Pre-gelled electrosurgical plates BLAYCO
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TECHNICAL DATA SHEET TELIC GROUP Pre-gelled electrosurgical plates BLAYCO > Product description Electrosurgical plates are used as closing element in the circuit constituted together with the active electrode and the electrosurgical unit in electrosurgical interventions. The electrode provides a large contact surface with the patient, compared with the active electrode, that allows reducing the current flow density and minimize the risk of Product charasteristics « This product does not contain natural latex, phthalates or compounds of animal or biologic origin. « This product is in compliance with RoHS standard. « Dual plates are compatible with electrosurgical generators provided with REM monitoring. Weight limitations for the patient established according to plate model are the following: - Adult « See annex of the present specification for further details about cables and their compatibilities. Compatible models for high energies up to 1100mA: 2125 Models compatible with conventional procedure: 2225, 2425, 2500, 2510, 2600, 2700, 2900 Materials « Backing material: Waterproof flexible white PE foam, closed cell, with biocompatible acrylic adhesive. + Conductive area: Aluminium / PET film with acrylic based hydrogel, biocompatible. This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 1-5

TECHNICAL DATA SHEET « Release liner: PET. » Cable (references —C/XX y —C/XX/5): - Staples: Plated brass. - Wire: Copper (10 x 0.14mm) coated with non-toxic PVC. - Inner terminal: Nickel-plated brass. - Plug: Non-toxic PVC. - Pin (cable 4212): Polycarbonate. « Pouch: PET / aluminium / PE film. « Service Box: Carton. Main dimensional properties Contact area: Conductive surface unipolar plate (em?) Conductive surface dual plate (em?) Adult Adult oblong « Hydrogel thickness: 0,69mm gel + aluminium support « Cable length: - REF-C/XX: eo Plug: See drawing in annex. Electrical properties...

TECHNICAL DATA SHEET . Electrical features of the cable: - High frequency leakage current (IEC 60601-2-2, cl. 201.8.8.3.102): OK. - High frequency dielectric strength (IEC 60601-2-2, cl. 201.8.8.3.103): OK. - Mains frequency dielectric strength (IEC 60601-2-2, cl. 201.8.8.3.104): OK. - Conclusion: Requirements established by electrical safety standards EN IEC 60601-2-2:2018 and ANSI/ AAMI Electromagnetic compatibility: The product is classified as group 1, class A product according to EN 55011/CISPR 11. This means that this product does not generate and/or use intentionally radio-frequency...

TECHNICAL DATA SHEET TELIC GROUP Instructions for use « Do not open the envelope until the plate is ready to be used, to avoid the gel drying out. o Select a well vascularised area near the incision. « Do not place on bony protrusions, metallic prosthesis, tattoos or scars. « Avoid if possible the areas with a lot of fat under the skin. « Shave if necessary. ¢ Clean and dry the application area. « In the case of the elderly, smooth out the skin beforehand. « Apply the adhesive face of the plate smoothing and pressing lightly. « Once the intervention is finished, remove the plate gently....

TECHNICAL DATA SHEET Plate with cable ERBE type connector VALLEYLAB type connector VALLEYLAB type connector AMICA type connector This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 5-5