Regulatory and Safety Information
Efficia CM Series Network Configuration Guide 7-1
Safety Standards
7
Regulatory and Safety Information
Safety Standards
The Efficia CM Series monitor has been tested to the following safety standards.
Safety
Efficia CM Series Patient Monitors conform to CISPR 11. Efficia CM Series Patient Monitors
are suitable for use in all establishments, except domestic establishments and those
directly connected to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Accessory equipment connected to the data interface of the Efficia CM Series monitor
must be certified according to EN Standard 60950 for data-processing equipment or EN
Standard 60601-1 for electromedical equipment. All combinations of equipment must be
in compliance with EN Standard 60601-1 systems requirements.
Applicable Standards
IEC 60601-1:2005/A1:2012
IEC 60601-1-2:2014
EN 60601-1-2:2015
IEC 60601-1-6:2013
IEC 62366:2007/A1:2014
IEC 60601-1-8:2006/A1:2012
IEC 62304:2006/A1:2015
IEC 60601-2-26:2012
IEC 60601-2-27:2011
IEC 80601-2-30:2018
IEC 60601-2-34:2011
IEC 80601-2-49:2018
ISO 80601-2-55:2018
ISO 80601-2-56:2017
ISO 80601-2-61:2017
Parameter Specification
Protection Class Class I, internally powered equipment, per IEC
60601-1
Degree of Protection Type CF defibrillator-proof: per IEC 60601-1
IPX1 Ingress protection against vertically falling water
drops
Mode of Operation Continuous
Protection Against Hazards of Ignition of
Flammable Anesthetic Mixtures
Equipment is not suitable for use in the presence of a
flammable anesthetic mixture with air or oxygen or
nitrous oxide, per IEC 60601-1.
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