Hologic NovaSure Advanced Instructions For Use And Controller Operator's Manual page 27

ENGLISH
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 Compliance
Test
RF Group 2
Emissions
CISPR 11
RF Class B
Emissions
CISPR 11
Harmonic Class A
emissions
IEC
61000-3-2
Voltage Complies
fluctuations/
flicker
emissions
IEC
61000-3-3
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 Environment –
Guidance
The NovaSure RF controller must emit
electromagnetic energy in order to
perform its intended function . Nearby
electronic equipment may be affected .
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 .
ELECTROMAGNETIC IMMUNITY
Immunity EN/IEC
Test 60601
Test Level
Electrostatic ±6 kV
discharge Contact
(ESD)
EN/IEC
±8 kV Air
61000-4-2
Electrical ±2 kV for
fast power
transient/ supply lines
burst
EN/IEC
±1 kV for
61000-4-4
input/output
lines
Surge ±1 kV line(s)
to line(s)
EN/IEC
61000-4-5
±2 kV line(s)
to earth
Voltage >95% Dip
Dips/ for 0 .5 Cycle
Dropout
EN/IEC
61000-4-11
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95%
Dip for
5 Seconds
26
Compliance Electromagnetic
Level Environment – Guidance
±6 kV Floors should be wood,
Contact concrete or ceramic tile .
If floors are covered with
synthetic material, the
±8 kV Air
relative humidity should
be at least 30% .
± 2kV for Mains power quality
power should be that of a typical
supply lines commercial or hospital
environment .
±1 kV line(s) Mains power quality
to line(s) should be that of a typical
commercial or hospital
environment .
±2 kV line(s)
to earth
>95% Dip Mains power quality
for 0 .5 Cycle should be that of a
typical commercial or
hospital environment . If
the user of the NovaSure
RF controller requires
60% Dip for
continued operation
5 Cycles
during power mains
interruptions, it is
recommended that the
NovaSure RF controller
30% Dip for
be powered from an
25 Cycles
uninterruptible power
supply or battery .
>95%
Dip for
5 Seconds
This
condition
causes the
RF controller
to shut
down and
then return
to standby
mode .
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