Vanguard BW Mode D'emploi page 29

be used.
25. The Vanguard Irrigated Ablation Catheter BW is gas sterilized with ethylene oxide. The catheter can be
used until the expiry date on the packaging label. Use of the catheter after the expiry data is prohibited.
26. The Vanguard Irrigated Ablation Catheter BW is a single-use product and intended for single patient
use only.
27. The catheter may not be resterilised or reused.
28. To minimise the risk of tissue injury, the insertion of the catheter must be monitored fluoroscopically
and by electrogram data.
29. MRI could shift the catheter or could lead to catheter heating and could result in distorting of the image.
The Vanguard Irrigated Ablation Catheter BW must be kept away from MRI devices.
30. During the scope of RF surgical procedures, there is a risk of flammable gases and other materials
igniting, which is why flammable materials may not be stored in the vicinity of RF surgical procedures.
This requires separate precautions.
31. The use of Vanguard Irrigated Ablation Catheter BW in combination with suitable, compatible RF
generators in normal operation creates electromagnetic interferences (EMI) which may negatively
effect the function of other devices.
32. Before using the catheter, check the porosity of the holes by irrigating the catheter and all tubes with
heparinised normal saline solution.
33. The user is responsible for regularly checks and has to test reusable cables and accessory parts.
34. Ablation on the septum side includes an increased risk for the patient for the appearance of a complete
AV block. A complete AV block occurring in a patient treated with RF ablation requires the insertion of a
permanent pacemaker.
35. Risks of myocardial infarctions exist due the placement of the catheter in the coronary vessels and/or
during the RF ablation. To prevent the placement of the catheter in the coronary vessels, a suitable
fluoroscopic visualisation has to be applied at the access to the aorta.
36. In contrast to standard RF ablation catheters without irrigation, the Vanguard Irrigated Ablation
Catheter BW creates larger lesions. Ablations near structural areas such as the sinu-atrial and
atrioventricular nodes must therefore be performed with extreme caution.
37. The Vanguard Irrigated Ablation Catheter BW is intended for use in connection with compatible
accessories (irrigation pump, RF surgical unit, Carto® EP system, cables, plug connectors). An
appropriately compatible irrigation pump is recommended to ensure the correct irrigation rate.
38. When using electrophysiological catheters, the accuracy of temperature measurement basically
depends on the RF surgical unit. This also applies to the Vanguard Irrigated Ablation Catheter BW. The
user manuals of the respective devices contain information on the accuracy of temperature
measurements.
39. If the output power is too low or the monitored impedance value is too high or if the device doesn't
functioned with correct settings, the reasons therefore could be a wrong application of the neutral
electrode or a faulty electrical connection. Before increase of power, it has to ensure that the electrical
connection is free of failures and the neutral electrode is in correct use.
40. Ensure that you minimise X-radiation during the ablation procedure. Within the scope of ablation
procedures with catheters, the X-radiation intensity and duration of fluoroscopic imaging can lead to a
significant release of X-radiation. This creates an increased risk as a result of somatic and genetic
effects on patients and laboratory personnel.
41. Minimise X-radiation during the procedure. During catheter ablation procedures, the intensity of X-
radiation and the duration of fluoroscopic imaging may lead to considerable exposure to X-radiation.
Only perform catheter ablations if radiation exposure has been taken into appropriate consideration
and measures to minimise radiation have been taken. The use of this catheter on pregnant women has
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