Boston Scientific Vercise Mode D'emploi page 26

Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Table 5: Manufacturer's Declaration
Proximity Fields
The Boston Scientific DBS System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The users of the Boston Scientific DBS System can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the Boston Scientific DBS System as recommended below,
according to the maximum output power of the communications equipment.
Proximity IEC 60601‑1‑2
Test Test Level
385 MHz: 27 V/m
@ 18 Hz pulse modulation
450 MHz: 28 V/m
@ FM modulation
IEC
61000-4-3
710 MHz, 745 MHz, 780 MHz: 9 V/m
@ 217 Hz pulse modulation
1720 MHz, 1845 MHz, 1970 MHz: 28 V/m
@ 217 Hz pulse modulation
1720 MHz, 1845 MHz, 1970 MHz: 28 V/m
@ 217 Hz pulse modulation
2450 MHz: 28 V/m
@ 217 Hz pulse modulation
IEC
61000-4-3
5240 MHz, 5500 MHz, 5785 MHz: 9 V/m
@ 217 Hz pulse modulation
Note: For the frequency bands in this table, use the specified recommended separation distance. The
recommended minimum separation distance of 30 cm between portable and mobile RF communications
equipment (transmitters) and the Boston Scientific DBS System apply to all other frequencies within the
specified ranges.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
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Compliance Electromagnetic
Level Environment Guide
27 V/m
28 V/m
Recommended
separation distance
d = 30 cm
9 V/m
28 V/m
28 V/m
28 V/m
Recommended
separation distance
d = 30 cm
9 V/m