| US 7,465,301 B2 | ||
| Systems and methods for monitoring and controlling use of medical devices | ||
| Robin Bek, Campbell, Calif. (US); John Gaiser, Mountain View, Calif. (US); Jay Qin, Fremont, Calif. (US); and David S Utley, Redwood City, Calif. (US) | ||
| Assigned to Respiratory Diagnostic, Inc., Redmond, Wash. (US) | ||
| Filed on Oct. 27, 2004, as Appl. No. 10/974,454. | ||
| Application 10/974454 is a division of application No. 09/974750, filed on Oct. 10, 2001, granted, now 6,827,713. | ||
| Application 09/974750 is a continuation of application No. 09/495390, filed on Jan. 31, 2000, abandoned. | ||
| Prior Publication US 2005/0070978 A1, Mar. 31, 2005 | ||
| This patent is subject to a terminal disclaimer. | ||
| Int. Cl. A61B 18/18 (2006.01) | ||
| U.S. Cl. 606—34 [606/41] | 7 Claims |
| 1. A system for controlling use of a device for treating a tissue region comprising
a device for treating a tissue region, the device having an identification code uniquely assigned to the device,
a controller to control operation of the device, the controller including non-volatile memory,
a reader to download information to the controller,
the controller including in the non-volatile memory a use table registering all identification codes downloaded by the reader
to the controller,
a usage key card not connected to the device and 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 comprising the identification code uniquely assigned
to the device that, upon reading by the reader, is downloaded to the controller,
a kit containing the device and the usage key card packaged together in a sterile fashion within a peripherally sealed environment
that is adapted to be opened at an instance of first use,
the controller including a matching function that compares the identification code downloaded from the usage key card, which
is uniquely assigned to the device, to all identification codes registered in the use table to determine either an absence
of a match or a presence of a match, in the absence of the match, the matching function operating to update the use table
by registering the identification code downloaded from the usage key card and enabling use of the device, in the presence
of the match, the matching function operating not to update the use table and also operating to disable use of the device,
the controller maintaining for each identification code registered in the use table a time record with a prescribed maximum
time period of permitted use, the controller including a use monitoring function that enables continued operation of the device
only if the prescribed maximum time period has not been equaled or exceeded and prevents continued operation of the device
if the maximum time period has been equaled or exceeded.
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