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IEC 60601-1-8 Ed. 2.0 (2006)/A1:2012 (EN 60601-1-8:2007/A11:2017) - Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical electrical systems
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IEC 60601-1-4: 1996/A1:1999 (EN 60601-1-4: 1996/A1: 1999) - Medical electrical equipment - Part 1-4: General
requirements for safety - Collateral standard: Programmable electrical medical systems
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IEC 60601-1-6:2010 (EN 60601-1-6:2010) - Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
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IEC 62366:2007 (EN 62366:2008) - Medical devices - Application of usability engineering to medical devices
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EN ISO 17665-1:2006 - Sterilization of health care products - Moist heat - Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
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EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of
resterilizable medical devices
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EN 1041:2008 - Information supplied by the manufacturer of medical devices
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ISO 15223-1:2016 (EN ISO 15223-1:2016) - Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements
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ISO 80601-2-61:2011 (EN ISO 80601-2-61:2011) – Medical electrical equipment: Particular requirements for basic safety
and essential performance of pulse ox equipment
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ISO 80601-2-55:2011 (EN 80601-2-55: 2011) - Medical electrical equipment -- Part 2-55: Particular requirements for the
basic safety and essential performance of respiratory gas monitors
14.3 Especificaciones
El ventilador pulmonar electrónico de transporte está compuesto de los siguientes componentes:
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DISPLAY de cristal líquido LCD a color con gráficos de 320 x 240 puntos, con pantalla sensible al tacto de 5,7";
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Placa de Control con:
Presentación de los datos en el display;
o
Interfaz serial RS-232C para la actualización de software;
o
Diagnóstico e assistência remota à distância Magnamed (ARM);
o
Teclas de acceso rápido para:
o
Lectura de la presión en el circuito respiratorio;
o
Lectura de presión regulada;
o
Cargador inteligente de batería;
o
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Altavoz para alarmas y alertas;
✓ HOLD;
✓ O2100%;
✓ NEXT (Próximos parámetros de ajustes);
✓ MANUAL (Disparo Manual de Ciclo Inspiratorio);
✓ LOCK (Bloquea Teclas, menos ésta);
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