NewTom VG User Manual rev 4.0 - Image Works

APPENDIX B: Standards conformity
The NewTom VGi equipment has been built in conformity with IEC normative regarding safety of electricmedical
devices of similar typology and, particularly, with the normative:
• IEC 60601-1: 1988-12 Medical electrical equipment - Part 1: General requirements for safety
• IEC 60601-1-1: Edition 2.0 2000-12 Medical electrical equipment - Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for medical electrical systems
• IEC 60601-1-2: 2001-09 Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic compatibility - Requirements and tests
• IEC 60601-1-3:1994-07 Part 1: General requirements for safety - 3. Collateral standard: General
requirements for radiation protection in diagnostic X-ray equipment
• IEC 601-1-4: Edition 1.1 2000-04 Medical electrical equipment - Part 1-4: General requirements for safety -
Collateral Standard: Programmable electrical medical systems
• IEC 601-2-7: Edition 2 1998-02 Medical electrical equipment - Part 2-7: Particular requirements for the
safety of high-voltage generators of diagnostic X-ray generators
• IEC 601-2-28: Edition 1.0 1993-03 Medical electrical equipment - Part 2: Particular requirements for the
safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• IEC 601-2-32: Edition 1.0 1994-03 Medical electrical equipment - Part 2: Particular requirements for the
safety of associated equipment of X-ray equipment
• IEC 601-2-44: Edition 2.1, 2002-11 Medical Electrical Equipment - Part 2.44:Particular requirements for the
safety of X-ray equipment for computed tomography
• IEC 60825-1: 2003-02 Edition 4, Safety of laser products - Part 1: Equipment classification, requirements
and user's guide
• 21 CFR 1020.33 Computed tomography (CT) equipment April 1, 2006]
CLASSIFICATION IEC 601-1
Protection against electrical shock
Degree of protection against electric shock
Use with flammable anesthetics
CLASS I
TYPE B
Have not been evaluated for use in the
presence of a flammable anaesthetic mixture
with air, oxygen, or nitrous oxide.
Sterilization and disinfection methods
The device is supplied not sterile and it must
not be subjected to sterilization.
See chapter 3.5 “Cleaning and disinfection”
Mode of operation
Continuous with intermittent loading.
Duty cycle
18sec ON / 15 min. OFF
modalities
Full and Zoom
27sec ON / 15 min. OFF HiRes Zoom modality
Rev. 1.0 - 02/15/2009 Page 64 of 72