US 11,709,747 B2
Patient assurance system and method
Patrick Hresko, Mount Pleasant, PA (US); Thomas E. Kaib, Irwin, PA (US); Trisha A. Pavel, Pittsburgh, PA (US); Grace Owens, Pittsburgh, PA (US); John Clark, Pittsburgh, PA (US); and Rachel Carlson, Falls Creek, PA (US)
Assigned to ZOLL Medical Corporation, Chelmsford, MA (US)
Filed by ZOLL Medical Corporation, Chelmsford, MA (US)
Filed on Jan. 3, 2017, as Appl. No. 15/397,102.
Claims priority of provisional application 62/276,612, filed on Jan. 8, 2016.
Prior Publication US 2017/0199797 A1, Jul. 13, 2017
Int. Cl. G06F 11/30 (2006.01); A61B 5/00 (2006.01); G16H 40/40 (2018.01); G16H 10/60 (2018.01); G16H 40/67 (2018.01); A61B 5/318 (2021.01); A61N 1/04 (2006.01); A61B 5/276 (2021.01); G16H 20/30 (2018.01); A61N 1/39 (2006.01)
CPC G06F 11/3013 (2013.01) [A61B 5/0002 (2013.01); A61B 5/0022 (2013.01); A61B 5/318 (2021.01); A61B 5/6804 (2013.01); A61B 5/6831 (2013.01); A61B 5/7425 (2013.01); G06F 11/3055 (2013.01); G16H 10/60 (2018.01); G16H 20/30 (2018.01); G16H 40/40 (2018.01); G16H 40/67 (2018.01); A61B 5/276 (2021.01); A61N 1/046 (2013.01); A61N 1/0484 (2013.01); A61N 1/3904 (2017.08); A61N 1/3993 (2013.01)] 26 Claims
OG exemplary drawing
 
1. An ambulatory medical device comprising a plurality of subsystems, the ambulatory medical device comprising:
a garment to be worn by an ambulatory patient, the garment comprising
at least one electrocardiogram (ECG) electrode that is disposed externally on the ambulatory patient's body, the at least one ECG electrode configured to acquire ECG data descriptive of the ambulatory patient's cardiac activity and indicative of whether the ambulatory patient is experiencing a life-threatening cardiac arrhythmia, and
at least one therapy electrode that is positioned external to the ambulatory patient's body, the at least one therapy electrode configured to provide one or more therapeutic defibrillating or pacing shocks to the ambulatory patient when the ambulatory patient is experiencing the life-threatening cardiac arrhythmia; and
a controller comprising
a user interface, and
at least one processor disposed in the controller and coupled to the at least one ECG electrode, the at least one therapy electrode, and the user interface, and configured to
execute a plurality of self-diagnostic tests to evaluate operational integrity of each of the plurality of subsystems of the ambulatory medical device, the plurality of self-diagnostic tests comprising at least
an ECG signal quality test of the at least one ECG electrode,
an ECG falloff test for the at least one ECG electrode, and
an operational test of the at least one therapy electrode,
produce test results indicative of the operational integrity of each of the plurality of subsystems, the test results comprising results of the ECG signal quality test of the at least one ECG electrode, the ECG falloff test for the at least one ECG electrode, and the operational test of the at least one therapy electrode,
identify subsystem status information descriptive of an operational status of the at least one ECG electrode based on the ECG signal quality test and the ECG falloff test,
identify subsystem status information descriptive of an operational status of the at least one therapy electrode based on the operational test of the at least one therapy electrode, and
provide a device health report for the ambulatory medical device to the ambulatory patient via the user interface, the device health report comprising
(a) a first indication of whether the at least one ECG electrode that is disposed externally on the ambulatory patient's body is in an operational state or a nonoperational state as determined based upon the ECG signal quality test of externally detected ECG signals,
(b) a second indication of whether a signal quality of externally detected ECG signals is compromised as determined based on the ECG falloff test, and
(c) a third indication of whether the at least one therapy electrode that is positioned external to the ambulatory patient's body is in an operational state or a nonoperational state as determined based upon the operational test.