Trilliant Surgical

10 mm Trial, Twist Subtalar Implant System

Twist Subtalar Implant and Disco Subtalar Implant System Cleaning and Sterilization Protocol

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CLEANING AND STERILIZATION PROTOCOL Twist Subtalar Implant and Disco Subtalar 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: Recommended Manual Cleaning Instructions: 1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation 6. Allow articles to dwell in detergent bath for 1 minute Recommended Automatic Cleaning Instructions: 7. Remove parts from bath and rinse using reverse osmosis/deionized (RO/DI) water 1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water 9. Allow parts to air dry. A clean lint-free cloth may be used to aid in drying and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) 10. Visibly inspect for remaining soil on part and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation NON-STERILE PRODUCT STERILIZATION 6. Allow articles to dwell in detergent bath for 1 minute Trilliant Surgical Implant Systems can be packaged non7. Remove parts from bath and rinse using reverse sterile and therefore must be sterilized prior to surgical use. osmosis/deionized (RO/DI) water Use of the sterilizer shall comply with the manufacturer’s 8. Fill syringe with RO/DI water (60mL) and flush part user instructions. The user facility must clean and disinfect cannulation, where applicable instruments prior to sterilization per standard hospital 9. Transfer parts into automated washer (STERIS® procedures. Non-sterile devices are sterilizable by steam Reliance Genfore) for processing using the following sterilization (autoclaving). The following parameters should parameters: be followed: Phase Recirculation Time Temperature Detergent Type and Concentration Pre-wash 1 02:00 Cold tap water N/A Enzyme Wash 02:00 Hot tap water Enzol® 1 oz/gal Wash 1 02:00 65.5°C Prolystica® 2X Neutral 1/8 oz/gal Rinse 1 01:00 Hot tap water N/A Drying 15:00 90°C N/A Sterilization Method Pre-Vacuum Steam Gravity Steam Condition Wrapped* Wrapped* Temperature 270°F (132°C) 270°F (132°C) Time 4 minutes 15 minutes Dry Time Recommended 50 minutes** Recommended 50 minutes** *The system shall be packaged for sterilization by double wrapping in standard central supply wrap (i.e. Bio-Shield® Sterilization Wrap). **Trilliant Surgical has validated the recommended sterilization cycle and dry time for trays. The dry time varies due to load configuration, wrapping method, and material. 10. Visibly inspect for remaining soil on part This document is controlled by Trilliant Surgical. When downloaded, printed, and/or copied, this document becomes UNCONTROLLED and users should always check Trilliant Surgical’s website, www.trilliantsurgical.com, to ensure they have the latest version. Trilliant Surgical 727 North Shepherd Drive Suite 100 | Houston, TX 77007 Phone: 800-495-2919 | Fax: 877-778-3864 | www.trilliantsurgical.com Page 1 of 1 900-06-015 Rev C

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CLEANING AND STERILIZATION PROTOCOL Twist Subtalar Implant and Disco Subtalar 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:

Recommended Manual Cleaning Instructions:

1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation 6. Allow articles to dwell in detergent bath for 1 minute Recommended Automatic Cleaning Instructions: 7. Remove parts from bath and rinse using reverse osmosis/deionized (RO/DI) water 1. Rinse with tap water to remove gross soil 2. Inject water (60mL) into cannulation to remove gross soil 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water 9. Allow parts to air dry. A clean lint-free cloth may be used to aid in drying and fully immerse parts 4. Use a soft bristled brush (Spectrum M16 or equivalent) 10. Visibly inspect for remaining soil on part and appropriately sized lumen brush to brush all surfaces 5. Use syringe to inject detergent (60mL) into cannulation NON-STERILE PRODUCT STERILIZATION 6. Allow articles to dwell in detergent bath for 1 minute Trilliant Surgical Implant Systems can be packaged non7. Remove parts from bath and rinse using reverse sterile and therefore must be sterilized prior to surgical use. osmosis/deionized (RO/DI) water Use of the sterilizer shall comply with the manufacturer’s 8. Fill syringe with RO/DI water (60mL) and flush part user instructions. The user facility must clean and disinfect cannulation, where applicable instruments prior to sterilization per standard hospital 9. Transfer parts into automated washer (STERIS® procedures. Non-sterile devices are sterilizable by steam Reliance Genfore) for processing using the following sterilization (autoclaving). The following parameters should parameters: be followed: Phase

Recirculation Time

Temperature

Detergent Type and Concentration

Pre-wash 1