Product Compliance - GE DINAMAP ProCare Service Manual

Product Compliance

Revision C
Equipment Overview: Product Compliance
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The DINAMAP ProCare Monitor is classified in the following categories for
compliance with IEC 601-1:
Internally powered or Class II when powered from external supply
Transportable
For continuous operation
Not suitable for use in the presence of flammable anesthetics
Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent)
Type BF applied parts
IPX1, degree of protection against ingress of water
Sterilization/Disinfection, see Appendix B
Software is developed in accordance with IEC 601-1-4.
This equipment is suitable for connection to public mains via power
adaptors as defined in CISPR 11.
The SpO parameter conforms to ISO 9919:2005.
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Defibrillation protected. When used with the recommended accessories, the
Monitor is protected against the effects of defibrillator discharge. If
monitoring is disrupted by the defibrillation, the Monitor will recover.
DINAMAP PROCARE MONITOR
CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE AND
MECHANCIAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE
WITH CAN/CSA C22.2 NO. 601.1. ALSO EVALUATED TO IEC-601-2-30.
This product conforms with the essential requirements of the
Medical Device Directive. Accessories without the CE mark are not
guaranteed to meet the Essential Requirements of the Medical
0086
Device Directive.
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DINAMAP ProCare Monitor Service Manual
2009381-001
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