English
M-5276-784B
9
Directions for Use
Please refer to the User Manuals for the
C
ARTO
®
3 System, irrigation pump and
RF generator for instructions on connecting and operating these systems in
conjunction with the Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF
Uni-Directional Navigation
Catheter. Use appropriate
Biosense Webster
accessory cables to connect the Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF Uni-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 c
ondition.
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 Fr
ench is
contraindicated
.
5.
The catheter is connected to the recording equipment and/or the RF
generator through the
C
ARTO
®
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 v
ia
the appropriate Biosense Webster
cable. Connect the PIU to the
appropriate recording and mapping systems, including the
C
ARTO
®
3
Navigation System
, with appropriate interface cables. Use only
Biosense Webster
interface cables. Connect the irrigation pum
p tubing to
the L
uer 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 irrigat
ion at a flow rate of 2 ml/min.
8.
Insert the Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF
Uni-Directional Navigation
Catheter via the entrance site using the insertion
tube and an appropriately sized introducer sheath. Advance the catheter to
the area under i
nvestigation.
9.
Verify that the “TCool SF” option is selected on the RF generator. When this
option is chosen, the generator defaults to the safety parameters
established for the Biosense Webster T
HERMO
C
OOL
S
MART
T
OUCH
®
SF
Catheter.
10.
Use both fluoroscopy and electrograms
(EGM) to aid in proper positioning.
11.
In order to achieve optimal force reading accuracy and stability, allow the
catheter to warm up for 2 minutes after connection to the
C
ARTO
®
3 System,
prior to use of the force feedback feature.
12.
Zero the contact force reading following insertion into the patient. The tip
electrode and all four 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 fluoroscopy and the
C
ARTO
®
3
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
C
ARTO
®
3 System for instructions on how to zero the contact force
reading.
13.
Zero the contact force reading when moving the catheter from one chamber
of the heart to another or upon re-
insertion.
14.
The catheter tip can be deflected to facilitate positioning by using the
thumbknob to vary tip curvature. Pushing the thumbknob forward causes
the catheter tip to deflect; when the thumbknob is pulled back, the tip
straightens.
15.
For RF application and flow settings refer to Table 1
.
Table 1: RF and Flow Settings when using Stockert’s RF generators
16B
RECOMMENDED RF APPLICATION PARAMETERS
ATRIAL
ABLATION
VENTRICULAR
ABLATION
Power Range
15 W to 30 W*
31 W to 50 W
Temperature Monitoring
<
40°C**
<
40°C**
Irrigation Flow Rate During
RF Application
8 ml/min
15 ml/min
Application Time
30 to 120 seconds
60 to 120 seconds
* Power levels exceeding 30 W may be used when transmural lesions cannot
be achieved at lower energy levels. For
power settings > 30 W, the
recommended irrigation flow rate is 15 ml/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 W
and up to 50 W should only be used if conduction block cannot be achieved
at lower power levels.
16.
Recommendation for irrigation
when using Stockert’s RF generators
:
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 until 5
seconds after termination of the energy application. For power levels up to
30 W, a high flow rate of 8
ml/min should be used. For power levels
between 31-50 W, a high flow rate of 15
ml/min should be used.
Do not use
catheter without irrigation flow.
17.
The application of RF energy must not be initiated until the increase in
irrigation flow rate is confirmed by a minimum of 2
°C
decrease in tip
elect
rode temperature.
18.
Monitor the catheter tip temperature throughout the procedure to ensure
adequate irrigation. The peak temperature should not exceed 40°C
during
RF energy delivery. Note: the displayed temperature represents the
temperature of the electrod
e only, not the temperature of the tissue.
19.
Start a procedure at 15-
20 W. 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.
20.
RF current may be reapplied to the same or alternate sites using the same
catheter. However, in the event of a generator cutoff (impedance or
temperature), the catheter must be withdrawn and the tip 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
electrode as damage to the tip electrode bond may occur and loosen the tip
electrode or damage may also occur to the contact force sensor and affect
measurement accuracy
. Prior to reinsertion, ensure that the irrigation holes
are not plugged as follows:
