General; Safety; Electromagnetic Compatibility; X-Ray Safety - AGFA DR 400 User Manual

220 | DR 400 | Product Information

General

• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have 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).
• ISO 13485
• ISO 14971

Safety

• IEC 60601-1
• AAMI ES 60601-1
• CSA C 22.2 No.60601-1

Electromagnetic Compatibility

• IEC 60601-1-2, EN 60601-1-2
Topics:
• For USA
• For Canada
For 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 installation 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 his own expense. If required,
contact your local service organization.
For Canada
This class A digital apparatus meets all requirements of the Canadian
Interference-Causing Equipment Regulations.

X-Ray Safety

• IEC 60601-1-3
• IEC 60601-2-54
3231E EN 20210708 1530