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FDA Class II Special Controls for Computer Assisted Design and
Manufacturing of Dental Restorations
International standards
ISO 14971:2007
ISO 13485:2003
15.1.2 Approvals (all systems)
North America
Product Safety Mark (NRTL) - UL C/US
International
CB Scheme Product Safety Test Certificate (UL) CB Scheme EMC Test
Certificate (INTERTEK) CE Mark (TUV)
Quality System Certifications
ISO 13485 Registered Firm
Complies with FDA performance standards for laser products, except for
deviations pursuant to Laser Notice No. 50, dated June 24, 2007.
This device complies with part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
NOTE
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 instruction 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.
This ISM device complies with Canadian ICES-001. (Cet appareil ISM est
conforme à la norme NMB-001 du Canada.)
WARNING
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.
15.1.3 Optical specifications
CAUTION
Using controls, making adjustments, or performing procedures in a manner
other than is specified in this documentation may result in hazardous
radiation exposure.
15 Technical specifications
110 KaVo ProXam iOS
Instructions for use
Содержание ProXam iOS
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