Trilliant Surgical

Arsenal Plating System Cleaning and Sterilization Protocol

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CLEANING AND STERILIZATION PROTOCOL Arsenal Plating System CLEANING 7. Non-sterile products must be carefully and thoroughly cleaned prior to sterilization. Trained personnel must perform cleaning and 8. mechanical inspection prior to sterilization. Compliance is required with the equipment manufacturer’s user instructions (manual and/or 9. machine cleaning, ultrasound treatment, etc.) and recommendations for chemical detergents. System Instrumentation Disassembly Instructions: The provided Depth Gauges (330-22-005, 330-27-005) 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. 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 Transfer parts into automated washer (STERIS® Reliance Genfore) for processing using the following parameters: Recirculation Temperature Time Phase 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 2. To reassemble after cleaning, pull the slide back through the 10. Visibly inspect for remaining soil on part body to protect the wire and snap the cone piece onto the body. 11. If the part is not visibly clean, repeat steps 1-10 3. Proceed to Calcaneal Slide Plate Placement Guide disassembly instructions. Recommended Manual Cleaning Instructions: 1. Rinse with tap water to remove gross soil The provided Calc Slide Plate Placement Guide (330-86-001) 2. Inject water (60mL) into cannulation to remove gross soil should be properly disassembled prior to cleaning. The following 3. Prepare enzymatic detergent (Enzol®) at manufacturer instructions demonstrate how to properly disassemble the provided recommendation (1oz/gal) using lukewarm tap water and fully Calc Slide Plate Placement Guide prior to cleaning: immerse parts 1. Unthread the two screws by rotating counterclockwise to 4. Use a soft bristled brush (Spectrum M16 or equivalent) and separate as shown: 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 2. Proceed to Cleaning Instructions. Instrumentation Cleaning Instructions Trilliant Surgical recommends the following cleaning and sterilization instructions: Recommended Automatic 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 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 user instructions. The user facility must thoroughly 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: 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. 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 1 900-06-021 Rev A

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CLEANING AND STERILIZATION PROTOCOL Arsenal Plating System CLEANING 7. Non-sterile products must be carefully and thoroughly cleaned prior to sterilization. Trained personnel must perform cleaning and 8. mechanical inspection prior to sterilization. Compliance is required with the equipment manufacturer’s user instructions (manual and/or 9. machine cleaning, ultrasound treatment, etc.) and recommendations for chemical detergents. System Instrumentation Disassembly Instructions: The provided Depth Gauges (330-22-005, 330-27-005) 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.

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

Phase

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

2. To reassemble after cleaning, pull the slide back through the 10. Visibly inspect for remaining soil on part body to protect the wire and snap the cone piece onto the body. 11. If the part is not visibly clean, repeat steps 1-10 3. Proceed to Calcaneal Slide Plate Placement Guide disassembly instructions. Recommended Manual Cleaning Instructions: 1. Rinse with tap water to remove gross soil The provided Calc Slide Plate Placement Guide (330-86-001) 2. Inject water (60mL) into cannulation to remove gross soil should be properly disassembled prior to cleaning. The following 3. Prepare enzymatic detergent (Enzol®) at manufacturer instructions demonstrate how to properly disassemble the provided recommendation (1oz/gal) using lukewarm tap water and fully Calc Slide Plate Placement Guide prior to cleaning: immerse parts 1. Unthread the two screws by rotating counterclockwise to 4. Use a soft bristled brush (Spectrum M16 or equivalent) and separate as shown: 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

2. Proceed to Cleaning Instructions. Instrumentation Cleaning Instructions Trilliant Surgical recommends the following cleaning and sterilization instructions: Recommended Automatic 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

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 user instructions. The user facility must thoroughly 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: 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.

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 1 900-06-021 Rev A

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