Electrosurgical Grounding Pad

The disposable Grounding Pad is a vital component in the surgical process. It minimizes thermal damage and reduces the risk of burning surrounding tissues during incision procedures by connecting to the electrocautery device and directing excess current away from the body.

An Electrosurgical Grounding Pad is a soft and flexible pad that completes the electrical current circuit in electro-surgical procedures. The flexibility of this plate allows for comfortable use on all body areas.
This Grounding Pad delivers the electrical current back to the electrocautery device through an electrode and its connected wire after the incision and cauterizing. This prevents the patient from getting burned.
This product is made with high-quality materials and available in two models of Split & Non-split, suitable for all electrocautery devices. It has obtained certification for all relevant safety and biocompatibility tests.
A continuous metal plate collects and conducts the input current from its surface to an external circuit in the non-split model. On the other hand, the split configuration offers enhanced safety by directing the accumulated electrical current through both plate edges. The other edge compensates by ensuring the continued conduction of the electrical charge, if one edge fails.

Direction for Use

  • The patient’s body should be clean, with no hair and oil.
  • Choose the proper plate size.
  • Remove the transparent layer and stick it onto the patient’s body.
  • The patient should remove all accessories and metallic objects.

Features

  • Excellent adhesion and proper conductivity
  • Use of biocompatible materials
  • Free from any allergenic factors
  • Available in Split/Non-split models
  • Available in adult and infant sizes
  • Manufacturing Licensed by Iran National Medical Device Directorate
  • Complies with the international standard ISO 13485:2016
  • CE certified by Eurofins Italy
  • Sterile and disposable
 

Technical Specification

TypeDisposable, single use, non-sterile ESU plate
VersionsNon-Split & Split
BiocompatibilityISO 10993-1 for all skin contact materials
PerformanceTemperature rise of less than 5°C (as per ANSI/AAMI HF18:2001)
Backing MaterialTemperature rise of less than 5°C (as per ANSI/AAMI HF18:2001)
Total AreaPE Foam
Gel AreaAdult: 177 cm2 Children: 122 cm2
Storage TemperatureAdult: 124 cm2 Children: 76 cm2
Shelf Life+5°C to + 30°C

Materials

  • Backing material: Waterproof flexible white PE foam, closed cell, with biocompatible acrylic adhesive
  • Conductive area: Aluminum / PET film with acrylic-based hydrogel, biocompatible
  • Hydrogel thickness: 0,69mm gel + aluminum support
  • Release liner: PET
  • Pouch: PET – aluminum – PE film
  • Service Box: Carton

Biocompatibility

  • ISO 10993-5: No Cytotoxic
  • ISO 10993-10: No Sensitizing
  • ISO 10993-10: Negative intracutaneous irritation test

Conclusion: The product is biocompatible.

Packaging

  • Unitary pouch in 50 units service box.

Regulatory information

D.G.Dena guarantees that this product is in conformity with Regulation (EU) 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 IIb product according to Annex VIII of Regulation (EU) 2017/745., rule 9.
  • GMDN code: 58494 – Electrosurgical return electrode, single-use, non-sterile.
  • EMDN code: K020102 (Electrosurgery pads (neutral electrodes) and cables, single-use)

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