Chapter 1: Introduction
LS 06311-002US Rev A
14
1.6
Reference Documents
The Sonata System 2.1 and 2.2 Instructions for Use with Technical Appendix describe:
•
Intended use, patient selection, and risks;
•
Room requirements, system setup, and accessories;
•
Sonata System description and procedure, including user control Interface and messages
•
Troubleshooting
•
Clinical trial results
•
Technical information
Additional copies of the Sonata System Instructions for Use with Technical Appendix may be obtained from
Gynesonics.
Table 1 Sonata System 2.1 and 2.2 Instructions for Use (IFU) with Technical Appendix
Sonata System
Durable Equipment
Sonata System
Software
IFU Order #
SONATA2-110
SW-002
Sonata System 2.1: REF-005
Sonata System 2.2: REF-009
1.7
Personnel Qualification and Service Documentation
The procedures in this manual are intended to be performed by personnel who are trained in the
maintenance of electrical equipment, such as typically found in hospital biomedical engineering
departments. Personnel should review and understand this manual thoroughly prior to performing
procedures described herein. Supplemental training is available from Gynesonics upon request. For
all other service, contact Gynesonics or an authorized distributor.
All service information and data should be recorded on the FRM 06311-004 Sonata System Service
Form: Basic Safety and Function Checks. An updated safety check label should be added to the
system cart with date and service signature.
CAUTION
Procedures in this manual are intended to be performed by personnel who are trained
in the maintenance of electrical equipment. Electrical testing may present shock risk to
the testing personnel and if performed improperly may lead to reduced safety or loss of
function.
