Katana High Strength Suture Cutters Cleaning and Sterilization Guidelines

ENGLISH/INSTRUCTIONS FOR USE

Cleaning and Sterilization Guidelines for Katana® High Strength Suture Cutters Ref

Description

GU1009

Katana® High Strength Suture Cutter - 142 mm

GU1009EL

Katana® High Strength Suture Cutter, Extended Length - 210 mm

Supplied

Materials

Reusable - Non-Sterile

Stainless Steel, CD 53 Carbide, Elgiloy

Reusable - Non-Sterile

Stainless Steel, CD 53 Carbide, Elgiloy

INDICATIONS The Katana® High Strength Suture Cutters are intended for cutting sutures or 2 mm High Strength Suture tape in arthroscopic or open procedures.

! CAUTIONS 1. Prior to use, cleaning or sterilization, remove all protective packaging and tip protector. 2. Inspect instrument prior to use to ensure it is in good physical condition and functions properly. There should be no loose pins or misaligned parts. 3. Inspect instrument after use to ensure it has not been damaged (reference Caution 2). 4. Do not use excessive force on instrument to avoid damage or breakage during use. 5. Avoid contact with other surgical instruments during use to prevent damage or breakage. 6. The Katana® High Strength Suture Cutter is for use with #2 braided high strength suture, #2 braided polyester suture, #1 monofilament suture, or 2 mm High Strength Suture tape. Use with other suture could cut off the knot stack or leave suture tails at an undesirable length. 7. Whether used arthroscopically or in open surgery the Katana® High Strength Suture Cutters must be used under direct visualization. 8. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. CONTRAINDICATIONS 1. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials. 2. Patients with active sepsis.

! WARNINGS 1. Careful attention must be paid to asepsis to prevent infection. 2. Instruments may be extremely sharp. Improper handling may result in injury or damage to the instrument. 3. Patient should be advised that product materials may cause allergic reactions including but not limited to, foreign body reaction, tissue irritation/inflammation or other allergic reactions. Where material sensitivity is suspected, appropriate tests should be made and sensitivity ruled out prior to use. 4. The instruments are supplied non-sterile and must be cleaned and sterilized before the first use and after every use to prevent infection. 5. Preoperative and operating procedures, including knowledge of surgical technique are important considerations in successful utilization of this device. 6. Improper use of the device may cause premature cutting of the suture. ADVERSE EVENTS 1. Infections, both deep and superficial. 2. Allergies, tissue irritation/inflammation and other reactions to instrument materials. 3. Transient local fluid accumulation or sinus formation, arthritis pain or deformity and stiffness. INSTRUCTIONS FOR USE 1. Upon completing the surgical repair, place the Katana® High Strength Suture Cutter perpendicular to the suture leads coming from the joint.

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ENGLISH/INSTRUCTIONS FOR USE

2. Place the suture leads in the side slot. For 2 mm High Strength Suture tape, only place one suture lead in side slot.

3. Turn the Katana® High Strength Suture Cutter so that it is parallel to the suture leads so that the sutures exit out of the top slot. For 2 mm High Strength Suture tape, only one suture lead exits out of the top slot.

4. Using a “knot pusher” method, slide the Katana® High Strength Suture Cutter into the joint, stopping at the proximal end of the knot stack. Do not squeeze the handle and keep the suture leads taught. 5. If possible, verify that the proximal knot remains outside of the distal tip and the suture strands remain inside the top slot of the Katana® High Strength Suture Cutter. For the 2 mm High Strength Suture tape, only one strand remains inside top slot.

6. Maintain tension on the suture leads and squeeze the handle to cut the suture strands. For the 2 mm High Strength Suture tape, maintain tension on the suture lead inside the top slot and cut the tape.

CLEANING

! WARNINGS: 1. The use of disinfecting solutions for exterior instrument wipe will not sterilize the equipment and is not recommended. CLEANING: 2. Follow universal precautions for protective apparel when handling and cleaning contaminated equipment. 3. It is recommended that instruments are cleaned as soon as reasonably possible following use. PREPARATION FOR CLEANING 4. Pre-clean instruments at point of use to prevent drying of bioburden and organic soil: Wipe with moistened towel/ sponge, rinse off gross debris using cool water, flush devices 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.

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ENGLISH/INSTRUCTIONS FOR USE

MANUAL CLEANING 6. Clean under running water to prevent aerosolization of microorganisms. 7. Rinse excess soil from instrument. 8. Instrument should be cleaned using a neutral pH detergent solution. 9. Follow detergent solution manufacturer’s recommendations for preparation and use. 10. Using soft bristle brush, apply detergent solution to all internal and external surfaces ensuring that all moving parts are cleaned in both open and closed positions. Repeat the cleaning process until instrument is visibly clean. Note: Clean cannulation and holes using an appropriate brush to ensure that full diameter and 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 ensuring running water passes through all crevices and cannulation. 12. Ensure instrument is visibly free of detergent or cleaning residues. 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 to remove detergent residuals or debris from the device. 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. LUBRICATION 16. A commercial, water-based lubricant should be used to minimize wear of movable parts. STEAM STERILIZATION For sterilization of instruments in a tray, consult guidelines provided with the specific sterilization tray. Note: Sterilization validation has been conducted in accordance with the requirements of AAMI TIR12. Method

Cycle

Minimum Temperature

Exposure Time

Steam (wrapped/unwrapped)

Pre-Vacuum

270°F (132°C)

3 minutes

Steam (wrapped/unwrapped)

Gravity

270°F (132°C)

10 minutes

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

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

Keep Dry

!

2797

CONMED Corporation 525 French Road Utica, NY 13502-5994 USA Customer Service: 1-866-426-6633 USA FAX: (727) 399-5256 International FAX: +1(727) 397-4540 email: [email protected] www.conmed.com ©2022 CONMED Corporation. All rights reserved.

W55-000-748

Rev AD

03/2022