Baylis RFP-100A

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• Only physicians thoroughly trained in RF Puncture techniques, in a fully equipped

catheterization laboratory, should perform RF Puncture procedures.

• Read and follow the manufacturer’s instructions for use of the return (dispersive) electrode.

Only use dispersive electrodes that meet or exceed IEC 60601-2-2:2017 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.

• The Generator is capable of delivering significant electrical power. Patient or operator

injury can result from improper handling of the BMC RF Device and dispersive electrode,

particularly when operating the BMC RF Device.

• During RF energy 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 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.

• Regularly inspect and test re-usable connector cables and accessory footswitch.

• Perform regular inspections of all system components, including separately cleared BMC

RF Devices and BMC Connector Cables, for damage to insulations.

• Associated equipment and BMC RF Devices should be selected with a rated accessory

voltage equal to or greater than the maximum output voltage of the mode it is to be used

for.

• Baylis Medical Company relies on the physician to determine, assess, and communicate to

each individual patient all foreseeable risks of the Generator.

• The mains power cord of the Generator must be connected to a properly grounded

receptacle to avoid the risk of electric shock. Extension cords, portable multiple socket

outlets and/or adapter plugs must not be used. The mains power cord assembly should be

periodically checked for damaged insulation or connectors.

• Although the BMC RF Device and BMC Connector Cables are sterilized, the Generator is

not. The Generator must not enter the surgical sterile field.

• Fluids pooled in the body depressions and cavities should be mopped up before RF energy

is delivered.

• There is a danger of ignition of endogenous gases (e.g., cotton and gauze saturated with

oxygen may be ignited by sparks produced) during normal use of Generator.

Baylis RFP-100A - Page 12