6
Product Compliance
• This equipment is suitable for connection to public mains as
defined in CISPR 11.
• This Monitor conforms to general safety standard for medical
devices to IEC 60601-1.
• This Monitor conforms to EMC safety standard to IEC 60601-1-2.
• This Monitor conforms to usability safety standard for medical
devices to IEC 60601-1-6.
• The application of usability engineering to medical device
conforms to IEC 62366.
• The software life cycle processes conforms to IEC 62304.
• The application of risk management analysis to medical device
conforms to ISO 14971.
• The SpO2 Parameter conforms to ISO 80601-2-61.
• The SpO2 Parameter controlled desaturation study conforms to
ISO 14155: 2011.
• The TEMP parameter conforms to ISO 80601-2-56.
• The gas parameter conforms to ISO 80601-2-55.
• This Monitor conforms to particular safety standard for
multifunction patient monitoring equipment to IEC 60601-2-49.
• The invasive blood pressure parameter conforms to the IEC
60601-2-34.
• The ECG parameter conforms to IEC 60601-2-27, with exception
of Sub-clause 201.12.1.101.15.
• The NIBP parameter conforms to IEC 80601-2-30, EN 1060-3,
ANSI/AAMI/ISO 81060-2.
• The Entropy parameter conforms to IEC 60601-2-26.
• The alarm systems of the Monitor conform to IEC 60601-1-8.
Exception
The ECG parameter conforms to IEC 60601-2-27, with exception of
Sub-clause 201.12.1.101.15 QRS detection.
WARNING: In clinical conditions, it is reasonable to
assume that spurious signals of this type are either
random in occurrence, or related to pacemaker
activity. The arrhythmia analysis algorithm is
designed to factor the randomness of spikes into its
rejection logic, and this randomness is not exercised
in the above referenced testing. The algorithm does
correctly reject pace signals as prescribed by IEC
60601-2-27.
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