TRILLIANT SURGICAL CLEANING AND STERILIZATION PROTOCOLS 3S Hemi Implant, Gridlock Plating, Disco Subtalar Implant, Twist Subtalar Implant, HTR® Hammer Toe Reaming, and Two-Step Hammer Toe Implant Systems CLEANING Non-sterile products must be carefully cleaned prior to sterilization. Trained personnel must perform cleaning and mechanical inspection prior to sterilization. Compliance is required with the equipment manufacturer’s user instructions (manual and/or machine cleaning, ultrasound treatment, etc.) and recommendations for chemical detergents. Trilliant Surgical recommends the following cleaning and sterilization instructions for instrumentation: 1. Clean all instruments thoroughly using mild detergent, a soft brush, and warm water. Ensure that the dried blood, bone particulate and other deposits are removed from the instruments and sterilization tray. 2. Thoroughly rinse all instruments and the sterilization tray with clean water. 3. Arrange all the instruments in the sterilization tray and ensure that the lid is in place and properly closed. 4. Steam autoclave per the following sterilization instructions. NON-STERILE PRODUCT STERILIZATION Trilliant Surgical Implant Systems can be packaged non-sterile and therefore must be sterilized prior to surgical use. Use of the sterilizer shall comply with the manufacturer’s used instructions. The user facility must clean and disinfect instruments prior to sterilization per standard hospital procedures. Non-sterile devices are sterilizable by steam sterilization (autoclaving). The following parameters should be followed: Pre-Vacuum Steam Sterilization: Condition: Wrapped* Temperature: 270°F (132°C) Time: 4 minutes Recommended 20-30 minute dry time** Gravity Steam Sterilization: Condition: Wrapped* Temperature: 270°F (132°C) Time: 15 minutes Recommended 15-30 minute dry time** *Recommended to use FDA approved wrap **Recommended dry times per AAMI ST79 6721 Portwest Drive, Suite 160 Houston, TX 77024 Phone: 800-495-2919 Fax: 877-778-3864 www.trilliantsurgical.com 900-06-008