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6. Especificaciones
ES
Notas:
Estas especificaciones están sujetas a cambios sin previo aviso.
En el estudio de validación clínica, se utilizó el ruido K5 en 85 sujetos para determinar la presión
arterial diastólica.
Este dispositivo se ha analizado desde el punto de vista clínico de acuerdo con los requisitos de la
ISO 81060-2:2013.
Este dispositivo no se ha validado para su utilización en mujeres embarazadas.
La clasificación IP se refiere a los grados de protección proporcionados por contenedores de acuerdo
con la norma IEC 60529. El dispositivo está protegido contra objetos sólidos extraños de 12 mm de
diámetro o más, como, por ejemplo, los dedos.
Este dispositivo cumple las disposiciones de la directiva comunitaria 93/42/EEC
(Directiva para Productos Sanitarios).
Este dispositivo se ha diseñado de acuerdo con la norma europea EN1060,
esfigmomanómetros no invasivos, parte 1: Requisitos generales, y parte 3: Requisitos
adicionales para sistemas electromecánicos de medición de la presión arterial.
Este dispositivo OMRON está fabricado bajo el estricto sistema de calidad de OMRON
HEALTHCARE Co., Ltd., Japón. El componente principal de los dispositivos OMRON, el
sensor de presión, está fabricado en Japón.
Material del manguito/tubo Nylon, poliéster, cloruro de polivinilo
Índice Monitor, manguito, manual de instrucciones, estuche protector, juego de pilas,
ficha para anotar la presión arterial, instrucciones de configuración
42


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