Peripheral Vascular Sheath Tunneler and Sterilization Cassette Instructions for Use

4. The Tunneler is supplied non-sterile and must be thoroughly cleaned, disinfected, and sterilized prior to each use. Cleaning, disinfection, and sterilization of the Tunneler prior to use is the responsibility of the healthcare facility. Reprocessing of the Tunneler Device The instructions provided below have been validated by the manufacturer as being capable of preparing the Tunneler device for surgical use. It remains the responsibility of the processing facility to ensure that processing of the device before use/ reuse using appropriate equipment, materials, and personnel achieves the desired result. This requires verification and/or validation and routine monitoring of the process. Note: Automated cleaning alone may not be effective for the tunneler device. Step 1 Preparation for Decontamination: Personal Protective Equipment (gloves, fluid resistant gown, face protection mask or protective glasses, see also instructions of the manufacturer for detergent and the disinfectant) should be utilized. Step 2 Pre-Cleaning: Note: It is recommended that the device is reprocessed no later than one (1) hour after use.

Step 3

1. Completely disassemble all tunneler components by unscrewing the handle, rod, sheath and tip as applicable. 2. Rinse the individual tunneler components and the empty sterilization cassette (lid and tray) under running tap water to remove all visual debris. Manual Ultrasonic Cleaning: Required Materials: Enzol® Enzymatic Detergent or Equivalent, Ultrasonic Tank, Soft Bristled Brush, Syringe 1. Prepare the enzymatic detergent solution utilizing warm tap water in an ultrasonic tank, making sure the tank is filled to the equipment specified fill level. Note: The enzymatic detergent solution must be prepared per manufacturer instructions for use. For Enzol® Enzymatic Detergent a concentration of 2 oz/gallon (15.625 mL/L) is required. 2. Turn on the ultrasonic tank and degas the enzymatic detergent solution per the ultrasonic tank manufacturer’s instructions. 3. Fully immerse the individual device components and the empty sterilization cassette (lid and tray) in the enzymatic detergent. 4. Exposure time shall be a minimum of ten (10) minutes. 5. Following the exposure time, while the individual device components and the empty sterilization cassette (lid and tray) are still immersed, use a soft-bristled brush to brush all components and a syringe to flush all holes and lumens. Note: Pay careful attention to all holes, lumens, threads, knurls, grooves, and other hard to clean areas. 6. Remove the individual device components and the empty sterilization cassette (lid and tray) from the ultrasonic tank. 7. Rinse all individual device components and the empty sterilization cassette (lid and tray) under running, hot, tap water. Total rinse time for all components must be a minimum of five (5) minutes collectively. Ensure all lumens are thoroughly flushed. Note: Pay careful attention to all holes, lumens, threads, knurls, grooves, and other hard to clean areas. 8. Check on cleanliness: If soil or enzymatic detergent is visible, repeat manual cleaning steps 1-7.

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Step 4 Option 1

Step 4 Option 2

Manual High-Level Disinfection Required Materials: Cidex® Ortho-phthaladehyde based disinfectant or equivalent, Disinfectant tank, Syringe 1. Fill the disinfectant tank with Cidex® Ortho-phthaladehyde based disinfectant or equivalent at room temperature. 2. Fully immerse the individual device components and the empty sterilization cassette (lid and tray) in the disinfectant. Ensure all air bubbles are removed. 3. Exposure time shall be a minimum of twelve (12) minutes. 4. Remove the individual device components and the empty sterilization cassette (lid and tray) from disinfectant solution. 5. Fully immerse the individual device components and the empty sterilization cassette (lid and tray) in a tank of fresh ultra-filtered, RO/DI, or distilled water. Ensure all air bubbles are removed. 6. Exposure time shall be a minimum of three (3) minutes. Utilizing a clean syringe flush all holes, lumens, threads, knurls, and grooves. 7. Discard of the used rinse water. 8. Repeat manual high-level disinfection steps 5-7 two more times for a total of three (3) rinses. 9. Wipe the empty sterilization cassette (lid and tray) and individual device components with a single use, lint free cloth. If available, place the individual device components back into the sterilization cassette. Thermal Disinfection Washer Disinfector according to EN ISO 15883-1&-2. Utilize the following thermal program: Table 1: Thermal Disinfection Parameters Phase:

Thermal Rinse

Recirculation Time:

1 minute

Temperature:

90ºC/194ºF

Detergent (if applicable)

N/A

1. Place the device into the washer disinfector. 2. After closing the door to the washer disinfector, start the program utilizing the parameters in Table 1. 3. At the end of the program remove the device from the washer disinfector. 4. Wipe the device with a single use, lint free cloth. Step 5

Maintenance and Inspection Inspect all Tunneler components and the Tunneler Sterilization Cassette to ensure that they are clean and free of damage prior to sterilization. Damage that could prevent proper function of the Tunneler includes scratches, cross-threading, etching, pitting, burrs, nicks, dents, or cracks. For proper use, the Sterilization Cassette should latch when closed and should be free of any structural damage. Reference Precautions #2, #3, #4.

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Step 6

Steam Sterilization Sterilizer according to EN 13060 and/or EN 285. Utilize the following sterilization set points: Table 2: Sterilizer Parameters Sterilizer Type:

Pre-Vacuum

Preconditioning Pulses:

4

Temperature:

132°C/ 270°F

Full Cycle Time:

4 minutes

Dry Time:

30 minutes

Warning: Do not stack Tunneler Sterilization Cassettes during sterilization period. 1. Prior to sterilization place the device components into the sterilization cassette and secure the lid; enclose it in a commercially available sterilization wrap. If a sterilization cassette is unavailable, device components may be individually wrapped in a commercially available sterilization wrap. 2. Place the loaded cassette or individually wrapped components into the sterilizer chamber. 3. Start the Program utilizing parameters in Table 2. 4. At the end of the program remove the loaded cassette or individually wrapped components from the sterilizer and allow to cool down. Note: Prior to opening the sterilization wrap, inspect the wrap for tears, pinholes, or other damage that might compromise sterility. The Cassette must be enclosed in an appropriate commercially available sterilization wrap in order to preserve sterility after reprocessing. Storage: No special requirements.

Using the Tunneler 1. Remove the sterile PV Sheath Tunneler components from the Tunneler Sterilization Cassette using appropriate aseptic technique. 2. To assemble the sterile Tunneler components: Carefully secure (thread) the Handle onto either end of the Rod. Slide the Rod through the Sheath, so that the threaded end of the Rod extends beyond the Sheath end. Attach (thread) the Bullet Tip to the exposed end of the Rod. Hand-tighten the assembly, making sure that the shoulders of the Bullet Tip and Handle are snug against the ends of the Sheath. 3. Follow standard surgical practice to create entrance and exit incisions for the Tunneler. 4. Use the sterile assembled Tunneler to create a tissue tunnel connecting the entrance and exit incisions. 5. When the Tunneler passes through the exit incision site and a satisfactory tunnel has been created, unscrew the Handle one half turn, and then completely remove the Bullet Tip from the Rod. 6. When tunneling is completed and the Bullet Tip will not be needed for the remainder of the procedure, remove the Bullet Tip from the surgical field and return it to the Tunneler Sterilization Cassette. 7. Secure (tie) the graft onto the Rod by placing a suture through the tapered hole at the exposed end of the Rod. Verify that the vascular graft outside diameter fits within the Sheath and the graft length is longer than the tissue tunnel. Reference Precaution #1.

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8. Carefully pull the graft through the Sheath, using the Handle and Rod assembly. a. When the graft has been pulled into position within the Sheath, release it from the Rod by cutting the suture. b. While holding the graft at the exit incision site, grasp the protruding Sheath end and carefully pull (remove) the Sheath from the tissue tunnel, leaving the graft properly placed inside the tissue tunnel. 9. Proceed with the vascular anastomoses.

Maintenance Procedures Proper maintenance of the PV Sheath Tunneler requires careful handling and inspection of each Tunneler component and the Tunneler Sterilization Cassette. Particular care should be taken to avoid damaging the threaded portions of the Rod, Handle, and Bullet Tip. If these areas are damaged through improper handling (i.e., dropping, cross-threading, brushing and/or cleaning with abrasives) the parts may not fit together properly or be inter-changeable on the Rod ends. Do not use the Tunneler if damaged (Reference Step 5. Maintenance and Inspection). After use, these products may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and local, state, and federal laws and regulations. Contact Bard Peripheral Vascular for appropriate replacement parts and ordering information.

Warranty

Bard Peripheral Vascular, Inc. warrants to the first purchaser of this product that this product will be free from defects in materials and workmanship for a period of one year from the date of first purchase and liability under this limited product warranty will be limited to repair or replacement of the defective product, in Bard Peripheral Vascular’s sole discretion or refunding your net price paid. Wear and tear from normal use or defects resulting from misuse of this product are not covered by this limited warranty. TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE TO YOU FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT. Note: Users and/or patients within the European Union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Users outside of the European Union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established. Some states/countries do not allow an exclusion of implied warranties, incidental or consequential damages. You may be entitled to additional remedies under the laws of your state/country. An issue or revision date and a revision number for these instructions are included for the user’s information on the last page of this booklet. In the event 36 months have elapsed between this date and product use, the user should contact Bard Peripheral Vascular, Inc. to see if additional product information is available.

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Tip Embout Spitze Punta Punta Punt Ponta Άκρο Spids Spets Kärki Spiss Końcówka Hegy Hrot Uç Наконечник 尖端 팁

Sterilization Cassette Boîte de stérilisation Sterilisationskassette Cassetta di sterilizzazione Contenedor para la esterilización Sterilisatiecassette Cassete de esterilização Κασέτα αποστείρωσης Steriliseringskassette Steriliseringskassett Sterilointikotelo Steriliseringskassett Kaseta do sterylizacji Sterilizációs kazetta Sterilizační kazeta Sterilizasyon Kaseti Стерилизационная кассета 滅菌收納盒 멸균 카세트

Rod Tige Stab Asta Varilla Staaf Haste Ράβδος Skaft Stav Tappi Stang Mandryn Rúd Tyč Çubuk Стержень 桿 막대

Set Set Leitung Set Conjuntos Set Conjunto Ρύθμιση Sæt Sats Setti Sett Zestaw Készlet Sada Set Набор 套組 세트

Sheath Gaine Hülle Guaina Vaina Huls Bainha Θηκάρι Skede Hylsa Holkki Hylse Koszulka Hüvely Plášť Kılıf Оболочка 鞘管 시스

Manufacturer Fabricant Hersteller Fabbricante Fabricante Fabrikant Fabricante Κατασκευαστής Fabrikant Tillverkare Valmistaja Produsent Producent Gyártó Výrobce Üretici Изготовитель 製造商 제조업체

Manufacturer Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 USA TEL: 1-480-894-9515 1-800-321-4254 FAX: 1-480-966-7062 1-800-440-5376 www.bardpv.com www.eIFU.bd.com

Authorized Representative in the European Community BD Ireland Limited Donore Road Drogheda, Co. Louth Ireland A92YW26

BAW1132800 Rev. 4 04/20