Custom Medical Device Wire Harness Cable Assembly RFI Shielding

Creating a cable assembly with silicone cables for a patient monitor involves several critical considerations to ensure reliability, patient safety, and durability. Here’s a guide on how to approach this:

Key Components and Materials

1. Silicone Cable:

   • Flexibility: Silicone cables are extremely flexible, which is essential for patient monitors that may need to be frequently repositioned or moved.
   • Temperature Resistance: Silicone can withstand a wide range of temperatures, making it suitable for various environments, including those that require sterilization.
   • Biocompatibility: Silicone is biocompatible, ensuring it’s safe for use in devices that may come into contact with skin.
   • Chemical Resistance: Resistant to many chemicals and cleaning agents, which is important for maintaining hygiene and durability in medical environments.

2. Connectors:

   • Medical-Grade Connectors: Use connectors that are certified for medical use, ensuring they meet safety standards and are compatible with the silicone cable.
   • Overmolding: Consider overmolding the connectors with silicone or other compatible materials to enhance durability, provide strain relief, and ensure a secure connection.

3. Shielding:

   • EMI/RFI Shielding: For patient monitors, maintaining signal integrity is crucial. Use shielding to protect against electromagnetic interference (EMI) and radio-frequency interference (RFI).
   • Grounding: Ensure proper grounding in the cable assembly to protect against electrical noise and ensure accurate monitoring.

Design Considerations

1. Biocompatibility:

   • Ensure all materials used in the cable assembly are biocompatible and meet medical standards, such as ISO 10993.

2. Flexibility and Durability:

   • Cable Strain Relief: Incorporate strain relief features at connection points to prevent wear and tear, particularly where the cable connects to the monitor or sensors.
   • Tensile Strength: Test the cable for tensile strength to ensure it can withstand pulling and bending without damage.

3. Environmental Sealing:

   • Waterproofing: Consider sealing the cable assembly to protect against moisture and fluids, especially if the monitor will be used in environments where exposure to liquids is common.
   • Chemical Resistance: Ensure the assembly can withstand cleaning agents and disinfectants used in medical settings.

4. Electrical Performance:

   • Signal Integrity: Use high-quality conductors and insulation materials to maintain signal integrity, ensuring accurate patient monitoring.
   • Low Capacitance: For cables transmitting sensitive signals, choose materials that minimize capacitance to avoid signal degradation.

Manufacturing Process

1. Prototyping:

   • Develop prototypes to test the cable assembly’s performance, including flexibility, durability, and signal transmission. Prototyping helps in identifying and resolving potential issues before mass production.

2. Assembly:

   • Cable Preparation: Cut and strip the silicone cables to the required lengths, ensuring clean and precise terminations.
   • Connector Attachment: Attach the connectors securely, ensuring proper alignment and secure electrical connections. Overmolding may be applied at this stage to enhance durability.
   • Shielding Integration: Apply shielding as needed, ensuring it is properly grounded and integrated into the cable assembly.

3. Testing:

   • Electrical Testing: Conduct tests to ensure the assembly maintains proper electrical continuity, insulation resistance, and signal integrity.
   • Mechanical Testing: Test the assembly for flexibility, tensile strength, and durability under conditions that simulate real-world use.

4. Quality Control:

   • Implement rigorous quality control processes to ensure every cable assembly meets the necessary medical standards and performs reliably in patient monitoring applications.

Applications

• Electrocardiogram (ECG) Monitoring: Silicone cables provide the flexibility and biocompatibility needed for accurate and comfortable patient monitoring.
• Pulse Oximetry: Used to connect sensors that monitor oxygen levels in the blood, requiring durable and reliable connections.
• Blood Pressure Monitoring: Ensures accurate data transmission from sensors to the monitoring device.

Conclusion

A silicone cable assembly for patient monitors offers the necessary flexibility, durability, and biocompatibility required in medical environments. By focusing on high-quality materials, precise manufacturing processes, and thorough testing, you can create a reliable and safe product tailored to the needs of healthcare providers and patients.

BEXKOM was established in 2016 and is headquartered in Shenzhen, China, a leading brand in the connector design and manufacturing industry. Shenzhen, a city renowned for its high-tech innovation, has a population of over 17 million and is located in southern China, near Hong Kong.

BEXKOM’s core team has nearly 20 years of experience in the connector industry. We possess our own core technologies such as connector development and design, mold design, reliability testing, injection molding, CNC, and automated production lines. BEXKOM is the primary supplier to over 2,000 customers worldwide, with clients in more than 60 countries. BEXKOM's products are widely used in various sectors, including medical equipment, military, industrial, detection, testing, measurement, broadcast television, communications, drones, agricultural machinery, robotics, automation production, new energy, and more.

BEXKOM specializes in custom solutions and receives more than 30 customized new projects from clients each year.

BEXKOM has a dedicated sample design team and sample production line, and we are generally able to deliver samples to customers within 2 weeks.

BEXKOM's shareholders have reached an agreement to ensure significant annual investments in product R&D, keeping us ahead of industry peers. We are committed to technological innovation while adhering to the principle of fast delivery.

BEXKOM’s vision is to become a leader in the new technology connector manufacturing industry.

BEXKOM steadfastly upholds values of integrity, innovation, and globalization in its business philosophy, and we are also passionate about promoting peace and freedom around the world.

BEXKOM has obtained ISO9001 and ISO13485 certifications, and our products comply with RoHS, REACH, CE, UL, CSA, COC, MSDS, and other international standards. Additionally, we can provide product certification testing based on customer requirements and obtain the necessary certificates.

BEXKOM ensures a safe working environment for employees and visitors and is committed to conducting business ethically and responsibly. Our comprehensive management system ensures product quality, environmental safety, health, and safety, and we strictly adhere to industry standards.