AFocus™ Steerable Diagnostic Catheters

Prescriptive Information

Indications
The AFocus steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The AFocus catheters are to be used to map the atrial regions of the heart.

Contraindications
The AFocus catheter is contraindicated for: Patients with prosthetic valves and patients with left atrial thrombus or myxoma, or interatrial baffle or patch via transseptal approach.

Warnings
This device should be used by or under the supervision of physicians experienced in the techniques of transvenous electrophysiology studies. When using ECG monitoring equipment for electrode placement, the equipment must be either "front end isolated" or have an isolated patient cable. Current leakage from the monitor must not exceed 10 microamps for intracardiac electrodes. Vascular perforation is an inherent risk of any electrode placement. Do not force the catheter through the vessel. The device should not be used in transcatheter ablation. It has not been demonstrated to be safe and effective for radiofrequency ablation. The A-Focus catheter is sterilized with ethylene oxide gas and is intended for one time use only. Do not autoclave. This device should not be used via retrograde approach, and is not recommended for use in the ventricles.

Potential Adverse Effects
To maintain optimal patient safety and electrode catheter integrity, do not wipe this catheter with alcohol. Excessive bending or kinking of the catheter may cause damage to the catheter. Standard grounding procedures should be followed if electrosurgical instruments are used.

Cautions
Federal law (USA) restricts this device to sale by or on order of a physician. Read directions prior to use.

Trademark
A-Focus is a trademark of Irvine Biomedical, Inc.