Table 11. Guidance And Manufacturer's Declaration - Electromagnetic Immunity - For All Medical Electrical Equipment And Medical Electrical Systems - Adaptec Sensica UO Instructions For Use Manual

Sensica™ UO System for ICU Instructions for Use, Model No. SCCS-1001, ver. 1001
Table 11. Guidance and Manufacturer's Declaration - Electromagnetic Immunity - for
all Medical Electrical Equipment and Medical Electrical Systems
The Sensica™ UO System for ICU is intended for use in the electromagnetic environment
specified below. The customer or the user of the Sensica™ UO System for ICU should assure
that it is used in such an environment.
Immunity Test
Electrostatic
discharge (ESD)
EN 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
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE: U is the a.c. mains voltage prior to application of the test level.
T
.
P/N 005-0175 Rev A
IEC 60601 Test
Level
± 6kV contact
± 8kV air
±2 kV for power
supply lines
±1 kV for
input/output lines
±1kV line(s) to
line(s)
±2kV line(s) to
earth
<5% U (>95% dip
T
in U ) for 0.5 cycle
T
40% U 60% dip in
T
U ) for 5 cycles
T
70% U 30% dip in
T
U ) for 25 cycles
T
<5% U (>95% dip
T
in U ) for 5 s
T
3 A/m
Adaptec Medical Devices
Compliance Level
± 6kV contact
± 8kV air
±2 kV for power
supply lines
±1 kV for
input/output lines
±1kV line(s) to
line(s)
±2kV line(s) to earth
<5% U (>95% dip
T
in U ) for 0.5 cycle
T
40% U 60% dip in
T
U ) for 5 cycles
T
70% U 30% dip in
T
U ) for 25 cycles
T
<5% U (>95% dip
T
in U ) for 5 s
T
3 A/m
Electromagnetic
Environment - Guidance
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic materials, 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 of a typical
commercial or hospital
environment. If the user of
the Sensica™ UO System
for ICU requires continued
operation during power
mains interruptions, it is
recommended that the
Sensica™ UO System for
ICU be powered from an
uninterruptible power
supply or a battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
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