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Guidance and manufacturer’s declaration –
electromagnetic emissions and immunity
The NovaSure RF controller is intended for use in the
electromagnetic environment specified below . The customer
or user of the NovaSure RF controller should ensure that it is
used in such an environment .
Electromagnetic emissions
Emissions
Test
Compliance Electromagnetic Environment –
Guidance
RF
Emissions
CISPR 11
Group 2
The NovaSure RF controller must emit
electromagnetic energy in order to
perform its intended function . Nearby
electronic equipment may be affected .
RF
Emissions
CISPR 11
Class B
The NovaSure RF controller is suitable
for use in all establishments other than
domestic, and may be used in domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes,
provided the following warning is
heeded:
WARNING:
This equipment/
system is intended for use by
healthcare professionals only . This
equipment/system may cause radio
interference or may disrupt the
operation of nearby equipment . It
may be necessary to take mitigation
measures, such as re-orienting or
relocating the NovaSure RF controller
or shielding the location .
Harmonic
emissions
IEC
61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC
61000-3-3
Complies
WARNING:
In some circumstances, the potential exists for
alternate site burns to a patient whenever a high-frequency
device is used . Patient skin-to-skin contact (for example, a
patient’s hand placed on her thigh) should be avoided, for
example, by insertion of dry gauze between skin surfaces .
WARNING:
With any electrosurgical device, the potential for
arcing exists, and neuromuscular stimulation may occur .
When this device is used properly in the uterus, the risk of
muscle stimulation, particularly heart muscle, is remote .
ELECTROMAGNETIC IMMUNITY
Immunity
Test
EN/IEC
60601
Test Level
Compliance
Level
Electromagnetic
Environment – Guidance
Electrostatic
discharge
(ESD)
EN/IEC
61000-4-2
±6 kV
Contact
±6 kV
Contact
Floors should be wood,
concrete or ceramic tile .
If floors are covered with
synthetic material, the
relative humidity should
be at least 30% .
±8 kV Air
±8 kV Air
Electrical
fast
transient/
burst
EN/IEC
61000-4-4
±2 kV for
power
supply lines
±1 kV for
input/output
lines
± 2kV for
power
supply lines
Mains power quality
should be that of a typical
commercial or hospital
environment .
Surge
EN/IEC
61000-4-5
±1 kV line(s)
to line(s)
±1 kV line(s)
to line(s)
Mains power quality
should be that of a typical
commercial or hospital
environment .
±2 kV line(s)
to earth
±2 kV line(s)
to earth
Voltage
Dips/
Dropout
EN/IEC
61000-4-11
>95% Dip
for 0 .5 Cycle
>95% Dip
for 0 .5 Cycle
Mains power quality
should be that of a
typical commercial or
hospital environment . If
the user of the NovaSure
RF controller requires
continued operation
during power mains
interruptions, it is
recommended that the
NovaSure RF controller
be powered from an
uninterruptible power
supply or battery .
60% Dip for
5 Cycles
60% Dip for
5 Cycles
30% Dip for
25 Cycles
30% Dip for
25 Cycles
>95%
Dip for
5 Seconds
>95%
Dip for
5 Seconds
This
condition
causes the
RF controller
to shut
down and
then return
to standby
mode .
INSTR
UCTIONS FOR USE ALL USERS
Summary of Contents for NovaSure Advanced
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