Vanguard BW Mode D'emploi page 26

Risk of burns
To reduce the risk of burns, position the electrodes and probes as far away as possible from the
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ablation site and dispersive electrodes.
Ignition of flammable gases and other substances!
Fire or explosion
Make sure that highly flammable substances are removed from the working area.
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The generator does not display a temperature!
Temperature control/monitoring not possible for ablation
Check the cable connection at the generator. If the temperature is not displayed, there may be a
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malfunction in the temperature sensor system. Rectify this fault before applying RF current.
Electrical contacts of the catheter or connected cables are electrically connected to the heart!
Ventricular fibrillation due to uncontrolled electrical energy
Do not touch the plug contacts of the catheter or connected cables with your fingers or objects.
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→ Only connect the plug contacts of the catheter to the suitable medical devices using proper connection
cables.
→ Do not allow the connectors of the catheter or a connection cable to come into contact with liquids.
This could affect electrical safety and functionality.
Electromagnetic interference due to an external pacemaker!
Damage or impairment of other devices, ventricular fibrillation and burns
→ Only use the catheter in a properly equipped and operated medical electrophysiology laboratory.
Transfer of electrostatic discharges to the catheter system!
Ventricular fibrillation due to uncontrolled electrical energy
Only use the catheter in a properly equipped and operated medical electrophysiology laboratory.
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Misplacement of the catheter into the coronary system during transaortic access!
Bleeding, shock or heart attack
→ Ensure good imaging during transaortic access.
Long fluoroscopy times with X-rays!
Somatic and genetic damage due to high exposure to ionising radiation
→ Review the benefit/risk ratio due to the possible radiation effects especially for pregnant women,
children and adolescent patients, and patients undergoing multiple examinations.
The long-term risks that are associated with RF lesions have not yet been proven!
Unclear risks and long-term risks
This should only be applied on prepubertal children after thorough consideration.
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Sterilized package is damaged or opened!
Infection of patients by non-sterile products
Check the package before you open it and do not use the catheter if the package is damaged.
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Damage due to continued use contrary to the intended use and due to unsuitable storage conditions!
Injury to the central circulatory system, infection, sepsis
Observe the intended use and corresponding information on the package.
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©Vanguard AG 1000001805_REV_A_25.09.2020 26