Stryker Isolibrium 2971, Operation & Maintenance Manual, Page: 98 / 202

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EMC Information
Guidance and Manufacturer’s declaration - Electromagnetic Immunity
Isolibrium is suitable for use in the electromagnetic environment specified below. The customer or the user of
Isolibrium should make sure 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 fast transient/
burst
IEC 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
Main power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5 *
+8 kV differential mode
+2 kV common mode
+8 kV differential mode
+2 kV common mode
Main power quality is that
of typical commercial and/
or hospital environment.
Voltage dips, voltage
variations and short
interruptions on power
supply input lines
IEC 61000-4-11 *
<5% U
T
(>95% dip in U
T
)
for 0.5 cycle
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 cycle
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
Main power quality should
be that of a typical
commercial and/or hospital
environment. If the user of
Isolibrium requires
continued operation during
power main interruptions, it
is recommended that the
device be powered from an
uninterrupted 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 and/or hospital
environment.
Note: U
T
is the a.c. mains voltage before applications of the test level.