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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).