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Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
92366224‑01 18 of 29
Table 2 (Continued): Guidance and Manufacturer’s Declaration
Electromagnetic Immunity
Immunity Test
IEC 60601‑1‑2
Test Level
Compliance Level
Electromagnetic
Environment – Guidance
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000‑4‑11
(Programming Wand
only)
<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
<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
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the Boston Scientic DBS
System requires continued
operation during power
mains interruptions, it is
recommended that the
Boston Scientic DBS
System be powered from
an uninterruptible power
supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000‑4‑8
30 A/m 30 A/m
Power frequency
magnetic elds should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
Magnetic elds from
common appliances are
not expected to affect the
device.
Note: UT is the a.c. mains voltage prior to application of the test level.
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.