Arsenal Ankle Plating System Cleaning and Sterilization Protocol

CLEANING AND STERILIZATION PROTOCOL ARSENAL ANKLE PLATING SYSTEM

900-06-023 Rev A April 2022

CLEANING Non-sterile products must be carefully and thoroughly 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.

System Instrumentation Disassembly Instructions:

The provided Depth Gauges should be properly disassembled prior to cleaning. The following instructions demonstrate how to properly disassemble the provided Depth Gauges prior to cleaning and then reassemble: 1. To remove the cone piece without wire damage, tap the back of the depth gauge firmly on a table. DO NOT REMOVE THE ATTACHED WIRE.

2.

To reassemble after cleaning, pull the slide back through the body to protect the wire and snap the cone piece onto the body.

The provided Drill Towers should be properly disassembled prior to cleaning. The following instructions demonstrate how to properly disassemble the provided Drill Tower prior to cleaning and then reassemble: 1. To disassemble un-screw the insert from the outer sleeve. 2. To reassemble after cleaning, insert the inner sleeve into the outer sleeve and screw clockwise.

Instrumentation Cleaning Instructions

DJO recommends the following cleaning and sterilization instructions:

Recommended Automatic Cleaning Instructions: 1. 2. 3.

4. 5. 6. 7. 8.

Rinse with tap water to remove gross soil Inject water (60mL) into cannulation to remove gross soil Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and fully immerse parts Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces Use syringe to inject detergent (60mL) into cannulation Allow articles to dwell in detergent bath for 1 minute Remove parts from bath and rinse using reverse osmosis/deionized (RO/DI) water Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable

9.

Transfer parts into automated washer (STERIS® Reliance Genfore) for processing using the following parameters:

Phase

Recirculation Time

Temperature

Pre-wash 1 Enzyme Wash Wash 1

02:00

Cold tap water

02:00

Hot tap water

02:00

65.5°C

Rinse 1 Drying

01:00 15:00

Hot tap water 90°C

Detergent Type and Concentration N/A Enzolâ 1 oz/gal Prolysticaâ 2X Neutral 1/8 oz/gal N/A N/A

10. Visibly inspect for remaining soil on part 11. If the part is not visibly clean, repeat steps 1-10

Recommended Manual Cleaning Instructions: 1. 2. 3.

Rinse with tap water to remove gross soil Inject water (60mL) into cannulation to remove gross soil 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 osmosis/deionized (RO/DI) water 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable 9. Allow parts to air dry. A clean lint-free cloth may be used to aid in drying 10. Visibly inspect for remaining soil on part

NON-STERILE PRODUCT STERILIZATION DJO 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 user instructions. The user facility must thoroughly clean and disinfect instruments prior to sterilization per standard hospital procedures. Non-sterile devices are serializable by steam sterilization (autoclaving). The following parameters should be followed: Sterilization Method Pre-Vacuum Steam Condition Wrapped* Temperature 270°F (132°C) Time 4 minutes Recommended Dry Time 60 minutes * The system shall be packaged for sterilization by double wrapping in an FDA cleared wrap and wrapping techniques outlined per ANSI/AAMI ST79, then adhered with FDA cleared chemical indicator autoclave tape. Note: Do not stack trays during sterilization.

Please contact company for product inquiries and surgical techniques, or to report any adverse experience. This document is controlled by DJO. When downloaded, printed, and/or copied, this document becomes UNCONTROLLED and users should always check DJO’s website, www.djoglobal.com, to ensure they have the latest version. Trilliant Surgical 727 N Shepherd Drive Suite 100 | Houston, TX 77007 www.djoglobal.com/foot-and-ankle/

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