B.O.L.T User Manual
48
© Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
21.2
Electromagnetic Immunity
Table 2
– Guidance and manufacturer’s declaration – electromagnetic immunity –
for all medical electrical equipment and medical electrical systems
Guidance and manufacturer’s declaration – electromagnetic immunity
The B.O.L.T device is intended for use in the electromagnetic environment specified below. The customer or
the user of the B.O.L.T device should assure that it is used in such an environment.
Immunity test
60601 test level
Compliance Level
Electromagnetic
environment
– guidance
Electrostatic
discharge (ESD)
EN 61000-4-2
± 8kV contact
± 15kV air
± 8kV contact
± 15kV 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
EN 61000-4-4
± 2 kV for power supply
Lines
± 2 kV for power supply
Lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
EN 61000-4-5
± 1 kV line(s) to line(s)
± 1 kV line(s) to line(s)
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
EN 61000-4-11
0 % UT; 0, 5 Cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 Cycle
and
70 % UT; 25/26 Cycles
0 % UT; 250/300 Cycle
0 % UT; 0, 5 Cycle
At 0°, 45°, 90°, 135°, 180°,
225°, 270° and 315°
0 % UT; 1 Cycle
and
70 % UT; 25/26 Cycles
0 % UT; 250/300 Cycle
Power
frequency
(50/60 Hz) magnetic
field
EN 61000-4-8
30 A/m
30 A/m
Power
frequency
magnetic fields 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.