Dena Electrosurgical Grounding Pad

Medical Disposable

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.

Dena Electrosurgical Grounding Pad

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.

Dena Electrosurgical Pad Direction

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.

Cautery Pad 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
Non-Sterile and disposable

Technical Specification

Type	Disposable, single use, non-sterile ESU plate
Versions	Non-Split & Split
Biocompatibility	ISO 10993-1 for all skin contact materials
Performance	Temperature rise of less than 5°C (as per ANSI/AAMI HF18:2001)
Backing Material	PE Foam
Total Area	Adult: 200 cm2 Infant: 135 cm2
Gel Area	Adult: 120 cm2 Infant: 76 cm2
Storage Temperature	+5°C to + 40°C
Shelf Life	24 Months

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: P1024ET – 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)