Vanguard BW Mode D'emploi page 28

when a patient's prior ablation procedure(s) resulted in atrial flutters.
6. The patient's fluid balance must be monitored during the application of RF ablation in accordance with
medical and clinical protocols. This measure serves to prevent fluid overload in a patient. Depending
on the patient, complications may occur which could impair the ability to deal with fluid overload. If
patients are affected, water retention and lung oedema or heart attacks may occur after finishing of the
procedure. Older patients, patients with congestive cardiac insufficiency or renal insufficiency contain to
the risk groups. The risk of fluid overload for the patient must be determined prior to application of the
ablation procedure.
7. Intravenous heparin should be used if the catheter is introduced into the left side of the heart. This may
prevent thromboembolisms. Clinical guidelines and general good practice should be applied for optimal
anticoagulation after the procedure.
8. There is no evidence available for the safety of this catheter at electrode temperatures above 40°C.
Therefore ensure that the CATHETER SELECTION BUTTON on the compatible RF generator is set to
"Tcool SF" or to a THERMOCOOL SF option. Ensure that the maximum temperature of 40°C is not
exceeded.
9. Take precautions to minimise collateral damages to neighbouring structures while performing ablations
near anatomical structures.
10. To prevent injuries to the oesophagus, take precautions when performing ablations near the
oesophagus (along the rear wall of the left atrium). The RF output should also be reduced accordingly.
11. Take precautions when performing ablations near the phrenic nerve to prevent its damage. The RF
output and stimulation should also be reduced accordingly in order to determine the proximity of the
ablation electrode(s) to the nerve.
12. The catheter may not be autoclaved.
13. Any kind of contact between the catheter and organic solvents (e.g. alcohol) is to be avoided.
14. The proximal handle and cable plug must be kept dry. Immersing these components may lead to
impairments in the electrical line and must therefore be avoided.
15. The head electrode may not be impaired by cleaning, e.g. scrubbing or twisting.
16. The saline solution for irrigation may not contain air bubbles. This must be ensured before use. The
presence of air bubbles in saline solution may cause embolisms.
17. The catheter and irrigation pipes must be irrigated with heparinised normal saline solution.
18. Before use, read and understand the respective instructions for use of the Vanguard Irrigation Ablation
Catheter BW completely.
19. Ablations on the heart must be performed in a fully equipped electrophysiological laboratory and by
appropriately trained personnel. Personnel must be trained in the use of the Vanguard Irrigation
Ablation Catheter BW.
20. Based on electromagnetic compatibility requirements and other safety regulations in the clinics,
electrophysiological catheters and systems may only be used in X-ray shielded rooms.
21. To insert or withdraw the catheter, the catheter tip must be set to straight. To insert or withdraw the
catheter, the catheter tip must be set to straight by always moving the rocker lever (bi-directional
curvature adjustment) or the thumb knob (uni-directional curvature adjustment) to the neutral position.
22. The Vanguard Irrigation Ablation Catheter BW may not be used without irrigation. To prevent
coagulation in the lumen of the catheter, a steady infusion of heparinised normal saline solution must
be maintained.
23. Neutral electrodes are recommended for application. These must comply with the requirements
according to EN 60601-2-2. For neutral electrodes, follow the respective instructions for use.
24. Before using the product, thoroughly check the sterile packaging and the catheter for damages.
Damages to the sterile packaging or to the catheter cannot be tolerated. Damaged products may not
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