Precautions - Baylis Medical RFP-100A Gebrauchsanweisung

3.2.

PRECAUTIONS

• The Generator is intended for use with approved Catheters, Wires and accessories
only. Ensure that the rated accessory voltage is equal to or greater than the
Generator's maximum output voltage.
• Ensure that the catheter connector cables and dispersive electrode cables are
positioned in such a way that contact with the patient or other leads is avoided.
• It is recommended not to exceed the specified number of power applications per
Catheter, as indicated within the Catheter's specific instructions for use.
• Do not attempt to use the Generator before thoroughly reading the Generator
User's Manual.
• Only physicians thoroughly trained in RF Puncture techniques, in a fully equipped
catheterization laboratory, should perform RF Puncture procedures.
• Adequate filtering must be used to allow continuous monitoring of the surface
electrocardiogram (ECG) during RF power applications.
• Read and follow the manufacturer's instructions for use of the Disposable
Indifferent (Dispersive) Patch (DIP) electrode. Always use dispersive electrodes
that meet or exceed IEC 60601-2-2 requirements. The entire area of the dispersive
electrode should be reliably attached to the patient's body and as close to the
operating field as possible.
• Placement of the dispersive electrode on the thigh could be associated with higher
impedance.
• The Generator is capable of delivering significant electrical power. Patient or
operator injury can result from improper handling of the Catheter and dispersive
electrode, particularly when operating the device.
• During power delivery, the patient should not be allowed to come in contact with
grounded metal surfaces or metal surfaces which have an appreciable capacitance
to earth (for example operating table supports, etc). The use of antistatic sheeting
is recommended for this purpose.
• Apparent low power output or failure of the equipment to function properly at
normal settings may indicate faulty application of the dispersive electrode or
failure of an electrical lead. Do not increase power before checking for obvious
defects or misapplication.
10 DMR RFP-100 3.3 V-13 16-Jan-2012_EN.doc