Johnson & Johnson DePuy Synthes Small Battery Drive II, Руководство пользователя

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Small Battery Drive II User Manual DePuy Synthes 57
Table 2: Immunity (all devices)
Guidance and manufacturer’s declaration – electromagnetic immunity
The Depuy Synthes Small Battery Drive II system is intended for use in the electromagnetic environment specified
below. The customer or user of the Depuy Synthes Small Battery Drive II system should ensure 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 ±8 kV contact
±15 kV air ±8 kV contact
±15 kV air Floors should be wood, concrete
or ceramic tile. If the 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
interruptions 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 AC mains voltage prior to the application of the test level.
Power frequency (50/60 Hz)
magnetic field
IEC 61000-4-8 30 A/m 200 A/m Power frequency magnetic fields
should be at levels characteristic
of a typical location in a
typical commercial or
hospital environment.