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Acessa
ProVu System User's Guide
®
1.
Introduction
Acessa Health Inc. is dedicated to providing service and support to its customers. If there are any questions concerning the use
of the Acessa ProVu System, please contact Customer Service at:
MANUFACTURED FOR:
Acessa Health Incorporated
317 Grace Lane, Suite 200
Austin, TX 78746 USA
Telephone: 877.412.3828
Fax: 925.605.0327
Email:
customerservice@acessahealth.com
2.
Indications For Use
The Acessa ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including
treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.
The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu
Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.
3.
Device Description and Components
The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound and guidance within a single console and includes
additional accessories.
The Acessa ProVu System is designed to deliver monopolar radiofrequency (RF) energy to tissue through a disposable Handpiece.
The System is capable of delivering up to 200W of power. The Console is specifically designed to be used only with Acessa Health
manufactured devices. The Acessa ProVu System has temperature or power displayed depending on the mode being used to
assist the physician in monitoring and controlling the ablation throughout the procedure.
The Acessa ProVu System must be used under laparoscopic ultrasound guidance. The basic function of ultrasound is to acquire
ultrasound echo data and to display the image in ultrasound B-Mode. Ultrasound wave pulses released from transducer are
reflected at the internal body system. Reflected waves are transmitted from the transducer, and ultrasound images are produced
with the reflected image on the monitor. The system is designed for imaging with the Acessa ProVu System Transducer (5-12
MHz).
The Acessa Guidance System feature is an advanced electromagnetic spatial tracking system designed to calculate the position
and orientation of sensors within a defined volume. The sensors are embedded in the tip of the Acessa ProVu Handpiece and the
Acessa ProVu Transducer with Sensor, so that the system can determine the position and orientation to each other within the
patient's abdominal cavity and display an animated image on a monitor.
The Acessa ProVu System consists of:
The Console contains the following hardware and electronic components:
•
RF Ablation system
•
Ultrasound system
•
Guidance system
The following accessories connect to the Console:
•
Dual Foot Pedal (one for RF, one for coagulation)
Video Cable
•
•
Power Cord
•
Acessa Pad (For IFU see PL-01-0015) and Acessa Pad Cable (For IFU see PL-01-0012)
•
Acessa ProVu Handpiece (For IFU see PL-01-0038) and Acessa ProVu Handpiece Cable (For IFU see PL-01-0041)
•
Acessa ProVu Transducer with Sensor (For IFU see PL-01-0044)
•
Acessa Table Top Field Generator and Table Pads (Not Shown)
Monitor (Hospital-owned, not provided by Acessa Health Inc. Monitor must have at least a 1920 x 1080 resolution and 27"
•
or larger diagonal screen diameter preferred.)
CO 20-131 Revision: C
PL-01-0040
3
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