Carestream Quantum Odyssey HF QG-32, Operator'S Manual, Page: 13 / 102

Chapter 1 Safety Notices
HF Series X-ray Generators - Operator’s Manual Revision Q
Quantum Medical Imaging, LLC
1-7
ACCOMPANYING DOCUMENTATION
The documentation consists of a User manual (this document) and related docu-
mentation:
• Service Manual P/N DC30-011: Contains technical and service documentation
for this product, including installation and configuration instructions to be
performed by qualified persons
The documentation shall be kept with the system for easy reference.
APPLICABLE STANDARDS
HF Series X-ray Generators comply with the following regulatory standards:
• FDA Center for Devices and Radiological Health (CDRH) - Title 21 CFR
Subchapter J
• EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996
• IEC 60601-2-7: 1998(E)
• CAN/CSA-C22.2 No. 601.1-M90, 2005 (Medical Electrical Equipment, part 1:
General Requirements for Safety)
• UL 60601-1, 1st Edition, 2006-04-26 (Medical Electrical Equipment, part 1:
General Requirements for Safety)
• IEC 60601-1 Medical electrical equipment, Part 1: General requirements for
safety
• IEC 60601-1-2: 2007
• EC Directive 93/42/EEC for Medical Devices
EU Authorized Representative:
Medizintechnik Berlin GmbH
Altentreptower, Strasse 59
12683 Berlin - Germany
Phone: +49-302-82 4726
Fax: +49-302-82 6382
E-mail: Medizintechnik.Berlin.GmbH@t-online.de