Becton Dickinson
AV Sheath Tunneler Set
Arteriovenous Sheath Tunneler Set and Sterilization Cassette Instructions for Use
104 Pages
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Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Instructions For Use Instructions for Use should be discussed with the patient, at the discretion of the physician.
Indication The Arteriovenous Sheath Tunneler (AV Sheath Tunneler) is intended to aid in creating subcutaneous tunnels for the placement of vascular prostheses (grafts) for arteriovenous access procedures. The Tunneler will facilitate the placement of externally supported grafts up to 7mm I.D. A Tunneler Sterilization Cassette is provided to hold and protect the Tunneler components when not in use and to allow penetration of steam during sterilization. The Cassette is to be used with an appropriate sterilization wrap. There are no known contraindications. The residual risks include infection, prolonged recovery time, re-intervention, excessive bleeding, and tissue injury.
Description The AV Sheath Tunneler consists of four components, that when assembled create a single unit device. The Tunneler components include the Handle, Inner Rod, Outer Sheath, and Tip. Reference Figure 1. Figure 1 Outer Sheath Handle
Inner Rod
Tip
The AV Sheath Tunneler and Sterilization Cassette are sold non-sterile and are to be decontaminated and processed (e.g. cleaned, disinfected, and sterilized) prior to use by the end-user. The product is intended for use by a qualified physician, qualified nurse, technician, or other appropriate hospital personnel. The product is intended for patients who require subcutaneous arteriovenous conduits for blood access. The clinical benefit of the AV Sheath Tunneler is to aid in creating subcutaneous tunnels for the placement of vascular prosthesis (grafts) for arteriovenous access procedures. The clinical benefit of the sterilization cassette is to hold and protect the tunneler components when not in use and allow penetration of steam during sterilization. Both the AV Sheath Tunneler and Sterilization Cassette are reusable medical devices. The Tunneler components are made of medical grade stainless steel. The Tunneler Sterilization Cassette is composed of Radel™ R (polyphenylsulfone) and has four medical grade stainless steel latches. These materials are designed to withstand repeated use, cleaning, disinfection and resterilization.
Precautions 1. Prior to utilizing the AV Sheath Tunneler, verify that the vascular graft outside diameter fits within the Sheath and the graft length is longer than the tissue tunnel to be created. Failure to do so may make it difficult to achieve optimal graft placement. 2. Care should be exercised to protect the Tunneler from mechanical damage. Rough handling may mar the surface of the Tunneler. 3. Do not soak Tunneler components in saline or bleach solutions. Doing so could cause damage to component surfaces.
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ENGLISH
Arteriovenous (AV) Sheath Tunneler Set and Sterilization Cassette
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
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.
Step 4 Option 2
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 AV Sheath Tunneler components from the Tunneler Sterilization Cassette using appropriate aseptic technique. 2. To assemble the sterile Tunneler components: Thread and hand tighten the Tip to either end of the selected Rod. Slide Sheath over Rod so that the exposed threaded end of the Rod extends beyond the Sheath end. Carefully secure (thread) the Handle onto the exposed fully threaded end of the Rod. Hand-tighten the assembly, making sure that the shoulders of the 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 Tip from the Rod. 6. When tunneling is completed and the Tip will not be needed for the remainder of the procedure, remove the Tip from the surgical field and return it to the Tunneler Sterilization Cassette.
Positioning the AV Graft Option 1: After ensuring Sheath position is optimum, remove Rod and Handle assembly, leaving the Sheath in place. Feed graft into Sheath using a gentle pushing method. Do not twist the graft. Visualize the orientation line to verify accurate placement. When graft has been pushed into position within the Sheath, hold 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. Reference Precaution #1.
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Option 2: 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. Carefully pull the graft through the Sheath, using the Handle and Rod assembly. When the graft has been pulled into position within the Sheath, release it from the Rod by cutting the suture. 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. Proceed with the vascular anastomoses. Reference Precaution #1.
Maintenance Procedures Proper maintenance of the AV 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 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. 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 INDIRECT, 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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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
BAW1136700 Rev. 3 04/20