Radiofrequency Ablation for Pain Management
PRESCRIPTIVE INFORMATION
FLEXTRODE Electrode and Cannula, and RCE – RF Injection Electrode
Indications for Use
The Boston Scientific G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific G4 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes.
Warnings
General Information
Safe and effective Radiofrequency (RF) lesioning is dependent not only on equipment design, but also on factors under control of the operator. Do not attempt to operate the RFG-4 (G4) prior to completely reading and understanding the instructions for use applicable to each component of the Boston Scientific System, consisting of generator, generator accessories, electrodes and cannula. For generator and generator accessories, refer to this manual; for the use of electrodes and cannula, refer to the respective electrode instructions for use.
WARNING: Electric Shock Hazard
There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Boston Scientific for servicing.
WARNING: Hazardous Electrical Equipment & Active Implants
This equipment is intended for use by qualified personnel only.
This equipment may damage or interfere with the operation of cardiac pacemakers and other active implants.
Do not use within 15 feet (4 meters) of a cardiac pacemaker unless proper cautions have been taken. Before use of the G4 RF Generator, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
This equipment has an output which is capable of causing a physiological effect.
WARNING: Risk of Burns and Fire
Do not use near conductive materials such as metal bed parts or inner spring mattresses.
WARNING: Protective Earth Grounding
Grounding reliability can only be achieved when the equipment is plugged into a receptacle marked “Hospital Grade”. Any interruption of the Protective Earth conductor will result in a potential shock hazard which cause injury to patient or operator.
WARNING: Electrical Safety Information
A needle electrode should not be used as the dispersive electrode, as it is possible to burn the patient at this site due to high current densities. In all applications, care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire area against the patient’s body and as close to the operating field as possible.
General Warnings and Precautions
This section contains warnings and precautions relevant to the G4 RF Generator. Additional warnings and precautions are listed throughout this Operator's Manual.
NOTICE: The physician and support staff must be the ultimate judge of the appropriateness of, and the method used to perform any medical procedure performed using Boston Scientific equipment. It is not the province of Boston Scientific to instruct in the proper medical use of the equipment. The availability of output modes, settings values, and default settings values on the G4 RF Generator should not be construed as a recommendation of the medical appropriateness of their use in a specific case.
WARNING: Proper electrode placement should be verified using anatomical landmarks, sensory and motor stimulation techniques, fluoroscopic guidance, Impedance reading, and good clinical judgment before RF lesion making procedures are initiated.
WARNING: The long-term risks of creation of RF lesions have not been established.
Non-Boston Scientific Equipment
WARNING: Electromagnetic interference (EMI) produced by the unit during normal operation may adversely affect the performance of other equipment. The performance of this device may be adversely affected by other high frequency surgical devices in close proximity. If a problem occurs, separate the devices. 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 the generator, including cables. Otherwise, degradation of performance of this equipment could result.
WARNING: Electrodes and probes of monitoring, stimulating and imaging devices, and metallic and conductive implanted hardware or probes, can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this G4 RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
CAUTION: Do not use the G4 Radiofrequency Generator with components, electrodes, and/or RF Cannulae/needles that are not approved by Boston Scientific.
The use of non-Boston Scientific approved components could negatively affect the EMC performance of the system or result in EMC non-compliance.
WARNING: Potentially hazardous conditions may exist when accessories of similar connector types are combined. Use only appropriate accessories certified by an accredited test body.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
WARNING: Do not touch the USB port and the patient simultaneously.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
The Dispersive Electrode ("Ground Pad")
WARNING: The use and proper placement of dispersive electrodes is a key element in the safe and effective use of this Radiofrequency lesion generator, particularly in the prevention of burns. Read and follow Boston Scientific’s dispersive electrode instructions for preparation, placement, surveillance, removal and use of any dispersive electrode. It is recommended that dispersive electrodes be used that meet or exceed the requirements of EN60601-2-2.
WARNING: Use a Boston Scientific approved gel-pad dispersive electrode with at least 110 cm² conductive plate area to disperse and return RF current over as large an area as possible, and thus minimize heating effects at that electrode, and to avoid high current densities and resultant burns in adjacent tissue.
NOTICE: The ground pad should be placed in close proximity to the lesion site.
WARNING: Observe the dispersive electrode during lesioning for signs of excessive heating.
NOTICE: Use of an approved ground pad with a stainless steel RF Cannula may provide a galvanic potential (the “battery effect”) resulting in a single stimulation pulse at the time the TC Electrode is placed into an RF Cannula. This should be anticipated, and does not present any risk or danger to the patient.
WARNING: Skin burns can result from the improper use of Ground Pads, including, but not limited to, the following:
- Use of Ground Pads with a conductive plate area less than 110 cm2.
- Use of expired Ground Pads or Ground Pads with dried gel.
- Ground Pads not placed on a well vascularized, muscular, convex area of patient skin.
- Use on patient with peripheral vascular deficiency.
- Reuse or repositioning of Ground Pad.
- Ground Pad placement over scar tissue, inflamed skin, adipose tissue, bony prominences, metal prostheses, ECG electrodes and cables, pacemakers, and areas where fluid may pool.
- Use of Ground Pad not in accordance with this G4 RF Generator Operator’s Manual.
- Use of a needle as dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.
Inspection
WARNING: Never proceed in a temperature monitored procedure if the generator does not read body temperature before you begin delivering RF energy.
WARNING: Verify functional safety of the device before each use, using the guidelines detailed in this manual.
CAUTION: Prior to each procedure, inspect all cables, electrodes, RF Cannulae, and dispersive electrodes for damage. Check the integrity of the electrode and cable insulation for signs of damage. Such damage could lead to RF Current loss, heating, and burning at undesired locations. A signal of undesired RF Current loss is that unusually high RF Voltage, Current, or Power values are required to achieve a desired electrode tip Temperature.
General Usage
WARNING: To avoid unanticipated stimulation to the patient, do not cycle the generator power or turn the generator power on while the patient is connected to the generator.
WARNING: The output of any electrode may change when patient output is being delivered. Do not move electrode(s) or change electrode connections to the generator when patient output is being delivered to any electrode.
CAUTION: Avoid electrode tip Temperatures near and above 100°C, as they may produce focal boiling and charring.
CAUTION: Raise the electrode Temperature slowly, particularly with large electrodes. Displayed temperature lags behind the actual temperature due to the thermal mass of the electrode.
WARNING: The generator is capable of delivering a significant amount of output. Patient or operator injury can result from improper handling of the active electrode and dispersive electrode, particularly when operating the generator. During energy delivery, the patient should not be allowed to come in contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Unshielded leads (active or return) should be positioned so that they cannot come into contact with the patient or other leads connected to the patient and so that they do not run parallel to nearby leads.
WARNING: To avoid accidental burns:
- Skin-to-skin contact (for example between the arms and body of the patient) should be avoided, for example by insertion of dry gauze.
- For surgical procedures where the high-frequency current could flow through parts of the body having a relatively small cross sectional area, the use of bipolar techniques may be desirable in order to avoid unwanted tissue damage.
- The output power selected should be as low as possible for the intended purpose.
WARNING: Failure of the generator could result in an unintended increase of output power.
CAUTION: The physician should observe and record all Voltage, Current, Power, Temperature and Impedance readings at all times, including when using Auto Ramp or Automatic Temperature Control (“Set Temp” or “Max Temp, see Sections 7.1 & 8.1). This gives the physician a measure of parameter normalcy for a given procedure and electrode size. Any anomalously high Voltage, Currents, Impedance, or Power readings would be apparent and signal possible problems.
WARNING: Apparent low power output or failure of the equipment to function correctly 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. Effective contact between the patient and the dispersive electrode must be verified whenever the patient is repositioned after the initial application of the dispersive electrode.
WARNING: Do not continue the application of RF if Temperature readings are erratic or do not rise a sufficiently rapid rate for the amount of RF energy applied. Erratic or sluggish Temperature readings may indicate a faulty cable connection, broken Temperature sensor of the electrode, loss of RF Power into an undesired location, an inability of the generator to control the Temperature or RF output of the electrode, or a misalignment of the temperature-sensing electrode tip with the uninsulated tip of the RF Cannula into which it is inserted.
NOTICE: Always have spare electrodes and cables on hand in case a problem arises with the first one during a procedure. Reuseable cables and accessories should be periodically tested.
WARNING: Any modification of the G4 Radiofrequency Generator done by unauthorized agents compromises the safety and efficacy of the equipment.
Mains Power
CAUTION: Make sure that the wall outlet voltage matches the voltage displayed on the Voltage Selector located on the rear of unit (100, 120, 220, or 240). If not, open the Fuse drawer, remove the Voltage Selector and rotate it to the proper voltage setting.
CAUTION: Disconnect all electrodes, ground pad, and associated cables from the G4 before turning the mains power on or off.
Electrical Safety and EMC
Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the RFG-4 (G4) or shielding the location.
Chassis Layout
WARNING: When connecting any non-medical peripheral equipment to this device, it must be ensured that the equipment combination meets the requirements of IEC 60601-1.
Electrode Setup Warnings and Guidelines
Review and adhere to these guidelines before turning on the electrode output:
- Attach electrodes and/or a ground pad to the electrode output connections on the front panel (Section 2) as shown in the Electrode Setup screen’s “Settings Graphic” (Section 5).
- Disconnect all electrodes and ground pads from output and/or reference connections marked with a red “X” in the Electrode Setup screen’s “Settings Graphic” (Section 5).
WARNING: Do not mix types and sizes of electrodes when delivering output to more than one electrode. All electrodes and their associated needles used in a multi-electrode configuration, including Bipolar configurations, should be identical.
WARNING: Do not deliver Pulsed RF output to any electrode whose active tip exposure is less 2 mm or whose diameter is less than 23 Gauge. The temperature response of such an electrode is too rapid for Automatic Temperature Control in Pulsed RF mode.
WARNING: Do not use the generator in a multi-electrode configuration with any electrode(s) whose active tip exposure is less than 2 mm or whose diameter is less than 23 Gauge. The temperature response of these electrodes is too rapid for Automatic Temperature Control of multiple such electrodes in Thermal RF and Pulsed RF modes.
WARNING: Do not move electrode(s) or change electrode connections to the generator when patient output is being delivered to any electrode.
WARNING: Do not place multiple electrodes too close together to create a large lesion when using a monopolar electrode configuration (i.e. Electrode Setup RF Type=Standard). Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.
WARNING: Do not place two bipolar electrode pairs too close together when using Electrode Setup RF Type=Bipolar and Active Electrodes=4. Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.
WARNING: Do not attach a ground pad to the generator or to the patient when using Electrode Setup RF Type=Bipolar. Both the ground pad and the reference electrodes (Electrodes 2 and/or 3) are at reference potential and will draw Current from the active electrodes (Electrodes 1 and/or 4). Failure to comply can cause a lesion with unpredictable size and shape and may result in patient injury.
Touch Screen Calibration
WARNING: Poor calibration of the touch screen may cause user input to be recognized incorrectly.
Sterilization
CAUTION: It is recommended the CB112-TC, the SKG Knob and the RFG-STP Test Pad be sterilized by steam autoclave.
The above parts may be sterilized in a Prevacuum Sterilizer at 132-135°C (270-275°F) for at least 4 minutes.
No other parts may be autoclaved.
Service
WARNING: Electric Shock Hazard
There are no user serviceable parts inside the G4. To avoid electric shock, return the device to Boston Scientific for servicing.
Fuse Replacement
WARNING: Risk of fire. Fuse must be replaced as marked.
Adverse Events
Reported adverse events or complications for RF heat lesions procedures include, but are not limited to, the following: Temporary motor deficit, post-operative pain, skin burns. Refer to the instructions for use for electrode kits used with the generator for additional adverse events that have been reported for specific RF applications.
Indications for Use
The RFG-1A and RFG-1B is intended to create lesions in neurological tissue and for use with Boston Scientific electrodes, cables, and accessories.
Warnings
General Information
Safe and effective lesioning is dependent not only on equipment design, but also on factors under control of the operator. Do not attempt to operate the RFG-1A and RFG-1B prior to completely reading and understanding the instructions for use applicable to each component of the Boston Scientific System, consisting of generator, generator accessories, electrodes and cannula. For generator and generator accessories, refer to this manual; for the use of electrodes and cannula, refer to respective electrode instructions for use.
WARNING: Electric Shock Hazard
There are no user serviceable parts inside the RFG-1A and RFG-1B. To avoid electric shock, return the device to Boston Scientific for servicing.
WARNING: Hazardous Electrical Equipment
This equipment is intended for use by qualified personnel only.
Do not use within 15 feet (4 meters) of a cardiac pacemaker unless proper cautions have been taken. Before use of the RFG-1A and RFG-1B Generator, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
This equipment has an output which is capable of causing a physiological effect.
Risk of Burns and Fire. Do not use near conductive materials such as metal bed parts or inner spring mattresses.
WARNING: Protective Earth Grounding
Grounding reliability can only be achieved when the equipment is plugged into a receptacle marked “Hospital Grade”. Any interruption of the Protective Earth conductor will result in a potential shock hazard which could cause injury to patient or operator.
General Warnings and Precautions
Electrical Safety and EMC
WARNING: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the RFG-1A and RFG-1B or shielding the location.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Electrical Safety Information
WARNING: A needle electrode should not be used as the dispersive electrode, as it is possible to burn the patient at this site due to high current densities. In all applications, care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire area against the patient’s body and as close to the operating field as possible.
WARNING: Apparent low power output or failure of the equipment to function correctly 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. Effective contact between the patient and the dispersive electrode must be verified whenever the patient is repositioned after the initial application of the dispersive electrode.
WARNING: Electromagnetic interference (EMI) produced by the unit during normal operation may adversely affect the performance of other equipment. The performance of this device may be adversely affected by other high frequency surgical devices in close proximity. If a problem occurs, separate the devices. 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 the generator, including cables. Otherwise, degradation of performance of this equipment could result.
WARNING: The use and proper placement of dispersive electrodes is a key element in the safe and effective use of this lesion generator, particularly in the prevention of burns. Read and follow Boston Scientific’s dispersive electrode instructions for preparation, placement, surveillance, removal and use of any dispersive electrode. The use of dispersive electrodes that meet or exceed ANSI/AAMI requirements (HF18) is recommended.
CAUTION: Do not use the RFG-1A and RFG-1B Radiofrequency Generator with components, electrodes, and/or RF Cannulae/needles that are not approved by Boston Scientific.
The use of non-Boston Scientific approved components could negatively affect the EMC performance of the system or result in EMC non-compliance.
WARNING: Use a Boston Scientific approved gel-pad dispersive electrode with at least 110 cm² conductive plate area to disperse and return RF current over as large an area as possible, and thus minimize heating effects at that electrode, and to avoid high current densities and resultant burns in adjacent tissue.
NOTICE: The ground pad should be placed in close proximity to the lesion site.
WARNING: Observe the dispersive electrode during lesioning for signs of excessive heating.
WARNING: The long-term risks of creation of RF lesions have not been established.
WARNING: The generator is capable of delivering a significant amount of output. Patient or operator injury can result from improper handling of the active electrode and dispersive electrode, particularly when operating the generator. During energy delivery, the patient should not be allowed to come in contact with metal parts which are earthed or which have an appreciable capacitance to earth. The use of antistatic sheeting is recommended for this purpose. Unshielded leads (active or return) should be positioned so that they cannot come into contact with the patient or other leads connected to the patient and so that they do not run parallel to nearby leads.
WARNING: Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures.
WARNING: Potentially hazardous conditions may exist when accessories of similar connector types are combined. Use only appropriate accessories certified by an accredited test body.
WARNING: Never proceed in a temperature monitored procedure if the generator does not read body temperature before you begin delivering RF energy.
WARNING: Raise the temperature slowly, particularly with large electrodes. Displayed temperature lags behind the actual temperature due to the thermal mass of the electrode.
WARNING: Verify functional safety of the device before each use, using the guidelines detailed in this manual.
WARNING: To avoid unanticipated stimulation to the patient, do not cycle the generator power or turn the generator power on while the patient is connected to the generator.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
NOTICE: Use of an approved ground pad with a stainless steel RF Cannula may provide a galvanic potential (the “battery effect”) resulting in a single stimulation pulse at the time the TC Electrode is placed into an RF Cannula. This should be anticipated, and does not present any risk or danger to the patient.
NOTICE: Always have spare electrodes and cables on hand in case a problem arises with the first one during a procedure.
Reusable cables and accessories should be periodically tested.
NOTICE: Always record the wattage readings that correspond to a given temperature for a given technique. This gives extra guidance and helps Boston Scientific diagnose problems.
NOTICE: Proper electrode placement should be verified using anatomical landmarks, sensory and motor stimulation techniques, fluoroscopic guidance, Impedance reading, and good clinical judgment before RF lesion making procedures are initiated.
Turning On the RFG-1A and RFG-1B
CAUTION: Make sure that the wall outlet voltage matches the voltage displayed on the Voltage Selector located on the rear of unit (100, 120, 220, or 240). If not, open the Fuse drawer, remove the Voltage Selector and rotate it to the proper voltage setting.
NOTICE: No electrodes or cables should be connected to the RFG-1A and RFG-1B.
Lesion Mode
WARNING: Never proceed in a temperature monitoring procedure if the RFG-1A and RFG-1B does not read body temperature before you begin delivering RF energy.
Use of Over Temperature Control in RF Mode
CAUTION: Set the output power setting as low as possible for the intended purpose. In particular, during temperature controlled RF lesioning, slowly increase the RF Output to achieve the target lesion temperature. Use of excessive RF output may cause too rapid temperature rise and overshoot, particularly with small electrodes.
General Guidelines
CAUTION: Never set the output to more than 10v or greater than 60°C as this may cause damage to the Output Test Plug.
Temperature Monitoring
WARNING: When connecting any non-medical peripheral equipment to this device, it must be ensured that the equipment combination meets the requirements of IEC 60601-1.
Sterilization
CAUTION: It is recommended the CB112-TC, the SKG Knob and the RFG-STP Test Pad be sterilized by steam autoclave.
The above parts may be sterilized in a Prevacuum Sterilizer at 132-135°C (270-275°F) for at least 4 minutes.
No other parts may be autoclaved.
Service
WARNING: Electric Shock Hazard
There are no user serviceable parts inside the RFG-1A and RFG-1B. To avoid electric shock, return the device to Boston Scientific for servicing.
Fuse Replacement
WARNING: Risk of fire. Fuse must be replaced as marked.
Adverse Events
Reported adverse events or complications for RF heat lesions procedures include, but are not limited to, the following: Temporary motor deficit, post-operative pain, skin burns. Refer to the instructions for use for electrode kits used with the generator for additional adverse events that have been reported for specific RF applications.
Boston Scientific TCN and CSK Electrode
Indications for Use
The TCN and CSK Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.
Warnings
Use only the ground pads provided by Boston Scientific. Failure to do so may result in patient injury or damage to the product.
For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the RF procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Do not modify this product, as modification could result in a safety hazard.
Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.
Do not use a needle as a dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.
Prior to use, visually inspect the electrode for damage or contamination. If the electrode is damaged please contact Boston Scientific customer support team. If the electrode is contaminated, clean and sterilize per the instructions below. Magnification may be necessary for proper visual inspection.
Users must adhere to universal precautions when handling or using this device to prevent transmission of diseases.
Precautions
Do not use if the electrode is defective or damaged. Discontinue use and contact the Boston Scientific customer support team for further assistance.
Adverse Events
Risks associated with use of TCN and CSK Electrodes for the ablation of peripheral nerve tissue include but are not limited to:
- Allergic reactions
- Unintentional burns
- Bleeding
- Device failure
- Increased pain
- Infection
- Need for additional treatment
- Nerve injury
- Paralysis
- Tissue/visceral injury
- Death
Boston Scientific CC & RFK RF Cannula
Indications for Use
The Boston Scientific CC RF Cannula and RFK RF cannula is indicated for use in RF heat lesion procedures for the relief of pain from peripheral nerve tissue only.
Warnings
For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Skin burns can result from the improper use of Ground Pads, including, but not limited to, the following:
- Use of Ground Pads with a conductive plate area less than 110 cm2.
- Use of expired Ground Pads or Ground Pads with dried gel.
- Ground Pads not placed on a well vascularized, muscular, convex area of patient skin.
- Use on patient with peripheral vascular deficiency.
- Reuse or repositioning of Ground Pad.
- Entire area of the Ground Pad is not reliably attached to the patient body.
- Ground Pad placement over scar tissue, inflamed skin, adipose tissue, bony prominences, metal prostheses, ECG electrodes and cables, pacemakers, and areas where fluid may pool.
- Use of Ground Pad not in accordance with RF Generator Operator’s Manual.
- Use of a needle as dispersive electrode since a needle may cause skin burns at the reference site due to high current densities.
Precautions
Do not use if the Boston Scientific RF Cannula is defective or if its packaging is damaged.
Adverse Events
The following adverse events or complications are possible with this procedure: temporary motor deficit, post-operative pain, skin burns.
Boston Scientific RF Injection Electrodes, Boston Scientific FLEXTRODE Electrode and Cannula, and Boston Scientific RCE – RF Injection Electrode
Indications for Use
The Boston Scientific RF Injection Electrodes, Boston Scientific FLEXTRODE Electrode and Cannula, and Boston Scientific RCE – RF Injection Electrode are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made. The CN is used for percutaneous nerve blocks only.
Warnings
For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.
Do not use Magnetic Resonance Imaging (MRI) while the RCE electrode and/or cannula are in place within the patient.
Precautions
Do not use if the Boston Scientific RF Injection Electrode is defective.
Adverse Events
The following adverse events or complications are possible with this procedure: temporary motor deficit and post-operative pain.
Boston Scientific Disposable LCED Electrode
Indications for Use
The LCED Electrode is indicated for use in radiofrequency (RF) heat lesioning of nervous tissue including the Central Nervous System.
Contraindications
Anticoagulant use or coagulapathy, infection, pregnancy, allergy to local anesthetics, and serious psychological deficits are contraindications for this procedure.
Cordotomy is contraindicated in patients with severe pulmonary dysfunction, patients unable to stay in a supine position for 40 minutes, and patients whose partial oxygen saturation is less than 80%.
Cordotomy is contraindicated for patients with bilateral intractable pain of the chest and arms, because bilateral high cervical cordotomy has a high risk of respiratory complications or death. Bilateral high (C1-C2) cervical cordotomy is contraindicated for all patients.
Warnings
For patients with cardiac pacemakers, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF Generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.
CAUTION: When using the generator near or in anatomy of the Central Nervous System (e.g. Trigeminal ganglion, spinal cord, brain stem, brain), it is recommended that only one electrode be energized at a time (i.e. Electrode Setup: RF Type=Standard & Active Electrodes=1, see Section 5.1 in the G4 Operator’s Manual) and that the Output Control Knob be used for manual control of the output level (i.e. Auto Ramp=Off, see Sections 6.1, 7.1, 8.1 in the G4 Operator’s Manual). The physician should pay close attention to generator readings and patient response at all times.
Precautions
Reuse of the Boston Scientific LCED Electrode may result in device malfunction and or exposure of patient to a non-sterile device.
Do not use if the Boston Scientific RF Electrode is defective, or if the package is damaged.
Avoid lesion temperatures above 90oC to avoid focal boiling at the tip.
Adverse Events
The following adverse events or complications are possible with this procedure: temporary motor dysfunction, ataxia, hypotension, temporary bladder retention, bladder retention, permanent dysesthesia, Horner’s syndrome, motor weakness in arm, motor weakness in leg, respiratory failure, and/or death.
Boston Scientific Stereotactic TCD Electrodes
Indications for Use
The Boston Scientific Disposable Stereotactic TC Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System.
Warnings
For patients with cardiac pacemakers, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
If any physiological monitoring of electrical apparatus is to be used on the patient in addition to the RF Generator, the safety aspects of the combination should be examined and approved by biomedical personnel.
If the patient has a spinal cord stimulator, contact the manufacturer of the stimulator to determine whether the stimulator needs to be in the bipolar stimulation mode and in the OFF position. If the spinal source is grounded, the RF current may go through the spinal cord stimulator and cause excessive damage and heating of the spinal cord.
Do not modify Boston Scientific equipment. Any modifications may compromise the safety and efficacy of the device.
Do not use with components not manufactured by Boston Scientific. Use of non-Boston Scientific products can result in procedure complications, and potentially serious injury.
Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.
Discontinue use if erratic or sluggish temperature readings are observed, which may indicate a faulty cable connection, broken temperature sensor of the electrode, or loss of RF power into an undesired location.
DO NOT USE A NEEDLE AS A DISPERSIVE ELECTRODE. A needle may cause skin burns at the reference site due to high current densities. Care should be taken to maximize the surface area of the dispersive electrode. The dispersive electrode should be reliably attached with its entire surface area against the patient’s body.
CAUTION: When using the generator near or in anatomy of the Central Nervous System (e.g. Trigeminal ganglion, spinal cord, brain stem, brain), it is recommended that only one electrode be energized at a time (i.e. Electrode Setup: RF Type=Standard & Active Electrodes=1, see Section 5.1 in the G4 Operator’s Manual) and that the Output Control Knob be used for manual control of the output level (i.e. Auto Ramp=Off, see Sections 6.1, 7.1, 8.1 in the G4 Operator’s Manual). The physician should pay close attention to generator readings and patient response at all times.
Precautions
Recording RF voltage, current, power, and tip temperature is recommended for each procedure since it gives the physician a
measure of parameter normalcy for a given procedure and electrode size. Any anomalously high voltage and currents would be
apparent and signal possible problems.
Prior to each procedure, check cable, electrode tip, and electrode insulation for damage.
Adverse Events
The following adverse events or complications are possible with this procedure: hemianesthesia, limb dystonia, worsening
dysarthria, dysphasia, cerebral infarction, intracerebral hematoma, oculomotor palsy, hemiballismus, persistent hemiparesis,
persistent gait disturbance, persistent numbness, seizure, transient monoparesis or facial palsy, homonymous hemianopsia,
worsening of balance, worsening of depression, acute confusion, personality change, cognitive disorder, worsening of dementia,
weight gain, and/or death.
Indications for Use
The TC Electrode is indicated for use in radiofrequency (RF) heat lesioning of non-central nervous system nerve tissue.
Warnings
For patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.
Precautions
Do not use if the Boston Scientific RF Electrode is defective.
Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.
Adverse Events
The following adverse events or complications are possible with this procedure: hemianesthesia, limb dystonia, worsening dysarthria, dysphasia, cerebral infarction, intracerebral hematoma, oculomotor palsy, hemiballismus, persistent hemiparesis, persistent gait disturbance, persistent numbness, seizure, transient monoparesis or facial palsy, homonymous hemianopsia, worsening of balance, worsening of depression, acute confusion, personality change, cognitive disorder, worsening of dementia, weight gain, and/or death.
Indications for Use
The TEW kit and TIC kit is indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.
Warnings
For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.
Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.
Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.
Precautions
Do not use if the RF Electrode is defective.
Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.
Adverse Events
The following adverse events or complications are possible with this procedure: masseter weakness, paresthesias, diplopia, keratitis, corneal reflex impairment, and vasomotor rhinorrhea.
Indications for Use
See the instructions for use (IFU) of the NeuroTherm Simplicity III device and the Operator's Manual of the G4 radiofrequency generator.
Warnings
The CB130-TC should only be used with the G4 radiofrequency generator and the Simplicity III device with Neurotherm catalog number RFDE-SI.
Since there is a potential hazard of nerve injury during any RF procedure, only physicians well trained in pain management procedures should perform an RF procedure.
Insertion of an RF electrode into tissue entails some risk of hemorrhage.
When RF output is delivered to the Simplicity III, tissue around all three electrodes can be heated to destructive levels. Only deliver RF to the Simplicity III if all three of its electrodes have been positioned within the patient's body, are displaying body temperature, are remote of the patient's skin to prevent skin burn, and are at anatomical positions that are appropriate for RF heat lesioning as determined by the physician's medical judgment. See the manufacturer's instructions for use for the Simplicity III probe for complete information.
Before lesioning, check that generator readings and outputs match each of the three electrodes and corresponding temperature sensors on the shaft of the Simplicity III device. Discontinue use if correspondence between generator readings and electrodes is erroneous or cannot be determined.
Before lesioning, ensure impedances are in the expected range and that all the thermocouples reads body temperature.
Discontinue use if erratic or sluggish temperature readings are observed. This may indicate a faulty cable connection, broken temperature sensor of the electrode, or delivery of RF power into an undesired location.
For patients with cardiac pacemakers, contact the pacemaker company to determine hazards and cautions associated with use of the RF lesioning.
If the patient has a SCS stimulator, DBS stimulator, VNS stimulator, or any other implanted stimulator, contact the manufacturer of the stimulator before proceeding with RF treatment.
If any physiological monitoring of electrical apparatus is to be used on the patient in addition to the RF lesion generator, the safety aspects of the combination should be examined and approved by biomedical personnel.
Recording RF voltage, current, power, impedance and electrode temperature is recommended for each procedure to give the physician a baseline for a given procedure and electrode size.
Adverse Events
Complications associated with radiofrequency lesioning are similar to those indicated with medication and anesthetic methods utilized in other surgical procedures including nerve blocks. For complete information, read the instructions for use of the NeuroTherm Simplicity III device and the Operator's Manual of the G4 RF generator.