Cardiocity RhythmPadGP, User Manual, Page: 12 / 41

Cardiocity Limited – RhythmPad
GP
– User Guide- Page 12
RhythmPadGP Manual.doc 20/05/16
To reduce the risk of permanent damage to the sensors, the procedure in section 3.2
of this manual should be followed at all times (i.e. the subject should firstly touch the
silver grounding discs with each hand, before touching the sensors directly).
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The RhythmPad
GP
is intended for use in the electromagnetic environment specified below. The customer or
the user of the RhythmPad
GP
should assure that it is used in such an environment.
Emission test Compliance Electromagnetic environment -
guidance
RF emissions
CISPR 11 Group 1 The RhythmPad
GP
uses RF energy only
for its internal function. Therefore, its RF
emissions are very low and are not likely
to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B The RhythmPad
GP
is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes
Harmonic emissions
IEC61000-3-2 Not applicable
Voltage fluctuations /
flicker emissions
IEC61000-3-3
Not applicable
Guidance and manufacturer’s declaration – Electromagnetic Immunity
The RhythmPad
GP
is intended for use in the electromagnetic environment specified below.
The customer or the user of the RhythmPad
GP
should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic
environment - guidance
Electrostatic
discharge (ESD)
IEC61000-4-2 ± 6 kV contact
± 8 kV air
± 6 kV contact*
± 8 kV air
*Permanent damage
can occur to the
sensors above a level
of 2kV. The subject
should touch the silver
grounding discs before
touching the sensors
directly – see section
3.2 of this manual. Floors should be wood,
concrete or ceramic tile. If
floors
are covered with
synthetic material, the
relative humidity should be at
least 30%. To reduce the risk
of permanently damaging the
sensors
above 2kV, the
subject should touch the
silver grounding discs before
touching the sensors directly
– see section 3.2 of this
manual.
Electrical fast
transient / burst
IEC61000-4-4 ± 2 kV for power supply
lines
± 1 kV for input /
output lines Not applicable Mains power quality should be
that of a typical commercial
or hospital environment.
Surge
IEC61000-4-5 ± 1 kV line(s) to line(s)
± 2 kV line(s) to earth Not applicable Mains power quality should be
that of a typical commercial
or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC61000-4-11
<5% U
T
(>95 % dip in
U
T
)
For 0.5 cycle
40% U
T
(60 % dip in U
T)
for 5 cycles
70 % U
T
(30 % dip in
U
T
)
for 25 cycles
<5% U
T
(>95 % dip in
U
T
)
For 5 s
Not applicable Mains power quality should be
that of a typical commercial
or hospital environment. If
the user of the RhythmPad
GP
requires continued operation
during
power mains
interruptions, it is
recommended that the
RhythmPad
GP
be powered
from an uninterruptable
power supply or a battery.
Power frequency
(50Hz)
Magnetic field
IEC61000-4-8 3 A/m 3 A/m If incorrect operation occurs,
it may be necessary to
position the RhythmPad
GP
further away from any
suspected sources of power
frequency magnetic fields.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.