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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The TriaDyne Proventa Critical Care Therapy System is intended for use in the electromagnetic environment specified
below. The customer or user of the TriaDyne Proventa Critical Care Therapy System should assure that it is used in
such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
In accordance with IEC 60601-1-2: 2007,
floors are covered with synthetic material,
the relative humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input / output lines
± 2 kV for
power
supply lines
Not applicable
(no I/O lines
present)
Mains power quality should be that
of a typical commercial or hospital
environment.
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 % Ur
(>95 % dip in Ur)
for 0.5 cycle
40 % Ur
(60 % dip in Ur)
for 5 cycles
70 % Ur
(30 % dip in Ur)
for 25 cycles
<5 % Ur
(>95 % dip in Ur)
for 5 cycles
<5 % Ur
(>95 % dip in
Ur)
for 0.5 cycle
40 % Ur
(60 % dip in
Ur)
for 5 cycles
70 % Ur
(30 % dip in
Ur)
for 25 cycles
<5 % Ur
(>95 % dip in
Ur)
for 5 cycles
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the TriaDyne
Proventa Critical Care Therapy System
requires continued operation during
power mains interruptions, it is
recommended that the TriaDyne Proventa
Critical Care Therapy System be powered
from an uninterruptible power supply or
a battery.
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
3 A/m Not applicable
TriaDyne Proventa Critical Care Therapy
System does not contain magnetically
sensitive components.
NOTE: Ur is the a.c. mains voltage prior to application of the test level.