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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
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soaking, actuate the instruments through a full range of motion (as appropriate) to allow complete penetration of the cleaning solution. Instruments that do not disassemble may require additional soaking. 4. After the soak, remove the instruments and wipe any soil or debris using a disposable towel. Then, place the instruments into a fresh batch of enzymatic cleaning solution using warm water. Scrub the entire surface of the devices with a soft bristle brush paying particular attention to hard to reach areas such as mated surfaces. A syringe, wire guide, and/or pipe cleaner should be used to aid in cleaning lumens/cannulations or other hard to reach areas. A minimum of 60ml of detergent should be used when flushing lumens and cannulations. Ensure no soil is visible in the rinse stream. 5. Remove from enzymatic cleaner solution and rinse with reverse osmosis or de-ionized (RO/DI) water for a minimum of 30 seconds to remove any residual cleaner solution. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 6. Prepare Prolystica® (or equivalent neutral pH detergent) according to manufacturer recommendations using warm tap water in an ultrasonic bath. Fully immerse into the sonication bath and sonicate for a minimum of 10 minutes. 7. Remove from the detergent solution and rinse by agitating and actuating in RO/DI water for a minimum of 30 seconds to remove any residual detergent and until no sign of soil is seen in the rinse stream. While rinsing, thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. AUTOMATED CLEANING 8. Transfer the instruments into the washer for processing. Position the instruments to allow for proper drainage. Process per the cycle below. These are minimum validated parameters: Recircula Water Detergent Type (if Phase tion Time Temp applicable) Cold tap Pre-wash 2 minutes N/A water Enzyme Hot tap Enzol or equivalent per 2 minutes Wash water manufacturer’s instructions Prolystica or equivalent per Wash 2 minutes 65.5°C manufacturer’s instructions PURW 2 minutes 43°C N/A Rinse 15 Drying 90°C N/A minutes 9. If needed, dry devices using a clean lint-free cloth. Pressurized air (20psi) may be used to assist in drying. 10. Visually examine devices to ensure all visible soil has been removed. 11. Once instruments pass visual inspection, reassemble devices that come apart for cleaning. 12. After cleaning, an instrument lubricant (i.e. Steris Hinge-Free® or equivalent) should be applied to moving devices to maintain fluid movement between components. Pay special attention to the instruments called out in system specific sections. MANUAL CLEANING INSTRUCTIONS Follow the instructions listed below prior to sterilization. 1. Disassemble 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 the lumens of the external shafts of disassembled instruments. 3. Prepare Enzol (or equivalent neutral 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 20 minutes. After the soak, scrub devices with a soft bristle brush paying particular attention to hard to reach areas such as mated surfaces. A syringe, wire guide, and/or pipe cleaner should be used to aid in cleaning lumens/cannulations or other hard to reach areas. A minimum of 60ml of detergent should be used when flushing lumens and cannulations. 4. Remove from enzymatic cleaner solution and rinse with reverse osmosis/de-ionized (RO/DI) water for a minimum of three minutes to remove any residual cleaner solution. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 5. Prepare Prolystica (or equivalent neutral pH detergent) according to manufacturer recommendations using warm tap water in an ultrasonic bath. Fully immerse into the sonication bath and sonicate for a minimum of 10 minutes. 6. Remove from the detergent solution and rinse with RO/DI water for a minimum of three minutes to remove any residual detergent and until no sign of soil is seen in the rinse stream. Thoroughly and aggressively flush lumens, holes and other hard to reach areas with a minimum of 60ml of water. 7. Repeat Steps 5 and 6. 8. Dry devices using a clean lint-free cloth. Pressurized air (20psi) may be used to assist in drying. 9. Visually examine devices to ensure all visible soil has been removed. INS-INST
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10. Once instruments pass visual inspection, reassemble devices that come apart for cleaning. 11. After cleaning, an instrument lubricant (i.e. Steris Hinge-Free® or equivalent) should be applied to moving devices to maintain fluid movement between components.
Rigid Container
Wrapped
STERILIZATION All instruments are provided non-sterile and must be cleaned and sterilized before use. Non-sterile instruments should be autoclave sterilized using the following validated cycle parameters: Sterilization Exposure Time Dry Time Method Cycle Type Temperature Gravity Steam 270°F (132°C) 15 minutes 45 minutes Displacement Steam
Pre-vacuum
270°F (132°C)
10 minutes
60 minutes
Steam
Pre-vacuum
270°F (132°C)
4 minutes
30 minutes
*Note: Rigid containers must have a minimum of 2 filters and require a 30 minute cooldown period post sterilization.
Sterilization parameters were validated per ANSI/AAMI/ISO 17665-1: 2006. Sterilization of Health Care Products – Moist Heat – Part 1 Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices and ANSI-AAMI ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities. These parameters were validated to a sterility assurance level (SAL) of 10-6. These sterilization cycles are not considered by the Food and Drug Administration to be standard sterilization cycles. It is the end user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration for the selected sterilization cycle specifications (time and temperature). INFORMATION:
h Catalog Number g Batch Code M Manufacturer Caution, Consult Y Accompanying Documents
MAT
Material
QTY
Packaged Quantity
N D
Date of Manufacture Do Not Re-Use
Device Not Sterile Prescription Only
i
Instruction for Use are provided electronically at ifu.spinalelements.com
© 2019 Spinal Elements Inc. Patents: patent.spinalelements.com For additional information regarding any of Spinal Elements’ devices, please contact Spinal Elements, Inc. Customer Service at (760) 6070121. CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.
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