CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
INTENDED USE/INDICATIONS FOR USE
ORBITER ST Bidirectional Steerable Diagnostic Catheter is intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.
- The catheter should not be used in conditions where manipulation of the catheter would be unsafe (e.g. Intracardiac mural thrombus).
- The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement.
- This device should be used only by physicians thoroughly trained in the techniques of intracardiac electrophysiology studies and temporary pacing.
- The risks of using electrophysiology catheters include those risks related to heart catheterization such as thromboembolism, perforation, tamponade, and infection. The induction of an unintended arrhythmia is a known complication.
- Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.
- Do not use excessive force to advance or withdraw the catheter when resistance is encountered.
- Catheter advancement should be done under fluoroscopic guidance.
- Use only sterile saline or water to wipe this catheter.
- Avoid submerging the catheter handle in any solution.
- For catheters equipped with a cable connector, use with the appropriate Boston Scientific cable.
- Excessive bending, torquing or kinking of the electrode catheter may cause damage to the catheter, including damage to the internal wires.
91063814 (REV AA)