Johnson & Johnson BPL II, Инструкция по эксплуатации

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Electromagnetic Compatibility
Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6
68
DePuy Synthes
Battery Power Line II Instructions for Use
Table 2: Immunity (all devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The BPL or BPL II System is intended for use in the electromagnetic environment specified below. The cus-
tomer or the user of BPL or BPL II System should assure that it is used in such an environment.
Immunity test
standard IEC 60601
test level Compliance
level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2

6 kV contact

8 kV air

6 kV contact

8 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 for power
supply lines
Not applicable Mains power quality should be that
of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5

1 kV line to line

2 kV line to earth
Not applicable Mains power quality should be that
of a typical commercial or hospital
environment.
Voltage dips, short interrup-
tions and voltage variations on
power supply lines
IEC 61000-4-11 <5 % U
T
(0.5 cycle)
40 % U
T
(5 cycles)
70 % U
T
(25 cycles)
<5 % U
T
for 5 s
Not applicable Mains power quality should be that
of a typical commercial or hospital
environment.
Note:
U
T
is the a.c. mains voltage prior to application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m
100 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical com-
mercial or hospital environment.