12
www.stryker.com
EN
0986-001-011 Rev-R
Guidance and manufacturer’s declaration - electromagnetic immunity
The CastVac (REF 0996-000-000) is intended for use in the electromagnetic environment specified below. The customer or the user of the CastVac (REF 0996-000-
000) 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 61000-4-2
±6 kV contact
±8 kV air
±2, ±4, ±6 kV contact
±2, ±4, ±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%.
Electrical 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
Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short interruptions and
voltage variations 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
95% Reduction (10ms)
60% Reduction (100ms)
30% Reduction (500ms)
95% Reduction (5s)
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the
CastVac (REF 0996-000-000) requires
continued operation during power
mains interruptions, it is recommended
that the CastVac (REF 0996-000-000)
be powered from an uninterruptible
power supply or a battery.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
@ 50Hz
CRT 1A/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.
Recommended separation distances between portable and mobile RF communications equipment and the CastVac (REF 0996-000-000)
The CastVac (REF 0996-000-000) is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or
the user of the CastVac (REF 0996-000-000) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the CastVac (REF 0996-000-000) as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d
=1.2√
P
80 MHz to 800 MHz
d
=1.2√
P
800 MHz to 2.5 GHz
d
=2.3√
P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d
in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where
P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1:
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
