Regulatory Requirements - GE Senographe DS Operator's Manual

GE Healthcare
Revision 1

Regulatory Requirements

This product complies with the regulatory requirements of the following:
• Council Directive 93/42/EEC concerning medical devices: the
testifies compliance to the Directive.
European registered place of business:
GE Medical Systems Société en Commandite Simple
Quality Assurance Manager
BP 34
F 78533 BUC CEDEX France
Tel: +33 (0)1 30 70 40 40
• Code of Federal Regulations Title 21, Subchapter J - Radiological health.
• Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
• Canadian Standards Association (CSA).
• International Electrotechnical Commission (IEC), international standards organization, when applica-
ble.
Compliance with these standards is evidenced by the presence of the appropriate labels on the exterior
of the Generator cabinet.
• USA/HHS: United States Federal law restricts this device to use by or on the order of a physician.
• General Electric Medical Systems is ISO 9001 and ISO 13485 certified.
• The original document was written in English.
Use within the patient environment
All components of the Senographe DS system (Generator Cabinet, Gantry, Control Station) are
designed to be suitable for use within the patient environment, and are compliant with the relevant
standards (UL 60601-1, IEC 60601-1).
Use in the presence of flammable gases
The Senographe DS system must not be used in the presence of flammable gases
Image annotations
• The equipment includes a function IMAGE ANNOTATIONS, which allows the physician to store infor-
mation on the patient.
• Note that the European Directive regarding "the protection of the people with regard of data manage-
ment on their private life and to the free circulation of these data" requests the users of computerized
files (radiologists, physicians) not to store data related to:
- race,
- philosophical opinions,
- religious opinions,
- political opinions,
- etc.
regulatory.fm
Senographe DS Acquisition System
Page no. 3
Operator Manual 5307907-3-S-1EN
Regulatory Requirements
label affixed to the product
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