Important Risk Information
Indications for Use
The NanoKnife System with six outputs is indicated for the surgical ablation of soft tissue. (510(k) Number: K150089)
Ablation procedures using the NanoKnife System are contraindicated in the following cases: ablation of lesions in the thoracic area in the presence of implanted cardiac pacemakers or defibrillators; ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts; ablation of lesions of the eyes, including the eyelids; patient history of Epilepsy or Cardiac Arrhythmia; and recent history of Myocardial Infarction.
Clinical Issues (including Arrhythmia, Hypertension, and Thrombus Risks)
Patients with Q-T intervals greater than 550 ms (milliseconds) are at an increased risk for inappropriate energy delivery and arrhythmia. Verification of proper function of a synchronization device before initiating energy delivery is essential in these patients.
Asynchronous energy delivery (240 PPM (Pulses Per Minute) or 90 PPM modes) might trigger atrial or ventricular fibrillation, especially in patients with structural heart disease. Ensure that proper interventions (e.g. defibrillator) and appropriately trained personnel are readily available for dealing with potential cardiac arrhythmias
Using QRS synchronization devices whose output is not compatible with the specifications listed in this manual may result in arrhythmias including ventricular fibrillation. Adequate precautions should be taken for patients with implantable electrical devices. Note the contraindication in certain patients. There are potential risks associated with the location of the ablation: near the pericardium (tachycardia), or near the vagus nerve (bradycardia).
Additional patients may be at risk with insufficient muscle blockade or anesthetic analgesia (reflex tachycardia and reflex hypertension); patients with abnormal sinus rhythm prior to an ablation (arrhythmia); patients with a history of hypertension (hypertension); or patients with partial portal venous thrombosis, low central venous pressure (CVP), and a prothrombotic condition (venous thrombosis).
Use of Electrodes
Avoid repeated vascular insult during electrode placement. As anticipated with a needle-related procedure, repeated vascular insult due to multiple insertions into a vessel by an electrode during electrode placement may cause thrombus.
Ensure continuous image guidance during the needle placements. Failure to do so can lead to traumatic injury to surrounding structures. Care should be taken during electrode placement in areas that require tissue be separated or retracted to avoid surrounding soft tissue damage.
To avoid risks of infection, always maintain the electrodes’ protective packaging (cap, tubes, etc.) when the electrodes are not placed in the patient. Only electrode probes with intact electrical insulation must be used. Any electrodes with damaged electrical insulation must be discarded immediately and not connected to the NanoKnife LEDC System. To preserve the electrode’s sterility do not remove the electrodes from the packaging until the User is ready to apply the electrode to the patient. Do not use the electrodes after the expiration date printed on their packaging. Observe the electrodes manufacturer’s specific instructions (e.g., printed on the electrodes’ packaging). Only use AngioDynamics electrode probes with the NanoKnife System Generator.
Maintain electrical separation of the electrodes from safety ground by doing the following: Disconnect any electrode from the Generator that is not applied to the patient. Avoid any clamping of the electrode’s cable, unless explicitly instructed or authorized by the electrode’s manufacturer. Do not connect any devices (e.g., measurement) to the electrodes unless they have been supplied by and specifically indicated for such a use by the manufacturer.
Use of Generator
Warning: No modification of this equipment is allowed.
Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
The Generator internally produces voltages that are dangerous and may be fatal. The Generator does not contain parts serviceable by the User, and should not be opened.
Do not use the Generator in the presence of flammable or explosive gas mixtures.
For electrical safety, the Generator needs grounding. Use only medical grade main power supply cords, e.g., those supplied by the manufacturer. Before plugging the Generator to the main, ensure that the main power cords are not damaged. Replace them if any damage is noticed—main cords cannot be repaired. Do not connect or disconnect the Generator from the main power cord with wet hands. Confirm that the main power cord will be connected to a properly grounded electrical outlet.
Whenever necessary, replace Generator fuses only with fuses specified in this manual, see Section 10.3. Maintenance should be carried out only by trained personnel. The Generator must undergo periodic preventative maintenance as specified in the Maintenance and Service see Section 9.
The NanoKnife User Manual is a fundamental part of the Generator and should always accompany it. Users must refer to this manual for correct and complete information on the use of the Generator.
Electrodes that are not parallel to each other may result in an incomplete ablation. Inappropriately positioned electrodes or metal implants in the field may distort the desired ablation field. A distance of at least 65 cm should be maintained between the front panel of the Generator and other medical devices susceptible to RF interference such as, but not limited to pacemakers and implantable cardiac defibrillators. Electrodes are subjected to potentially harmful electric energy. Do not touch the metal part of the electrodes while a procedure is in progress.
The effects of the NanoKnife procedure on a fetus are not known. Procedure on pregnant women should be contemplated only after ensuring that the procedure benefits outweigh the risks.
Procedure safety and efficacy may be affected if electrodes other than those supplied by AngioDynamics or by an authorized distributor are used.
Repeating an ablation on the same site is not advisable, because it is not believed to increase procedure efficacy.
Intra-operative hypertension can be an indication of insufficient anesthesia administration which possibly includes insufficient narcotic administration. Conditions in which muscle stimulation is occurring require immediate pharmacologic correction. All anesthesia administration must be in compliance with ASA (American Society of Anesthesiology) guidelines.
Energy delivery attempts must be terminated after an over-current warning during an ablation in anatomical locations in which there are abutting lumens or other critical structures. Continuous attempts to deliver energy during repeated over-current warnings during ablations such as these, may result in fistula formation, especially in patients who have had prior radiation therapy or surgery in the immediate zone of ablation.
Use of operator-defined parameters increases the risk of ineffective procedures or post-procedure complications, with respect to validated standard procedures.
Avoid short-circuiting the electrodes when delivering pulses. Electrode to electrode contact or electrode to electrode spacing less than 5 mm (millimeters) may result in short circuiting during energy delivery resulting in incomplete ablation.
Ensure the Generator is connected to the proper mains power supply (see Section 10.2) and that the mains power supply outlet is able to supply the required power. Do not use the Generator if a malfunction is suspected. Contact the manufacturer or the local authorized supplier. Avoid intentional or accidental spilling of liquids on the Generator. In particular, do not keep containers of liquids on the Generator. Do not handle the equipment with wet hands.
Store the Generator away from direct sunlight, heat sources, and dust; in particular, do not expose the LCD display to direct sunlight for long periods of time. Respect environmental operating and storing conditions, as specified in Section 10.4. Ensure that nothing obstructs the ventilation grids, which are on the rear panel of the Generator and also under the console, in order to allow the correct ventilation of the internal circuits. Avoid moving the device when powered ON. Avoid jarring the equipment during transport. Avoid scratching the LCD display in order to preserve the image quality.
Before cleaning the device, power it OFF and disconnect the main cord from the Generator. Turn OFF the Generator before connecting external devices. Connect only devices complying with relevant regulations (IEC 60601-1 3rd edition). Do not position ME Equipment in such a way that it is difficult to unplug the device in the event of an emergency. To isolate the ME Equipment from the supply mains unplug the device from the wall socket or power source.
Potential Adverse Effects
Adverse effects that may be associated with the use of the NanoKnife system include, but are not limited to the following: arrhythmia, atrial fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, damage to critical anatomical structure (nerve, vessel, and/or duct), fistula formation, hematoma, hemorrhage, hemothorax, infection, muscle contraction, pneumothorax, reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis.