Inquiry Luma-Cath™ Series Electrophysiology Catheter
Caution:
• United States law restricts this device to sale by or on order of a physician.
• Read directions prior to use.
Description:
Inquiry Luma-Cath™ fixed curve and steerable electrophysiology catheters are flexible, insulated catheters constructed of themoplastic elastomer material and noble metal electrodes, featuring an open lumen for the introduction of contrast media. The Inquiry Luma-Cath electrophysioly catheters are used for intracardiac recording of complex conduction disturbances and cardiac stimulation during diagnostic electrophysiology studies.
Indications For Use:
1. Inquiry Luma-Cath™ fixed curve electrophysiology catheters are used for measurement of electrical activity in the heart.
2. The Inquiry 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.
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.
• Maximum Guidwire
Fixed Curve 6F & 7F Steerable 6F Steerable 7F
.032"/0,813mm .018"/0,457mm .032"/0,813mm
• The Inquiry Luma-Cath™ is not intended for use with high pressure injection equipment. Hand injection with a 10ml syringe is suggested.
• When using EP 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. Do not reprocess or reuse. Reuse can cause patient injury and/or the communication of infectious disease(s) from one patient to another.
Directions:
1. Inspect the electrodes and catheter carefully for integrity, continuity of leads, and overall condition.
2. Insert the catheter by using a standard percutaneous catheter introducer.
3. The catheter should be passed from a peripheral vessel to the desired intracardiac position with the aid of fluoroscopy.
4. The catheter has a cable adapter and must be used with the appropriate cable. Refer to the cable instructions for details.
5. To record intracardiac electrograms, connect a patient cable to the catheter.
6. Observe the polarity of the proximal end connector pins of the patient cable when connecting to an EP monitoring system. Refer to the ECG amplifier/recorder instructions.
7. Use care to isolate any unused connector pins. This will reduce the chances of developing accidental current pathways to the heart.
For steerable versions of The Inquiry Luma-Cath™ Catheters:
8. To manipulate the tip portion of the catheter, push or pull the thumb control located at the distal end of the handle.
9. Always use fluoroscopy when manipulating the tip of the catheter.
10. Always straighten the catheter tip before removing the catheter from the patient.
Precautions:
• 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.
