57
Table 2
For all EQUIPMENT and SYSTEMS
Guidance and manufacturer's declaration - electromagnetic immunity
The arm type blood pressure monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the arm type blood
pressure monitor should assure that it is used in such an environment.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrostatic
transient / burst
EN 61000-4-4
Surge
EN 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
EN 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Note: U
is the a.c. mains voltage prior to application of the test level.
T
IEC 60601
Compliance
test level
level
± 6 kV contact
± 6 kV contact
± 8 kV air
± 8 kV air
± 2 kV for power
N/A
supply lines
± 1 kV for input/
output lines
± 1 kV differential
N/A
mode
± 2 kV common
mode
< 5% U
N/A
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 sec
3 A/m
3 A/m
Electromagnetic
environment-guidance
Floors should be wood, concrete
or ceramic tile. If floors 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 environment.
Mains power quality should be
that of a typical commercial
or hospital environment.
Mains power quality should be
that of a typical commercial
or hospital environment. If the user
of the arm type blood pressure
monitor requires continued
operation during power mains
interruptions, it is recommended
that the a rm type blood pressure
monitor be powered from an
uninterruptible power supply
or a battery.
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.