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Desfi-Dormo ED-1010

Desfi-Dormo ED-1010

Desfi-Dormo ED-1010

Product catalog summary
Product Description: The Desfi-Dormo adhesive pre-gelled pads are designed for manual defibrillation in adult patients, packaged in sets of two. They are latex-free, phthalate-free, and do not contain animal-derived compounds. The pads comply with RoHS standards and are intended for patients weighing at least 25 kg.
Technical Specifications: The pads can withstand up to 15 defibrillation loads at 360 J and should not remain in contact with the skin for more than 24 hours. The backing material is a waterproof, flexible white PE foam with a biocompatible acrylic adhesive. The conductive area consists of tin foil with a conductive acrylic-based hydrogel. The packaging is made from PET/aluminum/PE film.
Physical and Dimensional Properties: Each pad has an active area of 140 cm², with overall measurements of 165 mm x 132 mm and an active area size of 134 mm x 101 mm.
Electrical Properties: The pads meet electrical safety standards IEC 60601-2-4 and ANSI/AAMI DF-80. Key specifications include AC impedance at 10 Hz (<3000Ω) and 30 kHz (<5Ω), and defibrillation overload recovery with ΔV after 4s (<500 mV) and 60s (<400 mV).
Biocompatibility: The product is non-cytotoxic, non-sensitizing, and shows no intracutaneous irritation, complying with ISO 10993-5 and ISO 10993-10 standards.
Sterilization and Expiry: The pads are non-sterile with a shelf life of 2 years from the manufacturing date.
Storage and Maintenance: Store in a dry place away from direct sunlight, within a temperature range of 5-35ºC. The product is single-use and requires no maintenance.
Packaging: Each primary package contains a set of 2 defibrillation pads, with service boxes containing 50 units.
Instructions for Use: Ensure the application site is clean and dry, avoiding alcohol or disinfectants. Shave the area if necessary to minimize adhesion issues. Remove the protective film and apply the pads to the patient, ensuring no air pockets are trapped. Place defibrillator paddles on the metallic surface of the pads and apply firm pressure during electrical discharge.
Regulatory Information: The product is classified as a Class I medical device under MDD 93/42/EEC and conforms to MDD 92/43/EEC, with a GMDN code of 11130.
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Catalog excerpts

Desfi-Dormo ED-1010-1

TECHNICAL DATA SHEET Adhesive pre-gelled pads for defibrillation Desfi-Dormo Product description Pack of two adhesive pre-gelled pads for manual defibrillation for adult patients. 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. Maximum permanence time recommended for contact with patient skin is 24 h. Resists up to 15 consecutive defibrillation loads at 360 J. Product intended for adult patient. Minimum weight 25 kg. Technical specifications Materials • Backing material: Waterproof flexible white PE foam ring, closed cell, with biocompatible acrylic adhesive. Conductive area: Tin foil with conductive acrylic based hydrogel, biocompatible. Packaging: PET / aluminum / PE film. Physical and dimensional properties • Active area (each pad): 140 cm2. Active area size: 134 mm x 101 mm. This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allo

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Desfi-Dormo ED-1010-2

TECHNICAL DATA SHEET Electrical properties • AC large signal impedance specification: <3Ω Defibrillation overload recovery: • DC offset voltage specification: <100 mV. Combined offset instability and internal noise specification: <100 μV. Bias current tolerance 8 h specification: <100 mV. Conclusion: Requirements established by electrical safety standards IEC 60601-2-4 and ANSI/AAMI DF-80 are met. Biocompatibility • ISO 10993-5: No cytotoxic. • ISO 10993-10: No sensitizing. • ISO 10993-10: Negative intracutaneous irritation test. Conclusion: The product is biocompatible. Sterilization and expiry...

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Desfi-Dormo ED-1010-3

TECHNICAL DATA SHEET Clean and dry application site. Avoid contact with alcohol or other disinfectants. To minimize adhesion or burn problems, shave the application area, whenever possible. Open package and remove electrodes. Remove protective film from pads. Place pads on patient at clinically indicated site, making sure that all adhesive area is stuck to the skin. Be careful not to trap any pockets of air between hydrogel and patient’s skin. Place defibrillator paddles on the metallic surface of the pads. Apply firm and uniform pressure on each of the paddles when carrying out the electrical...

 Open the catalog to page 3
*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.