Indications, safety, and warnings for RFP-100A RF Puncture Generator*

INDICATIONS FOR USE

The Baylis Medical Company Radiofrequency Puncture Generator & Footswitch (optional accessory) is to be used with separately approved radiofrequency devices in general surgical procedures to cut soft tissues.

CONTRAINDICATIONS

The BMC Radiofrequency Puncture Generator is not recommended for uses other than the indicated use.

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.
• Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
• During RF output, implanted devices such as pacemakers may be affected. Qualified advice should be obtained as necessary, to minimize the risk from injury due to implanted device malfunction.
• Unless a compatible monitoring return electrode that meets or exceeds IEC 60601-2-2 is used with the contact quality monitor, loss of safe contact between the return electrode and patient will not result in an auditory alarm.
• The Generator should not be operated if the display area (LCD screen) is cracked or broken.
• Devices should be checked for exposed metal between shaft and handle, as well as check for any connection issues prior to use.
• Devices should not be used in the presence of flammable materials, chemicals, and substances (anesthetics, oxygen, etc.).
• No modification of Generator is allowed. Modification may result in patient or operator harm.
• Flammable solutions may pool under the patients or in body depressions such as the umbilicus, and in body cavities such as the vagina.
• Generator failure can lead to neuromuscular stimulation.
• When using RF On/Off switch, the Generator can deliver RF energy without continuous depression of RF On/Off switch for the specified treatment time. Failure to specify correct treatment time could result in an unintended RF delivery.

PRECAUTIONS

• The Generator is intended for use with separately cleared BMC RF Devices, BMC connector cables and an optional accessory footswitch only. Ensure that the rated accessory voltage is equal to or greater than the Generator’s maximum output voltage.
• Ensure that the Generator connector cables and dispersive electrode cables are positioned in such a way that contact with the patient or other leads is avoided.
• Ensure the application and connections of dispersive electrode before selecting a higher output setting on generator.
• Temporarily unused Devices should be disconnected from the Generator, from the Connector Cable or they should be stored in a location that is isolated from the patient.
• It is recommended not to exceed the specified number of RF energy applications per BMC RF Device, as indicated within the BMC RF Device’s specific instructions for use.
• 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 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.
• The use of a smoke-plume extractor is recommended for the operator during RF procedures.

ADVERSE EVENTS

Adverse events that may occur while using the Generator include:

• Atrial Fibrillation and/or Atrial Flutter
• Myocardial Infarction
• Sustained Arrhythmias leading to Ventricular Tachycardia
• Neuromuscular stimulation
• Electric shock
• Thermal damage to tissue
• Thromboembolic Episodes
• Sepsis and Infection
• Unintended Perforation

97185373 (Rev. A)