Non-Sterile Reusable Tools Reprocessing Instructions

TABLE OF CONTENTS DEVICE DESCRIPTION...3 WARNINGS...4 PRECAUTIONS...4 CONFORMANCE TO STANDARDS...5 PREPARATION...5 Additional Required Items...5 Disassembly...6 Reassembly...6 REPROCESSING INSTRUCTIONS...6 Point-of-Use Processing...6 Containment and Transportation...6 Manual Cleaning...6 Ultrasonic Cleaning...7 Automated Cleaning Washer/Disinfector... 8 Pre-Sterilization Instructions...9

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Steam Sterilization...10

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Reprocessing Instructions

Non-Sterile Reusable Tools ONLY

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. These instructions provide information on the use, care, cleaning, maintenance, and sterilization of reusable surgical tools manufactured by Boston Scientific Corporation (BSC) intended for reprocessing in a health care facility. The BSC reusable tools may be safely and effectively reprocessed using the manual or automated cleaning instructions and sterilization parameters provided. Do not use or reprocess if the product is damaged. DEVICE DESCRIPTION These instructions pertain to reusable surgical tools manufactured and/or distributed by BSC, for use with devices manufactured by BSC, including: Table 1.

X

X

X

Closing 72400155 Tool

X

X

Furlow 35400010 Insertion Tool

X

X

72400271

Quick Connect Assembly Tool

X

X

72100005

Insertion Package

X

X

AMS 800 Artificial Urinary Sphincter (with & without InhibiZone)

Product Name

The Quick Connect Assembly Tool, Furlow Insertion Tool, Insertion Package, Closing Tool and Sizers are constructed of stainless steel and therefore may contain the following substance defined as CMR 1B in a concentration above 0.1 % weight by weight: Cobalt; CAS No. 7440-48-4; EC No. 231-158-0 Current scientific evidence supports that medical devices manufactured from stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects. A device specific evaluation has determined that the presence of Cobalt does not present a risk within the clinical use of this device. Note: See applicable product’s instructions for use for instructions on how to use the tool.

Figure 1. Sizer 3

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Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Spectra Concealable Penile Prosthesis

720153-01 Sizer

Part Number

AMS 700 Inflatable Penile Prosthesis (with & without InhibiZone)

AMS Ambicor Inflatable Penile Prosthesis

Reusable Tool used with...

Figure 2. Closing Tool

Figure 3. Furlow Insertion Tool

Figure 4. Quick Connect Assembly Tool

Figure 5. Insertion Package

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

WARNINGS • Ethylene Oxide (EO), gas plasma sterilization, and dry heat sterilization methods shall not be used for sterilization of BSC reusable tools. Failure to follow instructions could lead to inadequate sterilization. • The cleaning procedures contained in this instruction manual must be executed as detailed prior to executing steam sterilization instructions. Failure to follow instructions could lead to inadequate sterilization. • Devices that fail functional checks, have identification markings that are not legible, and/or have visible wear, rust, or pitting should be safely disposed of in accordance with standard biohazard practices. Devices that have visible soil after repeated cleaning should be disposed of in accordance with standard biohazard practices. Using these devices could expose patients or users to biohazardous material or lead to an allergic reaction or infection. PRECAUTIONS • Tape or other material attached to the tool should be removed before reprocessing. Failure to remove foreign material may cause an allergic reaction or infection. • Healthcare facility procedures and precautions should be followed by hospital personnel who work with contaminated or potentially contaminated medical devices to prevent an exposure to biohazardous material or infection. • To avoid an exposure to biohazardous material, infection, or prolonged procedure, caution should be exercised when handling devices with sharp points or cutting edges. • To prevent damaging tools or devices, do not stack tools or place heavy tools on top of delicate devices. • Comply with local laws and ordinances; failure to comply may lead to an exposure to biohazardous material or infection. 4

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• Clean and sterilize tools prior to each use. The tools may also become contaminated with body fluids containing hepatitis virus, HIV, or other etiological agents and pathogens. • Fresh cleaning detergents should be prepared when existing detergents become grossly contaminated (turbid). Using turbid detergents may lead to an allergic reaction, exposure to biohazardous material, or infection. • Do not allow contaminated devices to dry prior to reprocessing. Do not allow blood, body fluids, bone or tissue debris, saline, or disinfectants to dry on used tools. Allowing contaminated devices to dry could lead to inadequate sterilization. • Articulating devices (devices that open/close, such as the Quick Connect Assembly Tool or Furlow Insertion Tool) should be in the open position or disassembled when being cleaned in an automated or manual process. Failure to open or disassemble devices could result in the retention of tissues or fluids that will prevent the device from being used as intended. • BSC does not sterilize the reusable tools. New and used tools must be thoroughly processed according to these instructions prior to use. Failure to reprocess the tools prior to use may lead to an exposure to biohazardous material or the tools to not perform as intended. CONFORMANCE TO STANDARDS These reprocessing instructions conform to the ISO 17664 standard “Processing of Healthcare Products” for reusable surgical tools. PREPARATION Reprocessing includes a manual, ultrasonic, or automated washer/ disinfector cleaning, followed by a steam sterilization cycle. Additional Required Items

• Legally marketed accessories, when applicable, should be used for performing all reprocessing steps. Note: Cleaning agent should be pH neutral. Saline and cleaning agents containing aldehyde, mercury, active chlorine, bromine, bromide, iodine, or iodide are corrosive and should not be used. Point-of-Use Processing • Cleaning detergent: pH neutral enzymatic detergent (i.e., Prolystica Enzymatic Detergent or equivalent) • Softened tap water • Absorbent, low-lint cloth Manual Cleaning • Cleaning detergent: pH neutral enzymatic detergent (i.e., Prolystica Enzymatic Detergent or equivalent) • Lumen brush: 0.118 inch (3 mm) diameter nylon brush • Surface brush: Soft nylon-bristled brush • Soaking container/tub • 20 mL or greater volume syringe • Critical water (RO or ≤ 0.2 micron filtered water) • Softened tap water • Absorbent, low-lint cloth Ultrasonic Cleaning • Ultrasonic bath: Capable of frequency 45 kHz minimum at 10 minutes • Cleaning detergent: pH neutral enzymatic detergent (i.e., Prolystica Enzymatic Detergent or equivalent) • Lumen brush: 0.118 inch (3 mm) diameter nylon brush • Surface brush: Soft nylon-bristled brush • Critical water (RO or ≤ 0.2 micron filtered water) 5

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Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

• Personal Protective Equipment (PPE) should be worn when handling or working with contaminated or potentially contaminated materials, devices, and equipment.

• Softened tap water • Absorbent, low-lint cloth Automated Washer/Disinfector Cleaning • Cleaning detergent: pH neutral enzymatic detergent (i.e., Prolystica Enzymatic Detergent or equivalent) • Critical water (RO or ≤ 0.2 micron filtered water) • Absorbent, low-lint cloth • ISO 15883 washer/disinfector Lubrication • Lubricant that does not interfere with steam sterilization per the manufacturer’s label (i.e., Symmetry Surgical Preserve Instrument Lube Concentrate or equivalent) Sterilization • Sterilization pouch • Pre-vacuum type OR Gravity type steam sterilizer Disassembly Only the Furlow Insertion Tool requires disassembly prior to cleaning and sterilization. To disassemble, pull the Obturator (round handle) (a) completely out of the Cylinder handle (rectangular handle) (b). Refer to Figure 6.

B A Figure 6. Disassembled Furlow Insertion Tool Note: Disassemble by hand. Never use aiding instruments to disassemble tools beyond what is recommended. Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Reassembly To reassemble the Furlow Insertion Tool, insert the Obturator into the Cylinder handle. REPROCESSING INSTRUCTIONS Point-of-Use Processing 1. Disassemble the Furlow Insertion Tool if used. 2. Remove gross soil using absorbent, low-lint cloths and thoroughly rinse the surgical tools with softened tap water. 3. Place devices in a container of distilled water or cleaning detergent, or cover with damp towels. Note: Soaking in a cleaning detergent prepared according to the manufacturer will facilitate cleaning especially in tools with crevices, hinged joints, rough surfaces, lumens, and areas with moving components or clips. Containment and Transportation Start the reprocessing steps within 1 hour of surgery completion. For the containment and transportation of the devices during point-of-use processing, procedures established by the healthcare facility must be followed. Manual Cleaning Notes: • Metal brushes or scouring pads must not be used during manual cleaning procedures. These materials will damage the surface and finish of the tool. • Manual scrubbing with brushes should always be performed with the tool below the surface of the cleaning detergent to prevent generation of aerosols and splashing, which may spread contaminants. Cleaning agents must be completely 6

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rinsed from device surfaces to prevent accumulation of detergent residue. 1. If not already disassembled, disassemble the Furlow Insertion Tool if used. 2. Prepare a cleaning detergent per detergent manufacturer instructions. 3. Submerge tools completely in the cleaning detergent for a minimum of 5 minutes. With the tools still completely submerged, for an additional 5 minutes scrub surfaces using a surface brush until all visible soil has been removed. Notes: • Minimum submerge and scrub time is 10 minutes. • All scrubbing should be performed below the surface of the cleaning detergent to minimize the potential of aerosolizing contaminated solution. 4. Actuate (open and close) moveable mechanisms and flush lumens with a syringe to ensure contact of the cleaning detergent with all surfaces, and to remove trapped bubbles. Particular attention should be given to crevices, hinged joints, rough surfaces, lumens, and areas with moving components or clips. 5. Insert the lumen brush into the lumen (if applicable) with a twisting motion while pushing in and out at least 3 times.

6. Remove the tools from the cleaning detergent and rinse in critical water 3 times for a total of 1 minute (e.g., rinse 40 seconds, 10 seconds, 10 seconds). Actuate (open and close) all moveable and hinged parts while rinsing. 7. The Furlow Insertion Tool lumen, if used, should be flushed with critical water 3 times using a 20 mL to 50 mL syringe. 8. Visually inspect the tools with sufficient magnification and light to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. 9. Dry tools with an absorbent, low-lint cloth, or clean, filtered compressed air. 10. Visually inspect the tools with sufficient magnification and light to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. Ultrasonic Cleaning Notes: • Separate stainless steel tools from other metal tools during ultrasonic cleaning to avoid electrolysis. • Fully open hinged tools and use wire mesh baskets or trays designed for ultrasonic cleaners. 1. If not already disassembled, disassemble the Furlow Insertion Tool if used. 2. Rinse the tools, including lumens (if applicable) with softened tap water to remove any visible soil or detergent residue from all areas (lumen and surface) of the tools using lumen and cleaning brushes. 3. Prepare an ultrasonic bath with a cleaning detergent per detergent manufacturer instructions.

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Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Note: The slot on the distal end of the Furlow Insertion Tool stem should be brushed by pushing the head of the brush against the slot starting at the proximal end and moving outwardly toward the distal end of the device. This allows the bristles of the brush to fit into the slot and push gross debris out of the end of the lumen.

Note: Ensure devices are fully opened and disassembled. Failure to open devices (e.g., Quick Connect Assembly Tool) could result in the retention of tissues or fluids that will prevent the device from being used as intended. 4. Immerse the device in the ultrasonic bath for a minimum of 10 minutes at a frequency of 45 kHz. 5. Remove the tools from the ultrasonic bath and rinse in critical water for a minimum of 1 minute or until there is no sign of soil or detergent residue. Actuate (open and close) all moveable and hinged parts while rinsing. 6. The Furlow Insertion Tool lumen, if used, should be flushed with critical water 3 times using a 20 mL to 50 mL syringe. 7. Visually inspect the tools with sufficient magnification and light to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. 8. Dry tools with an absorbent, low-lint cloth, or clean, filtered compressed air. 9. Visually inspect the tools with sufficient magnification and light, to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. Automated Cleaning Washer/Disinfector Precaution: Chemical disinfection programs should not be used due to the potential for chemical residues to remain on the tools. These residues could interfere with sterilization efficacy. Notes: • Follow the washer/disinfector manufacturer’s instructions for use. • Use a washer/disinfector with demonstrated efficacy.

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

• Increase the dry time as the load size increases. Follow the washer/disinfector manufacturer’s instructions. • Low-level disinfection must be used as part of a washer/ disinfector cycle, but the devices must also be sterilized before use. • Use critical water for the final rinse. 1. If not already disassembled, disassemble the Furlow Insertion Tool if used. 2. Place tools in a washer/disinfector basket. Observe the manufacturer’s loading requirements. Follow the cycle parameters given in Table 2. 3. Avoid contact between devices as movement during washing could cause damage and washing action could be obstructed. 4. Arrange the Furlow Insertion Tool lumens (if applicable) vertically to assist drainage. 5. The Quick Connect Assembly Tool (if applicable) should be in the open position. The following minimum wash cycle parameters are recommended: Table 2. Minimum Automated Washer/Disinfector Cycle for Surgical Tools Step

Description

1

4 minutes; 50 °C - 55 °C enzymatic wash

2

2 minutes; 50 °C - 55 °C wash

3

2 minutes; 50 °C - 55 °C final rinse

4

10 minutes; 70 °C Thermal disinfection

5

15 minutes; 80 °C air dry

If a lubrication cycle is available that applies a 6 (optional) water soluble lubricant, it is acceptable to use on the tools. 8

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Note: If the washer/disinfector does not have a lubrication cycle, refer to “Lubrication.” 6. Upon completion, unload the washer/disinfector. 7. Visually inspect the tools with sufficient magnification and light to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. 8. If needed, dry tools with an absorbent, low-lint cloth, or clean, filtered compressed air. 9. Visually inspect the tools with sufficient magnification and light to verify that all soil and detergent residue has been removed. If it has not, repeat the cleaning process. Warning: Failure to properly clean could lead to inadequate sterilization. The cleaning procedure outlined in these instructions must be performed as stated prior to steam sterilization. Pre-Sterilization Instructions Lubrication The Quick Connect Assembly Tool must be lubricated. Lubrication of other tools is optional. Warning: Mineral oil or silicone lubricants should not be used because they prevent proper steam sterilization. 1. Refer to the lubricating agent labeling for preparation and use instructions. 2. Disassemble the Furlow Insertion Tool before lubricating. 3. Dip the tools in the prepared lubricant or spray the prepared lubricant on per manufacturer’s instructions, paying special attention to crevices and joints. 4. Remove any excess lubricant with absorbent, low-lint cloth. Visually inspect each device for soiling, completeness, damage, and excessive wear. When inspecting devices, look for the following: • The tool should be free of soiling and biohazardous material. • Jaws and teeth should align properly. • Movable parts should operate smoothly throughout the intended range of motion. • Long, thin tools should be free of bending or distortion. • Where tools form part of a larger assembly, all components should be available and should assemble readily. • The identification marking should be readable. • There should be no reddish brown rust on the tool. Disposal If the tool fails an inspection and functional check due to soiling, the tool may contain biohazardous substances. Tools that contain biohazardous substances are considered biohazardous waste and should be stored in a biohazardous container that is labeled with the biological hazard symbol. Untreated biohazardous waste should not be disposed of in the municipal waste system. Treat biohazardous substances via steam sterilization for 30 minutes at 135 °C prior to disposal. Alternatively, biohazardous waste may be disposed of utilizing a certified facility for biohazardous waste for proper treatment in accordance with hospital, administrative, and/or local government policy. If the tool fails an inspection and functional check due to completeness, damage, or excessive wear and has been sterilized, the tool is not considered biohazardous. Dispose of the tool and packaging in accordance with hospital, administrative, and/or local government policy. Contact your BSC representative for a replacement.

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Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Inspection and Functional Check

Packaging 1. Before use, packaging materials should be held at room temperature (20 °C - 23 °C and RH of 30 % - 60 %) for a minimum of 2 hours. 2. Tool Preparation a. For the Furlow Insertion Tool, disassemble the tool with both parts together in the same pouch. b. The Quick Connect Assembly Tool shall be in the open position when placing in the pouch. 3. The cleaned and inspected tools should be double pouched. To double pouch: a. Place the tool in a smaller pouch and seal the pouch. b. Place the smaller sealed pouch in a larger pouch and seal it. Steam Sterilization Warning: Do not use rigid containers for steam sterilization. This configuration could limit steam penetration and prevent effective sterilization of the tools. Do not wrap the tools with tape. Precaution: Do not use flash sterilization for reusable tools. Load trays per the sterilization equipment manufacturer’s instructions. Table 3. Steam Sterilizer Parameters

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Sterilization Method

Exposure Time Exposure (minutes) Temperature

Dry time (minutes)

Pre-vacuum*

3

134 °C

30

Pre-vacuum*

18

134 °C

30

Pre-vacuum

4

132 °C

20

Gravity

30

121 °C

30

*This (Pre-vacuum: 3 minutes at 134 °C and dry time of 30 minutes, 18 minutes at 134 °C and dry time of 30 minutes) sterilization cycle is not considered by the United States Food and Drug Administration (US FDA) to be a standard sterilization cycle. Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature).

Post Sterilization Storage Conditions Sterile packaged tools should be stored in a designated, limited access area that is well ventilated, dry, and provides protection from dust, moisture, and temperature/humidity extremes. Note: Inspect every package before use to ensure that the sterile barrier 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 completely re-processed. AMS 700, AMS 800, AMS Ambicor, InhibiZone, and Spectra are trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners.

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Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

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Catalog Number Número de catálogo Numéro de catalogue Referência

www.

Consult instructions for use on this website Consultar las instrucciones de uso en este sitio web Consulter le mode d'emploi sur ce site Web Consulte as Instruções de Utilização neste website Contents Contenido Contenu Conteúdo Authorized Representative in the European Community Representante autorizado en la Comunidad Europea Représentant autorisé dans la Communauté européenne Representante Autorizado na Comunidade Europeia Manufacturer Fabricante Fabricant Fabricante Lot Number Número de lote Numéro de lot Número do Lote Recyclable Package Envase reciclable Emballage recyclable Embalagem Reciclável Australian Sponsor Address Dirección del patrocinador australiano Adresse du promoteur australien Endereço do Patrocinador Australiano

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Argentina Local Contact Contacto local en Argentina Contact local en Argentine Contacto local na Argentina Do not use if package is damaged. No usar si el envase está dañado. Ne pas utiliser si l’emballage est endommagé. Não utilize se a embalagem estiver danificada. Date of Manufacture Fecha de fabricación Date de fabrication Data de Fabrico

NON STERILE

Non-Sterile No estéril Non stérile Não esterilizado Medical Device under EU Legislation Producto sanitario bajo la legislación de la UE Dispositif médical relevant de la législation de l'UE Dispositivo médico ao abrigo da legislação da UE Open Here Abrir aquí Ouvrir ici Abra Aqui Unique Device Identifier Identificador único del dispositivo Identifiant unique du dispositif Identificador de Dispositivo Único Contains hazardous substances Contiene sustancias peligrosas Contient des substances dangereuses Contém substâncias perigosas

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Authorized Representative in the European Community Boston Scientific Limited Ballybrit Business Park Galway IRELAND

Boston Scientific (Master Brand IFU Template 3in x 9in Global, 92310029G), IFU, MB, Reprocess Instructions, Global, 51396361-01A

Australian Sponsor Address Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666

Argentina Local Contact Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link bostonscientific.com/arg

Manufacturer Manufactured for: Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA USA Customer Service +1-888-272-1001

www.bostonscientific.com

Do not use if package is damaged. Recyclable Package

2797 © 2021 Boston Scientific Corporation or its affiliates. All rights reserved.

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