Johnson & Johnson Biosense Webster THERMOCOOL SMARTTOUCH Mode D'emploi page 11

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 30 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
watts and up to 50 watts should only be used if conduction block cannot be
achieved at lower power levels.
15. 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 until 5 seconds after termination of the
energy application. For power levels up to 30 watts, a high flow rate of
17 ml/min should be used. For power levels between 31-50 watts, a high
flow rate of 30 ml/min should be used.
16. 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
electrode temperature.
17. Monitor the catheter tip temperature throughout the procedure to ensure
adequate irrigation. The peak temperature should not exceed 50°C during
RF energy delivery. Note: the displayed temperature represents the
temperature of the electrode only, not the temperature of the tissue.
18. 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. 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.
19. 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temperature), the catheter must be withdrawn and the tip electrode inspected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
by increasing the flow rate and verifying flow from each of the six irrigation
holes.
If irrigation hole occlusion occurs:
a) Fill a 1 or 2 ml syringe* with sterile saline and attach to the stopcock
or sidearm.
b) Carefully inject the saline from the syringe into the catheter. A stream
of fluid should be visible from all six (6) holes.
c) Repeat steps a and b, if necessary until the holes are cleared.
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.
f) Zero catheter following re-insertion into 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.
Adverse Reactions
A number of serious adverse reactions have been documented for catheter
ablation procedures including pulmonary embolism, myocardial infarction, stroke,
cardiac tamponade, and death.
The following complications were also noted to have occurred during prior
studies or have been reported in the literature:
•
Catheterization/catheter procedure related: vascular bleeding/local
hematomas, thrombosis, arteriovenous (AV) fistula, pseudoaneurysm,
thromboembolism and vasovagal reactions, cardiac perforation, pericardial
effusion/tamponade, thrombi, air embolism, arrhythmias and valvular
damage, pneumothorax and hemothorax, pulmonary edema, hypoxia,
pleural effusion, acute respiratory distress syndrome (ARDS), congestive
heart failure, aspiration pneumonia, pneumonia, asthmatic attack,
hypotension, implantable cardioverter-defibrillator (ICD) lead malfunction,
anemia, thrombocytopenia, disseminated intravascular coagulation,
epistaxis, systemic infection, urinary tract infection, sedation induced apnea,
sedation induced CO
•
RF related: chest pain/discomfort, ventricular tachyarrhythmia, transient
ischemic attack (TIA), cerebrovascular accident (CVA), complete heart
block, coronary artery spasm, coronary artery thrombosis, coronary artery
dissection, cardiac thromboembolism, pericarditis, cardiac
perforation/tamponade, valvular damage and increased phosphokinase
level.
•
Unrelated to device or procedure: urinary retention, transient extremity
numbness, Parkinson's disease and gastrointestinal diverticulosis.
DISCLAIMER OF WARRANTY AND LIMITATION OF LIABILITY
THERE IS NO EXPRESS OR IMPLIED WARRANTY, INCLUDING WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ON THE PRODUCT(S)
DESCRIBED HEREIN. UNDER NO CIRCUMSTANCES SHALL
BIOSENSE WEBSTER, INC., OR ITS AFFILIATED COMPANIES, BE LIABLE
FOR ANY SPECIAL, DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER
DAMAGES OTHER THAN AS EXPRESSLY PROVIDED BY APPLICABLE
LAW.
WITHOUT LIMITING THE FOREGOING, BIOSENSE WEBSTER, INC. OR ITS
AFFILIATED COMPANIES, SHALL NOT BE LIABLE FOR ANY SPECIAL,
DIRECT, INCIDENTAL, CONSEQUENTIAL, OR OTHER DAMAGES, ARISING
OUT OF THE REUSE OF ANY PRODUCT(S) LABELED FOR SINGLE USE
OR WHERE REUSE IS PROHIBITED BY APPLICABLE LAW.
Descriptions and specifications appearing in Biosense Webster, Inc. printed
matter, including this publication, are informational only and meant solely to
generally describe the product(s) at the time of manufacture and are not made or
given as a warranty of the prescribed product(s) in any way.
M-5276-684K
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.
Table 1: RF and Flow Settings
ATRIAL
ABLATION
15 W to 30 W*
< 50°C**
17 ml/min
30 to 120 seconds
retention with lethargy and cholecystitis.
2
English
VENTRICULAR
ABLATION
31 W to 50 W
< 50°C**
30 ml/min
60 to 120 seconds
Release Date: 11/1/2019
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