Installation and Operational Qualification of Lumax S-Cable Automated Test Equipment
Cooper Surgical required a validated automated test system for Lumax S-Series fiber optic extension cables used in surgical catheter applications. The challenge involved designing and qualifying a custom test system that could perform comprehensive optical and pneumatic testing without requiring external optical measurement equipment or reference standards. Critical concerns included ensuring accurate optical throughput measurements for fiber optic cables, detecting optical crosstalk between fiber channels, measuring pneumatic leakage and flow rate within tight tolerances, detecting pneumatic obstructions in cable pathways, integrating with existing Lumax Catheter ATE database via Ethernet, achieving self-calibration capability without external equipment, and providing an operator-friendly touchscreen interface for production environments.
Project Metrics
Tools & Standards
Problem Definition
Cooper Surgical required a validated automated test system for Lumax S-Series fiber optic extension cables used in surgical catheter applications. The challenge involved designing and qualifying a custom test system that could perform comprehensive optical and pneumatic testing without requiring external optical measurement equipment or reference standards. Critical concerns included ensuring accurate optical throughput measurements for fiber optic cables, detecting optical crosstalk between fiber channels, measuring pneumatic leakage and flow rate within tight tolerances, detecting pneumatic obstructions in cable pathways, integrating with existing Lumax Catheter ATE database via Ethernet, achieving self-calibration capability without external equipment, and providing an operator-friendly touchscreen interface for production environments.
System Constraints
Engineering Decisions
Designed custom test system with test computer and test box communicating via RS-485 serial link
Implemented self-contained design eliminating need for external optical measurement equipment
Developed built-in computer-guided calibration procedure for ongoing maintenance
Integrated optical and pneumatic testing in single system for comprehensive cable validation
Used internal pressure sensors verified against external NIST-traceable precision pressure calibrator
Implemented test and calibration strategy that cancels out effects of fiber losses and detector sensitivity
Designed touchscreen interface for operator ease of use in production environment
Integrated database architecture with existing Lumax Catheter ATE via Ethernet connection
Validation Strategy
- IQ Physical Qualification: Verified adequate space, proper component placement, interconnections, and physical assets (shop air, power, network)
- IQ Initial Calibration: All equipment requiring calibration initially calibrated on-site for safe and correct operation
- OQ Test Box Functions: Qualified receptacle functionality (optical fiber function, pneumatic integrity)
- OQ Detector Functionality: Validated 2mm and 0.5mm detector operation
- OQ Pneumatic Functions: Verified pressure detectors, solenoid valve, and leakage measurement accuracy
- OQ Optical Module: Confirmed proper function and sensitivity of optical modules
- OQ System Level Functions: Validated end-to-end system operation and database integration
- Computer-guided calibration procedure validated for accuracy of sensors and measurement components
Risk & Mitigation
Final Outcome
Successfully qualified Lumax S-Cable ATE for production use at Cooper Surgical. The automated test system demonstrated comprehensive optical and pneumatic testing capabilities without requiring external optical measurement equipment or reference standards. The self-calibration capability was validated through OQ testing, confirming the system can be maintained without external equipment. Database integration with the existing Lumax Catheter ATE was verified, ensuring seamless data flow and traceability. The touchscreen operator interface was validated for production environments, providing an intuitive user experience. The IQ/OQ validation established documented evidence that the equipment was properly installed, calibrated, and operates in conformance with design specifications, providing the foundation for PQ testing and production release.