Accessories And Auxiliary Equipment - Getinge Maquet FLOW-i 4.2 User Manual

| 2 | Important |
2.5 Accessories and auxiliary
equipment
• External equipment intended for connection
to signal input, signal output or other
connectors shall comply with relevant IEC
standards (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical
electrical equipment). In addition, all such
combinations – systems – shall comply with
the standard IEC 60601-1 'Safety
requirements for medical electrical
systems'. Equipment not complying with
IEC 60601-1 shall be kept outside the
patient environment, as defined in the
standard.
• Any person who connects external
equipment to signal input, signal output or
other connectors has formed a system and
is therefore responsible for ensuring that
the whole system complies with the
requirements of IEC 60601-1. If in doubt,
contact a qualified medical technician or
your local representative.
• For optional equipment and accessories,
refer to the user documentation supplied
by the manufacturer.
• Use of an anesthesia gas scavenging
system is compulsory and must comply
with ISO 7396-2 (wall connection) and ISO
80601-2-13 (tubings).
• Values measured at the signal outputs of
the anesthesia system, which have been
processed in auxiliary equipment, must not
be used as a substitute for therapeutic or
diagnostic decisions. Such decisions can
be made only by staff with medical
expertise, and according to established and
accepted practice.
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• If there should be any deviation between
information shown on the system and that
shown by auxiliary equipment, the
parameters shown on the system shall be
considered the primary source of
information.
• When electrical equipment is connected to
the auxiliary power outlet or
communications interface, a medical
electrical system (ME system) is effectively
created, potentially reducing the level of
safety. This could result in previously
unidentified risks to patient, users or third
parties. It is the responsibility of the user to
ensure that the connected equipment is
compatible with the requirements of IEC
60601-1.
• Connecting auxiliary equipment to the
auxiliary power outlet can potentially
increase leakage currents to values above
the allowable limits.
• External monitors or similar devices
connected to the VGA port of the system,
must be powered via a medical grade
isolation transformer. No other use is
allowed.
• The responsible organization should
identify, analyze, evaluate and control these
risks.
• Subsequent changes to the medical
electrical system could introduce new risks
and require additional analysis.
• Changes to the medical electrical system
include configuration changes, connection
of additional items, disconnection of items,
update or upgrade of connected equipment.
FLOW-i 4.2, User's Manual