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38 | Drystar 5301, Drystar 5302 | Introduction
General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and has been
tested as part of the conformity assessment procedures required by 93/42/
EEC Medical Device Directive (European Council Directive 93/42/EEC on
Medical Devices).
• CFR Part 21
• The printer 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
• IEC 60601-1(ed.3)
• IEC 60601-1-6(ed.3)
• IEC 60366(ed.1)
• ANSI/AAMI ES60601-1:2005/(R2012)
• CAN/CSA C22.2 No60601-1:14
• GB4943
Radio-interference regulations (interference suppression)
• IEC 60601-1-2:2007
• ETSI 300330
• ETSI 301489-1
• FCC Rules 47 CFR part 15 subpart B
• FCC Rules 47 CFR part 15 subpart C
• GB9254-1998(Class A)
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.
2831E EN 20161128 1410
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