Bipolar electrosurgical plate with gel for children, without cable

The electrosurgical plate is used in the field of surgery when tissues need to be sectioned with electrosurgical units. Its design allows it to be used as a return electrode, which significantly reduces the electric current flow produced by the equipment and properly closes the circuit. This way, accidents during the intervention, such as discharges or burns derived from electricity, are avoided.

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

General Features
- Part of the neck protected with insulation to prevent leaks
- Free of biological components, latex, and phthalates
- Compatible with conventional electrosurgery interventions
- Distributed without connection cable to electrosurgical unit
- Manufactured according to RoHS and ISO 13485 specifications
- Classified as a group 1, class A product, according to EN 55011/CISPR 11 standard
- Complies with EN IEC 60601-2-2:2018 and ANSI/AAMI HF-18 electrical safety standards
- Listed as a Class IIb medical device according to (EU) regulation 2017/745

Technical Specifications
- Model: bipolar
- Compatibility: pediatric patients
- Weight limit: 5 - 15 kg
- Width: 105 mm
- Height/length: 150 mm
- Total: 145 cm2
- Conductive surface: 73 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