Acelity Prevena Incision Management System, Application Instructions

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Guidance and manufacturer’s declaration - electromagnetic immunity
The Prevena™ 125 Therapy Unit is intended for use in the electromagnetic environment specified below.
The customer or user of the Prevena™ 125 Therapy Unit 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
Not Applicable Battery operated device
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Not Applicable Battery operated device
Voltage dips,
short interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5 % U
r
(>95 % dip in U
r
)
for 0.5 cycle
40 % U
r
(60 % dip in U
r
)
for 5 cycles
70 % U
r
(30 % dip in U
r
)
for 25 cycles
<5 % U
r
(>95 % dip in U
r
)
for 5 cycles
Not Applicable Battery operated device
Power frequency
(50Hz / 60Hz)
magnetic field
IEC 61000-4-8
3 A / m 3 A / m
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
NOTE: U
r
is the a.c. mains voltage prior to application of the test level.