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Medical Patent Abstract
Various present invention devices enable adherence to requirements
for medical items. A medical item of the present invention includes
a monitoring or data recording device to monitor and/or record medical
solution conditions. The device may further include indicators to
indicate compliance of the medical solution with prescribed requirements
(e.g., manufacturer, medical standard or regulation, etc.). The
medical item may alternatively include a barcode or transponder
to uniquely identify the medical item to a thermal treatment system
measuring and storing conditions in a central database. The present
invention further includes various thermal treatment systems that
monitor medical items for prescribed requirements and display the
monitored parameters to medical personnel. In addition, the present
invention may place time stamp information on medical items to enable
determination by medical personnel of compliance with prescribed
requirements.
Medical Patent Claims
What is claimed is:
1. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to confine operational usage of said temperature
control unit by a user for thermally treating said at least one
medical item to be within an authorized use interval for said user
defined by usage parameters associated with said user, wherein said
usage control unit disables operation of said temperature control
unit by said user for thermally treating said at least one medical
item outside said authorized use interval associated with said user
and said usage parameters include at least one of a time interval
for said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said system.
2. The temperature control system of claim 1, wherein said thermal
treatment unit heats said at least one medical item.
3. The temperature control system of claim 1, wherein said thermal
treatment unit cools said at least one medical item.
4. The temperature control system of claim 1, wherein said temperature
control unit further includes: at least one temperature sensor to
measure a temperature of a corresponding medical item, wherein said
controller controls said thermal output of said thermal treatment
unit to thermally treat said at least one medical item to said entered
desired temperature based on said temperature measured by said corresponding
temperature sensor.
5. The temperature control system of claim 4, wherein said temperature
control unit further includes: a timer to measure residence time
of each medical item thermally treated by said thermal treatment
unit.
6. The temperature control system of claim 1 further including:
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit.
7. The temperature control system of claim 6, wherein said information
storage device includes at least one of a card, a memory device,
a removable storage device, an integrated circuit and a chip.
8. The temperature control system of claim 6, wherein said usage
control unit includes: a system interface to transfer information
with said information storage device.
9. The temperature control system of claim 8, wherein said system
interface collects information pertaining to at least one of medical
item conditions, system conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information.
10. The temperature control system of claim 9, wherein said system
interface stores said collected information on said information
storage device.
11. The temperature control system of claim 10, wherein said information
storage device is provided to a service provider to retrieve said
stored information from said information storage device and generate
a report for said user.
12. The temperature control system of claim 10 further including:
an external interface to transfer information with said information
storage device; and an external processing device coupled to said
external interface to enable transfer of information with said information
storage device.
13. The temperature control system of claim 12, wherein said external
processing device enables an authorized user to perform at least
one of retrieval of information from said information storage device
in the form of a report and adjust said usage parameters stored
on said information storage device to enable further use of said
temperature control unit.
14. The temperature control system of claim 12 further including:
a server system in communication with said external processing device
to receive and store said information stored on said information
storage device, wherein said server system includes a web site accessible
by said user to perform at least one of retrieval of information
from said information storage device in the form of a report and
adjust said usage parameters stored on said information storage
device to enable further use of said temperature control unit.
15. The temperature control system of claim 1, wherein said temperature
control unit further includes: a communications device to facilitate
communications with an external device and to collect information
pertaining to at least one of medical item conditions, system conditions,
time, corresponding temperature information for at least one medical
item, patient information, user information, doctor information
and facility information.
16. The temperature control system of claim 15, wherein said external
device includes a server system to transfer information with said
communications device and to store said collected information.
17. The temperature control system of claim 16, wherein said server
system communicates with said communication device via a network.
18. The temperature control system of claim 16, wherein said server
system includes a web site accessible by said user via an end user
device to perform at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said temperature control system.
19. The temperature control system of claim 16, wherein said communications
device transfers said collected information to said server system
in real time to enable said user to access said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
20. The temperature control system of claim 19, wherein said end
user device provides at least one alarm to indicate conditions exceeding
prescribed requirements.
21. The temperature control system of claim 19, further including
a plurality of said temperature control units, wherein said communications
device of each temperature control unit transfers said collected
information to said server system in real time to enable said user
to access said transferred information via an end user device to
remotely monitor a status of said temperature control units.
22. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit and said usage parameters stored on said
information storage device are adjusted by a service provider to
enable further use of said temperature control unit.
23. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit; wherein said usage control unit includes
a system interface to transfer information with said information
storage device, and wherein said system interface disables said
controller in response to said usage parameters indicating completion
of authorized use of said temperature control unit.
24. A temperature control system for thermally treating medical
items to desired temperatures comprising: a temperature control
unit including: a unit housing; a thermal treatment unit disposed
within said housing to thermally treat at least one medical item;
a controller to facilitate entry of a desired temperature and to
control a thermal output of said thermal treatment unit to thermally
treat said at least one medical item to said entered desired temperature;
and a usage control unit to control usage of said temperature control
unit in accordance with usage parameters associated with a user;
an information storage device to store said usage parameters, wherein
said information storage device is provided by said user to said
temperature control unit; wherein said usage control unit includes
a system interface to transfer information with said information
storage device, and wherein said system interface updates said usage
parameters in accordance with use of said temperature control unit
by said user.
25. The temperature control system of claim 24, wherein said temperature
control unit further includes: a display to display at least one
of said updated usage parameters to inform said user of remaining
authorized use of said temperature control unit.
26. A system for confining operational use of a temperature control
unit that thermally treats medical items to desired temperatures
to be within an authorized use interval in accordance with usage
parameters associated with a user and defining said authorized use
interval, wherein operation of said temperature control unit by
said user for thermally treating at least one medical item is disabled
outside said authorized use interval associated with said user,
said system comprising: a server computer system including a web
site accessible by said user to modify said authorized use interval
by adjusting said usage parameters to enable further use of said
temperature control unit by said user, and wherein said usage parameters
include at least one of a time interval for said operational usage
of said temperature control unit to thermally treat said at least
one medical item, a quantity of thermal cycles, a quantity of medical
items to thermally treat, and a duration a medical item remains
within said temperature control unit.
27. The system of claim 26 further including: an information storage
device to transfer information with said temperature control unit
and store collected information; an external interface to transfer
information with said information storage device; and an external
processing device coupled to said external interface to enable transfer
of information between said information storage device and said
server computer system.
28. The system of claim 27, wherein said information storage device
stores said usage parameters to control use of said temperature
control unit.
29. A system for controlling use of a temperature control unit
that thermally treats medical items to desired temperatures in accordance
with usage parameters associated with a user, said system comprising:
a server computer system to receive and store information collected
by said temperature control unit, wherein said server computer system
includes a web site accessible by said user to perform at least
one of retrieval of said collected information in the form of a
report and adjustment of said usage parameters to enable further
use of said temperature control unit, wherein said server computer
system communicates with said temperature control unit to receive
said collected information and adjust said usage parameters.
30. The system of claim 29, wherein said server computer system
communicates with said temperature control unit via a network.
31. The system of claim 29, wherein said temperature control unit
transfers said collected information to said server computer system
in real time to enable said user to access said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
32. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) confining operational usage of said
temperature control unit by a user for thermally treating said at
least one medical item to be within an authorized use interval for
said user defined by usage parameters associated with said user,
wherein operation of said temperature control unit by said user
for thermally treating said at least one medical item is disabled
outside said authorized use interval associated with said user and
said usage parameters include at least one of a time interval for
said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said system.
33. The method of claim 32, wherein step (a) further includes:
(a.1) heating said at least one medical item.
34. The method of claim 32, wherein step (a) further includes:
(a.1) cooling said at least one medical item.
35. The method of claim 32, wherein step (b) further includes:
(b.1) measuring a temperature of a corresponding medical item and
controlling said thermal output of said thermal treatment unit to
thermally treat said at least one medical item to said entered desired
temperature based on a corresponding measured temperature.
36. The method of claim 35, wherein step (b) further includes:
(b.2) measuring residence time of each medical item thermally treated
by said thermal treatment unit.
37. The method of claim 32, wherein step (c) further includes:
(c.1) storing said usage parameters on an information storage device,
wherein said information storage device is provided by said user
to said temperature control unit.
38. The method of claim 37, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
39. The method of claim 37, wherein step (b) further includes:
(b.1) collecting information pertaining to at least one of medical
item conditions, unit conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information.
40. The method of claim 39, wherein step (c) further includes:
(c.2) storing said collected information on said information storage
device.
41. The method of claim 40 further including: (d) providing said
information storage device to a service provider to retrieve said
stored information from said information storage device and generate
a report for said user.
42. The method of claim 40 further including: (d) performing, via
an external processing device, at least one of retrieval of information
from said information storage device in the form of a report and
adjustment of said usage parameters stored on said information storage
device to enable further use of said temperature control unit.
43. The method of claim 40, wherein an external device transfers
information with said information storage device and is coupled
to a server system with a web site, and said method further includes:
(d) transferring said collected information from said information
storage device to said server system; and (e) performing, via said
web site of said server system, at least one of retrieval of said
collected information from said server system in the form of a report
and adjustment of said usage parameters stored on said information
storage device to enable further use of said temperature control
unit.
44. The method of claim 32, wherein step (b) further includes:
(b.1) collecting information pertaining to at least one of medical
item conditions, unit conditions, time, corresponding temperature
information for at least one medical item, patient information,
user information, doctor information and facility information; and
(b.2) storing said collected information on a server system in communication
with said temperature control unit.
45. The method of claim 44, wherein said server system communicates
with said temperature control unit via a network.
46. The method of claim 44, wherein said server system includes
a web site accessible by said user via an end user device, and said
method further includes: (d) performing, via said web site of said
server system, at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said temperature control system.
47. The method of claim 44, wherein step (b.1) further includes:
(b.1.1) transferring said collected information to said server system
in real time; and said method further includes: (d) accessing said
transferred information via an end user device to remotely monitor
a status of said temperature control unit.
48. The method of claim 47, wherein step (d) further includes:
(d.1) providing at least one alarm on said end user device to indicate
conditions exceeding prescribed requirements.
49. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) adjusting said usage parameters by a service provider
to enable further use of said temperature control unit.
50. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) transferring information with said information storage
device and disabling said temperature control unit in response to
said usage parameters indicating completion of authorized use of
said temperature control unit.
51. A method of thermally treating medical items to desired temperatures
comprising: (a) receiving at least one medical item within a housing
of a temperature control unit for thermal treatment by a thermal
treatment unit; (b) facilitating entry of a desired temperature
and controlling a thermal output of said thermal treatment unit
to thermally treat said at least one medical item to said entered
desired temperature; and (c) controlling usage of said temperature
control unit in accordance with usage parameters associated with
a user, wherein step (c) further includes: (c.1) storing said usage
parameters on an information storage device, wherein said information
storage device is provided by said user to said temperature control
unit; and (c.2) updating said usage parameters in accordance with
use of said temperature control unit by said user.
52. The method of claim 51, wherein step (c) further includes:
(c.3) displaying at least one of said updated usage parameters to
inform said user of remaining authorized use of said temperature
control unit.
53. A method of confining operational use of a temperature control
unit that thermally treats medical items to desired temperatures
to be within an authorized use interval in accordance with usage
parameters associated with a user and defining said authorized use
interval, wherein operation of said temperature control unit by
said user for thermally treating at least one medical item is disabled
outside said authorized use interval associated with said user,
said method comprising: (a) receiving and storing information collected
by said temperature control unit on a server computer system including
a web site accessible by said user; and (b) modifying said authorized
use interval by adjusting said usage parameters, via said web site,
to enable further use of said temperature control unit by said user,
wherein said usage parameters include at least one of a time interval
for said operational usage of said temperature control unit to thermally
treat said at least one medical item, a quantity of thermal cycles,
a quantity of medical items to thermally treat, and a duration a
medical item remains within said temperature control unit.
54. The method of claim 53, wherein step (a) further includes:
(a.1) storing said collected information on an information storage
device; (a.2) transferring information between said information
storage device and said temperature control unit; and (a.3) transferring
information between said information storage device and said server
computer system.
55. The method of claim 54, wherein step (a.1) further includes:
(a.1.1) storing said usage parameters on said information storage
device to control use of said temperature control unit.
56. A method of controlling use of a temperature control unit that
thermally treats medical items to desired temperatures in accordance
with usage parameters associated with a user, said method comprising:
(a) receiving and storing information collected by said temperature
control unit on a server computer system including a web site accessible
by said user, wherein said server computer system conununicates
with said temperature control unit, and step (a) further includes:
(a.1) receiving said collected information from said temperature
control unit and adjusting said usage parameters via said server
computer system; (b) performing, via said web site, at least one
of retrieval of said collected information in the form of a report
and adjustment of said usage parameters to enable further use of
said temperature control unit.
57. The method of claim 56, wherein said server computer system
communicates with said temperature control unit via a network.
58. The method of claim 56, wherein step (a.1) further includes:
(a.1.1) transferring said collected information from said temperature
control unit to said server computer system in real time; and said
method further includes: (c) accessing said transferred information
via an end user device to remotely monitor a status of said temperature
control unit.
59. A system for controlling usage of a medical device comprising:
a medical device; and a usage control unit to confine operational
usage of said medical device by a user to be within an authorized
use interval for said user defined by usage parameters associated
with said user, wherein said usage control unit disables operation
of said medical device by said user outside said authorized use
interval associated with said user and said usage parameters include
at least one of a time interval for said operational usage of said
medical device and a quantity of operational cycles.
60. The system of claim 59, wherein said medical device collects
information pertaining to at least one of system conditions, time,
patient information, user information, doctor information and facility
information.
61. The system of claim 60 further including: an information storage
device to store at least one of said usage parameters and said collected
information, wherein said information storage device is provided
by said user to said medical device.
62. The system of claim 61, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
63. The system of claim 61, wherein said information storage device
is provided to a service provider to retrieve said stored information
from said information storage device and generate a report for said
user.
64. The system of claim 60 further including: a server computer
system to receive and store said collected information, wherein
said server computer system includes a web site accessible by said
user to perform at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said medical device.
65. A method of controlling use of a medical device comprising:
(a) confining operational usage of said medical device by a user
to be within an authorized use interval for said user defined by
usage parameters associated with said user, wherein operation of
said medical device by said user is disabled outside said authorized
use interval associated with said user and said usage parameters
include at least one of a time interval for said operational usage
of said medical device and a quantity of operational cycles.
66. The method of claim 65, wherein step (a) further includes:
(a.1) collecting information, via said medical device, pertaining
to at least one of system conditions, time, patient information,
user information, doctor information and facility information.
67. The method of claim 66, wherein step (a) further includes:
(a.2) storing at least one of said usage parameters and said collected
information on an information storage device, wherein said information
storage device is provided by said user to said medical device.
68. The method of claim 67, wherein said information storage device
includes at least one of a card, a memory device, a removable storage
device, an integrated circuit and a chip.
69. The method of claim 67, wherein step (a) further includes:
(a.3) providing said information storage device to a service provider
to retrieve said stored information from said information storage
device and generate a report for said user.
70. The method of claim 66, wherein step (a) further includes:
(a.2) receiving and storing said collected information on a server
computer system, wherein said server computer system includes a
web site accessible by said user; and (a.3) performing, via said
web site, at least one of retrieval of said collected information
in the form of a report and adjustment of said usage parameters
to enable further use of said medical device.
71. The method of claim 65, wherein step (a) further includes:
(a.1) leasing said medical device to said user, wherein said usage
parameters include values to control use of said medical device
in accordance with an associated leasing arrangement.
72. The method of claim 65, wherein step (a) further includes:
(a.1) renting said medical device to said user, wherein said usage
parameters include values to control use of said medical device
in accordance with an associated rental arrangement.
Medical Patent Description
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention pertains to medical item thermal treatment
and/or monitoring systems, such as the types disclosed in U.S. Pat.
No. 5,408,576 (Bishop); U.S. Pat. No. 6,259,067 (Faries, Jr. et
al.); U.S. Pat. No. 6,294,762 (Faries, Jr. et al.); U.S. Pat. No.
6,371,121 (Faries, Jr. et al.); U.S. Pat. No. 6,384,380 (Faries,
Jr., et al.); U.S. Pat. No. 6,376,805 (Faries, Jr. et al.); U.S.
Pat. No. 6,467,953 (Faries, Jr. et al.); U.S. Pat. No. 6,566,631
(Faries, Jr. et al.) and U.S. Pat. No. 6,660,974 (Faries, Jr. et
al.); U.S. Patent Application Publication Nos.: 2002/0147426 (Faries,
Jr. et al.) and 2003/0114795 (Faries, Jr. et al.); and U.S. patent
application Ser. No. 09/380,507, entitled "Method and Apparatus
for Pressure Infusion and Temperature Control of Infused Liquids"
and filed Apr. 24, 2000. The disclosures of the foregoing patents,
patent publications and patent applications are incorporated herein
by reference in their entireties. In particular, the present invention
is directed toward monitoring intravenous solution or other medical
items for compliance with prescribed requirements (e.g., manufacturer,
medical standards or regulations, etc.) from the time the solution
is prepared through disposal of the solution after use in a medical
procedure. In other words, the medical solution or other medical
items are monitored from manufacture at a manufacturing plant, through
transport and/or storage to an end user or medical facility, through
subsequent thermal treatment by that user and during administration
to a patient. In this manner, a complete record of temperature and/or
other conditions for the medical item is ascertained to determine
and/or indicate to medical personnel compliance with the prescribed
requirements.
2. Discussion of Related Art
Various types of medical items require heating to a selected temperature
prior to utilization in a medical procedure. Generally, the medical
items may be heated for limited time intervals to preserve their
effectiveness. These items typically include intravenous solutions,
irrigation fluids, surgical instruments, bottles and blankets. Intravenous
(IV) fluids, for example, are typically stored in a cool environment
and, consequently, require heating to precise temperatures to prevent
thermal shock and injury from occurring during infusion of the fluid
into a patient. Similarly, irrigation fluids can be warmed or cooled
to various temperatures depending upon their intended use. These
types of fluids are typically provided to a patient utilizing a
flexible bag or container filled with the fluid and delivered via
a fluid line that conveys the fluid from the bag to the patient.
Some medical items can only be heated for a limited period of time,
or in accordance with controlled warming cycles, in order to avoid
adversely affecting their effectiveness. For example, some fluids,
such as whole blood or fluids containing medication, should be warmed
evenly to a specific temperature and can be rendered unusable or
unsafe if all or a portion of the fluid is overheated.
In order to provide the necessary heated items for use in medical
procedures, the related art provides devices for regulating and/or
monitoring temperature of medical items. For example, ovens may
be disposed within operating rooms to heat items to desired temperatures.
Further, U.S. Pat. No. 4,419,568 (Van Overloop) discloses a wet
dressings heater having a base with side walls defining a cavity,
and an insert connected to the base and defining at least one recess
in the cavity for receiving wet dressings. A heater has an electrical
heating element in close proximity to the insert recess for heating
the wet dressings, while the temperature of the heating element
is controlled in a desired temperature range for those wet dressings.
U.S. Pat. No. 4,495,402 (Burdick et al.) discloses a warmer for
heating wet dressings and other articles disposed within a heating
and storage compartment. The articles are arranged within the compartment
in stacked relation and disposed on a plate that is supplied with
thermal energy from a heater. The plate includes a center aperture
whereby a first thermal sensor is disposed in the aperture in contact
with a bottom most article. Control circuitry is disposed beneath
the plate to control the heater to maintain temperature of the bottom
most article at a desired level based on the temperatures sensed
by the first thermal sensor and a second thermal sensor responsive
to heater temperature.
U.S. Pat. No. 4,859,360 (Suzuki et al.) discloses a blood bag having
a temperature-monitoring device in the form of a tag or label adhered
to the bag outer surface. The temperature-monitoring device includes
plural reversible temperature indicators each associated with a
specific temperature range to indicate a current temperature of
the blood, and an irreversible temperature indicator to indicate
that the blood has currently or previously reached a predetermined
temperature. The reversible indicators individually provide visual
indications in response to the current blood temperature being within
a corresponding range, while the irreversible indicator maintains
a visual indication once the predetermined temperature has been
reached.
U.S. Pat. No. 5,408,576 (Bishop) discloses an intravenous fluid
warmer having a cabinet structure to accommodate a plurality of
intravenous fluid bags. A temperature sensor and pad of heating
filaments are disposed within the cabinet structure, whereby the
temperature sensor enables automatic temperature regulation of the
pad of heating filaments to heat the intravenous fluid bags. The
heating filaments are covered by a rubber layer to prevent melting
of the bags during heating. A temperature indicator disposed on
the cabinet structure permits a user to ascertain when a desired
temperature is attained, whereby an intravenous fluid bag is removed
from the intravenous fluid warmer via an opening defined in a side
of the cabinet structure.
U.S. Pat. No. 5,986,239 (Corrigan, III et al.) discloses a conductive
warmer for flexible plastic bags. The warmer includes a heat-conducting
member of thermally conductive material having a plurality of fins
which are parallel and spaced apart to define a plurality of bag-receiving
compartments. The fins are connected to a back portion of the heat-conducting
member to which a heating element is attached in a heat-exchanging
relationship. The heating element conducts heat through the back
portion and fins of the heat-conducting member to the bags.
The devices described above suffer from several disadvantages.
In particular, temperature and heating requirements are typically
prescribed for medical solutions or other medical items from various
sources (e.g., manufacturer, medical standard or regulation, etc.).
These requirements typically prescribe a particular temperature
range, expiration date or time and certain time intervals for heating
the medical solution in order to maintain the solution efficacy.
The above-described devices generally do not monitor medical items
for or indicate compliance with these prescribed requirements throughout
the life of the medical item (e.g., from manufacture through use
and disposal). For example, the above-described warming devices
may provide a temperature indication during heating, but do not
monitor the heating time intervals for the medical items, the medical
item temperatures during storage or usage outside of the device
or the medical item expiration date. Although the Suzuki et al.
device is secured to and monitors temperature of a blood bag, there
is no manner for that device to monitor or indicate the heating
intervals and/or passage of the expiration date or time for the
blood bag. Thus, medical personnel may unknowingly administer to
patients solutions and/or medication that are unusable and/or have
reduced potency due to non-compliance with prescribed requirements
(e.g., an exceeded expiration date, prolonged exposure to heat,
attainment of temperatures outside the prescribed range, etc.),
thereby risking serious injury to patients.
OBJECTS AND SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to monitor
medical item conditions and indicate compliance with prescribed
requirements from the time the item is prepared through item disposal
after use (e.g., throughout the life of the medical item) to prevent
use of compromised medical items with patients.
It is another object of the present invention to thermally treat
medical items and monitor medical item conditions (e.g., heating
time, temperature, etc.) for, and/or indicate compliance with, prescribed
requirements.
Yet another object of the present invention is to control usage
of thermal treatment systems.
Still another object of the present invention is to monitor medical
item conditions during thermal treatment and generate hardcopy or
electronic reports indicating those conditions.
A further object of the present invention is to mark or otherwise
transcribe information associated with a medical item on that medical
item to notify medical personnel of the medical item status with
respect to prescribed requirements.
The aforesaid objects may be achieved individually and/or in combination,
and it is not intended that the present invention be construed as
requiring two or more of the objects to be combined unless expressly
required by the claims attached hereto.
According to the present invention, various devices enable medical
personnel or users to adhere to medical regulatory and medical item
manufacturer requirements relating to medical item heating time,
temperature and/or other conditions in order to ensure patient safety.
For example, intravenous (IV) fluid bags are typically heated to
precise temperatures to prevent thermal shock and injury from occurring
during infusion of the IV fluid into a patient. Generally, the fluid
bags may be heated for limited time intervals to preserve their
effectiveness. These time limits may be prescribed by medical standards
or regulations, or by the manufacturer of the fluid. A medical solution
container or other medical item of the present invention includes
a monitoring or data recording device to monitor and/or record medical
solution conditions. The device may further include indicators to
indicate compliance of the medical solution with prescribed requirements
(e.g., manufacturer, medical standard or regulation, etc.), typically
pertaining to medical solution temperature and heating time intervals
sufficient to maintain efficacy of the medical solution. The monitoring
device may be embedded within or disposed on a container wall or,
alternatively, be disposed within the solution, and may utilize
a wireless communication link to transfer recorded information.
The medical solution container may alternatively include an electronic
memory device attached to or contained within the medical solution
container. The memory device is capable of recording information
received from an external device, such as a thermal treatment system
that has been configured to store warming cycle time, temperature
and/or other information in the respective container embedded devices.
The container may further include electronically activated visible
indicators that are triggered based upon compliance with prescribed
requirements.
The medical solution container may alternatively include an external
barcode or transponder, where the solution container is identified
with a unique bar code and/or transponder signal or code that identifies
the container to a thermal treatment system measuring medical solution
conditions. The thermal treatment system may transmit event data
and/or other information pertaining to the container to a central
database.
In another embodiment, the medical solution container may include
electrochromic ink cells and a control circuit. The control circuit
monitors external and/or internal conditions of the container environment
and triggers individual electrochromic cells in response to the
presence of one or more conditions (e.g. max temperature limit exceeded,
max humidity exceeded, etc.) to indicate compliance with prescribed
requirements. Alternatively, monitoring may be performed by an external
unit, such as a thermal treatment system or a box used to transport
medical solutions or other sensitive components. In this case, the
container includes the electrochromic cells (and, preferably, text
identifying the meaning of each) and a conducting lead to connect
the container and corresponding electrochromic cells to the external
monitoring unit. The unit monitors the container environment and
activates selected electrochromic cells upon the container to cause
the electrochromic cell to change color (e.g., from clear to opaque,
etc.) upon determining that allowable conditions have been exceeded.
In addition, the electrochromic cell on the container may be manually
activated by pressing a current source button upon the container
to cause the electrochromic cell to change color, thereby allowing
a manual over-ride to indicate medical item status with respect
to the prescribed requirements.
The present invention further includes various thermal treatment
systems that monitor medical solution containers or other medical
items for prescribed requirements (e.g., temperature, heating time
intervals, etc.) and display the monitored parameters to medical
personnel. These systems may be utilized with conventional medical
solution containers or the containers described above to monitor
solution conditions. The thermal treatment systems may be monitored
and controlled via an information device containing operational
parameters. Moreover, the systems may monitor the time, temperature
and/or other conditions of thermally treated items to generate reports
(e.g., printed reports, displays, reports in electronic form, etc.)
for users.
In addition, the present invention may place time stamp information
on medical solution containers (e.g., bags or bottles containing
saline or intravenous (IV) solutions, antibiotics or other drugs,
blood, etc.) or other medical items (e.g., instruments, blankets,
etc.) to enable determination by medical personnel of compliance
with prescribed requirements (e.g., residence time within a thermal
treatment system, the remaining effective or utilization life of
the medical solution or other item, etc.).
The above and still further objects, features and advantages of
the present invention will become apparent upon consideration of
the following detailed description of specific embodiments thereof,
particularly when taken in conjunction with the accompanying drawings,
wherein like reference numerals in the various figures are utilized
to designate like components.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view in perspective of a medical solution container
including a monitoring device to monitor solution conditions according
to the present invention.
FIG. 2 is a schematic block diagram of the monitoring device of
FIG. 1.
FIG. 3 is a view in perspective of a medical solution container
including a memory device to record and/or indicate solution conditions
according to the present invention.
FIG. 4 is a schematic block diagram of the memory device of FIG.
3.
FIG. 5 is a view in perspective of a medical solution container
including a bar code serving to identify the medical solution container
according to the present invention.
FIG. 6 is a view in perspective of a medical solution container
including a transponder unit according to the present invention.
FIG. 7 is schematic block diagram of the transponder unit of FIG.
6.
FIG. 8 is a view in perspective of a medical solution container
including electrochromatic cells to indicate solution conditions
according to the present invention.
FIG. 9 is a schematic block diagram of a control circuit for the
electrochromatic cells of FIG. 8.
FIG. 10 is a system level block diagram of an exemplary thermal
treatment system that monitors thermally treated items and may generate
reports and/or control system usage according to the present invention.
FIG. 11 is a block diagram of the report unit within the system
of FIG. 10 to generate and/or print reports according to the present
invention.
FIGS. 12A-12I are schematic illustrations of exemplary reports
produced by the system of FIG. 10 in accordance with the present
invention.
FIG. 13 is a block diagram of the usage control unit within the
system of FIG. 10 to control system usage according to the present
invention.
FIG. 14 is a diagrammatic illustration of an alternative embodiment
of the usage control unit of FIG. 13 with a computer system to access
monitored thermal treatment system information according to the
present invention.
FIG. 15 is a diagrammatic illustration of yet another embodiment
of the usage control unit of FIG. 13 in communication with storage
and monitoring devices via a network according to the present invention.
FIG. 16 is a procedural flow chart illustrating the manner in which
a medical item thermal treatment system thermally treats a medical
item and monitors and controls system use according to the present
invention.
FIG. 17 is a procedural flow chart illustrating the manner in which
the present invention enables a user to monitor and control thermal
treatment system use.
FIG. 18 is a view in perspective of an exemplary modular warmer
unit according to the present invention.
FIG. 19 is a top view in plan of a tray or drawer for the unit
of FIG. 18 including individual monitoring assemblies and a configuration
to enable storage of numerous medical solution containers in a generally
upright position.
FIG. 20 is a view in perspective of an exemplary type of thermal
treatment system for thermally treating and monitoring a medical
solution within a basin according to the present invention.
FIG. 21 is a view in perspective of an exemplary type of thermal
treatment system for thermally treating and monitoring solution
within an IV line according to the present invention.
FIG. 22 is a view in perspective of a temperature control system
for heating medical items and measuring and displaying residence
time of those items within the system in accordance with the present
invention.
FIG. 23 is a front view in elevation of the system of FIG. 22.
FIG. 24 is an exploded perspective view of a drawer of the system
of FIG. 22.
FIG. 25 is a view in elevation of an exemplary heating element
of the system of FIG. 22.
FIG. 26 is an electrical schematic diagram of an exemplary control
circuit of the system of FIG. 22.
FIG. 27A is a view in perspective of a temperature control system
including guides and a timer according to the present invention.
FIG. 27B is a top view in plan of a limit switch arm employed by
the system of FIG. 27A.
FIG. 27C is a side view in partial section of the system of FIG.
27A.
FIGS. 28A-28D are views in perspective of exemplary guides of the
system of FIG. 27A.
FIG. 29 is an electrical schematic diagram of an exemplary control
circuit for the system of FIG. 27A.
FIG. 30 is a view in perspective of a temperature control system
for heating plural medical items and measuring and displaying residence
time of those items within the system according to the present invention.
FIGS. 31A-31B are schematic illustrations of exemplary display
screens for the system of FIG. 30 with temperature indications in
Celsius and Fahrenheit, respectively.
FIG. 32 is an electrical schematic diagram of an exemplary control
circuit for the system of FIG. 30.
FIG. 33 is an electrical schematic diagram of a heat control circuit
of the control circuit of FIG. 32.
FIG. 34 is a system flow diagram of an exemplary system for placing
time stamp information on medical items and thermally treating those
items according to the present invention.
FIG. 35A is a view in elevation of an exemplary medical item in
the form of an intravenous solution bag including time stamp information
placed on the bag exterior surface according to the present invention.
FIG. 35B is a view in elevation of an exemplary medical item in
the form of an intravenous solution bag disposed within a liner
or overwrap, whereby time stamp information is placed on the liner
according to the present invention.
FIG. 36 is a schematic block diagram of a marking device of the
system of FIG. 34.
FIGS. 37A-37B are schematic illustrations of exemplary labels with
time stamp information for placement on a medical item according
to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention enables monitoring of a medical item (e.g.,
medical solution containers or bags, etc.) for compliance with prescribed
requirements (e.g., manufacturer, medical standard or regulation,
etc.) to ensure the medical item maintains efficacy and remains
pharmaceutically acceptable. The present invention enables monitoring
(e.g., continuously and/or at any intervals, etc.) of the medical
item at each or any of the stages (e.g., manufacture, transport,
storage, thermal treatment, use with patients, etc.) from the time
the solution is prepared through disposal of the solution after
use in a medical procedure. In other words, a medical solution or
other medical items are monitored (e.g., temperature, heating time,
age or utilization life, etc.) from manufacture at a manufacturing
plant, through transport and/or storage to an end user or medical
facility, through subsequent thermal treatment by the end user and/or
during administration of the solution to a patient. In this manner,
a complete record of temperature and/or other conditions for the
medical item is ascertained to determine and/or indicate to medical
personnel compliance with the prescribed requirements. Thus, the
present invention basically enables users to conform to regulatory
and medical item manufacturer requirements, typically relating to
medical item heating time, utilization life and temperature, in
order to ensure patient safety.
A medical item including a monitoring device according to the present
invention is illustrated in FIG. 1. Initially, a medical item 2
is preferably an intravenous solution bag; however, the medical
item may be implemented by a wide variety of medical items (e.g.,
medical solution containers, saline solutions, IV solutions and/or
lines, instruments, blankets, antibiotics or other drugs, blood,
irrigation fluid and/or lines, etc.). Specifically, intravenous
solution bag 2 is in the form of a conventional intravenous solution
bag and is constructed of plastic or other materials commonly utilized
for forming those types of bags. The solution bag may contain various
types of solutions, such as saline solution, blood, antibiotic or
other drugs, or any other intravenously administered solution. Intravenous
solution bag 2 further includes a generally triangular projection
4 attached to and extending from the bag upper portion. Projection
4 preferably includes a truncated upper portion having an opening
or hole 6 defined therein for interfacing an intravenous pole or
other support structure (not shown). The bag lower portion includes
an outlet 7 and associated fluid conduits 15 to interface an intravenous
tube (not shown) and enable the solution to flow through the tube
from the outlet to a patient.
Generally, intravenous solutions are required to be within a specific
temperature range prior to and/or during infusion to avoid injury
to a patient as described above. For example, fluids intravenously
administered to a patient have a temperature near the patient body
temperature, preferably in the approximate range of 86.degree. F.-104.degree.
F., and should not exceed a maximum temperature to maintain solution
efficacy. Further, the solutions typically have a prescribed utilization
life or expiration date and heating time in order to maintain their
efficacy as described above. The present invention monitors conditions
of the solution bag in order to ensure compliance with the prescribed
requirements (e.g., from the medical item manufacturers, medical
standard or regulation, etc.). In particular, solution bag 2 further
includes a monitoring or data recording device 10. The monitoring
device includes or is coupled to sensors 16 (FIG. 2) to monitor
the solution bag from the time the bag is filled with fluid to the
process of dispensing the fluid to the patient. The monitoring device
measures and stores information (e.g., age of solution, time, temperature,
humidity, heating interval, maximum temperature attained, manufacturing
date, expiration date or time, amount or volume of solution, strength
of solution, diluent, directions, etc.). The measured information
may be measured either on a periodic basis or in response to an
incremental positive or negative change in a monitored parameter
(e.g., a change in temperature, humidity, etc.).
Monitoring device 10 is typically attached to the interior or exterior
bag surface in a manner enabling the sensors to measure solution
conditions. The monitoring device may be attached to or embedded
within the bag surface at any desired locations via any conventional
or other techniques (e.g., adhesive, welding, lamination, etc.).
For example, the monitoring device may be attached to the bag during
bag construction, where a pouch or receptacle (not shown) may be
adhered or sealed to the bag interior or exterior surface to receive
the monitoring device. Alternatively, the monitoring device may
be disposed within the bag interior in a suspended or floating state
within the solution. In this case, the monitoring device may include
any conventional or other suitable floatation devices to suspend
the device within the solution.
The monitoring device may further include a display 12 and/or indicators
14 to indicate measured parameters to medical personnel. The display
may be of any shape, size or type (e.g., LED, LCD, etc.), may be
disposed at any location on the monitoring device or bag and may
display any information. Indicators 14 are preferably implemented
by light emitting diodes (LED) and may indicate to medical personnel
conditions and/or compliance with prescribed requirements. The indicators
may be disposed at any locations on the monitoring device or bag
and may be activated based upon a local assessment of the recorded
information or based upon an external assessment of the recorded
information by an external processor. In addition, the activation
of the indicators may be based upon local or external assessment
of the recorded information with respect to stored predetermined
parameters relating to the prescribed requirements. The monitoring
device further includes an interface 20 (FIG. 2) to facilitate communications
with an external device 21 as described below and transfer recorded
information. The external device may be coupled to an external database
for storage and retrieval of information.
Referring to FIG. 2, monitoring device 10 includes one or more
sensors 16, a processor 18 and an interface 20. A power source (not
shown), preferably in the form of batteries, provides power to the
components. The monitoring device may further include display 12
and/or indicators 14 as described above. Processor 18 is typically
implemented by a conventional microprocessor and controls operation
of the monitoring device. However, the processor may alternatively
be implemented by any hardware or circuitry. The processor is coupled
to display 12, indicators 14, sensors 16 and interface 20. Sensors
16 are preferably implemented by various conventional or other sensors
(e.g., proximity sensors, pressure sensors, temperature sensors
(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volume
sensors, flow sensors, fluid sensors, fluid level sensors, etc.)
to measure corresponding conditions (e.g., solution temperature,
humidity, fluid level, etc.). The sensors may be disposed in a common
monitoring device housing or be external of the monitoring device
within the solution bag to measure the corresponding conditions.
The measured parameters are provided to processor 18, where the
processor may record the measured conditions and time of measurement
for storage and/or display. The stored values may be downloaded
to an external device 21 as described below. The monitoring device
may further record item locations (e.g., manufacturing plant, storage
locations, transport, medical facility, etc.) and/or other information
to correspond with the time, temperature and/or other recordings
as described below.
The monitoring device is typically activated at the fluid bag manufacturing
plant. As the bag is being produced, solution temperatures and/or
other conditions are recorded in the processor (or an external)
memory. In addition, the monitoring device may store solution information
from the manufacturer or other source (e.g., name, strength, amount
or volume, expiration date or time, date prepared and diluent, location,
directions, etc.). The monitoring device records the temperature
of the solution and/or other conditions as the bag moves from the
manufacturer, through shipping and storage to the end user or medical
facility. The monitoring device further records solution temperature
and/or other conditions in the event of thermal treatment of the
bag by the end user and during administration of solution to the
patient. This provides medical personnel or the medical facility
with a complete record of temperature and/or other conditions for
each solution bag to enable determination of compliance with prescribed
requirements (e.g., age, temperature, re-warming, heating intervals,
etc.) based on the information in the record.
The processor may further include information associated with the
prescribed requirements (e.g., age, temperature, heating intervals,
no re-warming, etc.) and determine compliance with those requirements
based on the measured values. This enables the requirements to be
programmable, where the monitoring device may be used for any medical
solutions and/or prescribed requirements. The measured values and/or
a compliance indication may be indicated to medical personnel via
display 12 and/or indicators 14. For example, the processor may
control the display to indicate the measured values, prescribed
requirements and/or an indication (e.g., message, symbol, etc.)
of non-compliance with those requirements. The indicators may be
of different colors to indicate compliance (e.g., a green LED),
marginal compliance (e.g., a yellow LED) or non-compliance (e.g.,
a red LED) with any of those requirements (e.g., the indicators
may be associated with any quantity of the requirements (e.g., expiration
date, temperature, heating interval, re-warming, etc.) to indicate
non-compliance with those requirements). Thus, the monitoring device
continuously monitors medical items for compliance with prescribed
requirements at each stage of the solution life and immediately
indicates non-compliance or a compromised solution to medical personnel.
Interface 20 is coupled to processor 18 and facilitates communications
with an external device 21 for transfer of information. The interface
is typically in the form of a conventional wireless transceiver
(e.g., RF, infrared, etc.) to communicate with the external device.
The external device may be in the form of a corresponding wireless
transmitter/receiver (e.g., RF, infrared, etc.) of a processing
device or system (e.g., computer station or system, hand-held device,
etc.). The recorded information in the processor may be downloaded
at any time by the use of the wireless transmitter/receiver. A user
positions the solution bag in close proximity to the wireless transmitter/receiver,
where the external device instructs the monitoring device to transmit
the recorded information from memory. Alternatively, the interface
may be in the form of a connector or port for connection to a corresponding
port of the external device (e.g., connection to the processing
device or system) via a cable. The interface receives an instruction
from the external device and forwards the request to the processor
to retrieve the desired information. The processor further controls
interface 20 to provide the information to the requesting device.
The information transmitted to the external device includes raw
data that is processed by the external wireless transmitter/receiver
or processing system to produce a user friendly format (e.g., a
data sheet, a line graph that charts the temperatures over time
and location, etc.). The resulting information may be presented
on a screen for the user to view, printed for documentation purposes
or stored in local or remote database accessible by users or medical
personnel.
Location information (e.g., codes for a manufacturer loading dock,
hospital receiving or Operating Room, etc.) may be entered into
the external device by the user (e.g., by keying into the wireless
transmitter/receiver or processing device the location code) for
subsequent transmission to the monitoring device for storage. This
enables monitored parameters to be associated with the location
of the bag. Alternatively, the monitoring device may further include
a conventional Global Positioning System (GPS) transceiver 22 to
communicate with a GPS satellite to obtain location and/or time
information. The transceiver may be implemented by any conventional
or other GPS transceiver and is coupled to and controlled by processor
18 to retrieve the information for storage.
The external device may further enable entry or provide various
information (e.g., start date and start time of solution or other
item heating/cooling, the time interval the solution or other item
was heated/cooled, the temperature the solution or other item attained
during heating/cooling and/or the time and temperature of the solution
or other item when the solution was removed from the system (e.g.,
partial or complete history of time and solution or other item temperature,
facility information (e.g., including name, location, etc.), patient
information (e.g., including patient identification number, patient
age, patient name, patient sex, patient medications, patient diagnoses,
patient commodities and conditions, patient lab values, patient
allergies and sensitivities, patient weight and height, patient
pregnancy and lactation status, dosage information, etc.), doctor
information, type of procedure, the solution information described
above, type of instruments or other item being heated/cooled, amount
or quantity of solution or other item being heated/cooled, etc.)
for transmission to and storage in the monitoring device. The external
devices may be disposed at various locations (e.g., manufacturing
plant, transport station, medical facility, etc.) to enable entry
and/or retrieval of information. Alternatively, the information
may be entered into the monitoring device or retrieved for display
on display 12 via processor input devices (e.g., keypad, etc.).
The monitoring device may further determine and/or indicate various
conditions relating to the entered information. For example, a monitoring
device equipped with fluid sensors may determine and/or indicate,
via display 12 and/or indicators 14, when an appropriate dosage
has been administered to a patient. Moreover, the monitoring device
may include a unique identifier, where external device 21 may retrieve
and store information from the monitoring device in a local or remote
central database based on the identifier for subsequent access by
users or medical personnel. This enables information for the particular
bag to be retrieved and examined and/or be utilized for tracking,
inventory and/or availability purposes. By way of example, solution
bags 2 may communicate with external devices disposed at various
locations (e.g., manufacturing plant, transport, storage, medical
facility, etc.) to enable the bags to be located or tracked (e.g.,
via location codes or the GPS). The information may further be stored
in a database and accessed to determine inventory and/or solution
availability for the particular location. In addition, the monitoring
device and/or centrally stored information may immediately notify
medical personnel of compromised solutions (e.g., expired, damaged,
contaminated, unsafe, etc.), thereby enabling easy identification
and segregation of those compromised items until proper disposal.
The processor and/or interface may utilize any conventional or other
suitable protocol to communicate with and transfer information with
the external device.
In operation, the solution bag is constructed with fluid and appropriate
information is stored in the monitoring device. The bag is transported
to an intended facility, where the monitoring device continuously
monitors the solution. Prior to use, medical personnel may view
the monitoring device (and/or access the central database) to determine
compliance with prescribed requirements. The monitoring device continues
to monitor the solution and indicate compliance during thermal treatment
and/or administration of solution to a patient. The monitoring device
may be disposable with the bag or re-programmed for use with subsequent
bags.
The monitoring device may further be configured to communicate
with a thermal treatment system as described below to transfer the
recorded information. In this case, the thermal treatment system
includes the wireless transmitter/receiver or connection port to
continuously communicate with interface 20 of the monitoring device
as described above. The recorded information may be utilized by
the thermal treatment system to control heating of the solution
bag to a desired set point temperature.
A medical item including a memory device to store information pertaining
to conditions measured by a thermal treatment system according to
the present invention is illustrated in FIG. 3. Initially, medical
item 2 is substantially similar to the medical item described above
and is preferably an intravenous solution bag, but may be a wide
variety of medical items (e.g., medical solution containers, saline
solutions, IV solutions and/or lines, instruments, blankets, antibiotics
or other drugs, blood, irrigation fluid and/or lines, etc.). Specifically,
intravenous solution bag 2 includes a generally triangular projection
4 attached to and extending from the bag upper portion and including
opening or hole 6 defined therein as described above for interfacing
an intravenous pole or other support structure (not shown). The
bag lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
The present invention records conditions of the solution bag measured
by a thermal treatment system in order to ensure compliance with
the prescribed requirements. In particular, solution bag 2 further
includes a memory device 24. The memory device records information
received from an external device 21, such as a thermal treatment
system treating the solution bag. The thermal treatment system is
configured to measure and transmit warming cycle, time-temperature
and other information (e.g., start date and start time of solution
or other item heating/cooling, the time interval the solution or
other item was heated/cooled, the temperature the solution or other
item attained during heating/cooling and/or the time and temperature
of the solution or other item when the solution was removed from
the system (e.g., partial or complete history of time and solution
or other item temperature), the facility, patient and/or solution
information described above, doctor information, type of procedure,
type of instruments or other item being heated/cooled, amount or
quantity of solution or other item being heated/cooled, etc.) to
the memory device as described below.
Memory device 24 is typically attached to or embedded within the
bag surface and may be disposed at any desired locations via any
conventional or other techniques (e.g., adhesive, welding, lamination,
etc.). For example, the monitoring device may be attached to the
bag during bag construction, where a pouch or receptacle (not shown)
may be adhered or sealed to the bag interior or exterior surface
to receive the memory device. Alternatively, the memory device may
be disposed within the bag interior in a suspended or floating state
within the solution. In this case, the memory device may include
any conventional or other suitable floatation devices to suspend
the device within the solution.
The memory device may further include a display 12 and/or indicators
14 to indicate measured parameters to medical personnel. The display
may be of any shape, size or type (e.g., LED, LCD, etc.), may be
disposed at any location on the memory device or bag, and may display
any information. Indicators 14 are preferably implemented by light
emitting diodes (LED) and may indicate to medical personnel conditions
and/or compliance with prescribed requirements as described above.
The indicators may be disposed at any locations on the memory device
or bag and may be activated based upon a local assessment of the
recorded information or based upon an external assessment of the
recorded information by an external processor as described above.
For example, the memory device may activate a visible indicator
each time a warming cycle is initiated by a thermal treatment system
or trigger a visible indicator in response to exceeding a pre-determined
maximum number of warming cycles or heating interval, the solution
temperature being beyond an acceptable temperature range, re-warming
of the bag, etc. The activation of the indicators may be based upon
various criteria (e.g., stored logical data and concurrently measured
physical data, etc.). In addition, the activation of the indicators
may be based upon the local or external assessment of the recorded
information with respect to stored predetermined parameters relating
to the prescribed requirements. The memory device further includes
an interface 20 (FIG. 4) to facilitate communications with a thermal
treatment system as described below and receive information.
Referring to FIG. 4, memory device 24 includes processor 18 and
interface 20. A power source (not shown), preferably in the form
of batteries, provides power to the components. The memory device
may further include display 12 and/or indicators 14 as described
above. Processor 18 is substantially similar to the processor described
above and controls operation of the memory device. The processor
is coupled to display 12, indicators 14 and interface 20. Interface
20 facilitates communications with an external device 21 to transfer
information. The external device is typically in the form of a thermal
treatment system as described below that treats the solution bag.
The thermal treatment system may include various sensors (e.g.,
proximity sensors, pressure sensors, temperature sensors (e.g.,
RTD, infrared, etc.), presence sensors, weight sensors, volume sensors,
flow sensors, fluid sensors, fluid level sensors, etc.) to measure
conditions of the solution (e.g., temperature, heating intervals,
time, humidity, etc.) for transfer to the memory device. The interface
may be in the form of a conventional wireless transceiver as described
above to communicate with a wireless transmitter/receiver of the
thermal treatment system or, alternatively, may be in the form of
a conventional connector to physically connect to a port or connector
of the thermal treatment system. The thermal treatment system receives
the solution bag and measures various conditions or parameters either
periodically or in response to changes in conditions (e.g., measures
conditions each predetermined time interval, in response to changing
conditions, etc.). The measured parameters are transmitted from
the thermal treatment system to processor 18, where the measured
conditions and time of measurement may be stored in the processor
(or an external) memory and/or displayed. The memory device may
further record locations (e.g., medical facility, etc.) and other
information (e.g., patient, solution and/or facility information,
etc.) received from the thermal treatment system. This information
may correspond with the time, temperature and/or other recordings
as described above. The location and other information may be entered
by a user via system input devices.
The interface may further facilitate communications between the
memory device and an external device 23 for downloading the recorded
information to that external device. In this case, external device
23 may be in the form of a processing device or system (e.g., computer
station or system, hand-held device, etc.). The recorded information
in the memory device may be downloaded at any time by the use of
the wireless transmitter/receiver or physical connector. A user
positions the solution bag to communicate with the external device
(e.g., in close proximity to the device for a wireless link, in
a manner enabling the connector to engage the external device port
or connector, etc.), where the external device instructs the memory
device to transmit the recorded information from memory. The interface
receives the instruction and forwards the request to the processor
to retrieve the desired information. The processor further controls
interface 20 to provide the information to the requesting device.
The information transmitted to external device 23 includes raw
data that is processed by the external device to produce a user
friendly format (e.g., a data sheet, a line graph that charts the
temperatures over time and location, etc.). The resulting information
may be presented on a screen for the user to view, printed for documentation
purposes or stored in a local or remote database accessible by users
or medical personnel as described above. The memory device may include
a unique identifier to associate the bag with the stored information
as described above. This enables locating or tracking of bags based
on stored location information, and ascertaining solution inventory
and availability as described above. The processor and/or interface
may utilize any conventional or other suitable protocol to communicate
with and transfer information with the external processing device
and thermal treatment system.
The processor may further include information associated with the
prescribed requirements and determine compliance with those requirements
based on the measured values as described above. This enables the
requirements to be programmable, where the memory device may be
used for any medical solutions and/or prescribed requirements. The
measured values and/or a compliance indication may be indicated
to medical personnel via display 12 and/or indicators 14. For example,
the processor may control the display to indicate the measured values,
prescribed requirements and/or an indication (e.g., message, symbol,
etc.) of non-compliance with those requirements as described above.
The indicators may be of different colors to indicate compliance
(e.g., a green LED), marginal compliance (e.g., a yellow LED) or
non-compliance (e.g., a red LED) with those requirements as described
above. The memory device may be disposable with the bag or re-programmed
for use with subsequent bags.
The solution bags described above include devices to basically
store measured conditions and other information for respective solutions
within those bags. Alternatively, the information for medical items
may be stored based on an item identifier in a central storage unit
or database accessible by users or medical personnel. A medical
item including an identifier in the form of a bar code is illustrated
in FIG. 5. Initially, medical item 2 is substantially similar to
the medical items described above and is preferably an intravenous
solution bag, but may be a wide variety of medical items (e.g.,
medical solution containers, saline solutions, IV solutions and/or
lines, instruments, blankets, antibiotics or other drugs, blood,
irrigation fluid and/or lines, etc.). Specifically, intravenous
solution bag 2 includes a generally triangular projection 4 attached
to and extending from the bag upper portion and including opening
or hole 6 defined therein as described above for interfacing an
intravenous pole or other support structure (not shown). The bag
lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
Solution bag 2 further includes a bar code 26 disposed on the bag.
The bar code includes a unique identifier associated with the bag
to identify the bag to a thermal treatment system treating the solution
bag. The thermal treatment system is configured to measure and transmit
warming cycle, time-temperature and/or other information (e.g.,
start date and start time of solution or other item heating/cooling,
the time interval the solution or other item was heated/cooled,
the temperature the solution or other item attained during heating/cooling
and/or the time and temperature of the solution or other item when
the solution was removed from the system (e.g., partial or complete
history of time and solution or other item temperature), doctor
information, type of procedure, type of instruments or other item
being heated/cooled, amount or quantity of solution or other item
being heated/cooled, etc.) to a central storage unit or database
accessible by users or medical personnel as described below. The
database may further receive the patient, solution and/or facility
information described above for the medical item (e.g., entered
by a user via thermal treatment system input devices or a workstation).
Bar code 26 is typically attached to or embedded within the bag
surface and may be disposed at any desired locations on the bag
via any conventional or other techniques (e.g., adhesive, welding,
lamination, etc.). For example, the bar code may be attached to
the bag during bag construction, where the bar code may be adhered
or sealed to the bag interior or exterior surface. The bar code
may be updated and reapplied to the solution bag to provide any
desired additional information (e.g., requirements, manufacturing
date, operational parameters, etc.).
A thermal treatment system receives the bag and includes a bar
code reader to ascertain the item identification as described below.
The thermal treatment system may include various sensors (e.g.,
proximity sensors, pressure sensors, temperature sensors (e.g.,
RTD, infrared, etc.), presence sensors, weight sensors, volume sensors,
flow sensors, fluid sensors, fluid level sensors, etc.) to measure
solution conditions and provides information (e.g., temperature,
heating intervals, time, humidity, etc.) for transfer to a central
storage unit. The thermal treatment system measures various conditions
or parameters either periodically or in response to changes in conditions
(e.g., measures conditions each predetermined time interval, in
response to changing conditions, etc.). The measured parameters
are transmitted from the thermal treatment system to a central storage
unit to record the measured conditions and information. A common
interface may be employed to permit a wide range of devices (e.g.,
ranging from thermal treatment systems, intelligent storage rooms,
workstations, etc.) to report information (e.g., the solution, patient
and/or facility information described above, etc.) related to the
treatment of each container (e.g., with a bar code) to a central
database. The thermal treatment system may further record item locations
(e.g., medical facility, storage facility, etc.) to correspond with
the recorded information as described above. The central storage
unit may be local or accessed by the thermal treatment system via
a network as described below. The transferred information may be
retrieved by users or medical personnel to monitor the solution
bag for compliance with the prescribed requirements. Further, the
stored information may be utilized for item tracking, inventory
and/or availability purposes as described above.
A medical item including an identifier in the form of a transponder
unit according to the present invention is illustrated in FIG. 6.
Initially, medical item 2 is substantially similar to the medical
items described above and is preferably an intravenous solution
bag, but may be a wide variety of medical items (e.g., medical solution
containers, saline solutions, IV solutions and/or lines, instruments,
blankets, antibiotics or other drugs, blood, irrigation fluid and/or
lines, etc.). Specifically, intravenous solution bag 2 includes
a generally triangular projection 4 attached to and extending from
the bag upper portion and including opening or hole 6 defined therein
as described above for interfacing an intravenous pole or other
support structure (not shown). The bag lower portion includes an
outlet 7 and associated fluid conduits 15 to interface an intravenous
tube (not shown) and enable the solution to flow through the tube
from the outlet to a patient as described above.
Solution bag 2 further includes an identifier in the form of a
transponder unit 28. The transponder unit provides a unique identifier
associated with the bag that identifies the bag to a thermal treatment
system treating that bag. The thermal treatment system is configured
to measure and transmit warming cycle, time-temperature and/or other
information (e.g., start date and start time of solution or other
item heating/cooling, the time interval the solution or other item
was heated/cooled, the temperature the solution or other item attained
during heating/cooling and/or the time and temperature of the solution
or other item when the solution was removed from the system (e.g.,
partial or complete history of time and solution or other item temperature),
doctor information, type of procedure, type of instruments or other
item being heated/cooled, amount or quantity of solution or other
item being heated/cooled, etc.) to a central storage unit or database
accessible by users or medical personnel as described below. The
database may further receive the patient, solution and/or facility
information described above for the medical item (e.g., entered
by a user via thermal treatment system input devices or a workstation).
The transponder unit may be attached to or embedded within the bag
surface and may be disposed at any desired locations on the bag
via any conventional or other techniques (e.g., adhesive, welding,
lamination, etc.). For example, the transponder unit may be adhered
or sealed to the bag interior or exterior surface.
Referring to FIG. 7, transponder unit 28 includes processor 18
and a transceiver 30. A power source (not shown), preferably in
the form of batteries, provides power to the components. Processor
18 is substantially similar to the processor described above and
controls operation of the transponder unit. Transceiver 30 facilitates
communications with an external device 21 in the form of a thermal
treatment system as described below that treats the solution bag.
The transceiver may be in the form of a conventional wireless transceiver
(e.g., RF, infrared, etc.) to communicate with a corresponding wireless
transmitter/receiver of the thermal treatment system.
The thermal treatment system receives the bag and includes the
wireless transmitter/receiver to receive transmissions from the
transponder unit to ascertain the item identification. The thermal
treatment system further includes various sensors (e.g., proximity
sensors, pressure sensors, temperature sensors (e.g., RTD, infrared,
etc.), presence sensors, weight sensors, volume sensors, flow sensors,
fluid sensors, fluid level sensors, etc.) to measure solution conditions
and provide information (e.g., temperature, heating intervals, time,
humidity, etc.) for transfer to a central storage unit. The thermal
treatment system measures various conditions or parameters either
periodically or in response to changes in conditions (e.g., measures
conditions each predetermined time interval, in response to changing
conditions, etc.). The measured parameters are transmitted from
the thermal treatment system to a central storage unit to record
the measured conditions and information. Alternatively, the transponder
unit may receive and store the measured parameters and other information
from the thermal treatment system in the processor (or an external)
memory as described above. A common interface may be employed to
permit a wide range of devices (e.g., ranging from thermal treatment
systems, intelligent storage rooms, etc.) to report information
(e.g., the solution, patient and/or facility information described
above, etc.) related to the treatment of each container (e.g., with
a transponder unit) to a central database. The thermal treatment
system may further record item locations (e.g., medical facility,
storage facility, etc.) to correspond with the recorded information
as described above. The central storage unit may be local or accessed
by the thermal treatment system via a network as described below.
The transferred information may be retrieved by users or medical
personnel to monitor the solution bag for compliance with the prescribed
requirements. Further, the stored information may be utilized for
tracking, inventory and/or availability purposes as described above.
The transponder unit may be disposable with the bag or re-programmed
for use with subsequent bags.
A medical item including electrochromic ink cells to indicate solution
compliance with prescribed requirements according to the present
invention is illustrated in FIG. 8. Initially, medical item 2 is
substantially similar to the medical items described above and is
preferably an intravenous solution bag, but may be a wide variety
of medical items (e.g., medical solution containers, saline solutions,
IV solutions and/or lines, instruments, blankets, antibiotics or
other drugs, blood, irrigation fluid and/or lines, etc.). Specifically,
intravenous solution bag 2 includes a generally triangular projection
4 attached to and extending from the bag upper portion and including
opening or hole 6 defined therein as described above for interfacing
an intravenous pole or other support structure (not shown). The
bag lower portion includes an outlet 7 and associated fluid conduits
15 to interface an intravenous tube (not shown) and enable the solution
to flow through the tube from the outlet to a patient as described
above.
Solution bag 2 further includes electrochromic ink cells 38 and
a control circuit 32 that monitors external and/or internal conditions
of the container environment and triggers individual electrochromic
cells in response to one or more conditions (e.g., max temperature
limit exceeded, max humidity exceeded, re-warming, solution expired,
etc.) to indicate compliance with prescribed requirements. Examples
of electrochromic ink cells that may be employed by the present
invention are disclosed in U.S. Pat. No. 6,294,111 (Shacklett, III
et al.), the disclosure of which is incorporated herein by reference
in its entirety. The ink cells may be of any quantity, shape or
size and may be disposed on a label 36 affixed to the bag. The label
may be of any size or shape with the ink cells being arranged thereon
in any fashion. The control circuit may include various sensors
and triggers an appropriate electrochromic cell upon conditions
specific to the contents of the bag being exceeded. One or more
cells are associated with a particular condition (e.g., a particular
temperature, humidity, a temperature or time interval exceeded,
passage of an expiration date, re-warming of the bag, etc.) to notify
a user or medical personnel of the occurrence of that condition.
The prescribed requirements may be programmed into the control circuit
based upon the specific contents of the bag to allow the requirements
to be tailored to the needs of the bag.
The ink cells and/or label may be attached to or embedded within
the bag surface and may be disposed at any desired locations on
the bag via any conventional or other techniques (e.g., adhesive,
welding, lamination, etc.). For example, the ink cells and/or label
may be adhered or sealed to the bag interior or exterior surface.
Referring to FIG. 9, control circuit 32 includes one or more sensors
16 and processor 18. A power source (not shown), preferably in the
form of batteries, provides power to the components. Processor 18
is substantially similar to the processor described above and controls
operation of the control circuit. The processor is coupled to sensors
16 and ink cells 38. Sensors 16 are preferably implemented by various
sensors (e.g., proximity sensors, pressure sensors, temperature
sensors (e.g., RTD, infrared, etc.), presence sensors, weight sensors,
volume sensors, flow sensors, fluid sensors, fluid level sensors,
etc.) to measure corresponding conditions (e.g., solution temperature,
humidity, etc.). The sensors may be disposed within the control
circuit or be external of the circuit within the solution bag to
measure the corresponding conditions. The measured parameters are
provided to processor 18, where the processor includes information
associated with the prescribed requirements. The processor determines
compliance with those requirements based on the measured values
to activate the appropriate ink cells associated with the condition.
The ink cells may be activated by the processor altering voltage
signals provided to these cells. Activation of the cell produces
a color change (e.g., change from one color to another, clear to
opaque, opaque to clear, etc.) to indicate conditions. This enables
the requirements to be programmable, where the ink cells and control
circuit may be used for any medical solutions and/or prescribed
requirements. The measured values and/or a compliance indication
may be indicated to medical personnel via the ink cells. For example,
the processor may control the ink cells to indicate the measured
values, prescribed requirements and/or an indication (e.g., message,
symbol, etc.) of non-compliance with those requirements.
The solution bag may alternatively include the ink cells with the
control circuit being disposed within an external device 21. The
external device may be in the form of a thermal treatment system
or a housing used to transport medical solutions or other sensitive
components. In this case, solution bag 2 includes the electrochromic
ink cells (and, preferably, text identifying the meaning of each)
and a conducting lead to an external location upon the bag where
a remote monitoring clip 39 can be attached to connect the electrochromic
cells to the external device. The external device monitors the bag
environment and provides control signals to activate selected electrochromic
cells on the bag to cause the corresponding electrochromic cell
to change color (e.g., from clear to opaque, from one color to another,
etc.) upon determining that allowable conditions have been exceeded.
This allows a user or medical personnel to view a visible identification
mark on the bag indicating that bag contents have exceeded allowed
storage conditions and may be compromised.
In addition, solution bag 2 may include one or more current source
buttons or switches 34 each associated with a corresponding electrochromic
cell to activate that cell (e.g., change color, etc.) as described
above. The buttons provide voltage signals to activate the corresponding
cell in response to actuation and basically serve as a manual over-ride
to allow a user or medical personnel to indicate and/or identify
the bag contents as compromised.
The medical items described above enable measurement and/or recordation
of medical item conditions from the manufacturing plant through
transport, storage, thermal treatment and/or administration to a
patient. This enables the medical item to be monitored at each or
any of the stages throughout the life of the medical item and to
notify users or medical personnel of compliance with prescribed
requirements. Thermal treatment systems thermally treating solution
bags (e.g., conventional solution bags or the bags described above)
or other medical items may monitor and/or record solution conditions
for compliance with the prescribed requirements according to the
present invention. In addition, the present invention may enable
control of thermal treatment system use. An exemplary medical item
thermal treatment system 100 to monitor and/or record medical item
conditions and/or employing usage control according to the present
invention is illustrated in FIG. 10. The system may thermally treat
a wide variety of medical items (e.g., medical solution containers,
saline solutions, IV solutions and/or lines, instruments, blankets,
antibiotics or other drugs, blood, irrigation fluid and/or lines,
etc.). Specifically, system 100 may be of any of the types of thermal
treatment systems disclosed in the aforementioned patents, patent
publications and patent applications and includes a temperature
controller 102, one or more heating/cooling units 104 and one or
more monitoring sensors 106 associated with each heating/cooling
unit. The heating/cooling units (and/or corresponding sensors) are
associated with a corresponding individual medical item or a system
compartment receiving medical items to be treated. The system may
further include a report unit 101 and a usage control unit 1001.
The report unit facilitates collection of measured information to
generate a report, while the usage control unit enables control
of system operation as described below.
Temperature controller 102 may be implemented by any conventional
or other controller or microprocessor (e.g., chip, card, processor,
circuitry, etc.) and controls heating/cooling units 104 to thermally
treat a corresponding system compartment and/or medical item to
a desired temperature. Monitoring sensors 106 are disposed in the
proximity of a corresponding heating/cooling unit 104 or medical
item to detect various conditions (e.g., the insertion, presence
and/or removal of a medical item within the system, the medical
item and/or heating/cooling unit temperature, etc.). Monitoring
sensors 106 may be implemented by any conventional or other sensors
(e.g., proximity sensors, pressure sensors, temperature sensors
(e.g., RTD, infrared, etc.), presence sensors, weight sensors, volume
sensors, flow sensors, fluid sensors, fluid level sensors, etc.)
to measure and provide any information, and are coupled to temperature
controller 102. The temperature controller and/or monitoring sensors
may be further coupled to report unit 101 and/or usage control unit
1001.
Temperature controller 102 typically includes input devices (not
shown) to receive a desired or set point temperature for each medical
item and/or system compartment from a user and a display (not shown)
to display the desired and/or measured temperatures for each medical
item and/or compartment. The temperature controller compares the
set point temperature for a medical item and/or compartment to the
corresponding measured temperature and controls the associated heating/cooling
unit accordingly to maintain the medical item and/or compartment
at or near the desired temperature. For example, the temperature
controller may disable heating (or enable cooling) in response to
a measured temperature exceeding a desired temperature. Conversely,
the temperature controller may enable heating (or disable cooling)
in response to a measured temperature below a desired temperature.
Heating/cooling units 104 may be implemented by any conventional
or other heating and/or cooling devices (e.g., heating pad or coils,
refrigeration coils, thermoelectric device, etc.).
Referring to FIG. 11, report unit 101 includes a report controller
108, interface 20, a printer 110, memory storage 112, a display
114 and/or a timer 120. The system includes devices to measure,
record and/or provide a report (e.g., hardcopy or electronic form)
of system conditions (e.g., time, date, temperature, fluid loss
or removal, etc.) as described below. The report provides medical
personnel documentation for their files on the heating/cooling characteristics.
The primary information produced is the start date and start time
of solution or other item heating/cooling, the time interval the
solution or other item was heated/cooled, the temperature the solution
or other item attained during heating/cooling and/or the time and
temperature of the solution or other item when the solution was
removed from the system (e.g., partial or complete history of time
and solution or other item temperature). The report may further
include a variety of information (e.g., doctor information, type
of procedure, type of instruments or other item being heated/cooled,
amount or quantity of solution or other item being heated/cooled,
etc.). Specifically, report controller 108 is coupled to temperature
controller 102 and receives various information (e.g., enablement/disablement
of units 104, temperature, etc.) related to thermal treatment of
the medical item. The report controller may receive any additional
information (e.g., the facility, patient and/or solution information
described above, doctor information, etc.) from medical personnel
or users via report controller input devices (not shown). The report
controller may be implemented by any conventional or other controller
or microprocessor (e.g., chip, card, processor, circuitry, etc.).
Alternatively, the temperature controller and report controller
may be implemented by a single controller (e.g., temperature controller
102).
The report controller further maintains the date, elapsed heating/cooling
time and occurrence time of an event or condition (e.g., the time
when medical items are inserted and/or removed from the system,
etc.). The time may be measured and/or displayed by the report controller
or by timer 120 as described below. The report controller may measure
the elapsed time or record an occurrence time based on signals received
from the temperature controller and/or input devices. For example,
the report controller may initiate measurement of a time interval
in response to the temperature controller indicating enablement
of heating/cooling units 104, and may store the elapsed and/or occurrence
time in response to any condition (e.g., when solution or other
item is removed). The report controller may further measure elapsed
time or record elapsed and/or occurrence time in response to medical
personnel manually entering information on the report controller
input devices (e.g., start and stop keys). The report controller
collects the appropriate information and arranges the information
into a report. The report may be arranged in any fashion and include
any desired information. The report controller may further provide
corresponding information to solution bag 2 via interface 20 as
described above. The interface may be in the form of a wireless
transmitter/receiver (e.g., RF, infrared, etc.) or a connector or
port to communicate with the solution bag as described above. Alternatively,
the interface may be in the form of a bar code reader to identify
a particular medical item and enable the report controller to transmit
corresponding information to a central database for review, tracking,
inventory and/or availability purposes as described above. Moreover,
the report and/or information may be stored in a memory device (e.g.,
local memory, removable memory, card, disk, etc.) for later retrieval
as described below. In addition, the report controller and/or timer
are coupled to display 114 to display the elapsed (or running) time,
report or any desired information to medical personnel. The information
displayed may be selected via report controller input devices, or
the display may include display controls (e.g., buttons, keys, etc.).
The report may further be printed by the report controller via printer
110. The printer, timer and display may be implemented by any conventional
or other printer, timing and/or display devices.
A memory storage device 112 is coupled to report controller 108
and is used to store the collected information. Basically, the report
controller logs records containing system information (e.g., the
date/time that a medical item is inserted into system 100, the date/time
that the medical item is removed from the system, temperatures,
etc.). In this manner, use of the medical item warming/cooling system
is documented with recorded log entries. Log triggering events can
be user defined via report controller input devices that allow the
system to be configured to record information in response to a wide
variety of detected conditions and/or at particular times or periodic
intervals. The memory storage can be used to store a wide variety
of information related to use of the system and the thermal treat |