Covidien Nellcor OxiMax N-600x, Operator'S Manual

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Cautions
Operator’s Manual
3
Cautions
Caution
When connecting the OxiMax N-600x pulse oximeter to any instrument, verify proper
operation before clinical use. Both the pulse oximeter and the instrument connected to it
must utilize a grounded outlet. Accessory equipment connected to the pulse oximeter’s data
interface must be certified according to
IEC Standard 60950 -1: 2005 for data-processing
equipment or IEC Standard 60601-1:1988 + A1:1991 + A2:1995 for electromedical
equipment. All combinations of equipment must be in compliance with IEC Standard
60601-1-1:2000 Requirements for Medical Electrical Systems. Anyone connecting additional
equipment to the signal input port or signal output port (data port connector) is configuring
a medical system and, therefore, is responsible for ensuring that the system complies with
the Requirements for Medical Electrical Systems IEC Standard 60601-1-1:2000 and the
electromagnetic compatibility IEC Standard 60601-1-2:2001 + A1:2004. Oximeter accuracy
may degrade if it is connected to secondary I/O devices when the equipment is not
connected to earth reference.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Caution
Dispose of battery in accordance with local requirements and regulations.