Bevollmächtigte Vertreter in der Europäischen Union
PRODUKTBESCHREIBUNG
Indizen Optical Technologies S.L.U. (IOT) vertreibt halbfertige ophthalmische Linsen. Diese halbfertigen Linsen bestehen aus einer Vielzahl von Materialien, Behandlungen und Designs. Die verwendeten Materialien bestehen aus verschiedenen Kunststoffen, die gemäß den geltenden regulatorischen Anforderungen hergestellt und getestet wurden.
ANWENDUNGSHINWEISE
Die halbfertigen ophthalmischen Linsen von IOT sind nach der weiteren Verarbeitung in einem Labor geeignet für den Gebrauch und dienen zur Korrektur von Sehstörungen, die mit Kurzsichtigkeit, Weitsichtigkeit, Astigmatismus und Presbyopie verbunden sind. Sie sind für die Verwendung durch Patienten unter der Anleitung und Verschreibung eines Augengesundheitsfachmanns, d.h. eines Optometristen, bestimmt.
GEBRAUCHSANWEISUNG
Die halbfertigen ophthalmischen Linsen von IOT werden an autorisierte ophthalmische Labore zum weiteren Verarbeiten verkauft, das das Polieren, Schleifen, Beschichten usw. umfasst. Jedes Labor muss seinen eigenen Verfahren und internen Protokollen folgen, um die halbfertigen Linsen qualifiziert und angemessen zu verarbeiten.
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BETRIEBSANLEITUNG
Die Linsen dürfen nur mit anderen kompatiblen Geräten verwendet werden, wie in der Norm ISO 12870 für optische Fassungen definiert und gemäß der Norm ISO 21987 (montierte Brillengläser) montiert werden.
Für die halbfertigen Linsen "Camber" gibt es Markierungen für die horizontale und obere Ausrichtung auf der Außenseite der Linse.
HINWEISE UND VORSICHTSMASSNAHMEN
Die halbfertigen ophthalmischen Geräte von IOT gelten nicht als fertige Medizinprodukte und sind daher nicht für den Gebrauch bestimmt, bis sie von einem qualifizierten Labor ordnungsgemäß verarbeitet wurden. Sie sind nicht für die Verwendung durch Patienten oder Endverbraucher bestimmt, bis die Fertigstellungsprozesse des Produkts abgeschlossen sind und sie in Fassungen gemäß der Verschreibung eines Augengesundheitsfachmanns eingesetzt werden.**
Für weitere Informationen oder um eine gedruckte Kopie dieser Gebrauchsanweisung anzufordern, wenden Sie sich bitte an IOT.
Herstellers:
Advanced Photochromics
LLC 3625 Del Amo Blvd. #365
Torrance, CA 90503, USA
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WHICH COOKIES DO WE USE?
ANALYTICS COOKIES - Google Tag Manager
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These allow us to recognize and count the number of users of our Sites and understand how such users navigate through our Sites.
Use:
We use Google Analytics, and you can see below for how to control the use of cookies by Google Analytics.
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You can use this button to redirect to the profile of your account IOT on LinkedIn, YouTube, Instagram and Facebook.
THIRD PARTY COOKIE
Additionally, IOT has a presence in portals and third-party services for which, if you want to know the privacy conditions and use of cookies, you should consult the policies provided by them:
IOT offers information about its Cookies Policy at the bottom of the website.
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