CareFusion PulmoLife, Instructions For Use Manual

Page: 13 / 156

English 9
ELECTROMAGNETIC COMPATIBILITY (EMC)
WARNING: use of portable phones or other radio frequency (RF)
emitting equipment near the system may cause unexpected or
adverse operation
The Pulmolife 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 Pulmolife 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 Pulmolife.
Despite the testing of the Pulmolife that has been undertaken, normal
operation of the Pulmolife can be affected by other electrical/electronic
equipment and portable and mobile RF communications equipment.
As the Pulmolife is medical equipment, special precautions are needed
regarding EMC (electromagnetic compatibility).
It is important that the Pulmolife 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 Pulmolife may result in increased
emissions or decreased immunity of the Pulmolife in relation to EMC
performance.
The Pulmolife should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use with other equipment is necessary,
the Pulmolife and the other equipment should be observed/ monitored, to
verify normal operation in the configuration in which it will be used.
For the purposes of EN60601-1-2 the Pulmolife has an essential
performance (the Pulmolife must not begin to measure unintentionally
during a test and should pass a post test 3 litre calibration syringe
measurement).