Emc And Radio Regulatory Compliance - Philips G5 solution Instructions For Use Manual

Specifications
Regulatory and safety specifications continued
• EN ISO 10993-1:2009, EN ISO 10993-1:2009/AC:2010 ISO 10993-1 and
Biological Evaluation of Medical Devices
• EN ISO 10993-5:2009 Biological Information of Medical Devices-Part 5:
Test for cytotoxicity
• ISO 10993-10:2010 Biological Information of Medical Devices-Part 10:
Test for irritation and skin sensitization
• ANSI/AAMI/IEC 60601-2-47:2012, EN 60601-2-47:2001 Particular
requirements for the basic safety and essential performance and
ambulatory electrocardiographs system.
• ANSI/AAMI/IEC 60601-2-27:2011, IEC 60601-2-27 Ed 3.0 2011-03
Particular requirements for the basic safety and essential performance
of Electrocardiographic Monitoring Equipment
• ANSI/AAMI/ISO EC57:1998(R)2008, Testing and reporting performance
results of cardiac rhythm and st-segment measurement algorithm.
• ANSI/AAMI/ISO EC12:2000/®2010 Disposable electrodes

EMC and radio regulatory compliance

This Philips product complies with relevant international and national law
and standards on EMC (electromagnetic compatibility) for this type of
product when used as intended. Such laws and standards define both the
permissible electromagnetic emission levels from product and its required
immunity to electromagnetic interference from external sources.
Other electronic products exceeding the limits defined in such EMC
standards could, under unusual circumstances, affect the operation of the
product.
• Medical electrical products needs special precautions regarding
EMC, and needs to be installed and put into service according to EMC
information provided in this Instructions for use.
• The use of accessories and cables other than those specified, may
result in increased emission or decreased immunity levels.
• The product should not be used adjacent to or stacked with other
products and that if adjacent or stacked use is necessary, it should be
observed to verify normal operation.
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