Systems and methods for monitoring and controlling use of medical devices
First Claim
1. A kit for use with a system comprising a controller to control operation of a device for treating a tissue region and a reader to download information to the controller for controlling use of the device, the controller including a first data state prior to downloading of an identification code and a processing means for processing the identification code and enabling operation of the device if the identification code correlates in a pre-established manner with the first data state, the processing means operating, in response to enabling operation of the device, to change the first data state to a second data state that prevents subsequent operation of the device in response to downloading of the identification code, the kit comprisingthe device for treating a tissue region, a usage key card to be handled separate from the device comprising a storage medium formatted to contain the identification code, the identification code being unique to the usage key card, the usage key card being adapted to be read by the reader separate from the device to download the identification code for processing by the controller, and packaging for containing the device and the usage key card.
6 Assignments
0 Petitions
Accused Products
Abstract
A device for treating a tissue region is supplied with a separate usage key card. The usage key card comprises a storage medium, which is formatted to contain an identification code unique to the usage key card. The usage key card is adapted to be read by a remote reader, to download the identification code for processing by a controller for the device. Processing of the identification code by the controller either enables or disables operation of the device according to prescribed criteria.
145 Citations
21 Claims
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1. A kit for use with a system comprising a controller to control operation of a device for treating a tissue region and a reader to download information to the controller for controlling use of the device, the controller including a first data state prior to downloading of an identification code and a processing means for processing the identification code and enabling operation of the device if the identification code correlates in a pre-established manner with the first data state, the processing means operating, in response to enabling operation of the device, to change the first data state to a second data state that prevents subsequent operation of the device in response to downloading of the identification code, the kit comprising
the device for treating a tissue region, a usage key card to be handled separate from the device comprising a storage medium formatted to contain the identification code, the identification code being unique to the usage key card, the usage key card being adapted to be read by the reader separate from the device to download the identification code for processing by the controller, and packaging for containing the device and the usage key card.
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10. A system for controlling use of a device for treating a tissue region comprising
a controller to control operation of the device, a reader to download information to the controller, a usage key card adapted to be handled separate from the device and comprising a storage medium formatted to contain an identification code unique to the usage key card that, upon reading by the reader, is downloaded to the controller, and the controller including a first data state prior to downloading of the identification code and a processing means for processing the identification code and enabling operation of the device if the identification code correlates in a pre-established manner with the first data state, the processing means operating, in response to enabling operation of the device, to change the first data state to a second data state that prevents subsequent operation of the device in response to downloading of the identification code.
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16. A method for controlling use of a device for treating a tissue region comprising the steps of
providing a kit containing the device and a usage key card adapted to be handled separate from the device and comprising a storage medium formatted to contain an identification code unique to the usage key card, instructing reading of the usage key card by a reader separate from the device to download the identification code to a controller for the device, the controller having a first data state prior to downloading of the identification code, causing the controller to process the identification code by pre-programmed rules to enable operation of the device if the identification code correlates with the first data state, and changing, according to pre-programmed rules, the first data state to a second data state in response to enabling operation of the device, the second data state preventing a subsequent operation of the device in response to downloading of the identification code.
Specification