Applications Consulting Visit
The IQ/OQ documentation walkthrough covered the importance of each test parameter and detailed failure messages that can be expected when performing electrical safety tests. Since this was a medical equipment manufacturer, special attention was given to covering leakage current testing and how it related to the 60601-1 test standard. Review of testing documentation revealed multiple opportunities for improvement including; additional leakage current testing, Enclosure, Patient (Applied Part), Patient Auxiliary, and MOAP (Mains On Applied Part). We updated their procedures to assume future testing needs would evolve into more rigorous test routines.
Ahead of schedule on day 1, we covered how to connect their product for proper testing. We performed a sequence of tests according to their current procedures. A few inconsistencies were discovered, which involved a recent change to testing parameters that were required to meet a hardware change. This change did not necessarily meet the requirements of the testing according to 60601-1 standards. The team’s engineers made a note to discuss the changes with the organization’s product engineers. Some on-site design engineers took note and were interested in additional information from the standard, so we provided more detailed standard information, such as the proper voltage for Hipot testing with input line filters that have large capacitors.
On day 2, the team learned about their custom MedTEST system and operations as well as Autoware3 instrument control software. The operators learned about the importance and requirements of all electrical safety testing. Best practices in workstation safety were covered and it was stressed that the hipot equipment can potentially produce hazardous levels of voltage. We covered additional methods of safeguarding operators from the dangers of electric shock.
Having time left on day 2, we recommended some operator training, which included an electrical safety testing overview and safe workstation practices. We trained close to 20 operators and service personnel from the production floor during this training session.