![]() Potential Complications include, but are not limited to Hematoma at the entry site, Vessel perforation, Vasospasm, Hemorrhage, Contrast extravasation, Embolism, Drug reaction, Allergic reaction to contrast media, Neurological deficits including stroke and death, Pain and tenderness, Vessel dissection, Vascular thrombosis, Other – case (or patient) to which the therapeutic solution is inadequate.AngioDynamics, Inc. Determine the cause of resistance under fluoroscopy and take any necessary remedial action. Never advance the guidewire against resistance this could cause vessel trauma and/or wire damage.Complications may occur, if all the air has not been removed from the infusion catheter and displaced with saline prior to insertion into the body.Contamination of the device may lead to injury, illness or death of the patient. Reuse of single-use devices creates a potential risk of patient or user infections.Reprocessing may compromise the integrity of the device and/or lead to device failures.Failure to use an introducer sheath may result in damage to the catheter or occluding ball wire.Use an introducer sheath if the puncture is through a synthetic graft.Do not inject contrast medium with a pressure injector if the occluding ball wire is in place.This product should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures.These complications may include but are not limited to: After the system is positioned for use, lock the wheels, take out the footswitch pedal from the rear storage compartment, connect the footswitch pedal cable to the laser system and place the footswitch pedal on the floor.Īs with the use of similar therapies, the following potential complications may occur with the use of this catheter, accessories and adjunctive therapies (Balloon/stent). Before moving the system, release the wheels from locking, disconnect the footswitch pedal cable from its connector in the laser system and place the footswitch pedal in the rear storage compartment. When moving the AURYON Atherectomy System be careful to avoid crashing or sudden impacts.Pay attention when handling the AURYON OTW catheter to ensure that the fibers at the distal and proximal ends are not damaged.Sterility is guaranteed only if the package is unopened, undamaged and before the expiry date. AngioDynamics supplies sterile fiber optic catheters. Only catheters approved by AngioDynamics are allowed to be used in the AURYON Atherectomy System. ![]() Allow flammable materials to evaporate before the laser is used. The laser beam may ignite solvents of adhesives and flammable solutions. Possible explosion hazard if the laser is used in the presence of flammable anesthetics or other solutions and gases.Skin exposure to laser radiation should be avoided.The system is not intended to be used during a defibrillation event.Operating the system at the incorrect voltage may result in damage to the system units. The voltage rating is marked on the back panel of the laser controller. Ensure the system is connected to the proper voltage. ![]() Internal maintenance of the system must be performed only by personnel from AngioDynamics. To avoid electrical shock, do not open the AURYON Atherectomy System cover. The AURYON Atherectomy System contains high voltages which are potentially lethal.Observe all safety precautions for use of Class IV laser equipment. Improper use of the AURYON Atherectomy System could result in serious personal injury. The AURYON Atherectomy System is a Class IIb medical device which contains a Class IV laser that produces an invisible beam of high-energy ultraviolet radiation. ![]() Contraindications: In the US, the 0.9mm and 1.5mm catheters are not indicated for use in ISR lesions. ![]()
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