System and method for providing software updates to medical devices

Abstract

The medical device has an electromechanical pneumatic assembly configured to generate airflow. The electromechanical pneumatic assembly is located within the medical device and coupled to one or more components, and a controller is coupled to the electromechanical pneumatic assembly. The controller is configured to receive software update data associated with one or more components and to store the software update data in memory coupled to the controller. The software update data includes changes to one or more of the following: parameters of one or more components, functions of the electromechanical pneumatic assembly, and performance indicators of the medical device.

Description

Background Art

[0001] Cross - reference to Related Applications This application claims priority based on U.S. Provisional Patent Application No. 63 / 506,324, filed on June 5, 2023, entitled "System and Methods of Providing a Software Update to a Medical Device", the entire content of which is incorporated herein by reference.

Technical Field

[0002] Technical Field The present disclosure generally relates to systems and methods for providing software updates to medical devices, and in some embodiments, to systems and methods for providing software updates to ventilators.

[0003] Brief Description of the Drawings The following detailed description of embodiments of systems and methods for providing software updates to medical devices is better understood when read in conjunction with the accompanying drawings of exemplary embodiments. However, it should be understood that the present invention is not limited to the configurations and means shown as such.

Brief Description of the Drawings

[0004] [Figure 1] FIG. 1 is a top view of a ventilator connected to a patient, having a medical device unit, a breathing circuit, and a patient interface, according to an exemplary embodiment of the present invention. [Figure 2] FIG. 2 is a schematic diagram of the ventilator system of FIG. 1. [Figure 3] FIG. 3 is a top perspective view of the medical device unit of FIG. 1. [Figure 4] FIG. 4 is a bottom view of the medical device unit of FIG. 1. [Figure 5] FIG. 5 is a rear perspective view of the medical device unit of FIG. 1. [Figure 6]Figure 6 is a schematic diagram of the ventilator system shown in Figure 1. [Figure 7] Figure 7 shows a network environment configured to allow the ventilator system of Figure 1 to communicate with one or more external devices. [Figure 8] Figure 8 is a flowchart illustrating an exemplary method of using the ventilator system shown in Figure 1. [Overview of the project] [Problems that the invention aims to solve]

[0005] background Medical devices such as ventilators play a crucial role in modern healthcare, supporting the delivery of on-demand treatment to patients. These devices often rely on software to function optimally and require regular updates to improve their performance, security, and compliance with evolving healthcare standards and regulations.

[0006] Traditionally, updating medical device software has been a cumbersome process, often requiring physical access to the device by healthcare professionals or software specialists. This process is time-consuming, costly, and disruptive, potentially delaying critical updates and, in some cases, interfering with patient care. [Means for solving the problem]

[0007] overview Embodiments of the present disclosure are directed to a medical device having an electromechanical pneumatic assembly configured to generate airflow, the electromechanical pneumatic assembly being located within the medical device and coupled to one or more components. The device also includes a controller coupled to the electromechanical pneumatic assembly, the controller being configured to receive software update data associated with one or more components and to store the software update data in a memory coupled to the controller, the software update data including changes to one or more parameters of one or more components, functions of the electromechanical pneumatic assembly, and performance indicators of the medical device.

[0008] In some embodiments, the medical device includes a beacon configured to provide a display representing software update data. The beacon is configured to request a software update. The beacon is configured to determine the availability of a software update. The beacon periodically sends the software version of the medical device to a server, which compares the software version with the software update and sends the software update to the medical device.

[0009] In some embodiments, the controller receives software updates without human intervention. The controller is configured to output signals to one or more of the following: a speaker, a user interface, a storage device, an external device, a beacon, a writing device, a transmitting device, and an indicator.

[0010] In some embodiments, the medical device includes a wake-up controller coupled to the controller, which is configured to power on the medical device before the controller receives software update data. The controller is further configured to display the software status associated with the software update data on the user interface via a display screen or light indicator. The controller includes a low-power controller configured to receive the software update data.

[0011] In some embodiments, the controller is configured to receive multiple inputs from the user associated with the operation of a medical device, store the multiple inputs in a database, and receive subsequent software update data containing instruction data associated with the multiple inputs. The controller is further configured to receive multiple voice prompts from the user, and to use one or more models to parse and extract one or more keywords associated with the request from the voice prompts and output a voice response based on the request.

[0012] Another embodiment of the present disclosure may provide a method for providing software updates to a medical device. This method includes receiving software update data associated with one or more components of a ventilator, the ventilator including an electromechanical pneumatic assembly located within the ventilator and coupled to one or more components. The method also includes storing the software update data in a memory coupled to a controller, the controller being coupled to the electromechanical pneumatic assembly. The method also includes cases where the software update data includes changes to the parameters of one or more components.

[0013] In some embodiments, this method includes receiving a plurality of inputs from a user associated with the operation of a medical device, storing the plurality of inputs in a database, and receiving the next software update data which includes instruction data associated with the plurality of inputs.

[0014] In some embodiments, this method includes receiving multiple voice prompts from a user, using one or more models to parse and extract one or more keywords associated with a request from the voice prompts, and outputting a voice response based on the request.

[0015] In some embodiments, this method includes powering on the medical device via a wake-up controller coupled to the controller before the controller receives software update data. This method may include displaying the software status associated with the software update data on a user interface via a display screen or light indicator.

[0016] In some embodiments, this method includes determining that a medical device has transitioned from an in-use state to an in-use state, and, in response to the determination that the medical device is in an in-use state, retrieving software update data from memory for installation.

[0017] Another embodiment of the present disclosure may provide a method for providing software updates to a medical device. This method includes receiving software update data associated with a ventilator, the ventilator including an electromechanical pneumatic assembly coupled to one or more components. The method also includes storing the software update data in a memory coupled to a controller, the controller being coupled to the electromechanical pneumatic assembly. The method also includes determining that the ventilator is in a ventilating state, which is when the electromechanical pneumatic assembly is providing ventilation to a patient. The method also includes preventing the ventilator from retrieving the software update data from memory for installation in response to the determination that the ventilator is in a ventilating state.

[0018] In some embodiments, the method includes determining that the ventilator has transitioned from a ventilating state to a non-ventilating state and retrieving software update data from memory for installation in response to determining that the ventilator is in the non-ventilating state.

Mode for Carrying Out the Invention

[0019] Detailed Description Medical devices such as ventilators are generally used to provide respiratory therapy and / or support to patients with respiratory insufficiency. Most ventilators include a number of components that work together to provide appropriate breathing to the patient. During use or storage, the software controlling the ventilator may malfunction or become outdated, causing the ventilator to malfunction. In particular, when a ventilator is stored together with a number of other ventilators or supplies in a storage unit, an outdated ventilator may not be identified before the need for its use arises. Further, it takes time to perform consistent testing and transactions to ensure that the ventilator is up-to-date.

[0020] Exemplary embodiments of the present invention provide a system and method for providing software updates to medical devices. Embodiments of the present invention provide a system, generally designated 100 (e.g., a ventilator system), shown in FIGS. 1 - 6. In use, the ventilator system 100, which may also be simply referred to herein as a ventilator (e.g., ventilator 100), can be used to provide respiratory assistance for the treatment of patients in a medical setting such as an intensive care unit (ICU) of a hospital or clinic. The ventilator 100 can also be used in other settings such as an ambulance, an outpatient medical center, an inpatient / outpatient center, a nursing home / long - term care facility, and a mobile clinic that can go directly to the patient. In some embodiments, the ventilator 100 is portable to enable use in different environments. For example, the ventilator 100 may be easily transportable for use in a mobile environment (e.g., an ambulance). In some embodiments, the ventilator 100 includes a medical device unit that is compact in size to enable portability. For example, the medical device unit of the ventilator 100 (e.g., the ventilator) may include a single circuit board that contains all necessary or most important control components and desired components to reduce the overall footprint of the medical device unit.

[0021] In some embodiments, the ventilator 100 enables the rapid initiation of emergency ventilation for patients with respiratory failure. The ventilator 100 can be a rescue response system configured to provide emergency treatment (e.g., ventilation) to a user or individual with respiratory failure. The ventilator 100 can be configured to provide rapid emergency ventilation to the patient while minimizing or eliminating wasteful air leakage. The ventilator 100 can provide an efficient system for providing ventilation to the patient.

[0022] When in use, the ventilator 100 may be used for the treatment of a patient in a medical setting. For example, the ventilator 100 may be a ventilator for assisting a patient with respiratory failure or acute respiratory failure. The ventilator 100 may include a medical device unit 102, a breathing circuit 200, and a patient interface 300. The medical device unit 102 may be configured to provide mechanical ventilation to a patient with respiratory failure via the breathing circuit 200. The medical device unit 102 may provide the necessary gas or airflow that can be directed through the breathing circuit 200 to a patient interface 300 coupled to the patient's face. The medical device unit 102 may include a blower 104, a control system or controller 106, and a power supply 108. The breathing circuit 200 may include a tube 202 that can be coupled to the medical device unit 102 at a first end 204 and to the patient interface 300 at a second end 206.

[0023] In some embodiments, the medical device unit 102 may be a ventilator used to provide assistance to a patient with respiratory failure. The medical device unit 102 may be configured to provide the patient with different modes of ventilation. For example, the medical device unit 102 may be configured to provide assisted controlled ventilation, volume-controlled ventilation, pressure support, pressure-controlled ventilation, pressure-regulated volume control, positive end-expiratory pressure, synchronous intermittent forced ventilation, and / or manual ventilation. The medical device unit 102 may be used in place of a bag-valve device, an emergency transport ventilator, or any other mode or device for providing ventilation to a patient.

[0024] The medical device unit 102 may include software or firmware configured to control the medical device unit 102. For example, the medical device unit 102 may include memory (e.g., memory 115) configured to store software that provides instructions to a processor or control unit (e.g., control system 106). In some embodiments, the software may be updated periodically. For example, the software of the medical device unit 102 may need to be updated to add additional functionality, improve security, or fix problems with the medical device unit 102.

[0025] In some embodiments, software or firmware is stored in a System-on-Module (SOM) and / or microcontroller. For example, a medical device unit 102 may include one or more SOMs and / or microcontrollers, which may include software for controlling the functions and / or one or more components of the medical device unit 102. The SOMs and / or microcontrollers may also include operating software. In some embodiments, changes (e.g., updates) to the software or firmware of the medical device unit 102 include changes to the operating software.

[0026] The medical device unit 102 may receive a software update data package ("Software Update"), download the software update, and install the update. For example, the medical device unit 102 may receive a software update pushed (e.g., transmitted) via Bluetooth®, WiFi®, Near Field Communication (NFC), or a wired connection. In some embodiments, the software update is encrypted and verified before being flushed (e.g., updated) into the read-only memory (ROM) of the SOM and / or microcontroller. In some embodiments, the software of the SOM and / or microcontroller includes a bootloader configured to update and / or execute the software update. In some embodiments, the medical device unit 102 is configured to download the software update before installing it. For example, an external device may be used to push (e.g., wirelessly transmit) a software update to the medical device unit 102, and the medical device unit 102 may download the software before installation. In some embodiments, the medical device unit 102 downloads the entire software update before installation. Alternatively, the medical device unit 102 may download and install the software update segment by segment. For example, the medical device unit 102 may download a segment of a software update, install a segment of the software update, download subsequent segments of the software update, and then install segments of the software update. In some embodiments, an external device adjacent to the medical device unit 102 automatically transmits the software updates that the medical device unit 102 downloads while the external device is adjacent to the medical device unit 102. The external device may be adjacent to multiple medical device units 102, each of which may be configured to download software updates pushed from the external device.

[0027] In some embodiments, the medical device unit 102 is configured to revert to a previous software version. For example, the medical device unit 102 may receive a software update, but the installation of the software update may fail. The medical device unit 102 may revert to the most recent preceding working version to ensure that the medical device unit 102 remains operational. In some embodiments, a software update includes two or more versions. For example, a software update may include software A and software B, so that if software A fails (for example, during download or installation), software B can continue and allow the medical device unit 102 to be used. In some embodiments, the differences between software A and software B are minor. For example, software A may include one or more less critical features that are not present in software B.

[0028] In some embodiments, the medical device unit 102 includes a medical WiFi adapter ("WiFi adapter") configured to independently receive software updates via a WiFi connection without compromising critical functions of the medical device unit 102. The medical device unit 102 may receive updates via over-the-air (OTA) updates. In some embodiments, the medical device unit 102 is configured to receive OTA updates via cellular signals. For example, the medical device unit 102 may be configured to communicate with a server via a cellular network and receive software updates (e.g., OTA updates) via the cellular network when WiFi is unavailable. In some embodiments, the software or firmware of the medical device unit 102 may be updated wirelessly (e.g., over-the-air updates, Bluetooth, WiFi, Near Field Communication (NFC)) or via a wired connection. The software of the medical device unit 102 may be updated periodically or irregularly. In some embodiments, the medical device unit 102 is configured to have updates pushed from a central server or central database, and the medical device unit 102 is configured to install the updates.

[0029] In some embodiments, software updates include updates to the operating system (e.g., Linux® OS, Windows® OS, mac® OS), application code, and various resource files. The application code may add, repair, or enhance features in the performance of the medical device unit 102, which may affect patient treatment. Updates may affect the user experience, for example, by adding additional parameters and graphics to the GUI (e.g., user interface 124) or by adding additional languages ​​(e.g., English, Spanish, Japanese, etc.).

[0030] In some embodiments, the medical device unit 102 is configured to download and install software updates based on its location (e.g., geofencing). For example, the medical device unit 102 may include a GPS receiver configured to transmit the location of the medical device unit 102. The medical device unit 102 may receive software updates when it is in storage or not in use. In other words, the medical device unit 102 may be configured to download and install software updates when the GPS receiver is located within a safe zone.

[0031] In some embodiments, the medical device unit 102 is susceptible to tampering or hacking of wireless communications, and is therefore configured to activate and deactivate its wireless communication modality. Over-the-air updates or remote software updates may be enabled in a safe zone to minimize the risk of tampering or hacking of wireless communications. This risk can be partially mitigated by ensuring that over-the-air updates to the medical device unit 102 are performed only within a safe zone associated with the GPS coordinates of the medical device unit 102. In alternative embodiments, a user may define a safe zone within a hospital or secure setting, which also allows for the installation of over-the-air updates of the software or firmware of the medical device unit 102. In some embodiments, to further ensure the integrity of the update upon entering the safe zone, the user is required to perform authentication before manually accepting the over-the-air update.

[0032] The medical device unit 102 may be configured to update its software when it is stored, during storage, during startup, or during use. Prior to a software update, the control system of the medical device unit 102 may send one or more signals to various components of the medical device unit 102 to determine whether they are functioning correctly. For example, based on the desired use of the medical device unit 102, the medical device unit 102 may cause one or more components of the medical device unit 102 to perform calibrations and checks to ensure they are operating optimally or within specific parameters. Depending on whether a component is operating within the parameters, the medical device unit 102 may send a status update to an external device, and the medical device unit 102 may receive a software update accordingly.

[0033] In some embodiments, the medical device unit 102 performs a software update when powered on. The medical device unit 102 may perform a software update automatically without being requested to do so. In some embodiments, the medical device unit 102 is configured to perform a software update without human intervention. However, the medical device unit 102 may be configured to perform a software update in response to a request received from a remote device or server. The software update may be configured to modify or improve the user interface, the functionality of the medical device unit 102, or other parameters of the medical device unit 102 (e.g., sensor thresholds, calibration, timing protocols, etc.).

[0034] In some embodiments, software updates are configured to add additional functionality to the medical device unit 102. For example, a software update may modify existing software or firmware to add additional ventilation modes or change the range / thresholds of modes. For example, a software update may broaden the tidal volume (TV) range to include infants and children. A software update may provide non-invasive ventilation and / or add AI (artificial intelligence) optimization of ventilation, so that the medical device unit 102 can adjust / optimize ventilation parameters for a patient's specific clinical condition and respond to their changing clinical condition. A software update may add additional languages ​​and new tools to improve the graphical user interface (e.g., user interface 124) such as zoom, data panning, brightness, saturation, and contrast. In some embodiments, a software update is configured to change default ventilation parameters for a specific application. For example, the medical device unit 102 may be used in a military environment, which may require different default settings for default weight / size than, for example, a pediatric hospital. As one or more components of the medical device unit 102 degrade and additional post-market information and data become available, it may be necessary to change the parameters, thresholds, and / or calibration requirements of one or more components of the medical device unit 102 through one or more software updates.

[0035] In some embodiments, the medical device unit 102 is configured to perform software updates in response to passive requests. For example, the medical device unit 102 may receive software updates without sending a request. In some embodiments, the medical device unit 102 is configured to perform self-diagnostic tests to test the various components of the medical device unit 102. The results of the self-diagnostic tests may be used to determine which software updates need to be installed or applied to the various components of the medical device unit 102.

[0036] In some embodiments, the medical device unit 102 is configured to perform software updates on one or more components of the medical device unit 102 during initial startup (e.g., boot-up) and / or restart. The same components of the medical device unit 102 may be tested during startup and restart. However, the medical device unit 102 may perform software updates on different components depending on whether the medical device unit 102 is starting up or restarting. For example, at startup, the medical device unit 102 may perform software updates on a first set of components. At restart, the medical device unit 102 may perform software updates on a second set of components. The first set of components and the second set of components may be different, the same, or may include common components.

[0037] In some embodiments, the medical device unit 102 includes a button that, when operated, causes the medical device unit 102 to perform a software update. In some embodiments, the medical device unit 102 is configured to perform a software update without coupling with other devices. For example, in use, the medical device unit 102 may be coupled to the patient interface 300 via the breathing circuit 200. The medical device unit 102 may be configured to perform a software update before coupling with the breathing circuit 200. In some embodiments, the medical device unit 102 is configured to perform a software update without needing to be coupled to the breathing circuit 200 and / or the patient interface 300.

[0038] Referring to Figures 1 to 5, the medical device unit 102 may include a housing 132, a blower 104, a control system 106, and a power supply 108. The housing 132 of the medical device unit 102 may house and protect the components located within the medical device unit 102. The housing 132 may be lightweight to allow for easy portability of the medical device unit 102. For example, the housing 132 of the medical device unit 102 may be made of a lightweight polymer to allow for easy transport. In some embodiments, the housing 132 is made of one or more of the following: acrylonitrile butadiene styrene-acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), aliphatic polyamide (PPA), polycarbonate (PC), polyphenylsulfone (PPSU), polyetherimide (PEI), and polypropylene (PP). The housing 132 may be made of a lightweight yet durable material to provide portability while allowing for repeated use in harsh environments. For example, the housing 132 may be made of ABS to provide portability and to ensure that the components placed inside the housing 132 are fixed, protected, and remain undamaged. In some embodiments, the housing 132 of the medical device unit 102 is substantially rectangular in shape to allow for easy storage. However, the housing 132 may be square, circular, triangular, octagonal, or any other desired shape. In some embodiments, the housing 132 includes side walls 130. In a preferred embodiment, the housing 132 includes four side walls 130 to define the substantially rectangular shape of the medical device unit 102. In some embodiments, the housing 132 has rounded corners and chamfered edges to allow for a more ergonomic shape.

[0039] Referring to Figures 3 and 4, the housing 132 may include a top surface 122 and a bottom surface 139. In some embodiments, the top surface 122 is parallel to the bottom surface 139. The top surface 122 may be coupled to the bottom surface 139 via a side wall 130. The housing 132 may include a cutout 120 located on the top surface 122 of the housing 132. The cutout 120 may be sized and shaped to accommodate a user interface 124. The user interface 124 may be a display device located within the cutout 120 and may be configured to receive user input. In some embodiments, the user interface 124 is a graphical user interface. For example, the user interface 124 may be a touchscreen configured to receive user input and send that input to a control system 106. Furthermore, the user interface 124 may be used to display information about a patient using the medical device unit 102. For example, the user interface 124 may display a patient's respiratory status coupled to a patient interface 300.

[0040] In some embodiments, the user interface 124 may display various settings, parameters, and / or functions of components located within the medical device unit 102. For example, the user interface 124 may display peak airway pressure (PIP), tidal volume (TV), respiratory rate (RR), positive end-expiratory pressure (PEEP), inspiratory-to-expiratory ratio (I:E ratio), ventilation mode, peak flow rate, and sensitivity. The user interface 124 may be coupled to a control system 106 and configured to control various components of the ventilator 100. For example, a user may interact with the user interface 124 to change the parameters of the blower 104. In some embodiments, when the medical device unit 102 receives a software update, the visual representation of the user interface 124 is modified.

[0041] In some embodiments, the medical device unit 102 includes a speaker 141. The speaker 141 and / or the user interface 124 may be configured to provide instructions and / or warnings to the user. For example, the user interface 124 may provide the user with visual instructions to correct errors in the medical device unit 102, and the speaker 141 may provide the user with voice instructions to correct errors in the medical device unit 102. The medical device unit 102 utilizes natural language processing (NLP) to receive voice prompts from the user and generate voice instructions. For example, the medical device unit 102 may include a smart assistant (e.g., a digital assistant) that utilizes NLP. In some embodiments, the smart assistant is implemented within the medical device unit 102 to receive prompts from the user and provide instructions / guidance to the user. As described below, the medical device unit 102 may utilize one or more models to provide instructions to the user.

[0042] In some embodiments, the user interface 124 is configured to display videos or graphics to the user to instruct the user on how to correct or address errors in the medical device unit 102. In some embodiments, the speaker 141 is configured to provide the user with an audible warning or alarm based on an error detected by the medical device unit 102. The user interface 124 may be configured to provide the user with a visual warning or alarm based on an error detected by the medical device unit 102. In some embodiments, the medical device unit 102 includes a vibrator, and when an error occurs, the medical device unit 102 vibrates or provides other tactile feedback. The medical device unit 102 may transmit a signal to alert a remote user when an alert occurs.

[0043] In some embodiments, the user interacts with the user interface 124 to change various operating modes and / or parameters of the medical device unit 102. For example, the user interface 124 may provide options for adjusting PEEP, PIP, tidal volume, I:E ratio, or other parameters.

[0044] In some embodiments, the medical device unit 102 includes a beacon or indicator 134 to provide the status of the ventilator 100. The indicator 134 may provide the status of the ventilator 100 and / or the medical device unit 102. For example, the indicator 134 may indicate that the medical device unit 102 is damaged, inoperable, and / or functioning properly. The indicator 134 may be an LED, and the control system 106 may transmit a status to the indicator 134, causing the indicator 134 to light up in a specific color and flash at a specific frequency. For example, the indicator 134 may be a visual indicator, such as an LED, indicating that a software update has been received and installed by the medical device unit 102. In some embodiments, the indicator 134 displays a first state (e.g., a first color) when a software update has been received and a second state (e.g., a second color) when the software update has been installed. In some embodiments, the indicator 134 continuously provides a visual indication that the medical device unit 102 is functioning properly, and any interruption in the visual indication indicates that an error has occurred in the medical device unit 102 or that a software update is required.

[0045] In some embodiments, the medical device unit 102 receives specific updates based on errors that occur. For example, a software update may be sent to a particular medical device unit 102 based on an error received by that particular medical device unit 102. The software update may be pushed and / or sent to the medical device unit 102 based on an error received by the server in connection with a status check or self-diagnostic test performed by the medical device unit 102. For example, a software update may be used to adjust thresholds and / or parameters to improve the performance of a particular medical device unit 102 or to resolve a problem. Alternatively, a software update to adjust thresholds and / or parameters may be sent to multiple medical device units 102, even if only a subset of the medical device units 102 encounter errors.

[0046] In some embodiments, the medical device unit 102 includes a beacon in addition to, or instead of, the indicator 134. The beacon may be configured to transmit a signal (e.g., a wireless signal) relating to the status of the medical device unit 102. The beacon may be configured to periodically or irregularly transmit the current software version of the medical device unit 102 to a server. The server may compare the software version with the version of a software update, and if the software version does not match the version of a software update, the server may push a software update to the medical device unit 102.

[0047] In some embodiments, indicator 134 provides the status of the medical device unit 102 without requiring the user to interact with the medical device or power it on. For example, indicator 134 may be coupled to a separate power source from power source 108 and may be configured to light up to provide a status indication to the user without the user interacting with the medical device unit 102. Indicator 134 may transmit a signal to an external receiving device. In some embodiments, indicator 134 transmits a signal regardless of whether the external receiving device is near the medical device unit 102 or whether the external receiving device is requesting data from indicator 134. For example, indicator 134 may be configured to transmit a signal regardless of whether the device is listening or requesting a signal from indicator 134. In some embodiments, indicator 134 is configured to always transmit a signal when the medical device unit 102 is functioning correctly or operating normally.

[0048] In some embodiments, the indicator 134 is configured to flash a light of a different color. For example, the indicator 134 may flash green when the medical device unit 102 is operating normally, flash red when the medical device unit 102 is malfunctioning or requires a software update, or flash yellow when the medical device unit 102 has an error but is still functional. However, the indicator 134 may flash or remain constantly lit. The indicator 134 may be any desired color and may alternate between different colors depending on the status of the medical device unit 102. In some embodiments, the indicator 134 is coupled to a power supply so that the indicator 134 can continuously provide an indication of the status of the medical device unit 102.

[0049] In fact, the control system 106 may perform software updates without user intervention and may illuminate indicator 134 (e.g., green) based on the completion of the software update, or may illuminate indicator 134 (e.g., red) based on errors that occurred during the software update. The user may look at the medical device unit 102 and therefore may look at indicator 134 after the software update has been performed. The user may look at indicator 134 and determine whether the software update was successful and whether there are any errors related to the medical device unit 102 without interacting with the medical device unit 102. Interaction with the medical device unit 102 may include operating one or more buttons on the medical device unit 102, powering on the medical device unit 102, or interacting with the user interface 124. In fact, the user may look at indicator 134 immediately after the software update has been performed, or may look at indicator 134 some time after the software update has been performed.

[0050] The medical device unit 102 may include one or more buttons for controlling the ventilator 100. For example, the medical device unit 102 may include buttons 126 and 128 for controlling the power status and functions of the medical device unit 102. In some embodiments, button 126 is a power on / off button for controlling the power status of the medical device unit 102. For example, a user may press button 126 to power on the medical device unit 102. Button 128 may be a manual breathing button that delivers a breath of a predetermined tidal volume to the patient. In some embodiments, it may be necessary to press and hold button 128 for a predetermined amount of time before the medical device unit 102 delivers a breath to the patient.

[0051] Referring to Figures 1 to 5, the medical device unit 102 may include a pneumatic assembly or blower 104, which may include a motor 110 and a fan 112. The pneumatic assembly 104 may be an electromechanical pneumatic assembly or system. The motor 110 may be coupled to the fan 112, and the motor 110 may be configured to rotate the fan 112 to generate airflow. In some embodiments, the motor 110 is configured to rotate the fan 112 at a maximum of 37,500 revolutions per minute (RPM). The fan 112 may rotate to generate airflow out of the blower 104. The motor 110 may be coupled to a control system 106, which may control the motor 110. In some embodiments, the fan 112 is configured to provide a maximum of 1,000 liters per minute (LPM). In some embodiments, the fan 112 may rotate at speeds exceeding 37,500 RPM and be configured to exceed 1,000 LPM.

[0052] The blower 104 (e.g., an electromechanical pneumatic assembly) may be configured to receive software updates via a control system 106. For example, the blower 104 may be coupled to a control system 106, which may be configured to control the start-up and flow rate of the blower 104. The control system 106 may include software updates targeting the blower 104. In some embodiments, the software update modifies parameters of the blower 104 (e.g., flow rate, start-up threshold, start-up duration, flow direction). For example, the ramp-up and / or down of the blower 104 may be corrected during a software update based on the performance characteristics or history of the blower 104 (e.g., via a status update / check or self-diagnostic test).

[0053] In some embodiments, the blower 104 may be housed within an enclosure 114. The enclosure 114 may be sized and shaped to accommodate the blower 104, or it may be a single, integrated unit. For example, the enclosure 114 may consist of two parts, configured to house the blower 104 so that it is housed within the enclosure 114. By having the enclosure 114 consist of two parts surrounding the blower 104, the components and materials required to manufacture the ventilator 100 can be reduced. The blower 104 may include an inlet that can be housed within the enclosure 114. In some embodiments, the inlet of the blower 104 may be the only part of the blower 104 housed within the enclosure 114.

[0054] Referring to Figures 1 and 2, the medical device unit 102 may include a control system 106. The control system 106 may be a microcontroller, a peripheral interface controller (PIC), a system-on-a-chip (SoC), or a processor. In some embodiments, the control system 106 is a low-power controller. For example, the control system 106 may be a low-power controller coupled to a power supply so that the control system 106 is configured to operate for a longer period (e.g., several years). The control system 106 may be coupled to one or more components of the ventilator 100. In some embodiments, the control system 106 is coupled to a blower 104 to control a motor 110 that controls a fan 112. In some embodiments, the control system 106 controls the amount of gas delivered to the patient by attenuating the speed of the fan 112. For example, the control system 106 may reduce the speed of the fan 112 to reach a target amount of gas delivered to the patient through the breathing circuit 200 by attenuating the power delivered to the motor 110. The control system 106 may include a writing device 113, which may be configured to write information to a transmitting device 117, such as a radio frequency identification (RFID) chip / tag. In some embodiments, the control system 106 is coupled to a power supply 108. However, the control system 106 may be coupled to its own power supply. The control system 106 may include software configured to control the control system 106 and one or more components coupled to the control system 106. The software may be updated from a remote server or external device.

[0055] In some embodiments, the software of the control system 106 is updated wirelessly. For example, the control system 106 may receive software updates for software that provides instructions to the control system 106 and / or other components of the ventilator 100. In some embodiments, the medical device unit 102 includes an encryption engine to enable the medical device unit 102 to send and receive communications (e.g., software updates, software status, status of the medical device unit 102). The encryption engine may be stored in memory 115 and may be configured to encrypt any transmissions and / or communications before sending and / or delivering them to a server or other device. The encryption engine may use a lightweight encryption algorithm that enables rapid and efficient decryption by the medical device unit 102. Since the control system 106 may not have high processing power, a lightweight encryption algorithm enables the medical device unit 102 to decrypt transmissions and / or communications faster and requires less processing power for decryption.

[0056] In some embodiments, an external device (e.g., a server) communicates with the medical device unit 102 (e.g., a control system 106) via an encryption engine. The medical device unit 102 may store information such as software update data packages in trusted memory (e.g., memory 115) that does not communicate with other devices. Trusted memory ensures that software updates reside in a clean environment, i.e., an environment free from malware, spyware, viruses, rootkits, or other vulnerabilities. In some embodiments, the control system 106 sends any communications, commands, and / or instructions to the encryption engine before sending and / or communicating with the external device (e.g., a server). The encryption engine, residing in trusted memory, encrypts the transmission and / or communications before sending them to the external device via WiFi or a cellular network.

[0057] In some embodiments, an external device sending or pushing a software update pairs the software update with an authentication token. A cryptographic engine may be configured to authenticate the authentication token to ensure that the software update is from a trusted source. For example, an external device (e.g., a server) may interact with the medical device unit 102 and provide the medical device unit 102 with one or more authentication factors, such as a token, to authenticate the external device. The external device may transmit the authentication token to the medical device unit 102. In some embodiments, one or more authentication factors are configured to verify, authenticate, or authorize communication between the external device and the medical device unit 102. After verification, authentication, or authorization of the external device with the medical device unit 102, the external device and / or the medical device unit 102 may establish a secure connection.

[0058] An external device may obtain one or more authentication factors, which may include certificates, passwords, authentication tokens, and / or cloud authentication tokens. Passwords may be provisioned during the manufacture, assembly, packaging, or delivery of the medical device unit 102 and may contain any number of alphanumeric characters of any length, such as five alphanumeric characters or a 20-bit password length. Passwords may be written within the packaging or manual of the medical device unit 102 so that users of the medical device unit 102 and / or external devices can access the password. For example, the medical device unit 102 may receive passwords associated with software updates transmitted by external devices through user input via the user interface 124. In some embodiments, software updates received by the medical device unit 102 may be encrypted using tokens, keys, blockchain, passwords, hashes, or other cryptographic methodologies. In some embodiments, the management chain of the medical device unit 102, and / or software updates transmitted and installed by the medical device unit 102, are managed and tracked using a blockchain. For example, blockchain technology could be used to create an application for tracking ownership and possession of one or more medical device units 102 in order to securely track and determine the management chain.

[0059] In some embodiments, the server is configured to encrypt the software update with an encryption key before sending it to the medical device unit 102. The encryption engine may be configured to decrypt the software update when it is downloaded. In some embodiments, the server is configured to determine whether the medical device unit 102 is in a secure configuration (e.g., communicating securely with the server), and therefore the server does not need to encrypt the software update package.

[0060] In some embodiments, the server is configured to poll the medical device unit 102 periodically or irregularly. In response to polling, the medical device unit 102 may transmit status data indicating that there is an error and / or that a status update is needed. In some embodiments, the server is configured to poll the medical device unit 102 periodically or irregularly and respond if appropriate. Alternatively, the medical device unit 102 may transmit signals periodically or irregularly, and the server may respond (e.g., by sending a software update). Alternatively, a user may manually initiate a request for a software update, or the medical device unit 102 may poll the server. In some embodiments, a user receives a software update from the server to an electronic device (e.g., a mobile phone, laptop, desktop, tablet, etc.) and transmits the software update from the electronic device to the medical device unit 102. For example, a user may download the software update via an electronic device and transmit it to the medical device unit 102. In some embodiments, a user downloads the software update to their own electronic device and transmits it to the medical device unit 102 via a wireless or wired connection. An electronic device can transmit software updates to multiple medical device units 102. For example, an electronic device may be configured to automatically transmit software updates to multiple medical device units 102 when each medical device unit 102 is in proximity to the electronic device. In some embodiments, a drone or UAV may be used to wirelessly transmit software updates to one or more medical device units 102 when they are in proximity to the drone or UAV. The medical device units 102 may receive software updates via a hotspot, Bluetooth, WiFi, NFC, or other communication modality.

[0061] In some embodiments, the medical device unit 102 is configured to power on (e.g., via a self-diagnostic test or user) and poll a server to determine whether a software update is needed. The server may be configured to send a wake-up or power-on command to the medical device unit 102 in order to power it on. Upon power-on, the server may send a software update to the medical device unit 102 for download and installation.

[0062] In some embodiments, the server maintains the software upgrade transmission and authentication token / key as separate data packages to make hacking or interception more difficult. In some embodiments, the server generates a server private key and uses it to digitally sign the software update. The cryptographic engine may be configured to recognize the server private key and determine that the software update is from a trusted source. In some embodiments, the server encrypts the software update using the authentication key / token and then establishes a connection with the control system 106 to transmit the software update to the medical device unit 102. Once the server has encrypted the software update and established a connection with the medical device unit 102's control system 106, it may deliver, provide, and / or transmit the encrypted software update to the control system 106. In some embodiments, the medical device unit 102 determines, based on a self-diagnostic test, that a software update is needed and retrieves the encrypted software update from the server.

[0063] In some embodiments, the control system 106 cannot access the contents of a software update until it decrypts it. For example, the server may encrypt the software update using an authentication token / key and send the encrypted software update to the control system 106 of the medical device unit 102. The encryption engine of the control system 106 may be configured to decrypt the encrypted software update in order to access its contents and install the software update. In some embodiments, the encryption of the software data complies with FDA and HIPAA standards.

[0064] In some embodiments, the software update includes patient information that does not contain patient-identifiable information, or anonymized patient information. During the software update, anonymized patient and unit information may be transmitted to a server that checks the status of the software update, the status of the medical device unit 102, and / or the performance of the medical device unit 102.

[0065] In some embodiments, the writing device 113 is located inside the medical device unit 102. However, the writing device 113 may be located outside the medical device unit 102, or it may be an external device. The writing device 113 may be located inside, on, or outside the medical device unit 102 and may communicate wirelessly with the transmitting device 117. In some embodiments, the writing device 113 is configured to wirelessly write information to the transmitting device 117. The writing device 113 may be coupled to a control system 106 and may be located anywhere inside the medical device unit 102. The writing device 113 may further be coupled to a memory 115 which may be coupled to the control system 106.

[0066] In some embodiments, the transmitting device 117 is located inside the medical device unit 102 and is communicatively coupled to the control system 106. However, the transmitting device 117 may be located on or near the housing 132 of the medical device unit 102 and may be configured to communicate wirelessly with the control system 106. For example, the transmitting device 117 may be coupled to the outside of the housing 132 and may wirelessly receive information from the control system 106. The transmitting device 117 may be a storage device configured to transmit information wirelessly, such as a wireless transmitting device. For example, the transmitting device 117 may include one or more of the following: an RFID chip / tag, a near-field communication chip, a Bluetooth transmitter, a digital barcode, a QR code (registered trademark), or a WiFi module. In some embodiments, the user interface 124 is configured to display a digital barcode or QR code so that a user can scan the digital barcode or QR code to obtain status data for one or more medical device units 102. In some embodiments, the transmitting device 117 transmits information on request. However, the transmitting device 117 may be configured to automatically and / or autonomously transmit information associated with the self-diagnostic test without intervention from the user or an external device, or without receiving a request to transmit information. The transmitting device 117 may be configured for low power consumption. In some embodiments, the transmitting device 117 is configured to receive power only from an external power source. However, the transmitting device 117 may be powered by power source 108 or its own power source.

[0067] The control system 106 may, for example, receive information associated with the status of the ventilator 100 and store that information in the memory 115 or directly in the transmitting device 117. The writing device 113 can access the memory 115 and write the information stored in the memory 115 to the transmitting device 117. In some embodiments, the memory 115 includes the transmitting device 117. The memory 115 may include, for example, random access memory (RAM), a hard disk drive, and / or a removable storage drive such as a floppy disk drive, magnetic tape drive, optical disk drive, or a wireless device such as an RFID tag. The memory 115 may include other similar means for loading computer programs or other instructions into the ventilator 100. For example, the memory 115 may include a removable memory chip (such as an EPROM, PROM, or flash memory) and associated socket, as well as other removable storage units and interfaces that allow software and data to be transferred from the removable storage unit to the ventilator 100. In some embodiments, the memory 115 is non-volatile memory. In some embodiments, the memory 115 is configured for low power consumption or to receive power only from an external power supply.

[0068] In some embodiments, the control system 106 is coupled to a power supply 108 which can be configured to provide power to various components of the ventilator 100. For example, the control system 106 may be configured to set up a power path from the power supply 108 to the motor 110 of the blower 104. The power supply 108 may be located inside the medical device unit 102. The power supply 108 may include one or more of an internal rechargeable battery, a removable rechargeable battery, and a removable non-rechargeable battery. In some embodiments, the control system 106 is coupled to a power supply separate from the power supply 108.

[0069] As shown in Figure 4, the medical device unit 102 may be configured to house a battery pack via a battery compartment 137. In some embodiments, the user may place a removable rechargeable battery and / or a removable non-rechargeable battery in the battery compartment 137. In some embodiments, the power supply 108 may be coupled to a power source (not shown) via a power adapter. The power supply 108 may control the voltage and current from the power source to the control system 106.

[0070] Referring to Figure 5, in some embodiments, the medical device unit 102 may include an intake port 118 and an exhaust port 116. The intake port 118 may be located on one of the side walls 130 of the housing 132 and may allow air to flow to the blower 104 from the external environment (ambient air) or from an air source such as a gas (O2) reservoir. For example, the blower 104 may be configured to draw air in from the intake port 118 and push air out from the exhaust port 116. In some embodiments, the medical device unit 102 relies on the blower 104 for air supply and does not require compressed air to operate. In some embodiments, the blower 104 is coupled to the exhaust port 116 located on the outer periphery of the housing 132. For example, the exhaust port 116 may be located on the side wall 130 of the housing 132. The exhaust port 116 may be cylindrical and hollow. In some embodiments, the exhaust port 116 couples the blower 104 to the patient interface 300 via a breathing circuit 200. For example, the exhaust port 116 may be configured to allow air from the blower 104 of the medical device unit 102 to flow through the breathing circuit 200 to the patient interface 300. In some embodiments, the exhaust port 116 is a valve that can be opened and closed to control the airflow from the blower 104 to the breathing circuit 200. The exhaust port 116 may be controlled by pneumatic pressure or by a control system 106.

[0071] Referring to Figures 1 and 2, the ventilator 100 may include a breathing circuit 200. The breathing circuit 200 may be coupled to a medical device unit 102. For example, the breathing circuit 200 may be coupled to an exhaust port 116. In some embodiments, the breathing circuit 200 may be positioned between the medical device unit 102 and the patient interface 300. The breathing circuit 200 may be configured to receive air from the medical device unit 102. The breathing circuit 200 may include a tube 202, an exhalation valve 208, a flow sensor 210, and a patient filter 212. The tube 202 may include a first end 204 and a second end 206. The first end 204 may be coupled to the medical device unit 102, and the second end 206 may be coupled to the patient interface 300. In some embodiments, the tube 202 is a cylindrical lumen configured to allow airflow from the medical device unit 102 to the patient interface 300. The tube 202 may be configured to include an exhalation valve 208, a flow sensor 210, and a patient filter 212. The exhalation valve 208 may be located on or inside the tube 202 and may be configured to open to allow air to be expelled from the patient using the ventilator 100 during the patient's exhalation. The exhalation valve 208 may be made more efficient by closing during inspiration to prevent air from leaving the ventilator 100. For example, the exhalation valve 208 may be closed during inspiration to ensure that an appropriate amount and flow rate of air reaches the patient interface 300.

[0072] In some embodiments, the exhalation valve 208 is controlled by a control system 106 to control the patient's exhalation. In another embodiment, the exhalation valve 208 is controlled based on the patient's exhalation. In yet another embodiment, the exhalation valve is controlled by both the control system 106 and the patient's exhalation. The exhalation valve 208 may be configured to allow a specific respiratory rate, but may also be opened by the patient's exhalation. For example, if the respiratory rate is 12 (breath once every 5 seconds), the exhalation valve 208 may open every 5 seconds, or more frequently than every 5 seconds if the patient is breathing at a different respiratory rate.

[0073] In some embodiments, the breathing circuit 200 includes a flow sensor 210 which may be located on or inside the tube 202. The flow sensor 210 may be configured to sense the flow rate of air in the breathing circuit 200. For example, the flow sensor 210 may detect the velocity and volume of air flowing through the tube 202. In some embodiments, the flow sensor 210 is coupled to a control system 106 to provide feedback to the ventilator 100. For example, the flow sensor 210 may provide information to the control system 106, which may then modify the parameters of the blower 104 based on this information.

[0074] The breathing circuit 200 may further include a patient filter 212 which may be positioned adjacent to the second end 206 of the tube 202. For example, the patient filter 212 may be positioned on or inside the tube 202, adjacent to the second end 206 and adjacent to the patient interface 300. The patient filter 212 may be configured to filter and remove airborne particles. For example, the patient filter 212 may filter and remove particles and airborne viruses to protect a patient using the ventilator 100.

[0075] Referring to Figures 1 and 2, the ventilator 100 may include a patient interface 300. The patient interface 300 may be a device that is fixed to the patient's face. For example, the patient interface 300 may be a bag-valve mask (e.g., mask 302), a respirator, or an endotracheal (ET) tube used for intubation. In some embodiments, the patient interface 300 is an ET tube that is inserted into the patient by intubation. The patient interface 300 may include a mask 302 positioned over the patient's mouth and / or nose. In some embodiments, the mask 302 is connected to the medical device unit 102 via one or more tubes.

[0076] Referring to Figure 5, the medical device unit 102 may further include various inputs for connecting the medical device unit 102 to other components of the ventilator 100. In addition to the inspiratory port 118 and exhaust port 116, the medical device unit 102 may include a control line port 136, a pressure line port 138, a differential pressure tube port 140, a flow sensor support 142, a data communication port 144, and a power port 146. The control line port 136 may be used to connect the exhalation valve 208 to the medical device unit 102. For example, the exhalation valve 208 may be connected to the medical device unit 102 at the control line port 136 so that the medical device unit 102 can control the opening and closing of the exhalation valve 208. The pressure line port 138 and the differential pressure tube port 140 may be used to connect one or more pressure sensors to the medical device unit 102. The flow sensor support 142 may be used to connect a flow sensor 210 to the medical device unit 102. For example, the flow sensor 210 may be coupled to the medical device unit 102 in the flow sensor support 142 so that the medical device unit 102 can receive information from the flow sensor 210. The data communication port 144 may be used to couple the medical device unit 102 to an electronic device such as a computer system, mobile device, or server. The power port 146 may be used to couple the medical device unit 102 to a power source. For example, the power port 146 may be configured to couple the power supply 108 to a power source in order to supply power to the medical device unit 102 through the power supply 108.

[0077] In some embodiments, the ventilator 100 may be configured to perform a status check or self-diagnostic test to ensure that some or all of its components are functioning properly and are free from malfunctions. Depending on the status check or self-check, the ventilator 100 may receive software updates to address any errors or malfunctions detected by the status check or self-check. In some embodiments, the ventilator 100 is configured to perform a status check or self-check without any human intervention and to receive software updates based on the results of the status check or self-check. The ventilator 100 may also send the results of the status check or self-check to a server, which may determine whether a software update is needed. In some embodiments, a user or system (e.g., an AI or machine learning system) reviews the results to determine which components are malfunctioning and which updates are needed.

[0078] In some embodiments, the control system 106 is configured to test various components of the ventilator 100 in order to determine, for example, the functional status of the blower 104, power supply 108, writing device 113, memory 115, transmitting device 117, and the control system 106, in addition to reporting the operational status of the ventilator 100. For example, the control system 106 may be configured to receive information from the memory 115 regarding any damaged core, information from the blower 104 regarding blockage of the fan 112, information regarding blockage from the exhaust port 116 or intake port 118, information regarding inappropriate voltage from the power supply 108, or other information necessary to ensure that the medical device unit 102 is functioning properly. The control system 106 may be configured to perform one or more self-diagnostic tests on one or more components, including a system startup test, motor test, user interface test, button test, temperature sensor test, motor voltage test, motor current test, motor start test, patient pressure test, blower pressure test, oxygen sensor test, ambient sensor test, barometer test, speaker test, system fatal error test, and / or software test. The control system 106 may be configured to receive software updates directed at the results of all of the listed tests.

[0079] In some embodiments, the control system 106 automatically receives information from various components of the ventilator 100, either periodically or irregularly. For example, the control system 106 may receive information about some or all components of the medical device unit 102 without receiving a request from the user or other devices. However, the control system 106 may receive a request from the user to perform a self-diagnostic test on one or more components of the medical device unit 102.

[0080] In some embodiments, the medical device unit 102 includes a wake-up controller. The wake-up controller may be communicatively coupled to a control system 106. The wake-up controller may be configured to wake up (e.g., power on) the medical device unit 102 so that the control system 106 can perform a software update. In some embodiments, the wake-up controller is a microcontroller coupled to a timer. The timer may be configured to power on the medical device unit 102 via the wake-up controller. The timer may send signals to the wake-up controller periodically, irregularly, randomly, or on a pre-programmed criterion to power on the medical device unit 102. The wake-up controller may include a clock or timer.

[0081] In some embodiments, the wake-up controller is configured to receive a software update execution request. Upon receiving the signal, the wake-up controller may power on the medical device unit 102 and instruct the control system 106 to perform the software update. In some embodiments, the medical device unit 102 is powered on to download the software update. For example, the medical device unit 102 may receive a software update download request. The medical device unit 102 may install the software update upon completion of the download or at another time (for example, when the user starts the medical device unit 102).

[0082] In some embodiments, software updates are transmitted via a wireless connection (e.g., WiFi, Bluetooth, NFC, etc.) or a wired connection (e.g., Ethernet® connection, or an external device such as USB or an external computing device). The medical device unit 102 may be configured to enter a standby or sleep mode when stored, and may install software updates upon reception or power-on. In some embodiments, while the medical device unit 102 is being powered, a confirmation of software update installation appears on the user interface 124, and the user must interact with the user interface 124 to confirm the software update installation.

[0083] The medical device unit 102 may have a ventilated state or an in-use state and a non-ventilated state or an in-use state (e.g., a standby state and / or a powered-off state). In a ventilated state, the medical device unit 102 is actively providing ventilation (e.g., airflow / pressure) to the patient or is coupled to the patient to provide ventilation to the patient. In a non-ventilated state, the medical device unit 102 is not actively providing ventilation, is not coupled to the patient (e.g., the patient interface 300), and / or is not in a ventilated mode. Non-ventilated states may include a standby state in which the medical device unit 102 is powered on but not providing ventilation to the user, and a powered-off state in which the medical device unit 102 is not providing ventilation to the user and is not powered on.

[0084] In some embodiments, the medical device unit 102 is configured to prevent the installation of software updates while in use (for example, when the medical device unit 102 is in a ventilating state). For example, while providing ventilation to a patient, the medical device unit 102 may be configured to prevent the installation of software updates in order to prevent the medical device unit 102 from shutting down or malfunctioning. In some embodiments, the medical device unit 102 is configured to download software updates while in use, but waits until the medical device unit 102 is no longer in use before installing the software updates. The medical device unit 102 may have a default setting that prevents the installation of software updates while the medical device unit 102 is providing ventilation.

[0085] In some embodiments, the wake-up controller and the control system 106 are coupled to different power sources. For example, the wake-up controller may be coupled to a power source 108 (e.g., a battery), and the control system 106 may be coupled to a different power source and configured to operate with low power. In some embodiments, the control system 106 is coupled to a small battery configured to output very little power and have a long lifespan. The control system 106 may be coupled to a small battery because it performs software updates that require little power. In some embodiments, the control system 106 and the wake-up controller are coupled to the same power source. In some embodiments, the wake-up controller is a low-power controller. For example, the wake-up controller may be a low-power controller coupled to a power source so that the wake-up controller operates for a long period (e.g., several years).

[0086] In some embodiments, the control system 106 is configured to perform software updates daily, weekly, monthly, bimonthly, or at any other recurring time. The control system 106 may be configured to test certain components more frequently than others. For example, the control system 106 may be configured to test the blower 104 monthly and the speaker 141 daily to determine whether a software update is needed. As another example, the control system 106 may be configured to test all components sequentially or simultaneously each month, and individual components (e.g., the blower 104, speaker 141, user interface 124) weekly.

[0087] The control system 106 may communicate with one or more faulty components to pinpoint the problem causing the failure and may send the results to a server to determine whether a software update is needed. For example, if it indicates that the blower 104 is not functioning properly, the control system 106 may communicate with one or more pressure sensors of the blower 104 to determine whether there is an error in the pressure sensor (e.g., an inaccurate threshold). In some embodiments, when a fault is indicated, the control system 106 may cause a speaker 141 to output an audio display and / or a user interface 124 to output a visual display. The audio or video display may provide the user with information about the faulty component and / or whether a software update is needed.

[0088] In some embodiments, the medical device unit 102 of the ventilator 100 is configured to perform a software update and then power off. In some embodiments, the medical device unit 102 is configured to perform a software update while the medical device unit 102 is in storage or otherwise not being actively used (e.g., powered off). In some embodiments, the software update is stored in memory 115. The medical device unit 102 may be powered on without human intervention to install the software update. Alternatively, the medical device unit 102 may install the software update when the medical device unit 102 is started by the user. For example, the medical device unit 102 may be powered on, install the software update, store the software update in memory 115, and then powered off. This allows the medical device unit 102 to conserve power.

[0089] In some embodiments, the medical device unit 102 includes an accelerometer. The control system 106 may be configured to receive measurements from the accelerometer and may request accelerometer readings during a self-diagnostic test. The accelerometer may indicate whether the medical device unit 102 is moving, has been moved, or has been dropped. In some embodiments, the control system 106 determines whether the measurements from the accelerometer exceed a threshold indicating that the medical device unit 102 may have been dropped and damaged. The accelerometer may also indicate whether the medical device unit 102 has been moved, and a movement indication based on the measurements from the accelerometer may be included in the status data. In some embodiments, the accelerometer provides the orientation of the medical device unit 102. The medical device unit 102 may include a gyroscope for providing orientation information to the control system 106.

[0090] The medical device unit 102 may include optical sensors (e.g., infrared sensors, passive infrared sensors). The optical sensors of the medical device unit 102 may be coupled to a control system 106 which may be coupled to the user interface 124. The optical sensors may be configured to detect the amount of ambient light and reduce the power consumption of the user interface 124 by lowering the brightness of the user interface 124 based on the detected amount of ambient light. In some embodiments, the optical sensors are configured to detect the presence of a user who is close to or looking at the user interface 124. If a user is present, the user interface 124 may display the status or status data of the medical device unit 102. However, the optical sensors may not detect a user, or they may detect that there is no user close to the medical device unit 102, and therefore the user interface 124 does not need to display the status or status data of the medical device unit 102 because there is no user looking at the user interface 124. This allows for reduced power consumption because the user interface 124 does not need to be lit unless the optical sensors detect the presence of a user looking at the user interface 124.

[0091] In some embodiments, the medical device unit 102 includes one or more environmental sensors. These environmental sensors may include temperature sensors, pressure sensors, gas sensors, and humidity sensors. The medical device unit 102 may include a temperature sensor for measuring the ambient and / or internal temperature of the medical device unit 102. During use, the ambient temperature may affect the performance of one or more components of the medical device unit 102, such as the blower 104, pressure sensor, speaker 141, battery, or any other component of the medical device unit 102. In some embodiments, changes in ambient temperature detected by the temperature sensor result in changes to parameters of a self-diagnostic test. For example, the pressure threshold associated with the blower 104 may change based on the ambient temperature detected by the temperature sensor. In yet another example, the performance of the battery or power supply 108 may change based on the temperature sensor reading, resulting in a change in the alarm threshold level for low battery levels. In some embodiments, the medical device unit 102 outputs an alarm if the temperature reading of the temperature sensor deviates from a temperature range. The temperature range may be the range of temperatures in which the medical device unit 102 can operate properly. The temperature range may be -50°C to 50°C.

[0092] The medical device unit 102 may also include one or more gas sensors. For example, the medical device unit 102 may include a first oxygen sensor for measuring the oxygen level inside the medical device unit 102 due to a leak, and a second oxygen sensor for measuring the oxygen concentration of the gas / air delivered to the patient connected to the medical device unit 102 via the breathing circuit 200. The first oxygen sensor may be configured to send an alert when the oxygen level inside the medical device unit exceeds a predetermined threshold. For example, considering the risk of fire, the medical device unit 102 may prevent the accumulation of air / gas inside the medical device unit 102 by leaking a small amount of air / gas inside the medical device unit 102. The medical device unit 102 may release oxygen when the first oxygen sensor detects that the oxygen level inside the medical device unit 102 exceeds a predetermined amount. For example, the medical device unit 102 may be configured to release or leak air / oxygen when the first oxygen sensor determines that there is more than 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% oxygen inside the medical device unit 102. In some embodiments, the medical device unit 102 is configured to continuously release or leak air / oxygen to maintain the amount of oxygen inside the medical device unit 102 at or below 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50%.

[0093] In some embodiments, the first oxygen sensor is an ambient oxygen sensor, and the second oxygen sensor is a galvanic oxygen sensor. The first oxygen sensor may be used to calibrate the second oxygen sensor. For example, the ambient oxygen sensor may be a highly sensitive oxygen sensor and may be used to calibrate the galvanic oxygen sensor. The galvanic oxygen sensor may degrade over time and during use, and as a result may require recalibration. However, the second oxygen sensor may be used to calibrate the first oxygen sensor. In some embodiments, a single oxygen sensor is used to measure the oxygen level in the medical device unit 102 and to measure the oxygen concentration of the gas / air delivered to the patient.

[0094] The medical device unit 102 may include an altitude sensor, such as an altimeter, or a barometric pressure sensor. In some embodiments, the control system 106 receives a measurement from the altitude sensor and transmits a correction to another sensor, such as an oxygen sensor. For example, the control system 106 may determine that the oxygen level is lower than sea level because the medical device unit 102 is at a higher altitude. The control system 106 may calibrate the oxygen sensor based on the altitude measurement from the altitude sensor. For example, the control system 106 may apply a correction factor to the oxygen sensor based on the altitude measurement from the altitude sensor. The medical device unit 102 may also include a humidity sensor for detecting the ambient humidity level. The medical device unit 102 may output an alarm or alert if the humidity level detected by the humidity sensor exceeds a predetermined threshold. For example, excessive moisture, such as that detected by the humidity sensor, may damage one or more components of the medical device unit 102 or cause one or more components of the medical device unit 102 (e.g., a gas sensor, battery, speaker 141) to malfunction.

[0095] In some embodiments, the indicator 134 is configured to display or flash different colored lights based on the status of the medical device unit 102. For example, the indicator 134 may display or flash green when the medical device unit 102 is operating normally, display or flash red when the medical device unit 102 is malfunctioning, or display or flash yellow / orange when the medical device unit 102 has an error but is still functional. The indicator 134 may flash colors or remain constantly lit. The indicator 134 may be any desired color or may alternate between different colors depending on the status of the medical device unit 102. In some embodiments, the indicator 134 is coupled to a beacon power supply so that the indicator 134 can continuously provide an indication of the status of the medical device unit 102. The beacon power supply may be different from the power supply 108.

[0096] The control system 106 may perform software updates without user intervention and may illuminate indicator 134 based on the status of the software update (e.g., downloaded, installed, or failed). The user may look at the medical device unit 102 after the software update has been performed and may look at indicator 134. By looking at indicator 134, the user may determine the status of the medical device unit 102 and whether there are any errors related to the medical device unit 102 without interacting with the medical device unit 102. Interaction with the medical device unit 102 may include operating one or more buttons on the medical device unit 102, powering on the medical device unit 102, or interacting with the user interface 124.

[0097] In fact, a user may see indicator 134 immediately after a software update is performed, or they may see indicator 134 after some time has elapsed since the software update was performed. In some embodiments, the control system 106 is configured to send a signal to indicator 134 regardless of the power status of the medical device unit 102. In other words, indicator 134 may be configured to always receive a signal from the control system 106, regardless of the power status of the medical device unit 102. This may be because each of the control system 106 and indicator 134 has its own power supply separate from the power supply 108, or because the control system 106 and indicator 134 share a power supply separate from the power supply 108. In some embodiments, indicator 134 has a low-power sensor configured to receive a signal from the control system 106 to light up based on the status of the software update (e.g., downloaded, installed, failed).

[0098] The control system 106 may automatically test the medical device unit 102 periodically, on a schedule, irregularly, or randomly to pinpoint errors in one or more components of the medical device unit 102. For example, the control system 106 may periodically power on the medical device unit 102 and test all components of the medical device unit 102, for example, monthly, every three months, or every six months. Depending on the component tests, the control system 106 may automatically transmit the test results and receive software updates. The control system 106 may automatically download and install software updates.

[0099] In some embodiments, the user may schedule specific dates and times for the control system 106 to power on the medical device unit 102, test one or more components of the medical device unit 102, and perform software updates. For example, the medical device unit 102 may be configured to have a programmable schedule for pre-scheduling self-diagnostic tests and software updates. Pre-scheduled self-diagnostic tests and software updates may be used to identify defective, damaged, or non-functional medical device units 102 before use when a large number of medical device units 102 are being transported for use. In another embodiment, the control system 106 may periodically power on the medical device unit 102 and test all components of the medical device unit 102. For example, the longer the medical device unit 102 is stored, the more frequently the tests may need to be performed. In some embodiments, the control system 106 tests the medical device unit 102 without user intervention.

[0100] In some embodiments, the control system 106 is configured to autonomously power on the medical device unit 102 to perform a software update. For example, the control system 106 may be configured to periodically or irregularly wake the medical device unit 102 from sleep to perform a software update. In some embodiments, the control system 106 performs the software update in "silent mode" so that the user is unaware that a software update is being performed. For example, the control system 106 may download and install the software update without turning on the user interface 124, speaker 141, indicator 133, or indicator 134, and without user intervention. In some embodiments, the user requests the control system 106 to update the software that controls the medical device unit 102 by interacting with the user interface 124 or by acting on / operating on buttons 126.

[0101] In fact, the medical device unit 102 may start up / activate to perform a self-diagnostic test, transmit the results of the self-diagnostic test, and receive software updates depending on the self-diagnostic test. The self-diagnostic test may include testing of sensors (e.g., pressure sensors, oxygen sensors, temperature sensors, accelerometers, tachometers, gyroscopes). In some embodiments, the self-diagnostic test includes measuring the current drawn from one or more components (user interface 124, blower 104, speaker 141, control system 106) to determine whether one or more components are receiving the appropriate current. Measuring the current drawn from one or more components may also determine whether there are short circuits, broken wires, or disconnected wires. Once the status of one or more components of the medical device unit 102 is determined through the self-diagnostic test, the control system 106 may send a software update request and receive a software update data package to download and install.

[0102] The control system 106 may be configured to store and generate a history log based on previously performed software updates. In some embodiments, the control system 106 is configured to store all previously installed software updates. The control system 106 may automatically transmit the history log periodically, irregularly, or on a pre-scheduled basis. However, the control system 106 may be configured to transmit the history log on request.

[0103] In fact, multiple medical device units 102 may be stockpiled or stored for long periods before use, and therefore may require multiple software updates to ensure that the medical device units 102 are functioning properly before use. In fact, older medical devices require physical intervention (e.g., opening the device, turning on the device) to determine whether the device is functioning properly. This is an inefficient use of resources and also consumes the device's power. In some embodiments, the medical device unit 102 is automatically powered on to perform software updates. The control system 106 of the medical device unit 102 may store software status data of the software updates (e.g., downloaded, installed, failed) in memory 115. A writing device 113 may access the software status data from memory 115. In some embodiments, the control system 106 directly transmits the software status data to the writing device 113. The writing device 113 may write the software status data to a transmitting device 117, such as an RFID tag, which stores the software status data. After the writing device 113 has written the software status data to the transmitting device 117, the medical device unit 102 may shut down to conserve power. The user may retrieve the software status data by using a receiving or reading device, such as an RFID reader, to wirelessly receive the software status data while the medical device unit 102 is powered off.

[0104] In some embodiments, a single transmitting device 117 may be associated with multiple medical device units 102. For example, a pallet or stockpile of medical device units 102 may communicate with the single transmitting device 117, and each writing device 113 of each medical device unit 102 may write the results of a software update (e.g., software status data) to the single transmitting device 117. This allows a user to determine whether the software of a medical device unit 102 among a large number of medical device units 102 is up to date. This configuration allows monitoring and surveillance of a stockpile or large number of medical device units 102 without interaction with or proximity to each medical device unit. Furthermore, it provides a rapid assessment of whether the stockpile or group of medical device units 102 are ready for use.

[0105] In some embodiments, the medical device unit 102 may include a wireless network module, such as a WiFi chip / card, configured to communicate with a control system 106 and one or more external devices. One or more external devices may include a write device 113, a transmit device 117, a server, a computer, a mobile device, or an external transmitter. The wireless network module may receive signals from the external devices to power on the medical device unit 102, perform a status check, transmit the results of the status check, and receive software updates to download and install. Software status data resulting from a startup software update may be stored in memory 115 and / or transmitted wirelessly to a write device 113, which may be located outside the medical device unit 102. The write device 113 can then write the software status data to the transmit device 117, which may be stored inside, on, or outside the housing 132 of the medical device unit 102. In some embodiments, each of the write device 113 and the transmit device 117 is located near the medical device unit 102. In an alternative embodiment, the writing device 113 and the transmitting device 117 are each located away from the medical device unit 102.

[0106] In some embodiments, the medical device unit 102 may include a speaker 141, additional lights, and / or additional display screens. The medical device unit 102 may be configured to alert the user regarding the status of software updates via one or more of the following: user interface 124, indicator 133, indicator 134, user interface 124, display screens, or other modes of alerting the user. For example, the medical device unit 102 may provide the user with alerts, warnings, or messages by text, voice, or visual indicators.

[0107] In some embodiments, the controller 106 of the medical device unit 102 is configured to run one or more models (e.g., algorithms), such as mathematical models, machine learning models, deep learning models, and statistical models, in order to provide output to the user. The output may be presented on a user interface and / or may include instructions. In some embodiments, the ventilator 100 utilizes artificial intelligence and / or machine learning to evaluate errors and provide corrective instructions to the user (e.g., via a user interface).

[0108] Referring to Figure 7, the medical device unit 102 may be configured to communicate via the network 318 with a web server 304, a cloud-based engine 321 including one or more processing devices 320, a workstation 306, a database 316, and one or more user computing devices 314. For example, the controller 106 of the medical device unit 102 may be configured to communicate with one or more servers or devices via the network 318. In some embodiments, the medical device unit 102 communicates with one or more computing devices 314 via the network 318. For example, a user may use a mobile device or computer to communicate with the medical device unit 102 via the network 318.

[0109] In some embodiments, the medical device unit 102 assigns one or more models (or parts thereof) to be executed to one or more processing devices 320. For example, each model may be assigned to a virtual machine hosted by the processing device 320. The virtual machine may run the model or parts thereof on one or more processing units, such as a GPU.

[0110] The medical device unit 102 may be configured to communicate with one or more model training systems, which are communicatively coupled to at least one model database for managing trained models and one or more training data databases (e.g., database 316) for storing relevant training data for training and / or retraining one or more models used by the medical device unit 102. In some embodiments, the medical device unit 102 communicates with a server 304 that implements one or more models. The generated outputs of one or more models may be sent to the medical device unit 102. In some embodiments, the medical device unit 102 outputs the generated outputs (e.g., via a user interface 124).

[0111] The model training system includes one or more model training servers or managers, implemented through one or more computing systems, servers, computers, processors, and / or other such systems, which are communicably connected to one or more of the distributed communication networks 318 and configured to build and / or train machine learning models. In some implementations, the model training system includes multiple sub-model training systems, each associated with one or more different machine learning models.

[0112] In some embodiments, the ventilator 100 utilizes one or more natural language processing (NLP) models to process spoken language. In some embodiments, the neural network, machine learning model, and / or machine learning algorithm may include, but are not limited to, large-scale language models (LLMs), heuristics, univariate-based techniques, multivariate, control limits, isolation forests and LOF ensembles, deep learning models such as LSTM-based autoencoders, variational autoencoders, deep stacking networks (DSNs), tensor deep stacking networks, convolutional neural networks, stochastic neural networks, autoencoders or Diabolo networks, linear regression, support vector machines, naive Bayes, logistic regression, K-nearest neighbors (kNN), decision trees, random forests, gradient-boosted decision trees (GBDT), K-means clustering, hierarchical clustering, DBSCAN clustering, principal component analysis (PCA), and / or other such models, networks, and / or algorithms.

[0113] In some embodiments, the ventilator 100 utilizes a model (e.g., a machine learning model) to provide instructions or responses to the user. For example, the ventilator 100 may indicate that an error (e.g., a failure) has occurred, and the ventilator 100 may use one or more models to provide corrective instructions. One or more models may be trained on a set of data acquired from multiple ventilators 100. In some embodiments, one or more models are trained on data acquired from multiple ventilators 100. For example, the user may resolve a failure using a series of inputs to the ventilator 100. The series of inputs may be logged in a database (e.g., database 316) and similarly used to train one or more models to provide the user with instructions to resolve the detected failure.

[0114] In some embodiments, the ventilator 100 utilizes one or more models to provide guidance to the user of the ventilator 100. For example, one or more models may be trained to identify or predict errors and problems based on historical data and to provide the user with instructions to prevent errors and problems from occurring.

[0115] In some embodiments, the ventilator 100 is configured to provide the user with commands or guidance regarding the use of the ventilator 100 to resuscitate a patient. The ventilator 100 may provide commands in a step-by-step manner and may adjust the commands based on prompts from the user or signals received from various sensors communicating with the controller 106. For example, the ventilator 100 may provide voice and / or visual commands and guidance so that the user can interact with the patient without constant interaction with the ventilator 100. The ventilator 100 may utilize NLP to receive voice prompts and user input and provide responses so that the user can interact with the patient while simultaneously interacting with the ventilator 100. In some embodiments, the user can interact with the ventilator 100 without manual or physical interaction with the user interface 124. For example, the controller 106 may be configured to analyze and extract keywords associated with the operation of the medical device unit 102. Based on the analyzed and extracted keywords, the controller 106 may identify a request from the user and provide the user with a command (e.g., voice output) in response to the request.

[0116] In some embodiments, each ventilator 100 logs inputs, prompts, and actions taken (e.g., activity data) and sends the activity data to one or more databases (e.g., database 316). One or more models can be trained on the activity data and can generate outputs or commands to correct errors or problems that occur in the ventilator 100. The ventilator 100 can then receive remote updates, including the generated outputs or commands, so that each ventilator 100 stays up-to-date with the latest corrective commands.

[0117] In some embodiments, the ventilator 100 tracks how errors and problems are addressed during use (e.g., error data). The ventilator 100 may send error data to a database 316. In some embodiments, one or more models are trained using the error data to generate corrective instructions. Corrective instructions may provide the user with instructions on how to address and correct one or more errors or problems that occur during use of the ventilator 100. Corrective instructions generated by one or more models may be sent to the ventilator 100 via remote updates.

[0118] In some embodiments, the ventilator 100 is configured to communicate with adjacent ventilators 100. For example, the first ventilator may be configured to communicate with the second ventilator (for example, via a network 318). The first ventilator may receive remote software updates and may transmit remote software updates to the second ventilator. This allows a single ventilator to disseminate remote software updates to one or more adjacent ventilators without requiring one or more adjacent ventilators to communicate with a server (for example, a web server 304) to receive remote software updates. For example, multiple ventilators 100 may be stored in a stockpile, and at least one ventilator 100 may be coupled to a server to receive remote software updates. At least one ventilator 100 may be configured to receive, download, and install remote software updates and then transmit the remote software updates to other ventilators 100 in the stockpile. In some embodiments, at least one ventilator 100 that initially receives a remote software update is configured to install and check for errors in the software update before sending it to adjacent ventilators 100. If an error is detected (for example, indicating that the software update is corrupted), at least one ventilator 100 will not send the software update to adjacent ventilators 100 until the error is corrected. This prevents a large number of ventilators 100 from becoming infected with a corrupted software update. Allowing a single ventilator 100 to send software updates to adjacent ventilators 100 allows many ventilators 100 to be updated at once and also enables patching of software updates. Furthermore, this makes it possible to update many ventilators 100 without connecting all ventilators 100 to a server for communication. This also allows a single ventilator 100 to repair or correct multiple adjacent ventilators that have erroneous or corrupted software updates.

[0119] In some embodiments, the ventilator 100 is configured to continuously poll for remote software updates. Alternatively, the ventilator 100 may be configured to passively wait until it receives a push command for a remote software update. For example, multiple ventilators 100 may be stored in a stockpile, and a user may use a transmitting device to push a software update to one or more ventilators 100 in the stockpile. The ventilator 100 may be configured to receive the software update based on the pushed request.

[0120] In some embodiments, the ventilator 100 is configured to provide autonomous or semi-autonomous clinical management to the patient. For example, when a patient is connected to the ventilator 100, the ventilator 100 may be configured to detect vital signs (e.g., pulse rate, oxygen saturation, respiratory rate) and automatically adjust and configure ventilation parameters to provide ventilation to the patient. The ventilator 100 may be configured to adjust ventilation parameters without human intervention based on detected vital signs. In some embodiments, the ventilator 100 is configured to adjust ventilation parameters based on industry standard guidelines (e.g., American Heart Association guidelines). The ventilator 100 may be able to receive remote software updates, which may include any changes to established industry standard guidelines.

[0121] In some embodiments, the user can manually adjust the settings and parameters of the ventilator 100. The ventilator 100 may have upper and lower limits on the settings and parameters based on industry standard guidelines. In some embodiments, the ventilator 100 receives remote software updates that include changes or revisions to industry standard guidelines and automatically adjusts the settings and parameter limits of the ventilator 100.

[0122] In some embodiments, once the self-diagnostic test is complete, the ventilator 100 transmits the results of the self-diagnostic test to a server (e.g., a web server 304). The self-diagnostic test may indicate a change in the tolerance of one or more components. In some embodiments, the change in the tolerance of one or more components is within the acceptable range. However, if the change in the tolerance of one or more components is not within the acceptable range, the server may send a remote software update to adjust one or more components so that the tolerance falls within the acceptable range.

[0123] In some embodiments, remote software updates are configured to add additional functionality when additional functionality becomes available and / or is approved by a regulatory authority. For example, ventilator 100 may include necessary hardware but may require software adjustments to perform certain functions. In some embodiments, ventilator 100 includes one or more components whose normal use is restricted or blocked. These one or more components may become accessible and / or unblocked upon receiving a remote software update. For example, ventilator 100 may include a blower (e.g., blower 104) with a fan (e.g., fan 112) initially limited to a maximum RPM of 20,000. Upon receiving a remote software update, the fan's maximum RPM may increase to more than 20,000 RPM, for example, 37,500 RPM.

[0124] In some embodiments, the ventilator 100 includes one or more cameras, microphones, and / or sensors configured to receive audio and / or video input. The cameras, microphones, and / or sensors may be configured to receive and record audio and / or video. The ventilator 100 may utilize one or more models implementing machine vision to observe and / or hear in real time how the user interacts with the patient and provide instructions as needed. For example, the ventilator 100 may include cameras and sensors to detect the user's movements as the user interacts with the patient. The ventilator 100 may use one or more models implementing machine vision to detect an oxygen leak as a result of the user improperly connecting the ventilator 100 to the patient. The ventilator 100 may provide instructions (e.g., video and / or audio) to the user to correct the detected error. Figure 8 shows a flowchart of an exemplary method 500 that the ventilator 100 may use to provide a software update to a medical device. Method 500 may include step 502 of receiving software update data associated with one or more components without human intervention. Method 500 may also include step 504 of storing software update data in memory coupled to the control system. The software update data includes changes to the parameters of one or more components.

[0125] Those skilled in the art will understand that modifications can be made to the exemplary embodiments shown and described herein without departing from the broader concept of the invention. Therefore, it will be understood that the present invention is not limited to the exemplary embodiments shown and described herein, but is intended to cover modifications within the spirit and scope of the invention as defined by the claims. For example, certain features of the exemplary embodiments may or may not be part of the claimed invention, and various features of the disclosed embodiments may be combined. Unless specifically stated herein, the terms “a,” “an,” and “the” should be interpreted as meaning “at least one,” rather than being limited to one element.

[0126] It should be understood that at least portions of the drawings and description of the present invention have been simplified to focus on elements relevant to a clear understanding of the invention, but other elements that a person skilled in the art would understand may constitute part of the invention have also been omitted for clarity. However, since such elements are well known in the art and do not necessarily aid in a better understanding of the invention, no description of such elements is provided herein.

[0127] Furthermore, unless the method of the present invention relies on a specific order of steps described herein, no specific order of steps should be construed as limiting the claims. No claim directed to the method of the present invention shall be limited to the steps being performed in the order described herein, and those skilled in the art will readily understand that the steps may be modified while remaining within the spirit and scope of the invention.

Claims

1. A medical device, wherein the medical device is The medical device comprises an electromechanical pneumatic assembly configured to generate airflow, the electromechanical pneumatic assembly being located within the medical device and coupled to one or more components, the medical device further comprises The electromechanical pneumatic assembly is coupled to a controller, and the controller is The software update data associated with one or more of the aforementioned components is received, A medical device configured to store the software update data in a memory coupled to the controller, wherein the software update data includes changes to one or more parameters of one or more components, functions of the electromechanical pneumatic assembly, and performance indicators of the medical device.

2. The medical device according to claim 1, further comprising a beacon configured to provide a display representing the aforementioned software update data.

3. The medical device according to claim 2, wherein the beacon is configured to request a software update.

4. The medical device according to claim 2, wherein the beacon is configured to determine the availability of the software update.

5. The medical device according to claim 2, wherein the beacon periodically transmits the software version of the medical device to a server, the server compares the software version with the software update, and transmits the software update to the medical device.

6. The medical device according to claim 1, wherein the controller receives the software update without human intervention.

7. The medical device according to claim 1, wherein the controller is configured to output a signal to one or more of the following: a speaker, a user interface, a storage device, an external device, a beacon, a writing device, a transmitting device, and an indicator.

8. The medical device according to claim 1, further comprising a wake-up controller coupled to the controller, wherein the wake-up controller is configured to power on the medical device before the controller receives the software update data.

9. The medical device according to claim 1, wherein the controller is further configured to display the software status associated with the software update data on the user interface via a display screen or light indicator.

10. The medical device according to claim 1, wherein the controller includes a low-power controller configured to receive the software update data.

11. The controller further, The medical device receives multiple inputs from the user related to the operation of the aforementioned medical device. The aforementioned multiple inputs are stored in a database, The medical device according to claim 1, configured to receive subsequent software update data, which includes instruction data associated with the plurality of inputs.

12. The controller further, Receive multiple voice prompts from the user, Using one or more models, analyze and extract one or more keywords associated with the request from the voice prompt, The medical device according to claim 1, configured to output an audio response based on the aforementioned request.

13. A method for providing a software update to a medical device, wherein the method is The method includes receiving software update data associated with one or more components of a ventilator, wherein the ventilator includes an electromechanical pneumatic assembly located within the ventilator and coupled to the one or more components, and the method further includes: The software update data is stored in a memory connected to the controller, the controller being connected to the electromechanical pneumatic assembly, The software update data includes a method that includes changes to the parameters of one or more components.

14. Receiving multiple inputs from the user related to the operation of the aforementioned medical device, The above multiple inputs are stored in a database, The method of claim 13, further comprising receiving the next software update data which includes instruction data associated with the plurality of inputs.

15. Receiving multiple voice prompts from the user, Using one or more models, analyze and extract one or more keywords associated with the request from the voice prompt, The method according to claim 13, further comprising outputting an audio response based on the aforementioned request.

16. The method according to claim 13, further comprising powering on the medical device via a wake-up controller coupled to the controller before the controller receives the software update data.

17. The method according to claim 13, further comprising displaying the software status associated with the software update data on a user interface via a display screen or light indicator.

18. The determination that the aforementioned medical device has transitioned from an in-use state to an in-use state, The method of claim 13, further comprising retrieving the software update data from the memory for installation in accordance with the determination that the medical device is in a non-use state.

19. A method for providing a software update to a medical device, wherein the method is The method includes receiving software update data associated with a ventilator, wherein the ventilator includes an electromechanical pneumatic assembly coupled to one or more components, and the method further includes: The method includes storing the software update data in a memory coupled to the controller, wherein the controller is coupled to the electromechanical pneumatic assembly, and the method further includes: The method further includes determining that the ventilator is in a ventilated state, where the electromechanical pneumatic assembly is providing ventilation to the patient, and the method further includes: A method comprising preventing the ventilator from retrieving the software update data from its memory for installation, in response to the determination that the ventilator is in the ventilating state.

20. The ventilator determines that it has transitioned from a ventilated state to a non-ventilated state, The method of claim 19, further comprising retrieving the software update data from the memory for installation in response to the determination that the ventilator is in a non-ventilating state.

Images