Johnson & Johnson Biosense Webster ThermoCool Instructions For Use Manual page 7

The handle has an adjustable friction control that allows the operator to use
the Rocker Lever and deflecting tip in a "free" state or adjust the friction to
where the Rocker Lever and tip curve are "locked" in place (Figure 2). This
knob is located on the opposite side of the Rocker Lever. Out of the
package, the knob will be in the "off" position, which allows the freest
movement for the lever and deflecting tip. The amount of friction increases
as the Friction Control Knob is rotated clockwise until it reaches the fully
"on" position. Clockwise rotation from the "off" position increases the friction
within the Deflection Mechanism. Counter-Clockwise rotation from the "on"
position decreases the friction within the Deflection Mechanism.
12. For RF application and flow settings refer to Table 1.
RECOMMENDED RF APPLICATION PARAMETERS
Power Range
Temperature Monitoring
Irrigation Flow Rate During
RF Application
Application Time
* Power levels exceeding 30 Watts may be used when transmural lesions
cannot be achieved at lower energy levels. For power settings > 30 Watts,
the recommended irrigation flow rate is 15ml/min.
** The temperature displayed on the RF generator does not represent tissue
temperature or electrode tissue interface temperature.
Additional Recommendation:
For isthmus dependent flutter ablation, power applications exceeding 30
watts and up to 50 watts should only be used if conduction block cannot be
achieved at lower power levels.
13. Recommendation for irrigation: Increase the irrigation to high flow rate
starting up to 5 seconds before the onset of RF energy delivery and
maintaining this higher flow rate up to 5 seconds after termination of the
energy application. For power levels up to 30 watts, a high flow rate of
8ml/min should be used. For power levels between 31-50 watts, a high flow
rate of 15ml/min should be used.
14. The delivery of RF energy must not be initiated until the increase in
irrigation flow rate is confirmed by a minimum of 2º C decrease in tip dome
electrode temperature.
15. Monitor the catheter tip temperature throughout the procedure to ensure
adequate irrigation. Note: the displayed temperature represents the
temperature of the electrode only, not the temperature of the tissue.
16. Start a procedure at 15-20 Watts. After 15 seconds, power may be
increased by 5-10 W increments as needed, until a transmural lesion is
achieved, defined by > 80% reduction in unipolar atrial electrogram
amplitude, or emergence of double potentials of equal and low amplitude. It
is recommended that power not exceed 50 W when the catheter is parallel
to the tissue and 35 W if the catheter is perpendicular to the tissue. The
duration of each RF ablation should not exceed 120 seconds. Dragging the
catheter to the next location is permissible during the 120-second energy
application. RF current may be reapplied to the same or alternate sites
using the same catheter.
17. In the event of a generator cutoff (impedance or temperature), the catheter
must be withdrawn and the tip dome electrode inspected for coagulum
before RF current is reapplied. To remove any coagulum, if present, a
sterile gauze pad dampened with sterile saline may be used to gently wipe
the tip section clean; do not scrub or twist the tip dome electrode as
damage to the tip dome electrode bond may occur and loosen the tip dome
electrode. Prior to reinsertion, ensure that the irrigation holes are not
plugged as follows:
a. Fill a 1 or 2 ml syringe* with sterile saline and attach to the stopcock on
the end of the irrigation tubing.
b. Carefully inject the saline from the syringe into the catheter. Uniform
streams of fluid should be visible from the tip of the catheter.
c. Repeat steps a and b, if necessary.
d. Flush catheter and tubing per standard technique to ensure purging of
trapped air bubbles and to verify that the irrigation holes are patent.
e. The catheter can now be introduced into the patient.
WARNING: Do not continue use of the catheter if still occluded or if
it is not functioning properly.
NOTE: A small syringe provides sufficient pressure to produce a visible
stream of fluid.
M-5276-658A
WARNING: This is a controlled proprietary and confidential document. Verify revision is current prior to use.
AVISO: Este es un documento controlado, confidencial, y con derechos reservados. Revisar si es la revision mas actualizada.
Figure 1
Figure 2
Table 1: RF and Flow Settings
ATRIAL
ABLATION
15 W to 30 W*
<40°C**
8ml/min
30 to 120 seconds
English
VENTRICULAR
ABLATION
31W to 50 W
<40°C**
15ml/min
60 to 120 seconds
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