Systems and methods for monitoring and controlling use of medical devices

1. A system comprising

a device for treating a tissue region, and

a usage key card not connected to the device to be handled separate from the device comprising a storage medium formatted to contain an identification code uniquely assigned to the device, the identification code being unique to the usage key card, the usage key card being adapted to be read by a reader separate from the device, the storage medium being also formatted, when inserted into the reader, to retain data generated during operation of the device pertaining to operation of the device, the reader downloading the identification code to a controller to update a use table and register the identification code if not previously registered upon being downloaded to enable use of the device upon being registered.

2. A system according to claim 1

wherein the usage key card comprises a floppy disk.

3. A system according to claim 1

wherein the usage key card comprises a PC card.

4. A system according to claim 1

wherein the usage key card comprises a magnetic card.

5. A system according to claim 1

wherein the usage key card comprises flash memory.

6. A system according to claim 1

wherein the device applies radio frequency energy to the tissue region.

7. A system according to claim 1

wherein when the usage key card is inserted into the reader and the reader downloads the identification code to the controller the use table is not updated if the identification code is previously registered.

8. A system according to claim 1

wherein the storage medium contains at least first and second pre-formatted files, the first file containing the identification code and the second file containing operational and performance data.

9. A system according to claim 8

wherein the second file receives data generated by the controller during permitted use of the device.

10. A system according to claim 9

wherein the second file retains the data in a formatted array to create a procedure log.

11. A system according to claim 10

wherein the procedure log documents by date of treatment a magnitude of energy delivered by the device.

12. A system according to claim 10

wherein the procedure log documents by date of treatment a time duration of energy application.

13. A system comprising

a device for treating a tissue region; and

a storage medium associated with the device, the storage medium formatted to contain an identification code uniquely assigned to the device, the storage medium adapted to be read by a reader separate from the device for downloading the identification code to a controller to enable the controller to add to its registry the downloaded identification code if not already in its registry upon being downloaded to enable use of the device upon being added to its registry and to not add the identification code to its registry if already in its registry.

14. A system according to claim 13

wherein the storage medium contains at least first and second pre-formatted files, the first file containing the identification code and the second file containing operational and performance data.

15. A system according to claim 14

wherein the second file receives data generated by the controller during permitted use of the device.

16. A system according to claim 15

wherein the second file retains the data in a formatted array to create a procedure log.

17. A system according to claim 16

wherein the procedure log documents by date of treatment a magnitude of energy delivered by the device.

18. A system according to claim 16

wherein the procedure log documents by date of treatment a time duration of energy application.