FiberTech Medical Devices Fiber Optic medical device solutions

Medical Devices for laser medicine & endoscopy LEONI has been a reliable partner for a diversity of markets since 1917 ■ Access to all LEONI's competencies and technologies worldwide OEM/ODM service and development partner Fiber Optics experts with extensive value chain With clean rooms around the globe, LEONI offers a turnkey solution that spans a wide range of expertise for the medical device industry. LEONI has a complete value chain including: ■ LEONI offers the following services to OEM & ODM Assembly in one of our global clean rooms business partners: Fiber drawing Preform manufacturing...

Medical Devices for laser medicine & endoscopy Page Innovative Fiber Optics Solutions Extensive Fiber Optics value chain Design possibilities Regulatory affairs Product support Special optical fibers Medical devices / laser probes Disposable BareFibers Reusable BareFibers Disposable HardClad BareFiber Disposable BareFiber dentistry Reusable BareFiber dentistry Please note >> Starting on page 12 you will find an excerpt of our standardized medical devices with FiberTech branding, for which we operate as legal manufacturer. Marketing authorizations varying according to region and product. Please...

Medical Devices for laser medicine & endoscopy Innovative Fiber Optics Solutions Let's care about health together The Business Unit Fiber Optics in the LEONI Group is a leading provider of ultrapure Fused Silica, preforms, rods and Fiber Optics for demanding applications in industry, energy, commu- Integration of fiber optics solutions in OEM end-user applications and products (e.g. Life Science) From prototyping (development and consulting) to high-volume/large-scale production nications, Life Science, optical metrology, and transportation. We offer a unique product portfolio at every stage...

Medical Devices for laser medicine & endoscopy Extensive Fiber Optics value chain Your benefits Raw materials (SQ Fused Silica) Special optical fibers Biocompatible materials Medical laser probe assemblies ISO class 8 clean room assembly Product engineering and design Various tip designs and configurations Regulatory affairs support Fiber production Cable production Assembly and medical devices Optical switches Optical splitters Our strengths – your advantage ■ Client specific product and system solutions International development and system partner OEM & ODM service and development partner Unique...

Medical Devices for laser medicine & endoscopy Design possibilities It all starts with the development of solutions Full range of biocompatible fibers and assemblies Tailor-made solutions Our strengths – your benefits ■ Clean room assembly Product packaging Global distribution Commercial production German engineering and efficiency Customerspecific laser probes for therapeutic and diagnostic applications Global cleanrooms Due to our extensive value chain and expertise in the Product and Process engineering services to meet your needs manufacturing of medical probes we are an attractive partner...

Medical Devices for laser medicine & endoscopy Innovative solutions for medical applications Various distal tip designs Ring markings – laser inscription of connectors Connector options & design (for assembly) – label design – customer specific connector assembly Customer specific variations

Medical Devices for laser medicine & endoscopy Regulatory affairs Quality management Medical devices are subject to strict legal requirements to ensure safe and effective products worldwide. With our Regulatory Affairs team, we offer you assistance in approval or market clearance processes and all topics concerned. We have the knowledge and experience to support you in your target markets. Regulatory affairs for our medical laser probes Quality management system ■ in your target markets worldwide ■ Offering support for the approval or market clearance of our medical laser probes Complies with...

Medical Devices for laser medicine & endoscopy Product support along the whole product development and lifecycle process Support during product development Support of process for PLM, ODM and distributors Design input Provide documents relevant for approval Concept phase Design output Manage customer change request Design transfer Series production Risk management Management of medical devices ■ Risk management Monitor regulatory changes Implement customer requirements Manage change notices Manage design changes and manufacturing process changes Ensure customer satisfaction Postmarket surveillance...

Medical Devices for laser medicine & endoscopy Special optical fibers Optical fibers with customer-specific design Fiber with hexagonal core/cladding Fiber with octagonal core/ circular cladding Fiber with rectangular core/ circular cladding Optical fibers as a transmission medium for light can be fitted to every desired customer application. The fiber's composition offers different parameters that can be individually adjusted: Core   Clad   Coating   Jacket Cable design   Assembly Shape and size of the fiber core can be adjusted to the NCS fibers – Step-index fiber series with non-circular core...

Medical Devices for laser medicine & endoscopy Special optical fibers NCS fibers (Non Circular Shape) Hexagonal step-index fibers ➔ Fibers with rectangular shape ➔ are especially suited for the manufacturing of compact fiber can improve the signal strength in fiber laser applications by bundles, improving transmission efficiency in industrial and minimizing the energy density decrease at the end of the fiber medical applications. As part of fiber optic cables, our innova- core. This decrease occurs in particular when the emitted power tive fiber shapes help to optimize the guiding of laser light...

Medical Devices for laser medicine & endoscopy Disposable BareFibers Biocompatible fiber made of silica for a wide range of wavelengths and applications Standard length F-SMA905 connectors compatible to most standard connectors F-SMA extension sleeve available in various colors Laser inscription possible Customer-optimized designs on request Various accessories available Specialized version for Holmium lasers with standard extension sleeve (Ø 12mm) or slim extension sleeve (Ø 10mm) available in various colors Available as slim version