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Title:
CONTEXT SENSITIVE HELP FUNCTION FOR MEDICAL DEVICE MONITOR/DEFIBRILLATORS
Document Type and Number:
WIPO Patent Application WO/2018/109145
Kind Code:
A1
Abstract:
A portable medical device (20) comprises a plurality of medical device components (16,114,116,128), a user interaction module (140), a state parameter module (142), a controller (120,138) and an output (136) adapted to provide a user perceptible signal representative of a selected medical device feature advisory context-sensitive help item. The medical device components carry out functions that relate to medical device features. The user interaction module identifies user interactions with the medical device components. The state parameter module identifies operational state parameters of the medical device. The controller dynamically identifies a potential problem and selects a context-sensitive help item that comprises a device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the state parameter and (ii) the user interactions with the plurality of medical device components.

Inventors:
FREEMAN CURTIS (NL)
Application Number:
PCT/EP2017/082954
Publication Date:
June 21, 2018
Filing Date:
December 15, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
KONINKLIJKE PHILIPS NV (NL)
International Classes:
A61N1/39
Foreign References:
US6370428B12002-04-09
US20050070964A12005-03-31
US20030055458A12003-03-20
US20120064497A12012-03-15
US6356785B12002-03-12
Attorney, Agent or Firm:
DE HAAN, Poul, Erik (High Tech Campus 5, 5656 AE Eindhoven, NL)
Download PDF:
Claims:
CLAIMS:

1. A portable medical device (20) with a context-sensitive help function, the medical device comprising:

a plurality of medical device components (16,114,116,128), wherein one or more of the plurality of medical device components, individually or cooperating together, carry out one or more functions of the medical device that relate to at least one medical device feature of a plurality of medical device features;

a user interaction module (140) adapted to identify one or more real-time user interactions with the plurality of medical device components;

a state parameter module (142) adapted to identify at least one real-time operational state parameter of the medical device;

a controller (120,138) adapted to dynamically identify a potential problem situation for which a context-sensitive help topic for a particular medical device feature exists and select a context-sensitive help item, in response to the identified potential problem situation, that comprises a medical device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the identified real-time state parameter indicative of the at least one real-time operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components; and

an output (136) adapted to provide at least one user perceptible signal

representative of the selected medical device feature advisory context-sensitive help item.

2. The device (20) of claim 1, wherein the dynamically identifying and selecting by the controller (120) further includes traversing of a context-sensitive help decision-tree for both (i) the identified potential problem situation and (ii) a corresponding first order selected medical device feature advisory or a subsequent order selected medical device feature advisory other than the first order.

3. The device (20) of claim 2, wherein traversing the context-sensitive help decision-tree is based on one or more of (i) user interactions that comprise one or more of a direct user request for help and at least one user interaction response to the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item in real-time, and (ii) a state parameter that comprises one or more of changing conditions of the medical device, circumstances of the medical device, and a patient responsiveness to the medical device, in real-time.

4. The device (20) of claim 3, wherein the first order selected medical device feature advisory context-sensitive help item comprises a most likely context-sensitive help in the decision-tree from which the controller selects the medical device feature advisory context- sensitive help item to begin recommending corrections or solutions to the identified potential problem situation.

5. The device (20) of claim 1, wherein the portable medical device comprises an automated external defibrillator (AED).

6. The device (20) of claim 5, wherein the at least one user perceptible signal

representative of the medical device feature advisory context-sensitive help item comprises an advisory for a particular AED feature that includes one or more of a charge button advisory, an energy selection advisory, an attach electrode pads to patient torso advisory, an attach electrode pads to therapy cable advisory, a check electrode pads connection on patient advisory, and a replace electrode pads with a new set of pads advisory.

7. The device (20) of claim 1, wherein the user perceptible signal comprises at least one of an audio signal, a visual signal, a haptic signal, and a feedback signal via a digital media output for reception on an external media device.

8. The device (20) of claim 1, wherein the user interaction module is further configured to identify a user request for help based on one or more of (i) a direct recognition through use of a help request input control and (ii) an indirect recognition through other user interaction controls that are accessible through at least problem notifications of the medical device.

9. The device (20) of claim 8, wherein the problem notifications comprise at least one of alarms and prompt messages.

10. The device (20) of claim 1 , further comprising:

a help index module (144) configured to enable a user to manually search, via the user interaction module (140) and the controller (120,138), through an index of context- sensitive help topics in response to the medical device feature advisory context-sensitive help item selected by the controller not fully addressing an issue of a problem situation with the medical device.

11. A method of operating a portable medical device (20) with a context-sensitive help function, the method comprising:

providing a plurality of medical device components (16,114,116,128), wherein one or more of the plurality of medical device components, individually or cooperating together, carry out one or more functions of the medical device that relate to at least one medical device feature of a plurality of medical device features;

identifying, via a user interaction module (140), one or more real-time user interactions with the medical device;

identifying, via a state parameter module (142), at least one real-time operational state parameter of the medical device;

dynamically identifying, via a controller (120,138), a potential problem situation for which a context-sensitive help topic for a particular medical device feature exists and selecting, via the controller, in response to the identified potential problem situation, a context-sensitive help item that comprises a medical device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most- probable to least-probable based on both (i) the identified state parameter indicative of the at least one real-time operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components; and providing, via an output (136), at least one user perceptible signal representative of the selected medical device feature advisory context-sensitive help item.

12. The method of claim 11, wherein the dynamically identifying and selecting further include traversing, via the controller (120,138), a context-sensitive help decision-tree for both (i) the identified potential problem situation and (ii) a corresponding first order selected medical device feature advisory or a subsequent selected medical device feature advisory other than the first order.

13. The method of claim 12, wherein traversing the context-sensitive help decision-tree is based on one or more of (i) user interactions that comprise one or more of a direct user request for help and at least one user interaction response to the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item in real-time, and (ii) a state parameter that comprises one or more of changing conditions of the medical device, circumstances of the medical device, and a patient responsiveness to the medical device, in real-time.

14. The method of claim 13, wherein the first order selected medical device feature advisory context-sensitive help item comprises a most likely context-sensitive help in the decision-tree from which the controller (120,138) selects the medical device feature advisory context-sensitive help item to begin recommending corrections or solutions to the identified potential problem situation.

15. The method of claim 11, wherein the portable medical device (20) comprises an automated external defibrillator (AED).

16. The method of claim 15, wherein the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item comprises an advisory for a particular AED feature that includes one or more of a charge button advisory, an energy selection advisory, an attach electrode pads to patient torso advisory, an attach electrode pads to therapy cable advisory, a check electrode pads connection on patient advisory, and a replace electrode pads with a new set of pads advisory.

17. The method of claim 11, wherein the user perceptible signal comprises at least one of an audio signal, a visual signal, a haptic signal, and a feedback signal via a digital media output for reception on an external media device.

18. The method of claim 11, wherein identifying further comprises identifying, via the user interaction module (140), a user request for help based on one or more of (i) a direct recognition through use of a help request input control and (ii) an indirect recognition through other user interaction controls that are accessible through at least problem notifications of the medical device.

19. The method of claim 18, wherein the problem notifications comprise at least one of alarms and prompt messages.

20. The method of claim 11, further comprising:

enabling manual searching, via a help index module (144), the user interaction module (140) and the controller (120,138), through an index of context-sensitive help topics in response to the medical device feature advisory context-sensitive help item selected by the controller not fully addressing an issue of a problem situation with the medical device.

Description:
CONTEXT SENSITIVE HELP FUNCTION FOR MEDICAL DEVICE MONITOR/DEFIBRILLATORS

[0001] The present embodiments relate generally to medical devices and more particularly, to a context sensitive help function for a medical device monitor/defibrillator and a method of providing a context sensitive help function.

[0002] Automated External Defibrillators (AEDs) have been available for public use for several years, and have proven effective at treating Sudden Cardiac Arrest (SCA). SCA kills about 250,000 Americans a year and is the leading cause of death in the U.S.

Untreated SCA usually results in death in a very short time, and survival rates for SCA decline by about 10% for every minute defibrillation treatment is delayed. Because most EMS or other medical response cannot reach the scene of SCA within a very few minutes, it is important for witnesses or bystanders to be able to apply defibrillation treatment as quickly as possible, whenever a defibrillator is available.

[0003] Cardiopulmonary resuscitation (CPR) is often performed concurrent with AED use. CPR is a combination of artificial respiration and artificial circulation that keeps oxygenated blood flowing to the brain during cardiac arrest. The effectiveness of CPR is highly dependent on the proficiency of the rescuer's application, and as such, the American Heart Association (AHA) and American Red Cross have established detailed step-by-step CPR procedures. Many people receive CPR training each year, but most, even emergency responders, have not maintained their proficiency. Rescuers may find it difficult to recall these procedures, especially during high stress rescue situations and as standards evolve.

[0004] Similarly, successful defibrillation requires the rescuer to perform a specific sequence of steps in order for the AED to function properly. The rescuer must activate the AED, remove interfering clothing from the victim's torso, successfully apply the defibrillation electrode pads in their proper locations on the torso, and cause the

defibrillation shock to be delivered in order to defibrillate the heart. The victim's chance of survival improves greatly the faster these steps are completed.

[0005] AEDs are increasingly being deployed into environments where a minimally- trained or untrained user is likely to be the first responder. AEDs now appear in businesses, schools, public venues and homes in addition to the more traditional emergency responder, ambulance and rescue squad environments. [0006] The problems of minimal training, high levels of stress accompanied by noise and confusion, and a very limited time in which to effect a rescue negatively affects the chances of a successful rescue. The rescue of an SCA victim is a high stress event. In order to keep the rescuer on track during the stress of a rescue, many AEDs guide the user through the defibrillation process with audible or visual prompts. These prompting features are very useful to a user who is unfamiliar with the defibrillation procedure or with CPR protocol. An example of a defibrillator with automatic CPR prompting features is described in U.S. Pat. No. 6,356,785 by Snyder et al, entitled "External Defibrillator with CPR Prompts and ACLS Prompts and Methods of Use", which is incorporated herein.

[0007] On the other hand, the same prompting features can delay a proficient rescuer who is able to work faster than the prompts, or can complicate the already chaotic rescue situation with extraneous and distracting information. In some cases, the continuing prompting noise may tempt a rescuer to turn the AED off when a perceived "safe" time in the rescue is reached. If the SCA recurs, the AED then would not have the ability to sense or respond to the recurring emergency.

[0008] Thus, there is a need for an AED which provides appropriate information when it is needed, with minimal action by the user. Specifically, what is needed is an improved AED which selectively provides rescue information to the user in order to reduce confusion and improve the guidance for successful cardiac rescue. Further, an improved AED which can dynamically alter the guidance provided to the rescuer based on both the state of the rescue and on the rescuer's actions during that rescue state could improve the chances of a successful SCA treatment.

[0009] In addition, medical devices, including monitor/defibrillators have generally lacked a user help function on the device. Many clinical procedures involve setup steps of the device in coordination with the clinical treatment or therapy for the patient. A "help" function that is readily accessible and able to assess what the user might be attempting to do and suggest the most appropriate solution could provide quick remedies to the situation in time critical or frustrating circumstances.

[0010] Medical devices provide many clinical functions, some that require proper set up of the device. In some situations, medical devices already provide some indications that something is wrong, but the user may not know how to remedy the situation. For example, technical alarms may indicate that a patient sensor is unable to obtain a measurement, but the user is unsure about how to correct the condition. In other situations, the user may be attempting to have the device perform a certain action but the user is unaware about promptings or corrections or what they mean. For example, on a defibrillator, a clinician may not always be experienced in delivering a therapy such as defibrillation. Interactions with the defibrillator device may indicate this confusion such as repeated pushes of the "Charge" button when no appropriate patient electrode pads or paddles are attached to the device, so a shock is not possible. Thus, there exists a need for a context-sensitive help function that could recognize the state of the device and step the user through possible corrections.

[0011] Accordingly, an improved method and apparatus for overcoming the problems in the art is desired.

[0012] In accordance with one aspect, a defibrillator or other medical device having a context sensitive help function is disclosed. The context sensitive help function can assess the state of the defibrillator (or other medical device) and its context in real-time, and dynamically identify based on the assessed state and the context (i) whether there is a problem (i.e., a problem situation), (ii) what the problem (i.e., problem situation) is and (iii) recommend or indicate corrective actions/solutions of how to correct the problem (i.e., problem situation). Solutions can be recommended and/or indicated as (i) a first order and (ii) as alternative solutions that can be selected by the user and/or when the first order recommended solution does not solve the problem. The context sensitive help function can automatically update dynamically based on one or more of changing conditions, circumstances, user input and/or patient responsiveness in real-time, including taking into account first order recommended solutions that were not selected/passed over by the user or that were tried but did not successfully solve the problem, and whether/what changes in the condition (e.g., circumstances, user input and/or patient responsiveness) may have been caused by the solution that was tried and did not solve the problem.

[0013] According to an embodiment of the present disclosure, a portable medical device with a context-sensitive help function comprises: a plurality of medical device components, wherein one or more of the plurality of medical device components, individually or cooperating together, carry out one or more functions of the medical device that relate to at least one medical device feature of a plurality of medical device features; a user interaction module adapted to identify one or more real-time user interactions with the plurality of medical device components; a state parameter module adapted to identify at least one real-time operational state parameter of the medical device; a controller adapted to dynamically identify a potential problem situation for which a context-sensitive help topic for a particular medical device feature exists and select a context-sensitive help item, in response to the identified potential problem situation, that comprises a medical device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the identified realtime state parameter indicative of the at least one real-time operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components; and an output adapted to provide at least one user perceptible signal representative of the selected medical device feature advisory context-sensitive help item.

[0014] In one embodiment, the dynamically identifying and selecting by the controller further includes traversing of a context-sensitive help decision-tree for both (i) the identified potential problem situation and (ii) a corresponding first order selected medical device feature advisory or a subsequent order selected medical device feature advisory other than the first order. In addition, traversing the context-sensitive help decision-tree can be based on one or more of (i) user interactions that comprise one or more of a direct user request for help and at least one user interaction response to the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item in real-time, and (ii) a state parameter that comprises one or more of changing conditions of the medical device, circumstances of the medical device, and a patient responsiveness to the medical device, in real-time. Furthermore, the first order selected medical device feature advisory context-sensitive help item can comprise a most likely context-sensitive help in the decision-tree from which the controller selects the medical device feature advisory context-sensitive help item to begin recommending corrections or solutions to the identified potential problem situation.

[0015] In another embodiment, the portable medical device comprises an automated external defibrillator (AED). In addition, the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item comprises an advisory for a particular AED feature. The particular AED feature can include one or more of a charge button advisory, an energy selection advisory, an attach electrode pads to patient torso advisory, an attach electrode pads to therapy cable advisory, a check electrode pads connection on patient advisory, and a replace electrode pads with a new set of pads advisory.

[0016] In yet another embodiment, the user perceptible signal comprises at least one of an audio signal, a visual signal, a haptic signal, and a feedback signal via a digital media output for reception on an external media device. In a further embodiment, the user interaction module is further configured to identify a user request for help based on one or more of (i) a direct recognition through use of a help request input control and (ii) an indirect recognition through other user interaction controls that are accessible through at least problem notifications of the medical device. In addition, the problem notifications can comprise at least one of alarms and prompt messages. In a still further embodiment, the device further comprises a help index module configured to enable a user to manually search, via the user interaction module and the controller, through an index of context- sensitive help topics in response to the medical device feature advisory context-sensitive help item selected by the controller not fully addressing an issue of a problem situation with the medical device.

[0017] According to another embodiment of the present disclosure, a method of operating a portable medical device with a context-sensitive help function comprises: providing a plurality of medical device components, wherein one or more of the plurality of medical device components, individually or cooperating together, carry out one or more functions of the medical device that relate to at least one medical device feature of a plurality of medical device features; identifying, via a user interaction module, one or more real-time user interactions with the medical device; identifying, via a state parameter module, at least one real-time operational state parameter of the medical device;

dynamically identifying, via a controller, a potential problem situation for which a context- sensitive help topic for a particular medical device feature exists and selecting, via the controller, in response to the identified potential problem situation, a context-sensitive help item that comprises a medical device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the identified state parameter indicative of the at least one real-time operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components; and providing, via an output, at least one user perceptible signal representative of the selected medical device feature advisory context-sensitive help item.

[0018] In one embodiment, the method includes wherein the dynamically identifying and selecting further include traversing, via the controller, a context-sensitive help decision-tree for both (i) the identified potential problem situation and (ii) a corresponding first order selected medical device feature advisory or a subsequent selected medical device feature advisory other than the first order. In addition, traversing the context-sensitive help decision-tree can be based on one or more of (i) user interactions that comprise one or more of a direct user request for help and at least one user interaction response to the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item in real-time, and (ii) a state parameter that comprises one or more of changing conditions of the medical device, circumstances of the medical device, and a patient responsiveness to the medical device, in real-time. Furthermore, the first order selected medical device feature advisory context-sensitive help item can comprise a most likely context-sensitive help in the decision-tree from which the controller selects the medical device feature advisory context-sensitive help item to begin recommending corrections or solutions to the identified potential problem situation.

[0019] In another embodiment, the method includes wherein the portable medical device comprises an automated external defibrillator (AED). In addition, the at least one user perceptible signal representative of the medical device feature advisory context- sensitive help item comprises an advisory for a particular AED feature. The particular AED feature can include one or more of a charge button advisory, an energy selection advisory, an attach electrode pads to patient torso advisory, an attach electrode pads to therapy cable advisory, a check electrode pads connection on patient advisory, and a replace electrode pads with a new set of pads advisory.

[0020] In yet another embodiment, the method includes wherein the user perceptible signal comprises at least one of an audio signal, a visual signal, a haptic signal, and a feedback signal via a digital media output for reception on an external media device. In a further embodiment, identifying further comprises identifying, via the user interaction module, a user request for help based on one or more of (i) a direct recognition through use of a help request input control and (ii) an indirect recognition through other user interaction controls that are accessible through at least problem notifications of the medical device. In addition, problem notifications can comprise at least one of alarms and prompt messages. In a still further embodiment, the method further comprises enabling manual searching, via a help index module, the user interaction module and the controller, through an index of context-sensitive help topics in response to the medical device feature advisory context- sensitive help item selected by the controller not fully addressing an issue of a problem situation with the medical device.

[0021] Still further advantages and benefits will become apparent to those of ordinary skill in the art upon reading and understanding the following detailed description.

[0022] The embodiments of the present disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. Accordingly, the drawings are for purposes of illustrating the various embodiments and are not to be construed as limiting the embodiments. In the drawing figures, like reference numerals refer to like elements. In addition, it is to be noted that the figures may not be drawn to scale.

[0023] Figure 1 is a diagram of a prior art AED being used during the rescue of a cardiac victim;

[0024] Figure 2 illustrates an AED, with a user request button, according to an embodiment of the present disclosure;

[0025] Figure 3 is a block diagram of an AED apparatus according to an embodiment of the present disclosure;

[0026] Figure 4 is a schematic block diagram view of a portable medical device with a context-sensitive help function according to an embodiment of the present disclosure;

[0027] Figure 5 is a flow diagram view of a method of operating a portable medical device with a context-sensitive help function according to another embodiment of the present disclosure; and

[0028] Figure 6 is a flow diagram view of a method of operating a portable medical device with a context-sensitive help function according to another embodiment of the present disclosure. [0029] The embodiments of the present disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting examples that are described and/or illustrated in the drawings and detailed in the following description. It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the present disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the

embodiments of the present may be practiced and to further enable those of skill in the art to practice the same. Accordingly, the examples herein should not be construed as limiting the scope of the embodiments of the present disclosure, which is defined solely by the appended claims and applicable law.

[0030] It is understood that the embodiments of the present disclosure are not limited to the particular methodology, protocols, devices, apparatus, materials, applications, etc., described herein, as these may vary. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only, and is not intended to be limiting in scope of the embodiments as claimed. It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictates otherwise.

[0031] Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of ordinary skill in the art to which the embodiments of the present disclosure belong. Preferred methods, devices, and materials are described, although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the embodiments.

[0032] With reference now to Figure 1, the defibrillation of a SCA victim using an automatic external defibrillator of the prior art is illustrated. The rescuer 12 begins the process by connecting an AED device 10 to the victim 14 via a set of AED electrodes 16 which are attached to the victim as shown. The rescuer 12 activates the AED 10, which in turn analyzes the patient 14 cardiac parameters through the AED electrodes 16. If the cardiac parameters indicate that the victim is in ventricular fibrillation (VF), the AED 10 will prompt the rescuer 12 to remain clear of the patient and press the triangular shock button to initiate a patient shock through the electrodes 16. The cardiac parameters and prompts may be displayed visually on an AED screen as shown.

[0033] If the defibrillation shock is successful at restoring normal cardiac rhythm, the AED 10 will so indicate and will further prompt the rescuer 12 to perform other first aid actions. If the shock is unsuccessful, the AED 10 may repeat the cardiac analysis and shock sequence, or may prompt the user 12 to begin CPR. The prompting sequence in the prior art AED 10 follows a pre-programmed script, which in very basic AEDs, advances based upon elapsed time. In later generation devices, the script advances based on a detected status of the patient, as detected by signals from the patient electrodes. In addition, AED 10 may provide generic CPR instructions during the CPR period. The prompts are generally provided audibly, or can optionally be provided by text messages on an electronic display.

[0034] Figure 2 shows an AED apparatus according to one embodiment of the present disclosure. AED 20 comprises a set of patient electrodes that are stored inside cartridge 22. Activation of AED 20 may be through an on/off button 24 or by removing the protective electrode cartridge cover 22. The electrodes are removed from cartridge 22 and applied to the patient's bare torso, the detection of which automatically begins the analysis of the patient's condition. When indicated, a shock button 28 is pressed to deliver a defibrillation shock. The AED 20 of Figure 2 lacks the visual display of the prior art AED 10 of Figure 1 in order to reduce cost, size, weight and complexity in the device.

[0035] Figure 2 further illustrates a dedicated user information request button 26 on AED 20. The information request button 26 serves as an interface between rescuer 12 and AED 20. Information request button 26 may be selectively activated by the AED 20 and illuminated to indicate that information is available during that particular operational state. The illumination feature thus serves to draw the user's attention to the information request button 26 during appropriate situations. By keeping the information request button dark when it is not appropriate to press it, user distraction is minimized.

[0036] When the rescuer 12 presses the information request button 26, AED 20 issues help information based on the operational state of the device. By coupling the delivered information based to the operational state of the device, the device is able to provide information that is appropriate to the context in which it was requested. Thus, the provided information is "context-sensitive". In one embodiment, the context-sensitive help is audibly conveyed through speaker 30 or through buzzer 32. Visual help may optionally be displayed (not shown). One exemplary type of context-sensitive help is a detailed set of CPR instructions, wherein the CPR instructions can be provided in response to the information button being pressed during a CPR period.

[0037] Figure 3 is a schematic block diagram of a defibrillator system 110 according to an embodiment of the present disclosure. The defibrillator system 110 comprises an energy source 112 to provide a defibrillating shock to the patient 14 via electrode interface 114 and electrodes 16. Defibrillator system 110 may be implemented as a manual defibrillator, an AED, or a defibrillator trainer that simulates the behavior of a manual defibrillator or AED in use.

[0038] A controller 120 operates electrode interface 114 to selectively connect and disconnect energy source 112 to electrodes 16 in order to provide electrotherapy to the patient 14. Controller 120 also controls the information flow from an instruction generator 122 to the user via one or more of a sound generator 126 or a visual indicator or image generator 124. Instruction generator 122 may also activate protocol changes being performed by the defibrillator 110 based on information received from the controller 120. For example, controller 120 may sense how the AED 1 10 has been activated, either via the on/off button 24 (Figure 1) or by removing the electrode cartridge cover 22 (Figure 1), to determine which protocol to follow. Output of the selected instruction protocol is then accomplished through sound generator 126 and speaker 30 (Figure 1) or buzzer 32 (Figure 1). Audible commands may include verbal commands directing the rescuer in the proper sequence and timing for administering CPR or advanced cardiac life support (ACLS), or audible timing tones, such as those generated by a metronome, for timing the

administration of CPR. Optionally, output may be passed through visual image generator 124 to an LCD display (not shown) for displaying or highlighting textual and graphical instructions.

[0039] Controller 120 controls the information flow to the sound generator 126 or visual image generator 124 based on parameters that indicate the operational state of the defibrillator. Controller 120 further comprises an internal memory for storing operational state information and a timing circuit for determining the elapsed time between successive operational states or between successive user inputs. Operational state parameters are provided from electrode interface 114. Parameters passed from electrode interface 114 to controller 120 comprise patient electrocardiogram (ECG) signals and electrode-to- electrode impedance measurements, collectively indicated by signal line 118. Optionally, electrode interface 114 detects and passes to controller 120, via signal line 130, information on whether an electrode cartridge 116 is installed and if so, what type of electrode cartridge 116 is installed. Exemplary electrode cartridge types are: ADULT, PEDIATRIC, and TRAINING cartridges.

[0040] Controller 120 further controls user information flow based on the state of a user-operated information request button 128. Information request button 128 states may be as simple as PRESSED or NOT PRESSED. In an alternate embodiment, information request button 128 states can comprise one or more of: PRESSED FOR <2 SECONDS, PRESSED FOR >2 SECONDS, and PRESSED FOR >4 SECONDS.

[0041] Other embodiments of the present disclosure are contemplated in which controller 120 controls the state of the information request button 128 itself through an input indicator 132. To indicate that information request button 128 is active, indicator 132 causes the information request button 128 to illuminate, alerting the user that information is available at that particular operational state by pressing the button 128. The illumination feature thus enhances the usefulness of the AED 110, as well as realizing additional information request button 128 states of NOT PRESSED, PRESSED WHEN

ILLUMINATED, and PRESSED WHEN NOT ILLUMINATED. If button press time states are used, as outlined above, illumination of information request button 128 will generally occur only if a "PRESSED <2 SECONDS" state has a corresponding message available.

[0042] An exemplary set of context-sensitive user instructions can be issued in response to specific combinations of operational state and information request button states of "PRESSED <2 SECONDS", "PRESSED 2-TO-4 SECONDS", and "PRESSED >4 SECONDS" as will be explained further herein. In one embodiment, a cartridge containing rescue electrodes is installed in the AED 110. Exemplary operational states which are sensed by controller 120 with input from electrode interface 114 can include: "On, Pads Off, "On, Placing Pads", "On, Pads On, Analyzing", "On, Pads On, CPR Pause, CPR sensed", "On, Pads On, CPR Pause, CPR not sensed", "Standby, Self-Test OK", and "Standby, Self-Test Not OK". A brief description of the user information available at each state combination follows. [0043] "On, Pads Off - AED 110 activated with no user manipulation of stored electrode pads. In this operational state, a rescue has generally begun, and it is undesirable to distract the first-response user with information beyond the first tier voice prompting protocol. However, a second responder rescuer, presumably with a higher level of lifesaving skill, would have access to a "handof ' message which indicates the progress of the rescue. An exemplary handoff message is, "<number> shocks, <number> minutes" of operation, and might be available only if the information request button 128 is intentionally held down for 2 seconds or more. In this instance, and to avoid distracting the first- response user, the information request button would remain un-illuminated, yet would still respond to the request of an operator who had received more extensive and advanced training and knows that this "hidden" information is available if needed.

[0044] "On, Placing Pads" - AED 110 activated with concurrent manipulation of electrode pads, but both pads are not affixed to the patient. Like the "On, Pads Off operational state, it is undesirable to distract the first-response user with information beyond the first tier voice prompting protocol during this especially critical step in the rescue. A second responder rescuer, presumably with a higher level of lifesaving skill, again would have access to the "handoff message which indicates the progress of the rescue prior to the second responder rescuer's arrival.

[0045] "On, Pads On, Analyzing" - AED 110 activated with both electrode pads affixed to the patient. AED 110 is analyzing the patient ECG and delivering defibrillation therapy if so determined. No detailed level of user information is necessary during this operational state.

[0046] "On, Pads On, CPR Pause, Initiate CPR" - AED 110 operational state is a CPR period as defined by a CPR treatment protocol, generally following the "On, Pads On, Analyzing" operational state, and when conditions indicate that CPR may be initiated. During the CPR pause, the rescuer is expected to provide CPR to the victim if the victim's condition warrants. Many rescuers are not proficient in the correct CPR protocols, including airway management, where to place hands, and the sequence and cadence of chest compressions and rescue breaths. Thus, during this period, a momentary press of the user information request button 128 will initiate instructions that will guide the user through the proper CPR procedure. Input indicator 132 may further prompt the user that this information is available by illuminating the button 128 accompanied by a standard voice protocol message saying "For help with CPR, press the illuminated button". Because this CPR information can be relatively extensive, it is made optionally available through the second-tier request. Likewise, if CPR is not indicated, the rescuer is not bombarded by CPR instructions that are distracting and introduce confusion as to whether or not CPR should be performed or withheld. A more proficient rescuer can thus be spared the distraction of extraneous CPR instructions and proceed with the rescue faster. Also, as in operational states 1 and 2 above, the second responder rescuer has access to the "handoff message by holding the illuminated information request button down for 2 seconds or more.

[0047] "On, Pads On, CPR Pause, do not initiate CPR" - AED 110 operational state is a protocol-defined CPR period and when conditions indicate that CPR should not be initiated. In this case, the rescuer has perhaps panicked, or has not heard a post-analysis prompt saying that "It is safe to touch the patient" and has waited a significant period of time before requesting CPR assistance. When the information request button 128, again preferably illuminated, is pressed momentarily, the controller 120 delivers a message intended to reassure the user, such as "It is safe to touch the patient", but will not provide CPR instruction. A reason for withholding instruction is that the cumulative elapsed time from the start of the CPR pause to the press of the information request button 128 and then to the conclusion of the round of "instructed" CPR may exceed the recommendations of CPR treatment protocols. For example, if CPR protocol dictates a ninety second maximum CPR pause and the AED CPR prompting sequence consumes sixty seconds, then the "On, Pads On, CPR Pause, do not initiate CPR" operational state would begin 30 seconds after the beginning of the CPR pause, and last until the end of the CPR pause. Thus, an operator who delays requesting assistance for a significant period of time is not confused by abbreviated or interrupted CPR prompts. As in previous operational states, the second responder rescuer also has access to the "handoff message by holding the illuminated information request button down for 2 seconds or more.

[0048] "Standby, Self-Test OK" - AED 110 is in standby or has been inadvertently turned off during rescue, and the most recent AED self-test indicates "OKAY". Assuming the more severe case of the AED 110 being inadvertently deactivated during a rescue, the information request button 128, when pressed, prompts the user to "In case of emergency, press the on/off button". This operational state also provides the handoff instruction for button 128 presses of 2 seconds or more, again for second tier responder purposes.

[0049] "Standby, Self-Test Not OK" - AED 110 is in standby or has been inadvertently turned off during rescue, and the most recent AED self-test indicates "NOT OKAY". Anytime the AED 110 is inactive and in a non-operational state, the buzzer 32 makes a periodic audible signal and concurrently the information request button 128 illuminates. When pressed, AED 110 prompts the user with the self-test failure corrective action. This gives the user the opportunity to quickly address the situation and resume the rescue.

Exemplary self-test corrective action messages are: "Replace battery immediately" and "Pads not usable, insert new pads cartridge". This operational state also provides the handoff instruction for button 128 presses of 2 seconds or more, again for second tier responder purposes.

[0050] If controller 120 is disposed to detect the cartridge installed in AED 110 through electrode interface 114, additional instruction sets which depend upon operational state, button state, and cartridge type are contemplated. In a first example, a rescue cartridge can be either an ADULT or PEDIATRIC rescue cartridge. Because CPR protocols differ substantially between adults and infants, controller 120 causes instruction generator 122 to select the appropriate CPR protocol depending on detected cartridge type. The "On, Pads On, CPR Pause, Initiate CPR" operational state accompanied by a momentary press of the information request button 128 would then prompt the appropriate ADULT or PEDIATRIC set of detailed CPR instructions.

[0051] The electrode cartridge detection feature has additional utility by discerning when the AED is used in a non-rescue operational state. If the AED has a built-in training operational state, the training electrode cartridge should be disposed such that it cannot deliver a shock to a trainee or training mannequin. In the training operational state, the information request button 128 pressed momentarily would provide a means to select among a plurality of training scenario settings, or might optionally be used to select an alternate training scenario declaration. Such a feature is especially useful in an AED without a visual display.

[0052] The electrode cartridge detection feature has additional utility by discerning when no cartridge is present in the AED. An exemplary set of user instructions can be issued in response to specific combinations of operational state and information request button states of "PRESSED <2 SECONDS", "PRESSED 2-TO-4 SECONDS", and

"PRESSED >4 SECONDS" with no cartridge installed. Applicable operational states with no cartridge installed can include: "On, Pads Off, "Standby, Self-Test OK", and "Standby, Self-Test Not OK". A brief description of the user information available at each state combination follows.

[0053] "On, Pads Off - AED 110 activated with no electrode cartridge installed. If a rescue is intended in this operational state, a first-tier voice message automatically informs the user to install a cartridge, without requiring the push of the information request button. In this state, it is undesirable to distract the first-response user with information beyond that pertaining to cartridge installation since proceeding further with the rescue process is irrelevant without an installed electrode pads cartridge. Then, when a cartridge is installed per the automatic instruction, AED 110 reverts to the appropriate information protocol as previously discussed herein. Absence of a cartridge in AED 110 can also signal controller 120 to operate in an administrational mode, said signal confirmed by pressing the information request button for more than 4 seconds. The sequence of removing the cartridge, activating AED 110, and then holding the information request button 128 would be well known to a routine user. Entry into the administration mode is accompanied by an "Administration" or equivalent voice prompt. The information request button 128 can then be manipulated to further advance through the various administration mode features, with additional voice prompting as appropriate.

[0054] "Standby, Self-Test OK" - The cartridge is absent AED 110 while in standby, and the most recent AED self-test indicates "OKAY". If the AED 110 is inactivated during the rescue and the cartridge is concurrently removed from AED 110, buzzer 32 makes a periodic audible signal and the information request button 128 simultaneously illuminates. When the information button is pressed momentarily, the AED 110 prompts the user to "In case of emergency, press the on/off button", followed closely by a prompt to insert a cartridge. This instruction is especially important in an AED with no graphical or text display, because it may not be apparent to the user that the AED has been inactivated and that the cartridge is not installed. The presence of a single illuminated information request button 128 will attract the user's attention and get the rescue back on track. In the more likely case of the cartridge removal occurring during the routine standby mode, AED 110 automatically indicates by some means, such as illuminated LED or audible beep sounds, that the AED 110 is not ready for use and that an operator or other maintenance individual needs to provide it with service. This feature spares battery life and environmental noise clutter by making more detailed cartridge insertion prompting dependent on the press of the information request button 128. This operational state also provides the handoff instruction for button 128 presses of 2 seconds or more, assuming that second responders have arrived, have inactivated the AED 110 and removed the cartridge, but still need pre- arrival rescue information. For button presses of 4 seconds or longer AED 110 will begin the administration mode as described in the previous paragraph.

[0055] "Standby, Self-Test Not OK"-The cartridge is absent AED 110 while in standby, and the most recent AED self-test indicates "NOT OKAY". Assumptions and response of the AED 110 to operational state and information request button 128 states are the same as for "Standby, Self-Test OK" operational state.

[0056] It should be appreciated that the scope is not limited to the embodiments described above. The above-described AED provides a second, more detailed layer of help information that is appropriate to both the operational, i.e., rescue, state and to an explicit user request. Such an AED can be modified and altered by those skilled in the art without departing from the spirit and scope of the present embodiments.

[0057] With reference now to Figure 4, a schematic block diagram view is shown of the controller 120 for the portable medical device 20 with a context-sensitive help function according to an embodiment of the present disclosure. Portable medical device 20 includes a database 134, a user interface 136, and controller 120 operatively coupled with database 134 and user interface 136.

[0058] Features of a medical device, as disclosed herein, advantageously provide a context-sensitive help function on the device. The context-sensitive help function would assess the state of the device, the context, and recommend a first order correction or solution, or provide an indication of what the problem is and how to correct it. In many circumstances, if the user responds with an indication that the recommended solution wasn't the issue, then the context-sensitive help function could recommend another correction or solution, and so on. The context-sensitive help function could be activated by one or more of (i) a direct selection of a "help" control, (ii) in response to or by acting on a message that is present on the device such as a technical or physiological alarm message, or (iii) automatically by tracking user interactions with the device and recognizing that the tracked actions indicate a possible situation, i.e., or problem situation where the user is confused and needs additional help.

[0059] A principal feature of the embodiments of the present disclosure is a decision- tree for a given situation (i.e., problem situation) that is traversed by software (e.g., via a context engine and/or controller) according to user responses to recommend one or more corrective action or corrective actions (e.g., according to user responses to the

recommended corrective actions). Also in the software (e.g., context engine and/or controller) is logic that (i) recognizes a user's express or explicit request for help, or (ii) automatically assesses the state of the device and user interactions with it, to place the user at the most likely or best position in the help decision-tree for the given problem situation from which to begin recommending corrective actions or corrections to the given problem situation.

[0060] With reference again to Figure 4, the database or storage 134 comprises electronic storage media that electronically stores information. The electronic storage media of database storage 134 can include one or both of system storage that is provided integrally (i.e., substantially non-removable) with portable medical device 20 and/or removable storage that is removably connectable to portable medical device 20 via, for example, a port (e.g., a USB port, a FireWire port, etc.) or a drive (e.g., a disk drive, etc.). Database or storage 134 may include one or more of optically readable storage media (e.g., optical disks, etc.), magnetically readable storage media (e.g., magnetic tape, magnetic hard drive, floppy drive, etc.), electrical charge-based storage media (e.g., EPROM, EEPROM, RAM, etc.), solid-state storage media (e.g., flash drive, etc.), and/or other electronically readable storage media. Database or storage 134 may store software algorithms, information determined by controller 120, information received via user interface 136, and/or other information that enables portable medical device 20 to function properly. Database or storage 134 may be a separate component within portable medical device 20, or database storage 134 may be provided integrally with one or more other components of portable medical device 20 (e.g., controller 120). Furthermore, database or storage 134 may ideally be contained and maintained (i.e., updated) on a network server, shared computer, be internet based or contained within a third party data center and portable medical device 20 may access this data through a telecommunications protocol (e.g., via a wired or wireless communications connection with the third party data center). [0061] User interface 136 is configured to provide an interface between portable medical device 20 and a user (e.g., a rescuer 12) through which the user can provide information to and receive information from the portable medical device 20. The user interface 136 enables one or more of data, results, and/or instructions and any other communicable items, collectively referred to as "information," to be communicated between the user and portable medical device 20. An example of information that may be conveyed to user 12 is context-sensitive help throughout a period during which the patient is receiving rescue procedures. Another example of information that may be conveyed to user 12 is an alarm or unsafe condition detected by portable medical device 20. Examples of interface devices suitable for inclusion in user interface 136 include a keypad, buttons, switches, a keyboard, knobs, levers, a display screen, a touch screen, speakers, a microphone, an indicator light, an audible alarm, and a printer. Information may be provided to user 12 by user interface 136 in the form of auditory signals, visual signals, tactile signals, and/or other sensory signals. In one embodiment, the user interface 136 may be integrated with a removable storage interface provided by database or storage 134. In such an example, information is loaded into portable medical device 20 from removable storage (e.g., a smart card, a flash drive, a removable disk, etc.) that enables the user to customize the implementation of portable medical device 20. Other techniques for communicating information with portable medical device 20 are also contemplated as user interface 136.

[0062] As noted herein above, controller 120 is operatively coupled with database 134 and user interface 136. Controller 120 comprises one or more modules that include at least a context module 138, a user interaction module 140, a state parameter module 142, and a help index module 144, as will be discussed further herein. In addition, controller 120 can be configured for a wired or wireless communications connection with a remote device or network, for example, as indicated via reference numeral 146.

[0063] In one embodiment, controller 120 comprises one or more of a microprocessor, microcontroller, field programmable gate array (FPGA), integrated circuit, discrete analog or digital circuit components, hardware, software, firmware, or any combination thereof, for performing various functions as discussed herein, further according to the requirements of a given portable medical device (e.g., an AED) system apparatus implementation and/or application. Controller 120 can further comprise the one or more of the various modules as discussed herein. Additional details regarding the controller 120 will be provided herein below with reference to the Figures. In addition, the modules 138-144 can comprise one or more of an integrated circuit, discrete analog or digital circuit components, hardware, software, firmware, or any combination thereof, for performing various functions as discussed herein, further according to the requirements of a given portable medical device (e.g., AED) system apparatus implementation and/or application. Furthermore, one or more of the modules 138-144 can further comprise various combinations of one or more of the various modules.

[0064] According to one embodiment, the medical device comprises a plurality of medical device components. The medical device components can comprise, for example, a manual/auto mode selector, AED pads, lead wires, connectors, an energy level selector, a charge button, a shock button, etc. The one or more of the plurality of medical device components, individually or cooperating together, carry out one or more functions of the medical device. In addition, the one or more functions of the medical device relate to at least one medical device feature of a plurality of medical device features.

[0065] In one embodiment, the plurality of medical device components are configured to cooperate together to carry out one or more rescue functions of the medical device that directly relate to and/or correspond with at least one medical device feature of a plurality of medical device features. The functions can comprise, for example, "operating in either manual or automatic feature mode", "selecting an energy level for defibrillation",

"monitoring a patient vital sign via attached pads", "monitoring an impedance or other electrical characteristic via attached pads", "charging the shock circuit of the medical device", and "administering a shock via the charged shock circuit", etc. The medical device features can include, for example, "a manual or automatic mode via a user selection with the manual/auto mode selector", "an energy level selection via a user interacting with the energy level selector", "a charge activation via a user pressing a charge button", "a shock administration via a user pressing a shock button", "a patient monitoring via a user attaching pads to a patient's torso", and "establishing electrical connections with pads via a user attaching pad lead wires to a base unit", etc.

[0066] The user interaction module 140 of controller 120 is configured to identify one or more real-time user interactions with the plurality of medical device components. The state parameter module 142 of controller 120 is configured to identify at least one real-time operational state parameter of the medical device. The context module 138 of controller 120 is configured to dynamically identify a potential problem situation for which a context- sensitive help topic for a particular medical device feature exists. In response to the identified potential problem situation, the context module 138 of controller 120 selects a context-sensitive help item that comprises a medical device feature advisory from among a plurality of advisories. The context module 138 selects the context-sensitive help item according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the identified real-time state parameter indicative of the at least one realtime operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components.

[0067] In one embodiment, controller 120 is adapted to dynamically identify a potential problem situation for which a context-sensitive help topic or category for a particular medical device feature, e.g., an AED feature, exists. The controller is further adapted to select a context-sensitive help item that (a) comprises a medical device feature advisory selected from among a plurality of advisories according to a context-sensitive help decision-tree order of a most-probable solution/advisory to a least-probable solution/advisory and (b) characterizes the identified problem situation. The selected context-sensitive help item represents at least one recommended potential solution to the identified potential problem situation from among a plurality of potential context-sensitive help items. Selecting the context-sensitive help item is based on both (i) the identified state parameter indicative of the at least one real-time operational state of the medical device, e.g., an automated external defibrillator, and (ii) the identified one or more real-time user interactions with the plurality of medical device components of the medical device.

[0068] The dynamically identifying and selecting of the controller 120 can further include traversing of a context-sensitive help decision-tree for both (i) the identified potential problem situation and (ii) a corresponding first order selected medical device feature advisory or a subsequent order selected medical device feature advisory other than the first order. In addition, the traversing of the context-sensitive help decision-tree can be based on one or more of (i) user interactions and (ii) a state parameter. The user

interactions can comprise one or more of a direct user request for help and at least one user interaction response to the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item, in real-time. Furthermore, the state parameter can comprise one or more of (i) changing conditions of the medical device (e.g., an AED), (ii) circumstances of the medical device, and (iii) a patient responsiveness to a function (e.g., a rescue function) of the medical device, in real-time. As disclosed herein, the first order selected medical device feature advisory context-sensitive help item can comprise a most likely or best position of context-sensitive help in the decision-tree from which the controller 120 selects the medical device feature advisory context-sensitive help item to begin recommending corrections or solutions to the identified potential problem situation.

[0069] For an AED device, the at least one user perceptible signal representative of the medical device feature advisory context-sensitive help item for a particular AED feature (or features) can comprise one or more of a charge button advisory, an energy selection advisory, an attach electrode pads to patient torso advisory, an attach electrode pads to therapy cable advisory, a check electrode pads connection on patient advisory, and a replace electrode pads with a new set of pads advisory. Other advisories may also be possible.

[0070] The medical device 20 further includes an output, for example, via user interface 136, adapted to provide at least one user perceptible signal representative of the selected medical device feature advisory context-sensitive help item. In one embodiment, the user perceptible signal can comprise at least one of an audio signal, a visual signal, a haptic signal, and a feedback signal via a digital media output for reception on an external media device. In addition, the help index module 144 of controller 120 is configured to enable a user to manually search, via the user interaction module 140 and the controller 120 (or context module 138), through an index of context-sensitive help topics in response to the medical device feature advisory context-sensitive help item selected by the controller (or context module) not fully addressing an issue of a problem situation with the medical device, e.g., being confronted by the user.

[0071] In one embodiment, the user interaction module 140 can also be configured to identify a user request for help based on one or more of (i) a direct recognition through use of a help request input control (e.g., a help button) and (ii) an indirect recognition through other user interaction controls (e.g, user interface controls) that are accessible through problem notifications on the medical device (e.g., an AED). In addition, the problem notifications can comprise at least one of alarms and prompt messages. [0072] With reference now to Figure 5, there is shown a flow diagram view 150 of a method of operating a portable medical device with a context-sensitive help function according to another embodiment of the present disclosure. A help index 152 (e.g., implemented via help index module 144) comprises a topical index to be accessed, e.g., via a user control, to obtain help. The help index 152 may output a help tree 160 according to criteria of "Mode=Manual, Technical Alarm = "Pads Off, and Actions - null". In addition, a context engine 154 (e.g., implemented via context module 138) receives input of a current state of the medical device from state monitor 156 (e.g., implemented via state parameter module 142), plus input from the user's recent actions from user actions block 158 (e.g., implemented via user interaction module 140).

[0073] With reference still to Figure 5, the context engine 154 comprises logic that will end up pointing to a problem situation. In the example illustrated, the state monitor 156 sees that medical device is in manual mode, and there is no valid signal from defibrillation pads. The state monitor 156 outputs "state = manual mode, pads off. The context engine 154 is also monitoring user actions 158, and from that the context engine 154 is seeing that the user is constantly pressing the "charge" button. The user actions 158 outputs "action = pressing "charge"". In response, the context engine 154 outputs "topic= Attach pads". The context engine 154 is thus operable to figure out what the user is trying to do and suggest context-sensitive help, as disclosed herein. The context engine's logic vectors this to the problem: "Device Not Charging" (where the designation "PK" represents a Problem Key) in Help Tree 160. The context engine's best help suggestion for this example scenario is that the "Defibrillation Pads are not attached to the patient" in the Attach Pads Help 162. Three different help suggestions are presented for this: HelpOl (164) - "Attach pads to patient's bare chest"; Help02 (166) - "Verify Pads are connected to the Therapy cable"; and Help03 (168) - "Check pads connection. Make sure pads are well adhered to patient's chest. If still seeing "Pads Off, replace with a new set of pads."

[0074] If the context engine 154 presents "a plurality" of issues, i.e., in order from most likely to least likely, then the user may select the one that seems most pertinent and be presented with a remedy, or again, possibly multiple remedies. In selecting a possible problem presentation, the user may then decide that it isn't his/her situation, and need to move to another likely problem, either by the context engine presenting the next most likely problem (according to its decision tree), or alternatively, by returning to a list of potential problem situations the context engine has identified, and letting the user choose which problem he or she believes is the one. This same sort of logic would also apply to the solutions. It could be a list of, e.g., check a, b, and c, or it could be "Check (a). Did that work?" If yes, exit; otherwise, if no then check (b), etc.

[0075] Turning our attention now to Figure 6, there is shown a flow diagram view 170 of a method of operating a portable medical device with a context-sensitive help function according to another embodiment of the present disclosure. The method comprises:

identifying (at Step 172), via a user interaction module 140, one or more real-time user interactions with the medical device; identifying (at Step 174), via a state parameter module 142, at least one real-time operational state parameter of the medical device;

dynamically identifying (at Step 176), via a controller 120 (or context module 138), a potential problem situation for which a context-sensitive help topic for a particular medical device feature exists and selecting, via the controller, in response to the identified potential problem situation, a context-sensitive help item that comprises a medical device feature advisory from among a plurality of advisories according to a context-sensitive help decision-tree order of most-probable to least-probable based on both (i) the identified state parameter indicative of the at least one real-time operational state of the medical device and (ii) the identified one or more real-time user interactions with the plurality of medical device components; and providing (at Step 178), via an output 136, at least one user perceptible signal representative of the selected medical device feature advisory context- sensitive help item.

[0076] Although only a few exemplary embodiments have been described in detail above, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of the embodiments of the present disclosure. For example, the embodiments of the present disclosure can be advantageously applied to any defibrillator /monitor or other medical product/device that has sufficient complexity that a user might be confused and require assistance to the situation at hand. The embodiments of the present disclosure could further be applicable to the clinical operation of the device, device setup issues, device configuration, and device maintenance or service. Accordingly, all such modifications are intended to be included within the scope of the embodiments of the present disclosure as defined in the following claims. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents, but also equivalent structures.

[0077] In addition, any reference signs placed in parentheses in one or more claims shall not be construed as limiting the claims. The word "comprising" and "comprises," and the like, does not exclude the presence of elements or steps other than those listed in any claim or the specification as a whole. The singular reference of an element does not exclude the plural references of such elements and vice- versa. One or more of the embodiments may be implemented by means of hardware comprising several distinct elements, and/or by means of a suitably programmed computer. It is understood that the described modules may be computer program modules which are rendered in a non- transitory computer-readable medium. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to an advantage.