Safety Compliance - AGFA CR 25.0 User Manual

Safety compliance

Certificates
The CR 25.0 complies with:
• the general safety regulations:
EN 60601-1 :1990 / A1:1993, A2:1995, A13:1996,
EN 60601-1-2 :2001,
IEC 601-1 :1988/A1 :1991, A2 :1995,
IEC 601-1-1 / EN 60601-1-1,
UL 60601-1:2003,
CAN / CSA C22.2 No.601.1-M90.
• the laser safety regulations:
EN 60825-1: 1994 / A1:2002, A2:2001,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11,
ANSI Z 136-1980.
• EN ISO 14971:2000,
EN 1041:1998,
EN 980:1996/A1.
❖
The Digitizer is in compliance with the EG regulation 93/42/EEC Directive
(Medical Device).
Radio Interference Suppression
It is hereby certified that the Digitizer has interference suppression according to
the EN 55011 Class B as well as the FCC Rules CR47 Part 15 Class B (North-
America).
Short-range devices
EN 300 330-2 V1.1.1
EN 301 489-03 V1.2.1
For USA only:
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. In
case the equipment causes harmful interference to other devices, see the
User manual for help.
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2312A EN 20040909