Chapter 1: Introduction
LS 06311-002US Rev A
10
Chapter 1
Introduction
1.1
Manufacturer
Gynesonics, Inc.
600 Chesapeake Drive
Redwood City, CA 94063 USA
Telephone: +1 650-216-3860
Fax: +1 650-299-1566
[email protected]
www.gynesonics.com
1.2
Device Intended Use
The Sonata
®
Transcervical Fibroid Ablation System 2.1 and 2.2 are intended for diagnostic
intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those
associated with heavy menstrual bleeding.
1.3
Room Requirements
The Sonata System is intended for use in locations in which minimally invasive procedures are
performed. The Sonata System is suitable for use within the patient environment as defined by IEC
60601-1. Additional room requirements are defined in the Sonata System Instructions for Use.
•
Power
: AC 100-240V, 50/60 Hz, 15A max, grounded. Backup is recommended.
•
Temperature
: 10°C to 35°C for all equipment and components.
•
External Monitors
: The SMART Tablet may be connected to an external monitor through a
video cable and adapter. The output format is micro HDMI. An adapter from Micro HDMI to
HDMI is provided.
