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Defibrillation electrodes paediatrics

Defibrillation electrodes paediatrics

Product catalog summary

Product Description: The DESFI-DORMO is a set of two defibrillation electrodes designed for infant-child use, compatible with Automatic External Defibrillators (AED). They are available with pre-attached disposable cables or standard stud connections for reusable cables.

Technical Specifications: The electrodes are latex-free, phthalate-free, and do not contain animal or biological compounds. They comply with the RoHS standard and can remain in contact with the patient's skin for up to 24 hours. They can withstand up to 15 consecutive defibrillation loads at 360 J and are intended for pediatric patients weighing up to 10 kg. Detailed connector compatibility is provided in Annex I.

Product Characteristics: The electrodes are made with waterproof flexible white PE foam and biocompatible acrylic adhesive. The conductive area consists of tin foil with conductive acrylic-based hydrogel. The protective liner is PET, and the connection components include copper cables with non-toxic PVC coating and various plastic materials for plugs and sockets.

Physical and Dimensional Properties: Each pad has an active area of 25 cm², with electrode pad measurements of 105 mm x 110 mm. Cable length varies by reference, with a minimum of 1.2 m.

Electrical Properties: The electrodes meet IEC 60601-2-4 electrical safety standards, with specific impedance and recovery values detailed in the document. They do not allow CPR quality monitoring.

Biocompatibility: The product is biocompatible, meeting ISO 10993-5 and ISO 10993-10 standards, indicating no cytotoxicity, sensitization, or intracutaneous irritation.

Sterilization and Expiry Date: The product is non-sterile with a shelf life of two years from the manufacturing date. It should be stored in a dry place, protected from sunlight, at temperatures between 5-35ºC.

Instructions for Use: The document provides detailed instructions for cleaning the application site, applying the electrodes, and connecting them to the defibrillator. It emphasizes avoiding alcohol or disinfectants on the application site.

Regulatory Information: The product complies with Directive 93/42/EEC on medical devices and is manufactured under ISO 13485 certified Quality Assurance System. It is classified as a Class I medical device.

Packaging: The primary packaging contains a set of two defibrillation pads, with a service box containing 10 units.

Connector Compatibility: Annex I provides detailed compatibility information for various brands and models, including Axion, Physio-Control/Medtronic, Mindray, Agilent Philips, Zoll, and others.

Catalog excerpts

TECHNICAL DATA SHEET Set of two defibrillaঞon electrodes. Infant-child. DESFI--DORMO O Product descripঞon Defibrilla on electrodes AED compa ble (Automa c External Defibrillator). Available with pre-a ached disposable cable, in diﬀerent models, or with standard stud connec on for use with reusable cables. This product does not contain natural latex, phthalates or compounds of animal or biologic origin. This product is in compliance with RoHS standard. Maximum permanence me recommended for contact with pa ent skin is 24h. Resists up to 15 consecu ve defibrilla on loads at 360 J. Product intended for paediatric pa ent. Maximum weight 10 Kg. See annex I of the present Technical data sheet for further details about connectors and their compa bili es. Technical specificaঞons Materials x Backing material: waterproof flexible white PE foam, closed cell, with biocompa ble acrylic adhesive Conduc ve area: n foil with conduc ve acrylic based hydrogel, biocompa ble. Cable: copper (65/0.127mm) with non-toxic PVC coa ng. Plug mold: plas c material depending on the reference (PP,PVC…) Terminals rings: Brass Grommet: EVA/TPE Packaging: PET / aluminum / PE film. x This document is the property of Telic, S.A.U. Transmission to third-par es or non-authorized copies are not allowed 1-5

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TECHNICAL DATA SHEET Physical and dimensional properঞes x Cable length: depending on the reference. Minimum 1,2 m. See annex I for details about available connec ons. AC large signal impedance: <5 Ω Defibrilla on overload recovery: Conclusion: Requirements established by electrical safety standards IEC 60601-2-4 are met. Note: These electrodes do not allow monitoring the quality of CPR. ISO 10993-10: Nega ve intracutaneous irrita on test. Conclusion: the product is biocompa ble. Sterilizaঞon and expiry date x Non-sterile product. Shelf life: 2 year upon the manufacturing date. Keep protected...

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TECHNICAL DATA SHEET EDC-P1XX; EDC-P2XX: Primary packaging containing a set of 2 defibrilla on pads. Service box of 10 units. Clean and dry the applica on site. Avoid contact with alcohol or other disinfectants. Open the package and remove the electrodes. Remove the protec ve film from electrodes. Place the electrodes on the pa ent at clinically indicated site, making sure that all adhesive área is stuck to the skin. Be careful not to trap any pockets of air between the hydrogel and the pa ent’s skin. Connect the electrodes to the defibrillator or mul -func on cable. Follow the defibrillator...

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TECHNICAL DATA SHEET ANNEX I Conectors Reference Paediatrics Paediatrics preconnected Brand- Equipment-Model Physio-Control/Medtronic: Lifepack 12, Lifepack 15, Lifepack 20e/20, Lifepack 1000 Mindray: Beneheart D3 Lecor: Cor-Res A6S - Agilent Philips: Heartstart XL - Agilent: Heartstream XLT (cable M3507A) - Progetti: Rescue Life, Rescue Sam - General electric: Responder AED - Zoll: Serie E, Serie R, Serie M - M&B: AED7000/MB7000 - Nihon Kohden: Cardiolife Adapter cable JC-765V, Cardiolife Adapter cable JC-865V - Schiller: Defigard 4000, Fred Easy This document is the property of Telic, S.A.U....

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TECHNICAL DATA SHEET Reference Paediatrics Paediatrics preconnected Brand- Equipment-Model - Cu Medical Systems: Paramedic CU-ER1 - Nihon Kohden: Cardiolife, TEC-7731K Adapter cable JC-755V, ActiBiphasic Cardiolife TEC-5531K, Cardiolife Adapter cable JC-855V - Schiller: Defigard touch 7, Fred PA-1 This document is the property of Telic, S.A.U. Transmission to third-par es or non-authorized copies are not allowed 5-5

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