ECG Electrode

ECG Electrodes are single-use, foam conductive products that ensure accurate heart rhythm monitoring by transmitting clear, interference-free signals. Essential for monitoring, stress testing, and Holter monitoring, they offer reliable adhesion and hypoallergenic properties.

ECG Electrode is a type of conductive electrode in a pad form. The purpose of ECG Electrode is to transmit heart signals by connecting the wires of a cardiac monitoring device to the chest wall. These single-use ECG Electrodes are made of foam. They transmit heart rhythm and pulse to the cardiac monitoring device without any noise or interference. These ECG Electrodes are adhesive and retain their adhesive properties. They are completely hypoallergenic and allergy-free. ECG Electrodes are used in cardiac stress test, cardiac rehabilitation, monitoring, electrocardiography, and Holter monitoring. D.G. Dena ECG Electrodes are available in three different sizes with solid or liquid gel.

Direction for use

Wash your hands and ask the patient to shave the areas you want to apply the ECG Electrode since body hair can interfere with transmitting heart signals. Then remove the transparent plastic cover of the product and apply it on the considered area. Now, you can connect the monitoring device wires to the ECG Electrode Studs.

  • Impermeable foam layer suitable for surgical procedures
  • Excellent adhesion
  • Available in adult and infant sizes
  • Cost-effective with a competitive price
  • Anti-allergic
  • Latex & PVC free
  • Disposable
  • Long shelf life
  • Compliant with international standards ISO 13485 & ISO 9001
  • Produced under the international standard for manufacturing disposable Electrocardiography Electrodes (AAMI EC12)

Technical specifications

Materials

  • Supporting Material: PE foam
  • Adhesive: Acrylic (Biocompatible, ISO 10993)
  • Sensor: Stainless Steel / Ag-AgCl Coated
  • Cover: PET
  • Label: Film PET
  • Gel: Solid or Wet
  • Pouch: Aluminum / PE film

Biocompatibility

  • ISO 10993-5: No cytotoxic
  • ISO 10993-10: No sensitizing
  • ISO 10993-10: Negative intracutaneous irritation test

Conclusion: This product is biocompatible.

Sterilization and expiry date

  • Non-sterile product
  • Shelf life: 3 years after the manufacturing date

Storage and maintenance

  • Keep protected from direct sunlight / the outside
  • Keep in a dry place
  • Temperature limitation: 5-40ºC
  • Single-use product (Disposable)
  • Latex free

Packaging

  • 50 units per pouch
  • 40 pouches per service box, 2000 ( Wet Gel )
  • 50 pouches per service box, 2500 ( Solid Gel )

Electric properties ANSI/AAMI EC12

  • Offset DC voltage: <100mV
  • AC 10Hz Impedance: <2000Ω
  • Defibrillation overload recovery:
    • <100mV
    • <1mV/s
  • Combined offset instability and internal noise <150μV
  • Bias current tolerance in 8h: <100mV

Conclusion: safety electrical requirements are met

REGULATORY INFORMATION

D.G.Dena guarantees that this product conforms 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: 35035 Electrocardiographic electrode, single-use
  • EMDN code: C020501 (ECG Electrodes).

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