Guidance And Manufacturer's Declaration ± Electromagnetic Immunity - AirSep Focus Manual Del Paciente

EN
"Specifications continued"
Medical equipment needs special precautions regarding EMC and need to be
installed and put into service according to the EMC information provided in this
section.
Guidance and manufacturer's declaration ± electromagnetic immunity
The Focus is intended for use in the electromagnetic environment specified below. The customer or the user of the
Focus 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.
IEC 61000-4-11
Power frequency
magnetic field
IEC 61000-4-8
NOTE U is the a.c. mains voltage prior to application of the test level.
T
EN-38
IEC 60601
test level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
± 1 kV for
input/output lines
± 1 kV line to line
± 2 kV line to earth
<5 % U
T
(>95 % dip in U )
T
for 0,5 cycle
40 % U
T
(60 % dip in U )
T
for 5 cycles
70 % U
T
(30 % dip in U )
T
for 25 cycles
<5 % U
T
(>95 % dip in U )
T
for 5s
3 A/m
Compliance level
± 6 kV contact
± 8 kV air
± 2 kV for power
supply lines
Not Applicable
± 1 kV line to line
± 2 kV line to earth
<5 % U
T
(>95 % dip in U )
T
for 0,5 cycle
40 % U
T
(60 % dip in U )
T
for 5 cycles
70 % U
T
(30 % dip in U )
T
for 25 cycles
<5 % U
T
(>95 % dip in U )
T
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 Focus
requires continued operation during power
mains interruptions, it is recommended
that the Focus be powered from an
uninterruptible power supply (UPS) or
a battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
®
AirSep
MN172-1 rev. A - 02/13
Focus™
Corporation