Carestream DENTAL CS 7600, Руководство пользователя

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18 Chapter 2 Regulatory Information
Compliance with International Regulations
The product conforms to the following safety standards: IEC 60601-1:2005 -
Medical Electrical Equipment - Part 1: General requirements for safety and essential
performance, EN/IEC 60825-1:94 + a1(97) + a2(01) + Cor1(02), EN
60601-1:06/IEC 60601-1:05, UL 60601-1:03, rev. 06, IEC
60825-1:93+A1:97+A2:2001 (for LED module), IEC 60825-1:2007 (for laser
module CAN\CSA-C22.2 No. 601.1-M90, JIS T 0601-1:1999.
This device complies with 21CFR 1040.10.
•
Medical Device Directives 93/42/ European Economic Community
(EEC), Class IIa follow the rule 16 as amended by 2007/47/EEC.
•
The CS 7600 is an active device specifically intended for scanning of
X-ray diagnostic images.
•
ElectroMagnetic Compatibility (EMC) directive 89/336/EEC, Group
1, Class A
•
Radio and Telecommunications Terminal Equipment directives
1999/5/EEC
•
FCC rules part 15/EN 300 330-2 V1.3.1/47CFRp15sb.C/RSS/210:07
Issue 7
Compliance with FCC Rules
This equipment has been tested and found compliant 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.
However, there is no guarantee that the
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•
Increase the separation between the equipment and receiver.
•
Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
•
Consult the dealer or an experienced radio/TV technician for help.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions:
•
This device may not cause harmful interference.
•
This device must accept any interference received, including interference
that may cause undesired operation.
.