Indications for Use
See the instructions for use (IFU) of the NeuroTherm Simplicity III device and the Operator's Manual of the Cosman G4 radiofrequency generator.
The CB130-TC should only be used with the COSMAN 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.
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 Cosman G4 RF generator.