Nevro Senza - Page 44

Surge IEC
61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
± 1 kV line(s) to
line(s)
± 2 kV line(s) to
earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
<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 Nevro SCS system requires
continued operation during power
mains interruptions, it is
recommended that the Nevro SCS
system be powered from an
uninterruptible power supply or a
battery.
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment.
NOTE U
T
is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer’s Declaration - electromagnetic immunity
The Senza system is intended for use in the electromagnetic environment specified below.
The customer or user of the Senza system should assure that it is used in such an
environment.
Immunity
Test
IEC
60601
Test
Level
Compliance
Level
Electromagnetic environment guidance
Conducted
RF
IEC 61000-
4-6
3 Vrms
150 kHz
to 80
MHz
3 Vrms
150 kHz to
80 MHz
Portable and mobile RF communications
equipment should be used no closer to any part
of the Senza system, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance :
d=1.2√
Patient Manual 11052 Rev A (2015-01-16) 44