Table of Contents
Advertisement
B.O.L.T User Manual
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
Electrostatic
discharge (ESD)
EN 61000-4-2
Electrical fast
transient/burst
EN 61000-4-4
Surge
EN 61000-4-5
Voltage dips, short
interruptions
and
voltage variations on
power supply input
lines
EN 61000-4-11
Power
frequency
(50/60 Hz) magnetic
field
EN 61000-4-8
Note: UT is the AC mains voltage prior to application of the test level.
© Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
60601 test level
± 8kV contact
± 15kV air
± 2 kV for power supply
Lines
± 1 kV line(s) to line(s)
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
30 A/m
Compliance Level
± 8kV contact
± 15kV air
± 2 kV for power supply
Lines
± 1 kV line(s) to line(s)
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
30 A/m
Electromagnetic
environment – guidance
Floors should be wood,
concrete,
or
ceramic
tile. If floors are covered
with synthetic material,
the relative humidity
should be at least 30 %.
Mains
power
quality
should be that of a
typical commercial or
hospital environment.
Mains
power
quality
should be that of a
typical commercial or
hospital environment.
Power
frequency
magnetic fields should
be
at
levels
characteristic
of
typical location in a
typical commercial or
hospital environment.
a
48
Advertisement
Table of Contents
