Recommended Care, Cleaning and Sterilization Instructions for Surgical Instruments and Accessories

English - EN

Recommended Care, Cleaning and Sterilization Instructions for Surgical Instruments & Accessories These instructions are in accordance with ISO 17664 and AAMI ST81. They apply to: • Reusable surgical instruments and accessories (provided

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

single use instruments. • Non-sterile • Sterile STERILE single use 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 instruments and accessories for surgical use. It is the responsibility of the user/hospital/health care provider to ensure that reprocessing is performed using the appropriate equipment, 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. NON STERILE

WARNINGS AND LIMITATIONS Materials & restricted substances For indication that the device contains a restricted substance or material of animal origin see product label.

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WARNINGS U.S Federal law restricts this device to sale by or on the order of a physician. are intended to be • Instruments that are labeled single use used one time and then discarded. instruments include but are not • Risks of reusing single use limited to infection to the patient and/or reduced reliability of function. • Reprocessing instructions do not apply to Sterile STERILE - single instruments. use instruments are intended to be • Sterile STERILE - single use 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•

ONLY

must be cleaned and sterilized according to these STERILE instructions prior to each use. • Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated instruments and accessories. • If present, safety caps and other protective packaging material must be removed from the instruments prior to the first cleaning and sterilization. • Caution should be exercised while handling, cleaning, or wiping instruments and accessories with sharp cutting edges, tips, and teeth. • 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. NON STERILE

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• 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 with different shapes, lengths and sizes to aid with manual cleaning. • 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. • Silicone lubricants should not be used on surgical instruments. • 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. • Orthopedic instruments should not be utilized on internal organs, vascular structures, or nervous system structures. • The delivery systems are not intended to maintain sterility by themselves. They are designed to facilitate the sterilization process when used with an FDA approved sterilization wrap. Wrapping material is designed to allow air removal, steam penetration/evacuation (drying) and to maintain the sterility of the internal components.

Device Life • The life expectancy of a reusable instrument and its accessories are 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 and accessories 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 and accessories should be inspected for damage and wear before each use. Instruments and accessories 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. instruments are intended to be used one time and • Single use then discarded.

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Limitations on Reprocessing • Repeated processing according to these instructions has minimal effect upon metal reusable instruments and accessories 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 your Tecomet representative for your replacement needs. • Instruments with removable polymer sleeves or components must be disassembled for sterilization (e.g. acetabular reamer drivers with tissue protector sleeve). • Non-foaming, neutral pH enzymatic and cleaning agents are recommended for processing reusable instruments and accessories. • 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. • The delivery systems have NOT been validated for use with flexible endoscopes, or devices with lumens or working channels longer than 4 inches (3mm ID). Always refer to instrument manufacturer instructions. • The delivery systems have NOT been validated for ETO sterilization of devices. • Tecomet delivery systems have not been validated for use in filtered sterilization containers and Tecomet does not recommend use of such a system. If filtered sterilization container systems are used, the user is responsible for following the recommendations of the manufacturer for the proper placement and use of cases and trays inside the container. 4

REPROCESSING 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 as soon as possible after use to minimize the potential for drying prior to cleaning.

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

Preparation for Cleaning (Instruments Only) • Instruments designed to come apart must be disassembled prior to cleaning. Disassembly, where necessary, is generally selfevident however for more complicated instruments instructions for use are provided and should be followed. Note: All recommended disassembly will be possible by hand. Never use tools to disassemble instruments beyond what is recommended. • All cleaning solutions should be prepared at the 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 (Instruments Only) • 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.

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• Step 3: Soak instruments for a minimum of 10 minutes. While soaking, scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs. Lumens, blind holes and cannulas should be cleaned using a snug fitting round nylon bristle brush. Insert the snug fitting round brush into the lumen, blind hole or cannula with a twisting motion while pushing in and out multiple times. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 4: 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 5: 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. Notes: • Separate stainless steel instruments from other metal instruments during ultrasonic cleaning to avoid electrolysis. • Fully open hinged instruments. • 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 6: 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 6

all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. • Step 7: Dry instruments with a clean, absorbent non-shedding lint free cloth. Clean, filtered compressed air may be used to remove moisture from lumens, holes, cannulas and difficult to access areas.

Combination Manual/Automated Cleaning Steps (Instruments Only) • 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. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, roughened surfaces, and areas with moving components or springs. Lumens, blind holes and cannulas should be cleaned using a snug fitting round nylon bristle brush. Insert the snug fitting round nylon bristle brush into the lumen, blind hole or cannula with a twisting motion while pushing in and out multiple times. Note: All scrubbing should be performed below the surface of the enzyme solution to minimize the potential of aerosolizing contaminated solution. • Step 4: 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 5: 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

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baskets. If the washer/disinfector is equipped with special racks (e.g. for cannulated instruments) use them according to the manufacturer’s instructions. • Step 6: 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 Tap Water (64-66°C/ 146-150°F) • 2 minutes

Rinse • Hot Purified Water (64-66°C/146-150°F) • 1 minute Hot Air Dry (116°C/240°F) • 7 – 30 minutes

Notes: • 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 disinfection cycle should be performed to achieve a minimum value A0 = 600 (e.g. 90°C/194°F for 1 minute according to ISO 15883-1) and is compatible with instruments. • If a lubrication cycle is available that applies to watersoluble lubricant such as Preserve®, Instrument Milk or equivalent material intended for medical device application it is acceptable to use on Instruments unless otherwise indicated. 8

Cleaning (Delivery Systems Only) • Both physical and chemical (detergent) processes may be necessary to clean soiled items. • Chemical (detergent) cleansers alone cannot remove all soil and debris; therefore, a careful manual cleaning of each item with a soft sponge or cloth is essential for maximum decontamination. • For difficult areas, a clean soft bristled brush is recommended. • Once the items have been cleaned, they should be thoroughly rinsed with clean water to remove any detergent or chemical residue before sterilization. • Tecomet recommends the use of mild enzymatic detergent with near neutral pH. • Do not use solvents, abrasive cleaners, metal brushes, or abrasive pads. • Cases and trays may be placed in mechanical cleaning equipment. Disinfection • Instruments and accessories must be terminally sterilized prior to use. See sterilization instructions below. • Low level disinfection may be used as part of a washer/ disinfector cycle but the devices must also be sterilized before use. Drying • Dry devices with a clean, absorbent non-shedding lint free cloth. 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.

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• 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. • Make sure all latches and handles on the delivery systems are secure and in working order 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 material intended for medical device application. Always follow the lubricant manufacturer’s instructions for dilution, shelf life and application method.

Packaging for Sterilization (Instruments Only) • Single devices may be packaged in an approved (e.g. FDA cleared or ISO 11607 compliant) 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 double wrap or equivalent method (ref: AAMI ST79, AORN Guidelines). • Reusable wraps are not recommended. • Instruments may be packaged in an approved (e.g. FDA cleared or ISO 11607 compliant) general-use perforated tray or case 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 it is recommended. • The case or tray must be wrapped in an approved (e.g. FDA cleared or ISO 11607 compliant) medical grade sterilization wrap by following the double wrap method or equivalent (ref: AAMI ST79, AORN Guidelines). • Follow the case/tray manufacturer’s recommendations for loading and weight. Total weight of the wrapped case or tray should not exceed 11.4kg/25lbs. • Instruments may be packaged in an approved (e.g. FDA cleared or ISO 11607 compliant) rigid container system (i.e. those with 10

filters or valves) along with other devices under the following conditions: • The container manufacturer’s recommendations should be followed regarding preparation, maintenance and use of the container. • Arrange all devices to allow access of steam to all surfaces. Open hinged devices and ensure devices are disassembled if recommended. • Follow the container manufacturer’s recommendations for loading and weight. Total weight of a filled container system should not exceed 11.4kg/ 25lbs. Sterilization (Instruments Only) • Moist heat/steam sterilization is the recommended method for the instruments. • Use of an approved chemical indicator (class 5) or chemical emulator (class 6) 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 clearance, EN 13060 or EN 285 compliance,). Additionally the manufacturer’s recommendations for installation, validation, and maintenance should be followed. • Validated exposure times and temperatures to achieve a 10-6 sterility assurance level (SAL) are listed in the following table. • Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. Cycle Type

Temperature

Exposure Time

United States Recommended Parameters

Pre-vacuum / Vacuum Pulse Cycle Type

132°C / 270°F Temperature

European Recommended Parameters

Pre-vacuum / Vacuum Pulse

134°C / 273°F

4 minutes

Exposure Time

3 minutes

Drying & Cooling • The recommended drying time for single wrapped instruments is 30 minutes unless otherwise noted in device specification instructions.

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• 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: 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. Packaging for Sterilization (Instruments and Delivery System) • Place the clean instruments in their respective locations within the delivery system. • Balance contents uniformly within the container and arrange to allow steam to come into contact with all objects in the container. • Tecomet recommends that the cases and trays be wrapped according to the sterilization wrap manufacturer’s instructions prior to sterilization to maintain sterility of internal components/items and for proper aseptic presentation to the surgical field. • Always follow instrument manufacturer instructions if their sterilization or drying recommendations exceed these guidelines. Sterilization (Instruments and Delivery System) • Moist heat/steam sterilization is the recommended method for the device. • Use of an approved chemical indicator (class 5) or chemical emulator (class 6) 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.

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FDA clearance, EN 13060 or EN 285 compliance,). Additionally the manufacturer’s recommendations for installation, validation, and maintenance should be followed. • Validated exposure times and temperatures to achieve a 10-6 sterility assurance level (SAL) are listed in the following table. • Local or national specifications should be followed where steam sterilization requirements are stricter or more conservative than those listed in this table. Cycle Type

Temperature

Exposure Time

United States Recommended Parameters

Pre-vacuum / Vacuum Pulse Cycle Type

132°C / 270°F Temperature

European Recommended Parameters

Pre-vacuum / Vacuum Pulse

134°C / 273°F

4 minutes

Exposure Time

3 minutes

Drying & Cooling • The recommended drying time for wrapped cases 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.

Notice 1. DO NOT load cases into sterilizer on sides or upside down with lid side on shelf or cart. Load cases on cart or shelf so that the lid is always facing upwards. This will allow for proper drying. 2. DO NOT STACK cases or trays in an autoclave chamber. 3. After the autoclave door is opened, all cases must be allowed to cool thoroughly. Place cases on rack or shelf with linen cover

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until cooling is complete. The potential for condensation may increase if the case is not allowed to cool properly. 4. If condensation is observed, check to ensure steps 1, 2, and 3 were followed. In addition, verify that the steam, which is being used for sterilization processing, has a quality of more than 97% per ANSI/AAMI ST79. Also confirm that the sterilizers have been inspected for routine maintenance in accordance with manufacturer recommendations. 5. Silicone mat accessories should be placed in alignment with the perforations in the case or tray so that the sterilant pathways are not obstructed. The following table provides guidance on maximum loads. Do not overload delivery systems (cases and trays), and always follow AAMI, OSHA and hospital standards for maximum loading. Follow instrument manufacturer’s instructions for use.

Tray Size

Maximum Total Weight

Small (~ 4 x 8 x 1 in.)

1 lb. (0.45 kg)

½ Size Case (~ 7 x 7 x 4 in.)

8 lb. (3.6 kg)

Tray (~ 8 x 17 x 1 in.)

¾ Size Case (~ 7 x 12 x 4 in.)

Full Size Case (~ 9 x 19 x 4 in.)

2 lb. (0.91 kg) 13 lb. (5.9 kg)

22 lb. (10.0 kg)

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 or 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 reprocessed through cleaning, packaging and sterilization.

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Symbols Used on Labeling1

NON STERILE

STERILE

ONLY

Caution.

Non-Sterile Sterile

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

2797 EC

REP

CE Mark with Notified Body1

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 STERILE R

Distributor

Sterilized Using Irradiation Use By

Refer to the labeling for CE information

1

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Additional Labeling: “MANUAL USE ONLY” “REMOVE FOR CLEANING & STERILIZATION”

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

Device should be disassembled prior to cleaning and sterilization.

Manufactured By: 2797

Legal Name:

EC REP European Representative: Symmetry Medical Manufacturing, Inc. Symmetry Medical Polyvac S.A.S 486 West 350 North Parc d’Activités du Moulin Warsaw, IN 46582 USA 139, Avenue Clément Ader Phone: +1 574 267 8700 Wambrechies www.tecomet.com 59118 France Phone: +33 3 28 09 94 54

7053-99 Rev F (10/06/2021)