Group: Telic Group
Catalog excerpts
Technical data sheet E.C.G. Gel ELECTRO-GEL Product description Conductive gel for electromedical procedures (ECG, TENS). ELECTRO- 3il GEL CONDUCTOR CONDUCTIVE GEL GEICONDUCTEUR gel conduttore GEICONDUTOR [refIg-10 Product charasteristics • Highly conducive. • Short and long term monitoring. • Does not irritate the skin. • Hydrosoluble. • Non-greasy. • Gel can be easily and uniformly spread. • Does not damage terminals or contacts. Technical specifications B Ingredients Aqua (Water), Potassium Chloride, Propylene Glycol, Hydroxyethylcellulose, Magnesium Nitrate, Triethanolamine, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, CI 42051 B Materials • Cosmetic or pharmaceutical grade raw materials. • Packaging: HDPE bottle with PP cap, suitable for food contact. B Physio-chemical proprieties • Colour, Odour, Appearance: Transparent viscous gel with blue-greenish colour. Odour to its raw materials (does not contain perfume). . Viscosity (22°C): 220.000 - 360.000 mPa-s . pH: 6.7 - 7.5 . Density (22°C): 1.00 - 1.05 g/ml This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed 1 - 3
Open the catalog to page 1Technical data sheet B Electrical properties (ANSI/AAMI EC12 ) • DC Offset voltage: <100mV • AC Impedance 10Hz: <20000 • Defibrillation overload recovery: . AV <100mV . AV/t <1mV/s • AC Impedance 10Hz after defibrillation: <100mV • Combined Offset instability and internal noise: <150pV • Bias current tolerance 8h: <100mV Conclusion: safety electrical requirements are met B Microbiological properties • Total aerobes: <10 UFC/mL • Moulds and yeasts: <10 UFC/mL • Pathogens (Staphylococcus aureus, Candida albicans, Pseudomonas aeruginosa, Escherichia coli): Absence B Biocompatibility • ISO...
Open the catalog to page 2Technical data sheet Date: October 2022 Specification N°: ETP/011/14 Regulatory information TELIC, S.A.U. guarantees that this product is in conformity with Regulation (UE)2017/745 and that it has been manufactured following the directives of the Quality Assurance System certified as ISO 13485. This product is classified as: • Class I product according to Annex VIII of Regulation (UE) 2017/745, rule 1 • GMDN code: 11425 Electrodes, gel. • EMDN code: C020599 (Cardiac diagnostic Devices-other). This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized...
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