Low Cost Automated Functional Circuit Testing Kit for Ultrasonic Probe Controller PCBs in Ophthalmic Phacoemulsification Devices

Abstract

Validation of PCBs using manual means is time consuming, varies from one manufacturer to another and does not fulfil the traceability required by the international standards for quality control. This work proposes a low cost Automated Functional Circuit Testing (FCT) Kit for the ultrasonic probe controller of the Phaco machine used for ophthalmic phacoemulsification surgery. A hybrid configuration composed of a Raspberry Pi 3A+ and a STM32F407 is used. The former controls the system and the latter performs the real-time measurements. The repeatable electrical connection to the Device Under Test (DUT) is ensured through a Pogo Pin Test Fixture, and the device traceability required by FDA 21 CFR Part 820 and ISO 13485:2016 through a Barcode Scanner. Measurement accuracy has been demonstrated to be under 0.6% and the testing cycle time reduced to 8 to 10 seconds compared to the manual testing baseline of 40 to 50 seconds, with no system failures across all tests performed.