Electromagnetic Emissions; Electromagnetic Immunity - Hologic Nova Sure 08 RF Mode D'emploi Et Manuel

ENGLISH
Essential Performance:
• Air must be purged from the device for 10 seconds prior to
insertion in patient.
• The Cavity Integrity Assessment (CIA) must measure a pressure
of 50 ± 10 mm of Hg for 3 seconds minimum to pass. Otherwise
the CIA will report an error. The RF controller will not enable an
ablation to begin until CIA passes.
• RF power: The range of RF power delivery is 55 to 180 (+/-20%)
watts.
• Vacuum pressure monitoring: During an ablation the vacuum
pressure must be in the range of 0.7 ±0.2 in Hg to 6 ±1.0 in Hg.
If the vacuum pressure exceeds this range, the controller will end
the ablation.
• Impedance monitoring: The RF Controller will end an ablation
when the measured tissue impedance reaches 50 ohms. The
controller also will act the same if the impedance is measured as
less than 0.5 ohms.
• Two minute timer: After two minutes of RF energy delivery, the
controller will end the ablation
• Ten minute timeout: after completing the ablation procedure the
controller times out for 10 minutes, during which the controller is
incapable of delivering energy.
• DC Short Circuit protection: If the RF controller detects a short
circuit (i.e. <13+/-6ohms), the ablation will be ended.
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 1
Emissions
CISPR 11
Electromagnetic Environment –
Guidance
The NovaSure RF controller must emit
electromagnetic energy in order to
perform its intended function. Nearby
electronic equipment may be affected.
Emissions Compliance
Test
RF Class A
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 whenever a high-frequency device is used. Skin-to-skin
contact should be avoided, for example, by insertion of dry gauze.
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 IEC 60601
Test Test Level
Electrostatic ±2kV,
discharge ±4kV, ±8kV
(ESD) Contact
IEC 61000-
±2kV, ±4kV,
4-2
±8kV, ±15kV
Air
Electrical ±0.5kV, ±1kV,
fast ±2 kV for
transient/ power supply
burst lines
IEC 61000-
4-4
100kHz
repetition
frequency
26
Electromagnetic Environment –
Guidance
The NovaSure RF controller is intended
for use in Professional Healthcare
Facilities including hospitals and
physician's offices.
WARNING: The EMISSIONS
characteristics of this equipment
make it suitable for use in industrial
areas and hospitals (CISPR 11 Class
A). If it is used in a residential
environment (for which CISPR 11
Class B is normally required) this
equipment might not offer adequate
protection to radio-frequency
communication services. The
user might need to take mitigation
measures, such as relocating or re-
orienting the equipment.
Compliance Electromagnetic
Level Environment –
Guidance
±2kV, ±4kV, Floors should be wood,
±8kV Contact concrete or ceramic
tile. If floors are covered
with synthetic material,
±2kV, ±4kV,
the relative humidity
±8kV,±15kV
should be at least 30%.
Air
±0.5kV, ±1kV, Mains power quality
± 2kV for should be that of a
power supply typical commercial or
lines hospital environment.
100kHz
repetition
frequency