Vanguard BW Mode D'emploi page 27

Improper use of the catheter or incorrect operation of the curvature control!
Injury, perforation and tamponade of the heart and the vascular system
Ensure that the catheter is only used by trained users.
→
→ Always use the curvature control when inserting or removing the catheter to bring the catheter tip to a
straight position.
Do not forcefully push the catheter forwards or back if you encounter resistance.
→
Reprocessing/resterilization and reuse after intended use of the catheter by the user or operator!
Injury to blood vessels and intracardial injuries, infection, sepsis
→ The catheter is not to be reprocessed, resterilized or reused by the operator or user.
Use of RF current!
Impairment of implantable pacemakers and automatic implantable
cardioverter/defibrillators (AICDs)
An external cardiac pacemaker and a defibrillator must be available for use during the entire
→
procedure.
→ Temporarily reprogram the pacemaker system to the minimum delivery or switch OFF to minimise the
risk of an undesired stimulation.
Take the utmost care when the ablation point is in the vicinity of the atrial or ventricular electrodes. In
→
this case, program the AICD to the OFF mode during ablation and perform a full test of the implanted
equipment after the procedure has been completed.
Ablation at a septal accessory pathway!
Total AV block
→ Only perform ablation at septal accessory conduction pathways after a strict risk/benefit assessment,
as the risk of a total AV block requires the implantation of a permanent pacemaker.
An external cardiac pacemaker and a defibrillator must be available for use during the entire
→
procedure.
PRECAUTIONS
1. Monitoring of the tissue temperature is not possible with temperature sensors of the catheter. The
temperature sensor implemented in the catheter measures the temperatures of the head electrode not
the temperature in the interface of electrode/tissue and tissue. This temperature is displayed on the RF
surgical unit. The temperature sensor is used to ensure the appropriate irrigation flow rate.
A decrease of the electrode temperature shows, that the ablation electrode is irrigated with saline
solution. Then the supply of the alternating current could start. The monitoring of the electrode
temperature during the RF current flow ensures that the irrigation rate of saline solution is constant.
2. Comparative studies and animal testing have shown that, during the ablation, there was no significant
increase in electrode temperature. The electrode temperature is not a measure for tissue heating
caused by RF energy.
3. An overly rapid power increase during ablation may lead to perforation caused by the abrupt
development of steam. The procedure for increasing the power is described in the instructions for use
and must be followed.
4. If the catheter is accidentally passed through a patient's prosthetic tricuspid valve, the valve could be
damaged.
5. The risk of perforation and/or pericardial effusion during the application of catheter systems is greater
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