The PLA-600 Plasma Surgery System is a tabletop electrosurgical unit designed for urology surgeries, including BPH (Benign Prostatic Hyperplasia) procedures. It utilizes plasma energy for tissue disintegration through molecular dissociation, offering a lower temperature operation compared to conventional electrosurgical systems, which results in less collateral tissue damage. The system supports both bipolar and multi-polar functions.
Function Description:
The core function of the PLA-600 is to generate plasma energy, which is delivered to the target treatment area via a treatment handle and specialized probes. The system operates by transmitting energy to an electric conduction liquid (e.g., normal saline) near or on the surface of target tissues. This liquid forms a thin layer between the working electrode and the circuit electrode. When sufficient energy is applied, the liquid transforms into a steam layer (plasma) containing charged particles. These high-energy charged particles then contact the target tissues, causing molecular dissociation and tissue disintegration. The unit can also generate resistance heat at tissues when a stronger heat effect is required, such as for coagulation of blood vessels.
The system's internal control center, managed by a CPU, accurately controls the output based on preset power values. Signals are generated in a vibration unit and then output through an isolated control side and power amplifier. A detection circuit continuously monitors the output and provides feedback to the CPU, allowing for precise power regulation. The impedance of the treatment area is monitored in real-time to assess the "treatment degree." The display shows real-time treatment time, impedance changes, and power output values. Operators can preset power output, warning thresholds, and impedance values, and switch between working models.
Important Technical Specifications:
Treatment Handle:
- Length: 2.0m
- Cleanness way: Anhydrous ethanol
Host Device:
- Power Input: 700VA
- Voltage: 198-242VAC 50Hz / 110 VAC60Hz
- Frequency: 50Hz or 60Hz
- Fuse Type: F5A L250VAC
- Largest Weight: 10KG
- Height: 19CM
- Width: 39CM
- Length: 45CM
Power Output:
- General Frequency: 100KHz
- Voltage Range: 0-295V
- Highest Output Power: 380W
- Working temperature: 10-40°C
- Cable length: 4.5m
- Cleanness way: Anhydrous ethanol
System Classifications and Security Statement:
- Class I Type BF as per shock proof classification
- Class I device as per counter-shock protection type
- Type BF as per counter-shock protection degree
- Footswitch meets water-proof structure requirement of Term 44.6 of GB9706.4-2009.
- Operation model: Continuous operation in intermittent loading.
- Leakage electricity (Grounding): ≤200μA
- Leakage electricity (Patients): ≤20μA
- The unit cannot be used in flammable anesthetic environments.
Usage Features:
General Configuration:
The system includes:
- One tabletop generator device.
- One reusable and non-sterile power supply cable.
- One reusable and non-sterile footswitch.
- One reusable and non-sterile treatment handle (foot-controlled).
- Treatment probes (bipolar and multi-polar types available).
Clinical Indication:
- Urology Surgeries, BPH etc.
Contraindications:
- Patients with cardiac, renal, and brain insufficiency, severe anemia, or bleeding tendency.
- Patients using physiological monitors.
- Patients with combined acute infection.
- Patients with cruor dysfunction, severe infection, or malignant diseases.
- Patients using heart pacemakers or pacemaker electrodes (cannot be treated by this device or be near it when it works).
- Patients embedded with metallic implants.
- Patients with acute infection (unless treated with anti-inflammatory and infection control first).
- Patients during gestation.
System Operations:
- Footswitch: Activates host device functions. The yellow switch activates ABLATION mode, and the blue switch activates PLACOAG mode.
- Gear Position (Power Output Value) Adjustment: Output voltage levels can be increased or decreased by pressing corresponding keys. Each press changes the output by one level, ranging from 1 to 10. After reaching 10, it cycles back to 1, and vice versa.
- Voltage Output Display: ABLATION and PLACOAG voltage output values are displayed in single numbers on the front control panel.
- System Preparations: Involves careful unpacking, proper installation, and checkout procedures. The treatment handle must be cleaned and disinfected, and the connection dry before use. Probes are plugged into the disinfected handle. Power values are preset using arrow marks under the display screen.
- Demonstration: Pressing the ABLATION foot pedal and placing the probe into normal saline should generate an orange light, indicating plasma effect.
System Shut Down:
- Press the power supply switch to "O" and wait for all lights to turn off (below 5 seconds).
- Remove the probe from the treatment handle and unplug the handle from the host device.
- Dispose of single-use probes and disinfect the handle for future use.
Maintenance Features:
Attention and Safety:
- The unit is approved according to GB9706.1-2007 and GB9706.4-2009 medical device regulations, ensuring protection from harmful influence during installation.
- If harmful influence on surrounding devices occurs (due to plasma energy generation), it can be corrected by changing the unit's place, increasing distance from influenced devices, or connecting to a different electrical outlet.
- All enclosed documents and instructions must be read and understood before use.
- Power must be turned off and cables unplugged before maintenance.
- Only authorized and qualified persons may open the machine for repair.
- Only qualified persons can operate this unit.
- Manual contents and product specifications are subject to change without notice.
Transportation and Storage:
- Transportation: Can be transported by automobile, train, ship, or air. Must be well-packed to prevent shaking, crashing, or falling. Outer packaging should indicate "Upwards," "Handle with Care," and "Weather Proof."
- Storage: Store in a well-ventilated room free of corrosive gas, at least 30cm above ground and away from walls. Stack limit is 6 cases. Thorough cleaning and proper packing are required for long-term storage. The unit should be powered up annually to prevent moisture, mildew, or damage.
- Suitable Storage Conditions:
- Temperature: -40°C ~ +55°C
- Relative humidity: ≤90%
- Atmospheric pressure: 50kPa ~ 106kPa
Regulations on Scraped Equipment:
- The device contains integrated circuits and must be treated according to local government regulations and policies for scraped electronic devices.
- Accessories like probes and handpieces should be handled by professional callback organizations for medical castoffs.
Identification of Working and Warning:
- Working: Indicated by a discontinuous single sound (one time per second) and an illuminated working light, signifying active treatment function with output.
- Warning: Indicated by a glittering warning light, signifying detected impedance is too high.
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