CeramOptec GmbH

PDT Diode Laser System

Ceralas PDT 633, 633nm +-3nm, 2W User Manual

User Manual

26 Pages

biomedical technology  biolitec AG  MEDICAL LASER SYSTEMS MEDICAL LASER SYSTEMS  CeramOptec GmbH a company of biolitec gopup  CermanOptec GmbH a company of biolitec group  Siemensstrasse 44 - D-53121-Bonn - Germany - Fon: +49 (228) 97 967 – 0  - FAX: +49 (228) 97 967 99  CERALAS PDT 633  USER MANUAL Model Ceralas PDT 633, 633nm +/-3nm, 2W Manufacturer: CeramOptec GmbH a company of biolitec group Siemensstr... 4 D-53121 Bonn - Germany Fon: +49 (228) 97 967 –0 Fax: +49 (228) 97 967 99  Distributor:   biomedical technology  biolitec AG  MEDICAL LASER SYSTEMS Declaration of Conformity  Manufacturer: CeramOptec GmbH a company of biolitec group Siemensstraße 44 D–53121 Bonn -GermanyFon... +49 (228) 97 967 0 Fax...  +49 (228) 97 967 99  Product Designation: Ceralas PDT 630nm-800nm, 100mW-20W We herewith declare that the above mentioned products meet the essential requirements of the Medical Device Directive 93/42/EEC and are classified as a Class IIb medical device (Annex IX rule 9)... he products are designed in conjunction with the following safety standards: EN 60825-1 EN 60601-1 EN 60601-1-2 EN 60601-1-4 EN 60601-2-22  Safety of laser products Medical electrical equipment Medical electrical equipment - 2... llateral Standard Medical electrical equipment - 4... llateral Standard Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment  This declaration is based upon a Quality System meeting the requirements of DIN EN ISO 13485, DIN EN ISO 9001 (Annex II, 93/42/EEC)... Notified Body:  DQS Deutsche Gesellschaft zur Zertifizierung von Managementsystemen mbH August-Schanz-Straße 21 D–60433 Frankfurt am Main - Germany –  0297 Certificate No...  057946 MR2  Place, Date: Bonn, 8... ov... 002 Signature:  Name: Dr... x Title: Quality Manager of biolitec group  status: released version: B 18... 02  file: conformity... c page 1 to 1  biomedical technology
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