FujiFilm VisualSonics Vevo F2 User Manual page 469

ICES-003:2004 – Digital Apparatus, Spectrum Management and T elecommunications Policy
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Interference-Causing Equipment Standard (Canada)
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FCC Part 15 Subpart B:2012
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Vevo LAZR-X laser cart
In addition to all above regulations, the Vevo LAZR-X laser cart is compliant with the following:
Government and Industry Regulations
The Vevo LAZR-X laser cart has been designed to meet 21 CFR 1040.10 and 1040.11 except for deviations
pursuant to Laser Notice No. 50 dated 06/24/07 published by the U.S. Department of Health & Human
Services Center for Devices & Radiological Health, and EN 60825-1: (current Edition) Safety of Laser
Products - Part 1.
CDRH Declaration of Conformity
The Vevo LAZR-X laser cart has been designed to meet 21 CFR 1040.10 and 1040.11 except for deviations
pursuant to Laser Notice No. 50 dated 07/26/01 the radiation safety product report has been filed with
CDRH. An accession number will be provided to the end user upon request.
Electrical Safety Testing
The Vevo LAZR-X laser cart complies with the following Class 4 laser device and laboratory standards
related to electrical safety as follows:
EN 61010-1:2010 (General requirements)
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EN 60825-1 (Safety of laser products - Equipment classification and requirements)
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EN 61326-1:2013 (EMC General requirements)
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EN 61000-3-2 (Harmonics)
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EN 61000-3-3 (Flicker)
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EN 61000-4-2 (ESD)
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EN 61000-4-3 (RF Immunity)
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EN 61000-4-4 (EFT)
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EN 61000-4-5 (Surge)
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EN 61000-4-6 (Conducted Immunity)
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EN 61000-4-11 (Voltage Dips and Interruptions)
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Reference
Vevo F2 Imaging System User Manual
469