Our Process

The production of EKG components (both disposable electrodes and reusable lead wires) involves several steps and components meant to ensure reliable signal transmission, patient safety, and durability. HeartLead facilities adhere to the highest standards of safety, reliability, and compatibility with EKG machines.

An overview of our process:

Materials

Silver/Silver Chloride (Ag/AgCl): Used for the electrode surface due to its excellent electrical conductivity and stable electrochemical properties.

Adhesive Gel: Conductive gels or pastes are typically made from hydrogels, or sometimes our facilities substitute saline-based compounds.

Plastic and/or Foam Backing: The backing provides structural support and insulation. It is made from lightweight, hypoallergenic polyethylene foam.

Wires and Connectors: Reusable lead wires are insulated with flexible, durable materials, including PVC or silicone. Connectors are made of corrosion-resistant metals, including stainless steel or nickel-plated brass.

Electrode Manufacturing

  1. Coating the electrode surface with a base layer of silver. Another thin layer of silver chloride is added to enhance electrochemical properties.

  2. Integrating conductive gel by applying it to the electrode's contact surface. 

  3. Attaching foam and/or plastic backing to the electrode surface to provide structural support and make the electrode adhesive for skin application.

  4. Sterilization, if required.

Lead Wire Production

  1. Wire Fabrication: Conductive cores, typically made of copper or silver-coated copper, are produced. The core is designed for optimal signal transmission and flexibility.

  2. Insulation: The wires are insulated with PVC, silicone, or thermoplastic elastomers, ensuring durability and protection against electrical interference.

  3. Connector Assembly: Leads are terminated with standardized connectors (e.g., snap or clip connectors) to ensure compatibility with EKG machines.

  4. Testing: Each lead undergoes quality control testing to ensure low resistance, signal integrity, and durability under repeated use.

Quality Control & Certification

Electrical Testing: Each batch is tested for conductivity, impedance, and signal accuracy.

Durability Testing: Reusable leads are tested for repeated flexion and strain resistance.

Safety Compliance: Products are certified to meet medical device standards (e.g., ISO 13485, FDA regulations).

Packaging & Sterilization

Leads and electrodes are packaged to maintain sterility and prevent contamination, especially for disposable systems.