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Electromagnetic Compatibility (Emc) To En60601-1:2007 - CareFusion Micro I Bedienungsanleitung

Diagnostic spirometer
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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 Micro I 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 Micro I 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
Micro I.
Despite the testing of the Micro I that has been undertaken, normal operation
of the Micro I can be affected by other electrical/electronic equipment and
portable and mobile RF communications equipment.
As the Micro I is medical equipment, special precautions are needed regarding
EMC (electromagnetic compatibility).
It is important that the Micro I 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 Micro I may result in increased emissions or
decreased immunity of the Micro I in relation to EMC performance.
The Micro I should be used only with the accessories (USB cables, mains
adapter and turbine transducer) supplied (which are referenced in the
accessories section of this manual). None of the Micro I 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 Micro I EMC. None of the Micro I 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 Micro I has an essential performance – When verified with a 3 litre syringe
the readings remain within a tolerance of +/-3.5%, and unit firmware must
not cease operating. In the unlikely event of a Fast Transient / ESD event
occurring, the device should be reset and located away from the source of
interference.
WARNING: The Micro I should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use with other equipment is necessary, the
Micro I 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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