Bipolar electrosurgical plate with gel for adults, without cable

This electrosurgical pad is used as a tool to close the circuit produced by an electrosurgical unit. To use it, it must be positioned on the patient's skin, making sure that the gel-coated part adheres properly. In this way, the electric current is distributed at all times and the energy produced by the electrosurgical unit is dispersed, thus avoiding burns or shocks derived from the surgery.

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

General Features
- Neck part protected with insulation to prevent current leakage
- Free of biological components, phthalates and latex
- Compatible with conventional electrosurgical interventions
- Distributed without connection cable to electrosurgical unit
- Manufactured in accordance with RoHS and ISO 13485
- Categorized as a group 1 product, class A, 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

Technical Specifications
- Model: bipolar in landscape format
- Compatibility: adult patients
- Weight limit: ≥ 15 kg
- Width: 177 mm
- Height/Length: 125 mm
- Total: 221 cm2
- Conductive surface: 128 cm2
- Hydrogel thickness: 0.69 mm gel + aluminum
- Expiry: 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