Trilliant Surgical
Minimally Invasive Bunion Plating System Cleaning and Sterilization Protocol
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CLEANING AND STERILIZATION PROTOCOL Minimally Invasive Bunion Plating System Introduction
Cleaning Instructions
This document is intended to establish safe and effective Trilliant Surgical recommends the following cleaning reprocessing procedures in health care facilities for the instructions for all system components and instrumentation: Minimally Invasive Bunion Plating System.
Warning and Precautions
Recommended Automatic Cleaning Instructions:
1. Rinse with tap water to remove gross soil All non-sterile products must be carefully cleaned promptly 2. Inject water (60mL) into cannulation to remove gross soil prior to sterilization and proper sterilization must be 3. Prepare enzymatic detergent (Enzol®) at manufacturer recommendation (1oz/gal) using lukewarm tap water and performed prior to use. fully immerse parts Trilliant Surgical instruments within the Minimally Invasive 4. Use a soft bristled brush (Spectrum M16 or equivalent) and appropriately sized lumen brush to brush all surfaces Bunion Plating System are intended to contact normally sterile tissue or body space during use. Due to this intended 5. Use syringe to inject detergent (60mL) into cannulation use it is considered a critical device and must be thoroughly 6. Allow articles to dwell in detergent bath for 1 minute cleaned and sterilized after each use. Do not allow 7. Remove parts from bath and rinse using reverse osmosis/ deionized (RO/DI) water contaminated devices to dry prior to cleaning and reprocessing as subsequent reprocessing steps are 8. Fill syringe with RO/DI water (60mL) and flush part cannulation, where applicable facilitated by not allowing blood, bodily fluid, bone and tissue 9. Transfer parts into automated washer (STERIS® debris, saline, or disinfectants to dry on used instruments. Reliance Genfore) for processing using the following parameters: CLEANING Recirculation Temperature Time
Detergent Type and Concentration
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.
Pre-wash 1
02:00
Cold tap water
N/A
Enzyme Wash
02:00
Hot tap water
Enzol® 1 oz/gal
System Instrumentation Disassembly Instructions:
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
The provided Depth Gauge (310-00-010) should be properly disassembled prior to cleaning. The following instructions demonstrate how to properly disassemble the provided Depth Gauge prior to cleaning: 1. While holding the depth gauge, unthread the back slide from the main body in a counter-clockwise motion and remove completely.
Phase
10. Thoroughly rinse components using reverse osmosis / deionized (RO/DI) water for at least one minute 11. Allow parts to air dry. A clean lint-free cloth may be used to aid in drying 12. Visibly inspect for remaining soil on part
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 2. While holding the depth gauge, remove the thumb slide (black piece) from the depth gauge by pulling the slide up from the 4. Use a soft bristled brush (Spectrum M16 or equivalent) slot. DO NOT REMOVE THE ATTACHED WIRE 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 3. Proceed to provided cleaning instructions. 10.Visibly inspect for remaining soil on part
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Tray Base and Tray Lid Cleaning Instructions: Trilliant Surgical recommends the following cleaning instructions for the system tray and tray lid: 1. Thoroughly clean the tray base and tray lid to remove gross soil. 2. Cycle tray base and tray lid through automated washer (STERIS® Reliance Genfore) for processing using the parameters detailed above. 3. Visibly inspect the tray base and tray lid for remaining soil on components.
NON-STERILE PRODUCT STERILIZATION
System Instrumentation Assembly Instructions: Following proper cleaning, reassemble the provided Depth Gauge in the following manner prior to sterilization:
Sterilization Method
Pre-Vacuum Steam
Gravity Steam
Condition
Wrapped*
Wrapped*
Temperature
270°F (132°C)
270°F (132°C)
Time
4 minutes
40 minutes
Dry Time
Recommended 50 minutes**
Recommended 50 minutes**
1. While holding the depth gauge insert the wire through the slot into the smaller diameter cannulation. Insert the thumb slide (black piece) into the depth gauge slot by squeezing the underside tabs and pressing firmly on the thumb slide until it “snaps” into place.
The Minimally Invasive Bunion Plating System 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 clean instruments promptly prior to sterilization per standard hospital procedures. Non-sterile devices are sterilizable by steam sterilization (autoclaving). The following parameters should be followed:
*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. *** Do not stack trays during sterilization
Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have 2. Thread the back slide into the depth gauge in a clockwise been cleared by the US FDA for the selected sterilization motion until hand tight. cycle specifications (time and temperature).
3. Proceed to provided sterilization instructions.
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
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