Electromagnetic Compatibility (Emc) To En60601-1:2007 - CareFusion MicroRPM Manuel D'utilisation

Electromagnetic Compatibility (EMC)
to EN60601-1:2007
WARNING: Use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause unexpected or
adverse operation
The MicroRPM has been tested to EN60601-1-2:2007, regarding its ability to
operate in an environment containing other electrical/electronic equipment
(including other medical devices).
The purpose of this testing is to ensure that the MicroRPM is not likely to
adversely affect the normal operation of other such equipment and that other
such equipment is not likely to adversely affect the normal operation of the
MicroRPM.
Despite the testing of the MicroRPM that has been performed, normal
operation of the MicroRPM can be affected by other electrical/electronic
equipment and portable and mobile RF communications equipment.
As the MicroRPM is medical equipment, special precautions are needed
regarding EMC (electromagnetic compatibility).
It is important that the MicroRPM is configured and installed/put into service,
in accordance with the instructions/guidance provided herein and is used only
in the configuration as supplied.
Changes or modifications to the MicroRPM may result in increased emissions or
decreased immunity of the MicroRPM in relation to EMC performance.
The MicroRPM should be used only with the accessories (RS232 cables)
supplied (which are referenced in the accessories section of this manual). None
of the MicroRPM cables should be extended in length by the user.
If any cables are extended by the user or non-approved accessories are used,
this may result in an increased level of emissions or decreased level of
immunity in relation to the MicroRPM EMC. None of the MicroRPM accessories
should be used with other devices, as this may result in an increased level of
emissions or decreased level of immunity in relation to the other devices' EMC.
The MicroRPM has a minimum basic performance – The respiratory pressure
readings on the product must remain within a tolerance of +/- 3%, and the
unit firmware must not cease responding. Warning: In the event the product is
operated in the presence of significant electromagnetic fields (particularly in
the frequency range 40-60MHz) while in the PC connected mode, ensure the
results on the unit and PC are the same. If the results differ, then relocating
the product away from sources of interference should resolve any issue.
WARNING: The MicroRPM should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use with other equipment is
necessary, the MicroRPM and the other equipment should be observed /
monitored, to verify normal operation in the configuration in which it will be
used.
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