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PR-000 985_J
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9.2
Positioning the catheter
Insert the catheter via the vascular access, using a straight or steerable
introducer sheath.
Warning: When using a straight introducer sheaths, use ones with a
minimum diameter of 8.5 F only. When using sheaths with deflectable tip,
make sure the sheath tip is straight when catheter tip is passing through.
Warning: Establish an irrigation flow at the flow rate indicated in the table
below throughout the entire procedure to prevent occlusion of the
irrigation holes due to coagulation.
Procedure step
Recommended
irrigation
flow
Mapping, manipulation, etc. (NOT
ablation!)
2 ml/min
Ablation (power
≤
30 W)
17 ml/min
Ablation (power >30 W)
30 ml/min
1. Let the catheter soak in blood during 2 minutes before expecting full
performance. The soaking allows for stabilization of the force
measurement in the catheter. If force drift exceeds 5 grams in 2
minutes, leave the catheter in vena cava for another 2 minutes until
force drift is below 5 grams.
2. Advance the catheter to the area under investigation. Use both
fluoroscopy and electrograms to aid in proper positioning.
3. Use the thumb knob to facilitate the positioning of the catheter tip.
If you want to the catheter tip
Then … the thumb knob
deflect
push forward
straighten
pull back
Caution: You shall not use contrast fluid in catheter.
9.3
Applying radiofrequency current
1. Establish an irrigation flow at the high flow indicated in the table
above.
Watch the electrode tip temperature decrease.
2. When it has been determined that the tip electrode is in stable contact
with the intended ablation site, switch on the delivery of
radiofrequency current. Circuit impedance should be approximately
100 Ohms upon initiation of radiofrequency current.
3. After radiofrequency current is discontinued, turn irrigation flow back
to minimum 2 ml/min on the irrigation pump.
9.4
Reapplying radiofrequency current
Radiofrequency current may be re-applied to the same or alternate sites
using the same catheter.
In the event of a generator cutoff (impedance or temperature), proceed as
follows:
1. Withdraw the catheter and clean the tip electrode of coagulum before
reapplying radiofrequency current.
2. Gently wipe the tip section clean with a sterile gauze pad dampened
with sterile saline.
Warning: do not scrub or twist the tip electrode: damage to the tip
electrode bond may occur and loosen the tip electrode.
3. Prior to reinsertion, ensure that the irrigation holes are not occluded
by purging them at high irrigation flow.
9.5
Dealing with irrigation hole occlusion
If irrigation hole occlusion occurs, proceed as follows:
1. Remove the catheter from the patient.
2. Fill a syringe with sterile saline and attach to the system (ideally using
a 3-way stopcock).
3. Carefully inject the saline from the syringe into the catheter. A stream
of fluid should be visible from all six (6) holes.
4. If necessary, repeat steps 2 and 3.
5. If the holes are cleared, reintroduce the catheter 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.
10
ADVERSE REACTIONS
A number of serious adverse reactions have been documented for
catheter ablation procedures including:
•
Stroke
•
Tamponade requiring surgery
•
Symptomatic severe PV stenosis (>70 %), or complete
occlusion of a PV, even in the absence of symptoms
•
LA-esophageal fistula
•
Major bleeding, requiring surgery or transfusion
•
Death
The following complications were also noted to have occurred during prior
studies or have been reported in the literature
Catheterization/
catheter procedure related
Radiofrequency related
••••
Vascular bleeding/local
hematomas
••••
Thrombosis
••••
AV fistula
••••
Pseudoaneurysm
••••
Thromboembolism and
vasovagal reactions
••••
Cardiac perforation
••••
Tamponade
••••
Air embolism
••••
Arrhythmias and valvular
damage
••••
Pneumothorax
••••
Hemothorax
••••
Pulmonary embolism
••••
Chest pain/discomfort
••••
Ventricular tachyarrhythmia
••••
Transient Ischemic Attack
••••
Cerebrovascular Attack
••••
Complete heart block
••••
Coronary artery spasm
••••
Coronary artery thrombosis
••••
Coronary artery dissection
••••
Cardiac thromboembolism
••••
Pericarditis
••••
Cardiac
perforation/tamponade
••••
Valvular damage
••••
Increased phosphokinase
level
••••
Myocardial infarction
11
RECOMMENDED RF APPLICATION PARAMETERS
Atrial ablation
Power range
10 W to 30 W*
Temperature monitoring
45 to 50 °C**
Irrigation flow rate during RF
application
17 to 30 ml/min
Application time
30 to 60 seconds
* 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 generator does not represent tissue
temperature or electrode tissue interface temperature.
Additional recommendation:
For isthmus dependent flutter ablation, power applications exceeding 30
Watts should only be used if conduction block cannot be achieved at
lower power levels.
In any condition, power should not exceed 50 Watts
12
STORAGE
Storage temperature: 5 to 50 °C
Shelf life and maximum storage time: 1 year
13
DISPOSAL
Used products are contaminated and must be handled and disposed as
contaminated hospital waste.
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