Multi-modal respiratory treatment device, system and method

Abstract

A respiratory treatment device operable to perform multiple types of therapy on a patient. The device includes a main housing and a nebulizer tray selectively connected to a bottom portion of the main housing. The device also includes a filter housing unit having an antenna surrounding a pneumatic passageway and a transponder chip coupled to the antenna. The main housing also has an antenna surrounding a corresponding pneumatic passageway of a main outlet port of the device. The main housing includes a reader that controls communication between the antennas. The main housing of the device also has a pivotable hose support plate, a firmware upgrade port located below a top wall portion of the housing, and a graphical user interface (GUI) that displays various user inputs for controlling the device and displays various alarm conditions detected.

Description

Technical Field

[0001] This disclosure relates to respiratory therapy devices, systems, and methods, and more particularly to a multimodal respiratory therapy device operable for administering multiple types of respiratory therapy to a patient. More specifically, this disclosure relates to a multimodal respiratory therapy device, system, and method having multiple components selectively connected to a base module and having multiple user interface screens for selecting and controlling available respiratory therapies. Background Technology

[0002] Respiratory therapy devices used to administer various respiratory treatments to patients are well-known. For example, Hill-Rom sells the VITALCOUGH® system, which operates to provide mechanical inhalation / exhalation (MIE) therapy to patients. Hill-Rom also sells the METANEB® system, which operates to provide treatment and prevention for the mobilization of secretions, lung expansion therapy, and atelectasis. The METANEB® system operates in both continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) modes. The METANEB® system also features a nebulizer for delivering nebulized medications into the patient's airway. The METANEB® system is pneumatically driven by compressed gas (e.g., 50 psi oxygen) available from gas outlet ports in various rooms of a medical facility.

[0003] Nursing professionals such as respiratory therapists would prefer a single respiratory therapy device that can be operated to provide patients with multiple respiratory therapies, such as MIE, CHFO, and CPEP. A combined respiratory therapy device with a nebulizer is also desirable. However, equally desirable would be a lightweight, compact device with an intuitive and easy-to-use user interface. Utilizing various types of wireless communication technologies to communicate with a wide range of external devices and networks would also result in improvements over existing respiratory therapy devices. Summary of the Invention

[0004] An apparatus, system, or method may include one or more features recited in the appended claims and / or the following features, which individually or in any combination comprise the patentable subject matter:

[0005] According to a first aspect of this disclosure, a respiratory therapy device may include a housing having a bottom wall and a pneumatic system carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The respiratory therapy device may also have a pneumatic patient circuit and an outlet port carried by the housing. The pneumatic system may be configured to provide respiratory therapy to a patient through the outlet port and the pneumatic patient circuit. A nebulizer may be coupled to the pneumatic patient circuit. A nebulizer tray may be selectively coupled to the bottom of the housing such that it is located at least a majority of the bottom wall below the nebulizer. A second pressure source may be carried by the nebulizer tray and operable to supply compressed air to the nebulizer.

[0006] In some embodiments of the first aspect, the first pressure source may include a blower, and the second pressure source may include a pump. Optionally, the bottom wall of the housing may have an opening through which a cable can travel a predetermined route from the control circuit to the second pressure source. Therefore, the control circuit can be configured to turn the second pressure source on and off in response to user input.

[0007] The respiratory therapy device of the first aspect may further include a graphical user interface (GUI), which may be carried by the housing and connected to the control circuitry. The GUI may be operable to display at least one icon that a user can select to turn the second pressure source on and off. For example, the at least one icon may include a nebulizer icon that can be pressed repeatedly to turn the second pressure source on and off. If desired, the nebulizer icon may be color-coded to indicate whether the second pressure source is on or off.

[0008] Optionally, in response to a temperature signal indicating that a threshold temperature has been reached or exceeded, the control circuit may use a temperature signal from a temperature sensor located in an internal area above the bottom wall of the housing to shut off the second pressure source. Additionally, optionally, in response to a temperature signal indicating that a threshold temperature has been reached or exceeded, the control circuit may also use a temperature signal from a temperature sensor to shut off the first pressure source.

[0009] In some embodiments of the first aspect, the second pressure source can be operable regardless of whether the pneumatic system is being operated to provide respiratory therapy to a patient. When the patient is not being treated via the pneumatic system, the first pressure source can be operated to deliver a minimum threshold positive pressure to the outlet port when the second pressure source is operated to provide pressurized air to the nebulizer. For example, the minimum threshold positive pressure could be approximately 5 cmH2O.

[0010] If desired, the pneumatic patient circuit may include a hose and a patient interface. The hose may be connected to an outlet port, and the nebulizer may be connected to the patient interface. The respiratory therapy device of the first aspect may also include a nebulizer port, which may be connected to the tray, and a tube may extend from the nebulizer port to the nebulizer. Optionally, the hose may have a first outer diameter, the tube may have a second outer diameter, and the first outer diameter may be larger than the second outer diameter. Furthermore, optionally, the hose may include a corrugated hose, and the tube may be uncorrugated.

[0011] In some embodiments, the pneumatic patient circuit may further include a filter housing having a first end configured to be coupled to an outlet port and a second end configured to be attached to a first terminal of a hose. A pneumatic passage may extend between the first and second ends of the filter housing.

[0012] Optionally, the filter housing may further include a first antenna that surrounds the pneumatic channel and a transponder chip electrically connected to the antenna. If desired, the pneumatic circuitry may also include a filter that can be carried by the filter housing. The first antenna and the transponder chip may be located between the filter and a second end of the filter housing, such that the filter can be positioned between the first end and the antenna and transponder chip. Optionally, the outlet port may have an outlet channel passing through it, and the respiratory therapy device of the first aspect may include a second antenna that surrounds the outlet channel.

[0013] The second antenna is operable to transmit energy to the first antenna to power the transponder chip. Control circuitry can read data that can be transmitted from the first antenna to the second antenna from the transponder chip. For example, this data may include the total number of previous uses of the filter housing during respiratory therapy. If needed, the control circuitry can be configured to write new data to the transponder chip. Thus, new data can be transmitted from the second antenna to the first antenna. The new data may include a new total number of uses of the filter housing, which may include incrementing the total number of previous uses of the filter housing by 1.

[0014] According to a second aspect of this disclosure, a respiratory therapy device may include a housing having a bottom wall and a pneumatic system that may be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The respiratory therapy device of the second aspect may further include a pneumatic patient circuit and an outlet port that may be carried by the housing. The pneumatic system is configured to provide respiratory therapy to a patient through the outlet port and the pneumatic patient circuit. The respiratory therapy device of the second aspect may further include a nebulizer and a nebulizer tray, the nebulizer being coupled to the pneumatic patient circuit and the nebulizer tray being selectively coupled to the bottom of the housing. A second pressure source may be carried by the nebulizer tray and operable to provide compressed air to the nebulizer. A temperature sensor may be located in an internal region above the bottom wall of the housing. The temperature sensor may provide a temperature signal to the control circuitry. The control circuitry is configured to shut off the second pressure source in response to a temperature signal indicating that a threshold temperature may have been reached or exceeded.

[0015] In some embodiments of the second aspect, the temperature signal from the temperature sensor may also be used by the control circuit to shut down the first pressure source in response to a temperature signal indicating that a threshold temperature has been reached or exceeded. Optionally, the first pressure source may include a blower, and the second pressure source may include a pump. Furthermore, the bottom wall of the housing may optionally have an opening through which a cable can travel a predetermined route from the control circuit to the second pressure source. The control circuit may be configured to turn the second pressure source on and off in response to user input.

[0016] If desired, the second aspect of the respiratory therapy device may further include a graphical user interface (GUI), which may be housed within the housing and connected to the control circuitry. The GUI may display at least one icon that a user can select to turn the second pressure source on and off. The at least one icon may include a nebulizer icon, which can be pressed repeatedly to turn the second pressure source on and off. Optionally, the nebulizer icon may be color-coded to indicate whether the second pressure source is on or off.

[0017] This disclosure contemplates that the temperature sensor may include a thermistor. This disclosure also contemplates that the second pressure source can be operable regardless of whether the pneumatic system is being operated to provide respiratory therapy to a patient. In the absence of respiratory therapy to a patient via the pneumatic system, when the second pressure source is operated to provide pressurized air to the nebulizer, the first pressure source can be operated to deliver a minimum threshold positive pressure to the outlet port. For example, the minimum threshold of the positive pressure may be approximately 5 cmH2O.

[0018] In some embodiments of the respiratory therapy device of the second aspect, the pneumatic patient circuit may include a hose and a patient interface. The hose may be connected to an outlet port, and the nebulizer may be connected to the patient interface. The nebulizer port may be coupled to a tray, and the tubing may extend from the nebulizer port to the nebulizer. Optionally, the hose may have a first outer diameter, the tubing may have a second outer diameter, and the first outer diameter may be larger than the second outer diameter. Furthermore, optionally, the hose may include a corrugated hose, which may be corrugated, and the tubing may not be corrugated.

[0019] If desired, the pneumatic patient circuit may further include a filter housing having a first end and a second end, the first end being configured to connect to an outlet port and the second end being configured to connect to a first terminal of a hose. A pneumatic channel may extend between the first and second ends of the filter housing. Optionally, the filter housing may also include a first antenna that surrounds the pneumatic channel and a transponder chip electrically connectable to the antenna. Furthermore, the pneumatic circuit may optionally include a filter that can be carried by the filter housing. The first antenna and the transponder chip may be located between the filter and the second end of the filter housing.

[0020] This disclosure contemplates that the exit port may have an exit channel passing through the exit port. The respiratory therapy device of the second aspect may further include a second antenna surrounding the exit channel. The second antenna can be used to transmit energy to the first antenna to power the transponder chip. If needed, control circuitry can read data from the transponder chip that can be transmitted from the first antenna to the second antenna. For example, the data may include the total number of previous uses of the filter housing during previous respiratory therapy processes. Optionally, the control circuitry may be configured to write new data to the transponder chip. Thus, the new data can be transmitted from the second antenna to the first antenna. The new data may include a new total number of uses of the filter housing, for example, it may include incrementing the total number of previous uses of the filter housing by 1.

[0021] According to a third aspect of this disclosure, a method of converting a respiratory therapy device from a first configuration to a second configuration may include providing a respiratory therapy device in the first configuration. The respiratory therapy device in the first configuration may have a housing and a pneumatic system that can be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The respiratory therapy device in the first configuration may include a pneumatic patient circuit and an outlet port that can be carried by the housing. The pneumatic system may be configured to provide respiratory therapy to a patient through the outlet port and the patient circuit. For example, the respiratory therapy device in the first configuration may be operable to provide a variety of respiratory therapies to a patient. The method of the third aspect may further include providing a nebulizer, coupling the nebulizer to the patient circuit, providing a nebulizer tray capable of carrying a second pressure source, and coupling the nebulizer tray to the bottom of the housing so as to be located at least a majority below the bottom wall of the housing. The method of the third aspect may further include pneumatically coupling a second pressure source that can be carried by the nebulizer tray to the nebulizer, such that operation of the second pressure provides compressed air to the nebulizer. The respiratory therapy device in the second configuration may be formed by coupling the nebulizer tray carrying the second pressure source to the housing. The second configuration of the respiratory therapy device may be operable to provide the patient with nebulization and at least one of the multiple respiratory therapies.

[0022] In some embodiments of the third aspect, the first pressure source may include a blower, and the second pressure source may include a pump. Optionally, the method of the third aspect may also include arranging a cable in a predetermined route between the control circuit and the second pressure source through an opening in the bottom wall. The method of the third aspect further includes removing a cover obstructing the opening before the cable passes through it.

[0023] If desired, the pneumatic system of the third aspect may further include a graphical user interface (GUI), which may be housed in the housing and connected to the control circuitry. The GUI may operate to display at least one icon, which a user can select to turn the second pressure source on and off. Optionally, the method of the third aspect may further include displaying the at least one icon on the GUI in response to the cable electrical interconnection control circuitry and the second pressure source. Furthermore, optionally, the at least one icon may include a sprayer icon, which is pressed repeatedly to turn the second pressure source on and off. Further optionally, the sprayer icon may be color-coded to indicate whether the second pressure source is on or off.

[0024] In some embodiments, the method of the third aspect may further include providing a temperature sensor, which may be located in an internal region above the bottom wall of the housing, and may further include using control circuitry to shut down a second pressure source in response to a temperature signal from the temperature sensor indicating that a threshold temperature may have been reached or exceeded. The method may also include using control circuitry to shut down a first pressure source in response to a temperature signal indicating that a threshold temperature may have been reached or exceeded.

[0025] Optionally, the third aspect of the method may further include operating a second pressure source regardless of whether the pneumatic system is being operated to provide respiratory therapy to the patient. In the absence of respiratory therapy to the patient via the pneumatic system, the method may further include operating a first pressure source to deliver a minimum threshold positive pressure to the outlet while the second pressure source is being operated to provide compressed air to the nebulizer. For example, the minimum threshold of the positive pressure may be approximately 5 cmH2O.

[0026] This disclosure contemplates a pneumatic patient circuit of the third aspect that may include a hose and a patient interface. The hose may be connected to an outlet port, and the nebulizer may be connected to the patient interface. The method of the third aspect may also include connecting the tubing to a nebulizer port on a tray and a nebulizer. If desired, the pneumatic patient circuit may further include a filter housing having a first end and a second end, the first end being configurable to be connected to the outlet port, and the second end being configurable to be attached to a first terminal of the hose. A pneumatic passage may extend between the first and second ends of the filter housing.

[0027] Optionally, the filter housing may further include a first antenna that surrounds the pneumatic channel and a transponder chip electrically connected to the antenna. Additionally, the pneumatic patient circuit may optionally include a filter that can be carried by the filter housing. The first antenna and the transponder chip may be located between the filter and a second end of the filter housing. In some embodiments of the third aspect, the outlet port may have an outlet channel passing through the outlet port, and a second antenna may surround the outlet channel. The method of the third aspect may also include using the second antenna to transmit energy to the first antenna to power the transponder chip.

[0028] If necessary, the third aspect of the method may also include using control circuitry to read data transmitted from the first antenna to the second antenna from the transponder chip. For example, the data may include the total number of previous uses of the filter housing during previous respiratory therapy procedures. The third aspect of the method may also include using control circuitry to write new data to the transponder chip. The new data may be transmitted from the second antenna to the first antenna. The new data may include a new total number of uses of the filter housing, which includes incrementing the total number of previous uses of the filter housing by 1.

[0029] According to a fourth aspect of this disclosure, a filter device for a respiratory therapy apparatus may include a filter housing having a first end, a second end spaced apart from the first end, and a pneumatic channel extending between the first and second ends. An antenna may surround the pneumatic channel. A transponder chip may be electrically connected to the antenna.

[0030] In some embodiments, the filter device may further include a filter that can be carried by a filter housing. An antenna and a transponder chip may be located between the filter and a second end of the filter housing. Optionally, the filter may have a first substantially circular outer periphery with a first diameter, and the antenna may have a second substantially circular outer periphery with a second diameter. The first diameter may be larger than the second diameter. In these embodiments, the antenna may be configured as a substantially flat annular loop and may be substantially parallel to the filter.

[0031] Optionally, the antenna of the filter device in the fourth aspect can be configured as a substantially flat annular loop. Furthermore, optionally, the antenna can be sandwiched between a surface material and a substrate. If desired, at least one surface material and substrate can comprise polyethylene terephthalate (PET) material. For example, both the surface material and the substrate can comprise PET material. Alternatively or additionally, the surface material and substrate can be configured as a substantially flat annular loop.

[0032] The filter device of the fourth aspect may further include an adhesive layer on a substrate and a backing paper attachable to the adhesive layer, such that the adhesive layer can be located between the backing paper and the substrate. Optionally, the backing paper may include a silicon liner. Furthermore, the backing paper may optionally include siliconized paper. If desired, the antenna may be made of copper.

[0033] In some embodiments of the fourth aspect, the filter housing may include a first tubular portion that is generally cylindrical (which may include a first end), a second tubular portion that is generally cylindrical (which may include a second end), a first generally truncated conical portion extending from the first tubular portion, and a second generally truncated conical portion extending from the second tubular portion. The first and second generally truncated conical portions may intersect at a joint that defines an annular apex of the filter housing. Optionally, a shoulder wall portion may be formed on the second generally truncated conical portion, and an antenna may be mounted on the shoulder wall portion.

[0034] If desired, the first and second tubular portions can be aligned along the axis of the pneumatic channel. The shoulder wall portion may include a shoulder surface that may surround the axis and may be substantially substantially perpendicular to the axis of the pneumatic channel. The antenna can be mounted on the shoulder surface. Optionally, the antenna can be formed as a substantially flat annular ring that can be mounted to the shoulder surface.

[0035] The fourth aspect of the filter device may further include a filter that can be carried by a filter housing. For example, the filter may be formed as a generally circular disk that is substantially parallel to the antenna and shoulder surface. Alternatively, the filter may be formed as a generally circular disk with an outer periphery having an annular apex near the junction. Furthermore, alternatively, the transponder chip and antenna may cooperate to transmit and receive wireless communications in a frequency range of approximately 12 MHz to approximately 14 MHz. For example, the transponder chip and antenna may cooperate to transmit and receive wireless communications at approximately 13.56 MHz.

[0036] According to a fifth aspect of this disclosure, a respiratory therapy device may include a housing having a hose port extending from a front wall of the housing and defining a pneumatic passage through the front wall. A tag reader may be located within the housing and may have a first antenna located near an inner surface of the front wall and surrounding the hose port. A filter housing may be dimensioned to be coupled to the hose port. The filter housing may have a filter receiving space located between a filter inlet and a filter outlet. A filter channel may extend through the filter housing between the filter inlet and the filter outlet. A filter may be located within the filter receiving space. A second antenna may be coupled to the filter housing and surrounding the filter channel. An identification (ID) chip may be carried by the filter housing and coupled to the second antenna. The tag reader may be configured to read the ID chip via a wireless signal between the first and second antennas to verify that the filter housing is an authorized filter housing for a respiratory therapy device.

[0037] In some embodiments of the fifth aspect, the ID chip may be a radio frequency (RF) ID chip, and the wireless signal may include an RF signal that can communicate between a first antenna and a second antenna. If desired, the respiratory therapy device of the fifth aspect may also include control circuitry, which may be located within the housing and electrically connected to a tag reader. This control circuitry may be configured to command the operation of a pressure source that may be located within the housing. The RF signal may include data regarding the number of previous uses of the filter. If the number of previous uses of the filter exceeds a threshold number of uses, the control circuitry disables the operation of the pressure source.

[0038] Optionally, the control circuitry can be configured to command the tag reader to write new data to the RFID tag. For example, the new data can be transmitted from the second antenna to the first antenna. The new data may include a new total number of uses for the filter, which may include incrementing the previous number of uses for the filter by 1. Furthermore, the respiratory therapy device of the fifth aspect may optionally include a display that displays the previous number of uses for the filter in response to the filter housing being coupled to the hose port. If the previous number of uses for the filter exceeds a usage threshold, a notification may be provided on the display. If necessary, the notification may indicate that the filter needs to be replaced. Alternatively or additionally, the notification may include an icon that can be displayed on the display. The respiratory therapy device of the fifth aspect may also include an alarm that can be triggered if the previous number of uses for the filter exceeds a threshold number of uses.

[0039] In some embodiments of the fifth aspect, the tag reader may be configured to use a first antenna to transmit energy to a second antenna to power the ID tag. Optionally, the filter may have a first substantially circular outer periphery with a first diameter, and the second antenna may have a second substantially circular outer periphery with a second diameter, the first diameter being larger than the second diameter. Furthermore, optionally, the antenna may be configured as a substantially flat annular loop and may be substantially parallel to the filter.

[0040] If desired, an antenna configured as a substantially flat loop can be sandwiched between a surface material and a substrate. Optionally, one or both of the surface material and the substrate may comprise polyethylene terephthalate (PET) material. Furthermore, both the surface material and the substrate may optionally be configured as a substantially flat loop. The respiratory therapy device of the fifth aspect may also include an adhesive layer that may be located on the substrate, and may further include a backing paper that can be attached to the adhesive layer such that the adhesive layer may be located between the backing paper and the substrate. For example, the backing paper may comprise a silicone liner or silicone paper. Optionally, the second antenna may be made of copper.

[0041] In some embodiments of the fifth aspect, the filter housing may include a first tubular portion that is generally cylindrical (which may include a filter inlet), a second tubular portion that is generally cylindrical (which may include a filter outlet), a first generally truncated conical portion extending from the first tubular portion, and a second generally truncated conical portion extending from the second tubular portion. The first and second generally truncated conical portions may intersect at a joint that defines an annular apex of the filter housing. A shoulder wall portion may be formed on the second generally truncated conical portion, and a second antenna may be mounted on the shoulder wall portion.

[0042] Optionally, the first and second tubular portions may be aligned along the axis of the filter channel. The shoulder wall portion may include a shoulder surface that surrounds the axis and is substantially perpendicular to the axis of the filter channel. In these embodiments of the fifth aspect, a second antenna may be mounted on the shoulder surface. For example, the second antenna may be formed as a substantially flat annular ring that can be mounted on the shoulder surface. If desired, the filter may include a substantially circular disk that is substantially parallel to the second antenna and the shoulder surface. The filter may include a substantially circular disk with an outer periphery having an annular apex near the junction. In some embodiments of the fifth aspect, the ID chip and the second antenna may cooperate to transmit and receive wireless communications in a frequency range of approximately 12 MHz to approximately 14 MHz.

[0043] According to a sixth aspect of this disclosure, a method for determining when a filter unit of a respiratory therapy device may need to be replaced is provided. The method may include coupling the filter unit to a hose port of a respiratory therapy device housing. The filter unit may have a transponder chip and a first antenna coupled to the transponder chip and positioned around a flow channel through the filter unit. The method may further include reading data from the transponder chip using a tag reader coupled to a second antenna positioned near the hose port. The second antenna may position itself around the flow channel through the hose port. The data may include the number of previous uses of the filter. The method may further include comparing the number of previous uses of the filter to a threshold number using control circuitry of the respiratory therapy device coupled to the tag reader. The method may further include disabling a pressure source of the respiratory therapy device if the number of previous uses is equal to or exceeds the threshold number.

[0044] In some embodiments of the sixth aspect, reading data from the transponder chip may include communicating radio frequency (RF) signals between the first and second antennas. Optionally, the method of the sixth aspect may include enabling a pressure source for operation if the previous number of uses is less than a threshold number. Furthermore, the method of the sixth aspect may also include writing new data to the transponder chip using a tag reader. The new data may be transmitted from the second antenna to the first antenna. The new data may include a new total number of uses for the filter unit, the new total number of uses including incrementing the total previous number of uses of the filter housing by 1.

[0045] If necessary, the method of the sixth aspect may further include displaying the previous number of uses of the filter unit on a display of the respiratory therapy device in response to the filter unit being connected to the hose port. Optionally, the method of the sixth aspect may include displaying a notification on the display if the previous number of uses of the filter unit exceeds a threshold number of uses. For example, the notification may indicate that the filter unit needs to be replaced. Alternatively or additionally, the notification may include an icon displayed on the display. Furthermore, the method of the sixth aspect may also include triggering an alarm if the previous number of uses is equal to or exceeds a threshold number of uses. Additionally, reading the transponder chip may optionally include transmitting energy from the second antenna to the first antenna to power the transponder chip.

[0046] According to a seventh aspect of this disclosure, a respiratory therapy device may include a housing having a rear wall and a pneumatic system that may be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. An outlet port may be carried by the housing. A pneumatic patient circuit may include a hose and a patient interface that can be coupled to the hose. The patient interface may be configured to pneumatically communicate with a patient's airway. The pneumatic system may be configured to provide respiratory therapy to a patient through the outlet and the pneumatic patient circuit. The respiratory therapy device may also have a plate for supporting the hose. The plate is movable between an deployed position and a stored position, in which a portion of the plate may extend above the top wall of the housing such that a hose receiving slot of the plate is located above the top wall of the housing; in the stored position, the plate may be located behind the rear wall of the housing. When the plate is in the deployed position, the hose may be received in the hose receiving slot.

[0047] In some embodiments of the seventh aspect, when the plate is in the storage position, the front surface of the plate may face a battery cover or a portion of a battery housed in a battery receiving chamber of the housing. Optionally, a first stop may extend from the rear wall of the housing, and the plate may be configured to contact the first stop when the plate is in the unfolded position. Furthermore, optionally, a second stop may extend from the rear wall of the housing, and the plate may be configured to contact the second stop when the plate is in the storage position. If desired, at least one of the first and second stops may be integrally formed with the rear wall of the housing.

[0048] This disclosure contemplates that the plate can rotate about an axis as it moves between an unfolded position and a storage position. For example, this axis can be substantially perpendicular to the rear wall of the housing. Optionally, the outlet port can be substantially cylindrical about a port axis, and the axis of the plate can be substantially parallel to the port axis. Furthermore, the housing can optionally have spaced-apart first and second sidewalls, and the axis can be closer to the first sidewall than the second sidewall.

[0049] If desired, the respiratory therapy device of the seventh aspect may further include a first filter. The rear wall may have an air inlet filter receiving space configured to receive the first filter therein. Optionally, when the plate is in the storage position, the air inlet filter receiving space may be located below the plate. Furthermore, the respiratory therapy device of the seventh aspect may optionally include a nebulizer tray selectively attached to the bottom of the housing and configured to support the housing thereon. A second pressure source may be carried by the nebulizer tray. The respiratory therapy device of the seventh aspect may also have a second filter. The nebulizer tray may have a nebulizer filter receiving space configured to receive the second filter therein. When the plate is in the storage position, the nebulizer filter receiving space may be located below the plate.

[0050] In some embodiments of the seventh aspect, the first filter may be formed as a first rectangular prism having a first elongation that is generally vertically oriented when the first filter is received in the air inlet filter receiving space. If desired, the second filter may be formed as a second rectangular prism having a second elongation that is generally horizontally oriented when the second filter is received in the sprayer filter receiving space. Optionally, the first filter may occupy a larger volume than the second filter. Furthermore, both the first and second filters may optionally comprise foam material. If desired, the hose receiving slot may include a generally V-shaped slot that has a circular surface at its lower end when the plate is in the unfolded position.

[0051] According to an eighth aspect of this disclosure, a respiratory therapy device may include a housing having a top wall, the top wall including a first top wall portion and a second top wall portion, the first top wall portion being formed to include a recess, the second top wall portion being selectively received in the recess. A pneumatic system may be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The control circuitry may include a controller, which may include a processor and a memory. An outlet port may be carried by the housing. A pneumatic patient circuit may be configured to pneumatically communicate with a patient's airway. The pneumatic system may be configured to provide respiratory therapy to a patient through the outlet and the pneumatic patient circuitry. The control circuitry may include a firmware upgrade port accessible in the recess of the first top wall portion when the second top wall portion is removed from the recess.

[0052] In some embodiments of the eighth aspect, a handle receiving space may be formed between the outer edge of the second top wall portion and a recess defining the edge of the first top wall portion, the edge of the first top wall portion defining the recess. The respiratory therapy device of the eighth aspect may also include a handle that, when in a storage position, is received in the handle receiving space. When in a use position, the handle is movable to a position extending upward from the handle receiving recess. If desired, the handle may be coupled to the top wall for pivoting movement between the storage and use positions. Optionally, the handle may be U-shaped.

[0053] This disclosure anticipates that the second top wall portion may have a finger receiving recess, the size of which can accommodate one or more fingers of a user, to facilitate moving the handle from a storage position to a usage position. Alternatively or additionally, the first top wall portion may have a finger receiving recess, the size of which can accommodate one or more fingers of a user, to facilitate moving the handle from a storage position to a usage position.

[0054] The respiratory therapy device of the eighth aspect may further include at least one fastener configured to detachably connect the second top wall portion to the first top wall portion. For example, the at least one fastener may include a plurality of screws. If desired, when the housing is resting on a horizontal surface, the top wall of the housing may be tilted at an angle from the front to the rear of the housing.

[0055] In some embodiments of the eighth aspect, the control circuitry may include a graphical user interface (GUI) having user input configurable to control firmware upgrades to the control circuitry via a firmware upgrade port. Optionally, the firmware upgrade port may include a Universal Serial Bus (USB) port, and firmware upgrades may be provided on a USB drive coupled to the USB port. Additionally, the control circuitry may optionally include a foot pedal port accessible externally to the housing for attaching a foot pedal configured to turn a first pressure source on and off. If desired, the control circuitry may be configured to communicate wirelessly with a barcode scanner. Alternatively or additionally, the control circuitry may be configured to communicate wirelessly with a pulse oximeter.

[0056] According to a ninth aspect of this disclosure, a respiratory therapy device may include a housing and a pneumatic system that may be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The control circuitry may include a controller, which may include a processor and a memory. An outlet port may be carried by the housing. A pneumatic patient circuit may be configured to pneumatically communicate with a patient's airway. The pneumatic system may be configured to provide respiratory therapy to a patient through the outlet and the pneumatic patient circuitry. At least one sensor may be coupled to the control circuitry and configured to sense at least one of the patient's inhalation and exhalation. The control circuitry may include a graphical user interface (GUI). The controller may command the GUI to display a first warning message in response to the patient's inhalation or exhalation being sensed for exceeding a predetermined time threshold.

[0057] In some embodiments of the ninth aspect, the predetermined time period may be approximately 10 seconds. Optionally, the respiratory therapy device of the ninth aspect may also include a ventilation device, which may be carried by a housing and coupled to control circuitry. In these embodiments of the ninth aspect, the controller may be configured to command the GUI to display a second warning message in response to detecting a malfunction in the ventilation device.

[0058] If desired, the respiratory therapy device of the ninth aspect may further include a rechargeable battery that can be carried by the housing and coupled to control circuitry. In these embodiments of the ninth aspect, the controller may be configured to command the GUI to display a second warning message in response to the rechargeable battery's charge falling below 10% or 20% of its full charge. Optionally, a foot switch may be coupled to a port on the housing and may be coupled to control circuitry. The foot switch can be used to turn the first pressure source on and off. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to detecting a foot switch malfunction.

[0059] This disclosure contemplates that the respiratory therapy device of the ninth aspect may further include a stepper motor, which may be carried by a housing and coupled to control circuitry. The stepper motor is operable to control the position of at least one valve. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to a detected stepper motor malfunction. Optionally, the at least one sensor may include a pressure sensor, and the controller may be configured to command the GUI to display a second warning message in response to the pressure sensor detecting excessive pressure or inappropriate pressure conditions.

[0060] In some embodiments of the ninth aspect, the respiratory therapy device may further include a temperature sensor, which may be carried by the housing and coupled to the control circuitry. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to an overheating condition detected by the temperature sensor. For example, the overheating condition may involve one or more of the following: the air outlet temperature near the outlet port, the temperature of the first pressure source, the temperature of a stepper motor operable to move at least one valve, or the temperature of a battery carried by the housing.

[0061] Optionally, the respiratory therapy device of the ninth aspect further includes a rechargeable battery carried in a housing and connectable to control circuitry. In these embodiments, the controller can be used to command the GUI to display a second warning message in response to a detected battery recharging failure. Furthermore, optionally, the control circuitry can be configured for wireless communication, and the controller can be configured to command the GUI to display a second warning message in response to a detected wireless communication failure.

[0062] If desired, the patient circuitry of the ninth aspect may include a filter unit configured to be coupled to an exit port. Optionally, the filter unit may include a transponder chip, and the controller may be configured to command the GUI to display a second warning message in response to the reader of the control circuit failing to detect the transponder chip of the filter unit. Furthermore, the control circuitry may optionally include a reader configured to read wireless signals from the transponder chips of the patient circuitry and other patient circuits. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to the reader detecting multiple transponder chips.

[0063] This disclosure contemplates that the control circuitry of the ninth aspect may include a reader, and the patient circuitry may include a filter unit configurable to be coupled to an outlet port. Optionally, the filter unit may include a transponder chip, and the controller may be configured to command the GUI to display a second warning message in response to the reader reading data from the transponder chip of the filter unit, the data indicating that the total number of uses of the filter unit has equaled or exceeded a threshold number of uses. If desired, the at least one sensor may be operable to detect air leaks that may occur from the patient circuitry. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to the detection of excessive air leaks.

[0064] Optionally, the respiratory therapy device of the ninth aspect may further include a temperature sensor, which may be carried in the housing and coupled to control circuitry. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to a temperature sensor detecting a condition below the operating temperature. If desired, the condition below the operating temperature may involve one or more of the following: the air outlet temperature near the outlet port, the temperature of the first pressure source, the temperature of a stepper motor operable to move at least one valve, or the temperature of a battery carried in the housing.

[0065] In some embodiments of the respiratory therapy device of the ninth aspect, the control circuitry may include a real-time clock (RTC) battery, and the controller may be configured to command the GUI to display a second warning message in response to the RTC battery being depleted or falling below a threshold charge level. If desired, the control circuitry may include a first portion and a second portion that can form a controller area network (CAN), and the controller may be configured to command the GUI to display a second warning message in response to the loss of CAN heartbeat messages between the first and second portions of the control circuitry.

[0066] This disclosure contemplates that the first pressure source of the ninth aspect may include a speed sensor, and the controller may be configured to command the GUI to display a second warning message in response to a first pressure source malfunction detected by the speed sensor. Optionally, the controller may be configured to command the GUI to display a second warning message in response to a detected sensor malfunction of at least one sensor. The at least one sensor of the ninth aspect may include a pressure sensor or a flow sensor or both. Further optionally, the controller may be configured to command the GUI to display a second warning message in response to a detected memory malfunction.

[0067] In some embodiments, the respiratory therapy device of the ninth aspect may further include a nebulizer configurable to be coupled to a patient circuit and a second pressure source detachably coupled to a housing. The second pressure source may be used to supply compressed air to the nebulizer. In these embodiments, the controller may be configured to command the GUI to display a second warning message in response to a detected nebulizer malfunction condition associated with the second pressure source.

[0068] Optionally, the control circuitry of the ninth aspect may include an audio generator, and the controller may be configured to command the audio generator to beep once upon successful action. Additionally, optionally, the controller may be configured to command the audio generator to beep three times in conjunction with a first warning message or another warning message displayed on the GUI. Furthermore, optionally, the controller may also be configured to command the audio generator to beep three times per minute in conjunction with the attention required by the respiratory therapy device and the start-up screen instructions displayed on the GUI.

[0069] This disclosure contemplates that the controller of the ninth aspect may be configured to command the audio generator to beep three times, then beep twice after a pause, and repeat in conjunction with a serious malfunction that prevents the operation of the respiratory therapy device. Optionally, the control circuitry may be configured for wireless communication with a wireless network, and the controller may be configured to command the audio generator to beep five times in conjunction with a failure to communicate wirelessly with the wireless network. Alternatively or additionally, the controller may be configured to command the audio generator to emit a continuous tone in response to a disconnection of the patient circuit from the outlet port or in response to an unexpected pressure loss.

[0070] According to a tenth aspect of this disclosure, a respiratory therapy device may include a housing and a pneumatic system that can be carried by the housing. The pneumatic system may include a first pressure source, at least one valve, and control circuitry. The control circuitry may include a controller, which includes a processor and a memory. An outlet port may be carried by the housing. A pneumatic patient circuit may be configured to pneumatically communicate with a patient's airway. The pneumatic system may be configured to perform various respiratory therapies on a patient through the outlet port and the pneumatic patient circuitry. The control circuitry may include a graphical user interface (GUI). The controller may command the GUI to display a plurality of navigable screens that can be used to control the features and functions of the respiratory therapy device. A first set of screens among the plurality of navigable screens may be used to establish wireless communication between the control circuitry and a scanner (e.g., a barcode scanner) that can scan identification (ID) codes, such as patient and respiratory therapist identification (ID) barcodes, for storage in the memory of the control circuitry. A second set of screens among the plurality of navigable screens may be used to select a first set of operating parameters for a first respiratory therapy. A third set of screens among the plurality of navigable screens may be used to select a second set of operating parameters for a second respiratory therapy. The fourth set of screens among the multiple navigable screens can be used to establish wireless communication between the control circuitry and the patient monitor, which can be operated to sense the patient's physiological parameters.

[0071] In some embodiments, the first set of screens may include a barcode scanner connection screen, which may appear on the GUI in response to a selection of one of a variety of respiratory therapies on the GUI. This barcode scanner connection screen indicates that control circuitry may attempt to wirelessly connect to the barcode scanner. If desired, the first set of screens may include a device connection error screen, which appears on the GUI if no connection to the barcode scanner is established within a threshold time period. For example, the threshold time period may be approximately 15 seconds.

[0072] Optionally, the first set of screens may include a patient scanning screen, which may appear on the GUI in response to the control circuitry establishing wireless communication with a barcode scanner. The patient scanning screen may include a message instructing the user to scan the patient's ID barcode. Additionally, the first set of screens may optionally include a therapist scanning screen, which may appear on the GUI in response to barcode recognition of the scanned patient. The therapist scanning screen may include a message instructing the user to scan the respiratory therapist's ID barcode. If desired, the therapist scanning screen may include a first text box and a second text box, the first text box displaying a first alphanumeric code corresponding to the patient's ID barcode, and the second text box being blank until the respiratory therapist's ID barcode is scanned by a barcode reader.

[0073] This disclosure anticipates that the first set of screens may include a check and confirmation screen that appears on the GUI after scanning the respiratory therapist's ID barcode, such that a second alphanumeric code corresponding to the respiratory therapist's ID barcode can be displayed in a second text box. Furthermore, the first set of screens may include a scan error screen that appears on the GUI in response to a match between the first and second alphanumeric codes, due to an unintentional duplicate scan of either the patient's or the respiratory therapist's ID barcode, whereby the scan error occurs. After successfully scanning the patient's and respiratory therapist's ID barcodes, a confirmation button can be activated on the check and confirmation screen; selecting this button causes the GUI to display the main treatment screen for the selected respiratory therapy.

[0074] In some embodiments of the respiratory therapy device of the tenth aspect, the first respiratory therapy may include an automatic mode of mechanical inhalation / exhalation (MIE) therapy, and the second set of screens may include at least one parameter input screen, which may have inputs for setting the following: a first positive pressure value of a first positive pressure applied to the patient during inhalation, a first duration of the first positive pressure applied to the patient, a first negative pressure value of a first negative pressure applied to the patient during exhalation, a second duration of the first negative pressure applied to the patient, a second positive pressure value of a second positive pressure applied to the patient during the positive airway pressure (PAP) portion of the automatic mode of MIE therapy, and a third duration of the second positive pressure applied to the patient.

[0075] Optionally, at least one parameter input screen of the second set of screens may include an oscillation input for setting the amplitude and frequency of pressure oscillations superimposed on one or more of a first positive pressure, a first negative pressure, and a second positive pressure during automatic mode of MIE treatment. Further optionally, at least one parameter input screen of the second set of screens may include a respiratory synchronization screen, which may include at least one input for enabling and disabling the respiratory synchronization function of the respiratory therapy device. If desired, the respiratory synchronization screen may include at least one sensitivity input to select whether the respiratory synchronization function is operational based on low, medium, or high sensitivity.

[0076] This disclosure contemplates that the respiratory synchronization function may include sensing the patient's inhalation and, in response, initiating the blowing of an automatic mode of MIE treatment. Optionally, the respiratory synchronization screen may include sigh control inputs, which may include: a first sigh control input for enabling and disabling the sigh function at the end of the automatic mode of MIE treatment; a second sigh control input for setting a third positive pressure to be applied to the patient during the sigh function at the end of the automatic mode of MIE treatment; and a third sigh control input for setting a fourth duration of the third positive pressure applied to the patient.

[0077] In some embodiments, the second set of screens in the tenth aspect may include a main automatic MIE treatment screen that appears on the GUI in response to selecting a setting completion icon on at least one parameter input screen of the second set of screens. If desired, the main automatic MIE treatment screen may include a graph displaying a selected first positive pressure value, a first duration, a first negative pressure value, a second duration, a second positive pressure value, and a third duration. Before initiating automatic mode of MIE treatment, the main MIE treatment screen may include a flow input that can be selected to set the airflow rate of the pneumatic system to a high, medium, or low level.

[0078] Optionally, the main automatic MIE treatment screen may include a treatment progress indicator that moves graphically during automatic MIE treatment; and a digital pressure gauge, which may have icons indicating the peak positive air pressure setpoint, peak negative air pressure setpoint, and peak positive PAP setpoint. Additionally, optionally, if the pulse oximeter is communicating with the control circuitry during automatic MIE treatment, the main automatic MIE treatment screen may display the patient's heart rate and pulse oximetry data. Alternatively or additionally, during automatic MIE treatment, if available from the control circuitry, the main automatic MIE treatment screen may display the patient's peak cough flow (P0.05). CF Data and tidal volume (Vt) data.

[0079] This disclosure anticipates that the main automatic MIE treatment screen can display a graphical start button, selectable to initiate automatic MIE treatment mode; and a graphical stop button, selectable to stop automatic MIE treatment mode. Optionally, the graphical stop button can be inactive until the graphical start button is selected to initiate automatic MIE treatment mode. Furthermore, optionally, after the graphical start button is selected and automatic MIE treatment is in progress, the graphical start button can be converted into a graphical pause button.

[0080] In some embodiments of the tenth aspect, in response to the selection of the graphical start button, the control circuit can wirelessly query the transponder chip of the filter unit in the patient loop to determine whether the previous number of uses of the filter unit is less than a threshold number of uses. In these embodiments, if the previous number of uses exceeds or equals the threshold number of uses, and a notification message is provided on the GUI, the control circuit can prevent the automatic mode of MIE treatment from occurring and provide a notification message on the GUI. Optionally, if the respiratory therapy device is operating on battery power, the control circuit can check the battery charging status in response to the selection of the graphical start button. If the battery charging status is less than or equal to a threshold amount, the control circuit can prevent entry into the automatic mode of MIE treatment. For example, the threshold amount could be 10% or 20% of the battery's full charge.

[0081] If needed, the main automatic MIE treatment screen can display a cycle of the blow-in, exhale, and PAP portions of the automatic mode of MIE treatment, and can also display the total number of cycles to be completed during the automatic mode of MIE treatment. The graph can also optionally display how many cycles have been completed at any given time during the automatic mode of MIE treatment.

[0082] In some embodiments of the tenth aspect, after the automatic mode of MIE treatment is completed, an automatic MIE treatment completion screen appears on the GUI. The automatic MIE treatment completion screen may include a first set of data, which may include a first pressure value indicating the average positive pressure applied to the patient during inhalation, a second pressure value indicating the average negative pressure applied to the patient during exhalation, a third pressure value indicating the average pressure applied to the patient during the PAP portion of the automatic MIE treatment mode, the total number of times the filter unit of the patient circuit was used, whether the sigh mode was on at the end of the automatic MIE treatment mode, the date the automatic MIE treatment mode occurred, the start and end times of the automatic MIE treatment mode, the total time of the automatic MIE treatment mode, the total number of cycles of the automatic MIE treatment mode, and the peak cough flow (P) that occurred during the MIE treatment. CF), and the average tidal volume occurring during the automatic mode of MIE treatment. Optionally, if the wireless communication function of the control circuit is enabled and the control circuit successfully communicates wirelessly with the wireless access point, the control circuit of the tenth aspect can wirelessly transmit the first set of data for storage in a remote computer.

[0083] This disclosure contemplates that the second respiratory therapy may include a manual mode of mechanical inhalation / exhalation (MIE) therapy, and the third set of screens may include a main manual MIE therapy screen, which may include inputs for adjusting one or more of the following: a third positive pressure value for a third positive pressure applied to the patient during inhalation, a second negative pressure value for a second negative pressure applied to the patient during exhalation, and a fourth positive pressure value for a fourth positive pressure applied to the patient during the airway positive pressure (PAP) portion of the manual mode of MIE therapy. Optionally, the main manual MIE therapy screen may include a vibrating button, and the third set of screens may include an oscillation input screen that may be displayed on the GUI in response to selection of the vibrating button. The oscillation input screen may include oscillation inputs for setting the amplitude and frequency of pressure oscillations superimposed on one or more of the third positive pressure, second negative pressure, and fourth positive pressure during the manual mode of MIE therapy.

[0084] Optionally, the main manual MIE screen may include an inhalation icon that can be touched and held during manual MIE treatment mode to allow the patient to blow in, and an exhalation icon that can be touched and held during manual MIE treatment mode to allow the patient to exhale. Additionally, optionally, if neither the inhalation nor the exhalation icon is pressed and held, the PAP portion of the manual MIE treatment mode can be implemented in the manual mode of MIE treatment. If desired, inputs for adjustment may include up and down arrow icons, which may be adjacent to each of the third positive pressure value, the second negative pressure value, and the fourth positive pressure value.

[0085] In some embodiments of the tenth aspect, before initiating manual mode of MIE treatment, the main manual MIE treatment screen may include a flow input selectable for setting the airflow rate of the pneumatic system to a high, medium, or low level. Optionally, if the pulse oximeter is in communication with the control circuitry during manual mode of MIE treatment, the main manual MIE treatment screen may display the patient's heart rate and pulse oximetry data. Alternatively or additionally, during manual mode of MIE treatment, if available from the control circuitry, the main manual MIE treatment screen may display the patient's peak cough flow (P0.05). CF Data and tidal volume (Vt) data.

[0086] If needed, the main manual MIE treatment screen can display a graphical start button, which can be selected to initiate the manual mode of MIE treatment. After selecting the graphical start button, it can be converted into a graphical stop button, which can be selected to stop the manual mode of MIE treatment. Optionally, in response to selecting the graphical start button, the control circuit can wirelessly query the transponder chip of the filter unit in the patient loop to determine whether the previous number of uses of the filter unit is less than a threshold number of uses. Furthermore, if the previous number of uses exceeds or equals the threshold number of uses, and a notification message is provided on the GUI, the control circuit can prevent the manual mode of MIE treatment from occurring.

[0087] In some embodiments of the tenth aspect, if the respiratory therapy device operates on battery power, the control circuitry can check the battery charging status in response to selecting the graphic start button. If the battery charging status is less than or equal to a threshold amount, the control circuitry can prevent the manual mode of MIE therapy from occurring. For example, the threshold amount could be 10% or 20% of the battery's full charge. If desired, the main manual MIE therapy screen can display a first number of blow-in counts occurring during the manual MIE therapy mode, a first total time of blow-in occurring in the manual MIE therapy mode, a second number of exhalation counts occurring in the manual MIE therapy mode, a second total time of exhalation occurring in the manual MIE therapy mode, and the total duration of the manual MIE therapy mode.

[0088] Optionally, after completing the manual mode of MIE treatment, a manual MIE treatment completion screen appears on the GUI. The manual MIE treatment completion screen may include a first set of data, including a first pressure value indicating the average positive pressure applied to the patient during inhalation, a second pressure value indicating the average negative pressure applied to the patient during exhalation, a third pressure value indicating the average pressure applied to the patient during the PAP portion of the manual MIE treatment, the total number of times the filter unit in the patient circuit was used, the date the automatic MIE treatment mode occurred, the start and end times of the manual MIE treatment mode, the total time of the manual MIE treatment mode, the total number of cycles of the manual MIE treatment mode, and the peak cough flow (P) observed in the manual MIE treatment mode. CF The average tidal volume detected in manual mode of MIE treatment. If needed, and if the wireless communication function of the control circuit is enabled, and the control circuit successfully communicates wirelessly with the wireless access point, the control circuit can wirelessly transmit the first set of data to a remote computer for storage.

[0089] In some embodiments of the respiratory therapy device of the tenth aspect, the first respiratory therapy may include an automatic mode of oscillating lung expansion (OLE) therapy, and the second set of screens may include at least one parameter input screen having inputs for setting the following: a first positive pressure value of a first positive pressure to be applied to the patient during the continuous positive exhalation pressure (CPEP) therapy portion of the automatic mode of OLE therapy; whether the nebulizer connected to the patient's circuitry is on or off during the CPEP therapy portion; a first duration of the first positive pressure to be applied to the patient; a second positive pressure value of a second positive pressure to be applied to the patient during the continuous high-frequency oscillation (CHFO) therapy portion of the automatic mode of OLE therapy; whether the nebulizer is on or off during the CHFO therapy portion; a second duration of the second positive pressure to be applied to the patient; whether the oscillation frequency superimposed on the second positive pressure during the CHFO therapy portion is at a high, medium, or low level; and a third duration of the nebulizer being on in the absence of CPEP and CHFO therapy portions.

[0090] Optionally, at least one parameter input screen in the second set of screens may include a cough pause screen, which may include at least one input for enabling and disabling the cough pause function of the respiratory therapy device. If desired, the cough pause screen may include a first input for selecting a cough pause interval, during which the cough pause function will occur between cough pause intervals in the automatic mode of OLE therapy; and a second input for selecting a cough pause duration, during which the cough pause function will occur when the cough pause function is activated.

[0091] This disclosure contemplates that the second set of screens may include a main automatic OLE treatment screen, which may be displayed on the GUI in response to the selection of a setup completion icon on at least one parameter input screen of the second set of screens. Optionally, the main automatic OLE treatment screen may include a graph displaying the selected first positive pressure value, a first duration, a second positive pressure value, a second duration, and a third duration. Furthermore, the main automatic OLE treatment screen may optionally include a treatment progress indicator that moves along the graph during automatic OLE treatment; and a digital pressure gauge that may have a first icon indicating a peak positive pressure setpoint and a second icon indicating the current positive pressure applied to the patient during automatic OLE treatment.

[0092] If needed, and if the pulse oximeter is communicating with the control circuitry during automatic OLE therapy, the main automatic OLE therapy screen can display the patient's heart rate and pulse oximetry data. Alternatively or additionally, during automatic OLE therapy, if available from the control circuitry, the main automatic OLE therapy screen can display the patient's peak cough flow (P0.05). CF Data and tidal volume (Vt) data. Additionally, alternatively or otherwise, the main automatic OLE treatment screen may display a graphical start button for automatic mode that can be selected to initiate OLE treatment and a graphical stop button for automatic mode that can be selected to stop OLE treatment.

[0093] In some embodiments of the tenth aspect, the graphical start button may be inactive until it is selected to initiate the automatic mode of OLE treatment. If needed, the graphical start button can be converted to a graphical pause button after selection, and the automatic mode of OLE treatment will occur. Optionally, in response to selection of the graphical start button, the control circuitry may wirelessly query the transponder chip of the filter unit of the patient circuitry to determine whether the previous number of uses of the filter unit is less than a threshold number of uses. Furthermore, optionally, if the previous number of uses exceeds or equals the threshold number of uses, and a notification message is provided on the GUI, the control circuitry may prevent the automatic mode of OLE treatment from occurring.

[0094] In some embodiments of the respiratory therapy device of the tenth aspect, if the respiratory therapy device is operating on battery power, the control circuit can check the battery charging status in response to selecting the graphic start button. In these embodiments, if the battery charging status is less than or equal to a threshold amount, the control circuit can prevent the automatic mode of OLE therapy from occurring. For example, the threshold amount could be 10% or 20% of the battery's full charge.

[0095] If needed, the main automatic OLE treatment screen can display the total number of stages that will occur during the automatic mode of OLE treatment. For example, each stage may correspond to one of the CPEP sections, one of the CHFO sections, or the nebulizer being activated in one of the sections if neither the CPEP nor the CHFO section occurs. Alternatively or additionally, the main automatic OLE treatment screen can display how many stages have been completed at any given time during the automatic mode of OLE treatment.

[0096] In some embodiments of the respiratory therapy device of the tenth aspect, after the completion of the automatic mode of OLE treatment, an automatic OLE treatment completion screen may appear on the GUI. The automatic OLE treatment completion screen may include a first set of data, which may include a first pressure value indicating the average peak pressure that can be applied to the patient during the CHFO portion of the automatic OLE treatment mode, a second pressure value indicating the average peak pressure that can be applied to the patient during the CPEP portion of the automatic OLE treatment mode, the total nebulizer time during nebulizer operation, the total number of times the filter unit of the patient circuit is used, the cough pause interval and duration, the date the automatic OLE treatment mode occurred, the start and end times of the automatic OLE treatment mode, the total time of the automatic OLE treatment mode, and the total number of stages of the automatic OLE treatment mode. If desired, and if the wireless communication function of the control circuit is enabled and the control circuit is successfully communicating wirelessly with a wireless access point, the control circuit may wirelessly transmit the first set of data to a remote computer for storage.

[0097] This disclosure anticipates that the second respiratory therapy of the tenth aspect may include a manual mode of oscillating lung expansion (OLE) therapy, and the third set of screens may include a main manual OLE therapy screen, which may include inputs for adjusting one or more of the following: a third positive pressure value to be applied to the patient during the CPEP therapy portion of the manual OLE therapy, a fourth positive pressure value to be applied to the patient during the CHFP therapy portion of the manual OLE therapy, whether the nebulizer connected to the patient circuit is on or off during the CPEP therapy portion or the CHFO therapy portion, and whether the oscillation frequency superimposed on the fourth positive pressure during the CHFO therapy portion of the manual OLE therapy is at a high level, a medium level, or a low level.

[0098] Optionally, the main manual OLE treatment screen may include a first oscillation button, which may correspond to one of high, medium, or low level oscillations. Additionally, optionally, pressing the first oscillation button and holding it for a first threshold period will cause a second and a third oscillation button corresponding to the other two high, medium, or low level oscillations to appear on the main manual OLE treatment screen. Still optionally, pressing and holding one of the first, second, or third oscillation buttons for a second threshold period may result in selecting the corresponding high, medium, or low level oscillation for the CHFO treatment portion used in the manual mode of OLE treatment.

[0099] In some embodiments of the respiratory therapy device of the tenth aspect, the main manual OLE screen may include a CPEP icon for the CPEP treatment portion that can be touched and held to perform the manual OLE treatment mode, and a CHFO icon for the CHFO treatment portion that can be touched and held to perform the manual OLE treatment mode. This disclosure contemplates that if the nebulizer is turned on, medication can be delivered to the patient from the nebulizer of the tenth aspect, regardless of whether the CPEP icon is touched and held, whether the CHFO icon is touched and held, or whether either the CPEP icon or the CHFO icon is not touched and held. Optionally, the inputs for adjustment include up and down arrow icons adjacent to each of the third and fourth positive pressure values. If desired, the main manual OLE treatment screen may display the patient's heart rate and pulse oximetry data if the pulse oximeter is in communication with the control circuitry during the manual OLE treatment mode.

[0100] Optionally, the main manual OLE treatment screen may display a graphical start button that can be selected to initiate the manual mode of OLE treatment, and wherein, after selecting the graphical start button, the graphical start button can be converted into a graphical stop button that can be selected to stop the manual mode of OLE treatment. Alternatively or additionally, in response to the selection of the graphical start button, the control circuit may wirelessly query the transponder chip of the filter unit of the patient circuit to determine whether the previous number of uses of the filter unit is less than a threshold number of uses. Furthermore, if the previous number of uses exceeds or equals the threshold number of uses, and a notification message is provided on the GUI, the control circuit may prevent the manual mode of OLE treatment from occurring.

[0101] In some embodiments of the respiratory therapy device of the tenth aspect, if the respiratory therapy device operates under battery power, the control circuitry can check the battery charging status in response to the selection of the graphic start button. In these embodiments, if the battery charging status is less than or equal to a threshold amount, the control circuitry can prevent the manual mode of OLE therapy from occurring. For example, the threshold amount could be 10% or 20% of the battery's full charge.

[0102] This disclosure anticipates that the main OLE treatment screen of the tenth aspect can display a first number of stage counts of CPEP treatment portions that can occur during OLE treatment manual mode, a first total time of CPEP treatment portions that can occur during OLE treatment manual mode, a second number of stage counts of CHFO treatment portions that can occur during OLE treatment manual mode, a second total time of CHFO treatment portions that can occur during OLE treatment manual mode, and the total time that OLE treatment manual mode can occur.

[0103] If necessary, a manual OLE treatment completion screen can appear on the GUI after completing the manual mode of OLE treatment. The manual OLE treatment completion screen may include a first set of data, which may include a first pressure value indicating the average peak pressure that can be applied to the patient during the CHFO portion of the manual OLE treatment, a second pressure value indicating the average peak pressure that can be applied to the patient during the CPEP portion of the manual OLE treatment, the total nebulizer time during nebulizer operation, the total number of times the filter unit in the patient circuit is used, the cough pause interval and duration, the date the manual OLE treatment mode occurred, the start and end times of the manual OLE treatment mode, the total time of the manual OLE treatment mode, and the total number of stages of the manual OLE treatment mode. Optionally, if the wireless communication function of the control circuit is enabled and the control circuit successfully communicates wirelessly with a wireless access point, the control circuit may wirelessly transmit the first set of data for storage in a remote computer.

[0104] In some embodiments of the respiratory therapy device of the tenth aspect, the first respiratory therapy may include mechanical inhalation / exhalation (MIE) therapy, and the second respiratory therapy may include oscillating lung expansion (OLE) therapy. Each of the MIE and OLE therapies may have a manual operation mode and an automatic operation mode. Optionally, the patient monitor may include a pulse oximeter. Furthermore, optionally, the control circuitry may receive data from the pulse oximeter, and based on this data, the patient's SpO2 value and heart rate may be displayed on a GUI during treatment.

[0105] This disclosure contemplates that the pneumatic patient circuitry of the tenth aspect may include a filter unit configured to be coupled to an outlet port. The filter unit may include a transponder chip and an antenna configured to wirelessly communicate with the control circuitry. If desired, the control circuitry may, in response to data from the transponder chip of the filter unit, command the GUI to display a warning message indicating that the total number of uses of the filter unit may be equal to or exceed a threshold number of uses. Optionally, the filter unit of the tenth aspect may include a filter unit housing having a pneumatic flow channel passing through the filter unit housing, and the antenna may be attached to the filter unit housing and may surround the pneumatic flow channel.

[0106] Optionally, the respiratory therapy device of the tenth aspect may further include a nebulizer that can be coupled to the pneumatic patient circuit. The nebulizer tray may be selectively coupled to the bottom of the housing so as to be located below the bottom wall of the housing. A second pressure source may be carried by the nebulizer tray and operable to supply compressed air to the nebulizer. If desired, the controller may command the GUI to display at least one input to turn the second pressure source on or off after it is electrically connected to the control circuitry of the pneumatic system.

[0107] In some embodiments, the respiratory therapy device of the tenth aspect may further include a foot switch that is electrically connected to control circuitry and can be used to control a first respiratory therapy or a second respiratory therapy, or both. If desired, the controller may command the GUI to display a foot switch icon in response to the foot switch being electrically connected to the control circuitry. For example, the foot switch icon may indicate the usage status of the foot switch.

[0108] Optionally, in response to the settings button being selected in the main menu, a settings screen with multiple navigable screens can appear on the GUI. The settings screen may include one or more of the following information: model of the respiratory therapy device, serial number of the respiratory therapy device, software version of the control circuitry, bootloader version of the control circuitry, Federal Communications Commission (FCC) identification (ID) number, radio frequency (RF) identification (ID) firmware version, Bluetooth firmware version, total treatment runtime, total spray time, WiFi MAC address, WiFi firmware version, or LTE firmware version.

[0109] In some embodiments of the respiratory therapy device of the tenth aspect, the date-time screen of the plurality of navigable screens may appear on the GUI in response to the selection of a date-time label, and the date-time may also appear on the GUI in response to the selection of a device button on the settings screen. If desired, the date-time screen may include input allowing the user to set the following: date and time, time format, whether daylight saving time is on or off, and time zone. Alternatively or additionally, in response to the selection of a device button on the settings screen, a date-time label appears on the GUI, and in response to the selection of the date-time label, a language screen among the plurality of navigable screens may appear on the GUI. Furthermore, alternatively or additionally, the language screen may also include a language input menu that allows the user to set the language appearing on the plurality of navigable screens.

[0110] If needed, a control label appears on the GUI in response to a device button selected on the settings screen, and in response to the selection of that control label, a control screen with multiple navigable screens is displayed on the GUI. The control screen may include inputs that allow users to set the following: screen brightness, whether wireless communication with the barcode scanner is on or off, and whether wireless communication with the patient monitor is on or off. Optionally, a data screen with multiple navigable screens may appear on the GUI in response to a data button selected on the settings screen. The data screen may include inputs that allow users to check and export treatment logs, check and export error logs, import and export device settings, upgrade firmware, and import Health Level 7 (HL7) information.

[0111] This disclosure anticipates that, in response to communication with the receiving device to verify available storage space, an attempt is made to export the treatment log or error log to the receiving device where insufficient storage space is determined by the control circuitry. In response to this attempt, an insufficient storage space message appears on the GUI. Alternatively or additionally, if the portion of the memory allocated by the control circuitry to the treatment log or error log, respectively, does not have sufficient storage space, an insufficient storage space message may be displayed on the GUI in response to an attempt to import the treatment log or error log from the source device into the control circuitry.

[0112] Optionally, the GUI of the tenth aspect may display a dynamic process icon to indicate the process of exporting treatment logs or error logs to the receiving device. For example, the process icon may include a numerical percentage representing the percentage of export completion, and a circle, a portion of which is filled with an amount matching the numerical percentage. Furthermore, optionally, the GUI of the tenth aspect may display a dynamic process icon to indicate the process of importing treatment logs or error logs from the source device to the control circuitry. For example, the process icon may include a numerical percentage representing the import completion, and a circle, a portion of which is filled with an amount matching the numerical percentage.

[0113] In some embodiments of the respiratory therapy device of the tenth aspect, the GUI may display a dynamic progress icon to indicate the progress of exporting device settings to the receiving device. If desired, the progress icon may include a numerical percentage representing the amount of export completed; and a circle, a portion of which may be filled with an amount matching the numerical percentage. Alternatively or additionally, the GUI may also display a dynamic progress icon to indicate the progress of importing device settings from the source device. For example, the progress icon may include a numerical percentage representing the import completed; and a circle, a portion of which may be filled with an amount matching the numerical percentage.

[0114] If needed, the GUI can display a dynamic progress icon to indicate the progress of downloading upgrade firmware from the source device to the control circuitry. Similar to the scenario described above, the progress icon may include a numerical percentage representing the amount of upgrade firmware downloaded, and a circle surrounded by an amount that matches the percentage. Alternatively, or additionally, the GUI of the tenth aspect may display a dynamic progress icon to indicate the progress of importing HL7 information from the source device. Again, the progress icon may include a numerical percentage representing the amount imported, and a circle surrounded by an amount that matches the percentage.

[0115] This disclosure contemplates that, for the respiratory therapy device of the tenth aspect, the receiving device may include a USB storage stick that can be coupled to a USB port of the control circuitry. Alternatively or additionally, the source device may include a USB storage stick coupled to a USB port of the control circuitry. Furthermore, alternatively or additionally, in response to a connection button selected on a setup screen, a wireless connection screen of a plurality of navigable screens of the ninth aspect may be displayed on a GUI. The connection screen may include inputs that allow the user to control Bluetooth or WiFi wireless communication, or both, wherein Bluetooth or WiFi wireless communication, or both, may be enabled or disabled for the control circuitry.

[0116] Optionally, the wireless connectivity screen may include Bluetooth and WiFi tags. Selecting the Bluetooth tag causes a first slider button to appear on the GUI for turning the Bluetooth wireless communication function of the control circuitry on and off. Similarly, selecting the WiFi tag causes a second slider button to appear on the GUI for turning the WiFi wireless communication function of the control circuitry on and off. Therefore, when the first slider button is moved to the on position, the control circuitry can initiate Bluetooth communication with an external device that has Bluetooth communication capabilities. In this case, the GUI can list device information for any external device with which Bluetooth communication has been successfully established. For example, the external device may include a barcode scanner or a patient monitor, or both. If needed, selecting an external device from the device information list on the GUI will display additional information about the external device on the GUI.

[0117] In some embodiments of the ninth aspect, in response to the first slider button being moved to the open position, a scan button can be displayed on the GUI. In response to the selected scan button, the control circuitry can scan for external devices with Bluetooth communication capabilities. In this case, the GUI can list the device IDs of external devices that may communicate with via Bluetooth. If needed, selecting a specific device ID from the list of device IDs will cause a "Pair New Device" screen to appear on the GUI. This "Pair New Device" screen may include a continue button that can be selected to initiate a Bluetooth pairing operation between the control circuitry and the external device corresponding to the specific device in the device ID list.

[0118] Optionally, in response to the first slider button being moved to the open position, a manual setup button can be displayed on the GUI, and in response to the manual setup button being selected, the GUI can display a field in which the device ID of the external device with which the control circuit will establish Bluetooth communication can be accessed. Additionally, optionally, the device ID may include the MAC address of the external device with which the control circuit will establish Bluetooth communication. Alternatively or additionally, in response to the second slider button being moved to the open position, a scan availability screen can be displayed on the GUI. This scan availability screen may have a scan button, and in response to the selected scan button, the control circuit can scan for wireless access points (WAPs) with WiFi communication capabilities, and the GUI can list the WAP IDs of WAPs with which WiFi communication can be established.

[0119] If needed, selecting a specific WAP ID from the WAP ID list will display the Enterprise Setup screen on the GUI. The Enterprise Setup screen may include setup fields where users can enter the Extensible Authentication Protocol (EAP) method, the Microsoft Challenge Handshake Authentication Protocol (MSCHAP) method, a user ID, and a password. After the setup fields are filled, the Enterprise Setup screen may include a Continue button, which allows users to select the method used to verify WiFi communication between the WAP and the control circuitry corresponding to a specific WAP ID.

[0120] In some embodiments of the respiratory therapy device of the tenth aspect, if authentication between the WAP corresponding to a specific WAP ID and the control circuit is successful, a successful authentication flag can be displayed on the GUI adjacent to the specific WAP ID. Furthermore, if authentication between the WAP corresponding to a specific WAP ID and the control circuit fails, a "connection failed" screen can be displayed on the GUI. If necessary, the "connection failed" screen can contain a message related to the unsuccessful authentication. Similarly, if authentication between the WAP corresponding to a specific WAP ID and the control circuit is successful, a status label will be displayed on the GUI. This status label can optionally display information related to one or more of the following: Service Set ID (SSID) name, security type, MAC address, IP address, subnet mask, and gateway.

[0121] Optionally, in response to the second slider button being moved to the open position, a settings tab can be displayed on the GUI, and in response to the selected settings tab, a network window and a server window can be displayed on the GUI. The network window may have a third slider button, which can be used to select between a static IP address assigned to the control circuit and an IP address assigned to the control circuit based on the Dynamic Host Configuration Protocol (DHCP). Additionally, optionally, the server window may have a fourth slider button, which can be used to select between a first server and a second server to receive messages from the control circuit.

[0122] This disclosure contemplates that, if the third slider button of the tenth aspect is in the static slider position to select an assigned static IP address, a field may appear in the network window to enter one or more of the following: the IP address of the control circuit, the gateway IP address of the gateway, the subnet IP address of the subnet, and the Digital Multiplexing System (DMS) IP address of the DMS. This disclosure also contemplates that, for each position of the fourth slider button of the tenth aspect, depending on the position of the fourth slider button, a field may appear in the server window for entering one or more of the following of the first or second server: the server IP address of the server, the port ID of the server port, and the Network Time Protocol (NTP) IP address.

[0123] In some embodiments of the respiratory therapy device of the tenth aspect, the server window may include a selectable test connection button, which can be selected to test whether the control circuit can successfully connect to each of the network, the first server, and the second server. If necessary, after the test connection button is selected, the GUI displays messages indicating whether the connection between the control circuit and the network, the first server, and the second server is successful, respectively.

[0124] Optionally, in response to a connection button selected on the setup screen, a wireless connection screen of multiple navigable screens in the tenth aspect can be displayed on the GUI. The wireless connection screen may include inputs allowing the user to control whether the control circuitry enables or disables Long Term Evolution (LTE) communication. If needed, in response to inputs configured in the open position, the control circuitry can operate to search for an LTE carrier, and if an LTE carrier is found, the GUI can display carrier information. For example, carrier information may include one or more of the following: carrier name, International Mobile Equipment Identity (IMEI), and Subscriber Identity Module (SIM) card ID. This disclosure contemplates that if an LTE carrier is found, the GUI can display a test connection button, selectable to test whether the control circuitry has successfully connected to the LTE network of the LTE carrier. After the test connection button is selected, the GUI can display a message indicating whether the connection between the LTE network and the control circuitry is successful.

[0125] In some embodiments of the respiratory therapy device of the tenth aspect, selecting a help icon associated with any of the second or third group of screens on the GUI can cause a category selection help screen to appear on the GUI. The category selection help screen may include a category button menu, which may correspond to a category available for assistance. Optionally, the category button menu may include one or more of the following: an automatic treatment button, a manual treatment button, a treatment overview button, a treatment options button, and a modify treatment button. Furthermore, optionally, selecting one of the menu items in the category buttons will cause an annotation screen to appear, displaying textual descriptions of the screen features of the corresponding screen on the GUI.

[0126] If desired, the plurality of navigable screens may include a pressure limit screen for setting a maximum pressure limit, which may be a maximum therapeutic pressure boundary exceeding which pneumatic system operation is prevented. In some embodiments, the pneumatic system is operable to generate a baseline pressure and pressure oscillations, which may be higher and lower than the baseline pressure. The peak value of the pressure oscillation may be compared to the pressure limit to prevent pneumatic system operation such that the peak value exceeds the pressure limit. Alternatively or additionally, the plurality of navigable screens may include an auto-lock screen for selecting between locking or unlocking advanced settings functions after each power cycle of the respiratory therapy device.

[0127] Additional features, either alone or in combination with any other features, such as the features listed above and those set forth in the claims, may comprise patentable subject matter and will become apparent to those skilled in the art upon taking into account the following detailed description of various embodiments, which embody the best mode for implementing what is now considered to be the embodiments. Attached Figure Description

[0128] Detailed description is given in particular with reference to these accompanying drawings, in which:

[0129] Figure 1 This is a perspective view of a respiratory therapy device according to a first configuration of the present disclosure, showing that the respiratory therapy device has an outlet port extending from a recessed portion of the lower front wall of the housing, a graphical user interface (GUI) display screen on the upper front wall of the housing above the outlet port, and a U-shaped support handle extending upward from the top wall of the housing.

[0130] Figure 2 and Figure 1 Similarly, a perspective view of a second-configuration respiratory device is formed by adding a nebulizer tray to the bottom of the housing of the first-configuration respiratory therapy device, the nebulizer tray being located below most of the bottom wall of the housing, and the nebulizer port extending from a recessed portion of the front wall of the nebulizer tray;

[0131] Figure 3 It is an exploded view showing the sprayer tray exploding and separating from the bottom wall of the housing, and showing the cable arranged to be inserted into the interior area of ​​the housing through an opening in the bottom wall;

[0132] Figure 4 This is an exploded view of a sprayer tray, showing the tray housing of the sprayer tray, the sprayer pump located above the tray housing, and pneumatic piping with portions extending from the sprayer pump and portions exploded apart from the tray housing.

[0133] Figure 5 yes Figure 4 A perspective view of a sprayer tray, showing the sprayer pump and pneumatic piping assembled inside the tray housing of the sprayer tray;

[0134] Figure 6 yes Figure 2 The rear view of the respiratory therapy device shows the U-shaped handle in a storage position within a recess formed on the top wall of the housing, and the generally V-shaped hose support plate in a storage position behind the rear wall of the housing.

[0135] Figure 7A is an exploded perspective view of a generally V-shaped hose support plate rotated approximately 90 degrees from the storage position to the use position. The hose support plate has a V-shaped notch for receiving the hose therein, a battery and battery cover exploded apart from a rectangular battery receiving recess located in the rear wall of the housing, a sprayer tray exploded apart from the bottom wall of the housing, and a foot switch located on the left side of the sprayer tray.

[0136] Figure 7B is an exploded perspective view showing the exploded separation of the housing to reveal a portion of the bottom tray that supports the manifold and valve assembly and the blower above the bottom wall of the housing.

[0137] Figure 8 It is an exploded perspective view showing the housing mounted on the first and second sidewalls of the lower front wall portion of the housing, a portion of a generally cylindrical defining recess protruding into the interior region of the housing, a generally annular antenna aligned with the generally cylindrical defining recess portion, a flow control assembly aligned with the generally annular antenna, and a display circuit board attached to the lower part of the upper front wall of the housing.

[0138] Figure 9 This is an exploded view showing a patient interface circuit, which includes a flexible corrugated hose, a filter unit exploded from a first end of the hose, and various patient interface components exploded from a second end of the hose.

[0139] Figure 10 This is a perspective view of the filter unit, showing that the filter unit has a filter housing having a first cylindrical tubular portion and a second cylindrical tubular portion extending in the opposite direction to the annular central filter receiving portion;

[0140] Figure 11 yes Figure 10 A side view of the filter unit shows first and second truncated conical portions extending from the annular central filter receiving portion to corresponding first cylindrical tubular portions and second cylindrical tubular portions, and shows an annular shoulder extending from the first truncated conical portion located approximately midway between the annular central filter receiving portion and the first cylindrical tubular portion;

[0141] Figure 12 yes Figure 10 and Figure 11 A perspective view of the filter unit, showing the transponder ring exploded and separated from the annular shoulder surface of the filter housing;

[0142] Figure 13 A is Figure 10 and Figure 11 A front view of the filter unit shows a first cylindrical tubular portion, a transponder ring attached to the shoulder surface, and a central region of the filter contained within an annular central filter receiving portion of the filter unit, through a flow channel in the first cylindrical tubular portion.

[0143] Figure 13B is a cross-sectional view of the filter unit taken along line 13B-13B of Figure 13A, showing the filter extending through the annular central filter receiving portion between the first truncated conical portion and the second truncated conical portion of the filter housing;

[0144] Figure 14 yes Figure 12 A front view of the transponder coil;

[0145] Figure 15 yes Figure 12 and Figure 14 A cross-sectional view of a portion of the transponder coil, showing the top surface material layer, the copper antenna below the surface material (with an integrated circuit transponder chip sandwiched between the surface material and the copper antenna), the polyethylene terephthalate (PET) material substrate layer below the copper antenna, the adhesive layer below the substrate layer, and the backing layer below the adhesive layer.

[0146] Figures 16A-16D Together, they form a block diagram of the electrical architecture of the respiratory therapy device disclosed herein;

[0147] Figures 17A-17C Together they form a block diagram of the electronic wiring of the respiratory therapy device disclosed herein;

[0148] Figures 18-274 These are examples of screenshots of multiple navigable control screens that appear on the GUI of the respiratory therapy device and can be used to control the features and functions of the respiratory therapy device of this disclosure.

[0149] Figure 18 This is a screenshot of the main treatment selection screen, which features selectable mechanical inhalation / exhalation (MIE) buttons or icons and selectable oscillating lung expansion (OLE) buttons or icons.

[0150] Figure 19 It is in response to Figure 18 The screenshot shows the main MIE treatment selection screen that appears on the GUI when the MIE icon is selected on the main treatment selection screen. The main MIE treatment selection screen has selectable automatic and manual buttons for selecting the automatic and manual modes of MIE treatment, respectively.

[0151] Figure 20 It is in response to Figure 18 The screenshot shows the main OLE treatment selection screen that appears on the GUI when the OLE icon is selected on the main treatment selection screen. The main OLE treatment selection screen has selectable automatic and manual buttons for selecting the automatic and manual modes of OLE treatment, respectively.

[0152] Figure 21 It is in response to Figure 19 The main MIE treatment selection is on the right side of the screen and Figure 20A screenshot of the menu screen displayed on the GUI by selecting the menu arrow icon on the right side of the main OLE treatment selection screen. The menu screen includes a vertical menu of icons, which from top to bottom includes a home icon, a graphic icon, a lung icon, a settings icon, and an information or help icon.

[0153] Figure 22 It is in response to from Figure 21 A screenshot of the settings screen displayed on the GUI when the settings icon is selected from the menu. The settings screen includes a device information window related to the respiratory therapy device.

[0154] Figure 23 This is a screenshot of the barcode scanner connected to the screen. If the barcode reader feature of the respiratory therapy device is turned on or enabled, it responds in response to... Figure 19 and 20 Select the Auto or Manual button on any screen and that screen will be displayed on the GUI;

[0155] Figure 24 This is a screenshot of the device connection error screen. If the device does not connect to the barcode scanner within a threshold time, the device connection error screen will be displayed on the GUI.

[0156] Figure 25 It is a screenshot of the patient's screen, which is displayed on the GUI in response to the establishment of wireless communication between the respiratory therapy device and the barcode scanner;

[0157] Figure 26 It is a screenshot of a scanning therapist's screen, which is displayed on the GUI in response to the successful recognition of the scanned patient's barcode.

[0158] Figure 27 This is a screenshot of the check and confirmation screen, which is displayed on the GUI in response to the successful identification of the respiratory therapist being scanned. The check and confirmation screen includes a text box displaying the alphanumeric identification (ID) codes of the patient and respiratory therapist, as well as a confirmation button that is selected to confirm the successful scan of the patient and respiratory therapist.

[0159] Figure 28 This is a screenshot of a scanning error screen displayed on the GUI in response to a first alphanumeric ID code matching a second alphanumeric ID code, indicating that the same ID code was inadvertently scanned repeatedly.

[0160] Figure 29 This is a screenshot of the main automatic MIE treatment screen, which responds to... Figure 19 The main MIE treatment selection screen selects the automatic button, which is displayed on the GUI.

[0161] Figure 30 This is a screenshot of a low battery screen. If you select... Figure 29 The start button of the main automatic MIE treatment screen is pressed. At the same time, the respiratory therapy device is working under battery power control and the battery power is less than or equal to 20% of the full battery power. Then the screen is displayed on the GUI.

[0162] Figure 31 This is a screenshot of the automatic MIE treatment start screen. If you have selected... Figure 29 The start button of the main automatic MIE treatment screen is turned on. At the same time, the respiratory therapy device is operating under battery power control and the battery power is greater than 20% of the full battery power. In response to the start of automatic MIE treatment, the start button is graphically converted into a pause button, and the automatic MIE treatment start screen is displayed on the GUI.

[0163] Figure 32 This is a screenshot of the Automatic MIE Treatment in Progress screen displayed on the GUI during an Automatic MIE treatment. The screen shows a graphical treatment progress indicator that moves along a graphical waveform throughout one cycle of treatment and displays graphics being filled into the progress indicator to indicate the amount of treatment cycle completed in the current treatment cycle.

[0164] Figure 33 This is a screenshot of the automatic MIE treatment pause screen, responding to... Figure 32 The pause button on the screen is pressed, and the screen is displayed on the GUI.

[0165] Figure 34 It is pressed Figure 33 After pressing the Restore button on the screen, a screenshot of the Restore Auto MIE Treatment screen that appears on the GUI shows that pressing the Restore button at the start of the cycle restarts the current treatment cycle.

[0166] Figure 35 This is a screenshot of another automatic MIE treatment screen during another cycle of automatic MIE treatment, showing that the respiratory therapy device is programmed to superimpose oscillations on the baseline pressure of the inhalation and exhalation portions of the automatic MIE treatment;

[0167] Figure 36 This is a screenshot of another automated MIE treatment screen during the final cycle of an automated MIE treatment cycle, which is similar to... Figure 35 The automatic MIE treatment cycle, but at the end of the cycle there is a positive pressure sighing period instead of a positive airway pressure (PAP) period;

[0168] Figure 37This is a screenshot of the first example of the automatic MIE treatment completion screen displayed on the GUI at the end of the automatic MIE treatment course. The first example of the MIE treatment completion screen displays various statistics and other information related to the automatic MIE treatment that has just been completed, including the sigh function indicating that the automatic MIE treatment has ended has been turned on.

[0169] Figure 38 This is a screenshot of the manual MIE treatment completion screen displayed on the GUI at the end of the manual MIE treatment course. The manual MIE treatment completion screen displays statistics and other information related to the manual MIE treatment that has just been completed, including an instruction to turn off the sigh function when the automatic MIE treatment is completed, and the manual MIE treatment completion screen displays vital data related to the patient's heart rate and blood oxygen saturation percentage.

[0170] Figure 39 It is similar to Figure 21 A screenshot of the menu screen displayed on the GUI in response to selection. Figure 29 The main automatic MIE treatment selection screen has a menu arrow icon on the right side, and the menu screen includes a vertical menu of icons;

[0171] Figure 40 This is a screenshot of a help menu screen that is displayed on the GUI in response to... Figure 39 The help or information icon selected on the menu screen, which includes a menu of buttons or icons, allows navigation to the help screen for automatic treatment, manual treatment, treatment overview, treatment options, and treatment modification;

[0172] Figure 41 This is a screenshot of the main automatic MIE treatment screen, which responds to... Figure 19 The main MIE treatment selection screen displays a manual button on the GUI;

[0173] Figure 42 This is a screenshot of the manual MIE treatment preparation screen, which is in response to... Figure 41 The start button selected on the main manual MIE treatment screen is displayed on the GUI. The start button on the manual MIE treatment preparation screen is changed to a stop button, and the inhalation and exhalation icons displayed during the manual MIE treatment preparation operation are grayed out.

[0174] Figure 43 This is a screenshot of the manual MIE therapy ready screen displayed on the GUI after the operation is complete. The manual MIE therapy ready screen has inhalation and exhalation icons that are lit up and ready for use, as well as a positive airway pressure (PAP) field that is lit up to indicate that PAP is being applied to the user's airway through the respiratory therapy device.

[0175] Figure 44 This is a screenshot of the manual MIE therapy inhalation screen, showing that when the user presses and holds the inhalation icon to deliver positive pressure to the user's lungs through the breathing therapy device, the inhalation icon is lit up and filled, the surrounding border is highlighted, and the exhalation icon and PAP field are grayed out when the user presses and holds the inhalation icon.

[0176] Figure 45 This is a screenshot of the manual MIE therapy inhalation release screen, showing that the inhalation and exhalation icons are lit up again and ready for use, and the PAP field is lit up again to indicate that PAP is once again applied to the user's airway through the respiratory therapy device.

[0177] Figure 46 This is a screenshot of the manual MIE therapy exhalation screen, showing that when the user presses and holds the exhalation icon to deliver negative pressure to the user's lungs through the breathing therapy device, the exhalation icon is lit up and filled, the surrounding border is highlighted, and the inhalation icon and PAP field are grayed out when the user presses and holds the exhalation icon.

[0178] Figure 47 This is a screenshot of the manual MIE treatment exhalation release screen, showing that the inhalation and exhalation icons are lit up again and ready for use, and the PAP field is lit up again to indicate that PAP is once again applied to the user's airway through the respiratory therapy device.

[0179] Figure 48 It is similar to Figure 44 Another screenshot of the manual MIE therapy inhalation screen shows that when the user presses and holds the inhalation icon again to deliver positive pressure to the user's lungs through the breathing therapy device, the inhalation icon lights up and fills in again, with the surrounding border highlighted to indicate the second cycle of mechanical inhalation.

[0180] Figure 49 This is a screenshot of the manual MIE inhalation pressure adjustment screen, which is displayed on the GUI in response to user selections. Figures 41-48 Below the inhalation button is an inhalation value icon. The manual inhalation pressure adjustment screen includes a graphical numeric keypad on which the user selects a new value for the inhalation pressure.

[0181] Figure 50 This is a screenshot of the manual MIE PAP pressure adjustment screen, which is displayed on the GUI in response to the user selecting a value that appears on the screen. Figures 41-48 Below the PAP field is the PAP value icon. The manual PAP pressure adjustment screen includes a graphical numeric keypad on which the user selects a new value for the PAP pressure.

[0182] Figure 51 This is a screenshot of the manual MIE call-out pressure adjustment screen, which is displayed on the GUI in response to user selections. Figures 41-48 Below the call-out button is a call-out value icon. The manual call-out pressure adjustment screen includes a graphical numeric keypad on which the user selects a new value for the call-out pressure.

[0183] Figure 52 This is a screenshot of the manual MIE shake to turn the screen on / off, which is displayed on the GUI in response to... Figure 41 The indicated shudder icon is selected. The manual MIE shudder on / off screen includes first, second, and third slider inputs, which are used to turn the shudder characteristics of the respiratory therapy device on and off for the inhalation, exhalation, and PAP sections of manual MIE therapy, respectively.

[0184] Figure 53 This is a screenshot of the first manual MIE shudder parameter adjustment screen, showing the default shudder pressure and shudder frequency values ​​filled in the corresponding fields of the inhalation portion of the manual MIE treatment in response to the first slider input being moved to the open position.

[0185] Figure 54 This is a screenshot of the second manual MIE shudder parameter adjustment screen, showing the default shudder pressure and shudder frequency values ​​filled in the corresponding fields of the exhalation section of manual MIE treatment, in response to the second slider input being moved to the open position.

[0186] Figure 55 This is a screenshot of the third manual MIE vibration parameter adjustment screen, showing the exhalation vibration pressure range that has been selected for adjustment, and displaying up arrows, down arrows, and save and cancel icons, which are lit up for adjusting exhalation vibration pressure.

[0187] Figure 56 This is a screenshot of the fourth manual MIE vibration parameter adjustment screen, showing the exhalation vibration pressure domain, which indicates the response to using... Figure 55 The new pressure value generated by the upward arrow icon increases the exhalation flutter pressure from the default flutter pressure of 1 cmH2O to the new exhalation flutter pressure of 8 cmH2O.

[0188] Figure 57 This is a screenshot of the fifth manual MIE vibration parameter adjustment screen, showing the selected... Figure 56 The fourth manual MIE vibration parameter adjustment screen save icon is followed by the new exhale vibration pressure;

[0189] Figure 58This is a screenshot of the sixth manual MIE vibration parameter adjustment screen, showing the inhalation vibration frequency domain selected for adjustment, and displaying up arrows, down arrows, and save and cancel icons, which are lit up for adjusting the exhalation vibration frequency domain.

[0190] Figure 59 This is a screenshot of the seventh manual MIE vibration parameter adjustment screen, showing the inhalation vibration frequency domain, which indicates the response to using Figure 58 The new frequency value generated by the upward arrow icon increases the inhalation vibration frequency from the default vibration frequency of 5 Hz to a new inhalation vibration frequency of 8 Hz.

[0191] Figure 60 This is a screenshot of the eighth manual MIE vibration parameter adjustment screen, showing the selection... Figure 59 After the save icon is displayed on the seventh manual MIE vibration parameter adjustment screen, the new inhalation vibration frequency in the corresponding field will be displayed.

[0192] Figure 61 This is a screenshot of the first manual MIE flow control adjustment screen, showing the... Figure 41 Once the flow button (which uses a wavy arrow to indicate a low level of airflow) is selected, the flow button uses two wavy arrows in the flow button to indicate a medium level of airflow in the respiratory therapy device.

[0193] Figure 62 This is a screenshot of the second manual MIE flow control adjustment screen, showing that... Figure 61 Once the flow button (which uses two wavy arrows to indicate a medium level of airflow) is selected, the flow button uses three wavy arrows in the flow button to indicate a high level of airflow from the respiratory therapy device;

[0194] Figure 63 This is a screenshot of the first automatic MIE flow control adjustment screen, showing the flow button indicating a low level of airflow from the respiratory therapy device using a wavy arrow in the flow button;

[0195] Figure 64 This is a screenshot of the second automatic MIE flow control adjustment screen, showing the selection... Figure 63 After the flow button, the flow button uses two wavy arrows to indicate a medium level of airflow from the breathing therapy device;

[0196] Figure 65 This is a screenshot of the third MIE automatic flow control adjustment screen, showing the selection... Figure 64 After the flow button, the flow button uses three wavy arrows to indicate the high level of airflow of the breathing therapy device;

[0197] Figure 66 In the selection Figure 39 Following the lung icon in the vertical menu of the icon, a screenshot of the first care plan screen for automated MIE treatment is displayed on the GUI. This first care plan screen for automated MIE treatment has treatment tabs selected for the first care plan, and parameter tables for the inhalation, exhalation, and PAP sections of the first care plan are displayed in the table.

[0198] Figure 67 Is Figure 66 After selecting the option tab on the first care plan screen, a screenshot of the second care plan screen for automated MIE treatment is displayed on the GUI. The second care plan screen has a first on / off slider input for the patient synchronization characteristics of the respiratory therapy device, radio buttons for selecting low, medium and high sensitivity of the synchronization characteristics, a second on / off slider input for the sigh function for automated MIE treatment, and a field for inputting the sigh pressure and duration of the sigh function.

[0199] Figure 68 It's a screenshot of the screen when the synchronization function is turned on, similar to... Figure 65 However, it has a synchronization function on icon below the inhalation portion of the graphical waveform of one cycle of automatic MIE treatment;

[0200] Figure 69 This is a screenshot of the automatic MIE treatment start screen, which is similar to... Figure 68 However, it shows that the synchronization function icon has been removed because user inhalation has been detected to start automatic MIE treatment, and the start button has been changed to a pause button;

[0201] Figure 70 This is a screenshot of the Breathing to Start Treatment screen, which is displayed on the GUI in response to the respiratory therapy device failing to detect the user's breathing for 10 seconds or more during the initiation of automatic MIE treatment. The Breathing to Start Treatment screen includes a patient synchronization icon that can be selected to adjust the sensitivity settings of the synchronization function.

[0202] Figure 71 This is a screenshot of the treatment pause screen if the breathing therapy device fails to detect breathing or the user does not select [a specific function / function]. Figure 70 The patient synchronization icon then displays the treatment pause screen on the GUI, or the screen appears in response to the user selecting the pause button during automatic MIE treatment. The treatment pause screen includes a resume button and a stop button. The resume button can be selected to resume automatic MIE treatment, and the stop button can be selected to completely stop automatic MIE treatment.

[0203] Figure 72This is a screenshot of the first automatic MIE sigh pressure parameter adjustment screen, showing the sigh pressure area selected for adjustment and display of the keyboard, up arrow, down arrow, save and cancel icons. These icons are lit up for adjusting sigh pressure.

[0204] Figure 73 This is a screenshot of the second MIE sigh pressure parameter adjustment screen, showing the selected... Figure 72 The graphical keyboard displayed on the GUI is followed by the keyboard icon. This graphical keyboard is used to change the sigh pressure from the default 5 cmH2O to 10 cmH2O.

[0205] Figure 74 This is a screenshot of the third automatic MIE sigh pressure parameter adjustment screen, showing the selected... Figure 73 After the save icon is displayed on the second automatic MIE sigh pressure parameter adjustment screen, the new sigh pressure in the corresponding field will be updated.

[0206] Figure 75 This is a screenshot of the exhalation vibration screen used for automated MIE treatment, which is similar to... Figure 68 However, it shows the exhalation portion of the first cycle of automated MIE treatment with fibrillation function during the exhalation portion of automated MIE treatment;

[0207] Figure 76 This is a screenshot of the inhalation and exhalation vibrating screen used for automated MIE therapy, which is similar to... Figure 68 and Figure 75 However, it displays the graphical representation of the inhalation and exhalation portions of the seventh cycle of automated MIE therapy with vibration during both the inhalation and exhalation portions. The automated MIE therapy inhalation and exhalation vibration screen also displays the user's peak cough flow (P). CF Data and tidal volume (Vt) values;

[0208] Figure 77 This is a screenshot of the first advanced viewing screen for automated MIE treatment, which responds to selection. Figure 39 The menu screen displays a vertical menu of graphical icons on the GUI. The first advanced viewing screen has a first graphic and a second graphic for automatic MIE treatment that are tracked approximately in real time during automatic MIE treatment. The first graphic tracks pressure changes over time in cmH2O, and the second graphic tracks airflow changes over time in liters per minute (LPM).

[0209] Figure 78This is a screenshot of the second advanced viewing screen used for automated MIE treatment. The screen responds to selection if the filter unit usage count is below a threshold number of uses and if the battery level is greater than 20% of full charge. Figure 77 The first advanced view screen displays the start button on the GUI, while the second advanced view screen shows the start button transformed into a pause button.

[0210] Figure 79 This is a screenshot of the Advanced MIE treatment completion screen, which responds to selection. Figure 78 The second advanced view screen displays a stop button on the GUI, and the advanced MIE treatment completion screen displays various statistics and other information related to automatic MIE treatment, roughly corresponding to... Figure 37 The screen is the same as the MIE treatment completion screen, but it also displays vital data related to the patient's heart rate and percentage of blood oxygen saturation.

[0211] Figure 80 It is similar to Figure 33 A screenshot of the treatment pause screen in response to... Figure 78 The second advanced view screen allows you to select the pause button while the treatment pause screen is displayed on the GUI;

[0212] Figure 81 This is a screenshot of the advanced view menu screen, responding to... Figure 77 The first advanced view screen is selected via the arrow icon on the right, and this advanced view menu screen is displayed on the GUI. This advanced view menu screen includes elements similar to... Figure 39 The icons are vertical menu icons, but the graphic icons are linked to a single graphic format for automated MIE treatment;

[0213] Figure 82 It is similar to Figure 29 Another screenshot of the main MIE auto-healing screen, in response to... Figure 81 The icon selection in the vertical menu displays another main MIE auto-treatment screen on the GUI, but this screen also displays vital data related to the patient's heart rate and blood oxygen saturation percentage;

[0214] Figure 83 This is a screenshot of the third advanced viewing screen used for automated MIE treatment, in response to... Figure 39 The menu screen displays icons for vertical menus, while the third advanced view screen is displayed on the GUI. The third advanced view screen is related to... Figure 77 The first advanced viewing screen is basically the same, but it has a patient synchronization icon on the pressure graph to indicate that the synchronization function of the respiratory therapy device has been enabled;

[0215] Figure 84It is used for automated MIE treatment and Figure 78 The fourth advanced view screenshot is essentially the same; if the filter unit is used less than the threshold number of times it is used, and if the battery level is greater than 20% of the full charge, then in response to... Figure 83 The third advanced viewing screen shows the start button selection, while a screenshot of the fourth advanced viewing screen is displayed on the GUI. The fourth advanced viewing screen shows that the start button has been changed to a pause button and displays the patient synchronization icon.

[0216] Figure 85 It is similar to Figure 70 A screenshot of the Breathing to Start Treatment screen is displayed on the GUI in response to the breathing therapy device failing to detect the user's breathing for 15 seconds or more during the initiation of advanced automated MIE treatment. The Breathing to Start Treatment screen includes a patient synchronization icon that can be selected to adjust the sensitivity settings of the synchronization function.

[0217] Figure 86 This is a screenshot of the fifth advanced viewing screen used for automated MIE treatment, which is roughly the same as... Figure 84 The fourth advanced viewing screen is the same, but it shows that the MIE treatment has progressed to the second treatment cycle of 7 total treatment cycles as shown in the upper right window of the screen, and also displays the peak cough flow (P). CF Numerical data for tidal volume (Vt);

[0218] Figure 87 It is a with Figure 71 A screenshot of a basically identical advanced MIE treatment pause screen, in response to... Figure 84 The fourth advanced view screen allows you to select the pause button, and the advanced MIE treatment pause screen is displayed on the GUI;

[0219] Figure 88 Is with Figure 67 A screenshot of a similar synchronization and sigh adjustment screen used for automated MIE treatment, in response to... Figure 85 The patient selects a synchronization icon and displays the synchronization and sigh adjustment screen on the GUI;

[0220] Figure 89 This is a screenshot of the screen where the plan name is entered, in response to... Figure 66 The first care plan screen selects a care plan label from the vertical menu shown on the left, and the plan name input screen is displayed on the GUI, which includes a graphical keyboard for entering the plan name of the selected care plan label;

[0221] Figure 90This is a screenshot of a screen with restricted access, in response to the clinical access function of the respiratory therapy device being turned off or disabled. Figure 66 The first care plan screen's edit button selection results in the GUI displaying a restricted access screen;

[0222] Figure 91 This is a screenshot of the treatment settings screen, taken in response to the clinical access function of the respiratory therapy device being turned on or enabled. Figure 66 The first care plan screen displays the edit treatment settings screen via the edit button selection;

[0223] Figure 92 This is the first screenshot of the modified treatment screen, in response to the... Figure 91 The first modification treatment screen is displayed on the GUI by selecting the modification button on the edit treatment settings screen. The first modification treatment screen shows that the inhalation portion of cycle 1 of the automatic MIE treatment plan 1 is selected for parameter adjustment, as indicated by highlighting the first radio button of a group of first, second and third radio button groups.

[0224] Figure 93 This is a screenshot of the second modified treatment screen, which is displayed on the GUI in response to selecting the second radio button from the first, second, and third radio button groups. The second radio button corresponds to the exhalation portion of the selected cycle and the automatic MIE treatment plan number.

[0225] Figure 94 This is a screenshot of the third modified treatment screen, which is displayed on the GUI in response to selecting the third radio button from the first, second, and third radio buttons. The third radio button corresponds to the PAP section of the selected cycle and the plan number of the automatic MIE treatment.

[0226] Figure 95 This is the fourth screenshot of the modified treatment screen, in response to the one already shown. Figure 92 The first treatment modification screen selects the inhalation duration field for adjustment, while the fourth treatment modification screen is displayed on the GUI, which shows an illuminated keyboard, up arrow, down arrow, save and cancel icons for adjustment within the inhalation duration;

[0227] Figure 96 In the selection Figure 95 The screenshot shows the fifth modification treatment screen displayed on the GUI after the keyboard icon, which is used to change the inhalation duration from 2.8 seconds (e.g., ...). Figure 95 (As shown) changed to 3.0 seconds;

[0228] Figure 97This is a screenshot of the sixth modified treatment screen, in the selection... Figure 96 After the fifth modified treatment screen displays the save icon, the sixth modified treatment screen displays the new inhalation duration in the corresponding field;

[0229] Figure 98 This is a screenshot of the seventh modified treatment screen, in response to... Figure 92 The first modification to the treatment screen is the inhalation basal pressure domain or Figure 97 The sixth modification pressure screen displays the inhalation basal pressure field, while the seventh modification treatment screen is displayed on the GUI, and this screen shows a lit keyboard, up arrow, down arrow, save and cancel icons for adjusting the inhalation basal pressure;

[0230] Figure 99 In the selection Figure 98 The screenshot of the eighth modified treatment screen displayed on the GUI after the keyboard icon shows the current inhalation baseline pressure value and the graphical keyboard;

[0231] Figure 100 Is Figure 99 The graphical keyboard was used to adjust the inhalation baseline pressure from 48 cmH2O (e.g.) Figures 97-99 (As shown) After changing to 50 cmH2O, a screenshot of the ninth modified treatment screen displayed on the GUI;

[0232] Figure 101 This is a screenshot of the tenth modified treatment screen, which shows the screen after selecting... Figure 100 The new inhaled basal pressure in the corresponding field after the save icon of the ninth modified treatment screen;

[0233] Figure 102 This is the eleventh screenshot of the modified treatment screen, in response to... Figure 93 The second modified treatment screen displays the exhalation vibration frequency domain on the GUI, while the eleventh modified treatment screen is displayed. The second modified treatment screen displays a keyboard, an up arrow, a down arrow, and save and cancel icons, which are used to adjust the vibration frequency.

[0234] Figure 103 In the selection Figure 102 The screenshot shows the twelfth modification treatment screen displayed on the GUI after the keyboard icon, which is used to change the exhalation vibration frequency from 15Hz (e.g., ...). Figure 93 and 102 (As shown) Change to 12Hz;

[0235] Figure 104 This is a screenshot of the thirteenth modified treatment screen, showing the selection... Figure 103After modifying the save icon of the treatment screen for the twelfth time, the new exhalation vibration frequency in the corresponding field;

[0236] Figure 105 This is a screenshot of the fourteenth modified treatment screen, which responds to... Figure 93 The second modification to the treatment screen's exhalation flutter pressure domain or Figure 104 The thirteenth modification pressure screen displays the exhalation vibration pressure field, while the fourteenth modification treatment screen is displayed on the GUI, and the screen displays a keyboard, up arrow, down arrow, save and cancel icons, which are lit up to adjust the exhalation vibration pressure;

[0237] Figure 106 In the selection Figure 105 The keyboard icon is followed by a screenshot of the fifteenth modification treatment screen displayed on the GUI, which shows the current exhalation flutter pressure value and the graphical keyboard;

[0238] Figure 107 This is a screenshot of the sixteenth modified treatment screen. Figure 106 The graphical keyboard was used to control the exhalation vibration pressure from 10 cmH2O (e.g. Figure 93 and 104 After changing (as shown in -106) to 8 cmH2O, the sixteenth modified treatment screen is displayed on the GUI;

[0239] Figure 108 This is a screenshot of the seventeenth modified treatment screen, which shows the screen after selecting... Figure 107 After modifying the save icon on the treatment screen for the sixteenth time, the new exhaled flutter pressure in the corresponding field;

[0240] Figure 109 This is a screenshot of the deleted periodic screen, responding to the respective... Figures 92-94 Select the delete button on the first, second, or third modified treatment screen and display the delete cycle screen on the GUI. The delete cycle screen has a continue button that can be selected to delete the selected cycle and a cancel button that can be selected to exit the deletion and return to the previous screen.

[0241] Figure 110 It adds a screenshot of the cycle screen, responding to the screen. Figure 108 The seventeenth modification involves selecting an "Add Cycle" button on the treatment screen, which then displays the "Add Cycle" screen on the GUI.

[0242] Figure 111 This is a screenshot of the empty preset screen. If you select... Figure 19 If the Auto button on the main MIE treatment selection screen is not pressed and no parameters are entered to operate the care plan for automatic MIE treatment, then the empty preset screen will be displayed on the GUI.

[0243] Figure 112 This is a screenshot of the screen for creating a care plan. The arrow icon on the right side of the selected empty preset screen indicates the view is open. Figure 39 The vertical menu of the icon shown is roughly the same as the vertical menu of the icon, and after selecting the lung icon from the vertical menu of the icon, the Create Care Plan screen is displayed on the GUI, which has a Create button that can be selected to create a new care plan;

[0244] Figure 113 This is a screenshot of a screen with restricted access, in response to the selection if the clinical access function of the respiratory therapy device is turned off or disabled. Figure 112 The Create button on the Create Care Plan screen is displayed on the GUI as an access-restricted screen;

[0245] Figure 114 This is a screenshot of the first newly created treatment screen, in response to the selection if the clinical access function of the respiratory therapy device is turned on or enabled. Figure 112 The Create a Care Plan screen has a Create button, and the first Create a New Treatment screen is displayed on the GUI. The first Create a New Treatment screen shows that the inhalation portion of cycle 1 of plan 1 for automated MIE treatment is selected for parameter adjustment, and it has parameter fields filled with default parameter settings.

[0246] Figure 115 This is a screenshot of the second screen created to initiate the new treatment process. Figure 114 On the first Create a New Treatment screen, select the Complete button and the second Create a New Treatment screen will be displayed on the GUI. The second Create a New Treatment screen has the treatment labels selected for the new care plan, and the default parameter table for the inhalation, exhalation and PAP sections of the new care plan will be displayed in the table.

[0247] Figure 116 Is with Figure 31 A similar screenshot of the first new automatic MIE treatment start screen, if selected Figure 115 If the second start button for creating a new treatment screen is pressed, and the breathing therapy device is operating under battery power control and the battery power is greater than 20% of the full battery power, then the first new automatic MIE treatment start screen is displayed on the GUI. The first new automatic MIE treatment start screen displays a graph with the default parameters and a pause button that can be selected to pause the treatment.

[0248] Figure 117 This is a screenshot of the second new automatic MIE treatment start screen, similar to... Figure 116 If you choose Figure 115The second new automatic MIE treatment start screen is displayed on the GUI by the back button of the second new treatment screen. The second new automatic MIE treatment start screen displays a graph with default parameters and has a start button that can be selected to start the treatment.

[0249] Figure 118 This is a screenshot of the treatment settings screen. If the clinical access function of the respiratory therapy device is turned on or enabled, it will respond to the selection. Figure 66 or Figure 115 The second option is to create an edit button for the new treatment screen, which then displays the edit treatment settings screen on the GUI.

[0250] Figure 119 This deletes the screenshot of the preset screen, responding to... Figure 118 On the edit new treatment settings screen, select the delete button, and the delete preset screen will be displayed on the GUI. This delete preset screen has options to delete individual settings separately. Figure 115 or Figure 66 The table shows the continue button for the preset items, and the option to exit deletion and return respectively. Figure 66 or Figure 115 The cancel button on the screen;

[0251] Figure 120 It is similar to Figure 29 Screenshot of the alternative main MIE auto-treatment screen, in response to selection Figure 19 The main MIE treatment selection screen has an automatic button, while the alternative main MIE automatic treatment screen is displayed on the GUI. However, this screen has a foot switch control area with plus and minus indicators, which are highlighted to indicate the status of the input from the foot switch control of the respiratory therapy device.

[0252] Figure 121 This is a screenshot of the main automatic OLE treatment screen, responding to selection. Figure 20 The main OLE treatment selection screen has an auto button, and the main auto OLE treatment screen is displayed on the GUI. The main auto OLE treatment screen shows a treatment duration clock, which indicates the length of time the selected auto OLE treatment is programmed.

[0253] Figure 122 This is a screenshot of the automatic OLE treatment start screen. (If you selected...) Figure 121 The start button on the main automatic OLE treatment screen of the respiratory therapy device, when the respiratory therapy device is operating under battery power control and the battery power is greater than 20% of the full battery power, and in response to the start of automatic OLE treatment, the automatic OLE treatment start screen is displayed on the GUI, and the start button is graphically converted into a pause button that can be selected to pause the treatment.

[0254] Figure 123 This is a screenshot of the first automatic OLE treatment in progress screen displayed on the GUI during an automatic OLE treatment. The screen shows a graphical treatment progress indicator moving along a graphical waveform of the treatment, showing the graph being filled into the progress indicator to indicate the amount of treatment currently completed, and a treatment duration clock that counts down from the initial value.

[0255] Figure 124 This is a screenshot of the second automatic OLE treatment in progress screen displayed on the GUI during automatic OLE treatment, which is similar to... Figure 123 However, it displays a progress indicator from the CPEP section of the treatment to the CHFO section, and shows a treatment duration clock that further counts down;

[0256] Figure 125 This is a screenshot of the automatic OLE therapy pause screen, responding to a press. Figure 123 screen or Figure 124 The pause button on the screen is displayed on the GUI, indicating the automatic OLE treatment pause screen.

[0257] Figure 126 This is a screenshot of the cough pause screen. If the cough pause function of the respiratory therapy device is enabled and the interval between cough pauses has been reached, the cough pause screen is displayed on the GUI in response to the appearance of the cough pause portion of the automatic OLE therapy.

[0258] Figure 127 This is a screenshot of the third automatic OLE treatment in progress screen displayed on the GUI during automatic OLE treatment, which is related to... Figure 124 Similarly, but it shows that the progress indicator has advanced to the last CHFO section of the automated OLE treatment, and the clock showing the treatment duration is nearing the end of the countdown;

[0259] Figure 128 This is a screenshot of the first example of the automatic OLE treatment completion screen displayed on the GUI at the end of the automatic OLE treatment course. The first example of the OLE treatment completion screen displays various statistics and other information related to the automatic OLE treatment that has just been completed, including the nebulizer duration, which indicates the amount of time the nebulizer was on during the automatic OLE treatment.

[0260] Figure 129 This is a screenshot of the first advanced view screen for automatic OLE treatment, responding to selection and... Figure 39The menu screen displays icons that are roughly the same as the vertical menu icons, while the GUI displays a screenshot of the first advanced viewing screen. The first advanced viewing screen has a first graphic and a second graphic for automatic OLE treatment, which are tracked approximately in real time during automatic OLE treatment. The first graphic is used to track pressure changes over time in cmH2O, and the second graphic is used to track airflow changes over time in liters per minute (LPM).

[0261] Figure 130 This is a screenshot of the second advanced viewing screen used for automatic OLE treatment. It responds to selection if the filter unit usage count is below the usage threshold and if the battery level is greater than 20% of full charge. Figure 129 The first advanced view screen displays the start button, while the second advanced view screen is displayed on the GUI, showing the start button transformed into a pause button;

[0262] Figure 131 This is a screenshot of a second example of the automatic OLE treatment completion screen displayed on the GUI at the end of an automatic OLE treatment session. The second example of the automatic OLE treatment completion screen displays statistics and other information related to the automatic OLE treatment that has just been completed, including displaying the nebulizer duration and vital data related to the patient's heart rate and percentage of blood oxygen saturation.

[0263] Figure 132 It is similar to Figure 126 A screenshot of the second cough pause screen, which is displayed on the GUI in response to the occurrence of the cough pause portion of automatic OLE therapy if the cough pause function of the respiratory therapy device is enabled and if the interval for cough pause to occur is reached.

[0264] Figure 133 This is a screenshot of the alternative main automatic OLE therapy screen, in response to selection. Figure 20 The main OLE treatment selection screen has an automatic button, while the alternative main automatic OLE treatment screen is displayed on the GUI. The alternative main automatic OLE treatment screen displays the spray section of the automatic OLE treatment, which is programmed to perform between the first CHFO section and the second CPEP section of the treatment.

[0265] Figure 134 This is a screenshot of the first care plan screen for automated OLE therapy, after selecting with... Figure 39The menu screen displays icons that are roughly the same as the vertical menu icons for the lungs. After the lung icons, the first care plan screen is displayed on the GUI. The first care plan screen for automated OLE treatment has treatment labels for selection for the first care plan, and parameter tables for the various CPEP, CHFO and nebulizer (NEB) stages of the first care plan are displayed in the table.

[0266] Figure 135 This is a screenshot of a screen with restricted access, in response to the selection if the clinical access function of the respiratory therapy device is turned off or disabled. Figure 134 The edit button on the first care plan screen is displayed on the GUI, but the access-restricted screen is shown instead.

[0267] Figure 136 This is a screenshot of the treatment settings screen, taken in response to the selection if the clinical access function of the respiratory therapy device is turned on or enabled. Figure 134 The first care plan screen has an edit button, while the GUI displays the edit treatment settings screen;

[0268] Figure 137 This is the first screenshot of the modified treatment screen, in response to... Figure 136 Select the Modify button on the Edit Treatment Settings screen and the first Modify Treatment screen will be displayed on the GUI. The first Modify Treatment screen shows the CPEP section of Phase 1 of the Automatic OLE Treatment Plan 1 selected for parameter adjustment, as shown by zooming in on a set of horizontally arranged, overlapping Phase 1 tiles in the top area of ​​the first Modify Treatment screen.

[0269] Figure 138 This is a screenshot of the second modified treatment screen, in response to... Figure 137 The first modification treatment screen displays the horizontal arrangement and overlapping tiles of the Phase 2 tile selection on the GUI, and the second modification treatment screen displays the CHFO part of Phase 2 of the selected automatic OLE treatment plan 1 for parameter adjustment, as shown by enlarging the Phase 2 tile.

[0270] Figure 139 This is a screenshot of the third modified treatment screen, in response to selection. Figure 138 The second modified treatment screen displays horizontally arranged, overlapping stage 3 tiles, while the third modified treatment screen is displayed on the GUI. The third modified treatment screen displays the NEB portion of stage 3 of the selected automatic OLE treatment plan 1 for parameter adjustment, as shown by enlarging the stage 3 tiles.

[0271] Figure 140 This is a screenshot of the second care plan screen used for automated OLE therapy. Figure 134After selecting an option tab on the first care plan screen, the second care plan screen is displayed on the GUI. The second care plan screen has a first on / off slider input for turning the cough pause function of the respiratory therapy device on and off, and has fields for inputting the cough pause interval and cough pause duration.

[0272] Figure 141 This is a screenshot of the cough pause settings screen for automatic OLE treatment, which is similar to... Figure 140 However, it shows that the slider is moved to the open position, and during automatic OLE treatment, the cough pause interval is set to start once every 5 minutes, and the duration of each cough pause is set to 40 seconds.

[0273] Figure 142 This is the fourth screenshot of the modified treatment screen, in response to selection. Figure 141 The cough pause settings screen allows for adjustment of the cough pause interval, while the fourth modification treatment screen is displayed on the GUI, showing a lit keyboard, up arrow, down arrow, save and cancel icons for adjusting the cough pause interval.

[0274] Figure 143 In the selection Figure 142 The screenshot of the fifth modification treatment screen displayed on the GUI after the keyboard icon shows that the graphical keyboard can be used to change the cough pause interval value to a new value;

[0275] Figure 144 This is a screenshot of the sixth modified treatment screen, in response to selection. Figure 141 The cough pause settings screen has a cough pause duration field for adjustment, and the sixth modified treatment screen is displayed on the GUI. The sixth modified treatment screen displays a lit keyboard, an up arrow, a down arrow, and save and cancel icons for adjusting the cough pause duration.

[0276] Figure 145 This is a screenshot of the seventh modified treatment screen, in the selection... Figure 142 The keyboard icon is then displayed on the GUI as the seventh modification treatment screen, which can be used to change the cough pause duration value to a new value;

[0277] Figure 146 This is a screenshot of the eighth modified treatment screen, in response to selection. Figure 138 The second modified treatment screen displays the reference pressure domain on the GUI, while the eighth modified treatment screen is displayed. The second modified treatment screen displays an illuminated keyboard, an up arrow, a down arrow, and save and cancel icons for adjusting the reference pressure.

[0278] Figure 147 In the selection Figure 146 A screenshot of the ninth modification treatment screen that appears after the keyboard icon; this graphical keyboard can be used to change the base pressure to a new value.

[0279] Figure 148 This is a screenshot of the tenth modified treatment screen, in response to selection. Figure 138 The second modified treatment screen displays the duration field for adjustment on the GUI, and the tenth modified treatment screen displays a lit keyboard, an up arrow, a down arrow, and save and cancel icons for adjusting the duration.

[0280] Figure 149 In the selection Figure 148 The screenshot of the eleventh modification treatment screen displayed after the keyboard icon on the GUI shows that the graphical keyboard can be used to change the duration value to a new value;

[0281] Figure 150 This is a screenshot of the screen during the deletion phase, in response to... Figures 137-139 The user selects the delete button on the first, second, or third treatment screen to display the deletion stage screen on the GUI. The deletion stage screen has a continue button that can be selected to delete the selected stage and a cancel button that can be selected to exit the deletion and return to the previous screen.

[0282] Figure 151 This is a screenshot of the twelfth modified treatment screen, in response to selection. Figure 150 The Continue button is displayed on the GUI, and the twelfth modified treatment screen shows that the CPEP stage has been removed from the stage corresponding to stage 1, and CHFO, which used to be stage 2 of automatic OLE treatment, now corresponds to stage 1 of automatic OLE treatment.

[0283] Figure 152 This is a screenshot of the next stage screen, in response to the selection. Figures 137-139 The various modifications to the treatment screen of 151 display the Add / Next Stage button, while the GUI displays the Next Stage screen, which is initially a repetition of the stage selected by the Add / Next Stage button;

[0284] Figure 153 This is a screenshot of the stage menu screen, responding to selection. Figures 137-139 The various modifications to the treatment screens in 151 and 152 include the downward arrow icon for the treatment section labels, which is then displayed on the GUI as the stage menu screen. This stage menu screen includes the CPEP, CHFO, and NEB options listed in the results menu.

[0285] Figure 154 This is a screenshot of the screen changing in phase 2, in response to selection. Figure 153The CHFO option on the menu changes the automatic OLE treatment phase 2 from the CPEP phase to the CHFO phase, and displays the phase 2 change screen on the GUI.

[0286] Figure 155 This is a screenshot of the stage 3 screen, responding to... Figure 154 Swiping left on the stage 2 tile will display the stage 3 screen on the GUI. Figure 155 The Stage 3 screen displays the current Stage 3 settings for the automatic OLE treatment;

[0287] Figure 156 This is a screenshot of another level of menu screen, which is roughly the same as... Figure 153 The stage menu screen is the same, but responds to selection Figure 155 The Stage 3 screen is displayed with a down arrow icon on the GUI, and also includes the CPEP, CHFO, and NEB options listed on the results screen;

[0288] Figure 157 This is a screenshot of the screen changing in stage 3, in response to selection. Figure 156 The NEB option on the menu changes the automatic OLE treatment stage 3 from the CHFO stage to the NEB stage, and the stage 3 change screen is displayed on the GUI.

[0289] Figure 158 It is similar to automated OLE therapy. Figure 134 Another screenshot of the first care plan screen, in the selection Figure 157 After the "Complete" button appears on the Phase 3 change screen, a screenshot of the other "First Care Plan" screen is displayed on the GUI. Figure 158 The automated OLE treatment first care plan screen has a table displaying the parameters of each CPEP, CHFO and NEB phase of the first care plan, including the phases and parameters that have changed.

[0290] Figure 159 This is a screenshot of a blank preset screen. If you selected [the option] from the vertical menu of icons... Figure 39 If the menu screen displays the lung icon and no parameters are entered for any care plan to operate the automatic OLE treatment, then the empty preset screen will be displayed on the GUI.

[0291] Figure 160 This is a screenshot of the first newly created treatment screen, in response to the selection if the clinical access function of the respiratory therapy device is turned on or enabled. Figure 159The empty preset screen creation button is displayed on the GUI. The first creation of a new treatment screen shows that the CPEP stage is the default stage of stage 1 of the automatic OLE treatment plan, and displays the parameter field filled with the default parameter settings, and shows that the sprayer is turned on.

[0292] Figure 161 This is a screenshot of the second screen created in response to the creation of a new treatment screen. Figure 160 The first screen for creating a new treatment displays a "Complete" button, while the second screen for creating a new treatment is displayed on the GUI. This second screen allows selection of treatment tabs for new treatment plans. Figure 160 The first parameter table for the CPEP stage is entered on the screen to create a new treatment;

[0293] Figure 162 This is a screenshot of the first new automatic OLE treatment start screen. (If you selected...) Figure 161 The second new treatment screen start button is created while the respiratory therapy device is operated under the control of the battery power. If the battery power is less than 20% of the full battery power, the first new automatic OLE treatment start screen is displayed on the GUI. The first new automatic OLE treatment start screen displays a graphic indicating the default parameters and a start button. Even though the battery power is less than 20%, the start button to start the treatment can still be selected.

[0294] Figure 163 This is a screenshot of the second new automatic OLE treatment start screen. (If you selected...) Figure 161 The second new automatic OLE treatment start screen is displayed on the GUI when the respiratory therapy device is operated under the control of the battery power and the battery power is greater than 20% of the full battery power. The second new automatic OLE treatment start screen displays a graphic with indicators of default parameters and a pause button that can be selected to pause the treatment that has started.

[0295] Figure 164 This is a screenshot of the screen for editing new treatment settings, in response to selection. Figure 161 The second option is to create a new treatment screen with an edit button, which then displays the new treatment settings screen on the GUI.

[0296] Figure 165 This deletes the screenshot of the preset screen in response to selection. Figure 164 The delete preset screen is displayed on the GUI and includes a continue and cancel button. The continue button allows you to select whether to delete the preset. Figure 161 The second screen for creating a new treatment displays the presets in a table. A cancel button is available to exit deletion and return. Figure 161The second step is to create a new treatment screen;

[0297] Figure 166 This is a screenshot of the main manual OLE treatment screen, responding to selection. Figure 20 The main OLE treatment selection screen has a manual button, and the main manual OLE treatment screen is displayed on the GUI;

[0298] Figure 167 This is a screenshot of the manual OLE treatment preparation screen, responding to selection. Figure 166 The start button on the main manual OLE treatment screen is replaced by the manual OLE treatment preparation screen displayed on the GUI. The manual OLE treatment preparation screen shows that the start button has been changed to a stop button, and the CPEP and CHFO pressure parameters are displayed in gray during the manual OLE treatment preparation operation.

[0299] Figure 168 This is a screenshot of the manual OLE treatment ready screen, which is displayed on the GUI after the preparation operation. The manual OLE treatment ready screen has the CPEP and CHFO parameters lit up.

[0300] Figure 169 This is a screenshot of the CPEP activation screen for manual OLE therapy. It shows that after the user presses the CPEP icon to deliver CPEP to the user's lungs via the breathing therapy device, the CPEP icon is lit up and filled with a highlighted border. It also shows that during the delivery of CPEP to the user's lungs, the CHFO icon and nebulizer area are displayed in gray.

[0301] Figure 170 This is a screenshot of manually turning off CPEP during OLE treatment. It shows the CPEP and CHFO icons indicating the off state and the user pressing them. Figure 169 The CPEP icon is available after CPEP delivery is turned off, and it is displayed after the user presses the nebulizer icon to deliver nebulized medication to the user's lungs through the respiratory therapy device. The nebulizer icon in the nebulizer field is lit up and filled with a highlighted surrounding border.

[0302] Figure 171 This is a screenshot of manual OLE treatment of CHFO. It shows that after the user presses the CHFO icon to deliver CHFO to the user's lungs through the respiratory therapy device, the CHFO icon is lit up and filled with a highlighted border to indicate that the nebulizer is still on. It also shows that the CPEP icon is grayed out while CHFO and nebulized medication are being delivered to the user.

[0303] Figure 172This is a screenshot of the screen showing the CPEP and CHFO icons indicating that the device is off when the user presses the button. Figure 171 The CHFO icon is available after the CHFO delivery is turned off, and the sprayer icon in the sprayer field is lit up and filled with the highlighted border to indicate that the sprayer is still on;

[0304] Figure 173 This is a screenshot of the manual OLE CPEP pressure adjustment screen, displayed in response to user selection. Figures 168-172 The CPEP value field is located below the CPEP button, and the manual OLE CPEP pressure adjustment screen is displayed on the GUI. The manual CPEP pressure adjustment screen includes a graphical numeric keypad on which the user selects a new value for the CPEP pressure.

[0305] Figure 174 This is a screenshot of the manual OLE CHFO pressure adjustment screen, displayed in response to user selection. Figures 168-172 The CHFO value field is located below the CHFO button, and the manual CHFO pressure adjustment screen is displayed on the GUI. The manual CHFO pressure adjustment screen includes a graphical numeric keypad on which the user selects a new value for the CHFO pressure.

[0306] Figure 175 This is a screenshot of the CHFO frequency selection screen, which is displayed on the GUI in response to the user selecting the frequency icon that appears below the CHFO button and the CHFO value field. The CHFO frequency selection screen has low, medium, and high frequency buttons that can be used to set the CHFO frequency.

[0307] Figure 176 It is roughly the same as Figure 22 The same settings screen screenshot, responding to various OLE screens (such as...) Figure 134 , 140 The menu selection icon (those of 141, 158, 159, and 161) displays the settings screen on the GUI, which includes a device information window related to the respiratory therapy device.

[0308] Figure 177 This is a screenshot of the data screen, responding to selection. Figure 22 or Figure 176 The selected settings screen's data buttons are displayed on the GUI. The data screen includes buttons for viewing and exporting treatment logs, importing and exporting device settings, viewing and exporting error logs, upgrading firmware, and importing health level 7 (HL7) information. All buttons except the treatment log check button and the error log check button are grayed out.

[0309] Figure 178 It is a screenshot of the connected screen, responding to selection. Figure 22 or Figure 176 The connection screen is set up with a connection button, and the connection screen is displayed in the GUI. The connection screen has Bluetooth and WiFi tags. The Bluetooth tag is selected, and there is a Bluetooth slider for turning the Bluetooth function of the respiratory therapy device on and off.

[0310] Figure 179 It is a screenshot of the device screen, responding to... Figure 22 or Figure 176 The device settings screen has a device button and is displayed on the GUI. The device screen has date-time, language, and control labels. The date-time label is selected and has user input for setting the date and time of the respiratory therapy device.

[0311] Figure 180 This is a screenshot of the language screen, responding to the selection. Figure 179 The language label on the device screen is displayed on the GUI, and the language screen has language labels for the respiratory therapy device. Figure 18-274 The screen displays text information in one or more languages, and includes language buttons.

[0312] Figure 181 This is a screenshot of the control screen, responding to selection. Figure 179 The device screen displays a control screen on the GUI, which includes a slider for adjusting screen brightness, a barcode slider for turning the barcode reading function of the respiratory therapy device on and off, a clinical access slider for turning the clinical access function of the respiratory therapy device on and off, and up and down arrows for setting the pressure limit of the respiratory therapy device.

[0313] Figure 182 This is a screenshot of the screen that edits the date and time, in response to selection. Figure 179 The device screen displays a date-time modification button, while the GUI displays a date-time modification screen with a table that allows selection of time zones.

[0314] Figure 183 This is a screenshot of the language confirmation screen, in response to the selection. Figure 180 The language button is displayed on the language screen, and the confirmation language screen is shown on the GUI.

[0315] Figure 184This is a screenshot of the first access advanced features screen, which is displayed on the GUI in response to an attempt to move the clinical access slider from the off position to the on position. The first access advanced features screen has a graphical numeric keypad for entering key codes to unlock access to advanced features.

[0316] Figure 185 This is a screenshot of the second advanced features screen, which is roughly the same as... Figure 184 The same, but shows that the key codes have been entered into the key code fields using a graphical numeric keypad;

[0317] Figure 186 This is a screenshot of the screen that opens during clinical visits, and it is roughly the same as... Figure 181 The same, but it shows the response after a valid key code is entered in the key code field, in response to selection. Figure 185 The second access advanced features screen input button moves the clinical access slider to the open position;

[0318] Figure 187 It is similar to Figure 177 A screenshot of the screen that supports import / export / upgrade is shown, but the import, export, and upgrade buttons are no longer grayed out to indicate that the respiratory therapy device is successfully communicating with one or more external devices, enabling the import, export, and upgrade functions. Successful communication with external devices is also displayed in the storage stick icon at the top of the screen that supports import / export / upgrade.

[0319] Figure 188 This is a screenshot of the loading screen, responding to selection. Figure 187 The loading screen is displayed on the GUI and indicates that the respiratory therapy device is checking to confirm that the external device has sufficient memory to receive the treatment log, device settings or error log data to be exported.

[0320] Figure 189 This is a screenshot of an out-of-memory screen. This out-of-memory screen is displayed on the GUI if the external device does not have enough memory to receive the treatment logs, device settings, or error log data to be exported.

[0321] Figure 190 This is a screenshot of the pressure limit confirmation screen. If the clinical access function of the respiratory therapy device is turned on or enabled, it responds to the selection... Figure 187 The device settings import button is displayed on the GUI, showing a confirmation screen for the pressure limit.

[0322] Figure 191 This is a screenshot of the first error log check screen, in response to the selection. Figure 177 or Figure 187The error log check button is used to display the first error log check screen on the GUI, which has a list of the dates and times of the most recent errors in the respiratory therapy device;

[0323] Figure 192 This is a screenshot of the second error log check screen, in response to... Figure 191 The first error log check screen selects an error log date and time from the list, and the second error log check screen is displayed on the GUI. The second error log check screen displays the error code corresponding to the selected error log date and time.

[0324] Figure 193 This is a screenshot of the first treatment log check screen, in response to selection. Figure 177 or Figure 187 The treatment log check button is displayed on the GUI, and the first treatment log check screen has a list of the dates and times of the most recent treatments using the respiratory therapy device.

[0325] Figure 194 This is a screenshot of the second treatment log check screen, in response to... Figure 193 Select a treatment log date and time from the list on the first error log review screen and the second treatment log check screen will be displayed on the GUI. The second treatment log check screen displays treatment information corresponding to the selected treatment log date and time.

[0326] Figure 195 This is a screenshot of the alternative second treatment log check screen, which is similar to Figure 194 However, since the list of recent treatments shows fewer than seven recent treatments, but the scroll icon is omitted;

[0327] Figure 196 This is a screenshot of the treatment log export in progress screen. The treatment log export in progress screen is displayed on the GUI after the respiratory therapy device confirms that the external device has sufficient memory to receive the treatment log data and starts the treatment log export process.

[0328] Figure 197 This is a screenshot of the treatment log export completion screen, which is displayed on the GUI after the treatment log data has been exported to an external device.

[0329] Figure 198 This is a screenshot of the treatment log export interruption screen, which is displayed on the GUI if any interruption occurs during the treatment log export process.

[0330] Figure 199This is a screenshot of the "Device settings export in progress" screen. After the respiratory therapy device confirms that the external device has sufficient memory to receive the device settings data and starts the device settings export process, the "Device settings export in progress" screen is displayed on the GUI.

[0331] Figure 200 This is a screenshot of the screen showing the completion of the device settings export. After the device settings data is exported to an external device, this screen is displayed on the GUI.

[0332] Figure 201 This is a screenshot of the device settings export interruption screen. If any interruption occurs during the device settings export process, the device settings export interruption screen will be displayed on the GUI.

[0333] Figure 202 This is a screenshot of the error log export in progress screen. After the respiratory therapy device confirms that the external device has sufficient memory to receive the error log data and starts the error log export process, the error log export in progress screen is displayed on the GUI.

[0334] Figure 203 This is a screenshot of the error log export completion screen, which is displayed on the GUI after the error log is exported to an external device.

[0335] Figure 204 This is a screenshot of the error log export interruption screen, which is displayed on the GUI if any interruption occurs during the error log export process.

[0336] Figure 205 Is with Figure 190 The same screenshot as the original;

[0337] Figure 206 This is a screenshot of the device settings import in progress screen. After the respiratory therapy device confirms that it has enough memory to receive device settings data and starts the device settings import process, the device settings import in progress screen is displayed on the GUI.

[0338] Figure 207 This is a screenshot of the screen showing the completion of device settings import. After the device settings data has been imported from the external device into the respiratory therapy device, this screen is displayed on the GUI.

[0339] Figure 208 This is a screenshot of the device settings import interruption screen. If any interruption occurs during the device settings import process, the device settings import interruption screen will be displayed on the GUI.

[0340] Figure 209This is a screenshot of the screen when the AC power is connected. If the AC power is not already connected to the respiratory therapy device, it will respond in response to the selection. Figure 187 The upgrade button is displayed on the GUI screen indicating the AC power connection;

[0341] Figure 210 This is a screenshot of the firmware download in progress, showing the selection screen. Figure 177 or Figure 187 After clicking the upgrade button and confirming that the respiratory therapy device is connected to AC power, a screen appears on the GUI indicating that the firmware download is in progress.

[0342] Figure 211 This is a screenshot of the firmware download completion screen, which is displayed on the GUI after the new firmware is downloaded from the external device to the respiratory therapy device.

[0343] Figure 212 This is a screenshot of the firmware download interruption screen, which is displayed on the GUI if any interruption occurs during the firmware download process.

[0344] Figure 213 This is a screenshot of the firmware upgrade file presentation screen, which is displayed on the GUI in response to connecting a thumb drive containing a valid firmware upgrade file stored in memory to the Display Control Board (DCB) Universal Serial Bus (USB) port of the respiratory therapy device.

[0345] Figure 214 This is a screenshot of the HL7 file display screen, which is displayed on the GUI in response to connecting a thumb drive with a valid HL7 file stored in memory to the main control board (MCB) USB port of the respiratory therapy device;

[0346] Figure 215 This is a screenshot of the device setup file presentation screen, which is displayed on the GUI in response to connecting a thumb drive containing the device setup file stored in memory to the MCB USB port of the respiratory therapy device.

[0347] Figure 216 This is a screenshot of the firmware upgrade status screen, which is displayed on the GUI in response to the completion of the respiratory therapy device restart operation that occurs after the firmware upgrade operation. The firmware upgrade status screen displays a list of successful and failed upgrades for the respiratory therapy device's Bluetooth, Near Field Communication (NFC), MCB, and DCB circuits.

[0348] Figure 217 This is a screenshot of the HL7 import process in progress, during the selection... Figure 214After the HL7 file is displayed with the HL7 Import button on the screen to start the HL7 import process, the HL7 import in progress screen will be displayed on the GUI.

[0349] Figure 218 This is a screenshot of the HL7 import completion screen, which is displayed on the GUI after the HL7 data has been imported from the external device into the respiratory therapy device.

[0350] Figure 219 This is a screenshot of the HL7 import interruption screen, which is displayed on the GUI if any interruption occurs during the HL7 import process.

[0351] Figure 220 Is with Figure 178 The same screenshot as the original;

[0352] Figure 221 This is a screenshot of the first Bluetooth on screen, which is displayed on the GUI in response to moving the Bluetooth slider from the off position to the on position while simultaneously disabling the clinical access function of the respiratory therapy device. The first Bluetooth on screen displays a list of devices paired with the respiratory therapy device in Bluetooth communication.

[0353] Figure 222 This is a screenshot of the second Bluetooth screen, which is displayed on the GUI in response to moving the Bluetooth slider from the off position to the on position and simultaneously activating the clinical access function of the respiratory therapy device. The second Bluetooth on screen displays an SpO2 label and a barcode label, and the SpO2 label is selected.

[0354] Figure 223 This is a screenshot of the Bluetooth scan screen, in response to selection. Figure 222 The second Bluetooth activation button on the screen displays the Bluetooth scanning screen on the GUI. The Bluetooth scanning screen includes a process icon to show the progress of the Bluetooth scanning process.

[0355] Figure 224 This is a screenshot of the scan results screen, which is displayed on the GUI after the Bluetooth scan process is completed. The scan results screen shows a list of available SpO2 devices within the Bluetooth communication range of the respiratory therapy device.

[0356] Figure 225 It's a screenshot of the selected screen on the device, taken from... Figure 224 After selecting a device from the list of available SpO2 devices to pair with the respiratory therapy device via Bluetooth, a screen will appear on the GUI indicating that the device has been selected.

[0357] Figure 226 It's a screenshot of the screen when pairing with the new device. Figure 225 After selecting a device on the Selected Devices screen, the Pair New Device screen is displayed on the GUI;

[0358] Figure 227 This is a screenshot of the device's paired screen, in response to the selection. Figure 226 The screen for pairing a new device displays a continue button, while the GUI displays a screen for paired devices, which has a check mark in the pairing column next to the device selected for Bluetooth pairing.

[0359] Figure 228 This is a screenshot of the Bluetooth scan disabled screen. The Bluetooth scan disabled screen is displayed on the GUI in response to disabling the Bluetooth scan operation during Bluetooth scanning. The Bluetooth scan disabled screen has a manual settings button, which is activated to allow manual setup of Bluetooth communication with external devices.

[0360] Figure 229 This is a screenshot of the screen that is manually set, responding to the selection. Figure 224 , 225 The manual setup screen is displayed on the GUI via a manual setup button on any of the screens 227 or 228. The manual setup screen includes a graphical keyboard for entering a Media Access Control (MAC) address in the MAC address field so that an external device can pair with the respiratory therapy device via Bluetooth.

[0361] Figure 230 This is a screenshot of the "MAC address has been entered" screen. The MAC address is displayed at the bottom of the "MAC address has been entered" screen. Figure 229 Enter the MAC ID in the MAC address field, and then select... Figure 229 After manually setting the input button on the screen, the GUI will display that the MAC address has been entered.

[0362] Figure 231 This is a screenshot of the third Bluetooth activation screen, responding to the selection. Figure 222 The second Bluetooth power-on screen displays a barcode label, while the third Bluetooth power-on screen is displayed on the GUI. The third Bluetooth power-on screen has a process icon to display the progress of the automatic barcode scanner in response to the selection of the barcode label.

[0363] Figure 232 This is a screenshot of the barcode scan results screen. After the Bluetooth scan process is completed, the barcode scan results screen is displayed on the GUI. The scan results screen displays a list of available barcode scanner devices within the Bluetooth communication range of the respiratory therapy device.

[0364] Figure 233 It's a screenshot of the selected screen on the device, taken from... Figure 232After selecting a barcode scanner device from the list of available barcode scanner devices to pair with the respiratory therapy device via Bluetooth, the device is displayed as selected on the GUI screen.

[0365] Figure 234 This is a screenshot of the device's paired screen, taken when selecting... Figure 233 After the device has been selected on the barcode scanner screen, in response to the selected new device on the screen (and...), the pairing of the new device will begin. Figure 226 A similar (Continue) button is displayed on the GUI, and the device is paired screen with a check mark in the paired column next to the barcode scanner device selected for Bluetooth pairing;

[0366] Figure 235 This is a screenshot of the alternative scan results screen, in response to the selection. Figures 232-234 The scan button on any screen will be selected, and after the Bluetooth scan process is completed, the alternative scan result screen will be displayed on the GUI. The alternative scan result screen displays a list of available barcode scanner devices within the Bluetooth communication range of the respiratory therapy device.

[0367] Figure 236 This is a screenshot of the first WiFi startup screen, responding to the selection. Figure 220 The WiFi tag is displayed on the GUI in response to the WiFi slider moving from the off position to the on position. The first WiFi activation screen has a scan button that becomes active in response to the WiFi slider moving to the on position.

[0368] Figure 237 This is a screenshot of the WiFi scanning screen, responding to selection. Figure 236 The first WiFi scan is activated by clicking the scan button on the screen and then displayed on the GUI. The WiFi scan screen includes a process icon to show the progress of the WiFi scan.

[0369] Figure 238 This is a screenshot of the scan results screen. After the WiFi scan is completed, the scan results screen is displayed on the GUI. The scan results screen displays a list of available wireless access points (WAPs) within the WiFi communication range of the respiratory therapy device, and displays the WiFi signal strength icon for each WAP.

[0370] Figure 239 This is a screenshot of the selected screen in WAP mode, taken from... Figure 238 After selecting a WAP from the list of available WAPs for WiFi communication with the respiratory therapy device, the selected WAP will be displayed on the GUI screen.

[0371] Figure 240 This is a screenshot of the enterprise settings screen, responding to... Figure 239 The WAP is selected on the WAP selection screen and the enterprise settings screen is displayed on the GUI. The enterprise settings screen includes fields for entering enterprise settings information about the selected WAP.

[0372] Figure 241 This is a screenshot of the screen where you enter your user ID, in response to a selection. Figure 240 The enterprise settings screen displays the user ID field, and this user ID input screen is shown on the GUI. The user ID input screen has a graphical keyboard that can be used to enter the user ID for connection to [the relevant network / system]. Figure 239 The WAP network is selected on the screen that is associated with the WAP network;

[0373] Figure 242 This is a screenshot of the password input screen, responding to... Figure 240 In the enterprise settings screen, a password field is selected, and the password input screen is displayed on the GUI. The password input screen has a graphical keyboard for entering the password. Figure 239 Select the password for the Wi-Fi network associated with the WAP on the WAP selection screen;

[0374] Figure 243 This is a screenshot of the authentication process screen. After the user enters their user ID and password in the user ID and password fields, the system responds by selecting... Figure 240 The enterprise settings screen displays a "Continue" button, while the authentication process is displayed on the GUI as an in-process screen with an authentication progress icon to show the progress of the authentication process.

[0375] Figure 244 This is a screenshot of the successful authentication screen, displayed on the GUI in response to successful authentication between device 10 and the WiFi network associated with the selected WAP. Figure 239 The selected WAP on the screen has a checkmark next to it;

[0376] Figure 245 This is a screenshot showing an inability to connect to the screen, indicating that the respiratory therapy device cannot connect to the... Figure 239 The selected WAP-related WiFi network on the screen is displayed as "unable to connect" in the GUI.

[0377] Figure 246 This is a screenshot of the WiFi status screen. The WiFi status screen is displayed on the GUI after a status label is selected. This status label indicates successful authentication and connection to the WiFi network. Figure 239The WiFi status screen that appears after selecting a WAP-related WiFi network on the screen includes information related to the WiFi network to which the respiratory therapy device is connected.

[0378] Figure 247 This is a screenshot of the first WiFi settings screen, after selecting... Figure 246 After selecting the settings tab on the WiFi status screen, the first WiFi settings screen is displayed on the GUI. The WiFi settings screen includes a first slider that allows selection between assigning a static IP address to the respiratory therapy device and assigning an IP address to the respiratory therapy device based on the Dynamic Host Configuration Protocol (DHCP). The first slider is in a static position. The settings screen also includes a second slider that allows selection between communication with a first or second server of the WiFi network. The second slider is in a first position.

[0379] Figure 248 This is a screenshot of the second WiFi settings screen, which is similar to... Figure 247 However, this moves the first slider from the static position to the DHCP position;

[0380] Figure 249 This is a screenshot of the third-party WiFi settings screen, which is similar to... Figure 248 However, this causes the second slider to move to the second position;

[0381] Figure 250 This is a screenshot of the fourth WiFi settings screen, which is similar to... Figure 247 However, this causes the second slider to move to the second position;

[0382] Figure 251 This is the first setting to adjust the screen screenshot, in response to selection. Figure 247 The subnet domain is displayed below the first slider on the GUI, which has a graphical numeric keypad for editing the subnet IP address, and the subnet domain is highlighted to indicate that it is the domain that will be edited using the graphical numeric keypad.

[0383] Figure 252 This is a screenshot of the second settings adjustment screen, in response to selection. Figure 247 The second setting adjustment screen is displayed on the GUI below the port field of the second slider. The second setting adjustment screen has a graphical numeric keypad for editing the port address of the server selected using the second slider, and the port field is highlighted to indicate that it is the field to be edited using the graphical numeric keypad.

[0384] Figure 253This is a screenshot of the fifth WiFi settings screen, which is similar to... Figure 247 However, there are zero points in all domains below the first and second sliders, and they have... Figure 247 The test connection button shown in the image is located at... Figure 253 The word "WAP" is omitted to indicate that there is no WAP that can communicate with the respiratory therapy device.

[0385] Figure 254 This is a screenshot of the sixth WiFi settings screen, which is similar to... Figure 247 However, all fields below the first and second sliders are filled with relevant IP address and port address information, and an available test connection button is displayed;

[0386] Figure 255 This is a screenshot of the screen during the connection test, in response to selection. Figure 254 The test connection button is displayed on the GUI, and the connection test in progress screen is displayed with a test process icon to show the progress of the connection test.

[0387] Figure 256 It's a screenshot of a screen that can't connect to the display, similar to... Figure 245 In response to the respiratory therapy device being unable to connect to... Figure 254 The information on the screen relates to a WiFi network, but the GUI displays an error message indicating that the screen cannot connect.

[0388] Figure 257 This is a screenshot of the first connection result screen, which is displayed on the GUI after the connection test is completed. The first connection result screen indicates that the network connection is successful but the server connection is unsuccessful.

[0389] Figure 258 This is a screenshot of the second connection result screen, which is displayed on the GUI after the connection test is completed. The second connection result screen indicates that the network connection was successful and the server connection was unsuccessful.

[0390] Figure 259 This is a screenshot of the first Long Term Evolution (LTE) power-on screen appearing on the GUI, in response to the option to provide instead of a Wi-Fi network if the respiratory therapy device is configured to connect to an LTE network instead of a Wi-Fi network. Figure 220 The WiFi tag has an LTE tag, and the first LTE power-on screen is displayed on the GUI, which has a 4G slider in the off position;

[0391] Figure 260 This is a screenshot of the second LTE startup screen, which is similar to... Figure 259However, it has a 4G slider that moves from the off position to the on position, and the second LTE on screen includes an LTE progress icon to indicate the progress of searching for LTE networks;

[0392] Figure 261 This is a screenshot of the "No Carrier Found" screen. If no LTE carrier is found after the 4G slider is moved to the open position, this "No Carrier Found" screen will be displayed on the GUI.

[0393] Figure 262 This is a screenshot of the carrier discovery screen. If an LTE carrier is discovered after the 4G slider is moved to the open position, the carrier discovery screen will be displayed on the GUI. The carrier discovery screen contains information about the LTE carrier, which is automatically filled in the carrier name field, the International Mobile Equipment Identity (IMEI) field, and the Subscriber Identity Module (SIM) ID field.

[0394] Figure 263 This is a screenshot of the help category screen, in response to... Figure 21 or Figure 39 The menu screen displays an information icon or help icon, while the GUI displays the help category screen, which has a list of categories for which help is available;

[0395] Figure 264 This is a screenshot of the automatic OLE therapy help screen, responding to selection. Figure 263 Help category screen (if from) Figure 20 The automatic OLE treatment help screen is displayed on the GUI and navigates to the main OLE treatment selection screen.

[0396] Figure 265 This is a screenshot of the manual OLE treatment help screen, responding to selection. Figure 263 Help category screen (if from) Figure 20 The manual OLE treatment help screen is displayed on the GUI and navigates to the main OLE treatment selection screen.

[0397] Figure 266 This is a screenshot of the OLE treatment overview help screen, in response to selection. Figure 263 Help category screen (if from) Figure 20 The OLE treatment overview button is located on the main OLE treatment selection screen (which is navigated to from the main OLE treatment selection screen), and the OLE treatment overview help screen is displayed on the GUI.

[0398] Figure 267 This is a screenshot of an example of returning from the help screen, showing what happens if you initially navigate to the help category screen in response to a selection. Figure 141 The automatic OLE treatment cough pause settings screen has a help icon on the options tab. If selected... Figure 263 If you click the back button on the help category screen, you will return to the previous screen;

[0399] Figure 268 This is a screenshot of the OLE treatment options help screen, responding to selections. Figure 263 Help category screen (if from) Figure 20 The OLE treatment options are displayed on the GUI help screen via the main OLE treatment selection screen navigation (which is accessed via the OLE treatment selection screen).

[0400] Figure 269 This is a screenshot of the OLE-modified treatment help screen, responding to selection. Figure 263 Help category screen (if from) Figure 20 The main OLE treatment selection screen navigation comes from the "Modify Treatment Overview" button, or in response to the selection. Figure 137 The first modification of the treatment screen displays information or a help icon, and the OLE modification treatment help screen appears on the GUI.

[0401] Figure 270 This is a screenshot of the automatic MIE treatment help screen, responding to selection. Figure 263 Help category screen (if from) Figure 19 The automatic treatment button is located on the main MIE treatment selection screen (which is navigated to from the main MIE treatment selection screen), and the automatic MIE treatment help screen is displayed on the GUI.

[0402] Figure 271 This is a screenshot of the manual MIE treatment help screen, responding to selection. Figure 263 Help category screen (if from) Figure 19 The manual treatment button is displayed on the GUI (accessible via the main MIE treatment selection screen navigation) and the manual MIE treatment help screen is shown on the GUI.

[0403] Figure 272 This is a screenshot of the MIE treatment overview help screen, responding to selections. Figure 263 Help category screen (if from) Figure 19 The main MIE treatment selection screen navigation is accessed via the treatment overview button, which is displayed on the GUI screen.

[0404] Figure 273 This is a screenshot of the MIE treatment options help screen, responding to selections. Figure 263 Help category screen (if from) Figure 19 The treatment option buttons on the main MIE treatment selection screen (which is navigated to) and the MIE treatment option help screen displayed in the GUI; and

[0405] Figure 274 This is a screenshot of the MIE-modified treatment help screen, responding to selection. Figure 263 Help category screen (if from) Figure 19 The main OLE treatment selection screen navigation comes from the "Modify Treatment Overview" button, or in response to the selection. Figure 101 The MIE-modified treatment help screen adds information or help icons to the cycle screen, while the GUI displays this modified treatment help screen. Detailed Implementation

[0406] As shown in Figures 1 and 2, the respiratory therapy device or apparatus 10 includes a housing 12 having an inclined upper front wall portion 14a on which a display screen or graphical user interface (GUI) 16 is accessible to allow the user to input information into the device 10 and view display information related to the operation of the device 10, such as... Figure 18-274 As shown in the screenshot example (discussed in more detail below). The terms GUI and display screen are used interchangeably here. The housing 12 of device 10 also has a sloping bottom front wall portion 14b, which curves slightly downward and backward from the bottom of the upper wall portion 14a. Figure 1 and 2 As shown, port 24 of housing 12 extends from an annular recess 20 provided in front wall portion 14b. For example, in this document, port 24 is sometimes referred to as a pneumatic port or outlet port. Cover 26 in Figure 1 and 2 The image shows the opening of port 24 in the closed position.

[0407] The handle 18 is attached to the top of the housing 12 and can be gripped to support the device 10. The handle 18 can be positioned in the usage position (e.g., Figure 1 and 2 The handle 18 pivots relative to the housing 12 between a use position and a storage position, wherein, in the use position, the handle 18 extends upward from the housing 12, and in the storage position, the handle 18 folds downward against the housing 12. The handle 18 has a first side portion 26, a second side portion 28 spaced apart from and generally parallel to the side portion 26, and a gripper portion 30 connecting the first ends of the side portions 26, 28 to each other. The second ends of the side portions 26, 28 of the handle 18 are pivotally coupled to the top of the housing 12. Therefore, in the illustrative example, the handle 18 is generally U-shaped.

[0408] The housing 12 includes a first sidewall 32 (as shown in Figures 1 and 2), a second sidewall 34 (as shown in Figures 1 and 2), and a second sidewall 34 (as shown in Figures 2 and 3). Figure 3 (as shown) and bottom wall 36 (same as shown) Figure 3 (As shown). The housing 12 also includes a top wall 38 (as shown in Figure 6 and). Figure 7A ) and posterior wall 40 (also as Figure 6 and 7A(As shown). Device 10 includes a main on / off button 42, which is disposed in a rectangular opening 44 located below the GUI 16 on the upper front wall portion 14a of housing 12 and approximately midway between the side walls 32, 34 of housing 12. Pressing the on / off button 42 turns device 10 on and off. The lower wall portion 14b and the lower region of the rear wall 40 each have a plurality of ventilation holes 45, which allow air to flow in and out of the interior region of housing 12. In the illustrative example, the holes 45 are formed as slots.

[0409] As will be discussed in further detail below, device 10 is operable to provide a variety of types of respiratory therapy to a patient. In some embodiments, device 10 is operable to provide a patient with manual and automatic modes of mechanical inhalation / exhalation (MIE) therapy. MIE therapy is sometimes referred to by those skilled in the art as cough-assisted therapy. In other embodiments, device 10 is operable to provide a patient with manual and automatic oscillatory lung expansion (OLE) therapy modes. In other embodiments, device 10 is operable to provide a patient with both manual and automatic MIE therapy and manual and automatic OLE therapy. Each manual and automatic OLE therapy may include one or more phases of continuous positive expiratory pressure (CPEP) therapy and / or one or more phases of continuous high-frequency oscillation (CHFO) therapy, selected according to the user's preference for device 10. Configuring device 10 to provide other types of respiratory therapy to a patient is also within the scope of this disclosure.

[0410] When used for MIE treatment (manual or automated), device 10 provides a non-invasive treatment that can replace invasive suction. Device 10 is designed for patients, caregivers, and healthcare providers such as respiratory therapists. Therefore, the term “user” as used herein includes each of these types of people unless otherwise specifically stated. When delivering MIE treatment, device 10 simulates a cough to clear secretions from patients with impaired peak cough flow. During MIE treatment, device 10 delivers a positive inhalation pressure (inhalation) to the patient’s airway to inflate the lungs. Device 10 then rapidly switches to deliver a negative expiratory pressure (exhalation) to rapidly deflate the lungs to simulate a high expiratory flow rate, which mimics an effective cough. After exhalation, device 10 enters a pause state and maintains positive pressure flow to the patient (if programmed to do so). This is called positive airway pressure (PAP) open pause. An optional sighing phase may also be included after MIE treatment to inflate the patient’s lungs after the last exhalation of the MIE treatment.

[0411] When used for OLE treatment (manual or automatic), device 10 provides a treatment that enhances secretion clearance and helps prevent or resolve patchy atelectasis in patients. As mentioned above, device 10 can be configured for OLE treatment in two modes: CHFO mode, a pneumatic form of chest physiotherapy that delivers a drug-infused spray while oscillating the airway with continuous positive pressure pulses; and CPEP mode, which provides continuous positive pressure to help keep the airway open and dilated. In combination with OLE treatment in CPEP mode and / or CHFO mode, device 10 can also be operated to deliver nebulized medication using a nebulizer and to deliver supplemental oxygen from an external oxygen source. The nebulizer used with device 10 is configured to nebulize approved medications for nebulization and physician-prescribed medications.

[0412] If device 10 is to operate with atomizing characteristics, such as during OLE treatment, then as Figure 2 As shown, an optional sprayer tray 50 is attached to the bottom of the housing 12. When attached to the housing 12, the sprayer tray 50 covers the majority of the bottom wall 36 of the housing 12. The bottom wall 36 forms a peripheral recess 46 at the junction of the bottom wall 36 with each of the lower wall portion 14b, side walls 32, 34, and rear wall 40 of the housing 12. When the sprayer tray 50 is attached to the bottom of the housing 12, the upper edge 48 of the sprayer tray 50 is received in the peripheral recess 46. The sprayer tray 50 includes a front wall 52, a first side wall 54, a second side wall 56, a rear wall 58, and a bottom wall 60, as shown. Figure 4 and 5 As shown. The tray 50 is molded from plastic material into a single, integral component.

[0413] The front wall 52 of the tray 50 has a recess 62, and the sprayer tube port 64 extends from the front wall 52 into the recess 62. The port axis 24a of port 24 is substantially parallel to the port axis 64a of port 64, for example, as shown. Figure 3As shown. Since port 24 is primarily located within recess 20 and port 64 is located within recess 62, ports 24 and 64 are protected from impacts by falling objects. Furthermore, due to the concave or sloping shape of the lower front wall portion 14b, the junction between the upper front wall portion 14a and the lower front wall portion 14b extends beyond the distal ends of ports 24 and 64 just below button 42, providing further fall protection. When viewed from the front of the respiratory therapy device 10, recess 62 and port 64 are offset downwards and to the right of recess 20 and port 24. This position of ports 24 and 64 makes it easier for a right-handed user to attach and detach the nebulizer tube from port 64 while attaching the patient circuitry to port 24. If port 64 were located vertically below port 24 (a possible configuration in an alternative embodiment), the patient circuitry connected to port 24 would tend to obstruct or interfere with the attachment and detachment of the nebulizer tube from port 64.

[0414] like Figure 4 and 5 As shown, the sprayer pump 66 is supported by the bottom wall 60 of the tray 50. In the illustrative example, Figure 4 A rectangular foam gasket 68 is inserted between the pump 66 and the bottom wall 60. A pair of screws 70 pass through corresponding flat washers 72 and corresponding paired rubber washers 74, which are located above and below the corresponding mounting lugs 76 of the pump 66. Figure 4 and 5 Only one ear 76 of pump 66 can be seen in the middle. The lower end of screw 70 is screwed into screw receiving boss 78, which is integrally formed with the bottom wall 60 of tray 50. Figure 4 and 5 Only one boss 78 is visible in the image. The tray 50 includes multiple ventilation holes 80 formed in the walls 54, 56, 58, and 60. In the illustrative example, the holes 80 are formed as grooves. Heat generated by the pump 66 is released to ambient air through the holes 80.

[0415] Also refer to Figure 4 and 5 A pair of pump outlet pipes 82 and a pair of pump inlet pipes 84 extend from pump 66. The ends of pipes 82, spaced apart from pump 66, intersect and connect to the two branches of a first pneumatic Y-connector 86, and the ends of pipes 84, also spaced apart from pump 66, intersect and connect to the two branches of a second pneumatic Y-connector 88. One end of the main inlet pipe 90 connects to the main body of the Y-connector 88, and the other end connects to an inlet connector 92, which is coupled to the rear wall 94 of a filter receiving box 96, which is integrally formed with tray 50. Figure 4As shown, the internal region of the inlet connector 92 receives a compression spring 98, a circular inlet filter 100, and a rubber O-ring 102. An inlet nut and bushing 104 are screwed into one end of the connector 92 adjacent to the rear wall 94. More specifically, the threaded portion of the nut and bushing 104 is screwed into the hole of the connector 92 via a slot 106 formed in the rear wall 96 of the housing 96, such that a portion of the rear wall 94 adjacent to the slot 106 is clamped between the end surface of the connector 92 and the head of the nut and bushing 104. With the nut and bushing 104 screwed into the connector 92, the O-ring 100 presses against the filter 100, and the filter presses against the compression spring 98 to compress the spring 98 in the internal region of the connector 92.

[0416] Inlet filter 108 is received in recess 110 defined by housing 96 in rear wall 58 of tray 50 (see Figure 7A In an exemplary embodiment, filter 108 comprises a rectangular foam block. When the respiratory therapy device 10 having tray 50 is supported on a horizontal surface in its proper orientation, the long side of the foam block including filter 108 is generally horizontally oriented. Filter cap 112 includes a set of snap fingers 114 having angled distal ends that engage and pass through corresponding holes 116 formed in the rear wall 94 of housing 96, thereby allowing cap 112 to retain filter 108 within recess 110. Cap 112 has a pouch 118 in which inlet filter 108 is located when cap 112 is engaged in place in housing 96. When filter 108 is held in recess 110 by cap 112, filter 108 abuts the head of nut and bushing 104.

[0417] Similarly, Figure 4 and 5 As shown, tray 50 houses a first outlet pipe section 120 and a second outlet pipe section 122. Pipe sections 120 and 122 are pneumatically connected together via a diaphragm check valve 124. In this regard, a barbed connector 126 extending outward from the central disc-shaped portion 128 of the check valve 124 is inserted into the respective open ends of pipes 120 and 122, and a hose clamp 130 provides additional clamping force to secure the ends of pipes 120 and 122 to the respective barbed connector 126. One end of pipe 120, spaced apart from the check valve 124, is attached to a fitting portion 132, which is integrally formed with pipe port 64 and extends through a hole 134 formed in a portion of a defining recess 62 in the front wall 52.

[0418] Nut 136 is threaded onto the threaded area of ​​fitting portion 132, such that a portion of the front wall 52 surrounding hole 134 is clamped between nut 136 and an annular flange 138 formed between fitting port 64 and fitting portion 132. Hose clamp 140 provides additional clamping force to secure the corresponding end of tube 120 to fitting portion 132. One end of tube 122, spaced apart from check valve 124, is connected to the main body of Y-connector 86. However, another hose clamp 142 provides additional clamping force to secure the corresponding end of tube 122 to the main body of Y-connector 86. In use, motor 144 of pump 66 operates to draw ambient air into tube 90 via filter 108 and fitting 92, and then into the interior of manifold block 146 of pump 66 via Y-connector 88 and inlet tube 84. The motor 144 of pump 66 compresses air into manifold 146, and then the compressed or pressurized air is discharged from manifold 146 and moves through outlet pipe 82, Y connector 86, pipes 120, 122 and filter 124 and sprayer port 64 to the sprayer hose attached to port 64.

[0419] Refer again Figure 3 Cable 148 extends from pump 66 and has an attachment electrical connector 150, which is attached to mating electrical connector 152, such as... Figure 16D As shown. Connector 152 is accessible via an opening 154 provided in a rectangular recess 156, which is formed in the bottom wall 36 of the housing 12 of the respiratory therapy device 10. In a configuration of the respiratory therapy device 10 omitting the tray 50, a rectangular cover (not shown) fits within the recess 156 and is attached to a cylindrical boss 158 with suitable fasteners (e.g., screws). Power is supplied via cable 148 to operate the pump 66 of the nebulizer tray 50. Circuitry (described below) Figure 16A-17C (To be discussed) Located within the internal area of ​​the housing 12 of the device 10, the circuit controls the flow of water through the pipe 162 to the sprayer 160 when the pump 66 is turned on and off. Figure 9 (As shown) pneumatic pressurization is provided, a portion of tube 162 is in Figure 9 As shown in the figure, a portion of Figure 7B As shown in the image.

[0420] As shown in Figure 7B, the first connector 164, located near the proximal end of tube 162, is attached to port 64, as follows: Figure 9 As shown, a second connector 166 located at the distal end of tube 162 is attached to the pneumatic inlet 168 of nebulizer 160. Compressed air from pump 66 enters the interior region of nebulizer cup 170 of nebulizer 160 through port 64, connector 164, tube 162 and inlet 168 to vaporize or atomize the liquid medication contained in cup 170 for final delivery to the patient's airway.

[0421] Refer again Figure 3 A set of four screws 172 is provided for attaching the nebulizer tray 50 to the housing 12 of the respiratory therapy device 10. The screws 172 are inserted through openings 174 into the vertical tower column 176 (see...). Figure 5 and Figure 7A The internal region of the tray 50 has vertical columns near the corners of the tray 50, extending upward from the bottom wall 60 of the tray 50. The threaded portion of the screw 172 extends through a hole 178 formed in the top of the column 176 and is screwed into a threaded hole 180 formed in the bottom wall 36 of the housing 12. The head of the screw 172 is held within the internal region of the corresponding column 176 and clamps the top of the column 176 against the bottom wall 36 of the housing 12.

[0422] A set of four rubber feet 182 are attached to the bottom wall of the 60 sprayer trays 50. Specifically, the feet 182 are disc-shaped and receive in shallow circular recesses 184 formed in the bottom wall 60, such as... Figure 3 As shown, but thick enough to protrude downwards from recess 184. In the configuration of device 10 omitting the nebulizer tray 50, the foot 182 is received in recess 184' formed in the bottom wall 36 of housing 12. The foot 182 constrains the respiratory therapy device 10 to slide on the surface below (e.g., a table surface). If desired, the respiratory therapy device 10 can be mounted on a support surface or a shelf with a movable bracket (not shown). For example, see... Figure 52 and 53 The description of the movable bracket in the document and the relevant description in U.S. Patent No. 8,460,223 are incorporated herein by reference to the extent that they do not conflict with this disclosure, and any inconsistencies shall be controlled by this disclosure.

[0423] In order to mount the respiratory therapy device 10, which has a structure with a nebulizer tray 50, onto a mobile support, such as Figure 3 As shown, a pair of suitable fasteners, such as screws (not shown), pass through holes formed in the frame of the movable bracket and are inserted into corresponding threaded bosses 186 formed in the bottom wall 60 of the sprayer tray 50, as shown. Figure 3 As shown. The illustrative tray 50 also has an internal boss 187, which, as... Figure 4 and 5 (Only one boss 187 is visible) is formed above the bottom wall 60 of the tray and aligned with boss 186 so that the screw has additional material to be screwed in. In the configuration of device 10 omitting the tray 50, the fastener passes through a hole formed in the frame of the movable bracket and is inserted into a corresponding threaded hole 188 formed in the bottom wall 36 of the housing 12, as shown. Figure 3As shown. If needed, device 10 can be mounted to a stationary shelf or surface in a similar manner using fasteners (e.g., screws), depending on the configuration of device 10 (with or without tray 50), by screwing the fasteners into the boss 186 or hole 188.

[0424] In this illustrative example, the product label 190 is received in a complementary shape recess 192, which is formed in the lower front wall portion 14b of the housing 12, adjacent to the recess 20 containing the port 24, as shown. Figure 3 As shown. In some embodiments, the product label 190 includes the product name and / or manufacturer name of the device 10. Also in the illustrative example, a unique device identifier (UDI) label 194 is received in a complementary shape recess 196 formed in the bottom wall 60 of the tray 50 and / or in a complementary shape recess 196' formed in the bottom wall 36 of the housing 12. The content of the UDI label is determined by a government agency such as the U.S. Food and Drug Administration (FDA).

[0425] In the illustrative example, safety label 198 is received in a complementary-shaped recess (not shown, but similar to recesses 192, 196, 196') in the rear wall 40 of housing 12. Safety label 198 includes, for example, safety information relating to device 10 and Underwriters Laboratories (UL) and / or CE certification marks. Figure 4 As shown, the sprayer label 200 is received in a complementary-shaped recess 201 formed in the front wall 52 of the tray 50, adjacent to the recess 62 containing the port 64. The sprayer label 200 indicates to the user that the port 64 is for a sprayer (e.g., a sprayer). Figure 9 The illustrative sprayer 160 shown provides pressurized air.

[0426] Now refer to Figure 6 The handle 18 is shown to have descended to its storage position, abutting against the top wall 38 of the housing 12 of the respiratory therapy device 10. The top wall 38 includes a first top wall portion 38' and a second top wall portion 38'", the first top wall portion 38' being formed to include a recess 202, in which the second top wall portion 38' is selectively received. A U-shaped handle receiving space is formed by the portion of the recess 202 located between the outer edge 204 of the second top wall portion 38' and the recess-defining edge 206 of the first top wall portion 38' defining the recess 202. Therefore, when the handle 18 is in the storage position, the handle 18 is received in the handle receiving space of the recess 202. For example, as... Figure 6 As shown, for example, when the handle is in the storage position, the handle 18 and the second top wall portion 38 " substantially fill the entire recess 202.

[0427] The ends of the sides 26, 28 of the handle 18 adjacent to the front of the device 10 are pivotally connected to the first top wall portion 38' for rotation about a pivot. As shown in Figures 7A and 7B, the second top wall portion 38' has a finger receiving recess 208 sized to receive one or more fingers of the user to facilitate moving the handle 18 from a storage position to a use position. In the exemplary description, as Figure 6 and 7A As shown, the first top wall portion 38' also has a finger receiving recess 210, sized to receive one or more fingers of the user, to facilitate moving the handle 18 from the storage position to the use position. Figure 1 and 2 As shown, the gripper portion 30 of the handle 18 has a pair of small protrusions or small pieces 212 that engage with complementary-shaped recesses (not shown) at the edge 204 of the second top wall portion 38" to help secure the handle 18 in the storage position. With only a slight upward force applied to the gripper portion 30, the small pieces 212 can disengage from the corresponding recesses, allowing the handle 18 to be moved to the use position.

[0428] like Figure 1 and 2 As shown, ridge 214 is formed in the central region of the grip portion 30 of the handle 18, and as... Figure 6 As shown, when the handle 18 is in the storage position, the ridge 214 can be located within the recess 210. The ridge 214 abuts the surface of the first top wall portion 38', which defines the bottom of the recess 210. This abutment causes the handle 18 to stop in the proper orientation when in the storage position. The finger receiving recess 208 is deeper than the recess 210, allowing the user to insert a portion of the user's fingertip under the grip portion 30 so that the handle 18 can initially be pulled out of the storage position for movement toward the use position.

[0429] As shown in Figure 7A, a set of four fasteners 216 (illustratively screws) are provided and configured to detachably connect the second top wall portion 38'' to the first top wall portion 38'. In other embodiments, more or fewer than four fasteners 216 are used to detachably connect the top wall portion 38'' to the first top wall portion 38'. Thus, according to this disclosure, at least one fastener 216 is used to connect the top wall portion 38'' to the first top wall portion 38'. The top wall portions 38', 38'' are configured such that when portion 38'' is attached to portion 38', the upper surfaces are generally coplanar. Furthermore, when the housing 12 with or without the tray 50 attached is supported on a horizontal surface, the top wall 38 formed by portions 38', 38'' of the housing 12 slopes downward at an angle (e.g., downward as a ramp) from the front to the rear of the housing 12.

[0430] As mentioned above, the respiratory therapy device 10 includes a GUI 16. As will be described in detail below, the respiratory therapy device 10 also includes control circuitry. The GUI 16 provides user input configured to control firmware upgrades of the control circuitry. According to an illustrative embodiment, firmware upgrades are provided to the control circuitry via a firmware upgrade port 218 located below the top wall portion 38'', as... Figure 6 As shown (dashed line). Therefore, in order to access the firmware upgrade port 218 for uploading firmware upgrades, the top wall portion 38" is separated from and removed from the top wall portion 38', thereby exposing the firmware upgrade port 218 within the recess 202. In some embodiments, the firmware upgrade port 218 includes a Universal Serial Bus (USB) port, providing firmware upgrades on a USB drive coupled to the USB port 218.

[0431] Refer again Figure 6 A generally V-shaped hose support plate 220 is shown at a storage location behind the rear wall 40 of the housing 12. Plate 220 is attached to the rear wall 40 of the housing 12 for use in… Figure 6 The plate 220 pivots between the storage position shown in Figure 7 and the unfolded position shown in Figure 7A. In the unfolded position, a portion of the plate 220 extends above the top wall 38 of the housing 12, such that the flexible hose receiving slot 222 of the plate is located above the top wall 38 of the housing 12. When the plate 220 is in the unfolded position, as... Figure 9 As shown, the hose 225 of the configurable patient circuit 230 can be received in the hose receiving slot 222. Therefore, during operation of the device 10, if the patient is positioned appropriately close to the housing 12, the plate 220 supports the slack portion in the hose 225 to provide respiratory therapy to the patient.

[0432] As shown in Figure 7A, when the plate 220 is in the unfolded position, the battery 224 can be inserted into and removed from the battery compartment 226 formed in the rear wall 40 of the housing 12. When the battery 224 is received in the battery compartment 226 and the plate 220 is moved to the storage position, the plate 220 blocks a portion of the battery compartment, and the front surface of the plate 220 faces the portion of the battery 224 received in the battery compartment 226. In some uses of the device 10, the battery 224 is omitted, and power is supplied to the device 10 via an AC power cable 228 as shown in Figure 7A. This AC power cable has an AC power plug 231 with a pointed tip at one end, which inserts into a standard AC power socket (not shown), and a power connector 232 at the opposite end, which is attached to a mating power connector 234 disposed on the rear wall 40 of the housing 12, as shown in Figure 7A. Figure 6As shown, for example, as shown in Figure 7A, the power connector 234 has a recess 235 into which the connector 232 is inserted. If the battery 224 is installed in the battery compartment and AC power is supplied via the power cable 228 to operate the device 10, the battery 224 is charged by the power from the power cable 228.

[0433] When battery 224 is removed from compartment 226, battery compartment cover 236 can be inserted into compartment 226 to cover the opening leading to compartment 226. A pair of press-fit nut posts 238 are integrally formed with cover 226. When cover 236 is inserted into compartment 226, press-fit nut posts 238 descend to their lowest point against the portion of back wall 40 that defines the depth of compartment 226, so as to properly position cover 236 at the opening of compartment 226. When cover 236 is received in compartment 226 and plate 220 is in the storage position, the front surface of plate 220 is opposite to the portion of cover 236 received in battery compartment 226.

[0434] Battery 224 includes a retractable latch 240 and a spring-loaded button 242, as shown in FIG. 7A. Button 242 is coupled to latch 240 and spring-biased to a locked position, in which latch 240 extends from one end of battery housing 244 of battery 224 to be received in a latch receiving pouch (not shown), which is formed in a portion of the rear wall 40 defining a battery compartment 226. Button 242 moves from the locked position to a released position relative to battery housing 244 to retract latch 240 from the pouch, which allows removal of battery 224 from battery compartment 226. Cover 236 also has a latch 246, which is received in the same pouch as latch 240 to lock cover 236 of battery compartment 226. The latch 246 is integrally formed with a flexible finger 248, which is manually moved to retract the latch 246 from the bag, thereby allowing the cover 236 to be removed from the battery compartment 226.

[0435] like Figure 6 and 7A As shown, device 10 includes an air inlet filter 250, which, in an illustrative embodiment, comprises a rectangular foam block. When the respiratory therapy device 10 is supported in an appropriate orientation on a horizontal surface, the long side of the foam block including filter 250 is oriented substantially vertically. As shown in FIG7A, the air inlet filter 250 is received in a recess 252 defined in the rear wall 40 of housing 12, below battery compartment 226. Figure 6As shown, filter cover 254 (similar to filter cover 112, but appropriately sized for use with filter 250) is received in recess 252 to hold filter 108 within recess 110. As will be discussed further in detail below, as shown in FIG. 7B, device 10 includes a blower 260 that operates in relation to providing respiratory therapy to a patient. In use, blower 260 operates to draw ambient air through filter 250 and into a duct (not shown) leading to inlet 262 of blower 260. Therefore, according to this disclosure, either blower 260 or nebulizer pump 66 is considered a first pressure source, while the other is considered a second pressure source.

[0436] Device 10 also includes a fuse 264 and a fuse cover 266 as shown in FIG7A. In this illustrative embodiment, fuse 264 is a 4-amp (A), 250-volt (V) fuse, but other types of fuses may be used in other embodiments. Fuse cover 266 snaps into a fuse receiving recess 268 located near recess 235. In this illustrative embodiment, the sockets 268, 235 are molded into a single plastic power container assembly 270 (e.g., a no. 719W-00 / 02 power inlet connector socket, available from Qualitek Electronics, Mentor, Ohio), and the socket is mounted to the rear wall 40 of housing 12 using suitable fasteners (e.g., screws 272). Figure 6 and 7A As shown.

[0437] A set of ventilation slots 274 are formed in the rear wall 40 of the housing, adjacent to the container component 270, such as... Figure 6 and 7A As shown. Figure 7B As shown, a ventilation fan 276 is located behind the ventilation slot 274 in the internal region of the housing 12. The fan 276 operates to cool the internal region of the housing 12 by blowing air from the internal region of the housing 12 into the ambient air via the ventilation slot 274. A ridge or crossbar 278 is integrally formed with the rear wall 40 and includes a generally horizontal portion that projects outward from the housing 12 above each of the sockets 235, 252, 268 and the ventilation slot 274, as shown in Figure 7A. The ridge 278 also has a generally vertical portion that extends outward from the housing 12 near the ventilation slot 274.

[0438] When the hose support plate 220 is in the storage position, the first tip 280 of the hose support plate contacts the boss 278 to prevent the plate 220 from pivoting downwards relative to the rear wall 40 of the housing 12 beyond the storage position. Therefore, when the plate 220 is in the storage position, the boss 278 acts as a stop that contacts the tip 280 of the plate 220. The post 282 is also integrally formed with the rear wall 40 and protrudes from the housing 12, serving as another stop for the plate 220. When the plate 220 is in the unfolded position, the edge 284 of the plate contacts the post 282, preventing the plate 220 from pivoting through the unfolded position. As the plate 220 moves between the storage and unfolded positions, the plate 220 pivots about a generally horizontal pivot 286, as... Figure 6 As shown, pivot 286 is defined by pivot connector 288.

[0439] Plate 220 includes a second tip 290 that mates with tip 280 to define a V-groove 222 of plate 222. The circular edge 292 of plate 220 is generally the same size as the hose 225, such that when the hose 225 is placed within the groove 222 and plate 220 is in the unfolded position, the hose 225 is nested on the edge 292 of plate 222. The edge 292 smoothly integrates into the edges of the corresponding tips 280, 290 forming the V-groove 222. Plate 220 has an irregular or asymmetrical shape such that when plate 220 is moved from the storage position to the unfolded position, the center of gravity of plate 220 moves through an imaginary vertical plane (not shown) passing through axis 286, such that when plate 220 is in the unfolded position, edge 284 of plate 220 is biased by gravity into contact with post 282.

[0440] As shown in Figure 7A, the device 10 includes a foot switch 294 and a wire 300. The foot switch 294 has a foot pedal 296 connected to a foot switch base 298, and the wire 300 extends from the base 298 and terminates at an electrical connector 302. A mating electrical connector 304 is located below a ventilation slot 274 on the rear wall 40 of the housing 12, as shown in Figure 7A. Figure 6As shown. When connectors 302 and 304 are connected, foot switch 294 can be used to start and stop (or pause) respiratory therapy for a patient via respiratory therapy device 10. In this regard, foot pedal 296 signals the control circuitry of device 10 relative to base 298. In some embodiments, foot pedal 296 is spring-biased to an elevated initial position, and each continuous rocking motion of foot pedal 296 relative to base 298 from the initial position to a depressed position achieved by the user's foot causes a signal to be sent from foot switch 294 to device 10. Continuous movement of foot pedal 296 towards the depressed position starts and stops (or pauses) respiratory therapy. In other embodiments, foot pedal 296 can rock forward and backward from the initial position. For example, if the user places their foot on the upper surface of foot pedal 296 and presses down on one side of foot pedal 296 with their toes, the movement corresponds to the forward direction; if the user presses down on the other side of foot pedal 296 with their heel, the movement corresponds to the backward direction.

[0441] like Figure 6 As shown, a data port 306 is also provided below the ventilation slot 274 on the rear wall 40 of the housing 12. In some embodiments, the data port 306 includes a USB port 306 for connection to an external device. For example, a USB drive (sometimes called a thumb drive) may be connected to the data port 306 for wired data import and export to the control circuitry of the device 10, or for wired data import and export to other computer devices connected to the USB cable of the port 306. In other embodiments, patient monitors such as pulse oximeters, heart rate monitors, etc., may be connected to the data port 306 via a USB cable to provide patient physiological data to the control circuitry of the device 10. A crossbar 308 is integrally formed with the rear wall 40 and protrudes from the rear wall above the data port 306 to provide some degree of protection to devices, modules, memory sticks, etc., connected to the data port 306 from falling objects.

[0442] Referring now to FIG7B, the components forming housing 12 are shown disassembled to reveal numerous components of device 10 located within housing 12. Tray 50 is also shown in FIG7B, but many of its components have been removed. As shown in FIG7B, the lower front wall portion 14b is integrally formed with most of the first and second sidewalls 32, 34 to form a single or integral front component 312 of housing 12. The upper front wall portion 14a is separately molded from component 312 and attached thereto with suitable fasteners (such as screws 313), as... Figure 8 As shown.

[0443] Referring again to Figure 7B, the bottom wall 36 of the housing 12 is integrally molded with the bottom regions of the walls 14b, 32, 34, and 40 to form a single or integral bottom tray 310 of the housing 12. The top wall 38, particularly the top wall portion 38', is integrally molded with the top regions of the first and second side walls 32 and 34 to form a single or integral top cover 314 of the housing 12. Finally, the rear wall 40 is integrally molded with the rear regions of the side walls 32 and 34 and the top wall 38 to form a single or integral rear component 316 of the housing.

[0444] Device 10 includes a chassis 318 that supports components of a pneumatic system 320 within an internal region of the housing 12 of the respiratory therapy device 10. Thus, the pneumatic system 320 is carried by the housing 12. The chassis 318 is supported by a bottom tray 310 and extends upward from the bottom wall 36 of the housing 12. The chassis 318 includes a first tower 322, a second tower 324, and a set of rods 326 interconnecting the towers 322, 324, as shown in FIG. 7B. Each tower 322, 324 includes a plurality of interconnected bent plates 328. A plurality of screws 329 interconnect the various bent plates 328 of the towers 322, 324 and also connect the towers 322, 324 to the rods 326.

[0445] The blower 260 of the pneumatic system 320 is attached to the first tower 322 by suitable fasteners (such as screws, not shown). The manifold and rotary valve assembly 330 of the pneumatic system 320 is attached to the second tower 324 by suitable fasteners (such as screws 332). A conduit 364 interconnects the outlet of the blower 260 with the inlet of the manifold and rotary valve assembly 330. A stepper motor 334, operable to rotate and oscillate the rotating plate of the manifold and rotary valve assembly 330, is also coupled to and supported by the second tower 324 of the housing 318. Further details of the construction and operation of the blower 260 and the manifold and rotary valve assembly 330 of the pneumatic system 320 are shown and described in U.S. Patent Application Publication No. 2018 / 0085541 A1 (see [link to patent application]). Figure 40 and 72 (and related discussions), the patent is incorporated herein in its entirety to the extent that it does not conflict with this disclosure, and this disclosure shall control any inconsistencies.

[0446] Referring again to Figure 7B, the main control board (MCB) 340 of the respiratory therapy device's control circuit is supported by the chassis 318 above the bottom wall 36 of the bottom tray 310 of the housing 12. (The following is in conjunction with...) Figure 16A-17C The various aspects of the MCB 340 will be discussed in further detail. The main control board 340 is sometimes referred to here as the printed circuit board assembly (PCBA) 340. Multiple screws 342 are used for interconnecting the bottom tray 310, front component 312, top cover 314, and rear component 316. Figure 78As shown. A similar screw 342 connects the upper front wall portion 14a to the front component 312. Figure 8 As shown. The display control panel (DCB) 350 is mounted on the back of the upper front wall portion 14a, as... Figure 8 As shown below. Figure 16A-17C The various aspects of DCB 350 will be discussed in further detail. The display control board 340 is sometimes referred to here as the printed circuit board assembly (PCBA) 350.

[0447] As shown in Figure 7B, a large rectangular box 336 is integrally formed with the rear wall 40 of the rear part 316 of the housing 12. The box 336 opens at the rear of the housing 12 and provides a battery compartment 226 for receiving the battery 224. If the battery 224 is omitted, the battery compartment 226 receives the battery compartment cover 226. The battery mating plate 338 is mounted on the generally vertical wall of the box 336 using suitable fasteners (e.g., screws 339 as shown in Figure 7B). When the battery 224 is inserted into the compartment 226 of the box 336, the electrical contacts of the battery 224 connect with mating electrical contacts exposed within the compartment 226 that are electrically connected to the circuitry of the battery mating plate 338.

[0448] The filter housing 254 is nested within a box-shaped socket 346, which is also integrally formed with the rear wall 40 of the rear part 316 of the housing 12, as shown in Figure 7B. A suitably sized space is provided between the top of the socket 346 and the bottom wall of the box 336, allowing a duct leading to the inlet of the blower 260 to connect to the filter housing 254 at its circular opening 348. As can also be seen in Figure 7B, a pair of AC contacts 271 and a pair of fuse contacts 273 extend from the rear of the power socket part 270 within the internal region of the housing 12. The cable 305 from the connector 304 to the MCB 340 is also shown in Figure 7B, but shows the cable 305 disconnected from the MCB 340.

[0449] Now refer to Figure 8The image shows the flow control module 352 explosively separated from the front portion 312 of the housing 12. The lower front wall portion 14b has a set of four columns 354 integrally formed with the lower front wall portion 14b and extending cantileveredly from it within the interior region of the housing 12. A set of four screws 356 are used to attach corresponding lugs 358 of the flow control module 352 to the distal ends of the columns 354. An elbow connector 360 is coupled to the inlet 362 of the flow control module 352. A conduit (not shown) leads along a predetermined route from the outlet of the manifold and rotary valve assembly 330 to the elbow connector 360. When mounted to the columns 354 by the screws 356, the outlet (not shown) of the flow control module 352 is connected to the flow passage 364 via port 24. The flow control module 352 sealably engages the distal end 366 of a generally cylindrical wall 368 around its outlet surface, which is integrally formed with the lower front wall portion 14b and extends from this portion into the interior region of the housing 12. An annular ridge 367 protrudes from the distal end 366 of the cylindrical wall 368 to reinforce the sealing engagement between the flow control module 352 and the distal end 366. In some embodiments, one or more seals or gaskets are inserted between the module 352 and the distal end 366 to further reinforce the sealing engagement between them.

[0450] The flow control module 352 includes one or more pressure sensors and flow sensors to sense the pressure and / or flow of compressed air flowing out of or into the outlet port 24 through the patient circuit 230. The pressure sensors and flow sensors are disposed on the flow element plate 370 of the module 352. An electrical connector 372 is located at one end of a ribbon cable 374 extending from the flow element plate 370, for example as... Figure 8 As shown. Connector 372 is connected to... Figure 17B The mating connector 376 is shown in the figure. Further details of the flow control module 352 are shown and described in U.S. Patent Application Publication No. 2018 / 0243518A1 (see details). Figures 9 to 12 (and related discussions), the patent is incorporated herein in its entirety to the extent that it does not conflict with this disclosure, and any inconsistencies shall be controlled by this disclosure.

[0451] Still refer to Figure 8A radio frequency identification (RFID) antenna 380 is disposed in the device 10 and mounted on an antenna boss 378 integrally formed with and projecting cantileveredly from the lower front wall portion 14b of the housing 12. More specifically, the antenna 380 has an annular portion 382 and a set of three ears 384 extending radially outward from the annular portion 382. The ears 384 are attached to the boss 378 using suitable fasteners such as screws (not shown, but similar to, for example, screw 356). The RFID antenna 380 also serves as a protrusion 386 extending from the annular portion 382 and a wire or cable 388 extending from the protrusion 386, such as... Figure 8 As shown. The terminal of power line 388 has an electrical connector 389, which is attached to the RFID reader of the control circuit of device 10, as will be described below. Figure 16A-17C Further detailed discussion is needed.

[0452] Now refer to Figure 9 The pneumatic patient circuit 230 has a filter unit 390, which is coupled to the proximal end 392 of the hose 225. In the discussion of the components of the patient circuit 230, the term "proximal end" will be used to refer to the end or end region of the component closest to the housing 12 of the respiratory therapy device 10, while the term "distal end" will be used to refer to the end or end region of the component furthest from the housing 12. In some embodiments, the hose 225 is a corrugated breathing hose approximately 120 cm (approximately 47 inches) long and with an inner diameter of 22 mm. The filter unit 390 includes a filter housing 394, which in turn includes a generally cylindrical first tubular portion 396 comprising the proximal end of the filter housing 394 and a generally cylindrical second tubular portion 398 comprising the distal end of the filter housing 394.

[0453] When the cap 26 is removed from port 24 to expose the flow passage 364, the first tubular portion 396 of the filter housing 394 presses against port 24. The proximal end 392 of the hose 225 is also generally cylindrical and presses against the second tubular portion 398 of the filter housing 394. If a smaller diameter hose (not shown) is used instead of hose 225 in the patient circuit 230, a cylindrical tubular portion 397 supported within the tubular portion 398 by an annular support ring 399 receives the proximal end of the smaller diameter hose in a press-fit manner. In the illustrative example, the tubular portion 397 and the support ring 399 are integrally formed with the tubular portion 398.

[0454] The filter housing 394 also includes a first generally truncated conical portion 400 extending from the first tubular portion. Figure 11 (best shown) and a second generally truncated conical portion 402 extending from the second tubular portion 398 (as shown) Figure 10-12(As shown). The first and second generally truncated conical portions 400, 402 meet at an engagement defining an annular apex 404 of the filter housing 394. The housing 394 also includes a shoulder wall portion 406 formed on the second generally truncated conical portion 402. Figure 11 As shown, the first and second tubular portions 396 and 398 are aligned along a common axis 408, and the outer diameter d1 of the first tubular portion 396 is larger than the outer diameter d2 of the second tubular portion 398. In some embodiments, the diameter d1 is approximately 25 mm and the diameter d2 is approximately 22 mm, within a tolerance range of ±0.2 mm. In some embodiments, the outer and inner diameters and taper of the tubular portions 396 and 398 conform to ISO standard 5356-1.

[0455] As shown in Figures 13A and 13B, the filter unit 390 also includes a filter 410 carried by a filter housing 394. The filter 410 is circular, with its outer periphery clamped between multiple housings connected together to form the filter housing 394. One housing member of the housing 394 includes a first tubular portion 396, a first truncated conical portion 400, an inner cylindrical flange 412 of an annular apex 404, and an interconnecting portion 400 of a first annular wall 413 with the flange 412, as shown in Figure 13B. Another housing member of the housing 394 includes a second tubular portion 398, a second truncated conical portion 402, a shoulder wall portion 406, an outer cylindrical flange 414 of an annular apex 404, and an interconnecting portion 402 of a second annular wall 415 with the flange 414, as shown in Figure 13B. The annular flange 412 is nested within the annular flange 414 and is attached to the annular flange by, for example, adhesive, radio frequency (RF) welding, or ultrasonic welding.

[0456] In some embodiments, housing 394 is made of styrene-acrylonitrile resin, but other materials with suitable strength and durability may be used if desired. The illustrative filter unit 390 is available from AM Systems, LLC of Sequim, Washington as part number 1192300. In some embodiments, filter 412 comprises white TECHNOSTAT. ® The filter screen material is a hydrophobic material with bidirectional airflow capability, a bacterial filtration efficiency (BFE) greater than 99%, and a viral filtration efficiency (VFE) greater than 99%. The filter unit 390 also has low flow resistance, achieving a flow rate of 60 liters per minute (LPM) and 1.5 centimeters of water column (cmH2O). Therefore, as shown by the bidirectional arrow 416 in Figure 13B, the filter unit 390 has flow channels 416.

[0457] like Figure 10 , 12As shown in 13A and 14, filter unit 390 includes a transponder ring 420 mounted on the annular shoulder surface 418 of shoulder wall portion 406, as... Figure 12 As shown in Figure 13B. The transponder ring 420 includes a transponder chip 422 embedded therein, as... Figure 14 and 15 As shown. In some embodiments, the transponder chip 422 is an integrated circuit chip with model number SRF55V 10P HC, which is available from Infineon Technologies AG in Neubiberg, Germany. However, other transponder chips may be used in other embodiments.

[0458] The transponder ring 420 of this illustrative embodiment has multiple annular ring layers stacked together. Specifically, the illustrative transponder ring 420 includes a surface material layer 424, an antenna 426, a substrate 428, an adhesive layer 430, and a backing layer 432. In the illustrative example, the surface material layer 424 comprises a white polyethylene terephthalate (PET) material with a thickness of approximately 50 micrometers. The antenna 426 comprises elements formed as shown in the image. Figure 14 The copper material layers of the many loop coils shown. In some embodiments, antenna 426 is a SMARTRAC™ 140_9 antenna available from Smartrac NV in Amsterdam, Netherlands.

[0459] like Figure 15 As shown, the transponder chip 422 is sandwiched between the surface material layer 424 and the antenna 426. In some embodiments, the substrate 428 is made of PET material. In some embodiments, the adhesive layer 430 comprises RA-2 adhesive. In some embodiments, the backing layer 432 comprises silicone paper or a backing paper with a silicone liner. The adhesive layer 430 is disposed on the substrate, and the backing layer 432 is attached to the adhesive layer such that the adhesive layer 430 is located between the backing layer 432 and the substrate layer 428. During the manufacture of the filter unit 390, the backing layer 432 is peeled off, exposing the adhesive layer 430. The transponder ring 420 without the backing layer 432 is then attached to the shoulder surface 418 of the shoulder wall portion 406 of the filter housing 394. When the transponder ring 420 is attached to the filter unit 390, the antenna 426 is positioned in conjunction with... Figure 8 The antenna 380 shown surrounds the flow channel 364 in a similar manner to surround the flow channel 416.

[0460] like Figure 17AAs shown, the RFID reader 434 provides power to the antenna 380 to transmit energy to the antenna 426 to power the transponder chip 422. By providing antennas 380 and 426 with similarly sized annular shapes, the orientation of the transponder chip 422 relative to the antenna 380 is not important when the filter unit 390 is attached to the outlet port 24 of the housing 12 of the respiratory therapy device 10. That is, the filter unit 390 can be coupled to the port 24 in any direction around the axis 408, and successful communication between the reader 434 and the transponder chip 422 via the antennas 380 and 426 is still possible.

[0461] The transponder chip 422 stores a usage counter that indicates the number of times the filter unit 390 has been used for previous treatments. (The following will be combined with...) Figure 29 , 78 Further detailed in sections 84 and 130, when filter unit 390 is attached to port 24 and respiratory therapy device 10 is activated to provide respiratory therapy to a patient, reader 434 reads the usage count stored in transponder chip 422 to confirm that the usage count is equal to or less than a threshold number, such as 70 or 90 uses, for example only. After providing respiratory therapy to the patient, reader 434 sends a signal to transponder chip 422 via antennas 380 and 426, incrementing the new data corresponding to the number of uses by 1. For a few arbitrary examples, the time threshold could be 2 minutes or 5 minutes.

[0462] Refer again Figure 9 The pneumatic patient circuit 230 includes various patient interfaces 436. For example, a patient interface includes a handheld portion 438 with a tubular connector 440 inserted into the distal end 393 of the tubular hose 225 until a stop ring 442 abuts the distal surface of the end 393. The handheld portion 438 is used for selectively attaching an exhalation valve funnel 444 or a blocking valve funnel 446. Each of the funnels 444 and 446 has a large, open proximal end that attaches to the distal open end of the handheld portion 438. Each of the funnels 444 and 446 also has a small, open distal end for attachment to other components of the patient interface 436, which will be discussed below.

[0463] The exhalation valve funnel 444 has a pair of exhalation ports leading to the atmosphere, for inhaling the surrounding environment during the patient's inhalation and allowing some of the patient's exhaled air to escape into the atmosphere through these ports. Therefore, during treatment, the exhalation ports prevent carbon dioxide from accumulating in the funnel 444 and the handheld portion 438. In the illustrative example, the exhalation port is formed as a channel through a finger-shaped tag 445 extending radially outward from a locking ring portion 447 integrally formed with the rest of the funnel 444. Thus, the tag 445 is used to rotate the funnel 444 between a locked position where the funnel 444 is secured to the handheld portion 438 and an unlocked position where it can be manually disengaged from the handheld portion 438.

[0464] The blocking valve funnel 446 has no additional opening to the atmosphere and is used when the respiratory therapy device 10 is operated in conjunction with a mechanical ventilator or life support ventilator (not shown) that provides any necessary communication with the ambient atmosphere during the patient's inhalation and exhalation phases. The funnel 446 rotates integrally with respect to the handle 438 between a locked position and an unlocked position in a manner similar to that of the funnel 444. Therefore, the funnel 446 also has a locking ring portion 447 integrally formed therewith, but the finger-shaped label 445 in the funnel 446 is omitted. Each funnel 444, 446 includes a mark on the locking ring portion 447 that aligns with a locking mark on the handle 438 when the corresponding funnel 444, 446 is locked to the handle 438; and aligns with an unlocking mark on the handle 438 when the corresponding funnel 444, 446 is unlocked from the handle 438.

[0465] like Figure 9 As shown, each funnel 444, 446 has a sprayer port 448 to which the outlet port 450 of the sprayer 160 is connected directly or via an adapter 452. The sprayer port 448 is located between the proximal and distal ends of the respective funnel 444, 446 and defines a channel that is typically perpendicular to the main channel through the funnel 444, 446 between the proximal and distal ends. In some embodiments, the adapter 452 is a 22mm × 22mm adapter with an outer diameter of 22mm at one end and an inner diameter of 22mm at the other end. An annular ridge or flange 454 separates the end region of the adapter 452. In some embodiments, the end region of the adapter 452 conforms to ISO standard 5356-1. When the sprayer 160 is not used with the funnels 444, 446, a sprayer port plug 456 is provided to close the sprayer ports 448 of the funnels 444, 446. The plug 456 includes a stop area 458 for press-fitting into the port 448 and a finger grip label 460, which the user grips to insert the plug 456 into the port 456 and remove the plug 456 from the port 456.

[0466] The tracheostomy adapter 462, breathing mask 464, and suction nozzle 466 are components of the patient interface 436, which can be selectively attached to the distal ends of funnels 444, 446 or the distal end region 393 of tubing 225 to form various configurations of the patient interface 436 of the respiratory therapy device 10. In an illustrative example, the tracheostomy adapter 462 includes a flexible adapter 468, a proximal adapter 470 attached to the proximal end of the flexible adapter 468, and a distal adapter 472 attached to the distal end of the flexible adapter 468. Adapter 470 is configured to attach to the distal end of funnels 444, 446, and adapter 472 is configured to attach to the patient's tracheostomy tube (not shown). When the tracheostomy adapter 462 is used, the flexible adapter 468 can elastically and flexibly adapt to the patient's movement.

[0467] The illustrative breathing mask 464 includes a flexible, elastic face cushion or cuff 474, which is sized and configured to surround the patient's nose and mouth when the mask 464 is pressed against the patient's face. The face cushion 474 is sometimes made of soft rubber or foam. The mask 464 also includes a mask frame 476, which is a more rigid component of the mask 464, for example, made of a generally rigid plastic material. The mask frame 476 is generally funnel-shaped, tapering from its larger distal end to its smaller proximal end. In some embodiments, one or more straps or harnesses (not shown) are attached to the mask frame 476 to hold the mask 464 over the patient's head, while the cushion 474 presses against the patient's face in a generally sealed manner. In the illustrative example, the mask 464 also includes a pneumatic port 478, which is integrally molded with the proximal end of the mask frame 476. The port 478 of the mask 464 is cylindrical and is pneumatically connected, either directly or using an illustrative adapter 452 (or an adapter of a different type), to the distal end of the corresponding funnel 444, 446 or the distal end region 393 of the hose 225, as determined by the user.

[0468] The mouthpiece 466 includes a cylindrical proximal end 480 and a somewhat flattened distal end 482, which the user places in their mouth during use. In the illustrative example, the proximal end 480 of the mouthpiece 466 is shown near the oxygen delivery adapter 484. The oxygen delivery adapter 484 includes a main cylindrical portion 486 and an L-shaped tube 488, which is smaller in diameter than the portion 484 extending from the middle region of the main cylindrical portion 486. The distal end of the L-shaped tube 488 is configured to connect to an oxygen line that supplies oxygen to the internal region of the main cylindrical portion 486 through an internal channel in the L-shaped tube 488. When no oxygen line is attached to the tube 488, a cap 489 is fastened to the portion 486 and attached to the distal end of the tube 488. The oxygen delivery adapter 484 can also be used with a face mask 464 or a tracheostomy adapter 464, at the user's discretion. Additional adapters 490, such as... Figure 9 As shown, the adapter 490 can be used with the suction nozzle 466, mask 464, or adapter 462 as needed for connection to other components of the patient circuitry 230. In some embodiments, the adapter 490 is a 22mm / 15F-15F adapter with an outer diameter of 22mm at one end and an inner diameter of 15mm at the opposite end.

[0469] It should be understood that, Figure 9 Various components are illustrated, which can be mixed and matched by the user as needed to create a variety of different types of patient interfaces 436 for pneumatic patient circuits 230. Those skilled in the art will also recognize that other patient interface components (e.g., T-connectors, elbow connectors, swivel connectors, etc.) and other types of adapters can be used as incorporated herein. Figure 9 The components of the patient interface 436 discussed herein are supplementary or alternative. Therefore, the terms “patient circuit” and / or “patient interface” as used herein are intended to cover the entire domain of conduit components that can be used as the airway from the main unit (e.g., housing 12 of device 10, ventilation equipment, CPAP machine, etc.) to the patient.

[0470] about Figure 9The hose 225 shown is specifically designed to have longer, non-corrugated proximal and distal end regions 392, 393 than typical off-the-shelf corrugated hoses used in respiratory therapy devices. This is because the corrugated section of the hose 225 between end regions 392, 393 has a narrower cross-section than the non-corrugated end regions 392, 393, and is therefore more fragile. It is certain that when removing an off-the-shelf corrugated hose, such as from a filter unit 390 or from a component of the patient interface (e.g., the handle 438), the user tends to grasp the weaker corrugated section. This results in the holes in the corrugated section of the off-the-shelf hose breaking or tearing. By extending the stronger, non-flexible end regions 392, 393 of the hose 225, the user can more easily grasp the end regions 392, 393 during removal of the patient circuit 230 without compromising the flexibility of the hose 225 in the corrugated section.

[0471] In an exemplary embodiment, the total length of the hose 225 is 1200 mm ± 13.0 mm, and the length of each non-corrugated end region 392, 393 is 76.2 mm ± 5.0 mm. Therefore, the length of the corrugated area of ​​the hose 225 is approximately 1050 mm ± 18.0 mm (1200 mm - 76.2 mm - 76.2 mm = 1047.6 mm). The outer diameter of the end regions 392, 393 of the hose 225 is 23.37 mm, and the inner diameter is 21.1 mm. In some embodiments, the end regions 392, 393 are constructed within their tolerances according to ISO standard 5367. In an illustrative example, the corrugation width is approximately 3.45 mm, and the corrugation spacing is approximately 7.62 mm. The tubular portion 398 of the filter unit 398 is inserted into the end region 392 of the hose 225, and the tubular connector 440 of the handle portion 398 is one of the components of the patient interface 436 inserted into the end region 393 of the hose 225. However, in some embodiments, the length of the end regions 392, 393 of the hose 225 is at least twice that of the tubular portion 398 and the tubular connector 440. Therefore, approximately 50% of the end regions 392, 393 remain unoccupied by any portion of the filter unit 390 and the patient interface assembly 436 inserted therein.

[0472] When using degree terms such as "approximately," "roughly," or "usually" in relation to features or measurements in this document, they mean at least within manufacturing tolerances and at most ±10% of the feature. Thus, to give just a few examples, approximately 90 degrees would cover the range of 81 to 99 degrees; 75% would cover 67.5% to 82.5%; and approximately vertical would cover ±9 degrees of vertical (e.g., vertical is 90 degrees of horizontal, and vice versa).

[0473] Therefore, the ratios of various dimensions can be determined based on the dimensions described in the preceding paragraph. For example, the ratio of the length of each end region 392, 393 to its outer diameter is approximately 3.26 (e.g., 76.2 ÷ 23.37 = 3.26); the ratio of the total length of the hose 225 to the length of the corrugated area is approximately 1.145 (e.g., 1200 mm ÷ 1047.6 mm = 1.145), and the ratio of the non-corrugated areas 392, 393 to the total length of the hose 225 is approximately 0.127 (e.g., (76.2 mm + 76.2 mm) ÷ 1200 mm = 0.127). In other words, the length of each end region 392, 393 is more than three times its outer diameter. Similarly, the non-corrugated end regions 392, 393 account for approximately 12.7% of the total length of the hose 225 (e.g., a ratio of 0.127 × 100). All other comparisons of the numerical data in the preceding paragraph in a similar manner are within the scope of this disclosure and are intended to illustrate the geometric aspects of hose 225. In some embodiments, hose 225 is made of polyolefin plastic (POP) material.

[0474] Further views of the hose 225, filter unit 390, handpiece 438, funnel 444, funnel 446, and plug 456 of pneumatic patient circuitry 230 are provided in U.S. Design Application No. 29 / 712,899, filed November 12, 2019. The entire contents of that application are incorporated herein by reference.

[0475] Now for reference Figures 16A-16D The control circuit 500 is illustrated together with other electrical components of the respiratory therapy device 10. Generally, any printed circuit board assembly (PCBA) and... Figures 16A-16D The components on the PCBAs in the document are all considered part of the control circuitry 500 of device 10. Some of these have already been mentioned earlier in this document. For example, the display control board 350, main control board 340, battery docking board 338, and flow element board 370 mentioned above constitute part of the control circuitry 500 of device 10. Figure 17A The RFID reader 434 shown is another example of part of the aforementioned control circuitry 500. Generally, components of device 10 that are electrically controlled and connected to the PCBAs are not considered part of the control circuitry 500 to some extent. These components include, for example, the blower 260, stepper motor 334, ventilation fan 276, and sprayer motor 144. Other components, such as the rechargeable battery 224, foot pedal 294, and other elements that can be selectively connected and disconnected from the respective PCBAs, may be considered part of the control circuitry 500 in some cases, but in others, depending on the context of the discussion.

[0476] refer to Figure 16AThe display control board (DCB) 350 of the control circuit 500 includes a microcontroller unit (MCU) and a peripheral section 502, which includes a microcontroller unit (MCU) 504. In this example, MCU 504 is a microcontroller with model number no. STM32 F429BIT6, which is available from STMicroonics NV in Amsterdam, Netherlands. Section 502 of the control circuit 500 also includes a real-time clock (RTC) circuit 506, an external monitoring circuit 508, an RFID interface circuit 510 including an I2C interface and a universal asynchronous transceiver (UART), a 16-megabyte (MB) synchronous dynamic random access memory (SDRAM) 512, a 128 MB flash memory 514, a miniature security digital card (SD) 516, diagnostic light-emitting diodes (LEDs) 518, a controller area network (CAN) transceiver 520, an electrically erasable programmable read-only memory (EEPROM) 522, and an on / off switch 42.

[0477] The display control board 350 also includes a display module interface section 524, which has a pulse width modulation (PWM) backlight 526, a capacitive touch panel (CTP) interface 528 for communication according to the I2C protocol, and a thin-film transistor (TFT) interface 530 for providing 24-bit red, green, and blue (RGB) display pixel color control. Figure 16A As shown, the illustrated example display 16 is a 7-inch Ultra Video Graphics Array (SVGA) liquid crystal display (LCD) with projected capacitive touch. Screen 16 is electrically connected to two interfaces 528 and 530.

[0478] Still referencing Figure 16A The display control board 350 also includes a communication section 532, which has a Bluetooth board assembly 534, a 1 x USB full-speed (FS) 2.0 (Type A) Wi-Fi / LTE connector 218, and a 1 x USB FS2.0 (Micro AB) service tool connector 538. The Wi-Fi / LTE module 540, as... Figure 40As shown, module 540 is configured for connection to connector 218. More specifically, in some embodiments, module 540 is simply a WiFi module, in other embodiments it is simply an LTE module, and in still other embodiments it is a combination of WiFi and LTE modules. When connected to connector 218, module 540 provides device 10 with the type of wireless communication (WiFi and / or LTE) as its name suggests. This disclosure is contemplated as module 540 being an option that device 10 may or may not have. If module 540 is included in device 10, then various configuration screens will be used to set up device 10 for WiFi or LTE wireless communication, as discussed below.

[0479] As mentioned above, connector 218 also serves as a firmware upgrade port for device 10. Therefore, as described above, top wall portion 38'' is removed from top wall portion 38' to allow connector 218 to connect to module 540. Furthermore, once module 540 is attached to connector 218, top wall portion 38'' is reattached to top wall portion 38', with module 540 located below top wall portion 38''. Figure 16A A service tool 536 is shown corresponding to a device attached to connector 218 for upgrading the firmware of control circuitry 500 of respiratory therapy device 10. Therefore, if module 540 is attached to connector 218, it is temporarily removed during the firmware upgrade process to allow service tool 536 to be attached to connector 218.

[0480] In the illustrative example, the SpO2 / barcode scanner 542 also... Figure 16A The diagram schematically illustrates communication with Bluetooth board assembly 534 according to the Bluetooth protocol. Although in Figure 16A The SpO2 / barcode scanner 542 is schematically shown as a block, but it should be understood that these are separate components, and the Bluetooth board assembly 534 is capable of wireless communication with the pulse oximeter (e.g., the SpO2 device) and the separate barcode scanner. Furthermore, while this document discusses wireless communication between the pulse oximeter and the control circuitry 500 of device 10, it should be understood that the same principle applies to other types of patient physiological monitors with Bluetooth communication capabilities. Examples of other such physiological monitors include cardiac monitors (including heart rate monitors) such as electrocardiograms (ECGs), respiratory rate monitors, blood pressure monitors, temperature sensors, blood glucose monitors, neurological monitors (e.g., electroencephalograms (EEGs),) and blood gas monitors (including meningeal monitors).

[0481] like Figure 16A As shown, the DCB 350 of the control circuit 500 includes a bacterial filtration detection section 544, which in turn includes an RFID board 546. In some embodiments, the RFID board 546 is connected to... Figure 17AThe RFID reader 434 shown, or included in other embodiments, is described above. The terminal 389 of the power line 388 extending from the tag 386 of the RFID antenna 380 is attached to the RFID reader 434 of the control circuitry 500 of the device 10 to communicate with the antenna 426 and transponder chip 422 of the filter unit 390. Figure 16A Further illustration shows that the blower 260 includes a three-phase brushless direct current (BLDC) motor 548, and a cable assembly 550 interconnects the DCB 350 with the MCB 340. A portion of the blower motor cable 552 is also included. Figure 16A It is shown schematically in the middle.

[0482] Referring now to Figure 16B, the DCB 350 also includes a debug section 554 with a UART 556 and a Joint TestAction Group (JTAG) circuit 558. The DCB 350 also includes a voltage supply section 560, which includes a DC-DC regulator and sense feedback 5V circuitry and / or chip 562, a 3.3V low-dropout (LDO) circuitry and / or chip 564, and a 9.6V backlight power supply boost circuitry and / or chip 566. A portion of the stepper motor cable 568 is also schematically shown in Figure 16B.

[0483] Now refer to Figure 16C The main control board (MCB) 340 of the control circuit 500 includes a microcontroller unit (MCU) and a peripheral section 570, which includes a microcontroller unit (MCU) 572. In the illustrative example, MCU 572 is a microcontroller with model number no. STM32 F429IIT6, which is available from STMicroonics NV in Amsterdam, Netherlands. Section 570 of the MCB 340 also includes external monitoring circuitry 574, an inlet temperature sensor sensing circuitry 576, a controller area network (CAN) transceiver 578, and a 64 KB EEPROM 580. A portion of cables 550 and 552 is also shown in Figure 16C.

[0484] The MCB 340 of the control circuit 500 also includes a blower motor driver and control circuitry 582, which in turn includes a Hall sensor interface 584 for receiving signals from a Hall effect sensor of the blower motor 548 of the blower 260 via a corresponding conductor of cable 552. The Hall effect sensor signal indicates the speed at which the blower motor 548 operates. Circuitry 582 also includes a current sensing circuitry 586 and a temperature sensing circuitry 588 to determine the current consumption and temperature of the blower motor 584, respectively. The MCB 340 also includes a debugging section 590 with UART 594 and JTAG circuitry 592.

[0485] Still referencing Figure 16C The MCB 340 of the control circuit 500 includes a power management section 596, which in turn includes a pre-charge circuit 598, a DC-DC regulator and sensing feedback 5V circuit and / or chip 600, a 3.3V LDO and sensing feedback circuit and / or chip 602, and a 12V LDO and sensing feedback circuit and / or chip 604. The power management section 596 also includes a battery enable control circuit 606, a power selector circuit 608, and a battery charging interface control circuit and / or chip 610. The power selector circuit 608 determines whether AC power or battery power is supplying power to the device 10 at any given time. The AC input 234 of the device 10 is connected to the 225-watt (W) / 24VDC open-type AC / DC power supply 612 of the control circuit 500 via an AC power line assembly 614 having a live wire and a neutral wire (L&N), as shown in Figure 16C. AC / DC power supply 612 is connected to the power management section 596 of MCB 340 via a 24 VDC cable assembly 616. As shown in Figure 16C, a rechargeable battery 224, detachably connected to a battery docking plate 338, is electrically connected to MCB 340 via a power cable assembly 618 and a signal or data cable assembly 620. Electrical contacts 621 between battery 224 and battery docking plate 338 are also... Figure 16C It is shown schematically in the middle.

[0486] As shown in Figure 16C, the flow element board 370 is connected to the MCB 340 via the illustrated cable 622. The flow element board 370 includes a pressure sensor 624, a flow sensor 626, and an inlet temperature sensor detection circuit or chip 628. The pressure sensor 624 is used to control and monitor the treatment delivered by the device 10 via port 24, and the inlet temperature sensor detection circuit or chip 628 senses the air temperature entering the inlet 362 of the flow control module 352. Since the respiratory therapy device 10 can generate positive and negative pressure at port 24 depending on the position of the rotating plate of the manifold and rotary valve assembly 330, it should be understood that air can be discharged from port 24 of the housing 12 when positive pressure is applied to the patient's airway, and air can enter the housing 12 through port 24 when negative pressure is applied to the patient's airway. Similarly, when positive pressure is applied to the patient's airway, air flows towards port 24 via the flow control module 352 in a first direction, and when negative pressure is applied to the patient's airway, air flows away from port 24 via the flow control module 352 in the opposite second direction. Therefore, outlet port 24 is sometimes used as inlet port 24, and inlet 362 of flow control module 352 is sometimes outlet of flow control module 352. Therefore, the use of the terms "outlet" and "inlet" in this document is generally based on the application of positive pressure to the patient's airway through device 10.

[0487] Now refer to Figure 16D The MCB 340 portion 570 also includes a barometric pressure sensor 630, diagnostic LEDs 632, and one or more buzzers 634 for audible signals indicating device status or alarm conditions. The MCB 340 also includes a stepper motor driver and control circuitry 636, which in turn includes an encoder interface 638, current sensing circuitry and / or chip 640, and temperature sensing circuitry and / or chip 642. A stepper motor cable 568 is connected to circuitry 636, such as... Figure 16D As shown. Encoder interface 638 receives a signal on cable 568 indicating the position of the output shaft of stepper motor 334, which corresponds to the position of the rotating plate of manifold and rotary valve assembly 330. Current sensing circuit 640 and temperature sensing circuit 642 are operable to determine the current consumption and temperature of stepper motor 334, respectively.

[0488] Continue to refer to Figure 16DThe control circuit 500's MCB 340 includes a foot pedal sensing circuit 644 electrically connected to connector 304 via a foot pedal cable assembly 646. Circuit 644 senses whether foot pedal 294 is connected to connector 304 via wire 300. MCB 340 also includes a treatment data loading / unloading section 648 connected to connector 306, exemplarily a 1X USB FS2.0 (Type A) connector as shown in block 650. Under the control of section 648, treatment data and settings are downloaded and uploaded to the device connected to connector 306.

[0489] The MCB 340 also includes a sprayer control interface section 652, which is connected to the sprayer 66 via connector 152 and cable 148, and this section has input / output (I / O) interface circuitry 654. Circuitry 654 receives on / off control inputs (I / P) from section 570 and transmits these inputs to the sprayer 66 to turn the motor 144 on and off. Circuitry 654 also transmits frequency outputs (O / P) and detection O / Ps to section 570. Figure 16D As shown, the MCB 340 of the control circuit 500 includes a fan drive circuit 656, which is connected to the ventilation fan 276 via a 4-wire fan control cable 658.

[0490] Now for reference Figures 17A-17C The circuit diagram of the control circuit 500 of the respiratory therapy device 10 is shown. Figures 17A-17C Showing with Figures 16A-16D Similar components, but with specific jumpers or electrical connectors for the control circuit 500 shown. Generally, Figures 17A-17C The electrical connectors in the diagram use the same reference numerals as Figures 16A-16D The corresponding part, circuit, or component (depending on the situation) is indicated by an apostrophe ('). Therefore, for example, in... Figure 17A In the figures, reference numeral 546' refers to the electrical connector of RFID board 546, and reference numeral 556' refers to the electrical connector of UART 556. An exception is if a particular electrical connector has been previously mentioned herein. A first example of such an exception is connector 376 (as shown in Figure 17B), which has been previously mentioned in this disclosure. Another example of such an exception is connector 304 (as shown in Figure 17B). Figure 17C (As shown) has been previously mentioned in this disclosure. Figure 17C As shown, a thermistor 660 is disposed in the sprayer 66 to measure the temperature of the motor 144. Power line 662 electrically connects the thermistor 660 to the thermistor connector 664 of the MCB 340.

[0491] In some embodiments, a thermistor 660 or another temperature sensor-like thermistor 660 is located within the interior region of the housing 12 and serves as a monitoring temperature sensor for all heating elements, such as the blower motor 548, stepper motor 334, sprayer motor 144, exhaust fan motor 276, and various circuit components of the control circuitry 500. That is, the monitoring temperature sensor monitors the overall thermal condition of the device 10. For example, this monitoring temperature sensor is connected to the upper surface of the bottom wall 36. In embodiments with a monitoring temperature sensor, other temperature sensors disclosed herein (e.g., thermistor 660) are omitted. If the temperature sensed by the monitoring temperature sensor reaches or exceeds a predetermined maximum temperature threshold, one or more components, such as the blower motor 548, stepper motor 334, and sprayer motor 144, are shut down. However, the control circuitry 500 continues to operate, thereby displaying an appropriate over-temperature alarm message on the GUI 16.

[0492] Now for reference Figure 18-274 The example shows screenshots of multiple navigation control screens displayed on the GUI 16 of the respiratory therapy device 10 and used to control the features and functions of the respiratory therapy device 10. Figure 18-274 The screenshots shown include various numerical values ​​and other information provided to illustrate the general concepts of the operation of device 10. Furthermore, it should be understood that GUI 16 is used to provide input to control circuitry 500 and to display information stored in or determined by control circuitry 500 during operation of device 10. Therefore, the information disclosed below in relation to... Figure 18-274 The features and functions related to the screenshot constitute a description of the software stored in and executed by the control circuitry 500 of the device 10.

[0493] Now refer to Figure 18 The main treatment selection screen 670 has a selectable mechanical inhalation / exhalation (MIE) button or icon 672 and a selectable oscillating lung expansion (OLE) button or icon 674. The terms "button" and "icon" are used interchangeably herein and are related to... Figure 18-274 Related refers to the portion of GUI 16 that is touched by the user to make selections or to provide input to the control circuitry 500 to perform functions. In response to a selection of button 672 on screen 670, the main MIE treatment selection screen 676 is displayed on GUI 16, such as... Figure 19 As shown. The main MIE treatment selection screen 676 includes a selectable automatic button 678 and a selectable manual button 680, used to select the automatic mode and manual mode of MIE treatment, respectively. If button 672 is selected on screen 676, GUI 16 will return to display screen 670.

[0494] In response to the selection on button 674 on screen 670, the main OLE treatment selection screen 682 is displayed on GUI 16, as shown below. Figure 20 As shown. The main OLE treatment selection screen 682 includes a selectable automatic button 684 and a selectable manual button 686, used to select the automatic and manual modes of OLE treatment, respectively. If button 674 is selected on screen 682, GUI 16 will return to display screen 670. Each of screens 670, 676, and 682 includes a menu open icon 688 on the right side of the corresponding screen. In response to selecting icon 688 on screens 670, 676, and 682, GUI 16 displays menu screen 690, as shown. Figure 21 As shown. In Figure 21 In the illustrative example, icon 688 is selected on screen 676, so a portion of screen 676 remains visible on screen 690, but is grayed out and inactive (i.e., cannot be selected). Screen 690 includes a vertical menu of icon 692 along the right side of GUI 16. The illustrative vertical menu of icon 692 includes, from top to bottom, the home icon 694, the graphic icon 696, the lung icon 698, the settings icon 700, and the information or help icon 702. The screens resulting from selecting any of icons 694, 696, 698, 700, and 702 will be discussed in further detail below.

[0495] In response to Figure 21 On screen 690, select the settings icon 700. Settings screen 704 will then be displayed on GUI 16, as shown below. Figure 22 As shown. The setup screen 704 includes a window 706 containing device information related to the respiratory therapy device 10. In this illustrative example, window 706 includes the following device information: device 10 model number, device 10 serial number, main control board (MCB) software (SW) version, MCB bootloader version, display control board (DCB) SW version, DCB bootloader version, Federal Communications Commission (FCC) ID number, radio frequency (RF) firmware (FW) version, Bluetooth FW version, total treatment runtime, and total nebulization time. Also in this illustrative example, a series of "X's" are given as placeholder text for each item listed in window 706. However, it should be understood that the appropriate information (e.g., alphanumeric text, numeric text, etc.) is given in the actual implementation of device 10.

[0496] In some embodiments, setting icon 700 and home icon 694 are... Figure 22 On screen 704, icons remain active, while icons 696, 698, and 702 are inactive and grayed out. Selecting the home icon 694 on screen 704 returns the user to... Figure 21 The screen is 690. Figure 21 The vertical menu of icon 692 provides a menu close label 708 to the left, and selecting this menu close label 708 will return the user to any of screens 670, 676, and 682. The menu open icon 688 is initially selected on this screen. Figure 22 When screen 704 is first displayed on GUI 16 in response to the selection of settings icon 700, the About button 710 under the settings title is highlighted with a green graphic frame 712. Window 706 is associated with the About button 710.

[0497] Device button 714, data button 716, and connection button 718 are also displayed under the "Settings" heading and can be navigated to other information and controls related to the operation of device 10, as will be discussed in further detail below. Each of buttons 714, 716, and 718 has its own graphic box 712, which changes color from black or gray to green. Black or gray indicates that button 714, 716, or 718 is not selected, while green indicates that the corresponding button 714, 716, or 718 has been selected. The Close Settings tab 720 is displayed. Figure 22 The buttons 716 and 718 are located to the left of the text and can be selected to return to the previous page. Figure 21 The screen 690. The screen 704 also includes a clinical access unlock button 721, which has a locked image in the unlocked state to indicate that the clinical access function of the device 10 has been unlocked.

[0498] If you choose Figure 19 The screen 676 has buttons 678, 680 or Figure 20 If either button 684 or 686 on screen 682 is pressed and the barcode scanning function of device 10 is activated, then... Figure 23 As shown, a barcode scanner is displayed on GUI 16 via screen 722. Screen 722 includes a window 724 with the text "CONNECTING..." flashing in it to indicate that the control circuitry 500 of device 10 is attempting to connect to the barcode scanner. In the illustrative example, the "CONNECTING..." text flashes once per second during the search process. Also in the illustrative example, a generic barcode scanner icon and a generic barcode are displayed in window 724 to convey to the user that device 10 is attempting to establish wireless communication with the barcode scanner.

[0499] If no connection to the barcode scanner occurs within a threshold time (e.g., approximately 15 seconds in some embodiments), then as Figure 24As shown, a device connection error screen 726 is displayed on GUI 16. Screen 726 includes a box 728 containing the text "DEVICE CONNECT ERROR". Below box 728, the following explanatory text is provided: "Bluetooth device is not connected or properly paired. Please press 'Return' to connect a Bluetooth device. Reference location: Settings > Connect > Bluetooth. If problems persist, contact customer support." Screen 726 includes a return button 730, which the user selects to navigate to a settings screen 704 to begin the process of navigating to the reference location indicated in the explanatory text of screen 726.

[0500] If the wireless connection between the control circuit 500 of device 10 and the barcode scanner occurs within a threshold time, the patient scanning screen 732 is displayed on the GUI, such as... Figure 25 As shown. Screen 732 includes a window 734 in which the text "SCAN PATIENT" flashes to instruct a caregiver with a barcode scanner to scan the barcode on a patient identification token (e.g., a wristband). In the illustrative example, the text "SCAN PATIENT" flashes once per second until a scan is detected. Also in the illustrative example, a generic barcode scanner icon and a generic barcode are displayed in window 734 to convey to the user that the barcode scanner should be used.

[0501] Bluetooth icon 731 is displayed in the header area of ​​screen 732, near clinical access unlock icon 733 and battery charging status icon 735, as shown. Figure 25 As shown. Icon 731 indicates that control circuitry 500 has successfully communicated with another device via Bluetooth technology. A back button 736 is also displayed in window 734 of screen 732. Selection button 736 allows the user to return to screen 676 or screen 682, depending on which screen has the corresponding button 678, 680, 684, 686 to initiate the barcode scanning process. In some embodiments, control circuitry 500 may return to user screen 676 or screen 682 if a threshold time (e.g., 15 or 30 seconds) is exceeded and no barcode is scanned by the barcode scanner.

[0502] For successfully scanned patient barcodes, GUI 16 displays as follows: Figure 26 The screen 738 shown is for scanning therapists. Screen 738 includes a window 740 where the text “SCAN THERAPIST” flashes to instruct a caregiver with a barcode scanner to scan a barcode on a therapist identification token, such as an employee ID. In the illustrative example, the text “SCAN THERAPIST” flashes once per second until a scan is detected. Also in the illustrative example, a generic barcode scanner icon and a generic barcode are displayed in window 740 to convey to the user that a barcode scanner should be used. Window 740 also includes a back button 736, which operates in conjunction with the above. Figure 25 The same as described in screen 732.

[0503] Figure 26 Window 740 of screen 738 includes a patient ID field 742, in which the patient ID is displayed based on a scanned patient barcode. Window 740 displays a patient icon 744 with the letter "P" to the right of field 742, indicating that field 742 is associated with a patient. The caregiver ID field 746 is displayed below field 742 in window 740 and is blank because the caregiver ID has not yet been scanned by a barcode scanner. Caregivers with barcode scanners can scan themselves if they are the caregivers responsible for using device 10 to provide respiratory therapy to patients, or caregivers with barcode scanners can scan another caregiver responsible for this task. Window 740 includes a caregiver icon 748 with the letter "RT" to the right of field 746, indicating that field 746 relates to a respiratory therapist, who is typically a type of caregiver using device 10 to provide respiratory therapy to patients.

[0504] For successfully scanned nursing staff barcodes, GUI 16 displays a review and confirmation screen 750, such as... Figure 27 As shown. Screen 738 includes window 752 where the text "REVIEW & CONFIRM" flashes, indicating that the patient ID and caregiver ID should be confirmed. In the illustrative example, the text "REVIEW & CONFIRM" flashes once per second until the confirmation button 754 is selected. Button 754 is in an inactive state, as... Figure 26 As shown, button 754 becomes active only when the caregiver's barcode is scanned. Figure 27 As shown. Therefore, in Figure 26 On screen 738, button 754 is displayed as gray, and then... Figure 27After the barcode is highlighted on screen 750, the caregiver's barcode is scanned. Similar to before, a universal barcode scanner icon and a universal barcode are displayed in window 752 to inform the user that the barcode scanning process is not yet complete. Window 740 also includes a back button 736, whose operation is consistent with the above. Figure 25 The same as described in screen 732.

[0505] like Figure 27 As shown, the caregiver ID is displayed in field 746 based on the scanned caregiver barcode. After the user (usually a caregiver) checks and confirms the information in fields 742 and 746, the user selects button 754 to proceed to the corresponding... Figure 19 and 20 The main treatment screen contains buttons 678, 680, 684, and 686 on screens 676 and 682, which are initially selected to begin the barcode scanning process. However, if the control circuit 500 detects an error related to the patient or caregiver ID displayed in fields 742 or 746, the GUI 16 displays as follows: Figure 28 The scan error screen 756 is shown. For example, if the first alphanumeric ID code displayed in domain 742 matches the second alphanumeric ID code displayed in domain 746, an unintentional duplicate scan of the same ID code has likely occurred. That is, the user may have scanned the patient ID twice or the caregiver ID twice. This error situation will result in... Figure 28 Screen 756 displays window 758, which in turn includes a box 760 with the text "SCANNING ERROR". Below box 760, the following explanatory text is provided: "THERE WANINPUT ERROR WHILE SCANNING. PLEASE PRESS 'RETURN' TO REPEAT THE SCANPROCESS. THIS WILL ENSURE PROPER DATA ENTRY". Screen 726 includes a return button 762, which is selected by the user to navigate back to... Figure 25 The patient's screen is scanned 734 to restart the barcode scanning process.

[0506] Assuming that before the barcode scanning process, in Figure 19 On the main MIE treatment selection screen 676, the automatic button 678 is initially selected, and then the barcode scanning process is successfully completed and... Figure 27 After selecting the confirmation button 754 on screen 750, the main MIE treatment screen 764 is displayed on GUI 16, as follows. Figure 29As shown. Alternatively, if the clinical access function of device 10 is disabled, making Figure 23-28 If the barcode scanning process shown is omitted, then in response to the selection... Figure 19 The automatic button 678 is located on screen 676, while screen 764 is displayed on GUI 16. In the illustrative example of screen 764, it is assumed that the operating parameters of the MIE treatment have been previously stored in the control circuit 500. Therefore, in the illustrative example, screen 764 displays by default the details of the automatic mode plan 1 settings for the MIE treatment.

[0507] like Figure 29 As shown, screen 764 includes a start button 766 and a stop button 768. The start button 766 is selected to initiate the relevant automatic MIE treatment, and the stop button 768 is selected to stop the relevant MIE treatment. Button 768 is displayed gray on screen 764 because the treatment is not currently being edited. Screen 764 also features an information graphic 770 and an information bar 772 in the form of a digital pressure gauge. Graph 770 displays numerical parameters for relevant parts of the automated MIE treatment, including inhalation pressure (+53 cmH2O in the illustrative example), exhalation pressure (-62 cmH2O in the illustrative example), inhalation time (2.8 seconds in the illustrative example), exhalation time (2.5 seconds in the illustrative example), treatment progress indicator 774 that moves along the curve shown in Graph 770 during the relevant treatment, pause pressure (+6 cmH2O in the illustrative example), pause time (3.2 seconds in the illustrative example), and cycle box 776 (one of four cycles in the illustrative example) showing the cumulative total number of cycles completed during the relevant treatment.

[0508] Figure 29 The bar 772 of screen 764 includes an upward arrow 778 serving as an inhalation pressure marker, a middle arrow 780 serving as a pause pressure marker, and a downward arrow 782 serving as an exhalation pressure marker. In some embodiments, the inhalation, exhalation, and pause portions of the MIE treatment are color-coded. In some embodiments, for example, the inhalation portion of the MIE treatment is coded in blue, the exhalation portion is coded in orange, and the pause portion is coded in green. Therefore, referring to... Figure 29 In the example screen 764, the text "INHALE+53" is blue, "EXHALE-62" is orange, and "PAP+6" is green. Similarly, the up arrow 778 is partially or entirely blue, the middle arrow 780 is partially or entirely green, and the down arrow 782 is partially or entirely orange. Screen 764 also includes a flow control button 784 in the lower right corner and a peak cough flow (P) indicator to the left of button 784. CFDomain 786 and the tidal volume (Vt) below domain 786 in domain 788. Figure 29-274 All figures in the document use "PCF" and "VT" instead of "P". CF " and " V t This is to meet the USPTO's drawing requirements. Similarly, for the same reason, throughout... Figure 29-274 Use “CMH2O” or “CMH2O” instead of “cm H2O”.

[0509] In response to Figure 29 When the start button 766 is selected on screen 764, the control circuitry of device 10 performs an RFID count check to confirm that filter unit 390 is equal to or below its usage count limit. As described above, reader 434 reads the usage count stored in transponder chip 422 of filter unit 390 to confirm that the usage count is equal to or below a usage threshold number (e.g., 70 or 90 uses). If the usage count is greater than the usage count limit, an error message is displayed on GUI 16, instructing the user to replace the old filter unit 390 with a new filter unit. In some embodiments, device 10 may prevent any respiratory therapy from being administered to any patient until filter unit 390 meets the usage count requirement (i.e., equal to or below the threshold limit).

[0510] If device 10 is operating on battery power, in response to Figure 29 On screen 764, the start button 766 is selected. The control circuitry of device 10 also checks the battery level of battery 224. If the battery level is less than or equal to 20% of its full charge, a message is displayed on GUI 16 as follows: Figure 30 The low battery screen 790 is shown. The low battery screen 790 includes a window 792 with a text box 794 containing the text "LOW BATTERY". Below the box 794 is the explanatory text "BATTERY ≤ 20%. CONNECT AC POWER TO START THE THERAPY. IF PROBLEM PERSISTS, PLEASE CONTACT CUSTOMER SUPPORT". A back button 796 is also provided in window 792. Selecting button 796 allows the user to return to... Figure 29 The screen 764. If device 10 is operating on AC power (e.g., plug 231 of cable 228 is plugged into an AC power outlet to power device 10), the battery power check is skipped.

[0511] If filter unit 390 passes the RFID count check, and if the battery level check passes after pressing start button 766 on screen 764 (or device 10 is operating under AC power), then as Figure 31 As shown, GUI 16 displays the automatic MIE treatment start screen 798. Figure 31 The screen 798 and Figure 29 The screen 764 is largely the same, except that the start button 766 on screen 764 is graphically transformed into the pause button 800 on screen 798. Furthermore, the stop button 768 on screen 798 is no longer grayed out and becomes active, while... Figure 29 Menu tab 688 is active on screen 764. Figure 31 The screen on screen 798 turned gray and became inactive.

[0512] Now refer to Figure 32 During the automatic MIE treatment performed by device 10, the automatic MIE treatment in progress screen 802 is displayed at any point in time. For example... Figure 32 As shown, the graphical treatment progress indicator 774 moves along the graphical waveform of graph 770 to indicate the current treatment progress. As shown in box 776, the ongoing treatment is currently in the second cycle of four cycles. For the current cycle, graph 770 is filled onto the progress indicator 774 to indicate the amount of the current treatment cycle completed. Thus, the inhalation zone 804 is filled in blue in some embodiments, and a portion of the exhalation zone 806 is filled in orange in some embodiments, up to the progress indicator 774. Therefore, the progress indicator 774 moves from left to right on graph 770 until it reaches the right end of the depicted cycle, and then restarts the next cycle at the left end of graph 770. Box 776 also increments at that point to the next cycle.

[0513] like Figure 32 As shown, an exhalation segment 808 is superimposed on bar 772 from 0 cmH2O to down arrow 782 to indicate that the treatment is currently in the exhalation phase. In some embodiments, bar 808 is color-coded orange to match the color of region 806. Screen 802 also displays a peak cough flow rate of 123 liters / minute in box 786 and a tidal volume of 440 milliliters (mL) in box 788. Therefore, in Figure 32 At the moment indicated on screen 802, the control circuit 500 of device 10 has accumulated enough data during automatic MIE treatment to calculate the peak cough flow value and tidal volume value, and fill boxes 786 and 788 with the calculated values.

[0514] In response to pressing the pause button 800 during automatic MIE treatment, the automatic MIE treatment pause screen 810 is displayed on the GUI 16, as shown below. Figure 33As shown. Screen 810 includes window 812 with a box 814 containing the text "THERAPY PAUSED". Below box 814 is explanatory text, which in an illustrative example indicates "AUTOMATIC THERAPY STOP IN 3 MINUTES". Below the explanatory text in window 812 is a timer 816 to indicate how long the treatment has been paused in some embodiments, or how much time remains before the treatment automatically stops in other embodiments. Therefore, timer 816 increments in some embodiments and decrements in other embodiments. After the pause button 800 is selected, it will convert to as shown in the image. Figure 33 The resume button 818 is shown. Therefore, the user can select the stop button 768 on the screen 810 to completely stop the treatment without having to wait for the three-minute pause period to pass, or the user can select the resume button 818 to resume the automatic MIE treatment.

[0515] In response to Figure 33 Selecting the restore button 818 on screen 810 restores the MIE auto-healing screen 820, which is displayed on GUI 16, for ...

Claims

1. A respiratory therapy device, including A housing having a hose port extending from the front wall of the housing and defining a pneumatic passage through the front wall. A tag reader, located within the housing, has a first antenna adjacent to the inner surface of the front wall and surrounding the hose port. A filter housing, sized to be coupled to the hose port, the filter housing having a filter receiving space between a filter inlet and a filter outlet, and a filter channel extending through the filter housing between the filter inlet and the filter outlet. A filter, which is located in the filter receiving space, A second antenna is coupled to the filter housing and surrounds the filter channel, and An identification ID chip, carried by the filter housing and coupled to the second antenna, is provided, wherein the tag reader is configured to read the ID chip via a wireless signal between the first antenna and the second antenna to determine that the filter housing is an authorized filter housing for use with the respiratory therapy device; in, The first antenna includes a substantially flat annular ring that is substantially parallel to the filter, and a set of mounting ears extending radially outward from the substantially flat annular ring.

2. The respiratory therapy device according to claim 1, wherein, The ID chip is an RF ID chip, and the wireless signal includes RF signals that communicate between the first antenna and the second antenna.

3. The respiratory therapy device according to claim 2, wherein, It also includes control circuitry located within the housing and electrically connected to the tag reader, the control circuitry being configured to command the operation of a pressure source located within the housing, the RF signal including data on the previous number of uses of the filter, and the control circuitry disabling the operation of the pressure source if the previous number of uses of the filter exceeds a threshold number of uses.

4. The respiratory therapy device according to claim 3, wherein, The control circuit is configured to command the tag reader to write new data to the RFID tag, the new data being transmitted from the second antenna to the first antenna, and the new data including a new total number of uses of the filter, the new total number of uses including the previous number of uses of the filter incremented by one.

5. The respiratory therapy device according to claim 4, wherein, If the number of times the filter has been used previously exceeds the threshold number of times it has been used, a notification is provided on the display and / or an alarm is triggered.

6. The respiratory therapy device according to claim 4, wherein, The tag reader is configured to use the first antenna to transmit energy to the second antenna to power the RFID tag.

7. The respiratory therapy device according to claim 1, wherein, The filter has a first substantially circular outer periphery with a first diameter, the second antenna has a second substantially circular outer periphery with a second diameter, and the first diameter is larger than the second diameter.

8. The respiratory therapy device according to claim 7, wherein, The second antenna is configured as a substantially flat ring and is substantially parallel to the filter.

9. The respiratory therapy device according to claim 8, wherein, The second antenna is sandwiched between the surface material and the substrate.

10. The respiratory therapy device according to claim 9, wherein, Both the surface material and the substrate are constructed into a substantially flat annular ring.

11. The respiratory therapy device according to any one of the preceding claims, wherein, The filter housing includes: a first tubular portion that is substantially cylindrical and includes the filter inlet; a second tubular portion that is substantially cylindrical and includes the filter outlet; a first substantially truncated conical portion extending from the first tubular portion; and a second substantially truncated conical portion extending from the second tubular portion. The first substantially truncated conical portion and the second substantially truncated conical portion intersect at a junction defining an annular apex of the filter housing. A shoulder wall portion is formed on the second substantially truncated conical portion, and the second antenna is mounted on the shoulder wall portion.

12. The respiratory therapy device according to claim 11, wherein, The first tubular portion and the second tubular portion are aligned along the axis of the filter channel, the shoulder wall portion includes a shoulder surface that surrounds the axis and is substantially perpendicular to the axis of the filter channel, and the second antenna is mounted on the shoulder surface.

13. The respiratory therapy device according to claim 12, wherein, The second antenna is formed as a generally flat annular ring mounted on the shoulder surface.

14. The respiratory therapy device according to claim 12, wherein, The filter comprises a substantially circular disk that is substantially parallel to the second antenna and the shoulder surface.

15. The respiratory therapy device according to claim 11, wherein, The filter comprises a substantially circular disk having an outer periphery adjacent to the annular apex of the junction.

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