E E N N
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
Electrostatic Discharge
(ESD)
IEC 61000-4-2
Electrostatic fast transient/
burst
IEC 61000-4-4 *
Surge
IEC 61000-4-5 *
Voltage dips, voltage
variations and short
interruptions on power
supply input lines
IEC 61000-4-11 *
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
Note: U
is the a.c. mains voltage before applications of the test level.
T
1-90
EMC Information
Guidance and Manufacturer's declaration - Electromagnetic Immunity
IEC 60601 Test Level
+6 kV contact
+8 kV air
+2 kV for power supply
lines
+1 kV for input/ output lines
+8 kV differential mode
+2 kV common mode
<5% U
(>95% dip in U
T
for 0.5 cycle
40% U
(60% dip in U
T
T
for 5 cycles
70% U
(30% dip in U
T
T
for 25 cycles
<5% U
(>95% dip in U
T
for 5 sec
3 A/m
2971-109-001 REV B
Compliance Level
+6 kV contact
+8 kV air
+2 kV for power supply
lines
+1 kV for input/ output lines
+8 kV differential mode
+2 kV common mode
)
<5% U
(>95% dip in U
T
T
for 0.5 cycle
)
40% U
(60% dip in U
T
T
for 5 cycles
)
70% U
(30% dip in U
T
T
for 25 cycles
)
<5% U
(>95% dip in U
T
T
for 5 sec
3 A/m
Electromagnetic
Environment Guidance
Floors should be wood,
concrete, or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Main power quality should
be that of a typical
commercial or hospital
environment.
Main power quality is that
of typical commercial and/
or hospital environment.
)
Main power quality should
T
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.
)
T
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial and/or hospital
environment.
www.stryker.com