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2386G EN 20120110 Introduction
CR 30-X/CR 30-X
M
Harmonization
This document has been prepared to comply with the Study Group 1 guidance
document of the Global Harmonization Task Force (GHTF) (www.ghtf.org).
To assist development of a consistent, harmonized definition for a medical
device that could be used within a global regulatory model would offer
significant benefits to the manufacturer, user, patient or consumer, and to
Regulatory Authorities and support global convergence of regulatory systems.
The IECEE CB Scheme is the world's first truly international system for
acceptance of test reports dealing with the safety of electrical and electronic
products. It is a multilateral agreement among participating countries and
certification organizations. Agfa has produced a CB test report and claims
national certification in all other member countries of the CB Scheme.
Radio Interference Suppression
It is hereby certified that the digitizer has interference suppression according
to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
WARNING: This equipment has been tested and found to comply
with the limits for a Class A digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment
in a residential area is likely to cause harmful interference in which
case the user will be required to correct the interference at his own
expense.