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1. 发明授权

US09229015B2 Accuracy management method 有权
标题翻译：精准管理方法
公开(公告)号：US09229015B2
公开(公告)日：2016-01-05
申请号：US13141984
申请日：2009-11-19
申请人： Qing Li , Tomonori Mimura , Shinichi Fukuzono , Naomi Ishii
发明人： Qing Li , Tomonori Mimura , Shinichi Fukuzono , Naomi Ishii
IPC分类号： G01N35/00 , G01D18/00 , G01N35/02
CPC分类号： G01N35/00693 , G01D18/00 , G01N35/00613 , G01N35/00712 , G01N35/025 , Y10T436/10 , Y10T436/11
摘要： There is provided a comprehensive accuracy management method attained by including the steps of: displaying operation event information in time series in an accuracy management result chart or a calibration result chart on the same screen; accumulating a characteristic daily measurement value fluctuation pattern on the basis of a kind of an operation event; displaying the latest fluctuation pattern of measurement results and the daily measurement value fluctuation pattern in superposition with each other to warn of fluctuations which differ from the daily measurement value fluctuation pattern; and estimating and reporting the cause of the fluctuations.
摘要翻译：提供了一种全面的准确度管理方法，其包括以下步骤：在同一屏幕上的精度管理结果图表或校准结果图表中以时间序列显示操作事件信息; 基于操作事件的种类积累特征的日测量值波动模式; 显示测量结果的最新波动模式和每日测量值波动模式相互叠加以警告与日测量值波动模式不同的波动; 并估计和报告波动的原因。

2. 发明申请

US20120261260A1 ELECTROLYTE ANALYZER 有权
标题翻译：电解分析仪
公开(公告)号：US20120261260A1
公开(公告)日：2012-10-18
申请号：US13514187
申请日：2010-11-10
申请人： Qing Li , Tomonori Mimura , Shinichi Fukuzono
发明人： Qing Li , Tomonori Mimura , Shinichi Fukuzono
IPC分类号： G01N27/26
CPC分类号： G01N27/333
摘要： Electrolyte analyzers are used in a variety of ways, and problems vary from reagent deterioration due to reagent replenishment, mixing of foreign substances during reagent replenishment, electrode deterioration due to the passage of the validity date, to the operator's inputting errors. It is thus necessary to judge abnormalities of measured values resulting from such inappropriate usage, based on the fluctuation patterns of the results of daily electrolyte calibration.The fluctuation patterns of each measured item are extracted from the results of daily electrolyte calibration. The electromotive force balance ratio between the internal standard solution and high/low-concentration standard solutions is calculated as well as its fluctuation pattern. The obtained fluctuation patterns are compared against atypical fluctuation patterns stored in the electrolyte analyzer. When any of the extracted patterns matches any of the atypical patterns, the analyzer activates an alarm.
摘要翻译：以各种方式使用电解质分析仪，由于试剂补充，试剂补充期间的异物混合，有效期限以后的电极劣化，操作者的输入错误，试剂劣化的问题变化。因此，基于每日电解质校准的结果的波动模式，需要判断由这种不当使用引起的测量值的异常。从日常电解质校准的结果中提取每个测量项目的波动模式。计算内标溶液与高/低浓度标准溶液之间的电动势平衡比及其波动模式。将获得的波动模式与存储在电解质分析仪中的非典型波动模式进行比较。当任何提取的图案与任何非典型图案匹配时，分析仪启动报警。

3. 发明授权

US08871080B2 Management system for an electrolyte analyzer 有权
标题翻译：电解质分析仪管理系统
公开(公告)号：US08871080B2
公开(公告)日：2014-10-28
申请号：US13514187
申请日：2010-11-10
申请人： Qing Li , Tomonori Mimura , Shinichi Fukuzono
发明人： Qing Li , Tomonori Mimura , Shinichi Fukuzono
IPC分类号： G01N27/333
CPC分类号： G01N27/333
摘要： Electrolyte analyzers are used in a variety of ways, and problems vary from reagent deterioration due to reagent replenishment, mixing of foreign substances during reagent replenishment, electrode deterioration due to the passage of the validity date, to the operator's inputting errors. It is thus necessary to judge abnormalities of measured values resulting from such inappropriate usage, based on the fluctuation patterns of the results of daily electrolyte calibration. The fluctuation patterns of each measured item are extracted from the results of daily electrolyte calibration. The electromotive force balance ratio between the internal standard solution and high/low-concentration standard solutions is calculated as well as its fluctuation pattern. The obtained fluctuation patterns are compared against atypical fluctuation patterns stored in the electrolyte analyzer. When any of the extracted patterns matches any of the atypical patterns, the analyzer activates an alarm.
摘要翻译：以各种方式使用电解质分析仪，由于试剂补充，试剂补充期间的异物混合，有效期限以后的电极劣化，操作者的输入错误，试剂劣化的问题变化。因此，基于每日电解质校准的结果的波动模式，需要判断由这种不当使用引起的测量值的异常。从日常电解质校准的结果中提取每个测量项目的波动模式。计算内标溶液与高/低浓度标准溶液之间的电动势平衡比及其波动模式。将获得的波动模式与存储在电解质分析仪中的非典型波动模式进行比较。当任何提取的图案与任何非典型图案匹配时，分析仪启动报警。

4. 发明申请

US20120000268A1 ACCURACY MANAGEMENT METHOD 有权
标题翻译：准确管理方法
公开(公告)号：US20120000268A1
公开(公告)日：2012-01-05
申请号：US13141984
申请日：2009-11-19
申请人： Qing Li , Tomonori Mimura , Shinichi Fukuzono , Naomi Ishii
发明人： Qing Li , Tomonori Mimura , Shinichi Fukuzono , Naomi Ishii
IPC分类号： G01D18/00
CPC分类号： G01N35/00693 , G01D18/00 , G01N35/00613 , G01N35/00712 , G01N35/025 , Y10T436/10 , Y10T436/11
摘要： It is convenient and useful in inspection work to assess a fluctuation pattern of accuracy management results based on operation events occurring in a clinical laboratory and detect an abnormal fluctuation pattern before a control range is exceeded. However, an accuracy management system having such a function is not provided. When the cause of fluctuations in accuracy management results or calibration results is to be estimated, one depends on a variety of related information and one's specialized knowledge and experience. Much time and efforts are required to sort out useful pieces of information from useless ones and obtain organized information.There is provided a comprehensive accuracy management method attained by including the steps of: displaying operation event information in time series in an accuracy management result chart or a calibration result chart on the same screen; accumulating a characteristic daily measurement value fluctuation pattern on the basis of a kind of an operation event; displaying the latest fluctuation pattern of measurement results and the daily measurement value fluctuation pattern in superposition with each other to warn of fluctuations which differ from the daily measurement value fluctuation pattern; and estimating and reporting the cause of the fluctuations.
摘要翻译：在检验工作中，根据临床实验室发生的手术事件评估精度管理结果的波动模式，检测出超出控制范围之前的异常波动模式，方便实用。然而，没有提供具有这种功能的精度管理系统。当准确管理结果波动的原因或校准结果被估计时，一个取决于各种相关信息和专业知识和经验。需要大量时间和精力从无用的信息中整理出有用的信息，并获得有组织的信息。提供了一种全面的准确度管理方法，其包括以下步骤：在同一屏幕上的精度管理结果图表或校准结果图表中以时间序列显示操作事件信息; 基于操作事件的种类积累特征的日测量值波动模式; 显示测量结果的最新波动模式和每日测量值波动模式相互叠加以警告与日测量值波动模式不同的波动; 并估计和报告波动的原因。

5. 发明授权

US08150645B2 Automatic analzyer 有权
标题翻译：自动分析仪
公开(公告)号：US08150645B2
公开(公告)日：2012-04-03
申请号：US12362818
申请日：2009-01-30
申请人： Kumiko Kamihara , Tomonori Mimura , Shinichi Fukuzono
发明人： Kumiko Kamihara , Tomonori Mimura , Shinichi Fukuzono
IPC分类号： G06F17/18
CPC分类号： G01N35/00663 , Y10T436/101666
摘要： Measurement of the uncertainty used for quality control typically involves a plurality of factors. When the uncertainty exceeds a clinical permissible value, time is required for a medical technologist to investigate and to determine the factor causing the uncertainty. It is thus beneficial to automatically investigate factors in complicated uncertainty, particularly from the view point of reagents and samples which are subject to quality change and that are prone to affect the measurement quality. Quality control samples having a plurality of concentration levels are measured to calculate the average, coefficient of variation, standard deviation, and other numerical values. When quality control samples having n (n≧2) different concentration levels are measured, variation patterns determine the factor causing the uncertainty, the factor being specific to each of 3n different combinations of variation patterns.
摘要翻译：用于质量控制的不确定度的测量通常涉及多个因素。当不确定性超过临床允许值时，医疗技术人员需要时间调查并确定导致不确定性的因素。因此，自动调查复杂不确定因素的因素是有益的，特别是从质量变化的试剂和样品的角度出发，容易影响测量质量。测量具有多个浓度水平的质量控制样品以计算平均值，变异系数，标准偏差和其它数值。当测量具有n（n≥2）不同浓度水平的质量控制样品时，变化模式确定导致不确定性的因素，该因子特异于3n个不同组合的变化模式。

6. 发明授权

US10203277B2 Automatic analysis device and automatic analysis method 有权
公开(公告)号：US10203277B2
公开(公告)日：2019-02-12
申请号：US13641881
申请日：2011-04-05
申请人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
发明人： Chihiro Manri , Satoshi Mitsuyama , Tomonori Mimura , Kumiko Kamihara
IPC分类号： G01N21/27 , G01N35/00 , G01N21/78
摘要： There is provided a technique for automatically determining or predicting a line range specific to a sample that appears in a reaction curve in an automated analyzer for mixing a specimen and a reagent and measuring a change in a mixture of the specimen and the reagent with time. This invention approximates reaction curve data by a function and automatically determines a curve part at an early stage or a second stage of a reaction. The invention determines a line range not including a curve part for each sample and calculates a laboratory test value using absorbance data within the determined line range. This invention also automatically determines a start time of line at the early stage of the reaction on the basis of absorbance data obtained up to a point halfway through the reaction curve, predicts a line range on the basis of the end time of line and a planned end time of line, and calculates a predictive value on the basis of a result of the prediction.

7. 发明授权

US09664678B2 Automated analyzer and analyzing method 有权
公开(公告)号：US09664678B2
公开(公告)日：2017-05-30
申请号：US14238060
申请日：2012-09-03
申请人： Takeshi Yogi , Sakuichiro Adachi , Tomonori Mimura , Hajime Yamazaki
发明人： Takeshi Yogi , Sakuichiro Adachi , Tomonori Mimura , Hajime Yamazaki
IPC分类号： G01N21/51 , G01N33/543 , G01N21/82 , G01N35/02 , G01N21/47 , G01N35/04
CPC分类号： G01N33/54366 , G01N21/47 , G01N21/51 , G01N21/82 , G01N33/54313 , G01N35/025 , G01N2021/825 , G01N2035/0441 , G01N2035/0443 , G01N2035/0444 , G01N2800/24
摘要： An analyzer provides conditions suitable for a reagent for performing latex immunoassay with a high sensitivity using a method of measuring scattered light. Irradiation light having a wavelength in the range of 0.65 to 0.75 μm is used, and scattered light generated from a reaction solution is received at a light-receiving angle of 15° to 35° with respect to the irradiation direction during the rotational movement of the reaction container. The reagent contains latex particles the average peak particle diameter of which ranges from 0.3 μm to 0.43 μm and to which antibodies are sensitized. The reaction solution contains latex particles at a concentration at which the absorbance to irradiation light having a wavelength of 0.7 μm is 0.25 abs to 1.10 abs, and a change in the amount of scattered light caused by the aggregation of the latex particles through antigens in a sample is measured and quantified.

8. 发明授权

US09645160B2 Automatic analysis device 有权
公开(公告)号：US09645160B2
公开(公告)日：2017-05-09
申请号：US14116177
申请日：2012-05-09
申请人： Sakuichiro Adachi , Tomonori Mimura , Hajime Yamazaki , Masaki Shiba
发明人： Sakuichiro Adachi , Tomonori Mimura , Hajime Yamazaki , Masaki Shiba
IPC分类号： G01N35/02 , G01N21/51 , G01N21/82 , G01N21/47 , G01N35/04
CPC分类号： G01N35/025 , G01N21/51 , G01N21/82 , G01N2021/4711 , G01N2035/0453
摘要： The automatic analysis device measures time sequential data on a scattered light amount as reaction process data, and quantitatively determines the concentration of an analyte from a change in light amount. The automatic analysis device has a function of selecting reaction process data to be used for quantitative determination from the reaction process data obtained by measurement using a plurality of light receivers at different angles. As a result of using this function, data is selected from the reaction process data obtained by measurement using the plurality of light receivers at different angles in accordance with the concentration of the analyte and whether the priority is given to high sensitivity in the case where sensitivity is prioritized or a dynamic range, and the result of the quantitative determination is displayed.

9. 发明授权

US09395298B2 Blood coagulation analyzer 有权
标题翻译：凝血分析仪
公开(公告)号：US09395298B2
公开(公告)日：2016-07-19
申请号：US13509661
申请日：2010-11-19
申请人： Akihisa Makino , Tomonori Mimura , Terumi Tamura , Sakuichiro Adachi
发明人： Akihisa Makino , Tomonori Mimura , Terumi Tamura , Sakuichiro Adachi
IPC分类号： G01N33/50 , G01N21/00 , G01N21/51 , G01N33/49 , G01N33/86 , G01N21/53 , G01N21/82 , G01N33/18
CPC分类号： G01N21/51 , G01N21/532 , G01N21/82 , G01N33/18 , G01N33/1826 , G01N33/4905 , G01N33/86 , G01N2021/4711 , G01N2021/825
摘要： A blood coagulation analyzer that realizes both securement of a wide dynamic range and enhancement of sensitivity in blood coagulation analysis by selecting an appropriate angle of detection depending on the intensity of scattered light from each specimen without causing complexity of the analyzer. The analyzer has a reaction container. A storage unit is provided which takes in and stores multiple pieces of chronological light intensity variation data acquired from detectors arranged around a reaction container. A judgment unit selects light intensity variation data to be used for calculation of a blood coagulation time from the multiple pieces of light intensity variation data stored in the storage unit based on the amount of light intensity variation. A calculation unit calculates the blood coagulation time from the light intensity variation data selected by the judgment unit.
摘要翻译：一种血液凝固分析仪，其通过根据来自每个样本的散射光的强度选择适当的检测角度，而不会导致分析仪的复杂性，实现了动态范围的确定和凝固分析中的灵敏度的提高。分析仪具有反应容器。提供一种存储单元，其存储并存储从设置在反应容器周围的检测器获取的多个按时间顺序的光强度变化数据。判断单元基于光强度变化量从存储在存储单元中的多个光强度变化数据中选择要用于计算凝血时间的光强度变化数据。计算单元根据由判断单元选择的光强度变化数据计算凝血时间。

10. 发明申请

US20120141330A1 AUTOMATIC ANALYZER 有权
标题翻译：自动分析仪
公开(公告)号：US20120141330A1
公开(公告)日：2012-06-07
申请号：US13382316
申请日：2010-07-05
申请人： Sakuichiro Adachi , Muneo Maeshima , Isao Yamazaki , Tomonori Mimura
发明人： Sakuichiro Adachi , Muneo Maeshima , Isao Yamazaki , Tomonori Mimura
IPC分类号： G01N21/00
CPC分类号： G01N21/51 , G01N15/0205 , G01N21/253 , G01N2015/0065 , G01N2035/00396 , G01N2035/0453
摘要： To be adapted to various types of latex reagents for detecting scattered light and thereby measuring agglutination reactions with high sensitivity while sufficiently ensuring integration time. To be adapted to various types of latex particles of different particle sizes, a plurality of light receivers are arranged in a plane perpendicular to the direction of cell movement by rotation of a cell disk. To ensure sufficient integration time, the angle between the optical axis of the irradiation light and each of a plurality of optical axes of scattered light viewed from above the cell is made equal to or less than 17.7° including a mounting error.
摘要翻译：适用于各种类型的用于检测散射光的乳胶试剂，从而以高灵敏度测量凝集反应，同时充分确保积分时间。为了适应于各种类型的不同粒度的胶乳颗粒，多个光接收器通过旋转细胞盘而布置在垂直于细胞移动方向的平面中。为了确保足够的积分时间，使得照射光的光轴与从电池单元的上方观察的散射光的多个光轴中的每一个之间的角度等于或小于包括安装误差的17.7°。

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