Material
- Plastic casing: ABS resin plastic
- Activation switches (CUT & COAG): ABS resin plastic
- Socket mold: ABS resin plastic
- Connecting wire: copper with PVC coating
- Banana plugs: Nickel-plated brass
- Probe holder: Bronze
- Blade electrode: 70mm
- Blade: Stainless steel
- Printed circuit board: fiber
- Sterile pouch: Cellulose, medical grade. Film PET/Polyethylene
Main dimensional properties
- Hand length with active electrode: 215 ± 2 mm
- Banana plugs: 3 x Ø4.37 ± 0.05 mm
- Wire length: 270 ± 10cm
- Total electrode length: 70 ±1 mm
- Exposed electrode length: 44 ±1 mm
- Diameter of the electrode: 2.36 ± 0.02 mm
- Electrode insert: hexagonal
Electrical properties
- Electrical requirements according to IEC 60601-2-2 are met
- Electrical requirements according to IEC 60601-1-2 are met
- Electrical requirements according to IEC 60601-1 are met
Biocompatibility
- ISO 10993-5: No cytotoxic
- ISO 10993-10: No sensitizing, negative intracutaneous irritation test
Conclusion: This Product is biocompatible.
Sterilization and expiry date
- Sterility: Ethylene oxide
- Shelf life: 3 years
- Cannot be used if the package is damaged or torn
Storage and maintenance
- Keep protected from direct sunlight and the outside
- Keep in a dry place
- Relative humidity: 0% – 70%
- Temperature limitation: -10ºC to 40ºC
- Single-use product
Packaging
- Cardboard boxes containing 100 units
Regulatory Information
D.G.Dena guarantees that this product is in conformity with Directive 93/42/EEC and that it has been manufactured following the directives of the Quality Assurance System certified as ISO 13485.
This product is classified as:
- Class IIb sterile product according to Annex IX of Directive 93/42/EEC, rule 9.
- GMDN code: 61869. Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- UMDNS code: 11499. Electrodes, Electrosurgical, Active, Hand Controlled.
