# US 8,752,019 B2 · Version control for medical anesthesia devices

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- Number: US 8,752,019 B2
- Document ID: US8752019B2
- Status: Granted
- Kind: B2
- Application number: 13/564,846
- Filed: 2012-08-02
- Published: 2013-07-25
- Granted: 2014-06-10
- Earliest claimed: 2012-01-25
- Assignees: Dräger Medical GmbH
- Applicants: Klaus Marquardt; Jens Fritz Köhne
- Inventors: Klaus Marquardt; Jens Fritz Köhne
- Web page: https://patentgrep.com/patent/US8752019B2

## CPC

- G06F 8/61: Installation
- G06F 8/71: Version control (security arrangements therefor G06F21/57); Configuration management
- G06F 11/0796: {Safety measures, i.e. ensuring safe condition in the event of error, e.g. for controlling element}
- G06F 11/3051: {Monitoring arrangements for monitoring the configuration of the computing system or of the computing system component, e.g. monitoring the presence of processing resources, peripherals, I/O links, software programs (verification or detection of system hardware configuration G06F11/2247)}
- G06F 2201/865: Monitoring of software
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## Abstract

A testing system, a testing process, a medical device, e.g., an anesthesia device (G), and a computer program product are provided for testing installed program versions for acceptability. The anesthesia device (G) comprises a plurality of electronic components (K), which are operated and/or controlled with a program, which may have various versions. A release function (50) is activated for releasing the anesthesia device (G) or for putting same into operation only if a consistent set of acceptable program versions can be detected, and the anesthesia device (G) is otherwise blocked.

## Claims

### Claim 1

A testing system for a medical device or for a system of medical devices, the medical device comprising a plurality of components, each of said components comprising a microprocessor and an executable program, wherein said executable program may be installed in different program versions on the respective component and wherein said executable program installed on the respective component can be replaced and/or changed independently from one another, the testing system comprising:
an access module or an acceptability memory provided for the medical device or for the system of medical devices, said access module or acceptability memory storing entries for all acceptable combinations of program versions for the executable programs of said components;
a release and blocking device provided on the medical device or on each medical device of the system of medical devices, said release and blocking device controlling the initiation of operation of the medical device or each medical device of the system of medical devices or controlling the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices;
a testing module provided for the medical device or for the system of medical devices detecting all program versions of all currently installed programs automatically as an actual state of the medical device or each medical device of the system of medical devices and checking said access module or acceptability memory as to whether the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry and to activate a release by said release and blocking device to allow initiation of operation of the medical device or each medical device of the system of medical devices or to allow the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry, wherein: the test module is provided with access to the access module or the acceptability memory;
the testing module automatically detects all versions of all currently installed programs on all components of the medical device or system of medical devices as an actual state of the device;
the testing module tests to determine whether the detected actual state of the device is acceptable by accessing the access module or an acceptability memory; and the testing module activates a release by said release and blocking device.

### Claim 2 (depends on 1)

A testing system in accordance with claim 1, wherein said testing module is preconfigured to actuate a blocking by said release and blocking device wherein the release is activated subsequently only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry.

### Claim 3 (depends on 1)

A testing system in accordance with claim 1, wherein said access module or acceptability memory is dynamically updated by synchronization with a central server and/or by installing updated entries via an interface and/or a network connection.

### Claim 4 (depends on 1)

A testing system in accordance with claim 1, the medical device includes a medical device program memory or the system of medical devices includes at least one medical device program memory wherein said access module or acceptability memory is separated from said medical device program memory or said at least one medical device program memory.

### Claim 5 (depends on 1)

A testing system in accordance with claim 1, wherein said access module or acceptability memory comprises a secured memory in which additions, changes and/or deletions can be executed in an authenticated form only.

### Claim 6 (depends on 1)

A testing system in accordance with claim 1, wherein said testing module is automatically activated after detection of a trigger signal which trigger signal is generated at least one of:
after a change on the medical device;
after each change on a component;
after each change in configuration;
after each change on the acceptability memory; and
each time before the medical device is put into operation.

### Claim 7 (depends on 1)

A testing system in accordance with claim 1, wherein an acceptability signal is generated if said testing module determines that the detected actual state of the device exists as an acceptable state in the access module or acceptability memory and/or that an acceptability signal is transmitted in the signed form to other computer-based instances.

### Claim 8

A medical device comprising:
a plurality of replaceable, separate components, wherein each component comprises a microprocessor and at least one executable program, wherein the programs may be installed in different versions on the respective component; and
a testing system comprising:
an access module or an acceptability memory provided for the medical device or for a system of medical devices including the medical device, said access module or acceptability memory storing entries for all acceptable combinations of program versions for the executable programs of said components;
a release and blocking device provided on the medical device or on each medical device of the system of medical devices, said release and blocking device controlling the initiation of operation of the medical device or each medical device of the system of medical devices or controlling the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices;
a testing module provided for the medical device or for the system of medical devices detecting all program versions of all currently installed programs automatically as an actual state of the medical device or each medical device of the system of medical devices and checking said access module or acceptability memory as to whether the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry and to activate a release by said release and blocking device to allow initiation of operation of the medical device or each medical device of the system of medical devices or to allow the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry, wherein: the test module is provided with access to the access module or the acceptability memory;
the testing module automatically detects all versions of all currently installed programs on all components of the medical device or system of medical devices as an actual state of the device;
the testing module tests to determine whether the detected actual state of the device is acceptable by accessing the access module or an acceptability memory; and the testing module activates a release by said release and blocking device.

### Claim 9 (depends on 8)

A medical device in accordance with claim 8, wherein said testing module is preconfigured to actuate a blocking by said release and blocking device wherein the release is activated subsequently only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry.

### Claim 10 (depends on 8)

A medical device in accordance with claim 8, wherein said access module or acceptability memory is dynamically updated by synchronization with a central server and/or by installing updated entries via an interface and/or a network connection.

### Claim 11 (depends on 8)

A medical device in accordance with claim 8, the medical device includes a medical device program memory or the system of medical devices includes at least one medical device program memory wherein said access module or acceptability memory is separated from said medical device program memory or said at least one medical device program memory.

### Claim 12 (depends on 8)

A medical device in accordance with claim 8, wherein said access module or acceptability memory comprises a secured memory in which additions, changes and/or deletions can be executed in an authenticated form only.

### Claim 13 (depends on 8)

A medical device in accordance with claim 8, wherein said testing module is automatically activated after detection of a trigger signal which trigger signal is generated at least one of:
after a change on the medical device;
after each change on a component;
after each change in configuration;
after each change on the acceptability memory; and
each time before the medical device is put into operation.

### Claim 14

A process for testing a medical device or a system of medical devices, the medical device comprising a plurality of components, each of said components comprising a microprocessor and an executable program, wherein said executable program may be installed in different program versions on the respective component and wherein said executable program installed on the respective component can be replaced and/or changed independently from one another, the process comprising the steps of:
providing a testing system comprising:
an access module or an acceptability memory provided for the medical device or for the system of medical devices, said access module or acceptability memory storing entries for all acceptable combinations of program versions for the executable programs of said components;
a release and blocking device provided on the medical device or on each medical device of the system of medical devices, said release and blocking device controlling the initiation of operation of the medical device or each medical device of the system of medical devices or controlling the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices;
a testing module provided for the medical device or for the system of medical devices detecting all program versions of all currently installed programs automatically as an actual state of the medical device or each medical device of the system of medical devices and checking said access module or acceptability memory as to whether the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry and to activate a release by said release and blocking device to allow initiation of operation of the medical device or each medical device of the system of medical devices or to allow the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry;
providing access to the access module or the acceptability memory;
automatically detecting all versions of all currently installed programs on all components of the medical device or system of medical devices as an actual state of the device;
testing to determine whether the detected actual state of the device is acceptable by accessing the access module or an acceptability memory; and
activating a release by said release and blocking device.

### Claim 15 (depends on 14)

A process in accordance with claim 14, wherein said step of activating a release includes changing from a preconfigured blocking function of medical device to a release function for putting the medical device into operation or for releasing a tested function of the device if the detected actual state of the device was checked as permissible.

### Claim 16 (depends on 14)

A process in accordance with claim 14, wherein said testing module is preconfigured to actuate a blocking by said release and blocking device wherein the release is activated subsequently only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry.

### Claim 17 (depends on 14)

A process in accordance with claim 14, wherein said access module or acceptability memory is dynamically updated by synchronization with a central server and/or by installing updated entries via an interface and/or a network connection.

### Claim 18 (depends on 14)

A process in accordance with claim 14, the medical device includes a medical device program memory or the system of medical devices includes at least one medical device program memory wherein said access module or acceptability memory is separated from said medical device program memory or said at least one medical device program memory.

### Claim 19 (depends on 14)

A process in accordance with claim 14, wherein said access module or acceptability memory comprises a secured memory in which additions, changes and/or deletions can be executed in an authenticated form only.

### Claim 20

A computer program product, wherein the computer program product comprises a computer program, which is stored in a memory of a computer, or and which comprises commands readable by the computer, for use with a medical device comprising a plurality of components, each of said components comprising a microprocessor and an executable program, wherein said executable program may be installed in different program versions on the respective component and wherein said executable program installed on the respective component can be replaced and/or changed independently from one another, and with a testing system comprising:
an access module or an acceptability memory provided for the medical device or for the system of medical devices, said access module or acceptability memory storing entries for all acceptable combinations of program versions for the executable programs of said components;
a release and blocking device provided on the medical device or on each medical device of the system of medical devices, said release and blocking device controlling the initiation of operation of the medical device or each medical device of the system of medical devices or controlling the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices;
a testing module provided for the medical device or for the system of medical devices detecting all program versions of all currently installed programs automatically as an actual state of the medical device or each medical device of the system of medical devices and checking said access module or acceptability memory as to whether the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry and to activate a release by said release and blocking device to allow initiation of operation of the medical device or each medical device of the system of medical devices or to allow the initiation of operation of individual functions of the medical device or each medical device of the system of medical devices only if the detected actual state of the medical device or each medical device of the system of medical devices exists as an acceptable state in the acceptability memory as an entry, the computer program product comprising commands for carrying out the process comprising the steps of:
providing access to the access module or the acceptability memory;
automatically detecting all versions of all currently installed programs on all components of the medical device or system of medical devices as an actual state of the device;
testing to determine whether the detected actual state of the device is acceptable by accessing the access module or an acceptability memory; and
activating a release by said release and blocking device.
