Description

The MacroLyte® Dispersive Electrode by ConMed is an essential component in electrosurgical procedures, designed to ensure patient safety by providing a reliable return path for RF current. This single-use, non-sterile electrode minimizes the risk of burns and other complications, making it a crucial tool for healthcare professionals using electrosurgical generators during monopolar electrosurgery.

Key Features

• Versatile Sizing: Available in various sizes, including Premie, Infant, Pediatric, and Adult, accommodating patients from less than 5 kg (11 lbs) to over 15 kg (33 lbs).
• Secure Adhesion: Features a soft, conformable hydrogel adhesive that ensures secure skin contact, complemented by a thin foam material for enhanced conformability to patient anatomy.
• Design for Comfort: Scalloped edges and a non-conductive border adhesive provide comfort and isolate the conductive area from surgical fluids.

Configuration Options

The electrode is available in single-foil and dual-foil (split) configurations, supporting contact quality monitoring (CQM) in compatible electrosurgical units. It comes with pre-attached 10’ (3.05 m) cables or without cables, offering compatibility with reusable cable #T229. Multiple packaging options enhance flexibility for different surgical needs.

Material and Compatibility

Constructed from biocompatible materials in line with ISO 10993-1 standards, the electrode includes a conductive hydrogel adhesive and thin foam backing. It is compatible with ARM and Valleylab REM Generators, ensuring broad applicability across various surgical settings.

Regulatory Compliance

As an FDA Class II device, the MacroLyte® Dispersive Electrode meets rigorous safety and performance standards, including IEC 60601-2-2, ISO 10993-5, and ISO 10993-10. Its substantial equivalence to predicate devices is demonstrated through 510(k) K954633.

Usage Guidelines

For optimal performance, the electrode should be placed on an area with good blood flow and minimal weight concentration, such as the side of the thigh. Ensuring full skin contact is vital for proper function, particularly for split (dual-foil) electrodes used with CQM systems. Regular monitoring of electrode placement and contact quality during procedures is recommended.

Handling Instructions

The MacroLyte® Dispersive Electrode is intended for single use only and should be discarded after use. It should be stored in its original packaging until needed, and not used if the packaging is damaged. These guidelines help maintain the integrity and effectiveness of the electrode, supporting safe surgical outcomes.