Simplify Cervical Disc Tray Instructions for Use

Preparation for cleaning - Pretreatment Point of Use: Contaminated trays should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization. Remove excess soil and debris with disposable cloth or paper wipes. Promptly after use, rinse trays under running tap water (22°C to 27°C) until visibly clean. It is suggested to keep trays moist after point of use until the manual cleaning process is initiated. Tray Cleaning

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Clean with a soft sponge or cloth, in conjunction with mild enzymatic detergent. Do not use solvents, abrasive cleaners, metal brushes or abrasive pads.

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For difficult to access areas, a soft clean bristled brush is recommended.

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Once the tray is cleaned, it should be thoroughly rinsed with water to remove any detergent or chemical residue before sterilization.

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Trays may be placed in mechanical cleaning equipment. Load trays such that hinges are open. Run standard cycle, minimum five (5) minutes wash and three (3) minutes rinse.

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Inspect the tray for cleanliness and damage. Repeat cleaning if soil is visible.

Figure 1: Top Tray Insert

Figure 2. Second Tray Insert

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Figure 3. Tray Base

Figure 4. Representative Instrument Tray

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Limits on Reprocessing Simplify Disc tray lifespan is normally determined by wear and damage due to use. Trays should not be expected to last indefinitely. Before each use carefully inspect the tray. Do not use a tray that is severely corroded, marred or worn. Improperly functioning trays, trays with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn trays should not be used. It is the responsibility of the user to ensure each tray is visually inspected according to the instructions provided. NOTE: At some point in time, trays wear out and should be replaced. Warning Do not use the tray for any action for which it was not intended. NuVasive, Inc. does not and cannot warrant the use of Simplify Disc trays nor any of the component parts upon which repairs have been made or attempted except as performed by NuVasive, Inc. Possible Adverse Effects Improper maintenance, handling, or poor cleaning and sterilization procedures can render a tray unsuitable for its intended purpose, or even dangerous to the patient or surgical staff. Contraindications The instrument tray is intended only for use with Simplify Disc Instruments. Storage and Transportation Simplify Disc tray may be used as a packaging system for transportation of the instruments. Limited warranty and disclaimer: NuVasive, Inc. products are provided with a limited written warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness for a particular purpose, are hereby disclaimed.

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Table 1: Description of Symbols used in packaging

www.nuvasive.com/eifu

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NuVasive, Inc. 7475 Lusk Blvd. San Diego, CA 92121 USA USA Phone: +01.800.475.9131 USA Fax: +01.800.475.9134 www.nuvasive.com Australian Sponsor: NuVasive Australia & NZ PTY LTD. Building 9 588A Swan Street Richmond VIC 3121 Melbourne, Australia

NuVasive Netherlands B.V Jachthavenweg 109A 1081 KM Amsterdam The Netherlands Phone: +31 20 72 33 000

NuVasive Switzerland GmbH c/o Domenghini & Partners AG Falkengasse 3 6004 Luzern, Switzerland UK Responsible Person: NuVasive UK Limited Suite B, Ground Floor, Caspian House, The Waterfront, Elstree, Herts, WD6 3BS, United Kingdom

Please see www.nuvasive.com/eifu for complete instructions for use for Simplify Disc and Simplify Disc Instruments. 32224-EN_F-2022-06

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