Description

Designed specifically for neonatal care, this patient return electrode is an essential component in electrosurgical procedures for newborns and prematurely born infants. With a weight suitability range of approximately 1 to 6 lbs (0.45–2.72 kg), it ensures safe and effective circuit completion between the electrosurgical generator, active electrode, and the patient.

Key Features

• Single-Use, Non-Sterile, Latex-Free: Prioritizes hygiene and safety, reducing the risk of cross-contamination.
• Preattached 2.7 m (9 ft) Cord: Provides convenience and flexibility during surgical procedures.
• PolyHesive II Hydrogel: The high moisture, conductive adhesive hydrogel enhances electrode performance by minimizing mess while ensuring reliable adherence.
• Acrylic Adhesive Strip: Improves contact with the patient and acts as a moisture barrier, reducing fluid invasion.
• Closed-Cell Foam Backing: Conforms to patient contours, preventing tearing and enhancing comfort.

Performance and Safety

• Current Dispersion: The 0.050 in. thick layer of PolyHesive Hydrogel effectively disperses current, minimizing heat production and reducing the risk of burns.
• Compatibility: Works seamlessly with RECQM generators and Covidien’s REM Contact Quality Monitoring System, monitoring patient impedance to enhance safety.
• Hydrogel Properties: Lowers skin resistance, fills skin irregularities, and increases conductivity, minimizing thermal concentration risks.

Additional Features

• Non-Irritating and Non-Sensitizing: Gentle on delicate neonatal skin.
• Optional Adhesive Border: Provides additional securing options if needed.

Regulatory and Packaging Information

• Regulatory Class II: Product Code GEI, with 510(k) Number K994428.
• Prescription Use Only: In accordance with 21 CFR 801.109.
• Packaging: Comes with 12 electrodes per case, manufactured by Medtronic.

Important Considerations

• Compatibility: Designed for use with specific electrosurgical generators for enhanced patient safety.
• Return Policy: Not returnable or cancellable if lead time exceeds 48 hours.
• California Proposition 65: Subject to warnings for exposure to certain chemicals.

This electrode is a critical tool in ensuring the safety and effectiveness of neonatal electrosurgical procedures, providing healthcare professionals with the reliability and performance they need in a sensitive medical environment.