34
Table 202
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The PREVENA PLUS™ 125 Therapy Unit is intended for use in the electromagnetic environment specified below.
The customer or the end user of the unit should assure it is used only in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Intended Electromagnetic
Environment
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
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
±2 kV for power
supply lines
100 kHz repetition
frequency
±1 kV for input/output
lines
100 kHz repetition
frequency
±2 kV for power supply
lines
100 kHz repetition
frequency
±1 kV for input/output
lines
100 kHz repetition
frequency
Mains power quality should be
that of a typical commercial or
home healthcare environment.
Surge
IEC 61000-4-5
±1 kV differential
mode (line - line)
±2 kV common mode
(line - earth)
±1 kV differential mode
(line - line)
±2 kV common mode
(line - earth)
Mains power quality should be
that of a typical commercial or
home healthcare environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Dips: 0% Ut for 1 cycle
70% Ut for
25 cycles at 50 Hz or
30 cycles at 60 Hz
Single phase: at 0˚
Interruptions: 0% Ut
for 250 cycles at 50 Hz
or 300 cycles at 60 Hz
Dips: 0% Ut for 1 cycle
70% Ut for
25 cycles at 50 Hz or
30 cycles at 60 Hz
Single phase: at 0˚
Interruptions: 0% Ut for
250 cycles at 50 Hz or
300 cycles at 60 Hz
Product has internal battery
backup.
If the user of the PREVENA
PLUS™ 125 Therapy Unit requires
continued operation during
power mains interruptions, it is
recommended that the unit be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50Hz/60Hz) magnetic
field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or home healthcare
environment.
NOTE: Ut is the A.C. mains voltage prior to application of the test level.
