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.The steep pulse ablation system is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electrical field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability. The steep pulsed electrical field can induce apoptosis, and cause the tumor tissue shrink or even disappear without the involvement of toxic chemotherapy drugs, and at the same time, it can avoid inflammation, ulcer and adverse reactions of drugs, which is of great significance to tumor treatment. In view of tumor growth in complicated interleaving areas and near important organs, or because of the limitations of patients' physical conditions, it is not easy to carry out conventional surgical resection, and steep pulse ablation is a new treatment solution. Its performance has several characteristics: The boundary of ablation area is clear and there is no “gray area”. No matter the location, size and shape of the tumor, the cells in the ablation area can be completely affected by the pulse, and the boundary between the ablation area and the non-ablation area is clear. Other traditional thermodynamic effect ablation will generate a “gray area” with incomplete ablation and no thermal absorption effect. The nanosecond-level pulse does not concentrate joule heating generated by thermal energy, and does not generate thermal effect ablation. Meanwhile, the mechanism of ablation is different from that of thermodynamic effect ablation, and there is no recurrence caused by incomplete ablation of tumors around vessels due to the absorption of hot and cold energy by large vessels. Death mode of tumor cells. The main mechanism of steep pulse ablation is to puncture the nucleus, induce tumor cell apoptosis, remove cell debris by phagocytes and promote normal tissue regeneration and repair.The ablation process can be monitored in real time. Steep pulse ablation requires the placement of probes under the guidance of B-ultrasound or CT. After ablation, B-ultrasound or CT images can be used to show the changes of tumor, and the plan should be adjusted to conduct another ablation immediately.

• 1.0 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.

lDouble-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.

lTest 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.

• 2.0  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.

• 3.0  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.

• 4.0 Warning

 4.1 Risk of arrhythmi

Patients with Q-T intervals greater than 550 ms are at greater risk for improper energy transfer and arrhythmia than normal people. In these patients, it is necessary to adopt the working mode of ECG synchronization, and provide the ECG analog signal or TTL signal to the device through external medical equipment, thus triggering pulses.

Forced pulse sending mode (120PPM mode /240PPM mode) may cause atrial or ventricular fibrillation, especially with a greater risk for patients with structural heart disease. It is necessary to ensure the use of appropriate interventional (defibrillator, etc.) equipment and the presence of trained professionals to deal with arrhythmia that may occur during surgery.

If the output system of the ECG synchronization equipment used does not conform to the specifications listed in the Manual, it may lead to arrhythmia including ventricular fibrillation.

Adequate preventive measures should be taken for patients with implanted medical devices to remind patients of relevant contraindications.

4.2 Use of 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.

To 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.

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.

The 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:

 4.2.1.Do not connect any probes when the generator is not applied to the patient.

   4.2.2 .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.

3.3 Risk of electrical shock

The voltage generated inside the generator is dangerous and even fatal. It is forbidden to disassemble the generator.

The generator is strictly prohibited to be used in the environment containing flammable and explosive gases.

In order to ensure the electrical safety, only the power cable provided by the manufacturer can be used.

Make sure that the main power cable is not damaged before inserting it into the generator. The main power cable, if damaged, cannot be repaired. When any damage to the power cable is found, please contact the manufacturer for replacement in time.

Never connect or disconnect the generator and the main power cable with wet hands.

Make sure the main power cable is connected to an appropriate grounded power outlet.

In order to avoid the risk of electric shock, the device must be connected to the power supply network with protective grounding.

The generator fuse shall only be replaced with the fuse specified in the product manual.

The device requires regular preventive maintenance (see Chapter 9 for details), which should be performed by professionals.

For proper use of the device, the user should read the product manual carefully.

• 5.0 Precautions

The device shall only be operated by trained professionals.

lOperation should be carried out in strict accordance with the product instructions. Repeated ablation, overvoltage or excessive pulses can not improve the surgical efficacy, but will increase risks and complications.

To avoid incomplete ablation, the probes should be parallel to each other.

Improper insertion of probes or the presence of metal implants may result in deviations from the intended ablation area.

The probe may contain potentially harmful electrical energy. Do not touch the metal part of the probe during use.

In order to ensure the normal operation of the device, only the accessories provided by the manufacturer can be used.

Appropriate spacing should be kept between probes. If the spacing between probes is less than 1 cm, short circuit may occur during energy delivery, thus resulting in incomplete ablation; Due to individual differences, it is also possible to fail to pass the "impedance test” when the spacing between probes is kept at or above 1 cm. Click "End" to stop the "Impedance test" and adjust the spacing between probes.

Make sure that the device is connected to the input power supply specified in the product instructions.

If the device is suspected of a fault, stop using the device immediately and contact the manufacturer.

Avoid spilling liquid on the device intentionally or unintentionally. Pay special attention not to put the container filled with liquid on the device. Do not operate the device with wet hands.

Keep the device away from direct sunlight, heat sources and dust.

The operation, storage and transportation shall conform to the environmental conditions specified in Sections 1.6 and 10.2. Make sure that the ventilation grid at the rear and base of the device is not blocked, so as to ensure smooth internal ventilation.

Avoid severe vibration of the device during transportation. Avoid moving the device once it is connected to the power supply.

Before cleaning and maintaining the device or connecting to external equipment, turn off the device and disconnect the power cable.

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user or patient is established.

• 6.0 Potential adverse reactions

Potential adverse reactions include but not limited to:

Cardiac arrhythmia

Pneumothorax

Muscle contraction

Hemorrhage

Accidental mechanical perforation

Infection

Bradycardia

Vagal nerve stimulation, cardiac arrest

6.1 Assessment of potential adverse reactions

The design and development of the steep pulse ablation system is carried out under the risk management and the design and development control procedures. Pre-clinical large animal trials are carried out to verify the efficacy and safety of the device. Hazards related to the use of the device are indicated in the product instructions.

• 7.0 Operation of device

The steep pulse ablation system must emit electromagnetic energy in order to perform its intended function. In such case, nearby electronics may be affected.

7.1. It is strictly forbidden to use the device to perform surgery on patients with pacemakers or metal implants. The high-frequency signal generated during use of the device will result in heart fibrillation, damage to pacemaker or an electric shock, which will lead to serious injury and even death of the patient.

7.2. Do not entangle the probe and its cable with the cable of other devices, such as high-frequency electrosurgical unit, electrocardiogram and endoscopic system, which may lead to abnormal functions of other devices, thus resulting in adverse effects on patients.