General; Safety; Electromagnetic Compatibility; X-Ray Safety - AGFA 5522/100 User Manual

WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 |

General

• The product has been designed in accordance with Regulation (EU)
2017/745 on medical devices (MDR)
• ISO 13485
• ISO 14971

Safety

• IEC 60601-1
• IEC 60601-1-6, EN 60601-1-6
• CSA C22.2 60601-1
• AAMI ES 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
• IEC 60601-2-28
3252C EN 20191206 1610
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