Baylis RFP-100A - WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS; WARNINGS

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SECTION 3: WARNINGS, PRECAUTIONS, AND ADVERSE EVENTS

The safe and effective use of RF energy is highly dependent upon factors under the control

of the operator. There is no substitute for properly trained operating room staff. It is

important that the operating instructions supplied with the Generator be read and understood

before use.

3.1. WARNINGS

• DO NOT attempt to operate the Generator before thoroughly reading this User’s Manual.

It is vital that the operating instructions for the equipment be read, understood, and

followed properly. For future reference, retain this User’s Manual in a convenient, readily

accessible place.

• The Generator is intended for use with separately cleared BMC RF Devices, BMC

connector cables, and the accessory footswitch only. For respective devices/accessories,

refer to individual IFUs for more information.

• To avoid risk of electric shock, Generator must only be connected to supply mains with

protective earth.

• Do not remove the cover of the Generator. Removal of the cover may result in injury and/or

damage to the Generator.

• When the Generator is activated, conducted and radiated electrical fields may interfere with

other medical and electrical equipment. Care should be taken to limit the effects that

electromagnetic interference (EMI) produced by the Generator has on other equipment.

• Laboratory staff and patients can undergo significant x-ray exposure during RF Puncture

procedures due to the continuous usage of fluoroscopic imaging. This exposure can result

in acute radiation injury as well as increased risk for somatic and genetic effects.

Therefore, adequate measures must be taken to minimize this exposure.

• Do not attempt to perform an RF puncture with an initial cut setting other than that

recommended by the BMC RF Device Instructions for Use. The cut setting (and therefore

output power) should be as low as possible (as recommended for BMC RF device) to avoid

any unintended result.

• Failure of the Generator could result in an unintended increase of output power.

• Place monitoring electrodes as far away from the surgical site as possible, to avoid burns

or interference with other equipment. The use of needle monitoring electrodes (or other

small area electrodes) during RF output is not recommended. In all cases, incorporating

high frequency current limiting devices are recommended.