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Stryker System 5 - Specific Immunity Conditions

Stryker System 5
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14
Guidance and manufacturer’s declaration - electromagnetic immunity
The System 5 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the System 5
handpiece should assure that it is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
IEC 60601
test level
±6 kV contact
±8 kV air
±2 kV for power supply
lines
±1 kV for input/output
lines
±1 kV differential mode
±2 kV common mode
<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
3 A/m
Compliance level
±2, 4, 6 kV contact
±2, 4, 8 kV air
n/a
n/a
n/a
n/a
n/a
n/a
n/a
n/a
3 A/m
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
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%.
Power frequency magnetic fields should be at levels
characteristics of a typical location in a typical commercial
or hospital environment.