Systems and methods for simulation and software testing

• US 8,676,529 B2
• Filed: 01/31/2011
• Issued: 03/18/2014
• Est. Priority Date: 01/31/2011
• Status: Expired due to Fees

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Vij, Rohit, Ekaireb, Michael, McClure, Douglas K.
• Primary Examiner(s): Raymond, Edward
• Application Number:
  US13/017,277
• Publication Number:
  US 20120197578A1
• Time in Patent Office: 1,142 Days
• Field of Search: 702/113, 702/117, 702/118, 702182-185
• US Class Current: 702/113
• 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 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/8206 battery-operated
• 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
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

This disclosure describes systems and methods for testing a medical device. The disclosure describes a novel approach determining if the ventilator system is functioning properly without having to connect the medical device to a patient.

Claims

1. A ventilator-testing device system comprising:

a ventilator system, the ventilator system including;

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 and sends response data in response to at least one of the monitored data and operator input, wherein the response data includes commands for the breath delivery system; and

a software module, wherein the software module sends simulation data based on received simulation commands to the central processing unit instead of the monitored data sent by the breath delivery system to the central processing unit and receives the response data generated by the central processing unit in response to the simulation data; and

a testing device, the testing device including;

a ventilator electrical connection device that electrically connects the ventilator system to the testing device;

a controller on the testing device that interacts with the software module on the ventilator system and sends the simulation commands to the software module via the ventilator electrical connection device;

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

a compare module in communication with the ventilator system reader, the compare module compares the response data with expected ventilator system response data.

2. A method for testing a ventilator system, the method comprising:

sending simulation commands from a simulation system via a software module to a central processing unit on a ventilator system, thereby causing the central processing unit to generate response data and transmit the response data to a controller on the ventilator system;

sending an overwrite command that causes the software module to overwrite at least one of monitored data sent to the central processing unit from a breath delivery system and operator input with simulation data based on the simulation commands;

intercepting the response data, prior to delivery of the response data to the controller, from the central processing unit based on the simulation commands via the software module;

and

rerouting the response data to the simulation system via the software module based on the simulation commands.

3. The method of claim 2, wherein the simulation commands simulate at least one of a breath parameter, an alarm setting, a power supply, a gas supply, a compressor sensor reading, a flow sensor reading, a battery sensor reading, and an oxygen sensor reading.

4. The method of claim 3, wherein the breath parameter simulates at least one of a cough and a hiccup from a patient.

5. The method of claim 2, wherein the simulation commands simulate a ventilator scenario.

6. The method of claim 5, wherein the ventilator scenario simulates severe occlusion in a circuit.

7. The method of claim 5, wherein the ventilator scenario simulates high exhaled flow.

8. The method of claim 7, wherein the ventilator scenario simulates out of range autozero pressures.

9. The method of claim 2, further comprising recording the response data on the simulation system.

10. The method of claim 9, further comprising comparing the response data to expected ventilator system response data.

11. The method of claim 10, further comprising:

determining that the response data is at least one of within an acceptable range and the same as the expected ventilator system response data based on the comparing step; and

displaying a pass indicator.

12. The method of claim 10, further comprising:

determining that the response data is at least one of not within an acceptable range and not the same as the expected ventilator system response data based on the comparing step; and

displaying a fail indicator.

13. The method of claim 10 further comprising:

displaying the response data on the simulation system.

14. The method of claim 2, further comprising:

displaying the sent simulation commands on the simulation system.

15. The method of claim 2, further comprising:

receiving a selection of user selectable simulation commands from a graphical user interface on the simulation system.

16. The method of claim 2, wherein the software module further controls communication between the central processing unit and a graphical operator interface.

17. A system for simulating sensor data for testing a ventilator system comprising:

means for sending simulation commands from a simulation system via a software module to a central processing unit on a ventilator system, thereby causing the central processing unit to generate response data and transmit the response data to a controller on the ventilator system, wherein the response data includes commands for a breath delivery system;

means for sending an overwrite command that causes the software module to overwrite at least one of monitored data sent to the central processing unit from the breath delivery system and operator input with simulation data based on the simulation commands, wherein the monitored data includes sensor output;

means for intercepting the response data, prior to delivery of the response data to the controller, from the central processing unit based on the simulation commands via the software module;

and

means for rerouting the response data to the simulation system via the software module based on the simulation commands.

18. A computer-readable medium having computer-executable instructions for performing a method for simulating sensor data for testing a ventilator system, the method comprising:

repeatedly sending simulation commands from a simulation system via a software module to a central processing unit on a ventilator system, thereby causing the central processing unit to generate response data and transmit the response data to a controller on the ventilator system, wherein the response data includes commands for a breath delivery system;

repeatedly sending an overwrite command that causes the software module to overwrite at least one of monitored data sent to the central processing unit from the breath delivery system and operator input with simulation data based on the simulation commands, wherein the monitored data includes sensor output;

repeatedly intercepting the response data, prior to delivery of the response data to the controller, from the central processing unit based on the simulation commands via the software module; and

repeatedly rerouting the response data to the simulation system via the software module based on the simulation commands.