INSTRUCTION MANUAL
35
GUIDANCE AND MANUFACTURER’S DECLARATION —
ELECTROMAGNETIC IMMUNITY (CONTINUED)
The device is intended for use in the electromagnetic environment specified below. The
customer or the user of device should assure that it is used in such an environment.
IMMUNITY
TEST
EC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT — GUIDANCE
Electrostatic
discharge
(ESD)
lEC 61000-
4-2
±8 kV contact
±2 kV, ±4 kV,
±8 kV,
±15 kV air
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15
kV air
Floors should be wood, concrete
or ceramic tie. 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
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge IEC
61000-4-5
± 0.5kV, ± 1 kV
line(s) to lines
± 0.5kV, ± 1 kV, ±
2 kV line(s) to earth
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
IEC 61000-
4-11
0 % UT; 0.5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270°and 315°
O % UT; 1 cycle
and 70 % UT;
25/30 cycles
Single phase: at 0°
0 % UT; 250/300
cycles
Not applicable
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/ 60 Hz)
magnetic field
IEC 61000-
4-8
30 A/m
30 A/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
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