Porticos and Device Solutions worked closely to optimize placement efficiency to create the smallest BioMedical system package possible. This was especially important for both units because power consumption needs to support a 30-day transmission period, which is provided by a large battery cell.
Ambulatory ECG Monitoring System Product Development
BioMedical Systems (now part of ERT), has been providing medical data analysis and support for physicians and their patients for nearly 40 years. They saw a need for a mobile cardiac telemetry system that could take advantage of their sophisticated arrhythmia analysis software, record the data and transmit that information in real time to a group of certified cardiac technicians. To make their vision a reality, they came to Porticos and Device Solutions—one of Porticos’ partners—who experienced in hardware and software development for wireless devices. Herein, the TruVue™ product was born.
The TruVue™ system consists of a patient-worn ECG recording device, a hand-held device that receives and analyzes the information from the recording device. The device then transmits the real-time data to the BioMedical Systems headquarters in St. Louis, where the data is analyzed further and formatted for easy access by the physician.
Porticos’ hardware engineers created the 3D CAD data using Unigraphics software. Bluetooth was chosen as the wireless communication protocol between the patient-worn device and the hand-held device, while GSM-based-cellular was used to transmit between the hand-held and the cardiac center.
In order to minimize detuning of the chip antenna in the patient-worn device, snap features were incorporated into the PC/ABS housings to limit the need for metal assembly hardware. FEA was conducted in Ansys to ensure snap features would remain secure during normal use and drop scenarios.
One of the unique features for the hand-held was the keypad. In order to support the user interface and reduce confusion to the patient, the keys had to be individually backlit and, at the same time, isolated from the surrounding keys. This way, as the menu options changes on the display, only the keys applicable for those options would be lit. The result is deceptively simple-looking keypad, that integrates mechanical and software user interface to create an intuitive and positive experience for the patient.
Hardware Production Results
Thanks to the hard work of Porticos and Device Solutions, the US Food and Drug Administration (FDA) granted Biomedical Systems 510(k) clearance to market TruVue™, a truly wireless ambulatory ECG monitoring system. Additionally, TruVue™ has made its mark as the industry’s first cardiac Mobile Telemetry system that analyzes, records and transmits every heartbeat for up to 30 days.