Labomed PRIMA ENT User Manual

Also see for PRIMA DNT: User manual User manual

Labomed PRIMA ENT User Manual Manual pdf 10 page image

10Prima ENT/DNTSTANDARDS AND DIRECTIVES5The instrument described in this user manual has been designed in compliance with thefollowing standards:· ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments-Medical endoscopes and endoscopic accessories Part 3: Determination of field of viewand direction of view of endoscopes with optics.· ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments-Medicalendoscopes and endoscopic accessories Part 3: Determination of field of view anddirection of view of endoscopes with optics.· ISO 8600-5 First edition 2005-03-15 Optics and photonics-Medical endoscopes andendotherapy devices Part 5: Determination of optical resolution of rigid endoscopeswith optics.· ISO 9001/13485 Quality management systems approved by UL (notified body).· ISO 14971-2007 Risk management to medical devices.Directives Used· Directives 93/42/EEC, Article II, Section 5, Annex VII· IEC 60601-1-3rd edition (2005)· IEC 60601-1-2· EN 55011:2007Classifications· For Europe, per Directive 93/42/EEC, the unit is a Class I instrument, per rule 12,Annex IX.· For the United States, the FDA classification is Class I.· Please observe all applicable accident prevention regulations.