Systems and methods for medical device testing

• US 8,788,236 B2
• Filed: 01/31/2011
• Issued: 07/22/2014
• Est. Priority Date: 01/31/2011
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Vij, Rohit, McClure, Douglas K., Ekaireb, Michael
• Primary Examiner(s): Le, John H
• Application Number:
  US13/017,311
• Publication Number:
  US 20120197580A1
• Time in Patent Office: 1,268 Days
• Field of Search: 702/24, 702/100, 702/104, 702/105, 702/113, 702/114, 702/119, 702/123, 128/200.24, 128/204.18, 128/204.21, 128/204.23, 128/205.18, 128/205.24
• US Class Current: 702/114
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/02 Equipment for testing the apparatus
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/435 partial O2 pressure (P-O2)
• CPC Class Codes: A62B 27/00 Methods or devices for testing respiratory or breathing apparatus for high altitudesapparatus for testing gastightness in general G01M
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

The systems and methods for testing a medical device, as described herein, provide a novel approach for determining if the medical device is functioning properly without having to connect the medical device to a patient. For example, these systems and methods test the functionality of a medical device without utilizing an artificial lung or controlling pressure and flow monitored by the medical device and without making any hardware changes to the medical device.

Claims

1. A medical ventilator, the medical ventilator comprising:

a breath delivery system, the breath delivery system includes hardware components that control gas flow from a gas supply to a patient and control ventilator parameters,

wherein the hardware components include at least one sensor, the at least one sensor monitors at least one of patient data and breath delivery system data to form monitored data;

a central processing unit that generates commands for the breath delivery system in response to at least one of received data and operator input; and

a software module, wherein the software module overwrites the monitored data sent by the breath delivery system, and further wherein the software module sends simulation data to the central processing unit and receives the response commands generated by the central processing unit in response to the simulation data.

2. The medical ventilator of claim 1, wherein the software module compares the response data to expected ventilator response data.

3. The medical ventilator of claim 1, wherein the simulation data sent by the software module to the central processing unit are based on simulation commands received from a testing device separate from the medical ventilator.

4. The medical ventilator of claim 3, wherein the software module sends the response commands to the testing device based on the simulation commands received from the testing device separate from the medical ventilator.

5. The medical ventilator of claim 1, wherein the ventilator response commands are rerouted to a testing device by the software module.

6. The medical ventilator of claim 1, wherein the software module controls communication from the central processing unit to the breath delivery system and a graphical operator interface.

7. A method for testing a medical device, the method comprising:

sending simulation commands to the medical device via a testing device electrically connected to the medical device;

receiving a medical device response to the simulation commands;

recording the medical device response to the simulation commands as response data on the testing device, wherein the response data includes commands for the medical device;

and comparing the response data to expected medical device response data.

8. The method of claim 7, wherein the simulation commands simulate at least one of a breath parameter, an alarm setting, a power supply, a gas supply, a flow sensor reading, a compressor sensor reading, a battery sensor reading, and an oxygen sensor reading.

9. The method of claim 7, further comprising:

determining that the response data are at least one of not within an acceptable range and not the same as the expected medical device response data based on the comparing step; and

displaying on the testing device a fail indicator.

10. The method of claim 7, further comprising:

determining that the response data are at least one of within an acceptable range and the same as the expected medical device response data based on the comparing step;

displaying on the testing device a pass indicator.

11. The method of claim 7, further comprising:

displaying on the testing device at least one of the response data and the simulation commands sent to the medical device.

12. The method of claim 7, wherein the simulation commands are ventilation scenarios.

13. The method of claim 7, further comprising:

receiving a selection of user selectable simulation commands.

14. The method of claim 7, wherein the medical device is not pneumatically connected to a patient and to an artificial lung.

15. The method of claim 7, wherein the medical device is selected from a group of a pulse oximeter, a ventilation system, and a capnograph.

16. A testing device comprising:

an electrical connection device of the testing device that is configured to electrically connect a medical device to the testing device;

a first software module on the testing device that interacts with a second software module on the medical device and sends simulation commands to the second software module on the medical device via the electrical connection device;

a medical device reader that receives response data from the second software module generated by the medical device in response to the simulation commands, wherein the medical device generates the response data by analyzing simulation data generated in response to the simulation commands as if the simulation data were monitored data derived from the hardware within the medical device, wherein the response data includes commands for the medical device; and

a determination module in communication with the medical device reader, the determination module is adapted to determine if the response data are at least one of within an acceptable range and the same as expected medical device response data.

17. The testing device of claim 16, further comprising a pass-fail indicator in communication with the determination module, wherein the pass-fail indicator executes a pass-fail notification.

18. The testing device of claim 16, further comprising a graphical user interface in communication with at least one of the first software module on the testing device, the medical device reader, and the determination module.

19. The testing device of claim 18, wherein the graphical user interface allows an operator to select the simulation commands.

20. The testing device of claim 19, wherein the simulation commands simulate ventilation scenarios.

21. The testing device of claim 16, wherein the medical device selected from a group of ventilation system, a pulse oximeter, and a capnograph.

22. A testing device comprising:

means for sending simulation commands to a ventilator system via the testing device electrically connected to the ventilator system;

means for receiving a ventilator system response to the simulation commands;

means for recording the ventilator system response to the simulation commands as response data on the testing device, wherein the response data includes commands for the ventilator system; and

means for comparing the response data to expected ventilator system response data.

23. A non-transitory computer-readable medium having computer-executable instructions for performing a method for testing ventilator system function, the method comprising:

repeatedly sending simulation commands to a ventilator system via a testing device electrically connected to the ventilator system;

repeatedly receiving a ventilator system response to the simulation commands;

repeatedly recording the ventilator system response to the simulation commands as response data on the testing device, wherein the response data includes commands for the ventilator system; and

repeatedly comparing the response data to expected ventilator system response data.