BARD

QuickLink Delivery System Manual Radionuclide Applicator Directions for Use

5 Pages

QUICKLINK® Delivery System  FEATURES The QUICKLINK® Delivery System comes equipped with the following features [Figure 2]:  MANUAL RADIONUCLIDE APPLICATOR SYSTEM Model #: 70310QCA1  8  1 7 10  Manufacturer Bard Brachytherapy, Inc. Carol Stream, IL 60188 USA (800) 977-6733 www.bardmedical.com seed.order@crbard.com  2  9  6  4  3  5  [FIGURE 2]  PHYSICAL CHARACTERISTICS ®  1  QUICKLINK Cartridges The QUICKLINK® cartridges are constructed of radiation-resistant polycarbonate, and hold a maximum of 20 components. The cartridges are marked with a descriptive icon and scale to indicate the identity and approximate quantity of the contained component, as well as provide a visual key for insertion into the loader carriage.  ®  The QUICKLINK Delivery System is designed to assemble brachytherapy seeds, SOURCELINK™ synthetic spacers, and SOURCELINK™ Connectors in cartridges into seed trains of variable lengths and with variable seed-to-seed spacing as predetermined by the physician. The QUICKLINK® Loader is composed of stainless steel, GE Ultem® 1000 plastic, and shielding glass.  Carriage 2 The carriage is designed to hold the QUICKLINK® cartridges containing seeds, spacers, and SOURCELINK™ Connectors. Each slot in the carriage is keyed to a specific cartridge to prevent mix-ups. The carriage may be moved front to back to align the desired component cartridge with the dispensing indicator, or to allow compression and ejection of a seed train. The carriage is also equipped with a quick-release 3 button to allow for carriage removal and inspection.  SOURCELINK™ Connectors and SOURCELINK™ Spacers are synthetic absorbable monofilament seeding spacers that are designed to be assembled with brachytherapy seeds into seed trains of variable lengths and with seed-to-seed spacing as predetermined by the physician [Figure 1]. They are composed of a 70% L-lactide and 30% D,L-lactide copolymer. SOURCELINK™ Connectors are approximately 0.9mm in diameter and come in various sizes to provide accurate spacing of seeds in 0.5cm center-to-center increments.  4 Assembly Base and Ruler The assembly base is designed to provide a track for the compression of the seeds and SOURCELINK™ Connectors. The ruler provides a means for verifying that the desired train configuration is obtained prior to delivery into the needle.  5.5 mm  5 Dispense Button The dispense button transfers one component from the indicated cartridge to the assembly track when pressed.  5.5mm Standard SOURCELINK™ Connector 0.5 mm  Lead Glass Door 9 This shielding door is designed to provide radiation protection for the user while allowing for visual inspection of the seed train in the assembly track. The door is automatically latched closed, and may be opened by pressing the door release button on the rear of the assembly base. 7  0.5mm Seed-to-Seed SOURCELINK ™ Connector 5.0 mm  Compression Slide Handle 8 The compression slide is designed to deliver the necessary stylet force for compression of the seeds and the SOURCELINK™ Connectors into a seed train. The compression slide is factory adjusted to ensure that the proper compressive force is delivered every time. The compression slide is fitted with two support doors to minimize buckling of the stylet during compression.  5.0mm Extension SOURCELINK ™ Connector [FIGURE 1]  Gate Button 6 The gate button is designed to control the gate at the end of the assembly track which is the base for compression of SOURCELINK™ Connectors and seeds. The gate will be closed in normal (up) position to allow for compression. When depressed, the gate will open and allow the seed train to be dispensed through the needle adapter.  SOURCELINK™ Connector spacers are approximately 0.8mm in diameter and are available in lengths of 5.0 and 5.5mm. Information regarding the specific brachytherapy seed used may be found in the accompanying seed Instructions for Use.  Needle Adapter 10 Stainless steel adapters are provided for the attachment of implant needles to the QUICKLINK® Delivery System. They are designed in 4 different styles to fit all commercially available implant needles.  IN-VIVO CHARACTERISTICS As body fluids initially come into contact with the SOURCELINK™ Connectors and SOURCELINK™ Spacers, they chemically react with the polymer to break the polymer chains through hydrolysis. The material is then metabolized.1,2,3  Removable Stylet The stylet is designed to compress the seeds and SOURCELINK™ Connectors into a seed train and has been equipped with a luer-lock fitting for quick and easy replacement.  INDICATIONS The QUICKLINK® Delivery System is indicated for use with SOURCELINK™ Connectors, spacers and brachytherapy seeds in the assembly of seed trains of variable lengths and predetermined spacing between the seeds for use in brachytherapy procedures. SOURCELINK™ Connectors are indicated for use in seed spacing and linking in brachytherapy procedures. The SOURCELINK™ Connector spacer is used in seed approximation in brachytherapy procedures.  WARNINGS AND PRECAUTIONS Warning: Potential calculus formation with absorbable materials As with any foreign body, prolonged contact of synthetic absorbable material, including SOURCELINK™ Connectors and SOURCELINK™ Spacers, with salt solutions, such as those found in the biliary or urinary tracts, may result in calculus formation.  CONTRAINDICATIONS  Warning: Potential biohazard  SOURCELINK™ Connectors and SOURCELINK™ Spacers, being absorbable, should not be used where permanent spacing or linking is required.  After use, the QUICKLINK® Delivery System components may become biohazardous. Handle per accepted medical practice and within applicable laws and regulations. The QUICKLINK® Delivery System loader is reusable, and the loader components must be thoroughly cleaned and sterilized prior to use and between uses.  ADVERSE REACTIONS Adverse side effects associated with the use of SOURCELINK™ Connectors and SOURCELINK™ Spacers include: minimal acute inflammatory tissue reaction, calculus formation in urinary and biliary tracts in the event of prolonged contact with salt solutions such as urine and bile, and transitory local irritation.  Warning: Radioactive materials / Lead components The QUICKLINK® Delivery System components and the contained brachytherapy seeds should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclide brachytherapy sources and whose training and experience have been approved by the appropriate authorities authorized to license the use of radioactive materials. Use appropriate radiation safety protection practices when working with the QUICKLINK® Delivery System components that contain radioactive materials. Initiate radiation surveys on the QUICKLINK® Delivery System components at the completion of the brachytherapy  HOW SUPPLIED The QUICKLINK® Delivery System loaded cartridges and components are supplied sterile. The cartridges are indicated for single use only. The QUICKLINK® Delivery System Loader is supplied non-sterile and must be sterilized in an autoclave before use.  1
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File Name: BARD - PK0319939 - QuickLink Delivery System Manual Radionuclide Applicator Directions for Use - 2018-12.pdf

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