Boston Scientific Vercise Mode D'emploi page 23

Table 2 (Continued): Guidance and Manufacturer's Declaration
Electromagnetic Immunity
IEC 60601‑1‑2
Immunity Test
Test Level
<5 % U
(>95 % dip in U
for 0,5 cycle
40 % U
Voltage dips, short
(60 % dip in U
interruptions and
for 5 cycles
voltage variations on
power supply input
lines IEC 61000‑4‑11
70 % U
(Programming Wand
(30 % dip in U
only)
for 25 cycles
<5 % U
(>95 % dip in U
for 5 s
Power frequency
(50/60 Hz)
30 A/m
magnetic field
IEC 61000‑4‑8
Note: U
is the a.c. mains voltage prior to application of the test level.
T
Note: The Charger is used with rechargeable DBS Systems only.
Note: The Programming Wand is used with Vercise PC and Vercise Gevia DBS Systems only.
Compliance Level
<5 % U
T
) (>95 % dip in U
T
for 0,5 cycle
40 % U
T
) (60 % dip in U
T
for 5 cycles
70 % U
T
) (30 % dip in U
T
for 25 cycles
<5 % U
T
) (>95 % dip in U
T
for 5 s
30 A/m
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Electromagnetic Compatibility
Electromagnetic
Environment – Guidance
T
)
T
Mains power quality
should be that of a typical
commercial or hospital
T
environment. If the user of
)
the Boston Scientific DBS
T
System requires continued
operation during power
mains interruptions, it is
T
recommended that the
)
Boston Scientific DBS
T
System be powered from
an uninterruptible power
supply or a battery.
T
)
T
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
Magnetic fields from
common appliances are
not expected to affect the
device.
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