Stryker Hip Arthroscopy Instruments Instruments for Use

Table of Contents English...3 Français... 11 Deutsch... 19 Italiano... 27 Português... 35 Español... 43 Nederlands... 51 Dansk... 59 Suomi... 67 Norsk... 75 Svenska... 83 Polski... 91 Ελληνικά...100 简体中文...109 日本語...116 한국어...124

1

English Table of Contents Description/Intended Use...4 Contraindications...4 Warnings...4-5 Precautions...5 Using the Switching Stick Handle...5 Using the Suture Cutter...5 Replacing the Shear Pin...6 Fragment Removal...6 Reprocessing...6-9 Storage...9 Service Life...9 Symbols...10

3

Description/Intended Use: • The Stryker Hip Arthroscopy Instruments (hereafter hip instruments) are intended to be used in operative arthroscopic procedures in the hip joint. • The hip instruments consist of reusable instruments and non‑sterile, single-use blades: Catalog number Reusable Instruments: 0242-200-001 0242-200-002 0242-200-003 0242-200-004 0242-200-005 0242-200-006 0242-200-007 0242-200-008 0242-200-009 0242-200-010 0242-200-011 0242-200-012 0242-200-013 0242-200-014 0242-200-015 0242-200-016 0242-200-017 0242-200-018 0242-200-019 0242-200-020 0242-200-021 0242-200-022 0242-200-023 0242-200-027

Description 5.5mm Slotted Cannula 6.5mm Slotted Cannula 4.0mm Cannulated Switching Stick 5.5mm Cannulated Switching Stick 6.5mm Cannulated Switching Stick Hip Biter, Straight Hip Biter, 15° Up Hip Grasper, Right Hip Grasper, Left Hip Grasper, Straight Hip Suture Passer, Left Hip Suture Passer, Right Hip Suture Passer, Straight Hip Suture Passer, 35° Up Hip Suture Grasper Suture Cutter Hip Knot Pusher Hip Curette, 20° Hip Rasp, 30° Up Hip Tissue Liberator, 20° Hip Probe, 90° Curved Hip Probe Microfracture Pick, Straight Switching Stick Handle

Non-Sterile, Single-Use Blades: 0242-200-024 0242-200-025 0242-200-026

Curved Hip Blade, Sharp Tip Straight Hip Blade, Blunt Tip Straight Hip Blade, Sharp Tip

Contraindications: The hip instruments are NOT intended for use where one or more of the following conditions exist: • Pathological conditions of the tissue to be treated • Physical conditions that would retard healing, such as blood supply limitation and infection • Conditions which tend to limit the patient's ability or willingness to follow instructions during the healing period.

Warnings: • These instructions are not meant to replace proper training in surgical technique or hip arthroscopy. It is imperative that the surgeon and operating theater staff are fully conversant with operative arthroscopic procedures in the hip joint prior to using the hip instruments. • Inspect the instruments prior to each use and after each cleaning/sterilization cycle to ensure proper safety and functionality. Do not use damaged, worn, or bent instruments, as these may not function properly and may harm the patient or user. • Do not attempt to bend, straighten, or repair the hip instruments, as this will compromise instrument integrity and potentially harm the patient or user. For replacement or repair, contact your Stryker representative. • Handle hip instruments with care. Some hip instruments have sharp edges that can puncture skin. • The hip instruments are provided NON-STERILE and must be cleaned, disinfected, and sterilized prior to the first and every subsequent use. For proper cleaning, disinfection, and sterilization, follow the reprocessing instructions provided in this guide. 4

• Hip Blades are intended for SINGLE USE ONLY. Wear and tear from a single use can render the Hip Blades dull and ineffective, which may harm patient tissue if reused. Clean and sterilize the Hip Blades prior to use, then discard them immediately after use.

Precautions:

• Caution: Federal law (USA) restricts these instruments to sale by, or on the order of, a physician. • Do not use the hip instruments for any purpose other than their intended use, as this may result in damage. • Do not expose the hip instruments to highly alkaline conditions or hypochlorite solutions, as these will promote corrosion and product damage. • Do not clean delicate instruments with other instruments, as they may sustain damage from coarse handling. • End of useful instrument life is generally determined by wear or damage from handling or surgical use. Replace all dull instruments.

Using the Switching Stick Handle:

The switching stick handle provided in the Hip Arthroscopy Set facilitates inserting a switching stick into the surgical site. 1. Slide the entire handle over the switching stick before inserting the switching stick into the surgical portal. 2. Squeeze the handle to grip the switching stick for insertion or to aid extraction. 3. When removing the handle while the switching stick is within the joint, use care to keep the switching stick in position. 4. Remove the switching stick from the handle prior to reprocessing.

Using the Suture Cutter: The Suture Cutter is operated in three steps as illustrated below:

Load

Cut

Capture

d

a Lo

Cut

Cap t

ure

Cut

5

Replacing the Shear Pin: Some instruments with actuating loop handles contain a shear pin that connects the handle to the central operating rod. The shear pin is designed to fail prior to a more serious failure mode, such as the jaws breaking apart from excessive force. If the shear pin breaks, contact Stryker for repair or replacement.

Fragment Removal: In the rare event of instrument breakage, fragments can be located visually or by use of radiographic imaging equipment. Fragments can be removed manually through the incision site.

Reprocessing:

These reprocessing instructions are provided in accordance with ISO 17664. While they have been validated by the manufacturer of the medical device as being capable of preparing the device for re-use, it remains the responsibility of the processor to ensure that the reprocessing as actually performed, using equipment, materials, and personnel in the reprocessing facility, achieves the desired result. This normally requires validation and routine monitoring of the process.

Limitations on Reprocessing: 1. Repeated processing has minimal effect on instrument life and function. End of useful instrument life is generally determined by wear or damage from handling or surgical use. 2. Do not leave the instruments in solutions longer than necessary, as this may accelerate normal product aging. 3. Damage incurred by improper processing will not be covered by the warranty.

Containment and Transportation:

1. Reprocess the device as soon as reasonably practical following use. 2. Transport the device in an appropriate manner to prevent damage.

Warnings: 1. The following cleaning, disinfection and sterilization methods have been validated. Failure to follow reprocessing instructions as provided may result in incomplete decontamination. 2. Wear appropriate protective equipment (gloves, eye protection, etc.). 3. The Suture Cutter must be disassembled prior to cleaning, disinfection, and sterilization, or incomplete decontamination will result.

6

Disassembling the Suture Cutter: The suture cutter must be disassembled prior to cleaning and sterilization. 1. Depress the button on the top of the handles (1). 2. Pull the central cutting rod out of the cannulated shaft (2).

3. Prior to use, reassemble the Suture Cutter carefully. The proximal end of the central rod must be oriented as shown below. Verify that handle and trigger actuation moves the central rod.

Cleaning: Warnings: • Cleaning should be performed as soon as possible(1) after each procedure, before blood, saline and debris are dry. • Do not use metallic brushes, scrub pads, or other abrasive cleaning aids, as these are likely to damage the instruments. • Do not use highly alkaline solutions or harsh chemicals such as chlorine, caustic soda, and organic or ammoniated acids or solvents (such as acetone), as these are likely to damage the instruments. • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used. • Complex devices, such as those with tubes, hinges, retractable features, and matte or textured surface finishes, require special attention during cleaning. Manual pre‑cleaning of such device features is required before automated cleaning. (1)30 minutes was used for the Cleaning Validation.

Manual cleaning: 1. Rinse instruments with distilled or demineralized water. 2. Prepare an enzymatic detergent(2) according to the manufacturer's instructions. 3. Submerge the instruments in the enzymatic detergent solution for 20 minutes. Use a 5 ml syringe and needle to flush enzymatic detergent through lumens, and use a soft bristled brush to scrub the lumens, crevices, and slots. 4. Rinse instruments with distilled or demineralized water, agitating for one minute; repeat rinse twice. 5. Dry all instruments thoroughly before storage. 6. Inspect the instruments after each cleaning cycle to ensure proper functionality and safety: 6.1 If you suspect a problem, do not use the instrument. 6.2 Inspect all components for cleanliness: activate all moving parts to their maximum positions while inspecting for blood or debris. Place a pipe cleaner down any cannulation or crevice, and then inspect the pipe cleaner for blood or debris. If blood or debris is present, repeat the above cleaning procedure. (2) Cleaning efficacy was validated using ENZOL® at 1 oz./gal. of water at 35-40°C (95-104°F) 7

Automated Cleaning: 1 . Prepare an enzymatic detergent(3) according to the manufacturer's instructions. 2 . Perform pre-cleaning by flushing an enzymatic detergent through the lumens using a 5 ml syringe and needle and using a soft bristled brush to scrub the lumens, crevices, and slots. 3 . Rinse the instruments with distilled or demineralized water until no visible detergent is present. 4 . Place the instruments in the washer in a manner to facilitate draining. 5 . Clean in a validated automatic washer using the "INSTRUMENTS" cycle and detergents(4) intended for use with automated cleaning. Effective automated cleaning can be achieved using the following parameters: 5.1 Cold water wash (minimum of 35 seconds at 27°C / 80°F) 5.2 Hot water wash (minimum of 2 minutes at 60°C / 140°F) 5.3 Cold water wash (minimum of 45 seconds at 27°C / 80°F) 5.4 Hot water wash (minimum of 2 minutes at 60°C / 140°F) 5.5 Thermal rinse (minimum of 1 minute at 82.2°C / 180°F) 5.6 Drying (minimum of 6 minutes at 82.2°C / 180°F) 6 . Inspect the instruments after each cleaning cycle to ensure proper functionality and safety: 6.1 If you suspect a problem, do not use the instrument. 6.2 Inspect all components for cleanliness: activate all moving parts to their maximum positions while inspecting for blood or debris. Place a pipe cleaner down any cannulation or crevice, and then inspect the pipe cleaner for blood or debris. If blood or debris is present, repeat the above cleaning procedure. (3)Validation was performed using ENZOL®. (4)Validation was performed using Renuzyme Plus® and Tec Wash III®.

Disinfection: Warnings: Disinfection alone is not adequate to render the instruments sterile. Sterilization must be performed before each procedure. 1. After cleaning, disinfection should be performed by immersion in 2.4% CIDEX® (5) (or equivalent) with a minimum immersion time of 45 minutes at 25°C/77°F following the manufacturer's instructions. 2. Rinse with distilled or demineralized water, agitating for one minute; repeat rinse twice. 3. Dry all instruments thoroughly before storage. (5)Validation was performed using CIDEX®.

Maintenance, Inspection, and Testing: Inspect the Instruments for damage, such as deformed shafts or tips. Ensure proper functionality. If a problem is observed or suspected, contact your Stryker representative for replacement or repair.

Packaging for Sterilization: Use no more than two layers of sterilization wrap.

Sterilization: Warnings: • Sterilization is not a substitute for cleaning. Instruments must be thoroughly cleaned prior to sterilization, or incomplete decontamination will result. • The sterilization parameters provided for use with a sterilization tray might differ from those provided for the instruments alone. When sterilizing the instruments inside a tray, select the more stringent set of parameters. • These devices were not validated for ethylene oxide (EO) or gas plasma sterilization methods. Use only steam (autoclave) sterilization as outlined in these instructions, or incomplete sterilization may result.

8

• Drying time depends on several variables, including altitude, humidity, type of wrap, preconditioning, size of chamber, mass of load, material of load, and placement in chamber. Users must verify that drying time set in their autoclave yields dry surgical equipment. • The adequacy of any sterilization procedure must be tested. To substantiate the process and its reliability and reproducibility, it is critical that appropriate process parameters be validated for each facility's sterilization equipment and product/load configuration by persons who have training and expertise in sterilization processes. • The following autoclave processes have been validated by the manufacturer; however, the sterility assurance level for any given sterilization cycle is dependent on the actual conditions selected by the user and the correct calibration of the user's sterilization equipment and instrumentation. Because these factors are not within the control of T.A.G. Medical Products Corporation Ltd., the user is responsible for the sterility assurance level. Gravity - Displacement Steam Sterilization: ™™ Sterilizer Type: Gravity ™™ Minimum Temperature: 132°C (270°F) ™™ Minimum Exposure Time: 10 minutes ™™ Minimum Dry Time: 40 minutes Pre-vacuum Steam Sterilization: ™™ Sterilizer Type: ™™ Minimum Temperature: ™™ Minimum Exposure Time: ™™ Minimum Dry Time:

Pre-vacuum 132°C (270°F) 4 minutes 15 minutes

Pre-vacuum Steam Sterilization (alternate cycle): ™™ Sterilizer Type: Pre-vacuum ™™ Minimum Temperature: 134°C (273°F) ™™ Minimum Exposure Time: 3 minutes(6) ™™ Minimum Dry Time: 15 minutes (6) Exposure time of 18 minutes is permitted (as mandatory in some European countries). Do not exceed 140°C (284°F) during sterilization.

Storage: • Between uses, store instruments in a clean, dry environment. • To prevent damage, minimize contact between instruments and with other equipment. • Warning: These storage parameters are not intended to preserve instrument sterility. If necessary, reprocess the instruments again prior to use.

Service Life: The reusable instruments should be replaced after one year.

9

Symbols: Caution / Attention: See Instructions for Use Do Not Reuse Use by Non-Sterile Manufacturer Made In Israel Lot Number Authorized Representative in the European Community Do Not Use If Package Is Open or Damaged Caution: Federal law (USA) restricts this device to sale by or on the order of a physician Catalog Number Number of Units Date of Manufacture CE Mark (Class I) CE Mark (Class IIa) The Stryker logo is a registered trademark of Stryker Corporation. ENZOL® and CIDEX® are registered trademarks of Advanced Sterilization Products. Renuzyme Plus® and Tec Wash III® are registered trademarks of Getinge USA, Inc.

10

한국어 목차 설명 및 용도 (Description /Intended Use)...125 금기사항(Contraindications)...125 경고(Warnings)...125 주의사항(Precautions)...126 교체용 막대 핸들 사용(Using the Switching Stick Handle)...126 봉합사 커터 사용 (Using the Suture Cutter)...126 Shear Pin 교체(Replacing the Shear Pin)...127 파편 제거(Fragment Removal)...127 재처리(Reprocessing)...127-130 보관(Storage)...130 제품 수명(Service Life)...130 기호(Symbols)...131

124