U.S. patent application number 15/761796 was filed with the patent office on 2018-10-04 for maintenance systems and methods for medical devices.
The applicant listed for this patent is Dexter Chi Lun CHEUNG, Fisher & Paykel Healthcare Limited, Wenjie Robin LIANG. Invention is credited to Dexter Chi Lun CHEUNG, Ian Lee Wai KWAN, Wenjie Robin LIANG, Warushahennedige Hansinie SOYSA.
Application Number | 20180286510 15/761796 |
Document ID | / |
Family ID | 58386853 |
Filed Date | 2018-10-04 |
United States Patent
Application |
20180286510 |
Kind Code |
A1 |
KWAN; Ian Lee Wai ; et
al. |
October 4, 2018 |
MAINTENANCE SYSTEMS AND METHODS FOR MEDICAL DEVICES
Abstract
A maintenance system for a medical device includes a user device
configured to communicate with the medical device and execute
maintenance tasks on the medical device and communicate with a user
via a user interface of the user device or the medical device. The
maintenance tasks may be executed by either device or both devices,
and communication with a user may occur via a user interface of
either device or both devices. The system may also include a server
configured to communicate with one or both of the user device and
the medical device. The maintenance tasks may include an electrical
safety check, a physical check, a performance check, and a
functional check. Examples of functional checks include validation
of a transient current detector and a thermal cutout.
Inventors: |
KWAN; Ian Lee Wai;
(Auckland, NZ) ; SOYSA; Warushahennedige Hansinie;
(Auckland, NZ) ; LIANG; Wenjie Robin; (Auckland,
NZ) ; CHEUNG; Dexter Chi Lun; (Auckland, NZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LIANG; Wenjie Robin
CHEUNG; Dexter Chi Lun
Fisher & Paykel Healthcare Limited |
Auckland
Auckland
Auckland |
|
NZ
NZ
NZ |
|
|
Family ID: |
58386853 |
Appl. No.: |
15/761796 |
Filed: |
September 21, 2016 |
PCT Filed: |
September 21, 2016 |
PCT NO: |
PCT/NZ2016/050154 |
371 Date: |
March 20, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62221519 |
Sep 21, 2015 |
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62290819 |
Feb 3, 2016 |
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62321596 |
Apr 12, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
Y02A 90/10 20180101;
G06Q 30/0633 20130101; G16H 40/40 20180101; G06F 11/22 20130101;
G06F 17/40 20130101; G06Q 10/20 20130101 |
International
Class: |
G16H 40/40 20060101
G16H040/40; G06Q 30/06 20060101 G06Q030/06; G06F 11/22 20060101
G06F011/22 |
Claims
1. A maintenance system for a medical device, the maintenance
system comprising: a user device, the user device including a
processor and a user interface; and a server comprising a
processor; wherein the processor of the server is configured to:
establish a connection between a processor of the medical device
and the processor of the user device; generate user interface
information to cause one or more user interface elements to be
displayed by the user interface of the user device, the one or more
interface elements prompting a user at the user device to perform
an action; in response to the performed action, receive status
information from the processor of the medical device; using the
received status information, determine a status of a component of
the medical device; based upon the determined status, determine
whether the component is in need of replacement; and in response to
a determination that the component is in need of replacement,
automatically initiate an order for a replacement component for the
medical device.
2. The maintenance system of claim 1, wherein the processor of the
server is configured to automatically initiate an order for a
replacement component for the medical device by generating user
interface information to cause one or more user interface elements
to be displayed by a user interface of a second user device
associated with a second user, the one or more user interface
elements prompting the second user to confirm the order.
3. The maintenance system of claim 1, wherein the processor of the
server is further configured to generate user interface information
to cause the user to input one or more values at the user interface
of the user device, the one or more values used to perform one or
more diagnostic procedures on the medical device.
4. The maintenance system of claim 1, wherein the user device is
remote from the medical device.
5. The maintenance system of claim 1, wherein the status of the
component comprises a remaining operational life of the
component.
6. The maintenance system of claim 5, wherein determining whether
the component is in need of replacement comprises determining if
the remaining operational life of the component is under a
threshold value.
7. The maintenance system of claim 1, wherein the processor of the
server is further configured to determine whether the medical
device is associated with account information.
8. A maintenance system that provides automated maintenance for a
medical device, the maintenance system comprising: a processor
configured to execute one or more maintenance tasks for the medical
device and communicate with a user via a user interface.
9. The maintenance system of claim 8, wherein the processor is
housed within the medical device.
10. The maintenance system of claim 8, wherein the processor is
housed within a user device that is separate from the medical
device, the user device comprising a user interface, and wherein
the medical device comprises a separate processor.
11. The maintenance system of claim 10, comprising a server, the
server comprising a server processor, the server processor
configured to communicate with the processor of the medical
device.
12. The maintenance system of claim 10, comprising a server, the
server comprising a server processor, the server processor
configured to communicate with one or both of the processor housed
in the user device and the processor housed in the medical
device.
13. The maintenance system of claim 8, wherein each of the one or
more maintenance tasks comprises one of an electrical safety check,
a physical check, a performance check, or a functional check.
14. The maintenance system of claim 13, wherein a said electrical
safety check comprises evaluating the electrical functionality of
the medical device.
15. The maintenance system of claim 13, wherein a said physical
check comprises evaluating one or more physical aspects of the
medical device.
16. The maintenance system of claim 15, wherein the one or more
physical aspects of the medical device include a power cable, a
heater wire adapter, a housing, a front panel, a sensor cartridge,
or a general condition.
17. The maintenance system of claim 13, wherein a said performance
check comprises validating an operation of a system health
protection component of the medical device, the system health
protection component configured to respond to an unexpected
condition.
18. The maintenance system of claim 17, wherein at least one of the
user device and the medical device is configured to generate or
simulate an unexpected condition as part of validating the
operation of the system health protection component.
19. The maintenance system of claim 17, wherein the system health
protection component comprises a transient current detector.
20. The maintenance system of claim 17, wherein the system health
protection component comprises a thermal cutout.
21-53. (canceled)
Description
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 CFR 1.57.
FIELD OF THE DISCLOSURE
[0002] The present disclosure generally relates to maintenance
systems and methods for medical devices. More particularly, the
present disclosure relates to maintenance systems and methods that
enable a technician or other user to undertake maintenance tasks
associated with a respiratory assistance device.
BACKGROUND
[0003] To ensure reliability of a medical device, maintenance of
the device may be undertaken. Over the life of a medical device a
technician or other user may need to perform maintenance numerous
times. Maintenance ensures continued safe operation of the device,
as well as opportunities to diagnose any unexpected problems with
the device which can then be remedied. Failure to undertake
maintenance when recommended or required can lead to the medical
device functioning in an unsafe or suboptimal manner.
[0004] There are systems known in the art that are purpose-built
for performing limited maintenance tasks on medical devices. Such
systems can be expensive, difficult to update, and easy to
misplace.
SUMMARY
[0005] Maintenance systems and methods are disclosed that perform
maintenance tasks for medical devices. A maintenance system may
connect or communicate with a medical device, such as a respiratory
humidifier. A maintenance system may execute, or enable or assist
in the execution of a maintenance task related to a medical device,
such as a diagnostic test. A maintenance task may involve user
input or it may be autonomous.
[0006] A maintenance system for a medical device may comprise one
or more aspects of the medical device and/or one or more aspects of
a user device. A user of the maintenance system may interact with a
user interface of the medical device and/or a user interface of the
user device. The maintenance system may execute a maintenance task
comprising a maintenance check, including at least one of an
electrical safety check, a physical check, a functional check, and
a performance check. A result of the maintenance check, and any
associated information, may be displayed to the user via the user
interface. The result may be communicated to and/or stored on a
device, such as one or more of the medical device, the user device,
a server, or another device such as a storage device.
[0007] A maintenance system may execute one or more maintenance
tasks on a medical device without the use of a user device or a
server, unless otherwise stated. The one or more maintenance tasks
may be executed on a user interface located on the medical
device.
[0008] A maintenance system for a medical device may execute, for
example, a maintenance task comprising a maintenance check to
validate correct operation of a system health protection component
associated with a medical device, such as a transient current
detector. A system health protection component is sometimes
referred to as a fault protection component, and for the purposes
of this disclosure the two terms should be considered
interchangeable.
[0009] A maintenance system for a medical device may execute, for
example, a maintenance task comprising a maintenance check to
validate proper functioning of a component, such as a thermal
cutout device for a heater associated with a medical device.
[0010] A maintenance system for a medical device may execute one or
more maintenance tasks, including but not limited to multiple
maintenance tasks in sequence, multiple maintenance tasks in
synchrony, or any combination thereof. A maintenance task may
comprise one of the maintenance checks disclosed herein or another
maintenance check, or other action, suitable for maintenance of a
medical device.
[0011] According to at least one aspect of the present disclosure,
a maintenance system for a medical device can have one, some, or
all of the following features, as well as other features described
herein. The medical device comprises a processor and a user
interface. The maintenance system comprises a user device, the user
device comprising a processor and a user interface. The processor
of the user device is configured to communicate with the processor
of the medical device. At least one of the processor of the user
device and the processor of the medical device is configured to
execute one or more maintenance tasks on or for the medical device.
At least one of the processor of the user device and the processor
of the medical device is configured to receive information from or
provide information to a user via at least one of the user
interface of the user device and the user interface of the medical
device.
[0012] The maintenance system may comprise a server, the server
comprising a processor. The server may comprise a user interface.
The processor of the server may be configured to communicate with
at least one of the processor of the user device and the processor
of the medical device. The processor of the server may be
configured to execute one or more maintenance tasks on or for the
medical device. The processor of the server may be configured to
receive information from or provide information to a user via at
least one of the user interface of the user device, the user
interface of the medical device, and the user interface of the
server. Each of the one or more maintenance tasks may comprise one
of an electrical safety check, a physical check, a performance
check, or a functional check. The functional check may comprise
validating the operation of a system health protection component of
the medical device. The system health protection component may be
configured to respond to an unexpected condition. An unexpected
condition is sometimes referred to as a fault condition, and for
the purposes of this disclosure the two terms should be considered
interchangeable. At least one of the user device and the medical
device may be configured to generate or simulate an unexpected
condition as part of the functional check. The system health
protection component may comprise a transient current detector. The
system health protection component may comprise a thermal cutout
device. The functional check may comprise validating the operation
of one or more mechanical components of the medical device. The one
or more mechanical components may comprise a touch screen, a
button, a color display, a speaker, and a light-emitting diode.
[0013] According to at least one aspect of the present disclosure,
a method of validating the operation of a system health protection
component of a medical device can have one, some, or all of the
following features, as well as other features describe herein. The
system health protection component is configured to respond to an
unexpected condition. The method comprises generating the
unexpected condition. The method comprises determining a response
of the system health protection component to the unexpected
condition. The method comprises reporting the response to a user
via a user interface. A method is sometimes referred to as a
process, and for the purposes of this disclosure the two terms
should be considered interchangeable.
[0014] The system health protection component may comprise a
transient current detector. Generating the unexpected condition may
comprise generating a transient current or an overcurrent.
Determining the response of the transient current detector may
comprise determining whether the transient current detector has
activated a current interrupter. The system health protection
component may comprise a thermal cutout. Generating the unexpected
condition may comprise supplying power to a heating element.
Determining the response of the thermal cutout may comprise
repeatedly determining whether the thermal cutout has tripped or
whether a timer has exceeded a predetermined maximum time value.
The method may comprise, after determining that the thermal cutout
has tripped, instructing a user to reset the thermal cutout
device.
[0015] A maintenance system may function to replace hardcopy
versions of a Product Technical Manual (PTM) by providing access to
PTM content through the user interface of the user device, the user
interface of the medical device, or the user interface of the
server. A benefit of a maintenance system that replaces hardcopy
versions of a PTM includes the ability to update the content of the
PTM and verify the version of the PTM over the Internet. Hospital
maintenance staff currently must rely on hardcopy versions of the
PTM when performing maintenance tasks for medical devices. Updates
to the content of a hardcopy PTM currently require the delivery of
a hardcopy version of the updated PTM to hospital maintenance
staff. Alternatively, an electronic document of the updated PTM may
be emailed to the hospital maintenance staff. However, either
method requires reliance on the hospital staff to replace the
older, non-updated version of the PTM with the version of the PTM
containing the updated content. A maintenance system capable of
updating the PTM over the Internet provides the opportunity to
update the content of the PTM and verify the version of the PTM
without having to rely on the hospital maintenance staff.
Furthermore, a maintenance system provides additional benefits,
such as reducing the number of manual tasks required to be
performed by the hospital maintenance staff, automatically
gathering data and preparing a maintenance report for review, and
assuring uniformity of prepared maintenance report data over time
and across hospital maintenance staff, hospital wards, and
hospitals, in general.
[0016] According to one aspect, there is provided a maintenance
system for a medical device. The maintenance system comprises a
user device, the user device including a processor and a user
interface; and a server comprising a processor; wherein the
processor of the server is configured to establish a connection
between a processor of the medical device and the processor of the
user device; generate user interface information to cause one or
more user interface elements to be displayed by the user interface
of the user device, the one or more interface elements prompting a
user at the user device to perform an action. Further, the
processor of the server is configured to, in response to the
performed action, receive status information from the processor of
the medical device; using the received status information,
determine a status of a component of the medical device; based upon
the determined status, determine whether the component is in need
of replacement; and in response to a determination that the
component is in need of replacement, automatically initiate an
order for a replacement component for the medical device.
[0017] The processor of the server may be configured to
automatically initiate an order for a replacement component for the
medical device by generating user interface information to cause
one or more user interface elements to be displayed by a user
interface of a second user device associated with a second user,
the one or more user interface elements prompting the second user
to confirm the order.
[0018] The processor of the server may further be configured to
generate user interface information to cause the user to input one
or more values at the user interface of the user device, the one or
more values being used to perform one or more diagnostic procedures
on the medical device.
[0019] The user device may be remote from the medical device.
[0020] The status of the component may comprise a remaining
operational life of the component. In which case, determining
whether the component is in need of replacement may comprise
determining if the remaining operational life of the component is
under a threshold value.
[0021] The processor of the server may further be configured to
determine whether the medical device is associated with account
information.
[0022] According to one aspect, there is provided a maintenance
system that provides automated maintenance for a medical device.
The maintenance system comprises a processor configured to execute
one or more maintenance tasks for the medical device and
communicate with a user via a user interface.
[0023] The processor may be housed within the medical device.
Alternatively, the processor may be housed within a user device
that is separate from the medical device, the user device
comprising a user interface, and wherein the medical device
comprises a separate processor. In this latter case, the
maintenance system may comprise a server, the server comprising a
server processor, the server processor configured to communicate
with the processor of the medical device. The maintenance system
may further comprise a server comprising a server processor, the
server processor configured to communicate with one or both of the
processor housed in the user device and the processor housed in the
medical device.
[0024] Each of the one or more maintenance tasks may comprise one
of an electrical safety check, a physical check, a performance
check, or a functional check. Such an electrical safety check may
comprise evaluating the electrical functionality of the medical
device. Such a physical check may comprise evaluating one or more
physical aspects of the medical device. The one or more physical
aspects of the medical device may include a power cable, a heater
wire adapter, a housing, a front panel, a sensor cartridge, or a
general condition.
[0025] Such a performance check may comprise validating an
operation of a system health protection component of the medical
device, the system health protection component being configured to
respond to an unexpected condition.
[0026] At least one of the user device and the medical device may
be configured to generate or simulate an unexpected condition as
part of validating the operation of the system health protection
component.
[0027] The system health protection component may comprise a
transient current detector and/or a thermal cutout.
[0028] The functional check may comprise validating an operation of
one or more mechanical components of the medical device. The one or
more mechanical components may comprise a touch screen, a button, a
color display, a speaker, and a light-emitting diode.
[0029] The maintenance system may be configured to execute multiple
maintenance tasks in sequence, multiple maintenance tasks in
synchrony, or any combination thereof.
[0030] According to one aspect, there is provided a maintenance
system for a medical device, the medical device comprising a user
interface; and a processor configured to execute one or more
maintenance tasks on or for the medical device and receive
information from or provide information to a user via the user
interface.
[0031] The maintenance system may comprise a server, the server
comprising a processor, the processor of the server configured to
communicate with the processor of the medical device.
[0032] Each of the one or more maintenance tasks may comprise one
of an electrical safety check, a physical check, a performance
check, or a functional check. The electrical safety check may
comprise evaluating the electrical functionality of the medical
device. The physical check may comprise evaluating one or more
physical aspects of the medical device. The one or more physical
aspects of the medical device may include a power cable, a heater
wire adapter, a housing, a front panel, a sensor cartridge, or a
general condition. The performance check may comprise validating an
operation of a system health protection component of the medical
device, the system health protection component being configured to
respond to an unexpected condition. At least one of the user device
and the medical device may be configured to generate or simulate an
unexpected condition as part of validating the operation of the
system health protection component. The system health protection
component may comprise a transient current detector and/or a
thermal cutout. The functional check may comprise validating an
operation of one or more mechanical components of the medical
device. The one or more mechanical components may comprise a touch
screen, a button, a color display, a speaker, and a light-emitting
diode.
[0033] The maintenance system may be configured to execute multiple
maintenance tasks in sequence, multiple maintenance tasks in
synchrony, or any combination thereof.
[0034] According to one aspect, there is provided a method of
executing one or more maintenance tasks for a medical device, the
medical device comprising a processor and a user interface. The
method comprises establishing a connection with the processor of
the medical device; generating user interface information to cause
one or more user interface elements to be displayed by a user
interface of a user device, the one or more interface elements
prompting a user of the user device to perform an action; receiving
status information from the processor of the medical device in
response to the action; and recording the received status
information.
[0035] The method may comprise determining if the one or more
maintenance tasks has recently been performed. The one or more
maintenance tasks may comprise one of an electrical safety check, a
physical check, a performance check, or a functional check.
[0036] The physical check may comprise evaluating one or more
physical aspects of the medical device. In this case, the method
may comprise instructing the user to inspect the medical device for
one or more issues with one or more physical aspects of the medical
device; and prompting the user to input a result or a description
of the one or more issues. The one or more physical aspects of the
medical device may include a power cable, a heater wire adapter, a
housing, a front panel, a sensor cartridge, or a general
condition.
[0037] The method may comprise prompting a user to set up the
maintenance task; determining whether the user properly set up the
maintenance task; executing the maintenance task; and displaying
one or more results of the maintenance task to the user via the
user interface.
[0038] A said electrical safety check may comprise evaluating the
electrical functionality of the medical device. In this case, the
method may comprise determining whether the electrical safety check
passed; presenting the user with one or more troubleshooting
suggestions via the user interface in response to an electrical
safety check failure; and prompting the user to indicate whether
the one or more troubleshooting suggestions identified the reason
for the electrical safety check failure.
[0039] A said functional check may comprise validating an operation
of one or more mechanical components of the medical device. The one
or more mechanical components may comprise a touch screen, a
button, a color display, a speaker, and a light-emitting diode.
[0040] The method may comprise executing a speaker test; executing
a therapy touch screen test; determining whether the therapy touch
screen test passed; executing a mute touch screen test in response
to passing the therapy touch test; executing a color display test;
and executing a light-emitting diode test.
[0041] A said performance check may comprise validating an
operation of a system health protection component of the medical
device, the system health protection component configured to
respond to an unexpected condition. At least one of the user device
and the medical device may be configured to generate the unexpected
condition.
[0042] The system health protection component comprises a transient
current detector, in which case, the method may comprise generating
an unexpected condition; determining whether the transient current
detector recognized the unexpected condition; and displaying one or
more results of the performance check to the user via the user
interface.
[0043] The system health protection component may additionally or
alternatively comprise a thermal cutout. In this case, the method
may comprise supplying power to a heating element; and determining
whether the thermal cutout tripped in response to supplying power
to the heating element. The method may further comprise resetting
the thermal cutout in response to the thermal cutout being tripped;
resupplying power to the heating element; determining whether the
thermal cutout reset; and displaying one or more results of the
performance check to the user via the user interface.
Alternatively, the method may comprise determining whether the
thermal cutout failed to trip; and displaying one or more results
of the performance check to the user via the user interface in
response to the thermal cutout failing to trip.
[0044] The method may comprise using the received status
information to determine a status of a component of the medical
device; and determining whether the component is in need of
replacement based upon the determined status.
[0045] The status of the component may comprise a remaining
operational life of the component. In this case, determining
whether the component is in need of replacement may comprise
determining if the remaining operational life of the component is
under a threshold value.
[0046] The method may comprise determining whether the medical
device is associated with an account information. The method may
comprise prompting the user to order a replacement component for
the medical device in response to a determination that the
component is in need of replacement and/or automatically initiating
an order for a replacement component for the medical device in
response to a determination that the component is in need of
replacement. Automatically initiating an order for a replacement
component for the medical device may comprise generating a user
interface information to cause one or more user interface elements
to be displayed by a user interface of a second user device
associated with a second user, the one or more user interface
elements prompting the second user to confirm the order.
[0047] The action may comprise the user to input one or more
parameters at the user interface of the user device, the one or
more parameters being used to perform one or more diagnostic
procedures on the medical device.
[0048] The user device may be remote from the medical device.
[0049] The method may comprise executing multiple maintenance tasks
in sequence, multiple maintenance tasks in synchrony, or any
combination thereof.
[0050] For purposes of summarizing the disclosed systems and
apparatus, certain aspects, advantages and novel features of the
disclosed systems and apparatus have been described herein. It is
to be understood that not necessarily all such advantages may be
achieved in accordance with any particular embodiment of the
disclosed systems and apparatus. Thus, the disclosed systems and
apparatus may be embodied or carried out in a manner that achieves
or optimizes one advantage or group of advantages as taught herein
without necessarily achieving other advantages as may be taught or
suggested herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0051] These and other features, aspects, and advantages of the
present disclosure will be described with respect to the following
figures, which are intended to illustrate and not to limit the
preferred embodiments.
[0052] FIG. 1 shows an example block diagram of a maintenance
system comprising a medical device and a user device.
[0053] FIG. 2A shows an example block diagram of a maintenance
system comprising a medical device, a user device, and a
server.
[0054] FIG. 2B shows another example block diagram of a maintenance
system comprising a medical device, a user device, and a
server.
[0055] FIG. 2C shows a view of an example medical device.
[0056] FIG. 3 shows an example flowchart of a method for executing
an electrical safety check of a medical device.
[0057] FIG. 4 shows an example flowchart of a method for executing
a physical check of a medical device.
[0058] FIG. 5 shows an example flowchart of a method for performing
a functional check of a medical device.
[0059] FIG. 6 shows an example flowchart of a method for performing
a functional check of a transient current detector (TCD) of a
medical device.
[0060] FIG. 7 shows an example flowchart of a method for performing
a functional check of a thermal cutout of a medical device.
[0061] FIG. 8A shows an example block diagram of a maintenance
software application.
[0062] FIG. 8B shows an example block diagram of software modules
of a client component.
[0063] FIG. 9 shows an example block diagram of a maintenance
system where the user device communicates with a medical device
through a server.
[0064] FIG. 10 shows a flowchart of an example process for ordering
replacement components for a medical device, based upon received
status information of the medical device.
[0065] FIG. 11 shows another flowchart of an example process for
ordering replacement components for a medical device, based upon a
received status information of the medical device.
[0066] FIG. 12 shows a flowchart of an example process for
adjusting production based upon analyzed usage trends of medical
devices.
DETAILED DESCRIPTION
[0067] FIG. 1 shows an example of a maintenance system 100
comprising a medical device 105 and a user device 110. The medical
device 105 may comprise, for example but without limitation, a
humidifier, a ventilator, a positive air pressure (PAP) device, a
gases characteristic monitoring device, a high flow therapy device,
or an insufflator. In particular the medical device is a humidifier
that is configured to humidify respiratory gases prior to delivery
to a patient. The humidifier is a non life supporting device, and
is used as part of a respiratory humidification system, in
conjunction with a ventilator and suitable medical tubing. The user
device 110 may comprise, for example but without limitation, a
computer, a mobile phone, a tablet, or any other consumer
electronics device. The medical device 105 may communicate with the
user device 110. In some embodiments, the medical device 105 may
include a plurality of medical devices. In some embodiments, the
user device 110 may include a plurality of user devices. The
medical device 105 and the user device 110 each may include a
processor 115 and a processor 120, respectively.
[0068] In some embodiments, one or more maintenance tasks
associated with the maintenance system 100 may be executed on the
user device 110 by the processor 120 as well as on the medical
device 105 by the processor 115. In some embodiments, all of the
maintenance tasks associated with the maintenance system 100 may be
executed on the medical device 105 by the processor 115. In some
such embodiments, the maintenance system 100 may not include the
user device 110; the medical device 105 may include a user
interface 125, and the medical device 105 may display information
on the user interface 125. In other such embodiments, the
maintenance system 100 may include the user device 110, the user
device 110 may include a user interface 130, and the user device
110 may show information on the user interface 130.
[0069] A maintenance system for a medical device may also include a
server. FIG. 2A shows an example of a maintenance system 200
comprising a medical device 205, a user device 210, and a server
212. The medical device 205 may communicate with one or both of the
user device 210 and the server 212. The server 212 may communicate
with the medical device 205 and/or the user device 210 through a
direct connection, through a local area network, or through a wide
area network such as the Internet. The medical device 205 and/or
the user device 210 can send information to the server 212, or the
server 212 can retrieve information from the medical device 205
and/or the user device 210. In some embodiments, each of the
medical device 205, the user device 210, and the server 212 may
communicate with any or all of the other two of the medical device
205, the user device 210, and the server 212.
[0070] In some embodiments, the medical device 205 may include a
plurality of medical devices. In some embodiments, the user device
210 may include a plurality of user devices. In some embodiments,
the server 212 may include a plurality of servers. In some
embodiments, the maintenance system 200 includes at least one
server 212, at least one medical device 205, and at least one user
device 210. The medical device 205, the user device 210, and the
server 212 each may include a processor 215, a processor 220, and a
processor 222, respectively. The medical device 205 and the user
device 210 each may include a user interface 225 and a user
interface 230, respectively. In some embodiments, the server 212
may include a user interface 232.
[0071] In some embodiments, one or more maintenance tasks may be
executed on the user device 210 by the processor 220 and/or on the
server 212 by the processor 222. In some embodiments, one or more
maintenance tasks may be executed on the medical device 205 by the
processor 215. In some embodiments, the server 212 can undertake
one or more of the functions of the user device 210. The server 212
may store data locally or in an external data store such as,
without limitation, a database. In some embodiments, the medical
device 205 and/or the user device 210 may send a result of a
maintenance task, or additional information relevant to the
maintenance task, to the server 212. In some embodiments, the
server 212 may retrieve a result of a maintenance task, or
additional information relevant to the maintenance task, from the
medical device 205 and/or from the user device 210.
[0072] In some embodiments, one or more maintenance tasks disclosed
herein may be executed on a medical device 105, 205 without the use
of the user device 110, 210 or the server 212. The medical device
105, 205 may include executable instructions that permit a user to
interact directly with the medical device 105, 205 and execute one
or more maintenance tasks via the user interface 125, 225 located
on the medical device 105, 205. In some embodiments, the medical
device 105, 205 may compile the results of one or more maintenance
tasks into a report. This report may include information obtained
by the processor 115, 215 during execution of the maintenance task,
or from a storage device associated with the medical device 105,
205. This information may include the name of a user who initiated
the test and any notes the user may have entered via, for example,
the user interface 125, 225. In some embodiments, the report may
include a graph showing information obtained by the processor 115,
215 during the maintenance task. The report may include a history
of alarms for the medical device 105, 205. The report may include
information relating to the status of the medical device 105, 205
or of components associated with the medical device 105, 205. The
report may be saved on a storage device associated with the medical
device 105, 205 and later retrieved from the storage device. In
some embodiments, the processor 115, 215 may send the report to a
printer to be printed. In some embodiments the report may be
displayed on the user interface 125, 225. In some embodiments the
report may be accessed from the server 212 as an electronic report.
In some embodiments the report may be emailed or texted or
transmitted to the user in an appropriate electronic format.
[0073] Each of one or more maintenance tasks associated with the
maintenance system 100, 200 may include a series of acts. In some
such embodiments, one or more of the series of acts for each of the
one or more maintenance tasks may be executed on the medical device
105, 205 by the processor 115, 215 and/or on the user device 110,
210 by the processor 120, 220. In some such embodiments, one or
more of the series of acts for each of the one or more maintenance
tasks may be executed on the server 212 by the processor 222.
[0074] Acts for maintenance tasks associated with the maintenance
system 100, 200 can be executed concurrently or sequentially on any
or all of the medical device 105, 205, the user device 110, 210,
and/or the server 212. In some embodiments, the acts can be
synchronized between the medical device 105, 205 and the user
device 110, 210. In some embodiments, the acts can be synchronized
between the medical device 205, the user device 210, and/or the
server 212. For example, a maintenance task may include a series of
acts and some of the series of acts may be executed on the medical
device 205 and others of the series of acts may be executed on the
user device 210 or the server 212. In some embodiments, execution
of one or more maintenance tasks, or one or more of a series of
acts for one or more maintenance tasks, on the user device 110, 210
by the processor 120, 220 may reduce the computational load on the
processor 115, 215 of the medical device 105, 205. In some
embodiments, execution of one or more maintenance tasks, or one or
more of a series of acts for one or more maintenance tasks, on the
user device 210 by the processor 220 and/or on the server 212 by
the processor 222 may reduce the computational load on the
processor 215 of the medical device 205. Such an arrangement may
also extend the capability of the maintenance system 100, 200, as
it may be easier to add functionality to the user device 110, 210
or to the server 212, such as for example, updating or upgrading
software or replacing hardware, than to make changes to the medical
device 105, 205.
[0075] The medical device 105, 205, the user device 110, 210,
and/or the server 212 may communicate with each other via
connections that include wired connections, wireless connections,
combinations of wired and wireless connections, and/or connections
based on any other suitable technology. In some embodiments, one or
more of the connections may include a serial cable, for example but
not limited to a universal serial bus (USB) cable. In some
embodiments, one or more of the connections may include a wireless
connection, for example but not limited to a cellular (for example,
Global System for Mobile Communications or GSM), Bluetooth, or
Wi-Fi connection. A wireless connection may be provided by
technology (for example, a chip or chipset) integrated into one or
more of the medical device 105, 205, the user device 110, 210, or
the server 212. In some embodiments, a wireless chip or chip set
may be built into one or more of the medical device 105, 205, the
user device 110, 210, or the server 212. A wireless connection may
be provided by an external device (for example, a "dongle" or other
such device connectible via, for example, a USB port) connected to
one or more of the medical device 105, 205, the user device 110,
210, or the server 212. One skilled in the art would appreciate
that other implementations of wireless connections are
possible.
[0076] One or more of the user interfaces 125, 225, 130, 230, 232
may be used by a user to perform actions, including but not limited
to controlling the maintenance system 100, 200, providing
information to the maintenance system 100, 200, and receiving
information from the maintenance system 100, 200 regarding results
of any maintenance tests or checks. One or more of the processors
115, 215, 120, 220, 222 may execute user interface software
comprising instructions that cause information to be displayed on,
or retrieved from, the user interface 125, 225, 130, 230, 232,
respectively. One or more of the processors 115, 215, 120, 220, 222
may execute user interface software to cause at least one screen to
be displayed on one or more of the user interfaces 125, 225, 130,
230, 232. In some embodiments, the at least one screen may be
generated by the processor 222 of the server 212, and the processor
220 of the user device 210 and/or the processor 215 of the medical
device 205 may retrieve the at least one screen from the server 212
and then display the at least one screen to the user on the user
interface 225 or the user interface 230. In some embodiments, the
at least one screen may be generated by the processor 115, 215 of
the medical device 105, 205, and the processor 220 of the user
device 210 may retrieve the at least one screen from the medical
device 105, 205 and may then display the at least one screen to the
user on the user interface 125, 225. In some embodiments, the
processor 120, 220 of the user device 110, 210 may both generate
and display the at least one screen. In some embodiments, the at
least one screen may include a web page.
[0077] A user may be able to remotely view status information about
the medical device 105, 205 on the user interface 130, 230, 232 of
the user device 110, 210 or the server 212, respectively. As a
result, a user is not required to be physically located near the
medical device 105, 205 to access status information of the medical
device 105, 205. This is particularly useful when the maintenance
system 100, 200 comprises more than one medical device 105, 205, as
a user can view status information of the more than one medical
device 105, 205 at the same time. For example the user interface
130, 230 may be configured to provide a multi pane view, wherein
each pane on the user interface 130, 230 displays the status of a
particular medical device 105, 205. The processor 120, 220 may
execute appropriate user interface software to generate the multi
pane view on the user interface 130, 230 respectively.
[0078] For instance, FIG. 2B shows an example of the maintenance
system 200 wherein the medical device 205, the user device 210, and
the server 212 communicate through various different local and wide
area connections. The medical device 205 and the user device 210
may be local to each other and communicate through a direct
connection (for example, through a serial cable such as a USB
cable, a wireless connection such as Bluetooth, and/or the like) or
through a local area network such as a hospital network 240. In
some embodiments, the medical device 205 and/or the user device 210
may be connected to the Internet 250, either directly or indirectly
(for example, through the hospital network 240). In addition, the
server 212 may be located remotely from the hospital and
communicate with the hospital network 240, the medical device 205,
and/or the user device 210 through the Internet 250. As such, a
user may be able to view status information for the medical device
205 locally through the user interface 130 of the user device 210,
or remotely through the user interface 232 of the server 212. In
some embodiments, a remote user at the server 212 may need to be
authenticated (for example, through the hospital network 240)
before being able to access and communicate with the medical device
205 and/or the user device 210.
[0079] In some embodiments, a user may need to perform one or more
authentication procedures to access the user interface 125, 225,
130, 230, 232. The one or more authentication procedures may be
determined by authentication software executed by one or more of
the processors 115, 215, 120, 220, 222. The one or more
authentication procedures may involve interaction by a user with
one or more of the medical device 105, 205, the user device 110,
210, or the server 212 using a physical dongle, an RFID tag, a
biometric scanner, a keypad for entering a password or passcode, or
any other suitable authentication technology.
[0080] As an example of the medical device 105, 205, FIG. 2C shows
a respiratory humidifier 5. As an example of the user interface
125, 225 of the medical device 105, 205, the respiratory humidifier
5 includes a user interface 9. In the present disclosure the
medical device as referred to may also refer to the respiratory
humidifier 5, and the user interface may also refer to the
interface 9 on the respiratory humidifier 5. The user interface 9
is an example of the user interface 125, 225. In one configuration
the user interface 9 is a touch screen that allows a user to input
information or commands by touching the screen with the user's
finger or a suitable stylus. Alternatively the user interface 9 may
include a set of buttons or knobs or other suitable actuation
elements that can be actuated by the user to input information or
commands. The respiratory humidifier 5 also includes a coupleable
component or a removabley component. In the illustrated
configuration of FIG. 2C the coupleable component is a sensor
cartridge 6. The sensor cartridge 6 includes one or more integrated
sensors. The sensors may be temperature sensors or flow sensors or
a combination of temperature and flow sensors. The one or more
sensors may be inserted into a gases flow path such. For example
the sensors may be inserted into the inspiratory limb 3, or into
the humidification chamber 4. In one exemplary configuration the
sensor cartridge comprises at least a temperature sensor that
aligns with or is inserted into an inlet port of the humidification
chamber 4, and the sensor cartridge further comprising at least a
temperature sensor and a flow sensor that aligns with or is
inserted into an outlet port of the humidification chamber 4. An
expiratory limb 2, an inspiratory limb 3, and a humidification
chamber 4 may be removably attached to the respiratory humidifier 5
in preparation for or while providing therapy to a patient. As
described above, in some embodiments one or more maintenance tasks
may be executed on the respiratory humidifier 5 in cooperation with
the user device 210 and/or the server 212. In some embodiments, one
or more maintenance tasks may be executed by the respiratory
humidifier 5 without the user of the user device 110, 210 or the
server 212. In some embodiments, the user can interact with the
user interface 9 to cause the respiratory humidifier 5 to perform
one or more maintenance tasks. The respiratory humidifier 5 may
also comprise a chip or chip sets to allow wireless communication
with the server 212 and/or the user 210. The respiratory humidifier
5 includes suitable electronics hardware and a processor and a
memory unit. The maintenance tasks may be stored as a executable
software on the memory unit, and the processor being configured to
execute the software to cause the respiratory humidifier 5 to
perform one or more maintenance tasks. The respiratory humidifier 5
may be configured to generate a report of the maintenance tasks
performed and the results of the maintenance tasks. The respiratory
humidifier 5 may transmit the report to the user device 110, 210 or
to the server 212. Alternatively the respiratory humidifier 5 may
transmit the generated report to a printer, such as for example a
printer within a hospital via the hospital network. In a further
configuration the sensor cartridge 6 may include at least a memory
unit and may further include a processor that is configured to
cause the respiratory humidifier 5 to perform one or more
maintenance tasks.
[0081] One or more of the user interfaces 125, 225, 130, 230, 232,
9 may also display status information of the medical device 105,
205. Status information about the medical device 105, 205 may
include at least one of a model number, a serial number, or a
software version related to the medical device 105, 205, 5; the
remaining lifetime of a consumable component associated with the
medical device 105, 205; the time elapsed since the last
maintenance check of the medical device 105, 205; a history of
alarms for the medical device 105, 205; and an operational state of
the medical device 105, 205, for example whether or not the medical
device 105, 205 is currently being used to provide therapy to a
patient. For example, the user interface 9 may display status
information about the respiratory humidifier 5, including, among
other information as previously described, the remaining lifetime
of the sensor cartridge 6. In some embodiments, the status
information displayed on the one or more of the user interfaces
125, 225, 130, 230, 232 may also be recorded by the processor 115,
215, 120, 220, 222 on a storage device associated with the medical
device 105, 205, the user device 110, 210, or the server 212 after
the user device 110, 210 is disconnected from the medical device
105, 205.
[0082] A maintenance task associated with the maintenance system
100, 200 may include a maintenance check, including but not limited
to at least one of an electrical safety check, a physical check, a
functional check, or a performance check. A maintenance check may
be executed on a regular or semi-regular basis or at the discretion
of a user. A maintenance check may be undertaken annually,
bi-annually, weekly or at any other frequency. In some embodiments,
an execution frequency of a maintenance check may be defined by a
user. In some embodiments, an execution frequency of a maintenance
check may be pre-defined, for example, during manufacture or
configuration of the medical device 105, 205, the user device 110,
210, or the server 212. In some embodiments, a maintenance check
may be executed at a discrete time set by the user.
[0083] In some embodiments, the processor 115, 215, 120, 220, 222
may record results of maintenance tasks associated with the
maintenance system 100, 200 on a storage device associated with the
medical device 105, 205, the user device 110, 210, or the server
212. In some embodiments, the processor 115, 215, 120, 220, 222 may
use the recorded results to determine when to display a reminder on
the user interface 125, 225, 130, 230, 232 to remind a user that a
maintenance task is due. The reminder may provide a user with an
option to initiate the maintenance task by, for example, providing
input via the user interface 125, 225, 130, 230, 232. In some
embodiments, the processor 115, 215, 120, 220, 222 may
automatically initiate the maintenance task. The processor 115,
215, 120, 220, 222 may initiate the maintenance task during a
start-up sequence of the medical device 105, 205. In some
embodiments, the processor 115, 215, 120, 220, 222 may use an
operational state of the medical device 105, 205 to determine
whether to initiate the maintenance task. For example, the
processor 115, 215, 120, 220, 222 may wait until the medical device
105, 205 is in a standby or sleep state - such as when the medical
device 105, 205 is not providing therapy to a patient - to initiate
the maintenance check. The processor 115, 215, 120, 220, 222 may
display a message on the user interface 125, 225, 130, 230, 232
instructing a user to confirm that the medical device 105, 205 is
not providing therapy to a patient before the maintenance task is
initiated.
[0084] In some embodiments, the processor 115, 215, 120, 220, 222
may compile the results of one or more maintenance tasks associated
with the maintenance system 100, 200 into a report. This report may
include information obtained by the processor 115, 215, 120, 220,
222 during execution of the maintenance task, or from a storage
device associated with the medical device 105, 205, the user device
110, 210, or the server 212. This information may include the name
of a user who initiated the test and any notes the user may have
entered via, for example, the user interface 125, 225, 130, 230,
232. In some embodiments, the report may include a graph showing
information obtained by the processor 115, 215, 120, 220, 222
during the maintenance task. The report may include a history of
alarms for the medical device 105, 205. The report may be saved on
a storage device associated with the medical device 105, 205, with
the user device 110, 210, or with the server 212 and later
retrieved from the storage device. In some embodiments, the
processor 115, 215, 120, 220, 222 may send the report to a printer
to be printed. In some embodiments the report may be displayed on
the user interface 125, 225, 130, 230, 232.
[0085] In some embodiments, a maintenance task may include user
interaction. A maintenance task may include an act wherein the
processor 115, 215, 120, 220, 222 displays a message on the user
interface 125, 225, 130, 230, 232 requesting a user to take an
action or provide information needed for the maintenance task. A
maintenance task may include an act wherein the processor 115, 215,
120, 220, 222 allows a user to enter notes via the user interface
125, 225, 130, 230, 232. Such notes may be included in a report. In
some embodiments, a maintenance task may not require user
interaction. The processor 115, 215, 120, 220, 222 may execute such
a maintenance task autonomously.
[0086] A maintenance task may include one or more entry conditions
and one or more exit conditions. In some embodiments, the processor
115, 215, 120, 220, 222 may be able to automatically detect an
entry condition or an exit condition. In some embodiments, the
processor 115, 215, 120, 220, 222 may need to be informed of an
entry condition or an exit condition by user input via, for
example, the user interface 125, 225, 130, 230, 232. An entry
condition may be an event or state upon which the commencement of a
maintenance task is contingent. For example, an entry condition may
include the engagement of an electrical and/or pneumatic connector,
the engagement of a coupleable component, or the cooling to a
predetermined temperature of a heating element of the medical
device 105, 205. In some embodiments, the processor 115, 215, 120,
220, 222 may display a message on the user interface 125, 225, 130,
230, 232 instructing a user to take an action that will cause an
entry condition to be satisfied. For example, the processor 115,
215, 120, 220, 222 may display a message on the user interface 125,
225, 130, 230, 232 instructing a user to engage a coupleable
component with the medical device 105, 205. An exit condition may
be an event or state which, at least temporarily, causes a
maintenance task to cease. For example, an exit condition may
include the disengagement of an electrical and/or pneumatic
connector, the disengagement of a coupleable component, the
detection of an alarm, or the loss of a data connection between at
least two of the medical device 105, 205, the user device 110, 210,
and the server 212.
[0087] An electrical safety check may include validation of correct
and safe operation of one or more electrical components of the
medical device 105, 205. An electrical safety check may have
requirements specific to the operating locale of the medical device
105, 205. For example, local or national laws or regulations may
include differing electrical safety requirements. In some
embodiments, an electrical safety check may include an act wherein
the processor 115, 215, 120, 220, 222 displays a message on the
user interface 125, 225, 130, 230, 232 instructing a user to
perform one or more acts of the electrical safety check as
specified by local or national laws or regulations. An electrical
safety check may include an act wherein the processor 115, 215,
120, 220, 222 displays a message on the user interface 125, 225,
130, 230, 232 instructing a user to input a result of the one or
more acts of the electrical safety check performed by the user. The
user may be instructed to indicate success or failure, provide
measurements, or otherwise describe the result. An electrical
safety check may include an act wherein the processor 115, 215,
120, 220, 222 displays an image and/or an animation on the user
interface 125, 225, 130, 230, 232 showing how to connect a probe of
an electrical safety tester to the medical device 105, 205 to
perform an electrical safety test. The user interface 125, 225,
130, 230, 232 may also display a caution to the user indicating
areas where the safety tester probe is not to be connected.
[0088] FIG. 3 is a process 300 for executing an electrical safety
check of a heater base used by the medical device 105, 205
according to an embodiment of the present disclosure. At block 305
the process 300 begins. In some embodiments, an electrical safety
check is recommended or required to be performed on a periodic
basis, such as for example, annually. Accordingly, at block 310 the
process 300 determines whether a recent (periodically required)
safety check of the medical device 105, 205 has already been
performed. In some embodiments, an inquiry may be presented to the
user, who may be a maintenance technician, via the user interface
125, 225, 130, 230, 232, and the user may input a response to the
inquiry via the user interface 125, 225, 130, 230, 232 as well. If
the user indicates, or the process 300 otherwise determines that
the periodically required safety check of the medical device 105,
205 has been completed, the process 300 advances to block 330,
where results of the safety check are presented.
[0089] If the user indicates, or the process 300 otherwise
determines that the periodically required safety check of the
medical device 105, 205 has not been completed, then the process
300 advances to block 315, where the user is prompted to set up the
electrical safety check. In some embodiments, the electrical safety
check requires the use of an external electrical safety tester
having one or more probes. Illustratively, by way of non-limiting
example, such a probe may be placed in electrical communication
with the heater plate of the medical device 105, 205 to be used to
test the electrical safety of the heater plate operation. The
electrical safety tester may be provided by the user, who may be a
maintenance technician trained and equipped to conduct such tests.
In some embodiments, the user interface 125, 225, 130, 230, 232
displays instructions on how to connect or attach the one or more
probes of the electrical safety tester to the medical device 105,
205. In some embodiments, the user interface provides reference
and/or access to country-specific or region-specific standards or
regulations that apply to electrical safety checks of the medical
device 105, 205 being checked. In some embodiments, the user
interface 125, 225, 130, 230, 232 displays a message, including for
example, a modal message. As described previously the message may
be displayed on the user interface 9. The modal message can
include, such as for example, a pop-up window, to disconnect
certain connections to the medical device 105, 205. For example,
the modal message may request the user to disconnect a USB null
modem cable connected to medical device 105, 205 before executing
the electrical safety check. The modal message may instruct to user
to ensure that the user device 110, 210 is also disconnected from
the medical device 105, 205 when the electrical safety check is
performed. Such disconnection may be required to avoid damaging
components of or in communication with the medical device 105, 205
during the electrical safety check.
[0090] At block 320, the process 300 determines whether the
electrical safety check is set up properly. In some embodiments,
the determination is made by receiving input from the user. In some
embodiments, one or more of the processors 115, 215, 120, 220, 222
may determine whether the safety check set up is complete. If the
process 300 determines that the electrical safety check set up is
not complete, then the process returns to block 315 to prompt the
user to set up the electrical safety check. In some embodiments,
the user interface 125, 225, 130, 230, 232 may provide a plurality
of instructions and/or troubleshooting guides to assist the user in
setting up the electrical system check. Once the process 300
determines that the electrical safety check is set up properly, the
process 300 advances.
[0091] At block 325, the electrical safety check is executed. In
some embodiments, the processor 115, 215 controls the electrical
circuitry of the medical device 105, 205 to perform one or more
acts that exercise the electrical functionality of the medical
device 105, 2015. In some embodiments, the user may be prompted to
provide input as requested by the external electrical safety tester
and/or the user interface 125, 225, 130, 230, 232.
[0092] At block 330, the results of the electrical safety check are
presented via the user interface 125, 225, 130, 230, 232. In some
embodiments, the results may be stored in a memory device that may
be located in the medical device 105, 205, in the user device 110,
210, in the server 212, or in an external memory device.
[0093] At block 335, the process 300 determines whether the
executed electrical safety check has passed. If the electrical
safety check passes, then the process 300 ends at block 355. If the
electrical safety check fails, then the process 300 advances to
block 340, where the process 300 presents, via the user interface
125, 225, 130, 230, 232, troubleshooting suggestions for
determining the cause of the electrical safety check failure. In
some embodiments, the user interface 125, 225, 130, 230, 232
displays a series of suggestions for the user to explore, and after
each suggestion, the user may provide a response indicating whether
or not that particular suggestion identified the reason for the
electrical check failure. At block 345, the process 300 determines
whether the reason for failure of the electrical safety check is
understood or repairable. If it is, the process 300 returns to
block 310 to restart the electrical safety check. If at block 345,
the process 300 determines that the reason for failure of the
electrical safety check is not known or cannot be repaired, the
process 300 advances to block 350, where a manufacturer service
representative is contacted to identify the source of the
failure.
[0094] If performance of the electrical safety check according to
process 300 is interrupted, a message, such as a modal message, may
be displayed to the user indicating an interruption has occurred.
In some embodiments, if the electrical safety check is
re-established, the electrical safety check may continue from the
point at which the interruption occurred. In some embodiments, the
electrical safety check may start over at block 305.
[0095] Performance of the electrical safety check is not limited to
the order and number of steps described in the process 300. While
the electrical safety check according to the process 300 describes
the execution of a series of steps in a particular sequence, the
individual steps may be performed in any order, unless otherwise
specified. Additionally, performance of the electrical safety check
does not require execution of all the steps described in the
process 300. In some embodiments, the electrical safety check may
include additional steps not described in the process 300. In some
embodiments, the electrical safety check may not include all steps
described in the process 300. One or more steps of the process 300
may be executed by any one of or any combination of the processors
115, 215, 120, 220, 222 or other processors residing in the same
devices or other devices.
[0096] A physical check may include validation of correct and safe
operation of one or more physical aspects of the medical device
105, 205. In some embodiments, a physical check may include an act
wherein the processor 115, 215, 120, 220, 222 displays one or more
messages on the user interface 125, 225, 130, 230, 232 instructing
a user to look for physical defects or other issues in or on the
medical device 105, 205. In another example the message may be
displayed on the touch screen 9 of the respiratory humidifier 5.
The message may instruct the user to conduct an external inspection
of the medical device 105, 205. The message may in the form of
animations. In some embodiments, the message may instruct the user
to at least partially remove one or more components and/or housing
panels to access internal areas of the medical device 105, 205. A
physical check may include an act wherein the processor 115, 215,
120, 220, 222 displays one or more messages on the user interface
125, 225, 130, 230, 232 instructing a user to input a result or
description of the one or more acts of the physical check performed
by the user. The user may be instructed to indicate success or
failure, provide measurements, or otherwise describe the physical
check. In some embodiments, the user input indicates whether the
physical condition of the aspect being checked is in acceptable or
unacceptable condition. In some embodiments, the user interface
125, 225, 130, 230, 232 provides guidance on what to check for
regarding physical damage to the medical device 105, 205. For
example, the user interface 125, 225, 130, 230, 232 may ask if the
user has have already performed the checks by following the
instructions in the patient manual. If so, the application will ask
for the results. In some embodiments, checkboxes may be provided on
the user interface 125, 225, 130, 230, 232 to allow the user to
enter the results of the physical inspections. If the user has not
completed the physical check already, then the application will
provide instructions that guide the user through checking various
physical aspects of the medical device 105, 205. In some
embodiments, the user device 110, 210 or the server 212 does not
interact with the medical device 105, 205 to perform the physical
check; instead, the user is prompted on the user interface 125,
225, 130, 230, 232 to inspect and assess the physical condition of
the medical device 105, 205. In some embodiments, pass/fail buttons
or equivalents thereof are provided to the user to enter the status
of the physical characteristics being assessed by the user. In some
embodiments, a text panel is provided to permit the user to enter
comments about the status of the physical characteristics of the
medical device 105, 205 being checked. In an further alternative
embodiment the medical device 105, 205 may be configured to perform
a part or all of the physical check by checking for appropriate
conditions such as for example whether a chamber is correctly
connected, whether an inspiratory limb 3 is correctly connected,
whether an expiratory limb is correctly connected and so on.
[0097] FIG. 4 is a process flow diagram of a process 400 for
executing a physical check of the medical device 105, 205 according
to an embodiment of the present disclosure. At block 405, the
process 400 begins. In some embodiments, a physical check is
recommended or required to be performed on a periodic basis, such
as for example, annually. In some embodiments, the maintenance
system 100, 200 provides guided instructions for the user to follow
in performing the physical check of the medical device 105, 205. It
is possible that the user, such as for example, a maintenance
technician, does not need to use the provided guided instructions
based on, for example, training and/or experience in performing
such physical checks of the medical device 105, 205. Accordingly at
block 410, the process 400 determines whether the physical check of
the medical device 105, 205 has already been performed. In some
embodiments, an inquiry may be presented to the user, who may be a
maintenance technician, via the user interface 125, 225, 130, 230,
232, and the user may input a response to the inquiry via the user
interface 125, 225, 130, 230, 232 as well. If the process 400
determines that the physical check has been performed, then the
process 400 advances to block 412, where the user is prompted to
input the results of the various physical checks performed on the
medical device 105, 205. In some embodiments, the user interface
125, 225, 130, 230, 232 presents a set of graphical control
elements, such as option buttons or radio buttons, for the user to
select whether each of the performed physical checks passed or
failed. Once the results of the physical check are input, the
process 400 advances to block 445, where the results are presented
to the user. In some embodiments, the results may be stored in a
memory storage device that may be located in the medical device
105, 205, in the user device 110, 210, in the server 212, or in an
external memory storage device.
[0098] If the user indicates, or the process 400 otherwise
determines, that the physical check of the medical device 105, 205
has not been completed, then the process 400 advances to block 415,
where the user is prompted to inspect the physical condition of a
power cable used to supply outlet power to the medical device 105,
205. In some embodiments, the user interface 125, 225, 130, 230,
232 may provide images, animations, video presentations, audio
presentations, text, combinations thereof, and the like to provide
instructional guidance to the user on how to inspect the physical
condition of the power cable. Illustratively, by way of
non-limiting example, the user interface 125, 225, 130, 230, 232
may provide an animation illustrating how to access, secure, and
inspect the power cable. The user is also prompted to indicate
whether or not the physical condition of the power cable is
acceptable. The user interface 125, 225, 130, 230, 232 may provide
an input interface for the user to input the results of the
physical check of the power cable. In some embodiments, such input
may be provided by selecting a checkbox or radio button indicating
whether the physical check of the power cord passed or failed. In
some embodiments, the user interface 125, 225, 130, 230, 232 may
provide for the input of text comments which may be used to further
describe the condition of the inspected power cable. Once the
physical inspection of the power cable is completed and user input
is provided describing the assessed physical condition of the power
cable, the user interface 125, 130, 232 prompts the user to proceed
to a next physical check of the medical device 105, 205. In
response to a request by the user to proceed to a next physical
check, the process 400 advances to block 420.
[0099] At block 420, the user interface 125, 225, 130, 230, 232
prompts the user to inspect the physical condition of a heater wire
adapter. The heater wire adapter may be used to physically connect
and electrically communicate between the medical device 105, 205
and a heating wire or element configured to heat respiratory gases
as the gases pass through, for example, an inspiratory conduit to
the patient. As discussed above with respect to block 415, the user
interface 125, 225, 130, 230, 232 may provide images, animations,
video presentations, audio presentations, text, combinations
thereof, and the like to present instructional guidance to the user
on how to inspect the physical condition of the heater wire
adapter. The user interface 125, 225, 130, 230, 232 may prompt the
user to indicate whether or not the physical condition of the
heater wire adapter is acceptable. The user interface 125, 225,
130, 230, 232 may also provide an input interface for the user to
input the results of the physical check of the heater wire adapter.
Once the physical inspection of the heater wire adapter is
completed and user input is provided describing the assessed
physical condition of the heater wire adapter, the user interface
125, 130, 232 prompts the user to proceed to a next physical check
of the medical device 105, 205. In response to a request by the
user to proceed to a next physical check, the process 400 advances
to block 425.
[0100] At block 425, the user interface 125, 225, 130, 230, 232
prompts the user to inspect the physical condition of a housing of
the medical device 105, 205. The housing includes the external
structure of the medical device 105, 205 which, among other things,
serves to protect internal components of the medical device 105,
205 from the environment. Once again, as discussed above, the user
interface 125, 225, 130, 230, 232 may provide images, animations,
video presentations, audio presentations, text, combinations
thereof, and the like to present instructional guidance to the user
on how to inspect the physical condition of the housing. The user
interface 125, 225, 130, 230, 232 may prompt the user to indicate
whether or not the physical condition of the housing is acceptable.
The user interface 125, 225, 130, 230, 232 may also provide an
input interface for the user to input the results of the physical
check of the housing. Once the physical inspection of the housing
is completed and user input is provided describing the assessed
physical condition of the housing, the user interface 125, 130, 232
prompts the user to proceed to a next physical check of the medical
device 105, 205. In response to a request by the user to proceed to
a next physical check, the process 400 advances to block 430.
[0101] At block 430, the user interface 125, 225, 130, 230, 232
prompts the user to inspect the physical condition of a front panel
of the medical device 105, 205. The front panel may include the
user interface 125, 225, 130, 230, 232, such as, by way of
non-limiting example, a display, a dial, a switch, a plurality of
physical buttons or keys, a plurality of virtual buttons or keys, a
speaker, a microphone, and the like. The user interface 125, 225,
130, 230, 232 may provide images, animations, video presentations,
audio presentations, text, combinations thereof, and the like to
present instructional guidance to the user on how to inspect the
physical condition of the front panel. The user interface 125, 225,
130, 230, 232 may also prompt the user to indicate whether or not
the physical condition of the front panel is acceptable. The user
interface 125, 225, 130, 230, 232 may also provide an input
interface for the user to input the results of the physical check
of the front panel. Once the physical inspection of the front panel
is completed and user input is provided describing the assessed
physical condition of the front panel, the user interface 125, 130,
232 prompts the user to proceed to a next physical check of the
medical device 105, 205. In response to a request by the user to
proceed to a next physical check, the process 400 advances to block
435.
[0102] At block 435, the user interface 125, 225, 130, 230, 232
prompts the user to inspect the physical condition of a sensor
cartridge of the medical device 105, 205. In some embodiments, the
sensor cartridge is mechanically and electrically connected to a
heater base. The sensor cartridge may be a replaceable module that
houses a number of sensors used to measure parameters of the
medical device 105, 205 during operation and provide the
measurements to the processor 115, 215 to control the operation of
the medical device 105, 205. The sensor cartridge may be configured
to provide for the transfer of power to the sensors while also
provide mounting locations for the sensors within the medical
device 105, 205. The sensor cartridge may also allow for the
transfer of data between the sensors and the processor 115, 215 of
the medical device 105, 205. The user interface 125, 225, 130, 230,
232 may provide images, animations, video presentations, audio
presentations, text, combinations thereof, and the like to present
instructional guidance to the user on how to inspect the physical
condition of the front panel. The user interface 125, 225, 130,
230, 232 may also prompt the user to indicate whether or not the
physical condition of the sensor cartridge is acceptable. The user
interface 125, 225, 130, 230, 232 may also provide an input
interface for the user to input the results of the physical check
of the sensor cartridge. Once the physical inspection of the sensor
cartridge is completed and user input is provided describing the
assessed physical condition of the sensor cartridge, the user
interface 125, 130, 232 prompts the user to proceed to a next
physical check of the medical device 105, 205. In response to a
request by the user to proceed to a next physical check, the
process 400 advances to block 440.
[0103] At block 440, the user interface 125, 225, 130, 230, 232
prompts the user to inspect the general physical condition of the
medical device 105, 205. This is an opportunity for the user to
inspect the medical device 105, 205 for any other damage or
excessive wear that may render the medical device 105, 205
inoperable or not suited for use. The user interface 125, 225, 130,
230, 232 may also prompt the user to indicate whether or not the
general physical condition of the medical device 105, 205 is
acceptable. The user interface 125, 225, 130, 230, 232 may provide
images, animations, video presentations, audio presentations, text,
combinations thereof, and the like to present instructional
guidance to the user on how to inspect the physical condition of
the front panel. The user interface 125, 225, 130, 230, 232 may
also provide an input interface for the user to input the results
of the physical check of the front panel. Once the physical
inspection of the front panel is completed and user input is
provided describing the assessed general physical condition of the
medical device 105, 205, the user interface 125, 130, 232 prompts
the user to proceed in the process 400.
[0104] At block 445, the results are presented to the user. In some
embodiments, the results may be stored in a memory storage device
that may be located in the medical device 105, 205, in the user
device 110, 210, in the server 212, or in an external memory
storage device. A skilled artisan will appreciate that other
features, characteristics, or components of the medical device 105,
205 may also be included in the physical check without departing
from the scope of the present disclosure.
[0105] If performance of the physical check according to process
400 is interrupted, a message, such as a modal message, may be
displayed to the user indicating an interruption has occurred. In
some embodiments, if the physical check is re-established, the
physical check may continue from the point at which the
interruption occurred. In some embodiments, the physical check may
start over at block 405.
[0106] Performance of the physical check is not limited to the
order and number of steps described in the process 400. While the
physical check according to the process 400 describes the execution
of a series of steps in a particular sequence, the individual steps
may be performed in any order, unless otherwise specified.
Additionally, performance of the physical check does not require
execution of all the steps described in the process 400. In some
embodiments, the physical check may include additional steps not
described in the process 400. In some embodiments, the physical
check may not include all steps described in the process 400. One
or more steps of the process 400 may be executed by any one of or
any combination of the processors 115, 215, 120, 220, 222 or other
processors residing in the same devices or other devices. In a
further alternative the physical check may be performed by a user,
based on instructions presented on the medical device or the user
interface.
[0107] FIG. 5 is a process flow diagram of a process 500 for
executing a functional check of the medical device 105, 205
according to an embodiment of the present disclosure. The process
500 begins at block 505. At block 510, set up of the functional
check is performed. In some embodiments, the functional check is
configured to be performed in an automated or semi-automated manner
by the maintenance system 100, 200. In particular, the functional
check may be configured to be performed in an automated or
semi-automated manner by one or more of the processors 115, 215,
120, 220, 222. Accordingly, connection between one or more of the
user device 110, 210 and the server 212 with the medical device
105, 205 is established. For example, the user interface 125, 225,
130, 230, 232 may provide images, animations, video presentations,
audio presentations, text, combinations thereof, and the like to
present instructional guidance to the user on how to set up the
maintenance system 100, 200 to prepare for execution of the
functional check according to process 500.
[0108] In some embodiments, the maintenance system 100, 200 can
detect if the medical device 105, 205 is configured properly for
execution of the functional check. Illustratively, by way of
non-limiting example, the medical device 105, 205 is configured
such that a humidification chamber is operational, and both an
inspiratory limb and an expiratory limb are connected to the
medical device 105, 205. In some embodiments, the medical device
105, 205 is configured to operate in a therapeutic mode so as to
enable the process 500 to check the functionality of the medical
device 105, 205. The user device 110, 210 may be connected to the
medical device 105, 205 by, for example, a USB null-modem cable
that appears as a serial port on the medical device 105, 205. The
processor 120, 220 of the user device 110, 210 may be configured to
execute the process 500, which may be embodied in a set of
executable instructions. The user interface 130, 230 of the user
device 110, 210 may present messages to and receive responses from
the user during execution of the functional check.
[0109] If the medical device 105, 205 is disconnected from the user
device 110, 210 during the performance of the functional check, a
message, such as a modal message, may be displayed to the user to
reconnect the medical device 105, 205 to the user device 110, 210.
In some embodiments, when connection is re-established, the
functional check according to process 500 may continue from the
point at which the disconnection occurred. In some embodiments, the
functional check may start over at block 505. If, after connection
of the medical device 105, 205, the process 500 determines that the
connected medical device 105, 205 has a serial number different
than the serial number corresponding to a previously connected
medical device, then the user interface 130, 230 provides a
message, such as a modal message, to the user indicating that the
serial number of the connected medical device 105, 205 does not
match the serial number of the previously connected medical device
and inquires whether the user desires to check the "new" medical
device 105, 205. In some embodiments, the message may request the
user to re-connect the previously connected medical device that had
been previously used for the maintenance check. The message may
display on the user interface 125, 225, 130, 230, 232 the serial
number of the previously connected medical device. If a provided
response to the message indicates that the user desires to check
the "new" medical device 105, 205, then another message is provided
to the user indicating that a new maintenance test will be started
from the beginning, at for example, the electrical safety
check.
[0110] At block 515, the process 500 executes a speaker test. If
the user has reattached the inspiratory limb, the user is
instructed to disconnect it again. The user interface 130, 230 of
the user device 110, 210 asks whether, when the inspiratory limb
was disconnected, the user could hear an auditory alarm. In some
embodiments, the user interface 130, 230 of the user device 110,
210 provides an example of the alarm that is expected to be
generated by the user interface 125, 225, of the medical device
105, 205 for the purpose of comparison. Illustratively, by way of
non-limiting example, a "yes or no" prompt may be displayed for the
user to provide a response regarding the inquiry. The process 500
records the outcome of the speaker test and advances to block
520.
[0111] At block 520, the process 500 executes a therapy touch test
of the user interface 125, 225 of the medical device 105, 205. The
user interface 130, 230 of the user device 110, 210 provides
instructions to the user to change, through a touch feature of the
user interface 125, 225 of the medical device 105, 205, the therapy
being delivered by the medical device 105, 205. In response to the
change in therapy, the process 500 can detect whether the therapy
was changed by the medical device 105, 205. If the user is unable
to change the therapy via the user interface 125, 225 on the
medical device 105, 205 because, for example, the touch feature of
the user interface 125, 225 is not operable, the user can provide
user input to the user interface 130, 230 of the user device 110,
210 indicating that the user was not able to successfully change
the therapy via the touch feature. The process 500 records the
outcome of the touch test, and advances to block 530.
[0112] At block 530, the process 500 determines whether the therapy
touch test passed or failed. If the therapy touch test passes, the
process 500 advances to block 535 to execute a mute touch test. If
the therapy touch test fails, the process 500 advances to block 540
to execute a color test.
[0113] At block 535, the process 500 executes a second touch test
to determine whether a mute button on the user interface 125, 225
of the medical device 105, 205 is operable. If the user has
reattached the inspiratory limb to the medical device 105, 205, the
user is instructed to disconnect it again to generate a
disconnection alarm, including an auditory signal, to be presented
on the user interface 125, 225 of the medical device 105, 205. The
user interface 130, 230 of the user device 110, 210 instructs the
user to press a mute button on the user interface 125, 225 of the
medical device 105, 205. The user interface 130, 230 of the user
device 110, 210 then inquires whether the alarm sound was muted in
response to the user pressing the mute button. Illustratively, by
way of non-limiting example, a "yes or no" prompt may be displayed
for the user to provide a response regarding the inquiry. The
process 500 records the outcome of the touch test, and advances to
block 540.
[0114] At block 540, the process 500 executes a color test of the
user interface 125, 225 of the medical device 105, 205. The user
interface 130, 230 of the user device 110, 210 provides
instructions to the user to disconnect an inspiratory limb from the
medical device 105, 205 to generate a disconnection alarm to be
presented on the user interface 125, 225 of the medical device 105,
205. The user is then asked to compare the color of an alarm banner
displayed on the user interface 115, 215 of the medical device 105,
205 with a color display presented on the user interface 130, 230
of the user device 110, 210. Illustratively, by way of non-limiting
example, a "yes or no" prompt may be displayed for the user to
provide a response regarding the comparison of the colors. The
process 500 records the outcome of the color test, and advances to
block 545.
[0115] At block 545, the process 500 executes a check to determine
whether a light-emitting diode (LED) properly illuminates. The
process 500, executing on the user device 110, 210, causes the LED
to illuminate on the user interface 125, 225 of the medical device
105, 205. In some embodiments, the user interface 130, 230 of the
user device 110, 210 provides an image of the appearance of the
illuminated LED for the purpose of comparison. The user interface
130, 230 of the user device 110, 210 then inquires whether the LED
appears on the user interface 125, 225 of the medical device 105,
205. Illustratively, by way of non-limiting example, a "yes or no"
prompt may be displayed for the user to provide a response
regarding the inquiry. The process 500 records the outcome of the
LED test and advances to block 550 where the functional check
process 500 ends.
[0116] Performance of the functional check is not limited to the
order and number of steps described in the process 500. While the
functional check according to the process 500 describes the
execution of a series of steps in a particular sequence, the
individual steps may be performed in any order, unless otherwise
specified. Additionally, performance of the functional check does
not require execution of all the steps described in the process
500. In some embodiments, the functional check may include
additional steps not described in the process 500. In some
embodiments, the functional check may not include all steps
described in the process 500. One or more steps of the process 500
may be executed by any one of or any combination of the processors
115, 215, 120, 220, 222 or other processors residing in the same
devices or other devices.
[0117] In some embodiments, the maintenance system 100, 200 may
include a performance check. A performance check may include
validation that one or more performance characteristics of the
medical device 105, 205 are within acceptable limits. A performance
characteristic of the medical device 105, 205 may include a piece
of information that is available to the processor 115, 215, 120,
220, 222 or a combination of different pieces of information that
are available to the processor 115, 215, 120, 220, 222. A
performance characteristic of the medical device 105, 205 may
comprise, for example but without limitation: a flow rate, a
temperature, an electrical resistance or voltage or current, a
pressure, or a dew point. In some embodiments, a performance check
may include an act wherein the processor 115, 215, 120, 220, 222
measures a performance characteristic of the medical device 105,
205. A performance check may include an act wherein the processor
115, 215, 120, 220, 222 stores the performance characteristic in a
storage device associated with one or more of the medical device
105, 205, the user device 110, 210, or the server 212. A
performance check may include an act wherein the processor 115,
215, 120, 220, 222 determines whether the medical device 105, 205
has passed the performance check by comparing a performance
characteristic to one or more predetermined limit values. A
performance check may include an act wherein the processor 115,
215, 120, 220, 222 retrieves one or more predetermined limit values
from one of the medical device 105, 205, the user device 110, 210,
or the server 212. A performance check may include an act wherein
the processor 115, 215, 120, 220, 222 displays a message on the
user interface 125, 225, 130, 230, 232 indicating whether the
medical device 105, 205 passed or failed the performance check.
[0118] If performance of the performance check is interrupted, a
message, such as a modal message, may be displayed to the user
indicating an interruption has occurred. In some embodiments, if
the performance check is re-established, the performance check may
continue from the point at which the interruption occurred. In some
embodiments, the physical check may start over.
[0119] The performance check may include a warmup test. In some
embodiments, the warmup test may include a test of the response of
a heating element to ensure that the heating element is capable of
heating liquid contained in a liquid reservoir to a desired
temperature in a desired amount of time. In some embodiments, the
desired temperature may be between 30 and 70 degrees Celsius. In
some embodiments, the desired temperature may exceed 70 degrees
Celsius. In some embodiments, the desired temperature may be less
than 30 degrees Celsius. In some embodiments, the desired time may
be between 10 and 40 minutes. In some embodiments, the desired time
may exceed 40 minutes. In some embodiments, the desired time may be
less than 10 minutes.
[0120] In some embodiments, a functional check may include
validation of correct and safe operation of one or more functional
components of the medical device 105, 205, including but not
limited to a system health protection component. A functional check
of a system health protection component--or a system health
protection check--may be difficult to perform as the system health
protection component may be contained within the medical device
105, 205 and hence not directly accessible. A system health
protection check may include generating an unexpected condition,
for example, by providing the system health protection component
with a signal that the system health protection component would be
expected to detect as unexpected. A system health protection check
may be difficult to perform as, in some cases, it may damage the
medical device 105, 205.
[0121] In some embodiments, a system health protection check may
include an act wherein the processor 115, 215, 120, 220, 222
determines whether one or more entry conditions for the system
health protection check are satisfied before proceeding with the
system health protection check. A system health protection check
may include an act wherein the processor 115, 215, 120, 220, 222
displays a message on the user interface 125, 225, 130, 230, 232
informing a user of the status of the one or more entry conditions.
In some embodiments, a system health protection check may include
an act wherein the processor 115, 215, 120, 220, 222 generates or
simulates an unexpected condition and determines a response of the
system health protection component to the unexpected condition. In
some embodiments, a system health protection check may include an
act wherein the processor 115, 215, 120, 220, 222 generates or
simulates normal operating conditions and determines a response of
the system health protection component during normal operation. A
system health protection check may include an act wherein the
processor 115, 215, 120, 220, 222 measures an electrical value such
as a voltage or logic value in the system health protection
component to determine a response of the system health protection
component to the unexpected condition. A system health protection
check may include an act wherein the processor 115, 215, 120, 220,
222 compares the elapsed time between the generation of an
unexpected condition and the triggering of the system health
protection component to a predetermined threshold. A system health
protection check may include an act wherein the processor 115, 215,
120, 220, 222 displays a result of the functional check on the user
interface 125, 225, 130, 230, 232. The result could indicate, for
example but without limitation, that the system health protection
component does not successfully recognize an unexpected condition,
incorrectly identifies an unexpected condition, or is too slow to
recognize an unexpected condition. In some embodiments, a system
health protection check may include an act wherein the processor
115, 215, 120, 220, 222 displays details of a specific unexpected
condition and/or a suggested course of action to address the
unexpected condition.
[0122] In some embodiments, the medical device 105, 205 may include
hardware and/or software capable of generating an unexpected
condition. The medical device 105, 205 may include an electrical
circuit or component used to simulate or generate an unexpected
condition. Such an electrical circuit or component may be
beneficial in that it may be used to test both a hardware response
and a software response of a system health protection component of
the medical device 105, 205 to an unexpected condition. Software of
the medical device 105, 205 may also be used to generate or
simulate an unexpected condition. An unexpected condition simulated
in software may be used to test the response of a system health
protection component of the medical device 105, 205 to an
unexpected condition. The hardware response of a system health
protection component of the medical device 105, 205 may need to be
tested separately to that of the software response.
[0123] An example of a system health protection component is a
transient current detector (TCD), similar to that disclosed in U.S.
Pat. No. 6,598,604, which is herein incorporated by reference in
its entirety. In some embodiments, the medical device 105, 205 may
include a TCD that may detect a transient current or an overcurrent
in an electrical component, including but not limited to a heating
element of the medical device 105, 205. A TCD may detect a
transient current by monitoring current through the heating element
of the medical device 105, 205 and activating a current interrupter
if there is a rapid change in current that exceeds a predetermined
change threshold. A TCD may detect an overcurrent by monitoring
current through the heating element and by activating a current
interrupter if the current exceeds a predetermined current
threshold. The TCD is a fault protection circuit for a respiratory
conduit heater element in a respiratory humidification system. The
TCD is used as a fault protection circuit with a heater wire in an
inspiratory limb 3. The circuit includes a spark detector and an
overcurrent detector. The spark detector may include a two winding
transformer, a center tapped two winding transformer and/or a high
pass filtered inductor. The TCD further includes a semiconductor
switching configuration. Once the protection circuit detects a
change in current over a certain level, or the average level raises
above a threshold, then the current in the heater element is
interrupted for a preset period.
[0124] A functional check of a TCD may include an act wherein the
processor 115, 215, 120, 220, 222 causes a transient, or rapid
change in current, to be generated that exceeds a change threshold
for a heating element of the medical device 105, 205. A functional
check of a TCD may include an act wherein the processor 115, 215,
120, 220, 222 causes an overcurrent to be generated that exceeds a
current threshold for a heating element of the medical device 105,
205. A transient or overcurrent may be generated by the medical
device 105, 205, the user device 110, 210, or by some other
external device, for example a signal generator. The medical device
105, 205 or the user device 110, 210 may include electrical
circuitry or software to generate or simulate an unexpected
condition, including but not limited to an inbuilt signal
generator. A functional check of a TCD may include an act wherein
the processor 115, 215, 120, 220, 222 determines whether the
current interrupter has been triggered, and thus whether an
unexpected condition has been recognized.
[0125] FIG. 6 shows an example flowchart of a method 600 for
performing a functional check of a TCD of the medical device 105,
205. The method 600 starts at block 605.
[0126] At block 605, the processor 115, 215, 120, 220, 222
initiates the functional check of the TCD. In an alternate
embodiment, the functional check of the TCD may be initiated by
interaction of a user with the user interface 125, 225, 130, 230,
232. The method 600 then proceeds to block 610.
[0127] At block 610, the processor 115, 215, 120, 220, 222
generates an unexpected condition by causing a transient current or
overcurrent to be generated or simulated. The method 600 then
proceeds to block 615.
[0128] At block 615, the processor 115, 215, 120, 220, 222
determines a response of the TCD to the unexpected condition (for
example, the transient or overcurrent condition); if the response
of the TCD was correct (for example, activating a current
interrupter in response to the unexpected condition), the method
600 proceeds to block 620, otherwise the method 600 proceeds to
block 625.
[0129] At block 620, the processor 115, 215, 120, 220, 222 displays
a message on the user interface 125, 225, 130, 230, 232 indicating
that the functional check of the TCD succeeded. The method 600 then
ends.
[0130] At block 625, the processor 115, 215, 120, 220, 222 displays
a message on the user interface 125, 225, 130, 230, 232 indicating
that the functional check of the TCD failed. The method 600 then
proceeds to block 630.
[0131] At block 630, the processor 115, 215, 120, 220, 222
concludes the functional check of the TCD. The method 600 then
ends.
[0132] If performance of the functional check of the TCD according
to process 600 is interrupted, a message, such as a modal message,
may be displayed to the user indicating an interruption has
occurred. In some embodiments, if the functional check of the TCD
is re-established, the functional check of the TCD may continue
from the point at which the interruption occurred. In some
embodiments, the functional check of the TCD may start over at
block 605.
[0133] Performance of the functional check of the TCD is not
limited to the order and number of steps described in the process
600. While the functional check of the TCD according to the process
600 describes the execution of a series of steps in a particular
sequence, the individual steps may be performed in any order,
unless otherwise specified. Additionally, performance of the
functional check of the TCD does not require execution of all the
steps described in the process 600. In some embodiments, the
functional check of the TCD may include additional steps not
described in the process 600. In some embodiments, the functional
check of the TCD may not include all steps described in the process
600. One or more steps of the process 600 may be executed by any
one of or any combination of the processors 115, 215, 120, 220, 222
or other processors residing in the same devices or other
devices.
[0134] The medical device 105, 205 may include a heating element.
The heating element may include a heater plate or a heater wire and
may be configured to heat gases within the medical device 105, 205.
The medical device 105, 205 may include a thermal cutout device
configured to cut power to the heating element when a temperature
reaches or exceeds a predetermined threshold. A functional check
may include an act wherein the processor 115, 215, 120, 220, 222
validates the correct operation of the thermal cutout device of the
medical device 105, 205.
[0135] FIG. 7 shows an example flowchart of a method 700 for
performing a functional check of a thermal cutout device of the
medical device 105, 205. The method 700 starts at block 705.
[0136] At block 705, the processor 115, 215, 120, 220, 222
initiates the functional check of the thermal cutout device. In an
alternate embodiment, the functional check of the thermal cutout
device may be initiated by interaction of a user with the user
interface 125, 225, 130, 230, 232. The method 700 then proceeds to
block 710.
[0137] The heating element may include a heater plate configured to
heat and/or vaporize liquid in a humidification chamber adjacent to
the heater plate. In some such embodiments, the processor 115, 215,
120, 220, 222 may display a message on the user interface 125, 225,
130, 230, 232 instructing a user to ensure there is no liquid in
the humidification chamber to avoid damping or slowing the rise
time of the heater plate temperature.
[0138] At block 710, the processor 115, 215, 120, 220, 222 causes
power to be supplied to the heating element. In an embodiment, the
processor 115, 215, 120, 220, 222 may cause full power (for
example, 100% duty cycle) to be supplied to the heating element. In
an embodiment, the processor 115, 215, 120, 220, 222 may start a
timer. The method 700 then proceeds to block 715.
[0139] At block 715, the processor 115, 215, 120, 220, 222
determines a response of the thermal cutout device to the rising
temperature of the heating element. In an embodiment, the processor
115, 215, 120, 220, 222 may determine that the thermal cutout
device has tripped by measuring power supplied to the heating
element, as after the thermal cutout device has tripped, the power
supplied to the heating element will drop. In an embodiment, the
processor 115, 215, 120, 220, 222 may determine that the thermal
cutout device has tripped by measuring a temperature, as after the
thermal cutout device has tripped, a relevant temperature will
drop. If the thermal cutout device has not tripped, the method 700
proceeds to block 720, otherwise the method 700 proceeds to block
725.
[0140] At block 720, the processor 115, 215, 120, 220, 222
determines whether the thermal cutout device has failed the
functional check by not tripping. In an embodiment, the processor
115, 215, 120, 220, 222 may determine whether the thermal cutout
device has failed the functional check by comparing the value of
the timer to a predetermined maximum time value. If the value of
the timer has reached or exceeded the predetermined maximum time
value, then the thermal cutout device has failed the functional
check. In an embodiment, the predetermined maximum time value is
between 4 and 6 minutes. In an embodiment, the predetermined
maximum time value is about 5 minutes. In an embodiment, the
processor 115, 215, 120, 220, 222 may determine whether the thermal
cutout device has failed the functional check by comparing the
value of the measured temperature to a predetermined maximum
temperature value. If the value of the measured temperature has
reached or exceeded the predetermined maximum temperature value,
then the thermal cutout device has failed the functional check. In
an embodiment, the predetermined maximum temperature value is 160
degrees Celsius. In an embodiment, the processor 115, 215, 120,
220, 222 may determine whether the thermal cutout device has failed
the functional check by displaying a message on the user interface
125, 225, 130, 230, 232 instructing a user to confirm a status of
the thermal cutout device and to input that status. If the thermal
cutout device has failed the functional check, the method 700
proceeds to block 745, otherwise the method 700 returns to block
715. If the thermal cutout device has not failed the functional
check, the method 700 may wait for a predetermined period of time
before returning to block 715.
[0141] At block 725, the processor 115, 215, 120, 220, 222 causes a
message to be displayed on the user interface 125, 225, 130, 230,
232 instructing a user to manually reset the thermal cutout device
and then to confirm that the thermal cutout device has been reset.
In an embodiment, the processor 115, 215, 120, 220, 222 may
automatically reset the thermal cutout device. The method 700 then
proceeds to block 730.
[0142] At block 730, the processor 115, 215, 120, 220, 222 causes
power to be supplied to the heating element. The method 700 then
proceeds to block 735.
[0143] At block 735, the processor 115, 215, 120, 220, 222
determines whether the thermal cutout device has reset properly. In
an embodiment, the processor 115, 215, 120, 220, 222 determines
whether the thermal cutout device has reset properly by measuring
power supplied to the heating element, as after the thermal cutout
device has reset properly, the power supplied to the heating
element will rise. In an embodiment, the processor 115, 215, 120,
220, 222 determines whether the thermal cutout device has reset
properly by measuring a temperature, as after the thermal cutout
device has reset properly, a relevant temperature will rise. If the
thermal cutout device has reset properly, the method 700 proceeds
to block 740, otherwise, the method 700 proceeds to block 745.
[0144] At block 740, the processor 115, 215, 120, 220, 222 displays
a message on the user interface 125, 225, 130, 230, 232 indicating
that the functional check of the thermal cutout device succeeded.
The method 700 then proceeds to block 750.
[0145] At block 745, the processor 115, 215, 120, 220, 222 displays
a message on the user interface 125, 225, 130, 230, 232 indicating
that the functional check of the thermal cutout device failed. The
method 700 then proceeds to block 750.
[0146] At block 750, the processor 115, 215, 120, 220, 222
concludes the functional check of the thermal cutout device. The
method 700 then ends.
[0147] If performance of the functional check of the thermal cutout
device according to process 700 is interrupted, a message, such as
a modal message, may be displayed to the user indicating an
interruption has occurred. In some embodiments, if the functional
check of the thermal cutout device is re-established, the
functional check of the thermal cutout device may continue from the
point at which the interruption occurred. In some embodiments, the
functional check of the thermal cutout device may start over at
block 705.
[0148] Performance of the functional check of the thermal cutout
device is not limited to the order and number of steps described in
the process 700. While the functional check of the thermal cutout
device according to the process 700 describes the execution of a
series of steps in a particular sequence, the individual steps may
be performed in any order, unless otherwise specified.
Additionally, performance of the functional check of the thermal
cutout device does not require execution of all the steps described
in the process 700. In some embodiments, the functional check of
the thermal cutout device may include additional steps not
described in the process 700. In some embodiments, the functional
check of the thermal cutout device may not include all steps
described in the process 700. One or more steps of the process 700
may be executed by any one of or any combination of the processors
115, 215, 120, 220, 222 or other processors residing in the same
devices or other devices.
[0149] In some embodiments, a functional check may include an act
wherein the processor 115, 215, 120, 220, 222 validates the correct
operation of a software module or process of the medical device
105, 205. For example, but without limitation, the processor 115,
215, 120, 220, 222 may validate that a boot loader executes
correctly or that a watchdog or other monitoring process is able to
reset the medical device 105, 205.
[0150] In some embodiments, a functional check may include an act
wherein the processor 115, 215, 120, 220, 222 validates the correct
operation of an electrical component of the medical device 105,
205. For example, but without limitation, the processor 115, 215,
120, 220, 222 may validate that a relay correctly operates to
control power supplied to a heating element; a sensor correctly
measures, for example, a temperature, pressure, humidity, or flow
rate; or an analog to digital converter correctly converts an
analog signal to a digital signal.
[0151] In some embodiments, a functional check may include an act
wherein the processor 115, 215, 120, 220, 222 validates the correct
operation of a mechanical component of the medical device 105, 205.
A functional check of a mechanical component of the medical device
105, 205--or a mechanical component check--may include an act
wherein the processor 115, 215, 120, 220, 222 activates a function
of, or related to, the mechanical component. In some embodiments, a
mechanical component check may include an act wherein the processor
115, 215, 120, 220, 222 displays a message on the user interface
125, 225, 130, 230, 232 instructing a user to activate a function
of, or related to, the mechanical component. In some embodiments, a
mechanical component check may include an act wherein the processor
115, 215, 120, 220, 222 displays a message on the user interface
125, 225, 130, 230, 232 instructing a user to confirm correct
functioning of the mechanical component. For example but without
limitation, a mechanical component check may include an act wherein
the processor 115, 215, 120, 220, 222 instructs a user to validate
a discrimination of the user's touch on a touch screen, the
actuation of a button, or the correct operation of a speaker or a
light emitting diode (LED).
[0152] As a particular example, a mechanical component check may
include an act wherein the processor 115, 215, 120, 220, 222 causes
test data, such as but not limited to a word or an image, to be
displayed on the user interface 125, 225 of the medical device 105,
205, and then displays a message on the user interface 125, 225,
130, 230, 232 instructing a user to confirm that the test data is
correctly displayed on the user interface 125, 225 of the medical
device 105, 205. The processor 115, 215, 120, 220, 222 may cause
the test data to be duplicated on the user interface 130, 230, 232
of the user device 110, 210 or the server 212, so that a user can
make a visual comparison. Such a mechanical component check of the
user interface 125, 225 of the medical device 105, 205 may be used
to validate functionality, such as the proper display of color.
[0153] In some embodiments, the processor 115, 215, 120, 220, 222
executes a mechanical component check that validates the correct
operation of a speaker of the medical device 105, 205. The
processor 115, 215, 120, 220, 222 may cause a sound or tone to be
generated using the speaker of the medical device 105, 205. The
processor 115, 215, 120, 220, 222 may determine whether the
mechanical component check of the speaker succeeded or failed by
displaying a message on the user interface 125, 225, 130, 230, 232
instructing a user to confirm that the sound or tone was generated,
was not distorted, and/or was of sufficient loudness. For example,
the processor 115, 215, 120, 220, 222 may cause an audible alarm of
the medical device 105, 205 to be activated. In some embodiments,
the processor 115, 215, 120, 220, 222 may determine whether the
mechanical component check of the speaker succeeded or failed by
using a microphone of the medical device 105, 205 or the user
device 110, 210 to record the generated sound or tone. The
processor 115, 215, 120, 220, 222 may display a message on the user
interface 125, 225, 130, 230, 232 indicating whether the mechanical
component check of the speaker succeeded or failed.
[0154] In some embodiments, the processor 115, 215, 120, 220, 222
executes a mechanical component check that validates the correct
operation of the touch screen functionality of the user interface
125, 225 of the medical device 105, 205. The processor 115, 215,
120, 220, 222 may cause an image or icon to be displayed on the
user interface 125, 225 of the medical device 105, 205. The
processor 115, 215, 120, 220, 222 may display a message on the user
interface 125, 225, 130, 230, 232 instructing a user to press the
image or icon displayed on the user interface 125, 225 of the
medical device 105, 205. For example, the processor 115, 215, 120,
220, 222 may cause an audible alarm of the medical device 105, 205
to be activated and cause an icon representing a mute button to be
displayed on the user interface 125, 225 of the medical device 105,
205 for a user to press to mute the audible alarm. The processor
115, 215, 120, 220, 222 may determine whether the mechanical
component check of the touch screen functionality succeeded or
failed by confirming whether the touch functionality of the user
interface 125, 225 recognized the user's touch. The processor 115,
215, 120, 220, 222 may display a message on the user interface 125,
225, 130, 230, 232 indicating whether the mechanical component
check of the touch screen functionality succeeded or failed.
[0155] In some embodiments, the processor 115, 215, 120, 220, 222
executes a mechanical component check that validates the correct
operation of a button of the user interface 125, 225 of the medical
device 105, 205. The processor 115, 215, 120, 220, 222 may display
a message on the user interface 125, 225, 130, 230, 232 instructing
a user to press a button of the user interface 125, 225 of the
medical device 105, 205. For example, the message may instruct a
user to hold down a power button of the medical device 105, 205 to
initiate a restart. In some embodiments, the processor 115, 215,
120, 220, 222 may determine whether the mechanical component check
of the button succeeded or failed by confirming whether the button
actuated, for example, by completing an electrical circuit. The
processor 115, 215, 120, 220, 222 may display a message on the user
interface 125, 225, 130, 230, 232 indicating whether the mechanical
component check of the button succeeded or failed.
[0156] In some embodiments, the processor 115, 215, 120, 220, 222
executes a mechanical component check that validates the correct
display of color on the user interface 125, 225 of the medical
device 105, 205. The processor 115, 215, 120, 220, 222 may cause an
area - for example but not limited to a square, a circle, or
another bounded region - to be displayed in a selected color or
pattern of colors on the user interface 125, 225 of the medical
device 105, 205. The processor 115, 215, 120, 220, 222 may display
a message on the user interface 125, 225, 130, 230, 232 instructing
a user to confirm that the correct color or pattern of colors is
displayed on the user interface 125, 225 of the medical device 105,
205. The processor 115, 215, 120, 220, 222 may display the selected
color or pattern of colors on the user interface 130, 230, 232 of
the user device 110, 210 or the server 212 so the user can make a
visual comparison. For example, the processor 115, 215, 120, 220,
222 may cause a selected screen or webpage to be displayed on the
user interface 125, 225 of the medical device 105, 205 and
duplicate the screen or webpage on the user interface 130, 230, 232
of the user device 110, 210 or the server 212 for comparison. The
processor 115, 215, 120, 220, 222 may display a message on the user
interface 125, 225, 130, 230, 232 indicating whether the mechanical
component check of the display of colors succeeded or failed. In
some embodiments, the processor 115, 215, 120, 220, 222 may execute
similar mechanical component checks of the display of colors using
multiple colors, simultaneously or in sequence, or an image or a
test pattern, for example but without limitation.
[0157] In some embodiments, the processor 115, 215, 120, 220, 222
executes a mechanical component check that validates the correct
operation of a light-emitting diode (LED) of the medical device
105, 205. The processor 115, 215, 120, 220, 222 may activate an LED
of the medical device 105, 205, continuously or in a pulsed
pattern, for a predetermined period of time. In some embodiments,
the processor 115, 215, 120, 220, 222 may determine whether the
mechanical component check of the LED succeeded or failed by
displaying a message on the user interface 125, 225, 130, 230, 232
instructing a user to confirm that the LED was activated properly.
In some embodiments, the processor 115, 215, 120, 220, 222 may
determine whether the mechanical component check of the LED
succeeded or failed by using a camera of the medical device 105,
205 or the user device 110, 210 to record the displayed LED. The
processor 115, 215, 120, 220, 222 may display a message on the user
interface 125, 225, 130, 230, 232 indicating whether the mechanical
component check of the LED succeeded or failed. In some
embodiments, the processor 115, 215, 120, 220, 222 may execute
similar mechanical component checks of multiple LEDs,
simultaneously, in sequence, or in another predetermined pattern.
The processor 115, 215, 120, 220, 222 may display information on
the user interface 125, 225, 130, 230, 232 indicating the
location(s) and/or sequence of activation of the LED(s).
[0158] In some embodiments, a functional check may include an act
wherein the processor 115, 215, 120, 220, 222 validates the correct
operation of a component configured to couple with the medical
device 105, 205. In some embodiments, a coupleable component may
have a limited duration or lifetime of use. In some embodiments, a
coupleable component may be reusable. A coupleable component may
include a storage device, for example but without limitation an
electrically erasable programmable read-only memory (EEPROM). As an
example for the respiratory humidifier 5, a coupleable component
includes the sensor cartridge 6.
[0159] A functional check of a coupleable component may include an
act wherein the processor 115, 215, 120, 220, 222 retrieves status
data from such a storage device of the coupleable component,
wherein the status data may comprise, for example but without
limitation, usage or lifetime information such as the date and/or
time the coupleable component was first used with the medical
device 105, 205; the total amount of time--either elapsed time or
time-in-use--the coupleable component has been used with the
medical device 105, 205; the date of manufacture of the coupleable
component, or any other information related to the status of the
coupleable component. The processor 115, 215, 120, 220, 222 may
retrieve information from the medical device 105, 205, the user
device 110, 210, the server 212, or the coupleable component
relating to a recommended lifetime or usage information for the
coupleable component. The processor 115, 215, 120, 220, 222 may
determine a result of the functional check of the coupleable
component by comparing the status data retrieved from the
coupleable component against the recommended lifetime or usage
information. The processor 115, 215, 120, 220, 222 may display a
message on the user interface 125, 225, 130, 230, 232 that provides
the result to a user. The message may include information relating
to the remaining lifetime of the coupleable component. For example,
the message may indicate that the coupleable component should be
replaced when the coupleable component's usage or lifetime is
within a certain percentage of the recommended usage or lifetime,
or when the coupleable component's usage or lifetime is projected
to reach a certain percentage of the recommended usage or lifetime
before a next scheduled service. The coupleable component can be a
sensor cartridge 6 that is removably coupleable to a respiratory
humidifier 5 (i.e. a medical device).
[0160] If performance of a functional check is interrupted, a
message, such as a modal message, may be displayed to the user
indicating an interruption has occurred. In some embodiments, if
the functional check is re-established, the functional check may
continue from the point at which the interruption occurred. In some
embodiments, the functional check may start over.
[0161] In some embodiments, the processor 115, 215, 120, 220, 222
may determine that one or more software modules of the medical
device 105, 205 should be updated or upgraded. The processor 115,
215, 120, 220, 222 may retrieve a software upgrade or update from a
storage device associated with one of the user device 110, 210 or
the server 212. The processor 115, 215, 120, 220, 222 may initiate
an upgrade or update of the software of the medical device 105, 205
using the retrieved software upgrade or update.
[0162] In some embodiments, the maintenance system 100, 200
executes one or more self-tests. In some embodiments, the
maintenance system 100, 200 executes one or more self-tests
regardless of each particular self-test's outcome. Some self-tests
may require user interaction. Illustratively, by way of
non-limiting example, checks of the user interface 125, 225 of the
medical device 105, 205 may require the user to observe visual,
tactile, auditory, or other forms of communication provided by the
user interface 125, 225 and to provide an assessment in response to
the observed communications. Another non-limiting example of a
self-test that may require user interaction includes a heater plate
thermal cutout test that applies full power to the heater plate
until the heater plate reaches a predetermined temperature (such
as, for example, 160.degree. C.) that exceeds the temperature at
which the thermal cutout device is configured to cut power. The
self-test is able to automatically determine if the thermal cutout
device operated correctly to cut power delivery to the heater plate
before the heater plate reached the predetermined temperature. A
user may be needed to reset the thermal cutout device after the
test has been completed.
[0163] Some of the self-tests may execute autonomously and may be
implemented by, for example, software instructions executing on the
processor 115, 215, 120, 220, 222. Illustratively, by way of
non-limiting example, autonomous self-tests may include a transient
current test including setting a heater wire duty cycle to a level
that is more likely than other levels to trip the transient current
detector (TCD), such as, for example, 50%; activating the heating
wire; applying a pulse to the TCD test circuit during an AC peak,
determining whether the TCD is triggered, and checking the TCD
activation period.
[0164] A heater switch test (which may be used for either or both
the heater plate and the heater wire circuits) may be executed
autonomously, including (1) turning off a safety relay, turning on
a heater switch, and determining whether the current and voltage of
the heater are at zero; (2) turning on the safety relay, turning
off the heater switch, and determining whether the current and
voltage of the heater are at zero; and (3) turning on the safety
relay, turning on the heater switch, and determining whether the
current and voltage of the heater are at zero.
[0165] An infant relay self-test may be executed autonomously. An
infant relay circuit is a safety feature that does not allow two
heater wires to be activated concurrently. The self-test includes
enabling an infant relay, activating a first heater wire, and
determining whether there is voltage on a second heating wire, and
attempting to activate the first and second heating wires
concurrently.
[0166] A heater plate thermistor self-test may be executed
autonomously by applying power to the heater plate and determining
whether the heating plate reaches a predetermined threshold within
a predetermined period of time, for example, 60.degree. C. within
five minutes.
[0167] A watchdog timer self-test may be autonomously executed by
causing a boot loader to not toggle on the watchdog timer during
the processor's 115, 215 first initialization ("booting up") and
determining whether the watchdog timer correctly resets the
processor 115, 215 when it is un-toggled.
[0168] A temperature measurement self-test may be autonomously
executed by checking if an analog-to-digital converter (ADC) value
is within predefined limits and reporting a short/open circuit if
the ADC value is beyond the predefined limits; and checking the ADC
values of on-board calibration resistors, and reporting an
unexpected condition if the checked ADC values are outside of the
values of the on-board calibration resistors.
[0169] A patient-end sensor overheat self-test may be autonomously
executed by trimming back an overheat threshold in and ADC to
ensure it is within bounds, activating a self-test trigger to
simulate overheat conditions, and determining whether an overheat
signal is asserted and power is cut off to a heating wire in
response to the simulated overheat condition.
[0170] If performance of the self-tests are interrupted, a message,
such as a modal message, may be displayed to the user indicating an
interruption has occurred. In some embodiments, if the self-tests
are re-established, the self-tests may continue from the point at
which the interruption occurred. In some embodiments, the
self-tests may start over.
[0171] As illustrated in FIG. 8A, the maintenance system 100, 200
includes a maintenance software application 805 that implements
various maintenance checks of the medical device 105, 205 disclosed
herein. The maintenance application 805 may automate some or all
parts of these tests and provide diagnostic information regarding
the state of the medical device 105, 205 to provide a simple work
flow for maintenance tasks.
[0172] In an embodiment, the maintenance application 805 provides a
maintenance check sequence to the user. The sequence is a
semi-automated test sequence aimed at ensuring that essential
functions and safety features of the medical device 105, 205 are
performing as expected. In some embodiments, the user will be
referred to a user manual for information on how to service the
medical device 105, 205 upon failure of any of the checks in the
maintenance check sequence.
[0173] In some embodiments, the maintenance application 805 may be
implemented as a web application using a client-server
architecture, including a client component 810 and a server
component 830. In some embodiments, both the client component 810
and the server component 830 may execute on the user device 110,
210 or on the server 212, and an Internet connection between the
user device 110, 210 and the server 212 is not required for
operation. In some embodiments, the client component 810 and the
server component 830 may execute on different computing devices,
such as different user devices 210, on different servers 212, or
one each on the user device 210 and the server 212, and a network
connection (such as a LAN, WAN, cellular, Internet connection, or
the like) may be used for communication between the different
computing devices.
[0174] The client component 810 may be implemented in a web browser
environment and is responsible for displaying content on the user
interface 125, 225, 130, 230, 232 and for handling user
interactions, such as user input. Upon launching the maintenance
application 805, a web browser instance associated with the client
component 810 pointing to the address of the server component 830
is initiated to display a page on the user interface 125, 130, 232.
The web browser instance then requests the web page and any related
assets from the server component 830, and the server component 830
either generates the page via a templating engine or serves up
static files directly. In some embodiments, pages are presented on
the user interface 125, 225, 130, 230, 232 using standard
HTML5+CSS3+JavaScript which are compatible with most modern web
browsers. In some embodiments, alternative web technologies are
used.
[0175] The client component 810 includes multiple views for the
different functionalities in the maintenance application 805. FIG.
8B illustrates software modules of the client component 810
according to an embodiment, including a dashboard module 812, a
functional check module 814, a physical and safety check module
816, a performance check module 818, and a device data service
module 820.
[0176] The dashboard module 812 may present information regarding
the medical device 105, 205 including but not limited to
identification information such as a device serial number,
installed software version information, serial number of a
coupleable component, expiry date/time of the coupleable component,
due date of the annual maintenance check, date the last annual
maintenance check was completed, and device status (for example,
connectivity and alarm state). In some embodiments, the information
regarding the medical device 105, 205 is aggregated at the server
212, whether owned by the manufacturer of the medical device 105,
205 or the hospital. The aggregated data could be used for asset
tracking and other purposes. When the medical device 105, 205 is
connected to the maintenance application 805, the dashboard module
812 will be able to read the last date a maintenance check had been
performed on the medical device 105, 205 and display when the next
maintenance check is due. As an example for the respiratory
humidifier 5, the dashboard module 812 may present information
including, among other information as previously described, the
serial number of the sensor cartridge 6 and the expiry date/time of
the sensor cartridge 6, and may read usage information associated
with the sensor cartridge 6 and determine the remaining usage life
of the sensor cartridge 6 which may be presented in a number of
remaining hours or by a fixed date after which the sensor cartridge
6 should be replaced. If the sensor cartridge 6 has expired, the
dashboard module 812 will notify the user of this fact and request
its replacement via the user interface 9.
[0177] The functional check module 814 may enable execution of
functional checks of the medical device 105, 205. In some
embodiments, the functional check module 814 includes a user
interface check wizard to interactively guide the user through the
process of checking the user interface 125, 225 of the medical
device 105, 205. The functional check module 814 may also include a
program to interactively guide the user through the processes of
checking a transient current detector in the medical device 105,
205. The functional check module 814 may include a program to
present the results of the functional check in the form of a
report.
[0178] The physical and safety check module 816 may enable
execution of physical and safety checks of the medical device 105,
205. In some embodiments, the physical and safety check module 816
includes a safety check wizard to interactively guide the user
through the process of checking electrical safety features of the
medical device 105, 205. The physical and safety check module 816
may also include a physical check wizard to interactively guide the
user through the process of checking various physical properties of
the medical device 105, 205. The physical and safety check module
816 may include a program to present the results of the physical
and/or safety checks in the form of a report.
[0179] The performance check module 818 may enable execution of one
or more performance checks of the medical device 105, 205,
including without limitation a warm-up check of the medical device
105, 205. In some embodiments, the performance check module 818
includes a performance check wizard to interactively guide the user
through the process of checking the performance of the medical
device 105, 205 in an operational scenario. The performance check
module 818 may present, via the user interface 125, 225, 130, 230,
232, graphical information indicative of the performance checks as
the checks are being executed and once the checks have been
completed. The performance check module 818 may include a program
to present the results of the performance checks in the form of a
report.
[0180] The device data service module 820 manages communications
between the client component 810 and the server component 830 from
the client side of the interface.
[0181] The server component 830 communicates with the medical
device 105, 205 over a communication link, such as by way of
non-limiting example, a USB null modem cable. The server component
830 handles such communication and acts as the interface between
the medical device 105, 205 and the rest of the maintenance
application 805 (such as the client component 810) by gathering
device data from the medical device 105, 205 and by issuing
commands to the medical device 105, 205 upon the request of the
maintenance application 805. In some embodiments, only one medical
device 105, 205 is connected to the user device 110, 210 or the
server 212 at any given time. In some embodiments, more than one
medical device 105, 205 may be connected to the user device 110,
210 or the server 212 at a given time.
[0182] In operation, according to some embodiments of the
maintenance application 805, a web browser associated with the
client component 810 creates a dynamic user interface to avoid the
need to refresh pages and for the server component 830 to keep
track of client states. A model-view-controller (MVC) paradigm is
used to structure the client component 810. The model in this
instance is primarily the device data which is requested by the
server component 830 from a representational state transfer
application program interface via, for example, AJAX and HTTP
requests. The view takes this data and formats it for display,
while the MVC takes in user inputs and sends the appropriate
commands back to the server component 830 in order to manipulate
the model.
[0183] Establishing Internet access in a hospital environment,
where the medical device 105 is frequently used, may be challenging
due to, for example, security and confidentiality constraints.
Accordingly, in some embodiments, the server component 830 and all
of the server-end applications may be installed and run on the user
device 110. The user interface 130 is accessed via a web browser
pointing to a local address. In some embodiments, the communication
to the medical device 105 is achieved via an FTDI USB null-modem
cable which appears as a serial port on the user device 110. In
some embodiments, the server component 830 interfaces with one
medical device 105. In some embodiments, the server component 830
may run multiple instances of communication and application modules
on the user device 110 to interface with more than one medical
device 105.
[0184] Some environments in which the medical device 205 operates
may permit access to networks such the Internet. In such
circumstances, the maintenance system 200 may be implemented in a
distributed manner. For example, in some embodiments, the
maintenance application 805 may be installed on the server 212. In
some embodiments the server 212 is owned, operated, or otherwise
controlled by a manufacturer of the medical device 205. In some
embodiments, the server 212 is owned, operated, or otherwise
controlled by a hospital. Advantageously, when the maintenance
application 805 is hosted centrally on the server 212, the
maintenance application 805 may be implemented in an on demand mode
as, for example, software as a service (SaaS). Such an
implementation approach includes an easier process for updating the
maintenance application 805 since only one version is hosted on the
server 212. Additionally, the user device 210 will not be required
to have the maintenance application 805 installed, and hosting the
maintenance application 805 provides broader compatibility among
device platforms.
[0185] As discussed above, the server 212 in communication with the
medical device 205 may allow a user to perform operations relating
to the medical device 205 remotely (for example, remotely view
status information of the medical device 205, remotely operate the
medical device 205, and/or the like). In some embodiments, a user
at the user device 210 can access the medical device 205 through
the server 212 instead of communicating with the medical device 205
directly using the user device 210. FIG. 9 illustrates an example
block diagram of the maintenance system 200 where the user device
210 communicates with the medical device 205 through the server
212. In some embodiments, the server 212 communicates with the
medical device 205 through a network, such as the Internet, WLAN,
LAN, and/or the like.
[0186] In some embodiments, the user device 210 communicates with
the medical device 205 by accessing a server application 902 on the
server 212 through a client application 904. In some embodiments,
the client application 904 may be implemented using the client
component 810. In some embodiments, the client application 904 may
be implemented using a web browser. In some embodiments, the server
application 902 may generate one or more pages that may be
displayed to the user by the client application 904 via the user
interface 230 of the user device 210. In other embodiments, the
client application 904 may generate one or more pages to be
displayed to the user, using data received from the server
application 902. A user at the user device 210 may need to perform
one or more authentication procedures to access the server
application 902 provided by the server 212, in order to monitor
and/or perform operations on the medical device 205.
[0187] By having the user device 210 access the medical device 205
through the server 212, the user may be able monitor and/or perform
operations on the medical device 205 remotely from any location, as
long as a connection with the server 212 can be maintained. In
addition, by accessing the server application 902 on the server
212, an amount of software implemented on the user device 210 may
be reduced.
[0188] In some embodiments, a plurality of different user devices
210 may be used to access the medical device 205 through the server
212. In addition, the server 212 may be able to communicate with
more than one medical device 205. As such, the server 212 may serve
as a "central hub" connecting the various user devices 210 and the
various medical devices 205. In some embodiments, this allows for
updates to the server application 902 to be implemented at the
server 212, without affecting the user devices 210 or the medical
devices 205. In addition, updates to software or firmware on the
user devices 210 or the medical devices 205 may be propagated
through the server 212. In some embodiments, one or more
authentication procedures may be used to allow the user device 210
to access the medical device 205. For example, the server 212 may
be accessed by multiple user devices 210 and connected to multiple
medical devices 205 associated with a plurality of different
hospitals, and the user device 210 associated with a particular
hospital may be able to access the medical devices 205 associated
with the hospital through the server 212, but not medical devices
associated with other hospitals.
[0189] In some embodiments, the server 212 may be owned or operated
by an entity associated with the medical device 205, such as a
manufacturer of the medical device 205, allowing for software or
firmware for the medical devices 205 or the user devices 210 to be
kept up to date by the manufacturer. For example, the manufacturer
may be able to remotely update software or firmware of the medical
devices 205 through the server 212. In addition, documentation or
other information (for example, a product technical manual)
associated with the medical device 205 may be maintained and kept
up to date by the server 212, and provided to the user devices 210
and/or the medical devices 205 as needed. In some embodiments, the
documentation or other information is aggregated at the server 212,
whether owned by the manufacturer of the medical device 105, 205 or
the hospital. The aggregated data could be used for asset tracking
and other purposes. For example, a user wishing to perform a
maintenance task on the medical device 205 (for example, an
electrical safety check, a functional check, and/or the like) may
access the server 212 in order to obtain the most up-to-date
documentation on how to perform the task. In some embodiments, the
maintenance software application 805 may be maintained and kept up
to date by the server 212.
[0190] In some embodiments, the server 212 may receive and analyze
status information from one or more medical devices 205. The status
information can be used to assess maintenance needs of the medical
devices 205. For example, in some embodiments, the server 212 may
use received status information to determine an operational status
or remaining operational life of a component of the medical device
205, which can be used to assess whether or not the component needs
to be replaced. If a determination is made that the component
should be replaced, the user may be prompted to order replacement
components for the medical device 205.
[0191] FIG. 10 illustrates an example flowchart of a method 1000
for ordering replacement components for the medical device 205,
based upon received status information of the medical device 205.
At block 1002, the server 212 establishes a connection between the
user device 210 and the medical device 205. In some embodiments,
the connection is established in response to authentication
information being received from the user device 210, whereupon the
server 212 authenticates the user device 210 and verifies that the
user device 210 is authorized to connect with the medical device
205.
[0192] At block 1004, a user may be optionally prompted to perform
an action associated with the medical device 205. In some
embodiments, prompting the user may comprise generating and
displaying screen elements on the user interface 225, 230, 232
comprising instructions to perform the action. In some embodiments,
the action may be performed by the user using the user interface
225 of the user device 210 and may comprise one or more interactive
elements that enable or assist the user to perform the action. For
example, the user may be prompted to input one or more parameters
and/or press a button to initiate a diagnostic procedure to be
performed by the medical device 205. In some embodiments, the user
may be able to perform the action remotely from the medical device
205, using the user interface 230 of the user device 210.
[0193] In some embodiments, the action may comprise a physical
action to be performed on the medical device 205 (for example,
connecting a cable, flipping a switch, reading a display screen, or
the like). For example, the user may be presented with a user
interface prompt (for example, on the user interface 225, 230 of
the medical device 205 or the user device 210) to perform the
action on the medical device 205. In some embodiments, the action
may comprise a combination of an action performed on the user
interface 225, 230 and a physical action performed on the medical
device 205.
[0194] In some embodiments, the server 212 may receive an
indication that the user has performed the action. The verification
may comprise the user providing input on the user interface 125,
130 indicating that they have performed the action, a detection by
the server 212 of a status condition of the medical device 205
consistent with the action having been performed (for example,
receiving a signal from the medical device 205 indicating that a
diagnostic procedure has been initiated), or a combination
thereof.
[0195] At block 1006, status information relating to the medical
device 205 is received. In some embodiments, the status information
is received in response to the user performing an action (for
example, at block 1004). The status information may comprise
information sent by the medical device 205 to the server 212, such
as electrical measurements, diagnostic measurements, test results,
and/or the like. In some embodiments, status information may be
received from a user within proximity of the medical device 205,
the status information being provided by the user on the user
interface 225 (for example, based upon one or more observations or
measurements made by the user with regards to the medical device
205).
[0196] At block 1008, based at least in part upon the received
status information, a status of one or more components of the
medical device 205 is determined. For example, the status
information may comprise values of one or more measurements
indicative of a status of a particular component, which may be
aggregated in order to determine a status of the component. In some
embodiments, the status of the component may indicate a particular
state of the component (for example, whether the component is
working or not). In some embodiments, the status information may be
based upon the results of one or more tests. For example, a TCD
test failure may indicate that a TCD circuit is in need of
replacement (for example, by replacing a power PCB of the medical
device). On the other hand, a failure of a thermal cutout test may
indicate a need to replace a cutout (for example, by replacing the
heater plate or the power PCB, depending upon the location of the
cutout).
[0197] The status of the component may also comprise a remaining
operational life of the component. For example, where the value of
one or more measurements associated with a component change over
time with component use in a predictable manner, the values may be
compared to a look-up table or other data structure to determine a
remaining operational life of the component. For example, the
status of a component may indicate that its lifespan has expired or
its remaining operational life does not exceed a threshold, and is
thus in need of replacement. As an example for the respiratory
humidifier 5, the status of the sensor cartridge 6 may indicate
that the lifespan of the sensor cartridge 6 has expired or will
soon expire.
[0198] In some embodiments, the status of the component may
indicate that the component is obsolete. For example, versioning
information may be maintained at the server and downloaded to the
medical device or user device, from which a version mismatch may be
detected. In some embodiments, a version mismatch for a software
module may trigger a software download to update the software
module. However, in some embodiments a version mismatch may require
the replacement of one or more components. As an example for the
respiratory humidifier 5, the sensor cartridge 6 may need to be
replaced due to new functionality requiring a circuit change on a
PCB of the sensor cartridge 6.
[0199] At block 1010, a determination is made as to whether at
least one of the one or more assessed components of the medical
device 205 should be replaced, based upon the assessed status of
the components. For example, the determination may be made based
upon a state of the component. In some embodiments, a component may
be considered to be in need of replacement if the remaining
operational life of the component is less than a threshold value
(for example, less than 10% operational life remaining).
[0200] At block 1012, if it is determined that a component of the
medical device 205 should be replaced, the user is prompted to
order a replacement component. In some embodiments, this may
comprise displaying one or more screen elements to the user on the
user interface 230 of the user device 210, such as a button to
order the component, a link to a store page associated with the
component, and/or the like.
[0201] If the method 1000 for ordering replacement components for
the medical device 205 is interrupted, a message, such as a modal
message, may be displayed to the user indicating an interruption
has occurred. In some embodiments, if the method 1000 for ordering
replacement components for the medical device 205 is
re-established, the method 1000 may continue from the point at
which the interruption occurred. In some embodiments, the method
1000 for ordering replacement components for the medical device 205
may start over.
[0202] The process for ordering replacement components for the
medical device 205 is not limited to the order and number of steps
described in FIG. 10. While the process for ordering replacement
components for the medical device 205 according to FIG. 10
describes the execution of a series of steps in a particular
sequence, the individual steps may be performed in any order,
unless otherwise specified. Additionally, the process for ordering
replacement components for the medical device 205 does not require
execution of all the steps described in FIG. 10. In some
embodiments, the process for ordering replacement components for
the medical device 205 may include additional steps not described
in Figure 10. In some embodiments, the process for ordering
replacement components for the medical device 205 may not include
all steps described in FIG. 10.
[0203] In some embodiments, the server 212 may be configured to
order components for the medical device 205 automatically in
response to a determination that the component is in need to
replacement, allowing for hospitals and medical personnel to better
concentrate on patient care without having to worry about making
sure that needed components will always be available.
[0204] FIG. 11 illustrates a flowchart of an example process for
automatically ordering components for the medical device 205. At
block 1102, the server 212 establishes a connection between the
user device 210 and the medical device 205. At block 1104, a user
may optionally be prompted to perform an action associated with the
medical device 205. The action may be performed on the user
interface 225, 230 of the medical device 205 or the user device
210, physically performed on the medical device 205, or some
combination thereof. At block 1106, status information of the
medical device 205 may be received by the server 212, which may be
used to assess a status of one or more components of the medical
device 205 at block 1108. At block 1110, a determination is made as
to whether a component of the one or more components should be
replaced. In some embodiments, blocks 1102 through 1110 may be
similar to blocks 1002 through 1010.
[0205] At block 1112, a determination may be made as to whether the
medical device 205 is associated with an account. An account may
correspond to a user, a hospital, or other entity able to purchase
the medical device 205 and/or components of the medical device 205.
Accounts may be associated with payment information, delivery
information, and/or the like.
[0206] At block 1114, if the medical device 205 is not associated
with an account, the user may be prompted for account information.
The account information may comprise payment information, delivery
information, and/or the like. An order for the component may then
be placed using the received account information. In addition, the
account information can be stored by the server 212 to be used for
future component purchases.
[0207] On the other hand, if the medical device 205 is determined
to be associated with an account, then at block 1116, an order for
the component may be placed automatically, based upon stored
account information associated with the account. In some
embodiments, a user (for example, the user at the user device 210,
or a different user associated with the account) may be prompted to
confirm the ordering of the component. For example, a message may
be sent to a purchasing department of the hospital associated with
the account, which may then confirm the component order. In some
embodiments the automatic replacement order may be sent to a
server, such as server 212, which may be owned by the manufacturer
of the medical device. In this way the manufacturer automatically
receives replace orders and can ship out replacement components or
medical devices when required.
[0208] If the process for automatically ordering components for the
medical device 205 is interrupted, a message, such as a modal
message, may be displayed to the user indicating an interruption
has occurred. In some embodiments, if the process for automatically
ordering components for the medical device 205 is re-established,
the process may continue from the point at which the interruption
occurred. In some embodiments, the process for automatically
ordering components for the medical device 205 may start over.
[0209] The process for automatically ordering components for the
medical device 205 is not limited to the order and number of steps
described in FIG. 11. While the process for automatically ordering
components for the medical device 205 according to FIG. 11
describes the execution of a series of steps in a particular
sequence, the individual steps may be performed in any order,
unless otherwise specified. Additionally, the process for
automatically ordering components for the medical device 205 does
not require execution of all the steps described in FIG. 11. In
some embodiments, the process for automatically ordering components
for the medical device 205 may include additional steps not
described in FIG. 11. In some embodiments, the process for
automatically ordering components for the medical device 205 may
not include all steps described in FIG. 11. One or more steps of
the process for automatically ordering components for the medical
device 205 may be executed by any one of or any combination of the
processors 115, 215, 120, 220, 222 or other processors residing in
the same devices or other devices.
[0210] In some embodiments, how components are ordered may be
configurable for different components. For example, in some
embodiments, components under a certain price threshold may be
ordered automatically, while components above the price threshold
may require confirmation by one or more authorized users.
[0211] In some embodiments, the server 212 may receive information
from multiple medical devices 205. In addition to performing tasks
and ordering components for the medical device 205, in some
embodiments the information received from multiple medical devices
205 can be aggregated in order to determine usage trends for the
multiple medical devices 205. These usage trends may be used to
identify common errors associated with the medical device 205,
adjust production of the medical device 205 or related products and
components, and/or the like.
[0212] FIG. 12 illustrates a flowchart of an example process for
adjusting production based upon analyzed usage trends of one or
more medical devices 205. At block 1202, usage information is
received from one or more medical devices 205. In some embodiments,
the usage information is collected by the server 212. In some
embodiments, usage information may be collected by multiple servers
212. The usage information may comprise usage mode information
1202-1, usage time information 1202-2, usage location information
1202-3, error code history 1202-4, and/or the like. In some
embodiments, usage information may also comprise status information
as described above.
[0213] Usage mode information 1202-1 may refer to one or more
operating settings of the medical device 205. In some embodiments,
the medical device 205 may be run in one of a plurality of
different operating modes. For example, when the medical device 205
is a humidifier, it may be used in a plurality of different
discrete modes, such as an invasive mode, a non-invasive mode, a
neonatal mode, and/or the like. In some embodiments, usage mode
information 1202-1 may refer to different combinations of settings
with which the medical device 205 may be run. For example, a
humidifier device, in addition to one or more discrete modes, may
have a humidity setting that can be set to a plurality of different
values.
[0214] Usage time information 1202-2 may refer to a time period
that the medical device 205 is in use (for example, how long the
medical device 205 is in use, how often the medical device 205 is
in use, and/or the like). In some embodiments, usage time
information 1202-2 may include what times the medical device 205 is
in usage (for example, morning, afternoon, or night).
[0215] Usage location information 1202-3 may refer to a location of
the medical device 205 where it is operating. In some embodiments,
the usage location information 1202-3 may comprise geographic
location. In some embodiments, the usage location information
1202-3 may comprise a location type where the medical device 205 is
operated (for example, which ward in a hospital).
[0216] Error code history 1202-4 may refer to errors experienced by
the medical device 205 during the course of operation, and may
comprise error information automatically detected by the medical
device 205, the server 212, and/or the user device 210, or error
information entered by a user on the user interface 225, 230, 232,
based upon one or more user observations.
[0217] In some embodiments, one or more types of usage information
may be combined or correlated, to form a more complete picture of
the usage of the medical device 205. For example, usage mode
information 1202-1 and usage time information 1202-2 may be
correlated in order to analyze what modes the medical device 205 is
typically run in during different time periods (for example, the
medical device 205 may be run more often in a first mode in the
morning, and in a second mode at night).
[0218] In some embodiments, the usage information may be collected
while one or more of the medical devices 205 are running standalone
(for example, not connected to a server or user device). When the
medical device 205 is connected to a server or user device, the
collected usage information can be batched and uploaded to the
server or user device. In some embodiments, usage information
received by a user device may be batched and uploaded to a server
(for example, if the user device is not connected to the server
when interfacing with the medical device, but connects to the
server at a later time).
[0219] At block 1204, collected usage information from multiple
medical devices 205 can be combined or aggregated. In some
embodiments, multiple medical devices 205 may be connected to the
server 212, which receives and aggregates usage information from
each of the connected medical devices 205. In some embodiments,
usage information collected by multiple servers 212 may be
transmitted to and aggregated at one or more "hub" servers. For
example, the server 212 may be associated with the medical devices
205 operating within a particular geographic region, or associated
with a particular medical provider. Usage information collected by
the server 212 may be transmitted to a hub server to be aggregated
with usage information collected by other servers corresponding to
other geographic regions or medical providers.
[0220] At block 1206, the aggregated usage information is used to
identify one or more usage trends. In some embodiments, a usage
trend may indicate changes in usage of the medical device 205 over
time (for example, decrease in usage of the medical device 205 at
night over last three months, increase in usage of the medical
device 205 in neonatal mode over past year, and/or the like). The
one or more usage trends may be based upon any category of the
collected usage information, or a combination thereof.
[0221] At block 1208, one or more products associated with the
usage trends are identified. In some embodiments, the one or more
products may comprise components of the medical device 205 that are
associated with certain types of usage (for example, usage modes,
usage location, and/or the like). In some embodiments, the one or
more products may comprise other devices related to usage of the
medical device 205. For example, products related to premature
birth and infant care may be identified as being related to the
neonatal mode usage of the medical device 205.
[0222] At block 1210, a production characteristic of an identified
product is changed, based at least in part upon the one or more
identified usage trends. In some embodiments, a production quantity
of the identified product may be increased or decreased, in
response to the identified usage trend. For example, if it is found
that the medical device 205 is frequently used in neonatal mode,
the production quantity of products related to premature birth and
infant care (for example, an infant circuit kit) may be increased.
In some embodiments, a production quantity of a product may be
changed based upon geographic (for example, increased or decreased
production in certain geographic regions, based upon usage trends
within those regions). In some embodiments, a change in a
production characteristic of a product may comprise changing a
feature of the product in response to the identified usage trends.
For example, if the medical device 205 is found to only be operated
in a particular usage mode, a new product specializing in that
usage mode may be produced. In an alternative form, the production
characteristic may relate to ordering of medical devices or
components of the medical device. For example a hospital may be
instructed to modify purchasing patterns based on the identified
usage trends.
[0223] If the process for adjusting production based upon analyzed
usage trends of one or more medical devices 205 is interrupted, a
message, such as a modal message, may be displayed to the user
indicating an interruption has occurred. In some embodiments, if
the process for adjusting production based upon analyzed usage
trends of one or more medical devices 205 is re-established, the
process may continue from the point at which the interruption
occurred. In some embodiments, the process for adjusting production
based upon analyzed usage trends of one or more medical devices 205
may start over.
[0224] The process for adjusting production based upon analyzed
usage trends of one or more medical devices 205 is not limited to
the order and number of steps described in FIG. 12. While the
process for adjusting production based upon analyzed usage trends
of one or more medical devices 205 according to FIG. 12 describes
the execution of a series of steps in a particular sequence, the
individual steps may be performed in any order, unless otherwise
specified. Additionally, the process for adjusting production based
upon analyzed usage trends of one or more medical devices 205 does
not require execution of all the steps described in FIG. 12. In
some embodiments, the process for adjusting production based upon
analyzed usage trends of one or more medical devices 205 may
include additional steps not described in FIG. 12. In some
embodiments, the process for adjusting production based upon
analyzed usage trends of one or more medical devices 205 may not
include all steps described in FIG. 12. One or more steps of the
process for adjusting production based upon analyzed usage trends
of one or more medical devices 205 may be executed by any one of or
any combination of the processors 115, 215, 120, 220, 222 or other
processors residing in the same devices or other devices. Any one
or more of the maintenance methods disclosed above can be executed
by the medical device, in particular the humidifier 5. The
humidifier 5 is further advantageous because it can also run self
diagnostics using one or more of the maintenance methods described
above. The humidifier 5 may be configured to run any one or more of
the maintenance methods described earlier at regular time intervals
to ensure correct operation of the humidifier 5, or alert the user
if there is a fault or other anomaly.
[0225] Unless the context clearly requires otherwise, throughout
the description and the claims, the words "comprise", "comprising",
and the like, are to be construed in an inclusive sense as opposed
to an exclusive or exhaustive sense, that is to say, in the sense
of "including, but not limited to".
[0226] Reference to any prior art in this specification is not, and
should not be taken as, an acknowledgement or any form of
suggestion that that prior art forms part of the common general
knowledge in the field of endeavor in any country in the world.
[0227] The disclosed apparatus and systems may also be said broadly
to consist in the parts, elements and features referred to or
indicated in the specification of the application, individually or
collectively, in any or all combinations of two or more of said
parts, elements or features.
[0228] Where, in the foregoing description reference has been made
to integers or components having known equivalents thereof, those
integers are herein incorporated as if individually set forth.
[0229] It should be noted that various changes and modifications to
the presently preferred embodiments described herein will be
apparent to those skilled in the art. Such changes and
modifications may be made without departing from the spirit and
scope of the disclosed apparatus and systems and without
diminishing its attendant advantages. For instance, various
components may be repositioned as desired. It is therefore intended
that such changes and modifications be included within the scope of
the disclosed apparatus and systems. Moreover, not all of the
features, aspects and advantages are necessarily required to
practice the disclosed apparatus and systems. Accordingly, the
scope of the disclosed apparatus and systems is intended to be
defined only by the claims that follow.
* * * * *