111
"NIBP SYSTEM
FAILURE"
Appendix 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
Problem happens when measuring
the curve. The system cannot perform
measurement, analysis or calculation.
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
Check the connection of each part
and the patient situation. Measure again,
if the failure still exists, contact the
manufacturer for repair.
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.