Stryker Flyte 0408-600-000, Instructions For Use Manual

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EN 0408-600-705 Rev-AB
10 www.stryker.com
Specifications (continued)
Guidance and manufacturer's declaration - electromagnetic immunity
Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment specified below. The customer or the
user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 should assure that it is used in such an environment.
NOTE: The values provided in the table below have changed due to 60601-1-2 4th Edition requirements.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 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 at 100 kHz repetition frequency
for power supply lines
± 1 kV at 100 kHz repetition frequency
for input/output lines
Not Applicable Not Applicable
Surge
IEC 61000-4-5
± 0.5 kV, ± 1 kV line(s) to line(s)
± 0.5 kV, ± 1 kV, ± 2 kV line(s) to earth
Not Applicable Not Applicable
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
0% U
T
(100% dip in U
T
)
for 0.5 cycle at 0°, 45°, 90°, 135°, 180°,
225°, 270°, and 315°
0% U
T
(100% dip in U
T
)
for 1 cycle at 0°
70%
U
T
(30% dip in
U
T
)
for 25 and 30 cycles at 0°
<5% U
T
(>95% dip in U
T
)
for 5 s
0% U
T
(100% dip in U
T
)
for 250/300 cycles
Not Applicable Not Applicable
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m, 30 A/m at 50 and 60 Hz 3 A/m, 30 A/m at 50 and 60 Hz Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
NOTE:
U
T
is the a.c. mains voltage prior to application of the test level.
IEC 60601-1-2 3rd Edition:
Recommended separation distances between portable and mobile RF equipment and the Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000
Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 are intended for use in the electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF equipment (transmitters) and Flyte Helmet REF 0408-600-000, 0408-635-000 and 0408-645-000
as recommended below, according to the maximum output power of the equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d
=1.2√
P d
=1.2√
P d
=2.3√
P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.74
1 1.2 1.2 2.3
10 3.8 3.8 7.4
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.