Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Acelity PREVENA INCISION Manual De Instrucciones

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
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 supply input
lines
IEC 61000-4-11
Power frequency
(50Hz / 60Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
r
20
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(s) to line(s)
± 2 kV line(s) to earth
<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
3 A / m
Electromagnetic Environment
Compliance Level
In accordance with IEC 60601-1-
± 6 kV contact 2: 2007, floors are covered with
± 8 kV air synthetic material, the relative
humidity should be at least 30%.
Not Applicable
Not Applicable
Not Applicable
Power frequency magnetic fields
should be at levels characteristic
3 A / m
of a typical location in a typical
commercial or hospital environment.
Guidance
Battery operated device
Battery operated device
Battery operated device