Systems and Methods for Testing a Medical Device
US-2016274162-A1 · Sep 22, 2016 · US
US12487902B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-12487902-B2 |
| Application number | US-202318340374-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jun 23, 2023 |
| Priority date | Jan 8, 2016 |
| Publication date | Dec 2, 2025 |
| Grant date | Dec 2, 2025 |
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In one example, an ambulatory medical device is provided. The ambulatory medical device includes a plurality of subsystems, at least one sensor configured to acquire data descriptive of a patient, a user interface and at least one processor coupled to the at least one sensor and the user interface. The at least one processor is configured to identify subsystem status information descriptive of an operational status of each subsystem of the plurality of subsystems and to provide a device health report for the ambulatory medical device via the user interface, the device health report being based on the operational status of each subsystem.
Opening claim text (preview).
The invention claimed is: 1 . An ambulatory medical device comprising a plurality of subsystems, the ambulatory medical device comprising: a garment to be worn by an ambulatory patient; an electrode subsystem that comprises an electrocardiogram (ECG) electrode that is coupled to the garment and that is configured to acquire ECG data descriptive of cardiac activity of the ambulatory patient, and a therapy electrode that is coupled to the garment and that is configured to provide a therapeutic shock to the ambulatory patient; and a controller comprising a user interface disposed on a housing of the controller, at least one capacitor, a capacitor charging circuit configured to be electrically coupled to the at least one capacitor and charge the at least one capacitor for delivery of the therapeutic shock, and at least one processor configured to execute a self-diagnostic test of the electrode subsystem that includes an ECG falloff test for the ECG electrode, execute a self-diagnostic test of the controller that includes a discharge test for the at least one capacitor, and provide a device health report display for the ambulatory medical device to the ambulatory patient via the user interface, the device health report having a plurality of sections comprising a first section of the device health report display associated with the garment, the first section comprising information regarding at least one of garment fit and garment laundering, a second section of the device health report display associated with an electrode belt of the ambulatory medical device, the second section comprising information regarding an operational status of the electrode subsystem based at least on results of the ECG falloff test, and a third section of the device health report display associated with the controller, the third section comprising information regarding an operational status of the controller based at least on results of the discharge test. 2 . The ambulatory medical device of claim 1 , wherein the self-diagnostic test of the controller further includes a capacitor charge test that determines whether the capacitor charging circuit is capable of providing the at least one capacitor with sufficient charge to generate the therapeutic shock. 3 . The ambulatory medical device of claim 2 , wherein the operational status of the controller is further based on results of the capacitor charge test. 4 . The ambulatory medical device of claim 1 , wherein the operational status of the electrode subsystem and the operational status of the controller are each represented by a selectable user interface element configured to receive input from a user. 5 . The ambulatory medical device of claim 1 , further comprising an email client, wherein at least one of the operational status of the electrode subsystem or the operational status of the controller is provided to the ambulatory patient via the email client. 6 . The ambulatory medical device of claim 1 , wherein the device health report display comprises at least one of icons, animation, video, or textual information relating to at least one of the electrode subsystem or the controller. 7 . The ambulatory medical device of claim 1 , wherein the controller comprises a capacitor bank that includes a plurality of capacitors that are coupled to the capacitor charging circuit. 8 . The ambulatory medical device of claim 1 , wherein the operational status of the electrode subsystem and the operational status of the controller are each represented by a corresponding icon in the device health report display. 9 . The ambulatory medical device of claim 8 , wherein the corresponding icons are displayed in the device health report display simultaneously. 10 . The ambulatory medical device of claim 1 , further comprising a battery subsystem that comprises a battery capable of charging the at least one capacitor via the capacitor charging circuit. 11 . The ambulatory medical device of claim 10 , wherein the at least one processor is further configured to execute a self-diagnostic test of the battery subsystem. 12 . The ambulatory medical device of claim 10 , wherein the device health report display further indicates an operational status of the battery subsystem based on a remaining charge of the battery. 13 . The ambulatory medical device of claim 12 , wherein the device health report display displays the operational status of the battery subsystem, the operational status of the electrode subsystem, and the operational status of the controller. 14 . The ambulatory medical device of claim 12 , wherein the operational status of the battery subsystem, the operational status of the electrode subsystem, and the operational status of the controller are each represented by a corresponding icon in the device health report display. 15 . The ambulatory medical device of claim 1 , wherein the self-diagnostic test of the electrode subsystem further includes an ECG signal strength test. 16 . The ambulatory medical device of claim 15 , wherein the operational status of the electrode subsystem is further based on results of the ECG signal strength test. 17 . A system for distributing a device health report for an ambulatory medical device, the system comprising: a remote server; and an ambulatory medical device comprising a plurality of subsystems, the ambulatory medical device comprising: a garment to be worn by an ambulatory patient; an electrode subsystem that comprises an electrocardiogram (ECG) electrode that is coupled to the garment and that is configured to acquire ECG data descriptive of cardiac activity of the ambulatory patient, and a therapy electrode that is coupled to the garment and that is configured to provide a therapeutic shock to the ambulatory patient; a controller that comprises a user interface displayed on a housing of the controller, a capacitor that is coupled to a capacitor charging circuit, the capacitor configured to hold a charge capable of generating the therapeutic shock, and at least one processor; and a communications subsystem that comprises a network interface that is configured to communicate with the remote server; wherein the at least one processor is configured to: execute a self-diagnostic test of the electrode subsystem that includes an ECG falloff test for the ECG electrode and an operational test of the therapy electrode, execute a self-diagnostic test of the controller that includes a discharge test for the capacitor, and provide a device health report display for the ambulatory medical device to at least one of (a) the ambulatory patient via the user interface, or (b) the remote server via the network interface, the device health report having a plurality of sections comprising a first section of the device health report display associated with the garment, the first section comprising information regarding at least one of garment fit and garment laundering, a second section of the device health report display associated with an electrode belt of the ambulatory medical device, the second section comprising information regarding an operational status of the electrode subsystem based on results of the ECG falloff test and the operational test, and a third section of the device health report display associated with the controller, the third section comprising information regarding an operational status of the controller based at least on results of the discharge test. 18 . The system of claim 17 , wherein the controller further comprises a te
for electrocardiography [ECG] · CPC title
specially adapted for cooperation with other devices · CPC title
Protection against electrode failure · CPC title
for remote operation · CPC title
relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising · CPC title
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