Recommended Care, Cleaning, and Sterilization for Reusable Instruments

English - EN

INSTRUCTIONS FOR USE Recommended Care, Cleaning, and Sterilization for Reusable Instruments These instructions are in accordance with ISO 17664 and apply to: • Reusable surgical instruments and accessories (provided as

non-sterile and sterile STERILE ) supplied by Tecomet and intended for reprocessing in a health care facility setting. All instruments may be safely and effectively reprocessed using the manual or combination manual/automated cleaning instructions provided in this document UNLESS otherwise noted in instructions accompanying a specific instrument. NON STERILE

• Non-sterile • Sterile

NON STERILE

STERILE

single use

single use

instruments.

instruments.

In countries where reprocessing requirements are more stringent than those provided in this document it is the responsibility of the user/processor to comply with those prevailing laws and ordinances.

These reprocessing instructions have been validated as being capable of preparing reusable instruments for use. It is the responsibility of the user/hospital/health care provider to ensure that reprocessing is performed using the appropriate equipment and materials, and that personnel have been adequately trained in order to achieve the desired result; this normally requires that equipment and processes are validated and routinely monitored. Any deviation by the user/hospital/health care provider from these instructions should be evaluated for effectiveness to avoid potential adverse consequences. Materials & Restricted Substances For indication that the device contains a restricted substance or material of animal origin see product label.

Intended Use The below listed instruments are intended to be used in hip surgery with specific intended use: Acetabular Reamers • Reams and prepares the acetabulum for final implant. The reamer attaches to the reamer driver which then can be operated manually or by means of a powered surgical driver. Acetabular Reamer Driver • The device is used to prepare the acetabulum during a total hip replacement connecting to a surgical power tool with a Tecomet Bridgeback Acetabular Reamer. Angled Curette • Opens and probes the direction of the femoral canal.

Bone Hook • Elevates and move the femur for proper visualization of the hip joint.

Intended Patient Population The devices are prescriptive; therefore, knowledgeable orthopedic surgeon may utilize the device on any patient he or she deems applicable. The devices are to be used on patients undergoing hip surgery. Indications For Use The instruments are indicated for use on patient undergoing hip surgery.

1

Contra-Indications The instruments are prescription use and are only to be used by qualified health care personnel. There are no contra-indications for the instruments. Intended User The instruments are prescriptive and therefore to be used by qualified orthopedic surgeons trained in the respective surgical technique. Expected Clinical Benefits When use as intended, the instruments (reamer, reamer driver, angled curette, and bone hook) aid in the preparation of the acetabulum, femoral canal, and hip joint exposure respectively during hip surgery.

Adverse Events & Complications All surgical operations carry risk. The following are frequently encountered adverse events and complications related to having a surgical procedure in general: • Delay to surgery caused by missing, damaged or worn instruments. • Tissue injury and additional bone removal due to blunt, damaged, or incorrectly positioned instruments. • Infection and toxicity due to improper processing. Adverse events to user:

Cuts, abrasions, contusions, or other tissue injury caused by burs, sharp edges, impaction, vibration or jamming of instruments.

Adverse Events & Complications - Reporting of Serious Incidents Serious Incident Reporting (EU)

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Serious incident means any incident that directly or indirectly led, might have led, or might lead to any of the following: • The death of a patient, user, or other person, • The temporary or permanent serious deterioration of a patient’s, user’s, or other person’s state of health, • A serious public health threat.

Where further information is desired, please contact your local Tecomet sales representative. For instruments produced by another legal manufacturer, reference the manufacturer’s instructions for use. Performance and Characteristics The instruments (reamer, reamer driver, angled curette, and bone hook) aid in the preparation of the acetabulum, femoral canal, and hip joint exposure respectively during hip surgery. Accessories and/or other Device(s) intended to be used in combination with the product • The Offset Acetabular Reamer Drivers are intended to be used with a surgical power tool via an industry standard connection3 • The Offset Acetabular Reamer Drivers are intended to be used with Tecomet Bridgeback Acetabular Reamers3 For the combinations mentioned above, ensure firm connection prior to use. 3

WARNING

• Instruments that are provided NON-STERILE properly cleaned and sterilized prior to each use.

NON STERILE

• Instruments that are labeled single use used one time and then discarded. 2

must be

are intended to be

• Risks of reusing single use instruments include but are not limited to infection to the patient and/or reduced reliability of function.

• Reprocessing instructions do not apply to Sterile STERILE - single use instruments. • Sterile STERILE - single use instruments are intended to be used one time then discarded. • Sterile STERILE instruments in visibly damaged sterile STERILE packaging should be discarded. • Reusable instruments and accessories that are provided NON-STERILE must be cleaned and sterilized according to these instructions prior to each use. • Ethylene oxide (EO), gas plasma and dry heat sterilization methods are not recommended for sterilization of reusable instruments. Steam (moist heat) is the recommended method. • Saline and cleaning/disinfection agents containing aldehyde, chloride, active chlorine, bromine, bromide, iodine or iodide are corrosive and should not be used. • Do not allow biologic soil to dry on contaminated devices. All subsequent cleaning and sterilization steps are facilitated by not allowing blood, body fluids and tissue debris to dry on used instruments. • Automated cleaning using a washer/disinfector alone may not be effective for instruments with lumens, blind holes, cannulas, mated surfaces and other complex features. A thorough manual cleaning of such device features is recommended before any automated cleaning process. • Metal brushes and scouring pads must not be used during manual cleaning. These materials will damage the surface and finish of the instruments. Use only soft bristle nylon brushes and pipe cleaners. • When processing instruments do not place heavy devices on top of delicate instruments. • Use of hard water should be avoided. Softened tap water may be used for most rinsing however purified water should be used for final rinsing to prevent mineral deposits. • Do not process instruments with polymer components at temperatures equal to or greater than 140°C/285°F because severe surface damage to the polymer will occur. • Oils or silicone lubricants should not be used on surgical instruments. • Prior to cleaning and sterilization, disassemble all instruments that allow for disassembly. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated instruments. NON STERILE

Precautions

 .S Federal law restricts this device to sale by or on the order of U a physician. • The instruments should be inspected for damage and wear before each use. Instruments that show signs of damage or excessive wear should not be used. • Pay particular attention to quick connections and release buttons, as well as the cutting edges, sharp tips, and teeth. • If present, safety caps and other protective packaging material must be removed from the instruments prior to the first cleaning and sterilization. • As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument during use. Excessive force can result in instrument failure. • Careful attention must be paid to asepsis and avoidance of anatomical hazards. 3

• Caution should be exercised while handling, cleaning, or wiping instruments with sharp cutting edges, tips, and teeth.

Device Life • The life expectancy of a reusable instrument is dependent on the frequency of use and the care and maintenance the instruments receive. However, even with proper handling as well as correct care and maintenance, reusable instruments should not be expected to last indefinitely. Therefore, an accurate estimate of end of life is not possible for these types of manual, reusable devices. • Instruments should be inspected for damage and wear before each use. Instruments that show signs of damage or excessive wear should not be used. • Due to the high wear nature of cutting and reaming instruments, the device life of these types of devices is 1 year. These devices should be inspected before each use for wear and degradation.

• Single use instruments are intended to be used one time and then discarded.

Disposal • At the end of the device’s life safely dispose of the device in accordance with local procedures and guidelines. • Any device that has been contaminated with potentially infectious substances of human origin (such as bodily fluids) should be handled according to hospital protocol for infectious medical waste. Any device that contains sharp edges should be discarded according to hospital protocol in the appropriate sharps container. Limitations on Reprocessing • Repeated processing according to these instructions has minimal effect upon metal reusable instruments unless otherwise noted. End of life for stainless steel or other metal surgical instruments is generally determined by wear and damage incurred during the intended surgical use. • Instruments comprised of polymers or incorporating polymer components can be sterilized using steam however they are not as durable as their metal counterparts. If polymer surfaces show signs of excessive surface damage (e.g. crazing, cracks or delamination), distortion or are visibly warped they should be replaced. Contact you Tecomet representative for your replacement needs. • Non-foaming, neutral pH enzymatic and cleaning agents are recommended for processing reusable instruments. • Alkaline agents with a pH of 12 or less may be used to clean stainless steel and polymer instruments in countries where required by law or local ordinance; or where prion diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeld-Jakob Disease (CJD) are a concern. It is critical that alkaline cleaning agents are completely and thoroughly neutralized and rinsed from the devices or degradation may occur that limits the device life. INSTRUCTIONS

Point of Use • Remove excess biologic soil from the instruments with a disposable wipe. Place devices in a container of distilled water or cover with damp towels. Note: Soaking in proteolytic enzyme solution prepared according to the manufacturer will facilitate cleaning especially in instruments with complex features such as lumens, mating surfaces, blind holes and cannulas. • If instruments cannot be soaked or maintained damp then they should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning. 4

Containment and Transportation • Used instruments must be transported to the central supply for reprocessing in closed or covered containers to prevent unnecessary contamination risk.

Preparation for Cleaning • Multi-component instruments must be disassembled prior to cleaning. Disassembly, where necessary, is generally self-evident however for more complicated instruments instructions for use are provided and should be followed. • All cleaning solutions should be prepared at the use-dilution and temperature recommended by the manufacturer. Softened tap water may be used to prepare cleaning solutions. Note: Fresh cleaning solutions should be prepared when existing solutions become grossly contaminated (turbid). Manual Cleaning Steps • Step 1: Prepare a proteolytic enzyme solution according to the manufacturer’s instructions. • Step 2: Completely submerge instruments in the enzyme solution and gently shake them to remove trapped bubbles. Actuate instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. • Step 3: Soak instruments for a minimum of 10 minutes. Scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Particular attention should be given to crevices, roughened surfaces, cutting features, hinged joints, sharp edges, box locks, and areas with small components or springs. Lumens, blind holes and cannulas should be cleaned using a long narrow nylon bristle brush/pipe cleaner. Insert a snug fitting long narrow brush/pipe cleaner into the lumen, blind hole or cannula with a twisting motion while pushing in and out multiple times. • Step 4: While immersed, actuate and maneuver all moving parts of the instruments to ensure complete exposure of the cleaning solution to all surfaces. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 5: Remove the instruments from the enzyme solution and rinse in tap water for a minimum of one (1) minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 6: Prepare an ultrasonic cleaning bath with detergent and de-gas according to the manufacturer’s recommendations. Completely submerge instruments in the cleaning solution and gently shake them to remove any trapped bubbles. Lumens, blind holes and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. Sonically clean the instruments at the time, temperature and frequency recommended by the equipment manufacturer and optimal for the detergent used. A minimum of ten (10) minutes is recommended. Note: Separate stainless steel instruments from other metal instruments during ultrasonic cleaning to avoid electrolysis. Fully open hinged instruments and use wire mesh baskets or trays designed for ultrasonic cleaners. Regular monitoring of sonic cleaning performance by means of an ultrasonic activity detector, aluminum foil test, TOSI™ or SonoCheck™ is recommended. • Step 7: Remove the instruments from the ultrasonic bath and rinse in purified water for a minimum of one (1) minute or until there is no sign of residue detergent or biologic soil. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. 5

• Step 8: Visually inspect the instruments for visible soil and repeat the cleaning steps if remaining soil is observed. • Step 9: Dry instruments with a clean, absorbent non-shedding wipe. Clean, filtered compressed air may be used to remove moisture from lumens, holes, cannulas and difficult to access areas. Combination Manual/Automated Cleaning Steps • Step 1: Prepare a proteolytic enzyme solution according to the manufacturer’s instructions. • Step 2: Completely submerge instruments in the enzyme solution and gently shake them to remove trapped bubbles. Actuate instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulations should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. • Step 3: Soak instruments for a minimum of 10 minutes. Scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Particular attention should be given to crevices, hinged joints, roughened surfaces, cutting features, sharp edges, box locks, and areas with small components or springs. Lumens, blind holes and cannulas should be cleaned using a long narrow nylon bristle brush/pipe cleaner. Insert a snug fitting long narrow brush/pipe cleaner into the lumen, blind hole or cannula with a twisting motion while pushing in and out three (3) times. • Step 4: While immersed, actuate and maneuver all moving parts of the instruments to ensure complete exposure of the cleaning solution to all surfaces. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 5: Remove the instruments from the enzyme solution and rinse in tap water for a minimum of one (1) minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 6: Place instruments in a suitable validated washer/ disinfector. Follow the washer/disinfector manufacturer’s instructions for loading the instruments for maximum cleaning exposure; e.g. open all instruments, place concave instruments on their side or upside down, use baskets and trays designed for washers, place heavier instruments on the bottom of trays and baskets. If the washer/disinfector is equipped with special racks (e.g. for cannulated instruments) use them according to the manufacturer’s instructions. • Step 7: Process instruments using a standard washer/disinfector instrument cycle according to the manufacturer’s instructions. The following minimum wash cycle parameters are recommended: Cycle Description

1

Pre-wash ● Cold Softened Tap Water ● 2 minutes

3

Rinse ● Cold Softened Tap Water

2 4 5 6

Enzyme Spray & Soak ● Hot Softened Tap Water ● 1 minute Detergent Wash ● Hot (64-66°C/146-150°F) Tap Water ● 2 minutes Rinse ● Hot (64-66°C/146-150°F) Purified Water ● 1 minute Hot Air Dry (116°C/240°F) ● 7 – 30 minutes

Note: The washer/disinfector manufacturer’s instructions should be followed. A washer/disinfector with demonstrated efficacy (e.g. FDA approval, validated to ISO 15883) should be used. Dry time is shown as a range because it is dependent upon the load size placed into the washer/disinfector. Many manufacturers pre-program their washer/disinfectors with standard cycles and they may include a thermal low-level disinfection rinse after the detergent wash. The thermal rinse may be performed at (82-93°C/180-200°F) and is compatible with these instruments. 6

Disinfection • Instruments must be terminally sterilized prior to use. See sterilization instructions below.

Drying • Dry instruments with a clean, absorbent non-shedding wipe. Clean, filtered compressed air may be used to remove moisture from lumens, holes, cannulas and difficult to access areas.

Inspection & Testing • After cleaning, all devices should be thoroughly inspected for residue biologic soil or detergent. If contamination is still present repeat the cleaning process. • Visually inspect each device for completeness, damage and excessive wear. If damage or wear is observed that might compromise the function of the device, do not process them further and contact your Tecomet representative for a replacement. • When inspecting devices look for the following: • Cutting edges should be free of nicks and have a continuous edge. • Jaws and teeth should align properly. • Movable parts should operate smoothly throughout the intended range of motion. • Locking mechanisms should fasten securely and close easily. • Long thin instruments should be free of bending or distortion. • Where instruments form part of a larger assembly, check that all components are available and assemble readily. • Polymer surfaces should not show signs of excessive surface damage (e.g. crazing, cracks or delamination), distortion or are visibly warped. If the instrument is damaged, it should be replaced. Maintenance and Lubrication • After cleaning and before sterilization, instruments with moving parts (e.g. hinges, box-locks, sliding or rotating parts) should be lubricated with a water-soluble lubricant such as Preserve®, Instrument Milk or equivalent. Always follow the lubricant manufacturer’s instructions for use-dilution, shelf life and application method.

Packaging for Sterilization • Single devices may be packaged in a medical grade sterilization pouch or wrap. Care should be used when packaging so that the pouch or wrap is not torn. Devices should be wrapped using the AAMI double wrap or equivalent method. • Reusable wraps are not recommended. • Instruments may be packaged in rigid general-use trays and cases along with other devices under the following conditions: • Arrange all devices to allow access of steam to all surfaces. Open hinged devices and ensure devices are disassembled if they can be. • The cases or trays must be wrapped in a medical grade sterilization wrap by following the AAMI double wrap method or equivalent. • Total weight of the wrapped case or tray should not exceed 11.4kg/25lbs. • If the device is sterilized as part of an instrument set in a rigid container, it is the responsibility of the health care facility to ensure that the minimum recommended sterilization parameters are achieved since changes in instrument load size may affect sterilization efficacy. Use only approved sterilization wraps when processing rigid containers that require them. Sterilization • Moist heat/steam sterilization is the recommended method for Tecomet instruments. • Use of an approved chemical indicator within each sterilization load is recommended. • Always consult and follow the sterilizer manufacturer instructions for load configuration and equipment operation. Sterilizing equipment should have demonstrated efficacy (e.g. FDA approval, process validation, maintenance records).

7

• Validated exposure times and temperatures to achieve a 10-6 sterility assurance level (SAL) are listed in the following table. Cycle Type

Temperature

Exposure Time (Wrapped)

Pre-vacuum/Vacuum Pulse

132°C/270°F

4 minutes

Drying & Cooling • The recommended drying time for single wrapped instruments is 30 minutes unless otherwise noted in device specification instructions. • Drying times for instruments processed in containers and wrapped trays can vary depending upon the type of packaging, type of instruments, type of sterilizer and total load. A minimum dry time of 30 minutes is recommended, but to avoid wet packs, extended dry times greater than 30 minutes may be needed for larger loads under certain conditions or if otherwise recommended in accompanying documentation. For large loads verification of dry times by the health care provider is recommended. • A 30 minute minimum cooling time is recommended after drying but longer times may be necessary because of load configuration, ambient temperature and humidity, device design and packaging used. Note: Drying times may need to be increased for larger loads. Note: Disinfection/steam sterilization parameters recommended by the World Health Organization (WHO) for reprocessing instruments where there is a concern about TSE/CJD contamination are: 134°C/273°F for 18 minutes. These devices are compatible with these parameters. Storage • Sterile STERILE packaged instruments should be stored in a designated, limited access area that is well ventilated and provides protection from dust, moisture, insects, vermin and temperature/ humidity extremes. Note: Inspect every package before use to ensure that the sterile barrier (e.g. wrap, pouch, filter) is not torn, perforated, shows signs of moisture or appears to be tampered with. If any of those conditions are present then the contents are considered non-sterile and should be re-processed through cleaning, packaging and sterilization.

8

Symbols Used on Labeling: Caution.

NON STERILE

STERILE

2797 2797 EC

REP

Non-Sterile Sterile

U.S Federal law restricts this device to sale by or on the order of a physician CE Mark1

CE Mark with Notified Body # 1

Authorized Representative in the European Community Manufacturer

Date of Manufacture REF

Lot Number

Catalog Number

Consult Instructions for Use


Single Use; Do Not Reuse Medical Device Packaging Unit

Country of Manufacture Distributor Importer CH REP

Unique Device Identifier

Swiss Authorized Representative2

Refer to the labeling for CE information

1

Refer to the labeling for Swiss Authorized Representative

2

Additional Labeling: “MANUAL USE ONLY”

“REMOVE FOR CLEANING & STERILIZATION”

Device should not be attached to a powered source and is only intended to be handled manually. Device should be removed for cleaning and sterilization.

9

Manufactured by:

2797 2797 Legal Name: Symmetry Medical Manufacturing, Inc. 486 West 350 North Warsaw, IN 46582 USA Phone: +1 574 267 8700 www.tecomet.com

Distributed By: Howmedica Osteonics Corp. (subsidiary of Stryker Corp.) 325 Corporate Drive Mahwah, New Jersey 07430 USA Phone: 1-201-831-5000 www.stryker.com

7041-99 Rev F (10/13/2022)

EC REP European Representative: Symmetry Medical Polyvac S.A.S Parc d’Activités du Moulin 139 Avenue Clément Ader Wambrechies 59118 France Phone: +33 3 28 09 94 54