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Stryker 0240031065 - Immunity Guidance and Declaration

Stryker 0240031065
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29
Guidance and Manufacturers Declaration: Electromagnetic Immunity
The devices are intended for use in the electromagnetic environment speci ed below.
The customer or user of the devices should ensure that they are used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
Environment:
Guidance
Electrostatic Discharge
(ESD)
IEC61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be
wood, concrete, or
ceramic tile. If oors
are covered with
synthetic material,
the relative humidity
should be at least
30%.
Electrical fast transient/
burst
IEC61000-4-4
±2kV for power supply
lines
±1kV for input/output
lines
(if applicable)
±2kV line to ground
±1kV for input/output
lines
(if applicable)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC61000-4-5
±1kV differential mode
±2kV common mode
±1kV differential mode
±2kV 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
IEC61000-4-11
0% Ut; 0.5 cycle
0% Ut; 1 cycle
70% Ut; 25 cycles
0% Ut: 5 seconds
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of the
devices requires
continued operation
during power mains
interruptions, it is
recommended that the
devices be powered
from an uninterruptible
power supply or a
battery.
Power frequency
(50/60Hz) magnetic eld
IEC 61000-4-8
30 A/m 30 A/m Power-frequency
magnetic elds
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.
DRAFT

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