12
Manufacturer’s declaration-electromagnetic immunity
The DYNAFLOW is intended for use in the electromagnetic environment (for home
healthcare) specified below.
The customer or the user of the DYNAFLOW should assure that it is used in such an
environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic
environment-guidance
(for home healthcare
environment)
Electrostatic
discharge(ESD)
IEC 61000-4-2
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Contact:±8 kV
Air±2 kV,±4 kV,±8
kV,±15 kV
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%
Electrical fast
transient/burst
IEC 61000-4-4
+ 2kV for power
supply lines
+ 1kV for
input/output lines
+ 2kV for power
supply lines+ Not
applicable
Mains power quality should
be that of a typical home
healthcare environment.
Surge IEC
61000-4-5
+ 0.5kV, +1kV line(s)
to line(s)
+ 0.5kV, +1kV,+ 2kV
line(s) to earth
+ 0.5kV, +1kV
line(s) to line(s)
Not applicable
Mains power quality should
be that of a typical home
healthcare environment.
Voltage Dips,
short
interruptions
and voltage
variations on
power supply
input lines IEC
61000-4-11
Voltage dips:
0 %
U
T; 0,5 cycle
0 %
U
T; 1 cycle
70 %
U
T; 25/30
cycles
Voltage interruptions:
0 %
U
T; 250/300
cycle
Voltage dips:
0 %
U
T; 0,5 cycle
0 %
U
T; 1 cycle
70 %
U
T; 25/30
cycles
Voltage
interruptions:
0 %
U
T; 250/300
cycle
Mains power quality should
be that of a typical home
healthcare environment. If
the user of the DYNAFLOW
requires continued
operation during power
mains interruptions, it is
recommended that the
DYNAFLOW be powered
from an uninterruptible
power supply or a battery.
Power
frequency(50,
60 Hz) magnetic
field IEC 61000-
4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz, 60 Hz
The DYNAFLOW power
frequency magnetic fields
should be at levels
characteristic of a typical
location in a typical home
healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Summary of Contents for DynaFlow
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