Electromagnetic Interference - SALUDA MEDICAL Evoke SCS User Manual

to safeguard the integrity of the communication. There are no security settings that require
input or control by the user.

15.3 Electromagnetic Interference

The following tables indicate the electromagnetic environment in which the Evoke SCS System
is intended to operate. This is to ensure compliance with international standards for the
electromagnetic interference (EMI) produced by the Evoke SCS System or the susceptibility of
the Evoke SCS System to EMI. For more information on this section please contact a Saluda
Representative.
15.3.1 Guidance and Manufacturer's Declarations
Table 15-9 Electromagnetic emissions.
The Evoke SCS System is intended for use in the electromagnetic environment specified
below. The patient, doctor or any other user of the Evoke SCS System should ensure that it is
used in such an environment.
Emissions Test
Radiated disturbance,
30 MHz -6000 MHz
CISPR 11 (EN 55011)
Conducted Emissions
0.15 MHz - 30 MHz
CISPR 11 (EN 55011)
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker
emissions
IEC 61000-3-3
CLIN-UMAN-005176
Evoke® SCS System User Manual
Compliance
Group 1
Class B
Not applicable for the
battery powered devices or
device consuming less than
75 W from mains power
outlet (Charger with power
adapter)
Not applicable for the
battery powered devices.
Charger with power adapter
complies with requirements
of the standard
Revision: 4.01
Electromagnetic environment
– guidance
The Evoke SCS System uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause any
interference in nearby
electronic equipment.
The Evoke SCS System is
suitable for use in all
establishments, including
domestic establishments and
those directly connected to the
public low-voltage power
supply network that supplies
buildings used for domestic
purposes.
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