SPINAL elements


2 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  LUCENT® MIS FIBER OPTIC ASSEMBLY GENERAL INFORMATION Spinal Elements’ Lucent MIS Fiber Optic Assembly is a light guide that stems from a single cable and can have multiple illumination tips at the distal end. The end existing as a single cable contains a universal light source adapter that can be attached to a multitude of high intensity external light sources (ranging from 150 Watts to 300 Watts). Light provided from the external source is propagated through fiberoptic bundles contained by a jacket made of silicone sheathe. Fiber optic bundles terminate at one or multiple stainless steel illumination tips that deliver light to the surgical site. The energy (Lux) and color temperature (°K) of the light exiting illumination tips will vary, depending upon the wattage intensity of the external light source. INDICATIONS The Lucent MIS Fiber Optic Assembly is intended to provide surgical site illumination from a high intensity light source. WARNINGS 1. Light Guides are provided non-sterile and must be cleaned and sterilized before use. Validated sterilization cycle parameter protocols are noted in the STERILIZATION section of this insert. 2. Care should be taken in handling light guides to avoid injury to the user or patient. 3. Appropriate cutoff filters should be used to filter the light source attached to the Lucent MIS Fiber Optic Assembly (i.e. UV Filter, IR Filter). 4. This device is designed for attachment to a tool, instrument, or luminare, and under no circumstances should the light emitting end directly contact tissue or other heat sensitive materials. 5. Carefully read and follow the instructions provided by the manufacturer of the light source to which the Lucent MIS Fiber Optic Assembly is connected, as additional warnings may apply. PREOPERATIVE MANAGEMENT 1. Device components should be received and accepted only in packages that have not been damaged or tampered with. Damaged implants and/or instruments should not be used. Components must be carefully handled and stored in a manner that prevents scratches, damage, and corrosion. CLEANING Use a mild cleaning solution with a pH range of 5 to 9. DO NOT use synthetic detergents or oil-based soaps. The petroleum components of these soaps may be absorbed by the silicone rubber components and may leach out during use causing tissue reaction. Avoid scratching glass fibers at ends or light guide. Damage to fibers may reduce light transmission. 1. Clean thoroughly using a soft-bristled brush in a lukewarm water-soap solution to remove any possible contamination. 2. Rinse thoroughly in lukewarm water. 3. Rinse thoroughly in distilled water. 4. Allow to air dry STERILIZATION All instruments are provided non-sterile and must be sterilized before use. Non-sterile instruments should be autoclave sterilized using one of the following validated cycle parameters.  INS-LTG  Page 1 of 2  Rev. 20190823
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File Name: SPINAL elements - INS-LTG - LUCENT MIS FIBER OPTIC ASSEMBLY Instructions for Use - 2018-08.pdf

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