Medical Electrodes

Etronics offers an advanced range of medical electrodes designed to meet the needs of healthcare professionals. Our solutions are developed in collaboration with experts to provide precision, comfort, and safety in the medical field.

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Technical Features:

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• Substrate: Polyester or Polyimide film with Softese lamination, ensuring optimal flexibility and softness for the patient's skin.

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• Projection Materials: Our electrodes use silver (Ag), a silver/silver chloride (Ag/AgCl) blend, and a dielectric coating to ensure reliable and durable signal conduction.
   

• Conductive Gel Application: For optimal adhesion and transmission, each electrode is equipped with a hydrogel-based conductive gel, providing enhanced comfort during application.
   

Compliance and Quality:

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• ISO13485 Certification: Our electrodes meet the highest quality standards to guarantee safe and reliable medical devices.
   

• Non-Change Policy: To ensure consistency and trust in our products, we adhere to a strict non-change policy, guaranteeing unchanged performance over the long term.
   

• Class 10,000 Cleanroom: Manufacturing is carried out in a Class 10,000 cleanroom, with sterilization control to maintain the highest hygiene standards.

 

Applications:

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These medical electrodes are ideal for various uses in medical monitoring and treatment, including cardiac monitoring, electroencephalography (EEG), and other medical applications requiring precise and reliable signal transmission.

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Advanced Product Quality Process (APQP):

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We integrate advanced quality methods in the development of our products to ensure flawless manufacturing and performance. These methods include:
 

• Flow Chart: Detailed analysis of the production process for complete traceability.

• Control Plan: Monitoring of each step to ensure consistent quality.

• PFMEA (Process Failure Mode and Effects Analysis): Identification and evaluation of potential risks for enhanced safety.
   

Verification and Validation (V&V) Protocol:

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We follow a rigorous verification and validation protocol to ensure our electrodes meet the highest market expectations:
 

• IQ (Installation Qualification): Calibration of tools to ensure optimal accuracy.

• OQ (Operational Qualification): Design of Experiments (DOE) analysis to optimize operational processes.

• PQ (Performance Qualification): Three validation cycles are performed to ensure the stability of the production process.