sorin 3T - Page 74

Heater-Cooler System 3T • Appendix
7.8 CP_IFU_16-XX-XX_USA_015
Guidance and manufacturer's declaration – electromagnetic immunity
The Stöckert Heater-Cooler System 3T is intended for use in the electromagnetic environment specified below. The customer or
the user of the Stöckert Heater-Cooler System 3T 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 %.
Electrostatic transient /
burst
IEC 61000-4-4
± 2 kV for power supply
lines
± 1 kV for sensor lines
± 2 kV for power supply
lines
± 1 kV for sensor lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC 61000-4-5 ± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
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 1/2 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 sec
< 5 % UT
(>95 % dip in UT)
for 1/2 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 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
the Stöckert Heater-Cooler System 3T requires
continued operation during power mains
interruptions, it is recommended that the Stöckert
Heater-Cooler System 3T be powered from an
uninterruptible power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 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.