Guidance And Manufacturer's Declaration - Electromagnetic Immunity; Customer Contact Information - KCI CelluTome Système de prélèvement de cellules épidermiques Manuel D'utilisation

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The CelluTome™ Epidermal Harvesting System is intended for use in the electromagnetic environment
specified below. The customer or the end user of the CelluTome™ Epidermal Harvesting System should
assure it is used only in such an environment.
IMMUNITY Test
Electrostatic
discharge (ESD) ±6 kV contact
IEC 61000-4-2 ±8 kV air
Electrical fast ±2 kV for power
transient / burst supply lines
IEC 61000-4-4 ±1 kV for input /
output lines
Surge ±1 kV line(s) to
line(s)
IEC 61000-4-5
±2 kV line(s) to earth
Voltage dips, short <5% U
interruptions and (>95% dip in U
voltage variations for 0.5 cycle
on power supply
input lines 40% U
(60% dip in U
IEC 61000-4-11 for 5 cycles
70% U
(30% dip in U
for 25 cycles
<5% U
(>95% dip in U
for 5 seconds
Power frequency 3 A/m
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the A.C. mains voltage prior to application of the test level.
T
IEC 60601 Compliance Level
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
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 seconds
3 A/m
22
Electromagnetic Environment -
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
T
) of a typical commercial or hospital
T
environment. If the user of the
CelluTome™ Epidermal Harvesting
System requires continued
T
) operation during power mains
T
interruptions, it is recommended
that the CelluTome™ Epidermal
Harvesting System `be powered
T
) from an uninterruptible power
T
supply or a battery.
T
)
T
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environment.
Guidance