Boston Scientific Precision Spinal Cord Stimulator System, Clinical Manual

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Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
90607862-30 58 of 309
en
Guidance and manufacturer’s declaration – electromagnetic immunity
The Precision System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Precision System should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic
environment
– guidance
Electrostatic discharge
(ESD) IEC 61000-4-2
Air:
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV
Contact:
± 8 kV
Air:
Remote Control and
Charger: ± 2 kV,
± 4 kV, ± 8 kV, ± 15 kV
ETS: ± 2 kV, ± 4 kV,
± 8 kV
Contact:
Remote Control and
Charger: ± 8 kV
ETS: ± 6 kV
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least
30 %.
Note: Applies to
external devices.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m 30 A/m 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.
NOTE
U
T
is the a.c. mains voltage prior to application of the test level.