Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH Mode D'emploi page 10

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Catheter. Use appropriate Biosense Webster accessory cables to connect the
THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation Catheter to the
appropriate accessory equipment.
1. Using aseptic technique, remove the catheter from the package and place in
a sterile work area. Inspect the catheter carefully for electrode integrity and
overall condition.
2. Create a vascular access in a large central vessel using aseptic techniques.
3. In order to prevent damage to the catheter tip, use the insertion tube
supplied with the catheter to advance or retract the catheter through the
hemostasis valve of the sheath. After insertion, slide the insertion tube back
toward the handle.
4. To verify compatibility between the sheath and catheter, advance the
catheter through sheath prior to insertion. Any sheath < 8.5 F is
contraindicated.
5. The catheter is connected to the recording equipment and/or the RF
generator through the CARTO™ 3 System using the appropriate interface
cables. Connect the catheter to the Patient Interface Unit (PIU) via the
appropriate Biosense Webster cable. Connect the PIU to the generator via
the appropriate Biosense Webster cable. Connect the PIU to the appropriate
recording and mapping systems, including the CARTO™ 3 Navigation
System, with appropriate interface cables. Use only Biosense Webster
interface cables. Connect the irrigation pump tubing to the luer fitting of the
catheter. A 3-way stopcock may also be used. Connect the irrigation pump to
a room temperature, heparinized (1 IU heparin/ml) normal saline bag using
standard safe hospital practices. To complete the electrical circuit, connect
an indifferent electrode to the indifferent electrode input on the generator.
6. Flush the catheter and tubing per standard technique to ensure purging of
trapped air bubbles and to verify that the irrigation holes are patent.
7. Start continuous irrigation at a flow rate of 2 ml/min.
Insert the THERMOCOOL SMARTTOUCH™ Bi-Directional Navigation
8.
Catheter via the entrance site using the insertion tube and an appropriately
sized introducer sheath. Advance the catheter to the area under
investigation.
9. Use both fluoroscopy and electrograms to aid in proper positioning.
10. In order to achieve optimal force reading accuracy and stability, allow the
catheter to warm up for 2 minutes after connection to the CARTO™ 3
System, prior to use of the force feedback feature.
11. Zero the contact force reading following insertion into the patient. The tip
electrode and first two ring electrodes must be outside of the sheath so that
the force sensor is inside the body. Ensure the catheter tip is not in contact
with tissue by evaluating the location on fluoro and CARTO™ System, the
EGM amplitude, and catheter movement. Variations in the force reading at
the same rate as the cardiac or respiration cycle may indicate contact with
cardiac structures. Once these markers indicate the tip is not in contact, the
reading can be zeroed. Refer to the User Manual for your CARTO™ 3
System for instructions on how to zero the contact force reading.
12. Zero the contact force reading when moving the catheter from one chamber
of the heart to another or upon re-insertion.
13. Use the Rocker Lever to deflect the catheter tip (Figure 2). When the lever is
pulled back from neutral, the tip will deflect relative to the direction of rotation.
The amount of deflection is relative to the amount of lever rotation. When the
lever is pushed forward, the tip will deflect in the opposite direction. To
straighten the tip, return the Rocker Lever to neutral position.
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 3). 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.
14. For RF application and flow settings refer to Table 1.
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Figure 2
Figure 3
M-5276-684K
Release Date: 11/1/2019