Appendix A: Electromagnetic Compatibility Guidance - Shockwave Medical 825D Manuel D'utilisation

Electromagnetic Compatibility Guidance - Emissions
The Generator Model 825D is intended for use in the electromagnetic environment specified below.
The customer or the user of the Generator Model 825D should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Electromagnetic Compatibility Guidance – Power Supply Immunity
The Generator Model 825D is intended for use in the electromagnetic environment specified below. The
customer or the user of the Generator, Model 825D should assure that it is used in such an environment.
IMMUNITY test
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: UT is the A.C. mains voltage prior to application of the test level.
LBL 60780 rev. B

APPENDIX A: ELECTROMAGNETIC COMPATIBILITY GUIDANCE

Guidance and manufacturer's declaration – electromagnetic emissions
Compliance
Group 1
Class A
Class A
Complies
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for
input/output
lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
3 A/m
Electromagnetic environment – guidance
The Generator Model 825D 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 Generator Model 825D is suitable for use in all establishments other
than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for input/output
lines
± 1 kV line(s) to
line(s)
± 2 kV line(s) to earth
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
3 A/m
Electromagnetic environment –guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Generator
Model 825D requires continued operation
during power mains interruptions, it is
recommended that the Generator Model
825D be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
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