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Chapter 12, Reference Information
P/N 120745-IE, Manual revision: AA
Haemonetics
®
Cell Saver
®
Elite
®
User Manual
Table 18, Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Cell Saver Elite system is intended for use in the electromagnetic environment specified below. The
customer or user of the Cell Saver Elite device should ensure that it is used in such an environment.
Immunity Test
IEC/EN 60601 Test
Level
Compliance Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC/EN 61000-4-
2
±6kV contact
±8 kV air
±6kV 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/EN 61000-4-
4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power supply
lines
±1 kV for input/output
lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC/EN 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,
voltage variations
on power supply
input lines.
EC 61000-4-11
<5%
U
T
(>95% dip in
U
T
) for
0,5 cycles
40%
U
T
(60% dip in
U
T)
for 5 cycles
70%
U
T
(30% dip in
U
T)
for 25 cycles
<5%
U
T
(>95% dip in
U
T
) for 5
sec.
<5%
U
T
(>95% dip in
U
T
) for
0,5 cycles
40%
U
T
(60% dip in
U
T)
for 5 cycles
70%
U
T
(30% dip in
U
T)
for 25 cycles
<5%
U
T
(>95% dip in
U
T
) for 5
sec.
Mains power quality should be
that of a typical commercial or
hospital environment.
If the operator of the Cell
Saver Elite system requires
continued operation during
power mains interruptions, it is
recommended that the
Cell Saver Elite system be
powered from an
uninteruptable power supply
or battery or Haemonetics
approved battery.
Power frequency
(50/60 Hz)
magnetic field
EC 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:
U
T
is the AC mains voltage prior to application of the test level.
