System Installation Requirements - Philips Avalon FM20 Service Manual

1:2005+A1:2012/EN 60601-1:2006+AC:2010) that ensures mechanical fixing of the power cords
and covering of any unused power outlets.

System Installation Requirements

• Ensure that the medical electrical system is installed in a way that the user achieves optimal use.
• Make sure the user is informed about the required cleaning, adjustment, sterilization, and
disinfection procedures listed in the Instructions for Use.
• The medical electrical system must be installed in such a way that the user is able to carry out the
necessary cleaning, adjustment, sterilization, and disinfection procedures listed in the Instructions
for Use.
• Ensure that the medical electrical system is installed in a way that an interruption and restoration
of power to any part of the medical electrical system does not result in a safety hazard.
• We recommend using fixed mains socket outlets to power the medical system or parts thereof.
Avoid using multiple portable socket-outlets.
• Any multiple portable socket outlets used must be compliant with IEC 60601-1:2005+A1:2012/
EN 60601-1:2006+AC:2010.
• Ensure that any part of the system connected to multiple portable socket-outlets is only removable
with a tool, i.e. the multiple portable socket-outlet provides a locking mechanism to prevent power
cords from being plugged or unplugged unintentionally. Otherwise, the multiple portable socket
outlet must be connected to a separation device. Multiple socket outlets used within the medical
electrical system must only be used for powering medical electrical equipment which is part of the
system.
• Ensure that any functional connections between parts of the medical electrical system are isolated
by a separation device according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010 to
limit increased equipment leakage currents caused by current flow through the signal connections.
This only works if the equipment leakage current of the respective medical electrical system parts
is not exceeded under normal conditions.
• Avoid increase of equipment leakage currents when non-medical electrical equipment within the
medical electrical system is used. This only works if the equipment leakage current of the
respective medical electrical system parts is not exceeded under normal conditions. Use additional
protective earth connection, separation device, or additional non-conductive enclosures.
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