Stryker SDC Classic Benutzerhandbuch Seite 36

Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SDC Classic™ is intended for use in the electromagnetic environment specified below. The customer
or the user of SDC Classic should ensure that it is used in such an environment.
Immunity Test
Electrostatic Discharge
(ESD) IEC61000-4-2
Electrical fast
transient/burst
IEC61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC61000-4-11
Power frequency
(50/60Hz) magnetic
field IEC 61000-4-8
NOTE Ut is the a.c. mains voltage prior to application of the test level.
SDC Classic™ is intended for use in the electromagnetic environment specified below. The customer
or the user of SDC Classic should ensure that it is used in such an environment.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast,
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the SDC Classic system is used exceeds the applicable RF compli-
ance level above, the SDC Classic system should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating
the SDC Classic unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
32
IEC 60601 test
level
±6kV contact
±8kV air
±2kV for power ±2kV for power supply
supply lines
±1kV for input/ ±1kV for input/output
output lines
±1kV
±0.5, 1kV differential
differential
mode
±2kV common ±0.5,1, 2kV common
mode
<5% Ut (>95%
<5% Ut (>95% dip in Ut)
dip in Ut) for
0.5 cycle
40% Ut (60%
40% Ut (60% dip in Ut)
dip in Ut) for 5
cycles
70% Ut (30%
70% Ut (30% dip in Ut)
dip in Ut) for 25
cycles
<5% Ut (>95%
<5% Ut (>95% dip in Ut)
dip in Ut) for
5 sec
3 A/m
Compliance Level
±2,4,6kV contact
±2,4,8kV air
lines
lines
mode
mode
for 0.5 cycle
for 5 cycles
for 25 cycles
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%.
Mains power quality should be
that of a typical commercial or
hospital environment
Mains power quality should be
that of a typical commercial or
hospital environment
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of SDC Classic requires
continued operation during
power mains interruptions,
it is recommended that SDC
Classic be powered from an
uninterruptible power supply
or a battery.
Not Applicable