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

INTENDED USE 

The RFP-100A RF Puncture Generator is intended to deliver radiofrequency energy in a voltage-controlled monopolar mode between the distal tip electrode of a radiofrequency device and a return electrode. The RF device and return electrode are separately approved.

INDICATIONS FOR USE

The RFP-100A RF Puncture Generator & RFP-Footswitch (optional accessory) is to be used with separately approved radiofrequency devices in general surgical procedures to cut soft tissues.

CONTRAINDICATIONS

The RFP-100A RF Puncture Generator is not recommended for uses other than the indicated use.

WARNINGS

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.

• 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 RF Devices, Connector Cables, and the accessory Footswitch only. For respective devices/accessories, refer to individual IFUs for more information.
• To avoid risk of electric shock, the 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.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of this equipment, including cables specified by Boston Scientific. Otherwise, degradation of the performance of this equipment could result in patient or user harm.
• 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 initial time and cut settings other than those recommended by the RF Device Instructions for Use. The time and cut settings (and therefore output power) should be as low as possible (as recommended for 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 is 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 the shaft and handle, as well as checked 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 the 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 RF Devices, 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 the 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 RF Device, as indicated within the 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 RF Device and dispersive electrode, particularly when operating the 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 the re-usable Connector Cables and accessory Footswitch.
• Perform regular inspections of all system components, including separately cleared RF Devices and Connector Cables, for damage to insulations.
• Associated equipment and 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.
• Boston Scientific 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 RF Device and 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, but are not limited to, the following:

• Allergic Reaction
• Arrhythmias
• Burn
• Cardiac Arrest
• Cardiac Tamponade
• Cardiac Trauma
• Cerebral Vascular Accident
• Death
• Electric Shock
• Embolism
• Fistula
• Heart Failure
• Hematoma
• Hemorrhage
• Hypotension
• Infection
• Myocardial Infarction
• Nerve Injury
• Pain
• Pericardial Effusion
• Pneumothorax
• Radiation Exposure
• Respiratory Insufficiency/Failure
• Thrombosis
• Transient Ischemic Attack
• Vasovagal Response
• Vessel Trauma 

There may be other potential adverse events that are unforeseen at this time. The RF Device Instructions for Use should be consulted for any other adverse events that may be associated with use of that separately cleared device. The Dispersive Electrode manufacturer’s Instructions for Use should be consulted for any other adverse events that may be associated with use of that dispersive electrode. 

ADDITIONAL WARNINGS

• The Generator should not be used adjacent to or stacked with other equipment. If the Generator must be operated adjacent to or stacked with other equipment, the Generator should be observed to verify normal operation in that configuration.
• Do not remove the cover of the Generator. Removing the cover may result in personnel injury and/or damage to the Generator.
• Using different rated fuses than specified can result in permanent damage to the Generator.

97185373 (Rev. B)