User Manual

13
2921B EN 20031206
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
This equipment complies with:
• the Medical Devices Directive 93/42/EEC
• the standards UL2601-1 of Underwriters Laboratories
• CSA 22.2 No. 601.1-M90 of the Canadian Standards Association
• FDA 510k
• FDA Part 820 Good Manufacturing Practice for Medical devices
• IEC 601-1 and IEC 601-1-2
• EN 60601-1:1990 + A1:1993 + A2:1995
• EN 60601-1-2:2001
" The Drystar 5300 carries the CE, TÜV and CUL labels.