Cosman Disposable LCED Electrode

Prescriptive Information

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 Cosman LCED Electrode may result in device malfunction and or exposure of patient to a non-sterile device.

Do not use if the Cosman RF Electrode is defective, or if the package is damaged.

Avoid lesion temperatures above 90?C 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.