Documentos de Académico
Documentos de Profesional
Documentos de Cultura
Manual de Funcionamiento
Versión de software 2.n
Responsabilidad del Usuario
AAA B 12345
PRECAUCIÓN Precaución indica una situación que puede perjudicar el equipo. Lea y
siga todas las advertencias y precauciones.
On (encendido)
Off (apagado)
Toma de tierra
Equipotencial
Equipo tipo B
Los sistemas con este distintivo cumplen con las Directrices del
Consejo Europeo (93/42/EEC) para Equipos Médicos cuando son
usados de la manera que se especifica en los Manuales de
xxxx Funcionamiento y Mantenimiento. El “xxxx” es el número de
certificación del Cuerpo Notificado usado por los Sistemas de Calidad
del fabricante.
Conexión nebulizador
o AC Corriente Alterna
o DC Corriente Continua (Directa)
O2 280 … 600 kPa Entrada del suministro de O2 con presiones entre 280 y 600 kPa,
(2,8 y 6 bar, 40 y 80 PSI, )
AIR 280 … 600 kPa Entrada del suministro de AIRE con presiones entre 280 y 600 kPa,
(2,8 y 6 bar, 40 y 80 PSI)
2.1 Seguridad
Funcionamiento seguro Para usar el ventilador Centiva/5 ICU de forma segura utilice el
sistema sólo como se especifica. El usuario necesita familiarizarse con
este manual antes de utilizar el sistema. Sólo se permite el uso de este
sistema a usuarios entrenados. Asegúrese siempre de cumplir tanto
con los requerimientos de este manual de funcionamiento, como los
del gobierno local u otras autoridades para el funcionamiento de
ventiladores de cuidados intensivos.
Seguridad del paciente El Centiva/5 debe ser utilizado por o bajo las ordenes de un médico. El
Centiva/5 debe ser utilizado sólo por personal médico cualificado,
para asegurar una intervención adecuada en caso de un mal
funcionamiento del equipo.
Se requiere vigilancia constante por personal entrenado para el
paciente conectado a un ventilador de cuidados intensivos.
Asegúrese de que los límites de la alarma están fijados de acuerdo a la
situación del paciente, y de que las alarmas están fijadas siempre que
un paciente está conectado al sistema.
Utilice sólo circuitos de respiración aprobados por el fabricante del
Centiva/5 o por el fabricante de los accesorios.
Realice siempre la Comprobación “test de sistema” del Centiva/5
antes de utilizar el ventilador.
Riesgo residual Para reducir el riesgo del mal funcionamiento del equipo, se han
integrado sistemas redundantes en el Centiva/5.
Las funciones de riesgo alto y moderado se han diseñado para
proporcionar un sistema alternativo en caso de fallo primario.
Las funciones de bajo riesgo se examinan con el test de inicio antes de
su funcionamiento cada vez que se conecta la unidad.
El sistema proporciona un limitador ajustable de presión en los modos
CMV y SIMV. En los modos CMV o SIMV la Plímit se fija por defecto en 20
cmH2O en la forma Pediátrica o en 30 cmH2O en la forma Adulta.
El sistema posee un segundo nivel de seguridad adicional en la función
de presión, Plímit, que está activada en todos los modos. La Pmáx se fija
por defecto en 30 cmH2O en la forma Pediátrica y en 40 cmH2O en la
forma Adulta, en los modos CMV o SIMV/ASB. La Pmáx se fija por
defecto en 18 cmH2O en la forma Pediátrica y en 21 cmH2O en la forma
Adulta, en los modos Bi-Level/ASB, CPAP ASB o ASB Apnea.
Riesgo de daño eléctrico El Centiva/5 está diseñado para funcionar solamente en entornos
eléctricos de acuerdo a VDE 0107 o EN 60601-1.
Antes de limpiar, reparar, o de efectuar el mantenimiento, desconecte
siempre el sistema del suministro eléctrico. Antes de reconectar el
sistema al suministro eléctrico asegúrese de que la cubierta está seca.
Antes de conectar el equipo al suministro eléctrico, compruebe que el
voltaje local coincide con el voltaje de funcionamiento del equipo, que
está especificado en la chapa de serie en la parte posterior del mismo
Almacene el equipo de acuerdo a las especificaciones dadas para
temperatura y humedad.
El uso del sistema se realizará de acuerdo a las especificaciones dadas
para temperatura y humedad. En caso de que la temperatura del
sistema sea superior o inferior a la especificada, permita al sistema
estabilizarse durante al menos una hora antes de su funcionamiento.
No use materiales como Amoniaco, Fenoles o Acetona para limpiar el
equipo.
No use el Centiva/5 si existe duda de la correcta función de la toma de
tierra eléctrica en el entorno de la instalación.
Riesgo de interferencias Los campos electromagnéticos producidos por otros equipos, con una
electromagnéticas fuerza mayor a la especificada por EN 60601-1-2 pueden influir en el
funcionamiento seguro del Centiva/5 y pueden poner en peligro al
paciente.
Los campos de alta frecuencia producidos por otros equipos instalados
cerca del sistema, pueden influir en el funcionamiento seguro del
Centiva/5 y pueden poner en peligro al paciente.
No use teléfonos móviles a menos de 10 metros del Centiva/5. De otra
manera, puede resultar en una posible influencia para el
funcionamiento seguro del Centiva/5 y pueden poner en peligro al
paciente.
No use el Centiva/5 en presencia de equipos de resonancia magnética
nuclear (NMR, MRI).
Servicio y mantenimiento El Centiva/5 debe ser revisado al menos cada doce meses para su
seguridad y correcto funcionamiento.
Solamente personal de servicio autorizado debe llevar a cabo la
reparación, el servicio y el mantenimiento del equipo.
Los intervalos de mantenimiento y procedimientos están
documentados en la sección 9, ”Mantenimiento”.
Notas
3.2 Suministro
3.2.1 Suministro eléctrico El Centiva/5 puede ser configurado para que su suministro se realice
con voltaje eléctrico de 230 V o 115 V AC.
3.2.2 Suministro de gas El suministro del Centiva/5 puede hacerse con O2 y AIRE. Se puede
utilizar con suministro único de AIRE u O2.
3.3 Instalación
Bloque principal
Panel de control
Válvula de espiración
Centiva/5
Bi-Level / ASB Tubo : E 7.5 50% Adulto
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10 Datos técnicos
10.1 General
10.2 Suministros
Fundamentos del ventilador Modos de ventilación: CVM, PLV, PCV, SIMV, SIMV/ASB,
Bi-Level, Bi-Level/ASB,
CPAP, ASB/CPAP,
ASB Apnea
Principio de funcionamiento: tiempo controlado,
volumen constante,
ciclos de presión
Sistema de trigger: trigger por flujo
Menú de parámetros
ByFlow (flujo continuo): 3.0 a 30 L/min
Volumen de la alarma: 20 a 100 %
Menú de parámetros
Flujo-I: 2 a 99,9 L/min
Rampa ASB: 0,2 a 0,5 seg
Trigger: 0.5 a 20 L/min
ByFlow: 3 a 30 L/min
Vent. tiemp.: 20 a 90 % del tiempo espiratorio
ASB Endflow: 10 a 60 % del pico de flujo ASB
Volumen de la alarma: 20 a 100 %
Menú de parámetros
Rampa ASB: 0,2 a 0,5 seg
Trigger: 0.5 a 20 L/min
ByFlow: 3 a 30 L/min
Vent. tiemp.: 20 a 90 % del tiempo espiratorio
ASB Endflow: 10 a 60 % del pico del flujo ASB
Volumen de la alarma: 20 a 100 %
Menú de parámetros
Trigger: 0.5 a 20 L/min
ByFlow: 3 a 30 L/min
ASB Endflow: 10 a 60 % del pico del flujo ASB
Volumen de la alarma: 20 a 100 %
Modo ASB/Apnea Modo ASB/CPAP con modo BiLevel/ASB de apoyo en caso de apnea
Menú de parámetros
Trigger: 0.5 a 20 L/min
ByFlow: 3 a 30 L/min
ASB Endflow: 10 a 60 % del pico de flujo ASB
Volumen de la alarma: 20 a 100 %
Menú de parámetros
Rampa ASB: 0,2 a 0,5 seg
Trigger: 0.5 a 20 L/min
ByFlow: 3 a 30 L/min
Vent. tiemp.: 20 a 90 % del tiempo espiratorio
ASB Endflow: 10 a 60 % del pico del flujo ASB
Volumen de la alarma: 20 a 100 %
Notas
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A1 Funciones adicionales
A1.1.3 Concentración de O2 Dependiendo del ajuste de la FiO2, el suministro del nebulizador puede
realizarse con AIRE u O2 para mantener la desviación de la
concentración de O2 suministrado (O2 - I) en un rango de ± 4 Vol. %.
Para evitar un incremento en las desviaciones, el Centiva/5 apaga el
modo de nebulización con flujo inspiratorio <15 l/min y muestra en la
pantalla el mensaje “Flujo< 15 l/min”.
Si se cambia el modo de ventilación con el resultado de un flujo
inspiratorio < 15l/min, el Centiva/5 mostrará dicho mensaje y activará
automáticamente el parámetro “Flujo-I” para facilitar el ajuste. Si no se
modifica el flujo-I y se pulsa el ComWheel en esta situación, el modo
de nebulización termina.
A1.1.5 Test del nebulizador El Centiva/5 posibilita en el test de sistema la medición de las
características del nebulizador seleccionadas y la compensación
acorde a esta información. Para ello, conecte el nebulizador de la
manera explicada en A.1.1.4 y lleve a cabo el test de sistema.
El Centiva/5 detectará automáticamente si el sistema de nebulización
está conectado y
medirá el flujo del
nebulizador.
Centiva/5
Test de sistema Rev. X.nn
Este valor se visualiza El test de sistema: OK.
Para empezar ventilaciÛn pulsar <Enter>
en los resultados del Compliancia 2.3 ml/cmH2O
test de sistema y se Resistencia
Fuga de aire
0.8 cmH2O/L/s
15 ml/min
usará para
Flujo nebulizador 7,0 l/min
compensaciones
Adult
internas.
“Valor último”.
Esta función sólo puede ser activada con una vía de acceso rápido.
simultáneamente,
comenzará la
calibración del
sensor de O2 en Calibracion online sensor -O ON
cualquier modo de
ventilación.
Presionando de
nuevo las mismas
teclas, la
calibración del
sensor de O2 se detiene.
Centiva/5
Test de sistema Rev. X.nn
El test de sistema: OK.
Para empezar ventilaciÛn pulsar <Enter>
Adult
W-1
Datex-Ohmeda, Inc. Manufactured by Centiva/5
Ohmeda Drive Salvia Lifetec GmbH & Co KG O & M Manual, Spanish
PO Box 7550 Niederhöchstädter Str. 62 CM-920042
Madison WI 53707-7550 61476 Kronberg Rev. 2.0
USA Germany Printed in Germany
Tel 608 221 1551 Tel. 0617393330 TIM GmbH
Fax 608 222 9147 Fax 06173933329 All rights reserved
www.datex-ohmeda.com 0123 www.salvia-lifetec.de www.tim-gmbh.de