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Guidance and MANUFACTURER's declaration – electromagnetic IMMUNITY – for
all ME EQUIPMENT and ME SYSTEMS:
Guidance and manufacturer's declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment speci ed below. The customer or the user of the
device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 test level
Electrostatic
±6 kV contact
discharge (ESD)
±8 kV air
IEC 61000-4-2
±2 kV for
Electrical fast
power supply lines
transient/burst IEC
±1 kV for input/output
61000-4-4
lines
±1 kV line(s)
Surge IEC
to line(s)
61000-4-5
±2 kV line(s)
to earth
<5% UT
(>95% dip in UT )
for 0.5 cycle
Voltage dips,
40% UT
short interruptions
(60% dip in UT )
and voltage va-
for 5 cycles
riations on power
70% UT
supply
(30% dip in UT )
input lines
for 25 cycles
IEC 61000-4-11
<5% UT
(>95% dip in UT )
for 5 s
Power frequency
(50/60Hz)
magnetic eld
3A/m
IEC 61000-4-8
NOTE
UT is the a.c. mains voltage prior to application of the test level.
WIRELESS WRIST BLOOD PRESSURE MONITOR
Compliance level
Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic
±6 kV contact
tile. If oors are covered with synthetic
±8 kV air
material, the relative humidity should be
at least 30%.
±2 kV for power
Mains power quality should be that of a
supply lines
typical commercial or hospital environment.
±1 kV line(s) to
Mains power quality should be that of a
line(s)
typical commercial or hospital environment.
<5% UT
(>95% dip in UT )
for 0.5 cycle
Mains power quality should be that of a
40% UT
typical commercial or hospital environment.
(60% dip in UT )
If the user of the device requires continued
for 5 cycles
operation during power mains interruptions,
it is recommended that the device be
70% UT
powered from an uninterruptible power
(30% dip in UT )
supply or a battery.
for 25 cycles
<5% UT
(>95% dip in UT )
for 5 s
Power frequency magnetic elds should
be at levels characteristic of a typical
3A/m
location in a typical commercial or hospital
environment.
EN
IVBPW
21
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