MEDICAL DEVICE CASE STUDY
Applications Consulting / 2 Days
February 2019
MedTEST Setup and Install – Ultrasound Machine
A manufacturer of Ultrasound machines based in Europe, had recently acquired the Associated Research MedTEST System. They were in urgent need for system setup and training assistance. The customer was migrating from a competitor’s test system to the MedTEST with the hopes of reducing the overall test time. The manufacturer was required to comply with all the electrical safety testing requirements per the Medical Device Standard IEC 60601-1. The main goal for this visit was to train a group of engineers and technicians on the proper setup and use of the test system, along with configuring the MedTEST System in a fully automated fashion that would reduce the amount of operator intervention during testing and reduce the overall test time. After reviewing the manufacturer’s requirements, a 2-Day Applications Consulting package was proposed. This would allow enough time for reviewing the current test procedure and configuring the MedTEST System so that the customer could start testing their products and meet their goal of reducing the overall test time.
Consulting Visit
Day 1:
We started with a meeting to review the current test procedures, set goals and expectations, and finalize the agenda. Once the agenda was set, our focus shifted to the floor where the test station would be setup. Prior to our arrival, the group had already unpacked the hardware and had been self-learning the MEDTEST system. They also made themselves familiar with Autoware® 3 software. Next, we looked at the Ultrasound machines (DUTs) which would be tested with the MedTEST system. Their DUT was a Class 1 device with 3 Patient Leads (F & CF type), and one enclosure point. The next few hours were spent carefully wiring up the test system and explaining the function of all test connections. This was followed by programming the test routines in Autoware 3 software based on the customer test requirements. Toward the end of day one we were able to test some samples of ultrasound machines to compare the test data with expected results.
Day 2:
The second day started with more tests on ultrasound machines, focusing on reducing the overall test time and meeting the clients goal. This was achieved by making the necessary changes in the test routines and parameters. The total test time that was recorded for the Associated Research MedTEST system came out to be approximately 11 minutes. This was about half of the total test time recorded with the competitive test equipment. This was a big win for the customer as they now had a hands-free test system with a significantly reduced test time. The last few hours of the day were spent on educating the group on setting up a safe workstation, the importance of Personal Protective Equipment (PPE), and test system verification. A review of electrical safety tests was also provided to the group and any remaining questions were addressed along with troubleshooting tips.
KEY POINTS
- Setting up the test system and Programming test routines
- Proper Test Equipment Operations
- Test System Validation and Verification
- Performing EST Tests on ultrasound machines
- Train Operators and Engineers with Safe Workstation Practice
- Reduced test time.
Consulting Notes
At the end of the visit the group felt very comfortable in using the Associated Research MedTEST for their test application. The group also felt confident that they were trained well enough to make any necessary changes in the MedTEST System configurations should they need to test a different product. This training also enabled the engineers to be able to perform the IQ/OQ protocols to validate the test system. This customer was highly appreciative of our efforts to be able to fly out to Europe on a very short notice to help them.