Monopolar electrosurgical plate with gel for adults, without cable

This electrosurgical plate has been manufactured for use as a return electrode in electrosurgery procedures. Its design allows for the dispersion of current flow produced by the electrosurgical unit, with the intention of minimizing its power and avoiding burns or electric shocks.

To use it, a compatible connection cable must be purchased (Ref. 1208TCC12) (not included and at an additional cost). 

General Features
- Neck part reinforced with an insulating adhesive to prevent current leakage
- Free of latex, phthalates and biological compounds
- Compatible with high energy (up to 1100 mA)
- Supplied without a connection cable to electrosurgical unit
- Manufactured in accordance with RoHS regulations
- Classified as a group 1, class A product, according to EN 55011/CISPR 11 standard
- Complies with electrical safety standards EN IEC 60601-2-2:2018 and ANSI/AAMI HF-18
- Classified as a class IIb medical device according to Regulation (EU) 2017/745
- Produced by a manufacturer certified under ISO 13485 standard

Technical Specifications
- Model: monopolar
- Compatibility: adult patients
- Weight limit: ≥ 15 kg
- Width: 105 mm
- Height/length: 217 mm
- Total: 217 cm2
- Conductive surface: 136 cm2
- Hydrogel thickness: 0.69 mm gel + aluminum
- Expiration: 3 years from the date of manufacture

Materials
- Support material: flexible white PE foam, closed-cell structure (waterproof), with biocompatible acrylic adhesive
- Conductive area: aluminum/PET complex with biocompatible acrylic-based hydrogel
- Protector: PET

Electrical Properties (ANSI/AAMI EC12)
- Temperature increase (IEC 60601-2-2, cl. 201.15.101.5): < 6ºC
- Contact impedance (IEC 60601-2-2, cl. 201.15.101.6): < 50 Ω

Biocompatibility
- ISO 10993-5: non-cytotoxic
- ISO 10993-10: non-sensitizing
- ISO 10993-10: negative intercutaneous irritation test