8/3/2023 0 Comments Angioplasty ultra balloon![]() ![]() ![]() After use, this product may be a potential biohazard. To prevent over pressurization, use of a pressure monitoring device is recommended.ħ. Balloon rupture may occur if the RBP rating is exceeded. Do not exceed the RBP recommended for this device. Applying excessive force to the catheter can result in tip breakage or balloon separation.Ħ. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Do not advance or retract the catheter unless the balloon is fully deflated. When the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. To reduce the potential for vessel damage, the inflated diameter and length of the balloon should approximate the diameter and length of the vessel just proximal and distal to the stenosis.ĥ. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.Ĥ. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.ģ. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. This device has been designed for single use only. Do not reuse, reprocess or re-sterilize.Ģ. Do not use if sterile barrier is opened or damaged. Contents supplied STERILE using ethylene oxide (EO). This catheter is not for use in coronary arteries.ġ. This product is not manufactured with any latex.Ītlas PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. A re-wrapping tool is also provided on the catheter shaft. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. The over the wire catheter is compatible with 0.035" guidewire and is available in 75 and 120 cm working lengths. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. The Atlas PTA Balloon Dilatation is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. ![]()
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