Indications for Use
The Cosman Disposable Stereotactic TC Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System.
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 Cosman equipment. Any modifications may compromise the safety and efficacy of the device.
Do not use with components not manufactured by Cosman. Use of non-Cosman 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.
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.
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.