Declaration Of Conformity - InfoSight LabeLase 28 Series Basic Operations & Maintenance Manual

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InfoSight herby declares the equipment specified conforms to the Classification(s), Directive(s)

and Standard(s) set forth in this document.

InfoSight produces laser systems within one of two classes as identified and classified by the

CDRH. These are Class I and Class IV. (see CDRH 21 CFR (J) 1040.1 - 1040 .5). End user of

the equipment should be familiar with ANSI, CDRH and OSHA standards for radiation emitting

devices as they apply to them also.

ANSI Z136.1 - 1993

We will provide adequate data to the LSO (Laser Safety Officer) enabling LSO to designate NHZ

(nominal hazard zone) as required pursuant to Class IV 3.4.1

CDRH 21 CFR (J) 1040.1 1040.5

OSHA Publication 8-1.7

Section II Chapter 6

Certifications:

EMC Emissions

ICES-003 Issue 4 Class A Digital Apparatus emissions requirements (Canada)

CRF47 FCC Part 15 Subpart B Class A emissions requirements (USA)

EN55011:2007/A2:2007 Group 1 Class A ISM emissions requirements (EU)

EN61000-3-2:2006 Limits for harmonic current emissions

(equipment input current up to and including 16A per phase)

EN61000-3-3:2008 Limitation of voltage fluctuations and flicker in low-voltage supply systems

for equipment with rated current up to and including 16A

EN61326:2006, ICES-003 (230 V configuration only)

EMC requirements for Electrical equipment for measurement, control

and laboratory use – General Use

Name and Publication Date of Standard Used to Evaluate Laser safety:

IEC 60825—1:2007 (2

Safety

IEC 61010-1:2001 and EN6100-1:2001

Including Group and National differences as they apply for AU, CA, US, CH, JP, and KR

IEC 60825-1:2007 (2

Note: InfoSight design guidelines are drawn from ANSI and CDRH

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