Sterile Bipolar Radiofrequency Ablation Pen
Specification/Type: MZ-RFP-(01), MZ-RFP-(02), MZ-RFP-(03)
Intended Purpose
Sterile Bipolar Radiofrequency Ablation Pen (hereinafter referred to RF Pen) is intended to be used with MZ-RFS-I Radio Frequency Cardiac Tissue Ablation System for ablation of cardiac tissue and used as a mapping (sensing, stimulation and pacing) tool during cardiac surgery for the treatment of atrial fibrillation.
Indication for Use
Atrial fibrillation which requires surgical intervention.
Contraindications
Do not ablate cardiac valves directly.
Potential Complications
Possible complications related to the creation of spot or linear lesions in cardiac or soft tissues are:
• Tissue perforation
• Postoperative embolic complications
• Extension of Cardiopulmonary Bypass time
• Perioperative heart rhythm disturbance (atrial and/or ventricular)
• Pericardial effusion or tamponade
• Injury to the great vessels
• Conduction disturbances (SA/AV node)
• Acutemyocardial ischemia
• Bleeding
• Infection
• Pulmonary vein stenosis
• Cardiac Valve Injury
• Death
Please review the Instructions for Use for a complete listing of warnings and precautions prior to using these devices.
Functions:
Ablation: The Radiofrequency Ablation Generator (RFG) of the RF System delivers 460.8 kHz RF energy through the RF Pen to the target tissue for ablation.
Pacing or stimulation: The Stimulus Generator Unit (SGU) of the RF System provides the RF Pen with pacing/stimulation pulses (pacing rate: 30–350 bpm; stimulation rate: 100–1800 bpm). The RF Pen then deliver these pulses to the heart to implement pacing or stimulation.
Sensing: RF Pen can sense electrophysiological signals of the heart and transmit the signal to SGU. And the electrophysiological signal will be displayed on the RF System touch screen at the same time.
