WOLF Lone Bone Plate System Cleaning and Sterilization Instructions

c.

Inspect the O-ring and remove / clean / replace / reinstall as necessary.

Pre-Cleaning

Rinse with cold water for approximately 3 minutes.

Manual Cleaning Procedure

Applicable towards reusable devices and instrumentation. All reusable instrumentation shall be considered critical, especially the items with small lumens / cannula or silicone surfaces. 1.

2. 3.

4. 5.

6. 7.

Immerse the device(s) in an enzymatic detergent solution prepared in warm (30-35ºC) tap water (8 mL EcoLab Neutral Enzymatic Detergent per liter or equivalent detergent solution) and allow device(s) to soak for not less than five (5) minutes. Aspirate not less than sixty (60) mL of the detergent solution through any lumens present, as applicable, using an appropriate sized syringe. Brush all lumens present on device(s), as applicable, using an appropriately sized nylon bristled channel brush. Wet the brush in the detergent solution and run the brush down the entire length of each lumen and back, not less than five (5) times. Brush any silicone surface with a nylon bristled instrument cleaning brush for not less than two (2) minutes per device where silicone material is present. Prepare an enzymatic detergent solution in a sonicating water bath using purified water (2 mL EcoLab Neutral Enzymatic Detergent per liter of water or equivalent detergent solution). Sonicate the device(s) for not less than ten (10) minutes in the enzymatic detergent solution. Upon completion of the manual brushing and sonication steps, process the device(s) through a standard washer / disinfector surgical instruments cycle with the following parameters (or equivalent):

Program Step Pre-rinse Wash Rinse 1 Rinse 2 Thermal Disinfection Drying 8. 9.

Automated Cleaning Cycle Parameters Medium Temperature (ºC) Time Cold Water N/A 3 minutes 4 minutes heating from Cold and 35-60ºC, 60+ºC 35 to 60ºC, Warm Water 4 minutes > 60ºC Warm Water N/A 3 minutes Warm Water N/A 1 minute 5 minutes heating from Purified Water 30-80ºC, 80+ºC 30 to 80ºC, 5 minutes > 80ºC Air 120ºC 11 minutes

Perform a final rinse of the device(s) in running purified water, not less than ~250 mL per device, and allow the device(s) to air dry. Perform a visual inspection of the device(s) to ensure that all contaminants have been removed. Residual bodily fluids, excessive discoloration, unacceptable corrosion, etc., are typical reasons to further process the device(s). If the device(s) are determined to not be visually clean, the above relevant steps shall be repeated. If the device cannot be cleaned effectively, then it shall be disposed of safely or Toby Orthopaedics’ Customer Service shall be contacted at the phone number listed above.

Automated Cleaning Procedure

Automated systems are only recommended for the WOLF® surgical instruments when combined with the manual cleaning procedure detailed in the section above.

Disinfection

1.

Drying

Dry the instruments with a lint-free towel. The instruments may never be heated >140ºC. To avoid water residues, insufflate cavities of instruments by using sterile compressed air.

Inspection / Function Testing

1. 2. 3.

Submerge instruments in a disinfection detergent according to the detergent manufacturer's instructions. 2. Rinse the instruments with sterile water to remove the detergent. Note: Disinfection is only a supplementary step and does NOT replace steam sterilization.

Carefully inspect each device to ensure that all visible blood and soil has been removed. Visually inspect for damage and/or wear. Check the action of moving parts to ensure smooth operation throughout the intended

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range of motion. Check instruments with long slender features (particularly rotating instruments) for distortion. 5. Where instruments form part of a larger assembly, check that the devices assemble readily with mating components. Note: If damage or wear is noted that may compromise the function of the instrument, contact your Toby Orthopaedics representative for a replacement. 4.

Maintenance

Lubricate hinges, threads and other moving parts with a commercial water-based surgical grade instrument lubricant (such as instrument milk) to reduce friction and wear.

Reuse Life

1.

2.

3.

4.

Implantable components may not be reused, but may be resterilized, as required, through the moist heat method described herein. The implantable components have been validated for undergoing at least 15 sterilization cycles without loss of performance. Drill guides, drill guide sleeves, drivers, and similar instruments may be reused as long as the functionality of the device is sufficient to perform the intended use. Typically these types of instruments have a lifetime of 50+ surgical cases unless the threads or driver tip is damaged during use. The depth gauge assembly and drill bits / k-wires may be reused as long as the functionality of the device is sufficient and any marking used for measurements are clearly legible. The depth gauge scale and other similar laser markings on these devices begin to deteriorate after 10 to 15 sterilization / cleaning cycles, and should be visually inspected to ensure accuracy is still guaranteed. The cutting edges of the drill bits / kwires deteriorate at various times based on use, and the drill bits should be safely discarded once the edges become dull. The edges can become dull after one use or may last 10 to 15 surgical cases. Dull drill bits should be safely discarded to prevent localized burning of the bone during use. Similarly, it is not recommended that K-wire or drill bits be reused for multiple cases due to the high velocity rotation of the devices causing possible deformation of the item and deterioration of performance. The sterilization trays are designed to last hundreds of sterilization / cleaning cycles and only require replacement when functionality is lost or excessive contamination cannot be remedied.

Packaging

Instruments shall be loaded into the dedicated WOLF® sterilization tray for sterilization. If applicable, use standard medical grade, FDA-approved or equivalent, steam sterilization wrap following the AAMI double wrap method (ANSI/AAMI ST79).

Sterilization

Steam sterilize using a pre-vacuum cycle for 3 minutes at a minimum temperature of 135ºC. 20 Minute minimum drying time in accordance with ANSI/AAMI ST79. Note: Flash Sterilization is not recommended for WOLF®.

Storage

WOLF® surgical instruments should be stored in a cool dry place.

This document is in accordance with ISO 17664 current revision CONFIDENTIAL: This document is property of Toby Orthopaedics, Inc., and shall not be reproduced or distributed without the express written consent of Toby Orthopaedics, Inc..

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