AGFA Drystar 5500, Reference Manual

Page: 18 / 266

18
2900H EN 20071108 Introducing the Drystar 5500
D
RYSTAR
5500/5503 R
EFERENCE 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
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 5500 has been tested and found to comply with the following
international standards and regulations:
•
The Medical Devices Directive 93/42/EEC
•
CFR Part 21
• FDA 510K, FDA Part 820 Good manufacturing Practice for Medical devices
• The Quality Control test procedure for general radiography applications
(refer to
‘Quality control for general radiography applications (DT 2 B &
DT 2 C)’ on page 141 complies with the grayscale reproduction constancy
test, according to the international standard IEC 1223-2-4.
• The Quality Control test procedure for the optional mammography
application (refer to
‘Quality control for mammography application
(DT 2 Mammo) (optional)’ on page 153 ) complies with the Mammography
Quality Standard Act (MQSA) of the FDA.