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23 visualizzazioni4 pagine

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Caricato da

api-25887158
Copyright
© Attribution Non-Commercial (BY-NC)
Per noi i diritti sui contenuti sono una cosa seria. Se sospetti che questo contenuto sia tuo, rivendicalo qui.
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Scarica in formato PDF o leggi online su Scribd
DECLARATION OF CONFORMITY (WDD) OLYMPUS 1, Manufacturer Olympus Optical Co. Ltd. 2, Address 43-2, _Hatagaya 2 Chome, Shibuya-ku, Tokyo, Japan Model CV-145 4, Name of product “EVIS EXERA VIDEO SYSTEM CENTER, 5. Serial or Lot No. from 7000016 to. 6. Classification Class 1 7, Authorized representatives in EU © Name Olympus [Link].(Europa) GmbH Address ‘Wendenstr.14~16 20097 Hamburg, Germany Name Olympus Winter& Ibe GmbH Address Kuehnstr.61 22045 Hamburg, Germany Gl Name KeyMed (Medical & Industrial Equipment) Ltd. Address KeyMed House, Stock Road Essex S82 SQH, UK We herewith declare that the above mentioned product complies with the requirements of EC Directive 93 / 42 / EEC (MDD). ‘This declaration is based on : MDD, Annex VII Place 2981 Ishikawa~cho, Hachioji~shi, Tokyo, Japan Signature Z ee ~ Name Tatsuya Yamaguchi Title Management Representative, Endoscope Division Date 26. 04. 2000, IN-OIS D28001 Appendix 2) DECLARATION OF CONFORMITY (MDD) OLYMPUS ANNEX (RELATED ITEM LIST) Page 1of3 ‘The conformity in accordance with the EC directive 93/42/EEC (MDD) annex I is declared herewith also for the following related item/s that is/are provided together, as a part of the declaration of conformity of ; (model and name of the medical device) _CV-145__ EVIS EXERA VIDEO SYSTEM CENTER. ‘Model and Name of the related item Class Serial or Lot No. NB-677(BNC Cable) I fron (a) to ND-445(SCV Cable) I from (ta) to MH-154(White Cap Set) I fron (#a)__to MHI-978(Videoscope Cable 100) 1 fron (a) to WH-994(Wonitor Remote Cable) 1 fron__(#a) NH-995 (Remote Cable) I from__(ta) WAJ-227(Wonitor Rezote Cable) L from (t)__to WD-685(Moni tor Cable) 1 from (fa) to MH-884(Rater Container) Ha from (#a)__to WH-984(RGB Cable) 1 froo_(#a)__to wH-970(¥ater Container) Da from (4a) to WH-966(Light Control Cable) 1 fron (4a) fron from to Note (ta): The items manufactured on or after 1. Oct. 1998. Signature Name Tatsuya Yamaguchi Title Management Representative, Endoscope Division Date 14, 03. 2001 IN-OIS D28001 Appendix 6] Revision 2 : Mar. 14.2001 DECLARATION OF CONFORMITY (MDD) OLYMPUS ANNEX (RELATED ITEM LIST) Page 2of3 ‘The conformity in accordance with the EC directive 93/42/EEC (MDD) annex I is declared herewith also for the following related item/s that is/are provided together, as a part of the declaration of conformity of ; (model and name of the medical device) _CV-145_ EVIS EXERA VIDEO SYSTEM CENTER ‘Model and Name of the related item Class Serial or Lot No. WAJ-843(Videoscope Cable Exera) I fron (#b) MAJ-844(Keyboard) 1 fron__(#b) to MAJ-846(Woni tor Cable) 1 fron (#b) to WAJ-848(Woni tor Adapter) L fron (4b) WAJ-849(Printer Adapter) I fron (#b) MAJ-854(Renote Cable) I fron _(#b) to WAJ-884(Printer Cable Set~A) 1 fron (4b) to WAJ-885(Printer Cable Set-B) L fron (#b) to WAJ-887(Keyboard Cover) I from (#b) to WAJ-901(Water Container) Ma from (#b)_ to WAJ-902(fater Container) Da from _(#b)__to WAJ-905 (Container Protector) I fron (#0) to WAJ-921 (Moni tor Cable) I fron__(#b) to WAJ-920(Pump Renote Cable) I fron (tc) to WAJ-970(Moni tor Cable) I fron Gc) tw MAJ-971(Monitor Cable) I fron (4c) Note (#b): The items manufactured on or after 26. Apr. 2000. Note (#c): The items manufactured on or after 26. Sep. 2000. Signature CE LZ Name Tatsuya Yamaguchi Title Management Representative, Endoscope Division Date 14,03 2001 IN-OIS D28001 Appendix 6] Revision 2: Mar. 14. 2001

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