Available at: http://digitalcommons.calpoly.edu/theses/414
Date of Award
MS in Engineering
Biomedical and General Engineering
The St. Jude Medical SJM ConfirmTM Implantable Cardiac Monitor (ICM) is a small implantable device that is used to detect arrhythmias and stores the electrogram (EGMs) records for physicians to verify the arrhythmia. The objective of this device is to provide physicians with the technology to monitor patients who are suspected of having arrhythmias but do not exhibit any symptoms of this heart condition. This device allows for long term continuous monitoring of patients and provides recordings for physicians to prove the existence of an arrhythmia. With the help of this device, doctors can make better decisions on determining what type of treatment patients would need and provide care for those who otherwise may be diagnosed too late.
The effort that goes into creating an ICM device is a strict and stringent process. The reason is to ensure that the device is of high quality. The software itself is quite complicated and the verification of the software is critical. Reviews of all verification test designs and test implementations are conducted to ensure complete coverage of software requirements. As part of the submission process for approval of these devices, a traceability report of the requirements to passed test cases must be provided, along with evidence that the software poses no harm to the patient.