CN111610320A

CN111610320A - Blood testing system and method

Info

Publication number: CN111610320A
Application number: CN202010446355.9A
Authority: CN
Inventors: 凯文·贝尔斯; 克里斯蒂安·布兰特尔; 约翰内斯·维特曼
Original assignee: CA Casyso AG
Current assignee: CA Casyso AG
Priority date: 2015-06-29
Filing date: 2016-06-28
Publication date: 2020-09-01
Also published as: AU2016286647A1; WO2017002018A1; CA3085118A1; CA2990573A1; AU2020200814B2; CN107810412B; CA3085118C; AU2020200814A1; AU2016286647B2; CN107810412A; CA2990573C

Abstract

The present invention discloses a console for measuring coagulation properties of a blood sample, the console comprising: a control unit housing; a user interface connected to the control unit housing; and a plurality of individual thromboelastometry measurement modules housed in the control unit housing, each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprising a shaft configured to receive a probe for testing a blood sample using the probe cup device, wherein each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprises a dedicated actuation unit configured to provide linear translation of the sliding unit, and the actuation unit independently drives a respective shaft of each individual thromboelastometry measurement module to rotate relative to rotation of the shafts of all other individual thromboelastometry measurement modules of the plurality of individual thromboelastometry measurement modules.

Description

Blood testing system and method

The present application is a divisional application of the invention patent application with application number 201680038253.5 filed on 28.12.2017 under the name of "blood testing system and method".

Cross Reference to Related Applications

This application claims priority from U.S. application No.14/754,300 filed on day 29 of year 2015, European application No.15174565.0 filed on day 30 of month 2015, and Japanese application No.2015-132034 filed on day 30 of month 2015. The disclosures of these prior applications are considered to be part of the disclosure of the present application and are incorporated herein by reference.

Technical Field

This document relates to systems and methods for testing characteristics of blood samples, such as automated thromboelastometry systems for point-of-care whole blood coagulation analysis.

Background

Hemostasis is the reaction of the human body to vascular injury and bleeding. Hemostasis involves a synergistic interaction between platelets and many coagulation proteins (or factors), resulting in the formation of a blood clot and the subsequent cessation of bleeding.

Various methods have been introduced to assess the potential of blood to form an appropriate blood clot and to determine the stability of the blood clot. Common laboratory tests such as platelet count or fibrin concentration determinations provide information as to whether the component being tested is in sufficient quantity, but some of these tests may not be able to determine whether the component being tested is functioning properly under physiological conditions. Other laboratory tests are performed on plasma, which may require additional preparation steps and additional time, e.g., beyond the preferred time in the point of care (e.g., the surgical operating room during surgery).

Another set of tests to assess the potential of blood to form an appropriate blood clot is known as the "viscoelastic approach". In at least some viscoelastic approaches, clot firmness (or other parameters dependent thereon) is determined over a period of time, for example, from formation of the first fibrin fiber until the clot is dissolved by fibrin. Clot firmness is a functional parameter that contributes to hemostasis in vivo, as the clot must resist blood pressure and shear stress at the site of a vascular injury or incision. In many cases, clot firmness may be caused by a variety of interrelated processes, including coagulation activation, thrombin formation, fibrin formation and polymerization, platelet activation, and fibrin-platelet interactions. To isolate and test specific functions of platelets, fibrinogen, and other factors in a blood sample, reagent compounds may be mixed with the blood sample to activate or inhibit certain components of the blood sample.

Disclosure of Invention

Some embodiments of a system for testing a characteristic of a blood sample (which should be understood herein to include blood or a derivative of blood such as plasma) include a console configured to test the blood sample to provide point-of-care whole blood coagulation analysis. For example, the system may be used as an automated thromboelastometry system to provide detailed and rapid results of blood coagulation characteristics in response to receiving one or more samples of blood that have been mixed with various types of reagents.

In some embodiments, the thromboelastometry analysis system includes a reusable analyzer console and one or more disposable components configured to mate with the console. In one example, to operate the thromboelastometry analysis system, a user interface of the analyzer console prompts a user to initiate a plurality of blood and reagent transfer and mixing operations. The analyzer console then automatically performs the test (without further user interaction with the analyzer console or the blood sample) and displays the results on a graphical display using the qualitative graphical representation and the quantitative parameters. Such analysis provides information about the overall kinetics of hemostasis, such as clotting time, clot formation, clot stability and lysis; further, such information can be quickly output from the user interface of the system to provide reliable and quick results indicative of blood characteristics at the point of care (e.g., when the patient is performing an operation in the operating room).

In one embodiment, a console for measuring coagulation characteristics of a blood sample includes: (i) a control unit housing, (ii) a user interface coupled with the control unit housing for displaying coagulation characteristics of the blood sample, and (iii) a plurality of individual thromboelastometry measurement modules housed in the control unit housing. Each of the plurality of individual thromboelastometry measurement modules includes a shaft configured to receive a probe for testing the blood sample using the probe cup. Each individual measurement module of the plurality of individual thromboelastometry measurement modules comprises a dedicated actuation unit that drives rotation of a respective shaft of the individual measurement module independently of rotation of the shafts of all other individual measurement modules of the plurality of individual thromboelastometry measurement modules.

Such a console for measuring coagulation properties of a blood sample may optionally include one or more of the following features. In some embodiments, the actuation unit comprises a stepper motor. The stepper motor may optionally include a threaded drive shaft. In various embodiments, the actuation unit further comprises a sliding unit. The slide unit may have a threaded collar that is threadably engaged with a threaded drive shaft of the motor such that the motor may drive the slide unit to translate (move) linearly. In a particular embodiment, the actuation unit further comprises a spring wire. In some such embodiments, linear translation of the slide unit may cause pivoting of the shaft due to a spring wire extending between the slide unit and the shaft.

In various embodiments of the console for measuring coagulation properties of a blood sample, the actuation unit further comprises a magnet attracting the spring wire to the sliding unit. The spring wire may be magnetically attracted to the curved surface of the sliding unit. Alternatively, the actuating unit may include a sensor configured to detect the position of the sliding unit. In some embodiments, the sensor comprises a hall effect sensor. In various embodiments, the actuation unit may include one or more end-of-travel sensors configured to detect the travel limits of the slide unit. The console may also include one or more vibration sensors housed in the control unit housing. In some embodiments, each individual measurement module of the plurality of individual thromboelastometry measurement modules comprises one or more vibration sensors.

In a particular embodiment of the console for measuring coagulation properties of a blood sample, each individual measurement module of the plurality of individual thromboelastometry measurement modules comprises an evaluation unit for evaluating a charge-coupled device (CCD) component. In some embodiments, the evaluation unit may be configured to: (i) receiving the luminance distribution data from the CCD, (ii) generating CCD calibration data based on the luminance distribution data, and (iii) comparing the CCD calibration data with the CCD luminance distribution data measured in real time. In some embodiments, each individual measurement module of the plurality of individual thromboelastometry measurement modules may further comprise a heater configured to heat the cup of the probe cup device.

In another embodiment, a method for evaluating a CCD component of a thromboelastometry analysis system is performed by one or more processors of the thromboelastometry analysis system, or by one or more processors of a single AD module. The method includes receiving brightness distribution data from the CCD, generating CCD calibration data (where the CCD calibration data is generated based on the brightness distribution data from the CCD), and comparing (while the thromboelastometry analysis system is performing thromboelastometry analysis) the CCD calibration data with the CCD brightness distribution data measured in real time. In some embodiments, the luminance distribution data from the CCD represents individual luminance data from a plurality of individual pixels of the CCD.

Such methods performed by one or more processors of the thromboelastometry analysis system or one or more processors of a single AD module for assessing a CCD component of the thromboelastometry analysis system may optionally include one or more of the following features. In some embodiments, the method further comprises determining the position of a falling edge or a rising edge of the luminance distribution data from the CCD.

In another embodiment, a method of controlling accuracy of a thromboelastometry analysis system is performed by one or more processors of the thromboelastometry analysis system or by one or more processors of a single AD module. The method includes receiving vibration data indicative of a detected vibration level of the thromboelastometry analysis system, comparing the received vibration data to a threshold limit value, and generating a vibration error indication in response to the received vibration data being greater than the threshold limit value.

Such a method of controlling the accuracy of a thromboelastometry analysis system may optionally include one or more of the following features. In some embodiments, the method further comprises receiving, at the one or more processors of the thromboelastometry analysis system, position indication data indicative of a detected position of the slide unit relative to an actuation unit of the thromboelastometry analysis system. In certain embodiments, the method further comprises comparing, by the one or more processors of the thromboelastometry analysis system, the received position indication data to one or more threshold limit values. In various embodiments, the method further comprises: in response to the received position indicative data being greater than the one or more threshold limits, generating, by the one or more processors of the thromboelastometry analysis system and based on a comparison of the received position indicative data to the one or more threshold limits, a position error indication.

In another embodiment, a method of controlling accuracy of a thromboelastometry analysis system is performed by one or more processors of the thromboelastometry analysis system or by one or more processors of a single AD module. The method includes receiving position indicating data indicative of a detected position of the slide unit relative to an actuation unit of the thromboelastometry analysis system, comparing the received position indicating data to one or more threshold limit values, and generating a position error indication (based on the comparison of the received position indicating data to the one or more threshold limit values) in response to the received position indicating data being greater than the one or more threshold limit values.

Such a method of controlling the accuracy of a thromboelastometry analysis system may optionally include one or more of the following features. In some embodiments, the position indicating data includes one or more signals from one or more end-of-travel sensors that indicate whether the slide unit is located at the target end-of-travel position. In certain embodiments, the position indicating data includes one or more signals from one or more sensors that indicate a real-time position of the sliding unit as the sliding unit translates back and forth linearly along a linear path.

Some or all of the embodiments described herein may provide one or more of the following advantages. First, some embodiments of the thromboelastometry analysis systems described herein are configured with separate modules or independent actuation units of channels for multiple testing and measurement channels. For example, in some embodiments, the thromboelastometry analysis system includes four modules or channels, each having a separate actuation unit. Thus, the actuation of each test and measurement module may be controlled independently of the other test and measurement modules. In addition, the use of a separate actuation unit for each of the plurality of test and measurement modules provides a modular design, which in some cases provides advantages for the maintenance performance of the system.

Second, the actuation unit of some embodiments of the thromboelastometry system uses a position-controllable rotary actuator (e.g., a stepper motor coupled to a programmable stepper motor control system, or another type of suitable rotary actuator with encoder feedback coupled to a control system). The use of a position controllable actuator (e.g. an electric motor) advantageously allows for a programmable actuation pattern. Additionally, in some embodiments, the stepper motor allows for greater accuracy in actuation of the rotary thromboelastometry system as compared to some other types of motors. Further, in some embodiments, the stepper motor provides enhanced isolation from some external error effects, such as vibration.

Third, some embodiments of the thromboelastometry system are configured with firmware for self-evaluation and calibration of the CCD (Charge coupled device) portion of the thromboelastometry testing system. Accordingly, measurement inaccuracies may be reduced or eliminated in some cases. In some such embodiments, the function of each individual pixel of the CCD is verified prior to the thromboelastometry testing procedure. As a result, the consistency of performance of the thromboelastometry system is enhanced.

Fourth, some embodiments of the thromboelastometry system are configured with additional firmware for managing and evaluating functional aspects of the rotary thromboelastometry actuation and detection system. For example, in some embodiments, vibrations that may distort the measurement signal are detected and used to manage the thromboelastometry system. Further, in some embodiments, sensors are included that detect the movement and end-of-stroke position of the rotary thromboelastometry drive system. These systems for monitoring and evaluating functional aspects of the rotary thromboelastometry actuation and detection system provide a robust measurement system and help improve measurement quality (e.g., improve quality accuracy and/or precision of thromboelastometry measurements).

The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.

Drawings

Fig. 1 is a perspective view of an exemplary thromboelastometry system, according to some embodiments.

Fig. 2 is an example of a graph quantifying the firmness of a blood clot during clot formation as calculated and displayed by the thromboelastometry analysis system of fig. 1.

FIG. 3 is a schematic diagram depicting portions of an exemplary rotary thromboelastometry detection system of the thromboelastometry system of FIG. 1.

Fig. 4 is a perspective view of an exemplary actuation and detection module (also referred to herein as an "AD module" or "ADM") for an individual thromboelastometry measurement channel of the thromboelastometry analysis system of fig. 1.

Fig. 5 is a perspective exploded view of the exemplary AD module of fig. 4.

Fig. 6 is a perspective exploded view of an actuation unit of the exemplary AD module of fig. 4.

Fig. 7 is a perspective exploded view of a sliding portion of the actuation unit of fig. 6.

FIG. 8 is a flow chart of an exemplary CCD evaluation process that may be used in conjunction with the thromboelastometry analysis system of FIG. 1.

FIG. 9 is a flow chart of another CCD evaluation process that may be used in conjunction with the thromboelastometry analysis system of FIG. 1.

FIG. 10 is a flow chart of a thromboelastometry measurement quality control process that may be used in conjunction with the thromboelastometry analysis system of FIG. 1.

FIG. 11 is a flow chart of another thromboelastometry measurement quality control process that may be used in conjunction with the thromboelastometry analysis system of FIG. 1.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

Referring to fig. 1, some embodiments of an exemplary blood testing system 100 include a blood analyzer console 110 and a graphical user interface 120 connected to the analyzer console 110. In the depicted embodiment, the blood testing system 100 is a thromboelastometry system configured to determine some blood coagulation characteristics of a blood sample. An example of such a thromboelastometry system 100 is available from Tem International GmbH, headquarters in munich, germany

delta thromboelastometry system. Thromboelastometry and thromboelastography are based on blood elasticity measurements by continuous graphic recording of the hardness of blood clots during their formation (e.g. in relation to coagulation factors and inhibitors, platelets and fibrin) and subsequently during fibrinolysis.

The exemplary thromboelastometry analysis system 100 performs blood diagnostics ex vivo, and is particularly advantageous in point of care (e.g., a surgical operating room when a patient is undergoing or is ready to undergo surgery, etc.). In addition, the thromboelastometry analysis system 100 may be used as a whole blood coagulation analysis system in a laboratory environment. The thromboelastometry analysis system 100 provides a quantitative and qualitative indication of the coagulation status of a blood sample.

In some embodiments, the graphical presentation displayed on the graphical user interface 120 reflects various blood diagnostic results (e.g., one or more graphs, such as sometimes referred to as temograms, numerical data or measurements, or combinations thereof) that may describe the interaction between components such as coagulation factors and inhibitors, fibrinogen, platelets, and the like, and the fibrinolytic system. For example, referring also to fig. 2, in some embodiments, the graphical user interface 120 provides a continuous graphical record of the hardness of a blood clot during clot formation as a graphical representation 200. Fig. 2 is an example of a graph 200 that quantifies the hardness of a blood clot during formation of the blood clot, such as calculated and displayed by the thromboelastometry analysis system 100 in the course of performing an analysis. In some embodiments, a plurality of such graphical representations 200 relating to the firmness of a blood clot during its formation are displayed simultaneously on the graphical user interface 120.

With continued reference to fig. 1, in some embodiments, the analyzer console 110 houses hardware devices and subsystems that control the operation of the thromboelastometry analysis system 100. For example, the analyzer console 110 houses one or more processors and storage devices that may store an operating system and other executable instructions. In some embodiments, the executable instructions are configured to, when executed by the one or more processors, cause the system 100 to perform operations, such as analyzing blood test result data indicative of blood coagulation characteristics, and outputting via the user interface 120.

In some embodiments, analyzer console 110 also houses various internal subsystems, including various electrical connection receptacles (not shown), and includes a cartridge port (not shown). The various electrical connection receptacles may include network and device connectors such as, but not limited to, one or more USB ports, ethernet ports (e.g., RJ45), VGA connectors, Sub-D9 connectors (RS232), and the like. Such connection receptacles may be located at the rear of the analyzer console 110, or at other convenient locations on the analyzer console 110. For example, in some embodiments, one or more USB ports may be located in front of or near the front of the analyzer console 110. Such a positioned USB port may provide a user with convenience for, for example, recording data onto a memory stick. In some embodiments, the thromboelastometry analysis system 100 is configured to operate using a wireless communication modality (such as, but not limited to, Wi-Fi, bluetooth, NFC, RF, IR, etc.).

Still referring to fig. 1, in some embodiments, the graphical user interface 120 is also used to communicate graphical and/or textual user instructions to assist a user in preparing a blood sample for testing by the thrombelastometry system 100. Optionally, a graphical user interface 120 is coupled to the analyzer console 110 and is a touch screen display whereby a user can, for example, enter information and make menu item selections. In some embodiments, the graphical user interface 120 is rigidly connected to the analyzer console 110. In particular embodiments, the graphical user interface 120 is pivotable and/or otherwise positionally adjustable or removable relative to the analyzer console 110.

The blood testing system 100 may also include a keyboard 130 and/or other types of user input devices, such as a mouse, touchpad, trackball, or the like. In some embodiments, the thromboelastometry system 100 further comprises an external barcode reader. Such an external barcode reader may facilitate convenient one-dimensional or two-dimensional barcode entry of data (such as, but not limited to, blood sample data, user identification, patient identification, normal values, etc.). Alternatively or additionally, the thromboelastometry analysis system 100 may be equipped with a reader configured to read near field communication tags, RFID tags, or the like. In some embodiments, a computer data network (e.g., intranet, internet, LAN, etc.) may be used to allow a remote device to receive and/or input information from the thromboelastometry analysis system 100.

The depicted thromboelastometry system 100 also includes an electronic system pipette 160. Using the system pipette 160, a user can conveniently dispense a volumetric amount of a measurement liquid (e.g., blood or a reagent) during preparation of a blood sample prior to testing. In some embodiments, the system pipette 160 is a semi-automatic software controlled device. For example, in some embodiments, the system pipette 160 automatically extracts a target amount of liquid from one container and the user can then dispense the target amount of liquid into another container.

In some embodiments, operation of the blood testing system 100 includes the use of one or more reagents 170 that are mixed with the blood sample prior to performing the thromboelastometry assay. For example, the reagent 170 may comprise a compound, such as, but not limited to, CaCl₂Ellagic acid/phospholipids, tissue factor, heparinase, polybrene, cytochalasin D, tranexamic acid, and the like, and combinations thereof. In some embodiments, the thromboelastometry analysis system 100 will provide user instructions (e.g., via the graphical user interface 120) to mix a particular reagent 170 with the blood sample using the system pipette 160.

The thromboelastometry analyzer console 110 also includes one or more individual thromboelastometry measurement stations 180 (which may also be referred to herein as "channels" or "measurement modules"). The depicted embodiment of the thromboelastometry system 100 includes four separate thromboelastometry measurement stations 180 (i.e., four channels or four measurement modules).

As described further below, each thromboelastometry measurement station 180 includes a cup holder in which a user places a sample cup containing blood and reagents in preparation for performing a thromboelastometry test. In some embodiments, the cup holder is equipped with a heating system so that the sample can be heated to and maintained at about body temperature (e.g., 37+/-1.0 ℃).

As described further below, in some embodiments, each thromboelastometry measurement station 180 includes a probe or sonde that may be removably positioned within a cup containing a sample to be tested. There is a gap between the probe and the cup. In some embodiments, the shaft and detector oscillate or otherwise rotate back and forth at an angle of less than about 10 ° (in both rotational directions), preferably about 3 ° to about 6 ° (in both rotational directions). In some embodiments, the amplitude of such oscillations of the shaft and detector may be equal in both rotational directions. The measurement oscillations and the blood/reagent mixture starts to become stronger due to thrombolysis, so the oscillations are reduced. The measurement of such oscillations by the thromboelastometry measurement station 180 over a period of time thus produces thromboelastometry results.

Referring also to fig. 3, an exemplary rotary thromboelastometry actuation and detection system 300 that may be present in each thromboelastometry measurement station 180 (measurement module) is schematically depicted. In some embodiments, the shaft 310 of the actuation and detection system 300 may be engaged with the disposable probe 138 to perform rotational thromboelastometry on a blood sample contained in the disposable cup 136. In fig. 3, the probe 138 and cup 136 are shown in longitudinal cross-section to allow for better visualization and understanding of the entire rotary thromboelastometry actuation and detection system 300. In some embodiments, the probe 138 has an outer diameter of about 6mm and the cup 136 has an inner diameter of about 8 mm. However, the cup 136 and the probe 138 may be sized larger or smaller as appropriate.

In this particular embodiment, the schematically depicted exemplary rotary thromboelastometry actuation and detection system 300 includes a base plate 302, a shaft 310, a bearing 312, a mirror 314, a reaction force spring wire 320, a light source 330, and a detector 340 (e.g., a Charge Coupled Device (CCD), etc.). As indicated by arrow 318, the disposable cup 136 can be lifted (e.g., by a user) such that the end portion of the shaft 310 enters the aperture 139 of the probe 138, thereby becoming releasably coupled with the probe 138. Bearings 312 engage base plate 302 and shaft 310 to facilitate rotational movement of shaft 310 relative to base plate 302. Spring wire 320 is coupled to shaft 310 and the resulting movement of spring wire 320 (driven by a motor described further below) may cause shaft 310 to oscillate back and forth as indicated by arrow 316 by less than 10 ° (in both rotational directions), and preferably about 3 ° to about 6 ° (in both rotational directions). Mirror 314 is coupled to shaft 310. Light source 330 is configured to project light toward mirror 314, and the light may be reflected from mirror 314 toward detector 340 (in a direction that depends on the rotational orientation of shaft 310). Thus, the motion of the detector 138 is detected by an optical detection system (e.g., detector 340). It should be understood that other configurations of the rotary thromboelastometry actuation and detection system 300 are also contemplated as falling within the scope of the present disclosure.

As the blood in the cup 136 begins to clot, the amplitude of the motion of the shaft 310 begins to decrease (as detected by the reflection of the light beam from the mirror 314 toward the detector 340). During coagulation, the fibrin backbone of the blood (along with the platelets) creates a mechanically elastic connection between the surface of the cup 136 and the detector 138. The continued coagulation process induced by the addition of one or more of the aforementioned activating factors (e.g., agents) can thus be observed and quantified.

The motion data detected from the detector 340 is analyzed by an algorithm running on the analyzer console 110 to process and determine thromboelastometry analysis results. The system facilitates various thromboelastometry parameters such as, but not limited to, clotting time, clot formation time, alpha angle, amplitude, maximum clot firmness, lysis onset time, lysis index (%) and maximum lysis (%). In this way, various deficiencies of the hemostatic state of the patient may be revealed and interpreted as appropriate medical interventions. At the end of the testing process, the cup 136 may be lowered to separate the shaft 310 from the probe 138.

Still referring to fig. 1, the analyzer console 110 may house one or more rotary thromboelastometry actuation and detection modules (AD modules) 400 corresponding to (e.g., one-to-one with) one or more individual thromboelastometry measurement stations 180. Such a rotary thromboelastometry AD module 400 may operate, for example, like the exemplary rotary thromboelastometry actuation and detection system 300 described above with reference to fig. 3.

Referring to fig. 4, a single rotational thromboelastometry AD module 400 may broadly comprise a housing 410 and a shaft 420. The shaft 420 may be configured to releasably couple with a disposable probe (e.g., probe 138 of fig. 3) for performing thromboelastometry and/or thromboelastography as described above. That is, as described above, the shaft 420 may rotationally oscillate back and forth at, for example, less than 10 ° (in both rotational directions), and preferably about 3 ° to about 6 ° (in both rotational directions).

Referring also to fig. 5, an exploded view of the rotary thromboelastometry AD module 400 enables a better view of the main components of the AD module 400. For example, the rotary thromboelastometry AD module 400 comprises a housing 410 (comprising three

housing portions

410a, 410b, 410c), a shaft 420, an actuation unit 430, a spring wire 440, an LED 450, a CCD460, and a Printed Circuit Board (PCB) assembly 470.

In some embodiments, housing 410 includes a cover 410a, a base plate 410b, and a back cover 410 c. Housing 410 houses the other components of AD module 400, except that the portion of shaft 420 beyond base plate 410b allows shaft 420 to engage a disposable probe. Accordingly, in some embodiments, the AD module 400 is a discrete module that can be removed and replaced as a unit.

The rotary thromboelastometry AD module 400 further comprises a shaft 420. In the depicted embodiment, the shaft 420 includes a bearing 422 and a mirror 424. When the AD module 400 is assembled, the bearing 422 is rigidly coupled with the base plate 410 b. Thus, the shaft 420 may freely rotate relative to the base plate 410 b. A reflector 424 mounted on the shaft 420 is configured to reflect light from the LED 450 toward the CCD 460. When the shaft 420 oscillates during the rotational thromboelastometry test, the direction of the mirror 424 also oscillates accordingly (because the mirror 424 is mounted to the shaft 420). Thus, during the rotational thromboelastometry test, as the shaft 420 oscillates, light from the LED 450 will reflect from the mirror 424 (and toward the CCD 460) at varying angles.

The rotational thromboelastometry AD module 400 further comprises an actuation unit 430. An actuation unit 430 (described in more detail below with reference to fig. 6) provides a motive force that causes the shaft 420 to rotationally oscillate.

In the depicted embodiment, a spring wire 440 provides a connection between the actuation unit 430 and the shaft 420. In other words, the actuating unit 430 drives the spring wire 440, and the spring wire 440 transmits the driving force from the actuating unit 430 to the shaft 420.

The rotary thromboelastometry AD module 400 further comprises an LED 450. In some embodiments, the LEDs 450 are rigidly mounted to the PCB assembly 470, and the PCB assembly is rigidly mounted to the housing 410. The LED 450 emits light stably toward the reflecting mirror 424. In some embodiments, one or more lenses are used in conjunction with the LED 450.

Light from the LED 450 is reflected from the reflector 424 in the direction of the CCD 460. CCD460 includes a plurality of pixels arranged (e.g., substantially in-line) along a face of CCD 460. Accordingly, as the shaft 420 pivots, light reflected from the mirror 424 sweeps across the surface of the CCD 460. By detecting the position of a particular pixel of CCD460 receiving the LED light, the angular position and other characteristics related to the angular rotation of shaft 420 can be determined. In some embodiments, other types of light detectors (other than CCD-type detectors) are used instead of or in addition to CCD 460.

The rotary thromboelastometry AD module 400 further comprises a PCB assembly 470. The PCB assembly 470 includes the electronics and circuitry for operation of the rotary thromboelastometry AD module 400. In a particular embodiment, PCB assembly 470 (including executable code stored therein) includes an evaluation unit configured to receive the luminance distribution data from the CCD, generate CCD calibration data based on the luminance distribution data, and compare the CCD calibration data to the CCD calibration data measured in real time. In some embodiments, PCB assembly 470 includes a microprocessor, motor driver, fuse, integrated circuit, and the like. The PCB assembly 470 may also include one or more types of sensors such as, but not limited to, vibration sensors, accelerometers, hall effect sensors, end-of-travel detectors, proximity sensors, optical sensors, micro-switches, and the like.

Referring to fig. 6, an exemplary actuation unit 430 of the rotary thromboelastometry AD module 400 is shown in an exploded perspective view to better see the components of the actuation unit. In the depicted embodiment, the actuation unit 430 includes a motor 432, a sliding unit 434, and a sliding guide member 438. The motor 432 is mounted to the sliding guide member 438. The sliding unit 434 is slidably engaged with the slide guide member. As described further below, the motor 432 is engaged with the slide unit 434 such that the motor 432 can provide power to the slide unit 434.

The exemplary actuation unit 430 is designed to provide a number of operational advantages. For example, as will become more apparent from the following description, the actuation unit 430 is compact, lightweight, resistant to external vibrations, mechanically accurate, electronically instrumented, highly controllable, repositionable, durable, and the like.

In some embodiments, motor 432 is a stepper motor. Accordingly, in some such embodiments, the motor 432 may be programmed and controlled to rotate and operate in a prescribed manner. That is, in some embodiments, the motor 432 may be programmed to operate according to selected parameters, including parameters such as, but not limited to, rotational speed, number of revolutions, acceleration, deceleration, direction, and the like. These factors may be programmed into the memory of the rotary thromboelastometry AD module 400 or the analyzer console 110. Accordingly, various actuation profiles for the motor 432 may be readily selected and/or adjusted as desired. In some embodiments, all rotational thromboelastometry AD modules 400 are programmed to operate using the same actuation profile. In other embodiments, one or more of the rotary thromboelastometry AD modules 400 are programmed to operate using a different actuation profile as compared to one or more of the other rotary thromboelastometry AD modules 400.

The motor 432 includes a drive shaft 433. In some embodiments, the drive shaft 433 is a lead screw. The external thread of the lead screw may be threadedly engaged with the internal thread portion of the sliding unit 434. In some such embodiments, the drive shaft 433 is a fine threaded lead screw to facilitate precise and smooth control of the slide unit 434. When the drive shaft 433 and the slide unit 434 are threadedly engaged, rotation of the motor 432 will result in linear translation of the slide unit 434. That is, as the drive shaft 433 of the motor 432 rotates, the slide unit 434 will slidably translate within the slide guide member 438. When the motor 432 reverses its rotational direction (e.g., clockwise and counterclockwise), the linear direction of the sliding unit 434 relative to the sliding guide member 438 will correspondingly reverse.

Referring also to fig. 7, an example of the sliding unit 434 is shown in an exploded perspective view to better see the components of the sliding unit. The slide unit 434 includes a curved member 435, a threaded collar 436, a spring wire retaining magnet 437, a slide unit retaining magnet 439, a spring wire connecting member 452, and a slide body 454. The threaded collar 436 and the curved member 435 are mounted on the slider body 454. The spring wire holding magnet 437 is mounted on the curved member 435. The spring wire connecting member 452 is engaged with the curved member 435 and the sliding body 454. A slide unit holding magnet 439 is mounted to the slide guide member 438 and is magnetically coupled with the slide body 454.

The curved member 435 has a shaped side that contacts the spring wire 440 (refer to fig. 5). As the curved member 435 linearly translates back and forth within the sliding guide member 438, the contact area between the spring wire 440 and the shaped side of the curved member 435 is adjusted in position. This arrangement converts the linear motion of the curved member 435 into a smooth pivotal motion of the spring wire 440 (with the shaft 420 as the pivot point).

The spring wire holding magnet 437 attracts the spring wire 440 so that the spring wire 440 is held in contact with the shaped side of the bending member 435 while the back-and-forth movement of the sliding unit 434 occurs. Additionally, in some embodiments, the spring wire retention magnet 437 is used in conjunction with a hall effect sensor mounted on the PCB assembly 470 (see fig. 5) such that the position of the sliding unit 434 can be monitored electronically.

The threaded collar 436 has internal threads that are complementary to the external threads of the drive shaft 433 of the motor 432. Thus, as the drive shaft 433 rotates, the threaded collar 436, which is restricted from rotation due to engagement with the slider 454, translates linearly along the length of the drive shaft 433 of the motor 432. As the threaded collar 436 translates linearly, the slide body 454 and the curved member 435 also translate linearly (because the threaded collar 436 is mounted to the slide body 454). A slide unit retaining magnet 439 is mounted to the slide guide member 438 and is magnetically coupled with the slide body 454 for precisely maintaining the slide body 454 in close operative relationship with the slide guide member 438 as the slide body 454 translates back and forth relative to the slide guide member 438.

The spring wire connection member 452 coupled with the slider body 454 serves to mechanically engage the spring wire 440 (refer to fig. 5) with the slider unit 434. The spring wire connection member 452 thereby facilitates the mechanical coupling between the spring wire 440 and the sliding unit 434 (in addition to the above-described magnetic coupling between the spring wire 440 and the spring wire holding magnet 437). Also, in some embodiments, the spring wire connection member 452 includes physical features for travel or end of travel detection of the sliding unit 434. For example, in some embodiments, the spring wire connection members 452 include one or more protrusions detectable by sensor(s) mounted on the PCB assembly 470. A photo sensor, a proximity sensor, a mechanical sensor, or the like may be used to detect the position of the spring wire connecting member 452 in this manner.

Referring to fig. 8, in some embodiments, the one or more processors of the thromboelastometry analysis system 100 (see fig. 1) are configured to perform a CCD evaluation process 800. In particular embodiments, such a CCD evaluation process 800 may be performed in one or more processors of a separate AD module (e.g., in one or more processors of PCB assembly 470 of exemplary AD module 400; see FIGS. 4 and 5). In some such embodiments, each individual measurement module of the thromboelastometry analysis system 100 may include one or more processors configured to perform the CCD evaluation process 800. Using the CCD evaluation process 800, thromboelastometry measurement inaccuracies may be reduced or eliminated in some cases. As a result, consistency of performance (e.g., accuracy and precision) of the thromboelastometry analysis system 100 may be enhanced.

At step 810, one or more processors of the thromboelastometry analysis system or AD module receive CCD brightness distribution data. In some embodiments, a light source (e.g., LED 450 of exemplary AD module 400; see FIG. 5) is used to activate a plurality of pixels of the CCD of the AD module. The result data generated by the plurality of pixels is received by one or more processors.

In step 820, the one or more processors of the thromboelastometry analysis system or AD module generate CCD calibration data using the CCD brightness distribution data received in step 810. In some embodiments, this is done by evaluating the position of the falling or rising edge of the luminance distribution data from the CCD. The falling edge or rising edge of the luminance distribution data may also be referred to herein as a "side edge".

At step 830, the one or more processors of the thromboelastometry analysis system or AD module compare the calibration data generated in step 820 to the CCD brightness data measured in real-time. In some embodiments, the real-time CCD evaluation process of step 830 is repeated (cycled) while the thromboelastometry analysis system is running. For example, in some embodiments, the cycle time of the ongoing real-time CCD evaluation process 830 is less than about every 200 milliseconds. In some embodiments, the ongoing real-time CCD evaluation process 830 is an optimization process to fit (fit) the self-calibrated samples to the current measurement position of the falling or rising edge (or side of the luminance distribution) of the luminance distribution data.

Referring to fig. 9, in some embodiments, the one or more processors of the thromboelastometry analysis system 100 (see fig. 1) or AD module are configured to perform a two-stage CCD evaluation process 900. The two-stage CCD evaluation process 900 includes a start CCD evaluation process 910 and an ongoing real-time CCD evaluation process 920. Using the two-stage CCD evaluation process 900, thromboelastometry measurement inaccuracies may be reduced or eliminated in some cases. As a result, the consistency of performance (e.g., accuracy and precision) of the individual AD modules and the thromboelastometry analysis system 100 as a whole may be enhanced.

In some embodiments, the first stage of the two-stage CCD evaluation process 900 is to generate calibration data in the form of samples (data points) to fit. This is done by evaluating the side of the best possible intensity distribution at start-up of the thromboelastometry analysis system 100, starting from step 911. At each test position on the CCD, each light signal distribution is analyzed to determine whether the pixel is OK. For example, some pixels of the CCD may be considered non-OK due to performance defects caused by contamination on the CCD.

In some embodiments, the condition of the CCD pixels is analyzed by running a moving binomial average over the entire light distribution curve and comparing the resulting value to the measured data. For each pixel, if the difference between the moving binomial average over the entire distribution curve and the measured value of the pixel is greater than a threshold, then in some embodiments, the pixel is considered not OK. Conversely, a pixel is considered to be OK if the difference between the moving binomial average over the entire distribution curve and the measured value for that pixel is less than the threshold.

In step 912, data for each pixel is stored in a buffer. That is, since the entire CCD is analyzed in step 911, a map of the scattered pixels can be calculated by storing the positions of all the scattered pixels in a buffer. This data is also used as input to the ongoing real-time CCD evaluation process 920.

In step 913, the position of the CCD with the least concentration of non-OK pixels is determined as the best position to calibrate the CCD evaluation algorithm. The on-axis mirror (see fig. 4) is then rotationally positioned so that the LED light reflected from the mirror is directed to an optimal location on the CCD.

In step 914, the brightness profile measured at the optimal position is then filtered to remove outlier errors of the brightness profile measured at the optimal position. In some embodiments, a filtering process is applied to linearly approximate the outlier portion of the luminance profile. This stage is configured to solve a problem caused by, for example, dust blocking the CCD portion. These dirty parts are usually as distinct as wide and distinct areas of significantly less illumination (outlier error) than normal. In some embodiments, this step uses an algorithm that includes two phases. The first stage is to sample the curve with a fixed step size and find the unnatural outliers to correct. The second stage acquires a start point of the abnormal value and searches for an end point of the abnormal value. It is achieved by approximating the slope of the luminance profile. The algorithm assumes that the closest OK point is located in the region of the extension of the slope. Considering the shape of a typical CCD luminance distribution curve and errors caused by dust on the CCD, outliers should only be added to the point values. Compared with a plurality of more complex filter kernels and FFT methods, the algorithm has the advantages of low memory occupation and high running speed.

In step 915, a portion of the right falling edge or rising edge of the luminance distribution data (side) is extracted according to the filtered data of step 914. The algorithm is designed to perform robust detection of the right edge (right edge) of a given outlier filtered luminance distribution.

In some embodiments, starting from the minimum value, the search algorithm is designed to find the latest possible event that matches well with the search value. Since the luminance distribution data curve is rising, the latest possible event is likely to become the desired position. The customized algorithm is very fast and reliable, and occupies little memory.

The extracted sides of the intensity distribution are then smoothed and sampled in step 916. In some embodiments, this is done by applying very little noise to the sides and approximating the result with a curve fitting model. Cubic B-splines with sufficient interpolation points can approximate non-linear curves very well and therefore outperform typical polynomial or linear interpolation, which can only show good performance if the curve has the correct shape.

In

steps

917 and 918, samples with a fixed step size are taken as a final calibration step and stored in a buffer. This greatly reduces memory footprint and speeds up real-time assessment because fewer comparison operations need to be performed.

Once the buffer containing the positions of the non-OK pixels (step 912) and the buffer containing the samples for real-time beam position estimation (step 918) are properly occupied, initiating the CCD estimation process 910 is complete.

The ongoing real-time CCD evaluation process 920 is repeated (cycled) while the thromboelastometry analysis system 100 is running. For example, in some embodiments, the period of the ongoing real-time CCD evaluation process 920 is approximately every 50 milliseconds. The ongoing real-time CCD evaluation process 920 is an optimization process that fits the self-calibrated samples to the sides of the currently measured brightness distribution.

In step 921, the sample from step 918 is compared and fitted to the target location by an interval-based algorithm. The algorithm evaluates the sample in the middle of the interval, containing the left possible target position. In some embodiments, the first interval (space) is the entire CCD pixel range. The algorithm then decides whether the desired position is to the right or to the left of the desired position (this is possible because the luminance distribution is monotonic). That is, if any pixel on the middle right side is large, a new right boundary is determined. The currently evaluated position is now used as the new right or left boundary of the new interval that halves the searched CCD pixel range. This scheme is repeatedly performed until the interval (space) length is 1, which indicates the arrival at the destination. This first fast fitting algorithm greatly reduces the total time required to fit the sample to the measurement curve. The algorithm requires only about 10 iterations to find the target location within about 10 pixel accuracy. This algorithm outperforms the more common least mean method used after this fast fit in terms of speed.

In step 922, an accurate weighted convergence is performed to fit the sample as good as possible. This is done by calculating the average of the absolute distances between all samples and the part of the luminance distribution curve corresponding to the absolute distance. Since for each pixel the information about their state (OK or not OK) is in memory, the samples compared to the non-OK pixels can be ignored. This greatly enhances robustness compared to typical methods without ignoring the known bad pixels.

In step 923, the position of the sample on the X-axis (CCD pixel position, buffer position) of the beam position is determined and sent to the software.

Referring to fig. 10, an AD module error detection process 1000 is a cyclical process that can be performed by a processor of a thromboelastometry system. The AD module error detection process 1000 may be performed to evaluate parameters that may indicate the cause of a thromboelastometry actuation and detection system error.

In step 1010, the AD module error detection process 1000 begins. The AD module error detection process 1000 may be performed in parallel with the thromboelastometry measurement process.

In step 1020, the processor of the thromboelastometry measurement system receives data relating to the amount of detected vibrations that may affect the accuracy or precision of the thromboelastometry measurement data from the AD module. In some embodiments, the vibration is measured by a ball-based sensor that is a component of the AD module (e.g., located on a PCB within the AD module housing). In some embodiments, other types of sensors are used for vibration detection, such as one or more accelerometers, piezoelectric sensors, displacement sensors, velocity sensors, and the like.

In step 1030, the processor compares the received vibration data to one or more thresholds. If the received vibration data is greater than the threshold, the processor generates an error indication related to the vibration in step 1040.

In step 1050, a processor of the thromboelastometry measurement system receives data related to detected positions of moving parts of the AD module that may affect the accuracy or precision of thromboelastometry measurement data from the AD module. For example, the position indication data may include, but is not limited to, end-of-travel data, rotational position data, linear translation position data, and the like, as well as combinations thereof. In some embodiments, an end-of-travel switch, which is a component of the AD module (e.g., located on a PCB within the AD module housing), is used to detect the absolute position of the AD module actuation unit. In some embodiments, the end of travel switch takes the form of a photoelectric or proximity sensor, limit switch, or the like. In some embodiments, hall effect sensors that are components of the AD module (e.g., located on a PCB within the AD module housing) are used to generate the position indication data. Other types of sensors that provide position indicating data may also be used.

In step 1060, the processor compares the received data relating to the position of the moving parts of the AD module with one or more thresholds. If the received position data is greater than the threshold, the processor generates a position error indication in step 1070. Process 1000 loops back to step 1020 and repeats process 1000.

Referring to fig. 11, a process flow diagram details the AD module measurement cycle 1100 and the thromboelastometry measurement and evaluation cycle 1150. The

processes

1100 and 1150 include steps for managing the operation of the thromboelastometry system 100 (see fig. 1) to improve the error detection and accuracy of the thromboelastometry system.

The key aspects are managed and evaluated in real time using the

processes

1100 and 1150 during thromboelastometry. For example, vibrations that may distort the measurement signal are managed and evaluated. In addition, hall effect sensors are employed to manage and evaluate the motion quality of the rotary thromboelastometry actuation and detection system. In addition, one or more end-of-travel sensors are used to manage and assess the accuracy of the motion of the rotary thromboelastometry actuation and detection system. Furthermore, the quality of the measurement signal is evaluated. By combining the vibration, the moving mass and the moving accuracy with the beam position, the processor of the thromboelastometry analysis system is allowed to determine the current quality of the measurement signal, to analyze the cause of the distortion and to take corresponding measures.

In some embodiments, the AD module measurement loop 1100 is performed approximately every 50 milliseconds. In a particular embodiment, the AD module measurement cycle 1100 is part of a normal measurement routine on the AD module.

Steps

1104 and 1106 relate to the position of the LED beam of the AD module. For example, in some embodiments, the beam position is detected and evaluated.

Steps 1108 to 1114 relate to the evaluation of the vibrations. In some embodiments, the vibration is measured by a ball-based sensor that is a component of the AD module (e.g., located on a PCB within the AD module housing). In some embodiments, other types of sensors are employed for vibration detection, such as one or more accelerometers, piezoelectric sensors, displacement sensors, velocity sensors, and the like. The resulting data that needs to be evaluated is the vibration event over time. A typical evaluation algorithm may be a limit that only a certain number of vibration events are allowed within a certain time. If the limit is exceeded, an error message is sent to the processor running the thromboelastometry software.

Steps 1116-1120 include evaluating a rotary thromboelastometry actuation and detection system by managing with hall effect sensors as components of an AD module (e.g., located on a PCB within an AD module housing). The measurement data provides characteristics of the actual motion of the system. In some embodiments, an evaluation algorithm may be run to compare the measured motion to a theoretical motion that the rotational thromboelastometry actuation and detection system should perform. For example, the sum of absolute/squared differences between theory and reality is a suitable algorithm for correct optimization. If a threshold amount of difference is detected, an error message is sent to the processor running the thromboelastometry measurement software (in step 1122).

Steps

1124 and 1126 include evaluating the absolute movement position of the rotary thromboelastometry actuation and detection system. The end switch, which is a component of the AD module (e.g. located on a PCB within the housing of the AD module), is used to detect the absolute position of the actuation unit with the accuracy of the sub-steps (stepper motor). In some embodiments, the end switches take the form of photoelectric or proximity sensors, limit switches, and the like. The collected statistics of the deviation from the optimal position are used to determine whether the actuation is operating as expected. If the difference between the actual position and the target position with respect to time is large, an error message is sent to the processor running the thromboelastometry measurement software (in step 1122).

In step 1122, the data collected regarding the actuation quality from steps 1116 through 1126 allows for a complete assessment of the quality of motion of the rotary thromboelastometry actuation and detection system. In some embodiments, the evaluation may be achieved at low cost and in a small space compared to, for example, using an additional encoder for monitoring the stepper motor.

Turning now to a description of the thromboelastometry measurement and evaluation cycle 1150. Steps 1154 to 1158 relate to a thromboelastometry measurement process performed by a processor running thromboelastometry measurement software.

Steps

1160 and 1162 depict the evaluation of errors sent by the AD module from process 1100. After assessing the position, the additional errors sent by the AD module can be used to interpret currently known errors by the processor running the thromboelastometry measurement software. The type and frequency of errors are evaluated by the software and if the frequency is high enough or severe enough, an error message is displayed to the user. In some embodiments, AD module errors may be associated with measurement errors by a processor running thromboelastometry measurement software, passing additional information about the causing of the errors and assisting in further improvement of hardware, electronics, and firmware.

Various embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. A console for measuring coagulation properties of a blood sample, the console comprising:

a control unit housing;

a user interface connected to the control unit housing for displaying coagulation characteristics of the blood sample; and

a plurality of individual thromboelastometry measurement modules housed in the control unit housing, each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprising a shaft configured to receive a probe for testing the blood sample using a probe cup device,

wherein each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprises a dedicated actuation unit comprising a magnet magnetically connecting a spring wire to a sliding unit, and the actuation unit is configured to provide linear translation of the sliding unit, and the actuation unit independently drives rotation of a respective shaft of each individual thromboelastometry measurement module relative to rotation of the shaft of all other individual thromboelastometry measurement modules of the plurality of individual thromboelastometry measurement modules.

2. The console of claim 1,

the actuation unit includes a stepping motor.

3. The console of claim 2,

the stepping motor includes a threaded drive shaft, and the slide unit includes a threaded collar threadedly engaged with the threaded drive shaft such that the stepping motor can drive the slide unit to linearly translate.

4. The console of claim 3,

since the spring wire extends between the slide unit and the shaft, linear translation of the slide unit causes pivoting of the shaft.

5. The console of claim 1,

the spring wire is magnetically attracted to the curved surface of the sliding unit.

6. The console of claim 3,

the actuation unit further includes a sensor configured to detect a position of the sliding unit.

7. The console of claim 6,

the sensor comprises a hall effect sensor.

8. The console of claim 1,

the actuation unit further includes one or more end-of-travel sensors configured to detect a travel limit of the slide unit.

9. The console of claim 1, further comprising: one or more vibration sensors housed in the control unit housing.

10. The console of claim 1,

each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprises one or more vibration sensors.

11. The console of claim 1,

each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprises an evaluation unit for evaluating a charge-coupled device (CCD) component, the evaluation unit configured to (i) receive brightness distribution data from a CCD, (ii) generate CCD calibration data based on the brightness distribution data, and (iii) compare the CCD calibration data to CCD brightness distribution data measured in real-time.

12. The console of claim 1,

each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules further comprises a heater configured to heat a cup of the probe cup.

13. A method of evaluating a charge-coupled device (CCD) component of a thromboelastometry analysis system, the method comprising:

receiving, at one or more processors of the thromboelastometry system, brightness distribution data from the CCD, wherein the thromboelastometry system comprises a plurality of individual thromboelastometry measurement modules housed in a control unit housing, each individual thromboelastometry measurement module of the plurality of individual thromboelastometry measurement modules comprises a dedicated actuation unit comprising a magnet, and the brightness distribution data from the CCD represents individual brightness data from a plurality of individual pixels of the CCD;

generating, by the one or more processors of the thromboelastometry analysis system, CCD calibration data, the CCD calibration data generated based on the brightness distribution data from the CCD; and

comparing, by the one or more processors of the thromboelastometry analysis system, the CCD calibration data to real-time measured CCD brightness distribution data while the thromboelastometry analysis system is performing a thromboelastometry analysis.

14. The method of claim 13, further comprising:

determining, by the one or more processors of the thromboelastometry analysis system, a location of a falling edge or a rising edge of the intensity distribution data from the CCD.

15. A method of controlling accuracy of a thromboelastometry analysis system, the method comprising:

receiving, at one or more processors of the thromboelastometry analysis system, vibration data indicative of a detected level of vibration of the thromboelastometry analysis system, wherein the thromboelastometry analysis system comprises a plurality of individual thromboelastometry measurement modules housed in a control unit housing, each of the plurality of individual thromboelastometry measurement modules comprising a dedicated actuation unit comprising a magnet;

comparing, by the one or more processors of the thromboelastometry analysis system, the received vibration data to a threshold limit value; and

generating, by the one or more processors of the thromboelastometry analysis system and based on a comparison of the received vibration data to the threshold limit value, a vibration error indication in response to the received vibration data being greater than the threshold limit value.

16. The method of claim 15, further comprising:

receiving, at one or more processors of the thromboelastometry analysis system, position indication data indicative of a detected position of a slide unit relative to an actuation unit of the thromboelastometry analysis system, the actuation unit configured to provide linear translation of the slide unit;

comparing, by one or more processors of the thromboelastometry analysis system, the received position indication data to one or more threshold limit values; and

in response to the received position indication data being greater than the one or more threshold limit values, generating, by one or more processors of the thromboelastometry analysis system, a position error indication based on a comparison of the received position indication data to the one or more threshold limit values.

17. A method of controlling accuracy of a thromboelastometry analysis system, the method comprising:

receiving, at one or more processors of the thromboelastometry system, position indication data indicative of a detected position of a sliding unit relative to an actuation unit of the thromboelastometry system, wherein the thromboelastometry system comprises a plurality of individual thromboelastometry measurement modules housed in a control unit housing, each of the plurality of individual thromboelastometry measurement modules comprising a dedicated actuation unit, the actuation unit comprising a magnet, and the actuation unit configured to provide linear translation of the sliding unit;

18. The method of claim 17, wherein,

the position indicating data includes one or more signals from one or more end-of-travel sensors indicating whether the slide unit is located at a target end-of-travel position.

19. The method of claim 17, wherein,

the position indicating data includes one or more signals from one or more sensors indicating a real-time position of the sliding unit as the sliding unit translates back and forth linearly along a linear path.