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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 
 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 
) complies with the Mammography 
Quality Standard Act (MQSA) of the FDA.