Bipolar electrosurgical plate with gel for neonates, without cable

This electrosurgical plate is used to close the circuit generated by the use of an electrosurgical unit. To use it, it must be placed on the patient's skin on the side coated with gel. When used, the electric flow is distributed over the body's surface and the electrosurgical unit loses power, thus avoiding surgery-related damages such as burns or accidental discharges.

To use it, a compatible connection cable (Ref. 1208TCC12) must be purchased separately. 

General Characteristics
- Neck protected with insulation, prevents current leaks
- Contains no biological components, latex, or phthalates
- Suitable for conventional electrosurgery interventions
- Administered without a connection cable to an electrosurgical unit
- Produced in accordance with RoHS and ISO 13485 specifications
- Classified as 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
- Categorized as a class IIb medical device according to regulation (EU) 2017/745

Technical Specifications
- Model: bipolar
- Compatibility: neonate patients
- Weight limit: > 5 kg
- Width: 74 mm
- Height/length: 160 mm
- Total: 83 cm2
- Conductive surface: 31 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): < 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