Skintact Pediatric Multifunction Electrodes with DH03 Gel

• • Terminated Z-0802-2015 FDA Class I ·initiated 3 Dec 2014

  The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. This could lead to a situation, in which a patient who is in a life threatening situation requiring a defibrillation can receive such therapy only with a delay or not at all.

510(k) Number

K081371 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Skintact

  Class I

  CE/MDR

• megro

  Class I

  CE/MDR

• Skintact and Various Other Tradenames

  Class II

  FDA 510(k) K073104 Active Cleared 16 Nov 2007

• Skintact Radiotransparent Multifunction Electrodes

  Class III

  FDA 510(k) K103186 Active Cleared 8 Feb 2011

• Skintact Multifunction Electrodes, Model DF 21

  Class III

  FDA 510(k) K041883 Active Cleared 7 Sep 2004

• Skintact ECG Electrode

  Class II

  FDA 510(k) K040249 Active Cleared 24 Feb 2004

See all devices from Leonhard Lang GmbH →

• Are these electrodes suitable for use on infants and young children, and how does their design differ from adult electrodes?

  Yes, the Skintact Pediatric Multifunction Electrodes are specifically designed for pediatric use, ensuring a secure and reliable fit for infants and young children. Their smaller size and adhesive properties are optimized for delicate pediatric skin, providing better signal transmission for accurate ECG monitoring and electrotherapy procedures compared to adult electrodes.

• How should these electrodes be cleaned and disinfected between uses, given they are reusable?

  Since these electrodes are reusable, proper cleaning and disinfection between applications are essential to maintain performance and prevent contamination. The manufacturer recommends following standard clinical protocols for disinfection, though specific instructions should be confirmed with Leonhard Lang GmbH. Always ensure electrodes are thoroughly dried before reuse to preserve adhesion and functionality.

• Can these electrodes be used in non-sterile settings, and if so, what are the implications for patient care?

  Yes, the Skintact Pediatric Multifunction Electrodes are available in both sterile and non-sterile configurations. Non-sterile electrodes are suitable for use in clinical settings where sterility is not required, such as routine ECG monitoring in outpatient or non-critical care environments. However, sterile versions should be used when direct contact with broken skin or invasive procedures is involved to minimize infection risks.

• What types of procedures can these electrodes be used for, and why are they considered multifunctional?

  These electrodes are designed for cardiovascular applications, including ECG monitoring, defibrillation, and other electrotherapy procedures. The term *multifunctional* refers to their versatility in facilitating multiple diagnostic and therapeutic interventions—such as both recording heart activity and delivering electrical shocks—while maintaining reliable skin contact and signal transmission for pediatric patients.

• How do I determine the correct size or model for a pediatric patient, and are there multiple sizes available?

  The device data does not specify multiple sizes explicitly, but the electrodes are explicitly labeled for *pediatric* use, implying they are sized appropriately for children. For precise sizing, refer to the manufacturer’s guidelines or consult Leonhard Lang GmbH, as pediatric patients vary significantly in size. Proper fit ensures optimal adhesion, signal quality, and patient comfort during monitoring or therapy.