10 Specifications
68
Safety Specifications
IntelliVue CL SpO2 Pod and CL NBP Pod:
IntelliVue CL Charging Station and CL Transmitter:
The IntelliVue CL SpO
2
Pod, CL NBP Pod, CL Charging Station, and CL Transmitter comply with
the Medical Device Directive 93/42/EEC.
In addition, these devices comply with:
IEC 60601-1:1988 + A1:1991 + A2:1995; EN60601-1:1990 + A1:1993 + A2:1995; UL 60601-1:2003;
CAN/CSA C22.2#601.1-M90+S1+A2; JIS T 0601-1:1999; IEC 60601-1-1:2000; EN 60601-1-1:2001;
IEC60601-1-2:2001 + A1 2004; EN 60601-1-2:2001 + A1 2006
The possibility of hazards arising from software errors was minimized in compliance with ISO
14971:2007, IEC 60601-1-4:1996 + A1:1999; EN60601-1-4:1996 + A1:1999.
Classification (according to IEC 60601-1):
IntelliVue CL SpO
2
Pod, CL NBP Pod: Internally powered equipment, Type CF, Continuous
Operation
IntelliVue CL Transmitter: Internally powered equipment, Continuous Operation
IntelliVue CL Charging Station: Class I equipment, Continuous Operation
IntelliVue CL Transmitter Base Station and CL Hotspot:
The IntelliVue CL Transmitter Base Station and CL Hotspot comply with the Low Voltage Directive
2006/95/EC.
In addition, these devices comply with:
IEC 60950-1:2005; EN 60950-1:2006+A11:2009
EMC And Radio Regulatory Compliance
FCC and Industry Canada Radio Compliance
IntelliVue CL SpO2 Pod, CL NBP Pod, CL Charging Station, CL Transmitter:
This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme
NMB-001 du Canada.
IntelliVue CL Transmitter Base Station:
This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe B
est conforme à la norme NMB-003 du Canada.
IntelliVue CL Hotspot:
This Class A digital apparatus complies with Canadian ICES-003. Cet appareil numérique de la classe
A est conforme à la norme NMB-003 du Canada.
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