RFG-1A and RFG-1B Generator

Prescriptive Information

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 Cosman 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.

Cosman 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

Cosman CC & RFK RF Cannula

Indications for Use

The Cosman 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 Cosman 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.