28
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified
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
Compliance
level
Electromagnetic
environment -
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood,
concrete or ceramic
tile. If floors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines ±1
kV for input/
output lines
±2 kV line(s) to
line(s)
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
IEC 61000-
4-11
<5% UT
(>95% dip in UT)
for 0.5 cycle 40%
UT
(60% dip in UT )
for 5 cycles
70% UT
(30% dip in UT )
for 25 cycles
<5% UT
(>95% dip in UT )
for 5 s
<5% UT
(>95% dip in UT)
for 0.5 cycle
40% UT
(60% dip in UT )
for 5 cycles
70% UT
(30% dip in UT )
for 25 cycles
<5% UT
(>95% dip in UT )
for 5 s
Mains power quality
should be that of a
typical commercial or
hospital environment. If
the user of the device
requires continued
operation during power
mains interruptions, it
is recommended that
the device be powered
from an uninterruptible
power supply or a
battery.
Power
frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3A/m
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Table 2 Guidance and MANUFACTURER’s declaration – ELECTROMAGNETIC
IMMUNITY – for all ME EQUIPMENT and ME SYSTEMS
Summary of Contents for BPM200
Page 1: ...BPM200 Blood Pressure Monitor PLEASE READ ALL THE INSTRUCTIONS BEFORE USE ...
Page 2: ...2 ...
Page 4: ...4 ...
Page 5: ...5 English Manual ...
Page 32: ...32 Manuel d utilisation en français ...
Page 34: ...34 Informations de sécurité ...
Page 35: ...35 ...
Page 55: ...55 Gebrauchsanleitung auf Deutsch ...
Page 78: ...78 Manual De Instrucciones En Español ...
Page 101: ...101 Manuale D istruzioni In Italiano ...
Page 124: ...124 Instrukcja obsługi Polski ...
Page 147: ......
