3S Hemi Implant System Cleaning and Sterilization Protocol

CLEANING AND STERILIZATION PROTOCOL 3S Hemi Implant System

CLEANING

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 7. Remove parts from bath and rinse using reverse Recommended Automatic Cleaning Instructions: osmosis/deionized (RO/DI) water 1. Rinse with tap water to remove gross soil 8. Fill syringe with RO/DI water (60mL) and flush part 2. Inject water (60mL) into cannulation to remove gross soil cannulation, where applicable 3. Prepare enzymatic detergent (Enzol®) at manufacturer 9. Allow parts to air dry. A clean lint-free cloth may be used recommendation (1oz/gal) using lukewarm tap water to aid in drying and fully immerse parts 10. Visibly inspect for remaining soil on part 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces NON-STERILE PRODUCT STERILIZATION 5. Use syringe to inject detergent (60mL) into cannulation 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: 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:

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

Wash 1

02:00

Rinse 1 Drying

Sterilization Method

Pre-Vacuum Steam

Gravity Steam

Condition

Wrapped*

Wrapped*

Temperature

270°F (132°C)

270°F (132°C)

Enzol® 1 oz/gal

Time

4 minutes

15 minutes

65.5°C

Prolystica® 2X Neutral 1/8 oz/gal

Dry Time

Recommended 40 minutes**

Recommended 30 minutes**

01:00

Hot tap water

N/A

15:00

90°C

N/A

10. Visibly inspect for remaining soil on part

*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.

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 1 900-06-008 Rev H