Vanguard Irrigated Ablation Catheter SJ Gebrauchsanweisung Seite 19

catheter as trapped air can cause injury or death.
11. The materials of the catheter are not compatible with magnetic resonance imaging (MRI).
12. The catheter may get caught in heart or blood vessels, which is a possible complication in
electrophysiological applications.
13. There is a risk of vascular perforation or dissection with each placement of the electrodes. To avoid
heart damage, perforation or tamponade, move the catheter with caution.
14. Do not apply excessive force if you encounter resistance when advancing or retracting the catheter.
15. If you are using an electrophysiological measuring station, it must either be isolated from the patient
or have an isolated patient cable.
16. The right phrenic nerve can be injured during ablation along the vena cava.
17. This product is intended for single use only. It may not be reprocessed or reused. Reuse may result in
product failure, patient injury and/or transmission of infectious diseases from one patient to another
patient or third party.
18. The safety and efficacy of epicardial ablations have not yet been adequately investigated.
PRECAUTIONS
1. The HF energy is switched off in the event of an alarm signal from the Cool Point
Communication and liquid flow must be checked. Check the irrigation line for blockages such as kinks
and air bubbles. Remove the catheter from the patient and check both the catheter and the electrodes.
If necessary, clean the electrodes with sterile saline solution and gauze. Before reinserting the
catheter, ensure that the irrigation ports are unblocked and irrigate the catheter.
2. During HF ablation, the impedance display of the HF generator must be monitored continuously. If the
impedance suddenly increases without exceeding the preset limit value or if steam suddenly escapes,
HF ablation must be stopped manually. The doctor must assess the situation. If necessary, the
catheter must be removed from the patient and any clots removed from the distal tip. If the catheter is
defective, it must be replaced by a new catheter. Before reinserting the catheter, ensure that the
irrigation ports are unblocked. After completing the test, reinsert the catheter for another HF ablation
test.
3. At power levels above 40 watts, the sudden escape of steam may occur frequently. At the maximum
permissible power level (50 watts), increased collateral damage may also occur. This power level
should only be selected if the desired result cannot be achieved with a lower power level.
4. The catheter must be advanced under fluoroscopic imaging control. This minimises the risk of heart
damage, perforation or tamponade. Compatible catheter positioning and navigation systems can be
used in conjunction with fluoroscopic imaging.
5. Before inserting and withdrawing the catheter, always straighten the curvature using the control
elements.
6. Always ensure continuous irrigation to avoid coagulation in and around the electrodes.
7. Excessive bending or buckling can damage the catheter. Manual pre-bending of the distal end may
result in damage to the control mechanism and injury to the patient.
8. It has been proven that ablation systems with irrigation produce larger lesions than HF ablation
catheters without irrigation. Special care should be taken when ablating near structures that are
sensitive to electrical charges and near thin-walled or other arterial structures.
©Vanguard AG 1000001966_REV_C_26-08-2021
TM
irrigation pump.
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