1
www.stryker.com
2008/01
6205-001-700 Rev-A
Guidance and manufacturer's declaration - electromagnetic immunity
The System 6 handpiece is intended for use in the electromagnetic environment specified below. The customer or the user of the
System 6 handpiece should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment -
guidance
electrostatic discharge (eSD)
IeC 61000--2
±6 kV contact
±8 kV air
±2, , 6 kV contact
±2, , 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 0%.
electrical fast transient/burst
IeC 61000--
±2 kV for power supply lines
±1 kV for input/output lines
n/a
n/a
Surge
IeC 61000--5
±1 kV differential mode
±2 kV common mode
n/a
n/a
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IeC 61000--11
<5%
U
T
(>5% dip in
U
T
)
for 0,5 cycle
n/a
0%
U
T
(60% dip in
U
T
)
for 5 cycles
n/a
70%
U
T
(0% dip in
U
T
)
for 25 cycles
n/a
<5%
U
T
(>5% dip in
U
T
)
for 5 sec
n/a
Power frequency (50/60 Hz)
magnetic field
IeC 61000--8
A/m
A/m
Power frequency magnetic fields
should be at levels characteristics of a
typical location in a typical commercial
or hospital environment.
NOTe:
U
T
is the alternating current mains voltage prior to application of the test level.
Specifications (cont’d)
