Cardiocity Limited – RhythmPad
GP
– User Guide- Page 11
RhythmPadGP Manual.doc 20/05/16
1.16 EMC
Special Instructions & Notes regarding the RhythmPad
GP
& Electromagnetic
compatibility (EMC) testing to EN60601-1-2:2007.
The RhythmPad
GP
has been tested 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 the RhythmPad
GP
is not likely to adversely
affect the normal operation of other electrical/electronic equipment and that other
electrical/electronic equipment is not likely to adversely affect the normal operation
of the RhythmPad
GP
.
Despite the testing of the RhythmPad
GP
that has been undertaken, normal operation
of the RhythmPad
GP
can be affected by other electrical/electronic equipment and
portable and mobile RF communications equipment. As the RhythmPad
GP
is medical
equipment, special precautions are needed regarding EMC (electromagnetic
compatibility).
It is important that the RhythmPad
GP
is configured and installed/put into service, in
accordance with the instructions/guidance provided herein and is used only in the
configuration as supplied.
The RhythmPad
GP
has been tested (and should be used only with) the USB cable
supplied. If the RhythmPad
GP
is used with USB cables other than supplied, this may
result in increased emissions or decreased immunity of the RhythmPad
GP
in relation
to EMC performance. It should also be noted that the USB cable provided with the
RhythmPad
GP
should not be used with other equipment. To do so may result in
increased emissions or decreased immunity of the other equipment in relation to EMC
performance.
The RhythmPad
GP
should not be used adjacent to, or stacked with, other equipment.
If adjacent or stacked use with other equipment is necessary, the RhythmPad
GP
and
the other equipment should be observed/monitored, to verify normal operation in the
stacked/adjacent configuration in which it will be used.
For the purposes of EN60601-1-2, the RhythmPad
GP
does not have an essential
performance. The user should be aware that if the RhythmPad
GP
is subject to
electrical/electromagnetic interference in the form of conducted and radiated RF
fields (EMC phenomena detailed in the specifications EN61000-4-6 and EN61000-4-
3/EN61000-4-8 respectively), incorrect operation of the RhythmPad
GP
may occur in
the form of noise being present on measured waveforms or the RhythmPad
GP
may
cease to respond (3
rd
party software stops responding and the RhythmPad
GP
LED is lit
solid green). To correct this condition, the RhythmPad
GP
should be moved away from
any suspected sources of interference (with the USB cable disconnected and re-
connected, should the RhythmPad
GP
have ceased responding).
The user should also be aware that if the RhythmPad
GP
is subject to electromagnetic
interference in the form of Electrostatic Discharges (EMC phenomenon detailed in the
specification EN61000-4-2), incorrect operation of the RhythmPad
GP
may occur in the
form of noise being present on measured waveforms or the RhythmPad
GP
may cease
to respond (3
rd
party software stops responding and the RhythmPad
GP
LED is lit solid
green). To correct this condition, the RhythmPad
GP
should be moved away from any
suspected sources of interference (with the USB cable disconnected and re-
connected, should the RhythmPad
GP
cease responding). In addition, should the hand
sensors be directly subject to Electrostatic Discharges in excess of 2kV, this may
result in permanent damage to the sensors (which would require service/repair).