![]() Do not attempt ablation without using an irrigation pump. Reestablish irrigation flow prior to placing catheter in the body. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Always maintain constant irrigation to prevent coagulation within and around electrodes. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Precautions: If the irrigation pump alarm sounds, terminate RF delivery. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. The long terms risks of RF ablation lesions have not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long-term risk of protracted fluoroscopy has not been established. Warnings: Catheter ablation procedures present the potential for significant x-ray exposure. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.Ĭontraindications: In patients with active systemic infection. Indications: The FlexAbility™ Ablation Catheter, Sensor Enabled™ is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. ![]() Prior to use, reference Instructions for Use, inside the product carton (when available) or at or at for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Indications, Safety & Warnings FlexAbility Ablation Catheter, Sensor EnabledĬAUTION: This product is intended for use by or under the direction of a physician.
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