Certification apparatus and method for a medical device computer

Abstract

Provided herein are methods and apparatuses for certifying computers for use in conjunction with medical devices. These methods may be used in conjunction with a computer that includes software for operating the medical device. To certify a particular computer, one or more testing algorithms or routines for processing data, e.g., data representative of a typical output generated by use of the medical device on a patient, may be executed and the results may be compared to an expected result. In particular embodiments, the certification process may use data stored on the device itself to determine certification or may use data stored with or bundled with the software for operating the device.

What is claimed is: 
     
         1 . A physiological sensor, comprising:
 a light emitter;   a light detector;   a memory element storing information representative of a measurement data output of the light detector and information related to one or more computer compatibility specifications; and   a cable coupled to the light emitter and the light detector and configured to couple to a general purpose computer.   
     
     
         2 . The physiological sensor of  claim 1 , wherein the information representative of the measurement data output is stored as an analog signal. 
     
     
         3 . The physiological sensor of  claim 1 , wherein the sensor comprises a pulse oximetry sensor. 
     
     
         4 . The physiological sensor of  claim 1 , wherein the memory element is disposed on or in the cable. 
     
     
         5 . The physiological sensor of  claim 1 , wherein the information representative of the measurement data output is generated by a second detector not associated with the physiological sensor. 
     
     
         6 . The physiological sensor of  claim 1 , wherein the information related to one or more computer compatibility specifications comprises software version information. 
     
     
         7 . The physiological sensor of  claim 1 , wherein the cable is configured to couple to the general purpose computer via a USB connector. 
     
     
         8 . A system, comprising:
 a sensor comprising a memory element storing first information related to one or more computer compatibility specifications and second information representative of a measurement data output of the sensor; and   a computer configured to couple to the sensor and comprising a processor configured to execute routines for:   accessing the first information from the memory element determining if the computer is compatible with the sensor based on the first information;   accessing the second information only when the computer is compatible with the sensor;   generating simulated medical information from the second information;   comparing the simulated medical information to an expected result; and   determining a certification of the computer to generate medical information from the sensor based on the comparison.   
     
     
         9 . The system of  claim 8 , comprising determining one or more physiological parameters from a measurement signal generated by the sensor only if the computer is certified to generate medical information. 
     
     
         10 . The system of  claim 8 , comprising stopping or exiting routines for processing a measurement signal from the medical device if the simulated medical information deviates from the expected result. 
     
     
         11 . The system of  claim 8 , comprising displaying an indication related to the certification on a display. 
     
     
         12 . The system of  claim 8 , wherein the sensor comprises a pulse oximetry sensor. 
     
     
         13 . The system of  claim 8 , wherein the simulated medical information comprises a plethysmographic waveform, a heart rate, or an oxygen saturation value. 
     
     
         14 . The system of  claim 8 , wherein the second information is stored as an analog signal. 
     
     
         15 . The system of  claim 8 , wherein the second information is data collected from a test device. 
     
     
         16 . The system of  claim 8 , wherein the second information is simulated data. 
     
     
         17 . A method, comprising:
 using a computer coupled to a sensor comprising a memory element storing first information related to one or more computer compatibility specifications and second information representative of a measurement data output of the sensor to:   access the first information from the memory element;   determine if the computer is compatible with the sensor based on the first information;   access the second information only when the computer is compatible with the sensor;   generate simulated medical information from the second information;   compare the simulated medical information to an expected result; and   determine a certification of the computer to generate medical information from the medical device based on the comparison.   
     
     
         18 . The method of  claim 17 , comprising using the computer to determine one or more physiological parameters from a measurement signal generated by the sensor only if the computer is certified to generate medical information. 
     
     
         19 . The method of  claim 17 , comprising using the computer to stop or exit routines for processing a measurement signal from the medical device if the simulated medical information deviates from the expected result. 
     
     
         20 . The method of  claim 17 , comprising using the computer to generate an output that the computer is not compatible with the sensor if the specification requirements do not match the specifications of the computer.