USER MANUAL
(Instruction for Use)
SW 2.9
EMC Guidance and Manufacturer’s Declaration
Version 2.9.7 dated 2020-12-23
Page 70 of 75
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Table 2: ELECTROMAGNETIC IMMUNITY (1)
Guidelines and declaration of conformity – electromagnetic immunity
The Carriazo-Pendular is intended to be used in a PROFESSIONAL HEALTHCARE FACILITY
ENVIRONMENT. The electromagnetic environment is specified below. The customer or the
user of the Carriazo-Pendular should assure that it is used in such an environment. The
Carriazo-Pendular is not intended to be used in exclusions, such as hospitals with near active
HF SURGICAL EQUIPMENT and RF shielded rooms of an ME System for magnetic resonance
imaging or other environments where the intensity of EM DISTURBANCES is high.
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic
environment – guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
Refer to
NOTE
1
Floor should be according to
the
guidance
“Room
Requirements”. If floor is
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
±1kV for input /
output lines
100kHz repetition
frequency
±2 kV for power
supply lines
Refer to
NOTE
2
±1kV for input /
output lines
100kHz
repetition
frequency
Mains power quality should
be that
of
a
typical
commercial
or
hospital
environment.
Surge
IEC 61000-4-5
±1kV line(s) to
line(s)
±2 kV line(s) to
earth
±1kV line(s) to line(s)
±2 kV line(s) to earth
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
100% dip in U
T
for
0.5 cycle
at 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°.
100% dip in U
T
for
1 cycle
70% U
T
(30% dip in U
T
) for
25 cycles
100% dip in U
T
for
0.5 cycle
at 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°.
100% dip in U
T
for 1
cycle
70% U
T
(30% dip in U
T
) for 25
cycles
Mains power quality should
be that
of
a
typical
commercial
or
hospital
environment.
Refer to
NOTE
3.
