X-ray or gamma ray systems or devices – Accessory – Testing or calibration
Reexamination Certificate
1998-12-15
2001-03-13
Bruce, David V. (Department: 2876)
X-ray or gamma ray systems or devices
Accessory
Testing or calibration
C378S065000, C702S183000
Reexamination Certificate
active
06200025
ABSTRACT:
RESERVATION OF COPYRIGHT
A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, as it becomes available to the public, but otherwise reserves all copyright rights whatsoever.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to calibration of radiation devices, and more particularly to the automated specification testing, checking and calibration of radiation therapy devices for use in the oncology field.
2. Description of the Related Art
System calibration methods presently in use for specification testing, checking and calibration of radiation devices are cumbersome and error prone. In such known systems, measurement data is typically recorded by hand and is reviewed several times to verify the accuracy and completeness of the data. Scan data collection is accomplished through manual control of the radiation therapy devices using scanning equipment which requires each scan to be manually initiated.
The radiation therapy device settings are manually keyed into the scanning equipment software, and verification of the data entry is accomplished through a review of the scan printouts. Finally, the results of the analysis of the scan are manually recorded. The scenario outlined above applies to most clinical setting. Similar tasks are performed on a routine basis to verify proper operation of the radiation therapy devices.
A system calibration department of a medical device manufacturer is typically responsible for verifying that the radiation therapy device interlocks are operational and calibrated according to various machine parameters to ensure that the therapy device meets all performance specifications. The work performed by the system calibration department is documented in the DHR. The section of the DHR completed currently includes several pages that are filled out by hand. This procedure used may be broken into two main sections, pre-test and the radiation test.
The various machine interlocks are tested as part of the pre-test section. Typically a fault condition is simulated and the test technician verifies that an interlock trips. The fault condition is then removed and the test technician verifies that the interlock clears. The test technician then records his initials and the date in the appropriate section of the DHR.
The radiation test consists of testing to ensure that the machine meets its performance specifications. Several components of the radiation therapy devices need to be aligned as part of this procedure. These include the bending magnet, defining head jaws, flattening filters, and the light field. Typically rough scans are performed and adjustments are made to correct any alignment errors. Once the alignment is correct, a series of final scans are made and recorded as part of the DHR to document the machine performance. There are also several machine parameters that are calibrated as part of this procedure. These parameters affect the stability and intensity of the beam. They are calibrated using external equipment, such as oscilloscopes, multi-meters, and the scanning equipment. Once the alignment and calibration is complete, any remaining performance specifications are tested to ensure that the machine is operating properly. These include specifications such as rotational treatments and leakage measurements. Machine configuration information, machine parameters, and test equipment used are recorded as part of the DHR.
To this end, it would be desirable to provide a system for automatically collecting all information required for the device history records, which allows the information to be stored in a database. It would be further desirable to eliminate the human user interface in a calibration and testing system while performing a number of tests on the radiation devices. Accordingly, after the radiation device being tested is turned on by the user, the system may then perform the necessary programming via a communications network to carry out a series of tests and calibration checks. Accordingly, the package should allow the technicians to quickly and accurately record all data required for machine calibration, and allow information to be available on the company intranet or the like for access from remote locations.
SUMMARY OF THE INVENTION
In a described embodiment, linear accelerator based radiation therapy devices may be programmed via a communications network to facilitate automated specification testing, checking, calibration and integrated analysis of radiation therapy devices. Information is collected from individual radiation devices using dosimetry scanners operable with a client user interface in communication with a system calibration server. The radiation therapy devices are responsive to the client user interface for undergoing an operation sequence with dosimetry scanner performing a series of tests.
The radiation device may be operated automatically via the network in accordance with the series of tests performed by the dosimetry scanner. Document templates retrievable with the client user interface may be used for creating the device history records for the radiation devices. The document templates provide a user interface format including check lists, prompting, semi-automatic or automatic information collection with the radiation device undergoing operation sequences without manual activation of the radiation device by the user. Programming of the radiation device in the operation sequence of the testing commands is generated in accordance with a plurality of tests performed by the dosimetry scanner during which the radiation device may generate radiation.
The design of the system allows quality assurance data to be collected efficiently and accurately. This is accomplished through verification of manual data entry, automated control of the scanning equipment, automated analysis of the data collected by the scanning equipment and integrated control of the radiation therapy devices. The design also provides the flexibility to make changes to the data format easily through the use of document templates. A DHR template located on the server is used to create all new DHRs, allowing changes to the DHR format to be quickly and easily implemented. When a DHR is completed, the package notifies Document Control and the database becomes “frozen,” disallowing any further modifications.
The automation capabilities offered by the described software package provide integrated control of both the radiation therapy devices and the scanning equipment, as well as automated analysis capabilities. This allows scan sequences to be performed automatically with verification of analysis results after each scan. It also allows data to be collected efficiently and consistently. Template based data layout allows the package to be used in various applications without modification. Modular design allows additional functionality to be added as needed for custom applications to collect all information that would normally be provided as part of the DHR.
DHR information is stored in a database located on the system calibration server, which allows technicians to quickly and accurately record all data required for machine calibration. The data may be made available on the company intranet allowing users to access the information from remote locations. A DHR template located on the server may be used to create all new DHRs to facilitate changes in the format to be quickly and easily implemented. A separate database is maintained for each DHR, and completed DHRs can be archived regularly.
Briefly summarized, the present invention relates to a system and method for automated specification testing and checking using integrated analysis of collected system calibration information. A network interface couples the radiation devices to the network, and databases of device history records an
Bruce David V.
Dunn Drew A.
Siemens Medical Systems Inc.
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