SPINAL elements

SPINAL ELEMENTS Instruments Instructions for Use

3 Pages

Spinal Elements, Inc. · 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 · U.S.A. · 760.607.0121  SPINAL ELEMENTS, INC. INSTRUMENTS GENERAL INFORMATION Spinal Elements instruments are manufactured from various stainless steels, aluminums, and polymers. All materials used have a history of use in such instruments. WARNINGS 1. Instruments 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. Some instruments may be sharp, depending on their intended use. Care should be taken in handling such instruments to avoid injury to the user or patient. PREOPERATIVE MANAGEMENT 1. The surgeon should have a complete understanding of the surgical technique and of the instrument’s applications. 2. The surgeon should have a complete understanding of the function and limitations of each implant and instrument. 3. 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. INTRAOPERATIVE MANAGEMENT 1. Instruments that have threaded assemblies with other instruments, components, or implants should not be over-tightened. Over-tightening may cause damage to the instruments or implants. POSTOPERATIVE MANAGEMENT Postoperative management by the surgeon, including instruction and warning to and compliance by the patient, of the following is essential: 1. The patient should have a complete understanding of and compliance with the purpose and limitations of their surgical procedure. 2. Postoperative patients should be instructed to limit activity as determined by their surgeon. CLEANING AND MAINTENANCE All instruments must be free of packaging material and bio-contaminants prior to sterilization. Cleaning, maintenance and mechanical inspection must be performed by hospital personnel trained in the general procedures involving contaminant removal. Only neutral pH cleaners or detergents labeled for use in cleaning medical devices should be used for cleaning components. Only lubricants that are intended for use on surgical instruments should be used to lubricate instruments. Follow directions from the manufacturer of lubricating and cleaning agents regarding handling, concentration, and use of such agents. Cleaning instructions are provided in accordance with recognized standards and regulations and are intended to supplement a hospital’s existing device cleaning and disinfecting protocol. Contaminated devices should be wiped clean of visible soil at the point of use prior to transfer to a central processing unit for cleaning and sterilization. Contaminated devices must be cleaned promptly after use per the instructions provided in this insert to minimize drying and ensure an effective cleaning. AUTOMATED CLEANING INSTRUCTIONS All devices must be processed manually prior to automated cleaning. Follow the instructions below for the manual and automated washing. PRE-AUTOMATED WASHER: MANUAL CLEANING 1. Disassemble all instruments that come apart for cleaning. 2. Rinse under running tap water to remove gross contamination. Use a syringe, wire guide and/or pipe cleaner (as appropriate to the presented cleaning challenge) to push debris out of lumens/cannulations or other hard to reach areas. Pay special attention to lumens of the external shafts of disassembled instruments. 3. Prepare Enzol® (or equivalent neutral or mild pH enzymatic cleaner) according to manufacturer recommendations using warm tap water. Fully immerse devices in the enzymatic cleaner solution and allow to soak for a minimum of 1 minute. While INS-INST  Page 1 of 3  Rev. 20190823
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