LIGACLIP Dismantlable Endoscope Appliers

LIGACLIP™ Product Family

Nomenclature (Illustration 1)

Supported Instrument Codes (LC Series): LC2010Z, LC3010Z, LC4010Z.

1. Handle

Clip Applier Device Device Shaft Color Code Code Shaft Diameter (Handle/Clip) Length

Clip Size

3. Operating rod

LC2010Z

330 mm

10 mm

Silver/White

Medium

LT200, LT202

5. Handwheel

LC3010Z

330 mm

10 mm

Green

Medium/ Large

LT300

6. Drive ball

LC4010Z

333 mm

10 mm

Yellow

Large

LT400

llustrations 1

Clips Used

2. Sleeve 4. Cap nut

Instructions for Use Verify compatibility of all instruments and accessories prior to using the instrument (refer to Warnings and Precautions).

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1. Prior to use, where instrument is provided with a protective cap, remove protective cap from instrument prior to processing and sterilization.

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2. Prior to each use of the device, visually inspect the jaws of LIGACLIP™ Dismantlable Endoscopic Applier, for damage that may have occurred during handling and cleaning and verify that the instrument functions properly and is not in need of maintenance or repair. Discard and replace the instrument if damage or degradation is present. Refer to Inspection section for details of the visual inspection.

Dismantling: 2

Read all instructions carefully. Failure to properly follow the instructions may lead to serious surgical consequences.

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3. Before initial use, clean, lubricate and sterilize the LIGACLIP™ Dismantlable Endoscopic Applier as per recommended Instructions for Device Processing included in this insert.

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4. Using sterile technique, deliver the instrument to the sterile field. To avoid damage, do not flip or drop the instrument into the sterile field. 5. Select the appropriate size LIGACLIP™ Ligating Clip cartridge and corresponding clip applier.

Assembly:

6. With the cartridge slots facing away from the base, insert the cartridge into one of the channel openings of the LC800 stainless steel cartridge base. Ensure that the cartridge is past the channel opening and securely held in place (Illustration 8).

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7. For insertion of the LIGACLIP™ Ligating Clips please follow the steps described in the instructions for use relating to that product. 8. Position the clip around the tubular structure to be ligated. Apply sufficient force to fully close the applier to ensure that the clip is satisfactorily placed and secured.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Warnings and Precautions • Consult medical literature relative to techniques, complications, and hazards prior to performance of any minimally invasive procedure involving the use of metallic clips. • Minimally invasive instruments may vary in diameter from manufacturer to manufacturer. When minimally invasive instruments and accessories from different manufacturers are employed together during a procedure, verify compatibility prior to initiation of procedure. • A thorough understanding of the principles and techniques involved in laparoscopic laser and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical instruments. Ensure that electrical isolation or grounding is not compromised. • Ensure that the clip is the correct size for the vessel or tubular structure being ligated. • Upon each clip application, fully squeeze the handle of the instrument until it comes to a stop. • Failure to fully squeeze the handle can result in improper formation of clips, and therefore, unsatisfactory ligation of tissue. • Ensure that each clip has been securely and completely positioned around the tissue being ligated. • The condition of the LIGACLIP™ Dismantlable Endoscopic Applier, the closure force exerted by the surgeon, the thickness of the tissue to be ligated, and the nature of the clip itself are all critical to the performance of any ligating clip. • As with any ligating method, inspect each ligation site following placement of the clip to ensure that the clip has been satisfactorily placed. • Do not close the jaws of the instrument over other surgical instruments.

• Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. • Only non-silicone, water-based lubricants should be used. Silicone or oil-based lubricants should not be used because this may compromise the ability to sterilize the device. • All surgical instruments are subject to a certain degree of wear and tear caused by normal use. Because of this they should undergo regular careful visual inspection before use. Defective instruments (instruments which do not function properly, are subjected to heavy use, have fissures or pitting indicating corrosion, etc.) are associated with a high degree of risk to the patient and hence should not be used. • Instruments or devices which come into contact with bodily fluids may require special disposal handling to prevent biological contamination. Disposal of all medical device instruments and accessories should be performed according to local requirements and regulations. • Improper reprocessing or resterilization or maintenance may compromise the functional performance of the device or lead to device failure which in turn may result in patient injury or illness. • Improper reprocessing or resterilization of reusable devices may create a risk of contamination or cause infection or crossinfection, including, but not limited to, the transmission of infectious diseases. Contamination may lead to injury, illness, or death. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the local competent authority of the country in which the user and/or patient is established.

Instructions for Device Processing Table of Contents for Device Processing: I. How Supplied

• Appliers in disrepair should not be used. The use of such appliers could result in inadequate function of the clip.

II.

• Do not lubricate device after sterilization, as this may compromise sterility of the device.

IV. General Cleaning Information

• To minimize the chance of corrosion, do not use saline for cleaning. • Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection agents and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning agents with chlorine or chloride as they are corrosive.

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Initial Treatment at the Point of Use

III. Containment and Transportation V.

Cleaning and Disinfection Processing Options a. Option 1 – Validated Automated Process using Mild Alkaline Detergent Chemistries and Thermal Disinfection b. Option 2 – Validated Automated Process using Enzymatic and Neutral pH Detergent Chemistries and Thermal Disinfection

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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c. Option 3 – Validated Manual Cleaning Process using Enzymatic and Neutral pH Detergent Chemistries VI. Drying VII. Inspection and Maintenance a. Inspection b. Maintenance VIII. Sterilization IX. Storage Conditions X.

Detergent Chemistries and Equipment Used for Validation

I. How Supplied LIGACLIP™ Dismantlable Endoscopic Applier is supplied nonsterile. The device must be cleaned and sterilized prior to initial use and each subsequent use in accordance with cleaning and sterilization instructions in this insert. The processing information is provided in accordance with ISO 17664-1.

II. Initial Treatment at the Point of Use (in the operating room) 1. Clean device as soon as possible after use. 2. Immediately after use, excessive soil should be removed at the point of use. This can be done by using a damp disposable lint-free wipe. The device may be soaked in tap, sterile, or critical water (see definition in Section IV) and then covered in a container designed for transport, wrapped in a lint-free towel dampened with tap, sterile, or critical water or handled per hospital procedure to prevent drying. Soiled devices should be separated from unsoiled devices. Dried soil can increase the time and effort required to complete processing. Caution: To minimize the chance of corrosion, do not use saline for cleaning. To minimize the potential for fixation of blood to the device, do not use alcohol or products that contain alcohol for wiping or cleaning. 3. Follow the Cleaning and Sterilization instructions below.

III. Containment and Transportation Surgically used devices may be considered bio-hazardous and should be safely transported to a designated processing area in accordance with facility procedures and local policies.

IV. General Cleaning Information (after procedure) Cleaning should be performed as soon as possible after use, preferably within one (1) hour of use. The device has been designed for thorough cleaning and sterilization and must be disassembled before cleaning. It is the responsibility of the end user to ensure that the cleaning is performed using appropriate

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equipment, chemistries, materials, and personnel to achieve the desired result. Caution: Follow the instructions and warnings issued by the suppliers of any cleaning chemistries and equipment used. Avoid exposing devices to hypochlorite solutions, as these will promote corrosion. Do not use cleaning chemistries with chlorine or chloride as they are corrosive. The user must consider the appropriate local and national guidelines, standards, or National Health Authority requirements. Automated (mechanical) methods are preferred. Whichever cleaning method is used, staff must use suitable personal protective equipment (PPE) at all times. Refer to cleaning chemistry manufacturer’s instructions for correct handling, PPE, and use of the product. Hospital-grade low-foaming neutral pH to mild alkaline cleaning chemistries that may or may not include enzymes and that are labeled for use for medical device processing are recommended. Neutral pH is considered to be pH 7–9.5 in the prepared, diluted solution and mild alkaline refers to chemistries with a pH of ≤11 in its prepared, diluted solution for use. “Detergent(s) or detergent solution” will be used generically throughout the rest of these instructions. Section X includes the specific detergents and concentrations that were used for the validation studies of the three (3) cleaning options. Ensure that detergent manufacturer instructions are followed for concentration, temperature, time, and water quality throughout the cleaning process. Lumens/cannula of devices should be manually processed. Lumens/cannula should be first cleared of debris. Lumens/ cannula should be brushed thoroughly using an appropriately sized lumen or pipe cleaner type soft-bristle brush and a twisting action. Brushes should be tight-fitting. Brush size should be approximately the same length and diameter of the lumen/ cannulation to be cleaned. Using a brush that is too big or too small for the diameter of the lumen/cannulation may not effectively clean the surface of a lumen/cannulation. The chemical quality of the water used during processing can impact device safety. Facilities should use the recommended water quality requirements for device processing in accordance with local and national guidance, detergent manufacturers, and these instructions for use. Critical water is recommended for final rinsing of devices, thermal disinfection, and moist heat sterilization. For the purpose of these instructions for use, critical water is defined as a treatment process that may include deionization (DI), reverse osmosis (RO), or distillation with bacterial and endotoxin levels of <10 CFU/mL and <10 EU/mL. The following materials and equipment should be available for all manual processes for cleaning or pre-cleaning: tap water, cleaning solution, container, pressurized water jet, 60 mL syringe,

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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soft-bristle brush (toothbrush shape), appropriately sized lumen or pipe cleaner type soft-bristle brush, and an ultrasonic cleaner.

Device Disassembly Process: 1. Hold the device and rotate the cap nut as shown in Illustration 2 to disassemble the sleeve and operating rod from the handle. 2. Hold the sleeve and operating rod assemblies as shown in Illustration 3 and remove the sleeve by pulling it forward. 3. Lift out the drive ball from the handle side as shown in Illustration 4.

Device Re-Assembling Process: 1. Insert operating rod fork first into the sleeve. When locked in position, align as per the markings and insert the operating rod completely by twisting slightly in both the directions as shown in Illustration 5. 2. Connect the assembled sleeve to the handle by inserting the drive ball as shown in Illustration 6. 3. Tighten the cap nut with the handwheel as shown in Illustration 7.

V. Validated Cleaning and Disinfection Processing Options The following section identifies three (3) examples of cleaning and disinfection processes that have been validated, including specific chemistries and concentrations, and are appropriate for international use. It is the responsibility of the user to understand their respective facility, local, and national requirements when selecting an appropriate process for validation and use.

a. Option 1 - Automated Processing with Mild Alkaline Detergent Chemistries and Thermal Disinfection: Pre-Cleaning (Prior to Automated Cleaning): 1. Dismantle the device according to the instructions above in Section IV. 2. Fully immerse device in tap water not to exceed 40°C (104°F). Ensure that the lumen is completely filled with water. Use an appropriately sized lumen or pipe cleaner type soft-bristle brush to run through the sleeve. Use a toothbrush-style, softbristled brush and brush the entire external surface of the device for a minimum of 30 seconds. Pay particular attention to crevices, seams, and joints in and around the jaws. Actuate all moving parts while the device is immersed. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device.

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3. Use a pressurized water jet set to 1.5–2.0 bar to flush the lumen for a minimum of 10 seconds or until water exiting the lumen is clear. 4. Fill the lumen with the cleaning solution and immerse in ultrasonic cleaner that contains fresh detergent solution and sonicate for a minimum of five (5) minutes. The frequency should be set between 35–40 kHz. Follow manufacturer’s instructions for concentration, water quality, and temperature. 5. Remove the device from the ultrasonic cleaner and immerse in tap water. Use a pressurized water jet set to 1.5–2.0 bar to flush the lumen for a minimum of 10 seconds and until water exiting the lumen is clear. Note: If the water is not visibly clear, repeat steps 1-5.

Automated Cleaning Process: Following the pre-cleaning step, the device must be cleaned/ disinfected in a validated automated washer-disinfector in compliance to ISO 15883 or equivalent local or national standard, using a typical instrument cycle equivalent to the following validated cycle. When placing the device in the automated washer, ensure that the sleeve is positioned to allow for proper draining of the lumen. The following table details the specific parameters that were used for validation and reflects minimum parameters. Wash and rinse phases may be extended to support user needs and requirements. Phase

Recirculation Time (minutes:seconds)

Temperature

Detergent Type

Pre-Wash

02:00

Cold tap water 10°C–25°C (50°F–77°F)

N/A

Wash

05:00

Hot tap water 55°C–60°C (131°F–140°F)

Mild alkaline detergent

Rinse 1

03:00

Cold DI water 10°C–25°C (50°F–77°F)

N/A

Rinse 2

02:00

Cold DI water 10°C–25°C (50°F–77°F)

N/A

Thermal Disinfection

01:00–5:00

Hot DI water ≥90°C (194°F)

N/A

Drying*

30:00

115°C (239°F)

N/A

*Drying was validated with the parameters provided in the table. Other drying times may be used providing it is validated by the user and results in a dry device.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Note: Temperatures used during the wash phase should meet the requirements of the detergent manufacturer’s recommendations. It is the responsibility of the user to validate the processing method.

Thermal Disinfection: Thermal disinfection should be included as part of the automatic cleaning/disinfecting cycle. The device may be thermally disinfected at a temperature between 90°C (194°F) and 100°C (212°F) for one (1) minute or up to five (5) minutes to render the device safer for handling. Note that disinfection is mandatory in some regions. There are different A0 requirements in various countries, 5 min, A0 ≥600 (90°C for 1 minute) or A0 ≥3000 (90°C for 5 minutes). The user must consider the appropriate local and national guidelines, standards, or National Health Authority requirements.

b. Option 2 - Automated Processing with Enzymatic and Neutral pH Detergent Chemistries and Thermal Disinfection: Pre-cleaning Prior to Automated Cleaning: 1. Dismantle the device according to the instructions above in Section IV. 2. Fully immerse and soak the device for a minimum of 10 minutes in a detergent solution prepared according to detergent manufacturer’s instructions for concentration, water quality, and temperature. 3. Remove the device from the detergent. 4. Immerse the device in a clean sink with cold-to-warm tap water not to exceed 40°C (104°F). Ensure that the lumen is completely filled with water. Use an appropriate size lumen or pipe cleaner type soft-bristle brush to run through the sleeve. Use a toothbrush-style, soft-bristled brush and brush the entire external surface of the device for a minimum of 30 seconds. Pay particular attention to crevices, seams, and joints in and around the jaws. Actuate all moving parts while the device is immersed. Use a 60 mL syringe, or other pressurized water device (preferred), to flush the lumen while immersed with clean tap water until the fluid exiting the distal tip of the device is visibly clear. If using a 60 mL syringe, flush the lumen a minimum of three (3) times. If using a pressurized water device, flush for a minimum of 10 seconds.

5. Rinse the exterior of the device thoroughly under cold-to-warm running tap water for a minimum one (1) minute. While rinsing, actuate the handle. 6. Fill the lumen with detergent solution and completely immerse the device in an ultrasonic cleaner that contains fresh detergent solution and sonicate for a minimum of five (5) minutes. The frequency should be set between 35–40 kHz. Follow detergent manufacturer’s instructions for concentration, water quality, and temperature. 7. Remove the device from the ultrasonic cleaner and rinse under cold-to-warm running tap water, not to exceed 40°C (104°F), for a minimum of one (1) minute. Actuate the handle while rinsing the device. Use a 60 mL syringe, or other pressurized water device to flush the lumen while immersed with clean tap water until the fluid exiting the distal tip of the device is visibly clear. If using a 60 mL syringe, flush the lumen a minimum of three (3) times. If using a pressurized water device, flush for a minimum of 10 seconds and until water exiting the lumen is visibly clear. Note: If the water is not visibly clear, repeat steps 1–7.

Automated Cleaning Process: Following the pre-cleaning step, the device must be cleaned/ disinfected in a validated automated washer-disinfector in compliance to ISO 15883, FDA Guidance for Washer and Washer Disinfector manufacturers, or equivalent local or national standards or requirements, using a typical instrument cycle equivalent to the following validated cycle. The devices may be placed in a common washer basket, preferably at an angle to allow for proper draining of the lumen. The devices may also be placed in an MIS (minimally invasive surgery) rack. The following table reflects the specific parameters that were used for validation and reflect minimum parameters. Wash and rinse phases may be extended to support user needs and requirements.

Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device.

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This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Phase

Recirculation Time (minutes:seconds)

Temperature

Detergent Type

Pre-Wash

02:00

Cold tap water 20°C–25°C (68°F–77°F)

N/A

Enzymatic Wash

01:00

Hot tap water 45°C–55°C (113°F–131°F)

Enzymatic Detergent

Wash

02:00

Hot tap water 66°C (151°F)

Neutral pH Detergent

Rinse

00:15

Hot tap water 45°C–55°C (113°F–131°F)

N/A

Critical Water Rinse

01:00

Hot DI water 66°C (151°F)

N/A

Thermal Disinfection

01:00–5:00

Hot DI water ≥90°C (194°F)

N/A

Drying*

30:00

115°C (239°F)

N/A

*Drying was validated with the parameters provided in the table. Other drying times may be used providing it is validated by the user and results in a dry device. Note: Temperatures used during the wash phase should meet the requirements of the detergent manufacturer’s recommendations. It is the responsibility of the user to validate the processing method.

Thermal Disinfection: Thermal disinfection should be included as part of the automatic cleaning cycle. The device may be thermally disinfected at a temperature between 90°C (194°F) and 100°C (212°F) for one (1) minute or up to five (5) minutes to render the device safer for handling. Note that disinfection is mandatory in some regions. There are different A0 requirements in various countries, e.g., A0 ≥600 (90°C for 1 minute) or A0 ≥3000 (90°C for 5 minutes). The user must consider the appropriate local and national guidelines, standards, or National Health Authority requirements.

c. Option 3 - Manual Cleaning Method with Enzymatic and Neutral pH Detergent Chemistries: Manual Cleaning Process: This process may only be used when an automated method is unavailable in regions that do not require disinfection prior to sterilization.

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Pre-Cleaning Instructions (Prior to Manual Cleaning): 1. Dismantle the device according to the instructions above in Section IV. 2. Fully immerse and soak the device for a minimum of 10 minutes in a detergent solution prepared according to detergent manufacturer’s instructions for concentration, water quality, and temperature. 3. Remove the device from the detergent. 4. Immerse the device in a clean sink with cold-to-warm tap water not to exceed 40°C (104°F). Ensure that the lumen is completely filled with water. Use an appropriately sized lumen or pipe cleaner type soft-bristle brush to run through the sleeve. Use a toothbrush-style, soft-bristled brush and brush the entire external surface of the device for a minimum of 30 seconds. Pay particular attention to crevices, seams, and joints in and around the jaws. Actuate all moving parts while the device is immersed. Use a 60 mL syringe, or other pressurized water device (preferred), to flush the lumen while immersed with clean tap water until the fluid exiting the distal tip of the device is visibly clear. If using a 60 mL syringe, flush the lumen a minimum of three (3) times. If using a pressurized water device, flush for a minimum of 10 seconds. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. 5. Rinse the exterior of the device thoroughly under cold-to-warm running tap water for a minimum one (1) minute. While rinsing, actuate the handle. 6. Fill the lumen with detergent solution and completely immerse the device in an ultrasonic cleaner that contains fresh detergent solution and sonicate for a minimum of five (5) minutes. The frequency should be set between 35–40 kHz. Follow detergent manufacturer’s instructions for concentration, water quality, and temperature. 7. Remove the device from the ultrasonic cleaner and rinse under cold-to-warm running tap water, not to exceed 40°C (104°F), for a minimum of one (1) minute. Actuate the handle while rinsing the device. Use a 60 mL syringe, or other pressurized water device to flush the lumen while immersed with clean tap water until the fluid exiting the distal tip of the device is visibly clear. If using a 60 mL syringe, flush the lumen a minimum of three (3) times. If using a pressurized water device, flush for a minimum of 10 seconds and until water exiting the lumen is visibly clear. Note: If the water is not visibly clear, repeat steps 1–7.

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Manual Cleaning Method:

VII. Inspection and Maintenance

1. Dismantle the device according to the instructions above in Section IV.

a. Inspection

2. Fully immerse and soak the device for a minimum of five (5) minutes in a detergent solution prepared according to detergent manufacturer’s instructions for concentration, water quality, and temperature. 3. Remove the device from the detergent. 4. Immerse the device in a clean sink with cold-to-warm critical water not to exceed 40°C (104°F). Ensure that the lumen is completely filled with critical water. Use an appropriately sized lumen or pipe cleaner type soft-bristle brush to run through the sleeve. Use a toothbrush-style, soft-bristled brush and brush the entire external surface of the device for a minimum of 30 seconds. Pay particular attention to crevices, seams, and joints in and around the jaws. Actuate all moving parts while the device is immersed. Use a 60 mL syringe, or other pressurized water device (preferred), to flush the lumen while immersed with clean critical water until the fluid exiting the distal tip of the device is visibly clear. If using a 60 mL syringe, flush the lumen a minimum of three (3) times. If using a pressurized water device, flush for a minimum of 10 seconds. Caution: Do not use scouring pads, abrasive cleaners, or a steel wire brush, which may cause damage to the surfaces of the device. 5. Rinse the exterior of the device thoroughly under cold-to-warm running critical water for a minimum one (1) minute. While rinsing, actuate the handle. Note: If the water is not visibly clear, repeat steps 1–5.

VI. Drying Dry the external surfaces of the device with a clean, absorbent lint-free cloth. If applicable, the cavities and lumen of the device must be blown out with clean, medical-grade compressed air, up to 1.4 bar (20 psi). A drying chamber using a temperature below 140°C (284°F) may be used in order to eliminate the possibility of any residual water remaining in the device. The method described can also be used if the instrument is not dry at the end of an automated process after being removed from the washer-disinfector. Re-assemble the instrument per the instructions in Section IV. Important: Check the function and ensure that the instrument is firmly assembled.

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Cleanliness: Ensure all surfaces, tubes, holes, and movable parts are visibly clean and dry before they are lubricated. If soil or blood is present, the appropriate Cleaning and Disinfection processing options are to be applied. Visual inspection should be performed under a well-lighted condition and a minimum of 4X magnification should be utilized to examine difficult to visualize design features. Integrity/Functionality: These devices do not have an indefinite functional life. All surgical devices are subject to a degree of wear and tear as a result of normal use. They must therefore undergo a regular and precise visual check before each use. Evidence of damage and wear on a device may include but is not limited to corrosion (i.e., rust, pitting), discoloration, excessive scratches, flaking, wear, and cracks. After assembly, check the functionality of handle for opening and closing of jaws. Also, check the function of rotation knob before each use by rotating it in clockwise and counterclockwise directions to check smoothness in rotation. Ensure the jaws can be fully closed and opened repeatedly without excessive force. In the closed condition the jaws must be aligned parallel with no offset between them. Discard and replace the instrument if damage, degradation, or jaw misalignment is present. Defective devices (malfunctioning or difficult to operate devices and those with stress, corrosion, cracking, or pitting, etc.) increase the risk to the patient and must therefore not be used. b. Maintenance Lubrication can be applied using a manual process after cleaning or during the final rinse phase of an automated process. If done manually, after cleaning and prior to sterilization, apply 1–2 drops of lubricant to the hinges and rubbing surfaces of movable parts of device to ensure proper operation. Water soluble or oilbased lubricants may be used. Ensure that lubricant is labeled and approved for use with surgical equipment and moist heat sterilization and that it is biocompatible. If lubrication is performed in an automated process, use a water soluble lubricant. Ensure that the lubricant is labeled and approved for use with surgical equipment and moist heat sterilization and is biocompatible. Refer to lubricant manufacturer’s instructions for preparation and use.

VIII. Sterilization Steam (moist heat) sterilization is recommended in an approved, pre-vacuum cycle listed below. The steam sterilizer should be validated to the requirements of any local standards and guidance such as EN 285, ISO 17665, or AAMI/ANSI ST8. Ensure that the steam sterilizer cycle chosen is designed to remove air from porous loads and/or lumened devices in accordance

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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with manufacturer’s instructions. The pre-vacuum moist heat sterilization cycle was validated using the set point temperature of 134°C (273°F) in accordance with ISO 17665-1. The moist heat sterilization parameters identified in the table is an example of an appropriate cycle for use.

Prepare Device for Sterilization 1. The device should be fully assembled per the instructions above in Section IV. 2. Lubricate the assembled device prior to sterilization. 3. Place the assembled device in an approved sterile barrier wrap material or sterilization pouch, per hospital protocol and in accordance with ISO 11607-1 and any other local and/or national requirements using standardized wrapping techniques. VP Stericlin® Sterilization Pouches and Kimtech™ Kimguard™ KC600 sterile barrier wrap were used for validation. Devices should be double wrapped or double pouched. Other sterile barrier configurations can be used if validated by the user. 4. Place the packaged assembled device into the steam sterilizer in accordance with the sterilizer manufacturer’s instructions. 5. Complete the sterilization cycle. The following moist heat sterilization cycle parameter is an example of a cycle that is appropriate for use. Sterilizer Type

Prevacuum

Packaging Method

Wrapped / pouch

Preconditioning Pulses (Minimum Number)

Temperature Set Point

4

134°C (273°F)

Cycle Time (time at temperature)

5 minutes

Minimum Drying Time 30 minutes

Notes: 1. The above table includes the minimum temperature and exposure time validated to ensure sterility. The device can be sterilized with an exposure time of up to 18 minutes for the prevacuum temperature settings above, when required to comply with local standards and guidance. 2. Based on steam autoclave tolerances, the actual sterilization temperatures can exceed the set point temperature by a maximum of +3°C (+5°F). 3. Instruments can withstand temperatures up to 138°C (280°F) for up to 18 minutes.

IX. Storage Conditions Sterilized products should be stored in a dry, clean environment, protected from direct sunlight, and extremes of temperature and humidity. Refer to sterilization wrap manufacturer’s instructions for limits on sterile product storage.

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X. Detergent Chemistries and Equipment Used for Validation Ethicon used the following detergents and equipment during validation of the processing recommendations. Note: The product names ENZOL® and CIDEZYME® are synonymous. Automated Cleaning with Mild Alkaline Detergent Chemistries (Option 1): • Manual pre-cleaning with Ultrasonic Cleaning (Bandelin Electronic™ Sonorex™ Ultrasonic Bath RK 1028H) with CIDEZYME® Enzymatic Detergent (ASP)-concentration 8 mL/L at 20°C–25°C (68°F–77°F) • Miele™ Washer-disinfector G 7836 CD with MIS Rack (E450) with detergent Dr. Weigert neodisher® MediClean forte-concentration 5 mL/L at 55°C (131°F) Automated Cleaning with Enzymatic and Neutral pH Detergent Chemistries (Option 2): • Manual Pre-Cleaning with ENZOL® Enzymatic Detergent (ASP)-8 mL/L at 32°C–39°C (90°F–102°F) • STERIS Reliance® Genfore Washer/Disinfector o Cleaning with ENZOL® Enzymatic Detergent (ASP) during enzymatic phase-concentration 8 mL/L at 45°C–55°C (113°F–131°F) o Cleaning with Prolystica® 2x Neutral pH Concentrate Detergent during wash phase-concentration 1 mL/L at 66°C (151°F) Manual Cleaning with Enzymatic and Neutral pH Detergent Chemistries (Option 3): • Manual Pre-Cleaning with ENZOL® Enzymatic Detergent (ASP)-concentration 8 mL/L at 32°C–39°C (90°F–102°F) • Ultrasonic Cleaning (Bransonic® CPXH8800H) with ENZOL® Enzymatic Detergent (ASP)-concentration 8 mL/L at 32°C–39°C (90°F–102°F) Moist Heat Sterilizers and Sterile Barrier Materials: • MMM Selectomat HP666 using VP Stericlin® Sterilization Pouches (double pouched) • STERIS AMSCO® Eagle Century SG-120 and SV-120 using Kimtech™ Kimguard™ KC600 Sterilization Wrap (double wrapped)

This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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How Supplied

Symbols Used on Labeling

See Instructions for Device Processing Section I.

Storage and Transportation Conditions Keep Dry

Batch Code Caution

Keep Away from Heat

Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Storage Conditions See Instructions for Device Processing Section IX. The third-party trademarks used herein are the trademarks of their respective owners.

Medical Device Consult instructions for use or consult electronic instructions for use. EU: Call paper on demand help desk to get paper copies free of charge within 7 days. Non-sterile Unique Device Identifier Packaging unit Date of manufacture Keep away from heat

Keep dry Manufacturer Catalogue number Contains hazardous substances

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This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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Johnson & Johnson Medical GmbH Robert-Koch-Strasse 1 22851 Norderstedt Germany +1-513-337-6928

LAB100877869v1 397898E01

© Ethicon Endo-Surgery, Inc. 2022

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This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

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