MDR Marked Temperature-controlled 1-channel RF Lesion Generator for Neurosurgery
The Golead RFE2-A RF Lesion Generator is a professional radiofrequency lesion generator designed for interventional pain management, neurosurgical procedures, and selected orthopedic pain applications. With impedance monitoring, sensory stimulation, motor stimulation, thermal radiofrequency and pulsed radiofrequency modes, the RFE2-A provides an integrated platform for controlled RF procedures and procedural monitoring.
Professional RF Lesion Generator
Radiofrequency lesion procedures require controlled energy delivery, accurate temperature management and reliable procedural monitoring. The Golead RFE2-A combines RF energy delivery and monitoring functions in one compact clinical system.
- Impedance Monitoring
- Sensory Stimulation
- Motor Stimulation
- Thermal Radiofrequency
- Pulsed Radiofrequency
- Automatic intelligent control
- TFT touchscreen operation
This integrated design allows healthcare professionals to manage key RF procedure parameters from a single user interface.
Key Features
1. Impedance Monitoring
Real-time impedance monitoring provides information about the electrical characteristics of the electrode-tissue circuit during an RF procedure. This function can help clinicians monitor changes in the treatment environment and evaluate electrode-tissue conditions during RF energy delivery.
2. Sensory Stimulation
Sensory stimulation can be used as part of the electrode positioning and procedural assessment workflow before RF lesion creation.
3. Motor Stimulation
Motor stimulation provides an additional procedural assessment function when RF treatment is performed near neural structures.
4. Thermal RF
Thermal radiofrequency delivers controlled RF energy for thermal lesion creation according to the selected treatment parameters and clinical protocol.
5. Pulsed RF
The RFE2-A also supports pulsed radiofrequency applications, providing an alternative RF treatment mode for selected pain-management procedures.
6. TFT Touchscreen
The integrated TFT liquid crystal touchscreen provides a clear interface for viewing and controlling treatment parameters. Key information can be displayed directly on the screen during the procedure.
7. Automatic Intelligent Control
The automatic control system is designed to simplify operation and provide stable management of the RF treatment process.
Working Principle
An RF lesion generator delivers radiofrequency energy through a compatible RF electrode or cannula to the target tissue. During an RF procedure, the generator manages and monitors important treatment parameters such as:
- RF energy delivery
- Tissue impedance
- Electrode temperature
- Treatment duration
- Sensory stimulation
- Motor stimulation
The physician selects the appropriate RF mode and treatment parameters according to the target anatomy, electrode system and applicable clinical protocol.
Thermal RF vs. Pulsed RF
| Feature |
Thermal RF |
Pulsed RF |
| Energy delivery |
Controlled RF energy delivery |
Pulsed RF energy delivery |
| Primary parameter |
Temperature / treatment time |
Pulse parameters / voltage / temperature |
| Tissue effect |
Thermal lesion formation |
Pulsed RF treatment approach |
| Typical use |
Selected RF lesion procedures |
Selected pain-management procedures |
| Clinical decision |
Physician and procedure dependent |
Physician and procedure dependent |
The appropriate RF mode should always be selected according to the applicable clinical indication, target anatomy, electrode system and physician protocol.
Clinical Applications
Interventional Pain Management
The Golead RFE2-A is designed for professional RF procedures used in interventional pain management. Potential applications may include selected procedures involving:
- Peripheral nerve pain
- Spinal pain
- Facet-related pain
- Chronic pain management
- Radiofrequency denervation procedures
Neurosurgery
The system can support selected neurosurgical RF lesioning and stimulation workflows where radiofrequency energy is clinically indicated.
Orthopedic & Spine Pain Procedures
The RFE2-A may be incorporated into selected minimally invasive spine and orthopedic pain procedures using compatible RF electrodes and cannula systems. Clinical use should follow the applicable device indications, local regulations and physician protocols.
Designed for Controlled RF Procedures
The RFE2-A combines several important functions in a single RF lesion generator:
RF Energy Delivery
Controlled radiofrequency treatment according to selected parameters.
Impedance Monitoring
Continuous procedural information from the electrode-tissue circuit.
Sensory & Motor Stimulation
Support for procedural electrode positioning and assessment.
Temperature Monitoring
Temperature-related information for thermal RF procedures.
Touchscreen Control
Centralized visualization and operation of treatment parameters.
Technical Specifications
| Specification |
RFE2-A |
| Brand |
Golead |
| Model |
RFE2-A |
| Product Type |
RF Lesion Generator |
| Channels |
1 |
| Display |
TFT Liquid Crystal Touchscreen |
| Working Modes |
Impedance Monitoring | Sensory Stimulation | Motor Stimulation | Thermal Radiofrequency | Pulsed Radiofrequency |
| Control System |
Automatic Intelligent Control |
| Power Supply |
110-230 V |
| Weight |
8.5 kg |
| Working Temperature |
Up to 95°C* |
| Certification |
MDR CE / ISO 13485 |
| Packaging |
Carton Box |
| MOQ |
1 Unit |
| Delivery Time |
Approx. 2 Weeks* |
*Please confirm the final technical configuration and applicable specifications with Golead before purchase.
RF Electrode & Cannula Compatibility
The RFE2-A is designed for use with compatible RF electrodes and cannula systems. Because connector configurations and electrical characteristics can vary between electrode manufacturers and models, Golead can verify compatibility based on the exact electrode or cannula model before purchase.
Please provide:
- Electrode manufacturer
- Electrode model
- Connector type
- Active tip specification
- Intended RF procedure
Our technical team can then confirm the appropriate configuration.
Regulatory & Quality Assurance
MDR CE
The RFE2-A is offered as an MDR CE-marked RF lesion generator for international medical device markets. Regulatory documentation can be provided to qualified customers and distributors according to the applicable market requirements.
Available documentation may include:
- EU Declaration of Conformity
- CE/MDR documentation
- Product technical specifications
- Instructions for Use
- Applicable test documentation
- Risk-management documentation
- Quality-management documentation
ISO 13485 Quality Management
Golead operates under an ISO 13485 quality management system, supporting controlled medical device development, manufacturing and quality assurance processes.
Quality Control
Each Golead RF lesion generator undergoes quality-control procedures covering key manufacturing and functional requirements.
Quality processes include:
- Electrical performance verification
- RF output testing
- Functional testing
- Display and control testing
- Safety verification
- Final inspection
- Packaging inspection
Golead's quality-management approach is designed to support reliable production and international medical device distribution.
Why Choose Golead RFE2-A?
Integrated RF Platform
Impedance monitoring, stimulation and RF treatment functions are integrated into one system.
Multiple RF Treatment Modes
Thermal RF and pulsed RF provide flexibility for different clinical protocols.
Professional Pain Management Solution
Designed specifically around RF lesioning and interventional pain-management workflows.
Easy Touchscreen Operation
The TFT touchscreen provides centralized visualization and control.
Compact Clinical Design
At approximately 8.5 kg, the system provides a practical solution for hospitals, pain clinics and specialist departments.
International Medical Device Manufacturer
Golead Medical Group Co., Ltd. is a professional medical device manufacturer with product lines covering ultrasound systems, RF lesion generators, RF plasma surgical systems and other minimally invasive medical technologies. Golead provides manufacturing, technical support and OEM/ODM services for international healthcare companies and distributors.
Golead Medical Group
Established in 2010, Golead Medical Group specializes in the research, development, manufacturing and global distribution of medical devices.
The company's product portfolio includes:
- Handheld and portable ultrasound systems
- Veterinary ultrasound systems
- RF lesion generators
- RF plasma surgery systems
- Surgical power systems
- Minimally invasive surgical solutions
- Medical imaging and point-of-care technologies
Golead serves international healthcare markets through its R&D, sales, technical support and after-sales service capabilities.
Manufacturer: Golead Medical Group Co., Ltd.
Brand: Golead
Business Type: Medical Device Manufacturer / Distributor
OEM/ODM: Available
Target Markets
The Golead RFE2-A is suitable for:
- Hospitals
- Pain management centers
- Neurosurgery departments
- Spine centers
- Orthopedic departments
- Interventional pain specialists
- Medical device distributors
- Healthcare equipment importers
- OEM/ODM partners
For distributors, Golead can provide product documentation, technical specifications, training support and registration-related documentation according to the target market requirements.
Frequently Asked Questions
What is the Golead RFE2-A?
The RFE2-A is a 1-channel RF lesion generator designed for professional radiofrequency procedures in pain management, neurosurgery and selected orthopedic applications.
What RF modes does the RFE2-A support?
The system supports thermal radiofrequency and pulsed radiofrequency, together with impedance monitoring, sensory stimulation and motor stimulation.
Does the RFE2-A have impedance monitoring?
Yes. Impedance monitoring is one of the core working modes of the RFE2-A.
Does the system support sensory and motor stimulation?
Yes. The RFE2-A integrates both sensory stimulation and motor stimulation functions.
What is the difference between thermal RF and pulsed RF?
Thermal RF uses controlled RF energy to produce a thermal lesion, while pulsed RF delivers RF energy in pulses and is used for selected pain-management treatment approaches.
Is the RFE2-A suitable for pain management?
Yes. The RFE2-A is specifically positioned as an RF lesion generator for professional interventional pain-management procedures.
Is the RFE2-A suitable for neurosurgery?
The system can support selected neurosurgical RF lesioning and stimulation procedures where the device and compatible electrode system are indicated for use.
What electrodes can be used with the RFE2-A?
The generator should be used with compatible RF electrodes and cannulas. Golead can verify compatibility based on the exact electrode model and connector specification.
Is the Golead RFE2-A CE/MDR certified?
The RFE2-A is offered with MDR CE certification. Regulatory documentation can be provided for qualified customers and distributors.
Is Golead ISO 13485 certified?
Golead operates under an ISO 13485 quality management system for medical device manufacturing and quality management.
Can Golead provide OEM/ODM services?
Yes. Golead provides OEM/ODM support for qualified international distributors, healthcare companies and medical device partners.
Can Golead provide registration documents?
Yes. Golead can provide applicable product and regulatory documentation required for distributor evaluation and medical device registration, subject to the requirements of the destination market.
