradura se realizan según el tipo o sea a mano o sea automáticamente después de presionar el botón. Estas puertas se cierran con sellos inflados a presión.
4.4 PUESTA Y SACAMIENTO Material destinado para esterilización es posible ponerlo o sacarlo, según el equipaje requerido, en tablas o mediante
de carritos de transporte TW y carritos de cargo BW.
4.5
CONTROL AUTOMÁTICO DEL EQUIPO
Una parte importante del equipo es su control electrónico
con dos microprocesadores (master-slave), para controlar y registrar el proceso de esterilización en forma automática, así como indicar todos los posibles estados de funciones y
desperfectos. En el caso de una interrupción del proceso por causa externa (falta de energia eléctrica etc.) al volver la situación a la normalidad, este control en forma automática seguirá el proceso en donde se interrumpió o llevará al equipo a un a fase segura para el usuario.
4.6
ARCHIVAMIENTO DE DATOS, EXPORTACIÓN DE DATOS
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Instrucciones para el uso
Hay una manera estandardizada para todos los equipos
de modelos diferentes incorporados a la red. La función de SimCon se puede desconectar por el menú de servicio y luego está el canal liberado para mandar los datos de imprimir cuales es posible archivar por ejemplo mediante el software Printer Archiv. Archiv. Caso de que esté conectada la
función SimCon y de un motivo imposibilitada, por ejemplo cuando esté desacoplado el cable y etc., la impresora no vaya a imprimir y no haya salida de datos a cualquier equipo exterior. En caso de que ocurra esta situación hay que quitar la causa de la infuncionalidad de SimCon y luego hay que
desconectar y de nuevo conectar el esterilizador.
4.8 ALIMENTACIÓN A VAPOR En alimentación a vapor (aditivos) son posibles estas realizaciones – ver capítulo 1:
FD, ED, FDED.
5
INFORMACIONES TÉCNICAS
Voltaje de alimentación trifásca con tierra física:...............................3 × 230/400 V ±10 Frecuencia de la red eléctrica:........50 Hz ± 5
Categoria de sobretensión eléctrica:..........................................2 Tipo de conexión eléctrica
3 fases/neutro/tierra física:..............3/PE Presión de vapor:............................2,5 bar ± 10 de
sobrepresión Nivel promedio de ruido:.................< 78 dB(A) Condiciones ambientales:
Condiciones ambientales:...............+5 hasta + 40 °C Máxima humedad relativa del aire:..85 % a l os 31 °C
altitud máxima:.................................3000 m Para más datos técnicos, de instalación y conexiones vea el “diagrama de instalación BMT”. Algunos parámetros pueden diferenciarse según el modelo y lugar de destino.
5.2
COMPONENTES DE CONTROL Y DESPLIEGUE (PUPITRE DE MANDO)
5.2.1 LADO DE CARGA CARGA Y Y CONTROL
5.1 DATOS TÉCNICOS Denominación (modelo): STERIVAP STERIV AP HP Volumen útil de esterilización en unidades de esterilización: 446 : 1 559 : 1 636 : 2 666 : 4
Display táctil
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Instrucciones para el uso
5.2.2 LADO DE DESCARGA Failure
Proceden según el capítulo 3.1.3.
En casos problemáticos en caso de esterilización del material poroso estándar emplean el paquete de prueba
Display
según el art. 24.1 de la norma EN 285+A2 y el indicador según la norma EN 867-3. A evaluar el test mantengan mantengan las instrucciones de su fabricante.
6.6 Phase of the sterilisation
cycle
To open the door
Stop
To close the door
Phase of the
sterilisation cycle
VT (PRUEBA DE VACÍO)
Una de las condiciones más importantes para una esterilización exitosa y para con esto poder garantizar la eliminación total de microorganismos en el material, es la ventilación completa de la cámara de esterilización y todavía más importante del material a esterilizar, así como un sellado perfecto para el vacío. Aire no extraído o aire que se regresa al vacío formará “nidos de aire” dentro del
material, y estos nidos, debido a la mala conductividad
térmica del aire, evitarán que la temperatura llegue al grado
6 PROGRAMAS -
BÁSICOS
6.1 PRECALENTAMIENTO El programa de precalentamiento a la temperatura de servicio. ¡Este programa no se puede usar para la
esterilización!
6.2
UNIVERSAL
Programa de sterilización con estos parámetros:
necesario para un efecto de esterilización. Para probar y asegurar una buena evacuación del aire y sellado del
vacío contra fugas, se realiza la Prueba de Vacío (V-Test).
Esta prueba se efectúa sin carga, primero se evacúa todo el aire (se produce vacío) después pasa un tiempo de compensación de 5 minutos y al final se realiza la prueba de vacío durante 10 minutos.
Después de terminar el programa VT VT,, el display indica un mensaje correspondiente al resultado del test. En el caso del resultado negativo debe repetirse el V-test de nuevo. Si la hermeticidad del aparato no está aceptable por segunda vez, hay que retirar el equipo de marcha. Antes de otro uso hay que revisar revisar el aparato por un técnico de serivcio y si hace falta dejarlo arreglar. arreglar. Después hay que
repetir el V-test de nuevo.
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Instrucciones para el uso
El esterilizador puede disponer de hasta 20 programas. Otra opción es la utilización de tarjetas Chip para ampliar,
mantener, instalar y cambiar los programas.
6.9
USO DE PROGRAMAS PROGRAMAS Y Y VALIDACIÓN
El usuario del esterilizador es responsable por la selección correcta de los programas de esterilización dependiendo del tipo y cantidad de los objetos a esterilizar / medios sanitarios. Según la normativa de UE número 93/42EEC es el fabricante de medios sanitarios determinados al uso repetitivo obligado a proveerlos de informaciones sobre los procedimientos adecuados de la limpieza, desinfección y esterilización o eventualmente sobre la reducción del número de uso repetitivo. Además está en vigor que la confirmación del hecho, que la configuración de una hornada concreta (su tipo, cantidad, empaquetamiento y colocación en la cámara del
esterilizador) será esterilizada repetidamente a nivel pedido de la esterilización por un programa dado del esterilizador, es posible conseguir solamente por la validación del procedimiento de esterilización según la norma EN ISO 17665-1.
7 MANEJO 7.1
DEL EQUIPO
MANEJO BÁSICO
7.1.1 DISPLAY TÁCTIL Para el manejo y la comunicación con el esterilizador
● ●
Los equipos con alimentación externa de vapor (FD)
están listos para su uso.
En los equipos con alimentación de generador de vapor
propio (ED,FED) pulse el botón Generador (encendido (encendido del generador).
Al alcanzar la presión nominal (aprox. 340 kPa) empieza el ciclo automático seleccionado anteriormente. ● Realice el V-test. El resultado debe de registrarse en la bitácora del equipo. ● ●
Realice un ciclo de esterilización sin carga. Se recomienda realizar un test BD.
7.3
INSTRUCCIONES PARA EL USO DEL EQUIPO
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Instrucciones para el uso
El final del ciclo de esterilización se indica acústicamente. Indicación en el display:
●
Seguidamente pulse el programa seleccionado P1, P2, de la siguiente pantalla de programas básica. Pulse el botón OK OK..
El botón
posibilita apagar la señalación acústica.
7.3.2 DESCARGA DE MATERIAL DE ESTERILIZACIÓN Modelos con una puerta: Pulse el botón de puerta Ab puerta Abri ri r, así se abre la puerta.
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Instrucciones para el uso
Saque el material esterilizado. Saque el protocolo de la impresora (una opción).
La puerta de carga queda cerrada todo el tiempo que la
puerta de descarga esté abierta. Después de abrir la puerta de carga, la puerta de descarga ya está bloqueada. Después de un ciclo de test BD o de Vacío exitosos se
puede abrir sólo la puerta de carga del material.
Pulse el botón
Se recomienda para ahorrar energía y evitar que la cámara
Si desea que el programa continúe:
equipo no está en uso.
Pulse el botón Si desea apagar el programa y abrir la puerta de la cámara
se contamine, mantener las puertas cerradas mientras el
Indicación en el display:
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Instrucciones para el uso
7.6
INFORMACIÓN ADICIONAL INDICACIÓN
Pantalla en modo básico del ciclo de esterilización
Pantalla en modo simplificado (claro)
7.6.1 INFORMACIÓN ACTUAL DE OPERACIÓN Para la indicación de la información acutal de operación pulse el botón Info en la pantalla básica. En la pantalla hay información básica sobre el equipo, las
pruebas y los valores actuales de presiones y temperaturas. Los equipos con una función de monitorización de agentes
(accesorio) visualizan en la pantalla también la información sobre los valores actuales de presiones de los agentes de entrada. Los valores de presiones están indicados como valores absolutos (presión absoluta). Las presiones de los agentes están monitorizados continuadamente por la automática del equipo y en el caso de una presión de entrada insuficiente
de uno de los agentes aparecerá un aviso de servicio correspondiente. El aviso de una baja presión del agente aparecerá también en el protocolo de la impresora del equipo.
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Instrucciones para el uso
Registro digital de presión y temperatura
Para terminar este modo de pantalla pulse el botón para
7.7
MENÚ – FUNCIONES DE SERVICIO
Las funciones de servicio permiten al personal operativo
regresa
.
7.7.1 AJUSTE DE DISPLAY
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Instrucciones para el uso
7.7.2 FECHA Y TIEMPO
7.7.3 IMPRESORA -
Pulse las teclas
Pulse las teclas
Inserte el nombre (solamente si se se requiere en el régimen presente)
AJUSTE
Elija las funciones requeridas de la pantalla
Dirección de la salida: Dirección Impresora – activación de la impresora empotrada
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Instrucciones para el uso
(Los datos se imprimen según la actual configuración
seleccionada). Para terminar pulsen el botón de la vuelta
.
– esta función hace posible imprimir los valores del ajuste usuario de colores.
Para terminar pulsen el botón de la vuelta
.
En el supuesto caso de un defecto, la impresora imprimirá un mensaje de error correspondiente. Los documentos de la impresora deben ser almacenados en un lugar seco, frío y sin luz directa del sol si desea archivarlos a largo plazo.
7.7.4 ENCENDIDO AUTOMÁTICO Este servicio posibilita programar el encendido automático del equipo. Asimismo, posibilita la selección de la prueba de vacío y otro programa de esterilización.
Pulse Me Menú nú / Encendido automático
Para la selección del segundo programa (B) pulse Programa B. En el caso de necesidad, elija el programa de esterilización requerido desde la pantalla siguiente. Pulsando se omite el programa B.
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Instrucciones para el uso
7.7.5 CAMBIO DE LOS PARÁMETROS DEL PROGRAMA Este servicio posibilita al usuario ajustar los parámetros seleccionados del ciclo de esterilización (Aditamento).
!
De esta manera, la eficacia de esterilización del programa
Teclando flechas seleccionen el parámetro deseado.
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Instrucciones para el uso
Caso de modificar los datos de programa, aparezca la indicación también en el protocolo de la impresora. ¡El acceso al de los parámetros de programas de esterilización y posibilidad de editarlos en la pantalla del equipo tiene solamente el servicio!
7.7.6 SUMARIO DE ENTRADAS ENTRADAS Y Y SALIDAS Con este servicio se visualizan los valores actuales de entradas y salidas.
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Instrucciones para el uso
Para confirmar el copiado pulsen el botón
● Pulsen el botón del programa que quiren desplazar. ●
Pulsen el botón del programa libre (no definido) a donde quiren desplazar el programa.
●
Pulsen el botón Desplazar y luego el botón Confirmar.
Para terminar este servicio pulsen el botón para volver. .
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Instrucciones para el uso
Pulse la tecla Fuente de vapor exterior
Para terminar pulse la tecla de regreso Cierre la válvula manual de conducto del vapor desde el generador y abra la válvula de conducto de vapor de la fuente exterior. Al im iment entaci aci ón des de el gen erad erador or in integ teg rad rado o Compruebe si está abierta la válvula de conducto del agua desmineralizada - DW en el equipo.
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Instrucciones para el uso
Los comentarios a los programas individuales son memorizados en el aparato también durante la activación apagada. El comentario será visualizado con los parámetros durante de selección de programas y será imprimado también por la impresora.
7.7.13 HISTORIAL DE PROTOCOLOS, TARJETA DE MEMORIA
De la tarjeta de memoria es posible consecutivamente sacar el protocolo guardado a su representación.
7.7.14 HISTORIAL DE ERRORES Pulse los botones del servicio Menú / Historial de errores
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