Acessa
®
ProVu System User’s Guide
PL-01-0040
CO 20-131 Revision: C
16
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Ablate State.
In Ablate State (Figure below), the upper left-hand frame has a yellow background, and the array is
colored maroon to indicate RF delivery. The user depresses the left foot pedal (yellow) a second time to activate RF. If
the user does not depress the foot pedal a second time within 5 seconds, the system goes back to a neutral state. The
RF system adjusts power to provide a smooth upward ramp until target temperature has been reached. Ramp icon is
displayed beside the ablation temperature. Under normal conditions the ablation continues until the time at target
corresponds to the empirically determined time and deployment for the desired ablation size. Refer to tables on §12.3
and 12.4. At this point the user must manually turn off the RF energy by again depressing the foot pedal; an audible
finish tone sounds.
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Ready-Coag State.
In Ready-Coag State (Figure below), a different left-hand frame is outlined in blue. The settings allow
for 1-20 (power level), and default is always set to 12 or the last setting chosen. Immediately following a completed
ablation, the user is ready to cauterize the Handpiece track. First, the user retracts the device electrode arrays, then
depresses the right foot pedal (blue) to activate the Ready Coag state which enables the sounding of the system.
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Coag State.
In Coag State (Figure below), the upper frame has a blue background to indicate RF delivery and the timer
panel will show the elapsed time for coagulation. The user depresses and holds the right foot pedal (blue) to begin coag,
which enables sounding of the system. If the user does not depress the foot pedal a second time within five (5) seconds
the system goes back to a neutral state. The system provides a coag power output proportional to the level setting. The
user slowly withdraws the Handpiece while visually monitoring the coag laparoscopically, adjusting level setting as
necessary to achieve optimal results. Turn off RF power when track coagulation is completed by releasing the foot
pedal.
10.8.
Pad Temperatures
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Each pad has three thermocouples. Only the temperature of the warmest thermocouple is displayed on the screen. The
left temp is for the left pad, and the right temp is for the right pad.
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When the temperature of the warmest thermocouple reaches 40°C, that pad temperature will change to yellow.
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When the temperature of any thermocouple on either pad reaches 44°C, RF energy will no longer be delivered. The
pads must be cooled before ablation can be restarted. Coag can still be done if a pad temp reaches 44°C.
10.9.
The Acessa ProVu Guidance System Feature
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The Guidance System feature allow the physician to see the Ultrasound Transducer and the Handpiece shaft images in
real time as they are being positioned within the abdominal cavity. It places the image from the ultrasound machine
onto a virtual ultrasound transducer plane and displays a “Target Zone” with purple lines where the Handpiece shaft
will intersect the plane.
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The Guidance System feature is intended to be used as an
adjunct to the standard ultrasound image to assist the
positioning of the Handpiece during the Acessa Procedure.
The Guidance System feature aids in showing where the
tip of the Handpiece would intersect the ultrasound plane.
Once the tip of the Handpiece penetrates the uterine
serosa, ultrasound visualization must be used to complete
the process of positioning the Handpiece in the fibroid for
the Acessa procedure treatment.
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After using standard ultrasound imaging as described in
the Acessa procedure to locate and map a fibroid for
treatment (see Figure to the right for menu selection of
ultrasound only). The Guidance System can be used to help
determine the optimum location to enter the uterus with
the tip of the Handpiece.