Cleaning and Sterilization Guidelines for Linvatec, Hall Surgical, Concept and Shutt Manual Instruments

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Cleaning and Sterilization Guidelines for Linvatec®, Hall® Surgical, Concept® and Shutt® Manual Instruments WARNINGS

1. Instrument may be extremely sharp. Improper handling may result in injury or damage to the device. 2. Additional warnings include those applicable to any surgical procedure. In general, careful attention must be paid to asepsis and avoidance of anatomical hazards. 3. The instruments are supplied non-sterile and must be cleaned and sterilized before the first use and after every use.

PRECAUTIONS

1. Prior to use, cleaning or sterilization, remove all protective packaging and tip protector, if applicable. 2. Inspect instrument prior to use to ensure it is in good physical condition and functions properly. There should be no loose, broken or misaligned parts. 3. Exercise care in the use of the device to minimize side or bending loads. 4. Do not use excessive force on instruments to avoid damage or breakage during use. 5. Avoid unintended contact with other surgical instruments during use to prevent damage or breakage. 6. Inspect instrument after use to ensure it has not been damaged. 7. Instrument is designed for use by surgeons experienced in the appropriate specialized procedures. It is the responsibility of the surgeon to become familiar with the proper techniques for use.

ADVERSE EVENTS 1. 2. 3.

Infections, both deep and superficial. Allergies, tissue irritation/inflammation and other reactions to implant and/or instrument materials. Transient local fluid accumulation or sinus formation, arthritis pain or deformity and stiffness.

CLEANING 1. 2.

Follow universal precautions for protective apparel when handling and cleaning contaminated equipment. It is recommended that instruments are cleaned as soon as reasonably practical following use.

PREPARATION FOR CLEANING

3. For catalog HPS-BHNDL open and/or disassemble instrument immediately after use. Disassemble to expose all surfaces to cleaning process. Open all ports. HPS-BHNDL

Body Tip

4. Pre-clean instruments at point of use to prevent drying of bioburden and organic soil: Open all ports, wipe with moistened towel/sponge, rinse off gross debris using cool water, flush devices with cannulations with cool water then soak in water at 22°C-43°C/ 72°F-110°F to prevent coagulation of blood and proteins on the device. Temperature of pre-rinse water should not exceed 45°C (113°F). NOTE: Saline solution is not recommended as it has a corrosive effect on certain metals. 5. Maintain moisture during transport from point of use to decontamination area.

MANUAL CLEANING

6. Clean under running water to prevent aerosolization. 7. Rinse excess soil from instrument. 8. Instruments should be cleaned using a neutral pH cleaning solution. 9. Follow solution manufacturer’s recommendations for preparation and use. 10. Using a soft bristle brush, apply detergent solution to all surfaces ensuring that hinged instruments are cleaned in both open and closed positions. NOTE: Clean cannulation and holes using an appropriate brush to ensure that full depth of the feature is reached. 11. Rinse under running tap water (minimum temperature 38°C/100.4°F) for a minimum of 30 seconds using a minimum of 1 liter of rinse water. Ensure running water passes through cannulation, and that blind holes are repeatedly filled and emptied. 12. Ensure instrument is visibly free of detergent or cleaning residues. 2

FINAL RINSE

13. Rinse under running deionized water (minimum temperature 25°C/ 77°F) using a minimum volume of 1 liter of rinse water for a minimum of 30 seconds.

INSPECTION

14. Inspect for cleanliness. Ensure instrument is free of visible debris and/or soil. Failure to follow cleaning instructions may compromise the sterility of the device.

DRYING

15. Dry the device using a clean, lint free towel until visibly free of water droplets and/or condensation

LUBRICANT

16. If applicable, a commercial water-based lubricant should be used to minimize wear of movable parts.

STEAM STERILIZATION

17. Prepare instruments such that all surfaces have direct contact with steam. Hinged instruments and luer-locks should be in the open position. Disassemble HPS-BHNDL before steam sterilization. Reassemble as needed for use, after sterilization. Method

Cycle

Minimum Temperature

Exposure Time

Dry Time

Steam (wrapped)

Pre-Vacuum

270°F (132°C)

4 minutes

29 minutes

Steam (wrapped)

Gravity

250°F (121°C)

30 minutes

20 minutes

For sterilization of instruments in a tray, consult guidelines provided with the specific sterilization tray.

REASSEMBLY

18. For catalog HPS-BHNDL, reassemble the device. HPS-BHNDL

Body Tip

CONTACT INFORMATION

For more information or a product demonstration, contact your regional CONMED Linvatec sales representative, or call 1-866-426-6633 in the U.S.

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CONMED Corporation 2797 EC REP MDSS GmbH Schiffgraben 41 D-30175 Hannover, Germany

525 French Road Utica, NY 13502-4908 USA Customer Service: 1-866-426-6633 email: [email protected] www.conmed.com ©2023 CONMED Corporation. All rights reserved.

P000024126 Rev B 01/2023