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General | Device Type | Single-use, sterile electrosurgical accessory. |
Intended Use | For delivery of high-frequency electrical energy from a compatible electrosurgical generator to tissue for cutting, coagulation, fulguration, and ablation. | |
Material & Construction | Electrode Active Material | 304 Stainless Steel(Good conductivity, strength, corrosion resistance for electrosurgical use). |
Insulation Material (if applicable) | PTFE (Polytetrafluoroethylene/Teflon™), FEP, PEEK, Ceramic. | |
Handle/Connector Material | Medical-grade plastics (Polycarbonate, ABS). | |
Electrode Knife Specifics | Tip Designs | Blade Shapes:Needle point, extended blade, hook, loop, ball, spatula. Function:Cutting, Coagulation, Blended. |
Dimensions | Shaft Length:150mm, 200mm, 250mm, etc. Tip Size/Width:Customizable. | |
Ablation Electrode Needle Specifics | Tip Designs | Single Needle:Straight, J-tip, T-shaped. Multi-tine/Expandable:Deployable times for larger ablation volume. Cooled Tip:Internal cooling to prevent charring. |
Dimensions | Shaft Diameter (Gauge):14G (2.1mm) to 22G (0.7mm) common. Active Tip Length:10mm, 20mm, 30mm, etc. Overall Length:100mm - 300mm. | |
Electrical & Performance | Generator Compatibility | Must be specified. Compatible with major brands (Valleylab, Erbe, Bovie, etc.) and modes (Cut, Coag, Blend). |
Operating Frequency | Typically works with standard electrosurgical generators (e.g., ~350 kHz - 500 kHz for RF). | |
Power Rating (Typical Use) | Varies by design and procedure. Generally suitable for power outputs up to 100W - 300W. | |
Thermal Feedback (Ablation Needles) | Option 1:Impedance monitoring. Option 2:Thermocouple integrated at tip for temperature control. | |
Ablation Performance (for Needles) | Ablation Zone Size | Dependent on power, time, tissue, and needle design (e.g., single needle: ~2cm sphere; multi-tine: >3cm sphere). |
Safety & Insulation | Insulation Rating | Insulated sections rated for high voltage to prevent stray current and patient/staff burns. |
Sterility & Packaging | Sterilization Method | Ethylene Oxide (EtO)orGamma Irradiation. |
Sterility Assurance Level (SAL) | 10 | |
Packaging | Individual sterile pouch or blister pack. May include protective tip cover. | |
Safety Standards | Electrical Safety | Compliant withIEC 60601-2-2(Particular standard for high frequency surgical equipment). |
Biocompatibility | Compliant withISO 10993-1(Biological evaluation of medical devices). | |
Quality System | Manufactured underISO 13485. | |
Usability | Connector Type | Standardized pin connector specific to the generator brand/model. |
Handle | Ergonomic, color-coded, often with finger guards. May have activation buttons (for pencils). | |
Customization | Custom Lengths/Tips | Available. |
Procedure Kits | Often part of a procedure-specific kit with cables, dispersive electrodes, etc. | |



