Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
33
Guidance and manufacturer’s declaration – Electromagnetic Emissions
Emissions test
Compliance
Electromagnetic environment - guidance
take mitigation measures, such as relocating or re-orienting the
equipment.
If the system is operated within the electromagnetic environment listed in the Guidance and manufacturer’s
declaration – Electromagnetic Emissions table, the system will remain safe and provide the following essential
performance:
•
measure, monitor and control the RF energy output for ablation and coagulation
•
monitor the temperature of the thermocouples in the needles of the handpiece
•
monitor the temperature of the thermocouples in the pads that provide a return path for the RF energy
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
± 15 kV air
± 8 kV contact
±2kV, ±4kV, ±8kV, and
±15 kV 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
± 1 kV for
input/output lines
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
± 0.5kV, ±1 kV for
line to line
± 0.5kV, ±1 kV, ±2kV
for line to ground
±0.5kV, ±1kV line-to-
line
±0.5kV, ±1kV, ±2kV
line to ground
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
100% drop, 0.5
periods, 0⁰, 45⁰, 90⁰,
135⁰, 180⁰, 225⁰,
270⁰, 315⁰
100% dip, 1 period
30% dip, 25/30
periods
100% drop, 0.5
periods, 0⁰, 45⁰, 90⁰,
135⁰, 180⁰, 225⁰,
270⁰, 315⁰
100% dip, 1 period
30% dip, 25/30
periods
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the device
requires continued operation during
power mains interruptions, it is
recommended that the device be powered
from an uninterruptible power supply or a
battery.
Power frequency
(60 Hz) magnetic
field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or hospital
environment.
Guidance and manufacturer’s declaration – Radiofrequency Electromagnetic Immunity
Immunity
test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
3 Vrms
150 kHz to 80 MHz
6 Vrms ISM bands
150kHz to 80MHz
3 V/m
3 Vrms
6 Vrms
3 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the system,
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
d
= [1.2]
√
P
d
= [1.2]√
P
80 MHz to 800 MHz
d
= [2.3]√
P
800 MHz to 2.5 GHz
Where
P
is the maximum output power rating of the
