Safety Compliance - AGFA Drystar 5302 Reference Manual

Safety compliance

EMC issues
•
USA: 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
Drystar 5302 Reference 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
Canadian Interference-Causing Equipment Regulations.
•
EC: This is a class A product. In a domestic environment this product may
cause radio interference in which case the user may be required to take
adequate measures.
Compliances
The Drystar 5302 has been tested and found to comply with the following
international standards and regulations:
•
the Medical Devices Directive 93/42/EEC
•
CFR Part 21
•
The Drystar 5302 contains an automatic QC feature that has been designed
to comply with the grayscale reproduction constancy test, according to the
international standard IEC 1223-2-4.
Safety standards
•
IEC 60601-1 + A1 + A2
•
EN 60601-1 + A1 + A2
•
UL 60601-1
•
CSA 22.2 No. 601.1-M90
•
GB4943-2001 (for CCC-Mark)
2830A EN 20050526
D 5302 R
RYSTAR EFERENCE MANUAL
Introducing the Drystar 5302
15