157
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
®
CNP P3 therapy unit must ensure that it is operated
insuch an environment.
Immunity tests IEC 60601
testlevel
Conformity level Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
inaccordance with
IEC 61000-4-2
± 6kV contact
discharge
± 8kV air
discharge
± 6kV contact
discharge
± 8kV air
discharge
Floors should be made of wood or
concrete or covered with ceramic tiles.
If the floor is covered with synthetic
material, the relative humidity must
bemin. 30%.
Electrical fast
transient/bursts
immunity in
accordance with
IEC 61000-4-4
± 2kV for power
cables
± 1kV for input and
output cables
± 2kV for power
cables
± 1kV for input and
output cables
The quality of the supply voltage should
correspond to that of atypical business
or hospital environment.
Surges in
accordance with
IEC 61000-4-5
± 1kV voltage
phase-phase
± 2kV phase-earth
± 1kV voltage
phase-phase
± 2kV phase-earth
The quality of the supply voltage should
correspond to that of atypical business
or hospital environment.
Voltage dips, short
interruptions and
voltage variations
inaccordance with
IEC 61000-4-11
<5% UT (>95%dip
of the UT)
for0.5cycle
40% UT (60%dip
of the UT)
for5cycles
70% UT (30%dip
of the UT)
for25cycles
<5% UT (>95%dip
of the UT)
for5seconds
<5% UT (>95%dip
of the UT)
for0.5cycle
40% UT (60%dip
of the UT)
for5cycles
70% UT (30%dip
of the UT)
for25cycles
<5% UT (>95%dip
of the UT)
for5seconds
The quality of the supply voltage should
correspond to that of atypical business
or hospital environment.
If the user of the Suprasorb
®
CNP P3
therapy unit requires it to continue
functioning even if the power supply is
interrupted, we recommend connecting
the device to apower supply without
interruptions or running it off the
battery.
Magnetic fields
at the supply
frequency
(50/60Hz) in
accordance with
IEC 61000-4-8
3A/m 3A/m
Magnetic fields at the supply frequency
should be equivalent to the typical
values encountered in business and
hospital environments.
NOTE: UT is the mains alternating voltage prior to application of the test level.