Vanguard BW Mode D'emploi page 30

to be very carefully considered.
42. Electrodes and probes for monitoring and stimulation devices can emit high-frequency currents. To
reduce the risk of burning, you should take electrodes and/or probes as far as practically possible from
the place of ablation and neutral electrodes. Protective impedances may further reduce the risk of such
burns. They also permit continuous monitoring of the electrocardiogram during energy output.
43. The temperature sensor located in the catheter tip only measures the temperature of the electrode tip.
The catheter does not record the tissue temperature. This temperature is displayed on the RF surgical
unit and only applies to the cooled electrode. If the temperature is not displayed on the RF surgical unit,
check the wiring to the RF surgical unit. If the temperature is still not displayed, the temperature
measurement system may be faulty. If these errors occur, they must be rectified before the output of
RF energy.
44. The Vanguard Irrigated Ablation Catheter BW used in connection with a compatible RF generator can
emit enormous electrical output. Both the catheter and the neutral electrodes must be handled
correctly. In the event of non-compliance, the use of the catheter may lead to injury of the patient
and/or operator. Under no circumstances may the patient be in contact with grounded metal objects
during the course of energy output. If the temperature on the display of the RF surgical unit does not
increase during ablation, switch off the power supply and check the settings.
45. Use the Vanguard Irrigated Ablation Catheter BW in connection with conventional systems (under X-
ray/fluoroscopic control to determine the position of the catheter tip) or with the CARTO® EP
navigation system extremely carefully to avoid injuries to the heart, tamponades or perforations.
Advancing the catheter must follow not only under X-ray controlled conditions but also extremely
carefully due to the tip's strength properties. Avoid excessive force when advancing or retracting the
catheter.
46. If the limit value for the RF current is exceeded (rise in temperature or impedance), remove the
catheter and clean the tip (e.g. of adherent coagulate). When cleaning the head electrode, ensure that
its position is not twisted or changed. This ensures that the electrode is not loosened or damaged.
Before reinserting the catheter, ensure that the irrigation holes of the head electrode are not blocked.
47. The applied RF current during ablation may cause implanted pacemakers and implantable
cardioverter-defibrillators (ICD) to be impaired. To reduce the risk of undesired pacemaker function
during ablation, the function of an external pacemaker and defibrillator, as well as the possibility of the
pacemaker system's temporary programming to minimum output or system deactivation must be
temporary available.
During ablation, proceed with particular care if the procedure is performed in close proximity to
permanent wires around the atrium or ventricle. During ablation, the ICD must be set to the OFF mode.
After ablation, all patients must undergo complete analysis for implantable devices.
48. There is no evidence available for the following events:
a) Risk upon termination of an anti-coagulation therapy after catheter ablation.
→ affected patients must be treated in accordance with the "ACC/AHA/ESC Guidelines for the
Management of Patients in Atrial Fibrillation"
b) The efficacy and safety of RF ablation treatment of atrial fibrillation in patients with severe left-
ventricular dysfunction, progressive cardiac insufficiency, significant left atrial enlargement and
illnesses concerning the structure of the heart.
c) On the long-term risk of extended fluoroscopy and of RF-induced lesions.
→ application in prepubescent children should be carefully considered
→ the risk and benefit of the use of the catheter in asymptomatic patients were not investigated
49. Before using the catheter on a patient, check all operating elements for proper function.
50. Never use the lever of the curvature control with a fully tightened locking screw (set to max. "+").
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