SYSTEMS AND METHODS FOR TESTING PATIENT MONITORS

• US 20140275872A1
• Filed: 03/11/2014
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Abandoned Application

• Current Assignee: Masimo Corporation
• Original Assignee: Cercacor Laboratories
• Inventors: Merritt, Sean, Chen, Jesse, Lamego, Marcelo M., Pauley, Kevin, Paul, Justin Mathew
• Application Number:
  US14/204,708
• Publication Number:
  US 20140275872A1
• Time in Patent Office: Days
• US Class Current: 600/322
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: G01N 21/278 Constitution of standards

Abstract

A quality control system for patient monitors is disclosed. The quality control system can include a quality check insert having optical properties. In an embodiment, the insert is placed within a sensor, irradiated with light, and then the light is detected after attenuation by the insert. The detected light is processed using the same or different processing methodologies typically used to determine measurement values for physiological parameters of a monitored patient. When a patient monitor is functioning properly, the results of the processing provide values within a predetermined range of values. When the patient monitor is not functioning properly, the results of the processing provide values outside the predetermined range of values. The quality control system can include quality control parameters indicative of a properly functioning active pulse motor of the sensor, emitters of the sensor, detectors of the sensor, accelerometers of the sensors, and/or temperature sensors of the system.

Claims

1. A quality control system comprising:

a noninvasive optical sensor configured to detect light attenuated by body tissue of a patient and output a detector signal responsive to the detected light;

a patient monitor configured to process the detector signal to determine measurement values for one or more physiological parameters of the patient; and

an insert shaped generally to mechanically mate with surfaces of the optical sensor, the insert having optical properties, wherein when the insert is properly placed within the sensor and irradiated by the sensor, the monitor processes detector signals, wherein the patient monitor provides display indicia indicative of whether the processed detector signals generate values within a predetermined range of values, the predetermined range associated with the optical properties of the insert.

2. The quality control system of claim 1, wherein the insert has at least one of a color indicator or a symbol indicator corresponding to verification data.

3. The quality control system of claim 2, wherein the verification data comprises ranges of data.

4. The quality control system of claim 1, wherein the optical properties of the insert are at least in part due to light absorbing constituents suspended within a body of the insert.

5. The quality control system of claim 1, wherein the display indicia includes indicia indicating a quality pass or fail.

6. The quality control system of claim 1, wherein the processing by the monitor comprises processing detector signals when the insert is placed in the sensor is similar to processing detector signals when tissue is placed in the sensor.

7. A quality control system comprising:

a noninvasive optical sensor configured to detect light attenuated by body tissue of a patient and output a detector signal responsive to the detected light;

a patient monitor configured to process the detector signal to determine measurement values for one or more physiological parameters of the patient; and

an insert shaped generally to engage with surfaces of the optical sensor, the insert having optical properties, wherein when the insert is properly placed within the sensor and attenuates light emitted by the sensor, the monitor processes detector signals, wherein the patient monitor determines whether a processed detector signal generates a transmittance value within a predetermined transmittance range of values, the predetermined transmittance range associated with the optical properties of the insert.

8. The quality control system of claim 7, wherein the patient monitor generates at least one of a visual indicia or an audible indicia indicating a quality pass or fail.

9. The quality control system of claim 7, wherein when the insert is properly placed within the sensor and attenuates light emitted by the sensor, the patient monitor determines whether an electric current draw of one or more light emitters of the sensor to generate a desired level of light intensity is within a predetermined current range of values, and wherein when the electric current draw is not within the predetermined current range of values, at least one of the light emitters of the sensor is determined to have failed.

10. The quality control system of claim 7, wherein when the insert is properly placed within the sensor and attenuates light emitted by the sensor, the monitor processes the detector signal, wherein the patient monitor determines whether a gain level of the detector signal to generate a desired level of signal intensity is within a predetermined gain range of values, wherein the detector signal is associated with one or more detectors of the sensor, and wherein when the gain level is not within the predetermined gain range of values, at least one of the detectors of the sensor is determined to have failed.

11. The quality control system of claim 7, wherein when the insert is properly placed within the sensor, the patient monitor determines whether a rotation frequency of an active pulse motor of the sensor is within a predetermined frequency range of values, and wherein when the rotation frequency of the active pulse motor is not within the predetermined frequency range of values, the active pulse motor is determined to have failed.

12. The quality control system of claim 7, wherein the monitor processes the detector signals, and wherein the patient monitor determines whether a noise level associated with the detector signals is within a predetermined noise level range of values.

13. The quality control system of claim 7, wherein the patient monitor determines whether values generated by an acceleration signal associated with an accelerometer of the sensor are within a predetermined acceleration range of values, and wherein when the sensor is not moved and the values generated by the acceleration signal associated with the accelerometer are not within the predetermined acceleration range of values, the accelerometer is determined to have failed.

14. The quality control system of claim 7, wherein the patient monitor determines whether values generated by a temperature signal associated with a temperature sensor of the sensor are within a predetermined temperature range of values, and wherein when ambient temperature is within an ambient temperature range corresponding to the predetermined temperature range of values and the values generated by the temperature signal associated with the temperatures sensor are not within the predetermined temperature range of values, the temperature sensor is determined to have failed.

15. A quality control insert for quality control testing of a noninvasive patient monitor, the quality control insert comprising:

a body comprising light absorbing constituents having optical properties, the body configured to mate with a noninvasive optical sensor of a patient monitor configured to determine one or more physiological parameters of a patient,

wherein the optical properties are associated with the light absorbing constituents attenuating light at predetermined light absorption values based on wavelengths of the light when the body of the insert is irradiated by the sensor.

16. The quality control insert of claim 15, wherein the light absorbing constituents are suspended in the body of the insert.

17. The quality control insert of claim 15, wherein the body of the insert comprises features configured to place the body in the sensor at a predetermined position and help retain the body in the sensor at the predetermined position.

18. The quality control insert of claim 15, wherein the body comprises an emitter outline for aligning the emitter outline with emitters of the sensor.

19. The quality control insert of claim 15, further comprising bumpers configured to aid in positioning the body in the sensor at a predetermined position.

20. The quality control insert of claim 15, wherein the bumpers comprise a stop configured to inhibit insertion of the body into the sensor beyond the predetermined position

21. The quality control insert of claim 15, wherein the body comprises an indentation that mirrors a bump of the sensor, the bump housing light detectors of sensor, the indentation mating with the bump when the body is inserted into the sensor at a predetermined position.

22. The quality control insert of claim 15, wherein the body comprises a knob for holding the quality control insert during placement and alignment of the body in the sensor.