Chapter 1: Introduction
LS 06311-002US Rev A
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1.4
System Overview
The Sonata System is comprised of durable medical equipment, software, and various single-use and
reusable instruments. A Radiofrequency Ablation (RFA) Handpiece attaches to an Intrauterine
Ultrasound (IUUS) Probe to provide sonography-guided RF ablation. Once connected, the assembly of
the RFA Handpiece and the IUUS Probe is referred to as the Treatment Device. The Sonata Graphical
Guidance Software (GGS) integrates ablation planning, targeting, and ablation of fibroids. The SMART
Guide displays a real-time graphic overlay on the live ultrasound image for targeting and
deployment of radiofrequency ablation. The system enables a clinician to deliver radiofrequency
energy to fibroid tissue resulting in thermal fixation and coagulative necrosis of the tissue.
Electrical Overview:
Electrical input ratings (V~, Hz, VA):
100-240 VAC, 50-60 Hz, < 15 A
Electrical classification:
Class I
Mode of operation:
Suitable for continuous operation
Applied Part (patient lead):
Type BF
Figure 1-1. System Block Diagram
