EchoNous Bladder - Page 88

Safety
82 EchoNous Bladder & Vein User Guide
The user should assure the System is used in the electromagnetic environment specified below.
TABLE 2. Guidance and manufacturer's declaration: electromagnetic immunity
Immunity test IEC 60601 test level Compliance level
Electromagnetic environment:
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±15kV air
±8 kV contact ±15kV
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
±2 kV for power
supply lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 1kV line(s) to line(s)
± 2kV line(s) to earth
± 1kV differential
mode
± 2kV common mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
<5% U
T
1
(>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 sec
<5% U
T
1
(>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 sec
Mains power quality should be that of
a typical commercial or hospital
environment.
Power frequency
(50/60 Hz) 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.