Small Joint Reaming System Cleaning and Sterilization Protocol

CLEANING AND STERILIZATION PROTOCOL Small Joint Reaming System 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 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 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 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 Trilliant Surgical Implant Systems can be packaged non6. Allow articles to dwell in detergent bath for 1 minute 7. Remove parts from bath and rinse using reverse sterile and therefore must be sterilized prior to surgical use. Use of the sterilizer shall comply with the manufacturer’s osmosis/deionized (RO/DI) water 8. Fill syringe with RO/DI water (60mL) and flush part user instructions. The user facility must clean and disinfect instruments prior to sterilization per standard hospital cannulation, where applicable 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 be followed: parameters: Detergent Type and Concentration

Sterilization Method

Pre-Vacuum Steam

Gravity Steam

Condition

Wrapped*

Wrapped*

Cold tap water

N/A

Temperature

270°F (132°C)

270°F (132°C)

Hot tap water

Time

4 minutes

30 minutes

Enzol® 1 oz/gal

Dry Time

Recommended 50 minutes**

Recommended 40 minutes**

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

Phase

Recirculation Temperature Time

Pre-wash 1

02:00

Enzyme Wash

02:00

Wash 1

*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

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Trilliant Surgical 727 North Shepherd Drive Suite 100 | Houston, TX 77007 Phone: 800-495-2919 | Fax: 877-778-3864 | www.trilliantsurgical.com

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