Apéndice Iii - Gima CMS8000 Manual De Instrucciones

117
APÉNDICE III
Guidance and manufacture's declaration-electromagnetic emission
Guidance and manufacture's declaration – electromagnetic emission
The device is intended for use in the electromagnetic environment specified below. The customer or the
user should assure that it is used in such an environment.
Emission test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emission
IEC 61000-3-3
Electromagnetic immunity 1
Guidance and manufacture's declaration-electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user should assure that it is used in such an environment.
Immunity test
Electrostatic dischar-
ge (ESD)
IEC 61000-4-2
Electrical fast tran-
sient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,short
interruptions and
voltage vatiations on
power supply input
lines
IEC 61000-4-11
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
NOTE: U
is the a.c. mains voltage prior to application of the test level.
T
Compliance
Group 1
Class A
Class A
Complies
IEC60601 Compliance
test level level
±6kV contact ±6kV contact
±8kV air ±8kV air
±2kV for power ±0.5kV for power
supply lines supply lines
±1kV for input / ±1 kV for input /
output signal output signal
±1kV differential ±1kV differential
mode mode ±2kV
±2kV common common mode
mode
<5%UT(>95%dip <5%UT(>95%dip
in UT) for 0.5 cycle in UT) for 0.5 cycle
40% UT(60%dip 40% UT(60%dip
in UT) for 5 cycle in UT) for 5 cycle
70%UT(30%dip in 70%UT(30%dip in
UT) for 25 cycle UT) for 25 cycle
<5%UT(>95%dip <5%UT(>95%dip
in UT) for 5 sec in UT) for 5 sec
3A/m 3A/m
Electromagnetic environment-guidance
The device uses RF energy only for its internal fun-
ction. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
The Patient Monitor is suitable for use in all esta-
blishments, other than domestic establishments
and those directly connected to the public low-
voltage power supply network that supplies buil-
dings used for domestic purposes.
Electromagnetic environment-guidan-
ce
Floors should be wood, concrete or cera-
mic tile. If floor are covered with synthetic
material, the relative humidity should be
at least 30%.
Mains power quality should be that of
a typical commercial or hospital envi-
ronment.
Mains power quality should be that of
a typical commercial or hospital envi-
ronment.
Mains power quality should be that of
a typical commercial or hospital envi-
ronment. If the user requires continued
operation during power mains interrup-
tions, it is recommended that the devi-
ce be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical lo-
cation in a typical commercial or hospital
environment.