Hologic NovaSure Advanced, Instructions For Use And Controller Operator'S Manual

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NovaSure Disposable Device Description
The NovaSure disposable device consists of a single-patient use,
conformable bipolar electrode array mounted on an expandable
frame that can create a confluent lesion on the entire interior
surface area of the uterine cavity . The disposable device is inserted
transcervically into the uterine cavity, and the sheath is retracted to
allow the bipolar electrode array to be deployed and conform to the
uterine cavity .
The bipolar electrode array is formed from a metalized, porous
fabric through which steam and moisture are continuously
suctioned from the desiccated tissue . The disposable device
works in conjunction with a dedicated NovaSure RF controller to
perform customized, global endometrial ablation in an average
of approximately 90 seconds without the need for concomitant
hysteroscopic visualization or endometrial pretreatment . The
specific configuration of the bipolar electrode array and the
predetermined power of the controller create a controlled depth of
ablation in uteri sounding less than or equal to 10 cm and having a
minimum cornu-to-cornu distance of 2 .5 cm .
During the ablation process, the flow of radio frequency (RF) energy
vaporizes and/or coagulates the endometrium regardless of its
thickness and desiccates and coagulates the underlying, superficial
myometrium .
The controller automatically calculates the optimal power level (W)
required for the treatment of the uterine cavity, based on uterine
size . As tissue destruction reaches an optimal depth, increasing
tissue impedance causes the controller to automatically terminate
power delivery, thereby providing a self-regulating process . Blood,
saline and other liquid present in the uterine cavity at the time
of the procedure, as well as vapor liberated from the desiccated
tissue, are evacuated by continuous, automatic suctioning .
The disposable device is connected to the controller via a
cord containing the RF cable, suction tubing used for pressure
monitoring during the cavity integrity assessment cycle and for
suction during the ablation cycle, and vacuum feedback tubing used
for carbon dioxide delivery during the cavity integrity assessment
cycle and vacuum monitoring during the ablation cycle .
NovaSure RF Controller Description
The NovaSure RF controller is a constant power output generator with a
nominal maximum power delivery capability of 180 watts . The controller
automatically calculates the power output based on the uterine cavity
length (sound measurement minus the length of the endocervical canal)
and width measurements that the user key-enters into the controller .
Monitoring tissue impedance during the ablation process automatically
controls the depth of endo-myometrial ablation . The NovaSure procedure
self-terminates once endometrial vaporization and superficial myometrial
desiccation have reached 50 ohms of impedance at the tissue-electrode
interface, or when the treatment timer reaches two minutes . Integral
to the controller is the cavity integrity assessment system (CIA) which
is designed to determine whether there is a defect or perforation in the
wall of the uterus . After the disposable device is placed into the uterine
cavity, CO
2
is delivered through the central lumen of the disposable
device into the cavity, via the vacuum feedback tubing, at a safe flow
rate and pressure . If the CO
2
pressure in the cavity is maintained for a
short period of time, indicating that the uterine cavity is intact, then the
CIA will allow the NovaSure RF controller to be enabled and proceed with
the treatment phase . A vacuum pump contained within the NovaSure
RF controller creates and maintains a vacuum in the uterine cavity
throughout the endometrial ablation procedure . Once the vacuum is
stabilized, the vacuum level is monitored throughout the remainder of
the ablation process .
NovaSure Model 08-09
RF Controllers
NovaSure Model 10
RF Controller