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ECG electrodes for neonatal patients

ECG electrodes for neonatal patients

ECG electrodes for neonatal patients

Product catalog summary
Product Overview
DORMO® pre-gelled neonatal electrodes with cable are designed for medical use, specifically for neonatal electrocardiography. The electrodes are available in different models: KS-140, KFS-140, and KFS-150, each with specific backing and connection features.

Technical Specifications
  • Materials: The electrodes use a PE clear tape or PE foam backing, PET label with acrylic adhesive, conductive acrylic hydrogel, and an Ag/AgCl sensor. The connection includes a copper cable coated with PVC and an HDPE plug.
  • Dimensions: The backing diameter is 25mm, with a 60cm cable and female plug options of 1.5mm or 4.0mm.
  • Biocompatibility: The product is biocompatible, non-cytotoxic, non-sensitizing, and free from natural latex, phthalates, or animal-derived compounds.

Sterilization and Shelf Life
The product is 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. The product is single-use and requires no maintenance.

Packaging
Each pouch contains 3 units, with 33 pouches per service box, totaling 99 units.

Electrical Properties
The electrodes meet ANSI/AAMI EC12 standards, with specifications for offset DC voltage, AC impedance, defibrillation overload recovery, and bias current tolerance.

Regulatory Information
The product complies with MDR Regulation (UE) 2017/745 and is manufactured under ISO 13485 certified Quality Assurance System. It is classified as a Class I medical device with GMDN Code 17460 and UMDNS code -26935.
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Catalog excerpts

ECG electrodes for neonatal patients-1

TECHNICAL DATA SHEET Product DORMO® Pre-gelled neonatal electrodes with cable TECHNICAL SPECIFICATIONS Materials ■ Electrode: Backing: PE clear tape: KS-XXX PE Foam: KFS-XXX Label: PET with acrylic adhesive Conductive acrylic hydrogel, biocompatible Ag/AgCl sensor, 10mm diameter Siliconized PET protector ■ Connection: Cable: copper coated with PVC Plug: HDPE Inner connector: brass ■ Pouch: PET/Alu/PE, 100 x 140mm Biocompatibility ■ No cytotoxic (ISO 10993-5) ■ Negative intracutaneous irritation test (ISO 10993-10) ■ No sensitizing (ISO 10993-10) Conclusion: the product is biocompatible. This product does not contain natural latex, phthafates or compounds of animal or biologic origin. P.1/2 This document is the property of Telic, S.A.U. Transmission to third-parties or non-authorized copies are not allowed

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ECG electrodes for neonatal patients-2

TECHNICAL DATA SHEET Sterilization and expiry date ■ Non-sterile product. ■ Shelf life: 2 years after the manufacturing date Storage and maintenance ■ Keep protected from direct sunlight / the outside. ■ Keep in a dry place. ■ Single use product. No maintenance required. Packaging ■ 3 units per pouch. ■ 33 pouches par service box, 99 units. Electrical properties ANSI/AAMI EC12 ■ Offset DC voltage (specification <100mV): <20mV ■ AC 10Hz Impedance (specification <2000ft): < 1000ft ■ Defibrillation overload recovery: o specification <100mV: <25mV ■ Combined offset instability and internal noise...

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*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.