Spider Limited Wrist Fusion System Cleaning and Sterilization Instructions

Instructions for Cleaning and Sterilization Integra™ Spider™ Limited Wrist Fusion System Instruction for Reprocessing: The instrument tray and its contents are provided non-sterile and must be sterilized prior to surgery. The following instructions should be used for cleaning and decontaminating non-sterile product. All products should be cleaned, decontaminated and sterilized before use. Always immediately clean and decontaminate all devices that have been soiled.

Manual Cleaning Procedure: 1. Prepare a neutral pH enzymatic detergent, Enzol®, as per the manufacturer’s recommendation at 1 oz. per gallon using lukewarm tap water. 2. Fully immerse each device in the prepared detergent and allow them to soak for a minimum of two minutes. 3. After soaking the device, scrub them using a soft bristle brush and circular strokes to remove any visible soil. Pay particular attention to all areas where the soil could be imbedded (i.e. grooves, crevices, lumens, blind holes). Use a syringe to flush lumens and a pipe cleaner to clean lumens and holes. Perform cleaning under the water surface to limit aerosolization of the cleaning fluid and soil, as well as for worker and environmental safety. 4. Rinse device in lukewarm deionized water for a minimum of one minute to remove any detergent residuals. 5. Prepare a neutral pH enzymatic detergent, Enzol®, in a sonicator as per the manufacturer’s recommendation at 1 oz. per gallon using lukewarm tap water. Fully immerse the device in the detergent and sonicate for 10 minutes. 6. After sonication, rinse the device with lukewarm reverse osmosis/deionized water for one minute. 7. Dry the device using a clean cloth.

Automated Cleaning Procedure: 1. Prepare an enzymatic detergent (Klenzyme®) using lukewarm tap water as per the manufacturer’s recommendation. 2. Fully immerse the device, allowing to soak for a minimum of two minutes. 3. Following the soak time, flush any lumens of the implants or instruments using a syringe. 4. Rinse the device under lukewarm running tap water for a minimum of one minute. 5. Place the device into an automated washer (Steris 444 or equivalent). The washer cycle parameters are:

Phase Pre-Wash 1 Enzyme Wash Wash 1 Rinse 1

Recirculation Time (Min.) 02:00 01:00 02:00 05:00

Water Temperature Cold Tap Water Hot Tap Water 60°C Hot Tap Water

Detergent NA Klenzyme®, 1 oz/gal Renu-Klenz™ 1/2oz/gallon NA

6. Dry the device with a clean cloth and visually examine to determine if all adherent visible soil has been removed.

Thermal Disinfection Cycle for Automated Cleaning Procedure: Thermal disinfection rinse/cycle -should be used at 82.2°C for 1 minute.

Sterilization: Unless supplied sterile and clearly labeled as such, all devices must be steam autoclaved prior to use in surgery. The wrist fusion plates, screws and instruments may be steam sterilized using the following process parameters:

Method: Cycle: Temperature: Exposure Time:

Steam Gravity 270°F (132°C) 30 Minutes

Steam Vacuum 270°F (132°C) 4 Minutes

Surgical implants should not be reused. Any implant once used should be discarded. Even though it may appear undamaged, it may have small defects or internal stress patterns which could lead to failure.

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