L&R Suprasorb CNP P3 Mode D'emploi page 157

Dispositif médical d'aspiration
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Table 2
Guidelines and manufacturer's declaration – Electromagnetic immunity
The Suprasorb
CNP P3 therapy unit is intended for operation in an electromagnetic environment
®
as described below.
The customer or user of the Suprasorb
in such an environment.
Immunity tests
IEC 60601
test level
Electrostatic
± 6 kV contact
discharge (ESD)
discharge
in accordance with
± 8 kV air
IEC 61000-4-2
discharge
Electrical fast
± 2 kV for power
transient/bursts
cables
immunity in
± 1kV for input and
accordance with
output cables
IEC 61000-4-4
Surges in
± 1 kV voltage
accordance with
phase-phase
IEC 61000-4-5
± 2 kV phase-earth
<5% UT (>95% dip
of the UT)
for 0.5 cycle
40% UT (60% dip
Voltage dips, short
of the UT)
interruptions and
for 5 cycles
voltage variations
70% UT (30% dip
in accordance with
of the UT)
IEC 61000-4-11
for 25 cycles
<5% UT (>95% dip
of the UT)
for 5 seconds
Magnetic fields
at the supply
frequency
3 A/m
(50/60 Hz) in
accordance with
IEC 61000-4-8
NOTE: UT is the mains alternating voltage prior to application of the test level.
CNP P3 therapy unit must ensure that it is operated
®
Conformity level
Electromagnetic environment –
guidance
Floors should be made of wood or
± 6 kV contact
concrete or covered with ceramic tiles.
discharge
If the floor is covered with synthetic
± 8 kV air
material, the relative humidity must
discharge
be min. 30%.
± 2 kV for power
The quality of the supply voltage should
cables
correspond to that of a typical business
± 1kV for input and
or hospital environment.
output cables
± 1 kV voltage
The quality of the supply voltage should
phase-phase
correspond to that of a typical business
± 2 kV phase-earth
or hospital environment.
<5% UT (>95% dip
of the UT)
The quality of the supply voltage should
for 0.5 cycle
correspond to that of a typical business
40% UT (60% dip
or hospital environment.
of the UT)
If the user of the Suprasorb
for 5 cycles
therapy unit requires it to continue
70% UT (30% dip
functioning even if the power supply is
of the UT)
interrupted, we recommend connecting
for 25 cycles
the device to a power supply without
<5% UT (>95% dip
interruptions or running it off the
of the UT)
battery.
for 5 seconds
Magnetic fields at the supply frequency
should be equivalent to the typical
3 A/m
values encountered in business and
hospital environments.
CNP P3
®
157

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