Steep Pulse Ablation System
The steep pulse ablation system transmits non-thermal energy from the steep pulse ablation generator to the target area through the probe. The probe works in bipolar operation mode, and up to six probes can be placed at a fixed distance in soft tissues to create several bipolar probe configurations.
Safety features of steep pulse ablation system
It contains the following safety features, which helps the user provide a safe application:
Limit of output current:
When the generator detects that the current value between the probes exceeds the operating parameter value, the pulse sending will be stopped. Such safety feature can prevent the output current from exceeding the maximum current setting.
Double-trigger foot switch:
The system includes a double-trigger foot switch with a safety lock switch, which can prevent unexpected sending of surgical pulses prior to surgery.
Use of the double-trigger foot switch: Step on the "Release" pedal (yellow pedal on the left) to release the lock, and then step on and hold the "Send" pedal (blue pedal on the right) until the pulses are sent.
Test pulse:
During the impedance test, the generator will send a set of low-voltage test pulses to the ablation area to pre-detect the impedance in the ablation area. This function can prevent electric field abnormalities due to sending of pulses from the probes with large or small spacing, which results in unsatisfactory ablation effect.
Intended Purpose
The intended purpose is for the surgical ablation of soft tissue, not intended specifically for use in direct contact with the heart or central circulatory system or the central nervous system.
Contraindications
The use of the steep pulse ablation system for ablation is prohibited under the following circumstances:
An implanted pacemaker or defibrillator was present in the ablation area.
Electronics and metal parts are implanted near the ablation area.
Patients with history of epilepsy or cardiac arrhythmia.
Patients with a recent myocardial infarction.
Disposable Steep Pulse Probe
The specific use of the disposable sterile steep pulse probe (hereinafter referred to as the probe) is detailed in the instructions for probe.
- The probe should be used within the validity period. The expiration date is marked on the product label.
lTo ensure that the probes are sterile, the probes should only be taken out of the package if they are to be used on the patient.
2. To avoid the risk of infection, the metal needle of the probe shall be placed inside a metal needle protector when the probe is not placed on the patient.
lThe steep pulse ablation system can only be used with probes manufactured by Hangzhou Ruidi Biotechnology Co., Ltd.
To maintain the electrical separation of probes through safe grounding, the following needs to be done:
1.Do not connect any probes when the generator is not applied to the patient.
2.Clamping cables of the probe should be avoided without explicit instructions or authorization from the probe manufacturer.
Do not connect any other devices (such as a measuring device) to the probe unless such device is supplied by the manufacturer or the manufacturer explicitly indicates to do so.
