Axium Clinical Programmer Manuale d'uso - Pagina 13

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Guidance and Manufacturer's Declarations

GUIDANCE AND MANUFACTURER'S DECLARATION
Electromagnetic Emissions
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Spinal Modulation Neurostimulator System should
assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic Environment – Guidance
The Spinal Modulation Neurostimulator System must emit
RF Emissions 1
Group 2
electromagnetic energy in order to perform its intended
function. Nearby electronic equipment may be affected.
RF emissions
Class B
CISPR 11
Harmonic emissions
Class B
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Complies
IEC 61000-3-3
The Spinal Modulation Neurostimulator 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.
The Clinical Programmer is not intended to be connected to
CISPR 14-1
Complies
other equipment except the Programmer Charger.
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GUIDANCE AND MANUFACTURER'S DECLARATION
Electromagnetic Emissions
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Spinal Modulation Neurostimulator System should
assure that it is used in such an environment.
Immunity
IEC 60601 Test Level
Electrostatic
IEC 61000-4-2
discharge (ESD)
Electrical fast
± 2 kV for power supply lines
transient/burst
± 1 kV for input/output lines
IEC 61000-4-4
Surge
± 1 kV line(s) to line(s)
IEC 61000-4-5
± 2 kV line(s) to earth
input lines
IEC 61000-4-11
<5% UT (>95% dip in UT)
for 0.5 cycle
Voltage dips,
40% UT (60% dip in UT)
short interruptions
for 5 cycles
and voltage
70% UT (30% dip in UT)
variations on
for 25 cycles
power supply
<5% UT (>95% dip in UT)
for 5 s
NOTE UT is the a.c. mains
voltage prior to application of
the test level.
Power frequency
(50/60 Hz)
magnetic field
3 A/m
IEC 61000-4-8
Compliance
Electromagnetic
Level
Environment Guidance
Floors should be wood,
concrete or ceramic tile.
± 6 kV contact
If floors are covered with
± 8 kV air
synthetic material, the relative
humidity should be at least
30%.
Mains power quality should be
Pass
that of a typical commercial or
home environment
Mains power quality should be
that of a typical commercial or
home environment
Mains power quality should be
that of a typical commercial or
home environment
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial, hospital, or home
environment.
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