SPINAL elements


5 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  ORBIT™ DISCECTOMY INSTRUMENTS GENERAL INFORMATION The ORBIT Discectomy Instrument sets are comprised of reusable instruments that are intended to facilitate a complete discectomy in preparation for an intervertebral fusion surgery. The instruments are manufactured from stainless steel, aluminum and polymeric materials. The perforated instrument tray is comprised of aluminum and has various silicone and aluminum brackets to hold the instruments in place during handling and storage. INTENDED USE The ORBIT Discectomy Instruments are intended to facilitate a complete discectomy in preparation for lumbar interbody fusion surgery through a posterior or posterolateral approach. WARNINGS Unless otherwise indicated, instrument sets are NOT sterile and must be thoroughly cleaned and sterilized prior to use. Unwrapped instrument trays DO NOT maintain sterility. Utilize an approved sterilization wrap. Universal precautions should be observed by all hospital personnel that work with contaminated or potentially contaminated medical devices. Caution should be exercised when handling instruments with sharp points or cutting edges to prevent cutting surgical gloves. Care should be taken to avoid penetrating or cutting injuries to the user or patient. Follow the instrument layout guide for placing instruments in their proper locations within the instrument tray. Insert the instruments completely into their respective silicone brackets for full security. Failure to do so can compromise the steam sterilization processing. Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of instruments. Soft bristled, nylon brushes and pipe cleaners should be used. Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris, saline, or disinfectants to dry on used devices. The effectiveness of subsequent decontamination processes depends on prior removal of gross soil as it may be impaired by dried or coagulated protein. Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine, chloride, bromine, bromide, iodine or iodide are corrosive and should not be used. Instruments must not be placed or soaked in Ringers Solution. Instruments should only be lubricated with biocompatible, watersoluble instrument milk that is compatible with steam sterilization (Miltex® or equivalent). Silicone lubricants SHOULD NOT be used because they coat microorganisms, prevent direct contact of the surface with steam, and are difficult to remove. Instruments must be removed from instrument tray for recommended manual cleaning procedures. Instrument trays and lids must be cleaned separately. Stacking of instrument trays will adversely affect sterilization and drying effectiveness. DO NOT STACK trays in the autoclave chamber. DO NOT load instrument trays into the autoclave chamber on sides. Load trays on cart or shelf so that the lid is always facing upward. This will allow for proper drying. The instrument trays are designed to drain in this position. DO NOT load any instruments into the instrument tray that are not intended for use with the ORBIT Discectomy Instrument Set. This will adversely affect sterilization and drying effectiveness. Validated sterilization cycle parameter are noted in the STERILIZATION section of this insert. Surgical procedures should be performed only by experienced surgeons with training in the use of the device. This is a technically demanding procedure presenting a risk of serious injury to the patient. Further, the proper selection and compliance of the patient will greatly affect the results. Physician Note: The physician is the learned intermediary between the company and the patient. The intended use and warnings given in this document must be conveyed to the patient. POSSIBLE ADVERSE EFFECTS Potential risks associated with the use of the ORBIT Discectomy Instruments are similar to those associated with any surgical instrument with the same intended use. The most frequent risks are: 1. Bleeding 2. Damage to the surrounding soft tissue 3. Infection INS-ORB  Page 1 of 5  Rev. 20210723
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