1. SYSTEM OVERVIEW
1.1. Introduction
INSIGHTEC Exablate Prostate delivers MR-guided focused ultrasound energy into the prostate in a minimally
invasive manner by utilizing an endorectal transducer. In a matter of seconds, the tissue at the focal spot
of the ultrasound beam is heated to the point of irreversible thermal coagulation, while nearby tissue
remains unaffected. Over time, the body gradually absorbs the ablated tissue. This procedure is typically
performed in an outpatient setting using either Epidural anesthesia (combined with conscious sedation) or
general anesthesia. The patient is usually able to return to normal activity the following day.
The Exablate Prostate's focused ultrasound system operates inside a Magnetic Resonance Imaging (MRI)
scanner, used to provide images of the patient’s anatomy, and prepare an appropriate treatment plan. The
MRI also measures temperature changes inside the body during Focused Ultrasound (FUS) treatment. The
system acquires MR images and runs dedicated sequences to display temperature maps. The temperature
maps are used to calculate the extent of thermal ablation and to help ensure safety and efficacy.
1.2. Document Conventions
Notes, Cautions and Warnings are used throughout this manual to highlight important points of information
that could affect the health and safety of the patient and operator, as well as information intended to
preserve system integrity. The following conventions are used to highlight these messages:
CAUTION:
Cautions indicate instructions or cautionary notes that, if not followed, may result in
damage to the equipment or to the quality of treatment.
WARNING:
Warnings indicate precautions and instructions which, if not followed, may result in
personal injury or even death .
1.3. Scope of This Manual
This operator's manual covers the following systems:
◼ MR scanner: 1.5 and 3-Tesla
◼ System Model: 2100V1
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