12
160-104694 Rev 01
Version 2.2.0
2.2
Safety Features of the Generator
The Generator incorporates the following safety features to assist the User in delivering a
safe application:
a.
Output Current Restriction
When the Generator senses that the current between the electrodes exceeds
the operating parameters, the pulses are aborted. This safety feature protects
against applying output energy that exceeds maximum current settings.
b.
Double Trigger Foot Pedal
The system incorporates a double trigger foot pedal system that prevents
accidental delivery of procedure pulses. The foot pedals require the User to
first arm the system by depressing the "Arm" foot pedal, and then sequentially,
depressing the "Pulse" foot pedal within 10 seconds of arming to deliver energy
to the patient.
c. Test
Pulse
After electrodes are placed and prior to the procedure, the Generator sends a
low-energy test pulse to the ablation site to confirm the tissue impedance is
within an acceptable range. This prevents initiating a procedure if the probes
are too far apart or too close together.
2.3 Contraindications
Procedures based on high-voltage pulses are not recommended in the following cases:
•
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
•
Recent history of Myocardial Infarction.
2.4 Warnings
2.4.1 Arrhythmia
Risk
•
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
established arrhythmias or structural heart disease. Ensure that interventions
(defibrillator, etc.) and appropriately trained personnel are readily available for
dealing with cardiac arrhythmias.
•
Using QRS synchronization devices whose output is not compatible with the
specifications listed in this manual may result in ventricular fibrillation.
Summary of Contents for NanoKnife
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