Stryker Crossfire - EMC Immunity Declarations; Immunity Compliance and Guidance

EN-13
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The Crossre™ System is intended for use in the electromagnetic environment specied below. The
customer or the user of Crossre™ System should ensure that it is used in such an environment
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment: Guid-
ance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
±6kV contact
±8kV air
±2,4,6kV contact
±2,4,8kV air
Floors should be wood,
concrete, or ceramic
tile. If oors are covered
with synthetic material,
the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2kV for power supply
lines ±1kV for input/
output lines
±2kV for power supply
lines ±1kV for input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV differential mode
±2kV common mode
±0.5, 1kV differential
mode ±1, 2kV 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 0.5 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 0.5 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 Crossre™
System requires
continued operation
during power mains
interruptions, it is
recommended that
Crossre™ System
be powered from an
uninterruptible power
supply or a battery.
Power frequency
(50/60Hz)
magnetic eld IEC
61000-4-8
3 A/m N/A Power-frequency
magnetic elds
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.