Designed to Reduce the Risk of Occlusion (1)

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Transcription:

Designed to Reduce the Risk of Occlusion (1)

more efficient flushing better outcomes The Vortex* ports feature the Vortex Technology for a more efficient flushing. The Vortex Technology sets up efficient flushing action to hyper cleanse the entire reservoir, resist sludge build-up, and reduce occlusions and infections. Prospective randomized comparison of occlusion rates between the Vortex ports and conventional ports (1) : Vortex Port Conventional Port Total port occlusion 0 9 Partial port occlusion (Infuse but not aspirate) Occlusions as % of total access attempts (1) Stevens B, Barton SE, Brechbill M, et. al. A Randomized, Prospective Trial of Conventional Vascular Ports vs. The Vortex Clear-Flow Reservoir Port in Adult Oncology Patients. JVAD 2000; (Summer). Use of Vortex Port Technology results in average savings per patient of $1,224 over conventional ports (2). what is the Conventional Port: 90 right-angled walls Centered exit stem Fluid turbulence leaving dead spaces Reservoir not efficiently flushed The Vortex Technology improves fluid dynamics in the port. A spiraling fluid motion, allowing fluid to reach all surfaces in the chamber, helping eliminate dead spaces. The tangential outlet and clear-flow technology behind Vortex implantable ports set up efficient flushing action to hyper cleanse the entire reservoir. Vortex Technology: Rounded reservoir walls Tangentially offset exit stem Vortex fluid dynamics Reservoir fully flushed (2) Third party verification by Pinnacle Healthcare Management

SAFETY NEEDLE low-profile design high level patient comfort Safe has never been this easy: raise needle cover ninety degrees, hold base firmly, and lift wings straight up. The Lifeguard* needle is a safety non-coring needle for accessing ports. It can be power-injectable or with a Y-site. The Lifeguard s low profile design provides patient comfort and dresses easily. Low profile for patient comfort Soft wings designed for minimal skin irritation Non-siliconized needle helps prevent dislodgment from port Latex and DEHP free Needleless Access Connector (NAC) Y-site Our Needleless Access Connector (NAC) Y-site eliminates the step of removing an injection cap, making the connector quick and easy to use. One-handed clamps for positive pressure technique Universal luer locks accommodate all injection caps

Vortex Technology + power-injection capabilities The Smart Port* product line combines the benefits of the Vortex Technology with high pressure injection capabilities. Power-injectable The Smart Ports are clinically indicated for power-injections up to 5mL/sec and 300 psi and are MRI-conditional - 3 Tesla. Additional benefits of the Smart Ports: CT-engraved port body identified through chest X-Ray or CT Scout Scan Large septum diameter offers greater target area Silicone-filled suture holes prevent tissue ingrowth for ease of explants One-step locking mechanism / strain relief means fast, simple and secure procedures Silicone or Polyurethane catheter options with centimeter markings Safety non-coring needle included in all Smart Port trays. Smart Port patient Education Packet When a Smart Port power-injectable port is implanted, each patient receives an education packet including an information booklet, ID card, key ring card and ID bracelet.

ORDER REFERENCES Port design and dimensions material Dimensions ID x OD 9.6Fr 1.6mm x 3.2mm L 53cm 7.2Fr 1.3mm x 2.4mm L 53cm Silicone 6.6Fr 1.0mm x 2.2mm 5.1Fr 0.9mm x 1.7mm L 53cm 8.4Fr 1.6mm x 2.8mm Polyurethane (PUR) 5.7F 1.0mm x 1.9mm 5.1F 1.0mm x 1.7mm Vortex VX H: 13.5mm, Base: 26.8mm, Septum: 11.9mm, V: 0.6ml W: 12.5g Vortex LP Plastic H 13.2mm, Base 31.8mm, Septum 12.7mm, V: 0.7ml W: 6.5g Vortex LP H: 12.6mm, Base: 31.8mm, Septum: 12.7mm, V: 0.7ml W: 14.5g Vortex VX Low-Profile H: 11.0mm, Base: 23.0mm, Septum: 7.7mm, V: 0.2ml W: 8.5g Vortex TR Low-Profile H: 10.1mm, Base: 24.4mm, Septum: 10.2mm, V: 0.5ml W: 9.5g Vortex LP Low-Profile H: 9.7mm, Base: 25.3mm, Septum: 10.2mm, V: 0.3ml W: 9.0g Ideal for chest and peripheral placement Vortex MP H: 9.7mm, Base: 23.8mm, Septum: 10.2mm, V: 0.3ml W: 6.7g Ideal for chest and peripheral placement Detached P5455K P5355K - - - - - Attached P5405K P5305K - - - - - Detached LVTX7013 - - - LVTX7513 - - Attached LVTX7015 - - - LVTX7515 - - Detached LVTX5013 - - - LVTX5513 - - Attached LVTX5015 - - - - - - Detached - P12355K - P12155K - - - Attached - P12305K - P12105K - - - Detached - - PSDX-10-I** - - - - Attached - - PSAX-10-I** - - - - Detached LVTX5057 - - - LVTX5557 LVTX5555 - Detached - - - MP-P5SDT - - MP-P5PT Attached - - - MP-P5SAT - - - Vortex VX Vortex LP Vortex TR Low-Profile Vortex MP **Silicone-filled suture holes Tray components: Port system,, Locking mechanism (detached models), Non-coring needle, Introducer needle, Vein pick, Introducer, Guidewire, Infusion set, Blunt needle (detached models), Tunneler, 10 ml syringes Dual Port ORDER REFERENCES Port design and dimensions Dual Vortex LP H: 12.5mm Base: 28.7x 45.0mm Septum: 12.7mm each V: 0.9ml each W: 30g material Dimensions Detached Silicone 11.4Fr - ID 1.3mm each x OD 3.8mm LVTX5213 Dual Vortex Low-Profile

ORDER REFERENCES ( ** Silicone-filled suture holes) Port design and dimensions Smart Port CT H: 13.5mm, Base: 26.8mm, Septum: 11.9mm, V: 0.7ml W: 12.5g Smart Port CT Low-Profile H: 10.8mm, Base: 24.0mm, Septum: 10.2mm, V: 0.4ml W: 9.5g Smart Port CT Mini H: 10.2mm, Base: 17.3mm, Septum: 10.2mm, V: 0.3ml W: 6.8g material Silicone Polyurethane (PUR) Dimensions Detached 9.6Fr ID 1.6mm x OD 3.2mm L 66cm CT96STSD** CT96STSD-NF 7.5Fr ID 1.4mm x OD 2.5mm L 66cm CT75STSD** CT75STSD-NF 8.0Fr ID 1.5mm x OD 2.7mm L 66cm CT80STPD** CT80STPD-NF 6.6F ID 1.0mm x OD 2.2mm L 55cm Attached CT96STSA** CT75STSA** CT80STPA** - Detached - - - CT66LTPD** Detached - - - CT66PTPD** - Smart Port CT Smart Port CT Low-Profile Smart Port CT Mini **Silicone-filled suture holes Tray components: Port System,, Locking mechanism (detached models), Non-coring needle, 22 Ga, Introducer needle, 18 Ga, Vein pick, Introducer, 0.035 x 50 cm guidewire, Infusion set, Blunt needle (detached models), Tunneler, 10 ml syringes ORDER REFERENCES Gauge Length Power Injectable with Smart Port CT Catalog With Y-site NAC Gauge Length Power Injectable Catalog 19 Ga 0.75-19mm Yes LG-19-75 19 Ga 1-25mm Yes LG-19-100 20 Ga 0.50-13mm Yes LG-20-50 20 Ga 0.75-19mm Yes LG-20-75 20 Ga 1-25mm Yes LG-20-100 20 Ga 1.5-38mm Yes LG-20-150 22 Ga 0.50-13mm No LG-22-50 22 Ga 75-19mm No LG-22-75 22 Ga 1-25mm No LG-22-100 19 Ga 0.75-19mm No LG-19-75NY 19 Ga 1-25mm No LG-19-100NY 20 Ga 0.50-13mm No LG-20-50NY 20 Ga 0.75-19mm No LG-20-75NY 20 Ga 1-25mm No LG-20-100NY 20 Ga 1.5-38mm No LG-20-150NY 22 Ga 0.50-13mm No LG-22-50NY 22 Ga 75-19mm No LG-22-75NY 22 Ga 1-25mm No LG-22-100NY USA: 14 Plaza Drive, Latham, NY 12110 - Tel: 800-772-6446 or 518-798-1215 - Fax: 518-798-1360 International: Haaksbergweg 75 (Margriettoren), 1101 BR, Amsterdam Z-O, The Netherlands - Tel: +31 (0)20 753 2949 - Fax: +31 (0)20 753 2939 MLC 220 EN Rev A www.angiodynamics.com *AngioDynamics, the AngioDynamics logo, SmartPort, LifeGuard, Smart Angle, FluoroMax, PeelPro and Snap-lock are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or a subsidiary. CAUTION: Federal Law (U.S.) restricts the sale of this device by or on the order of a physician. Copyright 2013 AngioDynamics, Inc. All rights reserved. The specifications shown in this leaflet are for information only and are not, under any circumstances, of a contractual nature. This brochure is intended solely for use outside the United States. IMPORTANT RISK INFORMATION INDICATION FOR USE: AngioDynamics implantable access port systems are intended to facilitate frequent blood sampling or the delivery of medications, nutritions, blood products, and imaging solutions. The Smart Port CT power injectable port line is indicated for the same indications and power injection of contrast media for imaging. Use of the a non Y site LifeGuard Safety Infusion Set (size = 20Ga or 19Ga) is indicated for power injection of contrast media. For power injection of contrast media, maximum recommended infusion rate is 5ml/sec.) CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. CONTRAINDICATIONS: AngioDynamics port systems should not be implanted in the presence of known or suspected infections, septicemia, or peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter. WARNINGS AND PRECAUTIONS: Please see package insert for the complete list of warnings and precautions. POTENTIAL COMPLICATIONS: Use of port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: Infection; pneumothorax; catheter malposition, migration or fragmentation; catheter pinch-off or rejection; hemorrhage; hematoma; clot formation, thrombophlebitis or thromboembolism; vessel trauma, including puncture, laceration, and erosion of vessel and skin; cardiac arrhythmia, puncture and tamponade; endocarditis; thoracic duct injury; peritonitis; fibrin sheath; and drug extravasation (leakage). Occlusion may result from clot formation inside the lumen of the catheter, precipitate formation inside the port from incompatible drugs, or from catheter tip placement against a vein wall or valve. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.