• If the essential performance is lost or degraded, it may be necessary to take
mitigation measures, such as re-orienting or relocating the ME EQUIPMENT
or ME SYSTEM or shielding the location. During this time, the user should
stop using the monitor and contact the service personnel.
• The device needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided
below.
• Other devices may interfere with this device even though they meet the
requirements of CISPR.
• When an input signal is below the minimum amplitude provided in technical
specifications, erroneous measurements could result.
• The EMISSIONS characteristics of this device make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this device
might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating
or re-orienting the device.
Guidance and 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
IEC60601 test
level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 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
(length greater
than 3 m)
±2 kV for power
supply lines
±1 kV for input/
output lines
(length greater
than 3 m)
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge IEC
61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
B - 4 VS 8/VS 8A Vital Signs Monitor Operator’s Manual
Voltage dips
and Voltage
interruptions
IEC 61000-4-11
0% U
T
for 0.5 cycle:
at 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% U
T
for 1 cycle
and 70% U
T
for 25/
30 cycles: at 0°
0% U
T
for 250/300
cycles
0% U
T
for 0.5 cycle:
at 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% U
T
for 1 cycle
and 70% U
T
for 25/
30 cycles: at 0°
0% U
T
for 250/300
cycles
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
our product requires
continued operation
during power mains
interruptions, it is
recommended that our
product be powered from
an uninterruptible power
supply or a battery.
RATED power
frequency
magnetic
fields
IEC 61000-4-8
30 A/m
50 Hz/60 Hz
30 A/m
50 Hz/60 Hz
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Note: U
T
is the AC mains voltage prior to application of the test level.
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