10 Chapter 2 Regulatory Information
• Medical electrical equipment requires special precautions regarding
electromagnetic compatibility (EMC).
• KODAK RVG 6500 with or without IPS System must be installed and
put into service according to the EMC information provided in this
document.
EN 300 328
Electromagnetic Compatibility and Radio Spectrum
Matters
EN 301 489-17
ElectroMagnetic Compatibility and Radio Spectrum
Matters (ERM); ElectroMagnetic Compatibility (EMC)
Standard for Radio Equipment and Services; Part 17 :
Specific Conditions for 2,4 GHz Wideband
Transmission Systems and 5 GHz High Performance
RLAN Equipment
EN 50371
Generic Standard to demonstrate the compliance of
low power electronic and electrical apparatus with the
basic restrictions related to human exposure to
electromagnetic fields (10 MHz - 300 MHz). General
Public
Classification in Accordance with EN/IEC 60601-1
Type of protection against
electric shock
Class 1 equipment
Degree of protection
against electric shock
Type B F
Protection against harmful
ingress of water
Ordinary equipment
Operation mode Continuous operation
Flammable anesthetics Not suitable for use in presence of flammable
anesthetics or a mixture of flammable anesthetics
with air or oxygen or nitrous oxide
Conformity with EN/IEC 60601-1-3
Attenuation equivalent for the
enclosure of the image receiver
unit (at 100 kV)
0.2 mm eq. AI
Compliance with European and International Standards