Bipolar electrosurgical plate with gel for adults, without cable

This electrosurgical plate allows to dissipate the electrical flow produced by the use of an electroscalpel. It is designed to act as a return electrode, it must be adhered to the patient's skin to ensure that the circuit is properly closed and that the electricity generated by the electroscalpel disperses, thus preventing burns or shocks.

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

General Features
- Neck reinforced with insulating adhesive to prevent electrical leaks
- Free of latex, phthalates and biological origin compounds
- Compatible with conventional electrosurgery procedures
- Distributed without electroscalpel connection cable
- Produced in accordance with RoHS standards and ISO 13485 standards
- 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
- Cataloged as a Class IIb medical device according to regulation (EU) 2017/745

Technical Specifications
- Model: bipolar
- Compatibility: adult patients
- Weight limit: ≥ 15 kg
- Width: 105 mm
- Height/length: 217 mm
- Total: 217 cm2
- Conductive surface: 128 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 base hydrogel
- Protector: PET

Electrical Properties (ANSI/AAMI EC12)
- Temperature increase (IEC 60601-2-2, cl. 201.15.101.5): < 6°C
- 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