Adaptive control of medical equipment under adverse environments

Abstract

A medical device is configured to use one or more sensors to monitor environmental conditions in the physical environment near the medical device; determine when a value representing the environmental conditions exceeds a safe operating threshold for the medical device in terms of patient care. In response to the value exceeding the threshold, the operating mode of the medical device is automatically switched from a first mode currently programmed for patient care to a second mode, which uses different parameters to control the medical device than the first mode.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Application No. 62 / 891,869, filed August 26, 2019, entitled “MEDICAL DEVICE ADAPTIVE CONTROL FOR HOSTILE ENVIRONMENT”, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application generally relates to maintaining the safety and performance of medical devices throughout a healthcare facility. Background Technology

[0004] Temperature, atmospheric pressure, electromagnetic waves, certain radio frequencies, and other environmental factors can affect the operation of medical devices. For example, these and other environmental conditions may interfere with the intended operation of sensitive circuitry within medical devices (such as infusion pumps). These factors may have a greater impact on medications delivered by medical devices. Malfunctions of medical devices or medications increase health risks for patients in healthcare facilities. Summary of the Invention

[0005] According to various aspects, this subject matter provides a medical device configured to use one or more sensors to monitor environmental conditions in the physical environment adjacent to the medical device; determine when a value representing the environmental conditions exceeds a safe operating threshold for the medical device in patient care; and, in response to the value exceeding the threshold, automatically switch the operating mode of the medical device from a first mode currently programmed for the patient care to a second mode, the second mode using different parameters to control the medical device than the first mode.

[0006] According to various aspects, a machine-implemented method includes using one or more sensors to monitor environmental conditions in the physical environment near a medical device; determining that a value representing the environmental conditions exceeds a safe operating threshold for the medical device in terms of patient care; and, in response to the value exceeding the threshold, automatically switching the operating mode of the medical device from a first mode currently programmed for the patient care to a second mode, the second mode using different parameters to control the medical device than the first mode. Switching the operating mode of the medical device may include disabling the use of the first sensor measurements, wherein the first mode includes determining the operational performance of the hardware device based on the first sensor measurements, and the second mode includes determining the operational performance based on a software algorithm that does not use the first sensor measurements. Other aspects include corresponding systems, apparatus, and computer program products for implementing the machine-implemented method.

[0007] It should be understood that, through the following detailed description, those skilled in the art will readily understand other configurations of the subject matter, in which various configurations of the subject matter are illustrated and described by way of illustration. It will be recognized that the subject matter can have other and different configurations, and that several details thereof can be modified in various other ways, all without departing from the scope of the subject matter. Therefore, the accompanying drawings and detailed description should be considered illustrative in nature rather than limiting. Attached Figure Description

[0008] To better understand the various implementations described, reference should be made to the following detailed description in conjunction with the accompanying drawings. Throughout the drawings and description, the same reference numerals refer to corresponding parts.

[0009] Figure 1 Examples of institutional patient care systems in medical institutions are shown, based on various aspects of the technology in this subject matter.

[0010] Figure 2 Examples of medical devices that move between patient care areas and detect adverse environmental conditions, based on various aspects of the technology of this subject, are shown.

[0011] Figure 3 An example process is shown that automatically adjusts the control of a medical device in response to the detection of an adverse environment, according to various aspects of the subject matter.

[0012] Figure 4 This is a conceptual diagram illustrating an example electronic system that automatically adjusts the control of a medical device in response to the detection of an adverse environment, according to various aspects of the subject matter. Detailed Implementation

[0013] The implementation will now be referenced, examples of which are shown in the accompanying drawings. Numerous specific details are set forth in the following description to provide an understanding of the implementations of the various descriptions. However, it will be apparent to those skilled in the art that implementations of the various descriptions can be practiced without these specific details. In other instances, well-known methods, processes, components, circuits, and networks have not been described in detail to avoid unnecessarily obscuring the various aspects of the implementation.

[0014] This subject matter involves utilizing sensors and / or other operational features of medical devices (e.g., infusion pumps) to collect signals and, based on these signals, detect adverse environmental conditions that may interfere with the device's operating conditions. According to some implementations, the medical device may suggest corrective actions to address the interference.

[0015] For example, some care areas, such as MRI, may include magnetic fields that affect the function of medical devices. These strong magnetic fields may affect or even damage certain circuits and / or sensors of the medical device, including Hall sensors implemented by the device. In this regard, a disruption in the function of a Hall sensor may lead to a decrease in the ability of the volume sensing characteristics of the medical device (which rely on Hall sensors to obtain accurate readings), or even malfunction. According to various aspects of the subject matter, medical devices are configured to adjust or change their operating modes when the circuitry of the medical device is likely to be affected by conditions in an adverse environment, such as relying on software functions (e.g., software-based volume sensing) rather than the more accurate sensing that the circuitry may provide (e.g., Hall sensing).

[0016] Figure 1 An example of an institutional patient care system 100 in a healthcare facility according to various aspects of the subject matter is shown. In 1, patient care devices (or “medical devices”) 12 are connected to a hospital network 10. The term patient care device (or “PCD”) may be used interchangeably with the term patient care unit (or “PCU”), either of which may include various assistive medical devices, such as infusion pumps, vital sign monitors, medication dispensing devices (e.g., cabinets, pouches), medication preparation devices, automated dispensing devices, modules coupled to one of the above (e.g., syringe pump modules configured to connect to infusion pumps), or other similar devices. Each element 12 is connected to the internal healthcare network 10 via a transmission channel 31. The transmission channel 31 is any wired or wireless transmission channel, such as an 802.11 wireless local area network (LAN). In some implementations, network 10 also includes computer systems located in various departments of the hospital. For example, Figure 1 Network 10 may optionally include computer systems associated with admissions, billing, biomedical engineering, clinical laboratories, central supply, one or more unit station computers, and / or medical decision support systems. As further described below, network 10 may include discrete subnets. In the depicted example, network 10 includes a device network 40 through which patient care devices 12 (and other devices) communicate under normal operation.

[0017] Additionally, the institutional patient care system 100 may be integrated with a separate information system server 30, the functions of which will be described in more detail below. Furthermore, although the information system server 30 is shown as a separate server, its functionality and programs can be integrated into another computer if required by the engineers designing the institutional information system. The institutional patient care system 100 may also include one or more device terminals 32 for connecting to and communicating with the information system server 30. Device terminals 32 may include personal computers, personal data assistive devices, mobile devices (e.g., laptops, tablets, augmented reality devices, or smartphones), configured with software for communicating with the information system server 30 via network 10.

[0018] Patient care device 12 includes systems for providing patient care, such as those described in U.S. Patent 5,713,856 published by Eggers et al., which is incorporated herein by reference for this purpose. Patient care device 12 may include or contain pumps, physiological monitors (e.g., heart rate, blood pressure, ECG, EEG, pulse oximeter, and other patient monitors), therapeutic devices, and other drug delivery devices that may be used in accordance with the teachings set forth herein. In the depicted example, patient care device 12 includes a control module 14, also referred to as interface unit 14, connected to one or more functional modules 16, 18, 20, 22. Interface unit 14 includes a central processing unit (CPU) 50 connected to a memory, such as random access memory (RAM) 58, and includes one or more interface devices (e.g., user interface device 54), coded data input devices 60, a network connection 52, and an interface 62 for communication with additional communication modules or device auxiliary interfaces. While the interface unit 14 is not mandatory, it also includes a main non-volatile storage unit 56 (e.g., a hard disk drive or non-volatile flash memory) for storing software and data, and one or more internal buses 64 for interconnecting the aforementioned components.

[0019] In various implementations, user interface device 54 is a touchscreen used to display information to a user and allow the user to input information by touching a defined area of ​​the screen. Alternatively or additionally, user interface device 54 may include any device for displaying and inputting information, such as a monitor, printer, keyboard, soft keys, mouse, trackball, and / or light pen. Data input device 60 may be a barcode reader capable of scanning and deciphering data printed in barcode format. Alternatively or additionally, data input device 60 may be any device for inputting encoded data into a computer, such as a device for reading magnetic stripes, a radio frequency identification (RFID) device (thereby enabling the reader 60 to capture digital data encoded in an RFID tag or smart tag (as defined below) via radio waves), a PCMCIA smart card, an RFID card, a memory stick, a CD, DVD, or any other analog or digital storage medium. Other examples of data input device 60 include voice-activated or recognition devices or portable personal data assistants (PDAs). Depending on the type of interface device used, user interface device 54 and data input device 60 may be the same device. Although data input device 60 is... Figure 1 While shown as being housed within interface unit 14, it should be understood that data input device 60 may be integrated within pharmacy system 34 or located externally to pharmacy system 34 and communicate with pharmacy system 34 via an RS-232 serial interface or any other suitable communication device. Auxiliary interface 62 may be an RS-232 communication interface, but without departing from the subject matter, any other device for communicating with peripheral devices (e.g., printers, patient monitors, infusion pumps, or other medical devices) may be used. Furthermore, data input device 60 may be a separate functional module, such as modules 16, 18, 20, and 22, and configured to communicate with controller 14 or any other system on the network using suitable programming and communication protocols.

[0020] Network connection 52 can be a wired or wireless connection, such as via Ethernet, WiFi, Bluetooth, Integrated Services Digital Network (ISDN) connection, Digital Subscriber Line (DSL) modem, or cable modem. Any direct or indirect network connection can be used, including but not limited to telephone modems, MIB systems, RS232 interfaces, auxiliary interfaces, optical links, infrared links, radio frequency links, microwave links, or WLAN connections or other wireless connections.

[0021] Functional modules 16, 18, 20, and 22 are any devices used to provide care to patients or to monitor patient conditions. For example... Figure 1As shown, at least one of functional modules 16, 18, 20, and 22 can be an infusion pump module, such as an intravenous infusion pump for delivering medications or other fluids to a patient. For the purposes of discussion, functional module 16 is an infusion pump module. Each of functional modules 18, 20, and 22 can be any patient treatment or monitoring device, including but not limited to infusion pumps, syringe pumps, PCA pumps, epidural pumps, enteral pumps, blood pressure monitors, pulse oximeters, EKG monitors, EEG monitors, heart rate monitors, or intracranial pressure monitors. Functional modules 18, 20, and / or 22 can be printers, scanners, barcode readers, or any other peripheral input, output, or input / output device.

[0022] Each functional module 16, 18, 20, and 22 communicates directly or indirectly with interface unit 14, which provides overall monitoring and control of device 12. Functional modules 16, 18, 20, and 22 can be physically and electronically connected in series to one or both ends of interface unit 14, such as... Figure 1 As shown, or as detailed by Eggers et al. However, it should be recognized that other means for connecting functional modules to the interface unit can be used without departing from the technical subject matter. It will also be understood that devices such as pumps or patient monitoring devices, which provide sufficient programmability and connectivity, can operate as standalone devices and can communicate directly with the network without connection through a separate interface unit or control unit 14. As described above, additional medical devices or peripheral devices can be connected to the patient care device 12 via one or more auxiliary interfaces 62.

[0023] Each functional module 16, 18, 20, 22 may include a module-specific component 76, a microprocessor 70, volatile memory 72 for storing information, and non-volatile memory 74. It should be noted that, although... Figure 1 Four functional modules are shown, but any number of devices can be connected directly or indirectly to the central controller 14. The number and type of functional modules described herein are illustrative and in no way limiting the scope of the subject matter. Module-specific components 76 include any components necessary for operating a particular module, such as the pumping mechanism for the infusion pump module 16.

[0024] While each functional module may be capable of operating independently to some extent, the interface unit 14 monitors and controls the overall operation of the device 12. For example, as will be described in more detail below, the interface unit 14 provides programming instructions to functional modules 16, 18, 20, and 22 and monitors the status of each module.

[0025] Patient care device 12 can operate in several different modes or personalities, each defined by a configuration database. The configuration database can be an internal database 56 or an external database 37. The selection of a specific configuration database is based at least in part on patient-specific information, such as patient location, age, physical characteristics, or medical characteristics. Medical characteristics include, but are not limited to, patient diagnosis, treatment prescriptions, medical history, medical records, patient care provider identity, physical characteristics, or psychological characteristics. As used herein, patient-specific information also includes care provider information (e.g., physician identity) or the location of patient care device 10 within a hospital or hospital computer network. Patient care information can be entered via interface devices 52, 54, 60, or 62 and can originate from anywhere within network 10, such as from a pharmacy server, admission server, laboratory server, etc.

[0026] Medical devices incorporating various aspects of the techniques described herein can be equipped with a Network Interface Module (NIM), allowing the medical device to participate in a network as a node. While for clarity, the techniques described herein will be depicted operating in an Ethernet network environment using the Internet Protocol (IP), it should be understood that the concepts of the techniques described herein are equally applicable to other network environments intended to be within the scope of these techniques.

[0027] Data entering and exiting various data sources can be converted into network-compatible data using existing technologies, and information movement between medical devices and networks can be achieved in multiple ways. For example, patient care device 12 and network 10 can communicate through automatic interaction, manual interaction, or a combination of automatic and manual interaction. Automatic interaction can be continuous or intermittent and can be achieved through a direct network connection 54 (e.g., ...). Figure 1 (As shown) or via RS232 links, MIB systems, RF links (such as Bluetooth), IR links, WLAN, digital cable systems, telephone modems, or other wired or wireless communication methods. Manual interaction between patient care device 12 and network 10 involves the intermittent or periodic physical transfer of data between systems, for example, using user interface device 54, coded data input device 60, barcodes, computer disks, portable data assistants, memory cards, or any other media used for storing data. The communication devices of each aspect are bidirectional and can access data from as many distributed data source points as possible. Decisions can occur in multiple locations within network 10. For example, but not limited to, decisions can be made at HIS server 30, decision support 48, remote data server 49, hospital department or unit station 46, or within patient care device 12 itself.

[0028] According to the present invention, all direct communication with medical devices operating on the network can be performed through an information system server 30, referred to as a Remote Data Server (RDS). According to various aspects of the present invention, network interface modules integrated into the medical devices (e.g., infusion pumps or vital sign measurement devices) ignore all network traffic not originating from the certified RDS. The primary responsibility of the RDS in this invention is to track the location and status of all networked medical devices with NIM and to maintain open communication.

[0029] Figure 2 An example of a medical device that moves between a first care area 200 and a second care area 202 and detects adverse environmental conditions, according to various aspects of the subject matter, is illustrated. As shown, the medical device 12 may include a control unit 204 and one or more functional modules (e.g., functional modules 16, 18, 20, 22), including a first functional module 206 and a second functional module 208. The second functional module 208 is depicted as including a drug 210. In some implementations, the medical device 12 may be a dispensing device configured to dispense the drug 210 for patient care upon authorization by a clinician. In some implementations, the medical device 12 may be an infusion device configured to administer the drug 210 to a patient (e.g., intravenous administration via a connected infusion device). The control unit may include one or more processors, for example, configured to interface with functional units connected to the control unit and control and power these functional units.

[0030] According to various aspects of the subject matter, the medical device 12 may include one or more sensors 212 configured to detect corresponding environmental conditions. The medical device 12 may be configured to monitor environmental conditions of the physical environment near the medical device using the sensors 212. In this regard, the sensors 212 may include thermistors, radio frequency (RF) receivers, magnetometers, optical sensors, etc. For example, the sensors 212 may be configured to detect ambient temperature, radiant temperature, light intensity, acoustic transmission (sound), magnetic fields and their strength. The sensors 212 may have a range 214.

[0031] Medical device 12 may include circuitry enabling sensor 212 to acquire measurements representing environmental conditions. Sensor 212 may measure environmental conditions periodically or under certain triggering conditions. An example triggering condition may include medical device 12 detecting that it has moved to a new location. Medical device 12 may determine whether its new physical environment includes (potentially) hazardous environment device 216 by querying internal database 56 or server 30 and / or corresponding external database 37 based on its known coordinates (e.g., GPS) or by connecting to a new WiFi system, and receiving an indication of the triggering condition upon determining the (potential) presence of device 216. Device 216 may include various electrical or mechanical devices that emit energy fields 218 that may damage the circuitry of medical device 12. Destructive energy fields include, for example, magnetic fields (e.g., from an MRI machine), predetermined radio frequencies, heat, cold, air, vibration, and sound.

[0032] Upon receiving a measurement value, medical device 12 can determine when the value exceeds a safe operating threshold for patient care. For example, various thresholds can be stored in a database and indexed by one or more indexes, including care area, patient medical condition, time of day, etc. In response to the value exceeding the threshold, the operating mode of the medical device can automatically switch from a first mode currently programmed for patient care to a second mode. Depending on various aspects, the second mode can utilize different parameters than the first mode to control the medical device. For example, the first mode can operate the pump according to a first flow rate, while the second mode can operate the pump according to a second, lower flow rate. Parameters in the first mode can activate functional modules, while parameters in the second mode can deactivate functional modules.

[0033] Computer program code used to perform the operations of this subject matter can be written in an object-oriented programming language, such as... Smalltalk or C++. However, the computer program code used to perform the operations of this subject matter can also be written in conventional procedural programming languages ​​such as the "C" programming language, interpreted scripting languages ​​such as Perl, or functional (or fourth-generation) programming languages ​​such as Lisp, SML, Forth, etc. The software can also be written to be compatible with HLA-7 requirements.

[0034] Depending on the implementation, the medical device 12 may include and / or utilize one or more onboard sensors 212, such as magnetometers, temperature sensors, acoustic sensors, or light sensors, configured to measure environmental conditions and assign values ​​representing those conditions. The medical device 12 may include circuitry and / or software that monitors the measurements and / or values ​​received from each of these sensors. When the medical device (or its network circuitry) 12 detects that one of these measurements and / or values ​​meets (e.g., exceeds) a predetermined threshold, it may trigger the medical device to automatically adjust or change its mode.

[0035] Depending on the implementation, the drug 210 administered by a medical device or otherwise delivered may be sensitive to certain environmental conditions. Therefore, as previously described, the medical device 12 may be configured to monitor environmental conditions around the medical device 12 using one or more sensors 212 to identify conditions that may adversely affect the drug 210 or its delivery. The medical device 12 may also be configured to automatically assign predetermined thresholds to measured environmental conditions (e.g., temperature or light intensity) based on the drug 210 it delivers. In some implementations, the predetermined thresholds may reduce the drug's half-life by a predetermined amount based on the measured environmental conditions.

[0036] Thresholds or threshold ranges can be stored, for example, in a lookup table or in a database indexed by drug type and the specific environmental conditions being measured. For instance, a drug dispensing device can automatically measure the temperature value inside each cabinet containing the drug. When the temperature exceeds a predetermined safe temperature range for storing the drug, the device can automatically adjust or change mode. Similarly, an infusion device can be programmed to look up safe ranges of environmental conditions, such as the temperature and light exposure of the given drug, when administering a given drug, and begin monitoring environmental conditions near the device to ensure these ranges are met. When the medical device (or its network circuitry) detects that one of these measurements and / or values ​​meets (e.g., exceeds) a predetermined threshold, it can trigger the medical device to automatically adjust or change mode.

[0037] Depending on the implementation, adjusting or changing the operating mode may include taking corrective action. Corrective actions may include displaying an alarm and / or issuing an audible alarm on the medical device. Corrective actions may include stopping ongoing medication administration or locking the device to prevent administration or delivery of more medication until the alarm is acknowledged. Acknowledgment may include identifying the clinician's authorization to use the medical device by scanning their badge, and the clinician manually deactivating the alarm by manually entering information on the medical device or by manually deactivating it via a computing device connected to the medical device (e.g., via a network).

[0038] In one example, an infusion pump can be programmed to administer medication to a patient. The infusion pump may include a temperature sensor and / or a light sensor located near the location where the medication is stored for pump delivery. The infusion pump may include a radiant temperature sensor to detect radiant energy indicating heat emitted from the medication, and may include a thermistor to read the ambient room temperature or the temperature of the tubing used to deliver the medication. During medication administration to the patient, the pump may monitor (using sensors) environmental conditions around the pump, including temperature or light intensity. The pump may issue an alarm and / or stop medication administration to the patient when it detects that the light intensity exceeds a threshold light intensity within a threshold time, and / or when it detects that the temperature exceeds a threshold temperature within a threshold time.

[0039] In another example, the infusion pump can utilize a Hall sensor to measure stroke volume or detect air bubbles in the administration line. For instance, the sensor can be used to calculate the stroke rate and corresponding pumping rate, which the processor can then adjust to correct for setpoint deviations. The sensor can also be used to detect stroke count, allowing for the maintenance of a timing history of completed strokes, which can be used to calculate flow rate and total dispensing volume. The infusion pump may also include a magnetometer configured to measure magnetism near the infusion pump, including the direction, intensity, or relative change of the magnetic field. When the magnetometer detects a magnetic field (e.g., intensity or change) above a threshold level, indicating an impact on the Hall sensor measurement, the processor associated with the infusion pump (or magnetometer) can automatically disable the Hall sensor and switch to calculations of pumping rate, stroke rate, flow rate, and volume performed by the software.

[0040] In some implementations, software calculations may be less accurate than calculations performed by circuitry disabled due to given environmental conditions. Medical devices can be configured with a predetermined acceptable accuracy (e.g., 5%), which can trigger mode changes or other operational adjustments if this accuracy is exceeded. For example, in response to the detection of adverse environmental conditions, an infusion pump can switch to using software calculations, but if the pump determines that the software calculations cannot maintain the predetermined acceptable accuracy, it can switch drug administration or other operational parameters. In some implementations, the current settings of the medical device may further affect this accuracy, and these settings can be adjusted to compensate for a certain degree of potential error. For example, the potential error level (or accuracy) in the software calculation of flow rate can be further determined based on the flow rate itself when the temperature or Hall sensor of the infusion device is disabled due to environmental conditions. During critical drug administration, the infusion pump can be configured to adjust the flow rate by the minimum amount required to maintain an acceptable amount of error.

[0041] Many medical devices can operate on batteries, allowing them to remain functional during power outages or when moving between care areas. The battery unit of a medical device can, for example, power one or more processors responsible for operation, pumping mechanisms (e.g., in the case of an infusion pump), electronic locks (e.g., in the case of a dispensing device), or network circuitry. The battery unit can also power dependent or auxiliary devices connected to the medical device. For example, the battery unit of an infusion device can power one or more connected functional modules, each including an infusion pump, syringe pump, PCA pump, epidural pump, enteral pump, blood pressure monitor, pulse oximeter, EKG monitor, EEG monitor, heart rate monitor, intracranial pressure monitor, etc.

[0042] In some implementations, medical device 12 may utilize one or more temperature sensors to detect the ambient temperature of the room where the device is located, or to detect the internal temperature of the device itself or its battery or battery compartment. One or more temperature measurements may be obtained using temperature sensor 212 and used to determine whether to adjust the power allocation for various systems of medical device 12, including the power allocation for any connected functional modules 16, 18, 20, 22. Higher operating temperatures may shorten battery capacity and lifespan. Medical device 12 may obtain data regarding the expected capacity or lifespan of its battery based on various factors, including the current operating temperature, depth of discharge, discharge rate, and capacity under previously known similar conditions. If the medical device determines that the expected battery capacity is below a predetermined threshold for maintaining current operation for a predetermined time, the medical device may enter a power-saving mode and begin shutting down or reducing the operation of non-essential systems. Whether functional units and / or medical device features are necessary or non-essential may be determined based on various factors, including care areas 200, 202, patient status, time to next charge, etc. In some examples, network connectivity may be identified as a non-essential system. In other examples, network connectivity may be identified as a necessary system. In high-traffic, noisy intensive care units (such as ICUs), audible alarms are identified as necessary systems, but when equipment is moved from one area to another, audible alarms are identified as unnecessary systems.

[0043] In one example, a control unit 14 associated with an infusion pump configured according to the present invention can monitor temperature and determine if the battery has insufficient capacity to operate the pumping mechanism at a currently set flow rate for the time required to administer medication to the patient before receiving the next charge. This predetermined time can be a default operating period during a power outage, a configuration menu displayed on the device's screen, or a period provided to the infusion pump (or other medical device) by a hospital information server in conjunction with instructions to reposition the device from a first care unit to a second care unit. In response to determining that the battery lacks the capacity to maintain the current pumping load, the control unit can automatically enter a power-saving mode and reduce the pumping rate to a level that allows the pumping mechanism to continue pumping for the entire required time period. In some implementations, the control unit can shut down non-essential functional units (such as blood pressure devices or pulse oximeters) while maintaining the operation of essential functional units (such as the pumping mechanism responsible for delivering life-sustaining medications). The control unit can also lock the possibility of module connection, preventing the connection of additional functional modules while the device is in power-saving mode.

[0044] In some implementations, a predetermined threshold for a given environmental condition can be based on certain characteristics of the device connected to the medical device. For example, different tubing thicknesses in infusion sets may behave differently at different temperatures; in other words, in colder environments, thicker tubing may exert greater resistance to pumping. In this example, the threshold could be a colder temperature at which tubing flexibility decreases and the pump should switch to a more aggressive pumping intensity or speed to compensate for the increased pumping resistance.

[0045] In some implementations, environmental condition detection may respond to errors reported by components of medical device 12 (or any component or module of the medical device). For example, control unit 14 of medical device 12 may detect Hall sensor errors (e.g., sensor measurements exceeding the expected measurement range). In response to the detection of an error, environmental sensors are activated and control unit receives environmental signals. For example, medical device 12 may check measurements from a magnetometer, temperature sensor, acoustic sensor, or light sensor to confirm that the measurements are within the expected range. Furthermore, medical device 12 may receive other environmental conditions based on the device's location (e.g., measured via GPS), logged-in clinician profiles, network status, etc. If environmental conditions indicate that the characteristics of the medical device may be affected (from an adverse environment), the medical device may adjust or change its mode, as described above. In some implementations, the medical device may provide alerts and prompt the user to make or confirm changes. For example, an infusion pump may require manual confirmation to switch to software flow rate detection, where this switch responds to user input via a graphical user interface on or associated with the infusion pump. Therefore, this additional check for errors can reduce error alerts related to pump errors.

[0046] Certain environmental conditions may cause medical device 12 to lose its network connection. For example, some care areas include shielded rooms (such as MRI rooms) that prevent radio and electromagnetic energy from passing through walls. When medical device 12 (or its network circuitry) detects that it has lost its network connection, it can trigger the medical device to automatically adjust or change mode. In one example, upon detecting a loss of network connection, medical device 21 may switch to manual mode, in which it begins to use its onboard drug library instead of searching for operating parameters and limitations via the network connection.

[0047] Some medical devices 12 may include wireless circuitry for detecting other devices within a predetermined vicinity of the medical device, or other devices belonging to the medical device. For example, in certain environments, medical device 12 may use Bluetooth to connect to other pre-designated medical devices. Wireless signature broadcasts from the first medical device may interfere with the circuitry of the second medical device, or connections between devices may affect the normal operation of the circuitry or its ability to reach its full potential. In this regard, when the second medical device (or its network circuitry) detects interference or a connection to the first device, it may be triggered to automatically adjust or change its mode.

[0048] In some implementations, medical device 12 can be configured to generate an audible or visual alarm before or at the time of a mode change. In this regard, the medical device can provide options for mode adjustment on its associated display device when network connectivity is lost. For example, the medical device can prompt the user to choose whether to maintain the current mode or adjust network settings. Options may include selecting from available networks or choosing a different type of network to use (e.g., Bluetooth or wired instead of WiFi). In some implementations, alarms can escalate as environmental conditions worsen. For example, different levels of alarms may be generated as more critical life support systems are affected. The first alarm may include a visual alarm, while an audible alarm may gradually brighten based on different impact thresholds, with higher impact triggering a network message to be sent over the network to primary caregivers.

[0049] Figure 3 An example process for automatically adjusting the control of a medical device in response to the detection of an adverse environment, according to various aspects of the subject matter, is illustrated herein. For illustrative purposes, the various blocks of the example process 300 are referenced herein. Figure 1 and 2 The components and / or processes described herein are described. One or more blocks of process 300 may be implemented, for example, by one or more computing devices including, for example, medical device 12. In some implementations, one or more blocks may be implemented based on one or more machine learning algorithms. In some implementations, one or more blocks may be separate from other blocks and implemented by one or more different processors or devices. Further, for illustrative purposes, the blocks of example process 300 are described as occurring sequentially or linearly. However, multiple blocks of example process 300 may occur in parallel. Moreover, the blocks of example process 300 do not need to be executed in the order shown and / or one or more blocks of example process 300 do not need to be executed.

[0050] In the depicted example, medical device 12 uses one or more sensors 212 to monitor environmental conditions (302) of the physical environment approaching the medical device.

[0051] Values ​​representing environmental conditions are determined to exceed a safe operating threshold for the medical device in patient care (304). For simplicity, the relationship to the threshold can be described as "exceeding the threshold," but additional or alternative relationships may be included to determine whether a value corresponds to a threshold. Furthermore, the threshold can be a static value stored in memory or other configuration storage accessible by the medical device, or it can be a dynamic threshold determined based on one or more values ​​available to the medical device (e.g., programmed operating parameters, default configuration, etc.) or one or more values ​​detectable by the medical device (e.g., temperature, position, speed, orientation, etc.).

[0052] In response to the value exceeding a threshold, the operating mode of medical device 12 automatically (in real time) switches from a first mode currently programmed for patient care to a second mode, which uses different parameters to control the medical device (306) than the first mode. Depending on various implementations, switching the operating mode of medical device 12 may include disabling the use of first sensor measurements (or measurements provided by the first sensor). In this regard, the first mode may include determining the operational performance of the hardware device based on the first sensor measurements, and the second mode may include determining operational performance based on a software algorithm that does not use the first sensor measurements. For example, medical device 12 may include an infusion device, and one or more sensors 212 may include a magnetometer. In this example, environmental conditions may include a magnetic field, the first sensor measurements may be provided by a Hall sensor, and operational performance may be associated with a pumping mechanism that applies fluid to the patient.

[0053] In some implementations, the medical device 12 may include onboard diagnostics to determine if, during operation, the hardware components of the medical device have generated errors exceeding a predetermined error threshold, prior to monitoring environmental conditions. In these implementations, monitoring of environmental conditions may be initiated in response to errors exceeding the predetermined error threshold.

[0054] In some implementations, environmental conditions include temperature, and switching the operating mode of a medical device may include reducing the power of the device's hardware components in response to the temperature exceeding a predetermined temperature threshold. The temperature may be ambient temperature, the internal temperature of the device (e.g., a compartment), or the temperature of a medication supplied by the device.

[0055] According to various implementations, the medical device 12 can be an infusion device or a drug dispensing device, and environmental conditions may include sensing temperature or light intensity that affects the medication delivered by the device. A drug dispensing device 12 according to the present invention can determine that the medication stored in the compartment of the drug dispensing device has been exposed to temperature or light intensity for more than a predetermined time, and switch the operating mode of the medical device by locking the compartment to prevent drug dispensing. An infusion device 12 according to the present invention can determine that the medication designated for administration to a patient by the drug dispensing device has been exposed to temperature or light intensity for more than a predetermined time, and switch the operating mode of the medical device by electronically disabling the pumping mechanism of the medical device to prevent administration of the medication to the patient.

[0056] In some implementations, switching the operating mode of medical device 12 may include entering a power-saving mode. Medical device 12 may determine the battery capacity of the battery powering at least the hardware components of the medical device, and determine, based on a measured temperature exceeding a predetermined temperature threshold, that the battery capacity is insufficient to power the hardware components for a predetermined time. In this regard, switching the operating mode may include adjusting operating parameters used to control at least the hardware components to reduce the power load on medical device 12, and the power load may be reduced to a level where the battery is sufficient to power the hardware components for a predetermined time.

[0057] As previously described, the medical device 12 may include a control unit 14 configured to interface with a plurality of functional units 16, 18, 22, 22, and to control and power the respective functional units when they are connected to the control unit. In some implementations, the medical device 12 may determine the battery capacity of the battery powering the control unit and the plurality of functional units currently connected to the control unit. This determination may be performed periodically in response to a temperature rise or by a battery management system (e.g., circuitry and / or software). The medical device may determine, based on a temperature exceeding a predetermined temperature threshold, that the battery capacity is insufficient to power the plurality of functional units for a predetermined time, and disable at least one of the plurality of functional units in response to insufficient battery capacity. In some implementations, the medical device may determine, based on a temperature exceeding a predetermined temperature threshold, that the battery capacity is insufficient to power at least one functional unit currently connected to the control unit for a predetermined time, and disable the control unit's ability to power any additional functional units other than the at least one functional unit currently connected to the control unit in response to the determination of insufficient battery capacity.

[0058] Many of the examples 300 above, along with related features and applications, can also be implemented as software processes. These software processes are specified as a set of instructions recorded on a computer-readable storage medium (also known as a computer-readable medium) and can be executed automatically (e.g., without user intervention). When these instructions are executed by one or more processing units (e.g., one or more processors, processor cores, or other processing units), they cause the processing unit to perform the actions indicated in the instructions. Examples of computer-readable media include, but are not limited to, CD-ROMs, flash drives, RAM chips, hard disk drives, EPROMs, etc. Computer-readable media do not include carrier waves and electronic signals transmitted wirelessly or via wired connections.

[0059] The term "software" is intended, where appropriate, to include firmware residing in read-only memory or an application stored in magnetic storage, which can be read into memory for processor processing. Furthermore, in some implementations, multiple software aspects of this disclosure may be implemented as sub-parts of a larger program while retaining the different software aspects of this disclosure. In some implementations, multiple software aspects may also be implemented as separate programs. Finally, any combination of separate programs that collectively implement the software aspects described herein is within the scope of this disclosure. In some implementations, when run on one or more electronic systems, the software program defines one or more specific machine implementations that execute and implement the operations of the software program.

[0060] Computer programs (also known as programs, software, software applications, scripts, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and can be deployed in any form, including as standalone programs or as modules, components, subroutines, objects, or other units suitable for use in a computing environment. A computer program may, but does not necessarily, correspond to a file in a file system. A program may be stored as part of a file containing other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinating files (e.g., a file storing one or more modules, subroutines, or portions of code). Computer programs can be deployed to execute on a single computer or on multiple computers located at a site or distributed across multiple sites and interconnected by a communication network.

[0061] Figure 4 This is a conceptual diagram illustrating an example electronic system 400 that automatically adjusts the control of a medical device in response to the detection of an adverse environment, according to various aspects of the subject matter. The electronic system 400 may be a part or step of performing or executing the process 400, or may be composed of... Figure 1-3The computing device that provides the components and processes (including but not limited to the computing hardware or terminal device 37 within the information system server 30, production server 204, and patient care equipment 12) and the associated software. In conjunction with... Figure 1-3 As disclosed, electronic system 400 can be representative. In this regard, electronic system 400 can be a personal computer or mobile device, such as a smartphone, tablet computer, laptop computer, PDA, augmented reality device, wearable device, such as a watch or watchband or glasses, or a combination thereof, or other touch screen or television having one or more processors embedded therein or coupled thereto, or any other type of computer-related electronic device with network connectivity.

[0062] Electronic system 400 may include various types of computer-readable media and interfaces for various other types of computer-readable media. In the depicted example, electronic system 400 includes a bus 408, a processing unit 412, system memory 404, read-only memory (ROM) 410, permanent storage device 402, input device interface 614, output device interface 406, and one or more network interfaces 416. In some implementations, electronic system 400 may include or be integrated with other computing devices or circuits to perform the operation of the various components and processes described above.

[0063] Bus 408 represents all system, peripheral, and chipset buses that communicate with the numerous internal devices of electronic system 400. For example, bus 408 communicates with processing unit 412, ROM 410, system memory 404, and permanent storage device 402.

[0064] From these various memory units, the processing unit 412 retrieves instructions to be executed and data to be processed in order to perform the processes of this disclosure. In different implementations, the processing unit may be a single processor or a multi-core processor.

[0065] ROM 410 stores static data and instructions required by processing unit 412 and other modules of the electronic system. On the other hand, permanent storage device 402 is a read-write memory device. This device is a non-volatile storage unit that can store instructions and data even when the electronic system 400 is off. Some implementations of this disclosure use mass storage devices (e.g., magnetic disks or optical disks and their corresponding disk drives) as permanent storage device 402.

[0066] Other implementations use removable storage devices (e.g., floppy disks, flash drives, and their corresponding disk drives) as permanent storage device 402. Like permanent storage device 402, system memory 404 is a read-write memory device. However, unlike storage device 402, system memory 404 is volatile read-write memory, such as random access memory. System memory 404 stores some instructions and data required by the processor during runtime. In some implementations, the processes of this disclosure are stored in system memory 404, permanent storage device 402, and / or ROM 410. From these different memory units, processing unit 412 retrieves instructions to be executed and data to be processed in order to execute the processes of certain implementations.

[0067] Bus 408 is also connected to input and output device interfaces 414 and 406. Input device interface 414 allows the user to send information and select commands to the electronic system. Input devices used with input device interface 414 include, for example, alphanumeric keypads and pointing devices (also known as "cursor control devices"). Output device interface 406 is capable of displaying, for example, images generated by electronic system 400. Output devices used with output device interface 406 include, for example, printers and display devices such as cathode ray tube (CRT) or liquid crystal display (LCD). Some implementations include devices such as touchscreens, which function as both input and output devices.

[0068] In addition, such as Figure 4 As shown, bus 408 also couples electronic system 400 to a network (not shown) via network interface 416. Network interface 416 may include, for example, a wireless access point (e.g., Bluetooth or WiFi) or radio circuitry for connecting to a wireless access point. Network interface 416 may also include hardware (e.g., Ethernet hardware) for connecting a computer to a part of a computer network, such as a local area network (“LAN”), wide area network (“WAN”), wireless LAN, or intranet or internet (e.g., the Internet). Any or all components of electronic system 400 may be used in conjunction with this invention.

[0069] These functions can be implemented in computer software, firmware, or hardware. These technologies can be implemented using one or more computer program products. Programmable processors and computers can be contained in or packaged as mobile devices. Processes and logical flows can be executed by one or more programmable processors and one or more programmable logic circuits. General-purpose and special-purpose computing devices and storage devices can be interconnected through communication networks.

[0070] Some implementations include electronic components such as microprocessors, storage devices, and memories that store computer program instructions in machine-readable or computer-readable media (also known as computer-readable storage media, machine-readable media, or machine-readable storage media). Examples of such computer-readable media include RAM, ROM, read-only optical discs (CD-ROM), recordable optical discs (CD-R), rewritable optical discs (CD-RW), read-only digital multifunction discs (e.g., DVD-ROM, dual-layer DVD-ROM), various recordable / rewritable DVDs (e.g., DVD-RAM, DVD-RW, DVD+RW, etc.), flash memory (e.g., SD cards, mini SD cards, micro SD cards, etc.), magnetic and / or solid-state hard drives, read-only and recordable... Optical discs, high-density optical discs, any other optical or magnetic media, and floppy disks. Computer-readable media may store computer programs that can be executed by at least one processing unit and include a set of instructions for performing various operations. Examples of computer programs or computer code include machine code generated by a compiler, and files that include high-level code executed by a computer, electronic component, or microprocessor using an interpreter.

[0071] While the above discussion primarily concerns microprocessors or multi-core processors that execute software, some implementations are executed by one or more integrated circuits, such as application-specific integrated circuits (ASICs) or field-programmable gate arrays (FPGAs). In some implementations, such integrated circuits execute instructions stored on the circuit itself.

[0072] As used in this specification and any claim of this application, the terms "computer," "server," "processor," and "memory" refer to electronic or other technical devices. These terms do not include people or groups of people. For the purposes of this specification, the terms "displayed" or "being displayed" mean displayed on an electronic device. As used in this specification and any claim of this application, the terms "computer-readable medium" and "computer-readable media" are entirely limited to tangible physical objects that store information in a computer-readable form. These terms do not include any wireless signals, wired download signals, or any other transient signals.

[0073] To provide interaction with the user, the implementation of the subject matter described in this specification can be carried out on a computer having a display device for displaying information to the user, such as a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, and a keyboard and pointing device, such as a mouse or trackball, for the user to provide input to the computer. Other types of devices can also be used to provide interaction with the user; for example, feedback provided to the user can be any form of sensory feedback, such as visual, auditory, or tactile feedback; and input from the user can be received in any form, including sound, speech, or tactile input. Furthermore, the computer can interact with the user by sending and receiving documents from the device used by the user; for example, by sending web pages to a web browser on the user's client device in response to a request received from a web browser.

[0074] Embodiments of the subject matter described in this specification can be implemented in a computing system that includes back-end components (e.g., as a data server), or middleware components (e.g., an application server), or front-end components (e.g., a client computer with a graphical user interface or a web browser through which a user can interact with the implementation of the subject matter described in this specification), or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected via any form of digital data communication or media (e.g., a communication network). Examples of communication networks include local area networks (“LANs”) and wide area networks (“WANs”), the Internet (e.g., the Internet), and peer-to-peer networks (e.g., self-organizing peer-to-peer networks).

[0075] A computing system may include clients and servers. Clients and servers are typically geographically separated but can interact via a communication network. The client-server relationship is generated by computer programs running on respective computers and having a client-server relationship with each other. In some embodiments, the server transmits data (e.g., HTML pages) to the client device (e.g., to display data to a user interacting with the client device and to receive user input from that user). Data generated at the client device (e.g., the result of user interaction) may be received by the server from the client device.

[0076] The subject matter technology is explained in the clauses.

[0077] For convenience, various examples of aspects of this disclosure are described as numbered (1, 2, 3, etc.) terms. These terms are provided by way of example and do not limit the subject matter. The identification of figures and reference numerals provided below is for illustrative and explanatory purposes only, and the terms are not limited by these identifications.

[0078] Clause 1. A method comprising: using one or more sensors to monitor environmental conditions of a physical environment near a medical device; determining that a value representing the environmental conditions exceeds a safe operating threshold for the medical device in relation to patient care; and, in response to the value exceeding the threshold, automatically switching an operating mode of the medical device from a first mode currently programmed for the patient care to a second mode, the second mode using parameters different from the first mode to control the medical device.

[0079] Clause 2. The method according to Clause 1, wherein switching the operating mode of the medical device includes disabling the use of a first sensor measurement, wherein the first mode includes determining the operating performance of the hardware device based on the first sensor measurement, and the second mode includes determining the operating performance based on a software algorithm that does not use the first sensor measurement.

[0080] Clause 3. The method according to Clause 2, wherein the medical device includes an infusion device and the one or more sensors include a magnetometer, the environmental conditions include a magnetic field, and wherein the first sensor measurement is provided by a Hall sensor, and the operational performance is associated with a pumping mechanism for delivering fluid to the patient.

[0081] Clause 4. The method according to Clause 1 further includes: determining, prior to monitoring the environmental conditions, that a hardware component of the medical device has generated an error exceeding a predetermined error threshold, wherein the monitoring of the environmental conditions is in response to the error exceeding the predetermined error threshold.

[0082] Clause 5. The method according to Clause 1, wherein the environmental conditions include temperature, and switching the operating mode of the medical device includes reducing the power of the hardware components of the medical device in response to the temperature exceeding a predetermined temperature threshold.

[0083] Clause 6. The method according to Clause 5 further includes: determining the battery capacity of a battery powering at least the hardware components of the medical device; and determining, based on the temperature exceeding the predetermined temperature threshold, that the battery capacity is insufficient to power the hardware components for a predetermined time, wherein switching the operating mode includes adjusting operating parameters for controlling at least the hardware components to reduce the power load of the medical device, and wherein the power load is reduced to a level sufficient for the battery to power the hardware components for the predetermined time.

[0084] Clause 7. The method according to Clause 5, wherein the medical device includes a control unit configured to interface with a plurality of functional units and to control and power the respective functional units when they are connected to the control unit, and wherein the method further comprises: determining the battery capacity of a battery that powers the control unit and the plurality of functional units currently connected to the control unit; and determining, based on the temperature exceeding the predetermined temperature threshold, that the battery capacity is insufficient to power the plurality of functional units for a predetermined time; and disabling at least one of the plurality of functional units in response to determining that the battery capacity is insufficient.

[0085] Clause 8. The method according to Clause 5, wherein the medical device includes a control unit configured to interface with a plurality of functional units and to control and power the respective functional units when they are connected to the control unit, and wherein the method further comprises: determining the battery capacity of a battery that powers the control unit and at least one functional unit currently connected to the control unit; determining, based on the temperature exceeding the predetermined temperature threshold, that the battery capacity is insufficient to power the at least one functional unit currently connected to the control unit for a predetermined time; and disabling, in response to determining that the battery capacity is insufficient, the ability of the control unit to power any additional functional units other than the at least one functional unit currently connected to the control unit.

[0086] Clause 9. The method according to Clause 1, wherein the medical device is a drug dispensing device and the environmental conditions include temperature or light intensity, the method further comprising: determining that a drug stored in a compartment of the drug dispensing device is exposed to the temperature or light intensity for a predetermined time; and switching the operating mode of the medical device by locking the compartment to prevent the dispensing of the drug.

[0087] Clause 10. The method according to Clause 1, wherein the medical device is an infusion device and the environmental conditions include temperature or light intensity, the method further comprising: determining that a drug designated to be administered to the patient by the drug dispensing device is subjected to the temperature or light intensity for a period exceeding a predetermined time; and switching the operating mode of the medical device by electronically disabling the pumping mechanism of the medical device to prevent the administration of the drug to the patient.

[0088] Clause 11. A medical device comprising: one or more processors; and a memory including instructions that, when executed by the one or more processors, cause the medical device to: monitor environmental conditions of a physical environment adjacent to the medical device using one or more sensors; determine that a value representing the environmental conditions exceeds a safe operating threshold for the medical device in relation to patient care; and, in response to the value exceeding the threshold, automatically switch the operating mode of the medical device from a first mode currently programmed for the patient care to a second mode, the second mode using parameters different from the first mode to control the medical device.

[0089] Clause 12. The medical device according to Clause 11, wherein switching the operating mode of the medical device includes disabling the use of a first sensor measurement, wherein the first mode includes determining the operating performance of the hardware device based on the first sensor measurement, and the second mode includes determining the operating performance based on a software algorithm that does not use the first sensor measurement.

[0090] Clause 13. The medical device according to Clause 12, wherein the medical device includes an infusion device and the one or more sensors include a magnetometer, the environmental conditions include a magnetic field, and wherein the first sensor measurement is provided by a Hall sensor, and the operational performance is associated with a pumping mechanism for delivering fluid to the patient.

[0091] Clause 14. The medical device according to Clause 11, wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine, prior to monitoring the environmental conditions, that a hardware component of the medical device has generated an error exceeding a predetermined error threshold, wherein the monitoring of the environmental conditions is in response to the error exceeding the predetermined error threshold.

[0092] Clause 15. The medical device according to Clause 11, wherein the environmental conditions include temperature, and switching the operating mode of the medical device includes reducing the power of the hardware components of the medical device in response to the temperature exceeding a predetermined temperature threshold.

[0093] Clause 16. The medical device according to Clause 15, wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine the battery capacity of a battery powering at least the hardware components of the medical device; and determine, based on the temperature exceeding the predetermined temperature threshold, that the battery capacity is insufficient to power the hardware components for a predetermined time, wherein switching the operating mode includes adjusting operating parameters for controlling at least the hardware components to reduce the power load of the medical device, and wherein the power load is reduced to a level sufficient for the battery to power the hardware components for the predetermined time.

[0094] Clause 17. The medical device according to Clause 15, wherein the medical device includes a control unit configured to interface with a plurality of functional units and, when the functional units are connected to the control unit, control and power the respective functional units, and wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine the battery capacity of a battery that powers the control unit and the plurality of functional units currently connected to the control unit; determine that the battery capacity is insufficient to power the plurality of functional units for a predetermined time based on the temperature exceeding the predetermined temperature threshold; and disable at least one of the plurality of functional units in response to determining that the battery capacity is insufficient.

[0095] Clause 18. The medical device according to Clause 15, wherein the medical device includes a control unit configured to interface with a plurality of functional units and, when a functional unit is connected to the control unit, control and power the respective functional unit, and wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine the battery capacity of a battery that powers the control unit and at least one functional unit currently connected to the control unit; determine, based on the temperature exceeding the predetermined temperature threshold, that the battery capacity is insufficient to power the at least one functional unit currently connected to the control unit for a predetermined time; and, in response to determining that the battery capacity is insufficient, disable the ability of the control unit to power any additional functional unit other than the at least one functional unit currently connected to the control unit.

[0096] Clause 19. The medical device according to Clause 11, wherein the medical device is a drug dispensing device and the environmental conditions include temperature or light intensity, wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine that a drug stored in a compartment of the drug dispensing device has been exposed to the temperature or light intensity for more than a predetermined time; and switch the operating mode of the medical device by locking the compartment to prevent the dispensing of the drug.

[0097] Clause 20. The medical device according to Clause 11, wherein the medical device is an infusion device and the environmental conditions include temperature or light intensity, wherein, when executed by the one or more processors, the instructions further cause the medical device to: determine that a drug designated to be administered to the patient by the infusion device has been subjected to the temperature or light intensity for a period exceeding a predetermined time; and switch the operating mode of the medical device by electronically disabling the pumping mechanism of the medical device to prevent the administration of the drug to the patient.

[0098] Clause 21. A non-transitory machine-readable storage medium containing instructions that, when executed by a machine, cause the machine to perform operations including: monitoring environmental conditions of a physical environment near a medical device using one or more sensors; determining that a value representing the environmental conditions exceeds a safe operating threshold for the medical device in patient care; and, in response to the value exceeding the threshold, automatically switching the operating mode of the medical device from a first mode currently programmed for patient care to a second mode, the second mode using parameters different from the first mode to control the medical device.

[0099] Further consideration

[0100] In some embodiments, any provision herein may depend on any independent provision or any dependent provision. In one aspect, any provision (e.g., dependent or independent provision) may be combined with any other one or more provisions (e.g., dependent or independent provision). In one aspect, a claim may include some or all of the words (e.g., steps, operations, means, or components) referenced in a clause, sentence, phrase, or paragraph. In one aspect, a claim may include some or all of the words listed in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some words may be deleted from each clause, sentence, phrase, or paragraph. In one aspect, additional words or elements may be added to a clause, sentence, phrase, or paragraph. In one aspect, the subject matter may be implemented without utilizing some of the components, elements, functions, or operations described herein. In one aspect, the subject matter may be implemented using additional components, elements, functions, or operations.

[0101] Those skilled in the art will understand that the various illustrative blocks, modules, elements, components, methods, and algorithms described herein can be implemented as electronic hardware, computer software, or a combination of both. To illustrate this interchangeability between hardware and software, the various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally according to their functionality. Whether this functionality is implemented as hardware or software depends on the specific application and the design constraints imposed on the system as a whole. The described functionality can be implemented in different ways for each specific application. Without departing from the scope of the subject matter, the various components and blocks can be arranged differently (e.g., arranged in different orders or divided in different ways).

[0102] It should be understood that the specific order or hierarchy of steps in the disclosed process is illustrative of the method. Based on design preferences, it should be understood that the specific order or hierarchy of steps in the process can be rearranged. Some steps may be performed simultaneously. The appended method claims present the elements of each step in an illustrative order and are not intended to limit one to the specific order or hierarchy presented.

[0103] The foregoing description is provided to enable any person skilled in the art to practice the various aspects described herein. The foregoing description provides various examples of the subject matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects. Therefore, the claims are not intended to be limited to the aspects shown herein, but are to be consistent with the full scope of the language claims, wherein, unless expressly stated otherwise, elements referred to in the singular are not intended to mean “one and only one,” but rather “one or more.” Unless expressly stated otherwise, the term “some” means one or more. Male pronouns (e.g., his) include female and neutral genders (e.g., she and it), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention described herein.

[0104] As used herein, the term "website" can include any aspect of a website, including one or more web pages, one or more servers used to host or store web-related content, etc. Therefore, the term "website" is used interchangeably with the terms "web page" and "server." The predicates "configured as," "operably," and "programmed as" do not imply any specific tangible or intangible modification to the subject matter, but are intended to be used interchangeably. For example, a processor configured to monitor and control operations or components can also mean that the processor is programmed to monitor and control operations, or that the processor is operable to monitor and control operations. Similarly, a processor configured to execute code can be interpreted as being programmed to execute code, or a processor operable to execute code.

[0105] The described features may include machine learning. Machine learning may include models, equations, artificial neural networks, recurrent neural networks, convolutional neural networks, decision trees, or other machine-readable artificial intelligence structures. Examples of machine learning and modeling features that may be included in the above embodiments are described in “Asurvey of machine learning for big data processing” by Qiu et al., published in the EURASIP Journal on Advances in Signal Processing (2016), the entire contents of which are incorporated herein by reference.

[0106] As used herein, the term “automatic” can include actions performed by a computer or machine without user intervention; for example, by instructions in response to predicate actions of a computer or machine or other initiation mechanism. The word “example” is used herein to mean “as an example or illustration.” Any aspect or design described herein as an “example” is not necessarily to be construed as superior to or better than other aspects or designs.

[0107] Phrases such as "aspect" do not imply that such an aspect is essential to the subject matter or that such an aspect applies to all configurations of the subject matter. Disclosure relating to one aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. Phrases such as "aspect" may indicate one or more aspects, or vice versa. Phrases such as "embodiment" do not imply that such an embodiment is essential to the subject matter or that such an embodiment applies to all configurations of the subject matter. Disclosure relating to embodiments may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "embodiment" may indicate one or more embodiments, or vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the subject matter or that such a configuration applies to all configurations of the subject matter. Disclosure relating to configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. Phrases such as "configuration" may indicate one or more configurations, or vice versa.

Claims

1. A medical device comprising: One or more processors; as well as The memory includes instructions that, when executed by the one or more processors, cause the medical device to: During drug administration via an infusion device, sensor measurements are received from a first sensor associated with the infusion device; During the administration of the drug, the pulse rate, pumping rate, and volume of the drug are calculated based on sensor measurements received from the first sensor. Determine the location of the infusion device; The safe operating threshold of the infusion device is determined based on at least one of the nursing area where the infusion device is located and the patient's medical condition; During the administration of the drug, a second sensor associated with the infusion device is used to monitor environmental conditions of the physical environment near the infusion device. The value measured by the second sensor and representing the environmental conditions is determined to exceed the safe operating threshold of the medical device in patient care. as well as During the administration of the drug, in response to the value exceeding the threshold: Automatically disable the first sensor, and The calculation of applied pulse rate, pumping rate, and volume is switched from being based on sensor measurements to being based on a software algorithm, eliminating the need for measurements from the first sensor. The environmental conditions include temperature, and switching the operating mode of the medical device includes reducing the power of the hardware components of the medical device in response to the temperature exceeding a predetermined temperature threshold; Determine the battery capacity of the battery that powers at least the hardware components of the medical device; as well as Based on the temperature exceeding the predetermined temperature threshold, it is determined that the battery capacity is insufficient to power the hardware components for a predetermined time. Switching the operating mode includes adjusting the operating parameters used to control at least the hardware components to reduce the power load of the medical device, and The power load is reduced to a level sufficient for the battery to power the hardware components for the predetermined time.

2. The medical device of claim 1, wherein the second sensor comprises a magnetometer, the environmental conditions include a magnetic field, and wherein the first sensor is a Hall sensor, and the sensor measurement is based on stroke volume or air bubbles in the administration line when the infusion device administers medication to a patient.

3. The medical device according to claim 2, wherein the instructions further cause the medical device to: The pulse rate of the pumping mechanism is detected by the first sensor; and Based on the detected stroke count, maintain a timing history of the number of completed pumping beats. The rate and volume are calculated based on the timing history.

4. The medical device of claim 1, wherein when executed by the one or more processors, the instructions further cause the medical device to: Before monitoring the environmental conditions, it was determined that the hardware components of the medical device had generated an error exceeding a predetermined error threshold. The monitoring of the environmental conditions is in response to the error exceeding the predetermined error threshold.

5. The medical device of claim 1, wherein the medical device includes a control unit configured to interface with a plurality of functional units, and to control and power the respective functional units when the functional units are connected to the control unit, and wherein, when executed by the one or more processors, the instructions further cause the medical device to: Determine the battery capacity of the battery that powers the control unit and the plurality of functional units currently connected to the control unit; Based on the fact that the temperature exceeds the predetermined temperature threshold, it is determined that the battery capacity is insufficient to power the plurality of functional units for a predetermined time. as well as In response to determining that the battery capacity is insufficient, at least one of the plurality of functional units is disabled.

6. The medical device of claim 1, wherein the medical device includes a control unit configured to interface with a plurality of functional units, and to control and power the respective functional units when the functional units are connected to the control unit, and wherein, when executed by the one or more processors, the instructions further cause the medical device to: Determine the battery capacity of the battery that powers the control unit and at least one functional unit currently connected to the control unit; Based on the fact that the temperature exceeds the predetermined temperature threshold, it is determined that the battery capacity is insufficient to power at least one functional unit currently connected to the control unit for a predetermined time; as well as In response to determining that the battery capacity is insufficient, the ability of the control unit to power any additional functional units other than the at least one functional unit currently connected to the control unit is disabled.

7. The medical device of claim 1, wherein the medical device is a drug dispensing device and the environmental conditions include temperature or light intensity, and when executed by the one or more processors, the instructions further cause the medical device to: It is determined that the drug stored in the compartment of the drug dispensing equipment is subjected to the temperature or light intensity for a period of time exceeding a predetermined time; and The operating mode of the medical device is switched by locking the compartment to prevent the repackaging of the medication.

8. A non-transitory machine-readable storage medium containing instructions that, when executed by a machine, cause the machine to perform operations comprising: During drug administration via an infusion device, sensor measurements are received from a first sensor associated with the infusion device; During the drug administration, the administration rate and volume are calculated based on sensor measurements received from the first sensor; Determine the location of the infusion device; The safe operating threshold of the infusion device is determined based on at least one of the nursing area where the infusion device is located and the patient's medical condition; During the administration of the drug, a second sensor associated with the infusion device is used to monitor environmental conditions of the physical environment near the infusion device. The value measured by the second sensor and representing the environmental conditions is determined to exceed the safe operating threshold for the infusion device in patient care. as well as During the administration of the drug, in response to the value exceeding the threshold: Automatically disable the first sensor. The calculation of applied pulse rate, pumping rate, and volume is switched from being based on sensor measurements to being based on a software algorithm, eliminating the need for measurements from the first sensor. The environmental conditions include temperature, and switching the operating mode of the medical device includes reducing the power of the hardware components of the medical device in response to the temperature exceeding a predetermined temperature threshold; Determine the battery capacity of the battery that powers at least the hardware components of the medical device; as well as Based on the temperature exceeding the predetermined temperature threshold, it is determined that the battery capacity is insufficient to power the hardware components for a predetermined time. Switching the operating mode includes adjusting the operating parameters used to control at least the hardware components to reduce the power load of the medical device, and The power load is reduced to a level sufficient for the battery to power the hardware components for the predetermined time.

9. The non-transitory machine-readable storage medium of claim 8, wherein the second sensor comprises a magnetometer, the environmental conditions include a magnetic field, and wherein the first sensor is a Hall sensor, and the sensor measurement is based on stroke volume or air bubbles in the administration line when the infusion device administers medication to a patient.

10. The non-transitory machine-readable storage medium according to claim 9, further comprising: The pulse rate of the pumping mechanism is detected by the first sensor; as well as Based on the detected stroke count, maintain a timing history of the number of completed pumping beats. The rate and volume are calculated based on the timing history.

11. The non-transitory machine-readable storage medium according to claim 8, further comprising: Before monitoring the environmental conditions, it was determined that the hardware components of the infusion device had generated an error exceeding a predetermined error threshold. The monitoring of the environmental conditions is in response to the error exceeding the predetermined error threshold.

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