St. Jude Medical Wi-Box AO Instrucciones De Uso página 12

Table 8. Guidance and manufacturer's declaration – Electromagnetic emissions
Emissions test Compliance
Harmonic Class A
emissions
IEC 61000-3-2
Voltage Complies
fluctuations/ flicker
emissions
IEC 61000-3-3
Guidance and Manufacturer's Declaration - Electromagnetic
Immunity
Wi-Box™ AO transmitter is intended for use in the electromagnetic environment specified below.
The customer or the user of this device should assure that it is used in such an environment.
Table 9. Guidance and manufacturer's declaration – Electromagnetic immunity
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
(50/60 Hz) magnetic
field
IEC 61000-4-8
Electromagnetic environment - guidance
connected to the public low-voltage power supply network
that supplies buildings used for domestic purposes.
IEC 60601 test level Compliance level
±6 kV contact
±8 kV air
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV differential
mode
±2 kV common mode
<5% U (>95% dip in
T
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 in
T
U ) for 5 sec
T
3 A/m
±6 kV contact
±8 kV air
±2 kV for power
supply lines
N/A for input/output
lines
±1 kV differential
mode
N/A for common mode
<5% U (>95% dip in
T
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 in
T
U ) for 5 sec
T
3 A/m
8
Electromagnetic
environment - guidance
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 of a typical commercial or
hospital environment. If the
user of this device requires
continued operation during
power mains interruptions, it is
recommended that this device
be powered from an
uninterruptible power supply or
battery.
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment