6
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131
Device Standards
Electromagnetic Immunity
The ultrasound system is intended for use in the electromagnetic environment
specified in Table 6-6. The customer or the user of the ultrasound system should
ensure that it is used in such an environment.
NOTES
• The guidelines specified in Table 6-6 may not apply in all situations. Electro-
magnetic propagation is affected by absorption and reflection from structures,
objects, and people.
• U
T
is the AC mains voltage before application of the test level.
• At 80 and 800 MHz, the separation distance for the higher frequency range
applies.
Table 6-6 Electromagnetic Immunity
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Same as
IEC 60601 test
level
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
Same as
IEC 60601 test
level
Mains power quality should
be that of a typical
commercial or hospital
environment.
Surge
IEC 610004-5
± 1 kV differential
mode
± 2 kV common
mode
Same as
IEC 60601 test
level
Mains power quality should
be that of a typical
commercial or hospital
environment.