Operator’s Manual
6-18
Directions for Use
The Steerable Ablation Catheter is usually inserted into a vein or artery and is then
positioned into the appropriate chamber of the heart under fluoroscopic guidance. A
transseptal approach may be used. Precise placement of the catheter prior to ablation is
accompanied by endocardial mapping using the tip and/or ring electrodes. Once
appropriate positioning has been achieved, RF power is delivered via the EPT-1000 XP
TM
Cardiac Ablation Controller resulting in the ablation of the targeted cardiac tissue.
Temperature can be monitored during the ablation procedure through the use of an EPT
temperature sensing catheter.
1.
Prior to insertion of the Steerable Ablation Catheter, prepare the entry site according
to standard aseptic technique practices.
2.
Insert the catheter percutaneously into the appropriate artery or vein by the Seldinger
technique using an 8 French hemostatic introducer sheath.
3.
Once inside the vessel, the catheter tip can be deflected as necessary to facilitate
advancement into the selected heart chamber. The degree of tip deflection is
controlled by the Steering Lever on the catheter handle. If the Steering Lever is
pushed forward from its neutral position, the tip curves proportionately up to a
maximum of 270 degrees in one direction depending upon the curve option selected.
Pulling the Steering Lever back causes the tip to deflect in the opposite direction. To
prevent over stressing the tip, the Steering Lever movement is limited by the handle
design.
4.
When crossing the aortic valve with the ablation catheter, it is recommended that the
catheter tip be deflected to resemble a “pigtail” curve to avoid damage to the valve
leaflets.
5.
The catheter curve can be straightened completely and deflected in the opposite
direction against cardiac tissue, facilitating stability during ablation.
6.
The adjustable Tension Control Lever may be tightened to retain the tip in the
desired curvature or to increase steering resistance. The catheter is shipped with the
Tension Control Lever in the “(-)” position, which is the minimum tension
adjustment. In this position, the catheter steers freely and does not hold a preset
curve. Rotation of the Tension Control Wheel in the clockwise direction increase
tension. In the “(+)” position, maximum tension is achieved. The catheter should not
be steered in the maximum “(+)” position.
7.
Connect the XP APM to the ISOLATED PATIENT CONNECTOR located on the
Controller’s front panel using the attached patient cable. Be sure to carefully follow
the instructions in the Operator’s Manual to connect the XP APM.
