Safety Compliance - AGFA Drystar 4500 Reference Manual

Safety compliance

EMC issues
USA: This equipment has been tested and found to comply with the limits
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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 its own expense.
If required, contact your local service organization.
Canada: This class A digital apparatus meets all requirements of the
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Canadian Interference-Causing Equipment Regulations.
EC: This is a class A product. In a domestic environment this product may
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cause radio interference in which case the user may be required to take
adequate measures.
Compliances
This equipment complies with:
the Medical Devices Directive 93/42/EEC
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the standards UL2601-1 of Underwriters Laboratories
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CSA 22.2 No. 601.1-M90 of the Canadian Standards Association
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FDA 510k
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FDA Part 820 Good manufacturing Practice for Medical devices
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IEC 601-1 and IEC 601-1-1
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DOH
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VDE 0750 Teil 1 (12.91)
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TÜV
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2800E EN 20050215
D 4500 R
RYSTAR EFERENCE MANUAL
Introducing the Drystar 4500
13