Process for the management of data of analysis devices, analysis device and system comprising analysis devices

• US 9,886,560 B2
• Filed: 02/26/2010
• Issued: 02/06/2018
• Est. Priority Date: 12/12/2008
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Janschitz, Wolfgang, Gromann, Klaus, Kargl, Christian
• Primary Examiner(s): Lane, John A
• Application Number:
  US12/713,285
• Publication Number:
  US 20110066805A1
• Time in Patent Office: 2,902 Days
• Field of Search: 711103, 711161, 711162, 711165, 705 2, 705 3, 707640
• CPC Class Codes: G06F 12/00 Accessing, addressing or allocating within memory systems or architectures digital input from, or digital output to record carriers, e.g. to disk storage units, G06F3/06
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis

Abstract

A process for the management of data of an analysis device, which data serve for the operation of a further analysis device which is designed so as to be equivalent to the first analysis device, is disclosed. The analysis device newly creates or modifies data on an internal memory medium of the analysis device and the first analysis device, during its operation, continuously stores the newly created or modified data in a redundant manner in a non-volatile removable storage medium, with the removable storage medium being independent of the internal memory medium.

Claims

1. A process for the transfer of data between a first and a second analysis device, the process comprising:

newly creating or modifying data in an internal memory medium of a first analysis device, and continuously and automatically storing the newly created or modified data in a redundant manner in a non-volatile removable storage medium during at least body fluid analysis operations without synchronization of data stored in the internal memory medium of the first analysis device;

importing the data redundantly stored on the non-volatile removable storage medium of the first analysis device into internal memory medium of a second analysis device, wherein;

the first and second analysis devices are medical/diagnostic devices configured to receive as input and analyze body fluids,

the second analysis device is an equivalent device to the first analysis device,

the non-volatile removable storage medium is either directly inserted in a slide-in-module of the first analysis device or connected to the first analysis device,

the data redundantly stored on the non-volatile removable storage medium are imported into the internal memory medium of the second analysis device by physically transferring the non-volatile removable storage medium between the first and second analysis devices,

the data redundantly stored on the non-volatile removable storage medium is at least configuration data of the first analysis device, and

the configuration data represents device settings that comprise language, IP address, display screen, country settings, energy management, network settings, calculated and displayed measuring units, measuring parameters used, measuring, calibration and quality control limits, quality measurement materials, security settings, audio settings, and/or planned automatic executions of analyzer functions and/or peripheral devices; and

subsequent to physically transferring the non-volatile removable storage medium between the first and second analysis devices, both configuring automatically the second analysis device to have the identical configuration to the first analysis device based on the imported data via a startup process and continuing automatically with at least the body fluid analysis operations previously conducted by the first analysis device on the second analysis device based on the imported data.

2. The process according to claim 1, wherein the body fluid is blood.

3. The process according to claim 1, wherein the process further comprises redundantly storing in the removable storage medium data that represents at least one of the data types indicated below:

i) measured data that comprises measuring results, raw data, image data, measuring signals and/or data which have been processed further,

ii) subject data,

iii) sample data that comprises sample identifiers, sampling time, sample type and/or sample taking temperature, and

iv) user data that comprises user identifiers, user-specific authorizations and/or user profiles.

4. The process according to claim 1, wherein the data redundantly stored in the removable storage medium is encoded.

5. The process according to claim 4, wherein the encoded data is secured against misuse by passwords and/or user names.

6. The process according to claim 1, wherein the process further comprises connecting a new removable storage medium to the first analysis device such that the first analysis device exports the data stored in the internal memory medium into the new removable storage medium, unless said storage medium already contains valid data of an external analysis device.

7. The process according to claim 1, wherein the process further comprises, prior to a first startup of the first analysis device, storing a unique identifier of the removable storage medium in the internal memory medium the first analysis device or storing a unique identifier of the first analysis device in the removable storage medium.

8. The process according to claim 1, wherein the process further comprises checking the availability of the removable storage medium being inserted in the slide-in-module of the first analysis device or connected to the first analysis device during a startup of the first analysis device, wherein if the removable storage medium is not available, then operation of the first analysis device is not permitted at all.

9. The process according to claim 8, wherein the removable storage medium comprises a hardware token which is necessary for the operation of the analysis device.

10. The process according to claim 8, wherein the process further comprises checking an available removable storage medium for whether a data stock present on the removable storage medium originates from a different analysis device and, if this applies, importing the redundantly stored data contained in the removable storage medium into the internal memory medium of the analysis device.

11. The process according to claim 10, wherein the decision whether data redundantly stored in the removable storage medium are imported into the analysis device is dependent on a user interaction.

12. The process according to claim 10, wherein the import of data redundantly stored on the removable storage medium is recorded, in particular in an audit trail.

13. An analysis device for the management of data for carrying out the process according to claim 1, comprising

an internal memory medium for storing newly created or modified data;

and

a memory interface for accessing a non-volatile removable storage medium so that, with the aid of the memory interface, the newly created or modified data can be continuously and automatically stored in a redundant manner in the removable storage medium during the body fluid analysis operations of the analysis device;

wherein the analysis device is a medical/diagnostic analysis device configured to receive as input and analyze body fluids.

14. The analysis device according to claim 13, wherein the body fluid is blood.

15. A system comprising two analysis devices according to claim 13, wherein data which are continuously newly created or modified in one of the two analysis devices during the operation of one analysis device and data redundantly stored in the removable storage medium serve for the operation of the other analysis device, if the other analysis device accesses the removable storage medium.

16. A computer program product which is loadable directly into a main memory of a programmable analysis device and comprises program code sections which implement the process according to claim 1 if the computer program product is executed by means of the analysis device.

17. The process according to claim 1, wherein the process further comprises directly inserting the non-volatile removable storage medium in a slide-in-module of the first analysis device.

18. The process according to claim 17, wherein the act of physically transferring comprises providing the non-volatile removable storage medium from the first analysis device to a slide-in-module of the second analysis device.

19. The process according to claim 17, wherein the act of physically transferring comprises providing the non-volatile removable storage medium from the slide-in-module of the first analysis device to a slide-in-module of the second analysis device.

20. The process according to claim 1, wherein the process further comprises checking the availability of the removable storage medium being inserted in the slide-in-module of the first analysis device or connected to the first analysis device during a startup of the first analysis device, wherein if the removable storage medium is not available, then operation of the first analysis device is permitted to a limited extent, but without redundantly storing the data on the removable storage medium.

21. An analysis system comprising:

a pair of equivalent medical/diagnostic devices configured to receive as input and analyze body fluids, each medical/diagnostic device has an internal memory medium and a non-volatile removable storage medium, and each medical/diagnostic device is configured to;

newly create or modify data in the internal memory medium, and continuously and automatically store the newly created or modified data in a redundant manner in the non-volatile removable storage medium as at least body fluid analysis operations are conducted by the medical/diagnostic device and without synchronization of data stored in the internal memory medium of the medical/diagnostic device;

import the data redundantly stored on the non-volatile removable storage medium of the other medical/diagnostic device into internal memory medium upon insertion of the non-volatile removable storage medium into a slide-in-module of the first analysis device or connection of the non-volatile removable storage medium to the first analysis device by a physical transfer of the non-volatile removable storage medium between the first and second analysis devices; and

subsequent to the physical transfer of the non-volatile removable storage medium between the first and second analysis devices, both configure automatically the second analysis device to have the identical configuration to the first analysis device based on the imported data via a startup process and continue automatically with the body fluid analysis operations previously conducted by the other medical/diagnostic device based on the imported data, said imported data being at least configuration data which represents device settings that comprise language, IP address, display screen, country settings, energy management, network settings, calculated and displayed measuring units, measuring parameters used, measuring, calibration and quality control limits, quality measurement materials, security settings, audio settings, and/or planned automatic executions of analyzer functions and/or peripheral devices.