Certification apparatus and method for a medical device computer

• US 8,521,247 B2
• Filed: 12/29/2010
• Issued: 08/27/2013
• Est. Priority Date: 12/29/2010
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Wood, Lockett E.
• Primary Examiner(s): Winakur, Eric
• Assistant Examiner(s): Liu, Chu Chuan (JJ)
• Application Number:
  US12/980,971
• Publication Number:
  US 20120172687A1
• Time in Patent Office: 972 Days
• Field of Search: 600/310, 600/322, 600/323, 600/473, 600/476, 702/104, 702182-186, 382/115, 703 21- 22
• US Class Current: 600/323
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: G06F 8/60 Software deployment
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

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.

Claims

1. A computer, comprising:

a processor configured to be coupled to a medical device, wherein the processor is configured to execute routines for;

receiving an input representative of a medical device measurement data;

generating simulated medical information from the input;

comparing the simulated medical information to an expected result; and

determining a certification of the computer to generate medical information from the medical device based on the comparison.

2. The computer of claim 1, comprising stopping or exiting routines for processing a signal from the medical device if the simulated medical information deviates from the expected result.

3. The computer of claim 1, comprising displaying an indication related to the certification on a display.

4. The computer of claim 1, comprising accessing the input representative of the medical device from a memory associated with a medical sensor.

5. The computer of claim 1, comprising accessing the input representative of the medical device from a portable mass storage device.

6. The computer of claim 1, comprising accessing the input representative of the medical device from a memory of the computer.

7. The computer of claim 1, comprising providing information related to the certification to a regulatory agency.

8. The computer of claim 1, wherein the medical device comprises a pulse oximetry sensor.

9. The computer of claim 8, wherein the simulated medical device information comprises a plethysmographic waveform, a heart rate, or an oxygen saturation value.

10. A method, comprising:

using a computer to;

access a memory element associated with a medical device, wherein the memory element comprises stored information representative of a measurement data output of the medical device;

generate simulated medical information from the stored 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.

11. The method of claim 10, wherein the memory element further comprises stored specification requirements.

12. The method of claim 11, further comprising using the computer to compare the specification requirements to specifications of the computer.

13. The method of claim 12, comprising using the computer to generate an output that the computer is not compatible with the medical device if the specification requirements do not match the specifications of the computer.

14. The method of claim 10, comprising using the computer to generate an output that the computer is not compatible with the medical device if the simulated medical information deviates from the expected result.

15. The method of claim 10, comprising using the computer to prevent generating medical information from the medical device if the simulated medical information deviates from the expected result.