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Acessa
ProVu System User's Guide
®
Expected 3D Ablation Cage. The software can optionally display a visual indicator of the expected ablation volume at
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the end of the handpiece, shown in orange. This volume guide provides the user with a 3D visual reference for physical
dimensions to further assist in electrode array placement. The dimensions and distance from the handpiece's tip are
drawn according the tables on §12.3 and 12.4.
10.10.
Procedure Planning
The physician should determine the scope and sequence of ablations prior to starting any RF energy. Using the
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ultrasound, examine the uterus and map the fibroids that are present. After all fibroids are documented, determine the
sequence of ablations and path of Handpiece insertion.
10.11.
Performing an Ablation
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Locate the fibroid targeted for treatment on the ultrasound image.
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Determine the location of the tip of the Handpiece where it should enter the fibroid on the ultrasound image. Place the
tip of the Handpiece at a location on the patient's abdomen aligned with the targeted entry point on the fibroid.
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At this point, the Guidance can be used to help confirm this location by adjusting the angle of the Handpiece so that
the trajectory lines go through the targeted area on the ultrasound image and the purple target zone lines become
visible on the image, indicating alignment with the target.
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Advance the tip of the Handpiece through the abdomen and into the abdominal cavity.
Ensuring that the purple target zone remains located on the targeted entry point on the fibroid, advance the Handpiece
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until the tip is at the serosa of the uterus viewed on the laparoscopic monitor.
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After the tip penetrates the serosa, view image on the ultrasound monitor. Corrections to the path of the tip must be
made using ultrasound imaging. Inserting the tip into the fibroid and deploying the electrode array must be done under
ultrasound visualization only.
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Continue into the fibroid until the point of the tip is approximately 1 cm into the fibroid.
For fibroids less than 1.5 cm in diameter:
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If the fibroid is 1 cm or less, press the foot pedal (yellow) to ready the system
for an ablation, then press it again to start RF.
o
If the fibroid is 1.5 cm in diameter, deploy slightly (about .2 cm) until the
expected ablation size on the screen shows a 1.5 cm ablation size. Then press
the foot pedal (yellow) to ready the system for an ablation, then press it again
to start RF.
o
The ablation time will count up. When it reaches the correct time, a "Finished" tone will be heard.
Once the tone is heard, press the foot pedal (yellow) to stop the RF energy.
o
WARNING: Do not advance, reposition or rotate Handpiece when electrode arrays are deployed.
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For fibroids greater than 1.5 cm in diameter:
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Deploy the electrode array until the distal point of the center needle is approximately 1 cm away from the distal
edge of the fibroid.
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Read the amount of deployment on the handpiece handle. Adjust the deployment until it is on a centimeter or
half centimeter mark.
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Confirm that the deployment displayed on the screen matches the deployment on the Handpiece handle.
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Press the Foot pedal (yellow) once to ready the system for ablation, then press again to start RF.
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The system will display the Ramp icon signifying that the temperature is rising to the target temperature of 95°C.
CO 20-131 Revision: C
PL-01-0040
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