Medical Device Battery Charging
Industry: Medical Devices
INTRODUCTIONA Fortune 500 medical device company required battery charging stations for two different device assembly lines. These stations were intended to charge the internal backup battery stored inside each of the devices. Due to production deadlines, Optimation needed to design, fabricate, deliver and validate the stations in the shortest time possible.
SOLUTIONMonitoring Battery Levels and Charging Time
Both stations were required to physically interface with the devices to actively monitor and charge the internal batteries. Because Optimation has a strong background in National Instruments LabVIEW software (NI Gold Alliance Partner, NI LabVIEW certified architects and developers), NI hardware was chosen for its reliability and flexibility. The first charging station needed to be a single device station at the end of the manufacturing process. The station had to monitor the voltage level of the internal battery and apply/remove power as necessary. This charge level, along with other pertinent data, is displayed on a user interface that notifies an operator when charging is complete. The station was also required to check the length of the charging process. Should a device take longer then specified to charge or never reach its desired voltage, the station will alert the operator of a faulty device. The second charging station was intended to be a multi-device station, utilized after manufacturing to keep the internal battery at optimal voltage for storage and shipment to the end user. The second charging station needed to have charging functionality embedded within the electrical circuitry. This resulted in a simplified system layout, by removing the need for an external desktop computer to perform monitoring, display, and logging functions. The actuation of applying power to devices was still a necessity. With this change, the system no longer contains a GUI for an operator, but instead uses LEDs to display whether the test station was applying power or not.
The first battery charging station includes: a single nest for charging one pump at a time, a user interface that reports all necessary values during the charging process, a barcode scanner that is used to log which devices have been tested, and a printer to create charging reports. Optimation also designed a custom printed circuit board (PCB) to handle signal conditioning required for battery charging including interfacing with an embedded microcontroller. The second battery charging station is meant for larger throughput than the first. The second station includes five locations for charging five devices at one time with individual LEDs to indicate that a location is actively charging.
ISO 13485 and FDA Regulations
Optimation has been able to assist in the validation of the test systems by providing test plans that conform to FDA regulations. Optimation's familiarity with 21 CFR Part 820 and ISO 13485 standards has allowed the team to be highly effective and efficient at providing test system validation services. During validation, Optimation has helped to create: Installation Qualification Plans, Operation Qualification Plans, and Preventative Maintenance Schedules.
RESULTSBy having existing familiarity with the client's products, Optimation has been able to deliver a full turnkey solution with a quick turnaround. Optimation designed, programmed, fabricated, wired and validated the new stations. Optimation's sister company, Kingsbury fabricated both stations according to Optimation's design specifications.
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ISO-13485 Medical Devices