Novus Spectra
0642-543-01, Rev A, 12/02
64
Safety and Regulatory
Regulatory Compliance
Lumenis lasers and delivery systems comply with 21 CFR Chapter I,
Subchapter J, as administered by the Center for Devices and Radiological
Health of the US Food and Drug Administration (FDA).
CE-labeled devices comply with all appropriate performance standards as
specified in Annex II of the European Medical Device Directive MDD
93/42/EEC.
CAUTION -
US law restricts this device to sale by or on the order of a
physician.
CAUTION -
Lumenis medical lasers and laser delivery systems are intended
solely for physicians trained in the use of these instruments.
CAUTION -
Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous laser radiation
exposure.
This package conforms to the conditions and limitations specified in US federal
regulations, title 49 CFR 173.426 for radioactive material, excepted package-
articles manufactured from natural thorium, UN 2910.
Summary of Contents for Novus Spectra
Page 1: ...Novus Spectra Solid State 532 nm Green Laser Operator Manual...
Page 6: ...6 Contents Novus Spectra 0642 543 01 Rev A 12 02...
Page 8: ...Novus Spectra 0642 543 01 Rev A 12 02 8 General Operation...
Page 40: ...Novus Spectra 0642 543 01 Rev A 12 02 40 General Operation...
Page 42: ...Novus Spectra 0642 543 01 Rev A 12 02 42 Maintenance...
Page 56: ...Novus Spectra 0642 543 01 Rev A 12 02 56 Safety and Regulatory...
Page 72: ...Novus Spectra 0642 543 01 Rev A 12 02 72 Indications for Use...
Page 110: ...Novus Spectra 0642 543 01 Rev A 12 02 110 Indications for Use...
