U.S. patent application number 16/672553 was filed with the patent office on 2020-04-02 for specimen analyzer and specimen analysis method.
This patent application is currently assigned to Sysmex Corporation. The applicant listed for this patent is Sysmex Corporation. Invention is credited to James AUSDENMOORE, Hideki HIRAYAMA, Takeshi KOMOTO, Seiji TAKEMOTO, Takashi YOSHIDA.
Application Number | 20200103427 16/672553 |
Document ID | / |
Family ID | 1000004509551 |
Filed Date | 2020-04-02 |
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United States Patent
Application |
20200103427 |
Kind Code |
A1 |
TAKEMOTO; Seiji ; et
al. |
April 2, 2020 |
SPECIMEN ANALYZER AND SPECIMEN ANALYSIS METHOD
Abstract
This specimen analyzer includes: an analysis unit which analyzes
a specimen collected from a subject; a manual input unit which
receives an input of information by manual operation; an
information read unit which receives an input of information by
reading an information record section provided in a consumable; and
a controller which does not permit an input of information on the
consumable with the manual input unit, and permits an input of the
information on the consumable with the information read unit.
Inventors: |
TAKEMOTO; Seiji; (Kobe-shi,
JP) ; KOMOTO; Takeshi; (Kobe-shi, JP) ;
HIRAYAMA; Hideki; (Kobe-shi, JP) ; YOSHIDA;
Takashi; (Kobe-shi, JP) ; AUSDENMOORE; James;
(Elgin, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sysmex Corporation |
Kobe-shi |
|
JP |
|
|
Assignee: |
Sysmex Corporation
Kobe-shi
JP
|
Family ID: |
1000004509551 |
Appl. No.: |
16/672553 |
Filed: |
November 4, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15610087 |
May 31, 2017 |
10520518 |
|
|
16672553 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 33/80 20130101;
G01N 35/1004 20130101; G01N 35/00663 20130101; G01N 2035/00673
20130101; G01N 2035/00891 20130101; G01N 35/00722 20130101 |
International
Class: |
G01N 35/00 20060101
G01N035/00; G01N 33/80 20060101 G01N033/80; G01N 35/10 20060101
G01N035/10 |
Claims
1-22. (canceled)
23. A specimen analyzer comprising: an analysis unit comprising one
or more detectors, which perform measurement of a specimen
collected from a subject; a manual input unit comprising one or
more of a touch panel, a keyboard and a mouse; an information read
unit comprising one or more of a barcode reader, a two-dimensional
code reader, an RFID reader and a camera to read a consumable
information attached to a consumable; a display; and a processor
programmed to cause the display to show a screen with a message
prompting a user to input the consumable information with the
information read unit and accept the consumable information only if
the consumable information is entered through the information read
unit, wherein the analysis unit does not become ready unless the
consumable information is entered by the information read unit.
24. The specimen analyzer according to claim 23, wherein the
processor is programmed to cause the display to show a message
based on the inputted information.
25. The specimen analyzer according to claim 23, wherein the
processor is programmed to acquire an expiration date of the
consumable based on the information read through the information
read unit and cause the display to show a message based on the
expiration date.
26. The specimen analyzer according to claim 23, wherein the
processor is programmed to cause the display to show an error
message in response to information read from a used consumable.
27. The specimen analyzer according to claim 23, wherein the
processor is programmed to determine whether the consumable is
usable based on the information on the consumable and cause the
display to show an error message when the consumable is
unusable.
28. The specimen analyzer according to claim 23, further comprising
a communication unit comprising a network interface, the network
interface capable of communicating with an external server, wherein
the processor is programmed to cause the communication unit to
transmit the information on the consumable inputted through the
information read unit to the server.
29. The specimen analyzer according to claim 28, wherein the
processor is programmed to not permit the input of the information
on the consumable through the information read unit when
communication with the server is not established.
30. The specimen analyzer according to claim 28, wherein the
processor is programmed to inquire the server whether the
information of the consumable is registered in the server, and the
processor permits a use of the consumable when it is
registered.
31. The specimen analyzer according to claim 30, wherein the
processor is programmed to use a lot number included in the
information on the consumable to inquire the server.
32. The specimen analyzer according to claim 23, wherein the
processor is programmed to not shift to a next process concerning
placement or replacement of the consumable unless the information
on the consumable is input with the information read unit.
33. The specimen analyzer according to claim 23, wherein the
information on the consumable includes at least one of a type of a
consumable, an expiration date, a lot number, and a serial number
of the consumable.
34. The specimen analyzer according to claim 23, wherein the
analysis unit analyzes the specimen by use of the consumable.
35. The specimen analyzer according to claim 23, wherein the
specimen comprises a blood, and the analysis unit analyzes a number
of blood cells in the blood.
36. The specimen analyzer according to claim 23, wherein the
consumable comprises at least one of a reagent used for analysis, a
quality control sample, and a cleaning liquid.
37. A control method of a sample analyzer, comprising: showing on a
display of the sample analyzer a screen with a message prompting a
user to input a patient information or an operator information;
receiving, at a processor of the sample analyzer, the patient
information or the operator information at least through a manual
input unit of the sample analyzer, the manual input unit comprising
at least one of a touch panel, a keyboard and a mouse; showing on
the display a screen with a message prompting a user to input a
consumable information attached to a consumable by an information
read unit comprising at least one of a barcode reader, a
two-dimensional code reader, an RFID reader and a camera; and
receiving, at the processor, a consumable information only if the
consumable information is read through the information read unit
but not through the manual input unit.
38. A specimen analyzer comprising: an analysis unit comprising one
or more detectors, which perform measurement of a specimen
collected from a subject; a manual input unit comprising at least
one of a touch panel, a keyboard and a mouse; an information read
unit comprising at least one of a barcode reader, a two-dimensional
code reader, an RFID reader and a camera; a display; and a
processor programmed to receive a patient information or an
operator information at least through the manual input unit and
receive a consumable information attached to a consumable only if
the consumable information is read through the information read
unit but not through the manual input unit.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
15/610,087, filed on May 31, 2017, the entire contents of all of
which are incorporated herein by reference.
BACKGROUND
[0002] The invention relates to a specimen analyzer and a specimen
analysis method.
[0003] Consumables such as a reagent are used in a specimen
analyzer. Since it is necessary to use reagents of appropriate
kinds and quality in order to obtain correct measurement results,
consumables are managed by inputting information on the consumables
prior to use in the analyzer.
[0004] Japanese Patent Application Publication No. 2009-68979
discloses a specimen analyzer which includes a keyboard to input
information by manual operation, and a barcode reader which
receives barcode read information. This specimen analyzer of
Japanese Patent Application Publication No. 2009-68979 is capable
of inputting information on consumables such as a reagent with both
the keyboard and the barcode reader.
[0005] Here, a specimen analyzer intended to be used by a user with
insufficient expertise and test skills is required to be simply
operated while preventing mistakes and the like. However, the
specimen analyzer of Japanese Patent Application Publication No.
2009-68979 is capable of inputting information on consumables with
both the keyboard and the barcode reader, and this good usability
which enables inputting with the two input units may conversely
cause trouble in the form of input mistakes with the keyboard.
SUMMARY
[0006] The invention is aimed at appropriately managing consumables
such as a reagent.
[0007] Specimen analyzer (100) according to a first aspect of the
invention includes: analysis unit (10) which analyzes a specimen
collected from a subject; manual input unit (20) which receives an
input of information by manual operation; information read unit
(30) which receives an input of information by reading information
record section (51) provided in consumable (50); and controller
(40) which does not permit an input of information on the
consumable with manual input unit (20), but permits an input of the
information on the consumable information read unit (30).
[0008] As described above, specimen analyzer (100) according to the
first aspect includes controller (40) which does not permit the
input of information on the consumable with manual input unit (20),
but permits an input of the information on the consumable with
information read unit (30). This makes it possible to prevent a
situation where the information on the consumables is mistakenly
inputted due to an input mistake with manual input unit (20).
Hence, it is possible to appropriately manage consumables such as a
reagent. As a result, input mistakes and inappropriate use of
consumables (50) are prevented, enabling appropriate consumable
management.
[0009] It is preferable that above-described specimen analyzer
(100) according to the first aspect include display unit (131)
which displays information, and controller (40) perform control of
causing display unit (131) to display how to input the information
on the consumable. Such a configuration makes it possible to input
the information on the consumable in accordance with the display of
display unit (131), facilitating input operation without
mistakes.
[0010] In this case, it is preferable that controller (40) perform
control of causing display unit (131) to display an instruction
prompting to input the information on the consumable with
information read unit (30). Such a configuration makes it possible
to guide the user to read the information on the consumable with
information read unit (30). Hence, the user can easily input the
information on the consumable.
[0011] In the above-described configuration of specimen analyzer
(100) which includes display unit (131), it is preferable that
controller (40) perform control of causing display unit (131) to
display a message based on a determination as to whether or not the
inputted information is appropriate. Such a configuration makes it
possible to prevent use of inappropriate consumable (50) because
information on the inappropriateness is displayed as a message if
consumable (50) is inappropriate. Also, it is possible to prompt to
use the appropriate consumable by displaying the reason for
inappropriateness.
[0012] In this case, it is preferable that controller (40) perform
control of acquiring an expiration date of consumable (50) based on
the information on the consumable, and causing display unit (131)
to display a message based on a determination as to whether or not
the expiration date has passed. Such a configuration makes it
possible to prevent use of expired consumable (50), which can
prompt to use a more appropriate consumable.
[0013] In above-described specimen analyzer (100) which causes
display unit (131) to display a message based on an appropriateness
determination, it is preferable that consumable (50) include a
disposable consumable, and if information record section (51) of
disposable consumable (50) is read again after use of the
disposable consumable, controller (40) perform control of not
permitting use of consumable (50), and causing display unit (131)
to display an error message. Such a configuration makes it possible
to prevent a situation where disposable consumable (50) is used
again, which can prompt to use a more appropriate consumable.
[0014] In above-described specimen analyzer (100) which causes
display unit (131) to display a message based on an appropriateness
determination, it is preferable that controller (40) perform
control of acquiring whether or not consumable (50) is usable based
on the information on the consumable, and causing display unit
(131) to display an error message in a case where consumable (50)
is unusable. Such a configuration makes it possible to prevent a
situation where, for example, unusable consumables (50) such as
consumables (50) of different types are set and used.
[0015] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that information read unit (30)
receive an input of the information on each consumable by reading
information record section (51) provided in consumable (50). Such a
configuration makes it possible to reliably input information for
each of consumables (50) when using more than one consumable
(50).
[0016] It is preferable that the above-described specimen analyzer
(100) according to the first aspect include communication unit
(145) which is capable of communicating with external server (200),
and controller (40) perform control of causing communication unit
(145) to transmit the information on the consumable inputted with
information read unit (30) to server (200). Such a configuration
makes it possible to manage consumable (50) with external server
(200), enabling more appropriate and easier management of
consumable (50).
[0017] In this case, it is preferable that controller (40) do not
permit inputting of the information on the consumable when it is
impossible to connect to server (200) via communication unit (145).
Such a configuration makes it possible to reliably manage
consumable (50) with external server (200) because placement or
replacement of consumable (50) is not allowed when it is impossible
to connect to server (200).
[0018] In the above-described configuration of specimen analyzer
(100) which includes communication unit (145), it is preferable
that controller (40) permit use of consumable (50) if the
information on the consumable inputted with information read unit
(30) is registered in server (200). Such a configuration makes it
possible to effectively prevent use of inappropriate consumable
(50).
[0019] In this case, it is preferable that controller (40) permit
use of consumable (50) if a lot number as the information on the
consumable is registered in server (200). Such a configuration
makes it possible to more easily manage consumable (50) by managing
the lot number of consumable (50) with server (200).
[0020] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that controller (40) do not shift to
a next process concerning placement or replacement of consumable
(50) unless the information on the consumable is input with
information read unit (30). Such a configuration makes it possible
to advance the processing concerning the placement or replacement
of consumable (50) after inputting information to determine whether
or not consumable (50) is an appropriate one. Hence, it is possible
to reliably place or replace appropriate consumable (50).
[0021] In this case, it is preferable that the analyzer include
display unit (131) which displays information, and controller (40)
perform control of causing display unit (131) not to shift a screen
of display unit (131) concerning placement or replacement of
consumable (50) to a next screen unless the information on the
consumable is input with information read unit (30). Such a
configuration makes it possible to effectively prevent placement or
replacement of inappropriate consumable (50) because a screen to
advance placement or replacement of consumable (50) is not
displayed until the information on the consumable is input with
information read unit (30).
[0022] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that the information on the
consumable includes at least one of a type, an expiration date, a
lot number, and a serial number of consumable (50). Such a
configuration makes it possible to appropriately manage consumable
(50) to be used based on at least one of the type, the expiration
date, the lot number, and the serial number of consumable (50).
[0023] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that analysis unit (10) analyzes the
specimen by use of consumable (50). Such a configuration makes it
possible to accurately analyze the specimen because appropriately
managed consumable (50) is used for analysis.
[0024] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that the specimen is blood, and
analysis unit (10) analyzes the number of blood cells and a
concentration of a component contained in the blood. To be more
specific, specimen analyzer (100) is a blood cell counting
apparatus. The blood cell counting apparatus counts the number of
blood cells contained in a predetermined volume of a blood
specimen. The analysis results of the blood cell counting apparatus
can include analysis values such as the number of cell components
such as various blood cells and platelets, a measurement value of
e.g. a concentration of a component in blood, ratios of blood cells
based on the measured values, an average volume, and a distribution
width. The blood cell counting apparatus performs some of the blood
tests widely used in laboratory medicine. The analysis results of
the blood cell counting apparatus are important in the field of
laboratory medicine because they are related to various types of
diseases. For this reason, the invention, which is capable of
appropriately managing consumables such as a reagent, is suitably
applied to blood cell counting apparatuses.
[0025] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that consumable (50) include at
least one of a reagent used for analysis, a quality control sample,
and a cleaning liquid. Such a configuration makes it possible to
input information on the reagent used for analysis, the quality
control sample, or the cleaning liquid without mistakes.
[0026] In above-described specimen analyzer (100) according to the
first aspect, it is preferable that information read unit (30)
include a barcode reader. Such a configuration makes it possible to
easily receive an input of the information on the consumable using
the barcode reader.
[0027] A specimen analysis method according to a second aspect of
the invention includes: inputting information on a consumable by
causing information read unit (30) to read information record
section (51) provided in consumable (50), and placing consumable
(50) or replacing an old one with consumable (50); analyzing a
specimen collected from a subject; and rejecting reception of the
information on the consumable until the information on the
consumable is input with information read unit (30).
[0028] As described above, the specimen analysis method according
to the second aspect does not receive the information on the
consumable until the information on the consumable is input with
information read unit (30). This makes it possible to prevent a
situation where the information on the consumables is mistakenly
inputted due to an input mistake with manual input unit (20) and
the like. Hence, it is possible to provide a specimen analysis
method which can appropriately manage consumables such as a
reagent. As a result, input mistakes and inappropriate use of
consumables (50) are prevented, enabling appropriate consumable
management.
[0029] Specimen analyzer (100) according to a third aspect of the
invention includes: analysis unit (10) which analyzes a specimen
collected from a subject; an input unit which receives an input of
information on a consumable; communication unit (145) which is
capable of transmitting the information on the consumable inputted
with the input unit to external server (200); and controller (40)
which allows analysis unit (10) to analyze the specimen if
connection is established between server (200) and communication
unit (145).
[0030] As described, specimen analyzer (100) according to the third
aspect includes communication unit (145) which is capable of
transmitting the information on the consumable inputted with the
input unit to external server (200), and controller (40) which
allows analysis unit (10) to analyze the specimen under a condition
that connection be established between server (200) and
communication unit (145). This makes it possible to manage
consumable (50) with external server (200), enabling appropriate
management of consumables such as a reagent.
[0031] In above-described specimen analyzer (100) according to the
third aspect, it is preferable that the input unit include
information read unit (30) which reads information record section
(51) provided in consumable (50). Such a configuration makes it
possible to easily input the information on the consumable with
information read unit (30).
BRIEF DESCRIPTION OF DRAWINGS
[0032] FIG. 1 is a diagram for explaining an overview of a specimen
analyzer;
[0033] FIG. 2 is a perspective view illustrating a configuration
example of the specimen analyzer;
[0034] FIG. 3 is a schematic view illustrating an internal
configuration example of the specimen analyzer;
[0035] FIG. 4 is a block diagram illustrating a configuration of
the specimen analyzer;
[0036] FIG. 5 is a flowchart illustrating an example of operations
of the specimen analyzer;
[0037] FIG. 6 is a flowchart illustrating an example of a sample
measurement process;
[0038] FIG. 7 is a diagram illustrating display example 1 for
connecting an Ethernet cable;
[0039] FIG. 8 is a diagram illustrating display example 2 for
connecting an Ethernet cable;
[0040] FIG. 9 is a diagram illustrating display example 1 for
printer confirmation;
[0041] FIG. 10 is a diagram illustrating display example 2 for
printer confirmation;
[0042] FIG. 11 is a diagram illustrating display example 3 for
printer confirmation;
[0043] FIG. 12 is a diagram illustrating display example 4 for
printer confirmation;
[0044] FIG. 13 is a diagram illustrating a display example for
barcode reader confirmation;
[0045] FIG. 14 is a diagram illustrating a display example for
connecting various types of tubes;
[0046] FIG. 15 is a diagram illustrating display example 1 for
setting a reagent;
[0047] FIG. 16 is a diagram illustrating display example 2 for
setting a reagent;
[0048] FIG. 17 is a diagram illustrating display example 3 for
setting a reagent;
[0049] FIG. 18 is a diagram illustrating display example 4 for
setting a reagent;
[0050] FIG. 19 is a diagram illustrating display example 5 for
setting a reagent;
[0051] FIG. 20 is a diagram illustrating display example 6 for
setting a reagent;
[0052] FIG. 21 is a diagram illustrating display example 7 for
setting a reagent;
[0053] FIG. 22 is a diagram illustrating display example 1 for
cleaning by CELLCLEAN;
[0054] FIG. 23 is a diagram illustrating display example 2 for
cleaning by CELLCLEAN;
[0055] FIG. 24 is a diagram illustrating display example 3 for
cleaning by CELLCLEAN;
[0056] FIG. 25 is a diagram illustrating display example 4 for
cleaning by CELLCLEAN;
[0057] FIG. 26 is a diagram illustrating display example 1 for QC
measurement;
[0058] FIG. 27 is a diagram illustrating display example 2 for QC
measurement;
[0059] FIG. 28 is a diagram illustrating display example 3 for QC
measurement;
[0060] FIG. 29 is a diagram illustrating display example 4 for QC
measurement;
[0061] FIG. 30 is a diagram illustrating display example 5 for QC
measurement;
[0062] FIG. 31 is a diagram illustrating display example 6 for QC
measurement;
[0063] FIG. 32 is a diagram illustrating display example 7 for QC
measurement;
[0064] FIG. 33 is a diagram illustrating display example 1 for
sample measurement;
[0065] FIG. 34 is a diagram illustrating display example 2 for
sample measurement;
[0066] FIG. 35 is a diagram illustrating display example 3 for
sample measurement;
[0067] FIG. 36 is a diagram illustrating display example 4 for
sample measurement;
[0068] FIG. 37 is a diagram illustrating display example 5 for
sample measurement;
[0069] FIG. 38 is a diagram illustrating display example 6 for
sample measurement;
[0070] FIG. 39 is a diagram illustrating display example 7 for
sample measurement;
[0071] FIG. 40 is a diagram illustrating display example 8 for
sample measurement;
[0072] FIG. 41 is a diagram illustrating display example 1 for
maintenance;
[0073] FIG. 42 is a diagram illustrating display example 2 for
maintenance;
[0074] FIG. 43 is a diagram illustrating display example 3 for
maintenance;
[0075] FIG. 44 is a diagram illustrating display example 4 for
maintenance;
[0076] FIG. 45 is a diagram illustrating display example 5 for
maintenance;
[0077] FIG. 46 is a diagram illustrating display example 6 for
maintenance;
[0078] FIG. 47 is a diagram illustrating display example 7 for
maintenance;
[0079] FIG. 48 is a diagram illustrating display example 8 for
maintenance;
[0080] FIG. 49 is a diagram illustrating an example of print
content of printed sheet;
[0081] FIG. 50 is a diagram for explaining a result displaying
section of the printed sheet;
[0082] FIG. 51 is a diagram for explaining rules of outputting
analysis results on the printed sheet;
[0083] FIG. 52 is a diagram for explaining first determination
ranges;
[0084] FIG. 53 is a diagram for explaining numerical ranges for
evaluating analysis results for an infant;
[0085] FIG. 54 is a diagram for explaining numerical ranges for
evaluating analysis results for a youth;
[0086] FIG. 55 is a diagram for explaining numerical ranges for
evaluating analysis results for an adult;
[0087] FIG. 56 is a diagram for explaining a first modification of
a printing embodiment of the analysis results;
[0088] FIG. 57 is a diagram for explaining a second modification of
the printing embodiment of the analysis results;
[0089] FIG. 58 is a diagram for explaining first and second
modifications of the rules of outputting the analysis results;
and
[0090] FIG. 59 is a diagram illustrating an example of an error
display screen.
DETAILED DESCRIPTION
[0091] Hereinafter, embodiments are described based on the
drawings.
[0092] [Overview of Specimen Analyzer]
[0093] With reference to FIG. 1, an overview of specimen analyzer
100 according to an embodiment is described.
[0094] Specimen analyzer 100 according to the embodiment is an
analysis apparatus for analyzing a specimen collected from a
subject. As illustrated in FIG. 1, specimen analyzer 100 includes
analysis unit 10, manual input unit 20, information read unit 30,
and controller 40.
[0095] The specimen is blood of the subject, for example. Note that
the specimen may be, for example, a body fluid other than urine and
blood of the subject. Also, the specimen may be, for example, part
of the tissue or a cell of the subject. In addition, the specimen
may be, for example, DNA or RNA. Specimen analyzer 100 is, for
example, an analysis apparatus which analyzes blood. For example,
specimen analyzer 100 is a blood cell counting apparatus. Here,
specimen analyzer 100 may be an analysis apparatus which analyzes a
body fluid other than urine and blood of the subject. Moreover,
specimen analyzer 100 may be an analysis apparatus which analyzes,
for example, part of the tissue or a cell of the subject, DNA, or
RNA.
[0096] Analysis unit 10 analyzes the specimen collected from the
subject. Analysis unit 10 includes, for example, a controller which
includes a CPU and a memory. Analysis unit 10 analyzes the specimen
on the basis of measurement results obtained by measuring the
specimen. In addition, analysis unit 10 is configured to analyze
the specimen with use of consumables 50.
[0097] Manual input unit 20 receives inputs of information by
manual operation. Manual input unit 20 includes, for example, a
touch panel, a keyboard, and a mouse. Manual input unit 20
receives, for example, inputs of information on the subject. Also,
manual input unit 20 receives, for example, inputs of the
information on the user. In addition, manual input unit 20 receives
inputs of the information on the operation of specimen analyzer
100.
[0098] Information read unit 30 reads information record section 51
provided in each of consumables 50, and receives inputs of
information. Information read unit 30 includes, for example, a
barcode reader and an RFID reader. Information read unit 30
receives inputs of the information on the consumables. To be more
specific, information read unit 30 receives inputs of information
on the consumables by reading information record section 51
provided in each of consumables 50. Consumables 50 are placed or
replaced based on the inputs of the information on the consumables
by information read unit 30.
[0099] Controller 40 is configured to control the units of specimen
analyzer 100. Controller 40 includes, for example, a CPU and a
memory. Controller 40 does not permit manual input unit 20 to input
the information on the consumables, but permits information read
unit 30 to input the information on the consumables. To be more
specific, only information read unit 30 is permitted to input the
information on the consumables. Moreover, the analysis of the
specimen does not become ready if information read unit 30 does not
input the information on the consumables. Furthermore, the
information on the consumables is not received until the
information on the consumables is input with information read unit
30. This makes it possible to prevent a situation where the
information on the consumables is mistakenly inputted due to an
input mistake with manual input unit 20. Hence, it is possible to
appropriately manage consumables 50 such as a reagent. As a result,
input mistakes and inappropriate use of consumables 50 are
prevented, enabling appropriate consumable management. For example,
information read unit 30 is capable of reading even a code with
many digits fast and accurately compared to the inputting by manual
input unit 20.
[0100] Consumables 50 are consumables used for specimen analyzer
100. Consumables 50 include, for example, a reagent used for
specimen analyzer 100. Consumables 50 include, for example, a
reagent used for measurement of the specimen. Also, consumables 50
include a reagent used for the analysis. Moreover, consumables 50
include, for example, a reagent used for quality control of
specimen analyzer 100. Furthermore, consumables 50 include, for
example, a reagent used for cleaning of specimen analyzer 100.
[0101] Each of consumables 50 is provided with information record
section 51 which includes the information on the consumable.
Information record section 51 is attached to, for example, a
container of each consumable 50. Information record section 51
includes, for example, a one-dimensional or two-dimensional
barcode. Moreover, information record section 51 may be an RFID
tag. Furthermore, information record section 51 may be a sign being
a combination of characters, symbols, etc. It is possible to read
information record section 51 with information read unit 30. The
information which is possessed by information record section 51 and
is related to each consumable includes at least one of the type,
the expiration date, a lot number, and a serial number of the
consumable. In addition, the information on the consumables may
include information on the type of the analysis apparatus to be
used.
[0102] Controller 40 is configured to perform control such that the
process does not shift to the next one concerning placement or
replacement of consumables 50 unless the information on the
consumables is input with information read unit 30. This makes it
possible to advance the processing concerning the placement or
replacement of consumables 50 after inputting information to
determine whether or not consumables 50 are appropriate ones.
Hence, it is possible to reliably place or replace appropriate
consumables 50.
[0103] [Configuration Example of Specimen Analyzer]
[0104] With reference to FIG. 2 to FIG. 57, a configuration example
of specimen analyzer 100 is described.
[0105] (Overall Configuration)
[0106] In the example illustrated in FIG. 2, specimen 101 is blood
in specimen analyzer 100, and specimen analyzer 100 is a blood cell
counting apparatus. The blood cell counting apparatus is an
apparatus which counts the number of blood cells contained in a
predetermined volume of blood specimen. Analysis unit 120 analyzes
the number of blood cells and concentrations of the components
contained in the blood.
[0107] When specimen container 103 containing specimen 101 is set,
specimen analyzer 100 aspirates specimen 101 in specimen container
103 and analyzes the specimen. For example, a container in the
shape of a generally-used blood collection tube can be used as
specimen container 103. Specimen container 103 is, for example, a
vacuum blood collection tube capped with a rubber cap or an open
blood collection tube which has an opening. Specimen 101 to be
contained in specimen container 103 is, for example, whole blood of
a subject (human), and is added with an anticoagulant. The
necessary amount of added anticoagulant is, for example, 10 .mu.L
to 15 .mu.L inclusive.
[0108] Specimen analyzer 100 has apparatus body 110 which includes
analysis unit 120 for analyzing the specimen collected from the
subject, output unit 130 for outputting analysis results 102 of
analysis unit 120, and controller 140. Moreover, specimen analyzer
100 includes information read unit 150 connected to apparatus body
110. Further, specimen analyzer 100 is connected to various types
of consumables 104 used along with analysis operation for specimen
101.
[0109] Apparatus body 110 is a unit provided with analysis unit
120, output unit 130, etc. in a box-shaped housing. Apparatus body
110 is configured as a small blood cell counting apparatus which
can be a desktop one, including information read unit 150 and
consumables 104. Analysis unit 120 and controller 140 are built in
apparatus body 110.
[0110] Container set unit 111 is provided at a front and lower
portion of apparatus body 110. Container set unit 111 is configured
such that it is openable and closable from the front surface of
apparatus body 110 in the direction toward the user (see FIG. 3).
Using container set unit 111, specimen container 103 containing
specimen 101 is set in apparatus body 110.
[0111] In the example illustrated in FIG. 2, analysis unit 120 is
configured to analyze multiple analysis items. As an example, as
measurement items by analysis unit 120, the analysis items include
e.g. eight items: white blood cell count (WBC), red blood cell
count (RBC), hemoglobin concentration (HGB), hematocrit value
(HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin
(MCH), mean corpuscular hemoglobin concentration (MCHC), and
platelet count (PLT). As analysis items to be analyzed on the basis
of the analysis results of the measurement items, the analysis
items include e.g. nine items: WBC-small cell ratio (% Lymph),
WBC-middle cell ratio (% OtherWBC), WBC-large cell ratio (% Neut),
WBC-small cell count (# Lymph), WBC-middle cell count (# OtherWBC),
WBC-large cell ratio (# Neut), red blood cell distribution width
(RDW-SD and RDW-CV), mean platelet volume (MPV). In this example,
the number of analysis items of analysis unit 120 is 17.
[0112] Output unit 130 outputs various types of information on
specimen analyzer 100 to the user. In the example of FIG. 2, output
unit 130 includes display unit 131 and print unit 135. In the
example of FIG. 2, display unit 131 is an LCD (liquid crystal
display), and is disposed at a front and upper portion of apparatus
body 110. Display unit 131 displays information. In the example of
FIG. 2, print unit 135 is a thermal printer which prints on thermal
paper with use of heat, and is located on an upper surface of
apparatus body 110.
[0113] Moreover, specimen analyzer 100 includes manual input unit
132 which receives an input operation of the user. In the example
of FIG. 2, manual input unit 132 is a touch panel provided on
display unit 131. The user is allowed to input information and
perform various operations by touching the icons displayed on
display unit 131.
[0114] In the example of FIG. 2, information read unit 150 is
configured to read an information record section provided on each
of consumables 104, and to receive inputted information. To be more
specific, information read unit 150 is a read apparatus such as a
barcode reader, a two-dimensional code reader, and a camera. The
information record section is a barcode or a two-dimensional
code.
[0115] In the example of FIG. 2, inputting of information on
consumables 104 by manual input unit 132 is not permitted, but
inputting by information read unit 150 is permitted. Controller 140
determines whether to use consumables 104 based on information on
consumables 104 inputted by information read unit 150. To be more
specific, controller 140 allows use of consumables 104 if
information on consumables 104 inputted by information read unit
150 is registered on server 200.
[0116] Consumables 104 are consumed along with analysis operation
of specimen 101 by specimen analyzer 100. Consumables 104 contain
the reagent used for the analysis of specimen 101. In the example
of FIG. 2, used as consumables 104 are diluted solution container
104a containing a diluted solution for diluting specimen 101 and
hemolyzer container 104b containing a hemolyzer which hemolyzes
blood cells. Moreover, consumables 104 contain a cleaning agent for
cleaning specimen analyzer 100. In the example of FIG. 2, used as
consumable 104 is cleaning agent container 104c containing a
cleaning agent for cleaning a fluid circuit in the apparatus. Note
that the diluted solution is used for a cleaning process. The
cleaning agent contains a cleaning component such as a sodium
hypochlorite solution, and has more cleaning power than the diluted
solution. Cleaning with use of the cleaning agent is regularly
carried out each time a predetermined period elapses, e.g. one
week. Cleaning with use of the diluted solution is carried out more
frequently than the cleaning with use of the cleaning agent each
time the analysis of specimen 101 is performed, for example. The
information record sections provided on consumables 104 have
information on consumables 104 recorded therein. Information on
consumables 104 includes at least one of the type of consumable
104, expiration date, lot number, and serial number.
[0117] As an example, in the example of FIG. 2, "pocH-pack D
(manufactured by Sysmex Corporation, registered trademark)" is
preferably used as the diluted solution, "pocH-pack L (manufactured
by Sysmex Corporation, registered trademark)" is preferably used as
the hemolyzer, and "CELLCLEAN (manufactured by Sysmex Corporation,
registered trademark)" is preferably used as the cleaning
agent.
[0118] (Configuration of Each of Units of Specimen Analyzer)
[0119] In the example illustrated in FIG. 3, print unit 135 is
configured such that it can change the size of print sheet 136, and
is configured to print analysis results 102 on the same surface of
a single piece of print sheet 136. To be more specific, print unit
135 includes sheet set unit 135a which holds print sheet 136 which
is elongated, and changes the size of print sheet 136 by printing
on an area of print sheet 136 with an appropriate length depending
on the print amount. In the example of FIG. 3, set to sheet set
unit 135a is print sheet 136 which is roll paper being rolled
thermal paper which is elongated with a predetermined width. In
addition, print unit 135 includes print head 135b which heats print
sheet 136, and prints using print head 135b while forwarding rolled
print sheet 136 with a not-illustrated motor. Thus, print unit 135
prints on an area of print sheet 136 with an appropriate length
depending on the amount of information to be printed including
analysis results 102. The user cuts the printed sheet sent from
print unit 135 in an appropriate length, and acquires one sheet of
printed sheet on which analysis results 102 are printed.
[0120] Container set unit 111 includes adapter 112 for holding a
lower portion of specimen container 103. When open, container set
unit 111 is capable of holding specimen container 103 in an upright
state. Here, in addition to specimen container 103, it is possible
to set, to container set unit 111, a QC reagent container (not
illustrated) which contains a control specimen (hereinafter
referred to as QC reagent) for quality control and cleaning agent
container 104c.
[0121] Analysis unit 120 includes pipette 121 for aspirating
specimen 101 from specimen container 103 set to container set unit
111 and drive mechanism 122 for pipette 121. Moreover, analysis
unit 120 includes detector 123 for detecting components in specimen
101 and fluid circuit 124 for feeding liquid. Furthermore, analysis
unit 120 (see FIG. 4) includes a computer which has processor 141
and memory 142.
[0122] Pipette 121 is an aspiration tube for measuring the amount
of a liquid. Drive mechanism 122 includes linear mechanisms made up
of e.g. a guiderail, a motor, and a belt pulley mechanism, and
holds pipette 121. Pipette 121 is provided at a position above
specimen container 103 set in container set unit 111, and is
configured such that it can move in the up-down direction and in
the horizontal direction. Pipette 121 is connected to a syringe
pump provided in fluid circuit 124, and is capable of aspirating a
predetermined amount of specimen 101 contained in specimen
container 103. Pipette 121 is moved down from a position above
specimen container 103, enters the inside of specimen container
103, and is allowed to aspirate a predetermined amount of specimen
101 by fluid circuit 124. Moreover, pipette 121 is moved by drive
mechanism 122 to a position above a mixing chamber of fluid circuit
124 to be described later and to a position above container unit
123a of detector 123, and is allowed to aspirate and discharge
liquid by fluid circuit 124 at each of the positions. In the case
where the QC reagent container containing the QC reagent and the
cleaning agent container are set in container set unit 111, pipette
121 can also aspirate the QC reagent and the cleaning agent by
performing the same or similar operations.
[0123] Fluid circuit 124 includes e.g. a mixing chamber, a pressure
source, a syringe pump, a diluted solution, chambers for hemolyzer
and waste liquid, a cleaning Spitz for cleaning pipette 121,
various valves for switching liquid feed, and a sensor. Fluid
circuit 124 connects pipette 121 and detector 123 together in a
fluid manner via a flow path such as a liquid feed tube. Moreover,
fluid circuit 124 is connected in a fluid manner to external
connectors 124a provided on the back surface of apparatus body 110.
The number of external connectors 124a provided is three, which are
separately connected via connection tubes 105 to diluted solution
container 104a, hemolyzer container 104b, and waste liquid
container 106.
[0124] Fluid circuit 124 mixes a predetermined amount of specimen
101 aspirated by pipette 121 and a predetermined amount of diluted
solution in a mixing chamber to prepare an RBC/PLT measurement
specimen, which is a diluted specimen with a predetermined ratio.
In addition, fluid circuit 124 mixes a predetermined amount of
specimen 101, a predetermined amount of diluted solution, and a
predetermined amount of hemolyzer to prepare a WBC/HGB measurement
specimen which includes a mixed solution of blood specimen, diluted
solution, and hemolyzer.
[0125] Detector 123 is configured to measure the target components
in specimen 101 corresponding to the analysis items. In the example
of FIG. 3, detector 123 measures multiple items. In the example of
FIG. 3, detector 123 is configured to perform measurement in
accordance with multiple measurement principles depending on the
target components of the analysis items.
[0126] To be more specific, detector 123 performs RBC measurement
and PLT measurement using a sheath flow electrical resistance
method. Detector 123 performs WBC measurement using an electrical
resistance method. Detector 123 includes resistance detector 123b
for performing measurement using the sheath flow electrical
resistance method and the electrical resistance method. Moreover,
detector 123 performs HGB measurement using a colorimetric method.
Detector 123 includes optical detector 123c for performing
measurement using the colorimetric method.
[0127] The sheath flow electrical resistance method forms a sheath
flow of a specimen flow and a flow of sheath liquid surrounding the
specimen flow, and causes the sheath flow to pass through an
orifice. Electrodes are provided in front and rear of the orifice,
respectively, in the flow direction. A pulse signal, which
represents the presence and volume information of each blood cell,
is measured based on the change in resistance between the
electrodes generated by the blood cells passing through the
orifice.
[0128] Here, the diluted solution forms the flow of sheath liquid,
and the RBC/PLT measurement specimen forms the specimen flow.
Resistance detector 123b includes an orifice and a pair of
electrodes used for measurement. Analysis unit 120 obtains the red
blood cell count (RBC), the platelet count (PLT), and the
hematocrit value (HCT) from the measured count value of the pulse
signal.
[0129] The electrical resistance method causes the WBC/HGB
measurement specimen to pass through an orifice, and measures a
pulse signal which represents the presence and volume information
of each blood cell based on the change in resistance between the
front and rear electrodes of the orifice. Analysis unit 120 obtains
the white blood cell count (WBC) from the measured count value of
the pulse signal.
[0130] The colorimetric method causes a light source to emit
measurement light to the WBC/HGB measurement specimen, and detects
the measurement light having passed through the specimen with a
light receiving element. Additionally, the same process is also
performed on the diluted solution, and analysis unit 120 obtains
the hemoglobin concentration (HGB) based on the difference in
absorbance between the diluted solution and the WBC/HGB measurement
specimen. Optical detector 123c includes the light source and the
light receiving element used for measurement. The light source is,
for example, an LED, and the light receiving element is, for
example, a photodiode.
[0131] The mean corpuscular volume (MCV), the mean corpuscular
hemoglobin (MCH), and the mean corpuscular hemoglobin concentration
(MCHC) are calculated by analysis unit 120 from the measurement
values of the red blood cell count (RBC), the platelet count (PLT),
and the hematocrit value (HCT), respectively.
[0132] Based on the analysis results of the measurement items,
analysis unit 120 obtains the analysis items of the WBC-small cell
ratio (% Lymph), the WBC-middle cell ratio (% OtherWBC), the
WBC-large cell ratio (% Neut), the WBC-small cell count (# Lymph),
the WBC-middle cell count (# OtherWBC), the WBC-large cell ratio (#
Neut), the red blood cell distribution width (RDW-SD and RDW-CV),
the mean platelet volume (MPV).
[0133] As illustrated in FIG. 4, controller 140 includes processor
141 such as a CPU and memory 142. Memory 142 can include a volatile
memory such as a RAM, and a non-volatile memory such as a ROM, a
flash memory, and a hard disk. Memory 142 has, for example, a
control program for controlling specimen analyzer 100, analysis
program for obtaining analysis results 102, and display screen data
of display unit 131 recorded therein. Processor 141 executes a
program recorded in memory 142 and thereby functions as controller
140 which performs operation control of units such as drive
mechanism 122, fluid circuit 124, detector 123, display unit 131,
and print unit 135. Moreover, processor 141 functions as part of
analysis unit 120 which obtains analysis results 102 of the
analysis items by executing the programs recorded in memory 142.
Controller 140 and analysis unit 120 may be configured as a
separate processor and memory. Furthermore, controller 140 obtains
information inputted through manual input unit 132 and processes
that information. What is more, controller 140 controls read
operation by information read unit 150 through an external IF, and
processes the read information. Still further, controller 140 is
capable of connecting to network 250 via communication unit 145,
and thus accessing management server 200 of specimen analyzer 100.
Communication unit 145 includes a communication interface, and
establishes cabled or wireless connection to network 250.
Communication unit 145 connects to network 250 via, for example, an
Ethernet cable.
[0134] Controller 140 is configured to perform control of causing
display unit 131 to display how to input information on
consumables. This makes it possible to input the information on the
consumables in accordance with the display of display unit 131,
facilitating input operation without mistakes. More specifically,
controller 140 is configured to perform control of causing display
unit 131 to display an instruction prompting to input the
information on the consumables with information read unit 150. This
makes it possible to guide a user to read the information on the
consumables with information read unit 150. Hence, the user can
easily input the information on the consumables.
[0135] In addition, controller 140 is configured to perform control
of causing display unit 131 to display a message based on a
determination as to whether or not inputted information is
appropriate. This makes it possible to prevent use of inappropriate
consumable 104 because information on the inappropriateness is
displayed as a message if consumable 104 is inappropriate. Also, it
is possible to prompt to use the appropriate consumable by
displaying the reason for inappropriateness. For example,
controller 140 is configured to perform control of acquiring an
expiration date of a consumable based on information on the
consumable, and causing display unit 131 to display a message based
on a determination as to whether or not the expiration date has
passed. This makes it possible to prevent use of expired consumable
104, which can prompt to use a more appropriate consumable.
[0136] Also, consumables 104 include a disposable consumable. For
example, a cleaning agent for cleaning the inside of specimen
analyzer 100 is a disposable consumable 104. If an information
record section of disposable consumable 104 is read again after use
of the disposable consumable, controller 140 is configured to
perform control of not permitting use of consumable 140, and
causing display unit 131 to display an error message. This makes it
possible to prevent a situation where disposable consumable 104 is
used again, which can prompt to use a more appropriate
consumable.
[0137] Furthermore, controller 40 is configured to perform control
of acquiring whether or not consumable 104 is usable based on
information on the consumable, and causing display unit 131 to
display an error message in a case where consumable 104 is
unusable. For example, controller 140 is configured to perform
control of acquiring a type of consumable 104 based on information
on the consumable, and causing display unit 131 to display an error
message in a case where the type of consumable 104 is different.
This makes it possible to prevent a situation where consumable 104
of different types is set and used.
[0138] In addition, controller 140 is configured to perform control
of causing communication unit 145 to transmit information on
consumables inputted with information read unit 150 to server 200.
This makes it possible to manage consumables 140 with external
server 200, enabling more appropriate and easier management of
consumables 140. For example, controller 140 does not permit
inputting of information on a consumable when it is impossible to
connect to server 200 via communication unit 145. This makes it
possible to reliably manage consumables 104 with external server
200 because placement or replacement of consumables 104 is not
allowed when it is impossible to connect to server 200.
[0139] In other words, communication unit 145 can transmit the
information on the consumable inputted with information read unit
150, which works as an input unit, to external server 200.
Controller 140 is configured to allow analysis unit 120 to analyze
a specimen if connection is established between server 200 and
communication unit 145. This makes it possible to manage consumable
50 with external server 200, enabling more appropriate and easier
management of consumables 104 such as reagents.
[0140] Also, controller 140 is configured to permit use of
consumable 104 if the information on the consumable inputted with
information read unit 150 is registered in server 200. This makes
it possible to effectively prevent use of inappropriate consumable
104. More specifically, controller 140 is configured to permit use
of consumable 104 if a lot number as the information on the
consumable is registered in server 200. This makes it possible to
more easily manage consumable 104 by managing the lot number of
consumable 104 with server 200.
[0141] In addition, controller 140 does not shift to a next process
concerning placement or replacement of consumable 104 unless the
information on the consumable is input with information read unit
150. This makes it possible to advance the processing concerning
the placement or replacement of consumable 104 after inputting
information to determine whether or not consumable 104 is an
appropriate one. Hence, it is possible to reliably place or replace
appropriate consumable 104. For example, controller 140 is
configured to perform control of causing display unit 131 not to
shift a screen of display unit 131 concerning placement or
replacement of consumable 104 to a next screen unless the
information on the consumable is input with information read unit
150. This makes it possible to effectively prevent placement or
replacement of inappropriate consumable 104 because a screen to
advance placement or replacement of consumable 104 is not displayed
until the information on the consumable is input with information
read unit 150.
[0142] (Description on Server)
[0143] Registered with storage unit 210 of server 200 are serial
numbers of individual specimen analyzers 100. To be more specific,
the user is allowed to use only specimen analyzers 100 registered
with server 200. Registered with storage unit 220 of server 200 are
lot numbers and serial numbers of reagents. To be more specific,
the user is allowed to use only the reagents registered with server
200 in specimen analyzer 100. Moreover, stored in storage unit 220
of server 200 is information on a QC reagent. Information on a QC
reagent is stored associated with the lot number of that QC
reagent. To be more specific, information on a QC reagent includes
information on a measurement range of the QC reagent. For example,
QC reagents used include a High QC reagent containing a highly
concentrated component, a Normal QC reagent containing a normally
concentrated component, and a Low QC reagent containing a low
concentrated component. A normal value of the measurement result is
set for each QC reagent depending on High, Normal, and Low.
Moreover, the QC reagent has a varying normal value depending on
the lot. In light of this, storage unit 220 of server 200 stores
ranges of normal values in the case of measuring QC reagents
depending on the types High, Normal, and Low, and the lot
number.
[0144] [Operation Example of Specimen Analyzer]
[0145] With reference to FIG. 5, an operation example of specimen
analyzer 100 is described.
[0146] When the power is turned ON at step S10, a startup process
is performed at step S11. To be more specific, the system is
automatically checked. Also, the inside of the apparatus is
automatically cleaned. Additionally, blank check is performed.
[0147] At step S12, quality control is executed. The quality
control is performed at predetermined intervals. Display unit 131
displays a screen requiring quality control at predetermined
intervals. The user inputs data concerning quality control in
accordance with what is being displayed, and instructs to measure
quality control substances.
[0148] At step S13, a patient sample as a specimen is measured.
Display unit 131 displays a screen of an instruction for sample
measurement. The user performs sample measurement instruction in
accordance with what is being displayed. At step S14, the
measurement results are printed. To be more specific, the measured
and analyzed results are printed and outputted from print unit 135.
Note that display unit 131 does not display the measurement
results.
[0149] [Description on Sample Measurement Process]
[0150] With reference to FIG. 6, an example of a sample measurement
process by specimen analyzer 100 is described. In the example
illustrated in FIG. 6, specimen analyzer 100 measures and analyzes
the sample of a patient as a specimen.
[0151] At step S20, a sample container is checked. To be more
specific, display unit 131 displays images of the types of sample
containers available. The user checks the sample container by
comparing the images and the actual sample container. At step S21,
an operator ID is inputted. To be more specific, the user inputs an
ID for identifying the operator in accordance with the instructions
of display unit 131.
[0152] At step S22, a patient ID is inputted. To be more specific,
the user inputs an ID for identifying the patient in accordance
with the instructions of display unit 131. At step S23, the date of
birth of the patient is inputted. To be more specific, the user
inputs the date of birth of the patient being the sample to be
measured in accordance with the instructions of display unit
131.
[0153] At step S24, a measurement pre-treatment is performed. To be
more specific, display unit 131 displays the instructions on the
pre-treatment. The user performs the pre-treatment such as heating
and stirring of the sample in accordance with the instructions of
display unit 131. At step S25, a sample container is set. To be
more specific, display unit 131 displays the instructions on the
setting of the sample container. The user sets the sample container
in specimen analyzer 100 in accordance with the instructions of
display unit 131.
[0154] At step S26, the sample is measured. When the measurement of
the sample finishes, measurement results are printed at step S27.
To be more specific, after the measurement finishes, display unit
131 displays a button for starting of the printing. When the user
operates the button for starting of the printing, print unit 135
prints the measurement result. The printing results are, for
example, the name of the hospital, its location, the name of the
measurement apparatus, the date and time of measurement, the
operator ID, patient ID, the date of birth of the patient, the
measurement results, messages, information on the reference value,
and a print end mark.
[0155] At step S28, the sample container is removed. To be more
specific, display unit 131 displays the instructions for removing
the sample container. The user removes the sample container from
specimen analyzer 100 in accordance with the instructions of
display unit 131. At step S29, determination is made as to whether
or not there is a sample container. If there is a sample container,
the process returns to step S28, and if there is no sample
container, the sample measurement process finishes.
[0156] [Display Example of Display Unit]
[0157] With reference to FIG. 7 to FIG. 48, a display example of
display unit 131 in a case of using specimen analyzer 100 is
described. It is possible to operate specimen analyzer 100 by
following a series of instructions displayed on display unit
131.
[0158] (Display Example when Connecting Ethernet Cable)
[0159] With reference to FIG. 7 and FIG. 8, a display example when
connecting an Ethernet cable is described.
[0160] It is impossible to use specimen analyzer 100 unless it is
connected to server 200 via network 250. To be more specific, it is
possible to use specimen analyzer 100 if it is registered with
server 200. It is necessary to connect to server 200 in order to
check whether or not specimen analyzer 100 is registered. Specimen
analyzer 100 is connected to network 250 with an Ethernet cable. To
this end, it is necessary to connect an Ethernet cable to specimen
analyzer 100.
[0161] To begin with, when specimen analyzer 100 is set and the
power is turned on, display unit 131 first displays a screen for
connecting an Ethernet cable. To be more specific, as illustrated
in FIG. 7, display unit 131 displays screen P1. Screen P1 shows a
picture and an instruction on how to insert the Ethernet cable to
specimen analyzer 100. Also, screen P1 shows Complete button P1a.
When Complete button P1a is pressed, display unit 131 displays
screen P2. Screen P2 shows Continue button P2a. When Continue
button P2a is pressed, display unit 131 displays screen P3, as
illustrated in FIG. 8. Thus, communication unit 145 of specimen
analyzer 100 starts connection to server 200.
[0162] If the connection fails while screen P3 is being displayed,
display unit 131 displays screen P4. Screen P4 shows Call TAC
button P4a and Continue button P4b. When Call TAC button P4a is
pressed, display unit 131 displays screen P5. When Continue button
P4b is pressed, display unit 131 again displays screen P3.
[0163] Screen P5 shows error details. If the user telephones to a
TAC (Technical Assistance Center) and communicates the description
of screen P5, he/she can receive support smoothly. Screen P5 shows
Return button P5a. When Return button P5a is pressed, display unit
131 displays screen P4.
[0164] If the connections succeeds while screen P3 is being
displayed, display unit 131 displays screen P6. Screen P6 shows
Continue button P6a. When Continue button P6a is pressed, the
instructions to connect an Ethernet cable stop being displayed.
Then, the screen proceeds to a screen of printer confirmation.
[0165] (Display Example at Printer Confirmation)
[0166] With reference to FIG. 9 to FIG. 12, a display example at
printer confirmation is described.
[0167] Display unit 131 displays a screen for confirming a printer
as print unit 135. As illustrated in FIG. 9, display unit 131
displays screen P11. Screen P11 shows a picture and an instruction
on how to open a door of the printer. Also, screen P11 shows
Complete button P11a. When Complete button P11a is pressed, display
unit 131 displays screen P12. Screen P12 shows a picture and an
instruction on how to remove paper from the printer. Also, screen
P12 shows Complete button P12a. When Complete button P12a is
pressed, display unit 131 displays screen P13.
[0168] Screen P13 shows a picture and an instruction on how to
insert paper in the printer and close the door. Also, screen P13
shows Complete button P13a. When Complete button P13a is pressed,
display unit 131 displays screen P14. Thus, print unit 135 starts
test printing.
[0169] When the test printing finishes, display unit 131 displays
screen P15 as illustrated in FIG. 10. Screen P15 shows a question
asking whether or not the test printing has been correctly done,
Yes button P15a, and No button P15b. When No button P15b is
pressed, display unit 131 displays screen P16. When Yes button P15a
is pressed, display unit 131 displays screen P18.
[0170] Screen P16 shows Call TAC button P16a and Continue button
P16b. When Call TAC button P16a is pressed, display unit 131
displays screen P17. When Continue button P16b is pressed, display
unit 131 again displays screen P11 (see FIG. 9).
[0171] Screen P17 shows error details. If the user telephones to
the TAC and communicates the description of screen P17, he/she can
receive support smoothly. Screen P17 shows Return button P17a. When
Return button P17a is pressed, display unit 131 displays screen
P16.
[0172] Display unit 131 displays screen P18 and print unit 135
starts printing header information. When the printing of the header
information finishes, display unit 131 displays screen P19, as
illustrated in FIG. 11. Screen P19 shows a question asking whether
or not the header information is correct, Yes button P19a, and No
button P19b. When No button P19b is pressed, display unit 131
displays screen P20. When Yes button P19a is pressed, printer
confirmation stops being displayed. Then, the screen proceeds to a
screen of barcode reader conformation.
[0173] Screen P20 shows a description on update of header
information and Continue button P20a. When Continue button P20a is
pressed, display unit 131 displays screen P21. Screen P21 shows
Continue button P21a. When Continue button P21a is pressed, screen
P22 is displayed, as illustrated in FIG. 12.
[0174] Screen P22 shows a description on data download. Then,
display unit 131 displays screen P23. It is to be noted that if
screen P22 is repeated three times, display unit 131 displays
screen P19 (see FIG. 11). Screen P23 shows Call TAC button P23a and
Continue button P23b. When Call TAC button P23a is pressed, display
unit 131 displays screen P24. When Continue button P23b is pressed,
display unit 131 again displays screen P21 (see FIG. 11).
[0175] Screen P24 shows error details. If the user telephones to
the TAC and communicates the description of screen P24, he/she can
receive support smoothly. Screen P24 shows Return button P24a. When
Return button P24a is pressed, display unit 131 displays screen
P23.
[0176] (Display Example at Barcode Reader Confirmation)
[0177] With reference to FIG. 13, a display example at barcode
reader confirmation is described.
[0178] Specimen analyzer 100 can input information on a reagent as
a consumable and on CELLCLEAN for cleaning only through a barcode
reader as information read unit 150. To be more specific, it is
necessary to correctly attach a barcode reader to specimen analyzer
100.
[0179] As barcode reader confirmation, display unit 131 displays
screen P31, as illustrated in FIG. 13. Screen P31 shows a picture
of the barcode reader, a question asking whether or not the barcode
reader gives off red light when the button is pressed, Yes button
P31a, and No button P31b. When No button P31b is pressed, display
unit 131 displays screen P32. When Yes button P31a is pressed,
display unit 131 displays screen P36.
[0180] Screen P32 shows a picture instructing to connect the
barcode reader, a question asking whether or not the barcode reader
is connected to specimen analyzer 100, Yes button P32a, and No
button P32b. When No button P32b is pressed, display unit 131
displays screen P33. When Yes button P32a is pressed, display unit
131 displays screen P34. Screen P33 shows a picture and an
instruction on how to connect the barcode reader. Also, screen P33
shows Complete button P33a. When Complete button P33a is pressed,
display unit 131 displays screen P31.
[0181] Screen P34 shows a description on a problem with the barcode
reader and Call TAC button P34a. When Call TAC button P34a is
pressed, display unit 131 displays screen P35. Screen P35 shows
Return button P35a. When Return button P35a is pressed, display
unit 131 displays screen P34.
[0182] Screen P36 shows a picture and an instruction on how to read
the barcode of the Quick Guide using the barcode reader. When the
barcode reader completes reading the barcode of the Quick Guide,
display unit 131 displays screen P37. Screen P37 shows Continue
button P37a. When Continue button P37a is pressed, the screen of
barcode reader confirmation finishes being displayed. Then, the
screen proceeds to a screen of the connection of various types of
tubes.
[0183] (Display Example at Connection of Various Types of
Tubes)
[0184] With reference to FIG. 14, a display example at the
connection of various types of tubes is described.
[0185] Display unit 131 displays screen P41 in order to connect
various types of tubes to specimen analyzer 100, as illustrated in
FIG. 14. Screen P41 shows a picture and an instruction on how to
connect various types of tubes to specimen analyzer 100. Also,
screen P41 shows Complete button P41a. When Complete button P41a is
pressed, display unit 131 displays screen P42. Screen P42 shows
instructions to place a reagent container, a waste liquid container
etc. to be connected to tubes next to specimen analyzer 100. Also,
screen P42 shows Complete button P42a. When Complete button P42a is
pressed, display unit 131 displays screen P43.
[0186] Screen P43 shows a picture and an instruction on how to
connect the waste liquid container. Also, screen P43 shows Complete
button P43a. When Complete button P43a is pressed, display unit 131
displays screen P44. Finally, the screen on connecting various
types of tubes finishes being displayed. Then, the screen proceeds
to a screen of reagent setting.
[0187] (Display Example when Setting Reagent)
[0188] With reference to FIG. 15 to FIG. 21, a display example when
setting a reagent is described.
[0189] Display unit 131 displays screen P51 in order to set a
reagent, as illustrated in FIG. 15. Screen P51 shows a picture and
an instruction on how to set a container of a diluted solution used
to analyze a specimen. Also, screen P51 shows Complete button P51a.
When Complete button P51a is pressed, display unit 131 displays
screen P52. Screen P52 shows a picture and an instruction on how to
read a barcode attached on the container of the diluted solution.
When the barcode is correctly read, display unit 131 displays
screen P53. If a barcode is invalid, including the case where the
expiration date has passed, display unit 131 displays screen P54
(see FIG. 16). If the barcode does not match, display unit 131
displays screen P55 (see FIG. 16).
[0190] While screen P53 is being displayed, connection is
established to server 200, and whether or not the reagent can be
used is checked. Thereafter, display unit 131 displays screen P57
(see FIG. 17).
[0191] As illustrated in FIG. 16, screen P54 shows a description
that the reagent of the read barcode is invalid. Also, screen P54
shows Continue button P54a. When Continue button P54a is pressed,
display unit 131 displays screen P51 (see FIG. 15).
[0192] Screen P55 shows a description that there is a problem with
the connection. Also, screen P55 shows Call TAC button P55a and
Continue button P55b. When Call TAC button P55a is pressed, display
unit 131 displays screen P56. When Continue button P55b is pressed,
display unit 131 displays screen P51 (see FIG. 15). Screen P56
shows error details. If the user telephones to the TAC and
communicates the description of screen P56, he/she can receive
support smoothly. Screen P56 shows Return button P56a. When Return
button P56a is pressed, display unit 131 displays screen P55.
[0193] As illustrated in FIG. 17, screen P57 shows a picture and an
instruction on how to place the reagent container. Also, screen P57
shows Complete button P57a. When Complete button P57a is pressed,
display unit 131 displays screen P58. Screen P58 shows a
description to connect the reagent container and the tube together.
Also, screen P58 shows Complete button P58a. When Complete button
P58a is pressed, display unit 131 displays screen P59. Thereafter,
as illustrated in FIG. 18, display unit 131 displays screen
P60.
[0194] Screen P60 shows a picture and an instruction on how to set
a container of a hemolyzer used to analyze a specimen. Also, screen
P60 shows Complete button P60a. When Complete button P60a is
pressed, display unit 131 displays screen P61. Screen P61 shows a
picture and an instruction on how to read a barcode attached on the
container of the hemolyzer. When the barcode is correctly read,
display unit 131 displays screen P62. If a barcode is invalid,
including the case where the expiration date has passed, display
unit 131 displays screen P63 (see FIG. 19). If the barcode does not
match, display unit 131 displays screen P64 (see FIG. 19).
[0195] While screen P62 is being displayed, connection is
established to server 200, and whether or not the reagent can be
used is checked. Thereafter, display unit 131 displays screen P66
(see FIG. 20).
[0196] As illustrated in FIG. 19, screen P63 shows a description
that the reagent of the read barcode is invalid. Also, screen P63
shows Continue button P63a. When Continue button P63a is pressed,
display unit 131 displays screen P60 (see FIG. 18).
[0197] Screen P64 shows a description that there is a problem with
the connection. Also, screen P64 shows Call TAC button P64a and
Continue button P64b. When Call TAC button P64a is pressed, display
unit 131 displays screen P65. When Continue button P64b is pressed,
display unit 131 displays screen P60 (see FIG. 18). Screen P65
shows error details. If the user telephones to the TAC and
communicates the description of screen P65, he/she can receive
support smoothly. Screen P65 shows Return button P65a. When Return
button P65a is pressed, display unit 131 displays screen P64.
[0198] As illustrated in FIG. 20, screen P66 shows a picture and an
instruction on how to place the reagent container. Also, screen P66
shows Complete button P66a. When Complete button P66a is pressed,
display unit 131 displays screen P67. Screen P67 shows a
description to connect the reagent container and the tube together.
Also, screen P67 shows Complete button P67a. When Complete button
P67a is pressed, display unit 131 displays screen P68. Thereafter,
display unit 131 displays screen P69.
[0199] Subsequently, display unit 131 displays screen P70. In
addition, the diluted solution is fed to specimen analyzer 100.
Thereafter, display unit 131 displays screen P71. Moreover, the
hemolyzer is fed to specimen analyzer 100. Thereafter, display unit
131 displays screen P72. Finally, the screen of setting the reagent
finished being displayed. Then, the screen proceeds to a screen of
cleaning by CELLCLEAN.
[0200] (Display Example of Cleaning by CELLCLEAN)
[0201] With reference to FIG. 22 to FIG. 25, a display example of
cleaning by CELLCLEAN is described.
[0202] As illustrated in FIG. 22, display unit 131 displays screen
P81 in order to indicate the necessity of cleaning by CELLCLEAN.
Screen P81 shows Continue button P81a. When Continue button P81a is
pressed, display unit 131 displays screen P82. Screen P82 shows a
picture and an instruction on CELLCLEAN to be used. Also, screen
P82 shows Complete button P82a. When Complete button P82a is
pressed, display unit 131 displays screen P83.
[0203] Screen P83 shows a picture and an instruction on how to open
a door and insert an adapter. Also, screen P83 shows Complete
button P83a. When Complete button P83a is pressed, display unit 131
displays screen P84. Screen P84 shows a description to read a
barcode attached on the container of CELLCLEAN. Also, screen P84
shows Quit button P84a. When the barcode is correctly read, display
unit 131 displays screen P89 (see FIG. 24). In the case where the
expiration date has passed, display unit 131 displays screen P85
(see FIG. 23). If the barcode does not match, display unit 131
displays screen P87 (see FIG. 23). When Quit button P84a is
pressed, display unit 131 displays screen P91 (see FIG. 24).
[0204] Screen P85 shows a description that there is a problem with
the connection. Also, screen P85 shows Call TAC button P85a and
Continue button P85b. When Call TAC button P85a is pressed, display
unit 131 displays screen P86. When Continue button P85b is pressed,
display unit 131 displays screen P84 (see FIG. 22). Screen P86
shows error details. If the user telephones to the TAC and
communicates the description of screen P86, he/she can receive
support smoothly. Screen P86 shows Return button P86a. When Return
button P86a is pressed, display unit 131 displays screen P85.
[0205] Screen P87 shows a description that CELLCLEAN is invalid.
Also, screen P87 shows Call TAC button P87a, Continue button P87b,
and Quit button P87c. When Call TAC button P87a is pressed, display
unit 131 displays screen P88. When Continue button P87b or Quit
button P87c is pressed, display unit 131 displays screen P84 (see
FIG. 22). Screen P88 shows error details. If the user telephones to
the TAC and communicates the description of screen P88, he/she can
receive support smoothly. Screen P88 shows Return button P88a. When
Return button P88a is pressed, display unit 131 displays screen
P87.
[0206] As illustrated in FIG. 24, screen P89 shows a description on
validation and download of CELLCLEAN information. Thereafter,
display unit 131 displays screen P90. Screen P90 shows a picture
and an instruction on how to place CELLCLEAN. After CELLCLEAN is
placed and the door is closed, display unit 131 displays screen P94
(see FIG. 25).
[0207] Screen P91 shows a description that the adapter is set and
Continue button P91a. When Continue button P91a is pressed, display
unit 131 displays screen P92. Screen P92 shows a picture and an
instruction on how to remove the adapter. Also, screen P92 shows
Complete button P92a. When Complete button P92a is pressed, display
unit 131 displays screen P93. Screen P93 shows a picture and an
instruction on how to close the door. Also, screen P93 shows
Complete button P93a. When Complete button P93a is pressed, display
unit 131 displays screen P91.
[0208] As illustrated in FIG. 25, display unit 131 displays screen
P94. Also, CELLCLEAN cleans the inside of specimen analyzer 100.
Thereafter, display unit 131 displays screen P95. Screen P95 shows
a picture and an instruction on how to remove the container of
CELLCLEAN from specimen analyzer 100. Also, screen P95 shows
Complete button P95a. When Complete button P95a is pressed, display
unit 131 shows screen P96.
[0209] Screen P96 shows a description to prepare specimen analyzer
100 and Continue button P96a. When Continue button P96a is pressed,
display unit 131 displays screen P97. Also, the preparation of
specimen analyzer 100 proceeds. Finally, the screen of cleaning by
CELLCLEAN finishes being displayed. Then, the screen proceeds to a
screen of QC measurement.
[0210] (Display Example at QC Measurement)
[0211] With reference to FIG. 26 to FIG. 32, a display example at
QC measurement is described.
[0212] As illustrated in FIG. 26, display unit 131 displays screen
P101 in order to indicate the necessity of QC (Quality Control)
measurement. Screen P101 shows Continue button P101a. When Continue
button P101a is pressed, display unit 131 displays screen P102.
Screen P102 shows a picture and an instruction on how to open the
door and insert the adapter. Also, screen P102 shows Complete
button P102a. When Complete button P102a is pressed, display unit
131 displays screen P103.
[0213] Screen P103 shows a description to input the ID of the
operator. Also, screen P103 shows Complete button P103a, Quit
button P103b, input buttons P103c, and input region P103d. When
input buttons P103c are operated, input region P103d displays
inputted characters. The ID of the operator can be set using, for
example, any one to three alphabetical letters. Also, the ID of the
operator may be different for each of the High, Low, and Normal QC
reagents.
[0214] When Complete button P103a is pressed, display unit 131
displays screen P104. In the example of FIG. 26, the string "MJT"
is inputted as the ID of the operator. Screen P104 shows Complete
button P104a, Quit button P104b, input buttons P104c, and input
region P104d. When the pressing of Complete button P104a succeeds,
display unit 131 displays screen P106 (see FIG. 27). When Complete
button P104a is pressed but the input is NG, display unit 131
displays screen P105.
[0215] Screen P105 shows a description that the operator ID is
invalid, Continue button P105a, and Quit button P105b. When
Continue button P105a is pressed, display unit 131 displays screen
P103.
[0216] As illustrated in FIG. 27, screen P106 shows a question
asking whether or not the operator ID is correct, Yes button P106a
and No button P106b, and Quit button P106c. When No button P106b is
pressed, display unit 131 displays screen P103. When Yes button
P106a is pressed, display unit 131 displays screen P107.
[0217] Screen P107 shows a picture and an instruction on how to
read a barcode of a High QC reagent. Also, screen P107 shows Quit
button P107a. When the barcode of the QC reagent is read, display
unit 131 displays screen P108. Screen P108 shows a description on
validation and download of information on the QC reagent. Once
information on the QC reagent is downloaded from server 200, a
range of a normal value of the measurement value of the QC reagent
is obtained.
[0218] When the validation and download of information on the QC
reagent succeed, display unit 131 displays screen P112 (see FIG.
29). When the QC reagent is determined as invalid, display unit 131
displays screen P109 (see FIG. 28). When the QC reagent is
determined as a scanned QC reagent, display unit 131 displays
screen P111 (see FIG. 28).
[0219] As illustrated in FIG. 28, screen P109 shows a description
that the QC reagent is invalid. Also, screen P109 shows Call TAC
button P109a, Continue button P109b, and Quit button P109c. When
Call TAC button P109a is pressed, display unit 131 displays screen
P110. When Continue button P109b is pressed, display unit 131
displays screen P108 (see FIG. 27). Screen P110 shows error
details. If the user telephones to the TAC and communicates the
description of screen P110, he/she can receive support smoothly.
Screen P110 shows Return button P110a. When Return button P110a is
pressed, display unit 131 displays screen P109.
[0220] Screen P111 shows a description that the QC reagent is
invalid. Also, screen P111 shows Continue button P111a and Quit
button P111b. When Continue button P111a is pressed, display unit
131 displays screen P108 (see FIG. 27).
[0221] As illustrated in FIG. 29, screen P112 shows a description
to start stirring the QC reagent, Continue button P112a, and Quit
button P112b. When Continue button P112a is pressed, display unit
131 displays screen P113. Screen P113 shows a description to stir
the QC reagent, Quit button P113a, and timer P113b. Timer P113b is
displayed counting down from 15 sec, for example. When the time
counted down by timer P113b has elapsed, display unit 131 displays
screen P114.
[0222] Screen P114 shows Complete button P114a and Quit button
P114b. When Complete button P114a is pressed, display unit 131
displays screen P115. Screen P115 shows a picture and an
instruction on how to set the QC reagent. Also, screen P115 shows
Quit button P115a.
[0223] When the QC reagent is set and the door is closed, display
unit 131 displays screen P116, as illustrated in FIG. 30. Also,
measurement of QC reagent is performed. When the treatment of the
QC reagent fails, display unit 131 displays screen P117. Screen
P117 shows a description to perform measurement again. Also, screen
P117 shows Continue button P117a. When Continue button P117a is
pressed, display unit 131 displays screen P120. When the
measurement of the QC reagent finishes normally, display unit 131
displays screen P118. Screen P118 shows Continue button P118a. When
Continue button P118a is pressed, display unit 131 displays screen
P120.
[0224] Here, display unit 131 displays screen P119 when the Quit
button is pressed in any of the screens, or when a predetermined
time period has elapsed with the screen left unoperated. Screen
P119 shows Continue button P119a. When Continue button P119a is
pressed, display unit 131 displays screen P120.
[0225] Screen P120 shows a picture and an instruction on how to
remove the container of the QC reagent from specimen analyzer 100.
Also, screen P120 shows Complete button P120a. When Complete button
P120a is pressed, display unit 131 displays screen P121 (see FIG.
31).
[0226] As illustrated in FIG. 31, screen P121 shows a picture and
an instruction on how to remove the adapter from specimen analyzer
100. In addition, screen P121 shows Complete button P121a. When
Complete button P121a is pressed, display unit 131 displays screen
P122. Screen P122 shows a picture and an instruction on how to
close the door. Also, screen P122 shows Complete button P122a. When
Complete button P122a is pressed, the measurement process of the
High QC reagent finishes. Thereafter, a measurement process of a
Low QC reagent is performed.
[0227] If the QC adapter is remaining when Complete button P122a is
pressed, display unit 131 displays screen P123. Screen P123 shows
Continue button P123a. When Continue button P123a is pressed,
display unit 131 displays screen P121.
[0228] When the measurement process of the Low QC reagent starts,
display unit 131 displays screens similar to screens P101 to P106,
and similar processes are performed. Thereafter, display unit 131
displays screen P124. Screen P124 displays a picture and an
instruction on how to read a barcode of the Low QC reagent. Also,
screen P124 shows Quit button P124a. When the barcode of the QC
reagent is read, display unit 131 displays screens similar to
screen P108 to P123, and similar processes are performed. Finally,
the measurement process of the Low QC reagent finishes. Thereafter,
a measurement process of a Normal QC reagent is performed.
[0229] When the measurement process of the Normal QC reagent
starts, display unit 131 displays screens similar to screen P101 to
P106, and similar processes are performed. Thereafter, display unit
131 displays screen P125. Screen P125 displays a picture and an
instruction on how to read a barcode of the Normal QC reagent.
Also, screen P125 shows Quit button P125a. When the barcode of the
QC reagent is read, display unit 131 displays screens similar to
screen P108 to P123, and similar processes are performed. Finally,
the measurement process of the Normal QC reagent finishes. Then,
the screen of QC measurement stops being displayed. Subsequently,
the screen proceeds to a screen of sample measurement. Thus, the
preparation for sample measurement is done.
[0230] (Display Example at Sample Measurement)
[0231] With reference to FIG. 33 to FIG. 40, display example at
sample measurement is described.
[0232] As illustrated in FIG. 33, display unit 131 displays screen
P131 for measuring the sample of the patient as the specimen. In
the case of waiting for preparation of sample measurement, display
unit 131 displays screen P131. Screen P131 shows Standard Tube
button P131a and arrow button P131b. When arrow button P131b is
pressed, display unit 131 displays screen P160 for maintenance (see
FIG. 41). When Standard Tube button P131a is pressed, display unit
131 displays screen P132. Screen P132 shows a question asking
whether or not the sample container is correct, Yes button P132a
and No button P132b, and Quit button P132c. When No button P132b or
Quit button P132c is pressed, display unit 131 displays screen
P131. When Yes button P132a is pressed, display unit 131 displays
screen P133.
[0233] Screen P133 shows a picture and an instruction on how to
open the door and insert the adapter. Also, screen P133 shows
Complete button P133a and Quit button P133b. When Complete button
P133a is pressed, display unit 131 displays screen P134 (see FIG.
34).
[0234] As illustrated in FIG. 34, screen P134 shows a description
for inputting the ID of the operator. Also, screen P134 shows
Complete button P134a, Quit button P134b, input buttons P134c, and
input region P134d. When input buttons P134c are operated, input
region P134d displays inputted characters. The ID of the operator
can be set using, for example, any one to three alphabetical
letters.
[0235] When Complete button P134a is pressed, display unit 131
displays screen P135. In the example of FIG. 34, the string "MJT"
is inputted as the ID of the operator. Screen P135 shows Complete
button P135a, Quit button P135b, input buttons P135c, and input
region P135d. When Complete button P135a is pressed and the input
is OK, display unit 131 displays screen P137. When Complete button
P135a is pressed but the input is NG, display unit 131 displays
screen P136.
[0236] Screen P136 shows a description that the operator ID is
invalid, Continue button P136a, and Quit button P136b. When
Continue button P136a is pressed, display unit 131 displays screen
P134.
[0237] Screen P137 shows a question asking whether or not the
operator ID is correct, Yes button P137a and No button P137b, and
Quit button P137c. When No button P137b is pressed, display unit
131 displays screen P134. When Yes button P137a is pressed, display
unit 131 displays screen P138 (see FIG. 35).
[0238] As illustrated in FIG. 35, screen P138 shows a description
for inputting the ID of the operator. Also, screen P138 shows
Complete button P138a, Quit button P138b, input buttons P138c, and
input region P138d. When input buttons P138c are operated, input
region P138d displays inputted characters. The ID of the patient
can be set using, for example, any four or more characters. The ID
of the patient can be set using four to nine characters. Also, the
ID of the patient can include zero to two alphabetical letters. In
addition, the ID of the patient can include numbers from zero to
eight characters.
[0239] When Complete button P138a is pressed, display unit 131
displays screen P139. In the example of FIG. 35, the string "1234"
is inputted as the ID of the patient. Screen P139 shows Complete
button P139a, Quit button P139b, input buttons P139c, and input
region P139d. When Complete button P139a is pressed and the input
is OK, display unit 131 displays screen P141. When Complete button
P139a is pressed but the input is NG, display unit 131 displays
screen P140.
[0240] Screen P140 shows a description that the patient ID is
invalid, Continue button P140a, and Quit button P140b. When
Continue button P140a is pressed, display unit 131 displays screen
P138.
[0241] Screen P141 shows a question asking whether or not patient
ID is correct, Yes button P141a and No button P141b, and Quit
button P141c. When No button P141b is pressed, display unit 131
displays screen P138. When Yes button P141a is pressed, display
unit 131 displays screen P142 (see FIG. 36).
[0242] As illustrated in FIG. 36, screen P142 shows a description
for inputting the date of birth of the patient. Also, screen P142
shows Complete button P142a, Quit button P142b, input buttons
P142c, and input region P142d. When input buttons P142c are
operated, input region P142d displays inputted characters.
[0243] When Complete button P142a is pressed, display unit 131
displays screen P143. In the example of FIG. 36, "11/11/2000" is
inputted as the date of birth of the patient. Screen P143 shows
Complete button P143a, Quit button P143b, input buttons P143c, and
input region P143d. When the Complete button P143a is pressed and
the input is OK, display unit 131 displays screen P145. When
Complete button P143a is pressed but the input is NG, display unit
131 displays screen P144.
[0244] Screen P144 shows a description that the date of birth of
the patient is invalid, Continue button P144a, and Quit button
P144b. When Continue button P144a is pressed, display unit 131
displays screen P142.
[0245] Screen P145 shows a question asking whether or not the date
of birth of the patient is correct, Yes button P145a and No button
P145b, and Quit button P145c. When No button P145b is pressed,
display unit 131 displays screen P142. When Yes button P145a is
pressed, display unit 131 displays screen P146 (see FIG. 37).
[0246] As illustrated in FIG. 37, screen P146 shows a question
asking whether or not the sample container is cold, Yes button
P146a and No button P146b, and Quit button P146c. When Yes button
P146a is pressed, display unit 131 displays screen P147. Screen
P147 shows a picture and an instruction on how to warm the sample
container. Also, screen P147 shows Complete button P147a and Quit
button P147b. When Complete button P147a is pressed, display unit
131 displays screen P148.
[0247] Screen P148 shows a description to start stirring the
sample, Continue button P148a, and Quit button P148b. When Continue
button P148a is pressed, display unit 131 displays screen P149 (see
FIG. 38).
[0248] As illustrated in FIG. 38, screen P149 shows a description
to stir the sample, Quit button P149a, and timer P149b. Timer P149b
is displayed counting down from 15 sec, for example. When the time
counted down by timer P149b has elapsed, display unit 131 displays
screen P150. Screen P150 shows Complete button P150a and Quit
button P150b. When Complete button P150a is pressed, display unit
131 displays screen P152.
[0249] Here, display unit 131 displays screen P151 when the Quit
button is pressed in any of the screens, or when a predetermined
time period has elapsed with the screen left unoperated. Screen
P151 shows Continue button P151a. When Continue button P151a is
pressed, display unit 131 shows screen P152.
[0250] Screen P152 shows a picture and an instruction on how to set
the sample container. Also, screen P152 shows Quit button
P152a.
[0251] When the sample container is set and the door is closed,
display unit 131 displays screen P153, as illustrated in FIG. 39.
Also, measurement of sample is performed. When the measurement of
the sample finishes, display unit 131 displays screen P154. Screen
P154 shows a description for printing and Continue button P154a.
When Continue button P154a is pressed, display unit 131 displays
screen P155.
[0252] Screen P155 shows a description that the printing is in
progress. Also, print unit 135 prints the results. If one or more
of the measurement results are outside normal range, display unit
131 displays screen P156. Screen P156 shows a description to
perform measurement again, Continue button P156a, and Quit button
P156b. When Continue button P156a is pressed, display unit 131
displays first screen P131 of sample measurement (see FIG. 33).
[0253] As illustrated in FIG. 40, screen P157 shows a picture and
an instruction on how to remove the sample container from specimen
analyzer 100. Also, screen P157 shows Complete button P157a. When
Complete button P157a is pressed, display unit 131 displays screen
P158. Screen P158 shows a picture and an instruction on how to
close the door. Also, screen P158 shows Complete button P158a. When
Complete button P158a is pressed, the sample measurement process
finishes. Thereafter, display unit 131 displays first screen P131
of sample measurement (see FIG. 33).
[0254] If the adapter is remaining when Complete button P158a is
pressed, display unit 131 displays screen P159. Screen P159 shows
Continue button P159a. When Continue button P159a is pressed,
display unit 131 displays screen P157.
[0255] Thus, in the example of FIG. 40, display unit 131 displays
print operation screen (see screen P154) for starting of the
printing of analysis results 102.
[0256] In print operation screen P154, display unit 131 displays
operational guidance and instructions to deal with printed sheet
after printing.
[0257] The instructions to deal with the printed sheet include a
message instructing to deliver the printed sheet to the ordering
doctor.
[0258] Print unit 135 starts the printing of analysis results 102
based on the operations in accordance with print operation screen
P154 (see screen P155). To be more specific, print unit 135 starts
the printing of analysis results 102 based on the input of Continue
button P154a.
[0259] Also, in the example of FIG. 39 and the example of FIG. 40,
analysis unit 120 is capable of analyzing next specimen 101 if an
operation is performed in accordance with the print operation
screen. To be more specific, if a series of operations up to screen
P158 including an operation on screen P154 completes, controller
140 causes display unit 131 to display P131 (see FIG. 33) to be
ready for an analysis of next specimen 101.
[0260] In addition, if analysis results 102 include an abnormal
value, controller 140 causes display unit 131 to display an
abnormal value notification screen (see screen P156) to communicate
that an abnormal value is included. When abnormal value
notification screen P156 is displayed, analysis unit 120 is capable
of retesting same specimen 101 when an operation is performed in
accordance with abnormal value notification screen P156.
[0261] If analysis results 102 include an abnormal value,
controller 140 prohibits print unit 135 from printing analysis
results 102, and causes abnormal value notification screen P156 to
show a message prompting to perform retesting. The example of
screen P156 shows a message communicating it is necessary to retest
because one or more analysis results 102 are outside normal
range.
[0262] In the example of screen P156, when Continue button 156a is
inputted, a series of processes for performing retest are executed.
Here, by inputting Quit button 156b, analysis of another specimen
101 can be started.
[0263] (Display Example at Maintenance)
[0264] With reference to FIG. 41 to FIG. 48, a display example at
maintenance is described.
[0265] As illustrated in FIG. 41, screen P160 shows a screen for
performing maintenance. To be more specific, screen P160 Quit
button P160a, Auto Rince button P160b, Remove Clog button P160c,
Replace Pack-D button P160d, Replace Pack-L button P160e,
Preventive MaintP button P160f, Past Results button P160g, and Move
Instrument button P160h.
[0266] When Auto Rince button P160b is pressed, display unit 131
displays screen P161, as illustrated in FIG. 42. Also, a cleaning
process with use of a diluted solution is performed. Thereafter,
display unit 131 displays first screen P131 of sample measurement
(see FIG. 33).
[0267] When Remove Clog button P160c is pressed, display unit 131
displays screen P162, as illustrated in FIG. 43. Also, a process of
removing the clog of detector 123 is performed.
[0268] When Replace Pack-D button P160d is pressed, display unit
131 displays screen P171, as illustrated in FIG. 44. In addition,
display unit 131 displays screen P171 also in the case where it is
determined that the diluted solution has been used up. Screen P171
displays Continue button P171a. When Continue button P171a is
pressed, display unit 131 displays screens similar to screens P51
and P52, and similar processes are performed. Thereafter, display
unit 131 displays screen P172.
[0269] Screen P172 shows a picture and an instruction on how to
place the reagent container. Also, screen P172 shows Complete
button P172a. When Complete button P172a is pressed, display unit
131 displays screen P173. Screen P173 shows a description for
replacing the reagent container. Also, screen P173 shows Complete
button P173a. When Complete button P173a is pressed, display unit
131 displays screen P174.
[0270] Screen P174 shows a description to place and dispose of the
reagent container. Also, screen P174 shows Complete button P174a.
When Complete button P174a is pressed, display unit 131 displays
screen P175. Also, the diluted solution is fed to specimen analyzer
100. Thereafter, display unit 131 displays screen P176. After that,
display unit 131 displays first screen P131 of sample measurement
(see FIG. 33).
[0271] When Replace Pack-L button P160e is pressed, display unit
131 displays screen P181, as illustrated in FIG. 45. In addition,
display unit 131 displays screen P181 also in the case where it is
determined that the hemolyzer has been used up. Screen P181
displays Continue button P181a. When Continue button P181a is
pressed, display unit 131 displays screens similar to screens P51,
P52, and P172 to P176, and similar processes are performed.
Thereafter, display unit 131 displays first screen P131 of sample
measurement (see FIG. 33).
[0272] When Preventive MaintP button P160f is pressed, display unit
131 displays screen P191, as illustrated in FIG. 46. Also, display
unit 131 displays screen P191 when cleaning by CELLCLEAN is needed.
Screen P191 shows Continue button P191a. When Continue button P191a
is pressed, a process similar to the cleaning by CELLCLEAN is
performed. Thereafter, a process similar to the QC measurement is
performed, and display unit 131 displays first screen P131 of
sample measurement (see FIG. 33).
[0273] When Past Results button P160g is pressed, display unit 131
displays screen P201, as illustrated in FIG. 47. Screen P201 shows
Reprint button P201a, Quit button P201b, and select button P201c.
When select button P201c is used to select a past measurement and
Reprint button P201a is pressed, past measurement results are
printed. By pressing Reprint button 201a, display unit 131 displays
screen P202. Then, print unit 135 prints the measurement results.
Thereafter, display unit 131 displays first screen P131 of sample
measurement (see FIG. 33).
[0274] When Move Instrument button P160h is pressed, display unit
131 displays screen P211, as illustrated in FIG. 48. Screen P211
shows Continue button P211a. When Continue button P211a is pressed,
display unit 131 displays screen P212. Screen P212 shows a picture
and an instruction on how to remove the Ethernet cable from
specimen analyzer 100. Also, screen P212 shows Complete button
P212a. When Complete button P212a is pressed, display unit 131
displays screen P213.
[0275] Screen P213 shows a picture and an instruction on how to
remove the barcode reader from specimen analyzer 100. Also, screen
P213 shows Complete button P213a. When Complete button P213a is
pressed, display unit 131 displays screen P214. Screen P214 shows a
picture and an instruction on how to remove the container of the
diluted solution from the tube. Also, screen P214 shows Complete
button P214a. When Complete button P214a is pressed, display unit
131 displays screen P215.
[0276] Screen P215 shows a picture and an instruction on how to
remove the container of the hemolyzer from the tube. Also, screen
P215 shows Complete button P215a. When Complete button P215a is
pressed, display unit 131 displays screen P216. Screen P216 shows a
description to discharge the liquid. In addition, the liquid is
discharged from specimen analyzer 100. Thereafter, display unit 131
displays screen P217.
[0277] Screen P217 shows a picture and an instruction on how to
remove the container of the waste liquid from the tube. Also,
screen P217 shows Complete button P217a. When Complete button P217a
is pressed, display unit 131 displays screen P218. Screen P218
shows a description that shutdown is in progress. Thereafter,
display unit 131 displays screen P219.
[0278] Screen P219 shows a picture and an instruction on how to
power off specimen analyzer 100. Thereafter, the user powers
off.
[0279] (Outputting of Analysis Results)
[0280] In the example illustrated in FIG. 2, analysis unit 120
perform analysis on seventeen analysis items in total, eight
measurement items plus nine analysis items, as described above. In
the embodiment, controller 140 performs control of causing print
unit 135 to print analysis results 102, and prohibiting display
unit 131 from displaying analysis results 102. Thus, as a result of
analysis operations of specimen analyzer 100, the user obtains
printed sheet 300 being print sheet 136 on which analysis results
102 are written, as illustrated in FIG. 49.
[0281] In the example of FIG. 49, printed on printed sheet 300 are
facility information 301, apparatus information 302, date
information 303, operator information 304, subject information 305,
subject attribute information 306, result displaying section 307,
message section 308, and reference value information 309. Note that
although printed sheet 300 is separated for convenience in FIG. 49,
the separated portions are actually connected, and printed sheet
300 is one piece of print sheet 136 on which printing has been
performed.
[0282] Facility information 301 includes information on the name
and the address of the facility such as a hospital where specimen
analyzer 100 is installed.
[0283] Apparatus information 302 is information for identifying
specimen analyzer 100 which performed analysis. Apparatus
information 302 includes, for example, the model, the name, and the
serial number of the apparatus.
[0284] Date information 303 is information for identifying the time
point at which analysis was performed. Date information 303
includes the analysis date. In FIG. 49, date information 303
includes the analysis time in addition to the analysis date.
[0285] Operator information 304 is ID information for identifying
the operator who operated specimen analyzer 100. Operator
information 304 is not particularly limited, and is represented by
three alphabetical letters, for example.
[0286] Subject information 305 is ID information for identifying
the subject from which specimen 101 is collected. Subject
information 305 is represented by a seven-digit number, for
example.
[0287] Subject attribute information 306 is information on the
subject from which specimen 101 is collected, and shows the
characteristics and nature of the subject. Preferable as subject
attribute information 306 is information useful for diagnosis based
on analysis results 102. Subject attribute information 306 includes
at least one of the date of birth, age, and sex, for example. It is
possible to grasp the age of the subject using the date of birth.
Subject attribute information 306 may be an age, or information on
the corresponding one of the age sections. There is a case where
the criteria for diagnosis based on analysis results 102 differ
depending on the sex, in addition to the age. Hence, subject
attribute information 306 may include sex. Furthermore, subject
attribute information 306 may include body information such as the
height and the weight of the subject.
[0288] Result displaying section 307 is an area where analysis
results 102 are printed. Analysis results 102 include numerical
information 102a. In addition, if analysis results 102 include an
error, analysis results 102 include information 102b indicating the
type of the abnormality. As illustrated in FIG. 49, regarding
multiple analysis items, print unit 135 prints analysis results 102
for each of the analysis items. Regarding each analysis item, one
line of result displaying section 307 is assigned one item. To be
more specific, in each analysis item of result displaying section
307, the item name, numerical information 102a, and information
102b indicating the type of the abnormality (flag) are displayed in
sequential order from left.
[0289] Information 102b indicating the type of the abnormality is
printed to notify the user of the type of the abnormality when one
or more of analysis results 102 are outside normal range, or when
there is a predetermined analysis result error. If analysis results
102 include an abnormal value, controller 140 prints information
102b indicating the type of the abnormality as analysis results
102. Determination as to whether or not the results are normal or
erroneous is made based on the numerical ranges for analysis result
determination.
[0290] In the example of FIG. 50, for example, as information 102b
indicating the type of the abnormality, print unit 135 prints
information 102b indicating the type of the abnormality if analysis
results 102 includes an abnormal value. Information 102b indicating
the content of the error includes information 314 indicating a
first error showing that numerical information 102a is included in
a first erroneous ranges 372 (see FIG. 53), and information 315
indicating a second error showing that numerical information 102a
is included in a second erroneous ranges 373 (see FIG. 53).
Information 314 indicating a first error can include an indicator
indicating a high value (High) and an indicator indicating a low
value (Low) for each of analysis results 102. Information 315
indicating a second error can include an indicator indicating an
erroneously high value (ALERT H) and an indicator indicating an
erroneously low value (ALERT L), for example.
[0291] If a certain abnormal value included in analysis results 102
is included in a preset predetermined numerical range, controller
140 excludes the predetermined abnormal value in analysis result
102 from the content to be printed. An embodiment of displaying
result displaying section 307 is described later.
[0292] In FIG. 49, displayed in message section 308 is a
predetermined message to the user in a predetermined case. The
predetermined message includes message 311 prompting further
testing. Furthermore, the predetermined message includes, for
example, message 312 recommending the user to act immediately. If
analysis results 102 have no particular problem, no message is
displayed in message section 308.
[0293] The intention of reference value information 309 is to
provide information for evaluating analysis results 102 to the
user. Thus, in addition to analysis results 102, print unit 135
prints reference value information 309 to evaluate analysis results
102. Analysis result 102 of each analysis item has a numerical
range considered a normal range. Reference value information 309 of
FIG. 49 is information on numerical ranges indicating normal ranges
371 of analysis results 102. Here, the normal range for each
analysis item differs depending on subject attribute information
306 such as the age of the subject. In light of this, in FIG. 49,
reference value information 309 possesses several types depending
on subject attribute information 306 on the subject from which
specimen 101 is collected. Print unit 135 prints: subject attribute
information 306: and reference value information 309 corresponding
to subject attribute information 306 out of several types of
reference value information 309.
[0294] As described above, in the example of FIG. 49, in addition
to analysis results 102, print unit 135 prints the analysis date,
operator information 304 on the operator who performed analysis,
and subject attribute information 306 on the subject from which the
specimen is collected.
[0295] The information above is printed on the same surface of a
single piece of print sheet 136. To be more specific, print unit
135 prints analysis results 102, subject attribute information 306,
reference value information 309, and the predetermined message, if
necessary, on the same surface of a single piece of print sheet
136. In the example of FIG. 49, all information to be printed is
printed on the same surface of a single piece of print sheet
136.
[0296] (Output Rules and Display Embodiment of Analysis Results on
Printed Sheet)
[0297] Subsequently, output rules and a display embodiment in
result displaying section 307 of printed sheet 300 are
described.
[0298] Controller 140 determines whether or not analysis results
102 can be outputted depending on numerical information 102a as
analysis results 102. If numerical information 102a falls within a
predetermined range, controller 140 prohibits outputting of
numerical information 102a to printed sheet 300. Memory 142 of
controller 140 stores data of numerical ranges for analysis result
determination (see FIG. 53 to FIG. 55).
[0299] <First Determination Ranges>
[0300] As illustrated in FIG. 51, out of numerical information 102a
as analysis results 102 of analysis unit 120, controller 140
performs control of prohibiting the outputting of numerical
information 102a outside first determination ranges relating to
reliability of analysis.
[0301] FIG. 52 illustrates an example of first determination ranges
350. First determination ranges 350 (see FIG. 52) are each a
numerical range considered reliable enough for analysis itself by
analysis unit 120. First determination ranges 350 are each a
numerical range which surely has reproducibility, accuracy,
linearity, etc. of analysis results 102 of specimen analyzer 100
within a predetermined range, and is a numerical range set as the
specifications of specimen analyzer 100.
[0302] In the example of FIG. 52, first determination ranges 350
are each a linearity guarantee range for specimen analyzer 100. To
be more specific, analysis unit 120 outputs analysis results
proportional to the number and the concentration of the target
components in specimen 101. Here, the linearity guarantee range is
a range where the analysis results match the line of
proportionality within a predetermined error range. In other words,
the linearity guarantee range may be referred to as a measurable
range for analysis unit 120. Out of the analysis items, first
determination ranges 350 are set for five measurement items, WBC,
RBC, HGB, HCT, and PLT, which are measured by detector 123.
Regarding the measurement items, when numerical information 102a
outside the numerical ranges illustrated in FIG. 52 is obtained as
analysis results 102, controller 140 prohibits the outputting of
numerical information 102a as a measurement error.
[0303] In the example of FIG. 51, even in the case of numerical
information 102a within first determination ranges 350, controller
140 performs control of prohibiting outputting when numerical
information 102a includes a predetermined abnormal value. Regarding
numerical information 102a within first determination ranges 350,
controller 140 prohibits outputting when the information is within
second determination ranges 360 indicating a predetermined error of
the specimen, and performs control of permitting outputting when
the information is outside second determination ranges 360.
[0304] First, regarding numerical information 102a within first
determination ranges 350, analysis unit 120 performs analysis based
on the numerical ranges for analysis result determination
illustrated in FIG. 53 to FIG. 55. To be more specific, first
determination ranges 350 include normal ranges (reference ranges)
371 indicating normal values, first erroneous ranges 372 wider than
corresponding normal ranges 371, and second erroneous ranges 373
wider than first erroneous ranges 372. In the embodiment, second
determination ranges 360 are set as second erroneous ranges
373.
[0305] <Normal Range>
[0306] Controller 140 outputs analysis results 102 included in
normal ranges 371 illustrated in FIG. 53 to FIG. 55. In the example
of printed sheet 300 illustrated in FIG. 50, for instance, the
value of MCH (29.8 [pg]) falls within the normal range of an adult
(see FIG. 55), and numerical information 102a is printed as it is.
If analysis results 102 are included in normal ranges 371, this
means there is no error. Thus, information 102b indicating the type
of the abnormality for the analysis items is not printed.
[0307] As illustrated in FIG. 53 to FIG. 55, first erroneous ranges
372 include ranges of low value (Low) and ranges of high value
(High). Second erroneous ranges 373 include ranges of erroneously
low value (ALERT LOW) and ranges of erroneously high value (ALERT
HIGH). To be more specific, first erroneous ranges 372 are ranges
indicating minor errors near normal ranges 371, and second
erroneous ranges 373 are ranges indicating significant errors
further deviating from first erroneous ranges 372.
[0308] <First Erroneous Range>
[0309] In the example of FIG. 51, in the initial test, controller
140 prohibits the outputting of printed sheet 300 if numerical
information 102a is included in first erroneous ranges 372. To be
more specific, if numerical information 102a is included in first
erroneous ranges 372, controller 140 does not output printed sheet
300 but causes the user to perform retest on same specimen 101
using abnormal value notification screen P156 for notifying that an
abnormal value is included. Thus, in the initial test, all analysis
results 102 are prohibited from being outputted if numerical
information 102a is included in first erroneous ranges 372.
[0310] Controller 140 causes printed sheet 300 to output analysis
results 102 obtained in retest. If initial analysis results 102
match retested analysis results 102, controller 140 causes print
unit 135 to print analysis results 102, and if initial analysis
results 102 do not match retested analysis results 102, controller
140 prohibits the printing of mismatched analysis results 102. To
be more specific, if numerical information 102a of retest is
included in first erroneous ranges 372 and if determination results
of numerical information 102a match those of the initial test,
controller 140 permits the outputting of that numerical information
102a, and outputs information indicating the type of the
abnormality. For example, if numerical information 102a of the
initial test is included in the range of "Low" and if numerical
information 102a of retest is included in the range of "Low" as
well, the controller outputs information 314 indicating a first
error where numerical information 102a is included in first
erroneous ranges 372, together with numerical information 102a.
[0311] In the example of printed sheet 300 illustrated in FIG. 50,
the value of MCV (81.6 [fL]) corresponds to a low value (see FIG.
55) of an adult, and "Low" information 314 indicating a first error
is printed together with analysis results. Note that if the
analysis result corresponds to a high value, "High" is printed as
information 314 indicating a first error.
[0312] If numerical information 102a of retest is included in first
erroneous ranges 372 and if determination results of numerical
information 102a do not match those of the initial test, controller
140 prohibits the outputting of that numerical information 102a,
and outputs information indicating the type of the abnormality. For
example, if numerical information 102a of the initial test is
included in the range of "Low" and if numerical information 102a of
retest is included in the range of "High," the controller prohibits
the outputting of numerical information 102a. In this case, as the
analysis items, information 314 indicating a first error is
printed.
[0313] <Second Erroneous Range>
[0314] In the example of FIG. 51, out of numerical information 102a
included in second erroneous ranges 373, controller 140 prohibits
the outputting of numerical information 102a within second
determination ranges 360, and permits the outputting of numerical
information 102a outside second determination ranges 360. If
numerical information 102a is included in second erroneous ranges
373, controller 140 outputs information 102b indicating the type of
the abnormality. To be more specific, as has been illustrated in
FIG. 50, controller 140 displays an indicator indicating an
erroneously high value (ALERT H) or an indicator indicating an
erroneously low value (ALERT L) as information 315 indicating a
second error where numerical information 102a is included in second
erroneous ranges 373.
[0315] Second determination ranges 360 are each a range of abnormal
value presenting the possibility of having a predetermined serious
disease. Possible predetermined serious diseases in the blood cell
counting apparatus include, for example, leukemia, aplastic anemia,
myelodysplastic syndromes, paroxysmal nocturnal hemoglobinuria,
systemic lupus erythematosus, malignant lymphoma, disseminated
intravascular coagulation, thrombotic thrombocytopenic purpura,
hypersplenism, megaloblastic anemia, sepsis, tuberculosis,
sarcoidosis, hemangioma, infectious diseases, and congenital
thrombocytopenia.
[0316] Each of second determination ranges 360 is set as at least
part of corresponding one of second erroneous ranges 373. Each of
second determination ranges 360 is set within a range satisfying
corresponding one of first determination ranges 350 and within a
range of predetermined erroneously low value.
[0317] In the example of FIG. 53 to FIG. 55, each of second
determination ranges 360 is set within a range of erroneously low
value (ALERT LOW) of corresponding one of second erroneous ranges
373 set for at least one analysis item of white blood cell count
(WBC), hemoglobin concentration (HGB), hematocrit value (HCT), and
platelet count (PLT). In FIG. 53 to FIG. 55, the range of
erroneously low value (ALERT L) of each of white blood cell count,
hemoglobin concentration, hematocrit value, and platelet count is
set as corresponding one of second determination ranges 360.
[0318] Thus, if numerical information 102a is included in a range
of erroneously low value (ALERT L), controller 140 prohibits the
outputting of numerical information 102a. If there is numerical
information 102a within second determination ranges 360, controller
140 causes output unit 130 to output information 102b indicating
the type of the abnormality. To be more specific, if numerical
information 102a is included in a range of erroneously low value
(ALERT L), controller 140 prints information 315 indicating a
second error (ALERT L) being an erroneously low value.
[0319] If numerical information 102a is included in a range of
erroneously high value (ALERT H), controller 140 permits the
outputting of numerical information 102a. If numerical information
102a is included in a range of erroneously high value (ALERT H),
controller 140 prints information 315 indicating a second error
being an erroneously high value (ALERT H).
[0320] For example, in the example of printed sheet 300 illustrated
in FIG. 50, the value of HGB (24.3 [g/dL]) corresponds to an
erroneously high value of an adult, and "ALERT H" information 315
indicating a second error is printed together with numerical
information 102a.
[0321] On the other hand, in the example of printed sheet 300
illustrated in FIG. 50, numerical information 102a is not printed
for WBC and PLT. This is because numerical information 102a of WBC
and PLT falls within second determination ranges 360 (see FIG. 55).
In the example of FIG. 50, "ALERT L" information 315 indicating a
second error is printed for the analysis items of WBC and PLT.
Thus, it is possible to know which analysis items fall within
second determination ranges 360 even though numerical information
102a is not outputted.
[0322] When excluding a predetermined abnormal value from the
content to be printed, controller 140 causes substitute indication
313 to be printed in place of the predetermined abnormal value. For
example, controller 140 substitutes numerical information 102a
within second determination ranges 360 for substitute indication
313, and causes output unit 130 to print substitute indication 313.
In the example of FIG. 50, numerical information WBC and PLT within
second determination ranges 360 is printed in the form of
substitute indication 313 "****." Note that any display embodiment
of substitute indication 313 is possible as long as it can be
distinguished from numerical information 102a. Thus, substitute
indication 313 is preferably a character other than a number, a
symbol, or a plane figure, for example. If numerical information
102a is within second determination ranges 360, controller 140
prints information 102b indicating the type of the abnormality
together with substitute indication 313.
[0323] As described above, if numerical information 102a is
included in first erroneous ranges 372 or second erroneous ranges
373, controller 140 outputs information 102b indicating the type of
the abnormality as analysis results 102. Controller 140 prohibits
the outputting of numerical information 102a within second
determination ranges 360, and permits the outputting of information
102b indicating the type of the abnormality.
[0324] On the other hand, if numerical information 102a is outside
first determination ranges 350, controller 140 substitutes
numerical information 102a outside first determination ranges 350
for substitute indication 313 and causes output unit 130 to output
substitute indication 313, and prohibits the outputting of
information 102b indicating the type of the abnormality. To be more
specific, if numerical information 102a falls within none of normal
ranges 371, first erroneous ranges 372, and second erroneous ranges
373 described above, and is outside the linearity guarantee ranges,
the numerical information is substituted for substitute indication
313 on printed sheet 300. Information 102b indicating the type of
the abnormality such as information 314 or 315 is not printed.
[0325] In the example of FIG. 50, for the analysis items outside
first determination ranges 350 and for the analysis items within
second determination ranges 360, controller 140 prints the item
names and prohibits the outputting of numerical information 102a.
When excluding a predetermined abnormal value from the content to
be printed, print unit 135 prints substitute indication 313 in
place of the predetermined abnormal value.
[0326] Note that in the example of FIG. 51, the case where the
outputting of numerical information 102a is prohibited for the
analysis items other than the measurement items includes the case
of a fractionation error of the analysis results. In the case of a
fractionation error, controller 140 prohibits the outputting of
numerical information 102a, and outputs information 102b indicating
the type of the abnormality corresponding to the type of the
fractionation error. Information 102b indicating the type of the
abnormality corresponding to the type of the fractionation error
includes "WBC," "RBC," "PLT," "WBC/PLT," and "WBC Diff". FIG. 50
illustrates an example where WBC Diff is displayed, and "WBC,"
"RBC," "PLT," and "WBC/PLT" are also displayed in the same
manner.
[0327] "WBC" is printed if the number of particles of upper
discriminator value or lower discriminator value is erroneously
high in the particle size distribution of white blood cells. The
discriminator value is a value for distinguishing the distribution
of white blood cells from noise components called ghost. "RBC" is
printed if the number of particles of upper discriminator value or
lower discriminator value is erroneously high in the particle size
distribution of red blood cells, if it is impossible to analyze red
blood cell distribution width (RDW-SD and RDW-CV), or if the
particle size distribution of red blood cells is bimodal. "PLT" is
printed if the number of particles of upper discriminator value or
lower discriminator value is erroneously high in the particle size
distribution of platelets, or if it is impossible to analyze red
blood cell distribution width (RDW-SD and RDW-CV). "WBC/PLT" is
printed if the number of particles having a predetermined value or
less is erroneously high in the particle size distribution of white
blood cells. In the particle size distribution of white blood
cells, "WBC Diff" is printed in any of the cases where it is
impossible to fractionate into small-sized white blood cells and
medium-sized white blood cells, where the discriminator value for
fractionating into small-sized white blood cells and medium-sized
white blood cells is high, where it is impossible to fractionate
into medium-sized white blood cells and large-sized white blood
cells, or where the discriminator value for fractionating into
medium-sized white blood cells and large-sized white blood cells.
In the cases of these fractionation errors, controller 140
substitutes numerical information 102a for a substitute
indication.
[0328] As illustrated in FIG. 50, for each of the analysis items,
controller 140 prohibits the outputting of numerical information
102a outside first determination ranges 350 and the outputting of
numerical information 102a within second determination ranges 360.
For this reason, in the case where numerical information 102a
outside the linearity guarantee range is obtained or "ALERT L"
numerical information 102a is obtained for any of the analysis
items, other analysis items for which printable numerical
information 102a is obtained are printed.
[0329] (Age Section)
[0330] FIG. 53 to FIG. 55 illustrate data examples of numerical
ranges for analysis result determination, for each of the age
sections. As examples of age sections, FIG. 53 illustrates an
infant at the ages of two to eleven, FIG. 54 illustrates a youth at
the ages of twelve to twenty, and FIG. 55 illustrates an adult at
the ages of twenty one or more. The number of sections may be other
than three.
[0331] In the examples of FIG. 53 to FIG. 55, out of normal ranges
371, first erroneous ranges 372, and second erroneous ranges 373,
at least normal ranges 371 differ depending on the age sections.
Controller 140 calculates the age of the subject from subject
attribute information 306, and obtains the numerical ranges of the
age section corresponding to the calculated age. Then, when
numerical information 102a is obtained for each of the analysis
items, analysis unit 120 analyzes which of normal ranges 371, first
erroneous ranges 372, and second erroneous ranges 373, and second
determination ranges 360 numerical information 102a falls within,
based on the numerical ranges of the age section to which the
subject belongs.
[0332] In addition, controller 140 prints normal ranges 371 of the
age section to which the subject belongs on printed sheet 300 as
reference value information 309. In the example of FIG. 49, it is
possible to know from subject attribute information 306 (born in
1965) that the subject is an adult at the age of twenty one or more
as of date information 303. Thus, FIG. 55 illustrates normal ranges
371 of the age section of an adult printed as reference value
information 309. Reference value information 309 is printed for
each of the analysis items. Here, in FIG. 53 to FIG. 55, the
numerical ranges of "ALERT L" second determination ranges 360 are
the same regardless of the age section. However, second
determination ranges 360 may be different for each age section.
[0333] (Predetermined Message)
[0334] Subsequently, the predetermined message printed on printed
sheet 300 is described. In the example of FIG. 49, if there is
numerical information 102a within second determination ranges 360,
controller 140 causes output unit 130 to output the predetermined
message.
[0335] If numerical information 102a is within second erroneous
ranges 373, controller 140 prints message 311 prompting further
testing. To be more specific, if there is numerical information
102a corresponding to an erroneously high value (ALERT H) or an
erroneously low value (ALERT L) within second determination ranges
360 for any of the analysis items, message 311 prompting further
testing is printed. In FIG. 49, as an example, the message
"RECOMMEND FURTHER TESTING" is printed.
[0336] Also, if numerical information 102a is within second
erroneous ranges 373, controller 140 further prints message 312
recommending immediate action. In FIG. 49, as an example, message
312 "Potential ALERT Value should be acted upon IMMEDIATELY" is
printed.
[0337] Also, numerical information 102a of all analysis items is
within normal ranges 371, controller 140 does not display message
311 and message 312. Controller 140 may display a message in
message section 308 based on display conditions for other messages.
For example, regarding numerical information 102a of three analysis
items of WBC, RBC, and HGB, if those three items are not
erroneously low values (ALERT L), but if all of those three items
are low values (Low), controller 140 prints message 311 prompting
further testing but does not print message 312.
[0338] As described above, controller 140 controls the print
content of analysis results 102. "END REPORT" printed on the end of
printed information shows the end of printed sheet 300. Note that
memory 142 of controller 140 stores data necessary to output
analysis results 102 such as first determination ranges 350 and
second determination ranges 360, information 102b indicating the
type of the abnormality, and message 311 and message 312.
[0339] (Modified Example of Second Determination Range)
[0340] FIG. 53 to FIG. 55 illustrates an example where second
determination ranges 360 are set to ranges of erroneously low value
(ALERT L) within second erroneous ranges 373. However, all of
second erroneous ranges 373 may be set to second determination
ranges 360, for example. To be more specific, second determination
ranges 360 may be set also to ranges of erroneously high value
(ALERT H), in addition to ranges of erroneously low value (ALERT
L).
[0341] FIG. 56 illustrates a printing example where both
erroneously low values (ALERT L) and an erroneously high value
(ALERT H) are set as second determination ranges 360. In the
example of FIG. 50, numerical information 102a is printed for the
HGB item corresponding to an erroneously high value (ALERT H). In
the example of FIG. 56, on the other hand, the outputting of
numerical information 102a is prohibited for the HGB item
corresponding to an erroneously high value (ALERT H), and
substitute indication 313 is printed instead of numerical
information 102a. In FIG. 56, numerical information 102a
corresponding to an item being an erroneously low value is
substituted for substitute indication 313. "ALERT L" is assigned to
an item of erroneously low value as information 315 indicating a
second error, and "ALERT H" is assigned to an item of erroneously
high value (ALERT H) as information 315 indicating a second error.
Thus, it is possible to recognize which of an erroneously low value
and erroneously high value numerical information 102a is even when
the numerical information is not printed.
[0342] (Modified Example of Printing Embodiment)
[0343] The example of FIG. 50 and the example of FIG. 56 illustrate
examples of substituting numerical information 102a falling within
second determination ranges 360 for substitute indication 313 and
printing substitute indication 313. However, the configuration may
be such that numerical information 102a falling within second
determination ranges 360 is not displayed, for example. The example
of FIG. 57 illustrates an example where numerical information 102a
falling within second determination ranges 360 is not displayed
when both erroneously low values and an erroneously high value are
set as second determination ranges 360. In FIG. 57, from the
content to be printed, controller 140 excludes numerical
information 102a falling within second determination ranges 360
together with the item names of the analysis items. Thus,
information 102b indicating the type of the abnormality is not
printed either. For this reason, in the example of FIG. 57, the
analysis items themselves of WBC, HGB, and PLT with numerical
information 102a falling within second determination ranges 360
have been excluded from result displaying section 307.
[0344] On the other hand, also in the example of FIG. 57, if there
is numerical information 102a falling within second determination
ranges 360, controller 140 causes message 311 prompting further
testing in message section 308 to be printed. In the example of
FIG. 57, message 312 recommending immediate action is also printed.
The user can recognize there is an error in analysis results 102 by
message 311 prompting further testing and message 312 recommending
immediate action even in the case where numerical information 102a
falling within second determination ranges 360 is deleted together
with the analysis items in result displaying section 307.
[0345] (Modified Example of Output Rules for Analysis Result on
Printed Sheet)
[0346] The example of FIG. 51 illustrates an example where in the
initial test, controller 140 prohibits the outputting of printed
sheet 300 if numerical information 102a is included in first
erroneous ranges 372, and causes retest to be performed. However,
printed sheet 300 may be outputted in the initial test. In the
initial test, if numerical information 102a is included in first
erroneous ranges 372, controller 140 may substitute numerical
information 102a for substitute indication 313 and output the
symbol, or remove numerical information 102a as a not-displayed
item from the print content together with the item names of the
analysis items.
[0347] FIG. 58 illustrates a modified example of output rules for
analysis results 102. In a first modification of FIG. 58,
controller 140 permits the outputting of numerical information 102a
included in normal ranges 371. Controller 140 prohibits the
outputting of numerical information 102a outside first
determination ranges 350, numerical information 102a within first
erroneous ranges 372, numerical information 102a within second
erroneous ranges 373, and numerical information 102a in the case of
a fractionation error. Controller 140 substitutes numerical
information 102a for substitute indication 313 as in FIG. 56, where
the outputting of the numerical information is prohibited. In the
first modification, controller 140 permits the outputting of
information 102b indicating the type of the abnormality, out of
analysis results 102.
[0348] In the case of a second modification of FIG. 58, controller
140 permits the outputting of numerical information 102a included
in normal ranges 371. Controller 140 prohibits the outputting of
numerical information 102a outside first determination ranges 350,
numerical information 102a within first erroneous ranges 372,
numerical information 102a within second erroneous ranges 373, and
numerical information 102a in the case of a fractionation error.
Controller 140 does not display numerical information 102a on
printed sheet 300, where the outputting of the numerical
information is prohibited. To be more specific, numerical
information 102a not within normal ranges 371 is not printed on
printed sheet 300 as in FIG. 57. In the second modification,
controller 140 also prohibits the outputting of information 102b
indicating the type of the abnormality, out of analysis results
102. Thus, in the second modification, when an analysis item having
numerical information 102a outside normal ranges 371 is obtained,
all of its item name, numerical information 102a, and information
102b indicating the type of the abnormality are removed from
printed sheet 300, and the item itself is not printed.
[0349] Additionally, the initial test and the retest are not
distinguished in the first modification and the second modification
of FIG. 58. To be more specific, in the initial test, if numerical
information 102a is included in first erroneous ranges 372, the
outputting of numerical information 102a is prohibited and printed
sheet 300 is outputted.
[0350] (Error Display of Display Unit)
[0351] Subsequently, an error display of display unit 131 is
described. If analysis results 102 include an abnormal value,
controller 140 causes print unit 135 to print information 102b
indicating the type of the abnormality as analysis results 102, and
if there is an error with the apparatus other than with analysis
results 102, the controller causes display unit 131 to display
information indicating there is an error. Analysis results 102 are
outputted collectively on printed sheet 300, and display unit 131
displays information other than on analysis results 102.
Information displayed by display unit 131 includes information on
instructions concerning the series of operations illustrated in
FIG. 7 to FIG. 48, and on an apparatus error.
[0352] To be more specific, display unit 131 displays information
indicating there is an error if there is an error with the
apparatus other than with analysis results 102. Thus, print unit
135 prints an error with analysis results 102, and display unit 131
displays an apparatus error. An apparatus error is not printed by
print unit 135, but is displayed by display unit 131.
[0353] Display unit 131 displays information indicating there is an
error for at least one of an error with analysis unit 120 and an
error with a quality control process of analysis unit 120, for
example. In analysis unit 120, when there is an error in e.g. drive
mechanism 122, fluid circuit 124, or detector 123, controller 140
causes display unit 131 to display information 381 indicating there
is an error as illustrated in FIG. 59. In addition, in the quality
control process, for example, controller 140 causes display unit
131 to display information (screen P117) indicating there is an
error illustrated in FIG. 30 when the quality control process fails
such as when an analysis result of a QC reagent exceeds a reference
range set for the QC reagent.
[0354] Note that the embodiments disclosed herein should be
considered illustrative and non-limited in all respects. The scope
of the invention is given by the scope of claims, not by the
description of the embodiments described above, and moreover
includes all modifications (modified examples) within the meaning
and the scope equivalent to the scope of claims.
* * * * *