USER
MANUAL
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51331-006
Safety and EMC standards
The system has been certified and complies with the following standards:
IEC 60601-1
International standard for medical electrical equipment, general requirements.
UL60601-1:2003
USA standard for medical electrical equipment, general requirements.
CAN/CSA 22.2 No 601.1 M90
Canadian standard for medical electrical equipment, general requirements.
IEC 60601-1-2
International standard for medical electrical equipment, EMC requirements, calling:
*CISPR11
Conducted Emissions, Group 1, Class B
CISPR11
Radiated Emissions, Group 1, Class B
IEC61000-4-2
Electrostatic Discharges
IEC61000-4-3
Immunity - Radiated RF Field
*IEC61000-4-4
Immunity - Transients Bursts
*IEC61000-4-5
Immunity – Surges
IEC61000-4-6
Immunity – Conducted
IEC61000-4-8
Immunity – Power frequency fields
*IEC61000-4-11
Immunity – Voltage dips, interruptions
*IEC61000-3-2
Harmonic Emissions
*IEC61000-3-3
Voltage Fluctuations/flicker
*Note: Compliance is provided by the PC
Classification
Degree of protection against electrical shock
No patient-applied parts, no accessible metalwork
Type of protection against electrical shock
Note: When unit is connected to mains power supply
Class II device
Class 1 power supply
Degree of protection against harmful ingress of water
Ordinary (no protection)
Mode of operation
Continuous
Degree of safety of application in the presence of a
flammable anaesthetic mixture with air or with oxygen or
nitrous oxide
Not suitable
Light Hazards
The unit has been tested and is in conformance with the following requirements for optical radiation safety:
Standard
Description
ISO 15004-2:2007
Light Hazard Protection, Group 1 instrument.
Appendix 1
