Luma-Cath™ Fixed & Steerable Curve Diagnostic Catheters

Prescriptive Information

Indications
Luma-Cath fixed curve electrophysiology catheters are used for measurement of electrical activity in the heart. The Luma-Cath steerable electrophysiology catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the high right atrium, right ventricular apex, and HIS bundle.

Contraindications
See product information supplied with device for contraindications.

Warnings
This device should be used by or under the supervision of physicians experienced in the techniques of angiography and transvenous electrophysiology studies. For specific details, the physician should be referred to medical publication and rely on experience. Cardiac catheterization procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Careful consideration must therefore be given for the use of this catheter in pregnant women. Do not immerse the proximal handle or cable connector in fluids; electrical performance could be affected. Do not expose the catheter to organic solvents such as alcohol. Do not autoclave the catheter. See product label for guidewire specification. The Luma-Cath is not intended for use with high pressure injection equipment. Hand injection with a 10ml syringe is suggested. When using ECG monitoring equipment for electrode placement, the equipment must be either "front end isolated" or have an isolated patient cable. Vascular perforation is an inherent risk of any electrode placement. The device should not be used in transcatheter ablation. This device is intended for one time use only.

Potential Adverse Effects
The lumen of this catheter is intended for delivery of contrast medium and/or saline via syringe. 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
Luma-Cath is a trademark of Irvine Biomedical, Inc.