WO2022172237A1 - Dispositif de gestion des informations d'instruments de laboratoire et procédé associé - Google Patents

Dispositif de gestion des informations d'instruments de laboratoire et procédé associé Download PDF

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Publication number
WO2022172237A1
WO2022172237A1 PCT/IB2022/051284 IB2022051284W WO2022172237A1 WO 2022172237 A1 WO2022172237 A1 WO 2022172237A1 IB 2022051284 W IB2022051284 W IB 2022051284W WO 2022172237 A1 WO2022172237 A1 WO 2022172237A1
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WO
WIPO (PCT)
Prior art keywords
data
instruments
module
repository
laboratory
Prior art date
Application number
PCT/IB2022/051284
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English (en)
Inventor
Palekudy Sreejith Kumar Sukumaran
Original Assignee
Borosil Technologies Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Borosil Technologies Limited filed Critical Borosil Technologies Limited
Publication of WO2022172237A1 publication Critical patent/WO2022172237A1/fr

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Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063—Operations research, analysis or management
    • G06Q10/0631—Resource planning, allocation, distributing or scheduling for enterprises or organisations
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31—User authentication
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60—Protecting data
    • G06F21/606—Protecting data by securing the transmission between two devices or processes

Definitions

  • the present disclosure generally relates to data management. More particularly, the present disclosure relates to a device for managing the information of laboratory instruments and a method thereof.
  • Laboratory compliance or lab compliance refers to a procedure or approach required in a laboratory to ensure that the analytical results generated are convincing and appropriate and can be reliably used for making policy decisions.
  • An object of the present disclosure is to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
  • An object of the present disclosure is to provide a device for managing the information of laboratory instruments and a method thereof.
  • Another object of the present disclosure is to provide a device that facilitates retrieval of information from the laboratory instruments in a reliable and secure manner.
  • Still another object of the present disclosure is to provide a device for managing the information of laboratory instruments that brings in last-mile compliance to instruments used in scientific and industrial laboratories.
  • Yet another object of the present disclosure is to provide a device for managing the information of laboratory instruments that can connect to server programs such as Laboratory Information Management Systems (LIMS) through Ethernet or Wi-Fi Network.
  • LIMS Laboratory Information Management Systems
  • the present disclosure envisages a device for managing the information of laboratory instruments, wherein each laboratory instrument is associated with a unique identifier (ID).
  • the device comprises an enclosure housing a user interface, a connecter printed circuit board (PCB), a plurality of connectors, a processing circuit board, a processing unit, a power supply module, and a power switch.
  • the connectors are mounted on the PCB and are configured to facilitate connection of the device with one or more laboratory instruments.
  • the connectors can be selected from the group consisting of Personal System/2 (PS/2) port, Serial Port (SP) connector, Parallel Port (PP) connector, DC jack/connector, Local Area Network (LAN) connector, Universal Serial Bus (USB) connector, Video Graphics Array (VGA), connector, High-Definition Multimedia Interface (HDMI) connector, and Digital Visual Interface (DVI) connector.
  • PS/2 Personal System/2
  • SP Serial Port
  • PP Parallel Port
  • DC jack/connector DC jack/connector
  • LAN Local Area Network
  • USB Universal Serial Bus
  • VGA Video Graphics Array
  • HDMI High-Definition Multimedia Interface
  • DVI Digital Visual Interface
  • the processing unit is mounted on the processing circuit board.
  • the processing unit comprises a repository, an authentication module, a data retrieving module, and an output module.
  • the repository is configured to store a list of authorized users and a login credential associated with each user.
  • the authentication module is configured to receive an input login credential from a user via the user interface and is further configured to compare the received login credential with the login credential stored in the repository to authenticate the user and to authorize the user to use the device upon successful authentication.
  • the data retrieving module is configured to detect connected laboratory instruments and establish a secure communication with the connected instruments to retrieve data therefrom.
  • the data retrieving module is further configured to log the retrieved data in the repository.
  • the output module is configured to generate an output based on at least a part of the logged data.
  • the power supply module is configured to supply power to the PCB, the processing unit, and the printer.
  • the power switch is configured to facilitate the user to turn on or turn off the device by controlling the supply of power to the components of the device.
  • the repository is configured to store a list of instruments in the laboratory and the unique identifier (ID) associated with each of the instruments.
  • the data retrieving module comprises a connecting module, a comparator, and a data logging module.
  • the connecting module is configured to perform a handshaking operation with the one or more connected instruments and receive an identifier and a name of the connected instruments.
  • the comparator is configured to cooperate with the repository to compare the received identifier and name with the identifiers and names stored in the repository to identify the connected instruments and establish the secure communication therewith.
  • the data logging module is configured to send a data request command to the connected instruments to retrieve data therefrom and log the retrieved data into the repository upon establishing successful communication with the instruments.
  • the data retrieving module includes an encrypting module configured to encrypt the retrieved data before storing the data in the repository.
  • the data retrieved from the connected instruments comprises data related to sample preparation, testing, or analysis, and pertaining to operational parameters of the connected laboratory instruments selected from the group consisting of temperature, speed, time, measure weight, PH, and conductivity.
  • the device includes a communication module for connecting to the one or more laboratory instruments or to one or more data servers through a wired or a wireless interface.
  • the device further comprises a real time clock (RTC) configured to facilitate time stamping of the data logged into the repository.
  • RTC real time clock
  • the device includes a display unit, mounted on the processing circuit board, configured to display the generated output.
  • the device also includes a printer configured to facilitate the user to print the output.
  • the user interface is an alphanumeric Dual Tone Multiple-Frequency (DTMF) keypad.
  • DTMF Dual Tone Multiple-Frequency
  • the user interface is a graphical touch display.
  • the device can be connected to an external connector through a wire connector to retrieve data from legacy instruments that do not have electronic connectivity facility.
  • the device can be connected to a sensor module via the external connector, wherein the sensor module can be selected from the group consisting of temperature sensor, speed (RPM) sensor, time sensor, pressure sensor, PH sensor, and conductivity sensor.
  • the power supply module comprises a battery and a converter unit.
  • the converter is configured to receive power from an AC mains power supply to generate a processed power for the components of the device.
  • the battery is configured to supply power to the components of the device when the AC mains power supply fails.
  • the present invention further envisages a method for managing the information of laboratory instruments. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
  • Figure 1A illustrates a block diagram of a device for managing the information of laboratory instruments, in accordance with the present disclosure
  • Figure IB illustrates a schematic diagram of an exploded view of the device of Figure 1A, in accordance with the present disclosure
  • Figure 1C illustrates a schematic isometric diagram of the device of Figure 1A, in accordance with the present disclosure
  • Figure 2 illustrates a schematic diagram of the device of Figure 1A with an optional sensor module, in accordance with the present disclosure
  • Figure 3 illustrates a flow diagram of a method for managing the information of laboratory instruments, in accordance with the present disclosure
  • Figures 4A, 4B, and 4C illustrate a communication flow chart of the device of Figure 1, in accordance with the present disclosure.
  • USB First Universal Serial Bus
  • USB Second Universal Serial Bus
  • LAN Local Area Network
  • Embodiments, of the present disclosure will now be described with reference to the accompanying drawing. Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details, are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
  • first, second, third, etc. should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer, or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
  • an industrial or a scientific laboratory includes a variety of instruments for testing and analysing different specimens/samples. Before the test or analytical results can be generated, it is necessary to ensure the laboratory compliance of these instruments. For ensuring regulatory compliance of the laboratory instruments, it is essential to retrieve, store and manage vast amounts of laboratory data from the laboratory instruments in a secure and reliable manner. The data collection should happen in a controlled environment as data integrity is at the heart of laboratory compliance. To ensure integrity of data, it is essential to avoid violations such as use of a generic user account, improper safeguarding of usernames and passwords, lack of administrative procedural control, and any other reason that gives proximal cause to view data environment as uncontrolled. Further, it is becoming increasingly important to have an audit trail for the data including information regarding the source of data, the user who added, edited, or accessed the data, and corresponding time stamps.
  • the present disclosure envisages a device (hereinafter referred to as “device 100”) for managing the information of laboratory instruments and a method thereof (hereinafter referred to as “method 300”) ⁇
  • device 100 for managing the information of laboratory instruments
  • method 300 a method thereof
  • the device 100 comprises an enclosure housing a user interface 116, a connector printed circuit board (PCB) 108, a plurality of connectors (104a, 104b, 104c, 104d) mounted on the PCB 108, a processing circuit board 118, a processing unit 120, a power supply module 130, and a power switch 102.
  • the enclosure is defined by a front cap 112a, a top cover 112b, a bottom cover 112c, and a back side cap 112d.
  • the connectors (104a, 104b, 104c, 104d) facilitate the device 100 to be connected to one or more laboratory instruments.
  • the laboratory instruments can include, but are not limited to, water baths, stirrers, ovens, hot plates, weighing balances, and pH meters.
  • the connectors (104a, 104b, 104c, 104d) can be selected from the group consisting of, but not limited to, Personal System/2 (PS/2) port, Serial Port (SP) connector, Parallel Port (PP) connector, DC jack/connector, Local Area Network (LAN) connector, Universal Serial Bus (USB) connector, Video Graphics Array (VGA), connector, High-Definition Multimedia Interface (HDMI) connector, Digital Visual Interface (DVI) connector, and the like.
  • PS/2 Personal System/2
  • SP Serial Port
  • PP Parallel Port
  • LAN Local Area Network
  • USB Universal Serial Bus
  • VGA Video Graphics Array
  • HDMI High-Definition Multimedia Interface
  • DVI Digital Visual Interface
  • the device 100 includes a DC connector 104a, a first Universal Serial Bus (USB) connector 104b, a second Universal Serial Bus (USB) connector 104c, and a Local Area Network (LAN) connector 104d.
  • the device 100 includes a communication module 132 for connecting with the laboratory instruments and/or with one or more data servers through a wired or a wireless interface.
  • the device 100 may connect to server programs like Laboratory Information Management Systems (LIMS) through an Ethernet interface via LAN connection or through a Wi-Fi Network.
  • LIMS Laboratory Information Management Systems
  • Each of the instruments in the laboratory is provided with a unique identifier (ID).
  • ID is provided by way of an identification tag including the identifier manually inserted into the instrument’s memory and can be automatically retrieved at beginning of a data retrieval process.
  • the processing unit 120 is mounted on the processing circuit board 118 and comprises a repository 122, an authentication module 124, a data retrieving module 126, and an output module 128.
  • the repository 122 is configured to store a list of authorized users and a login credential associated with each user.
  • the authentication module 124 is configured to receive an input login credential from a user via the user interface 116.
  • the login credential can include a username and a password of the user.
  • the authentication module 124 is further configured to compare the received login credential with the login credentials stored in the repository 122 to authenticate the user and to authorize the user to use the device 100 upon successful authentication.
  • the data retrieving module 126 is configured to detect connected laboratory instruments and establish a secure communication with the connected instruments to retrieve data therefrom.
  • the data retrieving module 126 is further configured to log the retrieved data in the repository 122.
  • the output module 128 is configured to generate an output based on at least a part of the logged data. Since the communication between the laboratory instruments and the device 100 mostly happens through the USB communication protocol, the data that is received from the laboratory instruments is encrypted on a real-time basis and saved as an encrypted file. As the data is never saved in raw or decrypted format, there is no means of accessing the data other than relying on the decryption algorithm of the device 100. Therefore, the device 100 is tamper proof.
  • the repository 122 is configured to store a list of instruments in the laboratory (i.e., machine/instrument names) and the unique identifier (ID) associated with each of the instruments.
  • the data retrieving module 126 comprises a connecting module 126a, a comparator 126b, and a data logging module 126c.
  • the connecting module 126a is configured to perform a handshaking operation with the one or more connected instruments and receive an identifier and a name of the connected instruments.
  • the comparator 126b is configured to cooperate with the repository 122 to compare the received identifier and name with the identifiers and names stored in the repository 122 to identify the connected instruments and establish the secure communication therewith.
  • the data logging module 126c is configured to send a data request command to the connected instruments to retrieve data therefrom and log the retrieved data into the repository 122 upon establishing successful communication with the instruments.
  • the repository 122 is configured to store the list of instruments in the laboratory and the unique ID associated with each of the instruments in the form of a first lookup table.
  • the repository 122 is further configured to store the list of authorized users and the login credentials of the users in the form of a second lookup table.
  • the device 100 before initiating the information retrieval process, receives the login credential from the user handling the device 100 through the user interface/keypad 116.
  • the processing unit 120 compares the received login credential with the credentials pre-stored in the second lookup table to authenticate the user, and to thereby authorize the user to use the device 100 for performing the data retrieval process.
  • the user then connects the device 100 to one or more laboratory instruments for collecting data therefrom through a wired or a wireless interface.
  • the processing unit 120 performs the handshaking operation with the one or more connected instruments and checks the name and ID of the connected instrument(s) in the first lookup table.
  • the device 100 When the name and ID of the connected instrument(s) are found in the first lookup table, a successful communication is established between the device 100 and the instrument(s). The device 100 then sends a data request command to the connected instrument(s) to retrieve data therefrom and log the retrieved data into the repository 122.
  • the data retrieved from the instrument(s) can include sample preparation, testing, or analysis related data, for example, pertaining to operational parameters of the connected laboratory instruments such as, but not limited to temperature, speed, time, measure weight, PH, and conductivity.
  • the data retrieving module 126 includes an encrypting module configured to encrypt the retrieved data before storing the data in the repository 122. This ensures security of the laboratory data.
  • the device 100 includes a real time clock (RTC) 134 to keep a track of time and date and configured to facilitate time stamping of the data logged into the repository 122.
  • the device 100 further includes a display unit 106 mounted on the processing circuit board 118 configured to display the generated output.
  • the user interface 116 is an alphanumeric Dual Tone Multiple-Frequency (DTMF) keypad as shown in Figure IB.
  • the user interface 116 is a graphical touch display. In this case, the user interface 116 and the display unit 106 are integrated.
  • the device 100 facilitates the user to key in the process time and the data- interval when starting sample preparation process or analytical process on a laboratory instrument through the user interface 116.
  • the device 100 further facilitates an authorized user to set various parameters associated with the logged data through the interface 116.
  • the parameters can include, but are not limited to, a sample ID, a Process ID, and a Container ID.
  • the device 100 facilitates recording of time at which the data logging is started, time at which the data logging is completed, time at which a logged data is accessed, and time at which a logged data is edited along with the users who added, edited, or accessed the data using the RTC 134. Thus, the device 100 captures an audit trail of each users’ activities.
  • the device 100 can log data for the duration of working of the laboratory instruments for up to a maximum of 36 hours.
  • the instrument Auto resumes the function on power return.
  • the device 100 detects this event of resumption and restart data logging.
  • the device 100 generates the output in text, PDF, or XML formats.
  • the output is displayed on the display unit 106 in a graphical format or a text format.
  • the output can include logged and time stamped data related to sample preparation, testing, or analysis, and pertaining to various operational parameters.
  • the generated output may have the following form-
  • the device 100 includes a printer 114 to facilitate printing of the logged data or the output on a paper.
  • the printed paper may be output through a printhead 114a of the printer 114.
  • the printer 114 can be selected from the group consisting of, but not limited to a thermal printer, a dot-matrix printer, an inkjet printer, and a laser printer.
  • the device 100 can be connected to an external connector 204 through a wire connector 202.
  • a sensor module 200 can be connected to the device 100 via the external connector 204.
  • the sensor module 200 can include multiple sensors such as, but not limited to temperature sensor 208a, speed (RPM) sensor 208b, time sensor, pressure sensor 208c, PH sensor, and conductivity sensor.
  • the external connector 204 includes one or more LED indicators 206 for indicating the operating status of the sensors.
  • the device 100 can be connected to the sensor module 200 through the external connector 204 to retrieve data from legacy instruments that do not have electronic connectivity facility.
  • the power supply module 130 is configured to supply power to the connector PCB 108, the processing unit 120, and the printer 114.
  • the power supply module 130 includes a converter unit 130a configured to receive power from an AC mains power supply to generate an adequate or a processed power for the components of the device 100.
  • the converter unit 130a may include a rectifier to generate a DC power from the received AC power.
  • the converter unit 130a may include a combination of rectifier and a DC-DC converter to generate the adequate power for supplying to the components of the device 100.
  • the power supply module 130 additionally includes a battery 110.
  • the battery 110 is configured to supply power to the components of the device 100 when the mains power supply fails.
  • the battery 110 may be housed inside a battery cover 110a.
  • the operational components of the device 100 are housed in the ingress protected enclosure and can work in cold weathers.
  • the communication signals transmitted or received by the device 100 cannot be tampered with from the outside.
  • the device 100 is tamper-proof.
  • the power switch 102 may facilitate the user to turn on or turn off the device 100 by controlling the supply of power to the components of the device 100.
  • the device 100 is configured to automatically disable the functioning of the display unit 106 and the power switch 102 during the data retrieval process to reduce power usage.
  • the device 100 includes a speaker (not shown).
  • the processing unit 120 is configured to sound an alarm using the speaker on process termination or power failure.
  • the present disclosure further discloses the method 300 for managing the information of laboratory instruments, wherein each laboratory instrument is associated with a unique identifier (ID). Referring to Figure 3, the method 300 comprises the following steps:
  • processing unit 120 receives an input login credential from a user via a user interface 116.
  • the user interface 116 may be a keypad or a touch screen interface.
  • an authentication module 124 of the processing unit 120 compares the received login credential with login credentials associated with pre-authorized users stored in a repository 122 to authenticate the user.
  • the authentication module 124 authorizes the user to use the device 100 upon successful authentication.
  • a data retrieving module 126 of the processing unit 120 detects one or more laboratory instruments connected to the device 100 via one or more connectors (104a, 104b, 104c, 104d) of the device 100.
  • the data retrieving module 126 establishes a secure communication with the laboratory instruments connected to the device 100 to retrieve data from the connected instruments.
  • the data retrieving module 126 logs the retrieved data in the repository 122.
  • an output module 128 of the processing unit 120 generates an output based on at least a part of the logged data.
  • the step of establishing the secure communication with the connected laboratory instruments to retrieve data from the connected instruments comprises:
  • a user turns on the device 100 (also referred to as “portal”) using the power switch 102.
  • the user logs in by entering credentials such as username and password.
  • credentials such as username and password.
  • the user is allowed to initiate the data retrieval process.
  • the user connects the device 100 to a laboratory instrument from which the data is to be retrieved through a wired or wireless interface.
  • the device 100 starts a handshaking process with the instrument to establish a link with the instrument.
  • the device 100 sends a HND (Handshaking request) command to the instrument and checks if an ACK message (acknowledgement) is received back from the instrument.
  • HND Handshaking request
  • the device 100 Upon completion of the handshaking process i.e., upon receiving ACK message, the device 100 receives unique ID and machine name associated with the connected instrument. Once this information is received and verified, the device 100 sends ACK message to the connected instrument. The device 100 further checks for source routing from the instrument and sends an ACK message to the instrument once source routing transparent is found to be functional. This establishes secure communication between the device 100 and the connected instrument. The device 100 then sends data request command to the connected instrument. In response to this request, the connected instrument sends the process data to the device 100. The device 100 receives the process data. Upon completion of data transfer, an END command is sent by the instrument to the device 100. The END command indicates completion of data transfer operation. The device 100 then sends an ACK message to the instrument indicating receipt of the END command. The device 100 stores the retrieved data into its repository 122 for further checks and processing.
  • the processing unit 120 of the device 100 may be implemented using one or more microprocessors, microcomputers, micro-controllers, digital signal processors, central processing units, state machines, logic circuitries, and/or any devices that manipulate signals based on operational instructions.
  • the connector PCB 108 and processing circuit board 118 may be made using either flexible/ printed electronics or hybrid electronics (printed with bonded components).
  • TECHNICAL ADVANCEMENTS The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a device for managing the information of laboratory instruments and a method thereof that:
  • LIMS Laboratory Information Management Systems

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Abstract

La présente invention concerne le domaine de la gestion de données, et porte sur un dispositif (100) et un procédé (300) de gestion des informations d'instruments de laboratoire. Chaque instrument de laboratoire est associé à un identifiant (ID) unique. Le dispositif (100) comprend un boîtier logeant une interface utilisateur (116), une carte de circuit imprimé (PCB) de connecteurs (108), des connecteurs (104a, 104b, 104c, 104d) montés sur la PCB (108), une carte de circuit de traitement (118) et une unité de traitement (120), un module d'alimentation électrique (130), et un interrupteur d'alimentation (102). Les connecteurs (104a, 104b, 104c, 104d) facilitent la connexion du dispositif (100) à un ou plusieurs instruments de laboratoire. L'unité de traitement (120) authentifie un utilisateur sur la base de données d'accès saisies, reçues par l'intermédiaire de l'interface utilisateur (116), et autorise l'utilisateur à utiliser le dispositif (100) en cas d'authentification réussie. L'unité de traitement (120) détecte des instruments de laboratoire connectés et établit une communication sécurisée avec les instruments pour récupérer des données à partir de ceux-ci.
PCT/IB2022/051284 2021-02-12 2022-02-14 Dispositif de gestion des informations d'instruments de laboratoire et procédé associé WO2022172237A1 (fr)

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IN202121006072 2021-02-12
IN202121006072 2021-02-12

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110351231A (zh) * 2018-04-08 2019-10-18 湖南青普科技有限公司 基于互联网的仪器设备数据处理及通讯控制系统
US20200371124A1 (en) * 2013-10-07 2020-11-26 Eppendorf Ag Laboratory instrument, system and method for instrument-controlled treatment of at least one laboratory sample using at least one consumable

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20200371124A1 (en) * 2013-10-07 2020-11-26 Eppendorf Ag Laboratory instrument, system and method for instrument-controlled treatment of at least one laboratory sample using at least one consumable
CN110351231A (zh) * 2018-04-08 2019-10-18 湖南青普科技有限公司 基于互联网的仪器设备数据处理及通讯控制系统

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