LT-217
2Pages

technical operation optional • Olympus, Pentax, Fujinon and Storz leak test connectors models LT-217, LT-217B eak tester with integrated barcode reader to read the serial number of endoscopes and operators and related traceability of the executed cycles downloading data from USB port (already equipped with 50 instrument acid-resistant barcode labels and 20 for operators). DICHIARAZIONE DI CONFORMITÀ Declaration of conformity Fabbricante: (Manufacturer) Dispositivo Medico (Medical Device) Codici: (REF. code) Direttive Applicabili: (Applicable Directives) MDG ENGINEERING S.r.l. Via G. Fracastoro, 3 48124 Ravenna DRS-215 DRS-215 Vedere Allegato 1 See Attachment 1 DIRETTIVA 93/42/CEE concernente i dispositivi medici modificata dalla 2007/47/CE – recepita dal D.Lgs. n°46 del 24/02/1997 – modificato da D.Lgs. N°37 del 25/01/2010 DIRETTIVA 2011/65/CE sulla restrizione dell’uso di determinate sostanze nelle apparecchiature elettriche ed elettroniche (CE Directive 93/42/EC concerning medical devices and fallowing updates CE Directive 2011/65/CE restrictions in the use of hazardous substances in electrical and electronic equipment) Classificazione (Allegato IX D.Lgs. 46/97): Classification (Annex IX, MDD 93/42): Procedura di valutazione della Conformità (Conformity Assessment procedure): Classe I (Regola 12) Class I (Rule 12) Allegato VII Con la presente si dichiara, sotto la propria esclusiva responsabilità, che i prodotti sopra elencati soddisfano tutti i requisiti essenziali applicabili, previsti dall’Allegato I della Direttiva 93/42/CE concernente i Dispositivi Medici e alle norme applicabili. (Under our sole responsibility, we state that the above-mentioned products meet all the applicable essential requirements of Annex I of the Medical Devices Directive 93/42/EEC and all the applicable standards). MDG Engineering S.r.l. Via G. Fracastoro n. 3 - 48124, Ravenna (RA) Tel + 39 0544 1826013 - Fax + 39 0544 1826015 www.mdg-srl.com - info@mdg-engineering.com Norme europee armonizzate applicabili (Applicable harmonized European standards) La lista delle norme applicabili è riportata nel Cap.11 del Fascicolo Tecnico FT03. (The list of the applicable standards is reported in Chapter 10 of Technical File FT03). Il Fabbricante si impegna a conservare e a mettere a disposizione delle Autorità competenti la documentazione tecnica specificata nell’Allegato VII della Direttiva 93/42/CEE, per un periodo di 10 anni dalla data di ultima fabbricazione del prodotto. (The Manufacturer undertakes too keep available for the Competent Authorities the technical documentation quoted in Annex VII of Directive 93/42/EEC for a period of at least TEN years after the last manufacture of the product.) Legale Rappresentante (Authorized/Responsible Person) Firma: Andrea Fabbri Signed MDG Engineering srl is part of the MDG S.r.l. group Complies with the Directive 93/42/CEE Annex VII tester to check integrity of flexible endoscopes For all types of flexible endos

DATA TRANSFER throught USB flash drive LT-217™ To check endoscope channels, sheaths and o’ring conditions Italian technology and design tester to check integrity of flexible endoscopes LT-217™ is a patented system designed to check the integrity of flexible endoscopes. The device detects accurately leakage of the sheaths, of the endoscopes channels and the wear conditions of the o’ring. It checks also the conditions of internal channels and the little holes caused by twisted biopsy channels. This leak tester works through much higher standard compared to the actual product on the market and...